BioSpectrum Asia Feb 21

ternational
stant
cisive
formative

[email protected]/ [email protected] ASIA EDITION

www.biopectrumasia.com

BioSpectrum Promo Markeeng

Bridging the gap between bio suppliers and customer

Our results-oriented soluuons are designed to engage our audience from the
business of bio and healthsciences and guide you through the journey towards
customer acquisiion / engagement

The Prospects Journey
Each stage of the prospects journey forms the basis of how integrated
campaigns are designed. Depending on your needs, we will select products
to engage prospeccve customers and clients at each stage: Awareness,

Evaluaaon, Purchase and Retennon.

Are your prospects aware of your brand? Do they know RESEARCH
what sets you apart from your compeeeon? VIDEO
WEBINARS
In the compeeeve promooonal products marketplace, MAGAZINES
Brand Awareness is the foundaaon for a successful AUDIENCE EXTENSION
customer acquisiion campaign. When prospects know E-NEWSLETTERS
who you are and what you provide, they can think about PODCAST SPONSORSHIP
their needs and the available soluuons. PREMIUM DIGITAL DISPLAY
SEARCH
With premium print, e-newsleeers, podcasts, and many EVENTS
more customizable soluuons, BioSpectrum Promo
Markeeng can lii your brand awareness to the next
level.

GO BEYOND with BioSpectrum Promo Markeeng

For more informaaon, Please contact :
Ankit Kankar ( Manager - Products & Digital Strategic Communicaaons )

[email protected] | +91 9579069369

4 BIO EDIT

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Dr Milind Kokje REGAINING NEW-NORMALCY

Chief Editor Singapore, Indonesia, and India, where anti-COVID-19 vaccination has begun are
exceptions in Asia as several other Asian counties are yet to begin the drive or
[email protected] even yet to approve the vaccines. A report from our Asia Correspondent published
in this issue says that Singapore has administered 100,000 doses, Indonesia 132,000
and India 2.3 million doses, as per the latest figures available (by January 27). World
over, 40 million doses were administered by mid-January. Out of the top 10 countries
with the fastest vaccine rollout (as of January 13) only one – Israel - is from Asia. It is in
the top position with 22 doses administered per 100 people. But countries in the East,
Southeast and the APAC regions from Japan to Australia and Hong Kong to South
Korea, vaccines have not yet been approved. The approvals and vaccination drives are
scheduled between January and March/April, or even later, in some countries.

Compared to Europe and the US, these Asian countries appear to be very cautious
and going slow in vaccination drive. It is true that these countries did not experience
very large-scale number of infections and deaths, unlike Europe and the US. For
instance, in Thailand 17,023 people were infected and 76 lost their lives. Vietnam
recorded 1,657 patients and 35 deaths. Indonesia had over 1.5 million patients and
29,500 deaths. Japan had 383,000 patients and 5,559 deaths while South Korea has
78,200 patients and 1,420 deaths.

These countries managed to contain the numbers by early effective steps like
lockdowns, social distancing, tech-powered contact tracing and also, by extensive
testing. Handling of the pandemic by some of these countries like New Zealand and
South Korea was considered to be a model for other nations. Bloomberg recognised
New Zealand’s COVID-19 handling performance by putting the country in the top spot
in its COVID Resilience Ranking. Though some of these countries like South Korea
and Japan are witnessing a renewed wave of infections with record numbers, still,
those numbers are fewer than in Europe and the US. Probably, that is the reason that
the administrations in these countries are not feeling the pressing need to begin the
vaccination and going slow.

But now the people in these countries seem to be anxious to get vaccinated fast.
They are finding their respective country’s cautious approach strange particularly in
view of the urgency to re-start normal life as soon as possible. In an opinion poll in
South Korea six out of 10 people favoured urgency over safety and starting inoculations
as soon as possible. Korean media too has criticised the government approach towards
acquiring vaccine as ‘too relaxed’ with over-dependence on local vaccines, unavailable
anytime soon. In New Zealand, the opposition has asked the government why the
country has fallen behind in vaccination.

In contrast, some countries that have launched vaccination are plagued by
controversies over data inadequacy and security. In Israel, the people are upset over
the government promising vaccine producer US based pharma giant Pfizer to provide
statistical data on vaccine’s effectiveness by serving as a ‘model country’. People are
asking what kind of data has been promised by the government and demanding more
transparency in the whole issue.

Interestingly, although the people are being vaccinated, in general people’s
confidence in the vaccine seems to be low. A World Economic Forum-Ipsos survey
showed that the percentage of respondents agreeing to take vaccine dropped up to
nine percentage points from October to December. Japan has one of the lowest levels
of confidence in the world in vaccines in general, a study published in the Lancet said.

Whether there may be controversies over data, lower confidence in vaccines, or
slow moves for approvals and roll-out, governments will have to give some weightage
to speed since a vaccine is the only way to attain normalcy. The whole issue can be
summed up in the words of an editorial in South Korean Newspaper which said, “We
cannot forever ask people to stop their daily lives and endure economic pain.”

BIO MAIL 5

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Acknowledgements

The interview feature of Medix Global looks great. Thank you.
- Syed Talal, India

Thanks so much for the interview opportunity and a great story on Russian Direct
Investment Fund.

- Navreet Dhillon, Singapore

The cover story for BioSpectrum Asia New Year edition has come out well!
Thank you for featuring Reliance Life Sciences.

- Mahua Bhattacharya, India

Thanks very much for the feature on Fujitsu! The team will be happy to share
future announcements in the healthcare sector.

- Andrew Kane, Japan

Vol 16; Issue 2; February 2021 MM Activ Singapore Pte. Ltd. Taiwan
Media Representative:
Publisher & Managing Editor: Singapore Ms Christine Wu
Ravindra Boratkar MM Activ Singapore Pte. Ltd. Image Media Services Company
Editorial: Saradha Mani 2F-2, No. 35, Sec. 2, Flushing South Road,
Chief Editor: Dr Milind Kokje General Manager Taipei 10665, Taiwan
[email protected] #08-08, High Street Centre, Tel: +886-2-87734199
Advisor - Content: Vijay Thombre 1 North Bridge Road, Singapore - 179094 Fax:+886-2-87734200
Editor: Narayan Kulkarni Tel: +65-63369142 / Fax:+65-63369145 Mobile: 886-937890533
[email protected] Mobile: +65-90681202 E-mail: [email protected]
Executive Editor: Dr Manbeena Chawla [email protected] website: www.imagemediatw.com
[email protected] China
Sub Editor: Nitesh Pillai Asia Pacific & South East Asia Erika Cheng
[email protected] Ankit Kankar RFCOMMS
Asst. Manager Content Creation Manager- Product & Digital E101, East Lake Villas, 35 Dongzhimenwai
and Coordination- APAC Region: Strategic Communications Main Street, Dongcheng District,
Hithaishi C. Bhaskar 1st Floor, CIDCO Convention Center, Beijing 100027, P. R. China
[email protected] Sector 30A, Vashi, Navi Mumbai, Mobile: +86 17375668063
Social Media Communications: Maharashtra-400703. E-mail: [email protected]
Ankit Kankar Mobile: +91-9579069369 India
[email protected] [email protected] Alok Srivastava
CFO & Special Correspondent: Business Head- Ad Sales &
Manasee Kurlekar USA Marketing (India & APAC)
[email protected] BioSpectrum Bureau “NITON”, Block B, Lower Ground Floor,
Production & Design: MM Activ Sci-Tech Communications 11/3, Palace Road, Bangalore 560001
MM Activ Sci-Tech Communications Mobile: +91-9579069369 Tel: +91-80-41131912/13
Anil Walunj [email protected] Mobile: +91-9845128747
Cover Design: [email protected]
Dominix Strategic Design Pvt. Ltd. Europe
Business Enquiry: Mr. Stuart Smith Photo: Shutterstock
Manasee Kurlekar 6 Cobden Court, Wimpole Close, Go Digital:
[email protected] Bromley, Kent BR2 9JF T o request subscription
Subscription Services E-mail: [email protected] email: [email protected]
Print Edition: Saradha Mani E-mail: [email protected]
[email protected] Tel: +44 (0)20 8464 5577 Mobile: 07973 814753
Digital Edition: Ankit Kankar
[email protected] Chief Editor: Dr Milind Kokje
Database Executive: Sudam Walekar MCI (P) 012/06/2020
Media Intern’s: Copyright: MMActiv Singapore Pte Ltd.
Apoorva Mahajan / Sarang Khele

Printed and published by Ravindra Boratkar
on behalf of MM ACTIV Singapore Pte Ltd.

Printed at Times Printers Private Limited
16 Tuas Avenue 5, Singapore 639340
Tel : +65-63112888
Reprinted in India for private Circulation

6 BIO CONTENT

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

COVER STORY 17 While the world is looking forward
to potential vaccines to curtail the
COVID-19 pandemic, Asian countries
are in solidarity aiming to obliterate
the virus and to be resilient towards

future outbreaks. Countries are
generously announcing cost-free
vaccinations to the fellow residents
to achieve herd immunity. A safe and
effective vaccine seems to be the
only antidote to revitalize the global
economy and Asia is determined to

reinforce in the region.

A MAMMOTH TASK OF
COVID-19 VACCINE
PROCUREMENT AND

IMMUNISATION IN ASIA

24 26

9 trends of new Pharma industry’s reputation
post-COVID era rides on COVID-19 vaccine rollout

Dr K V Balasubramaniam, Saskia Kendall,
Life Sciences Consultant and Head of Health, Sandpiper
Former Managing Director – Communications, Singapore
Indian Immunologicals Ltd, Hyderabad
28

Enhancing vaccine confidence during
the time of COVID-19 and beyond

Prof. TIkki Pangestu,
Visiting Professor, Yong Loo Lin School of Medicine,
National University of Singapore and
former Director of Research Policy & Cooperation,
World Health Organization (WHO), Geneva, Switzerland

BIO CONTENT 7

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com Q&A

STRATEGY 42

30 “IoMT adoption can
bring quality results for
Japan creates new roadmap for growth patients and saves cost
in manufacturing”
COVID-19
Syed Suroor Anwar,
34 Vice President, Asia Pacific, Strategy, Product, Supplier,
Pricing & Inventory Management, RS Components, Hong Kong
Neglecting AMR could rack up
staggering ‘Death Numbers’ by 2050 REGULARS

Q&A BioEdit............................................................. 04
BioMail............................................................ 05
Policy and Regulatory News............................ 08
Company News............................................... 10
Finance News.................................................. 12
Start-up News................................................. 13
World News..................................................... 15
People News................................................... 44
R&D News........................................................ 46
Academic News............................................... 48
Supplier News................................................. 49

38 CONNECT
ENGAGE
“We will see either SS 656 SHARE
standard endorsed by the
ISO or used as the basis to CONNECT WITH US
develop their own standard”
twitter.com/BioSpectrumMag
Dr Zhou Lihan, facebook.com/BioSpectrumMagazine
CEO and co-founder, MiRXES, Singapore
https://goo.gl/QY4nUp/BS-LinkedIn
40
W W W. B I O S P E C T R U M A S I A . C O M
“With multi-cluster and
shared data architecture,
businesses can scale without
downtime or disruption”

Geoff Soon,
Managing Director, South Asia,
Snowflake, Singapore

8 REGULATORY NEWS BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Australia India opens institute for science
communication & policy research
secures
The government of India has opened a new institute of Council of
additional Scientific and Industrial Research (CSIR) i.e. CSIR-National Institute
of Science Communication and Policy Research (CSIR-NIScPR), in
vaccine New Delhi. The new institute has been established consequent to the
merger of two prestigious institutes of CSIR namely, CSIR-National
workforce Institute of Science Communication and Information Resources
(CSIR-NISCAIR) and CSIR-National Institute of Science, Technology
The Australian government is and Development Studies (CSIR-NISTADS), which work at the
preparing for the COVID-19 interface of science and technology (S&T) and Society; and Science
vaccine rollout by securing an Communication and Policy Research. The purpose of this merger
additional vaccine workforce is to combine the strength of the two institutes in a synergistic way
and working to deliver essential with a vision for India to become a globally respected think tank and
training to everyone, who will resource centre for understanding science, technology and innovation
administer the vaccinations. (STI), policy research and communication.
Australia’s vaccine roll out will
be carried out through hospitals, Singapore sets up multiple
general practices, state and COVID-19 vaccination centres
Commonwealth vaccination
clinics, Aboriginal Community To support COVID-19 vaccination efforts, the Singapore government
Controlled Health Organisations is setting up four COVID-19 vaccination centres, starting with two
and pharmacies. This additional – located at Changi Airport Terminal 4 and Raffles City Convention
vaccination workforce will help Centre, which have started operations from January 13, 2021. Two
support and supplement these
existing services and assist in more vaccination centres, located at the
outreach in areas such as aged former Hong Kah Secondary School and
care and remote and indigenous Woodlands Galaxy Community Centre,
communities working with are on track. The team will be ready to
existing providers. Through the have another four vaccination centres
plan, a panel of four providers by the end of February. More centres
have been appointed, who will across the island are being planned and
be called upon to provide a will be rolled out in tandem with the
vaccine workforce to supplement arrival of the vaccine shipments. These
the existing immunisation centres, together with the polyclinics and
workforce for specific populations. selected Public Health Preparedness Clinics, will ensure that every
The providers are Aspen Singaporean and long-term resident in Singapore, who is medically
Medical, Healthcare Australia, eligible can receive their vaccinations conveniently. Singapore is
International SOS, and Sonic making provision for all Singaporeans and long-term residents in
Clinical Services. The Australian Singapore to be able to get vaccinated by the third quarter of this
government has been closely year, if there are no unforeseen disruptions to vaccine shipments.
monitoring the immunisation
programmes operating overseas,
including in the United Kingdom
and the United States, and one
of the critical requirements has
been the availability of a ready and
capable immunisation workforce.
Work is also under way to prepare
the necessary and compulsory
training, which will be required
for each and every healthcare
professional administering
COVID-19 vaccines.

REGULATORY NEWS 9

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Taiwan buys China calls for international
vaccine cooperation
20M doses
China calls on the enterprises have provided
of COVID-19 international community vaccines to partner countries.
to work together to China has also joined the
vaccines contribute to the equitable World Health Organisation
distribution and use of (WHO)-led COVAX initiative
Taiwan’s Health Ministry and Central COVID-19 vaccines around to support the G20 in
Epidemic Command Center (CECC) the world and help defeat promoting international
have announced that the country the pandemic. Chinese cooperation on vaccines and
has purchased 20 million doses of enterprises are conducting multilateral cooperation to
coronavirus vaccines, including 10 joint vaccine research and promote the equitable global
million from AstraZeneca. Taiwan development with partners distribution of vaccines.
is also developing three of its own in more than 10 countries, According to reports, more
domestic vaccines. CCEC has including clinical trials than 40 countries have
negotiated the purchase of 20 million and production. As part of requested to import vaccines
doses of vaccines, including 4.76 the cooperation, Chinese from China so far.
million doses through the COVAX
global initiative and 10 million
doses of the Oxford/AstraZeneca
vaccine. The center is taking a
three-pronged approach to meeting
the country’s vaccination needs,
including investment in international
initiatives, purchasing directly
from manufacturers, and domestic
production. The center will begin
inoculating Taiwanese residents with
these vaccines by March of 2021. In
addition, discussions with several
other foreign vaccine makers who have
entered Phase III trials are ongoing.

South Korea inks pact with Moderna for 40M vaccine doses

Moderna, Inc., a US based will work with regulators to
biotechnology company pursue the necessary approvals
pioneering messenger RNA prior to distribution. The FDA
(mRNA) therapeutics and has authorized the vaccine for
vaccines, has entered into a emergency use in individuals 18
supply agreement with the years of age and older. Moderna
government of the Republic is advancing messenger RNA
of Korea to provide 40 million (mRNA) science to create a
doses of the Moderna COVID-19 new class of transformative
Vaccine to support the medicines for patients. mRNA
government’s aim of providing medicines are designed to direct
vaccines to the public as soon as the body’s cells to produce
possible. Under the terms of the intracellular, membrane or
proposed agreement, deliveries secreted proteins that can have
would begin in May 2021. The a therapeutic or preventive
Moderna COVID-19 Vaccine is benefit and have the potential
not currently approved for use in to address a broad spectrum of
South Korea, and the company diseases.

10 COMPANY NEWS

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

BeiGene, Seegene advance
business in Latin America
Novartis to
South Korea’s leading that can simultaneously
jointly develop molecular diagnostics firm screen and differentiate 8
Seegene Inc. is expanding its targets, including Flu A, Flu
oncology drug business in Latin America in B, RSV A/B and three target
2021 with a strong focus on genes of COVID-19 (S gene,
BeiGene, a China based its multiplex assay product. RdRP gene and N gene) along
commercial-stage biotechnology Seegene has received an with two internal control
company focused on developing approval from Brazil’s targets in a single tube of
and commercialising innovative ANVISA, the National Health reagent. The assay is known
medicines worldwide, has announced Surveillance Agency, in to accurately detect COVID-19
a collaboration and license January for the use of its viruses, even with mutated
agreement with Novartis Pharma Allplex SARS-CoV-2/FluA/ strains, as it targets multiple
AG to develop, manufacture and FluB/RSV Assay, a syndromic coronavirus genes. The
commercialise BeiGene’s anti-PD-1 test that can detect multiple multiplex assay will help the
antibody tislelizumab in the US, target genes including Southern Cone better prepare
Canada, Mexico, member countries COVID-19, influenza and for the influenza season,
of the European Union, the United common cold. Allplex SARS- which in Latin America
Kingdom, Norway, Switzerland, CoV-2/FluA/FluB/RSV Assay usually begins in the second
Iceland, Liechtenstein, Russia, and is a real-time RT PCR assay quarter.
Japan. The companies have agreed
to jointly develop tislelizumab
in these licensed countries, with
Novartis responsible for regulatory
submissions after a transition
period and for commercialisation
upon regulatory approvals. In
addition, both companies may
conduct clinical trials globally to
explore combinations of tislelizumab
with other cancer treatments, and
BeiGene has an option to co-detail
the product in North America,
funded in part by Novartis.

