BioSpectrum Asia June 2022

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4 BIO EDIT

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

Dr Milind Kokje INTENSIFYING DRUG CRUNCH

Chief Editor Several countries are sailing in the same boat, so to speak. Sri Lanka, Taiwan, the UK
and Malaysia are facing serious drug shortages. The causes may be different but the
[email protected] effect remains the same, patients suffering due to non-availability of the required
drugs to treat them. Doctors in Sri Lanka have warned that the shortage of medicines
in the country could soon lead to a catastrophic number of deaths as people are being
compelled to postpone life-saving procedures in the absence of necessary drugs. As Sri
Lanka imports more than 80 per cent of its drug requirements and pays for it in dollars,
the economic crisis leading to drying out of foreign currency reserves has hit the medicine
supplies. The local pharma suppliers have to pay Rs 33 billion in arrears.

Over 180 critical medical items are in short supply, affecting surgeries and diagnostics.
Almost five per cent of drugs were out of stock in the last month itself. They include
medicines for patients on dialysis, those who have undergone transplants, cancer patients,
drugs to treat heart disease and tunes to help newborn babies to breathe. India delivered
25 tonnes of medical supplies worth Rs 260 million. In addition, India has agreed to
receive back the loan in Sri Lankan rupees for the purchase of $200 million worth of
medicine given to Sri Lanka under the Indian loan facility. Some other countries are also
helping. The World Bank is providing $600 million to buy drugs. But it all may take
some time to reach the supplies. The French government has provided medicines and
anaesthetics making it possible to 90-day operation for emergency operations.

At the other end of Asia, people in another island country – Taiwan - are struggling
to get Chinese traditional herbal medicine NRICM 101 to treat COVID-19. The reason
for shortage is the steadily growing number of patients. From mid-April, the demand
increased by 200 per cent. Several COVID patients faced difficulty in getting the herbal
drug and many traditional Chinese medicine doctors could not prescribe it because of
its shortage. As the medicine was in short supply the people turned to Chinese medical
shops to get the ingredients used in the medicine. But even half of the ingredients are
also in short supply.

The traditional drug was developed by Taiwan’s National Research Institute of
Chinese Medicine and eight local Chinese medicine makers were given license to produce
it. The institute also made the formula of the medicine public so that even clinics could
produce it. Now the eight companies which were given licenses are expanding their
production capacity and seven more companies are being authorised to ramp up the
production. However, they will have to resolve the problem of shortage of some of the
ingredients. The National Research Institute of Chinese Medicine has now developed
an online form for the patients to check the availability of the drug. It will provide a list
of Chinese medicine clinics across the country where the herbal medicine is available.

Another Southeast Asian country, Malaysia, too, is facing a drug shortage. Its total
supply of pharmaceuticals depends on directly imported drugs or on imported Active
Pharma Ingredients (APIs) and intermediates. Both the supplies are affected either due
to the Russia-Ukraine war or prolonged lockdown in Shanghai. Surge in demand and
inadequate HR availability are also two reasons for the shortage.

The UK is experiencing shortage of Hormone Replacement Therapy (HRT),
antidepressants, and blood pressure drugs, steroids and medicines prescribed for
Arthritis. High increase in the costs of raw materials received from China and India and
delays in getting approvals from drug controllers are the reasons for the shortage. Generic
medicines producers supply 2.2 million packets of drugs to the National Health Scheme
per day. Two-third of the producers have reported problems in daily supplies. They fear
that the situation may further deteriorate. Barring two exceptions, impact of the war and
the COVID-19 lockdowns are the main reasons for the current shortages of medicines in
several countries. Until we are done and dusted with the pandemic and the war, there is
little hope for improvement in the situation, leaving the patients high and dry.

BIO MAIL 5

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

Acknowledgements We are happy to share that the
It was a pleasure working with Holomedicine Association has been
BioSpectrum Asia for the interview feature mentioned in BioSpectrum Asia in their
on TIBCO in the May edition. Looking Cover Story ‘Why Holomedicine is Rapidly
forward to more collaborations. Personally, Gaining Ground’ in April 2022 edition.
from a reader’s perspective, I find The article highlights the positive impact
BioSpectrum Asia really engaging. that mixed reality applications are having
on healthcare and features valuable
- Jung Yee Tan, Singapore insights from our founding members and
speakers who presented at our Inaugural
There is a pressing need to discuss the Summit in November last year. Thank
health policies and we are very thankful to you Biospectrum Asia for featuring us
BioSpectrum Asia for this opportunity. We and communicating the importance of
hope our partnering continues. Thank you Holomedicine technologies in all aspects of
for the article- ‘Bringing patient voices into healthcare.
HTA, health policy development in Asia’ in
the May edition. - Holomedicine
Association, London
- Khadijah Malik, Malaysia

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6 BIO CONTENT

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

COVER STORY 18

Targeting
Optimal

DRUG DELIVERY

In recent years, several innovations have emerged around long-acting formulations and medical
device development to improve patient compliance. Consequently, the growing need for controlled
drug release coupled with technological advancements in pharmacology is promoting the adoption
of novel drug delivery systems (NDDS). It is now crucial for Asia Pacific (APAC) drug formulators
to learn and act upon these advances in therapeutic modalities that address long-standing
bioavailability, dosage, and ingestion challenges of drug components to remain competitive in the
global market. Simultaneously, it’s essential to optimise the therapeutic efficacy and safety profiles
of a drug by regulating dosage parameters, while DDS plays an important role in administering
drugs, vaccines, and therapeutic agents. Optimising these techniques enhance the performance
efficacy ratio of medications by economically managing therapeutics assets. Let’s examine recent
advancements in drug delivery modalities that are greatly
encouraging stakeholders’ collaboration among innovators,
manufacturers, investors, and contract development and
manufacturing companies (CDMOs)
who are capitalising on competitive
advantages.

22

“We believe oral versions
of biologics have
the potential to take
significant market share”

Talat Imram
CEO, Rani Therapeutics

BIO CONTENT 7

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com INNOVATIONS

ORGAN-ON-CHIP 39

27 AIM brings innovations
from labs to hospitals
Drug Discoveries Without Animal Testing and masses

DIGITAL HEALTH Ranjan Das,
Innovation Lead,
29 NITI Aayog

Big Pharma Bets Big on Digital Health Solutions REGULARS

REGULATIONS BioEdit.........................................................................04
BioMail........................................................................05
31 Policy and Regulatory News...................................08
Company News........................................................10
Ensuring Digital Health Standards Finance News............................................................12
Start-Up News...........................................................13
SPEAKING WITH World News...............................................................15
WHO NEWS...............................................................17
33 People News..............................................................43
R&D News..................................................................45
“It is our goal to Academic News........................................................47
fuel R&D in the region” Supplier News...........................................................48
Lets Talk Health........................................................50
Rich Lane,
Director- Sales and Marketing, CONNECT
APAC, Abcam ENGAGE
SHARE
35
CONNECT WITH US
“80% of premature
heart attacks and twitter.com/BioSpectrumMag
strokes are preventable” facebook.com/BioSpectrumMagazine

Dr Ying Chen, https://goo.gl/QY4nUp/BS-LinkedIn
Head of Commercial Operations for APAC,
Bayer Pharmaceuticals W W W. B I O S P E C T R U M A S I A . C O M

37

“Our approach to
managing the side effects
of cancer therapy has evolved”

Mike McCullar,
Chief Executive Officer,
OnQuality Pharmaceuticals

8 REGULATORY NEWS

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

China, Brazil join hands to boost health cooperation

Ma Xiaowei, Minister of China’s agency exchanges, strengthen partnership under the framework
National Health Commission multilateral cooperation and of the China-Brazil High-level
(NHC) recently had a meeting promote sustained and in- Coordination and Cooperation
with Marcelo Queiroga, Brazil’s depth development of China- Committee in order to jointly
Health Minister to exchange Brazil comprehensive strategic build a global community of
views on further deepening health for all. Brazil hopes to
bilateral and multilateral health further collaboration with China,
cooperation. In recent years, maintain close exchanges at all
China and Brazil have maintained levels, strengthen communication
good health collaboration and and coordination in multilateral
achieved progress in solidarity fields and promote bilateral
in fighting the COVID-19 health cooperation to a higher
pandemic. China is willing to level for the health and well-
further deepen bilateral practical being of the people of the two
cooperation, enhance inter- countries.

Japan approves digital UKHSA inks agreement
therapeutic CureApp
for hypertension with KDCA for disease

Japan’s CureApp has received the medical device control and prevention
regulatory approval of a digital therapeutic (DTx) app
for hypertension. This marks the first time a standalone Dr Dame Jenny Harries, Chief Executive of
software app supporting doctors and patients has the UK Health Security Agency (UKHSA),
received medical device regulatory approval in Japan, has signed a Memorandum of Understanding
and is the first app addressing hypertension to be (MoU) with Dr Eunkyeong Jeong,
approved in the world. Preparations are now underway Commissioner of the Korea Disease Control
to receive reimbursement and launch the app in 2022. and Prevention Agency (KDCA). The areas
This app provides direct treatment guidance that has of mutual interest for cooperation under
been tailored to each individual patient, including advice this MoU include public health emergency
on diet, exercise, sleep, and other aspects of their lifestyle, preparedness and response; surveillance and
and information intended to encourage behavioural control of epidemic-prone diseases, including
improvements based on information entered by the viral haemorrhagic fevers; laboratory
patient, via their smartphone. The FY2022 revision of the capacity-building and enhancement to detect
national medical payment system added the ‘Addition of and respond to emerging disease threats
Medical Management of Software as a Medical Device, of global health importance; antimicrobial
etc.’, and this marks the first case of a standalone software resistance and healthcare associated infection
application acting as a doctor and patient aid receiving control; vaccine-preventable diseases and
pharmaceutical approval. This is also the first time in immunisations policy; pathogen information
the world medical device regulatory approval has been and resource; and public health training and
granted for DTx in the field of hypertension. experts exchange. The two organisations will
exchange best practice, pursue joint scientific
programmes and research projects, and
subsequently publish findings as appropriate.
As part of this MoU, UKHSA and KDCA
will engage in an annual or bi-annual policy
dialogue, host regular consultations to explore
potential areas of bilateral cooperation, and
establish mutually beneficial scientific training
opportunities, such as a personnel exchange
programme between the parties.

REGULATORY NEWS 9

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

NZ announces $40.7M Korea, Bangladesh
funding for mRNA
vaccines development join forces to boost

The University of Auckland in New Zealand AMR response
has received budget funding of $40.7 million,
as announced by Minister of Finance, Grant in South Asia
Robertson, for the development of novel mRNA
vaccines and other therapies. Wellbeing Budget South Korea-based International Vaccine Institute
2022 funding of $40.7 million over four years (IVI) and the Ministry of Health, and Family
will support scientists who are looking to leverage Welfare (MOHFW) of Bangladesh have shared key
exciting new mRNA technology and its findings from the Capturing data on antimicrobial
potential for new medical therapies. resistance Patterns and Trends in Use in Regions
Development of mRNA technology of Asia (CAPTURA) project. CAPTURA is an IVI-
has taken a quantum leap during the led initiative to increase the
COVID-19 pandemic, work that paves volume and quality of data on
the way for further novel vaccines antimicrobial resistance (AMR),
addressing challenging infectious consumption (AMC), and use
diseases and other human and animal (AMU) in South and Southeast
therapies. The funding is for a research Asia – funded by The Fleming
and development of mRNA ‘platform’ Fund, a UK Aid programme
that will allow New Zealand to develop working in partnership with
its emerging strengths in this field, identify and Mott MacDonald. Led by IVI, the
address gaps in terms of capability and create National Dissemination Workshop
high value jobs; bridge engagement between held in Dhaka reviewed the last
researchers and industry partners to test and two years of key CAPTURA activities in Bangladesh.
commercialise new approaches; support clinical The research findings will help the government
testing; and facilitate linkages with partners and of Bangladesh form evidence-based policies and
institutions overseas. practices to contain AMR, which is a critical and
growing threat to global public health.

Singapore announces new collaborative
project for cardiovascular disease research

The Agency for Science, understanding the underlying The project leverages large and
Technology and Research’s biology of HFpEF patients in Asia, well-phenotyped heart failure
(A*STAR) Genome Institute and carrying out comprehensive patient cohorts from the Asian
of Singapore (GIS) and studies of biomarkers that lead to neTwork for Translational
Bioinformatics Institute (BII), the segmentation of these patients Research and Cardiovascular
as well as the National Heart based on their pathologies, and in Trials (ATTRaCT), a translational
Centre Singapore (NHCS), order to advance the development cardiovascular research
National University of Singapore of therapeutics for heart failure. programme led by A*STAR
(NUS), and pharmaceutical that integrates efforts from
company Novo Nordisk basic, translational, and clinical
have signed an agreement scientists from multiple institutes
to study the mechanisms across Singapore. Specifically,
underlying cardiovascular the project will support the
disease progression especially integration of clinical imaging,
the condition called heart as well as molecular biological
failure with preserved ejection and clinical phenotypes; and
fraction (HFpEF). The research advance the development of novel
collaboration is focused on treatments for heart failure.

10 COMPANY NEWS

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

Dr. Reddy’s signs multi- Fujifilm Irvine Scientific
country deal with HK
inno.N for Tegoprazan completes construction

Indian firm Dr. Reddy’s Laboratories has entered of bioprocessing
into an exclusive partnership with South Korea-
based HK inno.N Corporation, for the supply and centre in China
commercialisation of HK inno.N Corporation’s
patented novel molecule Tegoprazan for Fujifilm Irvine Scientific, Inc. has announced
gastrointestinal diseases in India and six key the completion of its Innovation and
Emerging Markets. HK inno.N Corporation’s Collaboration Centre in Suzhou New District,
Tegoprazan induces fast onset of action and China. Construction of the new Innovation and
can control gastric pH for a prolonged period, Collaboration Centre began in December 2021
potentially offering significant clinical benefit
in acid-related disorders. Tegoprazan is already and is now open
approved in South Korea and China, and is under to facilitate
registration and clinical development in several collaboration
countries globally, including the USA. Under between experts
this partnership, HK inno.N Corporation will be and customers for
responsible for the manufacture and supply of the tailored design
Tegoprazan, while Dr. Reddy’s will be responsible of upstream cell
for local clinical development, registration, culture processes
marketing and sales in the licensed territories. The that can meet
agreement grants Dr. Reddy’s the exclusive rights individual
to develop and commercialise Tegoprazan under its biomanufacturing
own trademark in these markets for 10 years from needs. The new facility will provide the local
the first commercial launch. HK inno.N Corporation resources and expertise needed to optimise
will receive an upfront licensing fee, and will be cell culture media and associated workflows to
eligible for potential regulatory milestone payments support commercial production of new drugs
and royalties on net product sales. in China’s rapidly expanding market. There is
significant investment and growth within China’s
biopharmaceutical, vaccine, cell and gene therapy
markets, bolstered by the government’s dedication
to making more affordable drugs available.

Varian partners with Icon Group
to advance patient-centric solutions

Varian, a Siemens Healthineers accelerators across Australia and software systems involved in
company, has announced a five- and Asia, Varian and Icon will diagnostics, treatment planning,
year research and professional conduct clinical and technical and radiation therapy for
services agreement with research evaluating the hardware cancer patients. The companies’
Australia-based Icon Group. research will also be published
Through this agreement, Icon and used to advance broader
will participate in clinical and industry-wide education efforts,
technical research programmes, including training programmes
product evaluation projects, and to support healthcare providers
clinical consultations with Varian using radiation therapy. The
to offer Icon’s clinical expertise first project between the two
and industry perspectives organisations will focus on the
throughout product development. use of Artificial Intelligence in
Building on the agreement contouring to reduce the time it
between the two companies in takes to plan radiation therapy
April 2021 to install Varian linear treatment.

COMPANY NEWS 11

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

WuXi, A*STAR make advancements
with cell and gene therapy in APAC

WuXi Advanced Therapies, manufacturing for the cell and more AAV than plasmid-based
a wholly owned subsidiary of gene therapy industry. TESSA manufacturing, generating enough
WuXi AppTec, and A*STAR’s technology is a novel process material to address the growing
Bioprocessing Technology for transfection-free, scalable demand in healthcare needs for
Institute (BTI), have announced manufacture of adeno-associated patients suffering from cancer and
a new partnership to bring WuXi viruses (AAV) and represents other life-threatening diseases. As
ATU’s proprietary Tetracycline- a major advancement in AAV part of this collaboration, WuXi
Enabled Self-Silencing Adenovirus manufacturing by improving AAV ATU will supply the materials,
(TESSA) technology to the yields and particle quality. TESSA equipment, funding, and training
Asia-Pacific (APAC) region. This technology produces significantly required to further develop and
partnership aims to foster commercialise TESSA technology
scientific innovation in cell and in Singapore. BTI will contribute
gene therapy, and establish a research expertise, facilities and
joint professional development access to its network of partners to
programme to train and support WuXi ATU in its research
develop the next generation of and development in cell and gene
scientists and engineers in GMP therapy in Singapore.

