BioSpectrum Asia July 2020

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Enabling Lifescience, Biopharma, Health Sciences & Medtech
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4 BIO EDIT

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

A critical credibility

Milind Kokje Besides human lives, coronavirus has affected in different ways and in different forms
like political cultures and health systems in different countries as weaknesses of
Chief Editor both got exposed in many countries. The latest addition to the list is credibility of
two 200-year-old, well reputed, peer reviewed medical and science journals. Both – The
[email protected] Lancet and The New England Journal of Medicine (NEJM) - had to recently withdraw the
research papers they had published which were related to COVID-19.

Reputation of both the journals in the medical and scientific world need no
elaboration for the BioSpectrum readers. Both have a very high impact rate – 70.67
for NEJM and 56.702 of The Lancet – and the research details published in them are
considered as gospel truth by the research community world over. That is why papers
published in them are often quoted in new researches and hence having high impact rate.

Those outside the scientific sphere and are unaware of the technicalities like impact
rate also clearly saw The Lancet’s impact recently when World Health Organisation
(WHO) discontinued the trials of anti-malarial drug hydroxychloroquine (HCQ) as a
possible treatment for COVID-19 following publication of a study in the journal that the
medicine had no benefits and may even put COVID patients at risk of dying.

The study published in The Lancet concluded that neither chloroquine nor HCQ
with antibiotics hold any significant promise as a treatment for COVID-19. Following
WHO’s suspension of trials due to the study outcome some countries in Europe also
discontinued their trials.

However, The Lancet surprised the scientific community world over by publishing
a retraction from three of the four authors of that study. The Lancet admitted that
there were some serious scientific questions surrounding the data in the paper. The
WHO, which suspended the trials of HCQ, announced to resume the trials following the
Lancet’s retraction.

The Lancet’s reason for retraction is that it was unable to complete an independent
audit of the data and can no longer vouch for the veracity of the primary data sources.
The data was gathered by a Chicago based firm Surgisphere, which claimed having
studied 96,000 patients in 671 hospitals in six continents. It is surprising that how
doubts were not raised over gathering such a huge data in a short time of just over two
months when experts in clinical trials explain how it is a time consuming process.

Interestingly, Surgisphere is also connected with the NEJM study which is about the
relationship between cardiovascular diseases and COVID-19. It has been retracted as the
authors (or the reviewers?) were not granted access to the raw data, neither it was made
available to a third party auditor and hence the NEJM was unable to validate the primary
data sources.

Though Surgisphere has stood by the integrity of its data, it has declined to give
access to the data to reviewers citing client confidentiality as a reason. But alarmed over
the mismatch in number of deaths in Australia, given in the study and the country’s
own estimates scientific community has raised questions over the data. There have been
allegations that Surgisphere has compiled its data using electronic health records.

Serious concerns have also been raised over the expertise of Surgisphere’s staff, as
one of them as reported to be a mere science fiction writer and another acting in adult
films.

The whole controversy has exposed the chinks in the armours of these journals as
their peer reviewed process appears to have failed in these two cases. Even admitting the
compelling rush to publish the studies in view of the fast spreading pandemic, there is no
doubt that more precautions over scrutiny were needed for publication of studies. The
retractions also give an opportunity to have a look into the peer review process and make
necessary corrections to maintain the credibility of such journals. If that happens it could
be termed as at least one positive effect of an otherwise negative COVID-19 pandemic.

BIO MAIL 5

BIOSPECTRUM | |MAMJRUCALHYY 22002200 | |w|wwww.wbwiwows..bpbieioocsstpprueecmcttraruusmmiaa.acssoiiaam..ccoomm

Acknowledgements

WAcekanreovwerleydglgaedmfoer nthtescoverage that Piscium Health Sciences has
AMreccakenniyvoethdwailnekBdsigfooSerpmtehceetrniuntmtse.rvTiheawnckoyvoeura. ge on Cytiva. We appreciate this

TchoallnakboyroautiofnorwictohvBeriionSgpetchteruimnteArsaicat.ion with N- oMvaolaNyorDdiikskshiint,tIhnediFaebruary

edition. It has come out very well. - Francis Van Parys, South Korea

- Manisha Gupta, India

The piece titled ‘Can COVID-19 pandemic fast track digital

tTrhaensinfotremraaction?w’ inththLeuiAnparBiliiosslouoekis bwreilliwanritt.tTenh.aIntktso.uches upon

Tahnainmkpyoorutansot tompuichonfothr efepaottuernintigaltfhoer da-irgtLitcialselate‘DHchenavloetlhroegsaipeuesxnt,odAianusgsitshrtaalsiaa natural

businesses and communities in this pandemic.

Looks good. - Grace Ang, Singapore

Thank you so much for featuring the article by Cyient in yo-uDr avid Bloom, US

esteemed publication.

Thank you so much for covering the interactio-nSwaaitghaLruKcauVmisainr,i,India

Managing Director, Eli Lilly and Company (India) in the April edition.

The article on personalized medicine looks n-iAcem. IbtuisjaclKeaarslyhynaopt ,aItnrdeniady topic

aWnyemaoprper,eicniaftaectymouurcshumppoorrettwhiatnh tphuabt.lishing our work in BioSpectrum

magazine and we look forward to contributing in the fut-uAren. u Acharya, India

- Neel Fofaria, India

Vol 15; Issue 357; MJualyrc2h0220020 MM Activ Singapore Pte. Ltd. Taiwan
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6 BIO CONTENT BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

COVER STORY 18

Firms racing to develop

ANTIBODY

TREATMENT FOR

The Coronavirus COVID-19 has raged the world and has infected 8,993,659 cases and killed 469,587 (as of
June 23, 2020. Source World Health Organization (WHO)). Pharma firms, scientists and governments all over
the world are racing to find a cure for the virus. The entire world is waiting for the vaccine; Moderna’s mRNA
vaccine will begin phase III study in July. Amidst all this, some biopharma companies are pushing to develop
antibody based treatments for the virus. Does that have any merit? Why are firms putting billions of dollars
into it when vaccines are the ultimate solution? Let’s find out.

BIO CONTENT 7

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com Q&A

COVID-19 38

27 “So far COVID-19
has limited impact
Repurposing hepatitis on our business”
drugs for COVID-19 treatment
Dr Samantha Du,
31
Founder and CEO, Zai Lab, China
Controversial papers in NEJM and The Lancet
40
A knee-jerker during pandemic?
“Investment will flow
36 towards digital solutions
to augment treatment”
5 things pharma can learn from COVID-19
Dr Ruchir Mehra,
CEO & Co-founder, Remedo, India

42

“We see already a higher
awareness of why life science
needs to be a priority for
Japan and Australia”

Stephane Perrey,
General Manager - Japan,
Australia, New Zealand, Cytiva, Tokyo

REGULARS

BioEdit.................................................................04
BioMail.................................................................05
Policy and Regulatory News..............................08
Company News...................................................10
Finance News......................................................12
Start-up News.....................................................13
WHO News..........................................................15
World News.........................................................16
People News.......................................................44
R&D News............................................................46
Academic News..................................................48
Supplier News.....................................................49

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

Korea India, Australia announce
suggests COVID-19 collaboration
international
organization Indian Prime Minister Narendra technologies, data analytics,
to combat Modi and the Prime Minister modeling, AI applications, and
COVID-19 of Australia, Scott Morrison, screening and diagnostic testing
have jointly announced a special as priority areas. The project
The Seoul Metropolitan COVID-19 collaboration in duration would be for 12 months
Government held a Mayoral 2020. Accordingly, Department with maximum extension of six
Meeting with mayors of Science & Technology (DST), months. The objective of the
and governors from 42 Ministry of Science & Technology, grant opportunity is to fund short
cities around the world Government of India and collaborative research projects
participating at the video Department of Industry, Science, with tangible outcomes focused
conference studio prepared at Energy and Resources (DISER), on responding to the COVID-19
the Seoul City Hall recently. Australia have invited joint pandemic. The intended outcomes
Around 120 participants, research projects on COVID-19 of the grant opportunity are to
including Seoul Mayor Park from interested scientists and bring together leading research
Won-soon and other world researchers under the Australia- institutions and industry in both
city mayors, scholars, and India Strategic Research Fund Australia and India currently
experts participated in the (AISRF), a platform for bilateral working on areas relevant to
summit to discuss ways to collaboration in science, jointly COVID-19 such as vaccines,
overcome the worldwide crisis managed and funded by the therapeutics, and diagnostics,
of infectious diseases and a governments of India and and projects of a mutually
post-COVID-19 era. Seoul Australia. The research proposals beneficial nature whose outcomes
Mayor suggested the creation are expected to focus on antiviral contribute to the global response
of an intercity network, coatings, other preventive to the COVID-19 pandemic.
tentatively named Cities
Alliance Against Pandemic Singapore builds vaccine
(CAAP). It will be the first manufacturing capacity
international organization
of world cities dealing with Singapore Prime Minister Lee Preparedness Innovations (CEPI),
infectious diseases. It aims Hsien Loong has announced and donations of essential medical
at making solidarity and that Singapore is building up its equipment and supplies. The
cooperation between cities vaccine manufacturing capacity government is investing heavily
to preemptively respond to in order to offer fill and finish in research and development
global infectious diseases and contract manufacturing services on diagnostics, vaccines and
setting a model that can be to vaccine developers. Singapore therapeutics. The researchers have
applicable to cities around the has contributed about $13 million developed a range of serological
world. towards international efforts and nucleic acid-based diagnostic
to combat COVID-19, through tests, which have been deployed
the World Health Organisation to over 20 countries. They are
(WHO), Coalition for Epidemic also developing therapeutic
monoclonal antibodies as well as
a vaccine, and have started clinical
trials of various therapeutics.
The new vaccine manufacturing
capacity should help them ramp
up production faster, and assure
them high standards of safety
and quality in the manufacturing
process.

REGULATORY NEWS 9

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

New Zealand works on Taiwan
post-COVID mental wellbeing recalls cold
medicines
The Ministry of Health in things all can do to maintain their
New Zealand welcomes the mental wellbeing, digital self-help The health authorities in
recommendations of a newly tools like Melon, Mentemia and Taiwan have announced
released report about the need Staying on Track and boosting the removal of a dozen
for additional mental health and capacity for helpline services like cold medicines from
wellbeing support in the wake of Youthline’s webchat. the marketplace over
COVID-19. The report, Protecting a potentially harmful
and promoting mental wellbeing: ingredient. Fenspiride, a
beyond COVID-19, predicts an compound used to treat
unprecedented or increased need respiratory diseases,
from New Zealanders over the including rhinitis, laryngitis,
coming months for more mental and bronchitis, has been
health and wellbeing support and found to be associated with
suggests a move to community- adverse drug reactions
led solutions. The government (ADR), according to the
invested an extra $15 million in Taiwan Food and Drug
mental wellbeing support through Administration (FDA). The
the COVID-19 response that adverse reactions involve
were focused on helping people abnormal heart rhythms
maintain their mental wellbeing. that when serious, could
These included a national multi result in cardiac arrest. The
media campaign focusing on the drug recall is a pre-emptive
measure, as there have been
India sets up joint science no reports yet of serious
communication forum fenspiride induced ADR
cases in Taiwan. However,
amongst various public sector the country has recorded
two incidents involving heart
science communication palpitations in the past five
years related to medications
institutions and agencies. The containing the compound.
Given the risk of fenspiride’s
forum brings together science side effects and the adequate
availability of alternatives,
communication efforts spread the FDA has decided to
revoke 12 drug licenses and
across various institutions and withdraw the medications.

can help adoption of a common

policy and best practices at a wider

scale, ultimately aiming towards a

national science communication

framework. The forum would

be served by a Secretariat at the

National Council for Science

& Technology Communication

The Department of Science (NCSTC), DST, which is mandated
& Technology (DST) within
the Ministry of Science and for coordination with different
Technology in India, has
constituted a joint science organizations, programmes and
communication forum with a
view to facilitate interaction, activities focused on science
cooperation, and coordination
communication in the country and

orchestrating them for enhanced

public understanding of science

with a scientific bent of mind.

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

SpeeDx, Sinovac initiates Phase III
Roche trial of COVID-19 vaccine
expand
access to China based Sinovac Biotech has inked a clinical development collaboration
antibiotic agreement with a Brazilian producer of immunobiological products called
resistance Instituto Butantan to advance clinical trials of CoronaVac, Sinovac’s
tests inactivated vaccine candidate targeting SARS-
CoV-2 to Phase III. As stated by researchers,
Australia based CoronaVac vaccine candidate offered safety
SpeeDx, a developer of and protection to rhesus macaques (monkeys)
innovative molecular in an animal challenge study. The company
diagnostic solutions, is now building a commercial vaccine
has partnered with production plant in China that is expected
Roche, a global pioneer to manufacture up to 100 million doses of
in pharmaceuticals and CoronaVac annually. According to the new
diagnostics, in a non- deal, Instituto Butantan will sponsor Phase
exclusive agreement to III clinical trials in Brazil. The first in a series
expand global access of agreements, this broader collaboration will
to SpeeDx infectious also entail technology licensing, market authorization, and commercialization
disease and antibiotic of CornaVac in Brazil should the vaccine prove safe and effective, assuming it
resistance tests and ultimately is approved by regulators.
technology. SpeeDx
offers diagnostics Daiichi Sankyo enters research
tests for the sexually collaboration for COVID-19
transmitted infections
(STIs) gonorrhea and The University of Tokyo, RIKEN, the medical seeds generated from
Mycoplasma genitalium Nichi-Iko Pharmaceutical and basic research at RIKEN and at
(Mgen). Under the terms Daiichi Sankyo in Japan have universities for use in the drug
of the agreement, Roche reached a basic agreement on discovery process at pharmaceutical
will have non-exclusive collaborative R&D on a Nafamostat companies, and in clinical practice,
access to SpeeDx existing inhalation formulation for the as a bridge to companies and medical
tests and technology, to treatment of novel corona virus institutions. In this case, RIKEN will
enable global access and infection. The University of Tokyo also support this collaborative R&D
expansion of diagnostic has discovered that Nafamostat using RIKEN’s multidisciplinary
products for the could efficiently inhibit the advanced technologies. Nichi-
management of antibiotic viral entry process. RIKEN has Iko, the marketing authorization
resistance in STIs, established the programme for drug holder of FUTHAN (generic name:
and quickly bring new discovery and medical technology nafamostat mesilate), will provide
products to a broader platforms in order to optimize data collected on the product over
group of patients. many years as well as supply the API
for this collaborative R&D. Daiichi
Sankyo will carry out R&D on the
Nafamostat inhalation formulation
using technology gained in the
development of its anti-influenza
virus agent, Inavir. Non-clinical
studies are scheduled to begin in
July this year and after consultation
with authorities with the aim of
proceeding to clinical studies by
March 2021.

COMPANY NEWS 11

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

Zydus Cadila,

Dr. Reddy’s ink

deal with Gilead

for remdesivir

supply

Indian pharmaceutical firms Dr.

Reddy’s Laboratories and Zydus

Cadila have entered into a non-

exclusive licensing agreement

with Gilead Sciences, Inc. for the Tychan to begin Phase I trials
for mAb against COVID-19
manufacturing and distribution of
With approval from the Health Sciences Authority (HSA), Tychan,
remdesivir. Zydus will leverage its a Singapore based clinical-stage biotechnology company, has
completed recruiting healthy volunteers for Phase I clinical trials
ability to scale up to evaluate TY027, a monoclonal antibody (mAb) that specifically
targets SARS-CoV-2, the virus that causes COVID-19. Tychan
production to reach developed TY027 in partnership with the Ministry of Defence,
Ministry of Health, the Economic Development Board and other
patients across India government agencies. TY027 is being explored for the treatment of
patients with COVID-19 to slow the progression of the disease and
and across the 127 accelerate recovery, as well as for its potential to provide temporary
protection against infection with SARS-CoV-2. The Phase I trial,
countries in Gilead’s to be conducted by Sing Health Investigational Medicine Unit,
will take about six weeks to evaluate the safety, tolerability and
Global Patient pharmacokinetics of TY027. Upon reaching the key milestones of
the Phase I trial, Tychan will seek approval from HSA for TY027
Solution region. to be administered to a larger population of volunteer patients in
subsequent trials to establish the efficacy of the mAb. Presently,
On the other hand, there is no proven antibody-based treatment for COVID-19. There
is also no licensed vaccine to prevent SARS-CoV-2 infection.
Dr. Reddy’s will

receive technology

transfer from Gilead

for manufacturing of this drug.

