BioSpectrum Asia June 2020

4 BIO EDIT

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

Milind Kokje A Meaningful race?

Chief Editor The whole world is waiting with bated breath for an effective drug and/or vaccine to
combat COVID-19 as that is the only solution to overcome the pandemic. The scene
[email protected] on that front is still confusing with different positive and negative news of claims and
counter claims being bombarded each day. Much more than 100 efforts are on across the
world and are at different stages to develop a vaccine or medicine. Some existing medicines
which are being used for different diseases are also being tested for COVID-19 with claims
of encouraging results.

Russia will start giving its first approved drug, modified version of Avifavir, to the
patients from the second week of June with a capacity to treat 60,000 people a month.
Thailand has developed a vaccine and its prototype was tested on mice with successful
outcomes. It tried the vaccine on moneys also and soon, human trials will begin. South
Korean drug maker Celltrion has also claimed that its experimental antibody treatment has
shown successful results by viral load reduction in animal testing. Israel too has claimed
successful development of a vaccine.

In India, Hyderabad-based Indian Immunological Ltd. (IIL) and Pune-based Serum
Institute of India (SII) - have partnered with Australis’s Griffith University and UK’s Oxford
University respectively, to develop a vaccine. Outside Asia, Italy and the US have claimed
major breakthroughs. Takis from Italy claimed it’s vaccine has successfully neutralized
SARS-CoV2 virus in animals. Moderna in the US has joined the queue of claiming success
in making an mRNA vaccine.

Despite all these efforts that have reached at different stages nothing seems to be available
before September. Amidst this scene the warnings from World Health Organization (WHO)
that the vaccine/medicine may take even two years and even a possibility of having no vaccine
developed at all. Even if vaccine or treatment will be available at any time in near future will it
stop the pandemic? It will depend on two issues – cost and time to supply the drug.

Recent World Health Assembly has adopted a resolution for equitable access to and fair
distribution of essential health technologies to combat COVID-19. Over 140 world leaders
have called for making all vaccines and treatments patent free, mass produced, distributed
fairly and made available to all people. During the swine flu pandemic, the vaccine was
developed but its availability remained restricted to rich countries due to manufacturing
agreements and export policies on countries where it was developed.

Forty countries have pledged $8 billion for vaccine development, treatment and test
kits production. But how the successful outcome of these efforts will reach to the people
who cannot afford the price is still a question. It will have to be seen what effect such a fund
development will have on distribution from financial angle.

Another distribution issue is concerning production rate and transportation. Almost all
the countries are waiting for the vaccine or medicine as in several countries the healthcare
systems are under tremendous pressure with the burden of patients’ growing number.
When the vaccine production will begin in any country, it is likely to supply it first to its
own people. How will the priority of other countries for supplying vaccine will be decided
is another crucial issue? Again, money may play an important role and the poor countries
may suffer.

Simultaneous production by different companies in different countries could be one
solution, provided the company which would be successful in developing the vaccine will
be willing to provide the know-how to others at a reasonable price. Russia seems to have
agreed to provide know how of making a modified version of Avifavir.

The success in vaccine or medicine development is thus likely to trigger a different kind
of race among different countries and companies. WHO and governments of different
countries will have to play a key role in such a scenario. They will have to start the preparation
now only. Only then the World Health Assembly resolution and call by 140 country leaders
will be meaningful.

BIO MAIL 5

BIOSPECTRUM | |MAMJRUCANHYE22002200| |w|wwww.wbwiwows.b.pbieoiocsstprpueecmctratursumimaa.casosiaima.c.coomm

Acknowledgements

We are very glad for the coverage that Piscium Health Sciences has

ArAecckekninvoeodwwilnleeBdigoSepmecetrnutms. Thank you. I think the article ‘Maintain clear SOPs

TThhaenakrtyioclue bfoarsecdoovnertihneg inthterainctieornaction withanN-doMhvaovlaNeyoanrDdeiiksffksichieintn,ttIhwnedoriFakefblorwua’ riny the

ewditihonC.roItwhdaSstrciokme ereoaudtsvwereyll,waenlld. does May edition was nicely summarised

a good job at highlighting the responses and suc-cMinactn. iBsihoaSpGecutprutam, AInsidaiias a

fTrhoempSiehceeritfitEleld-N‘CabanawCiO. IVtIhDin-1k9wpeanaldlemic fastvterrayckusdeifguitlatlrade publication for APAC

tarpapnrsefcoiramteadtisoene?in’ ignhtihme Aonprtihleisfsruoentispwageell writtmened. Iictatloaunchdepshuapromnaceutical industries.

Tahnsawinmeklply!oorutansot tompuichonfothr efepaottuernintigaltfhoer dairgtitcalel te‘Hchenalotlhogsipeesntod-ianJsgusisshttains eaLnAaItu, rSainl gapore

business-eJsoannadtchoamnmBuunxiteiedsai,nStihnigsappaonrdeemic.

Looks good. - Grace Ang, Singapore

C-CAMP was- dDealivgihdteBdltooobme ,aUpaSrt of

Thank you so much for the coverage your webinar on ‘Exploring various

TonhaWnkesytoPuhsaormmau.cThhfeorinctoevrevrieinwgwthitehinteractioanspweitchtsLoufcCaOVVisIiDn-i,19’. Looking forward

MSteawnaagritnCgaDmiprebcetlol rl,oEoklisLgiolloyda.nd Company (Intdoiam) oinrethpearAtipcriiplaetdioitnioin.the future.

The article on pe-rRsoonhailtizMedomudedgiicliln, eInldoioaks n-iAce-m.DIbtruiDsjaeclbKeaarrslsyhhyniaonpti,aCIthnrdaenikadryabtoopritcy, India

anymore, in fact much more than that.

- Anu Acharya, India

Vol 15; Issue 356; MJuanryec2h20022200020 MM Activ Singapore Pte. Ltd. Taiwan
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6 BIO CONTENT

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

COVER STORY 15

candidate
vaccines in
clinical evaluation

The rapid spread of the novel coronavirus is a
reminder of how global populations and economies
are interconnected. The pandemic is integrating
the global healthcare force by exposing the obvious
realities that no single individual, company, or country
can solve the pandemic crisis alone. Researchers are
optimistically demonstrating best-in-class resources
from the lab to manufacturing to advance the
innovations at multiple vaccine candidates. Indeed,
the global biopharma manufacturing industry is
funding and expanding its capabilities for vaccine
production on an ‘’at-risk basis’’ to facilitate the world’s
immediate need and demand. Novel paradigms of
Next-generation vaccine technology platforms are
accelerating the development of “one life saving
vaccine” to nullify the repulsive humanitarian and
economic impact. According to the WHO, as of May
30 there are 10 vaccines under clinical evaluation
which have already progressed to human trials and
121 candidates are in preclinical evaluation.

COVID-19 30 34

24 Traditional If wishes were vaccines…
medicines & COVID-19
Australia’s ‘research
engine’ slows down

BIO CONTENT 7

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com 42 SPEAKING WITH

36 COVID-19 “We can make 13M doses
per week without expanding
A digital our current capacity”
bounce back post
COVID-19 Max Rossetto,
General Manager - Business Development,
Sujeet Sudhir, Luina Bio, Australia
Director, Business Development,
Cyient, India 43 COVID-19

37 SPEAKING WITH Face-lifting biopharma
industry image
“Merck is currently supplying
key products and services Dr Neel Fofaria,
to over 45 COVID-19 vaccine Partner, MP Advisors,
programmes around the world” India

Benoit Opsomer, REGULARS
Vice President & Head of Bio Processing,
Asia Pacific, Merck Pte. Ltd, Singapore BioEdit.................................................................04
BioMail.................................................................05
39 Policy and Regulatory News..............................08
Company News...................................................10
“COVID-19 crisis has brought Finance News......................................................12
together the scientific Start-up News.....................................................13
community like never before” People News.......................................................44
R&D News............................................................46
Francis Van Parys, Academic News..................................................48
Vice-President Commercial, Asia-Pacific, Supplier News.....................................................49
Cytiva (Formerly GE Life Sciences),
Seoul, South Korea

40

“CST is committed to
developing new rigorously
validated antibodies and
protein tools”

Roberto Polakiewcz,
Chief Scientific Officer, Cell Signaling
Technology, Danvers, United States

Critical process chemicals tailored to exacting The Life Science Business of
quality and regulatory standards Merck operates as MilliporeSigma
in the US and Canada.
We offer an extensive raw materials portfolio to suit your precise needs.
Our team of experts is committed to providing technical and regulatory
guidance to simplify regulatory filings and ensure you have the exact
raw materials you need at every step of your process.

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Merck, the vibrant M and SAFC are trademarks of Merck KGaA, Darmstadt, Germany
or its affiliates. All other trademarks are the property of their respective owners.
Detailed information on trademarks is available via publicly accessible resources.
© 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.

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

Japan lends Singapore develops comprehensive
$2.7M in medical strategy for COVID-19
support to
American The Multi-Ministry Taskforce in the bases for a comprehensive
countries Singapore has a comprehensive medical plan. The plan guides
medical strategy to ensure the admission of patients into
The Government of Japan that individuals infected with the appropriate tiered facilities
has agreed to contribute over COVID-19 receive prompt and for medical care and support, the
$2.7 million to help nine quality medical treatment. transfer of patients between these
countries in the Americas The clinical and scientific data facilities according to their needs,
namely Bolivia, Brazil, from managing COVID-19 and the discharge of patients who
Chile, Guatemala, Mexico, patients, as well as the current are well and no longer infectious.
Panama, Paraguay, Peru, epidemiological evidence on Persons with acute respiratory
and Venezuela, scale up the infection, have provided infections but are clinically well
their response to the novel are issued with five-day medical
coronavirus COVID-19 certificates and are asked to
pandemic. The financial isolate themselves at home.
contribution from Japan will Those who meet the clinical case
support the Pan American definitions for COVID-19 are
Health Organization tested and asked to self-isolate
(PAHO)’s critical response at home as they await their test
efforts deployed in those results. Those who are unable to
countries to mitigate the self-isolate in their homes can
impact of the spread of virus do so in a Swab Isolation Facility
and slow down the human- (SIF) while awaiting their test
to-human transmission of results.
COVID-19 in the Americas.
The project also aims to Taiwan objects triple antiviral
augment their national drug therapy for COVID-19
health systems ability to care
for COVID-19 patients and Taiwan’s Central Epidemic
protect vulnerable individuals, Command Center (CECC)
and to ensure that reliable Chief Advisor Chang Shan-
public health information on chwen recently mentioned that
the COVID-19 outbreak and a triple antiviral therapy that
protective measures is made has shown promise in treating
available to people involved patients with mild symptoms
in the response, as well as the of COVID-19 in Hong Kong
general population. is not being recommended in
Taiwan because it can produce
side effects. According to the use of the multiple sclerosis
Hong Kong study published treatment interferon beta-1b
in The Lancet, early treatment with the hepatitis drug ribavirin
with the triple combination of in its treatment guidelines for
antiviral therapy using interferon COVID-19 but dropped the idea
beta-1b with lopinavir-ritonavir because past clinical figures show
and ribavirin helps to rapidly that the treatment causes side
suppress the amount of virus effects in quite a high percentage
in a patient’s body and alleviate of patients.
symptoms. The CECC panel
had considered including the

REGULATORY NEWS 9

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com India fast

Korea approves new drug tracks global
trial for COVID-19
solidarity
Canada based Algernon Pharmaceuticals Inc., a clinical stage pharmaceutical
development company, announced that it has received approval from the trial roll out
Ministry of Food and Drug Safety in South Korea, as well as ethics approval,
for an investigator-led, Phase 2 COVID-19 clinical study of its re-purposed The Indian Council for
drug NP-120 (Ifenprodil), an NMDA receptor antagonist. The Lead Principal Medical Research (ICMR)
Investigator is Dr Dong Sik Jung, Professor, in the Division of Infectious has fast tracked the roll
Disease of Dong-A University Hospital, Busan. NP-120 is an N-methyl-D- out of the global Solidarity
aspartate (NMDA) receptor antagonist specifically targeting the NMDA- trial launched by the World
type subunit 2B (Glu2NB). Ifenprodil prevents glutamate signalling. The Health Organization (WHO)
NMDA receptor is found on many tissues including lung cells and T-cells, to help in finding an effective
neutrophils. The 40-patient, 4-week trial, is designed to test the effect of treatment for COVID-19.
Ifenprodil in COVID-19 infected patients with severe pneumonia. Patients Solidarity is an international
are randomized in a 1:1 fashion to receive either standard of care (SOC) or clinical trial to compare four
SOC with Ifenprodil. The primary endpoint will be the rate at which their lung treatment options against
function improves by measuring oxygen levels in the blood (Pa02/Fi02). standard of care to assess
Secondary endpoints will include mortality, rate of mechanical ventilation, their relative effectiveness
and patient reported effects on cough and breathlessness (dyspnea). against COVID-19. By
enrolling patients in multiple
New Zealand provides countries, the Solidarity
funding to tackle COVID-19 trial aims to rapidly discover
whether any of the drugs
New Zealand’s biotechnology company Pictor has received a double funding slow disease progression
boost from government and partners for two crucial development projects or improve survival.
to help combat COVID-19 and Mycoplasma bovis. Pictor has received a Importantly, this initiative
grant of $500,000 from the $25 million Ministry of Business, Innovation provides for both speed and
and Employment (MBIE) COVID-19 Innovation Acceleration Fund, which scale. The required regulatory
supports the speedy development of new products and services that could and ethical approvals have
help to detect, diagnose, treat or prevent the virus. Pictor’s grant will be already been obtained and
used to develop a test for detection of COVID-19 infection in less than clinical trial sites have started
an hour. Pictor has also concluded a research agreement with the M. to recruit patients in the trial.
bovisProgramme to develop a more sensitive diagnostic for M. bovis. The Over 100 countries have
programme has allocated up to $30 million for M. bovis research projects. requested participation to
find effective therapeutics as
soon as possible, via the trial.

