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4 BIO EDIT

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Dr Milind Kokje A case of lost credibility?

Chief Editor The revelation was not merely shocking but was hitting the core of confidence built
up among the professionals over the years by ‘The Lancet’ and the ‘New England
[email protected] Journal of Medicine’. The editors of the two prestigious medical journals appeared
to have expressed their exasperation over the pressure put by pharma companies. They
seemed to have used the word ‘criminal’ to describe erosion of science in the process.

At the meeting, Dr Richard Horton, Editor-in-Chief, The Lancet, apparently admitted,
“….pharmaceutical companies are so financially powerful; they are able to pressure us to
accept papers that are apparently methodologically perfect, but their conclusion is what
pharmaceutical companies want.” This was revealed by none less than a cardiologist and
former French Health Minister in an interview while providing insight into how series of
negative Hydroxychloroquine (HCQ) studies were published in these reputed journals. He
quoted the editors saying so in a closed-door meeting held some time back.

Dr Horton had written in 2015 itself that the case against science is straightforward:
much of the scientific literature, perhaps half, may simply be untrue. But the editors’
reported recent confession assumes very serious significance on the backdrop of the
ongoing COVID-19 pandemic affecting millions, claiming several lives and jeopardising
several economies across the globe. The significance is even more serious in view of the
controversy surrounding HCQ for the treatment of COVID-19 since the controversy began
with the research studies against the drug published in these journals.

In June, The Lancet had to retract a study showing HCQ is not useful in treating
COVID-19 following doubts were raised by the doctors over the authenticity of the data.
Dr Horton described the whole issue as “a monumental fraud”. Thereafter, once again
several doctors raised doubts over the authenticity of other anti- HCQ studies published
in these journals. And on that backdrop the editors confessing over the financial power of
pharma companies to manipulate the studies is amounting to destroying their reputation
as trustworthy publications in a crucial sector like healthcare and medical research.

This whole issue of anti-HCQ studies and even the anti-HCQ propaganda through other
media also brought several doctors together across the globe contesting the studies. In US,
Frontline Doctors held White Coat summit in the capital “to combat the misinformation
and propaganda” against HCQ. Their video went viral with 17 million views.

Dr Deborah Birx, the White House Coronavirus response coordinator, was criticised
for appearing on TV and encouraging people to use Remdesivir instead of HCQ stating
that science did not support the effectiveness of HCQ. Dr Anthony Fauci, Director of the
National Institute of Allergy and Infectious Diseases (NIAID) in US, too attacked a positive
study on the drug by two doctors. Those two Henry Ford Health System doctors in an open
letter to Dr Fauci said the persisting political climate has made any objective discussion
about the drug impossible. Several US doctors have now come forward in support.

Three Indian doctors, in an article in Indian Journal of Medical Ethics (IJME), have
observed that HCQ appears to be courting greater scrutiny on safety, risk and efficacy. They
have observed that a subtle push is being given to Remdesivir for COVID-19 treatment.
Their observation is important considering the huge price difference between the two
drugs.

In general, the role of Dr Horton during the pandemic has come under severe criticism
from the media with the prestigious US publication ‘The New Yorker’ summarising it as,
“In a manner that is unusual for the editor of a scientific journal, Horton has leaped into
the politics of the pandemic” and he has sought “to merge almost entirely the scientific
mission of The Lancet with a political purpose.”

It is in this context that the confession of the editors of the medical journals needs to
be viewed and its importance will strike rightly. But mere statements from the editors
are of no use, what is required are firm corrective steps to enhance the credibility of the
publications once again.

BIO MAIL 5

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

www.biospectrumasia.com S$ 5.00

Volume 15 | Issue 8 | August 2020 Acknowledgements

INVESTING Thank you for the feature on Lucence! It looks good!

for Future Generations - Gabriel Yap, Singapore

“APAC, post-COVID-19, will see an explosion of innovation in digital health” Thank you so much for putting this together. Appreciate the article
- Dr Ian Chuang, Chief Medical O cer, EMEALAAP Health, Elsevier, USA – 33 coverage on Artificial Intelligence in BioSpectrum Asia.
Pharma stands united against COVID-19 – 28
- Dr Amandeep Singh, India
MCI (P) 012/06/2020

The coverage on Philips is well taken in BioSpectrum Asia. Thank you.
- Kevin Seak, Singapore

The interview coverage on Luina Bio has come out well. Thank you so much.
- Lisa Devereaux, Australia

Vol 15; Issue 9; September 2020 MM Activ Singapore Pte. Ltd. Taiwan
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6 BIO CONTENT

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

COVER STORY 18

INDIAN PHARMA

PRODUCING

DRUGS FOR MASSES

Known for its expertise in manufacturing and supplying
quality generic drugs, Indian pharma sector is currently
using the generic tool as a critical arsenal in the fight against
COVID–19. At present, there are around 25 different drugs
brands available in the Indian market to treat the COVID-19

patients, with many more in the pipeline.

BIO CONTENT 7

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com OPPORTUNITIES

COVID-19 38

25 Intellectual Property in doldrums Adopt an agile & omni-
channel approach for success
27 Time to look for 2nd Gen vaccines
Dinesh Sampath Rangaraj,
30 WHO on the centre stage Frost & Sullivan, APAC region,
Kuala Lumpur, Malaysia
STARTUPS
TECHNOLOGY
34
39
LianBio – accelerating availability of
paradigm-shifting medicines for Asian markets Simulating technology
solutions to fight COVID-19
Q&A
Hemant Punekar,
36 Application Engineering
Manager- Healthcare, Ansys, India
“Value of research
conducted within academic ARTIFICIAL INTELLIGENCE
institutions will be better
appreciated in future” 40

Dr Peter Smith, Invest in building
CEO, Affinity Biosciences, Australia agile supply chains

37 Alagu Subramaniam,
Managing Director,
“We are speeding up West Pharmaceutical Services, India
distribution of IFN-β-1a
in Singapore for REGULARS
COVID-19 management”
BioEdit....................... 04 World News............... 16
Suchet Rastogi, Regulatory News...... 08 Event Report.............. 41
Chief Executive Officer, SRS Life Sciences, India Company News......... 10 People News............. 44
Finance News............ 12 R&D News.................. 46
Start-up News........... 13 Academic News........ 48
WHO News................ 15 Supplier News........... 49

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on trademarks is available via publicly accessible resources.
© 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.
The life science business of Merck KGaA, Darmstadt, Germany operates as
MilliporeSigma in the US and Canada.

8 REGULATORY NEWS BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Taiwan Singapore to create 4K new
provisionally jobs to support healthcare
approves
dexamethasone Singapore Deputy Prime Minister Heng Swee Keat has announced
to treat a new injection of S$8 billion stimulus package in addition to
COVID-19 the previously announced package in April 2020. With this
extended stimulus, the Singapore government is creating 4000
Taiwan Centers for Disease new jobs in healthcare as it redeploys more aviation workers
Control has provisionally to other industries.
approved dexamethasone, the Hiring in the public
relatively economical and widely- healthcare and long-
used steroid for the treatment term care sectors has
and cure of COVID-19. Based on been accelerated by the
the RECOVERY trial results in Singapore government
the UK, the National Institutes considering the need
of Health (NIH) in the US for more workers at
sought to place dexamethasone biomedical sciences,
on the clinical guidelines. financial services, and
The trial researchers showed ICT sectors. The new
dexamethasone as the first support is based on the
drug to save lives of COVID-19 projected recovery of the
patients. Taiwan’s Centres different sectors. Under
for Disease Control Deputy this, biomedical sciences will receive 10 per cent support for four
Director-General Chuang Jen- more months, for wages paid up to December 2020. As part of the
hsiang stated that though the efforts, the government is encouraging firms in fields like financial
Taiwanese regulatory agency has services and healthcare to hire more in the next six months. Under
chosen to temporarily permit a new S$1 billion initiative, the government will co-pay 25 per cent
dexamethasone as a COVID-19 of salaries for new local hires for up to a year.
treatment, it still needs to
undergo certain procedures Thailand pushes genomics
before being administered to project as centre of medical hub
patients. Currently, in Taiwan,
remdesivir is in high demand Thailand aims to enhance its role as a global medical hub by
after the intravenously- establishing a Thailand Genomics Sequencing Center in the country’s
administered medicine helped high-tech Eastern Economic Corridor (EEC). Thailand is developing
to shorten hospital recovery genomics medicine through cooperation between the EEC Office,
times in a clinical trial. The the Health Systems Research Institute, the Ministry of Public
steroid-based antiviral drug
dexamethasone is approved due Health and the Ministry of Higher
to the shortfall of the antiviral Education, Science, Research
drug remdesivir. and Innovation. The Thailand
Genomics Sequencing Center is a
key part of the Thai government’s
4.5 billion baht five-year plan
known as Genomics Thailand,
which was approved last year.
Soon after, the committee that runs the EEC and the Health Systems
Research Institute Thailand gave the go-ahead for a human whole
genome sequencing center to be established within the EEC. The EEC
is a coastal strip southeast of Bangkok that is at the heart of Thailand
4.0, a strategy to transform Southeast Asia’s second largest economy
into a fully developed nation and the region’s innovation hub.

REGULATORY NEWS 9

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Australia’s MRFF NZ offers free
reaches maturity at $20B access to
essential health
The Australian government’s target just five years after information
landmark Medical Research the fund was established
Future Fund (MRFF) has in 2015. The capital of the Ministry of Health in New
reached maturity at $20 MRFF is invested, with Zealand and mobile network
billion. This unprecedented the earnings used to pay operators have collaborated to
investment will provide for important health and offer free access to essential health
ongoing sustainable funding medical research projects, information and digital health
for ground breaking health supporting Australia’s best services. The Sponsored Data
and medical research. The and brightest health and partnership between the Ministry
MRFF is an ongoing research medical researchers over the of Health and mobile network
fund announced by the long term. This investment is operators Spark, Vodafone and
government in the 2014-15 critical, particularly in light 2degrees means Kiwis won’t
budget. The target was to of the devastating impacts incur mobile data charges when
grow the MRFF to $20 billion that the COVID-19 pandemic they access essential COVID-19
through annual credits, which is having on so many information, health information
are preserved in perpetuity. Australians. In the 2019–20 and resources, and eligible online
The government’s final credit Budget, the government health services. The number of
of $3.2 billion will enable the announced a $5 billion, 10- sponsored websites will increase
MRFF to reach the historic year investment plan for the over time so New Zealanders
$20 billion investment MRFF. can access even more key health
information and services without
India employs e-vaccine mobile data charges. In the first
intelligence network instance, anyone using the mobile
networks of the country’s largest
The Electronic Vaccine Intelligence Network (eVIN) is an innovative telco providers can now access
technological solution aimed at strengthening immunization supply 11 key health websites and two
chain systems across the country. This is being implemented under GP portals free of data charges.
National Health Mission (NHM) by Ministry of Health and Family All mobile data charges for these
Welfare, Government of India. eVIN aims to provide real-time websites will be charged back to
information on vaccine stocks and flows, and storage temperatures the Ministry until June 2021, with
across all cold chain points in the country. This robust system has six monthly reviews to confirm
been used with the requisite customization during the pandemic extensions to the initiative.
for ensuring continuation of the essential immunization services According to Director-General of
and protecting children and pregnant mothers against vaccine Health Dr Ashley Bloomfield, this
preventable diseases. Over 41,420 vaccine cold chain handlers have ensures people, who use pre-paid
been introduced to digital record-keeping by training them on eVIN. mobiles can continue to access
Nearly 23,900 electronic temperature loggers have been installed important health, mental health
on vaccine cold chain equipment for accurate temperature review of and wellbeing information through
vaccines in storage. their mobile if they run out of data.

10 COMPANY NEWS BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Dynavax, Mankind, Daewoong
Medigen focus study Niclosamide for
on adjuvanted COVID-19 treatment
COVID-19
vaccine Daewoong Pharmaceutical in South Korea through its subsidiary,
Daewoong Pharmaceutical India and Mankind Pharma, fastest-
US based Dynavax Technologies growing Indian pharmaceutical company, have collaborated for
Corporation and Medigen Vaccine conducting Phase I clinical trial of a long-acting intramuscular
Biologics Corporation, with formulation of Niclosamide. The trial is designed towards
presence in US and Taiwan, have addressing the need for a
announced their collaboration to science-based investigation
develop an adjuvanted vaccine on this new formulation
candidate to protect against Niclosamide (DWRX2003)
COVID-19. The collaboration is based on encouraging
evaluating the combination of preclinical evidence for the
MVC’s stable prefusion form of treatment of COVID-19.
the SARS-CoV2 recombinant Niclosamide is already in
spike protein with Dynavax’s clinical use as an anthelmintic,
advanced adjuvant CpG 1018, the however, the current
adjuvant contained in Dynavax’s formulation is expected to be a long-acting variant for this alternate
USFDA-approved adult hepatitis clinical indication. It is also expected to circumvent the downside
B vaccine. MVC’s subunit of oral administration. In vitro, Niclosamide was found to be 40, 26
vaccine is based on the stable & 15 times more potent than remdesivir, chloroquine & ciclesonide
prefusion form of the SARS- respectively for its anti-viral action against SARS-CoV-2 virus.
CoV2 recombinant spike protein
with global technology license Novavax, Takeda work
from the U.S. Vaccine Research on COVID-19 vaccine
Center at National Institutes of candidate for Japan
Health (NIH). Preclinical studies
demonstrated that the vaccine NVX‑CoV2373, Novavax’
candidate adjuvanted with CpG
1018 generated strong immune COVID‑19 vaccine candidate,
responses in experimental animals.
in Japan. NVX‑CoV2373 is a

stable, prefusion protein made

using Novavax’ recombinant

protein nanoparticle

technology and includes

Novavax’ proprietary Matrix‑M

adjuvant. Takeda will receive

Novavax Inc., a late-stage funding from the Government

biotechnology company of Japan’s Ministry of Health,

headquartered in the US Labour and Welfare (MHLW)

developing next-generation to support the technology

vaccines for serious infectious transfer, establishment of

diseases, and Japan based infrastructure and scale-up

Takeda Pharmaceutical of manufacturing. Takeda

Company Limited recently anticipates the capacity to

announced a partnership for the manufacture over 250 million

development, manufacturing doses of the COVID-19 vaccine

and commercialization of per year.

COMPANY NEWS 11

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

SII sets COVID-19 Hua Medicine, Bayer
bring novel diabetes
vaccine price at treatment in China

Rs 225/dose German pharmaceutical company Bayer and Hua Medicine
in China have announced a commercialization agreement
Pune based Serum Institute of India and strategic partnership for dorzagliatin, a novel diabetes
(SII) has entered into a new landmark treatment, in China. Dorzagliatin is an investigational first-in-
partnership with GAVI, The Vaccine class, dual-acting glucokinase activator, designed to control
Alliance and the Bill & Melinda the progressive degenerative nature of diabetes by restoring
Gates Foundation, to accelerate the glucose homeostasis in patients with Type 2 Diabetes. The
manufacture and delivery of up to 100 agreement aims to provide Chinese diabetes patients with
million doses of COVID-19 vaccines access to a new treatment option, building on Bayer’s existing
for India and low- and middle-income strength and leadership in diabetes management in China and
countries (LMICs). The collaboration the innovation capabilities of Hua Medicine. Under the terms
will provide upfront capital to SII to of the agreement, Hua Medicine as the market authorization
help them increase holder shall be responsible for clinical development,
manufacturing registration, product supply and distribution, whilst Bayer
capacity now as the promotion service provider shall be responsible for
so that, once a marketing, promotion and medical education activities in
vaccine, or vaccines, China. Hua Medicine will receive an upfront payment of RMB
gains regulatory 300 million and additional payments could reach up to RMB
approval and WHO 4.18 billion if certain milestones are met. Bayer receives the
prequalification, exclusive rights to commercialize the product in China and
doses can be will receive tiered service fee based on the net sales. Initially,
produced at scale both parties will share equally in sales derived from China net
for distribution to India and LMICs sales, with adjusting sales percentages based on agreed China
as part of the GAVI COVAX AMC net sales thresholds.
mechanism as early as the first half of
2021. The funding will support at-risk
manufacturing by SII for candidate
vaccines from AstraZeneca and Novavax,
which will be available for procurement,
if they are successful in attaining full
licensure and WHO Prequalification. SII
has set an affordable ceiling price of $ 3
or Rs 225.03 per dose.

Affinity makes COVID-19 antibodies ready for CT

Melbourne based Affinity Affinity is now aiming to
Biosciences has lodged a pre-
publication submission to have its COVID-19 antibody
the scientific journal mAbs,
detailing its results and therapy available to the public
observations relating to the
discovery of potent antibodies as fast as possible. Affinity has
against COVID-19. Affinity’s
lead antibodies have been requested proposals for the
shown to be capable of completely
neutralising SARS-CoV-2, the manufacture of their antibody
virus that causes COVID-19, and
are amongst the most potent for clinical trials (CT) from
reported to date. The virus
Australian and overseas

contract manufacturing

neutralisation data generated organisations and is in discussions
under contract by The Peter
Doherty Institute for Infection and with regulatory consultants
Immunity in Melbourne have been
previously announced by Affinity. to establish an expedited path

for manufacturing, trials, and

approval of the antibody therapy.