Dr. Reddy’s would need to do the

manufacturing scale up and obtain

regulatory approval for marketing of

this drug in respective countries. The

safety and efficacy of remdesivir to

treat COVID-19 are being evaluated

in multiple ongoing Phase III clinical

trials.

Celltrion expands COVID-19 testing portfolio

South Korea based Celltrion in blood testing and lab-on-a- care testing to support early
Group has announced plans to chip technology. The POCT kit is detection of COVID-19 positive
expand its diagnostic portfolio a portable and highly sensitive patients in clinical settings.
for SARS-CoV-2, the virus device for use in rapid point of Celltrion has also entered into
causing COVID-19, in its efforts a distribution agreement with
to improve access to COVID-19 Humasis, a South Korean
testing and help prevent the in-vitro diagnostic company,
further spread of coronavirus to distribute and sell a rapid
infection worldwide. Celltrion diagnostic test globally. This test
has completed development of is a COVID-19 rapid antibody
a point-of-care antigen testing diagnostic test (RDT) kit, which
(POCT) kit for COVID-19 together could offer a cost-effective option
with South Korean healthcare and can be used by hospitals to
company BBB, which specialises confirm patients to be discharged.

12 FINANCE NEWS

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

Takeda divests select APAC assets to Celltrion for $278M

Japanese firm Takeda and innovative drugs. Takeda will legal and regulatory closing
Pharmaceutical has receive $266 million upfront in conditions. The portfolio
announced that it has cash and up to an additional $12 to be divested to Celltrion
entered into an agreement million in potential milestone includes a variety of OTC
to divest a portfolio of select payments, subject to customary products and pharmaceutical
non-core over-the-counter products in the
(OTC) and prescription cardiovascular, diabetes and
pharmaceutical products general medicine therapeutic
sold exclusively in Asia areas sold predominantly
Pacific to Celltrion Inc., in Australia, Hong Kong,
an Incheon, South Korea based Macau, Malaysia, Philippines,
biopharmaceutical company Singapore, South Korea, Taiwan
specializing in the research, and Thailand, which are part of
development and manufacturing Takeda’s Growth & Emerging
of small molecules, biosimilars Markets Business Unit.

Dr. Reddy’s completes Naari acquires 10 ANDAs
from Intas Pharma
select biz acquisition
Naari Pharma, with operations in the US, Singapore
of Wockhardt and India, has entered into a definitive asset purchase
agreement to acquire 10 Abbreviated New Drug
Indian pharmaceutical firm Dr. Reddy’s Applications (ANDAs) for the US market from Indian
Laboratories announces that it has company Intas Pharmaceuticals. The portfolio acquired
completed the acquisition of select comprises eight US FDA approved ANDAs and two
divisions of Wockhardt Limited’s branded products pending approval. It includes generic products
generics business in India and a few other in female hormones which will be manufactured at
international territories of Nepal, Sri Naari’s dedicated female hormone facility in India and
Lanka, Bhutan and Maldives. The business commercialized over the next 24 months. The acquisition
comprises of a portfolio of 62 brands in follows a planned period of significant growth and
multiple therapy areas such as respiratory, investment for Naari. In October 2019, Naari acquired
neurology, dermatology, gastroenterology, three ANDAs from OC Pharm in the US and in February
pain and vaccines, which would transfer 2020 the company announced that it had received an
to Dr. Reddy’s along with related sales and equity investment of $17.5 million from Ascent Capital,
marketing teams; and the manufacturing a leading India-focused growth capital provider. With a
plant located in Baddi, Himachal Pradesh presence in more than 50 countries and over 30 hormonal
with all plant employees. On February 12, generics currently available or under development, Naari
2020, Dr. Reddy’s signed a Business Transfer has one of the most comprehensive hormonal portfolios in
Agreement (BTA) with Wockhardt, to acquire the world.
the above-referred business undertaking for
an upfront consideration of Rs 1,850 crore.

START-UP NEWS 13

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

Module Innovations receives upto
$3.2M funding from CARB-X

Indian startup Module days. The most used method Ubie raises
Innovations declared that it is of microbial Culture, requires $18.7M in
receiving funding of $702,000 2-3 days’ time, a laboratory and Series B
plus up to $ 2.5 million on meeting highly trained manpower. With financing
certain milestones from CARB-X ASTSENSe the results would
based out of Boston University, be available with in two hours Ubie, a Japan based
US. CARB-X is funding Module rather than two days. The test is healthtech startup that
to accelerate development of their very easy to operate. Just add the has developed AI-based
diagnostic system ASTSENSe. The urine sample in the cartridge of healthcare products,
size of a small printer, ASTSENSe ASTSENSe and run the test. Rapid has raised JPY2 billion
will identify drug resistant Urinary results would enable clinicians to ($18.7 million) in Series B
Tract Infections (UTI) bacteria make more informed and accurate financing led by Suzuken,
within two hours. Diagnosing decisions about the antibiotic a Japanese pharmaceutical
a drug resistant UTI can take prescriptions. distributor that also
entered into a strategic
CBIH invests in healthtech business partnership with
startup Biomoneta Ubie. With this new round
of funding, Ubie seeks to
Centre for Cellular and Molecular decontamination devices to market, realize rapid growth of
Platforms (C-CAMP) in India has and further develop its products its healthtech platforms,
recently collaborated with Beyond and technologies. Biomonetahas expand research and
Next Ventures (BNV), one of the developed an advanced air development capabilities,
leading independent accelerators decontaminant technology they call and staff its various sales
in Japan dedicated to incubation Zebox that can trap and kill a billion and engineering teams.
investment in technology startups microbes such as viruses, bacteria These funds will enable the
to launch the C-CAMP BNV and fungi (including spores) startup to quickly scale its
Innovation Hub (CBIH). CBIH is within 10 mins. An intelligent Hospital SaaS (Software as
facilitating Japanese investment of airflow design and active biological a Service) product ‘Ubie for
up to $5 million in Indian startups components come together in this Hospital’, and its consumer
working on exciting technologies in device to render a near-sterile zone application, AI symptom
the life sciences and biotech domain in a matter of minutes. checker Ubie, to reach new
through a jointly managed fund. partners and customers
CBIH has announced Biomoneta as nationwide. In addition,
the first Indian life sciences startup Ubie also aims to expand
to join its investment portfolio. its presence abroad in the
The current round of funding is near future as well.
led by CBIH in partnership with
Artha Vida Ventures and IVF
specialist and angel investor, Dr
Aniruddha Malpani. Biomoneta
will use the funds to take its

14 START-UP NEWS

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

SK Telecom provides additional $20 M to Nanox

Nanox Imaging, an imaging for all socio-economic and Vietnam. Such
innovative medical communities by deploying 2,500 deployment, subject to
imaging technology Nanox Systems integrating the obtaining regulatory
company in Israel, MsaaS (medical screening as a clearances, intends to
announced that South service) model in South Korea democratize medical
Korea based company imaging and promote
SK Telecom will preventive healthcare
increase its stake in through a significant
the startup with an increase of system
additional $20 million availability in these
equity investment. This markets. Nanox and
transaction follows SK’s joint initiative
the initial $5 million intends to target unit
investment made by SK Telecom a deployment in a wide range of
year ago. In addition, the startup clinics and medical centers that
and SK Telecom are entering into cannot afford medical imaging
a joint collaboration aiming to equipment to increase availability
increase accessibility to medical of imaging as a standard of care.

Homage Health Taiwan sets up $70M
launches new programme for Israeli startups
service segment
Innovation to Industry (i2i), a Israeli startups focused on
Singapore based on-demand home Taiwan based innovation and digital health, cybersecurity,
caregiving services startup Homage tech company that grew out and AIoT (Artificial
announced the launch of Homage of government run incubators Intelligence of Things). Some
Health, which will provide medical in Taiwan, has launched the of the participating startups
services such as such as mobile IP² Launch Pad which will include Serenno Medical,
medicine, teleconsultation, and provide Israeli startups with a medical device company
medication delivery for care recipients exposure, a centre to launch that monitors kidney
in their own homes. Building on top their activities, validate their health; Biop Medical, which
of Homage Care, which includes technologies and expand developed a point-of-care
Homage’s core nursing, caregiving into East Asian markets with device that helps in the early
and rehabilitation services, the strong strategic partners. detection of cervical cancer;
healthcare startup has observed a The firm has set up a new Resymmetry, the developer of
spike in enquiries from existing care $70 million programme to a smart exoskeleton robotic
service recipients on the availability collaborate and invest in wheelchair.
of medical teleconsultations and
home medical services as families
increasingly look for options to
minimize infection risk during the
COVID-19 pandemic. Homage Health
provides access to local doctors, all of
whom undergo a stringent selection
process, and are registered with
the Singapore Medical Council. All
doctors on Homage’s platform have
also received training on Singaporean
telemedicine guidelines.

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Luxembourg and WHO reveals impact
WHO sign new MoU of COVID-19 on NCDs

Luxembourg’s Minister for Development Prevention and treatment services for non-
Cooperation and Humanitarian Affairs and communicable diseases (NCDs) have been severely
Minister of the Economy, Franz Fayot, and disrupted since the COVID-19 pandemic began,
WHO Director General Dr Tedros Adhanom according to a survey conducted by the World
Ghebreyesus have signed a new Memorandum Health Organisation (WHO). The survey, which was
of Understanding (MoU) for the period 2020- completed by 155 countries during a 3-week period
2023 in support of the Organization’s Thirteenth in May, confirmed that the impact is global, but that
General Programme of work 2019-2023. The low-income
signature of the new MoU underscores the countries
longstanding commitment of the Government of are most
the Grand Duchy of Luxembourg, an important affected. This
partner in global health, to help WHO to achieve situation is
its ambitious triple billion targets by 2023: one of significant
billion more people will benefit from universal concern
health coverage; one billion more will be better because
protected in health emergencies, and one people living
billion more will enjoy improved health and with NCDs
wellbeing. The overall objective of the MoU is are at higher
to support the achievement of the Sustainable risk of severe
Development Goals through WHO’s work COVID-19-
in countries, focusing on three broad areas: related illness
achieving universal health coverage; addressing and death. The main finding is that health services
health emergencies; and promoting healthier have been partially or completely disrupted in many
populations. countries. More than half of the countries surveyed
have partially or completely disrupted services for
hypertension treatment; 49 per cent for treatment
for diabetes and diabetes-related complications;
42 per cent for cancer treatment, and 31 per cent
for cardiovascular emergencies. Rehabilitation
services have been disrupted in almost two-thirds
of countries, even though rehabilitation is key to
a healthy recovery following severe illness from
COVID-19.

WHO welcomes preliminary results of dexamethasone

The World Health Organization benefit was only seen in patients
(WHO) welcomes the initial clinical seriously ill with COVID-19, and was
trial results from the United Kingdom not observed in patients with milder
(UK) that show dexamethasone, disease. Dexamethasone is a steroid
a corticosteroid, can be lifesaving that has been used since the 1960s
for patients who are critically ill to reduce inflammation in a range of
with COVID-19. For patients on conditions, including inflammatory
ventilators, the treatment was shown disorders and certain cancers. It has
to reduce mortality by about one been listed on the WHO Model List
third, and for patients requiring only of Essential Medicines since 1977
oxygen, mortality was cut by about in multiple formulations, and is
one fifth, according to preliminary currently off-patent and affordably
findings shared with WHO. The available in most countries.

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FIND supports rapid diagnostic
tests for malaria & COVID-19

The Foundation record test results. The app
for Innovative New will be compatible with many
Diagnostics (FIND) and brands and types of both
US based Scanwell Health RDTs and mobile devices,
haveannounced a new enabling broad use in low-
partnership for developing and middle-income countries
a smartphone app that (LMICs). The Scanwell
uses machine learning and technology that interprets
computer vision algorithms lateral-flow tests required
to read rapid in vitro by FIND is being used not
diagnostic tests (RDTs) for only for malaria tests, but
malaria, helping healthcare also serves as the basis for
professionals interpret and Scanwell’s at-home antibody
test for SARS-CoV-2 (the virus
that causes COVID-19). This AstraZeneca to
test is under development and supply 400M
currently awaiting emergency vaccine doses
use authorization from the to Europe
FDA. The Scanwell app will
also support on-the-ground AstraZeneca has reached an
data collection and feed into agreement with Europe’s
regional and national digital Inclusive Vaccines Alliance
surveillance systems designed (IVA), spearheaded by
to help combat antimicrobial Germany, France, Italy and
resistance (AMR). the Netherlands, to supply up
to 400 million doses of the
FDA issues EUA to first next University of Oxford’s COVID-19
gen sequence test for COVID-19 vaccine, with deliveries starting
by the end of 2020. With this
The US Food and Drug Administration has issued an emergency use agreement, the IVA aims to
authorization (EUA) to American company Illumina, Inc., for the accelerate the supply of the
first COVID-19 diagnostic test utilizing next-generation sequence vaccine and to make it available
technology. The FDA authorized the Illumina COVIDSeq test for the to other European countries
qualitative detection of SARS-CoV-2 RNA from respiratory specimens that wish to participate in the
collected from individuals suspected initiative. The IVA is committed
of COVID-19. Illumina, Inc. is to providing equitable access to
paving the way for large-scale, next- all participating countries across
generation sequencing-based (NGS) Europe. AstraZeneca continues
COVID-19 testing. COVIDSeq test to build a number of supply
is a high-throughput, sequencing- chains in parallel across the
based, in vitro diagnostic (IVD) world, including for Europe. The
workflow enabling the detection company is seeking to expand
of SARS-CoV-2. The end-to-end manufacturing capacity further
workflow extends the options and is open to collaborating with
available for labs to scale diagnostic testing. COVIDSeq uses upper other companies in order to
respiratory specimens, including a nasopharyngeal or oropharyngeal meet its commitment to support
swab, and delivers sample receipt to result in 24 hours using the access to the vaccine at no profit
NovaSeq 6000 Sequencing System. during the pandemic.

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Africa launches Merck responds to COVID-19
medical supplies pandemic in Africa
platform for COVID-19
Merck Foundation, the philanthropic arm of Merck
South African President Cyril Ramaphosa KGaA Germany has raced to respond tothe coronavirus
has launched an online platform to enable all pandemic in partnership with 18 African First Ladies,
African governments access critical supplies Ministries of Health, Information and Education
to combat the novel coronavirus. The platform focusing on four main areas: community support,
was launched during a virtual meeting for the healthcare capacity building, community awareness
Extraordinary China-Africa Solidarity Summit through media, children and youth. Merck Foundation
against COVID-19, convened by the China- has partnered with the African First Ladies of Liberia,
Africa Cooperation (FOCAC) co-chaired by Ghana, DR Congo, Zimbabwe, Niger, Sierra Leone,
Chinese President Xi Jinping and Senegalese Malawi and Burkina Faso to support the livelihood of
President Macky Sall. According to Ramaphosa, thousands of women and families of casual and daily
currently many African countries are having to workers who are most affected by the coronavirus
purchase goods with resources largely obtained lockdown. The relief contribution was also undertaken
from the multilateral agencies and asked China in Egypt with the aim to support 500 families. As part
to consider supporting Africa in the provision of its strategy of responding to coronavirus lockdown,
of diagnostic and therapeutic supplies over a the Merck Foundation scaled up to more African and
period of six months. African Union (AU) has Asian medical postgraduates to provide online medical
established an African COVID-19 Response specialization scholarships.
Fund as a key intervention to mobilize and
direct resources towards the continent’s
response to the challenge.

Egypt receives funds for advancing healthcare

World Bank’s Board of Executive at achieving value care services,
Directors has approved $400 including to the most vulnerable, by
million to support Egypt’s eliminating existing disparities. The
Universal Health Insurance System project supports the government’s
(UHIS) for the country’s pathway efforts to put in place the building
towards achieving universal health blocks of the UHIS; to roll the
coverage (UHC) and improving the system out in Phase I Governorates;
health outcomes of its citizens. The and to offer temporary financial
Universal Health Insurance project protection to the most vulnerable
with the World Bank encompasses across the country to protect them
mandatory coverage for citizens and from high out-of-pocket health
unifies, for the first time, efforts with expenditures resulting from the
the private sector. The project aims COVID-19 outbreak.