NZ firm develops early warning indicator for viral infection

Datamine, a New Zealand (NZ) changes that occur as the body
based company, has created begins fighting viral infection.
ëlarm, a personal early warning While ëlarm is not a test and does
indicator for viral infection, not provide medical advice, the
including coronavirus. The system alerts users to biometric
ëlarm system overcomes what is changes that indicate viral
arguably our greatest obstacle, infection and provides relevant
viral spread by asymptomatic World Health Organisation
people, who do not know they (WHO) and CDC guidelines. This
are infectious. By developing enables people to proactively
personal baselines of biometric get tested and self-isolate before
data from smartphones and other any symptoms appear. This
wearables, ëlarm detects changes helps prevent the spread of
to those individual baselines viral infection to loved ones,
that fit COVID-19 patterns and communities, and workmates.

COMPANY NEWS 11

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Intas Pharma inks exclusive
agreement with Alteogen

South Korean firm Alteogen initial payment of $6 million Mitsubishi
Inc has announced that it has and is also eligible to receive
entered into an exclusive license additional milestones upon Tanabe, Takeda
agreement with India based Intas’ achievement of specified
Intas Pharmaceuticals Ltd to development, regulatory and accelerate
use ALT-B4, Alteogen’s novel sales milestones, totalling up
hyaluronidase, derived utilising to $109 million. In addition, data-driven
the Hybrozyme technology, to Alteogen will be entitled
develop and commercialise two to receive a tiered royalty drug discovery
products. Under the terms of ranging from mid-single digit
the agreement, Alteogen has to low double digit on sales Japanese firms Mitsubishi
granted worldwide rights, except of commercialised products. Tanabe Pharma Corporation
for a few Asian countries, for Alteogen will be responsible for (MTPC) and Takeda
Intas to develop two products regulatory development and Pharmaceutical have concluded
in combination with ALT-B4. commercial supply of ALT-B4 to the agreement to share internal
Alteogen will receive an Intas. experimental data as part
of open innovation to tackle
Holmusk strengthens accelerating drug discovery.
mental healthcare in Singapore Under the agreement, MTPC
and Takeda should share some
Singapore based health technology company Holmusk has signed a of early-stage pharmacological
Memorandum of Understanding (MoU) with Singapore’s National activity data and ADMETox
Healthcare Group (NHG) and the Institute of Mental Health (IMH), (pharmacokinetics/toxicology)
to jointly develop innovative solutions for mental healthcare. The data on publicly-known
MoU outlines a shared vision to use digital technology, data and compounds, most of which
predictive analytics to help improve the mental health and well- have been used only within
being of the population. The tripartite partnership seeks to address each company, and separately
the unmet clinical utilize them for drug discovery
needs of patients, activities at both companies.
populations and MTPC and Takeda aim to
healthcare professionals, increase the productivity of drug
through leveraging the discovery activities through
clinical expertise and the data sharing, and at the
translational research same time, they aim to further
capabilities of NHG and promote open innovation,
IMH, and Holmusk’s including collaboration with
expertise in generating other companies, to make
insights from mental drug discovery research more
health real-world data efficient.
through advanced
analytics and digital
technology. Building on
its evidence generation
platform (NeuroBlu)
and digital therapeutics platform (mConnect), Holmusk will work
closely with NHG and IMH to co-develop tools that aim to enable
earlier detection and intervention in mental health disorders such as
depression by using advanced analytics.

12 FINANCE NEWS

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

FUJIFILM announces major investment plans in US

Japan’s FUJIFILM Corporation in financing and signed a lease
is making a major capital for a 40,000 square-foot site
investment of approximately in Watertown, Massachusetts
4 billion yen ($40 million) at The Arsenal on the Charles,
in FUJIFILM Diosynth owned and operated by
Biotechnologies, a world-leading Alexandria Real Estate Equities,
Contract Development and Inc. The centre will advance
Manufacturing Organization research and development in
(CDMO) for biologics, viral cell and gene therapy, gene
vaccines and viral vectors, editing, immunotherapy, and
to establish a new process biotechnology. Further, the
development and manufacturing facility for viral company is making an investment of more than 200
vectors and advanced therapies in the US. This will billion yen ($2 billion) to establish a new large-scale
be the third location for viral vector CDMO services cell culture production site in the US to accelerate
provided by FUJIFILM Diosynth Biotechnologies. the growth of its biopharmaceutical contract
Additionally, the company has secured $76 million development and manufacturing business.

Concord Medical ADQ invests Rs 555 Cr
divests Singapore
CIH for SG$52.2M in Biocon Biologics

Concord Medical Services Holdings, a healthcare provider Biocon, an innovation-led global
specialising in cancer care, research and prevention by biopharmaceuticals company based in
operating a network of medically advanced comprehensive India, has announced that the Board
cancer hospitals and standalone radiotherapy and diagnostic of its subsidiary Biocon Biologics has
imaging centres in China, announced that the company has, approved a primary equity investment by
through its subsidiaries, entered into a definitive agreement Abu Dhabi-based ADQ, one of the region’s
to sell 90 per cent equity interest in Concord Healthcare largest holding companies. The long-term
Singapore, which operates and owns a general medical and ambition for ADQ’s healthcare and pharma
surgical hospital, namely Concord International Hospital portfolio is to create a provision-centred,
(CIH), for a total consideration of approximately SG$52.2 digitally enhanced ecosystem. As per the
million. The purchasers have taken over the management terms of the proposed agreement, ADQ
of CIH and Concord Medical has ceased control over the will invest Rs 555 crore for a 1.80 per cent
management of CIH since the closing date in November minority stake in the biosimilar business,
2020. Concord Medical has requested the purchasers to valuing Biocon Biologics at a post money
complete the renaming of CIH within the next six months valuation of $4.17 billion. The transaction is
or sooner. Concord Medical’s board of directors believes subject to customary condition precedents
the transaction price reflects the fair market value of CIH and approvals. Post the completion of this
based on a valuation report by an independent third-party transaction, Biocon will hold 89.89 per cent
appraisal company engaged by the company. stake in Biocon Biologics on a fully diluted
basis.

START-UP NEWS 13

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

VISEN raises $150M to
accelerate endocrinology
therapies in China

VISEN Pharmaceuticals, Pivotal bioVenture Partners
China, Logos Capital, and CDG
a biotech startup focused Capital, as well as all of the
existing investors, including
on developing and Ascendis Pharma A/S,
Vivo Capital and Sofinnova
commercializing innovative Investments. Proceeds of
the Series B financing will
endocrine drugs that address be used to accelerate the
clinical development of
significant unmet needs for the potential best-in-class
portfolio drug candidates and
patients in Greater China, to build a strong foundation for
commercialization.
announced the closing of a

$150 million Series B financing. Korean startup

The round was led by Sequoia introduces

China with participation from world’s first smart

OrbiMed, Sherpa Healthcare healthcare device

Partners, Cormorant, HBM Korean startup ICON.AI has
unveiled the world first smart
Healthcare Investments, healthcare device. With just one
touch of the detachable health
MiRXES launches multiplex tracker, the smart healthcare device
test for SARS-CoV-2 & takes comprehensive readings
influenza in Singapore from fingertips to track heart rate
information, blood pressure trends,
To assist in accurate diagnoses, the Agency for Science, peripheral oxygen saturation
Technology and Research (A*STAR), Tan Tock Seng Hospital levels and more, all in nearly 60
(TTSH), and MiRXES, a leading molecular diagnostic startup seconds. The device is composed
headquartered in Singapore, are launching a multiplex of two main parts: a Smart Display
COVID-19 kit that simultaneously tests for SARS-CoV-2 and Speaker with Alexa Built-in & a
influenza. This will make a decisive difference as accurate and Detachable Health Tracker. The
timely diagnosis is critical during the ongoing third wave of the Smart Display Speaker includes: a
COVID-19 outbreak in the Northern Hemisphere. MiRXES has LCD Touchscreen, 5W Speaker with
obtained Provisional Authorisation from Singapore’s Health High Bass and Surround, Bluetooth
Sciences Authority (HSA) for the deployment of the Fortitude & WiFi. Fully equipped with a Smart
SARS-CoV-2 & Flu A/B Test, and is currently applying for CE Display Speaker with Alexa Built-in
Mark, Emergency Use Authorisation (EUA) from the United & a Detachable Health Tracker, the
States Food and Drug Administration (FDA), and approval from Smart Healthcare Device defines
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). itself as a game-changing smart
The Fortitude SARS-CoV-2 & Flu A/B Test combines the tested healthcare device. Just putting
and proven RT-PCR Fortitude Kit with syndromic panel assays two fingers on the Health Tracker
for Influenza A, and Influenza B. allows to track the six critical health
readings: heart rate trends, heart
rate variability, blood pressure
trends, SpO2, ECG, and PPG, all in
nearly 60 seconds. Its lightweight
portability allows to send a detailed
health report directly to smartphone
and tablets anytime and anywhere.

14 START-UP NEWS

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Taiwanese startup Estonian health
offers handheld device
for metabolic analysis startup announces

One of the ways to control body weight is controlling new partnerships
metabolism. Thus, to prevent weight gain, a person must
know his/her resting and physical activity energy expenditure. in India
Traditionally, metabolic analysis requires an expensive test
done in hospitals that provides passive observation and results Within a month of setting its footprint
that are difficult to interpret. Gene-Hub, based in Taiwan, in the Indian market, Estonia based
is solving the challenges of global e-health innovator company
obtaining metabolic analyses Viveo Health, has announced two major
with its Meta G - Accurate partnerships with the Indian companies
Monitor Your Metabolism. Doceree and Credihealth. Trusted by
It is a portable, hand-held, thousands of health professionals in
and light-weight device able over 40 countries around the world,
to fit in a coat pocket and Viveo Health is committed to provide
easy to carry around. Meta world-class telemedicine solutions to the
G allows users to measure doctors and healthcare professionals in
metabolism with a simple India. Viveo Health has partnered with
breath to estimate their Doceree to set-up digital clinics for over
24-hour metabolism to the 3 lakh doctors. Digital clinics will be a
minute. Meta G is a consumer virtual office platform for doctors that
electronics device that is would be offered free of charge by Viveo
competitively priced, energy efficient, and supports multimode Health to doctors and other medical
connections. This Gene-Hub product is the world’s first professionals. To make healthcare
handheld metabolic device, allowing accurate measurements of more accessible and affordable in
the respiratory exchange rate and basal metabolic rate through India, Viveo Health has partnered
breathing to estimate the user’s body metabolism in real time. with Credihealth. The partnership will
Moreover, the user can actively measure the body’s metabolism enable 35000 doctors to connect with
at home, and may help reduce the demand for medical services over 10 million patients annually and
and related costs. further boost the confidence of patients
and their family members, as they get
personalised guidance from a team of
medical experts.

Doctor Anywhere builds regional
tech hubs in Vietnam and India

Doctor Anywhere (DA) is tech teams based in Bengaluru
establishing regional tech hubs and Gurugram will form part of
in Vietnam and India, as well the expanded India hub. DA will
as expanding the core product also be hiring fresh graduates
development and engineering from local universities, and
functions in the Singapore providing opportunities for
headquarters. This expansion growth and regional exposure
will play a critical role in DA’s within the company. The new
continued growth in the region. tech hubs will triple DA’s product
The Vietnam hub will also have development and engineering
the opportunity to collaborate capacity, as the company
closely with the local DA offices continues to expand and deepen
to tailor solutions that align with their presence in the regional
market demands. DA’s existing healthcare landscape.

WORLD NEWS 15

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

NIH reveals impact CEPI calls for
of blood thinners on
COVID-19 patients experts for

National Institutes of Health (NIH), along with other funding Scientific Advisory
organisations, is a part of a large clinical trial conducted
worldwide, where full dose anti-coagulation or blood thinner Committee
treatments were given to moderately ill patients hospitalized
for COVID-19. The treatment reduced the requirement of Norway based Coalition for Epidemic
vital organ support such as the need for ventilation. A trend in Preparedness Innovations (CEPI)
possible reduction of mortality was also observed and is being is calling for individuals to join its
further studied. With large numbers of COVID-19 patients Scientific Advisory Committee, or SAC.
requiring hospitalization, these outcomes could also help reduce It is an expert group providing broad
the overload on intensive care units around the world. Three guidance and recommendations to
clinical trial platforms spanning five continents in more than 300 CEPI on R&D programmes and broader
hospitals have been working together to test whether there is a outbreak response
greater benefit of full doses of heparin (blood thinners) to treat efforts. CEPI
moderately ill hospitalized adults with COVID-19 compared to seeks to engage
the lower heparin dose typically administered to prevent blood senior experts
clots in hospitalized patients. Moderately ill patients are those and global health
not in intensive care and who did not receive organ support professionals, who
such as mechanical ventilation at trial enrollment. The trial have extensive
investigators are now working as fast as possible to make the full experience across
results of the study available so clinicians can make informed relevant scientific
decisions about treating their COVID-19 patients. disciplines to
join the SAC for a
three-year period
starting April
2021. Successful applicants’ scientific
input, guidance and challenge will be
critical in the implementation of CEPI’s
new strategy from 2022, designed to
accelerate vaccine technologies to tackle
current emerging infectious diseases,
including COVID-19, and enhance
global preparedness for future threats.

COVAX announces plans for COVID-19 vaccines deliveries

COVAX, the global initiative to bring a rapid end to the acute stage
ensure rapid and equitable access to of the COVID-19 pandemic, COVAX
COVID-19 vaccines for all countries, also confirmed that it will exercise
regardless of income level, has an option via an existing agreement
announced the signing of an advance with Serum Institute of India (SII) to
purchase agreement with Pfizer for receive its first 100 million doses of
up to 40 million doses of the Pfizer- the AstraZeneca/Oxford University-
BioNTech vaccine candidate, which developed vaccine manufactured
has already received WHO emergency by SII. COVAX also anticipates
use listing. Rollout will commence that, via an existing agreement with
with the successful negotiation and AstraZeneca, at least 50 million
execution of supply agreements. In further doses of the AstraZeneca/
support of its mission to expedite Oxford vaccine will be available for
early availability of vaccines to delivery to COVAX participants in
lower-income countries and help Q1 2021.

16 WORLD NEWS BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Indian firm Novartis, GSK explore
to supply African genetic diversity
COVID-19 for malaria, TB treatment
vaccine to Brazil
Novartis and GlaxoSmithKline research proposals on the
Bharat Biotech, based in (GSK) have announced the relevance of African genetic
India, has announced that it launch of a collaboration to diversity to the treatment
has signed an agreement with support high-quality scientific of malaria and tuberculosis
Precisa Medicamentos for research investigating the (TB). Within the scope of the
the supplies of COVAXIN to link between genetic diversity agreement, the South African
Brazil. A team from Precisa across different regions Medical Research Council
Medicamentos had visited the in Africa and its potential (SAMRC) will administer the
Bharat Biotech facility in January impact on response to drug project, and a Joint Steering
2021 to discuss potential export therapeutics. The Project Africa Committee will oversee
possibilities of COVAXIN, Genomic Research Approach the review of submitted
India’s first indigenous vaccine for Diversity and Optimising proposals. Priority will be
for COVID-19. In principle, it is Therapeutics (GRADIENT), given to research aimed at
understood between both parties with a combined funding collecting data from currently
that supplies of COVAXIN to be commitment of $3.6 million under-represented regions
prioritised for the public market, over five years, calls on African and improving the scientific
through a direct procurement researchers to submit robust robustness of inconsistent data.
by the Government of Brazil.
Supplies to the private market Kenya adopts digital tool
would be based upon receipt for COVID-19 test verification
of market authorisation from
ANVISA, the Brazilian regulatory The government of the Republic of Kenya has announced the launch
authority. COVAXIN is an of its Trusted Travel platform, based on the Africa CDC Trusted
innovation and a perfect example Travel platform, becoming the first country to adopt the platform
of novel product development for managing travels during the COVID-19 pandemic. Developed
from India. The vaccine has by PanaBIOS Consortium and Econet Group as a public-private
generated excellent safety data
with robust immune responses partnership with Africa
to multiple viral proteins that CDC, Trusted Travel
persist. is a top-class digital
solution to support
member states in
verifying COVID-19
test certificates for
travellers and to help
harmonize entry and
exit screening across the
continent. The platform
provides information
on travel requirements
at the departure and
destination ports
and access to a list of
government approved laboratories for COVID-19 testing in African
countries. It allows travellers to upload their COVID-19 test results
online for easy verification by port health and travel officials and
helps in the detection of forged certificates.

COVER STORY 17

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

While the world is looking forward
to potential vaccines to curtail the
COVID-19 pandemic, Asian countries
are in solidarity aiming to obliterate
the virus and to be resilient towards

future outbreaks. Countries are
generously announcing cost-free
vaccinations to the fellow residents
to achieve herd immunity. A safe and
effective vaccine seems to be the
only antidote to revitalize the global
economy and Asia is determined to

reinforce in the region.