12 FINANCE NEWS

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Daiichi Sankyo signs agreement with AstraZeneca for $6B

Japanese firm Daiichi maintain exclusive rights. Daiichi HER2 directed DXd ADC.
Sankyo Company has Sankyo will manufacture and Under the terms of the
entered into a global supply DS-1062. This agreement agreement, AstraZeneca
development and represents the second global ADC will pay Daiichi Sankyo
commercialization collaboration between the two an upfront payment
agreement with companies following a similar of $1 billion, of which
AstraZeneca for Daiichi agreement in March 2019 for $350 million is due upon
Sankyo’s DS-1062, a TROP2 Daiichi Sankyo’s ENHERTU, a execution, $325 million
directed DXd antibody drug after 12 months and $325
conjugate (ADC), currently million after 24 months.
in phase 1 clinical development Contingent payments of up to
for non-small cell lung cancer $5 billion include $1 billion for
(NSCLC) and triple negative achievement of future regulatory
breast cancer (TNBC). Daiichi milestones, and $4 billion for
Sankyo and AstraZeneca will sales-related milestones. Total
jointly develop and commercialize payments under the agreement
DS-1062 worldwide, except in have the potential to reach up to
Japan where Daiichi Sankyo will $6 billion.

Isofol inks Samsung Biologics invests
oncology deal with $2B for further expansion
Solasia for $100M
South Korea based Samsung Biologics has announced its plans
Isofol Medical AB, Sweden has to break ground for a fourth plant within this year. This is part
entered into a license agreement with of its long-term strategy to maximize its operational efficiency
Solasia Pharma K.K, a specialized and scale up its development and manufacturing capabilities in
oncology company headquartered in response to growing biomanufacturing demands. The company
Japan, to develop and commercialize is in negotiations with the authorities at IFEZ (Incheon Free
Isofol’s proprietary late-stage drug Economic Zone) to purchase additional land for its second bio
candidate arfolitixorin in Japan. complex. Upon finalization of the terms under negotiation,
Under the terms of the agreement, the total size of the two investments is expected to be over 2
Isofol will receive a total amount of trillion Korean won, roughly equivalent to 2 billion US dollars,
$100 million as upfront, development, and over the total amount invested in the company’s previous
regulatory and sales-based milestone three plants combined throughout its nine-year history. Adding
payments and clinical development 256KL capacity to its site, Plant 4 is scheduled to commence
cost. In addition, Isofol will receive manufacturing activities in the second half of 2022, and
tiered royalties on net sales in solid further advance the company’s standing as the world’s largest
double digit figures. The license manufacturing facility at a single location, holding a 620KL total
agreement is initially focused on the capacity upon completion.
development and commercialization
of arfolitixorin as first-line treatment
for metastatic colorectal cancer
(mCRC) patients in Japan, which is
projected to be the second largest
addressable patient market for
arfolitixorin. Additional indications
will be evaluated jointly by Solasia
and Isofol. Isofol retains rights to
arfolitixorin in the rest of the world.

START-UP NEWS 13

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com Brain Navi
develops robot
HBM collaborates to perform nasal
with Viva Biotech to swab tests
promote biotech startups
Brain Navi, a biotechnology
Harbour BioMed (HBM), a global clinical-stage biopharmaceutical startup based in Taiwan’s
company based in the US and Shanghai based Viva Biotech have Hsinchu’s Biomedical Science
announced a strategic partnership under which both parties will Park, has developed a new robot
collate their respective expertise in drug discovery and development to perform nasal swab tests
to promote the incubation of innovative biotech startups. HBM will autonomously to prevent cross
combine its leading Harbour Mice platform H2L2 and its experience infections so we can save the
in global research and development of innovative molecules, with medical system and reestablish
Viva Biotech’s structure-based early-stage drug discovery services. economies. The coronavirus
This partnership will offer innovative biotech startups access to next- caused the lock-in policy over the
generation technologies that create synergies to accelerate the path world. To reopen and reboot the
between ideation to the product. The incubated startups will operate economy in this pandemic, a large
thorough scientific research and EFS (equity for service) model. HBM scale of testing is the essential
has made significant progress through strategic collaborations and key and solution, but it needs to
partnerships with leading academic institutions and pharmaceutical be done safely and effectively.
and biotech companies across the world. With the Brain Navi Nasal Swab
Robot’s assistance, users can test
Lumiere32 launches medical safely around the clock, so as to
inventory management platform spare medical healthcare workers
from the high-risk environment
during sample collecting. With
the unique robotic help, users can
control the spread of the virus
while waiting for a vaccine and
prevent cross-infections.

Lumiere32, a Singapore based much faster than before, clinics
B2B healthcare procurement
startup, known for its online and hospitals find themselves
platform of medical and dental
supplies, launches Pay32Clinic, spending more time handling
an artificial intelligence
(AI) powered inventory everyday administrative
management software platform,
dedicated to all clinics in tasks such as controlling and
Singapore. As more healthcare
providers move to digitalise managing their inventory. With
to adapt to the pandemic in
Singapore, Lumiere32 has led its integrated AI technology,
this digital shift with regards
to the procurement of medical Pay32Clinic will also allow
supplies, such as face masks
and thermometers. With all clinics in Singapore to
medical supply stocks moving
track the expiration dates

and monthly inventory data

trends to ensure that they will

no longer experience ‘Out of

Stock’ situations. Among other

features, the software will also

facilitate a digitalized and

paperless process for all vendor

payments.

14 START-UP NEWS

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Docquity partners with Novartis to support medical professionals

Singapore based startup Philippines and Malaysia. With and provide invitation
Docquity has partnered this latest partnership expansion codes to doctors to enable
with Swiss research based announcement, Docquity and them to join the continuing
healthcare company Novartis will be working closely medical education network.
Novartis to deliver bite- in Thailand, Vietnam, Pakistan, The COVID-19 pandemic
sized, continual learning, and Bangladesh. Novartis will has changed the way many
and education support work with local medical societies industries operate and
to doctors across seven has propelled the pace of
countries in Asia. Novartis digitization exponentially
will work with Docquity and as communities across the world
will host scientific information go virtual. Novartis is leveraging
for the doctors through the the Docquity network to provide
Docquity platform. Docquity and quality scientific and clinical
Novartis started this partnership engagement programmes for
in Indonesia in 2019 and doctors in the region to optimize
extended the relationship to the patient care.

ImmunoScape Abbott joins hands with
raises $11M to 1mg for CGM solutions
accelerate vital
immunotherapies In a move to expand access and empower Indian patients to take
charge of their health, American multinational medical devices
Singapore based biotech startup and healthcare company Abbott and Indian online pharmacy
ImmunoScape has raised $11 and healthcare startup 1mg have recently announced their
million in a global equity financing collaboration to make Abbott’s continuous glucose monitoring
round. US-based venture firm Anzu (CGM) products available online, including its professional flash
Partners led the round, joined by glucose monitoring system, FreeStyle Libre Pro. Patients in India
University of Tokyo Edge Capital can upload a healthcare practitioner’s prescription and purchase
(UTEC) in Japan, and NPR Holdings the product online on 1mg. An on-site phlebotomy service will be
in Indonesia. ImmunoScape’s provided at the patient’s home with a phlebotomist helping the
immune profiling platform, which patient administer the sensor and take readings of the data after
provides deep insights into the 14 days, enabling them to start using the device. Abbott′s FreeStyle
T-cells of the human immune Libre Pro consists of a small, round sensor, slightly larger than a
system, is already intensely engaged 10-rupee coin. A phlebotomist applies the discreet, water-resistant,
in COVID-19 related programmes and disposable sensor on the back of the upper arm of a patient.
on three continents. ImmunoScape The sensor is held in place with a self-adhesive pad and remains on
also has established collaborations the back of the upper arm for up to 14 days, requiring no patient
with several vaccine development interaction with the sensor.
companies, including US based
Arcturus, which is running clinical
trials in Singapore. ImmunoScape’s
technology was based on work
begun at Stanford University, and
continued at A*STAR of Singapore,
where the company was established
in 2017. ImmunoScape has received
support from A*STAR and its
commercialization arm A*ccelerate,
as well as Enterprise Singapore.

WHO NEWS 15

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

WHO emphasises WHO focuses on ensuring
medicines access for COVID-19
on fast-tracking HBV
The International Narcotics Control Board (INCB), the World
elimination Health Organization (WHO) and the United Nations Office
on Drugs and Crime (UNODC) call on governments to ensure
The proportion of children under five years that the procurement and supply of controlled medicines in
of age chronically infected with hepatitis countries meet the needs of patients, both those who have
B (HBV) dropped to just under 1 per cent COVID-19 and those who require internationally controlled
in 2019 down from around 5 per cent in medicines for other medical conditions. There is a need
the pre-vaccine era, the period between to ensure access to controlled medicines such as sedatives
the 1980s and the early 2000s, according and analgesics for intubation protocols for the treatment of
to new estimates from the World Health patients with COVID-19. Non-COVID patients continue to
Organization (WHO). This marks the require controlled medicines for the management of pain
achievement of one of the milestone and palliative care, surgical care and anaesthesia, mental
targets to eliminate viral hepatitis in health and neurological conditions, and for the treatment of
the Sustainable Development Goals to drug use disorders. It is important to remember the needs
reach under 1 per cent prevalence of HBV of existing patients, who require controlled medicines for
infections in children under five years of the management of these health conditions. These patients
age by 2020. WHO is calling for united faced barriers to accessing controlled medicines before the
and stepped-up action to build on this pandemic. COVID-19 has further resulted in interruptions of
achievement through intensified efforts to the medicines supply chain, and it is critical that access to
prevent mother-to-child transmission of essential health services and medications not be forgotten or
HBV through testing pregnant women and de-prioritised during this pandemic.
provision of antiviral prophylaxis to those
who need it and maintaining and expanding
access to hepatitis B immunization and
birth dose vaccine.

WHO introduces COVID-19 law lab

The COVID-19 Law Lab initiative on HIV/AIDS (UNAIDS) and the
gathers and shares legal documents
from over 190 countries across the O’Neill Institute for National and
world to help states establish and
implement strong legal frameworks Global Health Law at Georgetown
to manage the pandemic. The
goal is to ensure that laws protect University. The COVID-19 Law
the health and wellbeing of
individuals and communities and Lab is a database of laws that
that they adhere to international
human rights standards. The countries have implemented
new lab is a joint project of
United Nations Development in response to the pandemic.
Programme (UNDP), the World
Health Organization (WHO), the It includes state of emergency
Joint United Nations Programme
declarations, quarantine

measures, disease surveillance,

legal measures relating to mask-

wearing, social distancing, and

access to medication and vaccines.

The database will continue to grow

as more countries and themes are

added.

16 WORLD NEWS

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Regeneron, Roche plan global CARE, IMI to
supply of anti-viral antibody cocktail
accelerate
US based Regeneron Pharmaceuticals, Inc. and Swiss firm Roche have
announced that they are joining forces in the fight against COVID-19 therapy
to develop, manufacture and distribute REGN-COV2, Regeneron’s
investigational anti-viral antibody cocktail, to people around the globe. development
This collaboration is expected to increase supply of REGN-COV2 to at
least three and a half times the current capacity, with the potential for for COVID-19

even further expansion. REGN-COV2 is CARE (Corona Accelerated R&D
currently being studied in two Phase 2/3 in Europe) a new consortium
clinical trials for the treatment of COVID-19 supported by the Innovative
and in a Phase 3 trial for the prevention of Medicines Initiative (IMI)
COVID-19 in household contacts of infected public-private partnership
individuals. If it proves safe and effective has announced its launch to
in clinical trials and regulatory approvals accelerate the discovery and
are granted, Regeneron will distribute development of urgently needed
and record sales for REGN-COV2 in the medicines to treat SARS-CoV-2,
U.S. and Roche will be responsible for the virus that causes COVID-19.
distribution outside the U.S. Under the terms of the agreement, each With a grant totaling € 77.7
company has committed to dedicate a certain manufacturing capacity million, CARE is funded by
to REGN-COV2 each year, and the collaborators have already begun cash contributions from the
the technology transfer process. Each company will bear its own European Union (EU) and
distribution expenses in their designated territories. cash and in-kind contributions
from eleven European
Sanofi acquires Principia Federation of Pharmaceutical
Biopharma for $3.68B Industries and Associations
(EFPIA) companies and three
French multinational pharmaceutical firm Sanofi and Principia IMI-Associated Partners.
Biopharma Inc., a late-stage biopharmaceutical company focused on CARE aims to create effective
developing treatments for immune-mediated diseases in the US, have therapies with a positive safety
entered into a definitive agreement under which Sanofi will acquire profile for the COVID-19
all of the outstanding shares of Principia for $100 per share in cash, pandemic, and develop new
which represents an aggregate equity value of approximately $3.68 drugs and antibodies specially
billion (on a fully diluted basis). The Sanofi and Principia Boards of designed to tackle the SARS-
Directors unanimously approved the transaction. Principia’s Bruton CoV-2 virus. CARE is a 5-year
tyrosine kinase (BTK) inhibitors add to Sanofi’s efforts to accelerate project bringing together 37
and build a portfolio of the next generation of transformative partners from Belgium, China,
treatments for autoimmune diseases. BTK is present in the signaling Denmark, France, Germany,
pathways of key innate and adaptive cell types of the immune system. the Netherlands, Poland, Spain,
Being able to block or disrupt these signaling processes can help in Switzerland, the UK and the
stopping inflammation and tissue destruction related to autoimmune US, and is led by VRI-Inserm
diseases and target some of the underlying pathophysiology. (French National Institute of
Health and Medical Research,
Paris, France), Janssen
Pharmaceutica NV, one of
the Janssen Pharmaceutical
Companies of Johnson &
Johnson (Beerse, Belgium),
and Takeda Pharmaceuticals
International AG, (Zurich,
Switzerland). It integrates
partners’ COVID-19 projects
ongoing since February 2020.

WORLD NEWS 17

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Africa pushes Novavax initiates
R&D for COVID-19 COVID-19 vaccine
traditional medicine trial in South Africa

The World Health Organization (WHO) US based Novavax, Inc. has announced the beginning of a
and the Africa Centres for Disease Control Phase 2b clinical trial in South Africa to evaluate the efficacy
and Prevention (Africa CDC) are pushing of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate.
for COVID-19 traditional medicine research Dr Shabir Madhi, Professor of Vaccinology at Wits
in Africa. The WHO and Africa CDC have University, will lead the clinical trial, which is supported in
formed a 25-member expert advisory panel part by a $15 million grant from the Bill & Melinda Gates
selected from Central, Eastern, Southern and Foundation. NVX‑CoV2373 is a stable, prefusion protein
West African countries to provide scientific made using Novavax’ proprietary nanoparticle technology
advice and support to countries on the safety, and includes Novavax’ proprietary Matrix‑M adjuvant. The
efficacy and quality of traditional medicine randomized, observer-blinded, placebo-controlled Phase 2b
for fighting COVID-19. The committee will clinical trial of NVX-CoV2373 will include two cohorts. One
coordinate support to African countries to cohort will evaluate efficacy, safety and immunogenicity
collaborate in undertaking clinical trials in approximately 2,665 healthy adults. The second cohort
with a focus on traditional medicine-based will evaluate safety and immunogenicity in approximately
therapies. Some African medicinal plants 240 medically stable, HIV-positive adults. This allows for
such as Aloe ferox and Moringa oleifera evaluation of the vaccine across a diverse, representative
possess antiviral properties, and thus proper study population. Novavax expects that, if approved in South
scientific investigations on such plants may Africa, its COVID-19 vaccine would ultimately be supplied
yield herbal medicines with preventive or to South Africa through Novavax’ recently announced
curative effects on the novel coronavirus. collaboration with the Serum Institute of India.

Nigeria to boost capacity for COVID-19 response

The World Bank Board of local transmission and limit the expertise, coordination support,
Directors have approved a spread of coronavirus through detection, diagnosis and case
$114.28 million financing to containment and mitigation management efforts in all states
help Nigeria prevent, detect and strategies. In addition, the
respond to the threat posed by project will finance federal and the FCT as per the WHO
COVID-19 with a specific focus procurements of medical guidelines in the Strategic
on state level responses. Through equipment, laboratory Response Plan. It will
the COVID-19 Preparedness and tests, and medicines to be also help the government
Response Project (CoPREP), distributed to the states mobilize surge response
the Government of Nigeria will based on their needs. capacity through trained
provide grants to 36 states and CoPREP will enhance and well-equipped
the Federal Capital Territory the institutional and operational frontline healthcare
(FCT) as immediate support to capacity for disease detection
break the chain of COVID-19 through provision of technical workers and strengthen the
public healthcare network for
future health emergencies.

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INDIAN PHARMA

PRODUCING

DRUGS FOR MASSES

Known for its expertise in manufacturing and supplying
quality generic drugs, Indian pharma sector is currently
using the generic tool as a critical arsenal in the fight against
COVID–19. At present, there are around 25 different drugs
brands available in the Indian market to treat the COVID-19

patients, with many more in the pipeline.

