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4 BIO EDIT

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Dr Milind Kokje PRACTISING ‘HUMANE’ R&D

Chief Editor Adrive to phase out the use of animals in research and testing appears to be
gathering momentum and would continue to move ahead towards some concrete
[email protected] steps in the new year. Recently, Taiwan’s Vice President William Lai supported the
development of animal-free research methods in Taiwan. Taiwan is planning to establish
a centre for the 3 Rs (Replace, Reduce, Refine) to improve conditions for animal-free
research. It has already finalised a regulation to remove animal-testing health marketing
claims about food products. Just prior to that, the European Parliament (MEP) committed
itself to the cause by passing a resolution to make an action plan to curb animal testing.
Members of the European Parliament (MEP) requested the preparation of a European
Union (EU)-wide action plan with ambitious and achievable objectives and timelines for
phasing out use of animals in research. The members also supported a move to speed-up
the transition to innovative methods of research and testing without animals.

Around the same time, the People for Ethical Treatment of Animals (PETA) urged
India’s Prime Minister Narendra Modi to devise an action plan for India to phase out the
use of animals in research and experiments. Animals are used in testing because humans
share 90 per cent of their genes with other animals and both the humans and animals have
the same vital organs like hearts, lungs, brain, etc. Animals are used to predict the possible
effects the newly developed drugs will have on the human body. In the US, approximately
47 per cent of the National Institutes of Health (NIH) budget funds animal experiments.
Thousands of animals which are used each year in laboratories world over in drug-related
experiments and safety and efficacy tests, have to endure untold suffering, including death.

Naturally, animal activists and organisations like PETA are against the use of animals
in research. They claim that there are numerous scientific studies and reviews which
reveal that experiments on animals do not necessarily provide effective treatments and
cures for human diseases. PETA’s ‘The Research Modernisation Deal 2021’ report claims
that failure rates of new animal-tested drugs developed for certain diseases exceeds 95
per cent. For example, in case of cancer, it is 96.6 per cent and HIV vaccine is 100 per
cent. Nearly 95 per cent of all new drugs that test safe and effective in animal tests fail or
cause harm in human clinical trials, the report further claimed.

Though the concern of the animal activists towards animals is genuine and needs to
be considered, the role of animals in development of drugs has also been proved to be
important. In the UK, the five year survival rate of breast cancer was 50 per cent 40 years
back. It increased to 80 per cent now due to advances in treatments. Same is the case
with Leukaemia in children. The five year survival and full recovery rate was only 30 per
cent 20 years back and it has improved to 80 per cent now. The Ebola vaccine, which
was tested for safety in animals, showed promising results in humans, as in 2015 it was
found to be 100 per cent safe in 7,500 people. There are several similar cases about many
other diseases, which we don’t find dangerous or life threatening or non-curable due to
therapies developed after initial testing on animals.

Some scientists agree that the animals should not be used but some feel there is no
other alternative to testing on animals. Strict regulations are already in place with regard
to use of animals in drug testing. These can be further tightened with the changing
circumstances and development of alternative methods of research and tests where
animals are not needed. Animal tests for manufacturing cosmetics are already banned
in UK, Europe and several other countries. This ban can be imposed everywhere. For
research related to food processing also, a similar ban can be imposed. In case of drug
discovery and tests, a proper risk-benefit ratio must be determined by implementing a
cost benefit analysis system for research involving animals.

From 2022 onwards let’s hope that one branch of research will focus on adopting
alternative methods to animal testing in R&D. It is a long process to reach a goal of
not using animals in research so that we finally start displaying characteristics of a
‘compassionate society.

BIO MAIL 5

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

www.biospectrumasia.com S$ 5.00 Acknowledgements that it’s not too technical and I can
Huge thanks to BioSpectrum, the easily grasp the concepts. It’s also
Volume 16 | Issue 12 | December 2021 interview with Dr Udit Batra, President good that it covers stories from various
and Chief Executive Officer, Waters Asian countries which gives a better
Reality of Universal Cancer Prevention & Cure - 31 Corporation, is excellent and the layout perspective and understanding of the
“Our goal is to decouple process from the product.” in both magazines- BioSpectrum India latest news. Thank you featuring ASN
-Dr Udit Batra, President and Chief Executive Officer, and Asia, is very impressive! Thank you Technologies and MaTerra Solutions.
Waters Corporation, USA – 38 again for your interest. Wishing you,
your staff and your family a wonderful, - Paul Avila, Singapore
MCI (P) 014/06/2021 healthy and safe end to 2021 and best Thanks for choosing FedEx as one
wishes for a blessed 2022. of the contributors to the cover story
piece in BioSpectrum Asia, much
- Kevin Kempskie, US appreciated.

There has never been more disruption - Summer Reading, Singapore Happy New Year
in the biopharma industry and 2021 All went good with the placement of
is just the beginning. Our efforts in the interview snippet of Menarini BIOSPECTRUM
2021 laid the foundation for the future Asia-Pacific and happy with the way the WISHES ITS
and will only catapult us to greater cover story turned out! READERS,
heights in years to come. Thank you for
featuring Cytiva in the BioSpectrum - Louise Lam, Singapore CONTRIBUTORS,
Asia cover story. Envirotainer is thankful for this great ADVERTISERS
opportunity in BioSpectrum Asia’s
- Iris Zhao, China cover story, it’s much appreciated. AND ASSOCIATES

From a reader’s perspective, I find - Leila, Singapore
BioSpectrum Asia really insightful
and I like how it is written in a way

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6 BIO CONTENT

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

COVER STORY 18

DIGITAL RESET
Nothing could have prepared the world for the unprecedented chain of events over the past
two years. We prefaced 2020 and 2021 saying anything is possible, but no one saw this level
of hyper volatility completely disrupting business and life as we know it. While the world is
now firmly planted in a digital-format, the economic and business outlook for 2022 will remain
highly fluid owing to the pandemic. Moreover, it is indeed very likely that in 2022, the majority
of Asia Pacific’s GDP will be coming from digital products, services, and experiences across
industries, with life sciences being one of them.

20 26

SINGAPORE CHINA

Singapore is known globally for its economic With a population of more than 1.4 billion
development which continues to bring in world- and currently the world’s second-largest
class talent. It forms a veritable bridge between biopharmaceutical market, China has great
the east and west and a hub for adoption of new potential and benefits for the emerging
technologies and innovation. biopharmas that are launching niche and novel
therapies across the globe.
22
27
INDIA
JAPAN
The pandemic played the role of a catalyst
to solidify the country’s prowess as a global With one of the world’s fastest growing elderly
manufacturing hub. It has pushed India into populations, Japan is offering opportunities with
optimising the latent capabilities it possesses advanced and innovative products for exports, joint
across the public and private sector by promoting R&D and licensing-out technology at a rapid pace.
indigenous development and manufacturing
particularly in the space of diagnostics and
medical devices which is likely to continue in 2022.

24

TAIWAN

As Taiwan’s biomedical industry growth further
accelerates, global biopharma companies are
showing greater interest in potential strategic
collaboration and investment opportunities across
the industry’s value chain.

BIO CONTENT 7

BIOSPECTRUM | DECEMBER 2021 | www.biospectrumasia.com SPEAKING WITH

COVID-19 38

28 “We want to work with
global innovation leaders
Are boosters another in disruptive technologies”
Shot in the Dark?
SUPPLY CHAIN Erning Cao,
Investment Director,
31 Evonik Venture Capital, Asia Pacific, China

Can supply chains REFORMS
turn pandemic-proof?
ANTI-AGEING 40

35 2022 seeks
holistic revamping of
Seeking the ‘Fountain of Youth’ pharma regulations

Upendra N Sharma,
Partner,
J Sagar Associates, India

REGULARS

BioEdit.........................................................................04
BioMail........................................................................05
Policy and Regulatory News...................................08
Company News........................................................10
Finance News............................................................12
Start-Up News...........................................................13
World News...............................................................15
People News..............................................................42
R&D News..................................................................44
Academic News........................................................47
Supplier News...........................................................48
Lets Talk Health........................................................50

8 REGULATORY NEWS

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Australia invests $23.7 M to boost preventative health

Twenty-one health groups Advisory Bodies Programme so in the national health agenda.
across Australia will share $23.7 they can continue engaged, robust The Morrison Government’s
million over three years owing and constructive participation National Preventive Health
to the Australian Government’s Strategy is a 10-year plan to
National Preventative Health improve the health and wellbeing
Strategy, furthering support for of all Australians at all stages
the health and wellbeing of all of life. The strategy seeks to
Australians. Organisations such improve Australia’s health
as the National Rural Health system, fundamentally focused
Alliance, the Consumer Health on the treatment of illness and
Forum, and the Public Health disease, by increasing the focus
Association of Australia will on prevention, from illness to
receive funding through the third wellness, and from healthcare to
round of the Health Peak and health.

New Zealand Korea issues marketing
approves use of
Ronapreve to prevent authorisation to Moderna
& treat COVID-19
COVID-19 vaccine
The Ministry of Health’s medicine regulatory
arm Medsafe in New Zealand has approved a new American firm Moderna has announced that the
COVID-19 medicine Ronapreve that can both Ministry of Food and Drug Safety of Korea (MFDS)
prevent and treat COVID-19 though it is not a has issued a marketing authorisation for Spikevax,
substitute for vaccination and its effectiveness Moderna’s COVID-19 vaccine (mRNA-1273)
against the latest variant of concern is yet to manufactured by Samsung Biologics, a leading
be demonstrated. Ronapreve is a monoclonal global CDMO providing fully integrated end-to-end
contract development and manufacturing services.
antibody drug that mimics the This marketing authorisation obtained by Moderna
body’s natural defences for Korea officially allows
fighting disease. The clinical the Moderna’s COVID-19
advice is that it is a significant vaccine manufactured
advance, because it reduces the at Samsung Biologics’
severity of COVID-19 by keeping local pharmaceutical
more cases out of hospital production facilities to be
and shortens the duration distributed within Korea
of symptoms and infectious and exported to other
period which in turn reduces countries. In May 2021,
the risk of patients passing the Moderna and Samsung
virus on to other people, says Biologics announced the
Medsafe Group Manager Chris James. Ronapreve agreement for fill-finish
is approved for the treatment of COVID-19 for manufacturing of the Moderna COVID-19 vaccine.
people who are badly affected by COVID-19 and Upon execution of the deal, Samsung Biologics
who are at increased risk of progressing to severe successfully reduced the overall timeline by
COVID-19 disease. It is not approved for use in leveraging its technology and capabilities, enabling
children. Ronapreve, along with four other drugs the first batch of Moderna’s COVID-19 vaccine to
including molnupiravir, have been selected for be released for domestic supply within five months
fast tracked approval to help protect against from the signing of the contract. Moderna Korea
the COVID-19 pandemic, protecting people and applied for a full marketing authorisation for
hospital services against its worst impacts. Spikevax with the MFDS in early November, and
successfully obtained it within a month’s time.

REGULATORY NEWS 9

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

India announces Thailand enhances
position as regional medical
National Oxygen hub with new initiatives

Stewardship With a view to supporting the efforts in enhancing Thailand’s
position as a regional medical hub, the Thailand Board of
Programme Investment (BOI) has approved the investment promotion
zone status for the Yothi Medical Innovation District, a new
Taking cognisance of the role of medical initiative of the National Innovation Agency (NIA) located in
oxygen as a life-saving public health downtown Bangkok which
commodity and the need for capacity aims to build on Thailand’s
building of healthcare workers in internationally recognised
handling of medical oxygen, Dr Bharati medical capacity in terms of
Pravin Pawar, Union Minister of personnel, knowledge and
State for Health and Family Welfare, technology. This initiative
Government of India has inaugurated will promote increased
the National Oxygen Stewardship cooperation between the
Programme of the Union Health different institutions in
Ministry, at New Delhi, India. The the area and the private
initiative aims to empower all healthcare sector in developing deep
workers engaged in oxygen management tech and attracting medical
and administration with the essential startups and innovations
knowledge and skills to ensure rational in promising fields such as
utilization and avoid any wastage of tele-medicine, and precision medicine. The area currently
medical oxygen, especially in resource comprises 7 hospitals with a combined 7,000 beds, 6 medical
constraint settings. It envisages to schools, and 4,600 medical staff. This new measure will
identify and train at least one ‘Oxygen entitle investments in the targeted sectors to an additional 5
Steward’ in each district across the years of 50 per cent reduction of corporate income tax given
country. These trained professionals that the companies enter into collaboration with educational
would be responsible for leading or research institutions in the area to develop deep tech and
the training on oxygen therapy and the relevant human resources.
management in their respective districts
and also support audit of oxygen delivery
and preparedness for a surge scenario.

Singapore establishes pancreas
transplantation service as national programme

With the approval by the Ministry of This includes rigorous monitoring
Health (Singapore) for the pancreas of clinical outcomes as well as
transplantation service as a national strengthening of transplant
programme in April 2021, Singapore’s education and research. The national
National University Hospital (NUH) programme will also strengthen
and Singapore General Hospital processes and outreach efforts to
(SGH) will continue to collaborate and ensure that potential patients at all
bring together best practices to further hospitals are identified and screened
enhance patient care and outcomes in deceased donor for pancreas transplant suitability. The Director of the
pancreas transplantations. With this programme, National Pancreas Transplant Programme (NPTP)
Singapore will be the only Southeast Asian country is A/Prof. Tiong Ho Yee, who is a Senior Consultant
with a pancreas transplant service. The programme is in the Adult Kidney & Pancreas Transplantation
intended for Singaporeans and permanent residents. Programme at National University Centre for Organ
NUH and SGH will continue to work together to build Transplantation (NUCOT), and in the Department of
expertise and experience in pancreas transplantation. Urology at NUH.

10 COMPANY NEWS

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Moderna to bring Dr. Reddy’s expands
mRNA manufacturing
to Australia biosimilar offerings

US-based Moderna, Inc. has announced an agreement in in Southeast Asia
principle with the Australian Government to build a state-
of-the-art messenger RNA (mRNA) vaccine manufacturing Indian firm Dr. Reddy’s Laboratories
facility in Victoria, Australia including access to Moderna’s has entered into a binding agreement
mRNA development engine. The contemplated framework with Singapore-based Prestige
would build the foundation to support Australia with direct BioPharma for an exclusive partnership
for the supply and commercialisation
access to rapid pandemic response of Prestige BioPharma’s proposed
capabilities and to provide access to trastuzumab biosimilar in select
Moderna’s vaccines in development countries in Latin America and
for respiratory viruses. Moderna Southeast Asia. Prestige BioPharma’s
and the Australian government trastuzumab (HD201) is a proposed
are committed to finalising the biosimilar to Roche’s Herceptin and
agreement. Moderna expects to invest can be prescribed for the treatment of
in a state-of-the-art manufacturing HER2 positive breast and metastatic
facility for the production of mRNA gastric cancer. The license agreement
vaccines with the collaboration of grants Dr. Reddy’s the exclusive
the Commonwealth and Victorian rights to commercialise the proposed
Governments. The collaboration biosimilar in select countries in Latin
aims to provide Australians with access to a domestically America and Southeast Asia. Under
manufactured portfolio of mRNA vaccines against respiratory this partnership, Prestige BioPharma
viruses, including COVID-19, seasonal influenza, respiratory will be responsible for the sustainable
syncytial virus (RSV) and potential other vaccines, pending commercial supply of HD201 from
licensure. Moderna expects that up to 100 million vaccine doses its manufacturing facilities in Osong,
could be produced in Australia each year. The facility is intended South Korea, while Dr. Reddy’s will
to also be activated on an urgent basis to support Australia with be responsible for local registrations,
direct access to rapid pandemic response capabilities. marketing and sales in the licensed
territories.

China’s CanSinoBIO offers world’s
first inhalable COVID-19 vaccine

After months of collaborative of the COVID-19 respiratory inhalation as an aerosol requires a
development, Ireland-based virus and can bring additional much smaller vaccine volume and
Aerogen and China’s CanSinoBIO benefits by generating mucosal therefore offers the possibility of
have announced a development immunity. The interim results of administering the CanSinoBIO
and sales partnership for the CanSinoBIO’s Phase vaccine inexpensively to many
inhalation delivery of the novel 3 clinical trials
recombinant coronavirus vaccine have shown that more patients than
Convidecia from CanSinoBIO. Convidecia would have been
The proprietary Aerogen is 95.47 possible with an
vibration membrane technology is per cent injection. CanSinoBio
used to deliver active substances effective in
via aerosols. The aerosolised preventing is currently preparing
vaccine is delivered directly into serious an application for
the patient’s airway via a cup diseases 14 days after the market approval
dispenser. This pathway simulates single-dose vaccination. The in China. Further
the natural infection pathway introduction of the vaccine by clinical studies for
other countries are in
preparation.

COMPANY NEWS 11

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Prestige opens global-scale vaccine centre in South Korea

Prestige BioPharma units of 2,000 litre bioreactors) in currently focusing on
(PBP), a Singapore- only eight months by employing two COVID-19 vaccine
based biopharmaceutical Prestige Biologics’ proprietary projects to produce
company with engineering technology, ALITA Sputnik V and Sputnik
operations in US and Smart BioFactory. PBP is Light vaccines. The
South Korea, has new centre is capable
announced the grand of producing around
opening of its global- 2.6 billion doses of the
scale Vaccine Centre in first dose of Sputnik
Osong, South Korea. V vaccine (Ad26
PBP commenced adenovirus vector) per
construction of its year. The centre will
Vaccine Centre in April this year soon be prepared to produce
and completed the global-scale other types of vaccines including
manufacturing facility with a total mRNA vaccines to actively
area of 10,342.88 sq mt and a respond to the growing demands
total capacity of 104,000 litres (52 of COVID-19 vaccines.