Hyundai Bioscience opens Novo Holdings, Shionogi
offer treatment for invasive
new chapter in world’s fungal infections in Asia

antiviral drug history Novo Holdings has announced that its portfolio
company F2G has entered into a strategic
The birth of a universal antiviral drug with a collaboration with Japan-based Shionogi & Co. to
mechanism applicable to all viral infections is develop and commercialise its antifungal agent
approaching. This antiviral agent, developed olorofim for invasive fungal infections in Europe
in Korea, has an innovative ‘viral removal’ and Asia. F2G is a UK, US and Austria based biotech
mechanism applicable to all viruses, unlike company focused on the discovery and development
existing antiviral agents that target only specific
viruses. It is expected to open a new chapter in of novel therapies to treat
the world’s antiviral drug history if it produces life-threatening invasive fungal
valid clinical results. Hyundai Bioscience has infections. Novo Ventures,
announced that phase 2 clinical trial of CP- the venture capital team at
COV03 for COVID-19 patients has begun. CP- Novo Holdings, has led and
COV03 is an orally administered antiviral drug participated in a series of
(active ingredient: niclosamide) developed as a financings since 2016. Naveed
universal treatment for viral diseases including Siddiqi, Senior Partner at
COVID-19. CP-COV03 is an innovative broad- Novo Holdings, serves as a
spectrum antiviral agent with a pharmacological Board Member of F2G and
action that helps human cells to remove viruses Eric Snyder, Partner at Novo
by promoting ‘autophagy’ mechanism, in which Holdings, as Board Observer. Olorofim is a novel
cells recognise the virus as a foreign substance oral antifungal therapy developed by F2G to treat
and remove it themselves. If CP-COV03 is invasive aspergillosis (IA) and other rare mould
confirmed to be effective against COVID-19 in infections. It represents the first truly novel antifungal
this clinical study, it means that a universal class developed in the past 20 years and is the only
antiviral drug is born not only for COVID-19 and antifungal medication to be awarded a Breakthrough
its variants, but also for almost all other viruses Therapy Designation (BTD) for multiple indications
such as influenza, hepatitis, AIDS, Ebola, and by the US Food & Drug Administration (FDA).
herpes.

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

Fosun Pharma India-Australia’s COVID-19 vaccine
inks $125M project gets $19.3M funding
deal for novel
immunotherapies Norway-based Coalition for Epidemic Preparedness Innovations
in China (CEPI) is providing funding of up to $19.3 million to support the
development of a ‘variant-proof’ SARS-CoV-2 vaccine candidate
US-based startup VerImmune to an international multidisciplinary consortium comprising
and Fosun Pharma in China have Bharat Biotech International Ltd (BBIL), India, the University of
entered into an exclusive license Sydney, Australia and ExcellGene SA, Switzerland. CEPI’s funding
and option agreement. Under the will support the consortium as it seeks to establish preclinical
terms of the agreement, VerImmune and clinical proof of concept for an adjuvanted subunit vaccine
has granted Fosun Pharma an designed to provide broad protection against all known SARS-
exclusive license to VerImmune’s CoV-2 variants of concern, as well as future variants of the virus
lead AIR-ViP product candidate, which have not yet emerged. CEPI will fund the researchers to
VERI-101, with an option to conduct activities including immunogen design, preclinical studies,
license certain potential future manufacturing process development and a Phase 1 clinical trial. In
AIR-ViP products arising from this new vaccine design, modified trimeric spike immunogens will
the development of VerImmune’s be produced in a robust and scalable process with high purity and
pipeline for the territory of Chinese yield at low cost, based on a biomanufacturing approach that has
Mainland, Hong Kong and Macau provided significant quantities of protein therapeutics to the world.
Special Administration Regions
and Taiwan Region. Fosun Pharma Hanmi FC to invest 10 billion
will be responsible for all clinical KRW for building facilities
development and commercialisation for ‘high-tech CDMOs’
in these territories. VerImmune’s
core technology is an innovative South Korea-based Hanmi Fine Chemical, a subsidiary of Hanmi
Virus-inspired Particle (ViP) Pharmaceutical Group specialising in APIs (Active Pharmaceutical
platform technology that can be Ingredients) development & manufacturing, is now accelerating a
used as a delivery system to attack new business, expanding its specialties from ongoing APIs to ‘high-
cancer. Building upon this highly tech CDMO’ services. To this end, Hanmi FC will invest about 10
adaptable ViP platform, VerImmune billion KRW to build facilities for ‘high-tech CDMOs’. Last year,
has developed a First-in-Class novel Hanmi FC was selected to conduct the Korean government’s project
therapeutic strategy called ‘Anti- for expanding production facilities for COVID-19 vaccines & raw
tumor Immune Redirection’ (AIR). materials and received 1.6 billion KRW in support of such efforts.
This approach uses the ViP platform Furthermore, the company plans to upgrade these facilities even more
(now termed AIR-ViP) to redirect by supplementing 8 billion KRW from its own funds. Hanmi FC is
natural pre-existing immunity from currently in charge of the development & production of raw materials
past viral infections or childhood for Hanmi Pharmaceutical’s innovative new drugs, including
vaccinations to target cancer. Belvarafenib (in partnership with Genentech), MKI (in partnership
VerImmune is eligible to receive up with Aptose), & Poziotinib (in partnership with Spectrum).
to $125 million in total milestone
payments plus tiered royalties up to
the low double digits on net sales of
VERI-101 in specified territories.

START-UP NEWS 13

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

InxMed raises Ankere Therapeutics
launches with A$10M
$15M to advance seed investment in Australia

therapies for drug- A researcher from the Monash Institute of Pharmaceutical
Sciences (MIPS) is a co-founder of Australian biotech
resistant cancers company, Ankere Therapeutics, which has been launched
with A$10 million seed investment. Ankere is dedicated to
InxMed, a Chinese clinical-stage the development of new therapies that target inflammatory
biotechnology startup dedicated to diseases, particularly those affecting the lung. It was founded
developing innovative therapies targeting by MIPS Medicinal Chemist, Associate Professor Bernard
stroma microenvironment and drug Flynn, and Professor Stuart Pitson from the University of
resistance for hard-to-treat solid tumours, South Australia’s Centre for Cancer Biology. The funding
has completed $15 million in Series B+ round was jointly led by IP Group and Brandon Capital,
Financing. The Series B+ was funded by through Brandon BioCatalyst, and will support the company
Hyfinity Investments. InxMed will use the through its preclinical development and into clinical trials.
funds to accelerate ongoing clinical trials Ankere aims to develop new therapies for inflammatory lung
of IN10018 for multiple cancer types in disease, based on its proprietary small molecule chemistry.
both US and China, including the initiation The company is harnessing research from a decades-long
of pivotal trials in the second half year, and collaboration between Associate Professor Flynn & Professor
advance more stroma targeting pipelines Pitson, & has operations in both Melbourne & Adelaide.
into clinics in both US and China this
year, and strengthen the R&D capabilities
in Nanjing. IN10018 is a potent and
highly selective adenosine triphosphate
competitive FAK inhibitor, and InxMed
has its exclusive global development and
commercial operation rights. InxMed
Nanjing Translational Medicine Centre has
conducted extensive original exploratory
research on IN10018 and FAK targets
and has published research results in
renowned academic journals.

India unveils angel investor network for biotech startups

To unlock the potential of Indian an inclusive platform that engages to become the platform of choice
startups, the Biotechnology early-stage investors from India for investors and innovative
Industry Research Assistance and overseas from different angel startups to build globally
Council (BIRAC) has collaborated investor groups, to fund and competitive companies. BIRAC,
with the Indian Angel Network nurture high-quality startups, the not-for-profit Public Sector
(IAN) to launch an angel investor with both money and mentoring Enterprise of the Department
network, BioAngels. It is the backed with critical sectoral of Biotechnology, Government
country’s first sector-focused expertise. BioAngels’s vision is of India, has been instrumental
angel investor group to fuel the in supporting the technology
growth of startups from Biotech led startups right from ideation,
– the sunrise sector. Sub-domains incubation, and acceleration for
include Medtech, Healthtech, commercialisation. By partnering
Pharma, Cleantech & Agritech. with IAN, it fills up a critical gap of
The biotech sector has potential Angel money requirement to make
for cascading multiplier effect to Startups VC investment ready by
contribute to India’s economic unlocking high quality business
growth target of a $5 trillion mentoring and industry networks
economy by 2025. BioAngels is for the startups.

14 START-UP NEWS

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

SwipeRx secures DoctorOnCall
$27M to accelerate
growth across SEA bridges gap between

SwipeRx (formerly mClinica Pharmacy Solutions), HCPs and patients
Southeast Asia’s (SEA) leading platform for
pharmacies, announced it has secured a Series Malaysian startup Health Digital Technologies
B round of $27 million in equity and debt to Sdn. Bhd. (DoctorOnCall), has inked a strategic
accelerate growth across SEA. The round was led partnership with Pertubuhan Doktor–Doktor
by Indonesia’s MDI Ventures, with participation Islam Malaysia (PERDIM), an organisation that
from global investors, Bill & Melinda Gates manages general practitioners in the provision of
Foundation, Johnson & Johnson Impact Ventures, primary care in Malaysia. The partnership is aimed
SIG and existing investors. Singapore-based at providing PERDIM members with access to
startup mClinica Pharmacy Solutions recently list their services on the DoctorOnCall platform,
rebranded to SwipeRx, the name of its flagship app connecting them with potential patients seamlessly
and has acquired more than 235,000 pharmacy to bridge the gap between healthcare providers
professionals and 45,000 pharmacies across SEA (HCP) and patients. Members of PERDIM will be
to-date. With a strong presence across Indonesia, able to upload and list their treatments and services
The Philippines, Vietnam, Malaysia, Thailand and on the platform to tap a wider telemedicine and
Cambodia, SwipeRx is ready to grow its network digital health customer base. Reshaping healthcare
of pharmacies, expand their specialised healthcare provider-patient relationships and interactions,
logistics to fulfil B2B commerce, accelerate members of PERDIM will be able to offer remote
technological innovation and recruit talent across health-related services such as teleconsultation and
SEA. SwipeRx sees vast opportunities to expand its home monitoring aside from enabling patients to
community and commerce solutions for pharmacies make bookings for physical appointments at their
across SEA and build on its lead in its key markets. physical clinics.
With a strong team of over 400 employees,
SwipeRx is poised to grow and scale across SEA.

Biopharma Helico gets seed funding
for producing edible medicines

New Zealand-based startup Biopharma Wolfgang Leitner, and existing investor
Helico has completed an A$1.8 David Ross. Helico has strong backing
million seed funding round, attracting from the New Zealand Government’s
international interest in its plans Callaghan Innovation, which has bought
into the deep-tech startup’s vision to
to produce therapeutic replace large, expensive pharmaceutical
compounds from plants factories with growing high-value
and, ultimately, ‘edible therapeutic compounds via low-tech
medicine’. Led by agriculture. The long-term aim of the
Icehouse Ventures, startup is to develop a seed bank of
investors included different drugs able to be licensed to grow
Custos Privatestiftung, medical supplies in confined greenhouses
the family office of anywhere in the world.
Austrian billionaire

WORLD NEWS 15

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

DFC financing up to $1B for Gavi COVID-19 vaccine supply

The US International Gavi to monetise sovereign and waiting time for the funding. This
Development Finance private sector pledges to the tool will give the COVAX AMC
Corporation (DFC) and Gavi, COVAX AMC and consequently additional liquidity to support
the Vaccine Alliance have maximise impact by minimising the availability of COVID-19
partnered to create the COVAX vaccines, including variant-
Rapid Financing Facility, which adapted doses, in response to
will provide up to $1 billion to risks and shocks, and it will
accelerate COVID-19 vaccine and enable COVAX to act quickly to
ancillary supply purchase and secure access to extra doses. The
delivery on behalf of developing COVAX Rapid Financing Facility
countries participating in is particularly useful to donors
the COVAX Advance Market who, due to budgetary or other
Commitment (COVAX AMC). considerations, wish to make
The aim of this new innovative payment to Gavi over the next
financing instrument is to allow four years.

EffRx, Medis, Orpharm, US to set up 9 AViDD
Centres for Pathogens
OrphanDC, Vector of Pandemic Concern

Pharma form WODA The National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes
EffRx Pharmaceuticals, Medis, Orpharm, of Health, US has awarded approximately $577
OrphanDC, and Vector Pharma have million to establish nine Antiviral Drug Discovery
announced the newly formed World Orphan (AViDD) Centres for Pathogens of Pandemic
Drug Alliance (WODA). It aims to provide Concern. The AViDD centres will conduct innovative,
comprehensive support to pharmaceutical and multidisciplinary research to develop candidate
biotech companies with rare diseases, oncology COVID-19 antivirals, especially
and highly specialised therapeutics portfolio, those that can be taken in an
starting from named patient programmes outpatient setting, as well as
through to full commercialisation. By bringing antivirals targeting specific viral
together experts for rare diseases, WODA has families with high potential to
capabilities to provide all the services necessary cause a pandemic in the future.
for orphan medicines to reach patients in need, These include paramyxoviruses,
replacing local branches of global distributors bunyaviruses, togaviruses,
or multinational companies. In total, WODA filoviruses (including Ebola
covers 68 countries in the following regions: viruses and Marburg virus),
Turkey, Middle East and North Africa, Russia picornaviruses (including
and CIS region, Central and Eastern Europe, enteroviruses and other cold-
Latin America and Switzerland. causing viruses), and flaviviruses (including the viruses
that cause yellow fever, dengue and Zika). The awards
are a part of the Antiviral Programme for Pandemics
(APP), an intensive research programme designed to
speed development of therapeutics for COVID-19. APP
is led by NIAID, the National Centre for Advancing
Translational Sciences (NCATS) and the Office of
Research Infrastructure Programs, all part of NIH; and
the Biomedical Advanced Research and Development
Authority (BARDA), part of HHS.

16 WORLD NEWS BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

Benin, Uganda, Kenya to assess mix-and-match
Rwanda COVID-19 vaccine boosters in
eliminate people living with HIV
human African
trypanosomiasis The Coalition for Epidemic Preparedness Innovations (CEPI), in
Norway, and the Kenya-based Victoria Biomedical Research Institute
Human African (VIBRI) have announced a new programme of clinical research in
trypanosomiasis (HAT), Kenya, Democratic Republic of Congo, and Rwanda which aims to
otherwise known as sleeping evaluate the safety and immunogenicity of
sickness, is a life-threatening homologous and heterologous COVID-19
disease that afflicts poor rural vaccine booster regimens in adolescents
populations. Carried by tsetse and adults living with HIV. CEPI will
flies, the disease has long been provide up to $12.5 million to assess
a curse for communities in this “mix and match” booster approach
West, Central and East Africa, in these populations. This Phase 2B
where two different variants study will include adolescents and adults
of the disease were rife. Now, aged 12 to 64 years who are living with
countries and communities or without HIV infection. Participants
are fighting back with who have already received homologous
vigour and determination, COVID-19 vaccination with either Moderna or Pfizer mRNA vaccines,
and this is leading to very or the vaccines produced by Janssen, Sinovac or Sinopharm will receive
encouraging results. Three a booster of either the Janssen or Novavax vaccines five to seven
countries – Benin, Uganda months after completion of the primary vaccination series. Each study
and Rwanda – have now participant will be followed up over an 18-month period.
received validation from the
World Health Organization Ethiopia establishes
(WHO) that at least one form collaborating centre with Korea
of HAT has been eliminated for joint vaccine research
as a public health problem
in their lands. Uganda is South Korea-based International Vaccine Institute (IVI) and Armauer
the only country where both Hansen Research Institute (AHRI), established by the Government
forms are endemic but has
now achieved elimination of Ethiopia in collaboration with Save the
as a public health problem Children Organizations of Norway and
of the gambiense form. The Sweden, held a ceremony recently to launch
country remains committed the AHRI-IVI Collaborating Center. The AHRI-
to eliminating the rhodesiense IVI Collaborating Center is a research and
form as well, which affects training site to advance vaccines for global
central and southern regions. health. Collaborators from both organisations
Togo and Côte d’Ivoire were will conduct vaccine research and clinical
the first two countries to be development, engage in disease surveillance
validated as having eliminated and policy studies, provide training across
the gambiense form of HAT vaccinology, and support vaccine introduction
as a public health problem, in programmes. The AHRI-IVI Collaborating
2020. Center is the third of its kind, joining a network
of IVI Collaborating Centers in Ghana and
Madagascar with the aim of co-developing
research projects and building in-country capacity. Recently, IVI and
AHRI launched the first round of a mass vaccination campaign to
provide 100,000 residents of Ethiopia with oral cholera vaccine (OCV).