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Firms racing to develop

ANTIBODY

TREATMENT FOR

The Coronavirus COVID-19 has
raged the world and has infected
8,993,659 cases and killed 469,587
(as of June 23, 2020. Source
World Health Organization (WHO)).
Pharma firms, scientists and
governments all over the world are
racing to find a cure for the virus.
The entire world is waiting for the
vaccine; Moderna’s mRNA vaccine
will begin phase III study in July.
Amidst all this, some biopharma
companies are pushing to develop
antibody based treatments for the
virus. Does that have any merit?
Why are firms putting billions of
dollars into it when vaccines are the
ultimate solution? Let’s find out.

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Since the start of the outbreak; researchers, disease in model experiments.
pharma firms, governments all over the world That’s why the hunt is on to find the alternative
are scrambling to find a treatment. From herbal
medications to repurposing older drugs as potential treatment to save people’s lives till the vaccine
COVID-19 therapies, anything which could possibly arrives. And the antibody based treatments offer
save lives is being tested and of course the hunt for an excellent hope. That’s what companies like
a vaccine is on. There are 16 vaccine candidates in Regeneron, Eli Lilly, Vir Biotechnology and many
clinical evaluations and 125 candidates in preclinical more from USA, Europe and Asia Pacific are working
evaluation around the world. (As of June 24, 2020. on antibodies for COVID-19.
Source: WHO)
Why antibodies?
Developing a vaccine is a time consuming process.
Vaccines, on an average, take 10 years to develop. The Firms are racing to develop antibody based
fastest vaccine ever developed till date was approved treatments because this approach has proven
for the mumps in 1967, took four years. The latest effective against an infectious disease before. During
vaccine developed for an epidemic, Ebola vaccine, the Ebola epidemic in Africa, a cocktail of antibodies
also took five years,was approved in 2019. Both the developed by Regeneron were superior to other drugs
vaccines were developed by Merck. in reducing mortality from Ebola, according to a
study done in the Democratic Republic of the Congo.
Though the vaccine is touted as the fastest to No other treatments had worked against Ebola.
develop, developing a vaccine that is safe, effective Researchers are hoping that this turns the same way
and producing it in large quantities that the world for Coronavirus.
needs to fight a pandemic is a surmountable
challenge. It is interesting to note that there is still no Since April 2020, about 14 organisations across
licensed vaccine for an earlier Coronavirus, Severe Asia, Europe and the USA are working on antibodies
acute respiratory syndrome (SARS). Studies showed for COVID-19. Seven projects are still in research
that some preliminary SARS vaccines enhanced the phase and while others are under clinical trial.
The companies that have taken the research to the
trial phase include Eli Lilly, USA (Phase I trial),
Regeneron, USA (Phase I trial), Celltrion, South
Korea (Completed preclinical studies; Phase I trial
to start in July), Roviant Sciences, Switzerland (Trial
ongoing), Antibody Therapy Against Coronavirus
(ATAC) project funded by the European Commission
and led by Sweden’s Karolinska Research Institute
(Human testing in Germany/ animal testing in
Switzerland) and Institute for Biological Research
Institute (IIBRI), Israel (Human clinical trials to
start). In the Asia Pacific, South Korea’s Celltrion is
leading the way. Singapore’s Tychan is also initiating
Phase I clinical trials to evaluate TY027, the first
novel mAb.

Leading the way

Celltrion in partnership with Korea Centers for
Disease Control and Prevention (KCDC), has
identified 14 neutralising monoclonal antibodies
(mAbs) from a pool of 300 antibodies that bind
to SARS-CoV-2’s surface proteins. Following the
selection of antibody candidates which demonstrate
high potency in neutralising SARS-CoV-2, Celltrion
will begin cell-line development. Once this is
completed, Celltrion aims to roll out mass production
of the therapeutic antibody and, together with the
KCDC, Celltrion will conduct efficacy and toxicity
testing in mice and non-human primates. The
company announced positive results on May 31.

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Celltrion Group announced positive pre- for the treatment of patients with COVID-19
clinical results for its COVID-19 antiviral to slow the progression of the disease and
antibody treatment, with data demonstrating accelerate recovery, as well as for its potential
a 100-fold reduction in the viral load of SARS- to provide temporary protection against
CoV-2, the virus causing COVID-19. The infection with SARS-CoV-2.
treatment was also able to show improvement
in lung lesions to a normal activity level in On June 10 it announced that the Phase I trial,
animal models. to be conducted by Sing Health Investigational
Medicine Unit, will take about six weeks to evaluate
The pre-clinical study was conducted in an the safety, tolerability and pharmacokinetics of
animal model in collaboration with one of the Korean TY027. Upon reaching the key milestones of the
National Universities, Chungbuk National University Phase I trial, Tychan will seek approval from HSA for
College of Medicine. The trial set out to assess the TY027 to be administered to a larger population of
efficacy of two dosage amounts (low and high) for the volunteer patients in subsequent trials to establish
antiviral antibody treatment. In comparison to the the efficacy of the mAb.
placebo-controlled group, the research team observed
improved recovery in terms of clinical symptom scores The US based Eli Lilly, on June 1, became the first
such as runny nose, cough and body aches, after the company to begin world’s first study of a potential
first day of treatment. From the fifth day, significant COVID-19 antibody treatment in humans. This
clinical remission was observed. This announcement investigational medicine, referred to as LY-CoV555, is
follows the identification of antibody candidates for an the first to emerge from the collaboration between Lilly
antiviral treatment which Celltrion completed in April. and Canada’s AbCellera to create antibody therapies
In response to these positive results, Celltrion will now for the prevention and treatment of COVID-19.
conduct additional efficacy and toxicity testing in pre-
clinical settings and anticipates starting first-in-human Lilly scientists rapidly developed the antibody in
clinical trials in July. just three months after AbCellera and the Vaccine
Research Center at the National Institute of Allergy
Besides Celltrion, with approval from the Health and Infectious Diseases (NIAID) identified it from a
Sciences Authority (HSA), Tychan, a Singapore based blood sample taken from one of the first U.S. patients
clinical-stage biotechnology company, has completed who recovered from COVID-19. LY-CoV555 is the
recruiting healthy volunteers for Phase I clinical trials first potential new medicine specifically designed to
to evaluate TY027, a monoclonal antibody (mAb) that attack SARS-CoV-2, the virus that causes COVID-19.
specifically targets SARS-CoV-2, the virus that causes The first patients in the study were dosed at major
COVID-19. medical centers in the U.S., including NYU Grossman
School of Medicine and Cedars-Sinai in Los Angeles.
Tychan developed TY027 in partnership with
the Ministry of Defence, Ministry of Health, Should Phase I results show the antibody can be
the Economic Development Board and other safely administered, Lilly expects to move into the
government agencies. TY027 is being explored next phase of testing, studying LY-CoV555 in non-
hospitalized COVID-19 patients. The company also

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plans to study the drug in a preventative setting, LY-CoV555 bind different epitopes on the spike
focusing on vulnerable patient populations who protein and thus expand the diversity of options
historically are not optimal candidates for vaccines. for achieving efficacy and avoiding resistance.

Lilly is researching multiple approaches to In addition, Regeneron Pharmaceuticals, Inc.,
treating COVID-19. Existing Lilly medicines are a leading biotechnology company that invents life-
now being studied to understand their potential transforming medicines for people with serious
in treating complications of COVID-19, and the diseases on June 11, announced initiation of the first
company is collaborating with two biotech companies clinical trial of REGN-COV2, its investigational dual
to discover novel antibody treatments for COVID-19. antibody cocktail for the prevention and treatment of
COVID-19. The REGN-COV2 clinical programme will
On June 8, Eli Lilly and Company announced consist of four separate study populations: hospitalized
that its partner Junshi Biosciences has dosed the COVID-19 patients, non-hospitalized symptomatic
first healthy volunteer in a study of a potential COVID-19 patients, uninfected people in groups
neutralizing antibody treatment designed to fight that are at high-risk of exposure (such as healthcare
COVID-19. The investigational medicine, referred workers or first responders) and uninfected people
to as JS016, is being co-developed by Junshi with close exposure to a COVID-19 patient (such as
Biosciences and Lilly, with Junshi Biosciences the patient’s housemate). The placebo-controlled trials
leading development in Greater China. Lilly has will be conducted at multiple sites.
exclusive rights in the rest of the world and will begin
dosing patients in a complementary Phase I study Regeneron scientists evaluated thousands
in the United States in the coming days. Both Phase of fully-human antibodies produced by the
I studies aim to evaluate the safety, tolerability, company’s proprietary VelocImmune mice,
pharmacokinetics and immunogenicity of JS016 in which have been genetically-modified to
healthy participants who have not been diagnosed have a human immune system, as well as
with COVID-19. This is Lilly’s second neutralizing antibodies isolated from humans who have
antibody to start clinical trials, following LY-CoV555 recovered from COVID-19. They selected the
that recently entered Phase I and is currently being two most potent, non-competing and virus-
tested in hospitalized COVID-19 patients. neutralizing antibodies and have scaled them
up for clinical use with the company’s in-house
Lilly is planning a clinical development VelociMab and manufacturing capabilities.
programme which includes a portfolio of The two antibodies bind non-competitively to
monotherapy and combination antibody the critical receptor binding domain (RBD) of
regimens (the latter often referred to as the virus’s spike protein, which diminishes the
antibody “cocktails”) in order to understand ability of mutant viruses to escape treatment,
which provide the best efficacy and tolerability as demonstrated in upcoming Science
in patients. These cocktails will include JS016, publications of preclinical research.
LY-CoV555, as well as additional antibodies
currently in preclinical development. JS016 and Regeneron used the same ‘rapid response’

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capabilities and cocktail approach to develop REGN- number of days in the ICU, and number of days
EB3, a novel triple antibody treatment for Ebola of inpatient hospitalization. The study is being
that is now under regulatory review by the U.S. Food conducted with an adaptive design and includes
and Drug Administration (FDA). REGN-COV2’s a planned interim analysis. Work on the trial is
preclinical development and preclinical/clinical being conducted by Kinevant Sciences, a wholly
manufacturing has been funded in part with federal owned subsidiary of Roivant Sciences.
funds from the Biomedical Advanced Research
and Development Authority (BARDA), part of the In Europe, the European Commission since
office of the Assistant Secretary for Preparedness January 2020 awarded €48.2 million to 18 research
and Response at the U.S. Department of Health and projects, which involve 151 teams from across Europe
Human Services. and beyond, working on improving preparedness
and response to outbreaks, rapid diagnostic tests,
The first two adaptive Phase I/II/III studies are new treatments and new vaccines against COVID-19.
evaluating REGN-COV2 (REGN10933+REGN10987) Off these three projects are on antibody treatment
as a treatment for hospitalized and non-hospitalized therapy. Led by Karolinska Institutet (SE) the
patients with COVID-19. The Phase I portion will Antibody Therapy Against Coronavirus (ATAC)
focus on virologic and safety endpoints, and the project funded by the European Commission aims to
Phase II portion will focus on virologic and clinical optimise, produce and test antibody therapies based
endpoints. Data from the Phase I and Phase II studies on donated blood samples from recovered COVID-19
will be used to refine the endpoints and determine patients. With experimental and computational work,
size for the Phase III studies. the team plans to optimize, produce and test human
polyclonal and monoclonal antibodies for treatment
On May 13, Basel based Roivant Sciences of patients with COVID-19.
announced that an independent Data Monitoring
Committee (DMC) for BREATHE trial unanimously Led by Erasmus Universitair Medisch Centrum
recommended that the trial evaluating the impact Rotterdam (NL), the MANCO project intends to
of intravenous (IV) treatment with gimsilumab on develop and evaluate monoclonal antibodies as
mortality in COVID-19 patients with lung injury or treatments against 2019 New Coronavirus. Led by
acute respiratory distress syndrome (ARDS), continue Karolinska Institutet (SE), CoroNAb project aims to
after a pre-specified safety assessment evaluating rapidly identify, validate and produce nanobodies
data from the first 10 per cent of randomized subjects and antibodies against 2019-nCoV that block the
after six days of follow-up. In addition, Roivant
recently amended the protocol to permit the use of
investigational antivirals (e.g. remdesivir) during the
study, as well as treatment with convalescent plasma
prior to enrollment. 56 patients have been enrolled in
the study to date, and a total of seven sites have been
initiated in New York, Philadelphia, Detroit, New
Orleans, Dallas, and Atlanta.

Gimsilumab is a fully human monoclonal
antibody targeting GM-CSF. Gimsilumab has been
tested in numerous non-clinical studies and two
prior clinical studies, including a 4-week Phase I
study in healthy volunteers conducted by Roivant
which completed dosing in February. Gimsilumab
has demonstrated a favorable safety and tolerability
profile based on data collected to date.

Roivant’s clinical trial is expected to
enroll up to 270 patients with a confirmed
diagnosis of COVID-19 and clinical evidence
of acute lung injury or ARDS. Subjects will be
randomized 1:1 to receive either gimsilumab or
placebo. The primary endpoint of the study is
incidence of mortality by day 43. Key secondary
endpoints include the incidence and duration
of mechanical ventilation use during the study,

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ability of the virus to infect cells, for treatment and others; Atreca, Inc., USA and IGM Biosciences, Inc.
prevention in humans. The researchers have already USA along with BeiGene, Ltd, China and Tiziana Life
begun the work in animal models and aim to identify Sciences, UK.
antibody candidates that could be used for treatment
and prevention in humans before the world has The Asian firms that are working to develop the
access to a SARS-CoV-2 vaccine. antibody treatments for COVID-19 include Japan’s
Chugai Pharma, Singapore’s Agency for Science,
Along with global organisations efforts in the Technology and Research (A*STAR) and China’s
development of COVID-19 treatment, Israel Institute BeiGene. Their candidates are in the research phase.
for Biological Research (IIBR) announced on May There aren’t many drugs available to treat infected
5 that it has developed an antibody which can patients. The only treatment granted emergency use
neutralise the virus responsible for COVID-19 within by the United States Food and Drug Administration
the bodies of those infected. (USFDA) is Gilead’s antiviral drug remdesivir.
The regulator has now revoked the emergency use
IIBR has submitted patent application for authorization for malarial drugs chloroquine and
eight corona virus antibodies. The antibodies hydroxychloroquine.
will be used to create a cure for the virus.
On completion of the patent process IIBR is On April 29, BeiGene, Atreca, and IGM
looking industrial partners for commercial Biosciences, announced their plans to collaborate to
manufacturing. help address the COVID-19 pandemic. The companies
will leverage their combined technology and expertise
Not far behind in an effort to discover, develop, and manufacture
novel Immunoglobulin M (IgM) and immunoglobulin
The organisations that are still working on the A (IgA) antibodies targeting SARS-CoV-2 for the
research related to antibody treatment include potential treatment of COVID-19. Given the urgency
Vir Biotechnology, USA in partnership with of the global COVID-19 pandemic, the parties have
GlaxoSmithKline, UK; Amgen, USA in partnership agreed to begin work immediately and plan to finalize
with Adaptive Biotechnologies, USA; Agency for financial details and other terms in the future.
Science, Technology and Research (A*STAR),
Singapore in partnership with Chugai Pharmabody IGM Biosciences engineers IgM and IgA antibodies
Research, Japan; AbbVie, USA; Proteona, Singapore with greater binding power per antibody, relative
in partnership with Twist Bioscience, USA and to comparable IgG antibodies. This greater binding
power could potentially result in better activity
against a broader range of variants of the virus which
causes COVID-19, as compared to traditional IgG
antibodies. IgA and IgM antibodies also have the
inherent property of active transport from the blood
stream to mucosal surfaces, such as in the lung, which
may provide a therapeutic advantage for respiratory
diseases such as COVID-19. IgM and IgA are classes of
antibodies naturally produced by the human immune
system and are differentiated from immunoglobulin
G (IgG) antibodies in part by their greater number of
binding domains (IgM: 10, IgA: 4, IgG: 2).