Hilleman Lab sets Daiichi Sankyo
manufacturing facility
for vaccine development establishes new
in Singapore
subsidiaries in
Hilleman Laboratories has announced a first-of-its-kind
vaccine and biologics development and manufacturing Australia, Canada,
hub in Singapore. Established with the support of the
Singapore Economic Development Board (EDB), the and Singapore
hub comprises a 30,000 square foot current Good
Manufacturing Practices (cGMP) facility at 138 Depot Japan-based pharma firm Daiichi Sankyo
Road and a state-of-the-art research and development Company has established wholly-owned
(R&D) facility at Biopolis which began operations in April subsidiaries in Australia (Daiichi Sankyo
2021. Hilleman Laboratories is investing close to SG$ Australia), Canada (Daiichi Sankyo Pharma
80 million ($58 million) in operations, infrastructure Canada), and Singapore (Daiichi Sankyo
and capacity building over the next five years. The Singapore). With the establishment of
cGMP facility will supply clinical trial materials for the these three subsidiaries, there are now 27
development of vaccines and biologics up to Phase II countries in which the Daiichi Sankyo group
stage and is expected to be fully operational by early of companies is present. Through these
2023. The R&D facility at Biopolis focuses on early subsidiaries, Daiichi Sankyo will contribute
product development of vaccines and biologics, including to healthcare in countries where it has a base
candidate selection, design, early manufacturing process of operations and further strengthen the
development and preclinical studies. foundation for its global business, including
its oncology products.

12 FINANCE NEWS BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Piramal Pharma Gilead Sciences to help end HIV
invests epidemic in APAC with $1.5 M grant
Rs 101.77 Cr
in CDMO US-based Gilead Sciences has for Impact. In Singapore,
Yapan Bio announced the recipients of its
2021 Gilead Asia Pacific (APAC) the Greenhouse Community
Piramal Pharma Ltd (PPL) has Rainbow Grant, a regional
announced an investment of grant programme that supports Services and Sunshine Initiative
Rs 101.77 crore in Hyderabad- community-led projects which
based Yapan Bio, augmenting place people living with HIV and Singapore (Project X) are
the capabilities of its Contract their communities at the heart
Development and Manufacturing of care. Gilead is awarding more among the Grant recipients.
Organisation (CDMO) business, than $1.5 million to 44 projects
Piramal Pharma Solutions (PPS). across 16 locations in Asia The former focuses on capacity
PPL holds a 27.78 per cent equity Pacific, including Singapore,
stake in the company as a result of to help improve access to HIV building for service providers
this investment. As PPS continues prevention and treatment
to strengthen its capabilities services for people living with and peer training to strengthen
and position itself as a leading HIV (PLWH). Among the grant
CDMO, this acquisition marks a recipients, two projects are community-based support
significant addition to PPS’ global from Singapore. The projects
capabilities in the development seek to address three areas of while the latter will target the
and manufacturing of large critical unmet need i) Education
molecules for human clinical and Literacy; ii) Reducing the hard-to-reach populations who
trials. Yapan Bio provides process Health Disparities; iii) Research
development, scale-up, and are exposed to the risk of HIV
cGMP compliant manufacturing
of vaccines and biologics/bio- via digital and social media
therapeutics, including high
containment product classes platforms.
(up to BSL-2+), recombinant
vaccines, RNA/DNA vaccines, Australia-based CSL acquires
gene therapies, monoclonal Vifor Pharma for $12.3 B
antibodies, therapeutic proteins,
and other complex biologics. CSL Limited, based in Australia, and Swiss firm Vifor Pharma have

entered into a definitive agreement for CSL to launch an all-cash

public tender offer to acquire all publicly held Vifor Pharma shares

for $179.25 per Vifor Pharma share, for an aggregate equity value

for Vifor Pharma of $11.7 billion. The transaction, which has been

unanimously approved by both companies’ Boards of Directors,

further advances CSL’s

2030 strategy to create

value by adding a high-

growth, cash generative

and sustainable business

which complements

and expands the global

leadership positions of

CSL’s two business units,

CSL Behring and Seqirus.

CSL has a long-standing and committed presence in Switzerland,

where it has been an active corporate citizen since 1949 and currently

has a team of more than 1,800 people on the ground in R&D,

manufacturing and other operations. Since 2000, CSL Behring has

invested CHF 1,257 million into its Bern facilities to meet the growing

global patient demand for its immunoglobulin medicines.

START-UP NEWS 13

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Japan’s Jolly Good New biotech
launches R&D of VR
therapy for chronic pain incubator in Australia

Jolly Good Inc. in collaboration with Aichi Medical to drive world-class
University Hospital’s Pain Center, the first
interdisciplinary treatment and research facility for medical research
pain in Japan, will research the efficacy of virtual reality
(VR) therapy for chronic pain. Professor Takahiro CSL, the Walter and Eliza Hall Institute
Ushida, one of Japan’s leading experts in pain treatment, (WEHI), and the University of Melbourne
will collaborate in this research. This research will be have secured funding to create a startup
conducting incubator to support and grow early-
multifaceted stage Australian biotech companies.
research on the use The incubator, to be located at CSL’s
of VR in diverse new global corporate headquarters
situations, such under construction in the world-leading
as rehabilitation Melbourne Biomedical Precinct, will
of patients, to support startup companies to translate
develop VR therapy promising medical research into
for chronic pain. commercial outcomes. The incubator is
Professor Ushida scheduled to open to startups in 2023
has represented Japan in the revision of the definition and will be able to accommodate up to
of pain by the International Association for the Study of 40 early-stage companies from around
Pain. In the first phase of this research, Jolly Good and Australia. It will be open to applications
Aichi Medical University plan to study the development of from small biotech companies who
rehabilitation therapy using VR for people with complex have engaged in early research and are
regional pain syndrome (CRPS), post-stroke pain, and seeking to take their discoveries to the
other conditions that cause pain or fear of movement. In next stage of development. In addition
April 2020, Japanese startup Jolly Good established the to affordable, state-of-the-art wet-lab
DTx Division, a specialised team for developing digital facilities, equipment and office space, the
therapies that include psychiatrists and pharmaceutical incubator will provide a range of services,
strategy specialists, among others. including commercialisation education
programmes, facilitated access to
investors, industry mentoring and access
to service providers.

SenseTime advances smart health application with AI in China

SenseTime, a Hong Kong- hospital. SenseTime’s proprietary the phase-one deployment of the
based artificial intelligence (AI) SenseCare platform is a high- Cardiac Computed Tomography
software startup, has formed a performance diagnostic and Angiography (CTA), Lung
strategic partnership with Kiang treatment assistance platform Computed Tomography (CT),
Wu Hospital, one of the largest which provides various AI- Chest X-Ray modules in December
and oldest hospitals in Macau, powered tools for different 2020, Kiang Wu hospital has
China to advance smart health clinical departments. Following continued to expand the use of
application and research with SenseCare platform with Liver CT,
AI. The partnership builds upon Carotid CTA, Radiation Therapy
deployments of multiple AI (RT) Contour, Liver Magnetic
modules of SenseTime’s SenseCare Resonance Imaging (MRI) and
Smart Health Platform in the past more, achieving nearly 100 per
year, aiming to further accelerate cent utilisation rate for many of
the adoption and research of AI them, which demonstrates the
technologies in healthcare and reliability of SenseCare and the
create a new paradigm of smart strong confidence from doctors.

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Standigm, IPK team Taiwan’s Brain
up for AI-based drug
discovery research on TB Navi NaoTrac receives

South Korea-based startup Standigm Inc. has announced CE mark approval
the signing of a Memorandum of Understanding (MoU)
with Institut Pasteur Korea (IPK), the infectious disease- Brain Navi Biotechnology, a Taiwan-based
focused research institute contributing to public health, startup specialising in innovative navigation
for AI-based drug discovery research for infectious robots, has received CE mark approval for brain
disease. Under the MoU, the two parties will actively surgery procedures for its NaoTrac, a robotic-
conduct joint research and academic exchanges to assisted surgical robot. As the next step, Brain
derive innovative drug candidates for infectious disease, Navi Biotechnology is looking for FDA clearance.
setting the research priority on discovering novel anti- The NaoTrac is equipped with a high-precision
tubercular drug candidates. Previously, the two parties navigation system; the patient registration is
conducted research collaboration on anti-tubercular performed with a non-contact machine vision
drug discovery, applying Standigm’s deep learning process. Surgical instruments are recognised in
technology to the data generated through IPK’s cell- seconds with its patented registration algorithm.
based screening of one hundred thousand compounds Surgeons can choose the surgery pathway with a
against tuberculosis (TB). As a result, hit compounds 3D vision for precise anatomical location during
with several key scaffolds effective in multidrug-resistant the pre-operating planning preparation and
and extensively drug-resistant tuberculosis (MDR/XDR- monitor the robot during the entire procedure.
TB) were identified. The follow-up research on these hits, The unique navigation procedure allows the
‘Validation and optimisation of an AI-driven platform surgeon to plan and let Surgical Navigation act as
for anti-tubercular drug discovery’ has been selected for an assistant. This robotic technology is based on
the Research Investment for Global Health Technology a SMART (Surface Mapping Auto-Registration
Fund’s (RIGHT Fund) Technical Accelerator Award. Technology) platform, and is patented by Brain
Navi Biotechnology.

New medtech CoE in India to nurture 50 startups over 5 years

MedTech Centre of by STPI & MeitY in collaboration The CoE will be housed at the
with Sanjay Gandhi Post Graduate SGPGI campus, with a built-up
Entrepreneurship is being opened Institute of Medical Sciences space of 15,000 sq. ft. With an
(SGPGI), Lucknow; Department estimated budget of Rs 22 crore, the
at Sanjay Gandhi Post Graduate of IT & Electronics (Govt of UP); CoE will nurture 50 startups over
Association of Medical Device a period of five years, stimulating
Institute of Medical Sciences Industry (AiMED); and Andhra R&D in medical electronics and
Pradesh MedTech Zone (AMTZ). health informatics while facilitating
(SGPGI), Lucknow in India. an entrepreneurial ecosystem
to promote young innovators to
The MedTech – A Centre of create affordable, high-quality
indigenous medical products, drive
Entrepreneurship (CoE) in Medical employment, and contribute to the
economy.
Electronics & Health Informatics

is an initiative of The Software

Technology Parks of India (STPI),

an autonomous society under

the Ministry of Electronics &

Information Technology (MeitY).

This CoE at Lucknow is being set up

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CEPI funds project to develop COVID-19 vaccines for variants

Norway-based CEPI, innovative Multiple Antigen fund vaccine candidate
the Coalition for Presenting System (MAPSTM) design and selection,
Epidemic Preparedness technology platform. CEPI’s manufacturing process
Innovations, and investment in Affinivax will development and
Affinivax, Inc. in the preclinical testing
US have announced a against specific SARS-
partnership to advance CoV-2 variants. The
the development of a collaborative program
novel vaccine that could aims to establish
provide broad protection preclinical proof of
against SARS-CoV-2 concept for a novel
variants, and potentially vaccine candidate
other betacoronaviruses. designed to protect
CEPI will provide funding of up against new COVID-19 variants
to $4.5 million to support the and that is also suitable for use
initial development of a vaccine in low- and middle-income
candidate based on Affinivax’s countries.

Gavi approves FDA grants EUA for
malaria vax funding
for sub-Saharan Africa Pfizer’s COVID-19 pill

The Board of Gavi, the Vaccine Alliance has approved Pfizer Inc. has announced that the US
a number of measures aimed at tackling malaria, Food and Drug Administration (FDA) has
driving equitable global access to COVID-19 vaccines authorised the emergency use of PAXLOVID
and maintaining, restoring and strengthening routine (nirmatrelvir and ritonavir tablets) for the
immunisation in 2022. The Board approved a new malaria treatment of mild-to-moderate COVID-19 in
vaccination programme to support the introduction, adults and pediatric patients (12 years of age
procurement and delivery of the malaria vaccine to and older weighing at least 40 kg) with positive
Gavi-eligible countries in sub-Saharan Africa. An initial results of direct SARS-CoV-2 viral testing, and
investment of $ 155.7 who are at high risk for progression to severe
million for 2022- COVID-19, including hospitalisation or death.
2025 will initiate the The treatment includes nirmatrelvir, a novel
implementation of this main protease (Mpro) inhibitor originating
additional tool in the in Pfizer’s laboratories, which was specifically
fight against malaria designed to block the activity of the SARS-
alongside currently CoV-2 Mpro, an enzyme that the coronavirus
recommended malaria needs to replicate. With PAXLOVID now
control interventions, authorised for emergency use, Pfizer stands
which could save tens ready to start delivery in the US immediately.
of thousands of lives annually and drive down child In November 2021, Pfizer announced an
mortality in Africa. The Board has also approved the agreement with the U.S. government to supply
Vaccine Alliance’s strategic direction and role in COVAX. 10 million treatment courses of PAXLOVID,
In 2022, Gavi, through COVAX, will continue building with delivery fulfillment expected to be
the foundations of COVID-19 protection with a focus on completed in 2022.
lower-income countries and the most in need; deploying
a flexible portfolio of COVID-19 vaccines to manage
uncertainty and anticipate risk; and providing support
for delivery at-scale.

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Plasmid DNA as a starting material
for large-scale mRNA vaccines
from the PlasmidFactory

« The PlasmidFactory GmbH & Co. KG was founded
in 2000 in Bielefeld/Germany with 4 employees. In
Dr. Martin Schleef the meantime, under the founder and managing
Founder and director Dr. Martin Schleef, the company has become
Managing Director, a well-known contract manufacturer (CMO) for plasmid
PlasmidFactory and minicircle DNA. Today, PlasmidFactory has 30
GmbH & Co. KG, highly qualified employees, and for more than a year,
Germany the company has been working at full speed and on an
extraordinary scale - in addition to scientific investigations
and optimization of production - for vaccine productions.

You have been working in plasmid research concept for expanding the laboratories was finalized. We
and production for 20 years and were immediately received funding from the NRW state government and
available with your company when it came to have been able to produce on a multi-gram scale since
contributing to the development of the Covid vaccine December.
last year. How did this come about?
In contrast to previously available processes, which
Dr. Martin Schleef: PlasmidFactory specializes were qualitatively and quantitatively sufficient for the
in producing DNA of extraordinarily high purity for production of plasmid DNA for research, a process
gene therapy and genetic vaccine research and works has now been created through which plasmids can be
both scientifically and as a supplier with universities, produced in high quality grade and sufficient quantities.
biotechnology and pharmaceutical companies worldwide. Due to the high quality requirements, this represents
We are well known in the industry. All manufacturing as a considerable challenge, which currently needs to be
well as research and development is concentrated at the solved both in the area of cultivation and with regard to
Bielefeld site. Our manufacturing processes for plasmid the chromatographic processing of the DNA product. Due
DNA are ideally suited for the production of mRNA to the given expertise, PlasmidFactory has a pioneering
vaccines based on it. role here - we are happy to accept this challenge.

Was the production of mRNA vaccines a Is the expression “high quality grade” yours
surprise for you? and what exactly is it?

Dr. Martin Schleef: Not really. Dr. Martin Schleef: Yes, originally it is, but it
Plasmids have been used as starting material for the denotes “high quality”, so it is now also used by other
production of viral vectors (AAV, Lenti, etc.) and for the manufacturers.
production of RNA for quite some time. In particular, the
production of plasmid DNA as a starting material for the High Quality Grade plasmid DNA has been
production of RNA vaccines has become very important, established based on the EMEA guidelines CHMP/
especially against the background of the COVID-19 BWP/2458/03 and CPMP/BWP/3088/99 for highest
pandemic situation, since RNA is considered a promising quality requirements. For reasons of product safety, the
vaccine candidate for the prevention of certain viral manufacturing process avoids the use of substances
infections and has the advantage of neither integrating of animal origin throughout the entire process and
into the genome of the cell nor remaining in the long term guarantees the highest possible product purity
as a potentially effective molecule in the body of a patient. through reliable separation of impurities, e.g. bacterial
chromosomal DNA or damaged plasmids. To prevent
Did you have the capacity to jump in right further contamination, only one plasmid is produced at a
away? time in the facility used exclusively for High Quality Grade
Plasmids; no parallel plasmid productions take place in
Dr. Martin Schleef: We have been working in this the same facility.
area for several years and are constantly optimizing it:
Even before the pandemic, we significantly expanded The HQ fermentation is physically separated from the
our capacity in 2020 to meet the orders of our national purification (chromatography) to ensure that downstream
and international customers. In the summer of 2020, the processing of the sensitive DNA is not affected by live
contaminants.