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According to a recent report by the UK based General of India (DCGI). Priced at Rs 5400 per
data analytics and consulting company 100 mg vial, the drug has been approved for
GlobalData, infectious disease drugs have restricted emergency use.
overtaken oncology as 2020’s top therapy area for
contract service agreements (CSAs) as companies “Covifor is the first generic brand of
are shifting their current focus to developing Remdesivir which is indicated for the treatment
treatments to battle the COVID-19 pandemic. of COVID-19 patients in adults and children,
COVID-19 may also be disrupting other therapy hospitalized with severe symptoms of the
areas by reducing service agreements for other disease. The drug is available in injectable 100
non-COVID-19 drugs, as clinical trials are being mg vial Injectable. It needs to be administered
disrupted by the effects of the pandemic. intravenously in a hospital, critical care setting,
under the supervision of a registered medical
As a result, we are seeing many Indian practitioner. Covifor is anticipated to play a
pharmaceutical companies setting this as a top significant role in bringing down the mortality
priority and working towards developing effective rates caused by COVID-19, given its proven
drugs for treating the dreadful disease. Known positive clinical outcomes”, says M. Srinivasa
for its expertise in manufacturing and supplying Reddy, Managing Director, Hetero Healthcare,
quality generic drugs, Indian pharma sector is Hyderabad, India.
currently using the generic tool as a critical arsenal
in the fight against COVID–19. At present, there Around the same time, Mumbai based Cipla
are around 25 different drugs brands available in announced the launch of remdesivir under its
the Indian market to treat the COVID-19 patients, brand name Cipremi. Being sold at a much lower
with many more in the pipeline. price than Covifor, at Rs 4,000 per 100 mg vial,
Cipremi has been granted regulatory approval by
However, this gamble on making COVID-19 the DCGI for restricted emergency use. As part of
treatment a priority might hinder the growth of a risk management plan, Cipla is also providing
the pharmaceutical companies in the long run. training on use of the drug, informed patient
No doubt that the sales are getting bolstered consent documents, post marketing surveillance
by COVID-19 currently, it is likely that the as well as conducting a Phase IV clinical trial on
real winners in the pharma sector will be the Indian patients.
companies that are focused on expanding their
existing marketed drug portfolio rather than those “As part of its efforts to enable speedy
that have joined the race to develop a COVID-19 and equitable access to this treatment and in
asset. anticipation of demand, Cipla is commercialising
remdesivir through its own facilities and partnered
Remdesivir sites. The drug is being supplied through
government and open market channels, to ensure
Originally developed by the American equitable distribution”, shares Umang Vohra,
biopharmaceutical company Gilead Sciences Managing Director and Global Chief Executive
in 2014 as a possible treatment for Ebola Officer, Cipla, Mumbai, India.
Hemorrhagic Virus (EBV) and Marburg Virus
infection, remdesivir came across to be highly Noida headquartered Jubilant Life Sciences
effective in stopping the replication mechanism of has also launched the investigational antiviral
the coronavirus that causes COVID-19 during the drug remdesivir in the form of lyophilized
trials. In May 2020, this investigational antiviral injection for restricted emergency use in India.
drug received Emergency Use Authorization (EUA) Jubilant’s remdesivir product is being marketed
by the US Food and Drug administration (FDA) to under the brand name JUBI-R at a price of Rs
treat COVID-19. 4,700 per vial of 100 mg. In order to increase
accessibility of the drug to patients below the
Soon after this announcement, many Indian poverty line and to front line paramedical
pharmaceutical companies namely Zydus Cadila, staff, Jubilant Bhartia Foundation, a not-
Dr Reddy’s, Cipla, Hetero Healthcare and Jubilant for-profit organisation of Jubilant Group, is
signed agreements with Gilead for manufacturing launching unique programmes in India aimed at
and marketing the drug in India. distribution of the drug.

Hyderabad based Hetero Healthcare came The Netherlands based pharmaceutical
out to be the first one to launch remdesivir in company Mylan is the latest entrant in this space
the market under the brand name Covifor after after it announced the launch of remdesivir under
receiving approval from the Drugs Controller its brand name Desrem. The drug is approved for

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“Favipiravir offers rapid the treatment of suspected or laboratory confirmed
reduction in viral load within incidences of COVID-19 in adults and children
hospitalized with severe presentations of the
4 days and provides faster disease. Currently, the company is manufacturing
symptomatic and radiological Desrem in its state-of-the-art injectable facility in
Bengaluru.
improvement. Of most
importance, it has shown “Desrem is available to patients at a price of
clinical improvement of up to Rs 4,800 per 100mg vial, which is more than
88 per cent in mild to moderate 80 per cent less than the price at which the
branded version of this product will be available
COVID-19 cases.” to governments in the developed world. We are
- Sushrut Kulkarni, manufacturing remdesivir in India at its world-
class injectables facilities, which also make
Executive Vice President, Global R&D, product for the US and have been inspected by the
Glenmark Pharmaceuticals, India USFDA for compliance with good manufacturing
practices”, mentions Rajiv Malik, President,
“Itolizumab is the first anti- Mylan, US.
CD6 novel biologic therapy to
But the most economical offering comes from
be approved for emergency Ahmedabad based Zydus Cadila that has launched
use, anywhere in the world, Remdesivir under the brand name Remdac priced
at Rs 2800 for a 100 mg lyophilized injection.
for treating patients with
moderate to severe COVID-19 Although remdesivir has emerged as the most
complications. We plan to take sought-after drug for the treatment of moderate to
this therapy to other parts of severe COVID-19 in the country, it has become a
hot topic for discussions related to drug shortages,
the world impacted by the black marketing and price cuts. Thus, the National
pandemic.” Pharmaceutical Pricing Authority (NPPA) has been
- Kiran Mazumdar-Shaw, asked by the DCGI to remain vigilant towards the
sale and black-marketing of remdesivir.
Executive Chairperson, Biocon, India
On this note, Prashant Khadayate, Pharma
“We are disappointed that Analyst, GlobalData, Hyderabad, India says,
COVACTA did not demonstrate “The trend of price cuts by the new entrants will
continue as the market potential is high not only
a benefit for patients in either domestically but for exports to more than 100
clinical status or mortality at countries. Companies are trying to focus on the
volume opportunity so that they can leverage
week four. We will continue to price-cuts. In addition, a majority of the orders are
generate evidence to provide a supplied to government organizations and pricing
more complete understanding of does play a key role in getting these orders. With
Actemra/RoActemra in COVID-19 government intervention along with an increase
in the supply of remdesivir by manufacturers,
associated pneumonia.” black marketing can be curbed. However, this can
- Dr Levi Garraway, only be halted completely when sufficient vials of
remdesivir are made available for patients across
Chief Medical Officer & Head of India.”
Global Product Development, Roche, US
In any case, this drug is still under investigation
“HCQ study was highly in news and has not been approved by the FDA for any
due to the political angle with use, since the safety and efficacy of remdesivir
the US President endorsing it for the treatment of COVID-19 have not yet been
prior, and was also entangled established. “We are working to broaden our
in the monetary maze of huge understanding of the full utility of remdesivir. To
address the urgency of the continuing pandemic,
COVID-19 market.” we have been sharing data with the research
- Dr Dhananjay Bakhle, community as quickly as possible with the goal of
Executive Vice President,

Medical Research, Lupin, India

COVER STORY 21

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LIST OF COVID-19 DRUGS AVAILABLE IN THE INDIAN MARKET

Drug Company Specifications Cost
FabiFlu (Favipiravir) Glenmark Pharmaceuticals,
Faviton (Favipiravir) Mumbai For mild to moderate Rs 75 per
Favivent (Favipiravir) COVID-19 patients tablet (200mg)
Favivir (Favipiravir) Brinton Pharma, Pune
For mild to moderate Rs 59 per
Jenburkt Pharmaceuticals, COVID-19 patients tablet (200mg)
Mumbai
For mild to moderate Rs 39 per
Hetero Healthcare, Hyderabad COVID-19 patients tablet (200mg)

Covihalt (Favipiravir) Lupin, Mumbai For mild to moderate Rs 59 per
COVID-19 patients tablet (200mg)
Vergiflu (Favipiravir) Converge Biotech, hyderabad
For mild to moderate Rs 49 per
Afluenza (Favipiravir) Alkem Laboratories, Mumbai COVID-19 patients tablet (200mg)

Ciplenza (Favipiravir) Cipla, Mumbai For mild to moderate Rs 72 per
COVID-19 patients tablet (200mg)
FluGuard (Favipiravir) Sun Pharmaceuticals, Mumbai
Dr Reddy’s Laboratories, For mild to moderate NA
Avigan (Favipiravir) Hyderabad COVID-19 patients
Fusion Health Care, Hyderabad Rs 68 per
Xaravir (Favipiravir) For mild to moderate tablet (200mg)
PiFLU and Favenza FDC, Mumbai COVID-19 patients
(Favipiravir) Rs 35 per
Cipremi (Remdesivir) Cipla, Mumbai For mild to moderate tablet (200mg)
COVID-19 patients
Desrem (Remdesivir) Mylan India, Bengaluru Rs 99 per
For mild to moderate tablet (200mg)
Covifor (Remdesivir) Hetero Healthcare, Hyderabad COVID-19 patients
NA
Jubi-R (Remdesivir) Jubilant Life Sciences, Noida For mild to moderate
COVID-19 patients Rs 55 per tablet
Remdac (Remdesivir) Zydus Cadila, Ahmedabad (200mg)
For mild to moderate
Itolizumab Biocon, Bengaluru COVID-19 patients Rs 4000 per
100 mg vial
Actemra Roche, Cipla For moderate to severe
COVID-19 patients Rs 4800 per
Hydroxychloroquine (HCQ) Multiple makers 100 mg vial
For moderate to severe
COVID-19 patients Rs 5400 per
100 mg vial
For moderate to severe
COVID-19 patients Rs 4700 per
100 mg vial
For moderate to severe
COVID-19 patients Rs 2800 per
100 mg vial
For moderate to severe
COVID-19 patients Rs 7,950 per
vial (25mg/5mL)
For moderate to severe
COVID-19 patients Rs 40,000 per
400 mg
For severe
COVID-19 patients Rs 60-90 per
10 tablets
For mild to moderate
and severe condition Rs 3 for a strip
of 10 tablets
Dexamathasone Multiple makers NA
Rs 400-800 per vial
Methylprednisolone Multiple makers NA
Enoxaparin Multiple makers NA Rs 300- 600 per vial

NA- not available

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“Desrem is available to “Covifor is anticipated to play
patients at a price of Rs 4,800 a significant role in bringing
per 100mg vial, which is more
than 80 per cent less than the down the mortality rates
caused by COVID-19, given
price at which the branded its proven positive clinical
version of this product will be
outcomes.”
available to governments in
the developed world.” - M. Srinivasa Reddy,
- Rajiv Malik, Managing Director, Hetero Healthcare, India
President, Mylan, US

providing transparent and timely updates on new Pharmaceuticals, Mumbai, India.
developments with remdesivir,” says Dr Merdad Recently, few more companies have received
Parsey, Chief Medical Officer, Gilead Sciences, US.
the approval from DCGI to market favipiravir
Favipiravir drug for the treatment of COVID-19 patients. Pune
based Brinton Pharmaceuticals and Hyderabad
Favipiravir, a generic version of Avigan of Fujifilm based Hetero Healthcare have launched the
Corporation, approved for flu in Japan in 2014, drug under the brand name Faviton and Favivir
gained attention when it started showing positive respectively at a price of Rs 59 per tablet, while
results in early clinical trials in COVID-19 patients Mumbai based Jenburkt Pharmaceuticals has
with mild to moderate symptoms. Known to launched the antiviral drug favipiravir under the
selectively inhibit RNA polymerase, which is brand name Favivent at a price of Rs 39 per tablet.
necessary for viral replication, this drug was Covihalt brand has been launched by Mumbai
eventually picked up for further analysis. based pharma company Lupin at the cost of Rs 42
per tablet.
Without wasting much time, Mumbai based
Glenmark Pharmaceuticals gathered an approval Hyderabad based Converge Biotech has
from the DCGI to conduct phase III clinical trials recently stepped into this space with the launch of
on favipiravir antiviral tablets on COVID-19 generic favipiravir tablet under the brand name
patients in India, back in May 2020. Vergiflu priced at Rs 72 per tablet. But the most
economical price is being offered by Mumbai
The company generated strong clinical based Sun Pharmaceuticals that has launched
evidence that showed encouraging results in the drug under the brand name FluGuard at the
patients with mild to moderate COVID-19, cost of Rs 35 per tablet. Mumbai based Alkem
followed by the launch of this antiviral drug under Laboratories is another contender joining the line
the brand name FabiFlu. Earlier priced at Rs 103 with its newly launched brand Afluenza.
per tablet, the company has brought down its cost
to Rs 75 per tablet, for 200mg dosage. In collaboration with the Indian Institute
of Chemical Technology (IICT) in Hyderabad,
In addition, the company has also announced Cipla has developed the favipiravir drug under
the availability of the drug at a higher strength the brand name Ciplenza priced at Rs 68 per
of 400mg. The higher strength is intended to tablet. IICT was involved in the development of
improve patient compliance and experience, by a convenient and cost-effective synthetic process
effectively reducing the number of tablets that for the drug, while the entire process and active
patients require per day. pharmaceutical ingredient (API) of the drug has
been transferred to Cipla to manufacture and
“Favipiravir can be used in COVID-19 patients market the drug at scale.
with co-morbid conditions such as diabetes and
heart disease with mild to moderate COVID-19 Lately, Hyderabad based Dr Reddy’s
symptoms. It offers rapid reduction in viral load Laboratories and Fusion Health Care, and Mumbai
within 4 days and provides faster symptomatic and based FDC have also launched their specific
radiological improvement. Of most importance, brands of favipiravir drug in the market.
Favipiravir has shown clinical improvement
of up to 88 per cent in mild to moderate Itolizumab
COVID-19 cases”, points out Sushrut Kulkarni,
Executive Vice President, Global R&D, Glenmark Bengaluru based Biocon has received the approval

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“Cipla is commercialising “With government intervention
Remdesivir through its own along with an increase in
facilities and partnered sites.
The drug is being supplied the supply of Remdesivir by
through government and open manufacturers, black marketing
market channels, to ensure
can be curbed. However, this
equitable distribution.” can only be halted completely
- Umang Vohra,
when sufficient vials of
Managing Director and Global Remdesivir are made available
Chief Executive Officer, Cipla, India
for patients across India.”
- Prashant Khadayate,

Pharma Analyst, GlobalData, India

from DCGI to market itolizumab for emergency agreement for the promotion and distribution
use in India for the treatment of cytokine release of the drug Tocilizumab (Actemra) in India for
syndrome (CRS) in moderate to severe ARDS the treatment of rheumatoid arthritis. But this
(acute respiratory distress syndrome) patients drug recently came into the limelight when
due to COVID-19. Each itolizumab injection is it got approved by the USFDA to be tested in
presented as a 25mg/5mL solution, which costs Rs large phase-3 trial randomised, double-blinded
7,950 per vial. Based on an average body weight of control trial called COVACTA in March 2020, for
60 kg, the therapy cost of a single dose comprising COVID-19 treatment.
four vials is estimated to be approximately Rs
32,000. Although the drug was being recommended by
the Indian Council of Medical Research (ICMR)
“Itolizumab is the first anti-CD6 novel biologic for emergency use in COVID-19 patients, the latest
therapy to be approved for emergency use, trial results have shown it to be ineffective in
anywhere in the world, for treating patients with reducing the associated pneumonia.
moderate to severe COVID-19 complications.
Biocon has repurposed Itolizumab, an anti-CD6 “People around the world are waiting for
IgG1 monoclonal antibody launched in India in further effective treatment options for COVID-19
2013 as ALZUMAb for treating chronic plaque and we are disappointed that COVACTA did
psoriasis, for the treatment of CRS in moderate not demonstrate a benefit for patients in either
to severe ARDS patients due to COVID-19. clinical status or mortality at week four. We will
ALZUMAb has a seven-year proven track record continue to generate evidence to provide a more
of safety as doctors in India have been prescribing complete understanding of Actemra/RoActemra
this biologic to treat acute psoriasis and ensure in COVID-19 associated pneumonia,” says Dr Levi
a better quality of life for patients and now we Garraway, Chief Medical Officer & Head of Global
will be able to save many critically ill COVID-19 Product Development, Roche, US.
patients with our drug. We plan to take this
therapy to other parts of the world impacted by Hydroxychloroquine
the pandemic”, shares Kiran Mazumdar-Shaw,
Executive Chairperson, Biocon, Bengaluru, India. The absence of an effective treatment against the
coronavirus infection led clinicians to redirect
Even though the drug trial results indicate a drugs that are known to be effective for other
reduction in mortality, there are concerns over medical conditions to the treatment of COVID-19.
itolizumab’s efficacy due to the low number of Key among these repurposed therapeutic agents
patients enrolled for the trial. Hence, this could be is the antimalarial drug chloroquine (CQ) and
a limiting factor for its usage. In fact, the national its analogue hydroxychloroquine (HCQ). But
task force for COVID-19 has denied the inclusion what was being touted as a game changer in
of Biocon’s itolizumab in its clinical management the fight against COVID-19, soon got caught
protocols for the disease. into a controversy that highlighted the drug’s
ineffectiveness in treating the disease in global
Actemra studies.