The alliance will utilize Atreca’s proprietary
discovery platform to generate the sequences
of antibodies made by particular B cells
found in blood obtained from acutely infected
COVID-19 patients. IGM’s technology platform
will then be leveraged in an effort to develop
and manufacture engineered IgM and IgA
therapeutic antibodies from the identified
sequences. BeiGene has agreed to provide
global clinical development support by
leveraging its more than 1,100-person global
development team across China, the United
States, Europe, and Australia, including leading

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global regulatory interactions for any potential an antibody research project in dengue fever
drug candidate that is developed. under a grant by the Global Health Innovative
Technology Fund (GHIT Fund).
BeiGene is a leader in global clinical development
with 26 potentially registration-enabling trials On June 1, another organisation from Singapore,
ongoing and over 60 studies enrolling patients in ProteonaPte. Ltd., a biomedical company with
more than 35 countries. Its large, global clinical operations in Germany, and the US announced
development team is focused on high-quality, that Twist Bioscience Corporation will join the
efficient drug development optimized for global international alliance led by Proteona to develop
regulatory submissions. neutralizing antibody therapy against COVID-19 for
vulnerable immunocompromised patients. Utilizing
Atreca and IGM have entered into a Material the highly parallel silicon-based DNA synthesis
Transfer and Collaboration Agreement to enable the platform, Twist has the ability to manufacture
parties to begin working together immediately. If millions of oligos of different lengths with industry
research, manufacturing, and regulatory activities leading accuracy. This core capability enables Twist
proceed very well, then the companies believe that an Biopharma, a division of Twist Bioscience, to identify
antibody may be ready to begin clinical testing in the numerous neutralizing antibody sequences and use
first half of 2021. in house capability to generate and optimize IgG
antibodies ready for analysis.
On May 8, Chugai Pharmabody Research Pte.
Ltd. (CPR), a research center of the Chugai Group in Proteona, who is leading the alliance
Singapore, has begun joint research on a therapeutic with Twist, continues to conduct screening
antibody to fight COVID-19, with the A*STAR in for potential candidate antibodies. Using
Singapore. This joint research project focuses on a its single cell proteogenomics technology
potential therapeutic antibody for COVID-19 that was which enables the simultaneous screening of
discovered by a research team led by Senior Principal antibodies targeting multiple viral variants,
Investigator Dr Cheng-I Wang at A*STAR’s Singapore Proteona is analyzing blood samples from
Immunology Network (SIgN). Lead candidates recovered COVID-19 patients, and screening
were isolated from a high diversity synthetic human for B cells that produce neutralizing antibodies
antibody library and showed high potency in against the SARS-CoV-2 virus. 10x Genomics
neutralizing live coronavirus which causes COVID-19. and NovogeneAIT are providing enabling
technologies for single cell analysis and
Chugai Pharmabody Research will lead the sequencing respectively.
antibody optimization with its world-leading
antibody research capability, and by applying The clinical partners at the Heidelberg University
Chugai’s proprietary antibody engineering Hospital, the German Cancer Research Center, and
technologies, create a clinical candidate the Natural and Medical Sciences Institute (NMI) at
antibody. Successful past collaborations the University of Tübingen are assisting in sample
between A*STAR and Chugai have included

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Firms developing antibody based treatments

S No Firm(s) Type, Candidate Status

1 Eli Lilly, USA Monoclonal, LY-CoV555 Phase I trial

2 Regeneron, USA Cocktail, REGN-COV2 Phase I trial

3 Vir Biotechnology, USA in partnership Monoclonal Research and Development
with GlaxoSmithKline, UK

4 Amgen, USA has partnered Monoclonal Research and Development
with Adaptive Biotechnologies

5 Institute for Biological Research Monoclonal Human clinical trials to start
Institute (IIBRI), Israel

6 Celltrion, South Korea Monoclonal Completed preclinical studies;
Phase I trial to start in July

7 Roviant Sciences, Switzerland Monoclonal, Gimsilumab Trial ongoing

8 Agency for Science, Technology and Monoclonal Research and Development

Research (A*STAR), Singapore in partnership

with Chugai Pharmabody Research, Japan

9 The Antibody Therapy Against Coronavirus Monoclonal Human testing in Germany/
(ATAC) project funded by the European animal testing in Switzerland
Commission and led by Sweden’s Karolinska
Research Institute

10 AbbVie, USA Monoclonal Research and Development

11 Proteona, Singapore in partnership with Monoclonal Research and Development
Twist Bioscience, USA and others

12 Atreca, Inc., USA and IGM Biosciences, Inc. Immunoglobulin M (IgM) Research and Development

USA along with BeiGene, Ltd, China and immunoglobulin A (IgA)

13 Tiziana Life Sciences, UK Monoclonal, TZLS-501 Research and Development

14 Tychan, Singapore Monoclonal, TY027 Phase I trial

collection and coordination, and provide first-hand to rapidly screen the massive genetic diversity of the
clinical insight. Twist will synthesize and express the B cell receptors from individuals that have recovered
antibody sequences as functional antibodies, which from COVID-19. This enables the identification of tens
can then be tested by collaborators in animal and cell of thousands of naturally occurring antibodies from
studies for safety and efficacy. survivors of COVID-19 to select those that neutralize
SARS-CoV-2. Amgen will then leverage its world-
While the US based Amgen and Adaptive class antibody engineering and drug development
Biotechnologies on April 2 announced a collaboration capabilities to select, develop and manufacture
aimed at helping address the COVID-19 pandemic. antibodies designed to bind and neutralize SARS-
The companies will combine expertise to discover and CoV-2. deCODE Genetics, a subsidiary of Amgen
develop fully human neutralizing antibodies targeting located in Iceland, will provide genetic insights from
SARS-CoV-2 to potentially prevent or treat COVID-19. patients who were previously infected with COVID-19.
The mutually exclusive collaboration brings together
Adaptive’s proprietary immune medicine platform for Another US based Vir Biotechnology, a clinical-
the identification of virus-neutralizing antibodies with stage immunology company focused on combining
Amgen’s expertise in immunology and novel antibody immunologic insights with cutting-edge technologies
therapy development. Neutralizing antibodies defend to treat and prevent serious infectious diseases,
healthy cells by interfering with the biological function has assembled four technology platforms that are
of an invading virus. These antibodies may be used designed to stimulate and enhance the immune
therapeutically to treat someone currently fighting system by exploiting critical observations of natural
the disease and can be given to people who have immune processes. Its current development
heightened risk of exposure to SARS-CoV-2, such as pipeline consists of product candidates targeting
healthcare workers. hepatitis B virus, influenza A, SARS-CoV-2, human
immunodeficiency virus and tuberculosis.
Adaptive will extend its high throughput platform

26 COVER STORY

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Vir has two SARS-CoV-2 antibody in agreement with Bristol Myers Squibb (BMS).
development candidates, VIR-7831 and VIR-
7832 that have demonstrated high affinity for Tiziana is simultaneously developing an
the SARS-CoV-2 spike protein and the ability inhalation technology, in collaboration with
to neutralize SARS-CoV-2 in live-virus cellular Sciarra Laboratories, for the direct delivery
assays. of TZLS-501 into the lungs using a handheld
inhaler or nebulizer for treatment of patients
On May 29, Vir Biotechnology has finalized a with COVID-19. The proprietary novel technology
process development and manufacturing agreement to administer TZLS-501 directly into the nasal
with Biogen. Under the agreement Biogen will passages or lungs by inhaler or nebulizer has
perform process development activities and specified potentially significant clinical advantages for the
manufacturing and process transfer services to enable treatment of COVID-19 patients. The company
commercial supply of Vir’s SARS-CoV-2 monoclonal recently submitted a patent application for the
antibodies. The execution of this definitive agreement inhalation delivery of anti-IL6R-monoclonal
allows Vir to advance the development of its antibody for the treatment of COVID-19.
antibody candidates and complements its existing
manufacturing agreements with WuXi Biologics and TZLS-501, a unique and best-in-class anti-IL-6R
Samsung Biologics Co., Ltd. mAb, follows a dual mechanism by not only blocking
downstream signaling pathways from membrane-
Latest to add to these developments is the bound and soluble IL-6 receptors, but it also rapidly
announcement of AbbVie, Harbour BioMed (HBM), depletes blood-stream levels of IL-6, the major culprit
Utrecht University (UU) and Erasmus Medical for cytokine release syndrome (CRS) in lungs of
Center (EMC) on June 5 that they have entered into a COVID-19 patients. In receptor binding assays, TZLS-
collaboration to develop a novel antibody therapeutic 501 is considerably more potent than the other anti-IL-
to prevent and treat COVID-19, the pandemic 6R mAb in this class, such as Actemra (Roche). These
respiratory disease caused by the SARS-CoV-2 virus. biochemical features, differentiating TZLS-501 from
The focus of the collaboration is on advancing the fully other mAbs in this class, offer potential distinctive
human, neutralizing antibody 47D11 discovered by clinical advantages in effecting a rapid suppression of
UU, EMC and HBM and recently reported in Nature the cytokine storm at much lower doses.
Communications. This antibody targets the conserved
domain of the spike protein of SARS-CoV-2. The proprietary inhalation technology for direct
delivery of mAbs or other small molecule drugs such
Harbour BioMed having operations in Cambridge, as Remdesivir (Roche) to lungs could potentially be
Massachusetts; Rotterdam, The Netherlands; and a transformational therapy for developing a rapid
Suzhou & Shanghai, China, has internal discovery treatment of COVID-19
programmes centered around its two patented
transgenic mouse platforms (Harbour Mice) for Sciarra Laboratories, Inc., has been developing
generating both fully human monoclonal antibodies and manufacturing pharmaceutical aerosol products
and heavy chain only antibodies (HCAb) and HBICE for over 25 years. Previously, Sciarra worked with
immune cell engager technology for developing Tiziana to successfully manufacture clinical supplies
bispecific antibodies. for the nasal administration of Foralumab, a fully
human anti-CD3 mAb, for the recently completed
Under the terms of the collaboration, AbbVie will Phase I trial, and the company is currently working
support UU, EMC and HBM through the preclinical with Tiziana to manufacture Foralumab for nasal
activities, while simultaneously undertaking administration using a medical device, which will also
preparations for later stage preclinical and clinical be used for the upcoming Phase II trial in progressive
development work. AbbVie will receive an option multiple sclerosis. This phase II trial will commence
to exclusively license the antibody from the three shortly at the Brigham and Women’s Hospital,
parties for therapeutic clinical development and Harvard Medical School, Boston, MA.
commercialization worldwide.
Antibodies are not without drawbacks. The
On June 29, Tiziana Life Sciences plc, a clinical biggest problem with antibody treatments is
stage biotechnology company with operations in the their staying power and the difficulty in scaling/
US and the UK developing targeted drugs for cancer, manufacturing that is needed to fight the pandemic.
inflammatory diseases and COVID-19, announced But they could be an important component for the
the execution of an agreement with STC Biologics, treatment till we find a definitive cure.
Inc. (STC) for GMP manufacturing of TZLS-501, an
anti-IL-6 receptor (anti-IL-6R) monoclonal antibody Narayan Kulkarni
(mAb) acquired from Novimmune in 2017, currently [email protected]
(With inputs from Ayesha Siddiqui)

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Repurposing hepatitis
drugs for COVID-19 treatment

While researchers are still finding novel ways to cure hepatitis, the virus has shown them a new direction.
HCV shares similarity with the currently prevalent SARS-CoV-2 by having a single-stranded RNA, while
HBV has a double-stranded DNA as its genetic material. As a result, repurposing of existing therapies has
emerged as a major area of drug development for COVID-19 and selected hepatitis drugs among others are
being studied for repositioning to manage the pandemic.

As the world celebrates Hepatitis Day on 80-90 per cent of the population living with the
July 28, 2020, the count of people globally condition is unaware of their status also leading
affected by hepatitis would be more than to accidental transfer of the disease. The theme
325 million. Also, the count of annual average for World Hepatitis Day 2020 is therefore ‘Find
deaths by the most prevalent forms of Hepatitis- the Missing Millions’ to encourage people to get
B & C (HBV and HCV) would be 1.4 million. Being tested.
one of the leading causes of death, these two
viruses kill more than human immunodeficiency Taking a new direction
virus (HIV) and malaria and are responsible for
two out of every three liver cancer deaths globally. While researchers are still finding novel ways
to cure hepatitis, the virus has shown them a
Hepatitis E virus (HEV) infection is the major new direction. HCV shares similarity with the
cause of acute sporadic and epidemic hepatitis currently prevalent SARS-CoV-2 by having a
in India. The frequency of hepatitis C has been single-stranded RNA, while HBV has a double-
reported to be 1-2 per cent among voluntary stranded DNA as its genetic material. As a result,
blood donors and about 15-30 per cent cases of repurposing of existing therapies has emerged as
acute hepatitis in India is due to HBV. a major area of drug development for COVID-19
and selected hepatitis drugs among others are
These numbers may sound terrifying but being studied for repositioning to manage the
significant progress is being made in both the pandemic.
prevention and treatment of the various forms of
hepatitis. Vaccination is now available for both “Drug repurposing, which is defined as
hepatitis A (HAV) and hepatitis B, and since identifying alternative uses for approved or
hepatitis D (HDV) only occurs when a hepatitis investigational drugs outside their defined
B infection is present, this leaves only hepatitis indication, could be a possible way to overcome
C and hepatitis E in need of a vaccination for the time limitation of research and development
prevention. needed to design a therapeutic drug to
combat the pathogen. Apart from having a
Also, there are a number of drugs approved lower risk of failure, most repurposed drugs
by U.S. Food and Drug Administration (FDA) for
management of HBV and HCV infections which “Apart from having a lower risk
include interferon therapy- PEG-IFN alfa-2a, of failure, most repurposed
PEG- IFN alfa-2b; nucleoside and nucleotide drugs have cleared Phase
analogues- Adefovir, Entecavir, Emtricitabine, I trials and require lower
Lamivudine, Ribavirin Telbivudine, Tenofovir;
and newer direct-acting antiviral drugs investment, but above all, the
(DAAs)- Simeprevir, Sofosbuvir, Ledipasvir, drug repurposing strategy
Ombitasvir, Paritaprevir, Dasabuvir, Elbasvir and
Grazoprevir, Velpatasvir drastically reduces the time
frame for development”.
The question which comes now is that in spite - Dr Sarah S Cherian,
of drug and vaccination availability why is the
mortality so high? The answer to support the Scientist, Department of Bioinformatics, NIV, India
fact is that hepatitis B and C are silent killers and

28 COVID -19

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have cleared phase I trials and require lower to treat the coronavirus infection. The company
investment, but above all, the drug repurposing is leveraging its virology expertise, working on
strategy drastically reduces the time frame for Paritaprevir and Glecaprevir discovery, protease
development”, says Dr Sarah S Cherian, Scientist, inhibitors for HCV.
Department of Bioinformatics, National Institute
of Virology (NIV), Pune, India. According to a recent drug repurposing study
conducted by a few research institutes in Gujarat,
Recently, few hepatitis C drugs such as a known drug treatment available for hepatitis C,
Simeprevir, Paritaprevir, Grazoprevir, Sofosbuvir Paritaprevir is found to be a useful candidate for
have come into light as potential candidates for treating the coronavirus infection.
studies around COVID-19 management.In a study
conducted in Iran, a virtual screening procedure “Until any accurate treatment methodology
employing docking of different databases is available for COVID-19, the use of derivatives
including 1615 FDA approved drugs was used to of previously known antiviral drugs is a useful
identify new potential small molecule inhibitors strategy.In order to find a potential candidate for
for protease protein of COVID-19. The docking treating COVID-19, molecular docking studies
result indicates that among all, Simeprevir could are being performed over antiviral agents on the
fit well to the binding pocket of protease and binding pocket of enzyme COVID-19. We have
because of some other positive features might be found that Paritaprevir, an inhibitor of non-
a helpful treatment option for COVID-19. structural protein 3-4A serine protease for the
treatment of hepatitis C, can prove effective for
Another group in Iran has claimed that SARS- the COVID-19 treatment”, shares Dr Bhumi Shah,
CoV-2 infection could also be susceptible to HCV Assistant Professor, L. J. Institute of Pharmacy,
drug Sofosbuvir. “We advocate generic Sofosbuvir Gujarat, India.
beyond treatment of HCV-infected patients.
As it represents a safe and effective antiviral Almost three months into the disease,
option, compared to similar anti-viral agents, on March 28, 2020, USFDA had issued an
we encourage clinical investigators to consider Emergency Use Authorization (EUA) to authorize
these dual-component HCV drugs, (Velpatasvir/ use of chloroquine and hydroxychloroquine for
Sofosbuvir), as re-purposed treatment against management of the disease. However, usage of
SARS-CoV-2 infection”, says Prof. Babak Sayad, the drug still remains controversial. Progressing
Infectious Diseases Research Center, School of in the efforts and anticipations of disease control,
Medicine, Kermanshah University of Medical Gilead’s antiviral Remdesvir, which was originally
Sciences, Kermanshah, Iran. developed for HCV and was later tested for Ebola
and Marburg virus, also received an EUA for
Similarly, US based biotechnology firm COVID-19 management in early May 2020.
Enanta Pharmaceuticals has launched efforts to
identify direct-acting antiviral drug candidates Though the drug has been ineffective in
mentioned diseases, earlier in-vitro studies
“We advocate generic had demonstrated its broad spectrum antiviral
Sofosbuvir beyond treatment activity. Recently, the Drugs Controller General of
of HCV-infected patients.
As it represents a safe and
effective antiviral option,
compared to similar anti-viral
agents, we encourage clinical
investigators to consider these
dual-component HCV drugs,
(Velpatasvir/Sofosbuvir), as re-
purposed treatment against
SARS-CoV-2 infection”.
- Prof. Babak Sayad,
Infectious Diseases Research Center,
School of Medicine, Kermanshah University of
Medical Sciences, Kermanshah, Iran

