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BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Acknowledgements/ Feedback Congratulations to BioSpectrum Asia on
executing the awards. Inspiring to see the
Thank you BioSpectrum Asia for putting various life sciences innovations and their
together a memorable evening and to real impact. Looking forward to the next
all the old and new faces that attended batch!
the annual Excellence Awards event in
Singapore on December 2, 2022. I am - Christopher Hardesty,
looking forward to see the digital health Singapore
and life science industries continue
to grow strong in 2023 and to further Congratulations for the BioSpectrum
contribute to them. Asia Excellence Awards 2022 event and
thank you for recognising the life sciences
- Dr Dario Heymann, Singapore ecosystem in Taiwan. Looking forward to
working together for Bio Asia Taiwan in
Thank you BioSpectrum Asia for creating 2023.
a platform for the life sciences industry
and giving them this recognition in the - Dr Wallace Lin, Taiwan
form of BioSpectrum Asia Excellence
Awards.

- Xinyi Tow, Singapore

Vol 18; Issue 1; January 2023 MM Activ Singapore Pte. Ltd. Taiwan
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BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Ravindra Boratkar Letter from Publisher
Publisher &
Dear Readers,
Managing Editor, I wish A Very Happy and Prosperous New Year to all our readers and
MD, MM Activ Sci-Tech
Communications Pvt. Ltd. advertisers.
As you may be aware that for BioSpectrum Asia, the Year 2022 concluded on a

very positive and constructive note with the successful launch of the BioSpectrum
Asia Excellence Awards 2022. I am sure that you all must have read a detailed
report of the awards presentation ceremony held in Singapore.

This is just the beginning. BioSpectrum Asia wishes to make the awards
presentation an annual affair. We also wish to develop relationships with local
organisations and associations to plan more different types of programmes in the
region.

As we all are welcoming 2023, BioSpectrum Asia is also welcoming the new
year in a different way. It is encapsulating some of the leading 23 trends in the
life sciences sector expected to be witnessed in 2023. Some of these trends are
extensions of the trends observed during the previous years that will continue to
dominate 2023 too. On the healthcare front, 2023 is expected to see the rise of
smart hospitals. Global turbulences like war and recession are expected to impact
the APAC life sciences industry. The question is by how much and for that we will
have to wait and watch.

Our editorial team has gathered experts’ views and jotted down 23 of the key,
projected trends for 2023. So, which exactly are those trends? You will have to turn
the pages and discover them in the cover section. I am sure you will be interested
in reading them as they may have some bearing on your respective businesses and
may help you plan your business strategy for this year in a better way.

In addition, this issue also has articles on what’s new in Genome technologies
and its varied applications, another important area of rapid development in life
sciences. I am sure this informative content will not only add to your information
about Genome tech, but also will make an interesting reading on a relatively dry
and complicated subject.

I am sure that a new year issue full of rich content will keep you engaged in
reading and contemplating for a considerable part of the month.

Once again, wish you best for 2023.
Thanks & Regards,

Ravindra Boratkar

Publisher & Managing Editor

wishes its Readers, Contributors,
Advertisers and Associates

Happy, Healthy & Prosperous New Year 2023

6 BIO CONTENT

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

COVER STORY 19

23

Life Sciences

Trends to Watch

for in 2023

The past two years have been a rollercoaster ride for the global economy and the pharma
industry hasn’t been impervious to the major financial upheavals either. Yes, it’s the Pandemic
and Post-Pandemic world that’s been influencing people from all walks of life and industries,
alike. Buzzwords notwithstanding, we do have to thank the pandemic situation that forced all
stakeholders to innovate and pool the best and brightest resources to keep the Life Sciences
industry thriving. While all other industries either lost steam in their growth plans, pharma boomed,
not unlike the Phoenix rising from the ashes. It is this streak of resilience and growth that we want
industry insiders to comment on. With curtains down for 2022, it’s time to look to the new year
without the trepidation of the looming ‘Great Reset’. On an upbeat note, BioSpectrum brings you
23 trends and projections for 2023 that could reshape and influence our collective future.

26

HTAs, CGT Set to
Rule Life Sciences
Industry in 2023

Jeff Weisel,
Managing Director,
PRMA Consulting APAC,
part of Fishawack Health, UK

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Asia
Too Much Of A Good Thing… Digizine

SPEAKING WITH ARTIFICIAL INTELLIGENCE

31 40

“Crovalimab could potentially AI: Tremendous Potential to
become the first global drug Transform Bioprocessing Efficiencies
originating from Singapore”
Ruplekha Choudhurie,
Dr Hisafumi Yamada, Senior Industry Analyst/Team Lead
Executive Vice President (R&D), (Health & Wellness), TechVision, Frost & Sullivan
Chugai Pharmaceutical
AMR
33
42
“Innovations that serve a purpose,
paired with a good go-to-market Broad-impact Tech
strategy are attractive for VCs” Against AMR Threat

Audrey Lok, Dr Peter Dedon,
Director, Healthcare and Biomedical, Co-Lead Principal Investigator, SMART AMR,
EnterpriseSG Singapore, and Singapore Professor of
Biological Engineering, MIT, USA
35
REGULARS
“Our ambition requires us to take
long-term view, investing in scale BioMail. ................................................................................. 04
& building unmatched capabilities” BioEdit. .................................................................................. 08
Policy and Regulatory News.............................................09
Dr Ben Hindson, Finance News......................................................................11
President & Co-Founder, Company News...................................................................12
10x Genomics Start-Up News.....................................................................14
World News..........................................................................16
37 WHO News...........................................................................18
Academics News................................................................44
“We are seeing activity People News........................................................................45
within biotherapeutics R&D News.............................................................................47
market in Southeast Asia” Supplier News......................................................................49
Lets Talk Health...................................................................50
Jason Neo,
Director, Marketing J-KOSEA,
SCIEX, Singapore

GENOMIC RESEARCH

38

Propelling Genomic Research with
Future-Proof Digital Infrastructure

Eric Hui,
Director, IoT Ecosystems Development,
Equinix Asia-Pacific

8 BIO EDIT

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Dr Milind Kokje FOOLED ME TWICE?

Chief Editor In yet another blow to the Indian pharma sector, Nepal has black listed 16 Indian
pharma companies, including the one that produces yoga guru Baba Ramdev’s
[email protected] Patanjali brand of products. The drug regulatory authority of the neighbouring
country has also asked the local distributors of those companies to recall the medicines
supplied by their companies. This comes after the much publicised spurious medicine
notification by the World Health Organisation (WHO) in Gambia, Africa which was
resolved in favour of the Indian company after examining the medicine sample.

The drug authority of Nepal inspected, between April and July, the production
facilities of the Indian companies supplying drugs to them. The regulators found, during
inspection, that the companies were not complying with the production standards set by
the WHO, exact details of which are not forthcoming. In some cases, even the products
of some companies did not comply with regulatory requirements. As a result, the notices
were issued and the import from these companies was stopped. Nonetheless, there’s a
possibility that such moves could end up tarnishing the image of Indian pharma prowess
in the eyes of other nations, a larger impact to our economy.

Some of the companies that are blacklisted include Radiant Parenterals Ltd,
Mercury Laboratories Ltd, Alliance Biotech, Captab Biotec, Aglowmed Ltd, Zee
Laboratories, Daffodils Pharmaceuticals, GLS Pharma, Unijules Life Science, Concept
Pharmaceuticals, Shree Anand Life Sciences, IPCA Laboratories, Cadila Healthcare
Ltd, Dial Pharmaceuticals and Mackur Laboratories, among others. Divya Pharma is
another company which produces Baba Ramdev’s Patanjali products.

Black listing of 16 Indian pharma companies is another dent into the $42 billion
pharma sector’s reputation as a supplier of quality medicines in just three months. When
the Indian pharma sector is earning a good name as the world’s pharmacy, maintaining
standards in such a situation is of utmost importance. But, that does appear to be
happening in the case of some companies. Or, there might be malicious elements involved,
with a focused goal of maligning the good name and prowess of Indian pharma.

Complying with WHO’s manufacturing standards and quality production are
particularly important now as some other countries are trying to capture conventional
generics. Just recently, Pharmexcil has warned that China, Vietnam, Indonesia
and Bangladesh are competing with India to capture the market. Pharmexcil names
Indonesia and Vietnam as the most likely contenders.

Another challenge for Indian pharma is the low growth of the generic market. From
2016 to 2020 the global generic market grew only at a CAGR of 2 per cent. By some estimate,
in 2021, there was no growth at all. Though that did not affect India’s performance, as its
generic export grew at 9 per cent in the last five years. But it is important to note here
that India’s pharma exports mainly depend on the growth of the global generic market.
Pharmexcil has suggested that Indian pharma companies must develop high-technology
& scientific products & capture the market of complex generics & biosimilar products.

This is a very crucial time for Indian companies to ensure quality. Though it is true
that a large number of companies generally comply with norms, a few which do not,
bring disrepute to the entire sector. In Nepal itself, as the drug regulator published a list
of 16 companies for non-compliance to manufacturing norms, it has also published a list
of 46 companies that do comply with the standards.

It is important that the good practices of 46 companies are emulated by others. Some
of the associations of pharma companies are making efforts in guiding the members
about implementing standard production practices. But, the number of pharma units
are large and several of them are in the small and medium sector, making it difficult
to keep track of their production practices. They suddenly make the headlines when
exposed in situations like this.

All said and done, there needs to be a strong internal mechanism to ensure quality
and avoid such incidents that tarnish India’s image in the global sphere.

REGULATORY NEWS 9

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Australia launches Japan approves
manufacturing and
national COVID-19 marketing of Adtralza
for atopic dermatitis
health management
Denmark-based LEO Pharma A/S, a global leader in
plan for 2023 medical dermatology, has announced that the Japan
Ministry of Health, Labour and Welfare (MHLW) has
The Australian government has launched granted approval for the manufacturing and marketing
the National COVID-19 Health Management of Adtralza (tralokinumab)
Plan for 2023. The National Plan reflects a subcutaneous injection for adults
consistent approach across Australia, agreed with atopic dermatitis, which
by the National Cabinet on September has inadequately responded to
30, 2022, to transition the COVID-19 conventional therapies. Atopic
response. The clear priority is to minimise dermatitis is a chronic, inflammatory,
the incidence of death and severe illness, skin disease characterised by intense
particularly focusing on those most at risk. itch and eczematous lesions. Atopic
It will ensure Australia’s health system has dermatitis is the result of skin
the capacity and capability to respond to barrier dysfunction and immune
future waves and variants; promote uptake dysregulation, leading to chronic
of vaccination and treatments; and slow the inflammation. Adtralza is the first and
spread of transmission. Importantly, the only approved human, monoclonal
National Plan recognises that COVID-19 antibody developed to specifically target and neutralise the
continues to disproportionally impact some IL-13 cytokine, which plays a key role in the immune and
Australians and therefore the Australian inflammatory process which are the underlying causes of
Government will continue to support atopic dermatitis signs and symptoms. The MHLW has
those most at risk. The plan outlines a approved Adtralza to be administered as a subcutaneous
suite of measures, which provide vaccine injection in adults with an initial dose of 600 mg, followed
certainty, with a forward plan for vaccine by a 300 mg dose given every other week.
procurement and administration; empower
the community to make informed choices to
protect themselves and their loved ones.

Korea, Singapore strengthen bilateral
cooperation over digital health medical devices

South Korean Ministry (AI) healthcare and build a close digital health and AI-
of Food and Drug Safety cooperation system by holding enabled medical devices;
(MFDS) recently held a regular meetings in the future. introduction of the
bilateral meeting with the The key points of this meeting “Guidance for Review and
Health Sciences Authority included introduction of fast Approval of AI-Enabled
(HSA) of Singapore at track system on approval for Medical Devices” published
Seoul to support the by the MFDS for the first
advancement of domestic time in the world; sharing
medical devices into information on AI-enabled
the global market and medical device-related
strengthen bilateral guidelines published in
cooperation in the field of digital Singapore; and discussion on how
health medical devices. MFDS to promote joint clinical research
and HSA have agreed to exchange to verify clinical effectiveness
knowledge in approval policy for of AI-enabled medical devices.
digital health medical devices The next meeting is scheduled in
including artificial intelligence March 2023.

10 REGUL ATORY NEWS

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Singapore injects $1M into Global
Fund for fighting AIDS, malaria and TB

As part of Singapore’s continued to global efforts in pandemic investments and efforts were
commitment to support prevention, preparedness and rapidly mobilised to respond
multilateral efforts in tackling response. Throughout COVID-19, to the new pandemic threat,
key global health challenges, the many of Global Fund’s existing underscoring the importance of
Ministry of Health has announced establishing and maintaining
that the country has pledged resilient in-country health
a contribution of $1 million to systems. Many low- and middle-
the Global Fund to fight AIDS, income countries were able to
Tuberculosis (TB) and Malaria. make use of the resources built
The Global Fund is an important to fight HIV, tuberculosis and
pillar of the global health efforts malaria, such as laboratories,
against HIV, tuberculosis and supply chains, data systems,
malaria. Against the backdrop diagnostics tools, health workers
of the COVID-19 pandemic, the and community systems, as the
Global Fund’s objectives have foundation of their response to
evolved to contribute more COVID-19.

New Zealand explores ways India opens
to improve clinical trials
National Animal
New Zealand’s leading health agencies will explore system-
level changes to improve benefits from clinical trials, based Resource Facility for
on recommendations from an independent research report
‘Enhancing New Zealand Clinical Trials’. Funded by the Biomedical Research
Ministry of Health and the Health Research Council of
New Zealand (HRC), the report is developed by a diverse in Hyderabad
team of clinical researchers, advisory and consumer
groups. With the aim of strengthening the clinical trials Dr Mansukh Mandaviya, the Union Health
environment, the report shares key component of thriving Minister, Government of India recently
inaugurated Indian Council of Medical
health research sector and priority Research- National Animal Resource
of the New Zealand Health Research Facility for Biomedical Research (ICMR-
Strategy. The report includes NARFBR) at Genome Valley, Hyderabad,
a range of recommendations India. The significance of NARFBR can
for increasing access to, and be adjudged from the fact that study of
participation in, clinical trials, animals in biomedical research becomes
with a focus on reducing inequities crucial in discovering causes, diagnosis and
and conducting trials that are treatment of zoonotic agents and diseases.
relevant to Aotearoa New Zealand. NARFBR is an apex facility which will
It also proposes a new model for provide ethical care and use and welfare of
supporting clinical trials, including laboratory animals during research. The
a national centre for providing leadership, governance, newly built centre will work as the state-of-
expertise, and high-level coordination of trial activity, as the-art facility for not just ethical animal
well as multiple regional coordinating centres to support studies but spans from basic, applied to
trials at local level. In response to the report, Health New regulatory animal research. It will help in
Zealand and Māori Health Authority are establishing a capacity building of new researchers and
senior cross-agency working group to consider how the will create processes for pre-clinical testing
recommendations can be integrated within the health of new drugs, vaccines and diagnostics
system, with each agency appointing a lead for the work. within the country along with quality
assurance checks.

FINANCE NEWS 11

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Takeda signs Merck, Kelun-Biotech ink
$9.3B licensing pact for 7
deal worth $6B cancer candidates in China

with US-based Merck, and Kelun-Biotech (a holding subsidiary of
Sichuan Kelun Pharmaceutical in China), a clinical-
Nimbus Therapeutics stage biotech company focused on biologic and
small molecule discovery and development, have
US-based Nimbus Therapeutics, LLC has entered into an exclusive licence and collaboration
signed a definitive agreement under which agreement to develop seven investigational preclinical
Japanese pharmaceutical firm Takeda will antibody-drug conjugates (ADC) for the treatment
acquire Nimbus Lakshmi, Inc., a wholly- of cancer. Under the agreement, Kelun-Biotech has
owned subsidiary of Nimbus Therapeutics, granted Merck exclusive global licences to research,
and its tyrosine kinase 2 (TYK2) inhibitor develop, manufacture and commercialise multiple
NDI-034858. NDI-034858 is an oral, investigational preclinical ADC therapies and
selective allosteric TYK2 inhibitor being exclusive options to obtain additional licences to
evaluated for the treatment of multiple ADC candidates. Kelun-Biotech retains the right to
autoimmune diseases following successful research, develop, manufacture and commercialise
recent Phase 2b results in psoriasis. Under certain licensed and option ADCs for mainland China,
the terms of the agreement, Takeda will pay Hong Kong and Macau. Kelun-Biotech will receive an
Nimbus Therapeutics $4 billion upfront, upfront payment of $175 million from Merck.
and sales-based milestone payments up
to $2 billion. The transaction is expected
to be finalised in the first half of 2023.
Closing of the transaction is contingent
on completion of review under antitrust
laws, including the Hart-Scott-Rodino
(HSR) Antitrust Improvements Act of 1976.
Nimbus Therapeutics will retain ownership
of its other research and development
subsidiaries. Takeda will be solely
responsible for future development and
commercialisation of NDI-034858 and other
TYK2 inhibitors.