A MAMMOTH TASK OF
COVID-19 VACCINE
PROCUREMENT AND
IMMUNISATION IN ASIA
Globally nations are pouring billions of dollars
in search and procurement of life-saving COVID-19 vaccines. The committees are prioritizing
vaccines. Development of technologies, regulatory authorization, logistics, liability, health
scaling up manufacturing and distribution is a workforce planning, and access for humanitarian
herculean effort in which governments, R&D and and vulnerable populations to indemnify the
manufacturing entities are proactively venturing to pandemic impact. Global vaccination scheme,
endow life-saving vaccines at a speed never before COVAX Facility is coordinated by GAVI and assisted
in the history of the biopharmaceutical industry. by member countries along with the CEPI, the
Yet, there remains a scarcity of doses to meet the WHO, and UNICEF. COVAX aims to deliver at least
requirements and to safeguard 7.8 billion global 2B COVID-19 doses across the world, with at least
population. Asia with its 4.6 billion (B) population 1.3B supporting Low-and-middle-income Countries
is ahead in race by securing required quantity (LMIC). FDA) is expediting emergency approvals,
anticipating to fight the pandemic. skipping large-scale, randomized clinical trials.
Vaccinations under the WHO’s COVAX programme
The World Health Organisation (WHO), the are expected to begin by the end of February.
Global Alliance for Vaccines and Immunisation
(GAVI), The International Vaccine Institute By the third week of January 2021, already 68
(IVI), the Coalition for Epidemic Preparedness vaccines are in human clinical trials, and 20 of them
Innovations (CEPI), the United Nations Children’s have reached Phase III large-scale efficacy trials.
Fund (UNICEF), and many other regional and Around 24 candidates are in Phase II safety trials
international organisations are working together and 40 are in Phase I testing safety and dosage.
to accelerate the invention of most potential Vaccines which have shown considerable safety and
immunogenicity at Phase III trials are conditionally

18 COVER STORY

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

TOTAL COVID-19 VACCINE DOSES SECURED AND ADMINISTERED BY APAC NATIONS*

Country Total doses Total dose Timeline
secured (as Manufactures/Vaccines administered as of,
of Jan 27)

Singapore Undisclosed Pfizer-BioNTech; Moderna; Sinovac 100K dose of (Pfizer Approved on:
vaccine as of Jan 27) Dec 14
First vaccination:
Dec 30

India 2.2B Oxford-AstraZeneca (COVISHIELD ); 2.3M dose Covishield + Approved on: Jan
Bharat Biotech (Covaxin); Covaxin (as of Jan 27) 3 -4
Novavax; Sputnik V First vaccination:
Jan 16

Japan 310M Pfizer-BioNTech; Oxford-AstraZeneca NA Scheduled for
Moderna; Novavax mid Feb

Australia 53.8M Pfizer-BioNTech, Oxford-AstraZeneca, NA Scheduled for
Novavax first quarter
2021.

Indonesia 329.5M Sinovac, Novavax, Oxford-AstraZeneca, 132K (as of 22 Jan) First vaccination:
Pfizer-BioNTech Dec 30

Thailand 63M Oxford-AstraZeneca; Sinovac NA Scheduled for
Feb 14,2021

South Korea 56M Moderna; Oxford-AstraZeneca; Pfizer- NA Scheduled for
BioNTech ; Janssen (J&J) Feb 2021

Taiwan 10M Oxford- AstraZeneca NA Scheduled for
March 2021

China 300M Oxford-AstraZeneca, Sinovac, 22M doses Sinovac + First vaccination:
Sinopharm, CanSino, Pfizer-BioNTech
Sinopharm (as of Jan 27) late Dec 2020

Malaysia 51M Sputnik V, Sinovac, Pfizer-BioNTech, NA Scheduled for
Oxford-AstraZeneca Feb 26, 2021

New 24M Pfizer-BioNTech, Janssen (J&J), Oxford- NA To be disclosed
Zealand AstraZeneca, Novavax

*Countries have also secured fully subsidized vaccines under COVAX/GAVI facility in addition to the above mentioned quantities NA: Not Applicable

approved under ‘Emergency Use Authorisation’ herd immunity. A safe and effective vaccine is much
(EUA) for the jab. Though, deployed for mass needed to stabilize the economy of the region.
vaccination, these vaccine candidates are further
scrutinized vigorously for safety, quality and efficacy Here is a sneak-peek of the vaccination
during the vaccination programme while committing strategy and status of some major Asian
for continued submission of trial data. countries:

Globally 9 vaccines are in promising SINGAPORE: THE FIRST SEA COUNTRY
developmental stages out of which around 7 vaccines TO APPROVE COVID-19 VACCINE
have qualified regulatory requirements in 56
countries. As of January 23, more than 63 million Singapore became the first Asian country to approve
(M) doses of coronavirus vaccine jabs have been COVID-19 vaccine in mid-December 2020 with
administered globally, at an average of 3.21M doses Pfizer-BioNTech candidate. The Health Sciences
a day. Mass vaccinations achieves herd immunity, Authority (HSA) granted interim authorization on
where a sufficient section of the population December 14, 2020 under the Pandemic Special
becomes immune to the virus, breaking the chain Access Route (PSAR) which enables HSA to evaluate
of transmission and protecting vulnerable groups. the vaccines in real-time instead of waiting for
Getting vaccinated is individual’s choice in most complete final data procurement. PSAR’s agile
countries, as vaccinating around 60 to 80 per cent and flexible regulatory procedures help in tracking
of the population is considered sufficient to achieve early stages of clinical analysis allowing fast
development and evaluation of vaccine candidates.

COVER STORY 19

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

HSA can terminate PSAR authorisation at any time “The WHO will regularly
when benefits no longer outweigh the risks. Once convene experts from
sufficient data is available for full registration, Pfizer’s
BNT162b2 vaccine candidate will transit to registered around the world, promote
status. collaborative research, provide
standard protocols and develop
Singapore has ensured cost-free and sufficient a platform for sharing the latest
doses to all its 5.7M population by the third quarter
of 2021. The dual dose Pfizer-BioNTech vaccine is knowledge in the field.”
scheduled 21 days apart for people aged 16 years and
above. As of January 22, nearing 60,000 individuals - Dr Soumya Swaminathan,
received their first dose of the vaccine. On January
27, vaccination for seniors was launched. Chief Scientist, WHO, Geneva, Switzerland

The government has also secured Moderna doses), Bangladesh (2M doses), Mayanmar (1.5M
(mRNA-1273) and Sinovac vaccines along with Pfizer- doses), Mauritius (150K doses), Seychelles (50K
BioNTech candidate. The strong ecosystem for cargo doses). Brazil and Morocco have received 2M doses
handling has efficiently managed cold chain storage each under commercial agreement. India is awaiting
and shipment. Country has reserved more than S$1B Sri Lanka and Afghanistan’s approval to assist them
for the entire vaccination programme. in the pandemic fight. India with its largest number
of FDA approved plants caters to 50 per cent of global
INDIA: WORLD’S LARGEST vaccine demand. India is committed to supply 200M
VACCINE PRODUCER doses to COVAX alliance.

World’s biggest immunisation programme began Meanwhile, Russia has signed agreements with
in India after the Drug Controller General of four Indian manufacturers to produce about 300M
India (DCGI) approved ‘COVISHIELD’ vaccine doses of the Russian-developed Sputnik V vaccine.
manufactured in Serum Institute of India (SII) Dr Reddy’s Lab in India anticipates the launch of
(developed by Oxford University and AstraZeneca) Sputnik V vaccine by March-end and is awaiting
and ‘Covaxin’ developed indigenously by Bharat DCGI approval for EUA. Russian Direct Investment
Biotech (in collaboration with Indian Council of Fund (RDIF) has also signed a deal with Hetero
Medical Research (ICMR) and National Institute of Biopharma to produce 100M doses of Sputnik V.
Virology (NIV)) for emergency use on January 3/4.
CHINA
SII’s COVISHIELD has shown 70.42 per cent
efficacy in clinical trials. India’s Health Ministry China has injected more than 22M doses under its
stated that SII secured deals to manufacture 2.2B emergency use programme as of January 27. China’s
doses to meet domestic and neighbouring country’s National Health Commission is aiming to vaccinate
needs. SII is making 50-60M doses of the vaccine 50M people by the Lunar New Year (February 11).
every month. Bharat Biotech’s Covaxin (BBV152 A, B,
C) has been granted approval for domestic use alone China has three native vaccines among which
and is also seeking emergency use authorization in two are from Sinopharm and one is from Sinovac.
the Philippines. Both have filed their applications with the WHO,
which is reviewing and could make decisions on
India launched its vaccination drive on January both in March at the earliest. However, one of the
16. Country’s massive immunisation programme aims Sinopharm vaccine produced at Beijing Institute
to immunize 300M people of its 1.35B population in of Biological Products Co., Ltd (BIBP), has already
the first six to eight months of 2021. Under its first been approved by Chinese regulators for domestic
phase of vaccination, the country has vaccinated use. Sinovac is yet to release global Phase III trials,
1.04M people as of January 22. SII’s COVISHIELD but it has been approved for emergency use in
recommends two -dose regimes about 28 days apart. countries including Brazil, Indonesia, Malaysia
India has trained around 200,000 vaccinators, and Turkey. All three vaccine developers (Sinovac,
370,000 team members and is ready with 29,000 Sinopharm and Cansino Bio) are attempting to join
cold storage points for an effective vaccination COVAX Facility.
programme.
Meanwhile, Shanghai’s Fosun Pharmaceutical
As of January 22, under India’s vaccine Group has secured nearing to 100M doses of
diplomacy, India gifted millions of COVISHIELD Pfizer-BioNTech vaccine. China is also producing
vaccines to neighbouring countries to name, Bhutan AstraZeneca vaccine in mainland China, partnering
(150K doses), Maldives (100K doses), Nepal (1M with Shenzhen Kangtai Biological Products.

20 COVER STORY

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

“The world needs multiple Vector System’ (BEVS) of UMN Pharma Inc., a
vaccines that work in different subsidiary of Shionogi.

populations in order to meet According to GlobalData Pharma Intelligence
global demand and end the Center,“Japan has reserved approximately $6.32B
COVID-19 outbreak. Ideally, (JPY671.4B) from the emergency budget to
secure COVID-19 vaccines. There are 17 Japanese
those will be single-dose organizations (including Osaka University and
vaccines that do not require National Institute of Infectious Diseases) working on
cold chain, could be delivered COVID-19 vaccine development. AnGes and UMN
without a needle and syringe Pharma are the two Japanese contenders in Phase II
and are amenable to large- stage of COVID-19 vaccine development. Country is
eagerly procuring excessive COVID-19 vaccine doses
scale manufacture.” with pre-orders exceeding four times of its actual
population.”
- Prof. Mike Levine,
AUSTRALIA
Founder and Former Director, Center for
Australia has invested more than $3.3B in
Vaccine Development, University of promising vaccine candidates in four separate
supply agreements. Upon Australia’s Therapeutic
Maryland School of Medicine, USA Goods Administration (TGA) screening for a
safe and effective vaccine, Australia will cover
JAPAN: SECURED HIGHEST its whole population with equal distribution of
VACCINE DOSES IN THE WHOLE ASIA Pfizer-BioNTech (10M doses), Oxford-AstraZeneca
(53.8M doses), Novavax (51M doses) vaccines along
Japan has secured more than 310M doses of vaccine with doses to be obtained from COVAX facility
covering 119.9 per cent of its 126M population. for its 2.5M population. Australia has designed a
Country has sealed the deal with Pfizer-BioNTech calculated purchase for each phase of vaccine roll-
(120M doses) enough for 60M people for the year out strategy.
2021. Other major vaccine makers including Oxford-
AstraZeneca (120M doses), Moderna (50M doses) TGA approved Pfizer-BioNTech vaccine on
and Novavax (250M doses) have also signed deals. January 25 to use on priority groups which will be
Vaccinations are expected to initiate by mid-February. subsequently extended to residents by February
(for age 16 and over). Australian biopharmaceutical
Japanese Prime Minister Yoshihide Suga’s office company CSL domestically manufactures the
made headlines in early January by bypassing the Oxford-AstraZeneca vaccine. In partnership with
health ministry to secure Pfizer vaccine ensuring AstraZeneca, CSL aims to make 53.8M doses of
the arrival of the first batch of vaccine to Japan vaccine available to Australia in the first quarter of
by February, as the health ministry continued 2021. Among which, 3.8M doses will be delivered
awaiting for safety data of the vaccine. Government in early 2021 and the rest 50M doses will be
even created an exclusive position in the ministry manufactured on monthly batches.
for COVID vaccination by appointing Minister of
Regulatory Reform Taro Kono to be in-charge of The Australian Government has also invested
all vaccine’s transport, storage, distribution and $363M to support global COVID-19 R&D efforts.
vaccination program management. Government has made 2 financial commitments
to Gavi’s COVAX facility. COVAX has received an
Japan’s Ministry of Health Labour and upfront payment of $123.2M to allow the purchase of
Welfare (MHLW) in collaboration with Takeda over 25M doses of COVID-19 vaccines. This would be
Pharmaceutical, manufacturing Novavax vaccine sufficient for 50 per cent of the population to receive
(NVX CoV2373) by transferring Matrix-M adjuvant a 2 dose regimen. Australia has also contributed
technology to Takeda. Takeda is also producing 50M further $80M to support vaccine access for up to
doses of Moderna’s COVID-19 vaccine candidate, 94 lower-income countries through the COVAX’s
mRNA-1273 under similar three-way agreement with Advanced Market Commitment (AMC).
MHLW. Meanwhile JCR Pharmaceutical (90M doses)
and Daiichi Sankyo are assisting in local production The Australian government supported
of the Oxford-AstraZeneca vaccine. development of its indigenous “UQ-CSL v451”
COVID-19 vaccine at University of Queensland in
Japan’s indigenous vaccine by Shionogi & Co association with CSL. The Phase II/III study was
is still in Phase I/II clinical trial stage. Shionogi
has received around $400M from the Japanese
government for its prophylactic vaccine candidate.
Shionogi’s recombinant protein vaccine is being
developed using a unique ‘Baculovirus Expression

COVER STORY 21

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

terminated in December 2020 due to adverse immune “The spirit of collaboration has
response levels which induced HIV viral protein in to prevail in these challenging
trial volunteers under diagnostic conditions. times as we seek to understand

INDONESIA this virus. We have to be
mindful of the inequalities
Indonesia has secured approx. 329.5M doses and we must deliberately
of vaccine from at least five sources, viz.,
Sinovac, (125M doses), Novavax (50M doses), promote investment in
Oxford-AstraZeneca (50M doses), and Pfizer- regional capacities to level
BioNTech(50M doses). Yet, considering two doses the playing field and have
of vaccine and 15 per cent as backup, Indonesia meaningful collaboration to
aims to secure 426M doses of vaccine. Country is begin to address some of the
also looking forward to Gavi-COVAX facility under
AMC92 (Advance Market Commitment) to avail challenges.”
fully subsidized vaccines for its 20 per cent of total
population (54M people). As many as 15M doses - Dr John Nkengasong,
of Sinovac vaccine raw materials have also arrived
in Indonesia which will be filled into ampules by Director, Africa Centres for Disease Control
BUMN Bio Farma for domestic use.
and Prevention, Cameroon
While the local Food and Drug Supervisory
Agency (BPOM) approves emergency usage and SOUTH KOREA
Indonesian Ulema Council (MUI) verifies the halal
review process, the country aims to vaccinate at The South Korean government has secured vaccine
least 70 per cent of the population accounting 182M for approx. 56M people with Johnson & Johnson’s
people. In the first phase, approx. 700K doses out of Janssen (6M doses), Moderna (40M doses) and
the 3M pre-ordered doses arrived in different regions Pfizer (10M doses).
on January 5.
Korea Disease Control and Prevention Agency
Indonesia rolled out mass vaccination programme (KDCA) announced that the vaccination is expected
on January 13. In the first phase, the government is to start in late February aiming to immunise more
vaccinating around 1.6M health workers (January- than 70 per cent of the population to achieve herd
February) throughout Indonesia, followed by 17.4M immunity. Yet, KDCA has not disclosed vaccination
public service workers and 21.5M senior citizens. action plans and accurate schedules. Negotiations
Indonesia plans to start vaccinating the general for securing 40M doses of Novavax vaccine in
public in late April or May 2021. collaboration with South Korea’s SK Bioscience are in
progress. Country is accelerating the approval process
THAILAND for AstraZeneca vaccine to use before mid-February.
Efforts to secure Pfizer and Moderna vaccine are also
Thailand’s Ministry of Public Health, local firms in progress. Korean government has also secured
Siam Bioscience and SCG have joined forces with vaccines for 10M people from the COVAX facility.
AstraZeneca to manufacture and distribute AZD1222 Yet, there appears anxiety among public on delayed
vaccine for Thailand and South East Asia. A purchase planning of national vaccination strategy.
agreement has secured 26M doses of AstraZeneca
vaccine for the second quarter of the year. In total, The International Vaccine Institute (IVI)
Thailand aims to produce 200M doses of AstraZeneca headquartered in Seoul, Korea is conducting early-
vaccines per year. Phase 1 vaccination will begin on stage clinical trials to establish vaccine evaluation
February 14 with 50K initial doses for 19M people. systems and to develop COVID-19 vaccine adjuvants.
Government plans to procure the vaccine to cover at IVI is conducting a Phase I/II clinical trial of
least 33M people in 2021, accounting 50 per cent of INOVIO’s COVID-19 DNA vaccine (INO-4800) at two
the Thai population. sites in South Korea in collaboration with INOVIO
and the Korea National Institute of Health. IVI is
Thailand has secured the first 2M doses of Sinovac actively involved in providing a range of critical
vaccine expected to arrive starting from February lab supports for COVID-19 R&D like assessment of
up until April 2021. Country is also negotiating recombinant VSV vaccine, assessment of Genexine’s
with Moderna and Pfizer for additional purchases. COVID-19 DNA vaccine (GX-19N), immunogenicity
Thailand is also desirous to secure around 20 per evaluation of Phase I/IIa trials of Cellid’s COVID-19
cent population’s requirement via COVAX facility. vaccine (AdCLD-CoV19), and Celltrion’s COVID-19
vaccine candidates, establishing standard sera
for COVID-19 with KDCA and other international
collaborations and more. IVI has 36 signatory

22 COVER STORY

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

TOP COVID-19 VACCINE MANUFACTURING COMPANIES WITH ANNUAL TARGETS*

Manufacturer Candidate Dose specifications/ Status
Annual Manufacturing
target

Pfizer/BioNTech (BNT162b2) Two doses, Storage: -70°C, WHO assessment completed.
Trial size: 44K Received EUA on Dec 21.
First vaccine to report Efficacy: 95 per cent Deal: 836M doses
Costs: $20 per dose
high efficacy at Ph III) (1.35B doses annually)

Serum Institute of COVISHIELD Two doses, Storage: 2-8°C, Received EUA in India.
India/AstraZeneca (ChAdOx1_nCoV-19) Efficacy: 70 per cent. Under WHO final screening. Approval
Trial Size: 65K (2.2B doses annually) expected in Feb 2021; Deal: 1B doses
Costs: $4 per dose

Moderna mRNA-1273 Two doses; Storage: 2-8°C, Received EUA in U.S., U.K., E.U., other
Trial Size: 30K Efficacy: 95 per cent countries on Jan 8.
(600M doses annually) Deal: 600M doses
Costs: $33 per dose

The Gamaleya National Sputnik V Two doses: Ad26 (First); Received EUA in Russia and some
Research Centre (Gam-Covid-Vac) Ad5 (Second) Storage: other countries.
Trail Size: 40K (First vaccine to be -18°C and 2-8°C; Efficacy: Deal: 1.2B doses
registered early in 91.4 per cent Cost: $10 per dose
Aug 11, 2020) (1.2B doses annually)

Oxford- AstraZeneca AZD1222 Two doses, Storage: 2-8°C Received EU approval
Efficacy: 70 per cent Under WHO screening
Deal: 3036M doses

Novavax NVX-CoV2373 Two doses; Storage: 2-8°C, Under WHO screening;
Trial Size: 20K Efficacy: 89.3 per cent Expecting first approval in UK
(2B doses annually) Deal: 1314M doses

Janssen (J & J) Ad26.COV2.S Single dose; Storage: 2-8°C, Under WHO screening; Expects
Trial Size: 45K
(300M doses annually) approval by May/June 2021

Sinovac Biotech CoronaVac (Vero Two doses, Storage: 2-8°C, Under WHO screening; Expects
Trail Size: 26K Cell), Inactivated
Efficacy: 50 per cent approval by March 2021

CanSino Biologics Ad5.nCoV Single dose; Storage: 2-8°C Under WHO screening
Trial size: 40K

Sinopharm SARS-CoV-2 Two doses: Storage: 2-8°C, Under WHO screening; Expects
Trial Size: 50K Vaccine (Vero Cell),
Inactivated (lnCoV) Efficacy: 79 per cent approval by March 2021

*With reference to WHO “COVID-19 Vaccines within WHO EUL/PQ evaluation process” as of Jan 20, 2021 EUA/PQ: Emergency Use Authorisation (EUA) procedure/ Prequalification

countries (including Korea, Sweden, India, and is avoiding purchase of vaccines developed and
Finland as state funders) and WHO on its treaty produced in China. Country is more focused on the
committed to ‘Building Vaccine Diplomacy and preventative measures to curtail the pandemic than
Advocacy’ for a sustainable vaccine development. chasing for vaccines.