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What expertise do you have in this field? of Interest” (GOI). Unnecessary sequences used only for
Dr. Martin Schleef: The proprietary special the plasmid production process are completely removed.
purification process results in a high grade of pure, A safe, highly effective vector system is the result. It
supercoiled (ccc) plasmid monomers that meet regulatory already meets the regulatory requirements of the future
requirements to form a defined, homogeneous product for gene therapy and vaccination.
that undergoes a series of cell bank and plasmid DNA
product quality controls prior to release. We also produce customized minicircles using our
The High Quality Grade Plasmid DNA is produced unique, patented method: the plasmid containing the
based on a cell bank (RCB) created at PlasmidFactory gene of interest (GOI) is the starting material. This is
and the particularly effective proprietary ccc Grade inserted into the so-called “parental plasmid”. From
DNA technology. For both the cell bank and the plasmid this, the minicircle DNA molecule is produced by
DNA product, PlasmidFactory offers a wide range of recombination, which consists almost exclusively of the
quality controls, so that ultimately a product is created Gene of Interest.
that is tailor-made for the respective application or the
corresponding regulatory requirements. The Minicircle DNA, produced with our technology,
For example, our High Quality Grade Plasmid DNA is patented worldwide and exclusively available at
is used in the GMP-compliant production of recombinant PlasmidFactory.
viruses, antibodies and RNA for clinical trials.
Our products and processes are continuously and In the press, you read about R&D activities
specifically optimized and, if necessary, newly developed, and other business areas besides those already
because we want to be uncompromising in quality and mentioned. Can you manage that alone?
competence.
Dr. Martin Schleef: The R&D activities of the
PlasmidFactory is now benefiting from the PlasmidFactory are carried out in our laboratories, partly
Covid wave. What are your plans for the future? in close cooperation with national and international
partners, e.g. in the fields of
Dr. Martin Schleef: Of course, we are benefiting - Optimization of vectors for the production of viral
like the entire biotech industry and are doing everything
possible, but we also had some exhausting months to get vectors (AAV or LV) or for efficient antibody or RNA
this up and running under the challenging conditions. production
- Development of resistance gene-free vector systems
Due to the difficult availability of excipients and (e.g. minicircle)
starting materials worldwide - and especially of the key - Investigation of the influence of various factors on the
substance DNA for the pharmaceutical production of long-term stability of plasmid DNA (e.g. plasmid size,
the vaccine - there is an extraordinary and still very DNA concentration, storage medium, freezing and
long-lasting demand for it, which therefore has to be thawing conditions)
met not only in Germany or the European Community, - DNA vaccines
but worldwide. We ensure an independent supply of - Production of dimeric plasmids
the currently most important raw material for mRNA - Vector development
production and its deliverability in Germany and Europe. - Gene transfer
mRNA vaccines are gradually replacing viral ones. This
means that - just as before - there will be demand for our As CEO in your company, you have now become
products even after the pandemic. an entrepreneur? What part does science still play?

You work not only in vaccine production, but Dr. Martin Schleef: Actually, I am a biologist and
also in the field of cancer research. What exactly do researcher who also manages the company. The
you do there? products of PlasmidFactory are manufactured jointly by
an energetic team of motivated colleagues.
Dr. Martin Schleef: That’s right, with our national and
international customer base, we are also well positioned Our and my work here is in the service of science,
in other areas with the PlasmidFactory. but of course science also meets entrepreneurship in our
company. We remain researchers for researchers!
Exciting and no less important is the CAR-T cell
development: PlasmidFactory has developed and With new convincing ideas and extraordinary
patented a method with which so-called CAR-T cells techniques, we want to advance biotechnology together -
can be produced. In contrast to conventional methods,
no viral vectors are used here, but PlasmidFactory’s a simple part of my DNA, too.
proprietary minicircle technology. Corresponding products
are currently undergoing clinical trials.

Has the proprietary minicircle technology
contributed to the success in CAR-T cell therapy?

Dr. Martin Schleef: Yes, without “MC” it does not
work: Minicircle DNA contains practically only the “Gene

18 COVER STORY

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

DIGITAL RESET
Nothing could have prepared the world for the unprecedented chain of events over the past
two years. We prefaced 2020 and 2021 saying anything is possible, but no one saw this level
of hyper volatility completely disrupting business and life as we know it. While the world is
now firmly planted in a digital-format, the economic and business outlook for 2022 will remain
highly fluid owing to the pandemic. Moreover, it is indeed very likely that in 2022, the majority
of Asia Pacific’s GDP will be coming from digital products, services, and experiences across
industries, with life sciences being one of them.

One of the silver linings of the COVID-19 the first and largest 5G smart hospital project in
pandemic has been the fast-tracked Thailand and the ASEAN region. It aims to bring
adoption of digital transformation across a more efficient and convenient experience to
various sectors. There has been a quantum patients by introducing technologies such as 5G,
improvement in the utilisation of cloud-based cloud, and artificial intelligence (AI).
infrastructure, high-end processing for applications
such as Augmented Reality (AR), Virtual Reality Taiwan’s hospitals are also taking aggressive
(VR), 3D printing, 5G, remote patient monitoring, action to carry out its smart applications combining
robotics, etc. 5G and AI technology. For example, Tri-Service
General Hospital (TSGH) is building up a series of
With the help of technology, doctors in the surgery training sessions and telehealth instruction
Asia Pacific (APAC) region are looking to shorten for its branch hospital on outlying islands, using
the recovery period and improve the treatment
outcome for patients. For instance, the growing
adoption of AR, VR and robotics is enabling
healthcare professionals to train on any procedure
and to stay on top of the latest advancements in
medical technology.

Japan-based startup Jolly Good has entered
into collaboration with Aichi Medical University
Hospital’s Pain Centre to research the efficacy of
VR therapy for chronic pain.

On the other hand, Singapore-based Kyalio and
the Endoscopic and Laparoscopic Surgeons of Asia
(ELSA), a leading surgical association with over
2,600 members, have jointly launched the Day-to-
Day Endo-Laparoscopic Virtual Reality Surgical
Library.

A first in Asia, the multi-platform VR Surgical
Library, which utilises real-scene VR, addresses
the importance of continuous surgical training
and enables cross-border surgical education to be
sustained even in the face of COVID-19.

According to Global Data, APAC will be the
leading region in terms of 5G technology adoption
with 1.14 billion subscribers, accounting for 65 per
cent of global 5G subscriptions by 2024, with South
Korea, China, Japan and Australia leading the way.

Joining this list is Thailand that has recently
launched ‘5G Smart Hospital’ for upgrading the
country’s public health industry. This project marks

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technologies combining mixed reality (MR), “With the ongoing healthcare
augmented reality (AR) glasses, and virtual reality transformation in Asia, be
(VR). it owing to the pandemic
or existing challenges
On the other hand, Mackay Memorial and demographic trends,
Hospital in Taiwan has launched a set of mobile
mammography buses, which could transmit real- digitalisation and AI are likely to
time images back to the hospital, run AI analysis on be key enablers for healthcare
cloud, and if necessary, it could help make clinical providers. Increasing focus
appointments, providing healthcare service for on enhancing the overall
people in remote areas. patient experience, with better

Tagging along is Singapore where the National outcomes and reduction in cost
University Health system (NUHS) has joined of care, healthcare providers will
hands with Singtel to deploy a 5G indoor network relook at their business models
with Multi-Access Edge Compute for the National
University Hospital (NUH) operating theatres and and enhance preparedness
wards. This is a first for a public hospital. to respond to new COVID-19
outbreaks or other infectious
NUH has also launched a first-of-its-kind
3D Printing Point-of-Care lab, in collaboration disease events.”
with Johnson & Johnson (J&J) to improve - Fabrice Leguet,
patient care capability and enhance personalised
healthcare, supported by the Singapore Economic Managing Director, Siemens Healthineers,
Development Board (EDB). Southeast Asia (based in Vietnam)

Adding on, the concept of minimally invasive “COVID-19 has catalysed
surgery has picked up pace in many APAC decentralised clinical trials
countries. For example, researchers at the Chinese (DCT) and they will increasingly
University of Hong Kong (CUHK) have developed become the norm. Alongside
biohybrid soft microrobots with an endoscopy- this is the increased adoption of
assisted magnetic navigation strategy for rapid big data, artificial intelligence
endoluminal delivery. This work provides a new (AI), and machine learning (ML),
enabling technology for medical microrobot- including identifying potential
based minimally invasive intervention and has
the potential for treating various diseases in tiny drug candidates.”
and tortuous lumens which are hard-to-reach or - Dr Senthil Sockalingham,
inaccessible by regular medical devices.
Chief Medical Officer and Head,
CUHK has also recently come up with a IQVIA Biotech Asia Pacific, Singapore
soft robotic manipulator for transoral laser
microsurgery on head and neck cancer, guided by “We must continue to innovate,
intraoperative magnetic resonance (MR) imaging but in ways that we have not
(MRI). necessarily considered. For
example, pre-COVID-19, the
Ireland-headquartered Medtronic has installed
its new robotic-assisted surgery platform, Hugo demand for machine learning
RAS system, at its state-of-the-art Surgical Robotics & AI were too often seen as the
Experience Centre (SREC) in India. The SREC is most impactful technologies for
the company’s first in the APAC region. improving healthcare. However,

With so many digital initiatives being adopted these concepts need to be
by the life sciences sector across the APAC region, relegated to where they belong,
a new virtual healthcare ecosystem is in the
pipeline. However, a potential challenge would be as they are tools, a means to
to keep a hawk’s-eye on technological reliability to an end, but are not ends in
ensure seamless service and to build cost-effective themselves. Only people are both
redundancies. the means & the end together.”

Dr Manbeena Chawla - Larry Lofgreen,
[email protected] Vice President, Asia Pacific Sales and
with inputs from Hithaishi C Bhaskar Solutions Consulting, Health Catalyst, Singapore

20 COVER STORY

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SINGAPORE Singapore is known globally for its economic development which continues to bring in
world-class talent. It forms a veritable bridge between the east and west and a hub for
adoption of new technologies and innovation.

‘MAKING MEDICINES MORE ACCESSIBLE’ ‘LAUNCHING DENGUE VACCINE
CANDIDATE IN SELECTED APAC COUNTRIES’
“Novartis Singapore will hit a
historical milestone in 2022 with 15 “We will continue prioritising
of our medicines being included in capability building of our people, so
the Singapore Government Drug they can be future-ready in terms of
Subsidy List. Thus, more patients leveraging the power of data &
will have access to our medicine. We digital across our business. We are
hope to continue this momentum preparing for the launch of our
throughout the year to transform the standard of care near-term R&D pipeline that will
for twice as many patients, twice as fast. At Novartis, we make a critical difference to patients, including the highly
work every day to reimagine medicine and improve and anticipated launch of our TAK-003 dengue vaccine
extend people’s lives. We have a clear mandate to bring candidate in selected APAC countries where dengue is
our treatments to patients in a way that is as innovative endemic. Dengue is both an economic and healthcare
as our science. We aim to bring the most value to our burden in the region. With 3.5 billion people living in
customers – patients, healthcare providers (HCP) and dengue-endemic countries and over 1 billion of these
healthcare systems (HCS). By engaging in new ways of residing in Southeast Asia, there is a greater potential for
working with patients, HCPs and HCS, we can change the situation to escalate, particularly with the effects of
the landscape of healthcare and be successful for climate change and the spread of urbanisation. I’m
decades to come. 2022 will be an exciting year for us; by looking forward to what we will achieve with this dengue
putting our customers at the centre of everything we vaccine. Lastly, we will continue exploring innovative
do, we will be making bold decisions on how we pathways to deliver sustainable access to our
reimagine medicine and ultimately create value for HCS, transformative treatments to patients who need them
Novartis and most importantly, patients.” most. We are also taking a collaborative approach to
defining our post-pandemic ways of working, and I look
- HWEE TEE POH, forward to seeing how this will be brought to life in 2022.”
Managing Director,
Novartis Singapore and Asian Emerging Markets - THOMAS WILLEMSEN,
Senior Vice President,

Takeda Pharmaceuticals, APAC, Singapore

‘INCREASING MANUFACTURING CAPABILITIES’

“The global Antimicrobial Coatings
Market is now expected to be worth
$4.99 billion in 2021 and is growing
at a CAGR of 14.1 per cent to reach
$7.29 billion by 2026, thus proving a
much-needed opportunity to
develop innovative solutions for
applications related to Polymers, Specialty Chemicals
and Coatings. Our vision for 2022, is to capture growth
and further increase our present manufacturing
capabilities in Singapore, Malaysia, Canada and India,
with plans to invest in South Korea next.”

- NITIN SARUP CHOWDHARY,
Managing Director, MaTerra Solutions and Chief
Executive Officer, ASN Technologies, Singapore

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‘BUILDING ONCOLOGY INNOVATIVE ASSETS’ ‘PLANNING NEXT PHASE TRIALS GLOBALLY’

“We are seeing a profitable & “2022 will be an important year for
sustainable growth momentum Cerecin. We have data readouts
across the region & have set an planned for our two ongoing Phase
ambitious target of a $1 billion two pilot studies, in migraine
turnover in 2022. A big game changer prevention and infantile spasms. We
next year will be the export of MILab plan to request pre-IND meetings
products from Indonesia to other with the US Food and Drug
emerging markets in Southeast Asia. The goal is to develop Administration for the investigation of tricaprilin in
MILab into a regional high-value manufacturing hub for infantile spasms and tricaprilin in migraine. We are also
both Menarini & our business partners. We are also planning our next phase trials in migraine, IS and
currently building a tableting facility within MILab, that will Alzheimer’s disease that will be conducted globally. We
be fully operational by 2023. In Singapore, we will continue plan to expand our investigational pipeline through our
expanding our R&D capabilities through Menarini internal development efforts and pursuit of licensing
Biomarkers, placing emphasis on highly specialised and opportunities. Finally, we plan to continue our
scientifically valuable fields such as non-invasive prenatal fundraising efforts to progress the financial strategy that
diagnostics. Finally, 2022 is the year we will begin building we have defined this year.”
our next pipeline – oncology innovative assets. Strategic
partnerships and inorganic acquisitions remain a focus, as - CHARLES STACEY,
we seek to become the partner of choice to established President and Chief Executive Officer,
pharmaceutical players looking to maximise the value and
life cycle of their legacy portfolios, as well as startups & Cerecin, USA
MSMEs which have innovative products but minimal, or
zero presence in the region. What makes Menarini a
reliable partner in one of the world’s largest economies is
our capabilities in clinical development support, local
registration, as well as a demonstrated track record in
quality, pharmacovigilance, & compliance processes,
beyond our sales & marketing strengths.”

- MAURIZIO LUONGO,
Chief Executive Officer, Menarini Asia-Pacific, Singapore

‘GROWING NEW IDEAS WITH
OPEN INNOVATION PLATFORM’

“Singapore has been a strategic hub
for Medtronic with a manufacturing
facility, its APAC regional headquarters,
& now an epicenter for the Open
Innovation Platform (OIP). We are
excited to work with Singapore
Economic Development Board’s
support on this programme, aligned with our vision to lead
the way for healthcare technology & address the complex
challenges of the sector. Building on the entrepreneurial
spirit that we share with other companies, including our
Medtronic OIP startups serves as a launch pad for us to
grow new ideas, empower an innovative ecosystem &
translate collaboration into actionable outcomes.”

- CHRIS LEE,
President, Asia Pacific, Medtronic, Singapore

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INDIA The pandemic played the role of a catalyst to solidify the country’s prowess as a global
manufacturing hub. It has pushed India into optimising the latent capabilities it possesses
across the public and private sector by promoting indigenous development and
manufacturing particularly in the space of diagnostics and medical devices which is likely to
continue in 2022.

‘BOOSTING VACCINE ‘OFFERING FIRST CEREBROSPINAL
MANUFACTURING FOR EXPORTS’ FLUID-BASED ALZHEIMER’S TEST’

“We already have expressions of “We are excited about the
interest for the ZyCoV-D vaccine opportunities that we envision on
from many countries. Obviously, the horizon for in-vitro diagnostics
the first phase for us till we scale up and our pipeline. We are bringing to
to very large quantities is to supply India the first Cerebrospinal
to the Indian immunisation Fluid-based Alzheimer’s test that
programme and once that is will offer an improved diagnosis of
sufficiently catered to, we will also get export the disease. Currently, Alzheimer’s Disease (AD) is
permission for the vaccine. We are looking at diagnosed largely on the basis of cognitive symptoms,
partnering with one CMO outside India who also has with a significant number of patients being diagnosed
drug substance manufacturing capabilities. That will when their disease has advanced considerably. We are
further boost our manufacturing and supply for also looking at advanced tests catering to cardiac and
international markets. We have already developed the women’s health areas. The pandemic has definitely
DNA vaccine candidates for the Alpha, Beta, Kappa brought testing into the spotlight and people are today
Delta, Delta Plus and Lambda variants and established much more aware of different diagnostic interventions
process for the same as well in a very short period of that can help detect, monitor and manage diseases.”
time, which will provide a flexibility in programmatic
implementation to switch to newer vaccine candidates - NARENDRA VARDE,
based on new variants and thereby ensuring faster Managing Director,
control over the pandemic.”
Roche Diagnostics India & Neighbouring Markets
- DR SHARVIL PATEL,
Managing Director, ‘WORKING TO BRING DIAGNOSTICS
TO THE PALM OF CUSTOMERS’
Cadila Healthcare, India
“We will focus on expanding the
‘FOCUSING ON TECHNOLOGY ENABLEMENT’ footprint of our portfolio of
molecular diagnostics in the US and
“Our broad future plans include 10 other countries. We are working
focus on technology enablement with researchers from the Indian
which can be achieved by Institute of Technology (IIT) to
integrating disparate systems used develop future products which will
in clinical trial systems and which bring diagnostics to the palm and smartphones of the
enable us in providing real-time customers. These technologies will use artificial
insights and also data-driven intelligence and biological techniques for simplified
decisions, which are made for the studies. There will be diagnostics. We aim to launch the world’s first
greater implementation of patient engagement tools combined Extractor and PCR system. The diagnostic
and remote monitoring. Our market focus is on the sector is poised to grow further driven by rapid
US-Asia geographies or in particular the US-India technological advancements, increased awareness of
corridor. The only other market that we are currently preventive healthcare and several encouraging
focusing outside of this corridor is Russia.” measures taken by the government.”