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CURRENT STATUS OF HEPATITIS DRUGS BEING EXPLORED AGAINST COVID-19

Drug Status Company/ Institute
Interferon Alpha- 2b Phase I/II Roswell Park Cancer Institute and
National Cancer Institute (NCI), US
Pegylated Interferon Alpha-2b IND with FDA; Application for trials with DCGI Zydus Cadila, India
University of Hong Kong
Ribavirin (+Interferon Beta-1B Phase II
+ Lopinavir/ritonavir) Mansoura University, Egypt

Ribavirin Phase III Sichuan Academy of Medical
Sciences and Sichuan Provincial
(+ Nitazoxanide + Ivermectin People’s Hospital, China
Spanish AIDS Study Group and
Emtricitabine and Tenofovir NA Spanish National AIDS Plan, Spain

Emtricitabine and Tenofovir Phase III

NA- Not Available

India (DCGI) has granted approval to Remdsevir Cancer Institute (NCI) in combination with
for “restricted emergency use” on hospitalized Rintatolimod.
COVID-19 patients based on US based National
Institute of Allergy and Infectious Disease’s Ahmedabad based pharma giant Zydus Cadila
placebo controlled study and Gilead’s own phase has been commercially manufacturing Pegylated
3 SIMPLE trial. Interferon Alpha-2b under the brand name,
PegiHep, since 2011 for the treatment of Hepatitis
Looking at a promising option B and C with 1.5 lakh doses being administered.
The company has now approached DCGI to
In particular, interferons are being looked at as conduct clinical trials of the molecule in adult
a promising option for COVID-19 treatment. As COVID-19 patients. The firm has also approached
the first line of defense, interferons inhibit viral the Department of Biotechnology (DBT) to
multiplication and boost immune response. An investigate the role of PEG-INF-Alpha-2b in
exploratory study conducted in Wuhan, China has COVID-19 management.
shown that Interferon Alpha 2b can accelerate
viral clearance from the upper respiratory tract “At this juncture, as the healthcare fraternity
also reducing circulating inflammatory factors. the world over, is exploring options for a safe
PEG-INF-Alpha 2b is a part of COVID-19 and efficacious treatment to combat COVID-19,
treatment guidelines of the Chinese government Pegylated Interferon alpha emerges as one such
and has also been successfully used in Cuba. In- possibility with its potential to reduce virus titres
vitro studies by University of Texas also showed when given earlier in the disease and offering
better clinical outcomes. We are working with the
10,000-fold reduction in virus titer. Interferon U.S. Food and Drug Administration (FDA) and
Alpha 2b is also being studied by US have opened an investigational new drug (IND)
based Roswell Park Cancer Institute
and National

“We have found that
Paritaprevir, an inhibitor
of non-structural protein
3-4A serine protease for the
treatment of hepatitis C,
can prove effective for the

COVID-19 treatment”.
- Dr Bhumi Shah,

Assistant Professor,
L. J. Institute of Pharmacy, Gujarat, India

30 COVID -19

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ANTI-VIRAL THERAPIES FOR HEPATITIS

Hepatitis Virus Epidemiology (Annual infections- in million) Treatment
HAV ~1.4
HBV ~240 chronic carriers Supportive therapy

HCV ~ 71 chronic carriers Acute: Supportive therapy

HDV ~ 15 Chronic: PEG-IFN alfa-2a, oral nucleoside or
HEV ~ 20 nucleotide analogues- Tenofovir, Entecavir,
Lamivudine, Adefovir

Acute: INF Therapy

Chronic: INF (PEG-IFN alfa-2b, PEG- IFN alfa-2a)
+ Ribavarin

New therapies for Chronic:

1. Simeprevir and sofosbuvir

2. Ledipasvir/sofosbuvir

3. Ombitasvir, paritaprevir, and ritonavir tablets;
dasabuvir tablets

4. Elbasvir and grazoprevir

PEG-INF

Supportive therapy

filing for Pegylated Interferon Alpha-2b for the has shown that the triple antiviral combination
treatment of COVID-19”, says Dr Sharvil Patel, therapy is safe in alleviating symptoms,
Managing Director, Zydus Cadila, Ahmedabad, shortening viral shedding and hospital stay.
India. Ribavarin is also being studied in a Phase III trial
in combination with Nitazoxanide and Ivermectin
Finding a combination by Mansoura University in Egypt for COVID-19
management.
Experience with influenza therapy suggests that
combinational antiviral therapy is more effective Further, Truvada, a combination drug-
compared to single agent therapy. Hence, in some Emtricitabine and Tenofovir is being studied
parts of the world hepatitis drugs belonging to by Sichuan Academy of Medical Sciences
the class nucleoside and nucleotide analogues and Sichuan Provincial People’s Hospital for
are being investigated in combination with other COVID-19 management. The drug is also part of
antivirals. 4000 patient Phase III clinical studies by Spanish
AIDS Study Group and Spanish National AIDS
Researchers at the University of Hong Plan.
Kong are conducting Phase II trials for using a
combination of Multiple Sclerosis (MS) drug- Firms worldwide are researching various
Interferon Beta-1B, anti-HIV drugs Lopinavir/ vaccine models, monoclonal antibodies, gene
Ritonavir and anti-hepatitis drug Ribavarin which therapy, use of mesenchymal stromal cells, RNAi
therapeutics, etc. to combat COVID-19. Initiatives
“We are working with the to use plasma therapy also saw a wave of hope
USFDA and have opened an and symptom control. However, when it comes
investigational new drug (IND) to repurposing of drugs as a potential treatment
filing for Pegylated Interferon option, it has been observed that Interferon Alpha
Alpha-2b for the treatment of 2b is being considered as an option of ambition
because of its generalized effect towards a wide
COVID-19”. spectrum of viruses. Few other hepatitis drugs
- Dr Sharvil Patel, have also been isolated from a pool of candidates
binding to SARS-CoV-2, but it would need further
Managing Director, Zydus Cadila, Ahmedabad, India preclinical and clinical evaluations to be given a
status of potential therapy.

Swati Shrivastava

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Controversial papers in NEJM and The Lancet

A KNEE-JERKER
DURING PANDEMIC?

Praised as a potential miracle cure, hundreds of trials got initiated across the globe for HCQ. Scientists
started trying the drugs in low and high doses; alone or combined with other drugs in patients with mild or
severe disease. But this hope recently got struck by a big blow when a study came along claiming that these
antimalarial drugs not only look ineffective, but are downright deadly.

The absence of an effective treatment against School, US; Frank Ruschitzka fromUniversity Heart
the coronavirus infection has led clinicians to Center, University Hospital Zurich, Switzerland; and
redirect drugs that are known to be effective Dr Amit N Patel from Department of Biomedical
for other medical conditions to the treatment of Engineering, University of Utah, Salt Lake City, US.
COVID-19. Key among these repurposed therapeutic
agents are the antimalarial drug chloroquine (CQ) They used hospital records procured by an
and its analogue hydroxychloroquine (HCQ), which American healthcare analytics company Surgisphere
is used for the treatment of autoimmune diseases, Corporation, established in 2008 by an Indian
such as systemic lupus erythematosus and
rheumatoid arthritis. Sapan Desai, for their study. According to their
findings, COVID-19 patients taking CQ or
Praised as a potential miracle HCQ were associated with an increase in
cure,hundreds of trials got initiated the risk of ventricular arrhythmias and
across the globe for HCQ. Scientists a greater hazard for in-hospital death
started trying the drugs in low and with COVID-19. The study concluded
high doses; alone or combined with that these drug regimens should
other drugs in patients with mild or not be used outside of clinical
severe disease. trials and urgent confirmation
from randomised clinical trials is
But this hope recently got needed.
struck by a big blow when a study Hereafter, large randomized
came along claiming that these trials of these drugs came to a
antimalarial drugs not only look halt. It prompted even the World
in effective, but are downright Health Organization (WHO) to
deadly. This study, published pause HCQ clinical trials in
on May 22 in the elite COVID-19 patients under
journal The Lancet, its giant solidarity trial.
was conducted by And then came
three researchers- Dr another blow when
Mandeep R Mehra questions were
from Brigham and raised on the
Women’s Hospital authenticity
Heart and Vascular of this study.
Center and For example,
Harvard Medical the claim

32 COVID -19

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“While we all are working
at a record speed which is
the need of the hour, it is
of paramount importance

for all researchers to
ensure that the principles

of ethics are followed to
the core.”
- Dr Chirag Trivedi,

President, Indian Society Clinical Research, India

“The lost precious time
studying potential of the drug
will be hurtful, considering that

in many regions, the disease
has already peaked and is now

declining. Trial sponsors will
find it more difficult to also
convince patients to participate

in the studies.”
- Megha Joshi,

Consultant, Healthcare, Markets & Technology, India

that 96032 hospitalised patients from 671 hospitals the database, and to replicate the analyses presented
diagnosed with COVID-19 between December 20, in the paper.
2019, and April 14, 2020 met the inclusion criteria
for this study, seemed implausible. Gradually, the More eyebrows were raised when the authors
study came under the scanner within the research informed that Surgisphere would not transfer the
community. An open letter was signed by clinicians, full dataset, client contracts, and the full ISO audit
medical researchers, statisticians, and ethicists from report to their servers for analysis as such transfer
across the world and sent to The Lancet. would violate client agreements and confidentiality
requirements. Eventually, the authors retracted their
“While we all are working at a record speed which paper from the journal on June 5.
is the need of the hour, it is of paramount importance
for all researchers to ensure that the principles of “The publication shifted global focus from the
ethics are followed to the core. The clinical study humble HCQ to other promising candidates, in the
design, conduct, analysis and reporting should follow lead being Gilead’s remdesivir. With remdesivir
well-laid standards which will ensure the integrity expected to be priced between $2,000 and $5,000 per
and credibility of the data generated in addition course, pursuing HCQ could have potentially made
to the following of ethical principles. Protecting treatment accessible globally, sooner. The publications
patients’ safety is always of utmost importance in any doomed to retract led many regulatory agencies to
clinical study that we conduct. This is something that ask scientists to halt their trials evaluating HCQ.
we have been doing and hence, should continue doing The retraction will push safety committees to relook
it in the present times too”, shares Dr Chirag Trivedi, at those studies. No doubt, there has been time lost
President, Indian Society Clinical Research, India. which could have been used to accelerate treatment for
patients, especially in critical care. The lost precious
After several concerns were raised with respect time studying potential of the drug will be hurtful,
to the veracity of the data and analyses conducted considering that in many regions, the disease has
by Surgisphere Corporation, the authors of the already peaked and is now declining. Trial sponsors
paper apparently launched an independent third- will find it more difficult to also convince patients
party peer review of Surgisphere with the consent to participate in the studies”, says Megha Joshi,
of Sapan Desai to evaluate the origination of the Consultant, Healthcare, Markets & Technology, India.
database elements, to confirm the completeness of
Around the same time, on June 4, Dr Mandeep

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“Changes in policies “The Trial Steering
of funding agencies Committeehas
to ensure data from
research funded by decided that ASCOT
these bodies to be made should continue
publicly available will recruitment and
enhance transparency of
randomising patients
research.” to hydroxychloroquine
- Dr Shree Divyya,
containing arms.”
Manager Healthcare Advisory, - Dr Asha Bowen,
Sathguru Management Consultants, India
Clinician scientist, Perth Children’s Hospital, Australia

“The trial has now moved “We have clearly advised
on to try and urgently that HCQ should be
establish any benefits
taken with food, not on
from other treatments, empty stomach. We have
including antibiotics, expanded use of HCQ to
anti-inflammatories,
frontline workers also,
drugs used to treat HIV, considering the potential
and plasma therapies.”
benefits.”
- Frank Hester, - Prof Balram Bhargava,
Chief Executive Officer, The Phoenix Partnership, UK
Director General, Indian Council of
Medical Research, India

R Mehra and Dr Amit N Patel along with their against personal gain, vested interests, commercial
co-authors Dr SreyRam Kuy from Baylor College or political influences?” mentions Dr Marcus ONG
of Medicine, Texas, US and Dr Timothy D. Henry, Eng Hock, Professor & Director, Health Services and
from Christ Hospital, Ohio, US and Sapan Desai Systems Research Signature Research Programme,
from Surgisphere Corporation announced another Duke-NUS Medical School, Singapore.
paper retraction from the New England Journal of
Medicine (NEJM). This study titled ‘Cardiovascular An element of irony was later revealed by few
Disease, Drug Therapy, and Mortality in Covid-19’, media reports that meanwhile Desai, who according
had claimed that underlying cardiovascular disease is to court records has three outstanding medical
associated with an increased risk of in-hospital death malpractice suits against him, has written extensively
among Covid-19 patients. in the past on research misconduct. There were
further claims that major institutions including
“The recent high profile retraction of two Stanford University, which were described as
controversial papers on COVID-19 by The Lancet and research partners on the Surgisphere website, said
the New England Journal of Medicine raises several they were not aware of any formal relationship with
pertinent issues in the field of big data in medical the company.
research, and the fine balance of speed versus
maintenance of rigorous scientific review during “While the research community is always in a
outbreaks and pandemics. It would seem there was haste for publishing their research it is critical that
indeed deliberate fabrication and fraud committed they maintain integrity on the data being published.
by Surgisphere, a small Chicago-based company Journals rely on the declaration signed by the authors
that purportedly was able to collect and analyse tens on data reliability and any conflict of interests
of thousands of patient records from hundreds of stated. This current system has been unsuccessful
hospitals in the midst of a pandemic. It is thus timely in providing the required reliance on data when it is
to revisit the ethical issues regarding the use of big, most critical with the current pandemic caused by
‘real-world data’ (RWD) in order to derive ‘real world COVID-19. Hence it could be beneficial for additional
evidence’ to guide clinical care, healthcare policy checks and balances to be created to reduce such
decision making, and health service design, among incidences. Additionally, changes in policies of
other considerations. How can RWD be safeguarded funding agencies to ensure data from research
funded by these bodies to be made publicly available