TAIWAN Taiwanese are expecting vaccination to initiate
by March 2021. Aiming for herd immunity, the
Taiwan’s Central Epidemic Command Center (CECC), CECC plans to immunise approx. 65 per cent of the
has secured 20M doses of coronavirus vaccines population (23M people). Based on an estimated
and is also developing three of its own domestic two doses per person, the centre projects that 30M
vaccines. Country has inked deals to purchase doses requirement to reach estimated levels of
Oxford-AstraZeneca vaccine (10M doses) and even herd immunity. Meanwhile, Taiwan is approaching
from COVAX initiative (4.76M doses). Ministry is Germany through a mutual trade route to procure
distressed with panic excessive vaccine purchases, Pfizer-BioNTech vaccines.
stockpiling and monopoly of wealthy countries
which is delaying supply to Taiwan. To note, Taiwan According to the CECC, the status of Taiwan’s
three domestic vaccine candidates are as follows (as

COVER STORY 23

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

of January 1): Adimmune Corporation (Phase I to through clinical trials and safety testing.
determine optimal dose); Medigen Vaccine Biologics New Zealand has also announced $75M official
(combination of spike proteins and an adjuvant from
Dynavax is conditionally approved to enter Phase II development assistance to support Pacific and global
trials); United Biomedical (in Phase II trials) vaccine access and roll-out. This package includes a
$27M contribution to the COVAX facility’s Advance
MALAYSIA Market Commitment (AMC). COVAX allows NZ to
claim the vaccine required to cover 50 per cent of the
Health ministry has secured Pfizer-BioNTech population.
(24.28M doses), Oxford-AstraZeneca (6.4M doses),
Sputnik V (6.4M doses) and Sinovac (12M doses) Government has already allocated funds on
vaccines. First batch of Pfizer vaccination will initiate different international research collaborations
on February 26 scheduled in 3 different phases from ($15M), New Zealand’s vaccine R&D and global
March to August 2021, immunising 39 per cent of the efforts ($10M), to support manufacturing capability
population. To achieve herd immunity, government in New Zealand ($5M), and to assist Gavi alliance
aims to immunise 27M people out of the country’s ($7M). Government is also supporting ‘Vaccine
32M population (more than 70 per cent of the Alliance Aotearoa New Zealand’ to establish a
population) by the first quarter of 2022. national development and screening programme for
potential COVID-19 vaccines.
Two domestic distribution companies Duopharma
(M) Sdn Bhd and Pharmaniaga Berhad have taken up PREVAILING CHALLENGES
the supply and distribution responsibility.
Vaccines will help to curtail the COVID-19 pandemic.
Duopharma will supply the government with Yet, as the crisis continues it’s essential to adhere to
6.4M doses of Sputnik V vaccine (arriving March- healthcare measures as vaccines are not the supreme
end) and Pharmaniaga Berhad will supply 12M doses shield to the virus. Governments should strengthen
of Sinovac vaccine (arriving in February). Malaysia is public health infrastructure, enhance universal health
set for national vaccination programmes on February coverage, system capacities and functions to be
26 starting with Pfizer-BioNTech vaccine. resilient against future pandemics.

Pharmaniaga is procuring a bulk volume of Countries globally have already secured 8.49B
Sinovac vaccine to produce vaccine ampules in doses sufficient to cover more than half the world’s
Malaysia, and will manage further logistics. The deal population, if the shots are distributed evenly. But
includes, vaccine technology transfers to the group wealthy countries have accumulated extensive
and subsequent domestic manufacturing rights. supply deals creating scarcity at the poor countries
which are struggling to place pre-orders. WHO too
Another Malaysian firm, Bioalpha International is grappling to tackle the monopoly. Cold storage
Sdn Bhd (BISB) on January 25 has signed an requirements and availability of advanced supply
agreement to procure 10K doses of Sinovac doses. chain are additional challenges which low-and middle
Company is currently liaising with Ministry of Health income countries are facing. Though COVAX and
and National Pharmaceutical Regulatory Agency other WHO consortiums are assisting these countries
(NPRA), for regulatory approvals to distribute the with various subsidized schemes, some countries may
vaccines by mid-April 2021.The government has have to wait until 2022 or later before supplies are
allocated RM3B ($742M) for the initiative. Malaysia widely available.
has also donated $3M to CEPI for vaccine R&D.
Disputes on the safety and halal status of the vaccines In a recent global scientist’s forum at WHO on
still continues in the country. January 16, WHO stated that more than 30M vaccine
doses have already been administered in 47 mostly
NEW ZEALAND high-income countries. Vaccinations under the
WHO’s COVAX programme are expected to begin by
New Zealand has secured four COVID-19 vaccines the end of February. Rich countries’ direct deals with
through independent purchase agreements drug makers have been blamed for delaying the flow
viz; Pfizer-BioNTech (1.5M doses), Janssen of COVID-19 vaccines to poor nations. Struggle also
Pharmaceutical (5M doses), Oxford-AstraZeneca exists with insufficient funding to support R&D and
(7.6M doses) and Novavax (10.72M doses). New in ensuring equitable vaccine distribution. Global
Zealand’s drug regulatory agency Medsafe is vaccine rollout has exposed glaring inequalities in
monitoring the approval process. General public will access to vital life-saving tools.
have access to vaccines in the second half of 2021.
The schedule and regime has not been disclosed Hithaishi C Bhaskar
yet and wishes to wait as potential vaccines move [email protected]

24 COVER STORY

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

trends of new
post-COVID era

« infectious disease needs.
The private sector seized the initiatives and
Dr K V
Balasubramaniam, blockbuster vaccines soon hit the market. For
Life Sciences example, the pneumococcal vaccine market is now
Consultant and worth $8 billion, the human papilloma virus (HPV)
Former Managing vaccine is worth $3.8 billion, and the rotavirus
Director – Indian vaccine is worth $1.6 billion. No longer are vaccines
Immunologicals Ltd, in the ambit of government institutes. No longer are
Hyderabad they perceived as cheap. No longer are they low in the
priority list of pharmaceutical majors.
As the world wakes up to the new post-COVID
reality, the vaccine industry is entering a new The COVID-19 pandemic is now poised to propel
paradigm that is one in which vaccines are the vaccine industry into a new growth orbit. Just
perceived as effective medical interventions, which think, even if one half of the world population of 7.6
will have wider acceptance in the society, and which billion gets vaccinated for COVID each year with an
need to be supported. average price settling down to $2 per dose (there
would of course be wide disparity between prices
The global vaccine industry has hit pay dirt, in high income and low-income countries) and
thanks to the COVID-19 pandemic! Never has accounting for 10 per cent wastage, the market would
it been so good for the industry. be in the region of $16 billion! This is assuming
The scramble to find medical solutions to one that the vaccines develop not just robust protective
of the worst nightmares that haunts humanity has immunity but also sterilising immunity, which the
found a forceful response from the vaccine industry. vaccines approved so far have not yet convincingly
We now have vaccines which promise protection proved to be conferring.
against this horrible pandemic. The world is now
more positive about the post pandemic future albeit Compare this with the size of global vaccine
with new social norms. industry which is estimated to be presently $36
billion in revenues. That would be a huge jump of 44
Once perceived to be cheap with production in the per cent of industry revenues with just one product.
ambit of government institutes, and largely ignored by
the pharmaceutical majors, vaccines are now perceived On the profitability side, we can see a huge surge
to be of immense social value and new business growth in profitability, considering that the prices garnered
drivers in the pharmaceutical industry. are disproportionately high compared to cost of
manufacture, with development costs funded by
The defining changes came about at the beginning governments and public liability clauses waived. That
of this century with the United Nations adopting the would be hitting pay dirt for the vaccine companies! We
Millennium Development Goal (MDG) in 2000 of are already witnessing this with valuations of vaccine
reducing child mortality by half by 2015. Impetus to companies across the world soaring to new highs.
this was given by the creation of Global Alliance for
Vaccines and Immunization (GAVI) in 2000 to fund We must note however that the ability of the
immunization initiatives in low-income countries, vaccine industry to seize the opportunity and make
and more importantly develop low-cost vaccine a response at supersonic speed has not happened
solutions alongside new vaccine technologies. This overnight. There have been years and years of
apart, new recombinant biotechnology methods coordinated research in new vaccine technologies
were able to address vaccine solutions to pressing and new manufacturing systems behind this. The
past disease outbreaks of SARS, Ebola, MERS,
Nipah and Zika led the industry think of how it could
respond to new pandemic situations, about how new
technologies would help and how the regulatory
processes can be accelerated for emergency

COVER STORY 25

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

approvals. It is worth mentioning the role of the There are just about 30 vaccines in use today and
Coalition for Epidemic Preparedness innovations about 26 more in development. An accelerated rate
(CEPI) conceived in 2015 and launched in Jan 2017, of development for the 26 vaccines and for the new
which effectively marshalled resources to fight future emerging zoonotic diseases with new technologies, can
pandemics. The vaccine response to COVID-19 is a result in a sustained rise in the fortunes of the global
shining example of CEPI’s success. vaccine industry.

We now have new technology platforms in of development for the 26 vaccines and for the new
the mRNA, viral vectored and synthetic peptide emerging zoonotic diseases with new technologies,
vaccines working for a COVID-19 vaccine response. can result in a sustained rise in the fortunes of the
This is most definitely a disrupting and trailblazing global vaccine industry.
transformation for the industry. More important,
questions are being asked about why the regulatory However, considering that the supersonic
processes should not be reviewed to reduce vaccine response to COVID-19 vaccine development has been
development and deployment time frames from 8-10 due to the huge amount of money poured for vaccine
years to just 3-4 years. development, large advance purchase commitments,
creation of heightened sense of urgency and
Therefore, even as the world wakes up to the unconditional waiver of public liability for vaccine
new post-COVID reality, the vaccine industry is companies, it remains to be seen if similar responses
entering a new paradigm. The new paradigm is one play out in the future for emerging infectious and
in which vaccines are perceived as effective medical pandemic diseases.
interventions, which will have wider acceptance in
the society, and which need to be supported. The There is a section of leaders in the industry who
trends that are visible are: call for caution in any assessment of the future till
the dust has settled after the COVID-19 pandemic.
1. A spate of new vaccines developed using new There is also the need to ensure that people in poor
technologies and even vaccines presently in use, countries are not left behind, about which CEPI
redeveloped with new technologies. is working to solve with its COVAXX facility. For
countries burdened with the high cost of vaccinating
2. New initiatives for handling future pandemics their populations, the possibility of imposing price
giving fillip to the efforts already made in this controls or invoking compulsory licensing clauses on
direction by the multilateral agencies. IPR cannot also be ruled out. All this calls for more
responsible behaviour by the vaccine industry.
3. A new realization that emerging zoonotic
diseases like the ones we have witnessed in the Notwithstanding this, it can be stated that
last ten years need a more concerted and effective there would be significant positive changes which
response. can propel the industry to new orbits. If any, our
generation will be witness to the unfolding of the
4. Higher levels of venture capital and larger new vaccine paradigm, just as we were witness to the
capital investments in the industry which focus on internet revolution.
creating larger capacities and flexible manufacturing
systems.

5. Higher outlays by governments for mass
immunizations supported by better political
championing of the case for vaccine solutions to
emerging diseases.

6. Large private markets for new vaccines from
the society which sees more value in vaccination for
social good.

7. A more open regulatory process which looks
at reducing the time to market new vaccines being
developed from a better understanding of the
correlates of protection in the clinical studies.

8. A growing recognition of the digital overlay
required for large scale immunization efforts.

9. The possibility of more public private
partnerships to resolve urgent health issues that
haunt our society.

There are just about 30 vaccines in use today and
about 26 more in development. An accelerated rate

26 COVER STORY

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Pharma industry’s reputation
rides on COVID-19 vaccine rollout

« success of the national roll outs.
COVAX, the global initiative to ensure rapid
Saskia Kendall,
Head of Health, and equitable access to COVID-19 vaccines for all
Sandpiper countries, estimates that if access is not equitable, the
Communications, death toll could be doubled worldwide. Many Asian
Singapore countries will be reliant on COVAX to afford and
access the vaccines, so the recovery in the region will
From 230 vaccine candidates, seven COVID-19 be dependent upon the initiative working well.
vaccines are being used in at least one country,
three of which have been developed in Asia. These worthy efforts, however, could be
Manufacturing and distributing these high quality hampered by richer nations prioritising their own
vaccines, several of which must be kept at -80 populations. The World Health Organisation’s
degrees, on this scale is a monumental task. The true Tedros Adhanom, saw the 42 bilateral agreements a
success of developing these vaccines in such a short potential ‘catastrophic moral failure’. However, the
time, and long-term reputational impact will be tide appears to be turning, with the US finally joining
based on the messy reality of rolling out vaccination COVAX and Pfizer committing to supply 40 million
programmes worldwide over the coming years. doses to the initiative, adding to the 2 billion already
secured. After COVAX begins rolling out the initiative
From 230 vaccine candidates, seven COVID-19 this month, these tensions will no doubt remain.
vaccines are being used in at least one country,
three of which have been developed in Asia. Complexities in achieving
The unquestionable scientific achievements are now
giving way to the challenging logistical and human population immunity
task of worldwide vaccination programmes. As new
strains of COVID-19 develop and spread, intense Vaccination programmes tend to aim for herd
interest on the roll out will only heighten. This immunity, where enough people have immunity that
situation comes with reputational opportunities and it significantly reduces the spread of the pathogen.
risks for the pharmaceutical industry, and much will The exact proportion of the population that needs
hinge on how well roll outs are managed and the immunity is unclear for COVID-19 but many
communication around them. estimates that we would need to inoculate around
60 per cent or 70 per cent of a population. Trust
The research and development (R&D) feat that
has occurred over the last year is unprecedented and
recognition is high among experts and the general
public alike. Beyond R&D, AstraZeneca has already
pledged to provide the vaccine at-cost for poorer
countries and wealthier countries during the course
of the pandemic, a commitment that should be
commended. Notable changes in global perceptions
about the industry, one that often is viewed with
suspicion, are yet to be fully realised but the potential
is significant. However, much rides on how global
access to the vaccine occurs and ultimately the

COVER STORY 27

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

in the vaccines being administered is instrumental Asia alone represents over 4.5 billion people
in reaching this critical mass. However, many still
express doubts about the vaccine worldwide, and so and India is undertaking the world’s largest
vaccine hesitancy remains a key hurdle. Globally,
only one in three people are ready to take the vaccine vaccination programme. Providing access
as soon as possible. In many Asian nations this is
higher, for example, in Singapore and Japan, only to large rural populations in Asia will be
18 per cent of people would be vaccinated as soon
as possible and only 54 per cent are willing to be challenging. Careful reporting of any issues and
vaccinated at all, well below the level needed.
transparency will be important to maintain trust
Tackling distrust and misinformation
in the vaccines that are being administered.
The reasons for this are complex. The speed of the
R&D process and approval, plus the fact that some This is fertile ground for misinformation to spread.
vaccines are built on novel technology are making
some anxious. In some countries, counterfeit Transparency and reporting
medicines are an ongoing issue and confidence in
the supply chain will be important. Technology like Adverse reactions are inevitable, as they are with
Zuellig Pharma’s eZTracker, which allow people to all interventions, no matter how rare, and these will
test the authenticity of a product may well be an have particular attention in the media, online and
important part of the solution. Cultural and religious among stakeholders. Careful planning, processes
factors are also at play in some countries. Whether and most importantly, transparency and reporting,
the vaccines are halal is being hotly debated among will be necessary to reduce the impact of these
Muslim communities in Indonesia, Malaysia and events on trust and reputation. People tend to be
beyond. Governments, pharmaceutical companies biased towards information that they see regularly
and other partners will need to develop engaging so ensuring that success stories and the impact of
communications strategies to reassure the public, vaccinations are shared and discussed will help
recognising the complex emotions at play and the counter any other noise.
particular local issues.
Alongside this, the logistical challenge is vast.
Tackling misinformation will also be crucial. Social Asia alone represents over 4.5 billion people and
media is now one of the main sources of news and India is undertaking the world’s largest vaccination
information for people across Asia, reinforced by word- programme. Providing access to large rural
of-mouth discussions. And people tend to seek out populations in Asia will be challenging. Careful
information that reaffirms a belief they already hold. reporting of any issues and transparency will be
important to maintain trust in the vaccines that are
being administered.