Vaxxas raises A$34M to clinically
advance needle-free vaccines

Vaxxas has completed a financing COVID-19 vaccine candidate, and a second-generation version of
round which raised $23 million installation of the company’s first the spike protein used in all major
(A$34 million) in new funds. manufacturing lines with capacity US-approved COVID-19 vaccines.
This investment round was led by to support its first products Results from preclinical animal
existing investors OneVentures through late-stage clinical studies studies of HD-MAP delivered by
and UniQuest Pty Ltd. New as well as early commercial HexaPro published in Science
investors include members of production. The financing will Advances, showed the potential
the Vaxxas Board of Directors, accelerate the clinical programme efficacy of this COVID-19 vaccine
management team, and a for Vaxxas’ COVID-19 vaccine patch against all currently known
number of individual investors. patch candidate which is currently variants of concern.
Proceeds from the financing in Phase I clinical trials and is based
will be used to advance Vaxxas’ upon the company’s proprietary
clinical programmes, including high-density microarray patch
the company’s needle-free (HD-MAP) delivery of HexaPro,

12 COMPANY NEWS BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Catalent Alliance Pharma unveils state-of-
completes the-art bioanalytical lab in Brisbane
expansion
of clinical Alliance Pharma has opened its new 20,000-sq-ft (1,858-square-metres)
supply bioanalytical laboratory, Alliance Pharma Pty, Ltd., in Brisbane, Australia.
facility in The new Australia facility, which the company announced plans for earlier
China this summer, includes an expansive lab to provide much-needed small and
large molecule bioanalytical services for a region with limited choices for
Catalent has completed the bioanalytical support. In this new purpose-built laboratory, the talented
expansion of its clinical teams will use their diverse experience and expertise to provide high-quality
supply facility in the bioanalytical services. The new state-of-the-art science facility in Brisbane
Waigaoqiao Free Trade will further strengthen the company’s global bioanalytical capabilities. It
Zone (FTZ) in Shanghai, will allow biotech companies to work with Alliance in Australia in the early
China. The project has phase and then transfer the knowledge on these assays to other regions to
seen the site increase by support the later development phases.
approximately 30,000 sq
ft (approximately 2,800 Sysmex launches Alzheimer’s
square metres), which has detection kit in Japan
allowed the installation
of additional refrigerated Sysmex Corporation has received manufacturing and marketing
(between 2 and 8 degrees approval in Japan for the HISCL β-Amyloid 1-42 Assay Kit and the
celsius) and deep-frozen HISCL β-Amyloid 1-40 Assay Kit as in vitro diagnostics to measure
(between -70 and - 90 amyloid beta (Aβ) in the blood. The product assists in identifying Aβ
degrees celsius) storage,
and secondary packaging accumulation in the brain, which
capabilities to be expanded. is a characteristic of Alzheimer’s
The Waigaoqiao facility is disease, by measuring Aβ levels
one of two clinical supply in the blood using the company’s
facilities that Catalent automated immunoassay system
operates in Shanghai, the HISCL-5000/HISCL-800. The
other being in Tangzhen, company is preparing for market
outside the FTZ. Together, introduction in Japan to give
they provide sponsors patients access to this minimally
with optimised supply invasive and simple test as soon
solutions for studies being as possible. Currently, more than
undertaken in China, 55 million people worldwide
and through Catalent’s suffer from dementia, and with increasing life expectancy, this number is
extensive network, expected to rise to 130 million by 2050. Alzheimer’s disease, which is the
the Asia-Pacific region most common form of dementia and accounts for approximately 60-70
and globally. These per cent of all cases, is caused by Aβ peptides accumulating in the brain,
include clinical supply resulting in damage to nerve cells.
management, comparator
sourcing, FastChain
demand-led supply,
primary and secondary
packaging, storage, and
global distribution, as well
as clinical returns and
destruction.

COMPANY NEWS 13

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Hetero receives Pharmaniaga strives to
develop children’s
WHO PQ nod hexavalent vaccine by 2023

for PAXLOVID, Pharmaniaga LifeScience Sdn Bhd (PLS), a wholly-owned
subsidiary of Malaysia’s leading pharmaceutical company,
generic version Pharmaniaga Berhad (Pharmaniaga), signed a Research
Collaboration Agreement (RCA) with BioNet-Asia of Thailand
of COVID-19 for the development of a 6-in-1 combination vaccine (Hexavalent
vaccine) for children’s healthcare. The combinational vaccine
oral drug formulation will use BioNet formulation to develop Hexavalent
vaccine in Malaysia by
Indian pharmaceutical company the end of 2023. The
Hetero has announced the receipt initiative is in line with
of World Health Organisation Pharmaniaga’s plan of
Prequalification of Medicines establishing the world’s
Programme (WHO PQ) approval first Halal vaccine plant.
for its generic version of COVID-19 The production of vaccines
oral antiviral treatment candidate locally will reduce costs
nirmatrelvir. This is the first for the government as well
prequalification for a generic version as to ensure drug security
of Pfizer’s COVID-19 oral antiviral for the nation. Hexavalent
drug ‘PAXLOVID’, which the WHO vaccine is currently used
called, the best therapeutic choice in Malaysia National
for high-risk patients to date. The Immunisation Programme (NIP) and fully imported. The
combi pack, launched by Hetero Hexavalent vaccine is expected to complete its pre-clinical and
as NIRMACOM, will contain clinical development, registration, manufacturing and expected
nirmatrelvir 150 mg (2 tablets) and to be commercialised in 2026. Hexavalent vaccine will be
ritonavir 100 mg (1 tablet). It is made available for the use in Malaysia with a projected annual
available by prescription only and market value of RM200 million and the annual market demand
should be initiated as soon as possible regionally is estimated at an approximate value of RM500 to
after diagnosis of COVID-19 and RM600 million.
within five days of symptom onset.
NIRMACOM will be manufactured at
Hetero’s facilities in India.

IVI, ST Pharm exchange MoU on
clinical development of COVID-19 vaccine

The International Vaccine WHO Global Training Hub for Plan (CDP) and regulatory
Institute (IVI) and ST Pharm in Biomanufacturing (GTH-B) strategy for ST Pharm’s pan-
South Korea have exchanged a strategy. Specifically, IVI and coronavirus vaccine candidate.
Memorandum of Understanding ST Pharm will work together in IVI will act as a collaborative
(MoU) to establish a strategic defining a Clinical Development partner for Phase 1/2a clinical
partnership and facilitate trials of the vaccine candidate
collaboration for clinical to be conducted in Korea and
development of a pan-coronavirus a country in Africa. ST Pharm
mRNA vaccine. Under the won a grant from KmVAC
MoU, IVI and ST Pharm have (Korea mRNA Vaccine Initiative)
agreed to collaborate in clinical launched and funded by the
development of an mRNA Ministry of Health and Welfare
COVID-19 vaccine as well as and the Disease Control and
in efforts to promote Korea’s Prevention Agency.

14 START-UP NEWS BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Sonic XtalPi joins hands with
Healthcare Singapore’s EDDC for
acquires stake cancer drug discovery
in Australian
firm Microba China-based XtalPi, a pioneering pharmaceutical technology startup
for $17.8M powered by artificial intelligence (AI) and automation, has announced
a strategic collaboration with the Experimental Drug Development
Australian startup Microba Life Centre (EDDC), Singapore’s
Sciences has announced that national platform for drug
leading medical diagnostics discovery and development
provider Sonic Healthcare hosted by the Agency for
has agreed to invest $17.8 Science, Technology and
million to acquire a 19.99 Research of Singapore
per cent shareholding in (A*STAR), to discover novel
Microba. In addition, Sonic treatment candidates for
is seeking to acquire options non-small cell lung cancer
for an additional 5 per cent (NSCLC). In this collaboration,
equity position, subject to XtalPi joins forces with EDDC
shareholder approval. Exercise to apply its AI technology, automation platform, and expert domain
of the options by Sonic would knowledge to discover promising candidates against a NSCLC target
result in a further investment chosen by EDDC. XtalPi will leverage its quantum physics and AI-
of $7.5 million in Microba. driven platform to generate and screen through millions of molecules
Microba and Sonic have in de novo drug design. The predicted top-performing molecules
entered into initial terms of an with desirable drug properties will be validated and optimised in its
agreement which enables Sonic robotics-powered synthesis and testing lab through iterations.
Healthcare and its subsidiaries
to exclusively distribute Pictor raises $5M for
Microba’s microbiome testing product development
products to its customers,
including general practitioners New Zealand (NZ)-based startup Pictor, with operations in US and
and specialists, across India, has announced a funding round to help accelerate pipeline
Germany, Belgium and the product development projects along with market development
United Kingdom for a period activities within Australia/New Zealand, the US and Europe for its
of one year commencing on Human Health and Animal Health portfolios. This follows the recent
January 31, 2023 with the successful launch of the PictArray SARS-CoV-2 IgG Antibody Test
intention to extend subject through Rako Science in New Zealand and key partners in the US.
to finalisation of full licence Pictor’s multiplex technology enables two key different approaches –
and distribution agreements. testing for multiple diseases or testing for different stages/multiple
The initial agreed terms also markers of a disease, all within a single enzyme-linked immunosorbent
provide Sonic Healthcare and assay (ELISA) test well. This can provide both greater sensitivity
its subsidiaries with non- (accuracy), higher throughput and cost efficiencies. Within the
exclusive distribution rights for Human Health space, Pictor’s current focus is expanding access to its
Switzerland, the United States, highly accurate tests for COVID-19 antibodies and accelerating the
Australia and New Zealand. development of its test for tropical fevers. Pictor has also leveraged its
multiplex platform to develop an Animal Health business and is poised
to launch two tests in Q2, 2023. The PictArray Mycoplasma bovis (M.
bovis) and PictArray Johne’s Disease tests, developed with support
from the Ministry for Primary Industries’ Sustainable Food and Fibre
Futures fund, will enable more accurate and effective dairy and beef
herd management both in New Zealand and internationally.

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PredOmix Neuome Peptides develops
proven biomarkers for
launches blood cardiovascular diseases

test for early Neuome Peptides, a Singapore-based startup, with operations
in India as well, has established an assay-development platform,
cancer detection powered by machine learning and novel, patented algorithms
for the quantifiable detection of biomarkers. The company
in women has successfully designed specific peptides to bind to pre-
established, proven biomarkers for cardiovascular diseases and is
Indian startup PredOmix has currently developing effective diagnostic assays. The use of small
unveiled one-of-its-kind innovative peptides, conjugated with gold nanoparticles, allows a balance
cancer detection blood test, of high specificity
OncoVeryx-F, capable of detecting and sensitivity, giving
early-stage cancers in women with highly accurate and fast
a 98 per cent accuracy. Backed by results. According to the
advanced metabolomics technology World Heart Federation,
coupled with artificial intelligence cardiovascular disease
(AI), the new-age innovation will accounts for nearly
enable the screening for early-stage one third of all deaths
cancers. Designed for women, the in Southeast Asia,
screening tool accurately diagnoses killing four million
cancer before tumour development people every year.
begins. OncoVeryx-F, a patented Therefore, frequent
technology, is a blood-based testing with enhanced
screening approach that accurately diagnosis is required for preventive care. This is made possible
identifies four major female- with the product TruHeart, a point-of-care assay to diagnose
specific malignancies in a single Acute Coronary Syndrome that can give quantifiable results
blood test: breast, endometrium, within 3-5 minutes, using a finger-prick sample to test for the
cervix, and ovary. This is one of crucial biomarkers, Troponins I and T, and Myoglobin (eventually
the first of its kind Multi Cancer expanding to D-Dimer and Brain Natriuretic Peptide). It is in the
Early Detection (MCED) blood advanced stages of R&D and progressing to global clinical trials.
test developed by PredOmix that It will be submitted for FDA approval and then introduced to the
is now available in India and will market upon approval.
aid in determining the presence
or absence of cancer as well as the
tissue of origin or cancer type.

Doctor Anywhere acquires Asian Healthcare Specialists

Doctor Anywhere (DA), a multidisciplinary specialities otorhinolaryngology,
regional tech-led healthcare comprise orthopaedics, anaesthesia, family medicine
startup headquartered in ophthalmology, dermatology, and rehabilitation – all areas
Singapore, has acquired urology, gastroenterology, that complement DA’s regional
Catalist-listed Asian Healthcare healthcare services and offer
Specialists, an integrated consumers greater access
healthcare provider in to complex treatments. The
Singapore. Asian Healthcare acquisition is a strategic step to
Specialists is a group of 14 further DA’s long-term growth
medical specialists, with a ambitions, enabling it to deliver
patient-first approach and more holistic healthcare and meet
vision to make specialised the rising demand for complex,
care accessible to all. Its specialised treatment across
12 specialist clinics across Southeast Asia.

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Germany supports NIH’s All of Us returns
genetic health-related
implementation of results to participants in US

One Health Joint The National Institutes of Health’s All of Us Research
Programme in the US has begun returning personalised
Plan of Action health-related DNA results to more than 155,000 participants,
with reports detailing whether participants have an increased
The One Health approach aims to risk for specific health conditions and how their body might
achieve an equilibrium between the process certain medications. This marks a major milestone for
health of humans, animals, and the the programme, delivering on its promise to share information
environment and to prevent threats to and return value to participants. All of Us aims to partner
global health. The ambitious One Health with at least 1 million people who reflect the diversity of the
Joint Action Plan uses cross-disciplinary United States to accelerate medical breakthroughs. About 80
thinking and recommends preventive per cent of All of Us participants represent communities that
actions to strengthen health systems. have been historically underrepresented in medical research,
It was developed by the Quadripartite and nearly 50 per cent of All of Us participants identify with
organisations, namely the Food and a racial or ethnic minority group. The programme started
Agriculture Organisation of the United returning genetic ancestry and trait results to participants in
Nations (FAO), the United Nations December 2020. So far, the programme has offered genetic
Environment Programme (UNEP), the ancestry and traits results to more than 175,000 participants
World Health Organisation (WHO), and and continues to return about 6,000 results each month.
the World Organisation for Animal Health
(WOAH, founded as OIE). The German
government, through the support of the
German Federal Ministry for Economic
Cooperation and Development (BMZ) and
the German Corporation for International
Cooperation (GIZ), is working to
mainstream One Health into global
policies and practices. It has pledged over
€8 million to WHO for the period 2022-
2023, including €4 million support for
the action plan’s implementation.

Viatris, MedAccess, TB Alliance
reduce price of pretomanid by 34%

Viatris, a global healthcare tuberculosis patients. Pretomanid TB patients. A volume guarantee
company headquartered in (Pa) is used in combination with to be provided by MedAccess to
the US, MedAccess, and TB bedaquiline (B), linezolid (L), Viatris will see the ceiling price of
Alliance have announced a new and sometimes moxifloxacin pretomanid reduced to $240 Ex
agreement to reduce the price (M) to form BPaL and BPaLM Works per six-month treatment
of pretomanid, a drug used to – six-month, all-oral treatment course. It will help to bring both
treat multidrug-resistant (MDR) regimens, found to be effective BPaL and BPaLM substantially
tuberculosis (TB), by 34 per cent. at curing 89-91 per cent MDR- closer to $500 per patient course.
Pretomanid is part of two new Governments and global procurers
treatment regimens with high are expected to make direct
efficacy and shorter treatment savings of $15.6 million thanks
durations recently recommended to the guarantee, with additional
by the World Health Organisation savings for national healthcare
(WHO) as the preferred budgets as they care for fewer
regimens for most drug-resistant patients with long-term MDR-TB.

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Morocco explores medical manufacturing
JV to serve African market

Moroccan Ministry of Investment, market. The new facility would of viral inactivation, non-toxic
Convergence and Evaluation of help fulfill Africa’s need for health formation, and enabling labs to
Public Policies (MICEPP) as well sovereignty and accessibility, skip the RNA extraction step,
as with the Moroccan Ministry of and Morocco was chosen as the reducing costs and increasing
Industry and Commerce (MIC) site because it can also function
have signed Memorandum as a launchpad to serve testing throughput. Mawi
of Understanding (MoU) European markets. Mawi also has a broad portfolio
agreements with US-based Mawi has developed iSWAB- of iSWAB sample
DNA Technologies (Mawi), a Microbiome-EL, collection technologies for
medical device company focusing a product that is
on the development of innovative being extensively mammalian DNA,
technologies for biological sample deployed worldwide RNA, intact cells, and
collection, to explore a joint for population- microbiome (fecal,
venture with Mawi’s local partner scale surveillance testing for soil, surface, and skin), in
BIOTESSIA to establish a state- infectious diseases, notably addition to the HemaSure-
of-the-art manufacturing facility COVID-19 and its variants, OMICS whole blood collection
in Morocco to serve the African due to its unique properties technology allowing RNA, CTC,
cfDNA, and genomic DNA to be
isolated from a single sample.

WHO certifies Congo free of Senegal joins
dracunculiasis transmission
CEPI in the fight
The World Health Organisation (WHO) has certified the
Democratic Republic of the Congo (DRC), Africa as free against pandemics
of transmission of Dracunculus medinensis, or Guinea
worm, the parasite that causes dracunculiasis (Guinea- The Republic of Senegal in West Africa
worm disease). A disease of poverty and deprivation slated has joined the Coalition for Epidemic
for eradication, Dracunculiasis is a crippling parasitic Preparedness Innovations (CEPI),
disease, transmitted mainly when people drink stagnant Norway in its mission to prevent future
water contaminated with parasite-infected water fleas. epidemics and pandemics. An agreement
Certification follows an extensive and thorough evaluation was recently signed for a pledge of $1
of the country dossier presented by DRC officials to WHO. million by the republic of Senegal to
Evaluation for certification involves assessing several support CEPI’s pandemic preparedness
factors, including epidemiological surveillance data and plan, making Senegal the 35th country to
official records, as well as surveying health facilities and join the Coalition. Senegal’s investment
villages in formerly endemic areas. With the certification in CEPI comes at a critical time as the
of DRC, WHO has now certified 200 countries, areas global community continues to endure the
and territories, including 188 WHO Member States, as repercussions of the COVID-19 pandemic
free of dracunculiasis transmission. Only six countries and strives to ensure the world is better
remain to be certified, including five endemic countries prepared to respond to future threats.
(Angola, Chad, Ethiopia, Mali, South Sudan) and one Senegal’s political and financial support to
formerly endemic country (Sudan, which is now in the CEPI will bolster the organisation’s efforts
precertification stage). to reduce the risk posed by epidemics and
pandemics by developing vaccines for known
infectious disease threats (such as Lassa
fever, Middle East Respiratory Syndrome
and Nipah virus), and build on the scientific
advances made during COVID-19 to prepare
in advance for ‘Disease X’ – the threat of an
unknown virus with pandemic potential.