A Millipore® mind understands The Life Science Business of Preparation, Separation,
your world before it designs for it. Merck operates as MilliporeSigma Filtration & Monitoring Products
in the US and Canada.
Understanding your world drives everything we do. Our products and
support set new standards for reliability, ease of use and consistency,
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you surpass technical, regulatory and performance standards.

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or its affiliates. All other trademarks are the property of their respective owners.
Detailed information on trademarks is available via publicly accessible resources.
© 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.

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

Shionogi Astellas, Insilico Medicine
to develop bank on AI for drug discovery
prophylactic
vaccine for Hong Kong based Insilico Medicine has announced that it has
COVID-19 entered into a research collaboration agreement with Japanese firm
Astellas Pharma Inc. to utilize Insilico Medicine’s novel generative
Japan based Shionogi has artificial intelligence technology aimed at accelerating development
officially made the decision to of candidates against
develop a prophylactic vaccine a conventionally
for COVID-19, caused by the challenging target
novel coronavirus (SARS-CoV-2) family. This
infection. Regarding commitment collaboration builds
to vaccine development, UMN on AI platform
Pharma Inc., a subsidiary developed by
of Shionogi, is pursuing the Insilico Medicine
discovery and development of and will apply
a recombinant protein vaccine Astellas’ expertise
for COVID-19, using their in drug discovery.
unique technology, BEVS, in a Under the terms of
project supported by the Japan the agreement, Insilico Medicine will receive an upfront payment
Agency for Medical Research and milestones. Insilico Medicine will closely collaborate with
and Development (AMED), Astellas, which will synthesize, optimize and characterize the
which began in March, 2020. molecules generated using artificial intelligence.
The company has decided to
position the development of this Mesoblast scales up
vaccine as one of its top-priority remestemcel-L manufacturing
projects, alongside the discovery
of COVID-19 therapeutic drugs, Australia based Mesoblast remestemcel-L can reduce the
and to accelerate efforts to Limited, leader in cellular high mortality in COVID-19
rapidly progress into nonclinical medicines for inflammatory patients with moderate/severe
and clinical trials and scale-up diseases, announced that it ARDS is actively enrolling in
studies to enable it to offer this has successfully completed a up to 30 sites in the United
vaccine to 10 million people. At capital raising of $90 million States. This trial was initiated
the present time, the company via a placement of 43 million after promising results were
is coordinating its plans with shares to existing and new seen with remestemcel-L under
relevant parties, such as the institutional investors at a emergency compassionate use
Ministry of Health, Labour and price of A$3.20 per share. in COVID-19 ARDS, where 75
Welfare, Pharmaceuticals and A significant portion of the per cent ventilator-dependent
Medical Devices Agency, and the net proceeds will be used to patients were able to come off
National Institute of Infectious scale-up manufacturing of ventilators within a median of
Diseases (NIID), in order to start the company’s lead product 10 days.
clinical trials within the year. candidate remestemcel-L for
the treatment of critically ill
patients suffering with diseases
caused by cytokine release
syndromes associated with
high mortality, particularly
COVID-19 acute respiratory
distress syndrome (ARDS).
A randomized controlled
Phase 2/3 trial in up to 300
patients evaluating whether

COMPANY NEWS 11

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

Glenmark initiates 111 to launch
online diabetes
Phase 3 trials on management platform

Favipiravir for 111, Inc., a leading
integrated online and
COVID-19 in India offline healthcare platform
in China, hasannounced
Mumbai based Glenmark Pharmaceuticals, a that it is launching a
research-led integrated global pharmaceutical new diabetes patient
company, has initiated Phase 3 clinical trials in management platform
India on antiviral tablet Favipiravir, for which in cooperation with Lilly
it received approval from India’s drug regulator China. The two companies
Drugs Controller General of India (DCGI) will work together to build a
in late April. Glenmark is the first company comprehensive diabetes patient management platform
in India to initiate Phase 3 clinical trials on that includes services such as disease management,
Favipiravir for COVID-19 patients in India. disease education and patient support programmes
Favipiravir is a generic to enrich patients’ knowledge of chronic disease
version of Avigan of Fujifilm management and to better help diabetic patients to
Toyama Chemical, Japan, self-manage from home. The platform will seek to
a subsidiary of Fujifilm harness the power of internet hospital technologies,
Corporation. Clinical trials big data and artificial intelligence technologies to
have commenced and over provide diabetic patients with a comprehensive digital
10 leading government and health management solution. 111 has accumulated
private hospitals in India extensive experience in operations management in the
are being enrolled for the area of chronic disease, especially in diabetes, laying a
study. Glenmark estimates solid foundation for the development of the diabetes
study completion by July/August 2020. management platform. With the transformative power
Glenmark has successfully developed the API of technology, the platform will seek to provide patients
(Active Pharmaceutical Ingredient) and the with a one-stop solution for physician consultation +
formulations for the product through its in- medication services, allowing patients to consult with
house R&D team. Favipiravir has demonstrated qualified physicians online, and receive personalized
activity against influenza viruses and has been healthcare management services, online refill service,
approved in Japan for the treatment of novel and medication delivery services.
influenza virus infections. The molecule if
commercialized, will be marketed under the
brand name FabiFlu in India.

KT Corp. to conduct study on epidemic preparedness

KT Corporation, South Korea’s ability to cope with the ongoing Foundation and KT in 2019 and
largest telecommunications coronavirus pandemic. The three- the research will be conducted
company, announced a three- year research collaboration builds in South Korea, which possesses
year research study funded off discussions between the Gates a high mobile phone penetration
by the Bill & Melinda Gates rate and 5G infrastructure. With
Foundation for ICT-based Gates Foundation grant funding,
global epidemic response KT will develop Big Data
using artificial intelligence algorithms to improve early-
(AI) and Big Data. The $10 diagnosis based on AI during an
million project stems from the epidemic and prediction of viral
recognition of South Korea’s infections spread using mobile
advanced information and data. Research expenses will be
communication technology divided equally between the two
(ICT) as well as its proven organizations.

12 FINANCE NEWS

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

CEPI invests $3.5M in Clover Australia for COVID-19 vaccine

Norway based CEPI, the Coalition $39.6 million. This initial CEPI of its COVID-19 S-Trimer vaccine
for Epidemic Preparedness investment will support Clover candidate. This innovative vaccine
Innovations, has announced a Australia in its efforts to initiate candidate is based on Clover
ninth worldwide collaboration a phase 1 clinical trial in Australia Biopharmaceutical’s proprietary
to develop a COVID-19 vaccine. Trimer-Tag vaccine technology
CEPI will invest an initial $3.5 platform, which is a novel way
million in a partnering agreement to produce the spike proteins of
with Clover Biopharmaceuticals the COVID-19 virus in a native
AUS Pty Ltd (Clover trimeric form for use in a vaccine.
Australia) a wholly-owned If successful in clinical trials,
subsidiary of Sichuan Clover Clover Biopharmaceuticals has
Biopharmaceuticals, Inc. (China), the capacity to rapidly scale up the
bringing the organisation’s total production of the vaccine using
investment in COVID-19 vaccine its in-house biomanufacturing
research & development to capabilities.

Astellas acquires Nanna Takeda inks deal worth
$670M with Orifarm
Therapeutics for £12 M
Japan based Takeda Pharmaceutical has announced
Japan based Astellas Pharma Inc. and UK based that it has entered into an agreement to divest a
Nanna Therapeutics Limited have announced that portfolio of select non-core over-the-counter (OTC)
Astellas has acquired Nanna, that is focused on and prescription pharmaceutical products sold in
addressing age-related diseases with high unmet Europe, and two manufacturing sites located in
medical need including mitochondria-related Denmark and Poland to Orifarm Group (Orifarm), a
diseases. Consideration for the acquisition, £12 fast-growing Danish pharmaceutical company, for up
million, was paid upon closing of the acquisition, to approximately $670 million subject to customary
and Nanna became a wholly owned subsidiary legal and regulatory
of Astellas. Adding Nanna’s proprietary and closing conditions.
advanced screening platform with new DNA- The portfolio to be
encoded chemical libraries (DELs) technology divested to Orifarm
significantly bolsters Astellas’ early stage drug includes a variety of
development capabilities. Nanna’s unique OTC products and
capabilities enable the creation and rapid testing food supplements
of more diverse chemical libraries. The approach as well as select
enables phenotype-based screening which is prescription
not feasible with conventional DELs. It can also products in the
be applied to various assay systems including Respiratory, Anti-inflammatory, Cardiovascular and
cell-based assays utilizing patient-derived cells, Endocrinology therapeutic areas sold predominantly
potentially enabling screens that are tailored to a in Denmark, Norway, Belgium, Poland, Finland,
specific disease biology. Sweden, the Baltics and Austria. The portfolio
generated FY 2018 net sales of approximately $230
million, driven by strong sales of cough/cold and
vitamin OTC brands, as well as prescription products
Warfarin and Levaxin. While the products included in
the sale address key patient needs in these countries,
they are outside of Takeda’s chosen business areas,
Gastroenterology (GI), Rare Diseases, Plasma-
Derived Therapies, Oncology, and Neuroscience, core
to its global long-term growth strategy.

START-UP NEWS 13

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

Intellect launches digital
therapy app for masses

Singapore based mental pertaining to their personal Hummingbird
health tech startup, Intellect behaviors, relationships, closes extended
has launched an app that and work habits, through funding round
provides a new form of digital comprehensive month-long of $25M
therapy without any human programmes they’re calling
intervention. Unlike typical ‘Learning Paths’ as well as more Singapore &US based
wellness apps, Intellect’s instant standalone ‘Rescue Hummingbird Bioscience, an
modern approach to therapy Sessions’. While the app utilises innovative biotherapeutics
is developed by a team of clinical methods, Intellect startup focused on the discovery
psychologists and behavioral emphasizes that the app is built and development of new
experts to help users manage for the everyday person to work breakthrough therapies, has
their mental health, but more on improving themselves, closed an extended Series B
distinctively to help them hone not just for the clinically funding round of $25 million.
and develop new behavioral distressed. This brings the total capital raised
traits using cognitive behavioral through financing activities
therapy. The personalised app and strategic partnerships to
transforms conventional face- more than $65 million to date.
to-face therapy into bite-sized Leading the Series B extension
modern self-therapy sessions is new investor SK Holdings,
at users’ own convenience. It with participation from existing
tackles a variety of issues shareholders including Heritas
Capital and SEEDS Capital, the
Biolidics develops investment arm of Enterprise
rapid test kit for COVID-19 Singapore. The Series B round
was extended to $25 million due
A rapid test kit for COVID-19 launched by former National University to significant over-subscription,
of Singapore (NUS) startup company, medtech firm Biolidics with the addition of select
Limited, has been approved for distribution and sale in the US for quality and value-add investors.
use by clinical laboratories or healthcare workers for point-of-care Hummingbird will use the new
testing. The company has also appointed an exclusive distributor funds to accelerate development
in the US for its rapid of new candidates into clinical
test kit. The rapid test trials and strengthen its scientific
kit identifies antibodies and research and development
to SARS-CoV-2-the virus capabilities.
that causes COVID-19 at
an accuracy of more than
95 per cent in 10 minutes.
Co-founded by Director
of the NUS Institute for
Health Innovation &
Technology (iHealthtech)
Professor Lim Chwee Teck, Biolidics was formerly known as
Clearbridge Biomedics. Using human serum, plasma and whole
blood, the rapid test is one of the few that combines both IgG and
IgM antibody tests for COVID-19. IgG and IgM are both antibodies
that are produced by humans in response to COVID-19 infection. As
such, the rapid test serves as an added tool of detecting COVID-19,
indicating recent or prior infection.