Swiss multinational firm Roche and Mumbai However, the drug is still being used for the
based Cipla had previously entered into an treatment of COVID-19 patients in India and is
recommended as a prophylaxis of the virus as per

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MAJOR MANUFACTURERS Dexamethasone
OF DEXAMETHASONE,
METHYLPREDNISOLONE & ENOXAPARIN According to RECOVERY (Randomised Evaluation
of covid-19 therapy) trial in the UK that was
Dexamethasone Market Share established as a randomised clinical trial to test a
Company (in per cent) range of potential drugs for COVID-19, including
80.2 HCQ, low-cost drug dexamethasone came out as
Zydus Cadila, Ahmedabad 15.85 a surprise winner. It showed reduction in death
Wockhardt, Mumbai 1.53 by up to one third in hospitalised patients with
Cadila Pharma, Ahmedabad severe respiratory complications of COVID-19 in
this study. Dexamethasone is a steroid that has
Methylprednisolone Market Share been used since the 1960s to reduce inflammation
Company (in per cent) in a range of conditions, including inflammatory
43.41 disorders and certain cancers.
Pfizer, Mumbai 28.92
Sun Pharma, Mumbai 8.44 Thereafter, the government started
Neon Labs, Mumbai 7.67 directing the manufacturers namely Mumbai
Intas Pharma, Ahmedabad 5.85 based Wockhardt, Ahmedabad based Cadila
Zydus Cadila, Ahmedabad Pharmaceuticals and Zydus Cadila, to ensure the
adequate production of dexamethasone which
Enoxaparin Market Share is now a part of the clinical treatment protocol
Company (in per cent) of COVID-19. Although the UK trial data does
18.89 identify an improvement in mortality, its place in
Bharat Serums & Vaccines, COVID-19 treatment modalities remains unclear.
Mumbai 18.07
Sanofi India, Mumbai 13.41 Methylprednisolone & Enoxaparin
Emcure Pharma, Pune 8.49
Cipla, Mumbai 6.75 Besides dexamethasone, two more drugs
Abbott Healthcare, Mumbai methylprednisolone and enoxaparin have
been included in the clinical treatment
Source- National Pharmaceutical Pricing Authority, India protocol of COVID-19. While dexamethasone
and methylprednisolone are corticosteroids,
the national taskforce for COVID-19. Recently, which are used for anti-inflammatory and
the Union Health Ministry made the biggest immunosuppressive effects in COVID-19
allocation of HCQ tablets since the beginning of treatment, enoxaparin or heparin is an
the COVID-19 pandemic in India by distributing anticoagulant that helps prevent the formation of
4.24 crore medicines to the states and Union blood clots induced by the virus.
Territories.
Likewise, the manufacturers these two drugs
“Before this pandemic, we could close our have been asked by the National Pharmaceutical
eyes and believe the words printed in top medical Pricing Authority (NPPA) to ensure their
journals like The Lancet, NEJM, Annals of Internal adequate production for the coming time. The
Medicine, but not now. The same applies to the leading producers of methylprednisolone include
study on HCQ in prevention or treatment of Pfizer India, Sun Pharma, Neon Laboratories,
COVID-19. HCQ study was highly in news due to Intas Pharma and Zydus Cadila, while Bharat
the political angle with the US President endorsing Serums & Vaccines, Sanofi India and Emcure
it prior, and was also entangled in the monetary Pharmaceuticals are the top manufacturers of
maze of huge COVID-19 market”, points out Dr enoxaparin.
Dhananjay Bakhle, Executive Vice President,
Medical Research, Lupin, Pune, India. With many more drugs yet to reach the market,
we can expect better drug accessibility and
affordability in the coming months. Also, since
majority of the COVID-19 patients are falling in
mild to moderate stage, favipiravir brands might
be termed as the drugs for the masses amid the
COVID-19 outbreak.

Dr Manbeena Chawla
[email protected]

with inputs from Pooja Yadav

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Intellectual Property in doldrums

Governments around the globe have been waiving common Intellectual Property (IP) laws for the
treatment of COVID-19, which has adversely impacted the world. This has become a matter of
concern for pharmaceutical firms, who are fiercely protective of their IP. BioSpectrum Asia delves
into IP during the coronavirus pandemic and its impact on pharma innovation.

Not all firms think alike though. When it comes of dollars and the chances of developing something are
to sharing IP, pharma firms are quite divided still not very good,” said Dr Albert Bourla, CEO, Pfizer in
on the matter. There have been voluntary a statement.
licenses from firms such as US based AbbVie, which has
suspended its global patent rights for Kaletra, an HIV Some pharma firms have taken steps to protect
drug that has been identified as a potential treatment their IP. The Wuhan Institute of Virology of the Chinese
for the coronavirus. Similarly, Gilead Sciences, Inc, an Academy of Sciences announced that it has applied to
American biopharmaceutical company, has signed non- patent the use of remdesivir in China. In March 2020,
exclusive voluntary licensing agreements with generic Gilead had sought and was subsequently granted, an
pharmaceutical manufacturers based in Egypt, India orphan drug designation for remdesivir as a potential
and Pakistan to further expand supply of remdesivir, its treatment for COVID-19. But the company rescinded its
antiviral drug used for the treatment of COVID-19. decision following criticism and backlash from the public.

Labrador Diagnostics, an American company, Best practices
has also offered to grant royalty-free licenses to third
parties to use its patented diagnostics technology for Despite diverging views on IP, is it possible for pharma
use in tests directed to COVID-19. Swiss firm Roche, has firms to adopt some best practices to protect their IP
also recently released details of a formulation used in during this crisis? At the same time, there must be a
testing kits for the virus, following a plea from the Dutch balance between public health and private interests.
government, according to reports. Pharma firms have
been collaborating with each other, sharing expertise “Be flexible. If cash is tight, then stretch timelines
and technologies. Most of the firms are also part of the and costs out while keeping IP rights alive. Protect
World Health Organization (WHO’s) COVID-19 Tools COVID-19 related technologies quickly with IP filings,
Accelerator, which brings together many different because the space is highly competitive. And lastly, be
organizations to speed-up drug development. open to supporting public entities through collaboration
or materials. For example, in Canada, the French
However, most of the big pharma firms have pushed company, BioMerieux, provided proprietary diagnostic
back against waiving IP rights as well as the concept of reagent formulation information to a government
patent pool, as they feel it hampers innovation. microbiology lab to support the lab’s COVID-19 work,”
revealed Noel Courage, Partner, Bereskin & Parr LLP, a
The WHO announced on May 29, 2020, the COVID-19 Canadian IP law firm.
Technology Access Pool (C-TAP) that will compile, in
one place, pledges of commitment made under the For those who don’t wish to voluntary license their
Solidarity Call to Action to voluntarily share COVID-19 IP can still share their it though patent pool platforms,
health technology related knowledge, intellectual advises Noel. He said, ‘‘There are initiatives such as the
property and data. Most of the developing countries such Open Covid Pledge for those, who wish to make a license
as Indonesia, Malaysia, Bangladesh, etc. have joined the
WHO’s Solidarity Call to Action. However, none of the “With partnerships adding
pharma firms have joined the initiative as yet. another layer of regulatory

In fact, big pharma firms such as UK’s AstraZeneca complexity to the already
and USA’s Pfizer have criticized the move. complex pharmaceutical industry,

Pascal Soriot, CEO, AstraZeneca, said in a statement, companies should always seek
“I think IP is a fundamental part of our industry and if legal counsel and consult with
you don’t protect IP, then essentially there is no incentive relevant regulatory authorities
for anybody to innovate.” when navigating antitrust issues.”

“I think it is nonsense and at this point of time it’s also - Dr Marinella Sandros,
dangerous. There’s a giant effort right now happening to Senior Global Product Manager,
find a solution. The risks we are taking [represent] billions GenScript Biotech Corporation, USA

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‘‘There are initiatives such as the “This is not
Open Covid Pledge for those, the time for
who wish to make a license profiteering
widely available on relatively and maximizing
shareholder value
straightforward terms. For core but a time for
technologies, companies are
typically still doing their own solidarity.”

licenses and controlling the IP.” - Ellen ‘t Hoen,
- Noel Courage, Director, Medicines Law & Policy, The Netherlands

Partner, Bereskin & Parr LLP, Canada

widely available on relatively straightforward terms. For rigorous monitoring by governmental agencies (such as
core technologies, companies are typically still doing the Federal Trade Commission and the Department of
their own licenses and controlling the IP.” Justice in the United States). With partnerships adding
another layer of regulatory complexity to the already
As collaborative research agreements continue to complex pharmaceutical industry, companies should
increase rapidly, for a productive partnership, it is often always seek legal counsel and consult with relevant
inevitable that companies will need to share IP in order regulatory authorities when navigating antitrust issues.”
to advance research projects. It is important that these
companies have both legal and non-legal strategies in However, Ellen ‘t Hoen, Director, Medicines Law &
place to protect their IP. Policy, The Netherlands having a different stance said,
“Those of us involved in protecting public health and
“Legal non-disclosure and joint development assuring innovations are accessible are more concerned
agreements outlining the activities of the collaboration in with how firms are sharing their IP in order to ensure
detail should be signed after careful negotiation between the rapid development of much needed COVID-19
partners. In addition, partners should discuss the risks technologies, treatments and vaccines and the scale up
and technical intents of their partnership, and consider of production so all in need can be served. This is not the
training their employees in terms of information that can time for profiteering and maximizing shareholder value
and cannot be shared with a partner,” said Dr Marinella but a time for solidarity. “
Sandros, Senior Global Product Manager, GenScript
Biotech Corporation, USA. “It is also a period where a vast amount of public
money is spent on R&D so the classic model of needing
Echoing similar thoughts Noel said, “Where there is the exclusivity to protect investments is changing. Firms
an opportunity to partner with another company to get should not obsess over protecting IP but consider how
a COVID-19 technology out there, move quickly. But be they can contribute to the global efforts. One way of doing
sure to get IP agreements in place beforehand. Be aware that is by engaging with the WHO’s (C-TAP), which has
of confidentiality, since sometimes partners or media been established to bring IP, know-how, technology etc.
coverage of a technology can inadvertently publicly together at the global level to accelerate efforts and ensure
disclose an invention.” large scale production in various locations,” she added.

With partnerships there’s also an added risk of This is indeed a tricky situation. It’s unlikely that the
navigating anti-trust and competition issues. To avoid pharma industry will change its IP regime overnight,
that companies should seek legal counsel said Dr Sandros but perhaps firms should be a bit flexible with their IP in
and added “While the details of regulatory, insurance, and order to balance public health and private interests. After
agency relationships may differ slightly between different all, what’s the point of spending billions when the drug/
global regions and countries, it also goes without saying vaccine can’t be accessible to all?
that all companies must abide by antitrust and competition
policies in their respective markets and should expect Ayesha Siddiqui

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Time to look for 2nd Gen vaccines

Most pharmaceutical companies, across the world, are working at a breakneck speed to develop
a vaccine for the novel coronavirus. Some companies are concerned that these vaccines may
not be particularly effective in preventing COVID-19 infections in the long-term. This has evoked
the need in them to develop improved, next-generation vaccines against the novel coronavirus.
BioSpectrum discusses this next phase of vaccine development and if it’s too early to think about
the second generation when we don’t even have the first ready yet.

The first confirmed death from COVID-19 He further said “For one, there will likely not be
occurred on January 9, 2020 and triggered the sufficient time to assess the durability of the immune
race to find a course of treatment that would response. Given the existing questions about the
treat, cure and prevent the ill-effects of this novel immune-reactivity of less deadly strains of coronavirus
severe acute respiratory syndrome coronavirus 2 (e.g., those causing the common cold), it will be
(SARS-CoV-2). Most of the pharmaceutical firms chose important to be sure that the immune responses are
to work on developing a vaccine for the new virus. long-lived. Were these vaccines to elicit only temporary
immunity (or no immunity at all in some populations),
According to the World Health Organization then we might unintentionally convey a false sense of
(WHO) various types of vaccines are being researched protection, which in turn could lead to behavior that
and tested; some traditional and others experimental. increases the spread of virus”.
There are about 30 candidate vaccines in clinical
evaluation and 139 candidate vaccines in preclinical “All of this would be important under any
evaluation as of August 20, 2020. circumstance, but is particularly so today because we
are amidst a period of strong anti-science sentiments.
Although this rapid pace is an impressive example The anti-vaccine movement is one example of how the
of how science and medicine can be deployed to
address public health, there are potential problems “A vaccine is intended to trigger
that could arise. a long-lived response, ideally
conferring lifelong protection.
Sharing his concerns on the safety issues related Were a vaccine to trigger an
to COVID-19 vaccine, Dr Michael S Kinch, Director,
Center for Research Innovation in Biotechnology & unsafe cross reaction that causes
Drug Discovery, Washington University in St Louis, persistent inflammation or auto-
USA said, “Importantly, I am just as impatient for a immunity, the outcomes could be
vaccine as everyone else and am confident that we will tragic. Hopefully, the clinical trials
achieve our goal, but we must be aware that certain will exclude this but the time in
risks will likely arise if or because we are cutting
corners. A vaccine is intended to trigger a long-lived which follow up investigation
response, ideally conferring lifelong protection. Were occurs will be so brief that we
a vaccine to trigger an unsafe cross reaction that
causes persistent inflammation or auto-immunity, might miss some of this.”
the outcomes could be tragic. Hopefully, the clinical - Dr Michael S Kinch,
trials will exclude this but the time in which follow up
investigation occurs will be so brief that we might miss Director, Center for Research Innovation in
some of this.” Biotechnology & Drug Discovery,

Washington University, St. Louis, USA

ÄKTA go

Learn more

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DIFFERENT TYPES AND GENERATIONS OF VACCINES

Variables Different Types and Generations of Vaccines

1st generation

Live attenuated vaccines MMR Influenza OPV Chickenpox Yellow fever Hepatitis A

Inactivated vaccines Influenza Hepatitis B IPV Rabies Cholera Plaque Pertussis

2nd generation

Subunit vaccines Hepatitis B Diphtheria Pertussis Anthrax Hemophilus Influenza B

Recombinant vaccines Hepatitis B HSV Rota virus HPV FMD

3rd generation

DNA vaccines HIV Malaria Cancers Influenza Ebola Hepatitis HPV

Source: JAMM International

TYPE OF VACCINES public’s trust in science can be so easily undermined.
We must be careful to avoid adding fuel to that fire”,
AND THEIR CLASSIFICATION added Dr Kinch.

In general, vaccines are divided to 3 generations Next generation vaccines
based on the process of evolution and there are
specific characteristics and covering spectrum in each COVID-19 vaccine development efforts have been
generation. progressing rapidly, but to date remain largely focused
on eliciting a neutralizing antibody response to the
First-Generation Vaccines: Attenuated and spike protein of the virus. The only problem with
inactivated vaccines are identified in the first generation, this approach is that it is short- lived. In addition,
which use a primary method in their production. with vaccines that target spikes alone, there is a risk
Attenuated pathogens, full organisms or inactivated that they may be rendered ineffective due to the high
bacterial toxin, which are effectively immunogenic, likelihood of spike protein mutation.
are used in making these vaccines. There are some
advantages in these kinds of vaccines due to their high That’s why firms like TScan Therapeutics, a US
ability to stimulate innate immunity, induction of long- based biopharmaceutical firm, turned to ‘T cells’,
term protection, easy production, and low production another key component of the immune response, to
costs. However, there are some disadvantages in this address the short-term duration challenge of the first
generation, such as inducing disease due to the use of set of vaccines.
complete pathogen (live or inactivated) and virulence
recursively of the pathogen in the host body. This type of New studies are showing that circulating antibodies
vaccine is known as a traditional vaccine. to SARS-CoV-2 appear to diminish over time, as early
as three months post-infection. Data from SARS-
Second-Generation Vaccines: The first generation CoV-1, the original SARS virus, the virus that caused the
was made by live attenuated pathogens, which had eponymous severe acute respiratory syndrome (SARS)
the possibility of returning to natural and infectious outbreak in 2003, demonstrated a similar decline in
forms and finally disease. Thus, to solve this problem, circulating antibodies. In contrast, the T cell response
researchers and scientists offered second-generation to both SARS-CoV-1 and SARS-CoV-2 appears to be
vaccines. The basis of this generation was subunit long lived and may therefore be necessary to generate
elements, recombinant or synthetic proteins, non-protein long-term immunity.
antigens, and expressed bacterial imunogene or viruses,
which include numerous molecules and epitopes of “In our recent work pre-published on medRxiv,
different species and strains of pathogens. The subunit, we found that the CD8+ T cells in convalescent
conjugated, and recombinant vaccines are in this COVID-19 patients mostly target proteins other than
generation. the spike protein. In fact, only 10 per cent of the T
cell response targets the spike protein. This means
Third-Generation Vaccines: Immunogenic potential that first-generation vaccines will not generate a T
administration of a plasmid containing a gene encoding cell response that matches the natural T cell response
the antigen, known as genetic vaccines, is categorized to SARS-CoV-2. We think these findings are critical
as third generation vaccines, and is a valuable method, and can now be used to design second-generation
which has been considered by researchers since the vaccines that elicit a more natural T cell response
beginning of 1990s. Different names have been given and hopefully provide long-term protection”, said
for this kind of vaccine, such as DNA vaccines, RNA Dr Gavin MacBeath, Chief Scientific Officer at Tscan
vaccines, and plasmid vaccines. The expertise committee
of WHO vaccination in 1996 chose nucleotide acid that
includes both DNA and RNA vaccines. Furthermore,
genetic immunization and DNA immunization terms were
used for this type of immunization.