- SRINIVASAN H R, - HASMUKH RAWAL,
Managing Director, Managing Director,
Navitas Life Sciences, India
Mylab Discovery Solutions, India

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‘EXPECTING TO SEE MANY INDUSTRY- ‘OPTIMISING LOCAL
ACADEMIA PARTNERSHIPS AND SKILL MANUFACTURING CAPACITIES’
DEVELOPMENT PROGRAMMES’
“Pharma companies in India are
“Considering the recent growth of servicing almost 200 countries, and
the biotech industry, post-pandemic Avantor plays an important part in
scenario, and how India is making its collaborating with these companies.
mark globally in the healthcare We remain committed to the needs
sector, we can expect to see a lot of of the Indian life sciences industry,
opportunities for the skilled youth in leading biologics and vaccines
the biotech sector in 2022. Hiring manufacturers, all who play a critical role in developing
skilled freshers is already a preferred choice among life-changing therapies for patients. Reinforcing our
recruiters, but in 2022, we can expect to see it becoming commitment to India and working with the
the norm due to the tremendous pressure with which government towards its vision of ‘Make in India’, we will
pharma and biopharma companies are operating. With continue to focus on the country as one of our key
more work currently happening on the vaccine front, markets by optimising our local manufacturing
there is no doubt that Regulatory Affairs will be one of capacities in Panoli (Gujarat) and Dehradun
the most sought-after programmes in the biotech sector. (Uttarakhand), while offering unique solutions that meet
We’ve launched a first-of-its-kind certificate programme the needs of our customers in the region. Globally and
in Global Regulatory Affairs in partnership with JSS AHER in India, Biopharma is one of our largest business
at Biocon Academy where students are taught the segments, and we are working closely with the biotech
required industry skills along with the needed and pharma companies as well as the public sector to
professional skills, negotiation skills, project develop and manufacture a wide variety of therapies
management, stakeholder management and technical that will help improve global health.”
writing skills. Many biotech companies are slowly starting
up training centres to offer skill training for the students. - CHRISTOPHE COUTURIER,
With the backing and support of the Government of Executive Vice President, Asia Pacific,
India through initiatives like Skill India, we can expect to Middle East & Africa (AMEA), Avantor, Singapore
see a lot of industry-academia partnerships and skill
development programmes in 2022.”

- BINDU AJIT,
Programme Dean,
Biocon Academy, India

‘AIMING FOR 10% GROWTH
IN INDIAN LIFE-SCIENCE MARKET’

“For the current FY ending at Mar
2022, we expect 7-8 per cent
growth in the life-science market in
India. The first quarter (April-May)
was affected by the second wave of
COVID-19 and most of the
industries went slow due to
restricted movement of employees & logistics, so 7-8
per cent annual growth could be made in 10 months
only. Hopefully, next FY will be better, especially if
academia gets active again, so we should target 10 per
cent growth.”

- YOSHIYUKI FUJINO,
Managing Director,

Shimadzu Analytical (India)

24 COVER STORY

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As Taiwan’s biomedical industry growth further accelerates, global biopharma companies
are showing greater interest in potential strategic collaboration and investment opportunities

TAIWAN across the industry’s value chain.

‘STARTING OPERATIONS FOR NEW UNITS’ ‘STRENGTHENING PUBLIC
PRIVATE PARTNERSHIP’
“We will continue to support our
partners and customers to put an “The major goals and objectives for
end to the COVID-19 pandemic in Taiwan BIO in 2022 are to
2022. A new spin-off unit dedicated strengthen the public private
to antibacterial peptide drug, P113, partnership (PPP) by serving as a
will start its own operation in Q1 catalyst for advancing biomedical
2022. Together, CDMO unit, Digital industry development; bridge to
Healthcare Diagnostic Service Center in Taiwan and connect internationally; hub to
USA, and R&D and manufacturing reagent unit, 2022 cultivate industrial talents; and a partner to link
will be a strong year for GBC.” government and enterprises.”

- FRANK LIN, - CHUNG HSIUN WU,
President, General Biologicals Corporation (GBC), Taiwan Chairman, Taiwan Bio Industry Organisation

‘FOCUSING ON TECH FOR (Taiwan BIO), Taiwan
NUCLEIC ACID MEDICINE’
‘MAINTAINING BUSINESS GROWTH GLOBALLY’
“The speed of product development
has been proven to be the most “Major goals and objectives for
dominant factor during this EirGenix in 2022 are how to maintain
pandemic. A 4-year project starting our business growth global-wise
in 2022 has been awarded for DCB to and keep our timeline for our
further design novel technologies & products in development under the
platforms for nucleic acid medicine. pandemic and new threats of
The ‘drug targeting and delivery’ & complex medicine COVID-19 virus variants. My
will be of our particular interest to develop in 2022. projection for 2022 is that the COVID-19 virus variants
Further advanced gene-editing technologies could also would still be a threat for us.”
be applied for the “off-the-shelf” cell therapy potentially
using iPS cells. Aiming to take on challenge & - LEE-CHENG LIU,
preparation for the next pandemic & with the anticipated President and Chief Executive Officer, EirGenix, USA
2-year maturation of DCB-developed technologies for
the short- & long-chain nucleic acid drugs, the factory of ‘ON TRACK WITH INTERNAL PIPELINES’
contract development & manufacturing organisation
(CDMO) services for nucleic acid drugs & smart medicine “Looking ahead, we will continue to
shall also be established. Moreover, we would also take strive for R&D excellence and build
advantage of Taiwan’s ICT industries & govt policies in on the significant progress we have
promoting the biomedical industry to not only assist in made in 2021. We remain firmly on
drug development but also to provide informatics track with our internal pipelines and
solutions to precision health. In the aspect of business will strategically choose to conduct
prospective, DCB will focus on the potential therapeutic research and development projects
on tumor microenvironment, especially anti-CD73 on other potential products as opportunities arise. In
antibodies, & CHO-C high-yield cell line system for utilising our TDS technology platform, we will continue
developing recombinant proteins with clinical usages.” to deliver the outcome of contracted work for our clients
in 2022.”
- DR TSAI-KUN LI,
Vice President, Development Center for - CATHERINE LEE,
Chief Scientific Officer,
Biotechnology (DCB), Taiwan TAHO Pharmaceuticals, Taiwan

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‘TO USE ADOPTIVE CELL ‘PUBLICISING OUR TECHNOLOGY
TRANSFERRING THERAPY’ AND PRODUCT CANDIDATES’

“Our operation goal in 2022 is “Now that we have
finishing the initial public offering obtained more than 60
(IPO), and we will take several patents from many major
actions to reach the goal. First of all, countries covering our
to increase the revenue, we various inventions, and that
constantly apply for operating we have validated our
permission from the Ministry of major product candidates
Health and Welfare (MOHW) to our adoptive cell for the anticipated therapeutic uses, we plan to
transferring therapy, including CIKs-based therapy publicise our technology, product candidates,
(cooperated with Kaohsiung Medical University Chung- and animal model results actively in 2022. For
Ho Memorial Hospital) against gastric and colorectal the ADC and ARC platform technologies, we
cancer and next generation TCR gamma delta T cell will seek corporate partners to help develop the
therapy. We have applied for permission for CIKs-based process for large scale manufacturing. We plan
gastric and colorectal cancer therapy. In addition, we will to advance our on-going contract research
file the immunoprofiling platform and CTCs detection projects, so that by the end of 2022, we will be
method as Laboratory Developed Tests (LDTs). Finally, able to wrap up the studies for filing IND for
we will establish branch offices in Japan to expand two products.”
business in Japan. Second, we aim to perform clinical
trials for verifying the safety and anti-cancer efficacy of - DR TSE-WEN CHANG,
our cell products, PHYDUXON, next generation TCR Chief Executive Officer,
gamma delta T cells, and EBaT8.”
Immunwork, Taiwan
- JAN-MOU LEE,
General Manager, ‘PROVIDING FULL CDMO SERVICES
FullHope Biomedical, Taiwan TO GLOBAL PHARMA FIRMS’

‘INITIATING ADVANCED STAGE “We expect to grow more than 20
CLINICAL TRIALS FOR NEW DRUG’ per cent of business in 2022
mainly from contract
“As indicated in our slogan, GBC is development and manufacturing
thriving to develop breakthrough organisation (CDMO) service and
medicine patients desire. Patients Injectable Drug Product
always want to have their medical manufacturing. Equipped with
conditions treated with less adverse extensive experience in both areas of highly potent
effects. However, modern medicines active pharmaceutical ingredients (HPAPI) and
always come with undesired side antibody-drug conjugate (ADC), we will provide full
effects and drug resistance. With its multi-target CDMO services to global pharmaceutical companies
property, HOCENA from GBC shall be a much better and reach double business growth. After securing
choice than the mono-therapies and combination several major CMO contracts for global injectable
therapies in terms of efficacy and safety respectively in business, we anticipate having double to triple
treating complex diseases such as COVID-19, NASH, and potential business. Finally, the majority of our
Alzheimer’s disease. GBC’s major goals for 2022 are to revenue (~80 per cent) will be generated from API
initiate advanced stage clinical trials for these diseases CMO with double digit organic growth next year. In
(phase III for COVID-19, phase II for both NASH & the technology platform development forefront, we
Alzheimer’s disease) and to ensure the quality and have initiated both peptides and flow chemistry
quantity of HOCENA supply in an affordable and projects and will continue invest more resource in
accessible fashion.” coming years.”

- ALEX LIU, - DR CHIH-PING YANG,
Chairman, Chief Executive Officer,
Golden Biotechnology Corp. (GBC), Taiwan Formosa Laboratories Inc, Taiwan

26 COVER STORY

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With a population of more than 1.4 billion and currently the world’s second-largest
biopharmaceutical market, China has great potential and benefits for the emerging

CHINA biopharmas that are launching niche and novel therapies across the globe.

‘INDUSTRY 4.0 CONTINUES ‘STRENGTHENING OUR
TO DRIVE OUR PERFORMANCE’ PRESENCE IN HONG KONG’

“2021 was a rollercoaster journey for “In 2022, CMR will work to further
most businesses. Asia was hard hit cement itself as a leader in the
by the pandemic, which affected surgical robotics space. We will push
many of our manufacturing and ahead with our accelerated
engineering customers. Industry 4.0 commercial expansion and grow our
rose as a solution, and we made sure global presence, with a particular
to stick by our customers’ sides as focus on strengthening our presence
they adopted these technologies to navigate the new in Hong Kong and the wider APAC region. We look
normal. Within Asia Pacific, Industry 4.0 continues to forward to growing existing and new partnerships,
drive our performance for FY22. Thanks to our strong growing our digital capability to further demonstrate the
teams and clear strategy, we kicked off the year in good value systems like Versius hold to unlocking key
shape financially, and look forward to closing it on a healthcare insights to improve surgical standard and
high note. This was our second year seeing through our care, and continue in pursuing our mission to transform
Destination 2025 strategy, which brought us a step surgery for millions of patients around the world.”
closer towards reaching our sustainability, efficiency,
and scalability goals.” - PER VEGARD NERSETH,
Chief Executive Officer, CMR Surgical, UK
- SYED SUROOR ANWAR,
Vice President, Asia Pacific, Strategy and ‘WORKING WITH GLOBAL LEADERS
Commercial, RS Components, Hong Kong SAR WITH DISRUPTIVE TECHNOLOGIES’

‘TO RECRUIT MORE HIGH-LEVEL “Evonik will continue to focus on our
MEDICAL PROFESSIONALS’ key Innovation Growth Fields
spanning advanced food
“The Hospital is preparing for its 10th ingredients, cosmetic solutions,
anniversary in 2022 and we have lots membranes, & healthcare solutions
of tasks to do. Our major goal is to in the coming year. Moving forward,
implement the plan for high-quality our goal is that next generation or
development of public hospital, with sustainable solutions will continue to account for at least
a special focus on major specialties 35 per cent of our portfolio products and investments.
development and a plan to recruit As we look ahead to 2022, we want to push the
more high-level medical professionals. We will continue boundaries and work with global innovation leaders
the exploration of cross-border medical services, with disruptive technologies across MedTech, climate
enhance capability of our research and teaching, and tech & sustainability initiatives to positively change lives.
promote the integration and homogenisation of Evonik has been a leading integrated system solutions
healthcare in the Greater Bay Area. Our mission is not provider of Advanced Drug Delivery, Functional
just to build a hospital that is ‘first class nationally and Excipients, & Contract Manufacturing serving the
renowned internationally’. More importantly, we aim to pharmaceutical and medical device markets, as well has
become a world-class teaching hospital with integrated a broad coverage in nutraceutical system solutions for
training and research facilities that serves as a cradle for human dietary supplements. Evonik is continuously
grooming medical talents in Shenzhen and also for the pursuing in-house & external investment opportunities
nation.” of market-leading innovations.”

- PROF. CHUNG-MAU LO, - ERNING CAO,
Hospital Chief Executive, The University of Investment Director,
Hong Kong-Shenzhen Hospital, Hong Kong Evonik Venture Capital, Asia Pacific, China

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With one of the world’s fastest growing elderly populations, Japan is offering opportunities
with advanced and innovative products for exports, joint R&D and licensing-out technology at

JAPAN a rapid pace.

‘RE-ORGANISING SCIENTIFIC new healthcare platforms as the partner of choice for
SOLUTIONS BUSINESS’ companies and industries with complementary
capabilities and expertise in other fields. Shionogi is
“Our top priorities are to continue currently conducting a Japanese Phase 2/3 clinical trial.
our transformation into a global We will continue to consult closely with the Ministry of
medtech company, to better serve Health, Labor and Welfare, Pharmaceuticals and
our customers and patients, and to Medical Devices Agency (PMDA) and other
make people’s lives healthier, safer organisations for future applications for approval. As
and more fulfilling. On the business SARS-CoV-2 continues to have a major impact on
side we now forecast revenue to people’s lives and to represent a global threat, we will
grow 17 per cent year on year to ¥856 billion for this seek to contribute to re-establishing the safety and
fiscal year, and our operating profit and net profit are security of society by developing, delivering, and
expected to achieve record highs. In the current producing, in Japan, a vaccine for COVID-19.”
corporate strategy announced in 2019, we set an
ambitious timeline to achieve more than a 20 per cent - DR ISAO TESHIROGI,
operating margin by 2023, with the understanding that President and Chief Executive Officer,
this journey would be a process, not a moment. For our
journey to be successful, it requires a carefully charted Shionogi & Co., Japan
path, one that enables Olympus to realise its full
potential through a world-class organisational, ‘DEVELOPING CULTURE MEDIUM
operational and cultural approach. To achieve this, we BUSINESS UNDER GLOBAL PRODUCTION’
will continue to elaborate the growth strategy in our
medical business by sharpening our business focus and “We are expanding the culture
will further improve our business efficiency through our medium business globally through
transformation objectives. Upcoming key initiatives and our group companies, FUJIFILM
milestones are the business reorganisation of our Irvine Scientific, Inc. and Wako Pure
Scientific Solutions business, leveraging newly Chemical Industries, Ltd. Currently,
established corporate venture capital to speed up our we develop and provide high-quality
innovation & business opportunities & accelerating and high-performance media
global business services (GBS) to further improve our required by customers by utilising our high R&D
business efficiency.” capabilities, excellent quality control capabilities, and
cGMP-compliant production bases in Japan and the
- YASUO TAKEUCHI, United States. In addition, we are strengthening product
President and Chief Executive Officer, development and expanding globally, such as by
announcing the opening of the ‘Innovation &
Olympus Corporation, Japan Collaboration Center’, a base that provides culture
medium customisation services in the rapidly growing
‘CONDUCTING PHASE 2/3 Chinese market. Going forward, we will develop the
TRIAL FOR COVID-19 VACCINE’ culture medium business under the global production
system of three bases in Japan, the United States and
“Shionogi has launched its New Europe, and will provide stronger support for customers’
Medium-Term Business Plan‚ drug discovery and pharmaceutical manufacturing. We
STS2030’, aiming to realise our vision will accelerate global expansion by combining the
for 2030: Building Innovation technologies and know-how of the Group to develop
Platforms to Shape the Future of high-quality and high-performance media and provide
Healthcare. We will continue to them widely.”
build upon our established
capabilities as a drug discovery-based pharmaceutical - TEIICHI GOTO,
company based on innovation and highly advanced President and Chief Executive Officer,
expertise, while increasingly catalysing the formation of Representative Director, Fujifilm, Japan

28 COVID -19

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Are
boosters
another
SHOT IN
THE DARK?

Omicron and newer emerging variants have been portrayed as a cause of concern globally as
several low and middle-income countries have not been able to immunise their citizens due to the
shortage of COVID-19 vaccines. Notably, it was in the double-vaccinated South African individuals
that the Omicron variant was first discovered. The COVID-19 Vaccines Global Access (COVAX) had
promised two billion doses of COVID-19 vaccines by the end of 2021 to a total of 92 low-and middle-
income countries that are eligible to receive COVID-19 vaccines through the COVAX mechanism.
But, it has managed to deliver only about 95 million doses as developed nations hoarded surplus
doses of the vaccines. Approximately 75 per cent of the 4.5 billion first doses of the COVID-19
vaccine that were rolled out, went to affluent countries. Can emerging variants make vaccine
inequity a bigger challenge than it already is? Let’s unravel.