WHO NEWS 17

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com WHO compiles

WHO validates China’s Convidecia innovative
as 11th vaccine for COVID-19
concepts to
The World Health Organisation (WHO) has issued an emergency
use listing (EUL) for Convidecia, a vaccine manufactured by CanSino communicate
Biologics, China, adding to a growing portfolio of vaccines validated
by WHO for the prevention of COVID-19 caused by SARS-CoV-2. science
In addition to shortening the vaccination cycle by leveraging the
advantages of its single-dose regimen, Convidecia can be stably The COVID-19 pandemic has
emphasised the importance of
transported and stored translating science in a timely
between 2 and 8 degrees and accessible manner to
celsius, making it more different audiences. Throughout
accessible to developing the pandemic, individuals
countries with insufficient and organisations designed
storage facilities and innovative concepts to distil
medical resources, reducing the latest science and make it
the burden placed on meaningful and understandable
healthcare systems and to their respective communities.
medical workers, and contributing to building broad immune WHO has compiled case studies
protection globally. Currently, CanSinoBIO’s Convidecia has received to showcase the creative yet
approvals in more than 10 markets: China, Mexico, Ecuador, rigorous approach of several
Chile, Argentina, Hungary, Kyrgyzstan, Pakistan, United Arab science communication
Emirates, Indonesia & Malaysia. The company also established local initiatives worldwide. The
partnerships for distribution in various countries, including setting examples were collected through
up fill-and-finish facilities in Mexico, Pakistan, & Malaysia, allowing an open call that received 78
its COVID-19 vaccine access to more people in developing markets. submissions. All examples were
reviewed by two members of
WHO launches new the WHO science translation
guide on integrating team and analysed as regards
eye care in health systems to their (i) scientific accuracy,
(ii) innovation factor, (iii)
A new WHO guide on eye care was recently launched at the event consideration of gender, equity
- Universal Health Coverage and Eye Care: Promoting Country and human rights aspects,
Action - attended by government officials, WHO representatives and (iv) evaluation of their
and non-governmental organisations in the eye care sector. The Eye impact. Selected submissions
Care in Health Systems: Guide for Action provides practical, step- were consequently written
by-step, guidance to support Member up as case studies in close
States in planning and implementing the collaboration with the originators
recommendations of the world report on of the initiatives. The launch
vision with the goal to provide integrated features the 20 most highly
people-centred eye care services. This rated good practice examples
new resource leads Member States including initiatives directed
through a four-step process: situation at the health workforce, media
analysis; development of an eye care representatives, researchers and
strategic plan and monitoring framework; the public including older people
development and implementation of an and children and adolescents.
operational plan; and establishing and maintaining ongoing review Featured examples showcase the
processes. Currently, more than 2 billion people are living with a vision impressive creativity with which
impairment and of these, at least 1 billion people are needlessly living science communicators make the
with poor vision due to lack of access to eye care services. science behind COVID-19 more
accessible, understandable and
meaningful to their audiences.

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Targeting
Optimal

DRUG
DELIVERY

In recent years, several innovations have emerged around long-acting formulations and
medical device development to improve patient compliance. Consequently, the growing
need for controlled drug release coupled with technological advancements in pharmacology
is promoting the adoption of novel drug delivery systems (NDDS). It is now crucial for
Asia Pacific (APAC) drug formulators to learn and act upon these advances in therapeutic
modalities that address long-standing bioavailability, dosage, and ingestion
challenges of drug components to remain competitive in the
global market. Simultaneously, it’s essential to optimise the
therapeutic efficacy and safety profiles of a drug by regulating
dosage parameters, while DDS plays an important role in
administering drugs, vaccines, and therapeutic agents.
Optimising these techniques enhance the performance
efficacy ratio of medications
by economically managing
therapeutics assets. Let’s
examine recent advancements in
drug delivery modalities that are
greatly encouraging stakeholders’
collaboration among innovators,
manufacturers, investors, and contract
development and manufacturing companies
(CDMOs) who are capitalising on competitive
advantages.

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Advancements in the drug delivery systems (DDS) are
gradually offering solutions to the rising prevalence of chronic
conditions. It is now more crucial than ever before to improve
patient compliance while lowering the cost of treatment. As drug
manufacturers strive to overcome patient compliance concerns, both
small molecules and large molecule active pharmaceutical ingredients
(APIs) need to be efficiently managed to achieve the desired
therapeutic effect in moderate dosage.

According to experts a significant proportion of APIs or drugs
on the whole, exhibit low solubility, low bioavailability, and/or
low inconsistent dissolution rate. For biopharmaceutical pipelines
to advance, it is essential to address these concerns effectively by

identifying, resolving,
and reinventing drug
delivery channels.
Maximising solubility
and absorption

eliminate the need
for reformulation and,

hence, promotes the
market reach of a drug
candidate. Utilising
complementary drug
delivery technologies
can achieve a full
range of absorption
profiles by
modulating
pharmacokinetics.
As a result, CDMOs
are developing
a portfolio

of bioavailability
enhancement

technologies and
services.

Recent

developments in

DDS

Advanced drug
delivery technologies

are enabling and
enhancing the
next generation
of specialised
parenteral medicines.
Over the last decade, NDDS are evolving as smart, safe,
and efficient modes of a therapeutic regimen in a pulsatile,
sustained or controlled manner to enhance precision therapeutic
regimens. The objective of control and/or sustained drug release
is to reduce dose frequency and increase drug moiety efficacy
compared to conventional delivery. The industry is also being
propelled by the rapidly growing pediatric and geriatric population,

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APPROVED LNP DRUGS AND to extend the half-life of medicines inside the
THE DISEASES THEY TARGET body, dosing frequency can be minimised and
make treatments easier and more convenient for
Credit: ACS Nano 2021_Approved LNP drugs and the diseases they target patients. By maintaining drug levels within the
therapeutic window, active drug ingredients or a
owing to the high incidence of non-adherence to biologically active molecule will be regulated by
prescription drugs in these age groups. NDDS time, period, and release rate through systemic
modes also prevent doses from being missed or circulation while treating chronic diseases.
taken incorrectly by patients requiring third-
party assistance. Further, they simplify the Competitive landscape
challenge of patient compliance and facilitate
precision in dosage including reduced treatment The growing trend towards self-injection
cost, guards against overdosing, and reduced devices and the rapidly growing pipeline of
side effects. On the other side, the traditional biologics/biosimilars and auto-injectors could be
dosage form offers spontaneous drug liberation one of the reasons for market growth. According
that leads to drug concentration variation in the to the market research analytics at ‘Research
circulatory system. and Markets, the global advanced drug delivery
market was valued at $44,029 million in 2020
Advanced Drug Delivery Systems (ADDS) are and is estimated to reach $1,95,132 million by
essential for delivering medicine in a regulated or 2030, growing at a CAGR of 16 per cent from 2021
modulated manner within cells or tissues (organ, to 2030. North America currently dominates the
cellular, and subcellular level of specific tissue) global DDS market. The Asia Pacific DDS market
in order to ensure steady levels of medication is witnessing an expansion due to increased
in the blood. An ideal drug delivery system collaboration among stakeholders from the
performs multiple functions such as reducing/ industry and academia through R&D and M&A
eliminating adverse effects and improving the activities.
stability and solubility of the drug while being
non-toxic to the biological system on itself. While An integrated portfolio of drug delivery
developing advanced drug delivery systems, systems, and formulations, is attracting
various factors, such as pharmacodynamics, manufacturers and CDMOs alike to explore
drug toxicity, immunogenicity, biocompatibility, commercial opportunities by leveraging small
pharmacokinetics, and drug efficacy, are molecules, peptides, proteins, nucleic acids (DNA/
considered. mRNA), vaccines, and other drug substances or
combination products. The market segment is
Many therapies require frequent dosing to
maintain drug concentrations at therapeutic KEY PLAYERS OPERATING IN THE
levels. By using controlled release formulations GLOBAL LNP DRUG DELIVERY MARKET

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expected to continue to grow as the popularity of GLOBAL DDD MARKET
personalised and gene-based drugs with precision
therapeutic targets is burgeoning. Further, an The global drug delivery devices (DDD) market
increase in R&D spending, stakeholders’ interest
in nanomedicine across all disciplines of medicine is expected to grow from $79.68 billion in 2021 to
like oncology, cardiology, immunology, and
pain management, and a surge in healthcare $84.1 billion in 2022 at a compound annual growth
expenditure in developing APAC economies are
progressing DDS commercial-stage development rate (CAGR) of 5.5 percent. The market is expected to
and manufacturing capabilities.
grow to $100 billion in 2026 at a compound annual
Following advancements in formulation
technologies, multi-drug combination models, growth rate (CAGR) of 4.5 percent.
recent investments, and strategic acquisitions
across core technology areas, CDMOs are Source: Report Linker
uniquely positioned and investing in a major
expansion of R&D and CGMP manufacturing An increasingly diverse multifaceted market
capabilities. Though garnering attention as a
promising candidate for treatment for some of The market for DDS is diverse reflecting
the refractory diseases unmet up to this point, different types of systems and routes of
certain DDS products have to pass through administration. Leading CDMO markets are
hurdles, stringent regulations, and complex producing amenable DDS systems offering
regulatory approval. a wide variety of matrices and formulation
approaches in increasing kinetics and delivery
“One of pharma’s main needs today, in the strategies. A variety of ‘micro molecular vehicles’
development of new injectable DDDs, is to in the form of nano-sized vesicular carriers
accelerate time to market with integrated end- (liposomes, niosomes, dendrimers, micelles,
to-end technology platforms from formulation polymeric or lipid-based nanoparticles) or carrier-
development to small- and large-volume fill and based systems (nanoparticles, nanospheres,
finish, including complementary nanocapsules, nanoemulsions), and other drug-
services such as regulatory loaded nano-devices/implants are designed to
testing protocols to know carry medicine or new genes particles in capsule
exactly how to customise format.
platforms to customers’ drugs
and improve device efficiency,” CDMOs across APAC are catering to
says Chetan N Patel, CEO, integrated portfolios to meet the widespread
SMC Ltd, a global CDMO. adoption of these nanoparticles. In vivo devices,
transdermal devices, and reservoir implantation
Credit: ACS Nano 2021, 15, 11, 16982-17015_Key players operating in the global LNP drug delivery market devices are structured as capsules, robotics,
or microfabrication systems to deliver drugs/
therapeutics at a particular location in response to
a stimulus within the body or externally controlled
microprocessors as per the predetermined
schedule and protocol. Among established ADDS
formulations, a few diverse and distinctive drug-
loaded implant models are described here.

Lipid NanoParticles

For complex parenteral drug products
including vaccines, nucleic acids (mRNA, DNA,
siRNA), and ligand-targeted formulations,
microencapsulation has been the most preferred
choice in the biopharma industry.

Lipid-based formulations encapsulate API
ingredients in PEG-lipids, liposomes, or Lipid
NanoParticles (LNP) formulations to protect
them from degradation on their path acidic and
alkaline body fluids. There has been a resurgence
of interest in LNPs given their well-established
record, multiple faceted therapeutics usage while
achieving prolonged circulation regimens.

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5 TYPES OF DDD COMPANIES “We believe
oral versions of
● Own-IP DDD companies are integrated into biologics have
the potential to
the value chain and provide diversified types take significant
market share”
of services depending on each company’s
«
capabilities with or without manufacturing
TALAT IMRAM
capabilities. CEO,
● CDMOs offer a wide range of services throughout Rani Therapeutics

the entire value chain but do not own the IP of the How do you define the impact of Robo-pill
technology on patients and pharmaceutical
products they develop and/or manufacture. companies in APAC?
● Own-IP / DDD Platform companies + CDMOs
The RaniPill technology is poised to transform
combine both business models. the market for biologics in APAC, both for patients
● Design firms offer a broad set of design and and for pharma companies. Patient adherence
is an issue with biologics, as with all injectables,
development services, but without manufacturing and up to a third of patients on chronic injections
frequently skip prescribed doses. This can have
capabilities beyond prototyping and small-scale. major implications for the clinical progression of
● DTx companies provide digital-health ecosystems medical conditions such as osteoporosis, which
is notoriously overrepresented and undertreated
Source: AliraHealth in Asia. In Korea, for example, the prevalence
of osteoporosis in women over the age of 50 is
Global CDMO, Evonik’s Strategic Marketing, about 38 per cent. A rapidly growing population
and Business Development expert opines of elderly people throughout the continent
“Lipid-based drug delivery systems have been is set to exacerbate the problem (as with a
traditionally used for highly potent molecules host of other chronic age-related conditions),
such as anti-cancer agents, antibiotics or and by some estimates, hip fractures due to
antifungals and oligonucleotides that require osteoporosis in Asia will more than double in the
intravenous administration. While the market next few decades.
for nucleic acid-based vaccines and therapies is
yet to reach critical mass, there are hundreds of Rani is conducting a Phase 1 clinical trial
personalised medicines in development that are of RT-102, an oral formulation of parathyroid
expected to utilise these technologies moving hormone (PTH). Injectable PTH is an effective
forward.” way of treating osteoporosis, and its use is on
the rise in Korea. We expect patient preference
“One of the main advantages of LNP-based to strongly sway towards an oral option over
technologies is that they can reliably encapsulate
high payloads for both hydrophilic and lipophilic
drugs. That is a key reason why they are now
the de facto standard to deliver nucleic acid-
based vaccinations and other therapies, where
the payload must be protected until such time
as it can be delivered to the site to silence
targeted genes or express therapeutic proteins.
They can also be designed to exhibit specific
physicochemical properties such as particle size,
surface charge, and surface function to satisfy a
variety of performance requirements,” explains
Evonik’s LNPs Business Development expert.

The largest single application of LNPs in
drug delivery is in cancer treatment, because of
the improved bioavailability and selectivity of
LNP-encapsulated antitumor agents over the
free drugs. Lipid-based nanocarriers reduce the
toxicity of anticancer drugs to normal tissues,
increase the water solubilities of hydrophobic
drugs, extend the drug residence time, and
improve control over drug release. The second

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injectables. An oral PTH could reach more patients automation to increase throughput. We take a
earlier in the care continuum, and potentially improve progressive approach, starting with semi-automation
the clinical outcomes for millions of patients in APAC. and ultimately culminating in fully integrated
And osteoporosis is just one example. automation.

Oral versions of biologics also provide inherent The Robo-pill technology can transform the current
differentiation, which is especially valuable for APAC product portfolios of APAC pharma companies.
pharma companies that have historically focused on Overwhelming patient preference for oral over
“fast follower” products. Given higher reimbursement injectable therapeutics will be a game-changer, once
rates outside of the region, the RaniPill offers an oral alternatives of biologics become available on
attractive development opportunity for companies that the market. Additionally, there tends to be a larger
have had limited access to markets outside Asia. disparity in paying power in APAC markets. Oral
versions of injectable biologics will allow payers
How do you summarise the performance of and pharma companies the ability to stratify
Robo-pills in achieving high bioavailability and reimbursement based on product presentation.
precise delivery of drugs?
What is your prediction on APAC market
The enteric coating of the RaniPill capsule allows dynamics for Robo-pills? How do you foresee
it to pass through the acidic stomach environment, the future of Robo-pill in replacing subcutaneous
only dissolving once it has entered the small intestine. injection in modern-day therapeutics?
There, it injects the payload directly into the intestinal
wall, which is highly vascularised but has no sharp Our mission is to replace most chronically dosed
pain receptors. This approach achieves bioavailability subcutaneous injections with a daily oral RaniPill
similar to that of a subcutaneous injection, and dose. These types of injections are used across
enables the delivery of a dose that is close to or almost all therapeutic areas, including inflammatory
equivalent to a subcutaneous dose. disease, endocrinology, rare disease, oncology, and
more. Given the price competition in the market for
By contrast, most previous efforts to make oral biosimilars and the strong patient preference for oral
versions of biologics have been based on chemistry medications, we believe that oral versions of biologics
reformulations, but even the successful attempts have have the potential to take significant market share
achieved bioavailability no greater than low single around the world, especially in APAC.
digits. That requires a massive (up to a hundred times
larger) dose increase to achieve therapeutic effect, Would you like to add a note on the scalability of
which also leads to high dosing variability. Robo-pill’s design?