18 WHO NEWS BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

WHO lays WHO updates recommendations
focus on on HPV vaccination schedule
optimising use
of antibiotics In a new position paper, the World Health Organisation (WHO)
has updated its recommendations for the human papillomavirus
The World Health Organisation (HPV) vaccine. Of particular note, the paper states that a single-dose
(WHO) has published the WHO schedule, referred to as an alternative, off-label single–dose schedule
AWaRe (Access, Watch, Reserve) can provide a comparable efficacy and durability of protection to a
antibiotic book, to provide concise, two-dose regimen. The recommendation for alternative single-dose
evidence-based guidance on how scheduling was initially made by WHO’s independent expert advisory
to optimise use of antibiotics group, SAGE in April 2022. The position paper is timely in the context
included on WHO’s Model of a deeply concerning decline in HPV vaccination coverage globally.
Lists of Essential Medicines. Between 2019 and 2021, coverage of the first dose of HPV vaccination
It includes information on the fell by 25 to 15 per cent. This means 3.5 million more girls missed
choice of antibiotic, dose, route out on HPV vaccination in 2021 compared to 2019. The optimisation
of administration, & duration of of the HPV schedule is expected to improve access to the vaccine,
treatment for more than 30 of the offering countries the opportunity to expand the number of girls who
most common clinical infections in can be vaccinated and alleviating the burden of the often complicated
children & adults in both primary and costly follow-up required to complete the vaccination series.
healthcare and hospital settings.
Up until now, easily accessible, WHO makes health and
evidence-based guidance from economic argument for
trusted sources has been lacking investing in new TB vaccines
for many common infections in
many countries, especially in low- A new study commissioned by the World Health Organisation
and middle-income settings. The (WHO), and featured in the report “An investment case for new
AWaRe antibiotic book is expected tuberculosis (TB) vaccines”, predicts high health and economic
to be of particular value in those returns from investment in new TB vaccines. The report highlights
settings where WHO guidance that a focus on TB vaccine products that meet WHO preferred
might be the only high-quality
information source available. To product characteristics, could
further address the need for easy significantly reduce TB incidence
access to high-quality resources and mortality, improve antimicrobial
to improve antibiotic prescribing stewardship and health equity, and
globally, WHO has collaborated drive economic growth. A vaccine for
with the health technology adolescents and adults is projected
company, Firstline, to develop to have greater and more immediate
an innovative platform that impact than one for infants. The
delivers the recommendations report presents evidence on how a
in the AWaRe antibiotic book to more effective vaccine could deliver
health professionals at the point higher impact. A TB vaccine for
of care via a free web and mobile adolescents and adults that is 50 per
app, making authoritative clinical cent effective in preventing disease
support available anytime & could cumulatively avert 37.2–76 million people from falling ill
anywhere. with TB and 4.6–8.5 million deaths between 2025 and 2050. In
comparison, a vaccine that is 75 per cent effective could avert 54–
110 million people falling ill with TB and 6.7–12.3 million TB deaths
during the same period. Looking at economic benefits, a 50 per
cent effective vaccine could save $36.6–41.5 billion in TB-related
household expenditure, which helps avert two thirds of catastrophic
costs incurred by most people in the bottom wealth quintile.

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23

Life Sciences

Trends to Watch

for in 2023

The past two years have been a rollercoaster ride for the global economy and the pharma
industry hasn’t been impervious to the major financial upheavals either. Yes, it’s the Pandemic
and Post-Pandemic world that’s been influencing people from all walks of life and industries,
alike. Buzzwords notwithstanding, we do have to thank the pandemic situation that forced all
stakeholders to innovate and pool the best and brightest resources to keep the Life Sciences
industry thriving. While all other industries either lost steam in their growth plans, pharma boomed,
not unlike the Phoenix rising from the ashes. It is this streak of resilience and growth that we want
industry insiders to comment on. With curtains down for 2022, it’s time to look to the new year
without the trepidation of the looming ‘Great Reset’. On an upbeat note, BioSpectrum brings you
23 trends and projections for 2023 that could reshape and influence our collective future.

BioSpectrum interacted with a few leaders from Pharma
major market segments of the industry who
provided their insights into what the coming 1. Robotics
year is likely to hold for their particular sphere. As companies continue to innovate the pipeline of
Below are the 23 predictions from across the sub- drug discovery, design, and delivery, incorporating
sectors of life sciences - pharma, biotech, medtech, robotics is the logical next step.
healthcare, digital health and manufacturing that “Robots are more precise than humans, they
are expected to make a splash in the sector. Some can perform validation experiments, and they can
of these are extensions of trends observed in 2022 be run by an artificial intelligence (AI) platform.
that will continue into 2023; such as Artificial And in APAC, companies can tap into a wealth of
Intelligence (AI) assisted drug discovery, rise of robotics expertise. Insilico Medicine is opening a
mRNA therapies, and China’s dominance in CAR-T fully autonomous AI-run robotics lab in Suzhou
therapy. Besides these, the industry will focus on in early 2023. This state-of-the-art lab will feature
climate change, digital therapeutics, ageing, mental autonomous guided vehicles running experiments in
health, and much more. Let’s take a deep dive. place of human scientists. These robots will do cell
culture, high throughput screening, next-generation

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sequencing, cell imaging, and genomics analysis Chinese market will start having a significant impact
and prediction. As the robots generate on regional and global markets.
data, that data will feed directly into
Insilico’s Pharma.AI platform, “One of the major trends is the rising impact of
improving the system’s target Chinese biotech companies in global markets. The
hypotheses and ability to validate combination of relatively low clinical development
those hypotheses,” said Dr Alex costs, coupled with a highly competitive domestic
Zhavoronkov, Founder and industry has resulted in a growing number of locally
CEO of Insilico Medicine, developed, innovative drugs – especially in attractive
China. Insilico Medicine is an AI- categories such as Programmed death-ligand 1(PD-
driven drug discovery company. L1) inhibitors. Many of these companies, such as
Beigene and Legend, are actively seeking commercial
Asia-Pacific is seeing a hiring boom for robotics opportunities in global markets, particularly in the
roles in pharma in recent years, according to US and other rich markets as lower-price alternatives
GlobalData. In May 2022, Australia’s Monash to products from multinational
University invested $6.5 million in a new world-class companies. The Chinese players are
robotics research facility to train the next generation also looking at emerging markets
of engineers and global innovators, and drive the where their price points may
emerging AI economy. help make newer therapies
available to local patients for the
2. Licensing to pharma companies outside first time,” said Jeff Weisel,
APAC Managing Director for
PRMA Consulting APAC.
“There has been an exciting amount of PRMA Consulting is a market access
growth and development in the biotech industry consultancy and part of Fishawack Health, UK.
in APAC, but I predict that we will increasingly
see assets developed in China, licensed to global In 2022, innovative Chinese drugs made great
pharmaceutical companies in 2023. We will likely see progress, especially in CAR-T therapies. China
this in particular with cancer therapies, which APAC appears to have surpassed its western counterparts
has invested in heavily, and APAC-based biotechs in building a robust research pipeline of specialised
partnering with global pharmaceutical companies to CAR-T therapies with a maximum number of clinical
bring their early-stage assets to more advanced stages trials and drugs in the pipelines. China is set to take a
and clinical trials,” said Dr Zhavoronkov. bigger role in the world pharma stage in 2023.

Sanofi, which recently signed a $1.2 billion 4. Climate Change connection
strategic research agreement with Insilico, is The pharmaceutical industry is one of the largest
expanding the Sanofi Institute for Biomedical contributors to global climate change. The industry
Research (SIBR), Sanofi’s R&D centre in China,
leading the way.

On December 23, American drug major Merck,
and Chinese firm Kelun-Biotech inked a $9.3
billion licensing pact for seven cancer candidates.
Under the agreement, Kelun-Biotech has granted
Merck exclusive global licences to research,
develop, manufacture and commercialise multiple
investigational preclinical antibody-drug conjugates
(ADCs) therapies and exclusive options to obtain
additional licences for ADC candidates. On the same
day, South Korea-based LegoChem Biosciences,
Inc. (LCB) entered into a research collaboration and
licence agreement with US-based Amgen, whereby
it has granted Amgen rights to research, develop,
and commercialise ADCs directed against up to five
targets selected by Amgen based on LCB’s proprietary
ConjuAll ADC technology. The deal is worth $1.25
billion.

3) China’s expansion quest
2023 will be the year when developments in the

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has risen to the challenges, with a majority of big of new targets in a variety of diseases, generation
pharma firms aiming for carbon dioxide neutrality by of novel molecules with the desired properties,
2030 and Asian firms are no different. clinical pharmacology, clinical trials enrollment and
analysis, personalised medicine, and even marketing.
On December 22, 2022, Japanese firms Astellas, However, there are still very few companies linking
Eisai, Daiichi Sankyo and Takeda came together these steps in early discovery into one seamless
to promote the use of more environmentally pipeline leading all the way to clinical trials,” said Dr
friendly packaging for pharmaceutical products. In Zhavoronkov.
November 2022, CEOs from AstraZeneca, GSK,
Merck KGaA, Novo Nordisk, Roche, Samsung 6. Digital technologies
Biologics and Sanofi announced joint action to “Digital technologies have been quickly adopted
achieve near-term emissions reduction targets and in vast industries in APAC recently. This trend is
to accelerate the delivery of net zero health systems. also spread in the pharmaceutical industry to speed
For the first time, the global health sector has come up and save costs during the R&D process of novel
together to reduce greenhouse gas emissions through drugs. Using these technologies will gain
the Sustainable Markets Initiative (SMI) Health advantages for APAC’s small-mid-size
Systems Task Force, a public-private partnership companies,” said Tsz-Yin Chang,
launched at COP26. Deputy General Director,
ITRI’s Industry, Science and
In 2023, we will see more firms joining the Technology International
bandwagon, putting in more sustainable efforts. Strategy Center (ISTI),
Taiwan. The Industrial
5. Versatile and efficient AI Technology Research Institute
AI and big data are the top technologies currently (ITRI) is a leading technology
deployed in drug discovery and development across research and development institution in Taiwan.
the globe, which is expected to increase over the years
in the APAC region. AI is versatile and efficient with Biotech
wide ranging utility be it - genetic risk assessment,
early and accurate screening and diagnosis of 7. The growing ageing population
diseases, drug discovery and development, clinical “By 2050, one in four people in APAC will be over
trial design and analysis, precision medicine, and 60 years old, according to UNFPA (United Nations
monitoring of treatment response. Pharma firms will, Population Fund). This will pose a high demand
hence, continue to invest in this technology. for ageing-related healthcare measures, such as
“Many pharmaceutical companies in APAC degenerative therapy, regenerative medicine, etc,’’
are leaning into AI, utilising it at various stages of said Tsz-Yin Chang.
pharmaceutical R&D. From hypothesis generation Asian biotech firms are investing in research
from literature and biological data, identification to develop novel therapies that could prevent and
reverse the ageing process in humans. In October
2022, Australia pledged $25 million for dementia,
ageing and aged care research. Earlier in March
2022, Australia opened a new national academic
centre for healthy ageing research. In September
2022, Singapore set up the world’s first integrated
pre-clinical and clinical ageing research institute.
This will open up new vistas in longevity research
and boost developments in the region.
8. Increased clinical testing
In the past five years, the APAC region emerged as
the largest contributor to global clinical trial activities
and this trend is expected to continue in the future as
well because of its population, cost-effectiveness and
advancement in the healthcare infrastructure. The
region registered higher growth than the US and the
EU across the majority of therapeutic areas.
“The Asia Pacific region is home to 60 per
cent of the world’s population and consists of

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many countries that lead in technologic and advances and promises, it is also critical to optimise
manufacturing capabilities and include multiple utilisation of the effective tools that we already have
advanced centres of science, education and in hand. An example of this is through improvements
research. I see increased research and development in human papillomavirus (HPV) vaccination and
in the life sciences in many of these countries—in cervical cancer screening, which are highlighted
terms of basic science, pharmaceutical in 2020 WHO global strategy for cervical cancer
drug discovery, and the capacity to elimination, and is highly relevant to many countries
rapidly test for effectiveness and in the Asia Pacific region,” said Dr Wui-Jin Koh.
safety within large populations,”
said Dr Wui-Jin Koh, Senior On December 20, 2022, Bio Farma and Merck
Vice President and Chief signed a framework agreement related to technology
Medical Officer, National transfer cooperation to produce the HPV vaccine
Comprehensive Cancer locally in Indonesia. In September 2022, India
Network (NCCN), USA. The launched its first locally produced version of the HPV
NCCN is a not-for-profit alliance of vaccine made by the country’s largest vaccine maker,
32 leading cancer centres devoted to patient care, Serum Institute of India (SII).
research, and education.
11. Gene Therapy
“At the same time, patients’ needs are driving This is another trend that will be deployed even
innovations. There’s a growing focus on health more in 2023. The incorporation of gene technology
equity and personalised medicines. This goes and genetic information in treatments is projected to
hand in hand with diversified recruitment efforts soar.
for clinical studies. Targeting wider racial and “This is particularly important in the field of
gender demographics is paramount oncology as 1 in 6 global deaths are caused by cancer.
to developing drugs and products The advancements in gene technology allow health
that can effectively treat the global professionals to predict and trace disorders, enabling
population,” said Raman Singh, them to create more effective and efficient treatment
CEO and Founder of Juniper plans for patients,” said Singh.
Biologics, Singapore. The APAC region has taken the lead in cell and
Juniper Biologics is a science-led gene clinical trials, accounting for the largest share
healthcare company delivering of new trials during the first half of 2022, according
novel therapies to improve the to the Alliance of Regenerative Medicine’s report
quality of life of patients everywhere. mapping the sector’s progress. The APAC region
represents 42 per cent (61) of the 144 new clinical
9. Specialised treatments
“APAC headquartered companies have increased
their footprints in the research and development
(R&D) of specialised treatment modalities such as
Chimeric Antigen Receptor T-Cell Immunotherapy
(CAR-T), Natural Killer (NK) Cell Immunotherapy,
and Dendritic Cell Immunotherapy (DC
Vaccine). We expect investments in
these areas that will continue to
increase in the coming years,” said
Yogesh Rai, Practice Head
(Pharma Drugs Database),
GlobalData, UK. GlobalData
Plc is a data analytics and
consulting company.
Some of the firms leading the
development of next-gen CAR-NK cell therapy
include Korea-based GI Cell, HK inno.N’s and
China’s Antengene.
10. Improved prevention of HPV-related
malignancies
“While it is important to focus on technical

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trials started this year, and includes a healthy number MedTech
early in the pipeline (30); 26 in phase 2, and 5 in
phase 3, the report noted. 13. 3D Printing
3D printing allows the targeted creation of
It has already been a record year for the approval more complex geometries that mimic the shape
of new gene therapies to treat rare diseases, as and function of natural bone, and also the efficient
the United States Food and Drug Administration production of customised implants.
(USFDA) approved the first haemophilia B “It is more important for us to understand that 3D
gene therapy, from Australian behemoth CSL’s printing is existentially reshaping what implants can
HEMGENIX (etranacogene dezaparvovec-drlb). It do, how patients can be treated, patient comfort and
is the fifth gene therapy for a rare genetic disease to experience during recovery, as well as the efficiency
secure FDA approval. At present 16 therapies are on during operations that involve implants. As an
track for regulatory decisions in 2023 indicating an add-on to creating implants, 3D printed products
active late-stage pipeline. are a game-changer for surgical procedures and
have enabled surgeons to minimise the time during
12. Microbiome medicines operations – this makes the procedure
There has been a flurry of activities in microbiome shorter, safer, and also provides
drug space in 2022. In September 2022, Singapore better management of hospital
opened the Centre for Microbiome Medicine to resources, especially during the
improve human health. In June 2022, Cordlife pandemic when manpower is
Group, a Singapore Exchange mainboard-listed scarce,” said Goh Khoon Seng,
consumer healthcare company, and AMILI, launched Chief Executive Officer,
the first-ever gut microbiome banking service in Osteopore International,
Southeast Asia. Singapore. Osteopore is a global
On November 9, 2022, Australia announced the leader in regenerative solutions.
world’s first regulatory approval for a donor-derived Its bioresorbable implant is the first of its kind to
microbiome drug developed by the Australian startup be successfully developed and commercialised for
BiomeBank, setting the stage for others. Earlier in surgical use.
January 2022, the firm partnered with the Hudson
Institute of Medical Research for the development of Healthcare
life-saving microbial therapies. In the same month,
on November 30, the US FDA also approved the 14. The booming of emerging companies
first faecal microbiota drug, Rebyota by Ferring “The life sciences industry is experiencing several
Pharmaceuticals, USA. major shifts. For example, a growing number of
innovative startups are entering the market right now.
Many of these focus on personalised and value-based
medicines, putting patients’ needs first,” said Singh.
M&A is also set to remain a major theme. We’ve
had a few good examples of this in APAC through
2022 where distressed assets were available at
attractive valuations, and market capitalisations
overall have been affected by volatility.
“In 2023, I would expect to see life science
companies that have been holding off
on public market secondary raises
come out of the woodwork to shore
up their balance sheets. It feels
like the market is starting to
become more receptive to these
raises, while the IPO market
remains soft,” said Jane Lowe,
Managing Director, IR
Department, Australia.
15. Closing the access gaps
The challenge facing pharma companies across
both developed and emerging markets is the ‘access

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23 Life Sciences Industry Trends for 2023 easily-accessible sharing of information to assist
all clinicians in providing optimal healthcare to
1. Robotics everyone. An example is NCCN’s new collaboration
with Medlive in China to make gold-standard clinical
2. Licensing to pharma companies outside APAC practice guidelines for cancer care more accessible
across Asia. This is intended to enable more people
3. China’s expansion quest with cancer to live better lives through access to
the very latest in evidence-based expert consensus
4. Climate Change connection treatment recommendations.”