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BookDoc & WeDoctor announce strategic collaboration

Since the beginning of the outbreak wider transmission, BookDoc introduce the Global Consultation
of COVID-19 in Southeast Asia, has joined hands with WeDoctor, and Prevention Center (GCPC)
Malaysian startup BookDoc one of China’s biggest, and which supports English-Chinese
has been working tireless with the world leading technology- bilingual languages, brings
Ministry of Health, Malaysia to enabled healthcare company to together medical resources from
halt coronavirus contagion via its home and abroad, and offering
COVID-19 digital mobile platform 24/7 real-time online medical
by offering free virtual health services to fight the lethal invisible
advisory to the public, enable attacker. BookDoc and WeDoctor
them to order COVID-19 screening will explore partnerships in
test, access to the latest COVID-19 medical tourism and devise
news & updates and uberisation strategies to gain competitive
of healthcare via webinar. With advantage to reach out to medical
governments scramble to deal tourists from around the globe.
with rising cases of COVID-19 and The two companies will also
the World Health Organization leverage on their technology,
called on the region to scale up knowhow and local knowledge to
aggressive measures to prevent expand borderless healthcare.

SmartLabs Tessara Therapeutics
raises $2.7M funding
unveils global
Tessara Therapeutics, an Australia based
accelerator in Taiwan biotechnology company developing human mimetic
tissues, has closed its round one capital raising in the
Boston-based Laboratory-as-a-Service amount of $2.7 million, significantly over-subscribed.
(LaaS) leader, SmartLabs, has announced Tessara’s RealBrain technology manufactured 3D
the establishment of the Global Launch human mimetic brain tissue and has near-market
Programme, a world-class life sciences applications as a drug discovery model and longer-
accelerator. Through a partnership with the term applications as a tissue replacement therapy.
Ministry of Science and Technology (MOST), Australian and New Zealand-based sophisticated
SmartLabs is expanding internationally investors participated, and a New South Wales (NSW)
with a new biomedical innovation base in syndicate led the round with approximately 55 per cent
Hsinchu Biomedical Science Park, Taiwan. of the investment. The NSW syndicate included several
The Department of Academia-Industry medical specialists who recognized the potential
Collaboration and Science Park Affairs will of the RealBrain technology as a breakthrough for
carefully select biomedical innovation teams to the development of new drugs to treat neurological
participate in the Global Launch Programme. diseases with a great unmet medical need.
The programme is open to any promising
life sciences start up. SmartLabs has already
identified two participants with technologies
potentially suited for the detection of novel
coronaviruses. Through the Global Launch
Programme, the startups will have access
to training, mentorship and residency in
SmartLabs’ leading, adaptable lab spaces.
The three-month curriculum will include
guidance on creating a business plan, engaging
in fundraising and partnerships, developing
intellectual property, and conducting
product launches while navigating regulatory
environments.

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candidate
vaccines in
clinical evaluation

The rapid spread of the novel coronavirus is a reminder of how global populations and economies
are interconnected. The pandemic is integrating the global healthcare force by exposing the
obvious realities that no single individual, company, or country can solve the pandemic crisis alone.
Researchers are optimistically demonstrating best-in-class resources from the lab to manufacturing
to advance the innovations at multiple vaccine candidates. Indeed, the global biopharma
manufacturing industry is funding and expanding its capabilities for vaccine production on an ‘’at-
risk basis’’ to facilitate the world’s immediate need and demand. Novel paradigms of Next-generation
vaccine technology platforms are accelerating the development of “one life saving vaccine” to
nullify the repulsive humanitarian and economic impact. According to the WHO, as of May 30 there
are 10 vaccines under clinical evaluation which have already progressed to human trials and 121
candidates are in preclinical evaluation.

As COVID-19 continues to ravage the global
population, vaccination is becoming the sole
hope for an effective disease control and
prevention. Numerous pharmaceutical firms are
racing and competing to develop a potential vaccine
by deploying all their skills and resources. Companies
have substantially accelerated the timeframe of
vaccine production in comparison to the typical
vaccine development process.

The publication of genetic sequence of SARS-
CoV-2 on January 11, triggered intense global R&D
activity towards vaccine development. Fortunately,
up until the virus has not mutated to any significant
extent maintaining its relatively stable SARS-CoV-2
genome. Currently, there exist roughly 4 to 10 genetic
variations between the origin virus from Wuhan and
the strains currently circulating. That’s a relatively
small number of mutations for having passed through

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a large number of people. This makes it advantageous (BARDA), a U.S. Department of Health and Human
towards researchers attempt to create a single version Services (HHS) office of the Assistant Secretary for
of the COVID-19 vaccine. Preparedness and Response is another major funding
source who invests on potential vaccines through
This genomic data paved the way for range of clinical development and setting up manufacturing
novel technology platforms to evaluate vaccine capacity simultaneously.
development landscape for COVID-19, including
nucleic acid (DNA and RNA), virus-like particle, In February, the World Bank and the CEPI co-
peptide, viral vector (replicating and non- hosted a global consultation on these goals. This
replicating), recombinant protein, live attenuated consultation led to the launch of a ‘COVID-19 Vaccine
virus and inactivated virus approaches. Vaccines Development Taskforce’ that is now working on
based on viral vectors offer a high level of protein financing and manufacturing vaccines for global
expression and long-term stability, and induce access. CEPI estimates that developing up to three
strong immune responses. Of the confirmed active vaccines in the next 12–18 months will require
vaccine candidates, 72 per cent are being developed an investment of at least $2 billion. This estimate
by private/industry developers, with the remaining includes phase I clinical trials of say, eight vaccine
28 per cent of projects being led by academic, public candidates, progression of up to six candidates
sector and other non-profit organizations. through Phase II and III trials, completion of
regulatory and quality assessment for the final three
Researchers have discovered the structure of the vaccines, and lastly enhancing global manufacturing
spike glycoprotein (S) on the surface of SARS-CoV-2 capacity for those three prescribed vaccines.
virus to understand the vaccine target site. The spike
protein interacts and attaches with the host cell Fortunately, drug companies, contract
ACE2 receptor inducing an infection cycle. A vaccine manufacturers, governments, regulatory authorities
with a recombinant subunit mimicking the genome/ and taxpayers are accepting the challenge with a
protein of SARS-CoV-2 virus can generate antibodies collaborative efforts to shape the development of safe
targeting spike proteins on novel corona virus. The and efficacious vaccines. World Health Organization
synthetic protein generated by entities in the vaccine is coordinating global efforts for vaccine development
will interfere in viral binding, thereby neutralizing
the virus. This enabled scientists to target antigen
with multiple vaccine models backed by advanced
vaccine platforms.

According to GlobalData’s Pharma Intelligence
Center, as of May 25, there are 657 assets in
development for COVID-19, out of which 182 are
related to vaccine development. Within vaccines,
172 candidates are still in early stage development. A
recent statistical data revealed that most COVID-19
vaccine candidate development activity is happening
in North America, with 36 (46 per cent) developers,
compared with 14 (18 per cent) in China, 14 (18 per
cent) in Asia (excluding China) and Australia, and 14
(18 per cent) in Europe.

Funding agencies around the world have pledged
millions to help more investigators join the global
effort against COVID-19. Research is experiencing
never before fastest funding channels. The Coalition
for Epidemic Preparedness Innovations (CEPI), a
non-profit organisation dedicated to the development
of vaccines against emerging infectious diseases,
has been one of the major sources of monetary
support for this endeavour. The CEPI with a mission
to accelerate development of vaccines in epidemic
situations has invested millions of dollars in
several promising vaccine candidates. Biomedical
Advanced Research and Development Authority

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and clinical trials. According to the WHO, as of May licensed ‘MenACWY’ vaccine as an ‘active control’ for
30 there are 10 vaccines under clinical evaluation comparison in adult participants and in paediatric
which have already progressed to human trials and trials. The ‘control vaccine’ keeps the participants
121 candidates are in preclinical evaluation. Here remain blinded towards injected test vaccine or the
is an elaboration on the characteristics and clinical active control because ChAdOx1 nCoV-19 vaccine
stage status of some of the most promising SARS- might show minor temporary side effects such as
CoV-2 vaccines in race as depicted by WHO. sore arm, headache and fever while inducing good
immune responses and this blinding also helps in
ChAdOx1 nCoV-19 (Brand name: AZD1222) avoiding bias in the study results.
(Oxford University, UK)
On April 30, AstraZeneca and the University
The Oxford Vaccine Centre is evaluating its non- of Oxford partnered to develop, manufacture and
replicating adenovirus vector vaccine candidate large-scale distribution of the potential COVID-19
ChAdOx1 nCoV-19 (Brand name: AZD1222) with vaccine in a non-profit deal. AstraZeneca has agreed
the help of Jenner Institute and Oxford Vaccine to initially supply at least 400 million doses of the
Group. ChAdOx1 nCoV-19 is a recombinant version vaccine and secured total manufacturing capacity
of chimpanzee adenovirus vaccine vector ‘ChAdOx1’ to produce 1 billion doses, targeting first deliveries
developed at Oxford’s Jenner Institute. The vector in September 2020 depending on Phase III trial
caries genetic sequence for SARS-CoV-2 spike outcomes. On May 21, AstraZeneca received more
glycoprotein (S) to elicit the immune response than $1 billion from BARDA for the development,
against COVID-19 infection. production and delivery of the vaccine. The Serum
Institute of India is estimated to produce up to 60
On May 22, University of Oxford researchers million doses of the vaccine.
announced the commencement of phase II/III
human trials for the potential vaccine. Participants In a recent interpretation of preclinical study,
in both the Phase II (10,260) and Phase III (30,000) Oxford vaccine AZD1222 failed to protect a group
groups will be randomised to receive one or two of macaque monkeys infected with SARS-CoV-2
doses of either the ChAdOx1 nCoV-19 vaccine or a virus in a controlled laboratory conditions. The

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results did reveal that the vaccine may reduce the vaccine can be moved to further investigation phase.
severity of the infection but failed to stop spreading CanSino Biologics is progressing at Phase II in
of infection among the monkeys. The complexities China centre since mid-April. The National Research
at result interpretation underwent debate and re- Council, a Canadian federal R&D institution in
consideration based on other experimental factors Canada made a deal with CanSino Biologics to
like ‘dose of the vaccine’ and other combination advance bioprocessing and clinical development
strategies. The vaccine research team has reassured of Ad5-nCoV in Canada. Study team plans to enrol
on the clinical indications of this highly potent 696 participants atCanadian Center for Vaccinology
vaccine at later stages. Team is also looking at the (CCfV) in June.
further ways to improvise the immunogenicity. In the
last week of May a fresh funding has been released mRNA1273 (Moderna, USA)
together by Oxford, AstraZeneca and UK government
to manufacture 30 million doses for the UK by Moderna, a Cambridge, MA-based clinical-stage
September 2020. biotechnology company specializing in mRNA
therapeutics and vaccines is validating its mRNA
Ad5-nCov (CanSino Bio, China) vaccine candidate “mRNA1273” in collaboration
with the US National Institutes of Health (NIH)
The Beijing Institute of Biotechnology, Canadian through a relatively new and fast vaccine technology.
Center for Vaccinology and Hong Kong-listed The mRNA1273 is a genetically engineered synthetic
biotech firm CanSino Bio are progressing with the RNA transcripts shot which upon entering the cells
clinical trials of “Ad5-nCoV” vaccine against SARS- will translate the mRNA into protein components
CoV-2. The vaccine is the first to advance into Phase similar to coronavirus spike proteins to activate
II human trails and has gained the popularity as the immune response. This mRNA vaccine is
the most advanced candidate in private-public
partnership. Ad5-nCoV, a non-replicating DNA
vaccines with genetically engineered adenovirus
type 5 (Ad5) vector vaccine expresses SARS-CoV-2
spike protein in host to induce immune response
against novel coronavirus infection. The process
utilizes CanSino Biologics’ adenovirus-based viral
vector vaccine technology platform. Researchers
at Beijing Institute of Biotechnology cloned an
optimised full-length spike gene based on Wuhan-
Hu-1 and tailored it into its Ad5 vector to create ‘Ad5
vectored COVID-19 vaccine’ (Ad5-nCoV). Basically,
it’s a hybrid of “live adenovirus” and “recombinant
spike protein sequence” which can potentially infects
human cells to deliver recombinant viral DNA.