Manufacturing and distributing high quality
vaccines, several of which must be kept at -80
degrees, on this scale is a monumental task. It is
clear that pressure is already mounting from Western
nations to increase the volume of doses available
as supplies quickly run dry, with Italy recently
threatening action against the pharmaceutical giants
if their existing orders are not filled due to issues in
the manufacturing process.

The reputational chance of our lifetime

This is likely to be the most high-profile health
programme of our lifetimes and the intense media
interest will mean that every mistake and success
will be reported and dissected over dinner tables
worldwide. The vast potential of the pharmaceutical
industry’s R&D has been realised and rightly
celebrated. However, the true success, and long-
term reputational impact will be based on the
messy reality of rolling out vaccination programmes
worldwide over the coming years, and the effective
communications that support it.

28 COVER STORY

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Enhancing vaccine confidence during
the time of COVID-19 and beyond

« protect against several diseases.
Beyond COVID-19, influenza is a tangible example
Prof. TIkki Pangestu,
Visiting Professor, to share that shows the impact that infectious
Yong Loo Lin School diseases can have on the individual, society and
of Medicine, National healthcare systems if not prevented. Influenza
University of Singapore represents a critical public health issue. The WHO
and former Director estimates that annually, influenza infects nearly 1
of Research Policy & billion individuals, has 3 to 5 million cases of severe
Cooperation, World Health disease, and 290,000 to 650,000 deaths. There is
Organization (WHO), also evidence that influenza can trigger coronary
Geneva, Switzerland complications such as heart attacks and stroke, and
puts vulnerable populations, such as those living
Vaccination beyond childhood is not well with diabetes, at higher risk of complications. More
understood by populations, and subsequently often worryingly, given the rapidly aging global population,
elective vaccination rates are very low, worryingly the risk of influenza-related mortality increases
so for the elderly and more vulnerable. Despite the sharply after 65 years of age. The higher prevalence
benefits of vaccination, the WHO in 2019 recognised of comorbidities among the elderly increases the risk
the issues around vaccine uptake and coined and severity of influenza in this age group.
“vaccine hesitancy” as one of the biggest threats to
global health. In addition to health impact, influenza also has
an important economic impact. This includes direct
As COVID-19 continues to spread around costs (e.g. outpatient visit and hospitalisation costs,
the world, and at an accelerated pace for drug consumptions etc.) and indirect costs (e.g. work
some regions, many hopes are pinned on absenteeism, productivity lost etc.). In the elderly
the regulatory approvals and subsequent delivery and vulnerable populations, complication rates are
of various late-stage COVID-19 vaccines. As people high and medical care, including hospitalisations, are
and companies work around the clock in finding required.
the solutions to ensure the health of our healthcare
workers and people, and rightly so, we must not The benefits of vaccination are clearly
forget about other infectious diseases that we have documented, and need to be communicated to
worked hard to keep at bay. the public in order to increase awareness and
understanding around the value of vaccination.
The value of vaccines
The rise of vaccine hesitancy
According to research and analysis by the World
Health Organization (WHO), vaccination is one of Despite the benefits of vaccination, the WHO in
the most cost-effective ways to avoid diseases. An 2019 recognised the issues around vaccine uptake
estimated 5 million deaths are avoided every year and coined “vaccine hesitancy” as one of the biggest
with vaccination. If global vaccination coverage threats to global health.
increases, a further 1.5 million deaths can be
prevented. Beyond COVID-19, life-course immunisation
will continue to be an integral part of keeping
With the exception of clean, safe drinking water, infectious diseases at bay. They are critical and
no human endeavor rivals vaccination in combating yet under-utilised public health interventions.
infectious diseases and reducing mortality rates. Vaccination beyond childhood is not well understood
Vaccination beyond childhood brings significant by populations, and subsequently often elective
benefits at the individual, community and socio- vaccination rates are very low, worryingly so for the
economic levels and remains one of the most elderly and more vulnerable.
powerful and cost-effective preventions available to
I recently had the opportunity to deep dive into
the challenges and solutions to increasing vaccine
confidence in life-course vaccination at the EU-ASEAN
Business Council webinar on Vaccine Confidence in

COVER STORY 29

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

the Time of COVID-19: Asia’s Time to Act. and safety. The pace of information dissemination is
also crucial, so that the correct reporting reaches the
The barriers public before the gaps are filled by false or misleading
information.
For me, there are two key barriers that hamper efforts
to improving vaccine confidence in the region. 3. Local governments – Governments need
to be transparent and accountable as well as deliver
1. The spread of misinformation, and the information and address misconceptions rapidly
role of mainstream and social media. The most around vaccination in order to overcome fear and
important and significant barrier is the spread of mistrust. Accurate and transparent information
misinformation, falsehoods and conspiracy theories, around the role of vaccination can further motivate
which are creating fear, confusion and reduced trust the adult population to take up vaccination.
in the importance of vaccination. Sensationalised and
inaccurate reporting by media outlets can often cause 4. Community groups – One of the most
unintended and long-term consequences on vaccine important groups for me are community groups. For
confidence. And we now have the more recent issue example, small neighbourhoods and communities
of social media being at the centre of misinformation especially in rural areas whose members are close-
spreading at an alarming rate, to the point where the knit. A group such as this can positively influence one
WHO has coined the term “infodemic”. another in the spirit of the community and are the
foundation to the larger environment around vaccine
2. The need for more awareness and education on confidence. Locally-driven education and awareness
the benefits of elective vaccination. While the benefits campaigns are a great place to start.
of childhood vaccinations are clear, and many
countries have compulsory vaccination schedules 5. Public health professionals – As public
and mechanisms for delivering vaccines effectively health professionals, we also need to be able to tell
to a paediatric population, the challenge is bigger for more compelling stories around the importance of
adults and the elderly. Beyond needing a motivation vaccination. We need to be able to use more diverse
to seek vaccination that is not government mandated, platforms and compelling messages instead of just
understanding what the vaccine is for, and how the science, data, charts and graphs!
vaccination works is crucial in increasing vaccine
confidence, and subsequently uptake among the adult The majority of the public are undecided and on
population. the fence when it comes to getting vaccinated – so
this is the most important group that we need to
Multi-sectorial responsibility reach out to. To increase vaccine confidence, first,
there is a need to win the hearts and minds of the
Tackling vaccine confidence is not the job of one people, which will then help overcome confusion and
person or one sector. It is about collaboration distrust.
between all the key stakeholders – it requires a multi-
sectorial approach between government, professional At the end of the day, focusing on primary care
societies, media, the private sector, civil society as and prevention is the key to ensuring a robust,
well as communities and faith-based organisations. resilient and sustainable healthcare system.
That said, in my opinion, these are the key players in
this multi-sectorial partnership:

1. Social media companies – with such a
huge number of subscribers on these platforms,
social media companies have a crucial role to play in
directing people who are searching for information
on vaccination to reliable and credible sources such
as the WHO. This can help mitigate the spread of
misinformation. Social media companies can work
together with third-party organizations to ensure
that their content is easily accessible and searchable
through their social media platforms.

2. Mainstream media – Media outlets have
a social responsibility within the communities they
report in and need to work hand-in-hand with local
authorities and public health organisations to ensure
accurate and factual reporting on vaccine efficacy

30 STRATEGY

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Japan creates new

roadmap for growth

What particularly stands out for the Japanese pharmaceutical market is that it is highly
competitive and consists of several major players on a journey of proprietary drug discovery. But
as the industry is witnessing a major turning point and management strategies are being utilized
to constructively steer the business environment, Japanese firms are forging alliances to create a
new roadmap.

Japan’s pharmaceutical market has a strategic separate drug development partnerships in the US,
edge in its ability to make strong-quality with Arrowhead Pharmaceuticals, Charles River,
pharmaceutical drugs and high-quality Prothera Biosciences, Neurocrine Biologics and with
packaging technology. Japan also has the greatest Singapore based Carmine Therapeutics. Takeda
standard of quality assurance and control, as the also acquired US based PvP Biologics. All these
Japanese pharmaceutical market aims to enhance collaborations are directed to specialize in drug
the quality of pharmaceutical products across the discovery platforms and gene therapies for building
globe. According to IQVIA survey in 2018, Japan is an industry leading commercial expertize of novel
the third-largest single-country by GDP in the world drugs in focused therapies for the company.
and its pharmaceutical drug market accounts for 7.2
per cent of the world’s $1.2 trillion market. Similarly, Otsuka Pharmaceutical has entered
into a multi-project collaboration with UK based
What particularly stands out for the Japanese PhoreMost to explore the potential of phenotypic
pharmaceutical market is that it is highly screening through its SITESEEKER platform. The
competitive and consists of several major players platform potentially screens the entire proteome
working continuously on a journey of proprietary in a living cell to detect novel targets for a chosen
drug discovery. Of lately, Japanese firms are scouting disease.
for emerging science and unique combinations of
biology with modality or technology that can replace “On the opportunity side, we are working on the
conventional therapy or add new value. evolution of product development and technologies,
expansion of our presence in new regions, and
Antibody drug conjugates (ADCs), genome the forging of new research and commercial
editing, gene therapy technologies, nucleic acid collaborations” elaborates Tatsuo Higuchi, President
drugs, regenerative therapeutics, cell therapy are & Chief Executive Officer, Otsuka Pharmaceutical.
few of the novel approaches, which companies
are betting upon. Further, co-development of Ono Pharmaceuticals concluded separate
companion diagnostics, programmes to improve agreements with Swiss firm Numab Therapeutics
screening procedure standards and screening rates, to leverage Numab’s platform technology for
investments in drug discovery startups in seed stage development of an immuno-oncology drug candidate
are being considered. and with South Korean firm SK Biopharmaceuticals
for the development and commercialization of
To translate science into medicine, Japanese cenobamate, used for the treatment of partial-onset
firms, with deep knowledge of the medical needs and seizures in adults, in Japan.
long term commercial or regulatory experience, are
broadly categorizing growth investments to create Kyowa Kirin too, with the aim of expanding its
value over medium to long-term, which includes R&D pipeline, has collaborated with Axcelead Drug
R&D investments and to strengthen global networks Discovery Partners in Japan for integration of drug
among other factors. discovery technologies to uncover innovative drug
candidates. To enhance its global oncology pipeline,
R&D partnerships Kyowa has further entered into an agreement
with the US based MEI Pharma for investigational
In CY2020, Takeda Pharmaceutical inked multiple oncology drug-candidate ME-401.

S T R AT E G Y 31

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

“We still need to strengthen our pipeline for “On the opportunity side, we
the next decade and further into the future. We are are working on the evolution
also looking at acquiring development compounds of product development and
that have potential sales synergies with our global
strategic products”, mentions Masashi Miyamoto, technologies, expansion of
President and Chief Executive Officer, Kyowa Kirin. our presence in new regions,

Eisai has collaborated with the US based Personal and the forging of new
Genome Diagnostics Inc for development of cancer research and commercial
gene panel test to investigate cancer evolution and
acquired drug resistance via circulating tumor DNA collaborations.”
(ctDNA) in blood. Such genetic abnormalities of - Tatsuo Higuchi,
drug resistance could be the targets for new drug
discoveries. “We believe that partnerships with President & Chief Executive Officer,
companies and research institutes, who share Otsuka Pharmaceutical
strengths in the areas or fields we focus on can
potentially help us achieve goals that we would not “We still need to strengthen our
be able to achieve on our own,” points out Kazumasa pipeline for the next decade
Nagayama, Corporate Officer, Chief Strategy Officer,
Eisai. and further into the future. We
are also looking at acquiring
Strengthening global networks
development compounds that
To accelerate global network and connect value have potential sales synergies
creation to patients, Japanese firms are also
organizing operations across the globe to achieve with our global strategic
a local- centricity. This is aimed to enable patient products.”
access to drugs, ensuring stable supplies, early - Masashi Miyamoto,
approvals and maximizing value from strategic
products via overseas revenues. President and Chief Executive Officer, Kyowa Kirin

As comprehensive drug development “By moving 80 per cent of
programmes are planned globally, partnerships applications to the cloud,
usually include a clause of co-commercialization. For
instance, Daiichi Sankyo’s recent partnership with we will remove non-
AstraZeneca on oncology drug candidate DS-1062 differentiating technology,
benefits not only from AstraZeneca’s experience in
the worldwide oncology business but also gives a reduce our internal data
wider reach. center footprint, and decrease

“DS-1062 is one of our lead DXd ADCs that will capital expenditures.”
form a pillar of our next mid-term business plan.
This new strategic collaboration with AstraZeneca, a - Christophe Weber,
company with extensive experience and significant President & Chief Executive Officer,
expertise in the global oncology business, will enable
us to deliver DS-1062 to more patients around the Takeda Pharmaceutical
world as quickly as possible”, says Sunao Manabe,
Representative Director, President and Chief “DS-1062 is one of our lead DXd
Executive Officer, Daiichi Sankyo. ADCs that will form a pillar of
our next mid-term business
Japanese firms are also designing and plan. This new strategic
implementing their strategy by opening subsidiaries
to oversee business with distributors, engage in collaboration with AstraZeneca
direct sales and co-promotional activities. Local will enable us to deliver
centers for clinical developments also enable
companies to apply approvals thereby speeding DS-1062 to more patients
regulatory processes. Fast growing Asian markets around the world as quickly as
are geographies of interest and creation of a base for
autonomous operations is the plan of action for early possible.”
- Sunao Manabe,

Representative Director, President and
Chief Executive Officer, Daiichi Sankyo

32 STRATEGY

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Partnerships by Top 10 Japanese companies in CY20

Japanese Partner Name Area of Partnership
Player
RNAi therapy for alpha-1 antitrypsin-associated liver disease (AATLD)- Rare Genetic Disorder
Arrowhead Pharmaceuticals (US) Drug discovery platforms for Oncology, Gastroenterology, Neuroscience and Rare Disease
Drug development for psychiatry pipeline
Charles River (US) Plasma-derived Inter-alpha Inhibitor Proteins (IAIP) therapy for acute inflammatory
conditions
Neurocrine Biologics (US) Acquisition for drug development in celiac disease, an autoimmune disorder
Gene therapy for Rare Diseases
Prothera Biosciences (US)
CoVIg-19 Plasma Alliance for COVID-19
Takeda PvP Biologics (US)
Carmine Therapeutics (Singapore) Vaccine candidate for COVID-19
Otsuka CSL Behring, Biotest, Bio Products Laboratory, LFB,
Astellas Octapharma Divestment of OTC and non -core prescription assets
Daiichi Novavax (US)
Sankyo Acino, Orifarm Group, Celltrion, Cheplapharm, Corza Development/ commercialization of Bempedoic Acid and combination
Health, Hypera, Novartis and Ethicon Phenotypic screening platform to identify novel targets
Esperion (US) Stem-cell derived allogeneic T-cell therapies for cancer
PhoreMost Limited (UK) AAV-based genetic medicines
AdaptImmune Therapeutics (UK) T-cell engaging bispecific antibodies for cancer
Audentes Therapeutics (US) Acquisition for biosensing and treatment using wireless implantable medical devices
CytomX Therapeutics (US) Acquisition for Phenotype-based screening technology
Iota Biosciences (US) Antibody drug conjugates (ADCs) in Cancer
Nanna Therapeutics (UK) CRISPR/Cas9 genome editing technology
AstraZeneca (EU) Antibody drug conjugates (ADCs) in Cancer
ERS Genomics (EU) Clinical trial collaboration for Antibody drug conjugates (ADCs) in Cancer
Gustave Roussy (EU) Gene therapy technology
Merck & Co. (US) Termination of cooperative sales agreement for Influenza HA Vaccine post review of sales
Ultragenyx (US) strategy and discussions
Cancer genetics panel test
Kitasato Pharmaceutical Industry (Japan) Established JV firm- Jingyi Weixiang to provide online platform for elderly with dementia
Digital tool for self-assessment of cognitive function
Eisai Personal Genome Diagnostics (US) Outlicense antibody engineering technologies
Chugai JD Health (China) Outlicense antibody engineering technologies
Cogstate (Australia) Investigational anti-cancer agent
Argenex (EU) AI based iterature search system Amanogawa (trademark-pending), for drug discovery
Novo Nordisk (EU) process
Verastem Oncology (US) Digital solution for objective assessment of pain associated with endometriosis
Chugai’s antibody engineering technologies to develop COVID-19 treatment
Fronteo (Japan)
Business efficiency, increase in market presence
Sumitomo Biofourmis (US)
Dainippon Eli Lilly (US) Establish CDMO JV company-S-RACMO, for regenerative medicine and cell therapy
Shionogi US: Merger of subsidiaries Boston Biomedica & S. pneumoniae nasal vaccine candidate
Pharma Tolero Pharmaceuticals Acquisition for CDMO capabilities
Kyowa Sumitomo Chemical (Japan) Regeneration-inducing Medicine
Kirin HanaVax Inc (Japan) Acquisition for Brain disorder portfolio
Ono Nagase Medicals (Japan) Drug discovery technologies
StemRIM Inc (Japan) Investigational drug candidates for cancer
Tetra Therapeutics (US) Marketing collaboration agreement
Axcelead Drug Discovery Partners (Japan) Termination of Supply and Co-Promotion Agreement for Desmopressin
MEI Pharma (US) Termination of co-development/ co-marketing agreement with on ASACOL®
LEO Pharma (Denmark) Drug development and commercialization for Seizures
Ferring (Switzerland) Discovery/ Development for multi-specific cancer antibody drug candidate
Zeria Pharmaceutical (Japan) Formulation improvement and marketing
SK Biopharmaceuticals (Korea)
Numab Therapeutics AG (Switzerland)
Nichi-Iko Pharmaceutical (Japan)