5. Versatile and efficient AI There has been a notable increase in the number
of collaborations between different stakeholders in
6. Digital technologies the sector.

7. The growing ageing population Digital Health

8. Increased clinical testing 17. The rise of DTx
A new class of drugs called digital therapeutics
9. Specialised treatments (DTx) is on the rise. There are currently 5533 studies
registered in digital therapeutics on clinicaltrials.
10. Improved prevention of HPV-related malignancies gov as of December 28, 2022. The majority of these
are for psychiatric indications followed by diabetes
11. Gene Therapy and respiratory health. Changing medical protocols,
alongside the need to bring down the cost of care
12. Microbiome medicines is driving an upsurge in investments in digital
therapeutics, which is projected to grow at the rate
13. 3D Printing of 26.7 per cent to reach $6.9 billion for the period
2020-2025, according to MarketsandMarkets. In
14. The booming of emerging companies May 2022, Japan clears CureApp’s DTx app for
hypertension. This is the world’s first regulatory
15. Closing the access gaps approval of a DTx app for hypertension treatment.
On December 1, 2022, Moderna partnered
16. Information sharing and collaboration with Japanese startup Allm for building a digital
therapeutics (DX) against infectious diseases that aims
17. The rise of DTx to revitalise activities. In March 2022, Happify Health
and Zuellig Pharma partnered to commercialise
18. Tech solutions for mental health prescription DTx in Asia. The activities in this space
are expected to leap forward in 2023.
19. Smart hospitals 18. Tech solutions for mental health
Mental health tech scene is rapidly picking up in
20. Digital home care APAC and we’re on the cusp of seeing a major boom
in the region this year.
21. Patient empowerment In July 2022, Singapore-based Intellect raised
$20 million in its Series A funding, the largest
22. Singapore powering Asia’s biopharma boom amount raised by a mental health startup in Asia.
Singapore’s Ami, and ThoughtFull are some other
23. Digital transformation of CDMOs digital health firms making end-to-end mental
healthcare seamless and affordable in Asia.
gap’ where products are launched in the region often Leading pharmaceutical companies like Pfizer,
much later than in the US and Europe. Johnson & Johnson, and Sanofi are also developing
new tech solutions and novel drugs to improve
“Closing this gap will require addressing barriers mental health conditions.
relating to healthcare financing, availability of 19. Smart hospitals
healthcare services, supply, and distribution of Growing government initiatives in healthcare
products, and developing enablers such as strategic digitalisation activities in several countries will
partnerships and trust among the stakeholders in accelerate the rise of smart hospitals.
the healthcare system. We see awareness and actions
in this direction taking hold in the region in 2023,
ranging from new manufacturing capabilities such as
the BioNTech and GSK facilities in Singapore to the
many initiatives around alternative funding models
seen across the region,” said Weisel.

16. Information sharing and collaboration
Collaborations of different bioscience companies,
both with each other, and also with health science
organisations and governments, will have a big
impact in 2023.
“These collaborations are advancing
developments and causing a shift in the pricing of
products. More regulations are being passed that
are reducing the cost of medications and products
from pharma companies. Making medicine more
accessible will consequently result in more equity in
the health industry,” said Raman Singh.
Echoing similar sentiments, Dr Wui-Jin Koh
said “Collaborative, transparent, timely, and

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“Rapid technological advancements in AI, RVAC Medicines and A*STAR came together to build
automation, smart sensors, cloud IT and etc. not capabilities for mRNA production in Singapore.
only facilitate physicians to analyse critical clinical On November 16, 2022, ResMed unveiled a digital
data and their decision making, but also improve the health solutions manufacturing centre in Singapore.
hospital operational efficiency. Health IT and medical On November 17, 2022, GSK opened a S$44 million
devices with intelligent technologies embedded such as manufacturing facility in Singapore for cancer
computer-assisted diagnosis or predictive analysis will treatment. In July 2022, China’s WuXi announced
see market growth opportunities,” said Tsz-Yin Chang. plans to invest $1.4 billion for a production and R&D
centre in Singapore.
In 2022, Thailand launched ASEAN’s first 5G
smart hospital. South Korea’s KT Corporation and 23. Digital transformation of CDMOs
the Samsung Medical Center (SMC) are working to Pharma and Contract Development and
build a smart hospital. They have jointly developed Manufacturing Organisations (CDMOs) could
an innovative, 5G-powered medical service as an weather the storm caused by COVID-19 pandemic
initial step to establishing a 5G smart hospital. because of the technology and digitisation of the
development and manufacturing process, and
20. Digital home care moving forward technology will play an even more
Developed countries such as Japan, Korea, and important role in the functioning of the CDMOs.
Taiwan are facing the challenges of ageing population “Digital transformation is another trend. AI,
and labour force shortage. ML, automation and robotics will all aid in CDMO
“As the geriatric population are prone to several old operations.CDMOs are expected to answer the
age disorders, digital home care solutions and remote strong demand for technically high, sophisticated
patient monitoring are expected to ease these issues. manufacturing support for complex molecules.
Internet of medical things, smart medical devices, As a reliable partner, we have to find answers and
medical AI, cloud ERH, AI chatbots, homecare robots prepare for further upcoming trends like cell and
and digital platforms for coordinating all stakeholders gene therapies and DNA-based molecules. They have
would be keys to shape the future ecosystem of the made the leap from scientific innovation
care continuum,” said Tsz-Yin Chang. throughout to groundbreaking
21. Patient empowerment medications. This will be part of our
Digitalisation of healthcare solutions is a powerful future business,” said Carsten
tool to advance patient empowerment. Press, Senior Vice President
“With many healthcare providers investing Key Account Management,
in technology to ensure patient engagement and Supply Chain Management
healthcare provision during the COVID-19 crisis, and Marketing at Vetter,
technology-enabled patient empowerment will Germany. Vetter offers
continue as an influential trend in the APAC region,” comprehensive fill-and-finish
said Rai. services from clinical development to the product’s
market launch and beyond.
Manufacturing Technological advancements and innovations
have been at an all time high across industries and
22. Singapore powering Asia’s biopharma geographies, bringing with it new and efficacious
boom solutions and resilience. Whatever might be the next,
new man-made or natural crisis, the industry and
Singapore has emerged as a hotbed for biopharma the minds involved, are ready to fight it tooth and
manufacturing. In 2022, almost all the major nail. With that firm resolution and hope, we welcome
pharma firms announced plans to advance biologics 2023.
manufacturing in the region. On December 12, 2022,
Moderna announced its plans to expand its Asia- Ayesha Siddiqui
Pacific presence with a new Singapore subsidiary. A
week before that, on December 2, 2022, GSK, Sanofi
and Takeda partnered with research communities
from the Agency for Science, Technology and
Research (A*STAR); National University of Singapore
(NUS); Nanyang Technological University, Singapore
(NTU Singapore) and its innovation and enterprise
company, NTUitive; and Singapore Institute of
Technology (SIT) to boost Singapore’s biologics
manufacturing capabilities. On November 21, 2022,

26 COVER STORY

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HTAs, CGT Set to Rule Life
Sciences Industry in 2023

« financial pressures that arise and continue into 2023
as a result of macroeconomic trends regionally and
Jeff Weisel, across the globe.

Managing Director, Health technology assessments

PRMA Consulting Overall governments are increasingly looking
at and learning from each other in terms of health
APAC, part of technology assessments (HTAs).

Fishawack Health, UK In the mature markets, in which decisions are
largely driven through established systems for HTAs,
Governments and other payers make decisions we see several continuing trends:
in the context of the broader economic
environment. For 2023 we will continue to see ● Processes for assessing and reviewing
the impact of these global economic trends on payer innovative technologies are being streamlined,
decisions as they increase financial pressure in the especially for rare diseases and cell and gene
APAC region. therapies (CGT). This streamlining is impacting both
domestic processes as well as when compared with
Global macroeconomic trends global standards.

Though inflation is expected to ease in 2023, the ● We will continue to see HTA agencies increasing
price increases of the past 12 months will still affect in importance in reimbursement decisions – in effect
purchasing decisions. moving from being strictly advisors to core decision
makers.
● The likelihood of global recession means that
slowing economies in the region will have lower tax ● The importance of locally generated
revenues available for drug budgets. pharmacoeconomic and real-world evidence data
is increasing – and with newly defined standards.
● In many countries in the region, most imported Both China and Japan have already published recent
drugs are priced in USD which has strengthened guidelines on applying patient reported outcomes in
against nearly all regional currencies in the past year. mapping healthcare utilisation.

● We will continue to see the increasing ● Finally, we will continue to see increasing use of
availability of new lower cost options such as Managed Entry Agreements and other Risk Sharing
biosimilars and Chinese biotech products in areas Agreements in reimbursement decisions.
like immuno-oncology.
In emerging markets, where healthcare systems are
The impact of these headwinds on payers will still evolving and the use of HTA is generally still new,
be a greater focus on cost containment and reduced we see several developments continuing to play out:
budget impact. This will likely drive lower net
prices as payers seek to claw back more from both ● The adoption of HTA as a decision tool is
previously and newly reimbursed products. In South expanding and the focus will mostly remain on
Korea, for example, the method for calculating the capacity building. While the influence of the UK
foreign average drug price for referencing will be agency, The National Institute for Health and Care
revised in 2023 to consider ex-manufacturer prices, Excellence will remain high for many countries as they
exchange rates, value added tax, and distribution develop their HTA systems, we also see increasing
channels in each comparator country. In some reference to Thailand’s Health Intervention and
markets we are also likely to see increased switching Technology Assessment Program as a more relevant
to lower cost alternatives such as generics and local/ role model for other emerging markets.
regional products. Ultimately, there will be significant
● Budget impact and pricing will remain the
primary concern for emerging markets, with limited
opportunities for advanced medicines to be funded by
government payers.

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● At the same time, private insurance continues therapies were introduced just over two decades
to grow as an alternative in emerging markets ago the standard of care (SOC) in all markets
such as China, India and ASEAN countries and was chemotherapy. A decade later, when the
is increasingly becoming a focus of innovative first immuno-oncology drugs were launched, the
approaches to funding. targeted therapies had become the SOC in mature
markets while chemotherapy remained in place in
● Finally, the impact of digital health on access, emerging markets. Fast forward to 2023, with the
especially telemedicine and “super apps” but also first CGT treatments hitting the market, immuno-
including fintech and the convergence of mobile oncology products are now the SOC in mature
phones and medical devices, is still evolving and markets while emerging markets are still mostly
Asia Pacific markets have seen some of the fastest funding only chemotherapy. As a result, patients in
uptake in this space, especially since the COVID-19 mature markets (along with wealthier patients in
pandemic hit the region. emerging markets) have in effect had access to three
generations of innovation beyond what emerging
Closing access gaps market patients can get through their public systems.

One challenge facing pharma companies across Developments in China
both developed and emerging markets is the “access
gap” where products are launched in the region Finally, we see 2023 as the year when
often much later than in the US and Europe. The developments in the Chinese market will start having
main driver of this gap is that regulatory agencies in significant impact in other regional and even global
most Asia Pacific countries only start their process markets. Two key trends are quickly emerging.
following the Food and Drug Administration (FDA) or
European Medicines Agency’s approval, with Japan First, the increasingly low reimbursement price
and Australia as the only major markets historically levels on the National Reimbursement Drug List
conducting their review in parallel with the US. Later (NRDL) are not only affecting commercial decisions
launches mean lower peak and total sales – especially by global and domestic companies. These prices
when combined with the lower prices or more also raise the possibility of other countries including
restricted guidelines often seen in the region. China for international reference pricing purposes.
Though the NRDL prices are not openly transparent
The good news is that several countries have in public sources, they are available through research
made moves toward closing this gap. South Korea, for into cost-effective analysis and other sources. At this
example, will soon introduce parallel reviews where point, it seems unlikely that Chinese prices would
the Ministry of Food and Drug Safety submission be referenced in the US or Europe as the market
can be made just three months after US FDA wouldn’t be considered as similar. However, major
submission. The country is also working towards a emerging markets in the Middle East, Latin America
faster review system and conditional approval for or even in Asia Pacific may see the opportunity
marketing regenerative medicines. The Australian presented for leveraging the Chinese prices.
government has entered into strategic agreement
with pharmaceutical companies to explore new
evaluation and funding pathways to ensure more
efficient assessment of innovative treatments and
therapies that do not fit neatly into the system (such
as CGT and precision medicines).

Japan has been recently stepping up efforts to
drive regulatory harmonisation in Asia, with the
Pharmaceuticals and Medical Devices Agency being
the reference regulatory agency. As of 2022, Indonesia,
Thailand, the Philippines, Vietnam, Taiwan, and
India have been observed to provide expedited review
or certain exemptions for drugs approved in Japan,
leading to shortened approval timelines.

While such breakthroughs in innovation have
transformed the quality and value of care, they have
in some cases widened existing gaps in healthcare
access across and within markets in Asia Pacific.
In oncology, for example, when the first targeted

28 VACCINE

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

TOO MUCH OF

A GOOD THING…

Thinking long term to ensure that huge amounts of vaccines are not wasted, manufacturers need
to have a far-sightedness and not just go on a production spree.

During the first half of 2021 vaccine Apart from SII, Bharat Biotech, companies like
manufacturers were on a spree to launch Biological E., Panacea Biotech, Premas Biotech etc.
their products anticipating that public took part in vaccine development activities. Vaccine
apprehension will remain the same in 2022 as it manufacturers also teamed up with the academia and
was there in 2019 when COVID-19 struck. Three government to accelerate indigenous development
years down the line it is a different story altogether. of the COVID-19 vaccine. Indian Council of Medical
Indian manufacturers Serum Institute of India Research (ICMR) and Hyderabad-based Bharat
(SII) and Bharat Biotech have now decided to stop Biotech have partnered to develop a fully indigenous
manufacturing COVID-19 vaccines altogether due to vaccine for COVID-19 using the virus strain isolated
hesitancy among the general public. at ICMR’s National Institute of Virology (NIV) in
Pune. In the form of another industry-academic
During the recently held annual general meeting tie-up, the Indian Institute of Technology Guwahati
of the Developing Countries Vaccine Manufacturers (IIT-G) collaborated with Ahmedabad- based
Network (DCVMN) in Pune (India), Adar Poonawala, pharmaceutical company Hester Biosciences for
CEO, SII, was quoted saying “To be honest, I am fed vaccine development against COVID-19. Researchers
up with COVID vaccines.” from the Hyderabad-based Centre for Cellular
and Molecular Biology (CCMB) embarked upon
The COVID-19 vaccination drive began on developing an inactivated virus vaccine for the
January 16, 2020, with much fanfare and in 2022 it
all fizzled out. The Government of India announced a dreaded novel coronavirus.
free booster campaign from July 15 to September 30, Besides IIT Kanpur; Gennova
2022. More than 150 million adults received booster
doses. More than 95 million people between 18 and Pharmaceuticals, Pune; Auro Vaccines,
45 years received precautionary doses till September Hyderabad; Christian Medical College,
29, according to the Health Ministry. The count of Vellore; IIT Delhi; IIT Kharagpur; Central
people between 45 and 60 years who have taken their
boosters has increased 12-fold — from 3.7 million up Drug Research Institute, Lucknow;
to July 15 to 48 million on September 29. National Institute of Immunology,
New Delhi; International Centre
Despite all the moves, it was found that large for Genetic Engineering and
proportions of eligible adults shied away from Biotechnology (ICGEB), New
booster doses where only 95 million opted Delhi; Seagull Biosolutions, Pune;
for booster doses out of the 515 million that Mynvax, Bengaluru etc. all took
went in for the second dose. part in the vaccine development
activities. And the list goes on.
Way back in 2020 Despite all the initiatives and a lot of

It was in the year 2020 when money being invested, two years down the
30 vaccine projects were initiated line, all the enthusiasm has been lost.
in India. India adopted a cross- Researchers burned the midnight oil, and
functional collaborative approach, overcame regulatory hurdles, to launch
globally and locally, wherein life saving vaccines. Whether the vaccines
currently 30 vaccine
projects are afoot against were launched or did they see the day of
COVID-19. light remains a mystery. And with no taker, it
dealt a final blow to the initiatives.