2021 saw the approval of various vaccines The growth advantage that Omicron has over the
and drugs for the treatment of COVID-19, Delta variant that caused the second wave in India
in the new year, we are faced with will soon become the most dominant variant globally.
another mutation of the COVID-19 virus, Omicron
that is spreading rapidly across the globe. Omicron Addressing vaccine inequity
as per early research data is capable of escaping the
immune response of vaccines adding fuel to the ever- Omicron and newer emerging variants are a cause
increasing reasoning behind the need for booster of concern globally as several low and middle-income
doses to help maintain the efficacy of COVID-19 countries have not been able to immunise their
vaccines against severe infection and death. citizens due to the shortage of COVID-19 vaccines
globally. COVID-19 Vaccines Global Access (COVAX)
So far approximately 89 countries have reported promised to deliver two billion doses of COVID-19
cases of Omicron with the United Kingdom reporting vaccines by the end of 2021 to a total of 92 low-and
12 deaths due to the variant. According to the World middle-income countries that are eligible to receive
Health Organisation (WHO), COVID-19 cases are COVID-19 vaccines through the COVAX mechanism
doubling every 1.5-3 days in countries that are but has managed to deliver about 95 million doses
dealing with community transmission of the variant. as developed nations hoarded surplus doses of the

COVID-19 29

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vaccines. Approximately 75 per cent of the 4.5 billion “It is very interesting that
first doses of the COVID-19 vaccine that were rolled the biggest vaccine makers
went to the people in affluent countries, emerging
variants could make vaccine inequity a bigger in the world are in India
challenge than it already is. but the western vaccine
companies chose to use
Expressing her views during the Global Technology contract manufacturing
Summit 2021 on the impact of vaccine inequity on organisations (CMOs) in the
the global population, Dr Kiran Mazumdar Shaw, western world who didn’t have
Executive Chairperson, Biocon Biologics, Bengaluru, any experience with vaccines
India expressed, “It is very interesting that the biggest and I think many of the
vaccine makers in the world are in India but the problems that we have today
western vaccine companies chose to use contract in the supply chain is because
manufacturing organisations (CMOs) in the western of mistakes that vaccine
world who didn’t have any experience with vaccines companies have made.”
and I think many of the problems that we have today
in the supply chain is because of that mistakes that - Dr Kiran Mazumdar Shaw,
vaccine companies have made.” Executive Chairperson, Biocon Biologics, India

Sharing his views during the Bengaluru Tech “We need to have equitable
Summit 2021 (BTS 2021), Richard Hatchett, Chief vaccine manufacturing capacity
Executive Officer, Coalition for Epidemic Preparedness globally. If all regions have some
Innovations (CEPI), London, England commented,
“We need to have equitable vaccine manufacturing access to these rapid response
capacity globally. If all regions have some access to platforms and some ability to
these rapid response platforms and some ability to address their own national or
address their own national or regional health security,
we will be much positioned to reduce the equity gap regional health security, we
that has emerged during this pandemic.” will be better positioned to
reduce the equity gap that
Dr Gagandeep Kang, Professor, Microbiology,
Christian Medical College, Vellore in India reiterated has emerged during this
the importance of vaccine equity during the fireside pandemic.”
chat with Hatchett during BTS 2021. She commented, - Richard Hatchett,
“Partnerships are critical for vaccine equity and
access, CEPI has shown the way and will be doing Chief Executive Officer, Coalition for Epidemic
more in the next ten years.” Preparedness Innovations (CEPI), London

Hatchett further added, “We need new capacity “The evidence is out there
in regions that don’t have the capacity and that that different vaccines have
capacity needs to be sustainable for the long term. waning antibody levels post
The challenge that we face in ensuring that capacity
can be sustainable, is the new COVID-19 vaccines on four to six months post-
the new platforms. COVID-19 vaccines are the only vaccination some much more
vaccines currently authorised on those platforms, so
we need to expand the application of those platforms than others which is why
to other diseases that are important for the region there is a pretty determined
where vaccine manufacturing is occurring.”
need to include boosters.
Approval of booster doses What is unclear is that a lot of
information isn’t published or
There is early evidence to support the fact there
is reduced efficacy with time and a certain section isn’t spoken of is how these
of the population (elderly, immunocompromised, vaccines are working against
diabetic, etc.) may require booster doses to keep them the existing variants and the
protected against COVID-19 infection. The WHO’s
interim statement on booster doses dated October 4, new variants.”
2021, states: The degree of waning of immunity and - Mahima Datla,
need for booster doses of vaccine may differ between
Managing Director and CEO, Vaccines and
Branded Formulations, Biological E Limited, India

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The pandemic is far from over and variants and the new variants. One thing that seems
newer emerging variants, waning to be clear is that if the antibody levels stay high, it
efficacy of vaccines, shortage of seems to be preventing any kind of severe disease
vaccines in developing nations is a even if there is a variant change.”
cause of concern. 2022 may or may not
be the end of the COVID-19 pandemic, As the debate for booster doses rages on, several
the world is better prepared to handle a countries have approved booster doses and several
crisis on a global scale. 2021 saw pharma nations are mulling over approving booster doses.
majors and academia coming together Speaking on whether India should approve booster
and forging partnerships to address the doses or not Dr Kiran Mazumdar Shaw expressed,
challenge at hand and fast-tracking, “I think we don’t have enough data of the waning
scaling of live-saving solutions. The antibody if it is not protecting us against severe
newer generation of vaccines, drugs in disease. I think that data needs to be shared because
development and late stages of clinical right now it suits everyone to say let us go for an extra
trials, which could eventually lead to booster, but I would like to see data that says that
the pandemic becoming endemic. if you have two doses you are fairly well protected
However, there is a need to address against severe disease and whilst it is nice to boost
concerns of transparency in vaccine and your antibody levels with a booster dose, can we not
drug development, clinical trials and make sure that everybody in the world has at least
preventing deaths from the COVID-19 has their shot of the vaccine.”
infections as well as adverse events.
A transparent, equitable approach
“Partnerships are critical for
vaccine equity and access, The pandemic is far from over and newer emerging
CEPI has shown the way and variants, waning efficacy of vaccines, shortage of
will be doing more in the next vaccines in developing nations is a cause of concern.
Another cause of concern is the rising number of
ten years.” deaths due to adverse events post-vaccination. India
- Dr Gagandeep Kang, as of December 21, 2021, has vaccinated 138 crore of
Professor, Microbiology, its citizens, out of which 54.8 crore (39.7 per cent) are
fully vaccinated. There have been about 10,664 deaths
Christian Medical College, India reported by the Indian mainstream media so far (Data
collated by Awaken India Movement).
vaccine products, target populations, circulating
SARS CoV-2 virus, in particular variants of concern Scientists have been exploring a plethora
(VoC), and intensity of exposure. For some vaccines, of options for the treatment and prevention of
restricted booster indications have been included into COVID-19 infections, single-domain Variable New
the product label of some jurisdictions. Antigen Receptors (VNARs) could be a possible
therapeutic that is being explored, it is derived from
Mahima Datla, Managing Director and the immune system of sharks. VNARs may not be
Chief Executive Officer, Vaccines and Branded available to treat COVID-19 as of this writing, but it
Formulations, Biological E Limited, Hyderabad in could be helpful in future SARS CoV-2 outbreaks.
India shared, “The evidence is out there that different
vaccines have waning antibody levels post four to 2022 may or may not be the end of the COVID-19
six months post-vaccination some much more than pandemic, the world is better prepared to handle a
others which is why there is a pretty determined crisis on a global scale. 2021 saw pharma majors and
need to include boosters. What is unclear is that a lot academia coming together and forging partnerships
of information isn’t published or aren’t spoken of is to address the challenge at hand and fast-tracking,
how these vaccines are working against the existing scaling of live-saving solutions. The newer generation
of vaccines, drugs in development and late stages
of clinical trials, which could eventually lead to the
pandemic becoming endemic. However, there is a
need to address concerns of transparency in vaccine
and drug development, clinical trials and preventing
deaths from the COVID-19 infections as well as
adverse events.

Prabhat Prakash
[email protected]

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Can supply chains
turn pandemic-proof?

The sudden and extreme impact on supplier/distributor network in light of the pandemic, forced
policymakers and pharma companies to rethink about supply chains. Has the industry rose to the
challenge and mitigated those issues while also ensuring the supply chain remains resilient to future
disruptions? Let’s find out.

COVID-19 has upended the world and caused supply chain transparency was their top priority.
enormous challenges to economies and has Over-reliance on one supply source belonging to a
brought terrible human suffering. Almost
all industries have to rethink nearly every aspect specific geography (India and China mainly) created
of their operations and pharma is no different. significant disruption in the manufacturing especially
In fact, this outbreak has brought more attention for key starting material (KSM) in vaccines and
to the healthcare and pharma industry. Perhaps biopharma formulations.
the biggest impact has been on the supply chain
operations. The cracks in the supply chain are ‘‘Single source dependency, especially in
forcing policymakers and firms to reassess its categories like anti-infective, ARV (antiretroviral) and
management. antimicrobials, and lack of large-scale fermentation
capability created disruptions in the supply chain,’’
According to PricewaterhouseCoopers’ (PwC) said Matruprasad Priyadarshi, Senior Director-
Health Research Institute (HRI) report, 94 per cent Regional Programme Operations & General Manager
of life sciences executives and 86 per cent of provider – South Asia, United States Pharmacopeia (USP),
executives said that improving their supply chain an independent, scientific non profit organisation
overall was a priority in 2021. Specifically, improving focused on building trust in the supply of safe, quality
medicines, based in India.

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LATEST DEVELOPMENTS de-risk procurement,’’ said Gareth Crothers, Head
of Manufacturing & Supply Chain at Univercells
● In November 2021, Japan’s Amgen, Bushu Technologies, Belgium.

Pharma expanded supply chain partnership Many companies brought more manufacturing
in-house, whether that be late stage intermediates
across Japan and Asia Pacific. or specific chemicals. Companies are also qualifying
● In September 2021, The President of Taiwan numerous raw material suppliers in a variety of
different countries in order to minimise the risk of
proposed to implement space technology to disruption.

advance industrial development in biotech and ‘‘A lot of work goes into identifying, evaluating,
making contact and monitoring alternative suppliers
medical supply chain. – and with industry events impacted by COVID
● In August 2021, Cryoport, a leading global -19, online solutions such as Cortellis Supply Chain
Network are becoming more important for such
provider of innovative temperature-controlled efforts,’’ said Gareth Moore, Product Manager,
Clarivate, UK.
supply chain solutions and Mitsubishi Logistics
Clarivate Plc has launched Cortellis Supply Chain
Corporation, Japan’s leading pharma logistics Network, a digital solution that supports generics
companies, Active Pharmaceutical Ingredients
company, announced a multi-year strategic (API) manufacturers, fine chemical manufacturers,
excipient manufacturers, raw materials suppliers,
business alliance to create an integrated and biopharma in their pursuit to maintain a steady
supply chain.
regenerative medicine supply chain partnership in
Another strategy for bolstering supply chains
Japan. relates to inventory management. ‘‘When the
● In August 2021, EMA endorsed recommendations pandemic began, one of the early impacts to supply
chains was caused by plant and port closures. Delays
developed by the International Coalition of undermined the ‘just in time’ delivery model relied
upon by most manufacturers, pharmacies and
Medicines Regulatory Authorities (ICMRA) to hospital systems and led to shortages. To compensate
and provide more of a buffer in the event of future
facilitate the use of track and trace systems at supply delays, most companies have expanded their
inventories beyond the traditional two months,’’ said
the global level. Matruprasad Priyadarshi.

Addressing supply chain vulnerabilities The supply situation was aggravated with
the reduction in flights and tightening of local
With COVID-19 impacting lives around the transportation around the world. ‘‘During COVID-19
world, the pharma supply chain had to be one of the there were challenges with respect to continuous
most active sectors to avail all the essential goods to supply of high volume API, formulations and
industries and individuals. The players in the sector packaging materials, thereby causing disruptions.
had to create faster, more flexible operations that can The last mile connectivity was an issue in specific
cater to the on-demand economy. Both pharma and places, so multiple modes of transport were deployed
supplier companies were quick to take action and to help in the availability of key materials. During
had adopted various strategies to bolster their supply the early days of lockdown, industry had concerns
chains. about the short supply of manpower, but with
local government support these challenges were
‘‘We leveraged traditional supply chain strategies mitigated,’’ added Matruprasad Priyadarshi.
like dual vendor qualification, distribution resources
planning (DRP) and multiple shipping options with In the future, efforts such as digitisation/
a balance of in-house production methods,’’said automation of plant operations, virtual audit and
Gabe Longoria, CCO at Astrea Bioseparations, UK, testing will help in enabling the regular supply of
a leading provider of bioseparations products and drug substances and products.
services. To enhance its supply chain security, the
firm has made significant investment in Cambridge, ‘‘Assurance of supply is a key requirement
UK and Singapore. in many industries, especially in biopharma.
While no one could have anticipated what we all
Others like Belgium-based biosupplier Univercells
Technologies had adopted an active supplier
management approach.

‘‘On a regular basis, we are reassessing the
selection of potential suppliers for our key
components to keep both cost and lead-time under
control. In some cases where the lead-time remains
long (mainly for single-use items) we made the
choice to increase our inventory to ensure business
continuity. For highly critical items relying on
more than one supply source enables as well to

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have experienced in the last 20 months in this ‘‘We leveraged traditional
industry, companies should strive to provide better supply chain strategies like
information, improve lead times and continue to
ensure availability of the high quality products dual vendor qualification,
through better communication, additional cleanroom distribution resources
capacity and redundant manufacturing measures,’’ planning (DRP) and
said John Boehm, Vice President of Biopharma,
Colder Products Company (CPC), USA. multiple shipping options
with a balance of in-house
CPC has taken various steps such as opening a
new facility in the US, increasing manufacturing production methods’’
capacity etc. to ensure an efficient supply chain - Gabe Longoria,
during the pandemic.
CCO, Astrea Bioseparations, UK
While approximately half of pharmaceutical
organisations have already deployed visibility ‘‘A lot of work goes into
technology to track raw materials and to better plan identifying, evaluating, making
their manufacturing, many are dissatisfied with the
capabilities of their current solutions. As a result, contact and monitoring
more than nine in 10 executives plan to implement alternative suppliers – and
a more robust digital supply chain visibility (SCV) with industry events impacted
solution over the next 12 months. That’s according by COVID-19, online solutions
to ‘The Pharmaceutical Supply Chain: Closing the such as Cortellis Supply Chain
Visibility Gap’, a new report released in December Network are becoming more
2021 by FourKites, provider of the world’s leading important for such efforts’’
real-time supply chain visibility platform, and
Accenture. - Gareth Moore,
Product Manager, Clarivate, UK
Pandemic-proof supply chain
‘‘Assurance of supply is a
The traditional life cycle of a supply chain has key requirement in many
proved to be fragile and unpredictable with the
gradual increase in customer expectations and industries, especially in
sudden lockdowns. Experts suggest investing in biopharma. Companies
technologies, near-shoring or on-shoring of the should strive to provide better
supplies, having two trusted suppliers from different information, improve lead
parts of the world etc. to ensure the supply chain times and continue to ensure
remains resilient to future disruptions. availability of high quality

Industry players need to invest in the right products’’
technologies to better manage the supply chain - John Boehm,
lifecycle. There is an increased need for traceability
in the supply chain and organisations need to look at VP, Biopharma, Colder Products Company (CPC), USA
solutions that can deliver more detailed information.
Organisations are continuously looking for solutions ‘‘Technologies such as
to help increase inventory visibility, lower costs, and prescriptive analytics, real-time
reduce waste. inventory visibility, and digitised

‘‘Technologies such as prescriptive analytics, workforce management etc.
real-time inventory visibility, and digitised workforce are meant to bring more agility
management etc. are meant to bring more agility and and help eliminate the adverse
help eliminate the adverse effects of uncontrollable
industry disruptions in the supply chain sector,’’ effects of uncontrollable
opined Rajnish Gupta, VP and Head - India & industry disruptions in the
Subcontinent Business, Zebra Technologies, India.
supply chain sector’’
Some companies are working to bolster - Rajnish Gupta,
relationships with existing suppliers. ‘‘As much as
possible, we want to develop reliable long-term VP and Head - India & Subcontinent Business,
partnerships with our suppliers, regardless of Zebra Technologies, India

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‘‘We want to develop reliable China). As a result, many countries are encouraging
long-term partnerships with and incentivising onshore manufacturing. In a
survey conducted by Global Pharma Insights, 67 per
our suppliers, regardless of cent of respondents stated that their governments
their geographical location, and were attempting to bring manufacturing home, and
form strategies for longer term 84 per cent responded that their companies were
manufacturing supply in other actively seeking new supply chain partners.
regions to provide contingency
‘‘We have made significant investments to insource
and cost efficiency as our wherever possible activities that had been external
business grows’’ but fit well in our manufacturing competencies,
- Gareth Crothers, especially when it comes to manufacturing our custom
consumables,’’ said Gareth.
Head of Manufacturing & Supply Chain at
Univercells Technologies, Belgium Industry and governments are also evaluating
what local investment would be needed to increase
‘‘One way to diversify or build production within their own country for raw
supply chains is by creating materials or active ingredients.
geographic diversity by helping
more manufacturers, especially ‘‘For greater oversight, governments are
manufacturers in underserved continuing to enforce reporting systems of potential
areas, produce ingredients impacts on drug supply. However, it is not possible to
and medicines to international produce 100 per cent of the supply domestically, and
drug shortages are not solely due to dependence on
quality standards’’ supply from other countries,’’ said Moore.
- Matruprasad Priyadarshi,
This re-shoring of the supply chain is a much
Senior Director-Regional Program Operations & more difficult and time-consuming proposition
General Manager – South Asia, USP, India – especially for traditional batch manufacturing
facilities which can take years to re-tool, much less
their geographical location, and form strategies for build from scratch.
longer term manufacturing supply in other regions
to provide contingency and cost efficiency as our ‘‘One way to diversify supply chains is by creating
business grows. We also aim, where appropriate, to geographic diversity by helping more manufacturers,
reduce shipping risk on the sourcing side by selecting especially manufacturers in underserved areas,
raw material suppliers who are geographically close produce ingredients and medicines to international
to our production facility,’’ added Moore. quality standards,’’ said Matruprasad Priyadarshi.