34 COVID -19

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will enhance transparency of research. Creating “While additional clinical
awareness on any such deterrents established by trials continue to evaluate
journals and data disclosure requirements by the
funding agencies can increase the liability on the the potential benefit of
authors for data integrity, motivate additional these drugs in treating or
prudence on authors and enhance practices for preventing COVID-19, we
bioethics in the scientific community”, says Dr Shree determined the emergency
Divyya, Manager Healthcare Advisory, Sathguru use authorization was no
Management Consultants, India. longer appropriate. This action
was taken following a rigorous
Parallel to this episode came another assessment by scientists
announcement from the UK on June 4, that no
clinical benefit from use of HCQ has been observed in in our Center for Drug
hospitalised patients with COVID-19. In March 2020, Evaluation and Research.”
RECOVERY (Randomised Evaluation of covid-19
therapy) was established as a randomised clinical - Dr Patrizia Cavazzoni,
trial to test a range of potential drugs for COVID-19, Acting Director, FDA’s Center for Drug Evaluation, US
including HCQ. The trial had proceeded at
unprecedented speed, enrolling over 11,000 patients “Scientific rigor should not
from 175 National Health Service hospitals in the UK. and cannot be sacrificed
for speed, as clinicians,
On this note, Frank Hester, Chief Executive policy makers and the
Officer, The Phoenix Partnership, UK shares, “This is general public rely on
an important result for patient care. It was a well- evidence based literature
powered, well-run study, with a conclusive result. The for informed decisions.
trial has now moved on to try and urgently establish
any benefits from other treatments, including Lives may depend on this.”
antibiotics, anti-inflammatories, drugs used to treat - Dr Jenny Low Guek Hong,
HIV, and plasma therapies.”
Associate Professor, Emerging Infectious
On a positive side, low-cost drug dexamethasone Diseases Signature Research Programme,
showed reduction in death by up to one third
in hospitalised patients with severe respiratory Duke-NUS Medical School, Singapore
complications of COVID-19 in this study.
Dexamethasone is a steroid that has been used developed with controlled and well-designed studies”,
since the 1960s to reduce inflammation in a range says Dr Neel Fofaria, Partner, MP Advisors, India.
of conditions, including inflammatory disorders and
certain cancers. Following these developments, on June 15, U.S.
Food and Drug Administration (FDA)revoked the
“The world was shocked when two of the Emergency Use Authorization (EUA) for CQ and HCQ.
most renowned medical journals retracted an “While additional clinical trials continue to evaluate
article on COVID-19 studies. This doesn’t come the potential benefit of these drugs in treating or
as a surprise because the publishing system goes preventing COVID-19, we determined the emergency
through a flawed peer-review process. The lack of use authorization was no longer appropriate. This
transparency in the selection process of the peer- action was taken following a rigorous assessment
reviewers reduces the accountability towards the by scientists in our Center for Drug Evaluation and
articles published. Moreover, reviewers often try Research,” says Dr Patrizia Cavazzoni, Acting Director,
to block the competitors, steal ideas, favor authors FDA’s Center for Drug Evaluation, US.
from prominent institutions and hardly prevent bad
studies from being published. That said, the more After generating initial thoughts on resuming the
important question is, ‘Why is the world obsessed HCQ trial around June 4, the final verdict from WHO
over HCQ?’ The recent controlled studies, one from came on June 17 that the HCQ arm of the solidarity
the University of Minnesota and from the UK trial, trial to find an effective COVID-19 treatment has
show conclusive evidence of lack of HCQ’s clinical been stopped. Investigators will not randomize
benefit against COVID-19, neither for hospitalized further patients to HCQ in the Solidarity trial but
patients or early exposed patients. Therefore, it is patients who have already started the medication
time to focus the efforts and resources to dozens of and have not yet finished their course in the trial may
other novel and promising therapies that are being complete their course or stop at the discretion of the
supervising physician.

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“It is timely to revisit the ethical Ethics Committee. The Trial Steering Committeehas
issues regarding the use of big, decided that ASCOT should continue recruitment
‘real-world data’ (RWD) in order and randomising patients to hydroxychloroquine
to derive ‘real world evidence’ to containing arms”, reveals Dr Asha Bowen, Clinician
scientist, Perth Children’s Hospital, Australia.
guide clinical care, healthcare
policy decision making, and On the other hand, in Singapore, both the
National Centre for Infectious Diseases and National
health service design, among University Hospital have largely stopped using HCQ
other considerations. How can to treat COVID-19 patients. “More than 20,000
RWD be safeguarded against articles on COVID-19 can be found on any given
personal gain, vested interests, PubMed search since the start of the pandemic,
highlighting the unprecedented speed of scientific
commercial or political review and turnaround. With the pandemic moving
influences?” at an extraordinary pace, there is an urgent need for
- Dr Marcus ONG Eng Hock, accurate and timely scientific evidence. Yet, scientific
rigor should not and cannot be sacrificed for speed, as
Professor & Director, Health Services and clinicians, policy makers and the general public rely
Systems Research Signature Research Programme, on evidence based literature for informed decisions.
Lives may depend on this”, points out Dr Jenny Low
Duke-NUS Medical School, Singapore Guek Hong, Associate Professor, Emerging Infectious
Diseases Signature Research Programme, Duke-NUS
“It is time to focus the Medical School, Singapore.
efforts and resources
Amidst this confusion, another announcement
to dozens of other came from the Taiwan Food and Drug administration
novel and promising on June 17 in the form of recalling 11 medicines
containing a compound called fenspiride, used in
therapies that are the treatment of certain respiratory diseases. In
being developed with a statement announcing the recall, the FDA cited
the suspension of fenspiride medicines by the
controlled and well- European Union (EU) in 2019, which warned that
designed studies.” such medicines could cause sudden serious heart
- Dr Neel Fofaria, rhythm problems. This development has once again
Partner, MP Advisors, India. highlighted the damaging effects caused by certain
drugs being used for treating respiratory disorders.
On June 20, Switzerland headquartered
pharmaceutical company Novartis informed that it But for India, the speculations over the
is stopping its trial of HCQ against COVID-19 due to effectiveness of HCQ was never a cause of concern,
shortage of participants. The company had initially even when the negative study was published. On May
inked an agreement with the USFDA to proceed with 26, Prof Balram Bhargava, Director General, Indian
a Phase III clinical trial with approximately 440 Council of Medical Research stated, “We have clearly
patients to evaluate the use of HCQ. advised that HCQ should be taken with food, not
on empty stomach. We have also emphasized that
The results of The Lancet study also made one ECG should be done during the treatment. We
the researchers in Australia re-think about the have expanded use of HCQ to frontline workers also,
AustralaSian COVID-19 trial (ASCOT) initiated by considering the potential benefits.”
the Royal Melbourne Hospital. The trial is designed
to assess the safety and effectiveness of lopinavir/ As a matter of fact, Dr Shekhar Mande, Director-
ritonavir and HCQ at more than 70 hospitals across General, Council of Scientific and Industrial Research
Australia and 11 hospitals in New Zealand. in India had called WHO’s initial stay on HCQ trials
as a knee-jerk reaction. Any which way, the studies
“Results of a large database published in The on HCQ should finish and answer the questions they
Lancet showing an increased mortality were cause were designed for. So that we won’t have to revisit
for thought, discussion and convening of a host of this particular question again and we can look at new
meetings to consider how to progress a clinical trial options.
with emerging evidence. Here with the ASCOT trial we
did all of this: convened the Trial Steering Committee, Dr Manbeena Chawla
the Data Safety and Monitoring Board, the ASCOT [email protected]
Advisory Committee, and ultimately discussed
the ongoing equipoise with the Human Research

36 COVID -19

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5 things pharma can
learn from COVID-19
Almost all of the industries have to rethink nearly every aspect of their operations and pharma is no
different. To overcome this situation, the pharma industry can adopt five strategies - Rethink supply chain,
Technology is vital, Agility in manufacturing, Reprioritize portfolio strategy and Realign organizational
strategy for a better future and to be better prepared for any future crisis.

Coronavirus has upended the worldand caused Sciences Leader, EY India.
enormous challenges to economies and has However, restructuring supply chain may take
brought terrible human suffering. Almost all of
the industries have to rethink nearly every aspect of some time. For the short term, the uncertainty of the
their operations and pharma is no different. In fact, this pandemic has required supply chain flexibility and
outbreak has brought more attention to the healthcare transportation creativity.
and pharma industry. Though the pandemic is far from
over, its clear pharma industry will no longer be the “This period has been challenging with COVID-19
same post this crisis. Let’s look at what are the insights affecting nearly all regions, but creativity has helped
pharma can learn from this crisis. meet customers’ needs. The supply situation was
aggravated with the reduction in flights and tightening
Rethink supply chain of local transportation around the world. To address
this, we adopted different transportation routes;
China and India are the largest global producers moving from passenger to cargo, aircraft to truck –
of Active Pharmaceutical Ingredients (APIs) and even making multiple stops along the way,” said Steve
generics. Since the outbreak started, both the Cooper, Head of Integrated Supply Chain Operations,
countries have imposed lockdown; supply from their Life Science business of Merck, APAC, Singapore.
manufacturing facilities has reduced and caused
ripple effects in the pharma industry. This has forced Technology is vital
policymakers and pharma companies to rethink about
pharma supply chain. Digital practices have seen a boom. There has been an
increase in the awareness and acceptability of internet
“Due to the sudden and extreme impact on supplier healthcare by general public. Private internet healthcare
/ distributor network in light of the COVID-19 impact companies providing healthcare consultation/advice/
organizations will be forced to consider restructuring monitoring, selling healthcare related products (drugs/
internal supply chain strategies (e.g., more direct devices/consumables) has experienced further growth.
distribution/expanded safety stocks) to include Among major pharma companies, 60 per cent are
augmented emergency response mechanisms for already using telemedicine for trial visits in response
increased resilience and ensured dynamic response to the COVID-19 crisis and more seem likely to follow,
going forward,” said Fabio La Mola, Partner, Global says a report from McKinsey.
Healthcare Co-Head, Asia-Pacific, L.E.K. Consulting,
Singapore. It will be good to invest in digital solutions “Pharmaceutical firms will need to work on two
like real time supply chain monitoring. Also, reassess things. First and foremost, re-orient their commercial
APl and excipients sourcing strategy and manufacturing model, given that our survey shows 68 per cent of
footprint to minimize future disruption on downstream doctors will reduce medical representatives’ visits.
supply chain. Second, in operations and quality – build a digital
roadmap – as we have seen, investments in automation
“Use the opportunity to build agility and resilience and remote working will help reduce non value
in your supply chain. People who have been nimble adding work and enhance productivity further,” said
have been able to get back on their feet faster and do Rahul Guha, Managing Director and Partner & Lead,
business in these tough times vs those who were not. Healthcare Practice, BCG India.
Going forward this risk is going to continue and having
agile, resilient supply chains is the need of the hour,” Not only that, organizations must learn to digitize
said Sriram Shrinivasan, Partner and National Life their operational flow. Pharma is said to be slow when
it comes to digital transformation, that’s not an option
anymore, it has become imperative for firms to adapt to

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technological tools in their workflow. “Use the opportunity to
accelerate the digital journey
Agility in manufacturing
– doctor-patient and doctor
COVID-19 has forced firms to look at diversifying their company interactions can
manufacturing capacity across a number of markets. go online. Companies are
While earlier the motto was ‘local for global,’ countries
are starting to think ‘local for local’ now. using automation across the
enterprise.”
“With risks and problems exposed in current - Sriram Shrinivasan,
manufacturing enterprises as a result of the COVID-19
impact, focused bolstering of current capabilities Partner and National Life Sciences Leader, EY India
towards enhanced automation and digitalization
will evolve to ensure increased resilience to major “With increased pressure
disruptions in production and capacity,” said Fabio on enhancing patient care,
La Mola. Firms must be agile when it comes to lowering costs, minimizing
manufacturing. They should be able to scale up capacity
for critical products and training additional talent errors and improving
across geographies. productivity providers will
continue to adopt digital
“For our pharmaceutical customers, there are
operational challenges in scaling-up for filling and technologies.”
supplying vaccines due to geography, capacity, and - Fabio La Mola,
capabilities. To help address these barriers, partnering
with customers across the global to share experience in Partner, Global Healthcare Co-Head,
scaling operations and preparing for mass production Asia-Pacific, L.E.K. Consulting, Singapore
will help,’ said Cooper. He added, “Experiments
conducted at small or pilot scale provide data that “Pharmaceutical firms will need
can help extrapolate large-scale requirements and to work on two things. First
intermediate-scale production which are conducted to and foremost, re-orient their
confirm data linearity. Across the industry, creativity
and agility are critical from supply to production commercial model. Second, in
to delivery. More than ever, a close partnership operations and quality – build
with customers is the key to accelerating research, a digital roadmap and remote
manufacturing, and testing.” working will help reduce non
value adding work and enhance
Reprioritize portfolio strategy
productivity further.”
It’s nearly impossible to gauge which virus will strike - Rahul Guha,
the next and be ready with a vaccine/drug. Drug
development is an expensive business. In a crisis like Managing Director and Partner & Lead,
these, it becomes imperative for firms to realign portfolio Healthcare Practice, BCG India
strategy and pipeline priorities as appropriate and
make strategic choices. Revising clinical development “This period has been
timelines, risks for portfolio and allocate resources to challenging with COVID-19
respond quickly will help. Firms must also evaluate use affecting nearly all regions,
of digital technology to facilitate clinical trials. but creativity has helped meet
customers’ needs. The supply
Realign organizational strategy situation was aggravated with
the reduction in flights and
During a crisis, firms would have to navigate numerous tightening of local transportation
uncertainties, including the level of economic disruption
caused by the pandemic, and the nature of the response around the world.”
from governments, regulators, and health systems. All - Steve Cooper,
this would help in shaping the organizational strategy.
This pandemic will pass eventually, but it’s important Head of Integrated Supply Chain Operations,
that we learn the right lessons for a better future and to Life Science business of Merck, APAC, Singapore
be better prepared for any future crisis.

Ayesha Siddiqui

38 Q&A

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“So far COVID-19 has
limited impact on our business”

« drug candidates against targets in our focus areas.
We successfully listed on the Nasdaq Stock
Dr Samantha Du,
Founder and CEO, Exchange in September 2017 when we had four
Zai Lab, China clinical-stage assets. Today, we have two marketed
products, nine late-stage clinical assets with more
Established by Dr Samantha Du in 2014, China than 20 indications and 25 ongoing and planned
based Zai Lab, a biopharmaceutical company, trials. As of April 2019, the company has a global
has an impressive track record. The firm team of over 800 employees.
successfully completed NASDAQ listing in 2017, in
just three years after its inception. Today, it has two What’s driving the growth of the company?
marketed products, nine late-stage clinical assets We are proud of our global reputation as a biotech
with more than 20 indications and 25 ongoing pioneer and a partner of choice in China as we
and planned trials. In an email interaction with deliver exceptional execution across global and local
BioSpectrum Asia, Dr Samantha Du shares with clinical development, regulatory affairs, business
us about her company, milestones, achievements development, commercialization and infrastructure
and the ongoing coronavirus crisis’ impact on the expansion. Within the next few years, we are well
biopharma business. Edited Excerpts; positioned to reach our vision of becoming a leading
global biopharma company with a steady stream
Can you give us an overview of Zai Lab? of approvals and commercial launches in greater
Zai Lab is an innovative, research-based, commercial- China across multiple therapeutic areas, internally
stage biopharmaceutical company with seven offices generated global pivotal stage pipeline assets and
located in China, United States and Hong Kong, transformative partnerships. We are still the only
focused on bringing transformative medicines to company to take a global clinical-stage asset from
patients suffering from cancer, autoimmune and Clinical Trial Application (CTA) to approval to
infectious diseases to patients in China and around commercial launch. We obtained National Medical
the world. Products Administration (NMPA) (former State Food
and Drug Administration) approval for two products
Over the next three years, we aim to be one of the in mainland China in the past six months.
leading biopharma companies on the global stage.
Since our inception in 2014, Zai Lab’s experienced Based on our extensive track record of execution
team has secured partnerships with leading global
biopharma companies, generating a broad and
diverse pipeline of innovative drug candidates.
We have also established our own manufacturing
facilities and a highly specialized commercial team
to support marketing of our innovative products
in China. We believe our integrated approach will
provide sustainable competitive advantages for Zai
Lab. We have built an in-house team with strong drug
discovery and translational research capabilities,
aiming to establish a global pipeline of proprietary

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and delivering results, we have earned the “2020 is emerging as another pivotal
reputation as a trusted partner of choice for global year as we have launched Zejula and
biopharmaceutical companies seeking to not only will soon launch Optune in China.
access the Chinese market but also find a long-term In addition, near-term catalysts are
strategic partner for global clinical development. expected for Zejula in the first line
Through these partnerships, we believe Zai Lab ovarian cancer setting, ripretinib for
has built one of the strongest late stage oncology advanced GIST and omadacycline, as
portfolios, with global first-in-class and/or best-in- well as our internal R&D programmes
class profile, among innovative Chinese biotech and with two global IND filings in 2020, and
pharma companies. In addition, we continue to set potential strategic partnerships.”
new benchmarks in China for innovation in clinical
development, accelerated regulatory pathways and have launched Zejula and will soon launch Optune in
commercial strategies. China. In addition, near-term catalysts are expected
for Zejula in the first line ovarian cancer setting,
What are the company’s portfolio development ripretinib for advanced GIST and omadacycline,
and expansion strategies? as well as our internal R&D programmes with two
We focus on three therapeutic areas – oncology, global IND filings in 2020, and potential strategic
infectious disease and autoimmune disease. We partnerships.
also strive to pursue therapies with the potential
to be globally best-in-class and/or first-in-class. The COVID-19 situation has focused even more
We currently have over 10 clinical stage assets attention on the healthcare and pharmaceutical
representing more than 20 indications across more landscape. How do you think companies with a
than 25 ongoing and planned trials. significant footprint in China will be affected?