Based on preliminary Phase I safety data, on April
12, CanSino has enrolled participants in Wuhan,
China for a randomized, double-blinded and placebo-
controlled Phase II clinical study at days 0, 14, 28 and
6 months after vaccination. The study is designed to
evaluate the immunogenicity and safety of the Ad5-
nCoV vaccine which encodes for a full-length SARS-
CoV-2 spike (S) protein. Along with determining the
neutralizing antibody it also detects T-cell responses
(both CD4+ and CD8+).

On May 22, it is reported that the vaccine
is tolerable and immunogenic at 28 days post-
vaccination. Humoral responses against SARS-
CoV-2 peaked at day 28 post-vaccination in healthy
adults, and rapid specific T-cell responses were
noted from day 14 post-vaccination. Hence the
findings suggest that the Ad5 vectored COVID-19

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designed to generate potent and long-lived antibody As of May 27, Moderna is yet to start Phase II trials
responses delivering a therapeutic protein against which is expected to begin any time soon.
infectious diseases.
With the positive interim Phase I data and the
Moderna on May 18, announced the positive positive data in the mouse challenge model, Moderna
interim data from the Phase I study of mRNA- is finalizing the protocol for a Phase III study in
1273 run by the National Institute of Allergy and collaboration with NIAID and NIH. The trial is
Infectious Diseases (NIAID). The binding antibody expected to initiate in July 2020. Moderna has also
data, showed that mRNA-1273 elicited neutralizing received an U.S. federal government infusion of
antibody titter levels in all initial participants. The $483 million. BARDA is funding to support Phase
levels of neutralizing antibodies at day 43 were II and Phase III study and scale-up mRNA-1273
similar or above levels generally seen in convalescent vaccine. The clinical batch has also received funding
sera. Additionally, preclinical study in mice for first clinical batch from CEPI for analytical
conducted by NIAID showed that vaccination with testing. On May 1, Moderna announced a 10-year
mRNA-1273 prevented viral replication in the lungs strategic collaboration agreement with Lonza which
of animal models challenged with the virus. has two facilities in the U.S. and one in Europe to
manufacture the mRNA-1273. Moderna anticipates
On May 6, the U.S. Food and Drug Administration making 10 million doses per month in 2020 and 100
(FDA) completed its review of the company’s million doses per month in 2021.
Investigational New Drug (IND) application for
mRNA-1273 allowing it to proceed to a Phase II Sinopharm vaccine candidates (China
study. Also on May 12, the FDA granted mRNA-1273 National Pharmaceutical Group, China)
a Fast Track designation. Phase II study scheduled to
begin this quarter would randomize 600 participants. China National Pharmaceutical Group (Sinopharm)
is supporting the development of two ‘inactivated
vaccine’ candidate “Vero Cells” which are under
study at two different trial sites ‘Wuhan Institute
of Biological Products’ and ‘Beijing Institute of
Biological Products’ and are focusing at Phase I/
II trial of age group ‘6 and above’ and ‘3 and above’
respectively. The vaccine is the ‘first inactivated
vaccine’ worldwide to reach such a developed
approval stage.

Inactivated Novel Coronavirus Pneumonia
Vaccine [Vero cells] (Wuhan Institute of
Biological Products, China)

Ministry of Science and Technology, China is funding
SARS-CoV-2 vaccine clinical trial in association and
primary sponsorship from ‘Henan Provincial Centre
for Disease Control and Prevention’ and secondary
sponsorship from Wuhan institute of Virology and
Chinese Academy of Science (CAS). The Inactivated
vaccine candidate “Vero Cells” (registered on April
11) is progressing under clinical study at Wuhan
Institute of Biological Products. The study aims to
evaluate safety and immunogenicity of ‘Inactivated
Novel Coronavirus Pneumonia Vaccine’ in healthy
population aged 6 years and above in a randomized
double blind, placebo-parallel controlled Phase I/
II study. Phase II study is designed to measure the
serological immunogenicity of different age group
with varied vaccine doses at 90 days, 180 days and
360 days over the complete course of vaccination.
Study has recruited the subjects at ‘Wuzhi county
centre for Disease control and prevention’ and

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Vaccine candidates in clinical evaluation
with reference to WHO listing as of 30 May 2020

Vaccine Type Vaccine Developer Status Manufacturer
Candidate Distributor
Non Replicating Oxford Vaccine Centre in Phase I/II: In progress AstraZeneca, UK/
Viral Vector ChAdOx1 association with Jenner Phase II/III: Enrolment Serum Institute of
nCoV-19 Institute begun India
Non Replicating Brand name: CanSino Biological,
Viral DNA Vector AZD1222 CanSino Biological Phase I: Positive result in China
Beijing Institute of few subjects
Ad5-nCov Biotechnology(Ad5) Phase II: In progress Lonza
Wuhan Institute of Phase I/II: To begin in
LNP-Encapsulated mRNA1273 Biological Products Canada China National
mRNA (Wuhan-Hu-1) Pharmaceutical
Moderna and NIAID Phase I : Interim Data Group (Sinopharm)
Inactivated SARS- Vero Cells released China National
CoV-2 vaccine Wuhan Institute of Phase II : IND approved Pharmaceutical
Biological Products Phase III: To begin in July Group (Sinopharm)
2020 Sinovac, China
Yet to test on Animals
Novavax, Australia
Phase  I/II: In progress
Fosun Pharma,
New Inactivated Vero Cells Beijing Institute of Phase I/II: In progress China
SARS-CoV-2 Biological Products
vaccine CoronaVac Sinovac Biotech Ltd (SVA) Phase I: Completed Richter-Helm
(previously Novavax Phase II: In progress Biologics GmbH &
Inactivated virus PiCoVacc) Phase I: result expected Co. KG, Germany
+ CpG 1018 NVX-CoV-2373 BioNTech and Pfizer by July
adjuvant
BNT162 INOVIO Pharmaceutical Phase I/II: In progress
Protein Subunit: (BNT162a1, USA; Trails in Asia
SARS-CoV-2 spike BNT162b1, Phase I: In progress
protein antigen BNT162b2, Phase II/III: July/Aug
nanoparticle + BNT162c2)
Matrix M adjuvant INO4800

3 LNP-mRNA
formulated
vaccine

DNA Plasmid
vaccine with
electroporation

‘People’s hospital’ at Jiaozuo, He’nan province, sponsorship from ‘Beijing Institute of Biological
China. The study is expected to complete by Products’. The study registered on April 29, evaluates
November 10, 2021. the safety and immunogenicity of ‘New inactivated
SARS-CoV-2 vaccine’ (Vero Cell) in a randomised,
New Inactivated Novel Coronavirus double-blind, placebo parallel-controlled Phase I/II
Pneumonia Vaccine [Vero cells] (Beijing clinical study. Healthy participants aged 3 years and
Institute of Biological Products, China) above are enrolled to observe immunogenicity and
preliminary persistence at different age group and
Ministry of Science and Technology, China is funding dose between 90 days, 180 days and 360 days. Study
another clinical trial in association and primary has recruited the subjects at ‘Liangyuan Centre for
sponsorship from ‘Henan Provincial Centre for Disease control and prevention’ Shangqiu, He’nan
Disease control and Prevention’ and secondary

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province, China and is expected to complete by Three immunizations using two different doses (3
November 28, 2021. μg or 6 μg per dose) provided partial or complete
protection in macaques against SARS-CoV-2
Phase I/II study for both “Vero Cell” candidates challenge. These data support clinical development of
evaluates vaccine’s safety and determines SARS-CoV-2 vaccines for humans.
vaccination procedures, number of doses and
quantity of the dose to be effective against SARS- On May 22, Sinovac R&D announced receipt of
CoV-2. At Phase III vaccine will be screened for $15 million convertible investment injection from
efficacy and safety in a larger group of subjects. In Advantech Capital and Vivo Capital, to further the
mid May 2020, China’s National Medical Products development of CoronaVac. Earlier in April the
Administration (NMPA) has approved Phase II company had secured an $8.5 million low-interest
trial based on the safety and efficacy of Phase I trial line of credit from the Bank of Beijing. Based on the
data. The NMPA authorized its phase I and phase II sufficient credible Phase I data, the team received
human trials at the same time through a fast-track go-ahead in May for Phase II trials to evaluate the
channel based on highly promising results from immunogenicity and safety in a larger population in
preclinical trial studies. order to define dosage, regimen and immunization
schedule. The study is estimated to complete by
Since inactivated vaccines don’t provide immunity August 13, 2020 while the overall clinical study
as strong as live vaccines, several doses over time completion is targeted to December 2020. The
are needed to establish a stable immunity against company is also building a dedicated COVID-19
diseases. It might also take more than a year to finish commercial vaccine production plant to manufacture
all three phases of human trials. Sinopharm, has up to 100 million doses of CoronaVac annually, upon
invited Pakistan’s National Institute of Health for the success of the vaccine.
clinical trials through ‘HealthBee Projects Private
Limited’ and has set aside a fund of 1 billion yuan NVX-CoV-2373 (Novavax, Australia)
($141.33 million) to support the vaccines’ R&D.
Sinopharm is estimating to produce 100 million vials NVX CoV2373 is a vaccine created using Novavax’
of inactivated COVID-19 vaccines annually upon the proprietary recombinant nanoparticle technology
success of the trial. into a stable, prefusion protein. The candidate is
engineered from the genetic sequence of SARS CoV
CoronaVac (Sinovac Biotech, China) 2 virus to synthesise coronavirus spike (S) protein
antigen. This vaccine contains Novavax’ patented
Sinovac Biotech Ltd (SVA), a biopharmaceutical saponin-based Matrix-M adjuvant stimulating the
company in China, is developing CoronaVac entry of ‘antigen-presenting cells’ into the injection
(previously PiCoVacc) a chemically inactivated-virus site. This boosts the immune response and stimulates
vaccine. In a preclinical study the vaccine offered high levels of neutralizing antibodies.
complete protection in non-human primates against
SARS-CoV-2 strains by eliciting potent humoral In preclinical trials, NVX CoV2373 demonstrated
responses devoid of immunopathology. Sinovac high immunogenicity and robust levels of
has received an approval from Chinese regulatory neutralizing antibodies, a critical aspect for
authorities to conduct both Phase I and Phase II effective vaccine protection. Phase I activity result
human clinical trials in China. In mid-April Sinovac is expected by July 2020. On May 25, Novavax
partnered with Dynavax Technologies Corporation announced enrolment of participants in Phase
(DVAX), a US based Biopharmaceutical Company I/II clinical trial at two sites in Australia to
to adopt its well-developed adjuvant technology evaluate the immunogenicity and safety vaccine
platform. Dynavax synthesises an advanced vaccine candidate ‘with and without’ Matrix-M adjuvant.
adjuvant ‘CpG 1018’ which can elicit CoronaVac The company recently inked a deal with CEPI for
efficiency and thus potentially accelerate immune up to $388 million in funding to advance clinical
response. development of NVX CoV2373. Novavax also
acquired Praha Vaccines in Czech Republic part
On May 6, a preclinical animal study of of the Cyrus Poonawalla Group, in an all cash
CoronaVac has shown efficacious neutralizing transaction of approximately $167 million. The
antibodies as a promising results during an acquisition includes advanced vaccine and biologics
experimental trials on Rhesus macaque monkey, manufacturing facility and associated assets in
mice and rats. Moreover, these antibodies appear to Bohumil, Czech Republic. The facility is expected
be effective against ten different mutational forms of to provide 1 billion doses of NVX CoV2373 vaccine
the SARS-CoV-2 virus, suggesting a possible broader annually, starting from 2021.
neutralizing ability against SARS-CoV-2 strains.