Source: JAMM International

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“In our recent work pre-published “By additionally targeting the
on medRxiv, we found that the N antigen, which is highly
CD8+ T cells in convalescent
conserved between SARS-CoV
COVID-19 patients mostly target and SARS-CoV-2 and unlikely to
proteins other than the spike mutate, our vaccine candidate

protein. In fact, only 10 percent is designed to generate long-
of the T cell response targets the term memory T cells activated

spike protein. This means that by N protein, similar to those
first-generation vaccines will memory T cells that have been
not generate a T cell response discovered in SARS-CoV patients
that matches the natural T cell
response to SARS-CoV-2. We 17 years after they recovered.
think these findings are critical These findings underscore the
and can now be used to design
second-generation vaccines importance of developing a
that elicit a more natural T cell more broadly acting CD4+ T
response and hopefully provide cell-centric vaccine that activates
both cell-mediated and antibody
long-term protection”. - Dr Gavin MacBeath, immunity to protect against
Chief Scientific Officer, Tscan Therapeutics, USA
SARS-CoV--2D.”r Patrick Soon-Shiong,
Chairman and CEO, ImmunityBio, USA

Therapeutics, USA. Immunology and Allergy at the University of Sao Paulo
TScan recently inked a $30 million deal with (USP), who is leading the research team for the SARS-
CoV-2 vaccine also aims to discover the relevant B-cell
Novartis to discover and develop novel (T cell receptor) and T-cell epitopes for creating neutralizing antibodies,
TCR-engineered T cell therapies for solid tumors. says a report in BioWorld.

Another firm using the T-cell approach is US Is it too early to think about these second generation
based ImmunityBio. Preclinical results show its next vaccines when there’s no concrete results from the
generation Adeno (hAd5) vaccine, which targets both first, Dr MacBeath doesn’t think so. ‘First-generation
spike (S) and nucleocapsid (N) SARS-CoV-2 proteins, vaccines show promising results in terms of eliciting
generates CD4+ and CD8+ T-cell responses, both of antibodies against the spike protein. Like everyone
which can form long-term immune memory. The firm else, we hope that these vaccines will be effective in
plans to administer the hAd5 vaccine both as a prime preventing infection. However, the antibody response
and a booster to sustain protection against SARS- is only part of the natural immune response to a virus
CoV-2. and T cells play a critical role in providing both short-
term and long-term immunity.
“By additionally targeting the N antigen, which
is highly conserved between SARS-CoV and SARS- “It would be a mistake to wait to see if first-
CoV-2 and unlikely to mutate, our vaccine candidate generation vaccines work before starting development
is designed to generate long-term memory T cells of second-generation vaccines. Our study identified the
activated by N protein, similar to those memory T cells critical components to include in a second-generation
that have been discovered in SARS-CoV patients 17 vaccine and we hope that vaccine developers will
years after they recovered. These findings underscore recognize the value of these results and act quickly”, Dr
the importance of developing a more broadly acting MacBeath added.
CD4+ T cell-centric vaccine that activates both cell-
mediated and antibody immunity to protect against The response from pharmaceutical companies
SARS-CoV-2,” said Dr Patrick Soon-Shiong, Chairman has been exemplary in dealing with the crisis. It is an
and CEO of ImmunityBio in a statement. impeccable feat of science, research and collaboration
to be able to fast track the development of the vaccines
ImmunityBio has filed an Investigational New in merely a few months, which usually takes years.
Drug (IND) application with the US Food and Drug Concerns about the first generation are in no way
Administration (FDA) to initiate Phase 1 trials of this undermining the efforts of these companies. It’s just
next-generation hAd5 S+N vaccine to be administered that we should be realist with our expectations of the
subcutaneously in healthy volunteers. The company vaccine, which is currently seen as a silver bullet that
plans to submit the full data from this study for will end this pandemic. It’s likely we’ll need more than
publication in a peer-reviewed journal. one vaccine to protect everyone across the globe.

Aided by federal funds from the Brazilian Ayesha Siddiqui
government, Dr Jorge Kalil, professor of Clinical

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WHO on the
centre stage

The COVID-19 pandemic, with Wuhan in China as its epicenter has wreaked havoc worldwide on
a monumental scale. Nations of the world were caught unawares and so was the World Health
Organization (WHO). It would seem that this globally active organization has not been able to lead
the world in response to the pandemic. While some countries have been trying to fight and contain
the spread on their own terms, many countries rely on the WHO for its experience in handling
pandemics in the past. The United States of America, and particularly President Donald Trump
has been a vocal critic of the WHO. We will take a look at how the global organization has handled
previous epidemics and whether its criticism is warranted.

This is, perhaps, the first time since the WHO learn about a new virus and its behavior, and you
was established in 1948, that it is tasked with need to make decisions with much uncertainty. And
handling an epidemic of such magnitude. they remain constrained by the willingness and
The pandemic, first detected in December 2019, abilities of individual countries to share information
still rages on, killing 788,000 and affecting 22.4 and coordinate responses. Given the political and
million globally, according to the data from Johns resource constraints, the WHO has performed very
Hopkins University Center for Systems Science and well”, said Dr David Peters, Edgar Berman Professor
Engineering (as on August 20, 2020). and Chair, Department of International Health,
Johns Hopkins Bloomberg School of Public Health,
With an unknown virus, many early assumptions USA.
and strategies had failed. There was little success
in containing the spread of the virus. The WHO Appreciating the many successes of WHO over
has been criticised for its delayed declaration of the years, an editorial in the prestigious New England
a worldwide emergency, ambiguous guidelines Journal of Medicine said that their work touches
about the use of masks and a delay in prohibiting the lives of hundreds of millions. They, however,
international flights. It also delayed in suggesting that added that the “WHO is not perfect. It is governed
there may be airborne spread of infection in addition by a consensus of 194 member states, which often
to the droplet spread of infection. makes decision making slow and bureaucratic. In
particular, the WHO has not been a highly effective
While the US government has stopped funding to rapid response organization”. Their reasoning was,
the organization, most experts in the scientific and “It relies on information from affected countries to
medical field are positive about how the organization investigate outbreaks, and it lacks adequate funding
has handled the crisis. for these investigations.”

Votaries of WHO “A question often asked is whether this criticism
against the WHO is warranted. The answer to this
“In this crisis, the WHO has played a stronger question is not simple. Most governments and
leadership role and responded quickly and doctors have appreciated the efforts and guidance
proportionately to the threat. During the COVID from the WHO over many decades. Most felt that
pandemic, WHO’s leadership, communications, the criticism against WHO was unduly harsh and
and technical assistance have been particularly not justified, and had political overtones. However,
strong. The WHO has played a central role in many in the scientific community did feel that the
rapidly disseminating information about virus responses from the WHO were unduly measured and
isolation and characterization within a few weeks of cautious,” said Dr Soonu Udani, Medical Director,
recognizing the outbreak. They oversaw the rapid SRCC Chidren’s Hospital. Narayana Health, India.
development of reliable tests for the infection, and
have provided regular evidence-based guidance to Sharing his views Dr Mahesh Balsekar - Senior
address the pandemic. They’ve made missteps, as Consultant, Pediatric Medicine, SRCC Children’s
would be expected, particularly when we need to Hospital, Narayana Health, India, said “The general

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feeling is that China, where the infection originated, SOLIDARITY CALL
withheld crucial information in the early stages of TO ACTION FROM WHO
the outbreak from the WHO and the entire world.
Precious time was lost in the early stages of the The single most important priority
outbreak, when preventive measures were most likely of the global community is to stop the
to be effective.” COVID-19 pandemic in its tracks; to halt its
rapid transmission and reverse the trend of
The WHO’s 70-years of successes and consequential global distress. This goal is only
failures achievable when everyone, everywhere can
access the health technologies they need for
Responding to the criticism Dr Tedros Adhanom COVID-19 detection, prevention, treatment and
Ghebreyesus, Director-General, WHO said, “The response. Now more than ever, international
magnitude of this pandemic, which has touched cooperation and solidarity are vital to restoring
virtually everyone in the world, clearly deserves a global health security, now and for the future.
commensurate evaluation, an honest evaluation.” Toward this aim, WHO called to act key
The WHO issued a statement highlighting its prompt stakeholders and the global community to
responses to the pandemic giving a timeline for their voluntarily pool knowledge, intellectual property
official guidance. It also constituted a committee to and data necessary for COVID-19. Shared
assess the WHO response to the pandemic headed by knowledge, intellectual property and data will
former New Zealand Prime Minister Helen Clark and leverage our collective efforts to advance
former Liberian president Ellen Johnson Sirleaf. scientific discovery, technology development
and broad sharing of the benefits of scientific
The WHO, which was established to coordinate advancement and its applications based on the
international health policy and lead global disease right to health.
surveillance networks and disease control, has many
successes in the past right from its inception. It The COVID-19 pandemic has revealed the
played a pivotal role in the eradication of smallpox. fallibility of traditional ways of working when
It had halted outbreaks of many infectious diseases it comes to equitable access to essential
across countries, including influenza, multidrug- health technologies. This initiative sets out an
resistant tuberculosis, polio, onchocerciasis, alternative, in line with WHO’s efforts to promote
HIV/AIDS, guinea worm, Ebola, Zika, and now global public health goods, based on equity,
COVID-19. strong science, open collaboration and global
solidarity.
Eradication of Smallpox
As a complement to the WHO COVID-19
One of the WHO’s most successful stories is the Strategic Preparedness and Response Plan and
eradication of smallpox. Smallpox has existed for the Access to COVID-19 Tools (ACT) Accelerator,
at least 3,000 years and was one of the world’s most on May 29, WHO called on key stakeholders and
feared diseases with a fatality rate of 30 per cent. the global community to commit to undertaking
The disease killed an estimated 300 million in the the following actions, which are urgently
20th century alone, according to a review paper needed to advance the pooling of knowledge,
by Dr Donald Henderson. From 1958 to 1977, the intellectual property and data that will benefit all
WHO conducted a global vaccination campaign of humanity.
that eradicated smallpox, making it the only human
disease to be eradicated. The smallpox vaccine, vaccination required only one-fourth the amount
introduced by Edward Jenner in 1796, was the first of vaccine needed with previous methods and was
successful vaccine to be developed. simpler to perform.

The global eradication effort initially used a The last known natural case was in Somalia in
strategy of mass vaccination campaigns to achieve 1977. Since then, the only known cases were caused
80 per cent vaccine coverage in each country, by a laboratory accident in 1978 in Birmingham,
and thereafter by case-finding, followed by ring England, which killed one person and caused a
vaccination of all known and possible contacts to seal limited outbreak. Smallpox was officially declared
off the outbreak from the rest of the population. eradicated in 1979. It’s interesting to note that
there are still stocks of smallpox virus in many
In 1961 the bifurcated needle was developed as a laboratories.
more efficient and cost effective alternative, and was
the primary instrument used during the eradication
campaign from 1966 to 1977. The bifurcated needle

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“We need to have better
preparedness in tackling

future microbiological
threats by creating a scalable
infrastructure in diagnostics,
vaccine manufacture and drug
therapeutics, while being wary
of unsubstantiated data in our

need for quick answers.”
- Dr Soonu Udani,

Medical Director, SRCC Children’s Hospital,
Narayana Health, India

“Science is easy, but advising Severe Acute Respiratory Syndrome (SARS)
the public is much more
The 2002-04 SARS outbreak started in China and
complicated, where all other travelled to 30 countries, affecting 8,439 people and
factors must be taken into killed 812. The WHO was able to successfully contain
account, such as resources, the spread of the virus by following measures such as
early case detection, isolation and infection control,
economy, feasibility, and so on. and contact tracing and follow-up surveillance. This
WHO has a very difficult role approach saved thousands of lives as the virus had a
fatality rate of around 10 per cent.
and we are trying to help them”.
- Prof. Lidia Morawska, Sanofi was working on a SARS vaccine but later
halted the project as the virus had disappeared by
Director, International Laboratory for 2004. There’s no successful treatment for SARS yet.
Air Quality and Health, Australia
Swine flu swindle
“We need to revisit the roles,
authority, tools, and enforcement In June 2009, WHO issued a pandemic alert for
mechanisms of WHO in relation H1N1 swine flu virus. The outbreak was milder
than WHO had predicted and the organization
to sovereign states to be able to got a lot of flak for falsely escalating the outbreak
intervene in times of epidemics into a dangerous pandemic, boosting the profits
of pharmaceutical companies. Critics accused the
and health emergencies, to organization of having been too quick to proclaim
see if the current International a pandemic. The Council of Europe said that $18
billion was wasted, and branded WHO’s actions as
Health Regulations can be “one of the greatest medical scandals of the century.”
strengthened.”
- Dr David Peters, Almost all pharma major companies like UK’s
GlaxoSmithKline (GSK), AstraZeneca, France’s Sanofi
Chair, Department of International Health, Johns and Australia’s CSL etc. announced the development
Hopkins Bloomberg School of Public Health, USA of the Swine flu vaccine and governments around
the world committed contractually to purchase with
“The general feeling is that
China, where the infection
originated, withheld crucial
information in the early stages
of the outbreak from the WHO
and the entire world. Precious

time was lost in the early
stages of the outbreak, when
preventive measures were most

likely to be effective.”
- Dr Mahesh Balsekar,

Senior Consultant, Pediatric Medicine,
SRCC Children’s Hospital, Narayana Health, India

COVID-19 33

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

vaccine manufacturers. Pharmaceutical companies about what we need to do, to better manage future
banked more than $7 billion as governments’ pandemics. Clearly, we need to pay more attention
stockpiled drugs, according to City analysts. to healthcare and allocate adequate funds in national
budgets.
A total of three internal and external
investigations- the independent WHO panel, the “We need to have better preparedness in
Council of Europe and the BMJ/BIJ (the British tackling future microbiological threats by creating
Medical Journal /the Bureau of Investigative a scalable infrastructure in diagnostics, vaccine
Journalism) were launched into the organization’s manufacture and drug therapeutics, while being
management of the crisis. The investigations didn’t wary of unsubstantiated data in our need for quick
find any foul play but the whole episode did put a answers. Most importantly, we need to ensure full
dent in WHO’s image as a neutral body. and complete cooperation between the entire world,
to spearhead our battles against future infections and
Ebola pandemics”, said Dr Soonu.

The Ebola outbreak began in 2013 and the WHO “The WHO and other international organizations
declared a public health emergency in August 2014. are limited in how they respond to epidemics that
Health experts and critics alike blistered at the cross borders. Each country has their own priorities,
organization for the failure of quick response. This their own political and economic interests. We need
was the largest Ebola outbreak since the virus was to revisit the roles, authority, tools, and enforcement
first discovered in 1976. The outbreak started in mechanisms of WHO in relation to sovereign states
Guinea and then moved across land borders to Sierra to be able to intervene in times of epidemics and
Leone and Liberia. As of May 8, 2016, the WHO health emergencies, to see if the current International
reported a total of 28,646 suspected cases and 11,323 Health Regulations can be strengthened”, said Dr
deaths (39.5 per cent). V920, Merck’s investigational Peters.
Ebola Zaire vaccine approved by both the EU and the
FDA, which WHO used to stop the 2018-19 Ebola Every country needs to prepare for health
outbreak. emergencies better. This is not just limited to
technical issues like disease surveillance systems.
What’s next? We need stronger community-based public
health systems that can reach marginalized and
There has been much introspection and debate disadvantaged groups, who are often hardest hit by
epidemics like this one.

“We also need more investment in areas that
protect the health of the community, such as
sanitation systems, pollution control measures,
and health education, and then be able to rely on
community resources to be on the frontlines of
preparedness, prevention, and response to epidemics
and other health emergencies”, added Dr Peters.

“I’m lucky that I am a scientist and not a public
health regulator. Science is easy, but advising the
public is much more complicated, where all other
factors that have nothing to do with science must
be taken into account, such as resources, economy,
feasibility, and so on. WHO has a very difficult role
and we are trying to help them”, said Professor Lidia
Morawska, Director, International Laboratory for
Air Quality and Health; Co-Director for Australia,
Australia-China Centre for Air Quality Science and
Management, Australia.

The WHO is not without flaws, like every
organization it must evolve and learn from past
mistakes. What we need is a better and coordinated
response, as a world without the WHO is
unimaginable.

Ayesha Siddiqui

34 STARTUPS

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

LianBio – accelerating
availability of paradigm-shifting
medicines for Asian markets

New and dynamic companies are being formed to bridge the gap between global innovation
and the China market and accelerate access to innovative new drugs from the US, Europe and
elsewhere that address unmet patient needs. LianBio from China is one such company having
mission to provide access to the best science-driven therapeutic discoveries to patients in China
and major Asian markets.