S T R AT E G Y 33

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

“We aim to build up our “We believe that partnerships
business in China, which is with companies and
projected to see the strongest
growth in pharmaceutical research institutes who
demand over the next decade. share strengths in the areas
Tapping into China’s growth
will be crucial to expanding our or fields we focus on can
sales channels in other regions.” potentially help us achieve
goals that we would not be
- Isao Teshirogi, able to achieve on our own.”
President and Chief Executive Officer, Shionogi
- Kazumasa Nagayama,
Corporate Officer, Chief Strategy Officer, Eisai

market penetration. For example, Otsuka Pharma divestiture target and has announced 10 deals since
has recently established a subsidiary in Malaysia, January 2019 to date for a total aggregate value of
Sumitomo Dainippon Pharma in Taiwan while up to ~$11.3 billion. Restructuring sales strategies
Daiichi Sanko and Eisai in Vietnam. is also an approach with Daiichi Sankyo and Kyowa
Kirin that are terminating deals to realign focus.
Companies in Japan are also looking forward to
freeze opportunities in China, which is expected to Also, increasing complexity of target diseases,
be the fastest growing pharma market. Shionogi has decreased success rates of drug discovery, prolonged
signed an agreement with Ping An Insurance (Group) periods of research and rising costs of new drug
Company of China to launch a joint venture (JV) development require employment and upgradation
Ping An-Shionogi in Shanghai and Hong Kong. The of digital technologies including artificial
JV is expected to become a development center for intelligence (AI) for drug discovery, data analysis
innovative medicines under progress by Shionogi. and real-world data (RWD) based R&D. Areas as
oncology, neurology, regenerative medicines entail
“We aim to build up our business in China, high degrees of R&D uncertainties due to lack of
which is projected to see the strongest growth in biomarkers. Further, there is a limited number of
pharmaceutical demand over the next decade. eligible patients for precision medicine clinical trials.
Tapping into China’s growth will be crucial to Digital innovation improves operational efficiency,
expanding our sales channels in other regions”, raises development success rates and productivity.
say Isao Teshirogi, President and Chief Executive Hence, firms are adopting digitization for these skills
Officer, Shionogi. as well.

Adding to the list is Eisai that has entered into “We are investing in developing capabilities
separate collaboration agreements for Fuji Yakuhin’s and hiring new talent in emerging fields of data
hyperuricemia/gout treatment and Seikagaku and digital. We will also train employees in cloud,
Corporation’s osteoarthritis treatment in China. advanced analytics, robotic process automation
(RPA), agile and innovation sprint methodologies.
Other factors By moving 80 per cent of applications to the cloud,
we will remove non-differentiating technology,
Furthermore, ageing population puts financial reduce our internal data center footprint, and
challenges on the healthcare system and policies decrease capital expenditures”, says Christophe
are hence being designed to control healthcare Weber, President & Chief Executive Officer, Takeda
expenditure. Payers are becoming selective towards Pharmaceutical.
treatment reimbursement. Generics and biosimilar
drugs are being promoted to improve drug access The industry is witnessing a major turning point
increasing pressure to reduce drug prices. Amid and management strategies are thus being utilized
growing public controversies on rising health costs, to constructively steer the business environment,
pharmaceutical companies have also faced criticism responding to major trends, with initiatives, which
about high prices of some medicines. Firms thus have potential to affect the future of the company. It
perceiving decline in revenues and profits due to will be extremely difficult for any single company to
annual NHI price revisions and early penetration respond to the changes by itself and hence forging
of generics, are elevating competitiveness of their alliances with other pharmaceutical companies and
products. partners in other industries to aggregate strengths is
the new roadmap.
Certain players have opted for divesting their
non-core assets for cost-optimization. For instance, Swati Shrivastava
Takeda has exceeded its $10 billion non-core asset

34 COVID -19

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Neglecting AMR
could rack up staggering
‘Death Numbers’ by 2050

COVID-19 is not the only public health concern threatening the world. Antimicrobial resistance (AMR), a
designated slow pandemic, has the potential to kill 10 million people per annum by 2050. To overcome this,
the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has brought together
over 20 major pharma companies and public institutions to launch a $1 billion fund to support antibiotic
R&D. BioSpectrum analyses how the AMR action fund aims to solve this impending crisis and what we
could learn from the present global pandemic.

The current pandemic has put the spotlight on companies developing new antibiotics and today there
infectious diseases and the need to focus on are only a few. They include Merck, GlaxoSmithKline,
them. AMR is a looming global crisis that has Shionogi, and Roche – as well as Pfizer, which has
the potential to dwarf COVID-19 in terms of deaths acquired Arixa Pharmaceuticals, a California-based
and economic costs. While the death toll due to company involved in developing new antibiotics for
COVID-19 continues to rise, each year 700,000 people drug-resistant infections. Majority of the big pharma
die due to AMR. The World Health Organization firms like Novartis, Eli Lilly, Bristol-Myers Squibb,
(WHO) predicts that AMR could claim 10 million
lives per year by 2050 and cause a global economic
recession, similar to the 2008 financial crisis.

AMR is on the rise because microbes are getting
smarter and the drugs to treat them remain the same.
There hasn’t been much innovation in antimicrobials
in the recent years. This slowdown has coincided with
the widespread overuse of these medicines. Roughly
one-third of antibiotic prescriptions are unnecessary,
according to the Centers for Disease Control and
Prevention (CDC). This overuse has led to an explosion
of antibiotic-resistant bacteria. There aren’t many
incentives for pharma firms to invest billions of dollars
and years in a drug, which wouldn’t generate much
sales. Drugs for chronic disease such as diabetes
generate more revenue than the antimicrobials, and
that’s where much of the investment goes.

“The key issues around AMR (at least from an
innovation perspective) was lack of a pipeline of
new Antibacterial, extremely stringent regulatory
practices making it expensive and time-consuming to
get new products approved and a broken economics
model, as new Antibiotics will be used sparingly to
preserve them and use them only on the very ‘last
resort’ patients. Hence, they do not have volume,”
said Dr Anand Anandkumar, co-founder of Bugworks
Research, India.

In the 1980s, there were 18 major pharmaceutical

COVID-19 35

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

AstraZeneca, and Sanofi have abandoned their AMR ACTION FUND PLAN
antibiotics research division long ago.
With this investment from leading
It’s not like companies do not acknowledge the biopharmaceutical companies, the AMR Action Fund
threat of AMR, it has been a high priority for many will be the largest collective venture ever created to
organizations, but sadly nothing concrete has come address AMR. The Fund will:
out of it. ● Invest in smaller biotech companies focused on

“The fundamental business model for developing developing innovative antibacterial treatments that
new anti-infectives (antibiotics and antifungals) is address the highest priority public health needs,
broken. Because we want to use new anti-infectives make a significant difference in clinical practice,
sparingly to not drive resistance, revenues are low and save lives.
and companies are unable to be profitable. Big ● Provide technical support to portfolio companies,
pharma has largely abandoned the space and smaller giving them access to the deep expertise and
companies are struggling to raise money. We need resources of large biopharmaceutical companies,
to change the reimbursement of these drugs in such to strengthen antibiotic development, and support
a way that we pay for access not for volume of use, access and appropriate use of antibiotics.
in the same way that we pay for having a fire station ● Bring together a broad alliance of industry and non-
down the road not per fire extinguished”, said Aleks industry stakeholders, including philanthropies,
Engel, Partner, Novo Seeds and Director, REPAIR development banks, and multilateral organizations,
Impact Fund, Denmark. and help encourage governments to create market
conditions that enable sustainable investment in
In global health circles, it is becoming the antibiotic pipeline.
commonplace to refer to AMR as the slower-
moving pandemic in comparison to the fast-moving COUNTRIES TAKING
COVID-19 pandemic. We cannot deny that the STEPS AGAINST AMR
next pandemic could be caused by a drug-resistant
pathogen. While the need to invest in pandemic In January 2020, the Indian Ministry of Environment,
preparedness and antibacterial R&D is clear, the Forest and Climate Change (MoEF&CC) announced
stringent standards on concentrations of antibiotics
found in the waste discharged by pharmaceutical
factories into rivers and the surrounding environment.
By doing so it became the first state regulator
anywhere in the world to introduce such standards,
meant to reduce chances of creating drug-resistant
bacteria. Currently, there are no laws specifically aimed
at curtailing antibiotics in wastewater in order to limit
antibiotic resistance, even in Europe or the USA.

In June 2020, the UK launched its subscription
style payment model for antibiotics, with the first two
drugs to be selected and evaluated next year. The
scheme hopes to incentivise companies to invest in
researching and developing new antibiotics in the face of
growing antibiotic resistance. It will see pharmaceutical
companies paid upfront for their products, based on
the value it provides to the NHS rather than how much
is used. Similar to UK’s scheme, the US senate has
introduced a new bill known as PASTEUR Act which
would create a subscription payment model to jump-
start the development of urgently needed new antibiotics,
specifically those that can address unmet patient need.

36 COVID -19

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

“The fundamental business “The costs to develop
model for developing new and provide access to
anti-infectives (antibiotics antibacterial products
and antifungals) is broken. go beyond R&D and also
Because we want to use new include manufacturing,
anti-infectives sparingly to not supply chain activities,
drive resistance, revenues are commercialization and
low and companies are unable regulatory requirements.
to be profitable. Big pharma There is an urgent need
has largely abandoned the
space and smaller companies for secure funding,
are struggling to raise money. better incentives, more

We need to change the collaboration [public-
reimbursement of these drugs private] as well as policy and
regulatory reforms. Without
in such a way that we pay for viable and secure economics
access not for volume of use, in and reforms, the companies
that are responsible cannot
the same way that we pay for
having a fire station down the survive nor prosper”.
road not per fire extinguished”. - Fatema Rafiqi,

- Aleks Engel, Research Programme Manager for the
Partner, Novo Seeds and Director, AMR Benchmark, Access to Medicine
Foundation, the Netherlands
REPAIR Impact Fund, Denmark

economics of antibacterial needs fixing. have left this space. We see winds of change in
“The costs to develop and provide access to the offing, thanks to the global AMR Action Fund
announced in July 2020 to support post Phase 1
antibacterial products go beyond R&D and also assets (to take them to registration) and new acts
include manufacturing, supply chain activities, like PASTEUR, which are sitting for discussion in
commercialization and regulatory requirements. US Congress could make a big difference to the
There is an urgent need for secure funding, better economics of this space. Basically new mechanisms
incentives, more collaboration [public-private] as to pay for the ‘value of an antibiotic’ and not look at
well as policy and regulatory reforms. Without viable it as a ‘volume play’ are being envisaged by acts like
and secure economics and reforms, the companies PASTEUR. Hopefully AMR high burden countries
that are responsible cannot survive nor prosper”, said like India will also bring about some change to the
Fatema Rafiqi, Research Programme Manager for the market forces to make it viable for new antibiotics to
AMR Benchmark, Access to Medicine Foundation, be developed and sold in our market. Else, innovative
the Netherlands. products will have delayed entry into such markets”.

“Thanks to global efforts of agencies such as Combating AMR unitedly
the Department of Biotechnology-Biotechnology
Industry Research Assistance Council (DBT-BIRAC- A lack of funding for R&D of antibiotics, particularly,
India), Combating Antibiotic-Resistant Bacteria the later stages of clinical research, are creating a
Biopharmaceutical Accelerator (CARB-X), The Global ‘valley of death’ between discovery and patients. To
Antibiotic Research and Development Partnership bridge this gap, more than 20 leading pharmaceutical
(GARDP), etc, the pipeline is looking very exciting, companies have launched a collective AMR Action
and is totally dominated by SMEs from across the Fund $1 billion that aims to bring 2 to 4 new
world. In India, the two companies doing novel work antibiotics to patients by 2030. The concept of the
in new antibiotics include ‘Bugworks’ and ‘Gangagen’. AMR Action Fund was developed by the IFPMA and
Of course, larger players like Wockhardt and Cipla the Biopharmaceutical CEOs Roundtable (BCR), and
continue to be very much involved in this space”, said biopharmaceutical companies and foundation, in
Anandkumar. collaboration with the World Health Organisation
(WHO), the European Investment Bank (EIB), and
He added, “Regulatory mechanisms are also the Wellcome Trust. The Fund is supported by bio-
definitely improving, but the economics of it is still pharmaceutical companies and foundations such
a big issue. It’s because of a lack of clear return on
investment (ROI) that big pharma (most of them)

COVID-19 37

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

“The key issues around AMR
(at least from an innovation

perspective) was lack of a
pipeline of new Antibacterial,
extremely stringent regulatory
practices making it expensive
and time-consuming to get
new products approved and a
broken economics model, as
new Antibiotics will be used

sparingly to preserve them
and use them only on the very

‘last resort’ patients. Hence,
they do not have volume”
- Dr Anand Anandkumar,
Co-founder, Bugworks Research, India

as Almirall, Amgen, Bayer, Boehringer Ingelheim, terrible human suffering. Every crisis teaches us
Chugai, Daiichi-Sankyo, Eisai, Eli Lilly and Company, valuable lessons, and it’s clear that COVID-19 has
GlaxoSmithKline, Johnson & Johnson, LEO Pharma, yielded numerous lessons for the pharma industry.
Lundbeck, Menarini, Merck, MSD, Novartis, Novo
Nordisk, Novo Nordisk Foundation, Pfizer, Roche, It’s nearly impossible to gauge, which virus will
Shionogi, Takeda, Teva, and UCB pharma. strike next and be ready with a vaccine/drug. Drug
development is an expensive business; therefore,
While this is an important step, this alone won’t for a looming crisis like AMR, it would help to be
solve the looming crisis. There’s still much more to prepared beforehand.
be done, to halt the crisis before it begins. Changing
how novel antibiotics are reimbursed is the most “The value of being prepared is immense
important element of a solution addressing the (conversely, the cost of not being prepared is also
economic root cause of the AMR crisis. A core immense). It takes years to develop new therapies
element is to de-link payment from volume of use. and vaccines and as such we need to do that before
we need them. The WHO has already pointed out the
“An example solution is a subscription model bacterial pathogens that are likely to kill millions in
similar to Netflix in which subscribers (governments, the future because our existing antibiotics are losing
hospitals and doctors) pay a fixed fee to have their potency due to resistance. We know what the
unlimited access to new drugs. They may use only a problem is. We also know the solutions. As we get
small amount or they may binge during an epidemic. the present pandemic under control, we must apply
The developer of the drug benefits from having a the lessons learned to be better prepared for the next
predictable and sustainable revenue source and epidemic”, said Engel.
will allow investors to again be attracted to support
development of these life-saving drugs”, said Engel. The need to invest in R&D is clear as it is evident
from COVID-19, that it is too costly on all accounts to
“We need all hands on-deck. Pharmaceutical develop a cure on short notice. AMR is a health crisis
companies must engage and invest in R&D activities. that can be stopped if action is taken now.
Companies no longer active in R&D can re-engage
by sharing expertise and intellectual property to “We need to build on the current momentum
spur R&D, and by contributing manufacturing and invest in the necessary new tools, resources and
capacity, securing supply and addressing collaborations. We need to secure funding and push
affordability”, said Rafiqi. The commercial model for for robust pipelines, sustainable capacity and supply,
antibacterial needs to be reformed so that the costs and equitable access”, said Rafiqi. It is really sad to
in innovation, development and sustainable access see how unprepared we were for COVID-19 and how
are all accounted for. terribly we are dealing with AMR. The cost of being
prepared for a pandemic is one-hundredth or less,
Lessons from COVID-19 compared to ‘reacting’ to a pandemic. We need new
antibacterial and antiviral drugs to be ready for the
The pandemic has upended the world and created next one before it is too late.
enormous challenges to economies and has brought
Ayesha Siddiqui

38 Q&A

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

“We will see either SS 656 standard
endorsed by the ISO or used as the
basis to develop their own standard”

« Lihan, CEO and co-founder of Singaporean company
MiRXES, who was part of the working group
Dr Zhou Lihan, assembled for the development of SS 656 has more to
share with BioSpectrum Asia. Edited excerpts:
CEO and co-founder,
How significant is SS 656 evaluation and
MiRXES, Singapore how does it validate miRNA-based molecular
diagnostic assays?
On September 4, 2020, the Singapore
Standards Council, and Standards In the 20 years since the discovery of miRNA we have
Development Organisation, announced gained a pretty clear understanding of its biology and
the launch of a new industry standard, Singapore its potential for diagnostic assays. The challenges we
Standard 656 (SS 656) covering miRNA diagnostics. face in turning that potential into accurate, actionable
Singapore has become the first country in the world and affordable diagnostic tests are now mainly
to introduce a national standard to set out the key procedural; and that is where an industry standard
considerations for the design, development and can play a vital role.
performance evaluation of miRNA-based molecular
diagnostic assays. Despite the promise of miRNA-guided
diagnostics, several knowledge and practical issues
SS 656 also provides guidance for the have slowed the translation of the new science
development process and the design of the analytical into routine clinical practice, including: miRNA
and clinical performance evaluation studies of the sequence database errors, suboptimal RNA extraction
assay based on its defined intended purpose(s). This methods, detection assay variability, a vast array of
is applicable to all miRNA-based diagnostic assays online resources for bioinformatic analyses, and non-
including commercial in vitro diagnostic assays and standardised statistical analyses for miRNA clinical
also for assays developed and used within clinical testing.
laboratories for diagnostic purposes.
Having an industry standard like SS 656 has
The new SS 656 standard is the result of many potential advantages. It will provide a roadmap
collaboration between numerous stakeholders for all researchers and developers to follow that will
from organisations such as A*STAR (Agency for guide them through the entire process of developing a
Science, Technology and Research), Beth Israel miRNA in vitro diagnostic devices (IVD); the design,
Deaconess Medical Center, Health Sciences Authority development and performance evaluation of miRNA-
of Singapore (HSA), the Janssen Pharmaceutical based molecular diagnostic assays.
Companies of Johnson & Johnson, MiRXES Pte
Ltd, National Institute of Standards and Technology Adoption of the new standard SS 656 will ensure
(NIST), National University of Singapore, Singapore that researchers and developers, not just in Asia
Polytechnic and Tan Tock Seng Hospital in but around the world are all on the same page and
Singapore. using a unified approach. This will aid developers
by setting out standards for the early steps in the
The Singapore authorities are apparently in process such as discovery, ideation so that they
discussions with the United States Food & Drug know they have taken all the correct steps and
Administration (FDA) regarding their endorsement prepared all the necessary data by the time they
and adoption of the standard and ultimately aspire are ready for regulatory submission for evaluation
for SS656 to become an ISO standard. Dr Zhou and approval. An industry standard will also enable
greater collaboration in research. If we know we are
all using the same protocols for testing and analytical
validation it makes the sharing of data, samples
and other collaborations easier; even the evaluation