Oncology is one of our priority areas and we have It is a little early to make definitive statements
strategically identified several important disease about COVID-19 and its potential impact, but we’ve
areas – women’s cancer, lung cancer, gastric cancer seen limited impact on our business so far. We
and brain cancer – where we have multiple, highly cannot speak for other companies but at Zai Lab, we
differentiated drug products and candidates in prepared early and implemented both government-
each. With the recent deal with Regeneron, we also and company-mandated protocols to mitigate any
expanded into hematological cancers. By constructing risk. So far, we’re very happy to report that all 800+
our pipeline this way, leading to establishing several employees at Zai Lab are safe and sound. As listed
disease footholds, we have the ability to realize above, we have continued to deliver on milestones in
synergies during not only the clinical development such a difficult situation.
stage but also commercialization.
What was the motivation behind Zai’s
What have been your key milestones and partnership with Regeneron?
achievements? We have built a great pipeline in several disease areas
Despite the SARS-CoV-2 pandemic, we have had in solid tumors, and we felt it was time to expand
a very productive year-to-date. Over the past six horizontally into hematological cancers to further
months, we had two new product approvals in both leverage our platform and capabilities. In Regeneron,
Zejula and Optune, and had a successful commercial we believe we found the ideal partner and asset.
launch of Zejula in China. We had two New Drug
Application (NDA) accepted with priority review, The unmet medical need and commercial
initiated four key clinical trials, and had 12 CTAs potential in non-Hodgkin’s lymphoma (NHL) is
approved with four more submitted. Zejula’s 1L significant which makes the CD3xCD20 bispecific
sNDA was accepted prior to U.S. approval and class a potentially large market opportunity. From
omadacycline was fast-tracked. Our partnership the latest data shown at ASH 2019, REGN1979 shows
with Regeneron to develop and commercialize impressive ORR/CR for the most common types of
REGN1979 has enabled us to expand into NHL.
hematological oncology, and in a highly successful
follow-on securities offering, we raised $300 million Regeneron is a world leader in developing
significantly strengthening our future and balance breakthrough science and innovative medicines. We
sheets. share the same values with them, and they are the
ideal partner for us to collaborate with.
2020 is emerging as another pivotal year as we
Ayesha Siddiqui

40 Q&A

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

“Investment will flow towards digital
solutions to augment treatment”

« However, recently with the pandemic situation, we are
seeing positive changes in the behaviour, especially
Dr Ruchir Mehra, amongst the healthcare providers. There has been
CEO & Co-founder, substantially higher acceptance of using technology
Remedo, India to provide services to the patients. Having said that,
there is also a need of generating lots of awareness
In 2017, Dr Ruchir Mehra, Harsh V Bansal, and amongst the patients for adopting technology for their
Richeek Arya, came together and started Remedo benefits. In this new world of post corona, there are
as a digital engagement platform to help doctors lots more to offer through technology and to be able to
effectively manage their patients with chronic diseases, use it for the best for both the patients and healthcare
providing end-to-end care in their recovery process. providers. Another key challenge was in terms of
Remedo has partnered with the leading Indian pharma getting the right kind of business model because in a
companies to offer its telemedicine services to more country like India, where we do not have a concrete
than 3000 doctors across specialties. In three years of health insurance system there is always a challenge
its inception, it has already helped more than 1 lakh to decide who would be paying for the services. The
patients by connecting expert doctors with chronically pricing model specially during COVID-19 had to be
ill patients, even in remotely connected areas of the restructured. Our charges are as minimal as 5 per cent
country. By using the program, doctors have witnessed enabling it to be accessible to patients all across India
a 17 per cent increase in follow-up visits and 80 per cent with different paying capacity. Our app is founded by
reorder rate for medicines in a span of 4 to 5 months. doctors for doctors. The crux of our business model
has been to create synergy between doctors and
Telemedicine has become crucial amidst patients and not just be a simple ‘doctor discovery’
the ongoing crisis caused by COVID-19 and the platform which was more popular amongst doctors
government initiatives have helped Remedo reach to specially before pandemic 2020. Creating a business
the maximum share of patients. Social distancing and model to show the real value of our platform has been
remote consultations are now the future of the health one of the other challenges faced.
tech system which makes Remedo a perfect choice for
patients and doctors. BioSpectrum spoke Dr Ruchir
Mehra, CEO & Co-founder, Remedo, Delhi, India
about the challenges faced and growth plans of the
company. Edited excerpts;

What were the challenges faced while setting up
the business?
The main challenge faced was due to the existing
mind set of both the healthcare providers and patients
towards the adoption of technology in the healthcare
space. For example even though telemedicine was
introduced in India more than 10 years back its
acceptance was very low due to which it didn’t see
the glory it was due for. Even now the acceptance
of technology in healthcare practice is quite low.

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How do you plan to use the funds? We are planning on using AI & IoT to manage patient
We have received investments from Angel networks conditions in order to achieve measurable improved
like Angelist, IPV and IIIT-Hyderbad Alumni Angel health outcomes. Aim is to augment the efforts of the
Fund, Riverrocks Ventures, healthcare industry healthcare providers through ‘digitization’ of treatment
veterans, and serial entrepreneurs. Funds will be provided to the patient and to make it a ‘complete
utilized in order to grow the team, product and solution’ for managing patient’s health. It would require
business development efforts. a hybrid kind of approach where both physical + digital
platform could be used to deliver superior treatment
How your solutions works? which would be at lower cost to patients.
Our mobile application version is a one-stop-solution
that benefits both the doctors and patients who are What is the size of telemedicine industry in India?
connected via the platform. It runs on D.I.S.H.A Healthcare system has been changing rapidly
(Digital Integrated Smart Health Assistant) which is worldwide and is undergoing a massive change with
a smart health assistant that connects doctors with respect to the way doctors are connecting with their
their patients via customized plans. The application patients. Telemedicine bridges the gap between doctor
features consultation and follow-up reminders; diet, and patient and helps them maintain a sustainable
exercise, health and lifestyle tips; medical records and relationship especially during pandemic 2020. We
reminders; and daily educational videos and images, have witnessed a substantial growth in telehealth and
making a suitable digital companion for the patient. the overall market growth of telemedicine in India is
The content is tailor made for the Indian patients supposed to reach $5.4 billion in next five years with
and available in native language as well so that larger a CAGR of 31 per cent. The market size for patient
Indian audience can benefit from it. Remedo is a engagement and digital therapy in particular will cross
single solution through which doctors from various more than a billion dollar in the next 2-3 years.
specialties can engage their patients and augment
their treatment with digital care plans. What are your expansion plans?
We are already present across India, from North-
What are the growth plans of Remedo? eastern states to West till Rajasthan and from
Our aim is to transform the health of millions of people Srinagar in North till Kanyakumari in South. We plan
by improving the quality of care through technology. to increase our impact further, in locations where we
Our focus being chronic health conditions, that affects are already present. There is definitely a steep learning
around 25 crore of the Indian population today, we curve both for the doctors and patients (specially
plan to go deeper in chronic condition management. in India with a rural population of 65.97) and we
believe when the results and efficiency would start
outweighing the time investment, the adoption rates
will start increasing exponentially.

How tech has revamped healthcare industry?
Still a long way to go. But we are seeing increased
acceptance due to the current COVID-19 situation.
In the new hybrid world this will remain the case
for some time. As mentioned earlier the acceptance
amongst the patients have been quite varied. While
a large section of population in metro cities is
welcoming telehealth and benefiting from it there
has been quite a bit of resistance to this new way
of practice in tier 2 cities. As more people would be
accepting the new hybrid model, investment will
flow towards digital solutions to augment treatment.
Doctors have started taking help of technology and
finding solutions to manage their patients’ data,
history, appointments etc. and it has started showing
considerable results so far.

Narayan Kulkarni
[email protected]

42 Q&A

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

“We see already a higher awareness
of why life science needs to be a
priority for Japan and Australia”

« more patients turning up to the emergency room.
Every day counts.
Stephane Perrey,
General Manager - Today, the whole world is focused on finding
Japan, Australia, a solution to the global pandemic. Meanwhile,
New Zealand, Cytiva, individual countries are preparing for a potential
Tokyo ‘second wave’ of infection across their population.
Hope for a solution sits with the biotechnology
Cytiva (formerly part of GE Healthcare industry including biopharmaceutical companies,
Life Sciences), a global provider of diagnostic developers and academic researchers.
technologies and services that advance One of those is Cytiva, a global provider of
and accelerate the development and manufacture technologies and services that help advance and
of therapeutics, has joined hands with Takara accelerate the development and manufacture
Bio to manufacture a DNA vaccine candidate of therapeutics. We have provided equipment,
for COVID-19. In collaboration with Osaka consumables and expertise for the research,
University and AnGes, Inc. group, Takara Bio development and manufacturing of vaccines
is working on an innovative plasmid vaccine. and therapies.Many of our customers are
The DNA vaccine would generate the SARS- seeking technical advice and solutions on an
CoV2 protein which would become an antigen, unprecedented timeline and scale.
and help people develop immunity against
the virus. DNA vaccines are said to be safely Cytiva is working closely with Takara Bio
manufactured in a short period of time without on an innovative plasmid vaccine. The DNA
using any dangerous pathogens. By injecting vaccine would generate the SARS-CoV2 protein
circular DNA (plasmid DNA) that encodes the which would become an antigen, and help
protein of the target pathogen, the pathogen people develop immunity against the virus. The
protein is produced in the body and immunity work involves defining the most efficient and
to the pathogen is generated. Unlike attenuated effective way to produce the initial manufacture
vaccines, it has no pathogenicity. BioSpectrum of the vaccine candidate while preparing for
Asia spoke to Stephane Perrey, General Manager future commercial production. Usually, these
Japan, Australia, New-Zealand, Cytiva based in activities are planned in a linear fashion but under
Tokyo about the collaboration with Takara and COVID-19, everything needs to happen in parallel.
COVID-19 impact on the life sciences sector in For example, traditionally, clinical results lead to
Japan and Australia. Edited excerpts; decision towards large scale manufacturing plan.
Here, risk in investing in capacity expansion in
How is Cytiva helping Takara gear up for production needs to be taken to meet delivery
COVID-19 vaccine production? When will timeline if the clinical data are positive.
the vaccine be ready?
Developing vaccines and therapies for emergency Our approach centers on open
purposes is complex. Every day without a communication. We are connecting regularly
solution means more people getting infected and with our stakeholders including Takara Bio team.
This helps to pivot or quickly adapt our plan.

In parallel, we have organized ourselves
internally to ensure real-time flow of information
between all the stakeholders worldwide in
Cytiva. Delivering high quality product on time
is our number one priority and is critical as the
demand for technology to manufacture biologics
continues to rise.

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BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

Cytiva has also partnered with the The challenges with pandemic showed
University of Queensland for developing a how resilient we are as an organization.
COVID-19 vaccine? How is it progressing? The whole team in Japan, Australia and
We are extremely pleased to see the fast worldwide have risen to the occasion.
development of the COVID-19 vaccine candidate Although, we do not see each other
at The University of Queensland (UQ) in face-to-face anymore, the strong bond
Australia. Most recently, early preclinical results between the teams has helped us
showed that the vaccine candidate produced adapt and pivot to deal positively with
high levels of antibodies that can neutralize the the challenge. I believe we will be even
virus. stronger after COVID-19.

The UQ team have developed a novel strategy lot of similarities: developed economy, good
for the fast development of potent antigen governmental healthcare system, renowned
to build up a specific immune response. The academic research built on a powerful
molecular clamp platform they use helps present education. We see already a higher awareness of
the target protein (the antigen) in its native why Life Science needs to be a priority for Japan
prefusion structure, this means the protein is and Australia. From my perspective, both of
presented to the human immune system in its the two countries have realized that the vaccine
native virus surface form. It is expected to lead development and the response to pandemic
to a very potent vaccine. Usual vaccine strategies should be a matter of national security.
with isolated antigen leads to an antigenic
protein that is not identical to the protein on In both cases of UQ and Takara Bio, this
the surface of the virus, the molecular clamp is the right strategy to ensure capacity in the
technology overcomes this problem. country though they are still pending the results
of clinical trials.
Molecular clamp-based vaccines require
highly customized purification methods. This is What are the major plans in store at Cytiva
where Cytiva comes in. Our experts in protein post COVID-19?
purification in Uppsala Sweden and our support The challenges with pandemic showed how
team, namely Fast Trak, from Marlborough, resilient we are as an organization. The whole
MA in the US have helped developed a team in Japan, Australia and worldwide have
chromatography resin with a highly specific risen to the occasion. Although, we do not see
ligand that binds to the molecular clamp each other face-to-face anymore, the strong
attached to the protein. Working with the UQ bond between the teams has helped us adapt
team, together we have been able to develop the and pivot to deal positively with the challenge. I
process for large scale manufacturing in a very believe we will be even stronger after COVID-19.
short time frame.
More specifically for Australia and Japan,
In this race against the COVID-19 global we hope to facilitate the huge potential in
pandemic, industries, academia and funding the biopharma industry as well as enable
agencies are working together to advance sustainable access to the latest biologic
and accelerate urgently needed therapies. treatments. We want to support effort to
The whole Cytiva team are honoured to be improve the bioindustry ecosystem by working
involved in these projects and to accelerate the closely with academic researchers, biotech
development of life-changing therapies. start-ups and established industries to build
local capacity and the talent pool. This will
Besides vaccines, is Cytiva helping to allow more biological drug development as well
develop diagnostics solutions as well? as creating a sustainable local bio-economy,
We also partnering with diagnostic developers improving the trade balance of healthcare. A
such as Avacta, Genedrive and Sona Nanotech steep challenge but the COVID-19 pandemic
to develop and scale up the production of is showing us that this is a most needed
COVID-19 test kits. transformation of healthcare.

How has COVID-19 impacted the life Ankit Kankar
sciences sector in Japan and Australia? [email protected]
It is too early to see concrete changes but
what I can say is both countries are sharing a

44 PEOPLE NEWS

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

Corning announces CANbridge
new MD for India
Pharma brings
Corning Incorporated has announced that Sudhir Pillai has been
appointed to the role of Managing Director (MD) for Corning new Senior Vice
India. Pillai, who most recently served as Commercial Director,
Corning Life Sciences will be based in Gurugram, Haryana and will President

spearhead the company’s growth and CANbridge Pharmaceuticals Inc.,
operations in India and neighboring a China based biopharmaceutical
countries. He will also oversee company developing
Corning’s optical fibre manufacturing innovative drug candidates
operations in Pune, India. Pillai to treat underserved medical
brings with him close to twenty years conditions, announced that
of experience in increasing levels of it has appointed Carrie Ann
leadership in organizations across Cook to the position of senior
diverse industry segments, including vice-president or global head
telecommunications. Since joining of business development. With
the company last year, he has been more than 20 years’ experience
leading Corning’s Life Sciences and in the pharmaceutical industry,
Pharmaceutical Technologies businesses in India and neighboring Carrie has deep international
countries. In his last role before joining Corning, Pillai was the business development experience
General Manager and Director of Honeywell Electrical Devices & across multiple markets and
Systems. He graduated in electronics science and completed his disease areas. She came to
MBA in marketing from University of Pune, India. CANbridge directly from
Takeda Pharmaceuticals, in
Antengene Corporation Cambridge, MA, where she
appoints Donald Lung as CFO was Senior Director, Center
for External Innovation, Rare
China based Antengene Corporation has announced the Disease, leading research and
appointment of Donald Lung as Chief Financial Officer (CFO). development transactions for
Lung is reporting directly to Dr Jay Mei, Chairman and CEO the rare disease franchise. Prior
of Antengene. In this position, Lung will be to Takeda, Carrie was Head of
responsible for corporate financial strategy Global Business Development &
development, risk management, financial Licensing, MS, Medical Devices
reporting and investment activities, aiming and Global Health at EMD
to promote the long-term development of Serono, Inc, where she directed
Antengene in the biopharmaceutical sector. global business development in
In addition, he will play an important role in multiple indications; and Global
business development, M&A and initiatives in Business Development Director,
business operations. With 16 years of experience Neurology and Rheumatology
in investment banking and public equities, at Merck Serono SA, in Geneva,
Lung is a seasoned finance professional with Switzerland, where she led
experience in healthcare transactions across various stages. He licensing initiatives for the
started his career as an investment banker at Goldman Sachs. neurology and autoimmune
After that, he held senior investment positions across multi-billion business units.
asset managers. He was previously Senior Analyst at Myriad Asset
Management, a Hong Kong based multi-strategy fund, driving
investment recommendations on all primary market investment
opportunities. He most recently served as a Portfolio Manager at
BFAM Partners, leading investments across sectors including in
the healthcare and biotech space.