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A worrying trend “With reduction in infection
levels, there has been
A lot of money was invested to manufacture the
vaccines besides building capacity. Anticipating less interventions by the
a huge demand then, the two major vaccine government.This has also led
manufacturers are now on a move to eradicate the to idle capacity. It’s time for the
vaccines. organisations not to dismantle
the production facility but to
Bharat Biotech’s Covaxin was sold for Rs 400
per dose to the government and Rs 1200 for private look forward to R&D in the
hospitals whereas AstraZeneca’s Covishield was sold area of preventive medicine,
at Rs 300 per dose to government hospitals and Rs develop newer vaccines and
600 per dose to private hospitals.
try maximum usage of the
A whopping amount of 50 million doses of production capacities.”
Covaxin produced by Bharat Biotech is set to expire - Ashok Bhattacharya,
in 2023 due to poor demand. The production has
already stopped. Global Health Care Consultant
& Growth Enabler and
SII has already stopped the production of
Covishield in December 2021. Poonawala also Former Executive Director /
mentioned that the company will dump at least 100 Country Manager of Takeda
million doses after the products expire.
Pharmaceuticals India
The Government of India has decided against
procuring more COVID vaccines as of now. The “Over-dependence on
health ministry is surrendering Rs 4,237 crore of the government for technical,
2022-23 budget allocation for inoculation purposes, financial, administrative and
to the finance ministry. distribution (without scientific
and serological follow up) led
It may be noted that the same companies were to inconsistency in the vaccine
also moving ahead to launch vaccines for children. dosage (varying from one to
There was a general perception of fear among the three in short period of time)
public with health experts mentioning that COVID which further led to confusion
may turn fatal for children. Here also, the vaccine and low confidence in public on
manufacturers failed to make their mark. The entire the vaccine. This may be due to
concept of children getting vaccinated against lack of data, follow-up services
COVID has lost somewhere with the government and to produce omni-potent
not commenting either on what is the future of the
vaccines that were to be administered. vaccines.”
- Dr (Prof) Ajay Gambhir,
According to the COWIN website, Covovax, Chairperson, Vaccine India and
Corbevax and Covaxin are available for children. Ex National Technical Advisory
Group on Immunisation (NTAGI)
Recently, there was news about Bharat Biotech
producing Covaxin in a hurry due to political member
pressure. The allegations were, however, refuted
both by the Government of India and also by the According to Dr ( Prof) Ajay Gambhir,
company. Chairperson, Vaccine India and Ex National
Technical Advisory Group on Immunisation
And no one is talking about ZyCov-D, the world’s (NTAGI) member, “The industry got full support
first DNA –based vaccine that was developed of the international agencies, governments, Drug
by Cadila Healthcare in partnership with the Controller General of India (DCGI), NTAGI, World
Department of Biotechnology. Russia’s Sputnik Bank, Bill & Melinda Gates Foundation (BMGF) and
vaccine is priced at around Rs 1145 per dose. other agencies. However, their over-dependence on
government for technical, financial, administrative
The mRNA vaccine for COVID-19 was and distribution (without scientific and serological
touted as a game changer. Pune-based Genova follow up) led to inconsistency in the vaccine dosage
Biopharmaceuticals, a subsidiary of Emcure (varying from one to three in short period of time)
Pharmaceuticals, has announced that its mRNA which further led to confusion and low confidence
vaccine – GEMCOVAC-19 - has received the
Emergency Use Authorization (EUA) from the office
of the Drugs Controller General of India (DCGI).
Nothing much has happened on this front.

30 VACCINE

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Vaccination By Type Echoing similar views, Ashok Bhattacharya,
Global Health Care Consultant & Growth Enabler
Covishield : 174,46,92,627 and Former Executive Director / Country Manager of
Covaxin : 36,14,38,038 Takeda Pharmaceuticals India mentions, “We have
Corvevax : 73781,576 witnessed that Serum Institute was under tremendous
Sputnik : NA pressure to make Covishield available not only across
Covovax : NA the country but also in many other countries across
the globe. Bharat Biotech had to respond to higher
Source: cowin.gov.in demands. High investments were made to increase the
manufacturing capacity. The demand was significantly
Total registrations for COVID-19 vaccine high and considering the magnitude of high infection
rates coupled with government pressures for higher
Age Total registrations stock, the demand projections were more leading
12-14 4,20,74,546 to higher production and inventory levels. With
15-17 6,30,82,409 reduction in infection levels, there has been less
18-44 63,30,92,213 interventions by the government.This has also led
Age 45+ 37,01,95,298 to idle capacity. It’s time for the organisations not to
dismantle the production facility but to look forward to
As on Dec 2, 2022 Source: cowin.gov.in R&D in the area of preventive medicine, develop newer
vaccines and try maximum usage of the production
in public on the vaccine; over-dependence on the capacities.”
vaccine to curb and control the pandemic, in which
we failed to earn confidence of public and academia. What next?
This may be due to lack of data, follow-up services
and to produce omni-potent vaccines .Also led to the Vaccine manufacturers need to go back to the
failure to address the serious adverse events, both in drawing board to take stock of what went wrong.
youth and elderly and win public confidence.” Manufacturing millions of doses without anticipating
what is in store for the future was a wrong decision by
He went on to add, “As pandemic weaned off, the manufacturers not only in India but also abroad.
the role and scope of the vaccine also weaned off
by the government due to less availability in poor The government also started the ‘Har Ghar
countries and ineffectiveness in the rich countries Dastak’ campaign to propel the vaccination drive in
also due to vaccine hesitancy in most of the countries. November 2021. In May 2022, the second part of the
Few countries were producing and storing most of campaign was launched to propel the vaccination
the vaccines, while the other countries did not even drive in school, however, the public response was
get the single dose for their healthcare workers and less.
essential workers first vaccine. This led to global
and regional disparity, questions of equity, equality We may come across many more diseases, more
along with availability and affordability came at serious than COVID-19. Before launching any new
the international level. So, the role of vaccines after vaccines, companies need to understand the future
the pandemic was over, became questionable as sentiments and anticipate the future outlook before
the industry was unsuccessful in delivering cheap joining the fray to launch a large number of vaccines.
vaccines to masses and poor countries.”
The lesson learnt is that vaccine manufacturing
plants should be decentralised and each country/
continent should have its own vaccine manufacturing
process, depending upon the local needs. There
must be sharing of data and technology amongst
all countries- poor or rich during the pandemic.
Adverse Event Following Immunization (AEFI)
should be monitored, informed, counselled to win
public confidence. Latest data must be shared with
the public and made available to academia to contest
any false claim or mis-information. Free vaccination
drives by the government for a longer period may
have made the matter less serious.

Sanjiv Das
[email protected]

SPEAKING WITH 31

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

“Crovalimab could potentially become the

first global drug originating from Singapore”

There has been explosive growth in the mid- «
size molecules and therapeutic antibody
market as many cancers, autoimmune Dr Hisafumi Yamada,
diseases, metabolic diseases, and infectious
diseases have been successfully treated. Japanese Executive Vice
headquartered Chugai Pharmaceutical has
already developed world-class technologies for President (R&D),
antibody engineering and mid-size molecule drug
discovery which can reach some intracellular Chugai Pharmaceutical
targets that were previously difficult to access,
and have high binding activity, and good oral has great potential to address this challenge, as
absorption. Chugai Pharma has been operating they permeate the cell membrane where antibody
in Singapore since 2012 as a subsidiary, Chugai pharmaceuticals do not and specifically bind to
Pharmabody Research (CPR) developing innovative target proteins even where they do not have pockets
pharmaceutical products in collaboration with suited to a small-molecule drug for binding. We
Singapore’s biopharma R&D ecosystem. In an also aim to confer oral bioavailability to mid-size
interaction with BioSpectrum Asia, Dr Hisafumi molecule drugs, whereas antibodies can only be
Yamada, Executive Vice President (R&D) at administered by injection. We believe this will add
Chugai Pharmaceutical, echoes CRP’s enduring extra value for the patients.
association with the regional biopharma
industry on the occasion of completing a decade Could you explain CPR’s capabilities
of presence in Singapore. Edited excerpts; in cutting-edge antibody engineering
technologies towards pioneering new drug
How significant is the development of discoveries?
mid-size molecule drugs relative to small
molecule and antibody modalities to CPR was first established in Singapore as
address unmet medical needs? a suitable research hub to maximise the value
of Chugai’s proprietary antibody engineering
With mid-size molecule technology, we aim to technology. We have 10 research units that cover
discover new pharmaceutical drugs that act against the early drug discovery process from target
intracellular tough targets which are unreachable assessment to clinical candidate selection. Each
with small molecules or therapeutic antibodies. unit has different roles in antibody research and
development, and they collaborate as one to
Though they are the most common modalities accelerate the drug discovery process.
among pharmaceutical drugs, antibodies can target
only extracellular molecules (approximately 20 per Utilising Chugai’s antibody engineering
cent of all proteins), and small molecules target technologies, which include Recycling Antibody
only molecules with pockets (approx. 20 per cent of technology (SMART-Ig), bispecific antibody
all proteins). manufacturing technology (ART-Ig), and Switch
antibody technology (Switch-Ig), CPR focuses on
It is said that there may be approximately 2,000 innovative drug development that can deliver better
proteins involved with disease. However, new drugs clinical outcomes for patients. These novel antibody
launched within the last 10 years target only about technologies enable Chugai to expand druggable
50 of these proteins. Many are still considered target molecules and invent unique therapeutic
“undruggable,” as they are difficult to reach by actions to meet unsatisfied clinical needs. Chugai’s
either small molecules or antibodies. We must cutting-edge technologies have allowed us to
find a way to reach these tough targets so that we achieve a competitive advantage in the highly
can create innovative new drugs for patients with intensive field of drug discovery.
diseases where there are limited treatment options
and high unmet medical needs. Since its establishment in 2012, CPR has

I’m excited that our mid-size molecule platform

32 SPEAKING WITH

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contributed eight projects to Chugai’s drug antibody engineering technologies, to discover new
development portfolio. These include CPR’s innovative drugs.
successful application of recycling antibody
technology to create an anti-C5 antibody called These efforts include antibody projects to
crovalimab (SKY59), which is currently in fight COVID-19 and dengue fever, but they
phase 3 clinical trial for paroxysmal nocturnal have not proceeded to clinical development yet.
hemoglobinuria (PNH). Nevertheless, I look forward to new drug candidates
emerging from our collaborations in Singapore.
How do you describe the strategic
implementation of proprietary antibody How do you define Chugai’s contribution
and cyclic peptide technology for treating to Singapore’s R&D efforts and regional
multiple diseases, including oncological, collaborations? Could you brief the
inflammatory, fibrotic, and genetic disease? investment made so far in the region? What
In what ways did the Singapore Economic are the other drugs in CPR’s pipeline?
Development Board (EDB) play a significant
role? CPR has been contributing to Singapore’s
science community through collaboration,
Chugai’s drug discovery is technology-driven, participation in training events, and remaining
which is unique and different from other big connected with CPR’s Alumni network.
pharmaceutical companies. Chugai focuses on
the identification of target molecules that best fit CPR has multiple partnerships within
our novel antibody technology or cyclic peptide Singapore’s scientific community, including
technology, regardless of the therapeutic area. startups, which I believe energises Singapore’s
The identification of novel target molecules by scientific ecosystem.
disease biology can be complex, and many novel
target molecules can be classified as tough targets. Chugai has invested S$437 million into
Drug discovery activities for tough targets require Singapore via CPR’s operations over the past
advanced technology. Chugai’s novel proprietary decade, and an additional S$282 million has been
antibody engineering and cyclic peptide technology earmarked for the next five years. CPR has already
can expand target space by making tough targets played an important role in discovering multiple
approachable in multiple therapeutic areas. investigational antibodies, for which we’ve already
started clinical studies. I am confident there are
When CPR started operations in 2012, EDB more to come.
provided the Research and Innovation Scheme for
Companies (RISC) and advice on acquiring human Singapore’s first global drug is being
resources and talented scientists. Since then, CPR developed in collaboration with Chugai,
has continuously received timely support from EDB complimenting the country’s sustainable
and has expanded its operations steadily. growth in the biomedical ecosystem? What
is your perspective on this?
Describe Chugai’s efforts towards
developing drugs against COVID-19, CPR played a leading role in the creation
dengue fever, and other diseases. of the investigational antibody crovalimab for
paroxysmal nocturnal hemoglobinuria, a potentially
Chugai believes that collaboration with external life-threatening blood disease. It is currently
partners is the key to innovation. With science and undergoing a global phase 3 clinical trial, the final
technology evolving at an unprecedented rate, it phase in clinical development. The first new drug
has become increasingly difficult for a company application for crovalimab was submitted in Q3
working alone to generate innovation. Therefore, 2022 in China ahead of the rest of the world, based
collaboration with academia and companies that on positive results from an in-country dedicated
possess new modalities or technologies will be single-arm clinical trial. The application is currently
essential to achieve our goal of world-class drug under priority review.
discovery.
We are very excited about crovalimab – if the
Through CPR, Chugai has begun multiple results of the clinical trial turn out to be positive,
joint research projects with A*STAR and research it could potentially become the first global drug
institutes in Singapore. Our aim is to combine novel originating from Singapore. If that happens,
findings and the expertise of academia in Singapore crovalimab will become a good example of the value
with our drug discovery technologies, such as of Singapore.

Hithaishi C Bhaskar
[email protected]

SPEAKING WITH 33

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

“Innovations that serve a purpose,

paired with a good go-to-market

strategy are attractive for VCs”
Singapore’s health and biomedical landscape
constitutes a vibrant pool of innovative «
medical technology, biotechnology
and biopharmaceutical entrepreneurship. Audrey Lok,
Biomedical sciences industry is the fourth pillar
of the country’s manufacturing economy and is Director, Healthcare
extensively fostering local R&D and startups to
boost innate innovations. In 2016, the Singapore and Biomedical,
government committed to a S$4 billion budget to
drive research and commercialisation activities EnterpriseSG
in the health and biomedical sciences sector.
Further supporting the initiative, Enterprise new opportunities and encourage innovation
Singapore (EnterpriseSG), the statutory board to address healthcare challenges, pushing the
of the Singapore Ministry of Trade and Industry industry forward. In 2020, EnterpriseSG and the
plays a vital role in supporting local startup Ministry of Health co-organised the Healthcare
ecosystems. In an interaction with BioSpectrum Open Innovation Challenge comprising five public
Asia, Audrey Lok, Director of Healthcare and and private healthcare corporate sponsors. Eleven
Biomedical, EnterpriseSG shared insights on its problem statements were identified, 200 project
role in promoting Singapore as an Asia-Pacific hub submissions were received and seven projects were
for startups and innovations. Edited excerpts; eventually shortlisted to co-develop solutions in
areas such as fall prediction and prevention, patient
How conducive is Singapore’s engagement and experience, as well as disease
startup ecosystem for fostering diagnosis.
bioscience initiatives and empowering
entrepreneurship? How would you describe EnterpriseSG’s role
in stimulating startup ventures and creating
COVID-19 has rapidly accelerated the pace a thriving ecosystem for SMEs innovations?
of medical innovation and transformation, and
it comes as no surprise that we now have more Our core mandate at EnterpriseSG is to support
investors and startups in this sector. As of 2021, Singapore’s local enterprises to become more
400 biomedical startups and SMEs in Singapore productive, innovative and to internationalise. As
prioritise innovative solutions that address part of that, we also aim to create an environment
today’s healthcare needs or ones that address the that drives innovation and is conducive for
pandemic. S$1.3 billion in biomedical investments businesses. EnterpriseSG assists startups in three
across 40 deals have been recorded in the same ways.
year.
First, helping early-stage innovative startups
A part of this success can be attributed to the get access to financing, facilities, mentorship and
thriving ecosystem built upon strong public-private talent. We are committed to catalysing investments
partnerships. Our public healthcare clusters into deep-tech startups and increasing growth-
have enabled many healthcare and biomedical stage funding through Startup SG Equity, where we
startups to embrace innovation, by tapping the partner with other investors from across the world
clinical strengths and expertise of our healthcare to co-invest in high-growth and high-potential
system to refine, develop and testbed solutions. companies. This risk-sharing model gives investors
In fact, they have been supporting more than a boost of confidence that their financial support
100 industry engagements and facilitations every will be channelled to help competitive startups.
year. They are also critical partners who identify Although we face global headwinds and some

34 SPEAKING WITH

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

investors are taking on a more cautious stance, we that provide startups with tools and resources
are encouraged to see that the startup investments as they grow to go global. Many of the successful
grew a strong 45 per cent per annum from 2017 to entrepreneurs move on to provide mentorship
2021. or investment, grooming the next generation of
startups. This cycle adds to the vibrancy of our
To complement that, we are also creating a startup and innovation ecosystem and produces
robust network of innovation infrastructure to value-added services and new job opportunities for
connect our startup communities and catalyse Singaporeans.
co-innovation opportunities. We work with
polytechnics and research institutes to set up What are the collaborative and partnering
Centres of Innovation. To date, we have 11 such opportunities EnterpriseSG offers to the
centres with distinct industry focus, providing startup and SME community?
SMEs with access to an array of resources
ranging from laboratory facilities to training and In addition to the above, EnterpriseSG
consultancy services, to embark on industry-led ecosystem partners such as incubators, accelerators,
innovation. On the human capital front, we are also readily offer mentorship, networks and resources
doubling efforts to develop local talents and attract to support biotech startups. This is critical as the
global ones through initiatives such as the Global challenges faced by the industry are unique and
Ready Talent programme and EntrePass scheme. have a longer gestation period. For example, many
must navigate additional processes such as ensuring
Second, we work with partners to facilitate compliance, getting the necessary regulatory
connections to the market and achieve product- approvals, and adhering to moderated clinical
market fit. This involves nurturing a vibrant investigations. Early-stage biotech startups face the
startup ecosystem, underpinned by a consolidated added challenge of having to invest in expensive
and collaborative network of ecosystem partners- laboratory equipment even before starting their
accelerators, incubators, corporates and investors- experiments. Therefore, having ecosystem partners
that provide fertile ground for startups to tap into like NSG Biolabs that provides early stage biotech
the resources they need to scale from Singapore. startups access to equipment, laboratory and office
Our Open Innovation Challenges are one such space via a co-sharing model, is critical for biotech
avenue matching corporates and startups together entrepreneurs who need to optimise capital in the
to generate win-win outcomes. Corporates open to early years. Supported by EnterpriseSG, the site
leveraging open innovation can tap a bigger pool not only provides a conducive environment with
of ideas and spectrum of competencies to improve specialised resources and expertise, but also fosters
their business operations. For startups and SMEs, a community of biotech entrepreneurs to leverage
they can address industry demand and ensure complementary strengths in collaboration.
market fit, accelerating the commercialisation
process. Local startups can also tap into schemes
such as the Startup SG Tech and the Enterprise
Third, we support startups in finding the Development Grant for support.
right overseas partners and clients to scale their
businesses globally. We want to foster global How do you envision entrepreneurship in
connections to drive cross-border exchange in the highly competitive bioscience sphere?
ideas, knowledge and talent. We have recently
expanded our Global Innovation Alliance Network Whether in biotech or other sectors, the critical
to include nodes in over 17 cities, to facilitate thing is that the solutions being developed must
two-way flow of collaboration in innovation. By have a strong value proposition and solve real
connecting Singapore and other international challenges or market-led demand. Innovations that
startups to leading innovation ecosystems, startups serve a purpose, paired with a good go-to-market
based here are given the opportunities to set up, strategy will be attractive to VCs. This is why we
testbed and commercialise solutions with partners will continue to drive collaboration between all
across the region. Global tech startups and stakeholders in our innovation ecosystem, including
ecosystem players can also come to Singapore to 220 accelerators and incubators as well as the 30
access and expand into Southeast Asia. research institutes here, who provide valuable
research expertise and funding for the over 3,900
These three main guiding pillars will allow us startups based in Singapore.
to continue supporting innovative startups and
SMEs, by bridging the funding gap, catalysing deal Hithaishi C Bhaskar
flows and implementing the necessary networks [email protected]