Asia Pacific (APAC) is witnessing enormous local networks and capabilities in both emerging and
challenges related to accessibility and established markets.
affordability of healthcare solutions. This is
especially evident in China, where regulatory and Perceptive Advisors, LianBio’s parent company, is
Intellectual property (IP) reforms, as well as burgeoning a leading life science focused investment firm, which
consumer demand for innovative drugs are creating identifies and supports opportunities in the life science
favourable market conditions in the world’s one of industry and directs financial resources toward the
the largest pharmaceutical market. New and dynamic most promising healthcare technologies. The firm has
companies are being formed to bridge the gap between over $7 billion of assets under management as of June
global innovation and the China market and accelerate 30, 2020.
access to innovative new drugs from the US, Europe
and elsewhere that address unmet patient needs. Helmed by CEO, Bing Li PhD and President &
Chief Business Officer Debra Yu, MD, LianBio has
Investment platforms are providing smart solutions assembled a strong executive team of highly regarded
to bring in clinical providers, commercial partners and industry veterans with demonstrated experience
impactful startups to accelerate drug and therapeutic leading pharmaceutical development in local and
development to thrive into emerging Asian market. cross-border markets. Konstantin Poukalov, Managing
Ventures capitalists assist biopharmaceuticals Director, Perceptive Advisors and Executive Chairman
companies at all stages of development, be it company’s of LianBio, said “LianBio is positioned to leverage
early-stage designing, testing transformative critical resources in APAC countries to advance the
technologies or to commercial-stage companies seeking development of its promising pipeline to bring better
additional growth. With diversified portfolios, these medicines to patients.”
biopharmaceuticals, medical device and digital health
companies focus on significant healthcare needs. Dr Yu said, “We seek to establish various types of
relationships on the ground and become an important
One such company is Shanghai and Princeton- part of the ecosystem. A key differentiator is our ability
based LianBio, which was launched on August 11, 2020 to source unique paradigm-shifting assets and to bring
by Perceptive Advisors to catalyze the development and these transformative programmes from development
accelerate availability of paradigm-shifting medicines through registration in our territories. We may consider
to patients in China and major Asian markets through local partners to help us with commercialization to
partnerships that provide access to the best science- enable us to be more efficient and get needed medicines
driven therapeutic discoveries. LianBio collaborates to patients through established channels. It should also
with world-class partners across a diverse array of be noted that we source science globally and are open to
therapeutic areas to build out a pipeline based on supporting and advancing programmes sourced from
disease relevance and the ability to impact patients within APAC as well as from abroad”.
with transformative mechanisms and precision-based
therapeutics. “Our functional teams are based in China and the
US; this includes medical, clinical development, and
The agile structure of the company enables it to regulatory affairs. Our unique programmes inspire top
act quickly on opportunities through its network of talent to join us since these expert drug developers want
scientific advisors and strategic partners to enhance to shepherd the best medicines that can truly impact
treatment paradigms,” she added.

S TA R T U P S 35

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

LianBio’s operational leaders and executives mine “We hope the increased
science mechanism, clinical data, local epidemiology focus and awareness
and other factors to select their target programmes. on health at all levels
“Driven by patient need, we take a nimble approach of society today will
to regional development strategy and evaluate each
opportunity individually with an eye toward our further enhance global
potential to affect change and incremental value with a cooperation.”
specific partnership opportunity”, says Dr Yu. - Dr Debra Yu,

A new generation business model President & Chief Business Officer, LianBio

LianBio’s New Generation model is founded on the world’s leading precision-based therapeutics and
basis of several key elements leveraging knowledge, transformative mechanisms by employing a scientific
network, and resources to create a unique and and market insight-influenced approach. Products
promising opportunity in APAC healthcare markets. and unique technology platforms are selected with the
goal of bringing better medicines to patients. Potential
Elaborating further, Dr Yu says, “First and foremost assets are evaluated with a rigorous and data-driven
is access to world-class medicines discovered and approach, aligned with developmental opportunities.
developed by world-class companies through our
relationship with Perceptive who is not only the founder LianBio’s cardiorenal subsidiary is anchored by
but the foundation of our business development efforts. mavacamten. Mavacamten is a first-in-class small
Second is our organizational structure, which is built molecule therapeutic that reversibly binds to myosin
for operational flexibility. Third is the establishment to directly target the excess contractility and impaired
of important anchor partnerships which we expect to relaxation underlying hypertrophic cardiomyopathy
expand in the near future.” (HCM).

LianBio, with multiple strategic alliances, LianBio is also pursuing the study of infigratinib
collaborates with world-class partners across a diverse in first line cholangiocarcinoma in mainland China
array of therapeutic and geographic areas to build as part of QED’s PROOF global Phase 3 study and
out a therapeutic pipeline addressing core medical further plans to initiate a Phase 2a study of infigratinib
treatment needs. LianBio has established partnership in gastric cancer and other FGFR-driven tumors.
with BridgeBio Pharma, MyoKardia, and BridgeBio In addition, LianBio has licensed in BBP-398 from
Pharma affiliate companies Navire Pharma and QED Navire Pharma, a novel SHP2 inhibitor focused on
Therapeutics to develop and commercialize cutting- treating drug resistant tumors and other hard to treat
edge therapeutics in major APAC markets. cancers. LianBio will initially be studying BBP-398 in
combination with various agents in solid tumors such as
Additionally, LianBio is tapping an unparalleled NSCLC, colorectal and pancreatic cancer, in mainland
global innovation mining platform that matches China and other major Asian markets.
scientific opportunity to local medical need and
provides options to select venture partners. The model Sharing insights on investment opportunities at
opens access to the large and dynamic healthcare APAC life science sectors in the post-COVID era, Dr Yu
ecosystem in Asia. observes, “There continues to be a tremendous amount
of activity in the life sciences sector right now. The capital
Diversified therapeutic portfolio markets in US, Hong Kong and STAR/A shares are very
active with biotech and other healthcare listings, which
LianBio leverage Perceptive Advisors’ two decades is an indicator of the appreciation and interest for the
of investing experience in innovation to pick clinical sector. Focusing on China, the proliferation of new life
candidates based on a deep understanding of patient sciences companies, the growth in investment dollars
conditions and disease treatment paradigm in APAC targeting life sciences and the increasing reforms
markets. for regulatory approval, transparent pricing and IP
protection have been significant tailwinds for the past
Through a series of strategic partnership, licensing several years. We believe these trends will continue. We
and development agreements LianBio is assisting also have not seen the pace slow down on the partnering
industries at local Asian markets in developing front. We hope the increased focus and awareness on
promising late-stage assets. Currently the portfolio health at all levels of society today will further enhance
includes several late-stage cardiorenal and oncology global cooperation.”
assets for China and major Asian markets.
Hithaishi C Bhaskar
The firm builds a pipeline driven by disease [email protected]
relevance and patient impact to target critical unmet
medical needs. LianBio is focused on sourcing the

36 Q&A

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

“Value of research conducted within academic
institutions will be better appreciated in future”

« How challenging is the development of antibodies?
Affinity’s Retained Display (ReD) platform is more
Dr Peter Smith, than capable of generating quality antibodies against
CEO, Affinity the SARS-CoV-2 Spike protein. The challenge is in
Biosciences, Australia generating effective neutralising antibodies. Firstly,
the antibodies must be high affinity or they will not
Founded in 2009, Melbourne-based Affinity remain attached (and therefore neutralising) in
Biosciences, whose key focus is on discovering the bloodstream long enough to prevent infection.
antibodies for cancer therapeutics, is now Secondly, the antibodies must actually inhibit the
working on antibodies for COVID-19. The neutralizing ability of the COVID-19 spike protein to interact with
antibodies under trial could be useful for vaccine its target receptor ACE2. We were able to complete
development for a rapid therapy or to protect people this process successfully. The Peter Doherty Institute
in high-risk situations such as healthcare workers or for Infection and Immunity in Melbourne released
people in direct contact with COVID-19 patients. In an its assessment confirming that our lead antibodies
email interview with us, Dr Peter Smith, CEO, Affinity are capable of completely neutralising SARS-CoV-2,
Biosciences, Australia, shares with us key insights and are amongst the most potent reported to date.
into their COVID-19 antibody therapy and the biotech Additionally, through our screening, we also identified
industry in Australia. Edited excerpts; antibodies that could actually enhance the spike-
ACE2 interaction. Obviously, these are not our lead
antibodies, but they are now undergoing further study
at the La Jolla Institute for Immunology. Observation
of these antibodies will give us an understanding of
why they enhance binding and may help guide the
development of vaccines moving forward.

What are your reflections on the COVID-19 How has the pandemic affected your workforce?
situation? We are lucky to have a flexible team. From the onset of
Globally, the biotech industry has risen to the the pandemic, we broke into two quarantined teams,
challenge with an amazing degree of collaboration and ensuring that if any one did fall ill, the other half of
urgency. There will be relatively few winners out of all the company could keep working. This split allows for
of this activity but, if we are to get the pandemic fully longer experiments to be run and reinforces resilience
under control, there will be a need for multiple sources in our projects.
of vaccines, antibodies and other therapeutics. It will
be fascinating to see how well new technologies like What long term impact do you foresee on the
the RNA vaccines work. Australian biotech industry?
Hopefully, the value of the research that is conducted
What is your role in the global race to find a cure? within academic institutions will be better appreciated
Affinity’s core business is generating antibodies in the future. The industry may also get a boost from
against cancer targets. However, as the extent of greater research into pandemic preparedness to ensure
the COVID-19 crisis became apparent we decided that we are ready with vaccines, antibodies, small
to focus the majority of our research team to molecules and diagnostics much faster. There was no
screening for antibodies against the SARS-CoV-2 money available for such work before COVID-19. We
spike protein, running three screens in parallel. We know that because we had conversations with multiple
continue to screen human ACE2 for neutralising groups suggesting that Affinity’s ReD platform could
antibodies as part of a consortium funded by the be made faster to enable a more rapid medical
Medical Research Futures Fund and Department response. We would like to see Australian technologies
of Health and Human Sciences, supported by the such as our ReD platform being integrated with other
Australian federal government and state of Victoria technologies to provide the sort of medical counter
respectively. measures required when the next pandemic hits.

Ayesha Siddiqui

Q&A 37

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

“We are speeding up distribution of IFN-β-1a

in Singapore for COVID-19 management”

One of the first companies to partner with Gilead «
to manufacture remdesivir for COVID-19
treatment, Singapore headquartered SRS Life Suchet Rastogi,
Sciences is currently working on multiple projects to Chief Executive
combat this pandemic. Suchet Rastogi, Chief Executive Officer, SRS Life
Officer, SRS Life Sciences spoke to BioSpectrum Sciences, India
Asia and revealed the major steps being taken by the
company currently. Edited excerpts;

How is the company contributing to the fight their GDP on healthcare while in markets where SRS
against COVID-19 within Asia and outside? serves, the expenditure is less than 5 per cent of GDP.
We have entered into a partnership with Jubilant Life On a per capita basis, emerging market spending
Sciences to manufacture and distribute remdesivir, a is just 5 per cent of that of developed nations. With
potential therapy for the treatment of COVID-19 across scarce government resources channeled into testing
the world. The aim of this partnership is to scale up and treatment of COVID-19, longstanding challenges
production to enable expedited access to this medicine such as tackling diarrheal diseases, tuberculosis (TB),
in around 127 countries. We are also working with malaria, and AIDS are at risk of being neglected.
the National University Heart Centre in Singapore Together with respiratory tract infections, these
(NUHCS) to try and mitigate the risk of COVID-19 conditions normally account for more than 90 per cent
exposure to their doctors by providing SRS-designed of deaths in emerging nations. Other than increasing
and FDA-approved AI-enabled electronic stethoscopes spending on healthcare, there is a need to equip these
for teleconsultation. As the stethoscope has no tubing populations with innovative, cost-effective solutions
like a traditional stethoscope, this also makes it safe addressed to the most urgent needs of that country
for patients. Additionally, a very recent development is with the right analysis of its burden of disease. This
that we are working together with one of our partners can only be done through structured partnerships
Singapore Bio, to help speed up the distribution of between public and private stakeholders. The new
IFN-β-1a in the region. This distribution is based on paradigms opened by the pandemic can be seen by the
results from a clinical trial that supports the use of healthcare system as an opportunity in this crisis.
IFN-β-1a in combination with hydroxychloroquine and
lopinavir/ritonavir in the management of COVID-19. What are the major plans in store at SRS?
Tocilizumab, a monoclonal antibody directed against SRS is working on a framework to involve local partners
the interleukin-6 receptor, has been proposed to and healthcare practitioners with innovators. This is an
mitigate the cytokine storm syndrome associated with important step in seeing the healthcare system from
severe COVID-19. Patients with COVID-19 requiring the perspective of healthcare service providers, which
ICU support, who received tocilizumab had reduced gives us a real view of what skills and tools are needed
mortality. This product is also available by us through to fill the gaps and what the trends or predictions are
worldwide networks to organizations and governments for the future. We are working on minimally invasive
for use in their countries. Outside of the region, we are surgery tools, effective AI solutions for the diagnosis of
also spearheading a clinical trial among 315 healthcare respiratory and cardiac diseases as well as preventative
workers, who have been exposed to COVID-19, to cardiovascular solutions to name a few. With these
evaluate the efficacy of a supplement in preventing attempts, we would also like to invite innovators
COVID-19 infection. This trial is being run out of and change-makers to work collaboratively and
centers in Germany, the United Kingdom, and Spain. transparently with SRS to bring the change needed in
the world.
How has the pandemic impacted the healthcare
system in the emerging countries? Dr Manbeena Chawla
The pandemic has exposed a clear disparity i.e. [email protected]
developed markets spend about 12 to 14 per cent of

38 OPPORTUNITIES

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Adopt an agile & omni-channel
approach for success

« not just the startups but also the insurance companies
such as AIA, AXA, and Prudential that have partnered
Dinesh Sampath with hospitals and telemedicine companies to offer
Rangaraj, healthcare services and medicines to its customers.
Frost & Sullivan,
APAC region, Kuala Though the telemedicine platforms may not
Lumpur, Malaysia offset the in-person interactions, but pharmaceutical
companies could potentially leverage these
The COVID-19 pandemic has disrupted the partnerships to design a new Omni-channel approach
traditional business models of companies. to serve patients moving beyond just digital marketing
While digital transformation has been part of the initiatives.
pharmaceutical industry, typically it has been a slow
progress in adoption and implementation of digital It is critical for companies to adopt the following
transformation initiatives. best practices before embarking on an Omni-channel
approach.
Access to doctors has been impacted significantly
both for the pharmaceutical sales and also for 1. Segmentation – Assess various customers
physician’s access to patients due to the pandemic. A segments for their behavior, needs and expectations in
survey by IQVIA shows that there has been 74 per cent the new normal. Not all the customers will be ready to
decrease in in-patient visits, 36 per cent reduction in move to the new interactive approach hence there is a
patient referrals, 29 per cent delay in diagnosis and 28 need to assess the maturity level and develop a staged
per cent postponement of surgeries in the first three approach to address the needs through new approach/
months of year 2020. model.

Pharmaceutical companies have been at the 2. Services – Map out the new physician and
forefront in supporting the healthcare industry to focus patient journey during the pandemic and develop post-
on the immediate crisis, however it is an opportunity pandemic scenarios and their implications. Design and
for companies to have a holistic approach towards develop the portfolio of services/solutions based on the
servicing the healthcare industry through a patient- new journey and the touch points that are critical.
centric model. The top priorities for the pharmaceutical
companies is to ensure that the patients are able to 3. Structure – Follow the segmentation and the
get access to their physicians for consultation and services steps to design the structure of the organization
prescription, consistent delivery of drugs, monitoring that can deliver to the customers. If required, restructure
of patients outside clinical settings. teams that can be aligned by brand and therapeutic
areas to customer segments. Focus on partnerships
New age tech startups are enabling the healthcare with existing digital platform companies in the market
industry to adapt to the new normal and meeting to develop a modular and flexible solution.
the needs of the healthcare industry through digital
enablement. There are several telemedicine platform 4. Scale - A key challenge of healthcare companies
companies in South East Asia that have witnessed that adopt digital technology to provide services and
a surge in the number of subscribers as well as solutions has been the ability to scale. Pharmaceutical
consultations. It was estimated that these companies, companies have to align their value propositions to the
which include Doctor Anywhere, MyDoc, Halodoc, needs of the market – access to new patients, address
Alodoctor witnessed more than 100 per cent increase in challenges due to access or affordability, enable remote
the number of users and have been working with public diagnosis and increase physician and patient education.
health authorities to extend healthcare access and Customizing the partnerships based on geography and
services to patients during the on-going pandemic. It is the country landscape can enable companies to drive
penetration and scale.

The current situation offers multiple opportunities
for pharmaceutical companies to combine both the
traditional and the digital approach towards serving the
customer. However, companies have to adopt an agile
approach and execution is the key to success in moving
to a digital and an Omni-channel approach.