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BNT162 (Pfizer (US) and BioNTech Pfizer’s manufacturing sites are at three states in US
(Germany)) and one in Belgium have been identified as BNT162
manufacturing centres along with BioNTech’s
New York-based Pfizer and Germany-based existing mRNA production sites in Germany.
BioNTech are jointly developing BNT162, a series
of 4 mRNA vaccines. It’s the first clinical trial of a INO-4800 (INOVIO Pharmaceuticals,
COVID-19 vaccine candidate to start in Germany. On Philadelphia, US)
May 5 the team announced dosing the first American
participants in the Phase I/II trial of BNT162 clinical INOVIO Pharmaceutical’s COVID-19 ‘DNA vaccine
study. Pfizer and BioNTech’s global development candidate’ INO-4800 has demonstrated robust
program includes four vaccine candidates, each neutralizing antibody and T cell immune responses
representing a different combination of mRNA against SARS-CoV-2 virus in preclinical models,
format and target antigen. Around 7600 trial mice and guinea pigs. The recombinant DNA-based
participants will receive one of four vaccine vaccine candidate INO-4800 targets major surface
candidates – BNT162a1, BNT162b1, BNT162b2 and spike glycoprotein antigen in SARS-CoV-2 virus. The
BNT162c2 – or placebo in order to identify the safest candidate is progressing in Phase I testing and could
and potentially most efficacious candidate among the advance to Phase II/III trials by July/August 2020.
variants. INO-4800 is designed using INOVIO’s proprietary
DNA medicine platform which can activate immune
Two of the four vaccine candidates include a response in the host by delivering vaccine (optimized
nucleoside modified mRNA (modRNA), one includes plasmids) right into the human cell (intramuscularly
a uridine containing mRNA (uRNA), and the fourth or intradermally) with the help of a hand-held
vaccine candidate utilizes self-amplifying mRNA smart device ‘CELLECTRA’. The device uses a brief
(saRNA). Each mRNA format is combined with a electrical pulse to reversibly open small pores in
lipid nanoparticle (LNP) formulation. The larger the cell to allow the plasmids to enter, overcoming
spike sequence is included in two of the vaccine a key limitation of other nucleic acid (DNA/mRNA)
candidates. In other two candidates the smaller approaches. Once inside the cell, the DNA plasmids
optimized receptor binding domain (RBD) from the enable the cell to produce the SARS-CoV-2 spike
spike protein is included. The RBD-based candidates glycoproteins which further triggers the desired T cell
contain the piece of the spike that is thought to be and antibody-mediated immune responses. Thus,
most important for eliciting antibodies that can CELLECTRA ensures efficient and effective delivery
inactivate the virus. The team will further evaluate of the vaccine.
the safety and tolerability, immunogenicity, and
potential efficacy against COVID-19. The study INOVIO is planning to incorporate preclinical
started on April 29, with the estimated primary observations from Phase I study with animal study
completion date as August 11, 2021, and estimated challenges to evaluate safety and immune response
overall study completion date as March 8, 2023.
The novel design of the trial allows evaluation of the
various mRNA candidates simultaneously to facilitate
data sharing with regulatory authorities in real time.
These Four vaccine candidates from BioNTech are
part of its “Project Lightspeed” planned to enter
clinical development at its GMP-certified mRNA
manufacturing facilities in Europe.

The Phase I/II study is designed to determine
the safety, immunogenicity and optimal dose level of
four mRNA vaccine candidates evaluated in a single,
continuous study. The study will also evaluate the
effects of repeated immunization for three of the four
vaccine candidates which utilize uRNA or modRNA.
Subjects with a higher risk for a severe COVID-19
infection will be included in the Phase II of the study.
BioNTech has a deal with Fosun Pharma to evaluate
coronavirus vaccines locally in China. If development
goes according to plan, Fosun aim to scale up vaccine
production in millions of doses in 2021. Currently

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data and to expedite its effort to reach randomized novel corona virus and is expected to complete by
Phase II/III clinical trial. Earlier too INOVIO has mid-2020. Scientists at Germany’s Max Planck
extensively worked on coronaviruses and is the Institute for Infection Biology shown that the
only company with a Phase IIa vaccine for MERS, a VPM1002 activates the immune system in mice and
related coronavirus. On April 30, Inovio signed an could thus significantly attenuate the virus causing
agreement with the German contract manufacturer COVID-19 infection. Even if found successful, the
Richter-Helm BioLogics GmbH & Co. KG, to support real challenge lies in supplying 10 to 100 million
large-scale manufacturing of INOVIO’s investigational doses worldwide in a short time. Additionally, the
DNA vaccine INO-4800. The agreement is being VPM1002 vaccine is quite scarce, and the WHO is
partly funded by an initial grant of $1.3 million from now concerned that infants in countries with TB may
the CEPI, which brings CEPI’s total support for the fall short of vaccine shots if used for COVID-19. The
development of INO-4800 to $17.2 million up until Serum Institute of India has been licensed to produce
April 30. INOVIO is targeting to produce 1 million the VPM1002 vaccine with its ready production
dose of INO-4800 by gearing up for success at clinical facilities.
trials.INOVIO has assembled a global coalition of
collaborators, partners and funders to rapidly advance Wait for more months
INO-4800 clinical trials in America, China and
South Korea. To date, CEPI the Bill & Melinda Gates It is vital to accelerate the evaluation and innovation
Foundation, and the US Department of Defence have of as many vaccines as possible to reach at possible
contributed significant funding to the advancement remedy to protect us from the deadliest pandemic of
and manufacturing of INO-4800. the generation.

Besides these WHO listed top 10 potential The strong international coordination and
vaccine candidates in the race, only a recombinant cooperation between vaccine developers, regulators,
BCG vaccine (VPM1002) is in “Phase IV” stage of policymakers, funders, public health bodies and
the study. The age-old vaccine has a proven history governments is essential to ensure sufficient
for safety and efficacy to protect against childhood manufacture and equitable distribution to all affected
tuberculosis, meningitis, and other respiratory areas, particularly low-resource regions. There is also
diseases with a reported morbidity and mortality a need to prioritise vaccines availability to healthcare
reduction rate as high as 70 per cent. Researchers workers, frontline support staff, public-facing
are expecting VPM1002 to bridge the time gap until key workers who are at greatest risk. Fortunately,
a precise vaccine effective against SARS-CoV-2 is industry partners are agreeing to operate on a not-
available. A study approved by the Drug Controller for-profit basis without royalty to prioritise and
General of India is enrolling 6,000 high-risk accelerate the globalisation of a vaccine to stop the
individuals to test the efficacy of VPM1002 against future wave of global COVID-19 infections from being
more lethal.

However, vaccines which are efficacious in-
vitro and in animal models need not ensure safety
and efficacy at the human trials of large group with
varying degree of immune response. Yet, SARS-
CoV-2 vaccines is essential to reduce morbidity and
mortality to avoid virus from continuing to establish
itself in the population.

According to GlobalData, a leading data and
analytics company, “Considering vaccines typically
take years to develop, expectations surrounding
the timeframe for a vaccine should be tempered.
Additionally, once a vaccine is determined to be
effective, there is the manufacturing and distribution
of the vaccine to contend with. These could cause
delays and increase the time to availability of the
vaccine”.

“Despite massive efforts, the first vaccine will take
at least a year to develop” says Global data expert.

Hithaishi C Bhaskar
[email protected]

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AUSTRALIA’S

‘research engine’

SLOWS DOWN

As the COVID-19 has spread around the globe, Australian Government. The NCCC was established
it has created profound disruption across on March 25, 2020 by Prime Minister Scott Morrison
communities, patients and clinicians. Pharma to provide advice on public–private partnerships
and medtech companieshave found themselves and coordination to mitigate the social and economic
front and center—supplying (and rapidly scaling impacts of the COVID-19 pandemic in Australia.
up) vitally important medical products to support
patients in their time of need, while also attracting The report noted that the ‘research engine’ has
widespread attention as the industry sprints slowed down overall for several reasons. Much of
to develop new therapeutics and vaccines for Australia’s research workforce has placed its existing
COVID-19. At the same time, the clinical and research on hold to answer the call for COVID-19
product development “research engine” has research, both in the laboratory and clinic. Physical
experienced profound disruption as colleagues distancing and travel restrictions are hindering
adjust to remote work environments and lab some research, denying access to
capacity is reduced. Due to this crisis the focus has laboratories, major research
been now devoted to COVID-19 affecting research facilities and
and development in other areas across the globe archives. In
including R&D in Australia. addition to this,

What impact is the pandemic having and
likely to have on Australia’s research
workforce and will we have the research
workforce capability to support our recovery efforts?
Responding to this question from the Australia’s
Industry, Science and Technology Minister,
Karen Andrews; Health Minister, Greg Hunt; and
Education Minister, Dan Tehan, Australia’s Chief
Scientist, Dr Alan Finkel haveconvenedRapid
Research Information Forum (RRIF), a group of 35
research sector lead organisations,and its operations
are led by the Australian Academy of Science. The
RRIF has come up with report titled “Impact of the
Pandemic on Australia’s Research Workforce”. The
report noted that the Australian medical research
workforce will be severely impacted for an extended
period of time.

The report was submitted on May 6, to Neville
Power, Chair and David Thodey, Deputy Chair,
National COVID-19 Co-ordination Commission
(NCCC), a strategic advisory body for the national
response to the COVID-19 pandemic by the

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clinical trials and population health studies have been sector so that we can deal with this and future
affected by the new demands on clinical resources pandemics. The report outlines a harsh truth that it’s
and interrupted access to patients and population not just about this pandemic and the effects right now,
cohorts. it’s about how our future research capacity is at risk”.

Anecdotal evidence indicates that some Impact on funding and job security
organisations already have insufficient international
PhD students to conduct research, and some According to the report, for universities, significant
commercial partners are withdrawing their job losses have not yet been realised. This is because,
contributions to cut costs. However, it is too early to so far, universities that rely on international student
quantify the impacts of these factors. Restrictions are revenue have reduced costs elsewhere. However,
also limiting access to conferences and collaborative continuing loss of international students will reduce
teams, preventing international placements and income available to support research. Estimating a
reducing the ability to undertake fieldwork abroad loss of $2.5 billion in 2020, Professor Chris Moran
and locally, including research required to respond of Curtin University projects at least 38 per cent of
to urgent national needs such as the effects of the the research academic payroll is at risk. Universities
bushfire crisis. Australia estimate an even higher decline in revenue
of at least $3 billion and possibly up to $4.6 billion in
Dr Peter Thomas, Director of Policy & Operations, 2020, a decline that will be more acute for research
Association of Australian Medical Research Institutes intensive universities.
(AAMRI) and a contributing author on the piece
said “AAMRI has been seeing a drop off in revenue To try and make ends meet as budgets
streams at medical research institutes over the past contract, universities are reducing the number
few months, and if past downturns are any guide it of casual teachers and increasing the teaching
could take many years for these to bounce back to loads of permanent staff, further limiting their
pre-coronavirus levels.” research capacity. As well as taking on extra caring
responsibilities at home, teaching and research
Professor Jonathan Carapetis, President of academics have had to invest time to deliver online
AAMRI, said “We need teaching, with an unknown impact on future research
to ensure strong productivity. Universities are required to co-fund
support for the research from all sectors – industry, government
research and non-profit. The decline in revenue will severely
impact their ability to provide co-funding, which will
in turn compromise research collaborations with
industry and other sectors.