Q&A 39

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

of published research becomes easier if we are all What MiRXES advocates as a developer is a
adhering to the same standards and protocols. ‘miRNA-plus’ approach: rather than replacing
current standard tests, we want to add another layer
The standard describes key considerations for the of insight and information. In a clinical setting, if
design, development and performance evaluation of we can manage the workflow to provide the best
miRNA-based molecular diagnostic assays. It also information to the physician at an affordable price
provides guidance for the development process and then a multi-analytical approach is always worth
the design of the analytical and clinical performance exploring. I see miRNA and a multi-analyte approach
evaluation studies of the assay based on its defined having an important role to play as we move more
intended purpose(s). The considerations described towards precision medicine. Combining genome
in the standard are applicable to all miRNA-based sequencing with miRNA detection to determine,
diagnostic assays including commercial in vitro which patients will respond better to which drugs for
diagnostic assays and also for assays developed instance.
and used within clinical laboratories for diagnostic
purposes. Already miRNA medicine is moving beyond
biomarkers for diagnostics. One of the more
What will be the driving factor for developers promising arms of RNA medicine is looking at
and manufacturers to adopt SS 656 Standard ways to use RNA to deliver drugs or to target
in the existence of ISO accreditation? RNA. We already have sRNA drugs that can target
messenger-RNA as a therapeutic option for some
The growing industry around miRNA research diseases. We also have examples of delivering
and development is well aware of the advantages miRNA therapeutically, and there is currently a lot of
of having a well thought out and widely applicable research looking at developing an RNA-based vaccine
industry standard and I hope that will encourage for COVID-19.
their adoption well beyond Singapore and even Asia.
Ideally, we will see either this standard endorsed by Another promising area of research is antibiotics.
the International Organization for Standardization Preclinical studies on bacterial-type strains suggest
(ISO) or used as the basis for them to develop their that modulation of sRNAs could enhance bacterial
own standard. That would certainly facilitate the susceptibility to antibiotics. Further studies are
wider and faster adoption of miRNA technologies definitely warranted to see if there is any therapeutic
in medicine. There are many organisations involved value of sRNA modulation for the treatment of
in the development of SS 656, government bodies, multidrug-resistant bacterial infection. If we can
hospitals, research and academic institutions. break down resistance or prevent it from developing
during treatment, we could extend the usefulness of
Could the widespread adoption of SS 656 our currently dwindling armory of antibiotics.
speed up the process of bringing more
miRNA research projects from bench to Hithaishi C Bhaskar
bedside? [email protected]

Yes, in several ways. SS 656 provides a roadmap
that not only guides researchers through the process
of identifying and developing a viable marker but
also helps them to prepare for the complex and
demanding process of seeking regulatory approval for
their finished assay product; something which many
researchers may not have much experience of.

miRNA biomarkers offer more potential for
developing specific tests, tests for specific target
populations and for specific indications for use, than
the current generation of simple protein biomarkers.
The future of medicine will be multi-analyte tests.
Physicians will look at a combined report that will
include the results from protein, DNA, messenger
RNA, and miRNA tests for a comprehensive
understanding of the disease and the patient. And
depending on the disease application, maybe one of
the test classes will outweigh the others.

40 Q&A

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

“With multi-cluster and shared data
architecture, businesses can scale
without downtime or disruption”

« In recent days’ data analytics are playing

Geoff Soon, a crucial role in healthcare outcomes by

Managing Director, reducing administrative burdens, and by

South Asia, improving interoperability of patient data

Snowflake, Singapore access. Can you share more insight?

In December 2020, World Health Organistion Today’s healthcare providers such as
(WHO) announced ‘Digital Health biopharmaceutical companies and medical
Implementation Approach to Pandemic technology businesses need technology
Management’ at the G20 Summit, outlining platforms and tools to collect, store, analyse,
digital health emergency response landscape and share information. This information
and proposed actions and implementation includes data from electronic health records,
recommendations. With the growing demand for administrative and claims, patient registries,
healthcare analytics and the potential, it has to and clinical trial statistics. While this explosion
solve current healthcare challenges, it is essential of information is prompting a new era in
to empower and nurture analytics innovation in healthcare, transforming clinical diagnostics and
healthcare by enhancing data literacy capabilities. the delivery of patient care, many healthcare
organisations experience challenges with
Advanced analytics and AI enhance speed and safeguarding and protecting patient information,
accuracy of diagnosis, control costs and improve as well as interoperability in the exchange of
the operational performance of hospitals through information from multiple sources.
optimisation of resources. A recent forecast predicted
a global healthcare analytics market growth of At the same time, organisations are changing
16.3 per cent CAGR over the period of 2019- their value frameworks to focus on clinical
2027, with Asia-Pacific being the fastest-growing outcomes and treatment efficiency.
market globally. Factors like, rise in demand for
population health analytics, rapidly evolving big data Data analytics could improve health
technologies, cloud-based analytics solutions are outcomes for hospitals and patients in the
driving the market. As prediction and prevention go following ways through data interoperability and
hand-in-hand, predictive analytics allows clinicians, unites all consumer data from different sources
financial experts, policy makers and administrative and systems virtually.
staff to estimate and address the real-world
healthcare management challenges. In this regard, Increased care coordination – Data
BioSpectrum Asia spoke to Singapore-based Geoff silos caused by information scattered across
Soon, Managing Director at leading cloud data different clinic departments, IT infrastructure,
platform, Snowflake, understand the regulatory and systems can cause serious delays, mistakes,
guidelines to be adopted by healthcare organisations or other problems that can potentially be
to protect integrity of patient data and other issues. troublesome for patients. With proper
Edited excerpts; digitisation, hospitals can connect all data
collections and master every data element
in one place. The next step is to facilitate
communication and ensure easy information
flow within the healthcare organisation.

Enhanced customer satisfaction –
Analysis of patient feedback, onsite and in-app
behavioural data allows hospitals and clinics
to optimise their services. Then, by supplying
the information individuals look for, patient
satisfaction can be enhanced by enabling them

Q&A 41

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

to track and monitor their own health without researching vaccines, the WHO is seeking $31
unnecessary trips to healthcare facilities. billion to combat COVID-19.

Consistent care delivery – Hospitals Analytics through the Data Cloud could
and clinics gain a full overview of the patient’s surface trends and actionable insights across
interactions with their services, offers and a wide range of data sets to alleviate the cost
products by integrating online and offline data. burden researchers and analysts face as they
Then, they can apply this information to deliver look for clues that will accelerate vaccine
a smooth experience to their customers. development and identify effective treatments.
By using a secure platform, data scientists could
Through technologies such as the Data benefit from automated and self-service services,
Cloud, medical practitioners, healthcare team enabling life science companies to focus on their
and researchers can access diverse sets of data core business instead of IT management. With
on the same platform. With secure, seamless, near-zero maintenance, such platforms provide
and governed exchange of sensitive data at a simple-to-use and cost-efficient solution to
scale, organisations can easily share data and increase productivity. With multi-cluster and
collaborate with others. Data sharing capabilities shared data architecture, businesses can scale
of cloud platforms are built on top of secure data without downtime or disruption.
sharing technology which allows organisations
to give internal and external users access to What are the essential data science
live, ready-to-query data sets without having to
move, copy, or transfer data. Companies can also regulatory guidelines to be adopted
combine public data sets with their own data to
gain the diversity that enables deeper insights by healthcare organisations to protect
and better data-driven decisions.
integrity of patient data by remaining
How significant is centralised repository
amidst the pandemic impact in gathering complaint with regional laws?
data from various IoMT devices and
clinical applications? In the life sciences industry, companies must
comply with stringent regulations and quality
COVID-19 has presented healthcare guidelines that regulate practices in various
organisations with the challenge of managing settings to ensure medical products are safe
and analysing extremely large data sets. The for consumers. Organisations need to use
Data Cloud can integrate structured and semi- technology and platforms, which adhere to these
structured data from a variety of sources, guidelines to help them validate their workloads
including online transaction processing (OLTP) and meet the industry’s standards and best
databases, clinical applications, and internet of practices.
medical things (IoMT) devices, into a centralised
repository. From there, data scientists can use This includes protecting, exchanging
automated organisation tools to analyse the governed and sensitive data with internal and
data more quickly and efficiently. With data external data consumers with the help of built-in
integration, healthcare organisations could security that supports regulations such as Health
make data more accessible and valuable for Insurance Portability and Accountability Act
collaboration and reduction of errors. (HIPAA), Service Organisation Control 1 (SOC 1)
and (SOC 2), and Payment Card Industry Data
How can data analytics accelerate Security Standard (PCI DSS) requirements.
innovation at vaccine production?
Using a secure platform provides an
As the COVID-19 pandemic progresses, a deluge extensive portfolio of security certifications
of data is being generated every day and it is and granular controls that enable secure and
impossible for researchers to keep up. Vaccine governed access to all data. Healthcare providers
research takes time and resources and is a and payers can ensure governance by building a
risky enterprise which requires large data sets. single source of truth to power visual analytics
Globally, billions of dollars have been invested across their organisations. By securely storing,
for the purpose of research and the development sharing, and integrating data with multiple
of vaccines. As one of the organisations sources, providers and payers can democratise
that is supporting the funding of companies data and drive decision-making across their
organisations with meaningful insights to cope
with the rapidly changing healthcare sector.

Hithaishi C Bhaskar
[email protected]

42 Q&A

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

“IoMT adoption can bring
quality results for patients and
saves cost in manufacturing”

« costs for medical manufacturers. Cloud-based
solutions also spur collaboration and aid the
Syed Suroor Anwar, exchange of ideas and information across the
Vice President, Asia manufacturing chain.
Pacific, Strategy,
Product, Supplier, Big Data is another popular tech trend in
Pricing & Inventory the medical manufacturing industry. With the
Management, immense sets of data collected from healthcare
RS Components, devices, Big Data helps industry professionals
Hong Kong pinpoint insights for future innovations. Big
Data assists medical manufacturers in improving
The pandemic has changed the way the quality of medical devices, all at reduced
healthcare, pharma and clinical industry costs.
operate and has propelled the pace of
digitization exponentially. The unprecedented IoMT adoption in Asia can enable
time has a relatively positive impact on the manufacturers to produce individualized
healthcare and information and communications products that bring quality results for patients
technology (ICT) industry. The global health and saves cost in manufacturing. If more in
crisis has accelerated tech trends with a sharp Asia transition to adopt IoMT, we can expect
spike in tech reliance. During this time Internet the catalysation of innovation in the region, and
of Medical Things (IoMT) played a pivotal role industry standards to rise. To do so, companies
in improving and deploying a diverse range can tap Artificial Intelligence (AI) and Machine
of novel medical and healthcare applications. Learning (usually part of the IoMT ecosystem)
Big Data, digitalization of healthcare services, to understand the market trends. Deploying
and advanced IoMT applications are boosting these advanced technologies can further reduce
healthcare to be a competent segment. production waste and costs.
BioSpectrum Asia spoke to Syed Suroor Anwar,
Vice President, Asia Pacific, Strategy, Product, When it comes to managing the supply
Supplier, Pricing & Inventory Management, RS chain, AI can help manufacturers speed up and
Components, Hong Kong on the impact of IoMT improve processes. Machines can efficiently line
in Asia’s medical industry and more. Edited up parts needed for production and can also
excerpts; track the whereabouts of products - be it in the
factory or to a consumers’ delivery address.
How do you visualize the impact of IoMT
in Asia’s medical manufacturing industry? How do you foresee APAC IoMT market

One trend would be cloud-based solutions, which growth dynamics and will these influence
have emerged as a helpful way to reduce costs
in medical manufacturing, all while maintaining investments in the APAC medtech
the quality and standards of products. Aside
from being fast and easy to deploy in factories industry in the post-COVID world?
and back offices, cloud-based solutions have
been popular as they lower maintenance It’s projected that the global IoMT market will
rise to an estimated $135 billion by 2025. In
an annual report by the Asia Pacific Medical
Technology Association, it was found that APAC
will contribute to over 35 per cent of the sector’s
global growth between 2018 and 2023. This
makes it the second-largest regional market for
medtech in the world.

Many countries within the Asia Pacific

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com Q&A 43

region continue to have under-served markets, technologies needed for their modernisation
which provide healthcare vendors numerous plans, giving them added flexibility and agility
opportunities to offer innovative products and in their operations. Having access to leading
services targeting existing needs. Addressing technologies and procurement solutions help
these needs however will require medical device improve productivity, and enable faster go-to-
manufacturers, pharmaceutical companies and market for medical products. Additionally, speed
digital health providers to be able to successfully is also an important factor for manufacturers,
pre-empt market trends, navigate regulatory be it prototyping processing or components
environments and better understand diverse procurement, working with agile experts can
demographics unique to each market. keep production lines run smoothly.

With more realising the benefits of IoMT, Over the past few decades, medical
it’s likely that we’ll see more investments in the device safety regulations have remained
space post-pandemic. While adopting IoMT may relatively unchanged. Can you elaborate
come with an initial investment, studies show on your thoughts on legislative
that IoMT will save the healthcare industry on protocols to aid better management and
costs. Goldman Sachs has estimated savings implementation in the medtech industry?
of up to $300 billion in the US. Adopting
IoMT can also bring some savings in the long Asia is a diverse region, one with different
run. IoMT devices could also be monitored cultures, healthcare systems and coverage,
efficiently so hospitals can quickly repair and and legislative protocols for medtech. Policies
manage device maintenance and inventory that put innovation and technology adoption
well. It also improves the interaction of patients at the forefront, upskill people, and strengthen
and healthcare providers so staff can look the supply chain boost productivity in the
after patients while handling other tasks. With overall manufacturing industry and strengthen
the benefits of IoMT, coupled with foreseen the quality and delivery of products. By
investments post-pandemic, we can expect understanding the benefits of leveraging
greater innovation in the region in the months technology, the industry can benefit immensely.
to come. We believe that future innovations can For one, the right technologies can help
bring even higher value to patients and reduce businesses enhance monitoring through the
costs in the long term. product development process - from creating
products all the way to post-market. It can
How do you visualize adoption of best greatly improve the quality of products and can
practice and sustainable business boost innovation. It can also help them automate
models to transform medtech sector and supply chains to meet demands in unforeseen
to evolve amidst the present crisis? instances such as the pandemic.

During the pandemic, businesses learned the Currently, what are the challenges and
value of having digital capabilities and using opportunities the medical industry is
these to amplify business, people, and customer experiencing and how RS Components is
strategies. Digitalisation has been a key business coordinating in this arena?
evolution amidst the present crisis - the medical
manufacturing industry included. With mobility Through our eSolutions and eProcurement
restrictions and distancing measures in place, offerings, we are addressing healthcare and
manufacturers have seen the value of investing medical industry requirements. Pandemic
in the right technology to continue operations. essentials like ventilators requirement are
Many have been partnering with experts to monitored through setting up a dedicated
effectively adopt the right technologies and to section for our ventilator solutions. Additionally,
ensure that processes meet market regulations. through our online eProcurement platform,
These experts know the field and can suggest we make the procurement process quicker and
the best ways for manufacturers to move easier for manufacturers, especially those with
forward, and what technologies they should be complex industrial requirements. It saves them
prioritizing investing in. As an industrial and time searching for specific parts and products
electronic products omnichannel distributor and negotiating with third-party suppliers.
we supported medtech industry by leveraging
our platform to conveniently procure parts and Hithaishi C Bhaskar
[email protected]

44 PEOPLE NEWS

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Atsushi Sugita Dr Zidong Zhang
steps in as President
& CEO at Maruho joins Novotech Health

Japanese firm Maruho, working in research and Holdings as CFO
development, manufacturing and commercialization
of dermatological products, has announced that Novotech Health Holdings, a biotech specialist
its Board of Directors has named Atsushi Sugita as contract research organization (CRO) in Asia,
Representative Director, President & Chief Executive has announced the appointment of Dr Zidong
Officer (CEO). Koichi Takagi has served as President Zhang as Chief Financial Officer (CFO). Dr
Zhang will be responsible for all aspects of
& CEO since 1999 and financial management and work closely with
remains as Chairman Novotech Holdings’
of the Board. After executive team to
working at Johnson support the growth of
& Johnson’s US the business across
headquarters and Asia. Dr Zhang was
Janssen Japan, most recently CFO
Sugita joined Maruho at Henlius Biotech, a
in 2012. After holding Hong Kong-listed global
various positions biopharmaceutical
at Maruho’s R&D company based in
Labs, head office, and Shanghai, where he
global subsidiaries, built and managed the finance team and played
Sugita was elected an integral role in the company’s initial public
to the Maruho Board in 2016, becoming Senior offering in 2019. Prior to that, he was an equity
Corporate Officer in charge of Global Strategy and research analyst at UBS in New York, where he
Business Development, Finance and Accounting, and covered the Major and Specialty Pharmaceutical
Human Resources. Thereafter, Sugita was appointed Sector. He also previously served as Senior
Executive Corporate Officer of Business Operations Consultant for Bayer A.G. in its healthcare
& Administration in 2018, and then Executive Vice practice and conducted postdoctoral research
President in January 2020. in diabetes-related drug development at Boston
University’s School of Medicine.