PEOPLE NEWS 45

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

Dr Sophia Pathai takes
over medical affairs at
Santen Pharmaceutical

Japanese firm Santen and surgical ophthalmology in WuXi AppTec
Pharmaceutical has announced varied clinical environments ropes in
Dr Sophia Pathai as the new worldwide. In her new role, new CEO for
Vice President (VP) of Medical Dr Sophia is responsible advanced
Affairs EMEA (Europe, Middle- for leading the strategic therapies
East and Africa). As a qualified development of Medical
ophthalmologist and clinical Affairs EMEA. For FY 20, this WuXi AppTec has appointed Dr
scientist, she practiced medical will involve leading medical David Chang as Chief Executive
engagement by leveraging Officer (CEO) of WuXi
digital media. Dr Sophia will Advanced Therapies business
also focus on driving excellence unit (WuXi ATU). In this new
in key business processes, executive role, Dr Chang will
such as integrated evidence provide strategic, scientific
planning. Most recently, she and operational leadership
served as the Medical Affairs to the company’s global cell
Director at Johnson & Johnson and gene therapy R&D and
Surgical Vision (Asia Pacific manufacturing services. Dr
& Japan), where she led the Chang brings strong leadership
medical affairs strategy for and experience in cell and gene
the launch of three surgical therapy and biopharmaceutical
ophthalmic devices. technical development,
manufacturing operations,
Jim Schuermann engineering and strategy. Prior
joins Australia’s Saluda to joining WuXi AppTec, Dr
Medical as President Chang was Corporate Vice
President and Head of Cell
Australia based Saluda Medical, Therapy Global Manufacturing
at Celgene, a Bristol Myers
a neuromodulation company Squibb, where he oversaw the
CAR-T manufacturing network
leading the development and the global manufacturing
sciences and technologies
and commercialization of teams. He also served as the
Global Head of Engineering and
data-driven, personalized Strategy at Roche, Switzerland,
after roles that included Vice
therapies for patients with President/Site Head of Roche
Shanghai Technical Operations,
debilitating neurological China.

disorders, has announced a

key leadership appointment of

Jim Schuermann as President.

Schuermann brings over 25

years of extensive healthcare by Glaukos in 2019. Prior to
Avedro, he was Senior Vice
and medical device leadership President of sales and marketing
at HeartWare. Schuermann
experience to Saluda Medical. holds an MBA degree from
Golden Gate University and a
Prior to joining Saluda, BS from the Kelley School of
Business at Indiana University.
Schuermann was Chief

Business Officer at Avedro,

which executed its initial public

offering and then was acquired

46 R&D NEWS

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

China explores elimination of drug side effects

Scientists from Hong Kong Baptist Physics at HKBU, and his research University and the Southern
University (HKBU) in China have team devised a novel approach to University of Science and
developed a novel technique that manipulating molecular chirality Technology. It involves mediating
can produce pure therapeutic through macro-scale control the manipulation with helical
drugs without the associated side in collaboration with Sichuan metal nanostructures that are in
effects. The approach, which uses a University, Guangxi Medical the shape of a helical spring, and
nanostructure fabrication device, they have a characteristic size of
can manipulate the chirality of one-thousandth of the diameter
drug molecules by controlling of a human hair. Published in the
the direction a substrate is renowned international scientific
rotated within the device, thus journal Nature Chemistry, the
eliminating the possible side research findings pave the way
effects that can arise when people towards the mass production of
take drugs containing molecules purer, cheaper and safer drugs
with the incorrect chirality. Dr that can be made in a scalable and
Jeffery Huang Zhifeng, Associate more environmentally-friendly
Professor in the Department of way.

India focuses on Taiwan invents
host directed antivirals biosensor to detect
for COVID-19 viral Infections

The Science and Engineering Research Board A Postdoctoral Fellow researchers’ team at the
(SERB) has approved support for a study by the Institute of Medical Science and Technology,
National Centre for Veterinary Type Cultures National Sun Yat-sen University (NSYSU), Taiwan
(NCVTC), Indian Council of Agricultural Research has invented a mobile healthcare biosensor for
(ICAR)-National Research Centre on Equines rapid diagnostic test and detection of cancers
(NRCE) from Hisar in Haryana, India, which will and viral Infections. Their mHealth biosensor
screen their library of 94 small molecule chemical has been proven to accurately evaluate the risk
inhibitors for antivirals against coronaviruses. The in urothelial carcinomas, prostate cancer and
pancreatic cancer. Compared to the traditional
molecules are known diagnostic methods, the mHealth biosensor can
to inhibit cellular be performed on whole blood without filtration,
kinases, phosphatases, and the test can be easily operated by subjects
and epigenetic and quantified by a smartphone with 15 min.
regulators such These characteristics make it ideal for personal
as histone methyl use in early cancer diagnosis, postoperative
transferase, histone monitoring, and also in ports of arrival and
deacetylase, and DNA departure for travellers who come from endemic
methyl transferase. areas as well as for surveillance and geographical
The targets of these inhibitors are well characterized tagging for the infected.
in cancer, however, their role in the virus life cycle
is not known. The selected candidates with anti-
coronavirus activity will be subjected to study their
molecular mechanism of action, besides examining
generation of potential drug-resistant virus variants.
The host directed antivirals are believed to have
fewer tendencies in inducing drug resistance because
it is not possible for the virus to easily change
missing cellular functions by mutations.

R&D NEWS 47

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com Korea develops

Australia uses digital tools microscope
for personalised support
to reveal
Treatment effectiveness, healthcare costs and quality of life
outcomes for the two to four percent of Australians with the heart nanostructures
condition atrial fibrillation (AF), could be markedly improved
under a new research project now underway in western Sydney. Different teams at Korea
The project is a collaboration between the University of Sydney’s University have collaborated to
Westmead Applied Research Centre (WARC) and the Australian improve the resolution of existing
Government-funded Digital Health Cooperative Research Centre near-field scanning optical
(DHCRC). The project microscopes and developed an
will use a successful imaging technology capable of
engagement tool used determining even the microscopic
in the US to improve information of nanostructures
patient engagement that had been previously difficult
and adherence to observe. Although near-field
to immunisation scanning optical microscopy is
and medications, a useful tool for observing the
adapting it to nanoworld, it has the limitation
provide personalised that anything smaller than the
management and size of the aperture of the probe
support to AF patients who have a wide variety of healthcare tip is imperceptible. The smaller
needs. The project will also customise the tool to suit the the aperture size becomes,
Australian health system. The project being developed by the higher the resolution, but
Australian researchers could empower over 300,000 Australians the lower the intensity of the
who currently suffer from AF, to better manage their diagnosis. optical signal, complicating
measurement. This had made
Japan studies genetic differences it impossible to observe a
of COVID-19 & SARS viruses microstructure with an aperture
size smaller than about 150 nm
Researchers at the University of Tokyo in Japan have identified using a conventional near-field
specific portions of the genetic codes of the COVID-19 and SARS scanning optical microscope.
viruses that may promote the viruses’ lifecycles. The new technique The researchers overcame
is researchers’ first tool for determining what genetic sequences this limitation by successfully
stored as RNA - DNA’s chemical cousin - are more stable. The increasing the resolution of
research team named their technique Fate-seq because it aims to a near-field scanning optical
microscope.
determine the fate of a
genetic sequence, whether it
will persist or degrade based
on its stability. Researchers
compared 21 SARS-CoV
stable genome fragments
to the full genetic sequence
data available for other
types of coronaviruses.
Two of the stable fragments
from the SARS-CoV are very common in other evolutionarily similar
coronaviruses, including the virus that causes COVID-19, SARS-
CoV-2. In addition to better understanding dangerous viruses,
researchers hope to use Fate-seq to understand the fundamental
rules of RNA stability and advance new types of medicine.

48 ACADEMIC S NEWS

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

PolyU advances Sichuan & Oxford University set
diagnosis of up joint cancer research centre
COVID-19
pneumonia The University of Oxford and diagnosis and treatment of
China’s Sichuan University gastrointestinal tumors, as well
The Hong Kong Polytechnic have jointly launched a centre as developing management
University (PolyU) is committed to bolster research cooperation strategies for treating cancer
to the fight against COVID-19 on gastrointestinal cancer. The patients. The joint centre will
and has been collaborating with international collaboration be an open research platform
various partners in the prevention started in June 2019. It plans where scholars from the two
and control of the disease. PolyU to set up a gastrointestinal universities and their global
has announced the launch of a cancer centre in Chengdu, counterparts can jointly carry
new artificial intelligence (AI) capital of Sichuan Province, out scientific research, launch
system jointly developed with and research platforms at talent-training programmes,
the Macau University of Science the two universities. These hold international academic
and Technology (M.U.S.T.) in units will work together in conferences and publish
conjunction with other Chinese studying the pathogenesis, papers.
institutions, to assist in the
rapid diagnosis of COVID-19 India, Taiwan launch
pneumonia. The novel AI assisted PG programme in AI, ML
diagnostic system, based on
computed tomography (CT) The Indian Institute of Technology (IIT) in Ropar, one of the
chest imaging, can efficiently eight new IITs established by the Ministry of Human Resource
distinguish COVID-19 pneumonia Development (MHRD), Government of India, and The Second
from other viral pneumonia, and Wind (TSW), the executive education division of Times Professional
predict the severity level in 20 Learning, have launched a post graduate certificate programme in
seconds, with an accuracy of up artificial intelligence and deep learning.
to 90 per cent or above. It assists The programme will be coordinated
radiologists and physicians in by The Indo-Taiwan Joint Research
performing a quick diagnosis, Centre (ITJRC) on AI and ML, at IIT-
especially when the health system Ropar. Supported by the Ministry of
is overloaded. The scientists from Science and Technology, Taiwan,
PolyU and M.U.S.T. have also ITJRC is a bilateral centre
collaborated on other projects, for collaborative research in
including the seroconversion disruptive technologies like AI
study in SARS-CoV-2 patients and ML. The programme has
in China, which helped pave the a duration of six months and
way for further diagnostic and classes will be held over weekends as live online instructor sessions,
therapeutic development to treat with IIT-Ropar faculty and notable industry experts. This programme
SARS-CoV-2. comes with an exhaustive curriculum that includes modules on AI,
ML, data science, neural networks, image and speech recognition.

SUPPLIER NEWS 49

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

Thermo Fisher, CSL providing best-in-class pharma services

Thermo Fisher Scientific Inc. lease agreement with CSL, Thermo when construction is completed
and Australia headquartered CSL Fisher will operate a new state-of- in mid-2021. Within the Lengnau
Limited have announced that the-art biologics manufacturing site, Thermo Fisher will support
they have entered into a strategic facility in Lengnau, Switzerland, manufacturing of CSL’s next-
partnership to help meet the generation product for hemophilia
growing demand for biologic patients. The site will feature
therapies while also accelerating highly flexible bioproduction
CSL’s broader manufacturing technologies, including single-
objectives. Thermo Fisher will use and stainless steel, to provide
support CSL’s product portfolio a pathway from development
by leveraging its pharma to large-scale production as
services network, including drug customers’ needs increase. Over
product development, biologics time, Thermo Fisher plans to
manufacturing, sterile fill-finish, expand the use of the site to
packaging and clinical trials include additional biopharma
logistics. Through a long-term customers.

Atomo and NG Biotech Shimadzu unveils
expand COVID-19 partnership robust LCMS system

Australia based Atomo Diagnostics, a specialist Shimadzu has announced the release of
medical device design innovator and original the LCMS-8060NX liquid chromatograph
equipment manufacturing (OEM) company, mass spectrometer both within Japan and
has expanded its existing COVID-19 rapid test overseas. Together with world-class sensitivity
partnership with France based NG Biotech. Under and detection speeds, the triple quadrupole
the expansion of the Atomo NG Biotech partnership, mass spectrometer system promises to offer
Atomo now has exclusive rights to market and further improvements in ease-of-use and
distribute, as the listed manufacturer, the COVID-19 robustness. The LCMS-8060NX offers among
antibody test in Australia and New Zealand and a the highest sensitivity and detection speeds
number of countries in South East Asia, subject to in the world and includes internal mechanical
obtaining the required regulatory approvals in each improvements for promoting sample
jurisdiction, under the brand ‘AtomoRapid COVID-19 ionization. This enables high-sensitivity
(IgG/IgM). The exclusive rights arrangement for analysis even for compounds that are difficult
Australia, New Zealand and a number of South-East to ionize. The newly introduced IonFocus
Asian countries is strategically important for Atomo unit reduces instrument contamination by
as it repositions Atomo as a listed manufacturer of guiding ions to the interior more efficiently and
COVID-19 tests, building on its foundation of being removing unwanted components, which helps
the only manufacturer of an approved Class 4 Self- to prevent decreases in detection accuracy
Test in Australia. or sensitivity. In addition, more robust
components are used in ion-focusing, enabling
more reliable analysis. The LCMS-8060NX
therefore offers both higher sensitivity analysis
and lower downtime.

50 SUPPLIER NEWS

BIOSPECTRUM | JULY 2020 | www.biospectrumasia.com

Joimax develops partnership Medicom
with Japan Medicalnext opens mask
production
Joimax, the German based through natural openings in the facility in
market leader in technologies spinal canal. Japan Medicalnext Singapore
and training methods for full- has an orthopedics division that
endoscopic and minimally will focus on Joimax products. The Medicom Group, one of the
invasive spinal surgery, is The company is a wholly world’s leading manufacturers
starting, as of now, a new owned entity of MC Healthcare, of surgical and respiratory
partnership in Japan. The Inc., subsidiary of Mitsubishi masks, has announced the
distributor Japan Medicalnext Corporation, and prominent further expansion of its global
and Joimax are pursuing a supplier of medical devices in footprint with the opening of
long-term sales cooperation Japan. a mask manufacturing facility
that will result in an extensive in Singapore. Established
distribution agreement for as the KHM Engineering
the entire Japanese market. company, the factory will
In procedures for herniated produce millions of masks per
disc, stenosis, pain therapy or month. The ongoing COVID-19
spinal stabilization treatment, pandemic has highlighted the
surgeons utilize Joimax importance of resilient supply
technologies to operate through chains for personal protective
small incisions under local or equipment. The establishment
full anesthesia, via tissue and of the new manufacturing
muscle-sparing corridors and facility will see Singapore as
the latest of a growing number
Merck redesigns benchtop of countries that Medicom is
pure water solution investing in to ensure proximity
of production to end markets.
Merck has redesigned its benchtop pure water solution, introducing With manufacturing operations
the new Milli-Q IX 70XX Series Type 2 water purification system. strategically distributed across
The new compact, intuitive and ergonomic Milli-Q system provides three continents and an extensive
laboratories with a reliable and consistent source of high- quality pure global network of raw materials
water that meets the requirements of both critical applications, such suppliers, Medicom has been
as for microbiology culture media, as well as general uses, including uniquely positioned to meet the
preparing buffers and rinsing glassware. Users of the new age exponential demand for personal
protective products like face
Milli-Q IX pure water system masks throughout the current
can have full confidence that crisis.
water is not a variable in
their analysis. Powerful
purification technologies, an
intelligent pure water storage
solution, and convenient
quality monitoring at the
point of dispense supports
scientists in achieving reliable
and reproducible results.
In addition, integrated data

management automatically secures data and provides rapid data
access and full traceability for audits. The Milli-Q IX pure water
system proudly boasts a range of sustainable purification technologies
and design features aimed at minimizing environmental impact.