Supply chains with a single point of failure or Another way to build resilience is to diversify
limited suppliers are particularly vulnerable to production methods through the adoption
disruption. Some industry experts advise having at of advanced manufacturing technologies like
least two trusted suppliers from different parts of the pharmaceutical continuous manufacturing.
world and ensuring that they retain sufficient raw
materials in-house. ‘‘Pharmaceutical continuous manufacturing
(PCM) is one of the most promising advanced
‘‘Having multiple and backup supply sources manufacturing technology (AMT) advancements
across geographies can diversify supply chains and because it enables continuous use of a production
help minimise interruptions during an emergency. A line that can yield significantly more product output.
robust contingency plan includes early identification This type of AMT has the potential to improve
and negotiations with alternative suppliers, avoiding manufacturing efficiency, reduce production costs,
the need to reactively locate supply,’’ said Moore. and significantly reduce environmental footprints,’’
said Matruprasad Priyadarshi.
Therefore, it is important to diversify supply
chains, ensuring there are alternative suppliers in The pandemic has been a wake-up call for the
the event of an emergency situation in a specific pharma industry on the importance of building
geographic region. resilient supply chains. Firms should use this
opportunity to assess supply networks, understand
The recent supply chain shortages highlighted its vulnerabilities, and then take actions to improve
dependencies on the sourcing of raw materials and robustness. Going forward this risk is going to
APIs from only a few countries (e.g., India, Mainland continue and having agile, resilient supply chains is
the need of the hour.

Ayesha Siddiqui

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Seeking the
‘Fountain of Youth’

In September 2021, Amazon founder Jeff Bezos invested in longevity biotech startup, Altos Labs
putting the spotlight on the field of anti-ageing. Pharma and biotech firms are investing in research
that could prevent and reverse the ageing process in humans, but can novel therapies actually
provide longevity? Let’s find out.

Ageing is mostly associated with skin Researchers have also observed that COVID-19
conditions like wrinkles, crows feet etc., and patients taking the drug had less hospitalisations and
anti-ageing is considered a purview of the death rate.
cosmetic industry, but it’s a much more complicated
physiological process at a cellular and metabolic Another drug being repurposed for anti-
level categorised by telomere length, inflammation, ageing studies is rapamycin. Rapamycin was
oxidative stress, and slower cell metabolism. initially discovered as an anti-fungal metabolite.
Subsequently, rapamycin was found to possess
While ageing isn’t considered a disease or immunosuppressive and anti-proliferative properties
condition per se, companies are looking at bodily in mammalian cells, spurring an interest in
processes at the cellular level to see how ageing identifying the mode of action of rapamycin.
progresses and trying to find the right treatments that
might slow these processes down. It is the only pharmacological agent thus far
shown to reproducibly extend lifespan and delay
Anti-ageing drug research a subset of age-associated pathologies in multiple

It is incredibly difficult to develop a single ‘‘We have seen tremendous
drug that can cure ageing not only because of the interest in the anti-ageing
complexity, but because it shares similar traits - at
a cellular level, with other age related diseases like space in the past six months
cancer and neurodegenerative disorders. that actually aligns with

That’s why many of the firms studying age- discoveries that happened
related diseases like cancer and Alzheimer’s are now about 25 years ago. Since
collaborating with researchers looking at ageing more
broadly and vice versa. discovering that ageing is a
biological process, researchers
Metformin is the most promising anti-ageing drug have been conducting studies
candidate that is approved by the United States Food and publishing reports on what
and Drug Administration (USFDA). The drug has
been used successfully to treat diabetes for over 60 this means in practice. Some
years. Studies have already shown that Metformin of these findings are gaining
can delay ageing in animals. It may also influence significant traction and reach
fundamental ageing factors that underlie multiple human trial stages, which is
age-related conditions in humans. likely the source of this renewed

The Targeting Aging with Metformin (TAME) interest in the field. More
Trial, managed by the American Federation for researchers looking at ageing
Aging Research (TAFR), is testing whether those means a higher probability of
taking metformin experience delayed development or
progression of age-related chronic diseases—such as having treatments ready for
heart disease, cancer, and dementia. human trials and market entry.’’

Earlier studies found that people with type 2 - Garri Zmudze,
diabetes who take metformin have lower death rates. Executive Coordinator,
Longevity Science Foundation, Switzerland

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ANTI-AGEING STARTUPS strains of mice. Swiss firm Novartis is researching
rapamycin and its analog, everolimus, for potential
Startups working to discover the foundation of anti-ageing effects in humans.
youth, many of which are backed by tech billionaires:
● Chinese startup Insilico Medicine develops an One of the most popular areas of research is
around senolytics — a class of drugs that target
AI platform for drug development to treat age- ageing (or senescent) cells and destroy them via
related diseases. induced cell death.
● Singapore-based Gero, an AI platform that
develops new drugs to combat ageing and other In 2018, US based startup Unity Biotechnology
disorders. The firm raised $2.2 million in series A started the first human trial of its senolytic drug
funding in 2020. UBX0101.
● US’ UNITY Biotechnology is developing
therapeutics to slow, halt, or reverse diseases of In 2019, US’ Mayo Clinic published the positive
ageing. In October 2021, the firm announced the results of its pilot study using dasatinib (cancer drug)
positive results from phase I trial of its senolytic and quercetin (cardiovascular drug) in combination
drug. The firm is backed by Amazon founder Jeff as senolytics to treat idiopathic pulmonary fibrosis.
Bezos and tech billionaire Peter Thiel. This was a small pilot study that points to feasibility
● US’ Amazon founder Jeff Bezos has reportedly of larger trials in age-related diseases.
invested in Altos Labs, a newly minted anti-ageing
startup that hopes to prolong human life. Can pharma cure ageing?
● US’ Coinbase CEO Brian Armstrong has started a
new firm NewLimit, an ambitious new company Despite all the positive news and interest, anti-
focused on radically extending human healthspan ageing is still at a nascent stage. Majority of the
using epigenetic reprogramming therapies. research currently being done is at a preclinical stage,
● US’ Calico Labs, a longevity company announced it would be years, if not decades before we know
in 2013 by Google, has various anti-ageing drugs are a viable option to ageing or not.
research programmes in the pipeline. In
December 2020, an experimental drug, developed ‘‘We have seen tremendous interest in the anti-
by University of California scientists and licensed ageing space in the past six months that actually
by Calico, was found to reverse age-related aligns with discoveries that happened about
declines in memory and mental flexibility in mice. 25 years ago. Since discovering that ageing is a
● US’ Longevica is a life science company biological process, researchers have been conducting
researching the mechanisms of healthy aging and studies and publishing reports on what this means
life extension. It has announced its plan to launch in practice. Some of these findings are gaining
an end-to-end platform to facilitate scientific significant traction and reach human trial stages,
research collaboration and breakthrough which is likely the source of this renewed interest in
discoveries in the longevity science field. the field. More researchers looking at ageing means
● US’ AgeX Therapeutics is focused on the a higher probability of having treatments ready for
development and commercialisation of novel human trials and market entry,’’ said Garri Zmudze,
therapeutics targeting human ageing. Executive Coordinator of the Longevity Science
Foundation, Switzerland.

The Longevity Science Foundation is a Swiss
non-profit organisation advancing the field of human
longevity by funding research and development of
medical technologies to extend the healthy human
lifespan.

No single treatment or medicine will stop the
body’s ageing or reverse all age-related conditions.

‘‘While there may never be a definitive “cure” for
ageing, we believe there are promising findings that
can help us reconceptualise what ageing looks like in
our lifetimes. In addition to the drugs/treatments,
ageing interventions like nutrition and exercise show
a lot of promise in increasing lifespan and health-
span; we just need to figure out exactly which forms
are most effective,’’ said Garri.

Therapies to treat the hallmarks of ageing have
already begun. A cure for ageing will be arrived at

ANTI-AGEING 37

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gradually, step by step, as we tackle the various BIG PHARMA AND ANTI-AGEING
aspects of this multifaceted process and do so better
and better. The field of anti-ageing is still young and is
mostly a purview of innovative startups rather than
‘‘It will likely not be a single cure but a collection traditional pharma. But nonetheless, pharma firms
of therapies to address different aspects of ageing: haven’t totally abandoned the space.
telomere attrition, accumulation of senescent
cells, mitochondrial mutation, extracellular and Leading among them is Swiss firm Novartis,
intracellular waste products, extracellular matrix which is conducting human trials for rapamycin for
stiffening and more. It will involve stem cell therapy, anti-ageing benefit.
gene therapy, organ printing and replacement,
supplements like NAD (nicotinamide adenine In 2017, Novartis sold its two clinical-stage
dinucleotide) and epigenetic clocks that help alter programmes for ageing-related disorders to
erroneous information that has arisen with time,’’ PureTech Health. PureTech has a subsidiary,
said a spokesperson from BioViva, who don’t want to resTORbio, to develop two of Novartis’s Phase II-
be named. BioViva USA Inc is dedicated to improving stage mechanistic target of rapamycin complex 1
healthy human longevity through gene therapy. (mTORC1)-targeting drugs as potential therapies for
holding back age-related deterioration in immune
Regulatory challenges functioning. Novartis still has a 15 per cent stake into
those candidates. In 2018, resTORbio announced
Ageing is not yet classified as a disease by the FDA its $50 million IPO. In 2020, the firm completed its
and other regulatory agencies and until then, there merger with US’ Adicet Bio, Inc., a biotechnology
is a lack of context and regulatory support for such company discovering and developing allogeneic
research. gamma delta T cell therapies for cancer and other
diseases.
‘‘How close we are to a treatment will also depend
on grass-root movements that force regulatory bodies US’ Celgene’s spin out Cellular Therapeutics
to change their endpoints from the diseases of ageing develops anti-aging therapeutics derived from
- like diabetes type 2, dementia etc. - to ageing itself placental stem cells.
as a disease. The regulatory bodies do not regard
ageing as a disease and therefore do not fund cures In 2020, US’ Johnson & Johnson (J&J) entered
for it. They fund cures for amyloid plaques but Longevity market with “Immorbidity” play. In
not research for the condition that causes amyloid partnership with US’ National Academy of Medicine,
plaques in the first place. Only grass-root movements the new competition aims to find the next great
can change the endpoints of the regulatory bodies. breakthrough to help us stay active and healthy
In other words, a cure for ageing requires people to beyond the age of 100. The grand prize winners will
understand that ageing can be cured, and therefore be named in 2023 and given as much as $5 million to
to demand that the old regulatory system adapts turn their ideas into reality.
to current capabilities,’’ said a spokesperson from
BioViva. Google backed anti-ageing startup Calico is in
a long-running research collaboration with global
Garri feels there are other challenges to overcome biopharma US’ AbbVie for discovering novel therapies
before we think about regulatory ecosystem for such for age-related disease.
research.
there will be a better understanding of the science of
‘‘Right now, the key barrier in advancing longevity ageing and longevity. All this will open a new frontier
science is the lack of transparent, equity-free funding and will certainly translate to a better and healthier
for early-stage longevity tech. Much of this tech is life.
not yet eligible for venture funding but needs capital
to define a distinguishable therapy/product. This is Ayesha Siddiqui
a fundamental challenge in developing treatments;
until it is overcome, regulatory barriers will be a
problem that we will need to address in the future
when specific treatments are ready for international
introduction,’’ said Garri.

The global anti-ageing market is predicted to
skyrocket from around $191.5 billion in 2019 to a
whopping $421.4 billion by 2030, according to a
report by P&S Intelligence. As the research evolves,

38 SPEAKING WITH

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

“We want to work with global innovation
leaders in disruptive technologies”

« is a new opportunity for collaboration and
breakthroughs. Evonik Venture Capital has already
Erning Cao, executed a total of eight direct and fund investments
in Asia since 2018.
Investment Director,
How does Evonik evaluate market dynamics
Evonik Venture Capital, and operational growth in Asian Biomedical
R&D and early-stage companies for
Asia Pacific, China investment allocations?

Acompany’s agile structure depends on creating Throughout Asia, biomedical funding is on the
a network of scientific advisors and venture rise. Countries such as Japan and China continue
partners to accelerate its innovations and to report high levels of growth of up to 33 per cent.
potentials. To achieve this, venture capitalists assist Given the high levels of growth, coupled with strong
healthcare and biopharmaceutical companies at all commitments from various Asian governments such
stages of development, be it company’s early-stage as Singapore to life sciences (including biomedical)
designing, stimulating transformative technologies or research and funding, we are confident that the
nurturing business growth. Erning Cao, Investment region’s industry has tremendous potential. It is also
Director at Evonik Venture Capital (Shanghai, critical to have a deep understanding of the local and
China) shares insights on strategic venture capital regional regulatory environment, engage in research
investment towards innovative business models in and development and focus on needs specific to that
APAC healthcare industry promoting sustainable and market. More importantly, startups within the space
ethical practices in the region. Edited excerpts; are likely to be the ones to disrupt the industry as we
know it today.
How do you define growth-driven investment
strategies fostering transformative startups At Evonik, we have focused our venture capital
and technologies in major APAC markets? investments on Innovation Growth Fields, ranging
from additive manufacturing, healthcare solutions,
Asia is hitting a sweet spot for companies and and sustainable nutrition – this includes emerging
investors alike. However, the opportunities for technologies spearheading biotechnology, sustainable
growth within the startup ecosystem also mean that and ethical R&D practices.
there cannot be a one-size-fit-all investment strategy.
Investors must be able to tailor their strategies As we look ahead to 2022, we want to push the
across specific startups, technologies and even boundaries and work with global innovation leaders
across countries. For example, in Southeast Asia, with disruptive technologies across MedTech, climate
most ecosystems are still in the early development tech and sustainability initiatives to positively change
phase, but countries such as Singapore, Malaysia lives. Evonik’s investment strategies will continue to
and Indonesia have already entered the next phase, be anchored on three pillars – sustainability, growth
given their size and rapid development. Singapore, in and profitability, and platform technologies. Evonik
particular, has become a true leader in the region due will also continue to focus on its key Innovation
to its supportive government policies and dedicated Growth Fields spanning advanced food ingredients,
programmes contributing to the success of its startup cosmetic solutions, membranes, and healthcare
ecosystem. solutions in the coming year. We are aiming at next
generation or sustainable solutions accounting for
Asia holds major growth share within disruptive at least 35 per cent of our portfolio products and
fields such as additive manufacturing, sustainable investments.
nutrition and healthtech solutions. Every investment
How do you foresee the investment scenarios
in APAC for sustainable life science business
models while promoting ethical R&D
practices?

SPEAKING WITH 39

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

With Asia being a diverse region filled with distinct Philippines and Thailand are falling behind with high
sets of demographics, regulatory environments and levels of fragmentation across both public and private
bio-pharma needs, the potential for the market here health sectors slowing down digital health efforts.
is burgeoning at an estimated size of $40.25 billion
as of 2021. Furthermore, the pandemic has led to Given COVID-19, healthcare is now viewed
significant trends within the bio-pharma market – for as a new national defence for many countries
example, entrepreneurs are shifting R&D focus to across ASEAN. What we will begin to see is more
develop and commercialise new technologies that can investors stepping in during earlier stages of startup
address health challenges faced in the industry. In development, thus further boosting allocations even
recent years, we are seeing an increasing number of in underserved regions. Indeed, winning investors
corporations place a stronger focus on sustainability in healthcare private equity will be those who can
and ethical R&D practices within the industry. identify the long-term implications of the global
pandemic.
Consumers are also becoming more vocal in their
preferences. For example, more than 40 countries That being said, there are certain factors that
including Australia and India have passed laws to business leaders need to take into consideration
limit or ban animal testing. The European Union has before investing in healthcare. One challenge is the
banned such testing since 2004. These regulations lack of research when choosing investments. Some
have led to the rise of startups and corporations factors that need to be considered when evaluating
investing in next-generation technologies for whether a startup is worth investing include quality
sustainable and ethical R&D practices – such of basic research, skills of their management
as alternative to animal testing methods within team, financial capability of the company, and the
pharmaceutical and chemicals industries. possibility of future commercialisation when it comes
to long-term planning.
Evonik recognises these evolving preferences, and
strongly believes in the need to invest and accelerate How essential is it to build a strategic
the development of such technologies to boost R&D
in a sustainable manner. This has led to investments alliance through public/private collaboration
in companies such as Revivo BioSystems, a
Singaporean company who has developed an organ- to elevate the funding ecosphere in Asian
on-a-chip system as an alternative to animal testing,
which is an example of our goal to support emerging bio-pharma sectors?
technologies in sustainability. With Revivo we are
accelerating the development and commercialisation Within the fields of bio-pharma and medical
of the organ-on-a-chip system aiming to provide innovation, it can be challenging to bring new ideas
an alternative to reliable and cost efficient animal and technologies into practice. It is, rightfully so,
testing. Similarly, we have also invested in Modern a highly regulated domain, expensive and with
Meadow, a startup that sustainably produces bio continuously high attrition rates.
fabricated materials that are inspired by leather,
eliminating the need for animal skins. These issues can be addressed with stronger
collaboration between private and public
With countries moving towards stronger ethical stakeholders. By sharing risks and costs to accelerate
R&D regulations and practices, investors will need to the development pathway and generally funnel efforts
realise that it is not only about what the innovation is, towards areas where there is both an important
but how these technologies can contribute back to the unmet medical need as well as where progress would
industry and for society at every stage of its ‘life’. have significant value for society, public-private
partnerships can fundamentally change how we
What are your views on healthcare capital advance health and science.

investment, allocation, and deployment Collaboration across stakeholders such as
healthcare professionals and industry partners are
concerns at underserved ASEAN regions? crucial to providing quicker access to promising
health interventions while safeguarding the
When we look at the overall healthcare investment in sustainability of health systems and life science
ASEAN, there is a disparity in the level of growth and innovation. Government agencies can also encourage
maturity across different countries in the past year. innovation, research and development through
For example, Singapore and Indonesia are ahead ensuring that there are transparent and clear
of ASEAN countries when it comes to attracting frameworks in place. This transparency will then
healthcare and healthtech investments due to support encourage entrepreneurs to get engaged in the
from government entities. On the other hand, the discussion.