Alterity Therapeutics appoints Dr David Stamler as CEO

The Board of Alterity in addition to his Non-
Therapeutics, in Australia, has Executive Chairman role.
announced the appointment Dr Stamler has significant
of Dr David Stamler to the pharmaceutical development
role of Chief Executive Office and commercialisation
(CEO). Dr Stamler joined experience including three
the company in June 2017 New Drug Application
as Chief Medical Officer and approvals with the USFDA
Senior Vice President Clinical for drugs in the neurological
Development. Geoffrey space. His succession aligns
Kempler, who founded the with the next phase of
company in November 1997, Alterity’s commercial strategy
will step down from the and comes at a time when
role of CEO and continue as the company is preparing to
Non-Executive Chairman. advance its lead compound
Kempler will be engaged ATH434 to Phase II clinical
in a consulting capacity trials.

PEOPLE NEWS 45

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Bioforum hires Otto Damsma Boehringer
as VP of APAC operations
Ingelheim
Bioforum, a global data focused contract research organization (CRO)
based in Australia and Israel, has announced the appointment of Otto India ropes
Damsma as Vice President (VP) of Operations for Asia Pacific (APAC),
where he will lead Bioforum’s continued regional growth and expansion. in Vani Manja
Damsma has more than 30 years of experience in
establishing and supervising biometrics and IT as MD
departments within pharmaceutical companies,
contract research organizations and academic Boehringer Ingelheim
settings. Damsma joins Bioforum from has announced that Vani
Australian specialist CRO Clinical Network Manja is appointed Country
Services (CNS), part of Novotech, the largest Managing Director for
Asia-Pacific-based CRO, where he was Director India, effective January 1,
of Clinical Programming and previously Director 2021. In this role, she will
of Biometrics & IT from 2013-2019. Prior to CNS, assume responsibility for
Damsma was the Business Manager at the company’s businesses
The Centre for Integrated Preclinical in India, Bangladesh,
Drug Development at the University Nepal and Sri Lanka. Vani
of Queensland and a Business will also join the Board of
Development Officer, Queensland the Company. Vani was
Clinical Trials Network (now Life formerly the Global Head
Sciences Queensland). of Boehringer Ingelheim’s
Go-To-Market and Business
Tessa Therapeutics names Steering organisation,
David McIntyre as CFO based in the Company’s
headquarters in Germany.
Singapore headquartered Tessa appointment of David McIntyre She joined Boehringer
Therapeutics, a clinical-stage as its Chief Financial Officer Ingelheim in the US in 2011,
cell therapy company developing (CFO). McIntyre brings over working across Strategy &
next-generation cancer 25 years of global financial, Operations, Marketing and
treatments, has announced the operational and legal experience, Sales leadership roles before
including over 10 years as Chief moving to Ingelheim in
Financial Officer of various 2016 as Regional Business
publicly listed and privately held Manager for Japan. Her
entities. He joins Tessa from global experience in
AVITA Medical, Inc., where he healthcare spans nearly two
served as the CFO. Before joining decades across McKinsey &
AVITA Medical, McIntyre served Company, Becton Dickinson
as a Partner with Apple Tree and Boehringer Ingelheim,
Partners (ATP), a multibillion- and is characterised by
dollar life science venture capital strong global mobility and
and growth equity fund. At cross-functional leadership
ATP, McIntyre was responsible assignments across
for ATP’s medical device healthcare and management
portfolio, together with various consulting.
operating and Board functions,
including acting as CFO and
Head of Technical Operations at
Braeburn, Inc.

46 R&D NEWS

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Japan discovers combined drug therapy for lung cancer

Researchers at Kanazawa drug commonly used for treating It has been unclear, however,
University in Japan have reported patients with NSCLC. It addresses whether there is a correlation
that in the most common type of a gene rearrangement known between the use of alectinib
lung cancer, certain secondary as ALK that occurs in 3 to 5 per and the poorer prognosis in
mutations occurring with another cent of NSCLC patients. Alectinib ALK-NSCLC patients in which
gene alteration known as ALK belongs to a class of drugs called secondary cancer mutations are
make the efficacy of alectinib, an ALK tyrosine kinase inhibitors. observed, the latter are known to
otherwise commonly used drug occur with a frequency of about
for treating lung cancer, become 25 per cent. Now, researchers
unfavorable. Combining alectinib have investigated this correlation.
with another kind of drug can They not only found that such
however overcome this adverse secondary mutations reduce the
effect. Most lung cancers are of efficacy of alectinib, but they also
a type called non-small-cell lung suggest how to overcome this
carcinoma (NSCLC). This type issue. The findings show that the
of cancer is relatively insensitive combined use of a proteasome
to chemotherapy, so NSCLC inhibitor and alectinib restores
therapies are usually based on the latter’s unfavourable efficacy
drug treatment. Alectinib is a in ALK-rearranged NSCLC.

Australia develops Hong Kong designs
novel tool to study
test to predict cellular biology

mood disorders Scientists at City University of Hong Kong (CityU) have
developed a novel computer tool to extract, track and visualize
Scientists at the University of South cells, and analyze the formation, structure and functions of
Australia (UniSA) have developed the Caenorhabditis elegans (a type of worm) during cell division.
world’s first test to accurately predict The research can help scientists understand cancer and find a
mood disorders in people, based on possible cure by enabling them to learn how an animal’s body
the levels of a specific protein found and organs are formed through cell division. The computational
in the brain. Links between low levels framework is called CShaper. CShaper revolutionizes the
of mature brain-derived neurotrophic way biologists inspect experiment data. It cuts down the time
factor (mBDNF) and depression are required to annotate the images of an embryo from hundreds to
well known but, until now, it hasn’t just a few hours and enables biologists to implement quantitative
been possible to distinguish between and statistical analyses on cell morphological features on a large
the three forms of the BDNF protein scale. In addition, the researchers developed a deep-learning
in blood samples. The mature form method, called DMapNet, to segment embryo membranes. The
promotes the growth of neurons and team generated a time-lapse 3D atlas of cell morphology for the
protects the brain, but the other two Caenorhabditis elegans embryo from the 4- to 350-cell stages,
BDNF forms, its precursor and the including cell shape, volume, surface area, migration, nucleus
prodomain of BDNF, bind to different position and cell-cell contact with resolved cell identities.
receptors, causing nerve degeneration
and inflammation. An assay kit
developed by researchers from UniSA
can now precisely distinguish between
these proteins, unlike other commercial
kits in the market. The next step is to
examine whether imbalances between
proBDNF and mature BDNF can be
restored in electric convulsion therapy.

R&D NEWS 47

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Indian study Korea invents low cost
negative pressure room
focuses on rapid for COVID-19 patients

hepatitis diagnosis Researchers at Korea Advanced Institute of Science
and Technology (KAIST) have developed a low-cost
A team of researchers from the Department of and ready-for-rapid-production negative pressure
Biotechnology-Translational Health Science and room called a Mobile Clinic Module (MCM). The
Technology Institute (DBT-THSTI), International MCM expects to quickly meet the high demand for
Centre for Genetic Engineering And Biotechnology negative pressure beds in the nation and eventually
(DBT-ICGEB), in India and University of Turku, many other countries where the third wave of
Finland, have come together to develop an COVID-19 is raging. The module is now ready to
ultra-sensitive rapid test for detecting hepatitis. be rolled out after a three-week test at the Korea
Experiments by the researchers have shown that Cancer Center Hospital. Professor Tek-Jin Nam, who
the new test had a very high sensitivity even while developed the MCM, cites expandability as its key
it was based on a simple assay procedure and did feature. Eventually, it will serve as both a triage unit
not require skilled personnel to administer. A and bridge center in emergency medical situations.
comparison of assay performance among patients The research team specially designed the negative
positive and negative for hepatitis B Virus surface pressure frame to ensure safety level A, utilizing a
antigen (HBsAg) showed that the new test had multi-function panel wall roofed with an air tent. The
95.4 per cent sensitivity. In contrast, conventional multi-function panels can hold medical appliances
rapid tests have a sensitivity of 87.7 per cent. such as ventilators, oxygen and bio-signal monitors.
The scientists are now planning to get the assay Positive air pressure devices supply fresh air from
to the bedside in the form of a point-of-care kit outside the tent.
and evaluate the function of the assay in clinical
settings, with freshly drawn patient samples,
using a battery-operated reader device.

Singapore makes oral insulin
nanoparticles as alternative to injections

Scientists at Nanyang in their blood minutes later. overcome this challenge, the
Technological University, Delivering insulin orally would interdisciplinary team designed
Singapore (NTU-Singapore) be preferable over insulin a nanoparticle loaded with
have developed insulin jabs for patients because it insulin at the core, then coated
nanoparticles that may one day causes less pain than jabs, and with alternating layers of
become the basis for an oral could thus lead to improved insulin and chitosan, a natural
medicine, and an alternative to patient compliance. But oral sugar. Dosing is achieved by
insulin injections for diabetic dosage remains a challenge. controlling the number of
patients. In a pre-clinical As insulin is a protein, it layers in the nanoparticle.
study, the NTU Singapore gets broken down in the The NTU team is now in
team fed insulin-containing gastrointestinal tract before it talks with a pharmaceutical
nanoparticles to rats and can even reach the bloodstream company to further improve the
found that insulin increased to regulate blood glucose. To nanoparticles’ function.

48 ACADEMIC S NEWS BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

NTU Korea opens academic-
Singapore industry collaboration
launches new centre for medicine
strategic plan
South Korea’s Ajou University’s collaboration on related subjects.
Nanyang Technological The two new centers will involve
University, Singapore (NTU- LINC+ Project Group has 48 organizations and companies,
Singapore) has unveiled including the CBM Education
its NTU 2025 strategic opened the Chem-Bio Medicine Research Organization and the
plan, which details the Gyeonggi Biotechnology Center.
University’s education, (CBM) Industrial-Academic The participating organizations
research and innovation will work together to promote
ambitions and goals for the Collaboration Center and the local industries by facilitating and
next five years and offers a organizing original/intermediary
roadmap to achieve them. Industrial Cooperation Center research as well as marketization
At the top of its ambitious efforts. The CBM Industrial
agenda for NTU 2025, the (ICC). The CBM Education Collaboration Center was ranked
university will introduce new first among biotechnology,
paradigms that respond to Research Organization, leading health and innovative new drug
the changes brought about project groups in a four-stage
by the accelerating pace both centers, consists of BK21 evaluation.
of technology, and to the
challenges facing humanity in researchers drawn from the
the post-COVID world. The
NTU has identified six research departments of molecular science
clusters that are also aligned
with Singapore’s Research, and engineering, chemistry,
Innovation & Enterprise
2025 plan: health & society; biotechnology, and pharmacy at
brain & learning; culture,
organisations & society; the university’s graduate school.
artificial and augmented
intelligence; resilient By opening the two centers,
urbanisation & natural
ecosystems; and the future of the organization plans to lead
industry. NTU will develop
new academic and research industrial-academic research
entities and programmes
that build on its unique and India announces course in
globally-recognised strengths pharma sales & management
to support these six clusters.
To nurture entrepreneurs Apeejay Stya University (ASU) and National Skill Development
who drive innovation and Corporation (NSDC) in India have announced a certificate course
contribute to Singapore’s in Pharma Sales & Management. The course has been customised
future as a Smart Nation,
NTU will offer a new Second keeping in mind healthcare,
Major in Entrepreneurship. pharmaceutical, and fast-
The NTU will also introduce moving consumer goods (FMCG)
new pan-university advanced industry-specific dynamics. The
degree programmes in main objectives of the course
interdisciplinary areas, such as are to manage various activities,
neuroscience. including advertising, sales
promotion, marketing research,
physical distribution, pricing,
and product merchandising;
to develop skills required in
planning, direction, and control of
the personnel, selling activities of a
business unit, including recruiting,
selecting, training, assigning,
rating, supervising, paying, and motivating; and to develop skills
for a long-term relationship with the customer and skills to manage
their territories as if they were running their own business. Students
pursuing graduation in any discipline, preferably in life sciences / B
Pharm/ M Pharm/ MBA and D Pharm can apply. Working professionals
in the pharmaceutical, biotechnology and medical devices sector may
also pursue this course for further career progression.

SUPPLIER NEWS 49

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Jianshun Bio partners Avantor launches
with Etta Biotech for
cell culture supply Japanese

Jianshun Biosciences has announced its strategic e-commerce website
partnership with China based Etta Biotech to set up
a high titer transient protein expression platform Avantor, Inc., a leading global provider of mission-
for high quality protein production using Jianshun’s critical products and services to customers in the
transient transfection media. Jianshun becomes life sciences and advanced technologies & applied
the exclusive cell culture supplier for Etta Biotech’s materials industries, has launched its Japanese
transient transfection high titer protein expression e-commerce website, to better serve customers
platform. Etta Biotech is a leading cell electroporation locally with access to the company’s broad portfolio
technology and equipment supplier. Its proprietary of products and services, and related information.
large-capacity flow electroporator, X-Porator F1, The new e-commerce site enhances the shopping
is one of the only two products of its kind in the experience for Japanese customers. Customers
world, and leads the market with its outstanding now have easy access to Avantor’s scientific
performance and customer value. In accordance products and services, as well as detailed product
with the strategic agreement, Jianshun will provide information for each research field, including white
Etta Biotech with customised cell culture media papers and webinars on related topics.
for its transient protein expression platform. The
two parties also plan to join force further to build
a rapid protein production platform aiming at
producing gram-scale protein for R&D, e.g. molecular
assessment within two weeks after receiving
plasmids, to advance R&D process for antibody drug
development.

Cytiva delivers modular biologics factory to Lonza in China

Cytiva, formerly part of GE needs for biologics, including support its Good Manufacturing
Healthcare Life Sciences, monoclonal antibodies (mAbs) Practice (GMP) manufacturing
has successfully completed and other complex proteins, in integrated with its own platforms
another KUBio installation, and for China, and the rest of and expertise in development,
this time to global healthcare the world. This is Lonza’s first including cell line construction
solutions provider Lonza, in manufacturing site for biologics and process development. Scaling
Guangzhou Biopark, China. in China. Lonza will combine up production will be streamlined
The high throughput modular Cytiva’s KUBio modular facility when needed thanks to the
biomanufacturing facility will and single-use equipment to flexibility in the design.
offer process development and
manufacturing for Chinese
companies developing innovative
medicines,aswellasmultinationals
with manufacturing requirements
in China. The 17,000-square-
meter site includes 6,500 square
meters of lab space and one
KUBio modular facility, and will
enable quick ramp-up of antibody
development services and
manufacturing, which are urgently
needed to respond to market

50 SUPPLIER NEWS

BIOSPECTRUM | FEBRUARY 2021 | www.biospectrumasia.com

Jeol unveils Pelican BioThermal
advanced cold field
emission cryo EM partners with

Japanese firm Jeol has loading multiple samples, Asiana Airlines
announced the release of the CRYO ARM 300 has
a new cold field emission continued to achieve best- in South Korea
cryo-electron microscope in-class resolution for SPA.
(cryo-EM), the CRYO ARM However, the previous Pelican BioThermal, the global name in
300 II (JEM-3300). This workflow of SPA using cryo- temperature controlled packaging, has
new cryo-EM has been EM needs multiple electron announced its latest partnership with
developed based on the microscopes because the Asiana Airlines in South Korea, which
concept of quick and easy to workflows for sample will see an extensive expansion of the
operate and get high- company’s growing global network. In
contrast and screening and for the ongoing rapid response to support
high-resolution image data the global fight against COVID-19,
images. Recent acquisition are the new partnership provides Asiana
dramatic independent of Airlines access to Pelican BioThermal’s
improvement one another. Crēdo on demand rental programme
of resolution in This demands when shipping temperature-sensitive
single particle large operating pharmaceutical and pandemic payloads
analysis (SPA) costs for cryo- worldwide. The collaboration allows
using cryo-EM EM users. Pelican BioThermal to continue to grow
has led to SPA Since multiple its global network of key locations and
as an essential microscopes significant sector alliances to further meet
method for must be used, it the needs of its customers. It provides
structural is inconvenient Asiana Airlines customers with Pelican
analysis of to transfer BioThermal’s high-performing shipper
proteins. Jeol released the cryo-samples solutions, including the company’s
CRYO ARM 300 in 2017. recently expanded range of temperature
Equipped with a cold field between two cryo- controlled packaging to cover both deep
emission gun (Cold FEG) EMs. Hence there was a frozen and frozen applications, which
for enhanced resolution need for cryo-EM enabling include dry ice and phase change material
and a cryo-stage for the complete workflow from (PCM) coolants, covering parcel and bulk
sample screening to image sizes for single or multi use or reusable
data acquisition. including rental through the Crēdo on
demand programme.

Envirotainer invests in Taiwan for COVID-19 vaccines delivery

Envirotainer, the global market extremely cost efficient and high- Pacific (APAC) pharmaceutical
provider of secure cold chain performing solution compared market, especially in light of
solutions for air transport of to other active and passive the ongoing COVID-19 vaccine
pharmaceuticals, has announced alternatives, which provides distribution. Recognizing the
that they are expanding their a strong capacity increase to need for secure temperature-
network of RAP e2 stations by support the rapidly growing Asia- controlled air freight solutions,
adding Taipei (TPE)
to its growing list of Envirotainer has been
network stations. expanding its sales
Taipei (TPE) is the offering in APAC
42nd station in over the past years,
the Envirotainer investing in both
network to carry the service capabilities
flagship RAP e2, an and an agile network
model.