SPEAKING WITH 35

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

“Our ambition requires us to take

long-term view, investing in scale

and building unmatched capabilities”
The novel trend in single-cell analysis
is revolutionising biological research, «
unravelling underlying genetic credentials
while creating new therapeutic approaches and Dr Ben Hindson,
personalised treatments. For it to become more
feasible, powerful, reliable tools can fuel scientific President &
discoveries and drive exponential progress to refine
genetic analysis for developing better treatment Co-Founder,
regimens. A study by Grand View Research reveals
that the global single-cell analysis market size was 10x Genomics
valued at $3.28 billion in 2021 and is expected to
expand at a compound annual growth rate (CAGR) and spatial analysis. This is a big focus of our R&D
of 18.5 per cent from 2022 to 2030. Aware of the pipeline. Last year, we launched several new products
burgoing growth of single-cell-analysis market, that help open up large volumes of archive tissue
Dr Ben Hindson, President & Co-Founder of 10x samples for single cell and spatial analysis, and we’re
Genomics explains how innovative single cell, spatial, excited to see what researchers uncover with these
and in situ technologies enable discoveries across new capabilities.
oncology, immunology, neuroscience, and more areas
using innovative diagnosis and therapy techniques. Moving forward, we will continue to invest to
drive broad adoption, remove bottlenecks, and create
What are the drivers and trends shaping the more value for researchers around the world.
single-cell-analysis market? How do you
Identify growth segments for investment and What are the major milestones accomplished
expansion? in the Asia Pacific region and what are the
projections for FY 22-23?
More and more, we see that single cell methods
are becoming the standard for a growing fraction of We started to form our APAC commercial team in
life science research, an essential element of many 2018, and it’s been a great journey. APAC contributes
new grant applications and are increasingly becoming about a quarter of our global revenue. We opened
a requirement for publication. Singapore, China and Japan 10x Genomics entities
during this time, as these markets have particularly
Our goal at 10x Genomics is to make single cell strong research communities working hard to push
analysis accessible to every biology lab in the world to science forward.
make it the standard for most biological research.
Our Singapore entity also serves as our APAC
Since the initial launch of our Single Cell Gene regional headquarters and is home to our Singapore
Expression solution, we have released many new manufacturing hub, our first manufacturing centre
capabilities and versions of our products -- focused outside of the United States. Here, we manufacture
on expanding the range of applications on the our leading portfolio of consumables for single-cell
platform, including immune-profiling, epigenetics, analysis for global distribution.
proteins and multi-omics.
We look forward to continued growth in the
We have expanded the fundamental capabilities APAC region and around the world. In addition to
of the platform, highlighted by the release of the the opportunities, we have to increase adoption
Chromium X instrument, which has made it possible with both current and new customers in academic
for people to run up to 1 million cell experiments research. There is increasing demand for our tools in
routinely. clinical translational research, including in pharma/
biopharma and in medical centres. This will be an
We’re also working to make more samples and area of focus for us in the coming years.
more sample types available for routine single cell

36 SPEAKING WITH

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

At 10x, we are intensely focused on How do you envision empowering next-
innovation; it’s core to what we do.
Since inception, we’ve invested more gen innovations to achieve more medical
than $1 billion in R&D. Our culture of
innovation has yielded a strong cadence breakthroughs?
of technological advancement and
product development, launching over 20 We started the company with the premise
pioneering products. What’s more: 2022 that improving human health requires an
is shaping up to be the most exciting exponential increase in our understanding
and ambitious year of product launches of biology and that the main challenge to
in our history. This velocity of innovation, understanding biology is its enormous
development and execution is only complexity. To address this complexity, we set
possible because of the incredible cross- out to build technologies to measure biology
functional talent we have cultivated. at the right resolution and massive scale. We
catalysed the single cell revolution, built leading
How does the company intend to invest in platforms for spatial biology, and we’re still
next-gen tools and technologies through just getting started. With the launch of our
innovation? In light of this, what are the key Xenium platform for In Situ analysis, we’ll be
components and scope of the company’s the only company to have the three fundamental
intellectual property portfolio? technology approaches for single cell and spatial
biology under one roof, uniquely positioning
At 10x, we are intensely focused on innovation; 10x to be the best partner to help researchers
it’s core to what we do. Since inception, we’ve around the world interrogate, resolve and
invested more than $1 billion in R&D. Our culture master biology.
of innovation has yielded a strong cadence
of technological advancement and product How do you foresee the investment
development, launching over 20 pioneering
products. What’s more: 2022 is shaping up to be opportunities to integrate and scale APAC
the most exciting and ambitious year of product
launches in our history. operations for FY 2023 while unlocking

This velocity of innovation, development and novel biological discoveries?
execution is only possible because of the incredible
cross-functional talent we have cultivated. At 10x, we like to think of our technologies
Today, we have deep expertise across a wide as being ‘behind the breakthrough’. There have
range of disciplines, from biology, chemistry and already been more than 4,100 publications
microfluidics; to hardware engineering, data analysis using our tools. Our customers are making
and software development. This talent is supported fundamental advances across oncology,
by a robust product development infrastructure immunology, neuroscience, and infectious
focused on integration across these diverse diseases. In fact, it’s hard to think of an area of
disciplines. Our foundational strength – what’s biology that has not benefited from discoveries
truly differentiated about 10x -- are these integrated made using 10x products.
core capabilities which are essential for developing
the breakthrough products and technologies in our We expect that in future, just about all tissue
pipeline. samples, whether for basic research or for clinical
diagnostics, will need to be analysed at single
We are able to achieve these outstanding results cell resolution in spatial context and at large
in part from the strength of our intellectual property, scale. That’s because, to understand normally
which now includes over 1,600 patents issued functioning human biology and to understand
and pending. We believe that our deep and broad disease, we need to measure and understand
patent portfolio is a key competitive differentiator. what’s happening in individual cells.
As we look forward, we will continue to drive our
innovation engine, deliver on our R&D roadmap and The scope of our ambitions requires us to take
invest in the long-term with discipline and focus. the long-term view. Part of taking a long-term
view is investing in scale and building capabilities
that can’t be matched. That’s exactly what we
had in mind as we built our APAC manufacturing
and commercial hub in Singapore. We see our
Singapore hub as a key part of our future growth,
and we made sure to set aside the space to scale
and grow along with us.

Hithaishi C Bhaskar
[email protected]

SPEAKING WITH 37

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

“We are seeing activity within
biotherapeutics market in Southeast Asia”

Jason Neo, Director, Marketing J-KOSEA, SCIEX, Singapore

Aglobal leader in life science analytical Jason: This area continues to grow
technologies, and a company of Danaher rapidly across locations like China,
Corporation, SCIEX has been focusing Japan, and India, but we are also seeing

on enabling biomarker discovery and translation activity in areas like Southeast Asia.

through increased sensitivity, throughput and This is encouraging because it means

robustness with new launches in the market this that we are making steps forward in

year. With biomarkers and biotherapeutics gaining processes becoming more accessible, which is a core

significant attention in 2022, BioSpectrum spoke in industry goal. At SCIEX, we want to be able to support

detail with Jason Neo, Director, Marketing J-KOSEA, the full range of next generation modalities. Our

SCIEX, Singapore and Jose Castro-Perez, Senior portfolio is developed with a close ear to the voice of

Director, Market Development, SCIEX, Framingham, the customer. This led us to a workflow approach that

Massachusetts, CA, to find out about the we are engaging to make processes easier and more
company’s plans in these areas. Edited excerpts:
efficient, while delivering the best in data quality.
Jose: We have spent a lot of time and

resources on developing our approach

From your perspective, what are the top to critical workflows to streamline

highlights for SCIEX in 2022? global processes, as well as optimising
Jose: The 2022 launches of the Zeno
the capabilities of each solution. In the

SWATH DIA and the RNA 9000 Purity biopharma workflow, our approach to

and Integrity kit have deepened the CE allows for the separation of full, empty, and

level of support we can provide to partially filled AAV for the cell and gene therapies.

customers. We have also been working And as we see tighter EPA regulations, we are

on the software side of our solutions with always seeking to optimise our solutions—for

an improved SCIEX OS that increases efficiency and instance, detection of PFAS with the SCIEX 7500

reduces method maintenance. And we are continuing system can go down to 4pp.

to grow the extractables and leachables (E&L) library

to further streamline development and integration What are the major plans in store for 2023?
Jose: Our technologies are designed to
processes.

help scientists and manufacturers

How much growth is expected this year? bring new therapies and treatments
Jason: According to Market Data
such as mRNA, vaccines, and

Forecast, the size of the APAC oligonucleotides to market efficiently.

biopharmaceutical market was $40.25 We will continue to innovate and deliver

billion in 2021 and is estimated to be value-driven, scalable solutions like our biopharma

growing at a CAGR of 10 per cent to workflow solutions that can be applied throughout

$64.96 billion by 2026. This level of the development pipeline.

growth feels feasible, particularly when you consider

the continued strong investments from the How is SCIEX exploring analytical science

government and the private sector. Throughout the space in terms of new designing products?
Jose: We work closely with customers
year in APAC, bioanalysis saw increased demand. We

spent a lot of time aligning with customers to on new product designs to understand

optimise lab capabilities or scale-up for future their unmet needs. A good example of

demand applying a customer-centric approach to the this is the recent launch of Zeno

CE and LC-MS solutions we are delivering. SWATH DIA. This new DIA workflow

was realised through our customer

How is the biotherapeutics market collaborations. Dr Manbeena Chawla

developing in APAC? How is SCIEX [email protected]

contributing to it?

38 GENOMIC RESEARCH

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Propelling Genomic Research with
Future-Proof Digital Infrastructure

« store increasing data volumes.
Putting things into perspective, a single human
Eric Hui,
genome sequence alone takes up 200 gigabytes,
Director, IoT equivalent to the space of 200 short streams videos.
Future-proof digital infrastructure such as data
Ecosystems centers play an important role in advancing genomic
research possibilities, its applications, and future
Development, benefits to the public health agenda.

Equinix Asia-Pacific Collaboration with secure connections

Digital transformation in healthcare has been Effective collaboration among countries was
at breakneck speed since the outbreak of the a key factor that catalysed the development of
COVID-19. It took just a year to develop the COVID-19 vaccines. Considering the sensitivity of
COVID-19 vaccine – a record-breaking speed given vaccine development, data security was important
vaccine development usually takes up to 10 years for researchers. This gave rise to the need for an
or more. This medical achievement would not have interconnected infrastructure that is able to transmit
been possible without innovative technology and data in a secure, fast, and reliable form, allowing
the advancement of genomic sequencing, allowing researchers to bypass the public internet and reduce
researchers to map the entire genetic makeup of an security threats and attack surfaces.
organism.
Bringing in a real world case study, a major
BCC Research has forecasted the Asia Pacific genomics institute based in Asia has worked with
market for Bioinformatics in genomics to register Equinix to host genomics data. The infrastructure
a CAGR of 11 per cent from 2020 to 2025, against and interconnection bandwidth provided by Equinix
the rising prevalence of infectious diseases such provided them not only with direct connectivity to
as COVID-19. With the expanding market value of public clouds, required to run a variety of genome
genomics amid Asia Pacific’s MedTech landscape, applications, but also to connect with other genome
more R&D institutions are being established to institutes worldwide. The data generated was
explore novel solutions based on the study of essential to support genome analysis activities and
genomes. This can largely be attributed to the the creation of AI models to advance research. In
increase of awareness and adaptation of genomic this sense, connected and digital infrastructure not
applications in Asia Pacific countries as well as
improvements in health infrastructure, numerous
urgently needed advances, increased patient
disposable income and rising medical expenditures.

The advancement of genomics has helped develop
treatments that improve healthcare, delivering better
results for patients. Earlier in 2022, Singapore and
India entered into an agreement to collaborate on
genome and bioinformatics research, while the
Genome Institute of Singapore has embarked on
mapping Asian genomes to investigate how illnesses
can affect different groups, providing valuable insight
for researchers. The success of genomics innovation
relies on robust and agile digital infrastructure to
support the entire research programme, from data
processing and exchange to the ability to analyze and

GENOMIC RESEARCH 39

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

only advanced the speed of collaboration, but also Digital Health Trends in 2023
advanced the research process itself to be able to
deliver timely solutions. The outcome means that 1. More avenues to enable secure and
disease variations and solutions can be brought to compliant data collaborations
market faster in the future as the research chain
becomes more efficient, and barriers to sharing COVID accelerates life sciences and
and collaborating become smaller. Furthermore, pharmaceutical research collaborations. We
deploying an established digital infrastructure model can increase research velocity with data sharing
that is secure, reliable and stable enables genomics methods like federation and metadata. There will
institutions to focus on their data without concern for be an increasing use of high bandwidth private
slow or stolen information. point to point connections rather than open
internet with VPN due to petabyte scale data sizes
The future of genome research and regulatory requirements.

Genomic technologies are transforming the 2. More considerations in optimising cloud
future of healthcare at record speeds. Researchers resources with growing data needs.
are also tapping into artificial intelligence (AI) to
predict outcomes and automate actions. AI can help Cloud resources have kick-started quite a
identify DNA pieces quickly, a crucial factor in the number of healthcare and life sciences projects,
fight against ongoing antibiotic resistance, cancer but there are still quite some legacy and critical
treatment and rare disease research. AI tools are also data sets that require institutions to host it on their
helping researchers automate routine tasks, such as own. Therefore, we expect more hybrid cloud
trimming data, classifying relevant sequences and architectural deployments integrating physical and
submitting medical certificates—saving valuable time cloud resources happening in this sector.
for researchers.
3. More investments in health data ingestion
Government bodies are also increasingly points and processing engines.
recognising the importance of these advancements
and turning to genomic research to provide Travel restrictions and certain lock downs
personalised healthcare for patients. For instance, have driven demands in connected health and
the Singapore National Precision Medicine (SG- telemedicine. Video conferencing and healthcare
NPM) programme, established in 2017, aims to tracking IoT devices to sense vitals and postures
revolutionise healthcare by enabling a strategy that are increasingly popular to support patients
is tailored to country’s population diversity through who have mobility limitations. Healthcare
genomic sequencing. This effort is also coordinated service institutions have to upgrade their remote
under A*STAR’s Artificial Intelligence Analytics & data ingestion points to handle the traffic flow
Informatics office which catalyses the development and traffic load. Edge points of presence with
and application of a broad range of science, AI compute capability will be key to a speedy, an
uninterrupted flow of data.

capabilities and technologies. However, as healthcare
becomes increasingly digitised, a key consideration
is for government privacy frameworks to ensure
that data remains secure. Policymakers can examine
using blockchain to secure and trace instances of
data sharing. When certain health data classification
does not allow sharing, data federation techniques to
query data can be considered.

Transforming the way

Healthcare is being revolutionised. Whether we
are increasing the speed of response, uncovering
genetic mysteries, or collaborating with researchers
worldwide, public health benefits from the leaps that
researchers can make are plentiful. It is exciting to
see what the future unfolds for healthcare in making
new discoveries that would advance public health
with the aid of technology.

40 ARTIFICIAL INTELLIGENCE

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

AI: Tremendous Potential to
Transform Bioprocessing Efficiencies

« 4.0 solutions that incorporate intelligent automation
and advanced process control and optimisation tools
Ruplekha Choudhurie, using machine learning (ML) and AI. Advanced
ML algorithms and AI-based tools, along with
Senior Industry automation can play a key role in improving the
manufacturing efficiency of these modalities. On a
Analyst/Team Lead global scale, multiple Tier 1 biopharma companies
and large Contract Development and Manufacturing
(Health & Wellness), Organisations (CDMOs) such as GSK, Merck, Takeda,
Roche, Pfizer, Cytiva, GE Healthcare, Fujifilm
TechVision, Diosynth, and Catalent have adopted AI-augmented
software and tools to optimise and control their
Frost & Sullivan manufacturing processes.