TECHNOLOGY 39

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Simulating technology solutions to fight COVID-19

Use of engineering simulation technology is «
common in the global healthcare industry.
US Food and Drug Administration (FDA) & Hemant Punekar,
European regulatory agencies are encouraging the Application
healthcare companies to use Computer Modeling Engineering Manager
& Simulation (CM&S) to aid the approval process - Healthcare, Ansys,
for medical devices and achieve quality by design India
in pharmaceutical manufacturing. Simulations are
used for a variety of applications like disinfection of air velocity and the vortices formed in the conduit,
aircraft cabins with UV lights, studying the aerosol to enabling engineers to optimize sensor locations.
determine social distancing norms, modelling mask
for effective usage, designing the negative pressure Scaling up vaccine production
rooms, designing the ventilators, decontamination
of personal protective equipment (PPEs) in UV For the first time in the history of mankind, a vaccine
chambers, modelling mobile COVID-19 sample will be produced not for millions but for billions.
collection booths, inhalation and drug delivery, scaling Once a vaccine gets the approval, one of the biggest
up the production of vaccines and medicines etc. challenges facing the biopharma industry is scaling
up the production of the vaccine from laboratory
Ventilator design to industrial scale. This involves complex process
engineering in which key flow parameters have to
When the COVID-19 infection spreads to the lungs, the match at both the scales in order to get the right quality
patient often needs to be supported with a ventilator. and quantity of vaccine in the expected time. Although
With an exponential rise in the number of COVID-19 chemical engineers have developed the art of scale-
patients globally, we saw an unprecedented demand up in the past century or so, nobody can guarantee
for the ventilators. Several efforts started worldwide to success. CFD provides a virtual environment in which
meet this demand but the key challenges in the design the bioreactors of any scale can be modelled and a
of a ventilator are adequate delivery of air and oxygen 3-D flow field can be visualized and analyzed. Also,
to the alveola; efficient extraction of CO2; automating the computational effort required for a lab-scale and
manual resuscitator; lightweight design; reliability; industrial scale is similar, if not exactly the same.
and accurate flow control.
Hence it allows evaluation of different designs
To meet these challenges, simulation technology rather quickly, making possible parametric studies
can provide insights into airflow patterns and over the full Design of Experiments (DoE) space.
mechanical strength and life. For example, US By using this technology, vaccine manufacturing
based Bessel LLC worked with a team of doctors and companies can increase their chances of getting the
engineers from Texas University to develop the Texas scale-up process right the first time.
Power Bag Breather. Using simulations, in a matter
of a few weeks instead of months, a new emergency UV decontamination
care device was designed and extensively tested
to demonstrate its ability to safely meet required Time effective UV decontamination of worn masks is
emergency ventilatory support performance during a promising solution to prevent the shortage of clean
its expected life cycle. The approval from regulatory masks for healthcare workers. Simulation enables
agencies for emergency use is still awaited. sterilizer designers to ensure that each potentially
contaminated PPE surface will receive the necessary
An Indian startup Robotics has developed Noccarc dose of UV irradiation. Simulation technology can
V310, an indigenous, reliable and safe ventilator to be used to design any medical device or pharma
fight the COVID-19 outbreak in India. The company manufacturing equipment. It can lead to better
used simulations to design and optimize ventilators quality, increased safety and reduction in cost and
that can be manufactured on a large scale at multiple time to market, all of which is very much required to
sites using materials easily available with Indian combat COVID-19 pandemic.
suppliers and manufacturers. A computational fluid
dynamics (CFD) study provided a detailed flow field
of a conduit with different sensor tappings for the
flow circuit of a ventilator. The animation shows the

40 SUPPLY CHAIN

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Invest in building agile supply chains

« and cost-effective distribution strategies. In addition
to that, the Indian government had already done the
Alagu Subramaniam, groundwork for establishing stringent regulations,
Managing Director, even as price regulations were expected to have an
West Pharmaceutical impact on trade margins.
Services, India
The new normal
The current pandemic has significantly disrupted
the global economy, not to mention business Domestic companies are now working towards
continuity for many companies. This has also designing an adaptive, compliant and flexible supply
led to global disruption of supply chains for many chain environment. Transparency across the supply
industries, including the pharmaceutical and medical chain is a requisite to be able to determine the origin
device industries, thus making it necessary for of the product at any level of the supply chain, so
countries to introspect and plan accordingly. that probable shortages can be handled through
diversification. Also, existing complexities are being
In India, approximately 65- 70 per cent of Active reduced through consolidation and optimization
Pharmaceutical Ingredients (APIs) required for of the entire network based on product line, target
manufacturing key medicines in the pharma sector market and customer type.
are imported. The Indian pharmaceutical sector
caters to over 50 per cent of global demand for various Technology can play a crucial part in transforming
vaccines, while serving to 20 per cent of the global the medical device supply chain ecosystem. For
supply by volume. It accounts for 1.5 per cent of the instance, artificial intelligence, big data, automation,
value of global pharmaceutical production and had a and machine learning can offer real-time visibility
high probability of becoming the third-largest market to strategize and mitigate risks. These technologies
in the world, during the pre-pandemic period. can trigger alerts based on internal and external data
feeds, forecasting demand and improving workflows.
Like medicines, medical devices and equipment
are also key drivers of growth in the pharmaceutical Having alternate supply provisions can reduce
industry, with India currently being the fourth largest probable losses and ensure sufficient stockpiles as a
medical devices market in Asia after Japan, China and buffer during emergencies. On this premise, global
South Korea. In fact, the Indian medical device market pharmaceutical and medical device companies are
is expected to grow to $50 billion by 2025. reassessing their risk management strategies and
evaluating potential issues arising from the loss of a
However, even before the pandemic hit, the supply chain partner or location.
pharmaceutical supply chain infrastructure had
numerous challenges, including: (i) fragmented, Several global medical device manufacturers
multi-layered and complicated supply chain; are speeding up the development and large-scale
(ii) inter-state transfer pricing challenges, taxes, production of components required to serve customer
etc.; (iii) product proliferation resulting in higher needs, by adopting measures like labour and
manufacturing and distribution costs, larger supplier equipment resource expansion.
base, higher expirations rate and increased employee
turnover; (iv) legacy supply chain and manufacturing In addition, the central government has announced
methods with low tolerance to change; and (v) quality four schemes to stimulate domestic manufacturing of
and regulatory issues. bulk drugs and medical devices, earmarking a total
budget of about Rs 12,000 crore over multiple years.
An effective supply chain plays a pivotal role
in ensuring quality, safety and efficacy of the final The pharmaceutical supply chain is the lynchpin
product, be it drugs or medical devices and equipment. that connects the laboratory to the end user. However,
The industry was already working on developing an majority of investments in this industry is funnelled
integrated global supply chain system, with innovative into areas of research, development and marketing,
with less regard given to setting up proficient supply
chains. Proactive companies with next-generation
supply chain management systems can mitigate
downtime to deliver on customer commitments. Thus,
the most successful pharma players of tomorrow will
be those who invest in and build agile and efficient
supply chains, both virtually and physically, today.

EVENT REPORT 41

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Taiwan’s President Tsai Ing-wen (in the center) inaugurating the 5-day BIO Asia–Taiwan 2020 along with other dignitaries on July 22
at TaiNEX 2 Exhibition hall in Nankang, Taipei, Taiwan.

BIO Asia–Taiwan 2020

1,400 delegates, 450 exhibitors
take part in 5-day event
As the world is facing the unprecedented
challenge of COVID-19, biomedical companies, explore business opportunities with Taiwan’s emerging
emerging startups, MNC’s are being cooperative biotech sector. More than 1400 registrants from over
and rallying together to accelerate the development of 30 countries attended the annual conference either
therapeutics, diagnostics and vaccine to fight the global online or on-site adhering to the COVID-19 guidelines.
and regional healthcare crisis. Healthcare is more The conference offered 14 sessions in the areas of
strongly inclined towards international partnerships fighting pandemics, digital health, advanced therapies,
and collaborations than ever to upgrade to next- precision medicine, and investment and collaboration.
gen medical revolutions. Recently, BIO Asia-Taiwan There were also workshops covering entrepreneurship
congregated global experts to share lessons learnt and clinical trials. The Exhibition drew 450 exhibitors
from the pandemic, best practices, standardized public with 1500 booths on-site and 200 companies online.
private collaborations supporting advancements of Over 100 company presentations and startup pitches,
treatments and vaccines, novel therapeutic and digital and 6000 requests for one-on-one partnering meetings
health ventures, development of efficient public policies also took place online creating countless business,
in respond to the public health crisis and preparedness partnering and investment opportunities.
to tussle the future pandemics.
At the opening ceremony, Taiwan’s President
The BIO Asia–Taiwan International Conference Tsai Ing-wen announced the winners of the annual
and Exhibition (BIO Asia-Taiwan 2020) had a grandeur Taiwan BIO Biotech Industry Awards. Emphasizing
interactive Online + Live event held from July 22 to on Taiwan’s efforts, initiatives and interest in sharing
26 from the event’s onsite base at TaiNEX 2 Exhibition pandemic prevention experience worldwide, Tsai said,
hall in Nangang, Taipei, Taiwan. The novel BIO Asia– “Taiwan’s biotech sector is performing remarkably well,
Taiwan 2020 Online + Live model was co-organized by with 8.7 per cent revenue growth in the last year. Our
the Taiwan Bio Industry Organization (Taiwan BIO) clinical trial standards are recognized widely, with more
and Biotechnology Innovation Organization (BIO) and more overseas trials locating here. Investment in
biotech reached NT$55 billion ($1.8 billion) in 2019.
Event became the world’s first premier APAC With the biomedical industry at the frontline driving
biotech conferences to be held amidst pandemic and discoveries and developments to combat the pandemic,
united biotechnology and pharmaceutical executives opportunities are ripe for partnering, raising funds, and
and investors from North America, Europe and Asia to making deals.”

42 EVENT REPORT

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

BIO One-on-One Partnering system Analytics, New Technology, and Proactive Testing’
which highlighted the 124 action items that Taiwan took
BIO One-on-One Partnering was the official BIO in the first five weeks of the outbreak. The article was
partnering system for 2020 BIO Asia-Taiwan widely read and likely influenced many governments to
International Conference & Exhibition. The partnering emulate Taiwan with strong measures of their own.
platform was -an ideal and effective mode for
international business partnerships in the biopharma An inspirational session on ‘Taiwan’s efforts in
industry without geographical restrictions and with 24- combating COVID-19’ was also delivered by Taiwan’s
hour accessibility over 5 days. The system facilitated former vice president, Chen Chien-jen.
convenient search and meeting requests with potential
partners, biotech investors and senior business Online + Live event
development executives. Open meeting requests could
be generated to express interest in potential onsite BIO Asia–Taiwan 2020 Online + Live focused
and online cross border partnership, expansions, and primarily on five key sectors: Combating the Pandemic,
to identify companies of interest. The tool featured Precision Medicine, Advanced Therapies, Investment
convenient automatic detection of the time zone of the & Collaboration, and Digital Health. The conference
partnering company, self-scheduling meeting solutions, hosted 14 live sessions, 2 workshops, and more than
connectivity with the format of choice, links to online 100 speakers / panelist, company presentations, startup
sessions monitoring the event programming and more. pitching, and more. During the 5-day event, global and
The system also supported business development and Asian pandemic experts shared their experiences and
licensing goals. discussed the latest developments in rapid diagnostics,
therapeutics and vaccines.
Virtual One-on-One partnering allowed strong
insight into a company or organization’s details and On the second day of the conference, a marathon
also provided an interactive visitor engagement of interesting sessions entitled ‘Sharing Biotech
opportunities such as exchanging business cards, Successes’, ‘AI for Therapeutic Innovations’,
forming chat groups or rooms, online lounges, etc., ‘Combating Pandemics (B)’, and ‘Biotech Business
to facilitate and replicate the social and networking Models & Financing Strategy’ were held.
elements to relate with actual conference experience.
For the first three days, July 22- 24, ‘Entrepreneur
Focus on ‘Finding Cures in the Crisis’ Pitch’ sessions 1, 2 and 3 showcased startups coming
out of SPARK Asia, BMCC (BioMed Commercialization
BIO Asia–Taiwan 2020 focused on the theme, ‘Finding Center), and BEST (Biomedical Ecosystem
Cures in the Crisis’, and showcased emerging cutting Development Office in Taiwan) incubators. The session
edge technologies including precision medicine, uncovered the very latest early-stage innovations from
advanced therapies, digital health, telemedicine and startup teams. Additionally, six sessions of company
more. Sessions included ‘Global Trends in Biotech presentations from the best of Asia and around the
Industry’; ‘Accelerating Biomedical Innovations’; world were held; 60+ companies who are opened for
‘Combating Pandemics’; and a finance-focused session, immediate business and partnership held 10 min video
‘A New Paradigm in Biotech Innovation and Investment’ presentations.
immensely enlightened participant’s knowledge on
trending facts. An exclusive session ‘Biotech Business Models
and Financing Strategy’ co-organized by PwC Taiwan
David Flores, President and CEO of BioCentury in and a number of bio-business veterans took the stage
his presentation ‘Today’s Money Magnets in Biotech’, and video screen to share their wisdom in this vital
mentioned the wider impact of pandemic on the future discipline. Speaking in this session were Joseph
of healthcare funding and investments. He added, “A McCracken, Industry Advisor, former Global Head
bigger challenge remains in the financing ecosystem. of BD & Licensing at Roche and Genentech, with his
It’s the ability for companies to build new investor talk ‘Building a Biotechnology Company through
networks, and the ability of companies to find new Collaboration, Licensing and M&A’. He also presented
assets. As such ‘Series A’ financing deals are down on four case studies in collaboration and licensing
expectations, which will affect downstream progress involving Eli Lilly, Roche, IDEC and Genentech.
such as drug pipeline development.”
Ji Li, Venture Partner of Lilly Asia Venture presented
Jason Wang, a pediatrician and the director of ‘Bridge to the Future- Partnering and Collaboration’,
the Center for Policy, Outcomes, and Prevention Kenneth Carter, Head of Corporate Development,
at Stanford, shared his perception with his session Innoforce, presented ‘Swimming with Sharks: Early
‘Combating Pandemics’ quoting his own influential Stage Biotechnology Business Models and Financing
article ‘Response to COVID-19 in Taiwan: Big Data Strategies’.

Shaun Grady, senior vice president of BD

EVENT REPORT 43

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Operations, AstraZeneca, presented ‘AstraZeneca Marshall, Director of New Technologies, of the UK’s
Global Innovation Network at Work’, and mentioned Cell and Gene Therapy Catapult; Ruthanna Davi,
that “AstraZeneca had been busy recently actively Vice President, Data Science, Medidata Solutions;
investing in EU and Asian Union start up joint ventures Rachel Wang Hoffman, Executive Director, Clinical
and incubators. Current operating strategies of major Development, Medical Device & Diagnostics, Syneos
pharmaceutical companies are becoming diversified. Health; and Peter Fromen, Vice President of Population
Going forward cooperation will not be limited to just Genomics, Illumina shared their thoughts.
between other pharma or biotech companies, rather
medical equipment or digital health companies Liang Kung-Yee, the president of the NHRI stated
will increasingly become targets of interest and that while many countries are running large-scale
cooperation.” AstraZeneca established a partnership precision medicine operations where patients’ genetic
recently with the BioHub of National Biotech Research data is being collected, more regional and global
and Development Park affiliated with Academia Sinica, cooperation is essential to bring meaning to the data.
the top research institute in Taiwan. Government and the private sector interests should
be joining hands in this arena. In this way, better
Day three of the conference featured sessions treatments and outcomes industry can be delivered to
covering a wide range of topics including: ‘New Frontiers patients, and the industry can grow and develop.
in Therapeutics’; ‘From Precision Medicine to Precision
Health’; ‘Asian Opportunities & Collaborations’; Taiwan’s leading cancer specialists had an
‘Advances in Cancer Immunotherapy’; and ‘AI and opportunity to explore liver cancer therapy toolkit
Smart Healthcare’. The therapeutics session, opened by by Cheng Ann-Lii, president of National Taiwan
Wu Chung-Hsiun, CEO of the Development Center for University’s Cancer Center, who encouraged Taiwanese
Biotechnology (DCB), along with speakers from Linkou investigators to further achieve the milestone at
Chang Gung Memorial Hospital, DCB, KPMG Taiwan, therapeutic fields. Further, an in-depth session by
Pifzer, and Japan’s Forum for Innovative Regenerative Nobel Laureate Tasujo Honjo on ‘the future of cancer
Medicine, and others. Discussions were rooted to immunotherapy’ and Professor Hans Clever or
cutting-edge technologies and perspectives on new Hubrecht Institute on ‘Organoids to Model Human
innovations such as targeted drugs and cell therapy. Diseases’ among other plenary session speakers were
the major highlight of the event.
Toru Seo, Pfizer Senior Director and APAC
head of Scout and Evaluation, highlighted Pfizer’s Competent partner to enter the global market
emerging therapies based on antibody-drug conjugate
(ADC) technologies, nanoparticles and redirect cell Taiwan’s model of handling COVID-19 has been
cytotoxicity. acclaimed around the world. It demonstrated Taiwan’s
commitment to public health but also a testimony
Japan’s Kunihiko Suzuki, vice chairman of FIRM to Taiwan’s world-class healthcare system, , public
and vice president of cell product contract manufacturer awareness, government strategy, policy and actions
MEDINET, introduced MEDINET’s cell business toward public health crisis. These strengths, successes
and pointed out five major challenges that need to and evidences at Taiwan can contribute internationally.
be considered in the development of a cell therapy Global ecosystem is now expected to work together to
industry. These include the regulatory framework, the address the pandemic for a transformational work to
choice of autologous/allogeneic cell types, cold chain fuel, feel and heal.
logistics, technical transfer challenges of entrusting
production to a CMO after marketing approval, and Johnsee Lee, Chairman, Taiwan Bio Industry
reducing costs. Organization, concluded unique and exciting BIO
Asia–Taiwan 2020 by highlighting Taiwan’s renown
Wei-Kuang Chi, vice president, R&D, Development pandemic prevention efforts and country’s growing
Center for Biotechnology (DCB), reviewed Taiwan advantage in sector like biotech, pharmaceutical,
DCB’s achievements to date in antibody drugs, immuno- medical devices, precision medicine, AI applications,
oncology therapies and cell therapies, including the ICT and IoT technologies as a competent partner
Trimannosyl ADC, the TIM-3 monoclonal antibody, to enter the global market and to encourage local
the DCB’s CAR-T cell therapy technology platform, biotechnology industry.
production process development, and more.
As President Tsai said ‘Taiwan can help and Taiwan
In the session ‘From Precision Medicine to is helping”. BIO Asia-Taiwan 2021 is scheduled for July
Precision Health’, co-organized by Taiwan’s National 21- 25, 2021 in Taipei, hopefully in a COVID-19 free
Health Research Institutes (NHRI), experts such as situation.
Andree Blaukat, Senior VP, Global Head Translational
Innovation Platform Oncology, Merck; Damian Hithaishi. C Bhaskar
[email protected]

44 PEOPLE NEWS

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Maggie Chen steps ASLAN Pharma ropes in
in as CFO at CMAB Dr Kenneth Kobayashi as CMO

CMAB Biopharma (Suzhou) Inc. has Singapore based ASLAN Pharmaceuticals has announced
announced the appointment of Maggie that Dr Kenneth Kobayashi has been appointed Chief
Chen as the Chief Financial Officer (CFO). Medical Officer (CMO). Dr Kobayashi will be based in
Chen will lay a foundation for the long-term California and will be responsible for the global clinical
development of the contract development development of ASLAN’s pipeline, including the lead
and manufacturing organization (CDMO) program, ASLAN004, an antibody that blocks the IL-13
business and commences a new milestone receptor, which is being developed for atopic dermatitis
for CMAB. Maggie has nearly 20 years (AD). Dr Kobayashi has more than 25 years of experience
of experience in listing, in drug development, clinical practice and regulatory
merger and acquisition, affairs as a Dermatology expert. He most recently served
group comprehensive as Senior Medical Director at Dermira, a subsidiary of
financial management Eli Lilly, where he was responsible for
and capital operation. the development of lebrikizumab,
In her career, she has a monoclonal antibody for atopic
served many world- dermatitis, and supported five
renowned pharmaceutical Phase 3 registration studies
and biopharmaceutical together with preclinical and
group companies, and early clinical development for two
has extensive experience in financial and novel compounds. Prior to joining
capital management in pharmaceutical Dermira, Dr Kobayashi was Clinical
area. Before joining CMAB, Maggie served Development Medical Director at
as Vice President and CFO of FOSUN Novartis, in the Immunology,
Pharma Group, comprehensively led the Hepatology and Dermatology
financial management of the Group, and Global Development Unit,
promoted the upgrading of the financial where he supported the
system of both the Group and more than development programs
10 subsidiaries, and was responsible for the for anti-IL-17C and
group’s capitalization projects and external anti-IgE monoclonal
financing. antibodies.