How is Rani Therapeutics leveraging its We’re laser-focused on improving our
investments in manufacturing and automation manufacturing automation: first, to enable the
of novel drug delivery systems? As a venture production of RaniPill capsules to support a larger
capitalist, how do you map the growth and Phase 2/3 trial, and then at commercial scale. We
opportunities for Robo-pill in the APAC region? designed the RaniPill capsule with high-scale, low-
COGS manufacturability in mind.
We’re investing in manufacturing process-step

24 COVER STORY BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

largest group of liposomal drugs comprises “Developing polymer
fungicides. Nucleic acid therapeutics are an nanoparticles and
emerging class of LNP drugs showing potential nanocomplexes for
for treating viral infections like COVID-19,
Zika and more. The nucleic acid drug Patisiran RNA delivery regards
(ONPATTRO), a siRNA formulated in LNPs biocompatibility as
to reduce transthyretin protein formation in a bottleneck in RNA
the liver (hereditary transthyretin-mediated
amyloidosis) is the earliest FDA approved LNP- delivery. Indeed, polymer
formulated siRNA nucleic acid drug, marking an nanoparticles involve the
important milestone in nucleic acid therapeutics use of positively-charged
development.
polymers to pre-condense the nucleic acid,
LNP formulations are gaining global which makes approval by the regulatory bodies
awareness, notably after being instrumental
in boosting the immune system in mRNA difficult. For this reason, using LNPs has been
vaccine mode against the SARS-CoV-2 virus. advantageous for the fast development of
By advancing the existing classical LNP model, vaccines”.
researchers at Moderna developed the mRNA - Dr Olivia M Merkel,
COVID-19 vaccine from lipid libraries. FDA Professor of Drug Delivery,
Emergency Use Authorisation (EUA) of LNP Ludwig-Maximilians-University, Germany
encapsulated mRNA vaccines from Moderna
‘mRNA-1273’ and BioNTech/Pfizer ‘BNT162b2’ “Using nanoparticles to
has revamped LNP in the drug delivery sector. deliver promising drug
candidates to their site of
Scientists are developing advanced polymers action has the potential
with the aim of improving the biocompatibility to help us improve the
of polymeric nanoparticles hoping polymer
nanoparticles might offer a significant advantage therapeutic index of
over LNPs for pulmonary administration and small molecules and new
in regard to overall RNA loading. The invention
of LNPs has been promising to date in tackling modalities. By targeting
SARS-CoV-2 variants and has prepared the delivery of a medicine
healthcare system with an efficacious vaccine
delivery model to tackle future pandemics. The precisely to the tissue where it is needed, we
formulations that have been successful in the want to achieve a therapeutic concentration
current pandemic, can be customised for future while minimising the potential for unwanted
outbreaks. off-target activity at other sites that could cause
side effects and prevent patients staying on the
Drug-Loaded Implants
treatment they need.”
Microelectromechanical system (MEMS) - Marianne Ashford,
& Nano Electromechanical Systems (NEMS)
devices offer minimally invasive and controlled Senior Principal Scientist,
drug delivery. These MEMS devices filled with Advanced Drug Delivery,
prescribed drugs as micro reservoirs substrate are Pharmaceutical Sciences, R&D, AstraZeneca
implanted in the body or ingested as pills through
oral administration. Certain self-administering
device reservoirs offer the provision to load
multiple drugs in one pill as per the
treatment regimen.

Describing the major
trends in the DDD industry,
Riccardo Butta, Senior
Vice President at
Singapore’s Flex Health
Solutions, says, “Major trend

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“Each disease has a involves the wave of biologics coming to market
peptide sequence which and the need for different delivery mechanisms
is recognised as the key for their higher-viscosity, larger-volume. and
antigen. If we are able therapy-specific requirements. This sustained
to determine the most the idea to combine these large-molecule
appropriate administration formulations with electromechanical devices,
method for the vaccine allowing pharma companies to offer improved
carrying that specific user interface, sensing capabilities, programmable
sequence, and if we can delivery profiles (e.g., dosage, delivery rate), and
elucidate on the transmission mechanism of connected solutions to their patients”.
the antigen information after its administration,
we could apply this not only to this novel “Rapid expansion of digital health, not only
Coronavirus but also to other new infectious with sensing and connectivity features inside
diseases as well.” the device, but to include end-to-end solutions
- Dr Yoshiro Tahara, to capture, transfer, store, and manage data
Associate Professor, to improve clinical outcomes. This fuels the
Doshisha University, Japan need for the integration of connected devices,
cloud infrastructure, data analytics, and mobile
“We focus on the potential applications, all within a regulated and fully
use of mRNA to produce compliant ecosystem” explains Butta, while
therapies directly in the describing the digital DDD space on a survey by
cell, turning the cell into AliraHealth.
‘biological factories’ that
produce the therapeutic One such device is the RaniPill capsule, a
proteins, antigens and/ smart Robo-pill from Korea’s Rani Therapeutics,
or antibodies to treat which navigates through the stomach and enters
diseased organs and the small intestine to inject the drug painlessly
tissues. RNA therapeutics offer potential to into the intestinal wall.
specifically modulate cellular pathways in ways
not previously possible. We are investigating Transdermal Devices
lipid nanoparticles (LNPs) as a promising
vehicle for intracellular delivery of mRNA for As opposed to In vivo devices, transdermal
production of protein therapeutics in cells”. devices deliver one or more drug molecules
through the skin potentially offering a painless
- Lennart Lindfors, smart patch method for drug delivery. The needles
Adjunct Professor, Principal Scientist, on these patches are fabricated with micro-
channels through which the drug pumps into the
Advanced Drug Delivery, body. Innovations in transdermal include skin
Pharmaceutical Sciences, R&D, AstraZeneca ablation and microneedles with iontophoresis,
bringing transdermal drug-delivery devices into
the digital health space.

“The Asia Pacific transdermal drug delivery
system market, based on type, is segmented
into the transdermal patch and transdermal
semisolids. The transdermal patch segment is
further sub-segmented into drug-in-adhesive
patches, matrix patches, reservoir membrane
patches, and microneedle patches”, explains
Research and Markets, an analytics group. In
Asia, China is the largest market for transdermal
drug delivery systems owing to the increased
adaptation of transdermal patches for pain
management in the region.

Alternatives like Hollow Microneedles (for
higher doses) and Intelligent Iontophoresis
(biofeedback patch that is self-powered and
microprocessor-controlled with SmartPower LED)

26 COVER STORY

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

Approved nanodevices for different anticancer drugs

Trade Material description Indications Year of
name approval
Abraxane Albumin-bound paclitaxel
Doxil Liposomal doxorubicin Metastatic breast cancer 1995
Oncaspar Polymeric PEG-L- asparaginase
Onivyde Liposomal irinotecan HIV-related sarcoma, metastatic breast and ovarian cancer 2005
Mepact Liposomal mifamurtide
Myocet PEGylated liposomal doxorubicin Acute lymphoblastic tumor 1994

Pancreatic cancer 2015

Osteosarcoma 2009

Lymphoma, leukemia, carcinoma and sarcoma 2000

Souce: PubMed_Credit_Flavia Laffleur and Valérie Keckeis_University of Innsbruck

and many contemporary models are adding to the beneficial in pandemic situations.
transdermal drug delivery market. Alternatively,
Dissolvable microneedles will overcome risks Perspectives for the future
of reuse and needle-stick injuries as they will
dissolve in the skin leaving no marks. Advanced drug delivery technologies hold a
major part of the drug delivery market and will
A group of scientists at the Georgia Institute play a major role in shaping the future of the
of Technology (USA) has demonstrated that drug delivery domain and also in finding the
intradermal vaccination leads to a much cure for unmet diseases. The key benefit of ADD
better immune response than the classical is its flexibility and potential to increase drug
intramuscular vaccination. Vaccine dose delivered bioavailability, improve therapy, and avoid drug
intradermally by a microneedle patch can be degradation by enhancing drug stability.
equally immunogenic. As a result of reduced
doses, immunisation programmes could make The pharmaceutical industry’s focus is on
more vaccine supplies available to a larger accelerating innovation in delivery devices.
number of people, potentially reducing the Advances in therapeutic modalities and an
costs of vaccines and associated distribution. increase in molecular complexity have led to the
Additionally, logistical advantages have motivated need for an evolution in multidisciplinary drug
the development of microneedle patches for delivery approaches over the years. Several key
vaccination campaigns in remote locations. developments are set to shape and transform
Delivering vaccines by microneedle patches is easy the advanced drug delivery arena in the coming
and does not require the expertise of a healthcare years with the evolution of novel carriers for drug
professional in giving it as an injection, could be delivery. Understanding and acting on them now is
transported without/reduced refrigeration, and crucial for Asia-Pacific drug formulators to continue
does not generate sharp medical waste. This, in to thrive in a competitive global market.
turn, can enable quick and massive immunisation,
Hithashi C Bhaskar
[email protected]

ORGAN-ON-CHIP 27

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Drug Discoveries
Without Animal Testing

Animal testing is an old debate in the research community. There are both scientific and
ethical arguments to reduce the reliance on animal testing. Technological advancements,
like organ-on-a-chip (OOC), may hold the key to replacing animal testing. OOCs can model
organ functions and companies are looking for ways to incorporate the technology into
drug testing. How well used is OOC technology in drug discovery today and can a tiny
chip really encapsulate an incredibly complex system like organ/human? Let’s find out.

Only one out of ten drugs reaching clinical (antimalarial drug) reduced SARS-CoV-2 infection
trials makes it to the market. Drugs that by about 70 per cent for COVID-19 and prevented
fail during clinical trials do so because transmission of the virus in roughly 90 per cent
the results generated during drug discovery and of animals. OOCs models have also been used in
development fail to predict drug efficacy or toxicity disease modelling, compound screening and target
in humans. Unfortunately, traditional in vitro culture identification. For example, in 2020, scientists from
techniques and animal models are poor predictors Roche reported a human retinal microvascular tubule-
of human biology. Drug discovery scientists have on-a-chip designed to mimic the blood–retina barrier,
therefore turned to humanised technologies, such which can be disrupted in diabetic retinopathy and
as OOCs to help cross-validate and supplement age-related macular degeneration.
data from traditional methodologies to improve the
translatability of data between lab and the clinic and Adoption of organ chips in drug discovery
therefore increase medicines discovery success rates.
A related area of high potential for OOCs is the testing OOCs have been around for just over a decade.
of new drug modalities, such as cell or gene therapies, In the last five years, pharma companies have been
which rely on human-specific modes of action accelerating adoption of OOC technology throughout
rendering animal models unsuitable for use. drug discovery workflows, from early target
identification to late preclinical stages to facilitate
The global organ-on-chip market was valued at more informed decisions.
$103.44 million in 2020, and is projected to reach
$1.6 billion by 2030, growing at a CAGR of 31.1 “In the last few years we have seen increasing
per cent from 2021 to 2030, according to Allied adoption of Organ-on-a-Chip technology within drug
Market Research. Pharmaceutical firms are currently development pipelines, likely because researchers are
evaluating the applications of OOC in various phases recognising the need for better, more human-relevant
of drug discovery. In May 2022, Columbia Engineering preclinical models. Unlike conventional cell culture
team demonstrated the first multi-organ chip made of and animal models, organ-chips enable researchers to
engineered human tissues linked by vascular flow for closely observe the effects of candidate compounds on
improved modelling of systemic diseases like cancer. human cells in an environment that closely resembles
in vivo tissues. As the pace and scale of research using
In February 2022, data from preclinical studies organ-chips continues to grow, the value of organ-
using the Wyss Institute for Biologically Inspired chips is becoming increasingly clear,” said Dr Lorna
Engineering at Harvard University (pioneer of this Ewart, Chief Scientific Officer, Emulate, US.
technology) Human Alveolus Chip were included in
Cantex Pharmaceuticals’ Investigational New Drug Wyss Institute researchers launched Emulate, Inc.
(IND) application to the US FDA (United States Food in 2014 to further develop and commercialise organ
and Drug Administration) to initiate Phase 2 clinical chip technology, bringing these important research
trials for a drug it licensed from Harvard University to tools to market. Alongside the growing list of practical
treat COVID-19. applications, the US FDA has even put forth the FDA
Modernization Act of 2021, which calls for the use
In 2021, airway Lung-Chip developed by the Wyss of alternative testing methods to animal testing to
Institute demonstrated that the drug amodiaquine investigate the safety and effectiveness of a drug.

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“We are optimistic that as prevalent, these types of communications send a
adoption and research into this reinforcing message to the pharmaceutical sector
technology grows, organ chips supporting OOC use, helping to open doors and
remove adoption barriers,” said Dr Yassen Abbas,
will eventually become the Lead Scientist, CN Bio, UK based leading organ chips
primary model for predicting developer that designs and manufactures single- and
human response with regard multi-organ chips. As with any new technology, there
is a need for standardisation, i.e., benchmarking
to safety and efficacy in against appropriate reference elements to ensure the
drug development pipelines robustness, reliability and reproducibility of data.

everywhere.” Can a chip really mimic an organ?
- Dr Lorna Ewart,
Can an incredibly complex system like organs/
Chief Scientific Officer, Emulate humans, ever be modelled in enough detail for results
to be considered absolutely accurate?
“Acceptance of OOC
technology and its “Absolute accuracy can never be achieved as these
incorporation into systems will never be as complex as a human organism.
Having said that, we believe that it can be very accurate
preclinical workflows when the context of use is defined. It will even be possible
has been assisted by to generate clinical trial like data in the preclinical stages
regulators, such as the US of drug discovery using organ chips,” said Dr Reyk
FDA, who recognise its Horland, CEO at TissUse GmbH, a Germany-based
firm which has developed a unique “multi-organ-chip”
potential.” platform that provides unparalleled preclinical insight on
- Dr Yaseen Abbas, a systemic level using human tissues.

Lead Scientist, CN Bio Echoing similar sentiments, Dr Abbas said,
“An in vitro model of human biology can never
“Absolute accuracy can truly be perfect. OOCs technology aims to provide
never be achieved as these significant advances in human relevance to improve
data translatability over standard techniques. OOC
systems will never be models mimic a well-defined phenotype and function
as complex as a human of human organs and can be interlinked where
organism. Having said that, appropriate into multi-organ systems that recapitulate
we believe that it can be very processes such as drug absorption and metabolism,
accurate when the context of or to understand interactions between organs, such
as inflammation, which drive disease and cause
use is defined.’’ unexpected toxicities.’’
- Dr Reyk Horland,
CEO, TissUse GmbH Most of the organ chips developers have made
single organ chips of liver, lung, gut, kidney, heart,
The US FDA has also partnered with organ chip brain etc. Multi organ chips are rare, recently Columbia
developers like Emulate and CN Bio to develop University has developed the world’s first model of
industry standards and best practices for using organ human physiology in the form of a multi-organ chip.
chips in drug development.
“We are optimistic that as adoption & research
“Acceptance of OOCs technology and its into this technology grows, organ chips will eventually
incorporation into preclinical workflows has been become the primary model for predicting human
assisted by regulators, such as the US FDA, who response with regards to safety & efficacy in drug
recognise its potential. In a recent FDA publication, development pipelines everywhere. While no model will
the advantages of CN Bio’s PhysioMimix in drug safety ever be absolutely perfect, organ chips far outperform
and metabolism applications were demonstrated currently used models like animals,” said Dr Ewart.
over standard techniques and following on from this
success, the FDA has chosen to continue working Looking forward, the future of OOC is bright.
together with CN Bio and the PhysioMimix OOC The technology is becoming more sophisticated at
system, broadening the scope of their research plan modelling human biology and it won’t be long before it
to include evaluating lung-on-a-chip for inhaled provides a viable alternative to animal testing.
drug applications. With interactions between organ
chips developers and the regulators becoming more Ayesha Siddiqui

DIGITAL HEALTH 29

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Big Pharma Bets Big on
Digital Health Solutions

Big pharma and Digital health, once on opposite ends of the spectrum, are now coming together.
In 2022, there have been several acquisitions and deals by big pharma companies in the digital
health space. The pharmaceutical industry is increasingly relying on digital solutions to make further
inroads into healthcare delivery, with broad-spectrum implications. Let’s explore the major strides
taken by pharma giants are making in this sphere and the impact of these collaborations.