The impact of COVID-19 on medical research
institutes (MRIs) is mixed. While some institutes and
teams within institutes have experienced increased

workload and funding, the closure of most
laboratories is disrupting almost all lab-based
research not directly related to COVID-19.
Projects will need to be extended, and some
will be terminated. In some cases, research
can be re-commenced relatively easily, but
other projects will take months to recalibrate,
resulting in lengthy research delays. MRIs
report that revenue from philanthropy,
investments and commercial income is

falling.
Based on data from previous economic

downturns, the AAMRI has projected this fall in
revenue to be between $200 million and $400
million over the next two years.The main impact on
publicly funded research agencies (PRFAs), which
include Commonwealth Scientific and Industrial
Research Organisation (CSIRO), Australian Nuclear

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NHMRC Investigator research workforce is less
Grants Commencing 2020-21 easily assessed. It is difficult
to estimate the percentage
● $186 million in research funding for 124 of job losses across industry
projects in Victoria, including University of research, but manufacturing
Melbourne research to put 3D printing into the and professional scientific
reality of surgery by developing an approach and technical services
for regenerating joint cartilage within the body have experienced large
using one-step surgery employment layoffs or
reductions as illustrated in
● $119.8 million in research funding for 83 Table.
projects in New South Wales, including
University of New South Wales research to Sectors with largest numbers of FTE
explore how novel internet solutions can be researchers and jobs change by sector
used to overcome the burden of depression in
youth. Sector FTE Employee jobs
researchers change by sector
● $48.8 million in research funding for 29 by sector from March13, to
projects in Queensland, including QIMR (as at 2017) April 4, 2020
Berghofer Institute of Medical Research
research into the genetic basis of breast Information and 1,089 -6.8 %
cancer risk with the aim of reducing breast communication
cancer incidence and mortality.
Financial and 6,733 -3.2 %
● $24.1 million in research funding for 15 insurance
projects in South Australia, including University activities
of South Australia research into the monitoring
of medical conditions such as preeclampsia, Manufacturing 7,362 -4.3 %
epilepsy, fetal arrhythmias and heart attacks
through advanced technologies that can be Professional, 12,902 -7.9 %
integrated with point-of-care and wearable scientific and
diagnostic tools. technical
activities
● $8.4 million in research funding for nine
projects in Western Australia, including While some larger industry employers may be
University of Western Australia research protecting their R&D capacity so they can pivot
into novel and effective chemotherapy and after the pandemic, others rely on universities and
immunotherapy drug combinations to reduce research institutions for R&D capacity. In 2016,
deaths from cancer. universities performed approximately 43 per cent
of all applied research in Australia compared to
● $5.6 million in research funding for five 39 per cent by industry. Industry is most active in
projects in the Northern Territory, including the experimental development area of research,
Menzies School of Health Research work comprising 86 per cent nationally. Mirroring the
towards the elimination of chronic hepatitis B Australian experience, researchers in the US and
in the Northern Territory. Europe are reporting that research into COVID-19
is taking precedence. Research projects and
● $3.8 million in research funding for two laboratories not related to the pandemic have been
projects in the ACT, including Australian delayed or shut down. In the UK, the government
National University research to strengthen has established a multi-agency and funding councils
the detection and prediction of outbreaks of taskforce to consider what measures are necessary
emerging infectious diseases, and the control to support universities, the research community and
and elimination of neglected tropical diseases. research institutions.

Science and Technology Organisation (ANSTO) and Job losses and other labour market effects
Australian Institute of Medical Scientists (AIMS),
has been the redeployment of staff to address the While the scale of job losses in the research sector
pandemic. However, other laboratories classified as
conducting non-essential activities have been subject are hard to predict, analysis by Universities Australia
to closure. For the industrial sector, the impact on the
estimates up to 21,000 full-time equivalent (FTE)

jobs in the next six months alone are at risk in

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the university sector. Drawing on Commonwealth Key findings of
Department of Education staff data and assuming impact of the pandemic on
the loss of research-related staff mirrors the overall Australia’s research workforce
university workforce losses, it is estimated that at
least 7,000 research jobs are at risk. ● Australia’s research workforce will be severely
impacted by the pandemic and the effects are
Australia’s ability to pursue research activities likely to be felt for an extended period.
will be further hampered by international university-
based research students who are not expected ● Income to universities, medical research
to be able to resume their research programs if institutes, publicly funded research agencies,
international travel restrictions continue. Science and CRCs, and the industrial sector is suffering
Technology Australia forecasts that revenue loss in from the loss of foreign students and a sharp
2020 (calculated from 2016 HERD data ) will reduce decline in business research spending and
non-specified or discretionary university funding philanthropy.
from $5.8 billion to $1.8 billion, potentially reducing
research funding from $11.3 billion down to $7.3 ● To try and make ends meet as budgets
billion. These forecasts are in line with modelling by contract, universities are reducing the number
the Mitchell Institute, which forecasts revenue losses of casual teachers and increasing the teaching
of between $10 billion and $19 billion over the next loads of permanent staff, further limiting their
four years. research capacity.

Science and Technology Australia estimates ● These impacts are greater than during the
that this will translate to the loss of approximately 2008 global financial crisis and are being
14,000 FTE research workforce jobs in 2020 alone, observed internationally.
though these assumptions are very broad and based
on projected income losses (not counting loss from ● University job losses of up to 21,000 full time
industry investment) and FTE rather than actual equivalent (FTE) positions are projected over
staffing, and on averaged losses, cuts and salaries. the next six months of which an estimated
AAMRI forecasts that a 20 per cent reduction in MRI 7,000 could be research-related academic
revenue could translate into approximately 3,000 staff. There are concerns that women, early-
positions lost over the next 12 to 24 months. Access career researchers and recent graduates
to the JobKeeper program will offer some temporary will disproportionately experience negative
support to eligible MRIs, with around 70 per cent of impacts.
positions to date expected to be covered. However,
universities will not be eligible, and this will have a ● Domestic and international post-graduate
negative impact on some MRIs. students comprise 57 per cent of the university
R&D workforce. Research interruptions and
While the Medical Research Future Fund (MRFF) travel and visa restrictions suggest that more
than 9000 international research students will
not resume their research in 2020.

● Industry sectors may experience a reduced
capacity to innovate given that universities
perform approximately 43 per cent of all
applied research in Australia.

● A decline in innovation may limit economic
growth by slowing the development of new
technology, skills, and efficiency gains in
service and production processes.

Source: Australian Academy of Science

is ramping up in future years, projects under this
scheme will require co-investment from other at
risk discretionary income. Because of the highly
casualised and fixed term nature of the university
research workforce, expectations are that negative
employment impacts will be disproportionately felt
by junior researchers including recent graduates,
early-career and mid-career researchers, and

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Industry calls for support to keep biotech jobs

Despite this being the life sciences industry’s sector – urge the inclusion of pre-revenue life
‘finest hour’ as it pivots to fast track COVID-19 science companies in the JobKeeper eligibility
vaccines, treatment and diagnostics and digital criteria.
health solutions, the sector’s pre-revenues
companies are calling for support to keep their Australia’s pre-revenue biotech and
highly-skilled 65,000 jobs. Health and medical medtech companies house priceless talent and
start-ups, making up more than 85 per cent of the intellectual property that could be permanently
sector need JobKeeper to retain skills and talent. lost to Australia if they are not able to access
JobKeeper to weather the COVID-19 storm.
In a joint statement by all leading life sciences
associations - AusBiotech, ANDHealth, Medicines The Australian Taxation Office (ATO) recently
Australia, Medical Technology Association of denied the industry’s application to expand
Australia (MTAA), BioMelbourne Network and the JobKeeper payment eligibility criteria to
Life Sciences Queensland, pointed out that the include pre-revenue biotech and medtech
health industry’s R&D, including clinical trials, is companies working in Australia. These life
a key contributor to Australia’s patient wellbeing science companies are at the heart of the
and growth economy. The industry bodies – essential research and development of vaccines,
from the medical technologies, digital health, repurposed and emerging therapies, diagnostics,
biotechnologies and pharmaceuticals industry digital solutions, as well as test kits and
sector and the health and medical research ventilators to combat COVID-19. They raise the
quality of life for all Australians.

women, who more commonly than men have predominantly in information and computing
additional commitments of childcare and other home sciences and engineering. The proportion of R&D
responsibilities. expenditure by large businesses has declined in
recent years. During the global financial crisis
Journals are already observing that since the business investment in research fell by 3.1 per cent in
COVID-19 crisis began, submissions from women Europe. Statistics emerging from the US, Europe and
are underrepresented and articles authored solely by Australia indicate the current economic crisis will be
women are particularly affected. an order of magnitude worse, and a severe drop in
BERD is expected.
As a result of the reduction in international fee
revenue, research staff are likely to become less Publicly funded research institutes (PFRAs),
available to cooperative research centres (CRCs), including CSIRO, ANSTO and AIMS, source differing
impairing the ability of CRCs to attract and retain proportions of their annual revenue from external
industry and university partners to a program sources including industry and overseas entities. This
that has had a long-running positive impact on revenue is critical for current operations of these
commercialising research. Overall, gaps in Australia’s agencies and unless made up from other sources,
intellectual and technological capability will worsen reductions in revenue will have employment effects.
in the mid to long term as research labour supply
declines and the pipeline of researchers breaks down, CSIRO also employs early career research
risking a winding back of gains in cultural diversity staff from both domestic and international origin.
and gender balance. CSIRO’s postdoctoral research cohort turns over at
approximately 35 per cent each year, and about half
Job losses in the research sector will reduce are originally from overseas. All PFRAs use PhD
Australia’s ability to maintain research collaborations candidates, especially international PhD candidates,
with international partners. These are important as key components of their research teams.
for ensuring global participation and standards
of research as well as access to discoveries and Ninety percent of ANSTO-led peer reviewed
technologies. publications from 2016 to 2018 had external national
or international co-authors. ANSTO believes that
Falling business investment in R&D this pattern of collaboration and partnership will
re-establish itself after the pandemic. In this sense,
Business expenditure on R&D (BERD) in 2017–18 ANSTO’s workforce (at the level of publications and
was $17.4 billion, or 0.9 per cent of GDP. Around collaboration) is resilient and can also maintain key
60 per cent of BERD is spent on experimental functions.
development and 32 per cent on applied research,

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$400 million funding for health & medical Employed researchers in Australia
research
Sector Research Staff (FTE)
To support the R&D activates, on May 20, the Universities
Australian government announced that it will invest 79,008 (24,075 academic staff; 9,720
almost $400 million in world-leading health and Government other staff; and 45,212 postgraduate
medical research projects to improve the lives of all students, 2016 ABS data)
Australians. The government’ funding will strengthen Industry
Australians’ health through research to prevent 14,773 (including 7,482 researchers;
illness and deliver better health care as the country 4,512 technicians; and 2,777 other
recovers and restore the nation in the aftermath of staff, 2016 ABS data)
the COVID-19 pandemic.
74,991 (34,576 researchers; 26,912
A total of 237 new projects will receive funding technicians; and 13,504 other staff,
from the National Health and Medical Research 2017 ABS data)
Council (NHMRC), with a further 30 grants to
be funded through the Medical Research Future Source: Australian Bureau of Statistics (ABS)
Fund (MRFF) Priority Round.Funding will support
research in the areas of:Cancer – $87.1 million; and production processes, is the most significant
Cardiovascular Disease – $46.5 million; Mental factor. R&D also has positive spillovers, meaning
health – $54.0 million; Indigenous – $19.4 million that knowledge can result in increasing returns
and Infectious diseases – $84.7 million. to scale up production cheaply, and can generate
significant benefits for those other than the
Of the grants funded, a total of $84.7 million will primary investors as discoveries are made and
go towards 61 new research projects in infectious spread. Given the decline in immigration in
diseases – a significant strength of Australia’s the short term, and the uncertain outlook for
research sector. Whilst applications for this grant international mobility, Australia will be even more
round closed in 2019, prior to the outbreak of reliant on productivity as a driver of growth, and
COVID-19, infectious disease research into influenza therefore R&D. This is the rationale for public and
and pneumonia may contribute to our understanding university sector R&D, noted by, among others, the
of COVID-19 and translate into new treatment Productivity Commission, Innovation and Science
strategies and trials. Australia, and the 2016 review of the R&D tax
incentive.
Professor Allen Cheng from Monash University
will receive $1.7 million to optimise vaccine and During the global financial crisis and subsequent
treatment strategies to prevent illness and death from slump in international student enrolments, the
severe influenza in Australia. impact on Australia’s university research was offset
by the introduction of demand-driven funding with
Professor Cheng’s research project will transform the research sector benefiting from the stimulus. The
the prevention and treatment of influenza and its scale of the revenue losses for universities from the
complications by developing innovative public health COVID-19 pandemic is likely to be worse than 2008.
and treatment strategies that can be applied globally. While international education mobility will remain
While this round was closed for submissions last a significant industry globally, hopes should not be
year, the government is currently in the process of pinned on a quick recovery. Experts such as Simon
awarding $42 million for COVID research through Marginson from Oxford University expect recovery
the MRFF. to take at least five years. Australia will need to find
new sources of growth and improve productivity to
Medical research is one of the core elements of maintain our standard of living.
the Australian government’s $104 billion Long Term
National Health Plan. This vital investment across It is too early to say with confidence what form the
the broad health spectrum will continue the proud research workforce will take following the pandemic.
Australian tradition of discovery and translation for However, contractions in sources of discretionary
the better health for all. spending for universities, and industry and overseas
income for public and university bodies, strongly
Supporting recovery efforts indicate that the research workforce will contract and
will have less capacity than prior to the pandemic to
Modern economic theories argue that sustained contribute to economic recovery.
economic growth comes mainly from productivity
increases. There are several ways to improve Narayan Kulkarni
productivity but knowledge capital, through new [email protected]
technology, skills, R&D and efficient services

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TRADITIONAL
MEDICINES & COVID-19

Allopathic drugs are already being tried to treat COVID-19 but even with promising results these drugs

always comes with some side-effects unlike in case of traditional system of medicines.