Hithaishi C Bhaskar
[email protected]

40 REFORMS

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

2022 seeks holistic revamping
of pharma regulations

« Ingredients (APIs) and was initiated with a financial
outlay of Rs 6,940 crore. This was followed by a more
Upendra N Sharma, extensive and broader PLI Scheme, announced on
Partner, March 3, 2021, with a total sanctioned amount of Rs
J Sagar Associates, 15,000 crore, under which 55 of 278 applicants were
India recently selected by the government.

With the increasing relevance of the pharmaceutical It is imperative for the Indian pharmaceutical
industry, worldwide, as well as domestically, industry to grow adequately, particularly in view of
developments in regulation and policy pertaining the pandemic situation in India and the impending
to the industry are being keenly watched. We threat of disruption due to the new Omicron
explore the expectations of a few opportunities and variant of the virus. This suggests that the policy
challenges that are projected for this industry in the push towards consolidating India’s domestic
coming year. pharmaceutical industry is likely to continue, and
2022 may bring in further grants in the form of
India’s pharmaceutical industry is one of the additional PLI Scheme(s) or similar initiatives for the
largest in the world, as it currently ranks at No. pharmaceutical industry.
3 worldwide for pharmaceutical production by
volume and No. 14 by value. Notably, India is also This was further highlighted by Prime Minister
stated to be the largest provider of generic drugs Modi’s statements at the recent Global Innovation
globally, which majorly attributes to the status that Summit, stating that India’s healthcare sector has
the country commands as the “Pharmacy of the been called the ‘pharmacy of the world’, and that
World”. Currently, the Indian pharmaceutical sector the focus on developing indigenous manufacturing
contributes to 1.72 per cent of the country’s Gross abilities should continue, including for key
Domestic Product (GDP). ingredients for vaccines and medicines. This may be
seen as an opportunity especially for Indian players
Greater Focus on Domestic Production and should be duly capitalised upon in the coming
year.
In the backdrop of the pandemic highlighting
the need for a robust Indian manufacturing base Collaborations between
of pharmaceutical products, and finding its roots
in the current government’s “Atmanirbhar Bharat” Indian and Foreign Players
and “Make-in-India” policies, the pharmaceutical
industry (among others) has been a focus of multiple The government’s continuing, and potentially
schemes relating to domestic production-linked growing focus on incentivising domestic
incentives (PLI Schemes). PLI Schemes primarily manufacturing by the pharmaceutical industry
focus on making the Indian pharmaceutical industry would not only benefit Indian players but would also
self-reliant and to reduce dependency on other provide an opportunity to foreign pharmaceutical
countries for pharmaceutical manufacturing. players to collaborate with Indian companies.

The first PLI Scheme, announced on July The potential lies in collaboration between foreign
21, 2020, focused on the promotion of domestic players with established Indian manufacturers, as
manufacturing of Key Starting Materials (KSMs) or well as the various healthcare startups in India,
Drug Intermediates (DIs), and Active Pharmaceutical by way of joint ventures, investments, technology
transfer agreements, among others.

India has historically seen various successful
collaborations between domestic and foreign players,
such as Bayer-Cadila, Pfizer-Biocon, AstraZeneca-
Torrent Pharma, among various others. The coming
year may, similarly, bring with it opportunities and
avenues for collaborations between Indian and
foreign partners, in all shapes, sizes, and forms.
These ventures should aid domestic players in terms

REFORMS 41

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

of receiving foreign investment and/or technology The year almost gone by has been
and know-how, while also potentially allowing quite challenging and tumultuous for
foreign players to capitalise on the government’s the Indian market in general, including
efforts to promote the domestic industry. especially the pharmaceutical industry,
which faced its fair share of challenges.
New Drugs, Cosmetics, The industry, with the support of the
Government, has made many efforts
and Medical Devices Bill and taken various steps to tackle the
challenges previously faced. In this
One of the most significant regulatory changes backdrop, 2022 should come with its
to the Indian regulatory landscape expected relating own set of opportunities and challenges
to the pharmaceutical industry is an overhaul for the Indian pharmaceutical industry,
and revamp of the current legal framework. The which are likely to be focused largely on
Government of India has recently constituted an the Government’s concerted efforts to
eight-member panel, chaired by Dr V G Somani, promote and consolidate the domestic
Drugs Controller General of India, to frame a new pharmaceutical industry.
draft law for drugs, cosmetics, and medical devices
(New D&C Law). differences between drugs and medical devices.
(iii) Online Pharmacies: While there are
The current legal framework pertaining to drugs,
cosmetics, and medical devices is centred around many online pharmacy websites in India, the current
the Drugs and Cosmetics Act, 1940 and various rules framework does not duly address the various aspects
and regulations thereunder, including in relation to of such websites and portals. The New D&C Law
medical devices. should aim to provide for a specific framework
around online pharmacies as well, taking into
The existing framework has often been criticised account the nuances and differences between online
as being an aging and complex set of rules and pharmacies and brick and mortar pharmacies (which
regulations, with multiple piecemeal amendments the current regulations primarily focus to govern).
made over time to keep up with developments in the
pharmaceutical industry. There is thus a need for a The New D&C Law, once submitted by the
holistic revamp to tackle the same, and to focus on panel and which may potentially come into force
more nuanced issues within the law. in the course of 2022, may provide for a significant
collection of opportunities and challenges for the
In view of the same, the New D&C Law is expected pharmaceutical industry, depending on how effective
to play a significant role in revamping the regulatory it is at meeting the expectations of the industry
framework relating to the pharmaceutical industry. participants.
Certain key aspects that the New D&C Law should
ideally incorporate are, among others: Road ahead

(i) Streamlining and Restructuring the The year almost gone by has been quite
Regulatory Structure: The New D&C Law should challenging and tumultuous for the Indian market
aim to simplify and streamline the regulations in general, including especially the pharmaceutical
around the pharmaceutical industry, putting an end industry, which faced its fair share of challenges. The
to the piecemeal manner in which various aspects industry, with the support of the Government, has
are currently governed and regulated. This may made many efforts and taken various steps to tackle
also include revamping the various functionaries the challenges previously faced.
established under the law, and clearly defining their
roles in ensuring that uniformity in regulation and In this backdrop, 2022 should come with its own
enforcement is achieved across the country, to the set of opportunities and challenges for the Indian
greatest extent possible. pharmaceutical industry, which are likely to be focused
largely on the Government’s concerted efforts to
(ii) Medical Devices: In view of the promote and consolidate the domestic pharmaceutical
growing relevance of medical devices within the industry. Further, the New D&C Law (if enacted
pharmaceutical industry and the functioning of any in 2022) may have its own collection of regulatory
robust medical system, a key aspect to tackle the opportunities and challenges for the industry.
regulatory framework for medical devices, which
are currently regulated as ‘drugs’ within the existing
legal framework. The New D&C Law should have a
separate and holistic framework for the regulation
of medical devices, and should ideally not be linked
fully to the regulation of drugs, given the significant

42 PEOPLE NEWS BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Hummingbird Metro Pacific Hospital Holdings
Bioscience names Dr Harish Pillai as CEO
picks Jan Moller
Mikkelsen as Dr Harish Pillai has been physician and staff engagement
Board Chairman appointed as the Chief and clinical quality. Before
Executive Officer (CEO) of joining MPHHI, Dr Pillai has
Hummingbird Bioscience Metro Pacific Hospital Holdings helped in strategising and
Holdings, a Singapore and US- Inc (MPHHI), which manages managing large-scale healthcare
based innovative clinical-stage the largest private hospital organisations that have helped
biotech company focused on network in the Philippines with deliver consistent results in
developing precision therapies 19 hospitals and 3750 beds, clinical, service and business
against hard-to-drug targets two allied healthcare colleges, a excellence in countries like
in cancer and autoimmune growing primary care network, India, Egypt and the UAE. He
disease, has announced the oncology centres and a central was previously the CEO of Aster
appointment of Jan Moller laboratory. Dr Pillai will work
Mikkelsen as Chairman of its closely with the Board of India a unit of Aster
Board of Directors. Mikkelsen Directors to direct and guide DM Healthcare
currently serves as President, the MPHHI management and was
Chief Executive Officer and team as it delivers on responsible for
Board member of Ascendis its clinical, service and the network of 14
Pharma, a pharmaceutical business strategy while hospitals across
company he founded in 2007. ensuring alignment five states, stand-
He was previously President and continual alone laboratory
and CEO of LifeCycle Pharma, improvement chains, retail
President of the Pharmaceutical in its patient pharmacy
Division of Maxygen, Inc., as experience, and home
well as co-founder of ProFound service care.
Pharma where he also served as development,
co-CEO. Prior to that, Mikkelsen
held various positions at Novo Transcenta Holding names
Nordisk, a global healthcare Daniel Weng as CFO
company, including Vice
President of Protein Discovery. Transcenta Holding has announced the appointment of Daniel Weng
as the company’s Chief Financial Officer (CFO), reporting to Xueming
Qian, Chief Executive Officer (CEO). As a member of the executive
leadership team, Weng will be fully responsible for the company’s
financial strategy, performance reporting, capital markets activities
and investor relations, helping the company to take a leap forward.

Prior to joining Transcenta, he served
as the vice president and Head of
finance at CStone Pharmaceuticals,
a company listed in HKEX, and
has the overall responsibilities
for financial functions, where he
made tremendous contributions to commercial strategy leading to
successful commercial launch in China and Taiwan as well as research
and development prioritization. Prior to CStone Pharmaceuticals, he
served as the vice president and head of finance at Everest Medicines,
a company listed on the HKEX. He led the overall IPO team and
partnered with bulge-bracket investment banks for IPO preparation
and achieved a successful listing. Prior to that, Daniel served as the
CFO of China at Amgen.

PEOPLE NEWS 43

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com Eli Lilly India

Ascentage Pharma appoints appoints
Yiqing Chen as CFO
Vineet Gupta
Ascentage Pharma, based in China, has announced the appointment of
Yiqing Chen as Chief Financial Officer (CFO), reporting directly to Dr Dajun as GM
Yang, Chairman and Chief Executive Officer (CEO) of Ascentage Pharma. As
a member of the company’s senior executive team, Chen will focus his work Eli Lilly and Company
on the capital market, financial management, and investor relations, to drive (India) has appointed
the company’s long-term and sustained growth in the capital market. Prior Vineet Gupta as the
General Manager (GM)
to joining Ascentage of its India subsidiary
Pharma, Chen was with effect from January
Vice CFO and General 1, 2022. Gupta will take
Manager of Investor over from Luca Visini
Relations and Capital who served as Managing
Deployment at Fosun Director of the company in
Pharma; and Deputy India from February 2018
General Manager and CFO at BGI Genomics for years, having accumulated to December 2021. Gupta
deep expertise in the capital market and corporate finance. During his tenure joined Eli Lilly in 2010 as
at BGI Genomics, Chen accomplished a series of well-known financing Marketing Director for
projects in the life sciences industry, under the leadership of the company’s India, followed by a role as
Chairman and General Manager. These projects include capital transactions Corporate Affairs & PRA
and operational initiatives such as Initial Public Offering (IPO) in mainland (Pricing Reimbursement
China, issuance of corporate debt, refinancing, and restructuring the and Access) Director
company’s financial organization. in 2012, and has since
served in various
NUS Prof. Too Heng-Phon receives strategic leadership
President’s Technology Award roles across multiple
countries including
Associate Professor Too Heng-Phon from the Department of Biochemistry General Manager roles in
and National University of Singapore (NUS) Centre for Cancer Research Thailand, Philippines and
at NUS Medicine has been conferred the President’s Technology Award Indonesia. He is currently
2021 for his groundbreaking work in developing a method for accurate, based out of the Lilly
versatile detection of microRNA disease biomarkers, leading to the clinical Corporate Headquarters
implementation of blood tests for early detection of diseases such as in Indianapolis (US).
cancer. Prof. Too is also the Co-founder, Chief Scientific Advisor and Non-
executive Chairman of MiRXES, a leading Singapore-headquartered
biotechnology company started in 2014, which has licensed
and commercialised his miRNA detection technology. For
more than 10 years, Prof. Too has been developing methods
and assays for the accurate detection of miRNA biomarkers,
the smallest pieces of genetic material. In 2010, he patented
and published his work on the development of a miRNA
qPCR assay platform technology which was subsequently
commercialised and applied to the discovery of
biomarkers for the early detection of cancers and
other diseases. Notably, the technology has enabled
the development of GASTROClear, the world’s
first molecular blood test for the early detection
of gastric cancer, which received the CE mark in
2017 and regulatory approval from Singapore’s
Health Sciences Authority in 2019.

44 R&D NEWS BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Nasal spray to China designs injectable,
fight COVID-19 adhesive surgical gel to
heads to clinical prevent scar tissue
trial in Australia
Up to 90 per cent of patients formulated a hydrogel, dubbed
An at-home nasal spray HAD, with a photocurable
treatment for COVID-19 will who undergo open abdominal twist. When injected, the side
be put to the test by Melbourne of the hydrogel not touching
biomedical researchers, as or pelvic surgery develop the wound was cured with
the University of Melbourne an ultraviolet light for three
and Monash University in postoperative adhesions, or to five seconds. Similar to its
Australia receive $4.2 million function in a gel manicure, the
to establish a six-month clinical scar tissue. Minimally invasive UV exposure dried the hydrogel
trial lead by Northern Hospital and prevented it from sticking
in collaboration with Oxford laparoscopic surgical approaches elsewhere. The researchers
University. Heparin, a widely plan to continue studying and
used blood-thinning drug to treat can reduce the severity of the verifying the clinical value of
or prevent blood clots forms the HAD hydrogels, with a specific
base of the nasal spray treatment adhesions, but the scar tissue focus on how the compound may
that is simple to administer, help heal chronic wounds and
stable at room temperature and still forms. There may be a prevent adhesions in a variety of
available globally. The IntraNasal diseases.
HEpaRin Trial (INHERIT) will potential solution available soon,
be led by the Northern Hospital,
using an innovative monitoring according to researchers from
and treatment platform that
allows researchers to access and Southern Medical University
remotely treat patients within 24
hours of their diagnosis, speeding in China. They have developed
up treatment and providing
monitoring through portable an injectable hydrogel that can
oximeter devices that measure
oxygen levels in blood. With the plug up wounds without sticking
help of University of Melbourne,
Monash and Oxford University to off target tissue, effectively
researchers, the team has
confirmed Heparin can block the preventing postoperative
transmission of COVID-19 and
prevent infection, making way for adhesions. The researchers have
clinical trials to begin.
Singapore develops algorithm to
assess immunotherapy benefit
in stomach cancer patients

Recent clinical studies indicate that patients with stomach cancer
treated with a combination of immunotherapy and chemotherapy
have a higher survival rate compared to those who were treated with
chemotherapy alone. However, it was found that not all patients
benefit from a joint immunotherapy-chemotherapy treatment.

Researchers at the National
University Cancer Institute,
Singapore, and the Department of
Medicine at NUS Medicine have
identified a group of stomach
cancer patients who may not
benefit from undergoing joint
immunotherapy-chemotherapy
treatment, using a novel
algorithm they developed on
their own. The algorithm, called
KMSubtraction, was validated
with over 500,000 simulations to demonstrate its robustness and
explore its limits of error. The implementation of KMSubtraction in
these trials resulted in new findings confirming that more than 20
per cent of the patient population will not benefit from the addition
of immunotherapy into chemotherapy regimen.