Pharmaceutical giants have recognised vast accomplish these goals, pharma-digital health
opportunities digital health firms bring to partnerships are typically centered on improving
the table and are actively engaging in the diagnosis time and medication adherence rates,
space. There has been a flurry of activities be it integrating real-world evidence into clinical trials,
collaborations, deals, investments, acquisitions and enhancing drug discovery.
etc. between big pharma and digital health firms in
recent times. “As to where big pharma is focusing resources,
it truly continues to evolve as technology evolves.
Big pharma firms have been eyeing apps, Some of the primary investments we’ve witnessed
remote monitoring, virtual trials, digital over the last year or two have been in data
therapeutics, data management in this sector, science i.e., the aggregation of real-world and
particularly the solutions that can improve comprehensive patient data within cloud-based
treatment experiences. ecosystems and subsequent platforms. Companies
that can parse and analyse this data to drive insight
COVID-19 has been a propellent of big pharma’s discovery and in the technology that allows pharma
growing engagement in the sector. Big pharma to design and execute studies more efficiently
companies see massive value in digital health across their portfolios,” said Caty Reid, Senior
across the development lifecycle for diagnostics and Director, Corporate Market, PathAI, US.
therapeutics.
Impact of collaborations
“For the pharmaceutical industry, there are
many challenges where digital health solutions can According to ZS’s digital health team’s research,
directly help patients which also aligns with their the potential impact of digital health for pharma
interests. These types of solutions span the patient represents a $100 billion opportunity. These
journey; from tools that help ensure patients are
diagnosed correctly (i.e.,AI/ML algorithms) to “For the pharmaceutical
dosage titration tools, to solutions that improve industry, there are many
medication adherence, to financial assistance tools challenges where digital
or remote monitoring solutions to ensure patients health solutions can directly
stay healthy just to name a few. In addition, help patients which also
there are also applications of digital health that aligns with their interests.
can accelerate drug discovery and improve These types of solutions span
the outcomes of clinical trials. These are all of the patient journey; from
significant interest to pharma leaders,’’ said Pete diagnosis, to dosage titration
Masloski, Managing Principal with ZS Associates, tools, to solutions that improve
USA. medication adherence, to
financial assistance tools or
According to a survey from consulting firm remote monitoring solutions”.
Accenture, the reasons why pharma and biotech
executives are working with digital health - Pete Masloski,
companies are to access new technology (90 per Managing Principal, ZS Associates, USA
cent), reduce operational costs (83 per cent) and
meeting new patient demands (83 per cent). To

30 WDIOGMITEANL SHPEEACLTIAHL

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BIG PHARMA PARTNERSHIPS IN DIGITAL HEALTH

S.No Year Deal Sector
1 Mar-22 UK's AstraZeneca to acquire a stake worth up to £25M ($33M) in Virtual clinical trials
UK's Huma for digital ‘hospitals at home’ and supports decentralised clinical trials
2 Apr-22 US' Pfizer to acquire Australia's ResApp for $100M Apps
3 Jan-22 US' J&J’s investment arm joins $150M investment in digital health firm US' Verana Health Data management
4 Mar-22 France's Sanofi strikes $30M strategic agreement with digital health company DarioHealth Digital Therapeutics
5 Jul-21 US' Evidation partnered with Merck on digital monitoring study for Alzheimer’s disease Apps, wearables
6 Apr-21 US' Pfizer partnered with DoctorOnCall in Malaysia Telehealth
7 May-21 Germany's Bayer invests $30M in German's AI based system checker Ada Health Apps
8 Apr-21 Swiss' Novartis & Finland's Kaiku Health partner for for melanoma monitoring & support Apps
9 Mar-21 Takeda China launched incubator for digital health companies N/A
10 Apr-21 US' Liva Healthcare and US' Amgen to co-create a digital tele-rehabilitation platform Telehealth

“Some of the primary have changed in some specific ways. Nearly all big
investments we’ve witnessed pharma has created internal teams or functions
over the last year or two have that are focused on digital health. These groups
been in data science. Companies are exploring partnerships with digital health
that can parse and analyse this innovators and launching their own solutions
data to drive insight discovery that are meant to address some of the challenges
I mentioned. A more potentially transformative
and in the technology that change is that by investing more to help solve some
allows pharma to design and of healthcare’s more challenging problems, pharma
execute studies more efficiently is ultimately moving closer to what their true end
goal should be, which is to improve the lives of
across their portfolios..” patients. There are many examples of companies
- Caty Reid, and partnerships between digital health companies
and pharma, but the problems are difficult and
Senior Director, Corporate Market, PathAI, USA changing healthcare takes time. This movement will
be a decades-long journey of digital transformation
“More than 80 per cent of big but we all will ultimately benefit,” he added.
pharma companies have started
Sharing similar views Romain Marmot, Chief
developing or have already Business Officer at Voluntis, part of Aptar Pharma
launched a digital solution Digital Health, US, said, “According to a recent
connected to a drug delivery study, more than 80 per cent of big pharma
system. In other words, this companies have started developing or have already
trend is not a revolution, but an launched a digital solution connected to a drug
evolution of our industry that delivery system. In other words, this trend is not
started many years ago and is a revolution, but an evolution of our industry that
clearly reaching maturity today.” has started many years ago and is clearly reaching
maturity today.’’
- Romain Marmot,
Chief Business Officer, Voluntis, Big pharma companies can leverage digital
part of Aptar Pharma Digital Health, USA health across their organisation and operations,
from early drug discovery to in-market
partnerships seem to be the win-win situation for differentiation. In a few years from now, all
all- be it pharma firms, digital health providers or new drugs will be launched in connection with
patients and clinicians. a digital companion that will allow us to deliver
individualised treatment experiences that patients
But, could these collaborations end up changing need. Therefore, these collaborations are essential
the dynamics of the pharmaceutical/ digital health for both industries in the future.
sector(s)?
Ayesha Siddiqui
“Yes, indeed”, feels Pete. “In fact, they already

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Ensuring
Digital
Health

Standards

The use of digital health (DH) has grown rapidly over
the last couple of years – accelerating even more

during the COVID-19 pandemic. As DH becomes part
of the traditional healthcare system, it’s important to
have stringent regulations and higher levels of scrutiny.
Regulators around the world and in Asia are realising
this fact and changing regulations accordingly. Let’s

look at the regulatory landscape in APAC.

Digital health devices and applications pose of health conditions, specify a treatment or provide
unique challenges to regulators, and the therapy. The reforms also amend the “Essential
agencies are getting serious about meeting Principles” – the requirements relating to the
them. Within a region as diverse as APAC, with safety and performance of medical devices – in
different levels of both healthcare provision and relation to cyber security, the management of data
regulatory expertise, there is inevitably a wide and information, and requirements relating to
variation in how DH solutions are brought to market. development, product and maintenance of medical
Let’s look at how countries - Australia, Singapore, devices. Digital health technologies that collect
Japan, China, Korea, most active in enacting such personal information also need to comply with
laws, are establishing regulatory frameworks. Australia’s privacy laws as set out in the Privacy Act.

Australia Digital health goods and services which do not
comply with the consumer guarantees set out in
There is no single legislation which governs digital the ACL (The Australian Consumer Law) would
health technology in Australia. Rather, different laws fall within the regulatory scope of the Australian
govern different aspects of digital health technology. Competition and Consumer Commission (ACCC).
In Australia, the main legislation in relation to
digital health technology falls into three categories: The Australian Digital Health Agency (ADHA)
therapeutic goods law (TGA), consumer protection is responsible for the operation of the My Health
law and privacy law. The TGA regulates medical Records system and focuses on improving health
devices, including software as a medical device, such outcomes for Australians through the delivery of
as software that uses information about symptoms the National Digital Health Strategy. The Digital
to make a diagnosis, and mobile apps coupled with Health Cyber Security Centre also works alongside
devices for calculating medication dosages. the ADHA to provide a range of cyber security
capabilities to support secure national digital health
The TGA Act was updated in August 2021 to operations across Australia. In 2021, ADHA began
address the increase in medical related software- the process to define Australia’s next national digital
based products being developed. The TGA Act health strategy. The current national digital health
includes new classification rules for software-based strategy, whose implementation began in 2017, is set
medical devices, including for those that provide a to end next year when a new strategy is targeted for
diagnosis for health conditions, monitor the state enforcement.

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Singapore Services Act, Pharmaceutical Affairs Act, Medical
Devices Act, and Personal Data Protection Act (for
The main regulatory bodies in Singapore for cases involving data) are applied to digital health.
digital health are the Ministry of Health (MOH),
Singapore Medical Council (SMC) and the Health Because there are no separate laws regulating
Sciences Authority (HSA). digital health, the ministry responsible for relevant
existing laws becomes the pertinent regulatory body.
Key regulations underpinning the framework As a result, regarding the Medical Services Act, the
include: Health Products (Medical Devices) Ministry of Health and Welfare (MOHW) acts as
Regulations 2010, Personal Data Protection Act the regulatory body. Likewise, the Ministry of Food
2012 (PDPA), Regulatory Guidelines for Software and Drug Safety (MFDS) acts as the regulatory
Medical Devices – A Life Cycle Approach and the body regarding the Medical Devices Act and the
National Telemedicine Guidelines (NTG) (non- Pharmaceutical Affairs Act. Additionally, for cases
legally binding). While there is no overarching involving data and the Personal Data Protection Act,
regulatory regime for digital health, the regulation the Ministry of Public Administration and Security
of telehealth comprises an accretion of various codes acts as the regulatory body.
and guidelines issued by regulatory bodies, including
the NTG issued by the MOH in 2015, the Ethical In October 2020, MFDS implemented a
Code and Ethical Guidelines (ECEG) and Handbook revision to its medical device regulatory system
on Medical Ethics (Handbook) issued by the SMC that introduced a separate category for SaMD. The
in 2017, and the Telehealth Product Guidelines (TP regulatory body also released a series of guidance
Guidelines) issued by the HSA in 2017. documents on medical respirators, digital treatment
devices, innovative medical devices and software, and
The Singapore Personal Data Protection medical device re-evaluation.
Commission (PDPC) has released an Advisory
Guidelines for the Healthcare Sector which provides China
guidance to healthcare providers on complying
with their obligations under the PDPA in a variety The National Medical Product Administration
of scenarios where personal data of individuals (NMPA), under the State Administration for Market
may be collected, used or disclosed. In April 2022, Regulation (SAMR), is the primary regulator of
HSA updated its guidelines for software as medical digital health products in China. It is tasked with
devices (SaMDs) to broaden its scope on a number granting marketing authorisations and carrying out
of related matters. New guidance addresses multiple post-approval supervision. The SAMR regulates
risks of SaMDs. It marks the second revision of HSA the advertising and promotion of digital health
guidelines on SaMDs, the first revision was meted products. The National Healthcare Security
out in April 2020. In October 2021, Singapore started Administration (NHSA) regulates centralised
working with the UK and Canada on the development procurement and reimbursement of digital health
of a common regulatory approach. products under the Chinese Basic Medical Insurance
(BMI) scheme. The Cyberspace Administration of
Japan China (CAC) and the Ministry of Public Security
(MPS) are tasked with formulating data security
The Ministry of Health, Labour and Welfare and privacy laws and regulations and ensuring their
(MHLW) is the main regulatory body for digital compliance within the scope of their respective
health in Japan. There are no specific regulations for functions. The Ministry of Industry and Information
digital health, and they are regulated by individual Technology (MIIT) and local Communications
laws such as the Medical Practitioners Act and the Administrations also have an important role in
Pharmaceuticals and Medical Devices Act. Several regulating the digital health sector. They are in
guidelines on the Act on Protection of Personal charge of formulating and implementing rules
Information (APPI) regulate data in relation to governing internet content provider (ICP) licensing
digital health. In April 2022, Japan granted the and record fling, which apply to digital health
first ever regulatory approval for a therapeutic app products and services that provide information
for hypertension. CureApp’s app assists patients in services via the internet.
maintaining lifestyle improvements as part of their
treatment for hypertension. It’s encouraging to see countries in the APAC
establishing regulatory frameworks specific for DH.
Korea Regulations that are flexible and adaptive would
better suit the rapid pace of technological change.
There are no separate laws regulating DH in
korea. Instead, existing laws including the Medical Ayesha Siddiqui

SPEAKING WITH 33

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

“It is our goal to

fuel R&D in the region”

UK-based Abcam, a global innovator working «
together with life scientists to advance
research and enable faster breakthroughs, Rich Lane,
has officially opened its newest regional hub in Director-
Singapore recently. With healthcare expenditure Sales and Marketing,
in Asia projected to grow by 135 per cent to $2.3 APAC, Abcam
trillion by 2026, the life sciences sector in the
region continues to expand rapidly. At its new base early days and have gradually grown our presence
at the Biopolis Biomedical Research Hub, Abcam to serve customers’ needs in the region. To date,
joins over 350 life sciences companies, including this includes two sites in China, one in Japan and
eight of the top 10 global pharma players, that have one in Australia, covering corporate functions,
laid down roots in the country. Abcam’s new site sales, distribution, R&D, manufacturing and IT
will service the growing Asia Pacific (APAC) life development.
sciences community, offering scientific and technical
support, providing a commercial headquarters for Our new regional hub in Singapore complements
the region. In conversation with BioSpectrum Asia, our local presence and will geographically cover
Rich Lane, Director- Sales and Marketing, APAC everything from New Zealand in the east to India in
region, Abcam talks more about the company’s the west, excluding China. This means that we are
growth plans in the APAC region. Edited excerpts; able to provide expert scientific support, customer
support and commercial support in our customer’s
What are the major plans in store for the new preferred time zone.
APAC hub at Singapore?
It is worth noting that mainland China is still
For a company like Abcam which strongly believes being served by our recently expanded sites in
that collaboration is a big driver of progress, it is Shanghai and Hangzhou.
an exciting opportunity to join one of the world’s
leading life sciences clusters. We have long standing How much of your revenue comes from the
relationships with key local players (such as A*STAR, APAC region?
Singapore’s Agency for Science, Technology and
Research) and we are looking to build stronger APAC is an important and growing market for
connections with organisations that share our goal of us and currently makes up 15 per cent of our overall
pushing the boundaries of research. revenue (based on the 18 months ended December
31, 2021). Including China, that increases to 34 per
We recognise that there is a growing mass of cent.
world-class academic institutes, biopharma, medtech
and other organisations in APAC that need access What are your growth plans in this region?
to the latest innovations and support in order to
progress and advance their research. We have The past years have demonstrated that APAC is
established this physical presence at the centre, to be a central place to drive innovation and life sciences
able to better understand their needs and enable us research. For example, the number of life science
to work together more closely. Singapore is one of the journals in Asia Pacific increased by more than 40 per
most recognised locations for life sciences in APAC, cent between 2016 and 2020 – reflecting the growing
so it is a great place to base ourselves. R&D engine in the region.

How is the Singapore hub different from Through our multilingual, multicultural team here
the other Abcam’s centres in China and in Singapore we hope to strengthen our interactions
Australia? with the growing scientific community across APAC

We’ve been active in the APAC region since our

34 SPEAKING WITH

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

and help them to advance at pace research that could teams developed and launched over 2,500 high-
benefit everyone. quality antibody products, including recombinant
RabMAb antibodies, antibody pairs, SimpleStep
Are you providing more job opportunities at ELISA kits and new formulations that enable faster
APAC? labelling and assay development.

We’re excited to be hiring for a number of It is part of our multi-year strategy to build an
positions not only in our new hub in Singapore but effective R&D engine that will continue to anticipate
also at our facilities in China, Japan and Australia. and meet future research needs in APAC and beyond,
In Singapore, we’re currently at about 50 per cent and increase differentiation of our product and
capacity, giving us room to expand as the market services.
demand grows.
How do you foresee the growth and
Are there any investment/ expansion plans
for India or any other Asian country? challenges of the life sciences market in

As you know, the dynamic of the life science/ the APAC region? How does Abcam plan to
healthcare sector in APAC is rapidly changing.
Consequently, we are continually reviewing and contribute/address it?
evolving our global presence (direct or indirect)
to ensure researchers everywhere in the world are We see huge opportunities for the life sciences
best served as their needs progress over time. For community in APAC. Despite being home to 60 per
example, we have recently increased our number cent of the global population, health expenditure in
of distributors in India to be able to better reach APAC accounts for just 6 per cent of the region’s GDP
customers and serve their needs. (compared to ~17 per cent in the US). This combined
with growing R&D capabilities, supportive policies,
Any new product launches in store for the large public investments and a societal need driven
APAC market in 2022 or later? by an ageing population, the life science sector in
APAC has a huge potential for growth.
The life sciences community is global and
reproducible science is critical to enable progress. This opportunity is increasingly attracting life
That’s why all our products and services, such as our sciences companies to APAC from all over the globe,
antibodies, assays, proteins, engineered cell lines, as well as inspiring the inception of numerous
conjugation kits, and the recently added BioVision home-grown organisations. Through our new hub in
range, are launched and made available globally. Singapore, and expanded presence in APAC, it is our
goal to fuel R&D in the region and support the growth
We increasingly invest into technology and and excellence of Asia in the global life sciences
product innovation. For example, in CY2021, our landscape.