The biopharmaceutical industry is witnessing Several technology startups focused on
unprecedented growth, with a surge in demand biomanufacturing targeted AI-based solutions have
for vaccines, monoclonal antibodies (mAbs), emerged to improve process analytics, process
and advanced modalities including RNA therapeutics, control, product characterisation, supply chain
mRNA vaccines, and cell and gene therapies (CGTs). management, and factory operations. Companies
Bioprocessing requirements for advanced modalities such as Nucleus Biologics, Culture Biosciences,
are increasingly complex, time-consuming, and Valitacell, BiologIC Technologies, and Trakcel
expensive, with challenges associated with scaling up have developed innovative platforms and solutions
and reproducibility. Manufacturing of these advanced for biopharma companies and CDMOs that can
biopharma products using microbial, or mammalian be adopted in their workflows. US-based Nucleus
cell lines needs to be safe, reliable, and cost-effective Biologics’ AI-enabled NB-AIR (first of its kind
to enable the production of industrial levels of globally) and NB-Lux are AI platforms that help
therapeutics with the desired quality. select optimal cell culture conditions and identify
precision formulations suitable for CGTs.
While bioprocessing technologies have advanced
exponentially over the years, with a shift to On a similar note, Hong Kong-based Great Bay
digitisation, single-use systems, robust analytics, Bio (GBB) has also launched AI-powered platforms
and near real-time product release (enabled by for cell line development and media design, known
in-line or at-line monitoring), enabling continuous as AlfaCell and AlfaMedX respectively. It aims
manufacturing for traditional vaccines and mAbs, to develop AI-based end-to-end solutions for
there is still a huge unmet need to replicate this biomanufacturing. Similarly, Culture Biosciences
for advanced modalities. It is therefore critical to has a cloud-based platform that helps in scaling
optimise the cell culture conditions, upstream and up bioprocesses, designing optimal bioreactor
downstream processes, and monitor and control the conditions to translate from bench to the bioreactor,
processes and product characteristics to improve and achieving desired manufacturing efficiency.
yield, quality, and overall process efficiency. The
COVID-19 pandemic has created a huge demand for Unravelling “Unknown” Patterns
scalable and rapid manufacture of mRNA vaccines
and other vaccine formats, making it a strategic A key bottleneck in biopharma manufacturing is
imperative to focus on high throughput, scalable, and to achieve the desired critical quality attribute (CQAs)
cost-effective manufacture of such biomolecules. by optimising process variables known as critical
process parameters (CPPs) based on conventional
Artificial intelligence (AI) has already made a multivariate data analysis (MVDA). With an
huge impact on the healthcare industry with multiple improved understanding of the non-linear, complex
stakeholders across the healthcare continuum relation between CPPs and CQAs, and the growing
leveraging data-driven tools and AI in their number of CPPs, the adoption of advanced modelling
workflows, with the highest impact in drug discovery solutions and ML algorithms can support the
and diagnostics. The biopharma manufacturing development of a QbD (quality by design) approach
industry has also started embracing Bioprocessing

ARTIFICIAL INTELLIGENCE 41

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

for biopharma manufacturing. The use of soft sensors The potential for growth of biopharma
based on advanced neural networks such as ANNs manufacturing is picking up in Asia
(artificial neural networks), DNNs (deep neural and is poised to grow over the next
networks), and RNNs (recurrent neural networks), decade. Many of the new bioprocessing
can boost upstream processes by predicting the facilities are being built in the region,
impact of different CPPs on CQAs, and pave the way with advanced digitisation and AI
for the development of robust models, which can be capabilities. Some of the key players
used to standardise GMP for biologics and develop a are making enormous investments
DoE (design of experiment) approach. in capacity building as well as
strengthening infrastructure and
Augmenting bioprocess monitoring with AI data-enabled platforms, presenting a
can be useful for analysing large amounts of data potential market opportunity for AI-
generated by the manufacturing processes, which augmented bioprocessing.
are used to develop predictive models and build in
silico Digital Twins to guide process optimisation. Globally renowned bioprocess software
The seamless integration of AI and advanced deep developers have also partnered with Asian entities.
learning algorithms across the bioprocessing value For instance, one of the key innovators in the
chain right from cell culture and media optimisation biomanufacturing software and digital twin solutions
to upstream processing, downstream processing, space – Insilico Biotechnology (headquartered in
and overall operations would improve the efficiency Germany) – had partnered with several companies in
and robustness of bioprocessing. It can simplify the Asia before being acquired by Yokogawa Electric Corp
integration and analysis of siloed, multimodal data (Japan) in November 2021. Insilico’s AI solutions
and decipher “hidden” patterns and develop predictive include digital twin models and real-time process
models for process optimisation. Deep learning-based monitoring to improve the cell culture environment.
soft sensors that use DNNs have been shown to be In October 2021, Insilico Biotechnology, had entered
accurate even without extensive training data sets. into an agreement with Ajinomoto and its subsidiary
Ajinomoto Genexine Co. Ltd., to leverage Digital
Poised to grow further twin technology to improve process development and
production of biologics.
The potential for growth of biopharma
manufacturing is picking up in Asia and is poised The collaborative landscape is also evolving with
to grow over the next decade. Many of the new many established CDMOs leveraging partnerships
bioprocessing facilities are being built in the region, with AI platform developers such as the one between
with advanced digitisation and AI capabilities. Some Swiss-based Securecell and Japanese company
of the key players such as Wuxi Biologics, Samsung Yokogawa Life Science which uses advanced process
Biologics, Yokogawa, Celltrion, Beigene, and Dr. information management systems to optimise mAb
Reddys are making enormous investments in capacity productivity. Product characterisation using AI
building as well as strengthening infrastructure is a lesser traversed area, especially for complex
and data-enabled platforms, presenting a potential biomolecules and their visualisation remains a
market opportunity for AI-augmented bioprocessing. key bottleneck in novel therapeutics and vaccine
manufacturing. Waters Corporation, a reputed
Within Asia, China, Japan, & Singapore lead in US-based instrumentation company partnered
terms of initiatives, innovations and partnerships in with A*STAR’s Bioprocessing Technology Institute
the data & AI-powered bioprocessing space. China- (BTI) in 2021 to advance structural analysis and
headquartered Beigene has made rapid strides in annotation of complex biomolecules using advanced
the digital biomanufacturing space & was the first bioinformatics and ML.
company to launch a digitised “paperless” biological
manufacturing facility in China in its Guangzhou site. Though the overall AI-based bioprocessing
In addition, manufacturing efficiencies are also being ecosystem is still nascent in Asia, and the innovation
improved with the integration of 3D modelling, digital index is lower compared to the US and Europe,
twin, augmented interfaces, and AI in the plant. On a recent investments, and the proactive approach of the
similar note, China-based WuXi Biologics leverages biomanufacturing companies operating in the region
AI in its WuXia Cell line Development Platform & is will spur further innovations and developments.
leveraging big data analytics and AI in its bioprocessing
workflow. Samsung Biologics (South Korea) has
also been quick to adopt AI & advanced data-driven
analytics in its biologics manufacturing units.

42 AMR

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Broad-impact Tech Against AMR Threat

« pathogen, so researchers need to focus efforts on
developing convergent technologies and making
Dr Peter Dedon, fundamental mechanistic discoveries that can
be broadly translated to all AMR pathogens, and
Co-Lead Principal ultimately to clinical studies and commercial
products for the public.
Investigator,
Thus, the Antimicrobial Resistance
SMART AMR, Interdisciplinary Research Group (AMR IRG) at the
Singapore-MIT Alliance for Research Technology
Singapore, and (SMART) – the Massachusetts Institute of
Technology’s (MIT) research enterprise in Singapore
Singapore Professor of strives to tap into the country’s robust research
and deep tech ecosystem to advance the tools that
Biological Engineering, governments and healthcare professionals can use to
detect and treat AMR infections.
MIT, USA
Precision diagnostics
According to one of the most comprehensive
studies of antimicrobial resistance (AMR), Developing accurate and rapid diagnostic
4.95 million deaths were associated with – methods is essential to prevent erroneous use of
including 1.27 million deaths attributed to – bacterial antibiotics before pathological analysis. Existing
AMR in 2019. Forecasts show that by 2050, the Asia methods – such as microbial cultures or polymerase
Pacific region will account for 47 per cent of AMR- chain reaction (PCR) tests – require a longer
related deaths worldwide. Left unaddressed, AMR- turnaround time for results, and often the amount
related costs in Asia are projected to rise from $550 of a pathogen in a sample is too low, leading to
billion to $700 billion by 2050, absorbing 0.8 per inaccurate results. In clinical settings, rapid and
cent to 1 per cent of regional gross domestic product affordable point-of-care tests that can distinguish
(GDP). between bacterial and viral infections would reduce
unnecessary antibiotic prescriptions at the first
As the rapidly growing AMR threat transcends line of care. In parallel, researchers are also mining
geography, economic status, and culture, we must large datasets for potential markers that distinguish
find novel solutions that can be rapidly translated to bacteria from viruses.
commercial products for public health.
With current standard testing being inaccurate
Singapore recognises the urgency of this AMR and time-consuming, SMART has developed quick
issue, with a robust suite of education, infection and easy methods for concentrating microbes in
control, and research programmes implemented by clinical samples for better evaluation accuracy in a
local ministries and agencies responsible for human cost-effective configuration.
health, animal health, food and the environment.
Developing new therapies
AMR is a ‘hidden pandemic’ that affects all forms
of infectious disease: viruses, bacteria and parasites. Beyond encouraging wise use of
These pathogens are all capable of developing antimicrobial agents, new therapies
resistance to vaccines and drugs, with the situation are needed to protect patients
exacerbated by the overuse of antibiotics.

Novel, high-impact solutions: Top priority

Apart from preventing excessive use and
misuse of antibiotics through shepherding and use
restrictions, other tools for combating AMR include
monitoring, diagnostics, therapeutics, and regulatory
reform. However, according to a 2021 report by
the World Health Organisation, the antimicrobial
pipeline was described as stagnant and far from
meeting global needs. COVID-19 made things worse
by diverting research efforts and investor attention.
It’s time now to refocus on developing adaptive
solutions to combat AMR.

The AMR problem is not limited to a specific

AMR 43

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

and prevent AMR. Fortunately, advances in combinations that are effective at targeting highly
understanding pathogens and developing new drug-resistant tuberculosis-like infections.
technologies are already leading to new solutions:
antibiotics to which pathogens have not developed What’s next?
resistance, drugs that reverse resistance (similar
to the classic Augmentin), and bacteriophage and With the soaring rate of AMR, the push to develop
antibody biologics capable of attacking specific AMR novel technologies will help us design and discover
pathogens. new therapeutics against ever-evolving pathogens.
These will lead to improved patient outcomes,
For example, SMART AMR’s researchers recently reduced antimicrobial use, and some degree of
discovered a novel phage lysin Abp013, an enzyme control of the AMR problem. Nevertheless, AMR
with promising potential as an antibiotic alternative, threats persist because microbes are capable of
especially against drug-resistant strains of evolving and adapting unpredictably. Minimising the
Acinetobacter baumannii and Klebsiella pneumoniae problem is the goal of the researchers.
– superbugs responsible for life-threatening
infections such as pneumonia and meningitis. With New types of therapies – such as antibodies
the ability to penetrate the bacterium and kill it, and bacteriophage – will broaden our arsenal of
Abp013 quickly and directly targets key structures bacteria-killing solutions. Recent efforts by SMART
in a bacteria’s cell walls. This discovery opens the AMR Investigators have shown that developing
door to engineering potent lysins that target AMR antimicrobial antibodies can take less than four
pathogens. months with new computational and analytical tools.
Using multiplexed analytics could further reduce
SMART AMR’s researchers are also developing antibody development costs to make this therapeutic
nanoparticles capable of transporting therapeutics modality more affordable. The widespread and
through thick infection biofilms, in which the bacteria cost-effective application of bacteriophages to cure
temporarily stop growing and become drug tolerant. drug-resistant infections requires significantly more
By using nanoparticles to deliver drugs directly investment in R&D than currently available.
into the biofilm, the bacteria have fewer chances of
survival and develop permanently resistant strains. Further, investment in developing small molecule
antimicrobials still represents the most rapid, cost-
Innovative bacteriophage-based therapies are effective, and practical public health solution to AMR,
also being designed to treat bacterial infections with more drug combinations for an optimal and
in individuals and communities around affected affordable approach.
patients. Bacteriophages are viruses that identify
and kill bacteria highly specifically – even antibiotic- It is not so much the science and technology
resistant strains – and have been used in patients that are holding us back from tackling AMR, but the
with chronic, untreatable bacterial infections. economics of developing new antimicrobials. Most
new companies that have been granted FDA approval
Boston-based biotechnology company PhagePro for new antimicrobials have gone bankrupt due to
Inc. has developed an oral dose of bacteriophage development costs not being repaid by drug sales.
to protect at-risk household members of cholera This is due to mandatory hold-back policies to use the
patients, and platform technologies such as this new drugs only for otherwise incurable infections, the
billion-dollar costs to develop new drugs, and the fact
could be adapted for the protection against other that most countries cannot afford high drug prices.
deadly bacterial infections. The next Thus, it’s essential to adopt proactive government
frontier in phage-based therapy and economic policies to lower the financial burden
includes further engineering of antimicrobial development, coupled with new
phage “cocktails” and science and technology to reduce discovery and
developing phage-derived development costs.
antimicrobials for the swift
targeting of antimicrobial COVID-19 has demonstrated how focus,
pathogens. dedication and cooperation within the scientific,
This innovation extends industrial, and government communities can
to technologies to rapidly overcome pressing issues of concern at remarkable
screen drugs to identify speeds – giving rise to new innovations. Although it
combinations that resensitise AMR may take a while to see novel ideas transformed into
clinical use, broad- and high-impact solutions born
microbes to widely-used antibiotics. For from collaboration and emerging deep technology
example, such high-throughput screening may help us in our continued fight against AMR.
has led to the development of drug

44 ACADEMIC S NEWS

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

NTU Singapore and Imperial College London strengthen ties

Building on their successful research and development Hub the two universities
collaboration in setting up the Lee that tackle some of the world’s will explore ways that new
Kong Chian School of Medicine most pressing challenges. This technology can be harnessed
(LKCMedicine), Nanyang includes- Artificial intelligence to improve diagnostics,
Technological University, (AI) and robotics for healthcare; treatments, and care of patients.
Singapore (NTU Singapore) Healthy cities and pollution; The partnership will also see
and Imperial College London Neuroscience; and Infectious the two universities carry out
have signed a new strategic disease modelling. Through joint training for PhD students
university-wide partnership the NTU-Imperial Health, and early career researchers
to expand their scope of Sustainability and Technology and promote academic and
collaboration across research, knowledge exchange between
education, and innovation and the institutions. New research
enterprise. The two universities projects that have been identified
are establishing the NTU- include the development of
Imperial Health, Sustainability a diabetes AI network led by
and Technology Hub (NTU- NTU LKCMedicine’s Professor
Imperial Research Hub), which Josip Car in collaboration with
will focus on collaborative Imperial’s Dr Pantelis Georgiou
research in fields of scientific and Professor Nick Oliver.

One Health Trust & China nurtures
young optometrists
BITS Pilani offer PhD by providing
clinical training
programme in Data Sciences for global health
The Birla Institute of Technology and Science, The Hong Kong Polytechnic University (PolyU)
Pilani (BITS Pilani), India and the One Health has joined hands with Aier Eye Hospital Group to
Trust (founded as Centre for Disease Dynamics, provide six to eight weeks of clinical training in
Economics & Policy or CDDEP) have agreed to Aier’s eye hospitals and clinics in mainland China
establish a PhD programme in Data Sciences for and overseas cities for a maximum of 30 selected
Global Health to train graduates/ postgraduates students with outstanding academic performance
on current global health issues and cutting-edge from PolyU’s School of Optometry in five years.
research methodology, with rigorous fieldwork and The two parties will also explore opportunities
data analysis. The unique full-time interdisciplinary to conduct collaborative research on major eye
degree will provide advanced education in global health challenges. The partnership brings together
health along with expertise in statistical/quantitative the complementary strengths of the School’s
and qualitative skills to future students. The first world-leading research capability (with its
cohort will begin coursework in July 2023. Students research impact ranking first in Asia according to
will take courses and conduct research at both BITS Clinical and Experimental Optometry), and Aier’s
Pilani, Hyderabad, and at the Nimai Valley Center of vast network of over 900 hospitals and clinics in
the One Health Trust, set to open in January 2024. Asia, the US, Europe, and Southeast Asia, making
it a leading global ophthalmology hospital group.
The School has been proactively collaborating
with local ophthalmologists and counterparts
around the world to provide students with hands-
on experience, preparing them for their future
careers in optometry. With the clinical training
offered by Aier, the students will further benefit.