Prof. Sung joins NTU as Dean of Medicine

Nanyang Technological (Health and Life Sciences) taking will formally begin his tenure at
University, Singapore (NTU) responsibility for the integration NTU on April 1, 2021, succeeding
has announced that Professor of university-wide activities in Prof. James Best, who will be
Joseph Sung, an eminent health, medicine and life sciences. retiring after nearly seven years
gastroenterologist and as Dean of LKCMedicine. Prof.
academic leader from He will also be appointed to Sung was the Vice-Chancellor
Hong Kong, will the tenured faculty rank of and President of The Chinese
join NTU Singapore Distinguished University University of Hong Kong (CUHK)
as the new Dean of Professor, the highest from 2010 to 2017, and has held
its Lee Kong Chian faculty rank at NTU the title of the Mok Hing Yiu
School of Medicine bestowed upon faculty Professor of Medicine at CUHK’s
(LKCMedicine). members with extraordinary Department of Medicine and
Prof. Sung will be scholarly achievements Therapeutics since 2007. Before
concurrently that typically serving as vice-chancellor, he was
appointed span multiple Associate Dean of CUHK’s Faculty
NTU’s Senior disciplinary of Medicine and Head of the Shaw
Vice President boundaries. College.
Prof. Sung

PEOPLE NEWS 45

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com Merck appoints
Liz Henderson
DBT India Alliance appoints as RVP at Merck
Dr Sambandamurthy as CEO Biopharma APAC

DBT/Wellcome Trust India Alliance announced the appointment Merck has announced that Liz
of Dr Vasan Sambandamurthy as its next Chief Executive Officer Henderson has been appointed
(CEO). He will succeed Dr Shahid Jameel. Dr Sambandamurthy Regional Vice President (RVP),
joins the India Alliance with over 20 years of Merck Biopharma Asia Pacific
experience in vaccine and drug discovery. He has (APAC). The role is based in
previously held leadership positions at Novartis, Singapore and Liz reports to Chris
AstraZeneca, Syngene and most recently at Round, Head of International
Biocon Limited where he has worked as Chief Operations & Global Core
Scientific Manager and General Manager Franchises, Merck Biopharma.
over the past 6 years. He completed his Liz succeeds Andre Musto, who
post-doctoral training as a Howard Hughes has been promoted within the
Medical Institute (HHMI) fellow at the Albert organization as Senior Vice
Einstein College of Medicine in New York. President and Head of the Global
Dr Sambandamurthy gained his PhD from the Cardiometabolic & Endocrinology
Tuberculosis Research Centre (Indian Council of Franchise, still based in Singapore.
Medical Research) in Chennai and completed Liz’s career began at Merck in
his post-graduate degree in Medical 2009. She will move to Singapore
Microbiology from the Christian Medical from London, where she has been
College and Hospital in Vellore. Managing Director and General
Manager, Merck UK & Republic
WuXi Vaccines of Ireland for the last 18 months.
names Jian Dong as CEO In her new role, she will have
overall P&L responsibility for
WuXi Vaccines has announced the appointment of Jian Dong as the Merck Biopharma Business,
Chief Executive Officer (CEO). WuXi Vaccines is a joint venture covering 11 APAC countries across
established between WuXi Biologics and Shanghai based Hile Bio- the company’s four therapy areas:
Technology. Dong joined WuXi Biologics in 2014, and had been oncology, fertility, neurology
responsible for global biomanufacturing, global and immunology, and general
engineering, and the overall operations of medicine and endocrinology.
Wuxi site since 2015. Under the excellent She is a member of the Global
leadership of Dong, Wuxi site became Commercial Operations Leadership
the first GMP biologics Drug Substance Team at Merck Biopharma and
(DS) and Drug Product (DP) facilities the co-sponsor for the Women in
in China certified by both the US FDA Leadership Asia Council.
and EMA. Prior to WuXi Biologics,
Dong spent decades in various roles
with increasing responsibilities at
Eli Lilly & Co. in the US, Shanghai
United Cell Biotechnology and Shenzhen
Kangtai Biological Products. With
extensive experience in vaccine
manufacturing and facility
qualification, he had made
significant contributions to
the tech transfer and large
scale commercial production
of recombinant hepatitis B
vaccine in China.

46 R&D NEWS

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Singapore offers solution to reverse drug resistance

Scientists at Nanyang

Technological University,

Singapore (NTU) have developed

a synthetic peptide that can make

multidrug-resistant bacteria

sensitive to antibiotics again when

used together with traditional

antibiotics, offering hope for

the prospect of a combination

treatment strategy to tackle

certain antibiotic-tolerant

infections. On its own, the

synthetic antimicrobial peptide

can also kill bacteria that have

grown resistant to antibiotics. The

NTU Singapore team developed structural resemblance to the bacterial cell wall helps the peptide
bacterial cell wall, and repeated interact with and embed itself in
an antimicrobial peptide known units of the amino acid lysine. The it, causing defects in the wall and
scientists believe that chitosan’s membrane that eventually kill the
as CSM5-K5 comprising repeated structural similarity to the bacteria.

units of chitosan, a sugar found

in crustacean shells that bears

Japan studies Korea designs cough
building blocks of detection camera
pharmaceutical drugs
Researchers at the Department of Mechanical
Scientists from Japan based Waseda Engineering in Korea Advanced Institute of Science and
University have recently demonstrated a new Technology (KAIST) have developed a cough detection
method of producing a specific class of organic camera that can contribute to the prevention and early
compounds, which promises to accelerate drug detection of epidemics in public places. Especially when
discovery research for several diseases. Drugs, applied to a hospital room, the patient’s condition can
including those for depression, schizophrenia, be tracked 24 hours a day and support more accurate
and malaria, would not be there if not for a diagnoses while reducing the effort of the medical
type of organic chemical compound called staff. Engineers have developed the model to be able to
alicyclic compounds. By dearomatizing classify a cough from just one second of sound. Coughing
arenes, one can get alicyclic compounds. and other noises, as well as background sounds, are all
Dearomatization is one of the most powerful inputs to allow the model to detect and it is 87 per cent
ways of obtaining alicyclic compounds. But accurate. When combined with a sound camera, the
some of the most abundantly available arenes, software can work out the direction of the incoming
such as benzene and naphthalene, are very noise and label it as a cough.
stable, and breaking them up to construct
alicyclic compounds has been challenging. In
the novel method, bromoarenes are reacted
with two other classes of organic compounds,
diazo compounds, and malonates, in the
presence of a palladium catalyst, under
optimal conditions of concentration,
temperature, and time. Subsequently, good
amounts of the corresponding alicyclic
compounds are produced.

R&D NEWS 47

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com Australia
explores
India builds AI model to repurpose diabetes drug
drugs for COVID-19 treatment to prevent
kidney failure
In a bid to counter the coronavirus pandemic that has been rampaging
around the world, Indraprastha Institute of Information Technology A University of Queensland
(IIIT), Delhi has worked on a computational AI (artificial intelligence) research team has been
model for drug repositioning in the treatment of COVID-19. The AI model awarded $2.57 million
computes the similarity between the chemical structures of the drugs and in federal funding to
the similarity between the genomic structures of existing viruses and the run a clinical trial on the
novel coronavirus. The model then looks at the historical information effectiveness of the low-
about the efficacy of the drugs on different viruses and selects similar cost diabetes medication,
drugs based on chemical structure that have been successful in treating metformin, and its role
viruses that have a genomic structure close to that of the novel coronavirus. in autosomal dominant
Thus far, the AI model has selected remdesivir, umifenovir, ribavirin and polycystic kidney disease
sofosbuvir as prospective cures, and all of them are undergoing trials for (ADPKD). ADPKD begins
COVID-19. The computational model and the state of clinical practice are in childhood and young
thus in sync with each other. adulthood with kidney cyst
growth, and over decades
Hong Kong discovers liver culminates in enlarged
injury in COVID-19 patients painful kidneys, early-onset
hypertension and chronic
Researchers from the Faculty its association with adverse kidney disease. It is the
of Medicine at The Chinese clinical outcomes in COVID-19 fourth-leading cause of
University of Hong Kong (CU patients. These findings have kidney failure that results
Medicine) have recently conducted been published recently in the in people having to go on
a study to investigate the impact world-renowned medical journal dialysis, globally. Only
of liver injury on clinical outcomes Gut. Liver injury, in the form of one treatment therapy for
in COVID-19 patients. Data from hepatitis, cholestasis or both, can polycystic kidney disease is
over 1,000 COVID-19 patients in be observed in patients infected currently available and this
Hong Kong was analysed and liver by different coronaviruses. For is not suitable for everyone.
injury was found in around 20 per the territory-wide study in gut, Research and clinical trials
cent of the patients. The estimated researchers from CU Medicine that deliver new treatments
risk of COVID-19 patients with analysed the data from 1,040 are needed. The trial will
liver injury experiencing adverse COVID-19 patients in Hong be coordinated by the
clinical outcomes such as intensive Kong. It was found that the Australasian Kidney Trials
care unit (ICU) admission, level of liver enzyme alanine Network.
use of invasive mechanical aminotransferase (ALT) or
ventilation or death was almost aspartate aminotransferase (AST)
eight times of other patients. It was elevated in 23 per cent of
is suggested that liver function the COVID-19 patients, which
monitoring is important regarding indicated liver damage.

48 ACADEMIC S NEWS BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

Bow Valley Chulalongkorn University
College signs MoU with Huawei
collaborates
with Chitkara The Faculty of Engineering, Chulalongkorn University in Thailand
University and Huawei Technologies (Thailand) have jointly signed a
memorandum of understanding (MoU) to support research and
Bow Valley College in Canada has development (R&D) for engineering innovation through 5G,
announced a pathway programme
with Chitkara University in India, artificial intelligence (AI) and Cloud.
in the faculty of healthcare for This collaboration aims to help drive
students. Chitkara students, who Thailand forward to full-scale digital
have graduated from any stream transformation. This partnership will
of healthcare programmes can lead the university towards the exchange
now transfer to the Health & and enhancement of technological
Human Services Management knowledge in response to digital
(HHSM) one-year post-diploma transformation. It will also enable robots
certificate at Bow Valley College invented by the faculty members and
through Chitkara University. students in the robotics laboratory to be
Eligible candidates will be offered more intelligent and to be automatically
a letter of acceptance from Bow operated with AI and 5G technology.
Valley College. The students Both partners hope that this partnership
will apply for their study permit will benefit society at large in the public
and go through four weeks of health dimension. The Faculty of Engineering has been conducting
orientation programming at R&D programmes on robotic system and automatic control system
Chitkara University, before coming that contributes to industrial workforces and medical robots, and
to Canada. The first cohort under in particular, on robots used in the recovery process of patients
the HHSM post-diploma certificate suffering from strokes.
arrangement is expected to start in
January 2021, based on the easing NYMU in Taiwan
of travel and other restrictions collaborates with US firm
in Canada. Students, who will
graduate from Bow Valley College US based Vyripharm International has executed a memorandum of
will be eligible to apply for a post- understanding (MoU) with National Yang-Ming University (NYMU),
graduate work permit in Canada a research institution in Taipei, Taiwan. NYMU is famous for its
or even pursue other diploma research in medicine, life sciences and biotechnology. The MoU
programmes from Bow Valley expresses the intent to develop the bio-distribution information and
College or a degree with a public targeting profile of VYR-206 for diagnosis and monitoring treatment
university pathway partner. outcomes of neurological disorders. NYMU’s Brain Research Center
and Translational Medical Imaging
Center is one of the leading institutes
in cognition and behavioral research
along with functional and structural
brain imaging. Vyripharm’s drug
platform technology is a personalized
medicine application for diagnosis,
monitoring and treatment of some
infectious diseases, neurological disorders and cancers. Moreover,
the platform provides a means for labeling diagnostic and therapeutic
agents to allow for tissue specific targeted diagnostic imaging and
radiotherapy. The company developed VYR-206 as one of its lead
compounds from several of its platforms for both proof of concepts
and commercialization development.

10th

Anniversary

28th-30th OCT 2020

EH 103-104 | BITEC | BANGKOK

THE INTEGRATED LABORATORY TECHNOLOGY PLATFORM

• Analysis • Testing • Calibration • Metrology • Clinicals • Diagnostics
• Life Sciences • Biotechnology • R&D • Chemicals • Safety • Digital Health

LABORATUVAR VE SAĞLIK GAZETESİ

50 SUPPLIER NEWS

BIOSPECTRUM | SEPTEMBER 2020 | www.biospectrumasia.com

GenScript enters into partnership Mindray sets
with Premas Life Sciences new standard for
infusion systems
US headquartered GenScript Biotech Corporation has
announced a strategic sales distribution agreement, appointing China based Mindray has released
Indian firm Premas Life Sciences (PLS) as the exclusive its new generation infusion system,
BeneFusion n Series. By rethinking
technology and knowledge distributor of cPass SARS safety, simplicity, interoperability
CoV-2 neutralization antibody detection kit in and data synergy, the BeneFusion
India. This kit is co-developed n Series sets a new standard in
with Duke-NUS Medical infusion delivery. With a large
School Singapore and 7-inch full-touch screen and an
Diagnostics Development intuitive interface, the BeneFusion
Hub from Singapore’s n Series delivers a refreshing user
Agency for Science, experience with superior ease of use
Technology and for greater precision and higher work
Research (A*STAR) and efficiency. The system’s versatile
manufactured by docking portfolio also provides
a comprehensive solution for a
GenScript Biotech Corporation. It is the first-in-the-world variety of infusion scenarios, with
rapid test kit, which can measure neutralizing antibodies within a flexible docking solution ranging
an hour. GenScript Biotech along with PLS will provide in- from 2 to 24 slots. With 15-25 per
depth technical support to allow customers in India to have the cent of medication errors resulting
access to cPass SARS CoV-2 kit and ramp up the current efforts from confusion with drug names,
in COVID-19 testing and vaccine development. the BeneFusion n Series’ SafeDose
drug management system allows
Joimax expands for innovative color-coding and
presence in Australia customizable drug profiles from
the drug library, which can be
Joimax, the Germany based market leader in technologies automatically filled out and configured
and training methods for full-endoscopic and minimally to eliminate such errors to improve
invasive spinal surgery, has announced a new partnership patient safety.
with Australian medical device distributor LifeHealthcare.
The two companies have entered into a long-term relationship
to provide a broader surgical choice for patients considering
spinal surgery. Endoscopic
spine surgery has been steadily
growing in popularity since the
late 1990’s with exponential
growth in the technique for
the past ten years. Surgeons
throughout the world have
reported that this type of surgery
can assist patients in faster
recovery, allowing them to
reduce their post-operative stay.
LifeHealthcare is a leading independent provider of healthcare
solutions in Australia and New Zealand bringing healthcare
professionals innovative medical devices by partnering with
world class companies who share the vision of innovation and
making a real difference to people’s lives. Joimax strengthens
its sales activities in Australia and enters into another
important partnership across APAC.