Dr Manbeena Chawla
[email protected]

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BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

“80% of premature heart attacks

and strokes are preventable”
Widespread chronic disease and ageing
populations are necessitating a pressing «
change in the model of care, as there will
be close to half a billion people aged 65 and older Dr Ying Chen,
in the Asia Pacific (APAC) region by 2025. In a
recent chat with BioSpectrum Asia, newly appointed Head of Commercial
Bayer Pharmaceuticals Head of Commercial
Operations for APAC, Dr Ying Chen shared the Operations for APAC,
division’s latest business results in FY 2021, her
outlook for 2022, and how Bayer’s pharmaceutical Bayer Pharmaceuticals
division is transforming itself to fuel future growth
with breakthrough innovations for patient’s yet What major plans are in store for FY 22-23
unmet medical needs, as well as the company’s for the APAC region? How much growth are
vision for a sustainable future. Edited excerpts; you expecting?

What were the key highlights at Bayer Bayer plans to grow its global pharmaceuticals
Pharma APAC in FY 21-22? sales by 3-4 per cent in 2022 on a currency and
portfolio adjusted basis. The market outlook for
Looking back at the last decade, Bayer has grown the Asia Pacific region remains positive, as IQVIA
from strength to strength, with sales nearly doubled projects an average growth rate of ~4 per cent in the
from 3 billion Euro in 2012 to 5.8 billion Euro today, pharmaceutical markets across the region from 2022
driven by innovative medicines such as Xarelto to 2026.
and Eylea, but also being sustained through our
established portfolio including women’s healthcare. Among the APAC countries, India will continue to
be an important market contributing to the region’s
We remain as the Top 10 leading multinational growth in years to come, especially with the new
pharmaceutical companies in Asia Pacific, and we launches expected in the country this year which will
have been operating in India for over 125 years. address disease burden in diabetes and cardiology.

Despite the APAC region being only a quarter of the Any investment or collaboration plans lined
global pharma market, we at Bayer have almost a third up within the region? Please elaborate.
of our topline coming from the region, underscoring
our focus and commitment to the region. Bayer heavily invests in R&D to find new
compounds and molecules for difficult to treat
We are extremely proud of what we have achieved diseases, whilst at the same time innovating across
through Xarelto, which is a novel oral anticoagulant the spectrum of healthcare provision, engaging in
that we launched more than 10 years ago, and Eylea partnerships and collaborations for prevention of
which has been the market leader in anti-VEGF disease.
treatment with a well-established efficacy and safety
profile. These have been one of the most successful In India we already have a successful joint
launches that we have in the region including India. venture partnership with Zydus for more than 10
We have also been investing in Women’s Healthcare years now. Additionally, our collaborations with
for decades, and we are proud to see how women key stakeholders in healthcare with partners like
across the region continue to benefit from our short Federation of Obstetric and Gynaecological Societies
acting contraceptives Yaz Family and gynecology of India (FOGSI) for women’s healthcare and Arogya
treatments like Visanne for endometriosis. Finance for the patient access programme for Eylea
enable us to leverage Bayer’s expertise and create
Our growth in India grew by an average of 11 per access to our innovative health solutions.
cent in 2021 and we are confident that it will keep the
strong growth momentum as we continue to launch One local campaign in India that has seen traction
new innovative products and expand our portfolio in over the years is Bayer’s “Preserve the Uterus”
India. campaign, in partnership with FOGSI to address

36 SPEAKING WITH

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Every year across the globe, 15 million
people die before the age of 70

from chronic diseases which include
cardiovascular diseases, cancers,
diabetes, and obesity. Couple that

with the fact that by 2050, one in four
people in APAC will be over 60 years old.
Besides the overall diabetes prevalence

is increasing in APAC, with over 70
million people living with diabetes in

India alone.

the high number of uterus removal (hysterectomy) of therapeutic areas on new treatment approaches
cases, even among much younger women. Since for cardiovascular and kidney diseases with high
2019, more than 3,800 healthcare practitioners have unmet medical needs. Bayer also has over a decade of
been trained through over 50 sessions to educate and learned experience and real-world evidence with our
address the concerns of unwarranted hysterectomies oral novel anticoagulant, Xarelto, which is going to
among women in India, and they in turn taught the help us lay the foundation with more pipeline assets
subject to post-graduate medical students. currently being evaluated in this area.

With Bayer’s expertise in women’s healthcare, Are you planning to launch new products
the company has committed to provide 100 million
women in low- and middle-income countries for the treatment or management of chronic
with access to family planning by 2030. Bayer’s
sustainability effort has reached 7 million women in diseases in the APAC market?
Asia Pacific in 2021.
2022 will be a breakthrough year for Bayer’s
How is the company addressing the growing Pharmaceuticals division in Asia Pacific with three
upcoming launches of innovative products in the
burden of chronic diseases in APAC? fields of cardiovascular disease such as vericiguat
for worsening heart failure, finerenone for chronic
The burden of cardiovascular disease is staggering kidney disease in Type 2 diabetes and darolutamide
in APAC. According to WHO, India reported 63 per for prostate cancer in oncology, across the APAC
cent of total deaths due to NCDs in 2016, of which 27 region with varying regulatory timelines. We are
per cent were attributed to cardiovascular diseases, currently also working towards making these
which also account for 45 per cent of deaths in the products available for patients in India.
40-69 year age group.
Every year across the globe, 15 million people
Yet, 80 per cent of premature heart attacks and die before the age of 70 from chronic diseases which
strokes are preventable. Many opportunities to find include cardiovascular diseases, cancers, diabetes,
and treat risk factors are missed every day. and obesity. Couple that with the fact that by 2050,
one in four people in APAC will be over 60 years old.
This is where the industry plays a significant
role to not only provide new treatment options to India is home to nearly 40 per cent of the world’s
tackle cardiovascular diseases but also ensure that heart failure patients, yet there is poor awareness
more people are aware of managing their risks and about the condition and its treatment. The available
symptoms. data from India heart failure registries show that
patients in India are younger by 10-years, and the
When it comes to Bayer’s advantage, our strong majority of the burden lies below 65 years of age,
heritage and expertise in cardiovascular disease as compared to the patients from high-income
stemmed from the invention of Aspirin over a countries.
century ago. Bayer’s researchers continue to study
compounds in various stages of preclinical and Overall diabetes prevalence is increasing in APAC,
clinical development, which prioritises targets and with over 70 million people living with diabetes in
pathways with the potential to impact the way that India alone. One in 10 adults is living with diabetes
cardiovascular diseases are treated. and almost half are undiagnosed.

Understanding that the heart and the kidneys Dr Manbeena Chawla
are closely linked, Bayer is working in a wide range [email protected]

SPEAKING WITH 37

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

“Our approach to managing the side

effects of cancer therapy has evolved”

Although there has been tremendous progress «
in discovering and developing new therapies
to treat cancer patients, innovation in Mike McCullar,
treating or preventing the side effects has lagged in
comparison. The number of patients with cancer Chief Executive Officer,
is growing, and patients continue to struggle with
treatment side effects, leading to dose reduction or OnQuality
discontinuation of cancer therapeutics. This creates
an opportunity for a new generation of cancer Pharmaceuticals
supportive agents to help an underserved population
of patients in need. To find out more in this regard, will increase from 120,000 in early 2020 to around
BioSpectrum Asia spoke to Mike McCullar, Chief 200,000 by 2029, while the number of patients
Executive Officer, OnQuality Pharmaceuticals in using VEGFR inhibitors will be more than twice the
detail. The company has operations in the US and figure. So it is in Japan. The large potential patient
China. Edited excerpts; population and growing attention to the quality of life
would definitely further promote cancer supportive
What is the market landscape for cancer care therapeutics in Asia in the future.
supportive care therapeutics in Asia?
Can you tell us about your research
Cancer is the second most prevalent cause of endeavours in the US and China?
death worldwide, prompting many to develop
therapeutics to help patients in need. Approved Our footprint in China is a source of competitive
cancer therapies provide patients with the hope of advantage for us. It provides access to world-
complete remission but are also characterised by class science in an environment that supports
potentially severe side effects. This holds true for entrepreneurs. The quality of the research in China
classical therapies, such as chemotherapy, surgery, is an asset to the development of our pipeline. We
and radiation, as well as modern approaches such as are working closely with our partners to facilitate
targeted immunotherapies. medical research and advance opportunities to bring
treatment to patients sooner.
Due to the growing burden of cancer in Asia,
accounting for over 30 per cent of all cases For early discovery research, we have close
worldwide, and an increasing number of cancer collaboration with top University in Shanghai,
survivors, cancer-related morbidities have been where the partners continue to demand and drive
rapidly growing. There is a significant unmet need innovations in our discovery platform and pipeline
in cancer supportive care with limited treatment expansion. The majority of China-based world-class
options. In fact, skin toxicities are among the most non-clinical contract research organisations (CROs)
common adverse events associated with cancer are in the Yangtze River Delta, where our Shanghai
treatments and gastrointestinal (GI) side effects office is conveniently located. This is a very friendly
are correlated with high rates of cancer therapy and supportive environment for entrepreneurs.
discontinuation. We are developing therapies to treat
both of these side effects. Meanwhile, in the US, our late-stage research
team keeps in good contact with the world top key
Actually, cancer supportive care therapeutics opinion leaders (KOLs) and medical professionals
share a similar history in Asia as it is in the United in the area, as well as the regulatory agency ‘the US
States, thanks to Kyowa Kirin’s initial partnership FDA’, which provides most frontier insights back
with Amgen back in the 1980s, making it widely to our pre-clinical research. Further, a big portion
accepted in most Asian countries. Of course, China of our team is bilingual, playing key roles from
and Japan are the Big Two not only in Asia but also discovery, preclinical development, translational
worldwide. According to the DRG data, the number research, regulatory affairs, to clinical developments;
of China patients who use EGFR-targeting treatments

38 SPEAKING WITH

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

their titles range from Director to C-Suites. The How are you addressing those challenges?
‘US and China team’ is working closely to facilitate
translational medical research and advance We have organised our strategic focus into two
opportunities to bring treatment to global patients areas: oncodermatology and oncogastroenterology.
sooner. We target these areas because we clearly understand
the unmet medical need in these areas, and we
What are the opportunities and challenges believe we can create market-leading franchises. In
addition, using our proprietary AI-assisted discovery
facing this market of cancer supportive care platform, CARE, we have developed deep insights
into how to treat or prevent cancer therapy side
therapeutics? effects in these areas and have a diverse pipeline to
address these issues. By organising our pipeline this
There is a tremendous opportunity for what we way, we create a tremendous amount of operational
can describe as oncology supportive therapies 2.0, synergy that will be important for us both as an
or the second generation of agents to manage the R&D organisation and over the long run when we
side effects of cancer treatments. Despite all of the transition to a commercial company.
progress we have made over the last decade or more
in discovering and developing new ways to treat What are your major milestones for this year?
cancer, innovations in developing agents to manage
the side effects of these new cancer treatments have For the remainder of 2022, we are launching the
not kept up. For example, we have been using new second stage of our NOVA-II study of OQL011 for
anti-cancer agents such as monoclonal antibodies, the treatment of VEGFR inhibitor-associated Hand-
targeted small molecules, and, more recently, Foot Skin Reaction (HFSR). As you know, there
immunotherapies for over a decade. These agents are no approved agents to treat VEGFR inhibitor-
have serious side effects. This creates a significant associated HFSR and the data from stage 1 of
opportunity for a new generation of supportive NOVA-II were very informative for us to be able to
therapies, which we call oncology supportive optimise the design for stage 2. We are also planning
therapies 2.0. We see new supportive therapies on submitting an IND for our novel gut-restricted
as more widely needed than the first generation of CDK4/6 inhibitor OQL051, to prevent chemotherapy-
supportive agents to treat bone marrow toxicity and induced diarrhea. In addition, we have several other
emesis. investigational targeted supportive therapies that
should enter clinical trials soon that will form the
We have world-class science and a clear unmet foundation for our oncodermatology franchise.
medical need. The challenge we face is increasing
awareness outside of treating physicians and How do you foresee the growth of the cancer-
patients. For example, treating or preventing side supportive therapeutics market in Asia?
effects of cancer therapy, particularly those caused by
newer anti-cancer agents, is overlooked outside these For certain Asian countries such as Japan,
groups, creating a unique challenge. cancer supportive therapies are central in managing
patients. Our products could be rapidly adopted
there, and there is an existing commercial presence to
ensure successful commercialisation. As other Asian
regions continue to expand and mature, we anticipate
that the medical need will also enable successful
commercialisation.

Our approach to managing the side effects of
cancer therapy has evolved since the first generation
of supportive agents to manage bone marrow
toxicity and emesis. We leverage our AI-assisted
drug discovery platform to understand the drivers of
cancer treatment-related toxicities to design targeted
agents to prevent or treat these unwanted effects. It is
very similar to the approaches of precision medicine
or targeted therapeutics by aiming at unique targets
in specific pathways.

Dr Manbeena Chawla
[email protected]

I N N O V AT I O N S 39

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AIM brings innovations from
labs to hospitals and masses

The human body, like Space, is an endless «
frontier made even more complex by the
irreversibility of life by the arrow of time. Similar Ranjan Das,
to the mystery of origin of the Universe some Innovation Lead,
problems in the human body are so complex, NITI Aayog
for example, the problem of qualia or the hard
problem of consciousness– ‘Why any physical state spread by respiratory droplets before showing any
is conscious rather than nonconscious’ that it has detectable symptoms. With widespread transmission
given the league of neuroscientists, philosophers and viruses accumulate more mutations and the current
empiricists a perpetual “Whereof one cannot speak, strains are becoming more infectious, virulent and
thereof one must be silent” or the Upanishadic ‘Neti stealthy due to changes in its spike protein and
Neti’ limbo. genetic material. The only way COVID-19 outbreak is
going to end is when enough people have developed
Another such outlier among the mysteries immunity (by a combination of innate, adaptive and
of nature which has currently eclipsed the passive immunity) through infection or vaccination
developmental goals of poor and rich countries alike against the prevalent and most virulent strains. A
is an infinitesimally small virus, rather a particular good vaccine along with other treatment options
strain of coronavirus that ordinarily causes the like repurposed drugs, plasma therapy, antibody
common cold. Let’s dig deeper. mixtures, antivirals, immunomodulators and other
adjunctive therapies are the tools we are using to tide
Evolutionary biologists are still to figure out over the pandemic.
whether to classify viruses as living or dead or
something in between; whether they are a rare We hardly give a second thought while taking any
anomaly of nature or the first and the most abundant over the counter (OTC) medication for our minor
form of cellular organisation in the Universe. Human ailments but we will be very surprised to know that
genome that is made up of 5-10 per cent of viral
DNA tells us that we have been at the receiving
end of countless virus attacks throughout our
evolutionary history but scientists are now coming
to terms with the fact that viruses may have played
a very important role in our evolution e.g. in the
development of female placenta which essentially
helped us establish at the top of the food chain. In
the far future scientists envision using viruses in
development of nanomachines, cancer killing cyborgs
and advanced geriatric care.