India has perhaps the world’s oldest as well as of transmission as Gatrasansparsat (physical contact)
largest tradition of systems of medicine. The and Nihsvasat (expelled air) and Saha Bhojanata
term Indian Systems of Medicine covers both the (using same utensils). Ayurveda has spoken of very
systems which originated in India as well as outside potent immuno-modulators. Ashwagandha, Peepli,
but got adopted in India in course of time. These Giloy and Amla are some of the common ones that
systems are Ayurveda, Siddha, Unani, Homoeopathy, are often recommended by Ayurveda doctors. In
Yoga, and Naturopathy. They have become a part addition to that, AYUSH ministry has also issued
of the culture and traditions of India. India with several immunity enhancing guidelines such as
its strong base in traditional knowledge on herbal drinking lukewarm water, consuming concoction of
medicine and vast plant biodiversity has a great Tulsi and Haldi in water, and applying Anu Oil in the
potential in this sector which can be examined in the nostrils.”
current pandemic situation where the entire world
has been majorly affected with COVID-19. Highlighting the promising role of Ayurveda,
Vikram Thaploo, CEO, Apollo Tele Health said,
At a time when the world is looking for preventive “There is currently no approved treatment or vaccine
and therapeutic solutions against coronavirus for COVID-19. Multiple lines of treatment have been
spread and its effects, examining the ways in which put forward and even practiced in different countries
traditional medicine system can play a role can be to treat seriously ill patients of COVID-19. Initially,
crucial. Allopathic drugs are already being tried to doctors in India, as well as other countries, used anti-
treat COVID-19 but even with promising results these retroviral drugs used in AIDS treatment; influenza
drugs always comes with some side-effects unlike in drug Oseltamivir was also used in select cases. In the
case of traditional system of medicines. US, the use of drug Remdesivir has been authorized
to be used for critically ill patients. However, all
How promising it can be?

Ayurveda has spoken of epidemics in great details.
Acharya Chakrapani has written on simultaneous and
widespread manifestation of disease with the same
set of symptoms throughout a community.

Talking about the promising role of Ayurveda
Dr Partap Chauhan, Director, Jiva Ayurveda said,
“The global Ayurveda community is working on a
war footing to develop treatment for COVID-19. The
Ayurvedic term for an epidemic is Janapadodhwansa
Roga and has been described to be caused by
Abhisyangaja, which means spread by pathogens
because of unhygienic conditions. Vitiation of Vayu
(air), Jala (water), Desh (geographic location) &
Kala (season) leads to mass-level infections. Acharya
Charak describes two causative factors of epidemic:
Niyata Hetu (inevitable factors caused by forces of
nature) and Aniyata Hetu (avoidable factors such
as pathogens, acts of terrorism, or war). Acharya
Sushruta has also written about the epidemiological
aspects of microorganisms. He describes the modes

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these lines of treatment have not been backed by curative treatment also. The high contagiousness,
any conclusive clinical trial so far. Coronavirus fast progression and associated complications of
has therefore exposed an area of concern for COVID-19 also underline the need for a rapid-action
pharmaceutical companies which is the low amount medication, and ayurvedic medicines have to be
of antivirals in the market especially when compared evaluated on this parameter also.”
to antibiotics. This void has understandably turned
people’s attention to traditional medicines.” Sharing his views on possible challenges & gaps,
Dr Muhammed Majeed, Founder and Chairman,
Health & AYUSH Ministries recently launched Sami-Sabinsa Group said, “Traditional medicine
inter-disciplinary studies involving AYUSH has been widely appreciated around the globe for its
interventions for COVID-19 situation. Ministry of safe, economical and holistic health improvement,
AYUSH in collaboration with the Council of Scientific however there are a few challenges that need to
& Industrial Research (CSIR) has started clinical be addressed for Indian traditional medicine to be
trials testing formulation of four important Ayurvedic accepted with complete faith.”
herbs in fighting the novel coronavirus which
includes Ashwagandha, Guduchi, Yasthimadhu, Some of the challenges faced include:
Peepli and another formulated drug, ‘AYUSH- 64’. Quality issues: Adulteration, misidentification
of plants, faulty collection & preparation and
Major Challenges incorrect formulation process are some of the major
problems which reduce the effectiveness of herbal
Although widely used for the prevention of various preparation and thus resulting in ineffectiveness or
types of infection, therapeutic use of traditional even adverse reactions.
system of medicine is still low due to lack of large- Harvesting and processing: Indiscriminate
scale clinical trials and studies to create scientifically- harvesting, poor agriculture practices and lack of
backed conclusive medicinal system. processing techniques lead to the substandard quality

Talking about the major challenges in this “Traditional medicine has
direction, Kamal Narayan, CEO, Integrated Health & been widely appreciated
Wellbeing (IHW) Council (A preventive, promotive around the globe for its safe,
health think tank) said, “The major challenge for economical and holistic health
ayurvedic medicines will be providing treatment improvement, however there
specifically for COVID-19, in which the virus is are a few challenges that need
reported to be changing its behaviour regularly. to be addressed for Indian
This may require wide-ranging research to explore traditional medicine to be
how ayurvedic medicines can help in preventing accepted with complete faith.”
infection and whether it can help in providing
- Dr Muhammed Majeed,
Founder & Chairman, Sami-Sabinsa Group, India

“It’s a tough journey because the
traditional medicine system that

is there for thousands of years,
has not be updated with time.
It’s been ages that new research

and development took place
in Ayurveda. It’s an alarming
sign for those who are in power
to take necessary steps in the
direction of reviving the heritage
of traditional medicine system
for the benefit of humanity”.

- Kamayani Naresh,
Founder & CEO, Zyropathy, India

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“There is currently no approved MINISTRY OF HEALTH &
treatment or vaccine for AYUSH LAUNCHES STUDIES
AGAINST COVID-19
COVID-19. Multiple lines of
treatment have been put Clinical research studies on Ayurveda
forward and even practiced interventions as prophylaxis and as an add-on to
standard care to COVID-19: Collaborative clinical
in different countries to studies as a joint initiative of Ministry of AYUSH,
treat seriously ill patients of Ministry of Health and Family Welfare (MoHFW)
COVID-19. Coronavirus has and the Ministry of Science & Technology through
therefore exposed an area of Council of Scientific & Industrial Research (CSIR)
concern for pharmaceutical with technical support of ICMR.
companies which is the low
amount of antivirals in the The Interdisciplinary Ayush R&D Task Force
headed by Dr Bhushan Patvardhan, Vice Chairman,
market especially when University Grant Commission (UGC), has formulated
compared to antibiotics. This and designed clinical research protocols for
void has understandably turned prophylactic studies and add-on interventions in
people’s attention to traditional COVID-19 positive cases through thorough review
and consultative process of experts of high repute
medicines.” from different organisations across the country
- Vikram Thaploo, for studying four different interventions viz.
Ashwagandha, Yashtimadhu, Guduchi +Pippali and
CEO, Apollo Tele Health, India a poly herbal formulation (AYUSH-64).

“We have treated over 200 a. Ashwagandha for the Prophylaxes against
COVID-19 positive cases, using SARS-COV-2 in subjects with increased risk during
the COVID 19 Pandemic: A comparison with
e-consultation in patients in Hydroxychloroquine in the health care providers and
the United States, the United
Kingdom, France, Singapore b. Effectiveness of Ayurveda Formulation as an
and different parts of the world. adjunct to ‘Standard of Care’ for the Treatment of
Mild to Moderate COVID-19: A Randomized, Open
We need better cohesion Label, Parallel Efficacy, Active Control, Multi-Centre
between conventional doctors Exploratory Drug Trial.

and homeopaths especially cases of a new illness like COVID-19 and a new virus
in serious cases which are not like the novel coronavirus or SARS-CoV2. We need
to use evidence-based principles and ensure that our
responding to conventional data is based on an adequate sample of participants.
treatment.” On the ground, it has been difficult for homeopaths
- Dr Kalyan Banerjee, to get access to patients who have tested positive
Dr Kalyan Banerjee’s Clinic, India for COVID-19, until recently. We, at Dr Kalyan
Banerjee’s Clinic, have of course been prescribing
of herbal drugs. prophylaxis medicines to more than 40,000 patients
Scientific research: Research on efficacy, in over 18 countries. We have also treated over 200
COVID-19 positive cases, using e-consultation in
dosage, processing and techniques are needed so that patients in the United States, the United Kingdom,
it can be properly validated in clinical trials. France, Singapore and different parts of the world.
We need better cohesion between conventional
Validation through controlled clinical doctors and homeopaths especially in serious cases
trials: Clinical trials are necessary to understand the which are not responding to conventional treatment.”
safety and efficacy of these drugs before introducing
them in the global market. Way Forward

Biopiracy: Biopiracy is a major hurdle in the Ministry of AYUSH has created an interdisciplinary
promotion of herbal traditional medicine. Moreover task force comprising of members from various
documentation of traditional knowledge about herbs
is important to be passed onto the future generations.

Dr Kalyan Banerjee of Dr Kalyan Banerjee’s
Clinic, Delhi said, “Objectively evaluating treatment
outcomes is the most important aspect of assessing
the impact of any treatment regimen especially in

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Population based interventional studies on “The major challenge for
impact of AYUSH based prophylactic interventions: ayurvedic medicines will be
The ministry of AYUSH is initiating population- providing treatment specifically
based studies to study the impact of Ayurvedic for COVID-19, in which the virus
Interventions in prevention of COVID-19 infection in is reported to be changing
high risk population. The core objectives comprise its behaviour regularly. This
of, assessment of preventive potential of AYUSH
interventions for COVID-19 and also to assess may require wide-ranging
the improvement in Quality of Life in high risk research to explore how
population. The study will be carried out through
four Research Councils under Ministry of AYUSH ayurvedic medicines can help
and National Institutes in 25 states across the in preventing infection and
country and several State Governments covering
approximately 5 lakh population. The outcome of whether it can help in providing
the study would certainly pave a new horizon in curative treatment also.”
understanding the preventive potential of AYUSH - Kamal Narayan,
interventions during pandemics like COVID-19 CEO, Integrated Health &
through scientific evidence. Wellbeing (IHW) Council, India

Elaborating on the importance of these studies, “The global Ayurveda
Dr Harsh Vardhan, Union Health & Family Welfare community is working on a war
Minister stated that these studies shall re-establish
the importance of AYUSH pathies with the help of footing to develop treatment
rigour of CSIR, ICMR and DCGI. “The technology for COVID-19. Ayurveda has
alliance provides valuable opportunity for such
knowledge based solutions to continue to benefit spoken of very potent immuno-
us even after the COVID-19 pandemic has passed, modulators. Ashwagandha,
by possible integration of AYUSH in the mainstream Peepli, Giloy and Amla are
scientific efforts”, he added. Let us also understand
that the modern pathies of medicine and science some of the common ones that
are not in competition with those of AYUSH, but are often recommended by
they complement and strengthen each other in
intrinsic ways, Dr Harsh Vardhan stated. Ayurveda doctors. In addition
to that, AYUSH ministry has
research agencies, working on addressing the issues also issued several immunity
the traditional medicines faces today. Traditional enhancing guidelines such
medicines can be the game changer and will emerge as drinking lukewarm water,
as a future of medicine in India only if there is consuming concoction of
enough support from the government in terms of Tulsi and Haldi in water, and
proper funding for R&D and other factors.
applying Anu Oil in the nostrils.”
Talking about the way forward and importance of - Dr Partap Chauhan,
investing in R&D, Kamayani Naresh, Founder & CEO,
Zyropathy said, “If I go by the rules of ICMR, we Director, Jiva Ayurveda, India
should treat all medicine systems equally. But at the
same time, we also need to understand the purpose From hypertension, diabetics, cancer, lung disorders,
of the system for which it has been introduced. Many to kidney failures all can be cured from its root,
of us don’t know that Allopathy was introduced for it’s just we need to go back invest in research and
symptom control only and not for curing ailments, development of new herbal combinations keeping the
but today, people take it as an ultimate remedy nature of disease in mind and see the difference.”
thinking it will provide cure to the disease or ailment
from the root. This gap of understanding has “It’s a tough journey because the traditional
hampered the system a lot. We need to understand medicine system that is there for thousands of years,
that when it comes to curing an ailment from its has not be updated with time. It’s been ages that new
root, only Ayurvedic Herbs has the ability to do so. research and development took place in Ayurveda.
It’s an alarming sign for those who are in power to
take necessary steps in the direction of reviving the
heritage of traditional medicine system for the benefit
of humanity”, he concluded.