PEOPLE NEWS 45

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com Shreehas

Antengene appoints Amily Tambe steps
Zhang as Chief Medical Officer
in as Managing
China-based startup Antengene Corporation has announced that
Amily Zhang has been appointed as the company’s Chief Medical Director &
Officer, succeeding Dr Kevin Lynch who will continue working with
Antengene in a senior advisory role. Before joining Antengene, CEO of Biocon

Amily served in various key leadership positions Biologics
in clinical development at Jiangsu Hengrui
Pharmaceuticals, including Vice President, Shreehas Tambe, Deputy Chief
Head of Clinical Development - Oncology, Executive Officer (CEO) of Biocon
Corporate Vice President and Chief Medical Biologics, has been appointed as
Officer for Oncology. Under her leadership, the Managing Director and CEO
Hengrui Pharma successfully obtained of the company from December
multiple Investigational New Drug (IND) 5, 2022. Tambe will lead Biocon
approvals in China and the US, as well as Biologics in realising its goal
of being a global biosimilars
numerous New Drug Application (NDA) approvals leader. Tambe takes over from
in China, in nearly three and a half years. Building on strong expertise Dr Arun Chandavarkar, who
in oncology and a wealth of experience in the pharmaceutical industry, will continue to serve as a non-
Amily will spearhead Antengene’s global clinical development strategy Executive, non-Independent
and continue to build out the company’s medical team. She will be Director on the Board of Biocon
based in both New Jersey, the United States, and Shanghai, China. Biologics. As Deputy CEO of
Biocon Biologics since March
CSL announces Dr Paul 2021, Tambe has played an
McKenzie as next CEO & MD important and very effective
role in supporting Dr Arun
The Board of Directors of CSL Limited, Australian pharma major, has Chandavarkar steer the company
appointed Dr Paul McKenzie as Chief Executive Officer (CEO) and towards sustainable growth and
Managing Director (MD) of CSL from March 6, 2023. Dr McKenzie build a strong foundation for the
will succeed Paul Perreault, who has advised the Board of his intention future. Both have also played an
to retire after serving 10 years in the role, and more than 25 years with integral role in Biocon Biologics’
the company. Dr McKenzie has been appointed following a thorough historic acquisition of Viatris’
process conducted by the Board. Currently serving as CSL’s Chief global biosimilars business
Operating Officer (COO), Dr McKenzie, will immediately join the and the strategic alliance with
Board of Directors as an Executive Director. Perreault will step down Serum Institute Life Sciences
as CEO and from the CSL Board of Directors on March 6, 2023 and (SILS), which will drive the
he will remain with the company as a strategic adviser to assist in an company’s future growth and
orderly transition until he retires on September 6, 2023. Dr McKenzie create long-term value for all its
has more than 30 years of leadership experience in the global stakeholders. Tambe has been
biotechnology industry, including managing complex organisations with Biocon since 1997 and has
through compelling growth and transformation. Since held diverse leadership and
joining CSL as COO in 2019, Dr McKenzie has been operational roles.
accountable for optimising CSL’s operations as
well as growing the CSL Seqirus, CSL Plasma, and
CSL Vifor businesses. He transformed CSL’s global
end-to-end operations, advanced CSL Seqirus’
differentiated portfolio strategy, and
led CSL Plasma through COVID-19
challenges while surpassing plasma
collection volumes beyond pre-
pandemic levels.

46 PEOPLE NEWS BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Evelyn Pang AstraZeneca India appoints
takes charge Dr Sanjeev Panchal as
as General Country President & MD
Manager of
Moderna AstraZeneca Pharma India has announced a change in its leadership
Singapore with the appointment of Dr Sanjeev Panchal as Country President &
Managing Director (MD), with effect from
US-based pharmaceutical firm January 1, 2023. Dr Panchal has been with
Moderna has appointed Evelyn AstraZeneca for 19 years and began his
Pang as its Singapore General career in India back in 2003 as a Brand
Manager. A pharmacist by Associate. Over time, he progressed through
training, Evelyn joins Moderna several positions in India, Indonesia, Asia
with a wealth of experience Pacific and the International region, based
across many different roles in Singapore and the UK. He was previously
within the healthcare industry. the Country President for AstraZeneca
With a strong hold on sales, Malaysia, where he has been instrumental
marketing, medical, strategy in transforming the business, by driving
planning and commercial new launches, innovative patient centric
operations roles for Singapore, partnerships and Market Access strategies, guiding an inclusive and
Japan-Asia Pacific Region, diverse team to achieve double digit growth outpacing the market.
she has successfully launched
blockbuster brands in both SK Biopharmaceuticals names
primary and specialty care Donghoon Lee as new CEO
areas including immunology,
oncology, diabetes, cardiology, South Korea-based SK Biopharmaceuticals has named Donghoon
CNS and vaccines; and Lee, Executive Vice President and Head of Bio Investment Centre
maximised life cycle of SK Inc., as the new Chief Executive Officer (CEO) and President
management of these products of SK Biopharmaceuticals and its US subsidiary SK Life Science,
through strategic medico- effective January 1, 2023. Lee will bring expertise in global new
marketing and resilient crisis business development and deal-making to further spur the growth of
management plans. In the SK Biopharmaceuticals. Dr Jeong Woo Cho, who had been the CEO
Asia-Pacific region, Moderna of SK Biopharmaceuticals and SK Life Science since 2017, will serve
has a commercial presence in as the President of Future Growth. Lee previously held leadership
Australia, Hong Kong, Japan, positions at a renowned global professional services firm,
South Korea, Singapore, KPMG, and pharmaceutical companies, including as
and Taiwan, with plans to the CEO and Executive Vice President of Dong-A
also establish a commercial Socio Holdings. At SK Inc., Lee headed the Bio
presence in Malaysia. Investment Centre, executing key investment deals
in line with SK Group’s vision to fortify battery,
bio, and chip (BBC) businesses as its main growth
drivers. He spearheaded SK’s global deals such as
launching a US joint venture called ProteoVant, a
protein degradation company, with Switzerland-
based Roivant Sciences; acquiring France-
based Yposkesi, a CDMO for cell and gene
therapies; and making investments in the
Centre for Breakthrough Medicines,
a Philadelphia-based cell and gene
therapy CDMO, and Singapore-based
biotech company Hummingbird.

R&D NEWS 47

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Australian first research trial Hong Kong develops
to explore use of psychedelics
for alcohol use disorder new aptamer drug

Researchers at the University of Sydney are embarking on for bone anabolic
an Australian first research trial into the use of psychedelics
in combination with psychotherapy for the treatment of therapies
alcohol use disorder. The trial builds on a growing body
of innovative research on psychedelic medications for A research team led by Hong Kong
substance use disorders supported by the National Health Baptist University (HKBU) has identified
and Medical Research Council, Medical Research Future a molecular target for bone amabolic
Fund and pharmaceutical industry partners. The University therapies using a selected aptamer that
plans to conduct a randomised placebo-controlled Phase serves as an inhibitor of sclerostin, a
IIB trial of a novel synthetic formulation of the naturally protein that prevents bone growth. The
occurring psychedelic, psilocybin, developed by Sydney- discovery offers hope for the development
based company Woke Pharmaceuticals. The trial is designed of an effective next-generation treatment
to recruit participants with alcohol use disorder who are for osteoporosis and osteogenesis
unresponsive to current therapies. Psilocybin, the drug to imperfecta that is free of cardiovascular
be used in the trial, is a naturally occurring psychedelic risk compared to the marketed antibody
prodrug produced by more than 200 fungi. When used drug. The research findings have been
in combination with psychotherapy, a previous proof-of- published in the international academic
concept study indicated that psilocybin may be effective for journals Nature Communications and
the treatment of people with alcohol dependence. Theranostics. The new drug is at the pre-
clinical trial development stage, and the
research team plans to start clinical trials
in the US and China in 2024. Osteoporosis
is a metabolic condition which leads to
a reduction in bone density, resulting in
weakened bones that are more fragile and
likely to break. Osteogenesis imperfecta,
also known as “brittle bone disease”,
is a rare congenital genetic disorder
characterised by extremely fragile bones.

Singapore offers affordable and
highly sensitive blood test for cancer

Scientists from the National up to S$1,000 to conduct. The industry partnerships to bring
University of Singapore (NUS) team, comprising researchers their technology to market. The
have discovered a novel low-cost from the NUS Department of Heatrich-BS assay has been
method of testing for cancers. Biomedical Engineering under trialled at the National Cancer
Called the Heatrich-BS assay, the College of Design and Centre in Singapore, monitoring
this new test sequences clinical Engineering as well as the NUS patients with colorectal cancer.
samples that have been heated Institute for Health Innovation By comparing the results of their
in order to isolate cancer-specific & Technology, is now exploring blood analysis with CT scans
signatures found in a patient’s that imaged the size of patients’
blood. The new method provides tumours, the team found that
a promising non-invasive there was a high correlation
alternative to tissue biopsies. It between how much cancer-
costs around S$50 from start specific DNA was detected in a
to finish, compared to other patient’s blood sample and the
sequencing methods that can cost size of their tumours over time.

48 R&D NEWS

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

CELLINK, IISc Thailand develops speech-
recognition AI tech for
launch first Centre screening depression

of Excellence for 3D A team of scientists at Chula Computer Engineering,
Chulalongkorn University in Thailand has developed
bioprinting in India “Gowajee” a Thai speech-recognition artificial intelligence
(AI) technology that understands and executes commands
Sweden headquartered CELLINK, the in the Thai language more naturally and accurately. Actual
global leader in developing 3D bioprinters, usage has shown only a 9 per cent incidence of linguistic
and the Indian Institute of Science (IISc), inaccuracy compared to 15 per cent for other language-
Bengaluru have opened the doors to the recognition AIs. The AI-based technology has three main
first 3D bioprinting Centre of Excellence features: Automated Speech Recognition (ASR); Text-
(CoE) in the Indian subcontinent. Housed to-Speech (TTS); and Automatic Speaker Verification
in the Centre for BioSystems Science and (ASV). Gowajee has been used for screening patients
Engineering (BSSE) at IISc’s Bengaluru with depression. Though the emotional contexts proved
campus, the CoE will provide access to 3D challenging, Gowajee performed well in decoding emotional
bioprinting systems, enabling researchers cues. The AI technology can also be used in many other
to accelerate their work across critical contexts such as dental clinics, detection of stroke risk in
applications with the ultimate goal of patients with slurred speech, life coaching, and aids for the
improving health outcomes. The CoE hard of hearing.
currently houses several CELLINK
instruments, including the BIO X, BIO X6
and the BIONOVA X. It will now officially
be accessible to the region’s current and
future researchers. This CoE offers the
most cutting-edge and industry–leading
3D bioprinting technology that CELLINK
has developed, to enable significant
strides in research and in developing the
future of health.

Korea designs myocardial infarction treatment patch

Myocardial infarction is an cell regeneration. A joint team of on the utilisation of a thermos-
ischemic disease in which a researchers at Pohang University responsive nanofiber membrane.
coronary artery supplying of Science and Technology Their work has attracted attention
blood to the heart muscle is (POSTECH) and Catholic from academic circles for
stenotic or obstructed, resulting University of Korea, along with developing a human umbilical
in cardiac tissue necrosis. Kiwon Ban of the City University vein endothelial cell (HUVEC)
Due to the irreversible loss of Hong Kong, has announced the sheet specially designed for
of cardiomyocytes, damaged successful transplantation of a enhancement of an angiogenesis
heart tissue cannot be naturally highly integrable in vivo priming (formation of new blood vessels
regenerated. The most recent bone marrow mesenchymal from pre-existing vessels), which
effort to regenerate the damaged stem cell (BMSC) sheet based promoted cardiac repair when
heart tissue is to transplant transplanted together with the
stem cells to the damaged area. BMSC sheet. This technique
However, this approach has low is assessed to have proposed
engraftment rates stemming from a new-concept heart patch by
the highly curved surface of the improving the heart function
heart and its dynamic nature – for the treatment of myocardial
hindering the cells from settling infarction as well as increasing
on the heart to allow time for integration and engraftment.

SUPPLIER NEWS 49

BIOSPECTRUM | JANUARY 2023 | www.biospectrumasia.com

Prejex joins hands with Polybond
to make needle-less injections in India

Prejex Inc., a spin-off of needle-less injection is a cutting- reluctance of patients in drawing
Germany-based Prejex GMBH, edge innovation that the medical blood and receiving vaccines or
has entered into an agreement world has long been waiting for. intravenous fluids. Two different
with Polybond, headed by Prejex provides a solution to a
Adit Rathi of Rathi Group variety of issues that professionals models to
to manufacture needle-less face in day-to-day be launched
injections. This partnership operations. Syringes are the
has enabled shifting of the and disposable N-Jector
manufacturing capabilities of the needles Series—a single-
German company from Berlin are major dose disposable device; and
to India, for global distribution. contributors the Prejex Multi-Reusable Device.
The Prejex-Polybond factory will to toxic waste and their A broad spectrum of applications
make needle-less injections for disposal cost is sky-rocketing. can be covered using these
the entire world. Prejex’s New Trypanophobia (fear of needles) needle-less injections including
Drug Delivery System (NDDS) via is a common factor leading to the diabetes, oncology supportive
care, biosimilars, vaccines etc.

Agilent unveils Thermo Fisher opens
new facility in China
new customer
Thermo Fisher Scientific is opening a new facility in Hangzhou,
experience China, as part of its global effort to help companies provide
therapies to patients more quickly. The site can address the needs
centre in US of organisations in China, as well as those outside that country,
for biologics and steriles development and manufacturing
Agilent Technologies Inc. has capabilities in the Asia Pacific region. The 80,000-square-
announced the opening of a new metre current Good Manufacturing Practices (cGMP) facility
Customer Experience Centre (CEC) in will offer integrated clinical and commercial drug substance
Lexington, MA, in the US, focused on and drug product capabilities, including process development,
solutions from Agilent genomics and cell line development, biologics drug substance manufacturing
diagnostics product portfolios. The and sterile fill-finish. Eventually, it will also feature commercial
facility will serve as a regional hub for packaging and labelling capabilities. Advanced technologies
Agilent representatives to showcase in the facility include Thermo Fisher 2,000-litre HyPerforma
and demonstrate both product Single-Use Bioreactors and associated Single-Use equipment
capabilities and complete workflow and, in the future, bioreactor capacity up to 5,000 litres through
solutions to customers. Hands-on Thermo Scientific DynaDrive technology. The site incorporates
training, education, assay development, stringent quality control processes that meet or exceed regulatory
and optimization are critical to a guidelines established by the China National Medical Products
laboratory’s success. Scientists are Administration (NMPA), the US Food and Drug Administration,
looking for suppliers to support their and authorities in Europe and elsewhere.
discovery work and product and
solution development efforts. The new
Agilent CEC delivers an immersive
experience for pathologists, clinicians,
and researchers to increase their
confidence in using Agilent products
to meet the unique needs of their lab.
The facility is strategically located
where Agilent has a high concentration
of genomics and pathology customers
who can easily access the CEC.

50

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Data-driven War on AMR
The emergence and spread of drug-resistant
pathogens that have acquired new resistance COVID-19 pandemic.
mechanisms, leading to antimicrobial However, AMR rates remain difficult to interpret
resistance (AMR), continues to threaten our ability
to treat common infections. Especially alarming is due to insufficient testing coverage and weak
the rapid global spread of multi- and pan-resistant laboratory capacity, particularly in low- and middle-
bacteria (also known as superbugs) that cause income countries. To overcome this critical gap, the
infections that are not treatable with existing WHO will follow a two-pronged approach aiming at
antimicrobial medicines such as antibiotics. short-term evidence generation through surveys and
long-term capacity building for routine surveillance.
According to the World Health Organisation This will entail the introduction of representative
(WHO), AMR occurs naturally over time, usually national AMR prevalence surveys to generate AMR
through genetic changes. Antimicrobial resistant baseline and trend data for policy development
organisms are found in people, animals, food, plants and monitoring of interventions and an increase of
and the environment (in water, soil and air). They can quality-assured laboratories reporting representative
spread from person to person or between people and AMR data at all levels of the health system.
animals, including from food of animal origin. The
main drivers of AMR include the misuse and overuse The clinical pipeline of new antimicrobials is dry.
of antimicrobials; lack of access to clean water, In 2019 WHO identified 32 antibiotics in clinical
sanitation and hygiene (WASH) for both humans development that address the WHO list of priority
and animals; poor infection and disease prevention pathogens, of which only six were classified as
and control in healthcare facilities and farms; poor innovative. Furthermore, a lack of access to quality
access to quality, affordable medicines, vaccines and antimicrobials remains a major issue. Antibiotic
diagnostics; lack of awareness and knowledge; and shortages are affecting countries in all levels of
lack of enforcement of legislation. development and especially in healthcare systems.

A latest report from WHO reveals high levels Antibiotics are becoming increasingly ineffective
of resistance in bacteria, causing life-threatening as drug-resistance spreads globally leading to
bloodstream infections, as well as increasing more difficult to treat infections and death. New
resistance to treatment in several bacteria causing antibacterials are urgently needed – for example, to
common infections in the community based on data treat carbapenem-resistant gram-negative bacterial
reported by 87 countries in 2020. infections as identified in the WHO priority pathogen
list. However, if people do not change the way
The Global Antimicrobial Resistance and Use antibiotics are used now, these new antibiotics will
Surveillance System (GLASS) report shows high suffer the same fate as the current ones and become
levels (above 50 per cent) of resistance in bacteria ineffective.
frequently causing bloodstream infections in
hospitals, such as Klebsiella pneumoniae and Responding to trends of AMR requires high-level
Acinetobacter spp. These life-threatening infections commitment from countries to boost surveillance
require treatment with last-resort antibiotics, such capacity and provide quality assured data as
as carbapenems. However, 8 per cent of bloodstream well as action by all people and communities. By
infections caused by Klebsiella pneumoniae were strengthening the collection of standardised quality
reported as resistant to carbapenems, increasing the AMR and antimicrobial consumption (AMC) data,
risk of death due to unmanageable infections. the next phase of GLASS will underpin effective data-
driven action to stop the emergence and spread of
Although most resistance trends have remained AMR and protect the use of antimicrobial medicines
stable over the past four years, bloodstream for future generations.
infections due to resistant Escherichia coli and
Salmonella spp. and resistant gonorrhoea infections AMR threatens contemporary medicine
increased by at least 15 per cent compared to rates and endangers the lives of millions of people.
in 2017. More research is needed to identify the Microbiology testing must be expanded and quality-
reasons behind the observed AMR increase and to assured data must be made available to all nations,
what extent it is related to raised hospitalisations not just the so-called first world nations.
and increased antibiotic treatments during the
Narayan Kulkarni
Editor

[email protected]