Beating the sneaky microbes

Globalisation and extensive deforestation have
caused a lot of pathogens of animal origin to adapt
and infect humans, and viruses are so adaptable that
they have started developing increasingly stealthy
mechanisms to remain undetected by the human
immune system. The initial strains of SARS-CoV-2
had developed mutations with respect to SARS-CoV-1
that allowed it to first replicate silently in the upper
respiratory tracts of patients for the first few days and

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OTHER FLAGSHIP INTERVENTIONS OF AIM THAT HAVE ALREADY MADE A HUGE IMPACT

● AIM-ICDK Water Innovation Challenge - AIM, aims at accelerating social entrepreneurship and
NITI Aayog has partnered with Innovation Center innovation in young India recognising young people
Denmark (ICDK), Denmark Embassy in India as critical drivers of sustainable development.
and the Denmark Technical University (DTU) Through Youth Co:Lab, young entrepreneurs
to identify Innovative and next-gen solutions and innovators will get a chance to connect with
to solve proposed challenges in collaboration governments, mentors, incubators and investors,
with corporate and public partners. The initiative who will help equip them with entrepreneurial skills.
engages young talent from leading universities ● AIM-PRIME - AIM, NITI Aayog has launched AIM-
and innovation hubs to come up with technology PRIME (Program for Researchers on Innovations,
driven innovative solutions for effective water Market-Readiness & Entrepreneurship), an initiative
management for digital water management to promote and support science-based deep-tech
solutions, solutions for monitoring and prevention startups & ventures across India through hands-on
of leakage in city water supply, wastewater practical insights and mentoring from experts and
management across rural/agri belts and urban mentors who have been nurturing science-based
settlements, rainwater harvesting in rural and deep-tech startups in global innovation hotspots
urban settlements. as well as in India. Beneficiaries get access to in-
depth learning via a comprehensive lecture series,
● India Australia Circular Economy Hackathon curated video library, live team projects, exercises,
(I-ACE) - a joint effort by AIM, NITI Aayog, and project-specific mentoring and plenty of peer-
Government of India and Commonwealth Scientific to-peer learning opportunities.
and Industrial Research Organisation (CSIRO), ● AIM iCREST - Incubator Capabilities Enhancement
Australia to enable the students and startups/ for a Robust Ecosystem for high performing
MSMEs of both the nations in fostering innovative Startups – launched in collaboration with Bill
solutions for the development of a circular & Melinda Gates Foundation and Wadhwani
economy across the food system value chain Foundation –providing global expertise and
with the aim of increasing the long-term health showcase proven best practices to the incubator
and resilience of our planet, through innovative networks. It enables incubators and their teams
technology solutions. to gain deep insights about incubation and
acceleration and learn about best practices of
● Youth Co:Lab - AIM, NITI Aayog in collaboration about 200 incubators and accelerators globally.
with United Nations Development Programme
(UNDP) India has launched Youth Co:Lab which

most modern medications under Allopathy and for Like the olden wars for spice, the big silent wars are
that matter, any other system of medicine work like now for averting hospice.
black boxes. In a few cases we know the chemical
composition or the active chemical groups in the Vaccines differ from drugs in that they are always
medicine but how they interact with thousands of biological products and larger, more complex,
receptors in human body giving rise to a cascade requiring special cold storage conditions up to -50
of effects finally resulting in the alleviation of the degrees. These special storage conditions create a
symptom troubling us is a problem that is too hard logistical nightmare for their global distribution and
to figure out with the current level of technological administration from their source of production. An
advances in a complex living system. So all clinical ideal vaccine is defined in terms of its safety profile,
research on medicines works on the principle of cost, efficacy, need for booster doses, thermal stability
cause and effect, trying to maximise desirable effects and mode of administration. Many pharmaceutical
while trying to minimise the undesirable side effects. companies have specialised vaccine verticals and
Novel drug discovery process starts with thousands they may choose any of the methods to generate a
of trial compound collections which are then reduced vaccine depending on their expertise like attenuated
to hundreds of lead compounds by high throughput or inactivated viruses, recombinant- DNA vaccines,
screening to finally identify few novel drug candidates RNA vaccines, subunit – virus protein, sugars or
by secondary assays which may or may not pass four other structural components from the virus.
phases of clinical trials to get apex drug authority
approvals; the whole exercise costing a billion dollars. Translational Medicine

This is a ‘bench to bedside’ approach to medical

I N N O V AT I O N S 41

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research that tries to better translate the results of providing support for large scale manufacturing of
laboratory studies or clinical research to be used ventilators, PCR-based and serology-based COVID
for better clinical prognostics and facilitate better diagnostic kits through proposals. AMTZ in its efforts
clinical outcomes. There is a clear disconnect to curb shortage of ventilators and other COVID-19
between academia, medical training and research, targeted products, have developed TECHRx APP
and medical practice; most of the medical colleges to help all innovators, startups and manufacturers
and research centres are not tied up with hospitals to connect with Electronic Spares, Components
because of the highly commercial nature of medical and Machinery suppliers. AIC -SMU Technology
practice in India. The primary reason for this state of Business Incubation Foundation (SMUTBI) team
affairs of medical education is the high costs involved were able to design and 3D print the mask as an
in it compared to the average household income of intervention to the acute shortage of mask in initial
the middle class. COVID-19 surge. The mask can be converted to
N95 standards with the filters being replaced with
In response to the pandemic COVID-19, Atal 0.3 microns fibre/materials. AIC- Rambhau Mhalgi
Innovation Mission (AIM), NITI Aayog was entrusted Prabodhini has launched I-CAN (India Co-Win
to identify promising startups that can offer Action Network) initiative in collaboration with
innovative solutions to address the current crisis by Connecting Dreams Foundation (CDF) to help
the Government of India Inter-Ministerial Working underprivileged communities that have been hardest
Group. This working group is also critically supported hit due COVID-19. It is a unique movement to
by industry bodies like Confederation of Indian combat the pandemic through an online platform
Industry (CII), National Association of Software that connects those help seekers and help givers. In
and Service Companies (NASSCOM), United addition to this numerous AIM startups and Atal
Nations Development Programme (UNDP) and The Tinkering Lab (ATL) innovators have come up with
Indus Entrepreneurs (TiE) who are committed to solutions such as Artificial Intelligence (AI) enabled
tackling COVID-19. This resulted in identification diagnostic decision-making support for pulmonary
and industry-connect opportunities for 1,000+ diseases, telemedicine and case management
COVID-19 related startups and startups working in platforms and other innovations in the field of Drug
different categories such as equipment, hygiene and Discovery, Biotherapeutics, Devices and Diagnostics
also those working on awareness and sensitisation and Bioinformatics and Computational Biology.
campaigns. These startups are now actively helping
the government to tackle COVID-19. AIM is also In medicine, many of the old doctrines get
leveraging the strength of Indian academic research progressively invalidated but it happens at a
and translational resources of its Atal Incubation meticulously slow rate, the most recent is that
Centres (AICs) at Centre for Cellular & Molecular functional Magnetic Resonance Imaging (fMRI) that
Biology (CCMB) and Centre for Cellular And is used to scan any sort of brain activity in relation
Molecular Platforms (C-CAMP) to boost research
translation and commercialisation in the medical
field focussing on COVID-19 research in the current
scenario supported by other AICs like 91Springboard,
Andhra Pradesh MedTech Zone (AMTZ), AIC
-Pinnacle etc. Atal Incubator Centres and Established
Incubator Centres (EICs) under AIM have played
an instrumental role in controlling the emerging
COVID-19 scenario in the country and are expected
to further raise the bar in coming times. EIC-C-
CAMP started a nationwide search for innovations
that were ready to be deployed immediately or in
the near future to curb the COVID-19 outbreak. EIC
91Sprinboard has launched a community repository
of resources supported by AIM and updated in real
time for solving COVID-19 challenges. AIC-Pinnacle
in partnership with Garage48 organised an online
hackathon, inviting Non-Medical Solutions from
the Quarantined Minds of Young India against
COVID-19. Andhra Pradesh MedTech Zone has been

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Multiple vaccine platforms are in spends 100+ man hours and 1000 slides to complete
development, and enrolment in a a five year study. Multiple vaccine platforms are in
clinical trial with different candidate development, and enrolment in a clinical trial with
vaccines will become centralised with different candidate vaccines will become centralised
a translational medicine platform. with a translational medicine platform. Clinical
Clinical endpoints of various trials endpoints of various trials should be normalised
should be normalised as much as as much as possible so that relative efficacy can
possible so that relative efficacy be determined clearly. The effectiveness criteria
can be determined clearly. The for COVID-19 vaccines are going to be prevention
effectiveness criteria for COVID-19 of infection, reduction in mortality or reduction
vaccines are going to be prevention in severe hospitalisations. After vaccination the
of infection, reduction in mortality or studies that need to be conducted are the degree of
reduction in severe hospitalisations. prevention of infections and reinfections, the most
After vaccination the studies that effective dose and the length of protective immunity.
need to be conducted are the degree Other studies that need to be conducted are the
of prevention of infections and need for the booster doses and the effects of the
reinfections, the most effective dose booster doses. Our body does not develop a long
and the length of protective immunity. term immunity from the conventional coronavirus.
A genetic/family history screening may be required
to various diseases like Alzheimer’s to Sleep apnea for those predisposed to ailments like Multi organ
is at best a false representative of the blood flow in Inflammatory syndrome and a thorough analysis of
the brain. This new research finding has invalidated autoimmune disease spectrum. The populations in
the previous research of hundreds of neuroscientists developed countries with high mortality rates and
who had designed their studies on the basis of comorbidity rates will be very reluctant to try a new
fMRI. Patents, intellectual property, innovation vaccine but in India the onus for this rests with the
in translational medicine and big pharmaceutical Government and the medical fraternity. Storage
industries need to be well coordinated to bring about of some vaccines developed by biopharmaceutical
this change at a quicker pace. To meet the country’s companies require -80 degrees of storage, a logistical
growing healthcare needs, cost effective and high nightmare for global distribution but Serum Institute
quality preclinical and clinical research needs to be of India (SII) has been able to locally manufacture 50
facilitated by core stakeholders and augmented by million doses a month of Oxford-AstraZeneca vaccine
product development support services. Interaction by modifying weakened versions of Chimpanzee
with enterprises, particularly Small and Mid-size adenovirus. Vaccines developed by SII can be stored
Enterprises (SMEs) involved in new technology at 2-8 degrees which are more suitable for the
innovation can facilitate translation of scientific impending hot summer in the country. The United
know-how into viable products. A network of Centres Nations (UN) has applauded Indian vaccine efforts
of Excellence (CoE) in clinical research through and India has been able to export 2 million doses to
partnerships with leading institutions conducting Brazil and 1 million doses to Canada as a friendly
clinical trials in India needs to be developed and gesture. No wonder India is called the pharmacy
synergised. Providing comprehensive and sustained of the world and it also produces 60 per cent of the
training in clinical research through these CoEs in total vaccines of the world and 80 per cent vaccines
order to build a cadre of world class investigators imported in the USA are from India.
capable of conducting clinical trials for regulatory
submissions will fast track drug development and A Central Institutional Review Board (CIRB)
clinical research in India. facilitated by a Translational platform will be
well equipped to achieve this objective and tackle
Developing a vaccine is an inordinately tough emerging COVID-19 scenarios and future vaccination
task limited by time and capacity, a safe and effective efforts in India. A combination of vaccines is a
vaccine often requires more than a decade to be dangerous concoction and the clinical studies
licensed and used globally, and requires more than attempting to study the comorbid side effects of more
$500 million in capital. To give some perspective than two vaccines have never been attempted but to
an average molecular biology doctorate student tackle the increasing complex nature of pandemics
and epidemics it needs to be attempted and India is
possibly the only country in the world that has the
capability to take on this herculean task.

PEOPLE NEWS 43

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com Genexine

Johns Hopkins Bloomberg appoints Neil
School of Public Health
honours Dr Cyrus Poonawalla Warma as CEO

The Johns Hopkins Bloomberg School of Public Health has awarded South Korea-based
the Dean’s Medal to Serum Institute of India (SII) Chairman, Dr Cyrus Genexine has announced the
S Poonawalla for his outstanding work in developing and delivering appointment of Neil Warma
affordable vaccines and contributing to the Indian biosciences industry as its President and Chief
for decades now. The honour was presented to Dr Poonawalla during Executive Officer (CEO).
the Convocation ceremony held on May 21, 2022. Past award winners Warma who has over 25 years
include social justice advocate Cheryl Dorsey, Pulitzer Prize–winning of experience as a global
journalist Laurie Garrett and former Baltimore Health Commissioner entrepreneur, company builder
Leana Wen. Founding the Serum Institute of India (SII) in Pune in 1966, and successful CEO will lead
Dr Cyrus Poonawalla’s foresight has helped SII achieve global leadership Genexine onto the world stage
in terms of production with 4 billion doses annually. SII had partnered with a focus on advancing
early on with UNICEF and the Pan-American Health Organization Genexine’s key products to
(PAHO). Its measles vaccine supply to UNICEF and PAHO between market, expanding its pipeline
1990 and 2016 has prevented 22 million deaths. and focusing on global drug
development. Warma has
CANbridge Pharma names been a successful healthcare
Dr Pauline Li as SVP of entrepreneur for over 25
Clinical Development years having led and managed
numerous biotechnology and
CANbridge Pharmaceuticals, Inc., a China-based global pharmaceutical companies
biopharmaceutical company committed to the research, development across the globe. He had been
and commercialisation of transformative rare disease and rare oncology serving as the General Manager
therapies, has appointed Dr Pauline Li to the position of Senior Vice of I-Mab Biopharma US, with
President (SVP) of Clinical Development and Operations. Dr Pauline offices in Shanghai, Beijing,
brings to CANbridge a wealth of international clinical Hangzhou, Guangzhou, Lishui
development experience, in both small molecule and Hong Kong in China, and
and biologic products, across multiple indications Maryland and San Diego, in the
and markets. Most recently, she was at Connect US, where he was a member of
Biopharma, where she held the position of Vice the executive team responsible
President of Clinical Development and was responsible for the company’s expansion
for creating and implementing the clinical development onto the global stage and for
strategy. During her time there, she oversaw five NMPA establishing I-Mab’s state-
IND approvals, three FDA IND approvals, eight clinical trial of-the-art research facilities
initiations and six clinical trial completions. Earlier, she was Executive in San Diego, California.
Director of Clinical Operations at Shanghai Haihe Pharmaceutical Warma has held several key
Company and Medical & Scientific Director at Servier China. senior management roles at
Novartis Pharmaceuticals at
its corporate headquarters in
Basel, Switzerland, in Pharma
Policy and Global Marketing.

44 PEOPLE NEWS BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

Jawed Zia Dr Shreeram Aradhye
joins as CEO of to lead Global Drug
Cadila Pharma’s Development at Novartis
Domestic
Prescription Swiss firm Novartis has recently announced the appointment of Dr
Business Shreeram Aradhye to lead the global drug development business.
As President, Global Drug Development & Chief Medical Officer
Jawed Zia has joined as the Chief for Novartis, Dr Aradhye is responsible for advancing the Novartis
Executive Officer (CEO) of Indian pipeline of investigational medicines to bring transformative new
firm Cadila Pharmaceuticals. treatment options to patients with
Zia, who will report to the Board serious diseases. The organisation
of Cadila Pharmaceuticals, will leads the clinical development of
lead the strategy and business potential new medicines, running
operations of Cadila’s branded large clinical trials and steering the
prescriptions pharmaceuticals path to regulatory approval, while
business. A seasoned industry also maintaining oversight of ongoing
professional with more than patient safety and regulatory activities
three-and-a-half decades of for licensed therapies. With an aim to
experience, he last served as vice bring up to 20 major new medicines
chairman of healthcare startup to patients by 2026 including for
Rivaara Holdings. A strategic cardiovascular and immunological
thinker with versatile experience, conditions, neurological disorders and various forms of cancer, Dr
Zia has deep knowledge and Aradhye and his team will play a central role in driving the company’s
extensive experience in building long-term growth and delivering on its purpose to improve and
and managing businesses in the extend people’s lives. He took on his current role at Novartis in
healthcare Industry. His innate May 2022, rejoining the company after spending several years at
ability to drive the growth of US biotechnology companies, including leading the development of
people and businesses, build multiple clinical stage RNAi assets at Dicerna Pharmaceuticals.
brands, transform operations
and scale capabilities has been Robin Joffe steps in as Partner-
the hallmark of his success. He MD of Frost & Sullivan MEASA
joined Novartis in 1987 and had
a successful career, passing over With an aim to better serve an increasingly strategic customer
30 years across market research, segment, Frost & Sullivan has appointed Robin Joffe as Partner-
brand management, marketing, Managing Director of its Middle East, Africa, and South Asia
and other functions in Ireland, (MEASA) operations. He brings over 25 years of international
Singapore, Saudi Arabia, Canada, business experience in market entry across Asia, the United
Switzerland, Turkey, and India. States, and Europe. He has successfully designed,
His experience includes roles in implemented, and driven growth strategies,
Rx Pharmaceuticals, Consumer developed top talent, and identified new markets
Health and Medical Devices and to grow revenues and profits across industries and
Instrumentations. He also led continents, from the startup creation process to
Abbott India operations. directing mature businesses. He excels in sales
and channel management, strategy mapping,
and business transformation across sectors such
as Information & Communications Technology,
Healthcare & Pharmaceuticals, and Financial
Services. Prior to this appointment, Joffe
spearheaded Frost & Sullivan’s Japan
operations.