R&D NEWS 45

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Bionic eye study in India develops
RT-PCR-based assay for
Australia paves way identification of Omicron

towards human trials Researchers at the Indian Institute of Technology
(IIT) Delhi’s Kusuma School of Biological Sciences
A bionic eye being developed by a team of have developed an RT-PCR based assay for the specific
biomedical researchers at the University of detection of the Omicron (B.1.1.529.1) variant of
Sydney and University of New South Wales SARS-CoV-2. The assay is based on detecting specific
(UNSW) in Australia has shown to be safe mutations, which are present in the Omicron variant and
and stable for long-term implantation in a absent in other currently circulating variants of SARS-
three-month study, paving the way towards CoV-2. Primer sets targeting these unique mutations in
human trials. The Phoenix99 Bionic Eye is the S gene were designed for the specific amplification
an implantable system, designed to restore a of either the Omicron variant or other currently
form of vision to patients circulating variants of SARS-CoV-2 and tested using
living with severe real-time PCR. Using synthetic DNA fragments, the
vision impairment and assays were optimised to distinguish the wild-type from
blindness caused by the Omicron variant in a dynamic range from 10 million
degenerative diseases, to <100 copies /reaction. Currently, the identification
such as retinitis or screening for Omicron is done worldwide using next-
pigmentosa. The device generation sequencing-based methods, which require
has two main components over 3 days. By using this RT-PCR based assay, it will
which need to be be possible to test for the presence of the Omicron
implanted: a stimulator variant within 90 minutes. IIT Delhi has filed an Indian
attached to the eye and a communication patent application for the same and is in the process of
module positioned under the skin behind the initiating talks with potential industry partners.
ear. The researchers used a sheep model to
observe how the body responds and heals when
implanted with the device, with the results
allowing for further refinement of the surgical
procedure. The biomedical research team is
now confident the device could be trialed in
human patients. The team will now apply for
ethics approval to perform clinical trials in
human patients, as they continue to develop
and test advanced stimulation techniques.

NZ explores needle-free anaesthetic for skin graft surgery

Researchers from the to control the spread of the injected
fluid; it requires one ‘shot’ at a time.
Bioinstrumentation Lab at the Researchers are now aiming to improve
this by developing a needle-free ‘multi-
Auckland Bioengineering Institute orifice nozzle’, which would act less like
a small gun and more like a mini shower
(ABI) in New Zealand, have been rose, delivering a drug to multiple sites
in one ‘shot’. This would allow for a
developing and investigating jet- greater volume of a drug to be delivered,
and for more controlled spread than
injection as a promising alternative to the technology currently allows. The
team is researching this particularly in
hypodermic needles for several years. relation to its use in general anaesthetic
prior to skin graft surgery.
This technology delivers the drug as

a hair-thin jet of fluid, at a speed that

pierces the skin and delivers the drug

without the need for needles. While

depth and volume of a jet injected drug

can be controlled using an electric

motor, there is currently no method

46 R&D NEWS BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Hong Kong Batman-inspired lightweight
studies impact of 3D printed knee brace for
Pfizer vaccine on elderly hits market
Omicron variant
A lighter, yet more robust brace 3D-printed by NTU
A recent study jointly conducted by researchers, Delsson and the
the LKS Faculty of Medicine, The knee brace for the elderly who Centre for Orthopaedics in
University of Hong Kong (HKUMed) Singapore have developed
and the Faculty of Medicine, The suffer from knee problems a unique product, named
Chinese University of Hong Kong X-Brace, which looks similar
(CU Medicine) has revealed that has been developed locally by to the sleek knee brace used
Omicron, the latest COVID-19 by Batman in the movie, The
variant, can significantly reduce the Singapore engineering firm Dark Knight Rises. It weighs
virus neutralisation ability of Pfizer about 720 grams, 30 per
BioNTech (BNT162b2) vaccine by Delsson, in collaboration cent lighter than the typical
32 folds or more. A similar test of metal orthopaedic braces that
another vaccine used in Hong Kong, with 3D printing specialists weigh over 1 kg. The X-Brace
CoronaVac, is being conducted and is expected to be available in
the results will soon be available. from Nanyang Technological the market now at a price of
The researchers observed that most SGD$1,000 ($782) depending
individuals had high levels of virus University, Singapore (NTU on the user’s required
killing (neutralisation) activity configuration. The product
against the original SARS-CoV-2 but Singapore). Using 3D printing is distributed by Wearable
this ability was markedly reduced by Kinetics, a subsidiary
32 folds or more against the Omicron techniques, also known as company of Delsson.
variant. These findings suggest
that vaccine-protection against additive manufacturing, the
breakthrough infection with Omicron
will be much reduced. The data from team has managed to reduce
CoronaVac vaccinated individuals
will also soon be available but the weight of a traditional
because previous studies suggested
that virus-killing antibody levels exoskeleton knee brace,
in CoronaVac vaccines were lower
than with the BioNTech vaccines, it typically built using metal, by
is very likely that the loss of activity
against CoronaVac will also be very 30 per cent, thanks to a new
large. The joint research team will be
testing the blood of those who have design that uses lightweight
received a booster dose of vaccines
in the coming week and it is expected plastic and assistive springs.
that the booster dose will provide
increased levels of protection. Based on the prototype

assistive orthopaedic

Korea offers accurate early cancer
diagnosis with a drop of blood

Liquid biopsy, which detects tumor DNAs in the blood, is not
only more convenient than the biopsy that requires collection
of patients’ tissues, but is attracting much attention since the
blood contains tumor DNAs in presence of any cancer in the
body, whereas the tissue collection frequently misses cancerous
cells. Currently, polymerase chain reaction (PCR) is widely
employed to detect a small number of mutated genes. However,

there is a strong need to improve the
reliability of the conventional method
since its sensitivity and specificity
are compromised especially at low
concentrations. A research team at
South Korea-based Pohang University
of Science and Technology (POSTECH)
in collaboration with Seoul National
University College of Medicine and
Seoul St. Mary’s Hospital has shown
that the use of an atomic force microscope overcomes such
shortcomings. The liquid biopsy method developed by the
researchers demonstrates sensitivity high enough to detect even
one to three specific tumor DNAs in the blood while showing
specificity close to 100 per cent.

ACADEMICS NEWS 47

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

PolyU, C-MER Eye Care to nurture IIT Mandi
young Hong Kong optometrists
signs MoU
The Hong Kong Polytechnic studies about myopia management
University (PolyU) has signed a five- and ageing eyes, the main eye health with AIIMS
year Memorandum of Understanding challenges shared by Hong Kong and
(MoU) with C-MER Eye Care Holdings the nation. The collaboration also Bilaspur in
to advance optometry development brings together the complementary
and eye and vision health in Hong strengths of the School’s world- research,
Kong and Mainland China. About leading research capability (with
60 students of PolyU’s world- its research impact ranking first academics
leading School of Optometry will in Asia according to Clinical and
receive up to three weeks of clinical Experimental Optometry), and Indian Institute of
training in C-MER hospitals, clinics C-MER’s vast network of some twenty Technology (IIT),
and optical centres in Hong Kong ophthalmic clinics and hospitals in the Mandi has collaborated
and other Greater Bay Area (GBA) GBA, Beijing, Shanghai, etc., making with All India Institute
cities every year; while researchers it the only Hong Kong medical service of Medical Science
and specialists from the School and provider that has sizeable operations (AIIMS), Bilaspur on
C-MER will collaborate on scientific in the Mainland. research and academic
activities. The two
Australia lays focus on creating institutions have signed
continuous medical education pathway a Memorandum of
Understanding (MoU)
One hundred future doctors will get training in the Darling Downs and South aimed at conducting
West regions in Australia within three years, set to ramp up to 120 each year by joint research activities
2026, in a partnership between universities and and academic exchange
health services. The University of Queensland activities. Under
(UQ) and University of Southern Queensland this MoU, both the
(USQ), along with Darling Downs Health institutions plan to
(DDH) and South West Hospital and Health work on joint research
Service (SWHHS), have signed a memorandum projects and involve
of understanding (MoU) to create a continuous in short-term joint
medical education pathway. The programme academic programmes
unveiled will allow university students to in the future providing
complete all of their undergraduate and the researchers and
postgraduate studies and practical training in students with an
the region. It would open the door for future opportunity to visit and
doctors and the health of regional communities. The ‘Medical Pathway’ concept work collaboratively
is now seen as the future blueprint to improving health outcomes in regional, with the other
rural and remote Queensland, available for postgraduate students from 2024. Institution. The joint
research and academic
collaboration activities
under this MoU
will cater to various
domains related to
medical science and
technology including
medical imaging,
digital pathology,
point-of-care testing
devices, bioinformatics,
endocrinology,
biomaterials,
telemedicine, among
others.

48 SUPPLIER NEWS

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Fujifilm opens bioprocessing OriCiro Genomics
innovation & collaboration
centre in China launches new

FUJIFILM Irvine Scientific, Inc. has announced the enzymatic DNA
establishment of an ‘Innovation and Collaboration Centre’
in Suzhou New District, China. Through this new centre, synthesis tool
experts will collaborate with customers to design upstream
cell culture processes that meet their biomanufacturing OriCiro Genomics Inc., based in Japan,
has announced the launch of OriCiro
needs. The market for cell culture media Cell-Free Switching system. In the
in China has been expanding, and it is biological sciences, cell-based cloning
currently expected to grow at an annual and manufacturing of DNA is still the
rate of about 20 per cent. Researchers gold standard. However, cell-based DNA
and drug manufacturers require methods pose many problems from time
high-performing, safe, and reliable lost to slow cell-growth for researchers
bioprocesses to drive down the cost of as well as downstream manufacturing
therapeutics. The centre will incorporate concerns regarding low or no yield due
advanced cell culture automation to cytotoxic sequences and the necessity
and analysis into process and media to remove host cell contaminants such as
development to enable highly accurate endotoxins. OriCiro Cell-Free Switching
evaluation and identification of optimal upstream cell culture system allows the researchers to quickly
processes. Furthermore, it will provide the local resources switch the plasmid DNA amplification
and expertise for optimised cell culture media and associated from using living cells to easy to use cell-
workflows, to achieve the quantity and product quality free, enzymatic amplification system. SS
attributes necessary to support commercial production of OriC Cassettes can be inserted by a two-
new drugs. The new centre in Suzhou will join the network step isothermal enzymatic reaction to
of optimisation services offered from FUJIFILM Irvine enable cell-free amplification within hours.
Scientific’s facilities in the USA and Japan. Construction has The core technology is based on OriCiro
begun and is planned for completion by March, 2022. Genomics’ optimized in vitro propagation
process based on over 20 proteins which are
essential for E. coli genome propagation.

Shimadzu releases six new models of analytical balances

Shimadzu Corporation has increase global market share to operations to be performed
released six new models in about 10 per cent. AP-AD series without touching the operating
its AP-AD series of analytical models include new automatic panel on the main unit, which
balances simultaneously in doors that improve operation. helps prevent infections and
Japan and other countries. The Touchless sensors enable reduces the risk of foreign matter
new AP-AD series models not the entire range of weighing contaminating the analytical
only offer excellent basic samples. By using a Shimadzu
performance, such as fast
weighing times of about analytical network system
two seconds and high via LabSolutions Balance
measurement stability that software to manage weighing
minimiss errors, but also data, information can be
include new functionality managed in combination with
that improves convenience, measurement data from liquid
such as automatic doors chromatographs or a variety of
and touchless sensors. By other analytical instruments in
releasing the AP-AD series order to comply with the latest
of these high-end analytical
balances, Shimadzu intends to regulations relevant to the
pharmaceutical industry and
other industries.

SUPPLIER NEWS 49

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

BD enhances Sartorius acquires
high-throughput
molecular testing for major stake in
infectious diseases
ALS Automated
BD (Becton, Dickinson and Company) has expanded
the BD COR System to include a new MX instrument Lab Solutions
for high-throughput molecular testing for infectious
diseases. The new instrument and its first test The life science group Sartorius is expanding its
for sexually transmitted infections have been CE bioanalytics portfolio by acquiring a majority
marked to the IVD directive 98/79/EC. The new MX stake in ALS Automated Lab Solutions GmbH.
instrument is the final piece of the BD COR System, The laboratory technology company based in
which also includes a PX instrument that can prepare Jena, Germany, develops, manufactures and
diagnostic samples by automating appropriate pre- markets solutions for the automated analysis,
analytical processing steps and a GX instrument selection and isolation of cells. With these
that can leverage the BD Onclarity HPV Assay with solutions, ALS enables life science customers
extended genotyping to screen for HPV infections. to significantly reduce time to result and cost in
The first test available on the MX instrument is the cell line development and antibody discovery.
BD CTGCTV2 for BD COR System, which is designed Other application areas are the development
to use a single test to detect the three most prevalent of cell and gene therapeutics as well as rare
non-viral sexually transmitted infections — Chlamydia single cell molecular diagnostics in cancer
trachomatis (CT), Neisseria gonorrhoeae (GC) and and prenatal research. Sartorius is initially
Trichomonas vaginalis (TV). purchasing 62.5 per cent of the shares in ALS as
of January 3, 2022. The remaining 37.5 per cent
will be acquired in 2026. ALS currently employs
around 30 people and is expected to generate
sales in the high single-digit million-euro area
in 2021, with a double-digit EBITDA margin.

Lonza, Agilent collaborate to integrate new analytical technologies

Lonza and Agilent Technologies analytical technologies both at-
have announced a collaboration line and in-line within the Cocoon
that has the potential to transform Platform automated manufacturing
the way personalised cell therapies workflows, manufacturers will
are manufactured and realised. be able to ensure that in-process
This collaboration will integrate controls and analytics can be
Agilent’s current and new analytics employed on-demand to deliver a
technologies and techniques into the more consistent drug product. The
Lonza Cocoon Platform’s cell therapy Cocoon Platform is an automated
manufacturing workflow to explore and closed platform for patient-
current and assess new Critical scale cell therapy manufacturing,
Quality Attributes (CQAs) required designed to overcome manufacturing
for the release of the therapeutic to challenges associated with patient-
the patient. By integrating Agilent scale personalised medicines.

50

BIOSPECTRUM | JANUARY 2022 | www.biospectrumasia.com

Jabbed for good Due to these measures China’s current prevention
and control strategies are effective against the
From January 3, 2020 to December 29, 2021, COVID-19 Omicron variant as well as the number
there have been 131,315 confirmed cases of new confirmed cases are less than 200 per day
of COVID-19 with 5,699 deaths in China, as reported by the National Health Commission
reported to the World Health Organisation (WHO). (NHC).
Whereas the other countries in South East Asia
namely India - 34,922,882 (481,893), Indonesia Infectious diseases are easy to spread in
- 4,263,433 (144,102), Thailand - 2,232,485 schools and kindergartens which are densely
(21,738), Bangladesh - 1,586,466 (28,077), Nepal populated. Launching a vaccination programme
- 829,277 (11,598), Sri Lanka - 588,300 (15,037) for children aged between 3 and 11 is an important
and Myanmar - 531,155 (19,277) have significantly part of building an immune barrier for the whole
higher number of confirmed cases and number of population as well as a key measure to curb the
deaths respectively reported during the period. COVID-19. Many districts in Beijing started the
COVID-19 vaccination for children aged between 3
Globally, there have been 281,808,270 and 11 on October 28. Beijing started administering
confirmed cases of COVID-19, including a second dose of COVID-19 vaccine for children
5,411,759 deaths. As of January 2, 2022, a between 3 and 11 from December 6, 2021.
total of 8,693,832,171 vaccine doses have been
administered. However, India has launched its next Phase
of COVID-19 vaccination drive by vaccinating 4
China has always kept the health of its citizens million adolescents between 15-18 age group, on
on priority and taken many measures to prevent January 3, 2022.
and control the spread of the pandemic since
January 2020. Nearly 2.85 billion COVID-19 On New Year’s Eve, delivering his 2022 New
vaccine doses had been administered on the Year Address through China Media Group and the
Chinese mainland as of January 2, 2022, data internet, President Xi Jinping referring to COVID-
revealed by the National Health Commission 19 related developments four times said “the whole
(NHC) on January 3, 2022, about 18 months after nation staying united in solid COVID-19 response.
the commencement of the vaccination drive in To date, China has provided two billion doses of
China, on July 22, 2020. COVID-19 vaccines to more than 120 countries and
international organisations.”
Not lagging behind, India too, has achieved
significant progress in vaccinating its people As of December 31, 2021, India has exported
as it has exceeded 1.47 billion as on January 3, 115.42 million doses of COVID-19 vaccines to more
2022. This has been achieved through 15,738,732 than 97 countries including 13.77 million doses
sessions. India started its vaccination drive on under grant, 68.44 million doses under commercial
January 16, 2021. basis and 33.21 million to COVAX. India will soon
increase these export figures in the coming months
Currently 10 vaccines are available for as companies have increased their production
emergency use as per the WHO emergency capacities.
use listing (EUL). Of these, five are from Asian
region including three from India (COVISHIELD Both India and China are playing a major
(ChAdOx1-S [recombinant]) and COVOVAX role in controlling the spread of COVID-19 in the
(SARS-CoV-2 rS Protein Nanoparticle respective countries and also supporting the world
[Recombinant]) from Serum Institute of India with their generous contribution.
Pvt. Ltd and COVAXIN (Whole Virion Inactivated
Corona Virus vaccine) from Bharat Biotech As rightly pointed out by President Xi Jinping
International Ltd and two from China (CoronaVac “Only through unity, solidarity and cooperation
(Vero Cell), Inactivated from Sinovac Life Sciences can countries around the world write a new chapter
Co., Ltd and Inactivated COVID-19 Vaccine (Vero in building a community with a shared future for
Cell) from Beijing Institute of Biological Products mankind.”
Co., Ltd. (BIBP).
Narayan Kulkarni
China is way ahead in pushing for vaccination Editor
and strict implementation of COVID-19 guidelines.
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