R&D NEWS 45

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

Fertilis develops Japanese population
new micro device to
boost IVF success projected to live longer

A research team led by the University of Adelaide in without dementia
Australia, in partnership with medical technology
company Fertilis, has delivered a ground-breaking new A new detailed microsimulation, using a
micro-device to streamline the only fertility treatment database of 40 million people, has examined
procedure available for men with low sperm counts. the future of Japan’s aging population up to
The first-of-its-kind device will allow more in-vitro 2043. It projects that more people will live
fertilisation (IVF) clinics to offer Intracytoplasmic Sperm longer, and that overall years spent living
Injection (ICSI) as a with dementia will decrease. However, the
treatment, while several model highlighted the diversity of impacts
IVF procedures, such as on different segments of the population,
embryo culture, embryo as Japanese women with a less than high
cryopreservation and in school education aged 75 and over may be
vitro maturation, will also disproportionately affected by both dementia
be improved by using the and frailty. Better understanding where
device. ICSI is a slow and health gaps like this exist can help inform
difficult procedure which public health planning, to minimise future
involves the injection economic costs and support those most in
of a single sperm into need. Microsimulation models, which are
an egg for fertilisation, and it can only be carried out by computer models that can provide detailed
experienced embryologists. This new technology, smaller analysis on an individual basis, are currently
than a pinhead in size, holds up to 10 eggs in segregated used to project future population health in
positions for quicker injection, making it easier for some countries, such as the UK and the US.
embryologists to track and avoid the risk of errors. Professor Hideki Hashimoto and researchers
According to the researchers, the device will cut treatment at the University of Tokyo, along with
time in half, require less training for embryologists with researchers from Stanford University in the
less expensive equipment than current ICSI treatment U.S., wanted to create a new microsimulation
and improve access to the procedure for more patients. model for Japan, which would take into
account more diverse conditions than had
been considered before.

India develops tiny robots to enhance dental care

Nano-sized robots manipulated generates a low intensity magnetic Crucially, the team was able to
using a magnetic field can help field. These nanobots were then manipulate the magnetic field to
kill bacteria deep inside dentinal injected into extracted tooth make the surface of the nanobots
tubules, and boost the success of samples and their movement generate heat, which can kill
root canal treatments, as per a new was tracked using a microscope. the bacteria nearby. As per the
study by researchers at the Indian researchers, no other technology
Institute of Science (IISc) and IISc- in the market can do this right
incubated startup, Theranautilus. now. The team has tested the
The dentinal tubules are very dental nanobots in mice models
small, and bacteria reside deep in and found them to be safe and
the tissue. Current techniques are effective. They are also working on
not efficient enough to go all the developing a new kind of medical
way inside and kill the bacteria. device that can easily fit inside
The researchers designed helical the mouth, and allow the dentist
nanobots made of silicon dioxide to inject and manipulate the
coated with iron, which can be nanobots inside the teeth during
controlled using a device that root canal treatment.

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

Thailand invents Korea designs tool for
rapid detection studying inflammatory
test for diseases related to COVID-19
gastrointestinal
cancer Apart from the symptoms associated with COVID-19 infection, it has
recently been reported that the coronavirus also leads to a subsequent
Researchers at Chula Engineering development of autoimmune diseases like rheumatoid arthritis,
and Chula Medicine departments lupus, or multi-inflammatory syndromes in patients. To address
in Chulalongkorn University, this concern, a team of researchers from the Gwangju Institute of
Thailand have co-invented an Science and Technology (GIST) in South Korea has developed a
innovative device for a rapid new bioinformatics pipeline. Their new tool is called cross-reactive-
gastrointestinal cancer detection epitope-search-using-structural-properties-of-proteins (CRESSP).
that yields accurate results hoping The team hopes that their new tool will facilitate comparison between
to foster preventive medicine studies, providing a robust framework for further investigation on
in gastrointestinal malignancy molecular mimicry and autoimmune diseases. Although autoimmune
and reduce the number of diseases affect less than 10 per cent of the population, studying them
cancer patients. The device is important since it severely impacts the quality of life. The new tool
called DeepGI processes the can be used to study the possible involvement of molecular mimicry
images captured from the video in the development of other autoimmune conditions in a systemic
footage during the procedure and scalable manner. Hopefully, the new invention will help us deal
and detects abnormalities by with SARS-CoV-2 and other viral infections better.
the machine learning technique
called Deep Learning. The model Singapore makes transparent
sets a bounding box annotating medical masks for speech therapists
the abnormal area and alert
doctors in real-time with over The Agency for Science, Technology and Research (A*STAR),
90 per cent accuracy. The Sengkang General Hospital (SKH), and local masks manufacturer
technology will also accurately Forever Family have announced the development and deployment
produce characterisation of the of a medical-grade disposable face mask with a transparent window
polyps if they are potentially that allows patients to view the mouth movements of healthcare
becoming malignant in the professionals, and vice-versa. With mask-wearing still required
future (Neoplastic) or benign
(Hyperplastic). This additional indoors, especially in patient-facing
capability supports doctors’ areas, this transparent medical mask is
confidence in their diagnoses. The particularly useful for speech therapists
team is currently in the process working in hospitals, schools, and other
of applying for a national patent settings to assist patients with speech,
and continues to develop with language, communication and even
the Technology Readiness Level 5 swallowing difficulties. This transparent
(TRL5). The researchers are also medical mask has a 3D design and an
expanding DeepGI’s capability anti-fog shield to maintain visibility. It is
to test other organs such as the rated ASTM Level 2 for its performance
stomach and bile ducts. as a medical mask, while Forever Family,
manufacturer of the masks, has achieved
ISO 13485 certification and approval by Singapore’s Health Sciences
Authority (HSA) for its manufacturing processes related to the
production of these masks. The project builds on the first-generation
reusable transparent face mask manufactured by Forever Family
and supplied to help the deaf and hard-of-hearing community. This
collaboration combines manufacturing and product development
expertise from A*STAR’s Singapore Institute of Manufacturing
Technology (SIMTech) with Forever Family’s textile expertise.

ACADEMICS NEWS 47

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

India to launch Jyoti and Taiwan’s
Bhupat Mehta School of
Health Sciences & Technology NTHU

The Indian Institute of to IIT Guwahati through GATE opens Post-
Technology- Guwahati (IIT-G) 2022. The new programme will
has signed a Memorandum of emphasise extending training in baccalaureate
Understanding (MoU) with both theoretical as well as hands-
Mehta Family Foundation (MFF), on perspectives, which will enable Programme
US, to establish the ‘Jyoti and the development of academic
Bhupat Mehta School of Health leaders with a strong scientific in Medicine
Sciences and Technology.’ The foundation alongside having the
New School at IIT Guwahati will capability to translate the ideas Taiwan-based National
commence academic activities into biomedical technologies. The Tsing Hua University
during the current academic year. school aims to train the students (NTHU) recently held the
The Jyoti and Bhupat Mehta in topics related to health science opening ceremony for
School of Health Sciences and and technology, with the emphasis the Post-baccalaureate
Technology has launched new on courses from other disciplines Programme in Medicine.
Master’s and PhD programmes in of science and engineering The new programme will
Health Sciences and Technology such as biosciences and train students to meet the
this academic year. The first bioengineering, electronics and challenges of tomorrow
batch of 20 MTech students in electrical engineering, chemical by focusing on the ABCs
the stream of Biomedical Science engineering, mathematics and of the medical science of
and Engineering will be admitted statistics, and design. the future, viz., Artificial
intelligence (AI), Big
Monash University unveils world- data, and the Cloud-based
class robotics research facility internet of things. The Post-
baccalaureate Programme
The Monash University Faculty of Engineering has launched a new in Medicine belongs to the
world-class robotics research facility to train the next generation of College of Life Science. The
engineers and global innovators, and drive the emerging Artificial first batch of students will
Intelligence (AI) economy. The $6.5 million investment into Monash include 23 publicly-funded
Robotics furthers the work of Monash University in the development students, 16 of which will
of a world-leading be based in the Natural
robotics precinct, Science Group, and seven in
which includes the the Information Technology
Makerspace, Monash Group. The Programme
Smart Manufacturing has already appointed
Hub, Data Futures over 100 full-time and
Institute and Monash joint-appointment faculty
Generator. The members, and that all the
innovative lab will required facilities will soon
foster collaboration be ready for use, including
and effective robotics a dissection room with
development, nine dissection tables. The
providing experimental space and equipment to enable realistic Programme’s curriculum
experimental validation. Governments are now road-mapping and conforms to international
investing heavily in robotics research across the world. With the launch standards. NTHU’s
of the Robotics Research Facility, Monash University is taking advantage Programme takes more of a
of the immense research and industry collaboration opportunities. systems approach, in which
basic and clinical courses are
combined, as in the course
on the cardiovascular system
which integrates such related
areas as pharmacology.

48 SUPPLIER NEWS

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

Thermo Fisher, Qatar Genome Program
collaborate to advance precision medicine

Thermo Fisher Scientific custom genotyping array for pan- help drive scientific research
and Qatar Genome Program Arab populations using whole and insights into conditions
(QGP), a member of Qatar genome sequencing data from 19 including diabetes,
Foundation (QF), have Arab countries. The array, with cardiovascular and metabolic
partnered with the goal about 800,000 variants, aims to diseases, autism, inherited
of accelerating genomic genetic disorders and cancer.
research and clinical Once available through
applications of predictive Thermo Fisher’s global
genomics in Qatar as a commercial channels in late
step toward expanding the 2022, the array is intended to
benefits of precision medicine provide a cost-effective alternative
across Arab populations globally. to whole genome sequencing
Under the agreement, Thermo for Arab populations, enabling
Fisher and Qatar Genome increased diversity in large
Program will develop an Axiom genome-wide studies.

Avantor, Inc. invests PerkinElmer
in manufacturing and
distribution hub in Singapore expands genomic

Avantor, Inc. has announced that it will create a new manufacturing testing services
and distribution Hub in Singapore, by integrating its existing
distribution facility with new manufacturing operations. The new with urWGS
Hub, which brings Avantor solutions closer to regional customers
and strengthens global supply chain capabilities, will be fully PerkinElmer has announced the
operational early next year. The Singapore Manufacturing and availability of ultrarapid whole
Distribution Hub will enable Avantor to better serve the fast- genome sequencing (urWGS)
growing Asia Pacific Biopharma market by facilitating shorter lead through PerkinElmer Genomics. This
times, enhancing supply chain security and increasing capacity addition to the company’s portfolio
in the region. The Hub will boost regional innovation and serve of whole-genome sequencing
as an industry benchmark for Singapore and Asia Pacific’s global (WGS) offerings provides physicians
quality and regulatory standards, and demonstrates Avantor’s with comprehensive, meaningful
commitment to growing its presence in the region. The new Hub will results in five days to help inform
provide a range of services including quality control and inventory clinical management and improve
management expertise, and feature cGMP manufacturing suites outcomes for critically ill patients
and testing labs for process ingredients and excipients. in neonatal and paediatric intensive
care units (NICUs and PICUs). The
PerkinElmer Genomics urWGS
offering uses a dried blood spot
sample to provide phenotype-driven
analysis with a mean coverage of 40x
of a patient’s genome. It includes a
StepOne Comprehensive Biochemical
Profile. The StepOne offers screens
for more than 70 inherited conditions
and disorders, including the
Recommended Universal Newborn
Screening Panel (RUSP) and many
others that may not be found in state-
mandated programmes.

SUPPLIER NEWS 49

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

Sartorius Waters, University of
Delaware announce opening
continues global of Immerse Delaware Lab

capacity expansion Waters Corporation and the University of Delaware in the US
have announced the grand opening of Immerse Delaware,
with new extended a new Waters innovation and research laboratory. As part
of their multi-year research partnership announced in
plant in Tunisia October 2021, the lab opening is the first step on a journey
to collaborate with biopharma scientists both in industry
Sartorius is further growing its global and academia to advance industrial processes for making
production capacity with the expansion and characterising biotherapeutics. Located at the University
of its manufacturing site in Tunisia, of Delaware Science, Technology and Advanced Research
Africa. Enabling the Germany-based (STAR) campus, Immerse Delaware is a fully functional, fit-
company to increase the production for-purpose, bioprocess laboratory enabling a dedicated focus
of fluid management technologies, it on the entire manufacturing process from clone selection to
invested more than 20 million euros for quality control (QC) of drug substances. It will give students,
a new 10,000 square-metres building faculty and industry researchers access to use and evaluate
and corresponding operation equipment state-of-the-art analytical technologies from Waters as well
at its existing M’Hamdia location. The as novel analytics, consumables and software that will enable
extension includes clean rooms totalling the next generation of biotherapeutics.
around 2,400 square metres with
adjacent warehouse and logistics facilities,
among others. Sartorius currently has
almost 800 employees in M’Hamdia and
anticipates job growth at the site in the
future. The site in Tunisia has been in
operation since 2001. In 2019, Sartorius
established the Sartorius Academy
Tunisia, a training centre to develop the
skills of its employees, especially for new
employees joining the plant.

BD introduces fully automated infectious
disease molecular diagnostic platform

BD has announced the US launch most prevalent non-viral sexually complications to increased risk
of its new, fully automated, transmitted infections (STIs) of HIV. The BD COR MX/PX
high-throughput infectious — Chlamydia trachomatis (CT), System integrates and automates
disease molecular diagnostics Neisseria gonorrhoeae (GC) and the complete molecular
platform. With 510(k) clearance Trichomonas vaginalis (TV). laboratory workflow, from sample
from the US Food and Drug These three STIs can include processing to diagnostic test
Administration (FDA), the new a range of negative patient result for large, high-throughput
BD COR MX instrument is a new outcomes, from pregnancy labs. The BD COR System
analytic instrument
option for the BD eliminates the need
COR System. The to sort specimens
first test available enabling the lab
on the new system tech to have very
is the BD CTGCTV2 little interaction
molecular assay, with the specimen
a single test that freeing up time for
detects the three other critical lab
processes.

50

BIOSPECTRUM | JUNE 2022 | www.biospectrumasia.com

If Seeing Is Believing…

Over 2 billion people are currently living with the future while delivering quality services.
vision impairment and of these, at least Globally, more than 800 million people have
1 billion are needlessly living with poor
vision due to lack of access to eye care services. distance impairment or near vision impairment
This 1 billion people includes those with moderate that could be addressed with an appropriate pair of
or severe distance vision impairment or blindness spectacles. An estimated 100 million people have
due to unaddressed refractive error (88.4 million), moderate-to-severe distance vision impairment or
cataract (94 million), glaucoma (7.7 million), blindness that could be corrected through access to
corneal opacities (4.2 million), diabetic retinopathy cataract surgery.
(3.9 million), and trachoma (2 million), as well as
near vision impairment caused by unaddressed Achieving the targets endorsed at the 74th World
presbyopia (826 million). Health Assembly will require the combined and
proactive efforts of all stakeholders to fully integrate
These figures, according to the World Health eye care within national health services including
Organisation (WHO) are expected to increase at primary health care level and to ensure that
substantially due to population growth, ageing, the eye care needs of more people are addressed
and changes in lifestyle such as reduced time spent through prevention, early detection, treatment
outdoors, and greater time spent on intensive near and rehabilitation. In addition, collective efforts
vision activity. Combined with limited access to to monitor progress toward the targets will also be
eye care, particularly in low- and middle-income required. Governments from across the world have
countries, half of the global population is expected adopted a new resolution at the United Nations
to be living with a vision impairment by 2050. General Assembly, committing to greater efforts to
make eye care services an integral part of universal
Vision impairment poses an enormous global health coverage (UHC) and address the increasing
financial burden with the annual global costs of impact of vision loss on sustainable development.
productivity losses associated with vision impairment
from uncorrected myopia and presbyopia alone Exactly a year later on May 24, 2022, the WHO
estimated to be $244 billion and $25.4 billion. has launched ‘The Eye Care in Health Systems:
Guide for Action’ that provides practical, step-by-
The prevalence of distance vision impairment step, guidance to support governments in planning
(i.e. myopia and hypermetropia) in low- and middle- and implementing the recommendations of the
income regions is estimated to be four times higher ‘World report on vision’ with the goal to provide
than in high-income regions. With regard to near integrated people-centred eye care services.
vision, rates of unaddressed near vision impairment
(i.e. presbyopia), are estimated to be greater than 80 This new resource leads the governments through
per cent in western, eastern and central sub-Saharan a four-step process: situation analysis, development
Africa, while comparative rates in high-income of an eye care strategic plan and monitoring
regions of North America, Australasia, Western framework, development and implementation of an
Europe, and of Asia-Pacific are reported to be lower operational plan and establishing and maintaining
than 10 per cent. The burden of eye conditions and ongoing review processes. The Guide links to other
vision impairment is far greater in people living in tools developed by WHO, through consultations with
rural areas, those with low incomes, women, older international experts, including: Eye care situation
people, people with disabilities, ethnic minorities analysis tool (ECSAT), Eye care indicator menu
and indigenous populations. (ECIM), Package of eye care interventions (PECI) and
Eye care competency framework (ECCF).
Looking at the gravity of the situation in May
2021, the World Health Assembly endorsed the The above processes and tools and the
global targets for effective coverage of refractive implementation of integrated people-centric eye
errors and cataract surgery to be achieved by care has the potential to improve millions of lives
2030 - namely, a 40 per cent increase in coverage worldwide and translates to huge benefits for the
of refractive errors and a 30 per cent increase in economy.
coverage of cataract surgery. These targets will play
a key role in increasing global eye care coverage in Narayan Kulkarni
Editor

[email protected]