Kalyani Sharma
[email protected]

34 COVID -19

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IF WISHES
WERE

VACCINES…

The long road till commercial availability compelling
sustained funding at unprecedented levels.
Combined with the $ 2 billion outlay expected from
GAVI / CEPI and various government institutions
and alliances across the globe, the total economic
interest invested in this research would be at a
never-before-seen or imagined level.

One of the most obvious positive fallout of this 100 vaccine candidates currently at various stages of
COVID-19 pandemic has been the tremendous research. Moderna of USA is leading the pack with
increase in focus on, and funding for, Sanofi and Pfizer not far behind. As many as 5 vaccines
vaccines. When COVID-19 first broke out in China are in advanced trials in China. The most interesting
in December 2019, the number of influenza vaccines economic feature of this global feverish enthusiasm
under research and discovery were about 15. At that has been that quite a lot of funding for this vaccine
level, this was still higher by several times compared research has emanated from private sources as well.
to two decades ago. Combined with the $ 2 billion outlay expected from
GAVI / CEPI and various government institutions and
Vaccines have traditionally always lagged behind alliances across the globe, the total economic interest
drug discovery as a favoured area of research for the invested in this research would be at a never-before-
pharma and biotech sector as a whole. The reasons seen or imagined level.
are many, starting from the time and investment
needed for the research and discovery. Before the All premier companies of the pharma world
COVID-19 pandemic and current feverish pace are competing with not only each other but also
of the race to find the vaccine against it, the 2015 prominent universities and research organisations
ZIKA vaccine held the record for the shortest time to win the race with an effective vaccine against
taken from initiation to completion of trials – seven the dreaded Novel Coronavirus. As of now, either
months. Add to this the cumbersome process of Moderna or Sanofi (France) look all set to pip
production which would take years to produce everyone at the post with their vaccine, and already
sufficient doses for the affected populations: the ZIKA in discussions with countries for distribution of
pandemic had already fizzled out before large scale the future production. Serum Institute of India has
commercial production could be achieved. collaborated with the Oxford University to start
producing their vaccine candidate soon after the
This leads to the most critical economic aspect success of animal trials, to achieve production of
of the process - the uncertainty surrounding the sufficient quantity of the vaccine in the shortest of
final take-up of the vaccine by populations. It time upon final approval.
is not surprising therefore that the funding for
them has grown primarily through sources from With this much amount of money floating about
government institutions like BARDA and charity around vaccines, controversy cannot be far behind
outfits like the Bill and Melinda Gates Foundation, either. There are virologists and medical doctors
via the critical role executed by organisations like crying foul over whether the current focus on
Coalition for Epidemic Preparedness Innovations vaccines is a result of a force majeure event or the
(CEPI) and GAVI (Global Alliance for Vaccines and
Immunisation), the vaccine alliance.

The growth in the interest of the vaccine research
explodedas the COVID-19 pandemic spread, with over

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source of the same. There is no evidence whatsoever holding any relation or promise for helping recovery
however, to back up such conjectures. Further, process if not cure. All universities and research
the shape-shifting nature of this new monster laboratories are after the same, trying to find a cure
called Novel Coronavirus has gone beyond any sort quickly. However, if one looks at ‘investor interest’
of human capacity to control it, posing the core and funding patterns, a different picture emerges.
problem in arriving at the cure and the vaccine both. Compared to the funds in hot pursuit of the vaccine,
Fortunately, the thinking about shortening vaccine the investor interest in finding an adequate cure for
discovery process via RNA-based technologies and COVID-19 can be described as warm at best.
‘plug and play’ platforms developed which will work
for any, or a wide number of viruses, started way back After 325,000 deaths (and counting), and millions
in 2017 itself. Encouraged by National Institute of of people already infected, the pandemic is nowhere
Allergy and Infectious Diseases (NIAID), one of the near tapering out. World Health Organisation
27 institutes and centers that make up the National (WHO) is now issuing warnings that it may be years
Institutes of Health (NIH), an agency of the United before we are rid of the threat from this particular
States Department of Health and Human Services, virus. Coming months are going to be tough, with
Moderna was one of the laboratories doing valuable second wave already apparent in Asia. While this is
research, leading to bringing out their vaccine a terrible vision for the wellness of the mankind as a
solution to the stage of human trials in a record whole, it may still be a contributing factor to sustain
time. In May, Moderna struck a 10-year strategic the funding interest in COVID-19 vaccine to the
collaboration with Lonza Group that over time ultimate goal of global availability of the same. As
will allow the company to make up to 1 billion 50 much as 70 per cent of the cost of vaccines comprise
mcg doses by the end of 2021. In an online summit of the research and development costs, remaining
organised by the EU attended by over 40 countries 30 per cent being the production and distribution
and donors, more than $8 billion has been pledged to costs. Many vaccines are therefore developed
help develop a coronavirus vaccine and fund research and kept mainly in the form of a reserve vaccine
into the diagnosis and treatment of the disease. stockpile for future outbreaks if any rather than
going into commercial production cycle. A raging
The researchers’ interest in finding a cure for pandemic that is showing no signs of waning any
COVID-19 is equally high, as that in finding a vaccine. time soon, is perhaps the only perfect time to ensure
Most pharma industry players – whether small or big compliance by the world’s population to take up the
- are tweaking their knowledge and experimenting immunisations in a very large scale, which answer the
with quick repurposing of their proprietary drugs commercial compulsions of the vaccine production.
Astra Zeneca has been handed $ 1 billion-plus by
Biomedical Advanced Research and Development
Authority (BARDA),a U.S. Department of Health
and Human Services (HHS) office responsible for the
procurement and development of countermeasures,
to race through phase III and ramp up deliveries of
the pandemic vaccine well before fall.

The cure will not lag far behind in the race,
though. The current efforts by approving authorities
like US Food and Drug Administration (FDA) to
fast-track approvals will go a long way in relieving the
time and pain in the process of finding the much-
needed cure for COVID-19. Glenmark’s Ramdesivir
was approved by USFDA in record time and has been
accepted as a standard of practice for encouraging
faster recovery of COVID patients.

Let us hope that the spirit of urgency will expedite
the process as all stops are pulled out, and we find the
cure for COVID-19 at the earliest as also achieving
a successful vaccine for preventing further waves of
infections.

Manasee Kurlekar
[email protected]

36 COVID -19

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A digital bounce back post COVID-19

« documentation and filing. An example includes
developing safety and efficacy related documentation
Sujeet Sudhir, for European Medical Device Regulation (MDR) 2017
Director, Business using XML. Another example is in adhering to new
Development, Cyient, labeling requirements released by the FDA and NIH.
India Utilizing cloud automation, one can release labeling
updates across geographies reaping cost benefits and
MedTech industry is at the epicentre of the COVID-19 time-savings. Besides, combining industry-specific
crisis. Supplying everything, from protective masks, domain experience with digital and analytics expertise
gowns, gloves to diagnostics kits to ventilators, the machine data for enhanced equipment utilization
industry is essentially a lifeline during these troubled and predictive asset maintenance. Predictive asset
times. Since this is a novel virus, the epidemiology of maintenance solutions can significantly improve
the disease wasn’t clearly understood. Therefore, clear equipment uptime and reduce warranty costs.
diagnostic and care pathways could not be carved
out. And yet, within a record time of just two to three Digitizing Operations
months, medtech firms have come up with game-
changing innovations to address the unmet clinical Digitizing operations, including supply chain and
needs of the market. manufacturing through deploying IoT will ease out the
burden of medtech firms post COVID-19. Digital supply
As the medical device companies are pressure chains are known to optimize inventory management,
tested to deliver in these trying times, they logistics, and distribution by utilizing sensor-based
face herculean challenges, including disrupted connected ecosystems. Also, additive manufacturing
supply chains, increasing operational costs, adjusting or 3D printing can help in rapid prototyping to quickly
to new demand for elective surgeries post COVID-19, validate designs, thereby contracting product life
improving R&D productivity, launching market-ready cycles as well as ensuring design for manufacturability.
products quickly and reconfiguring manufacturing.
For medtech companies, another breakthrough in
Digital technologies such as artificial intelligence, operations will come about by the quick adoption of the
machine learning, Internet of Medical Things game-changing theme of Industry 4.0. Industry 4.0 is
(IoMT), Industry 4.0, cloud, mobile, additive a culmination of IoMT, artificial intelligence, machine
manufacturing have shown a lot of promise to help learning, smart devices, and robotics all applied to
medtech companies overcome the current challenges. drastically improve manufacturing productivity,
Unfortunately, scaling these technologies across regulatory compliance, and quality adherence.
ecosystems and geographies has been a significant
roadblock. This includes delays in clinical trials and Product and Service Innovation
lengthy procedures to market access. Given the new
realities, adopting these technologies is no longer an Healthcare systems have traditionally been a pay-
option. The organizations that will quickly rebound for-service model rather than a pay-for-outcomes
post COVID-19 will be the ones that will leverage model. COVID-19 has highlighted how important
digital as a core to their operations. and urgent is the need for outcomes-based and
value-based healthcare. Medtech companies can
Process Automation support this transition by developing products and
services that lead to better outcomes, lower costs, and
Automation is a proven method to reduce errors, save decrease the burden of diseases. This can be achieved
costs, and improve time-to-market. In MedTech space, through platform-based technologies that cover the
technologies such as cognitive automation and process overall care continuum rather than addressing just
automation have been leveraged for creating regulatory a part of it. One example is how managing diabetes
has evolved by tightly integrating on screening,
diagnostics, prognosis, treatment, and follow-up. As
companies emerge out of the crisis, the focus will be
on sustaining the business and eventually growing it
to the pre-COVID-19 era. Organizations that adopt
digital technologies and efficiently scale them will
successfully accelerate the transition.

SPEAKING WITH 37

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“Merck is currently supplying key products

and services to over 45 COVID-19 vaccine

programmes around the world”
Asia Pacific Life Science business of
Merck develops improved and enhanced «
technologies from biopharmaceutical
therapies to cutting-edge systems for scientific Benoit Opsomer,
research and production. Responding to Vice President & Head
COVID-19 outbreak, Merck’s BioProcessing of Bio Processing,
unit is engaged in consolidating and supplying Asia Pacific, Merck
raw materials along with characterization and Pte. Ltd, Singapore
detection of vaccine research products. Merck
actively evaluates and leverages business With the global population exceeding 7.5
continuity plans for COVID-19 vaccines and billion, vaccine developers require unprecedented
therapies development. Merck’s SARS-CoV-2 capabilities for large-scale production of any
detection, characterization, vaccine and therapy approved therapies to meet the demand.
production capabilities are leveraged at the
Jenner Institute for the development of Oxford While we don’t produce vaccines ourselves,
vaccine. Prioritizing on crucial timeline Merck’s Merck has over four decades of experience in
advanced upstream and downstream portfolios supporting customers in vaccine development and
target faster yield and productivity to support and manufacturing, which is being leveraged during
expedite the need of an hour. BioSpectrum Asia this critical time. Our biggest value add is our
spoke with Benoit Opsomer, Vice President & experience, not just in terms of routine business
Head of Bio Processing, Asia Pacific, Life Science operations, but as a reliable and agile technology
business atMerckto explore the company’s partner.
commitment towards researchers, developers and
manufacturers to combat COVID-19 pandemic. Can you elaborate on the significant role
Edited excerpts; Merck is playing at the Jenner Institute and
the wider vaccine development ecosystem?
How do you describe the crucial steps In partnership with the Jenner Institute, we have
and measures in COVID-19 vaccine laid the foundation for large-scale production
development? of the institute’s COVID-19 vaccine candidate:
A major factor that contributed to the acceleration ChAdOx1 nCoV-19. We are supporting the
of vaccine development for the SARS-CoV-2 institute’s development process by scaling up
virus (COVID-19) has been the early and speedy downstream unit operations, preparing for mass
identification of the novel coronavirus’ genome production efforts, as well as enabling the seamless
sequencing, which contributed to an array of technology transfer to the Institute’s contract
vaccination and treatment development efforts manufacturing organizations.
around the world.
Prior to the pandemic, our partnership with
Diagnostic tests play a critical role in the global the Jenner Institute had been going strong for the
effort to contain and fight the virus. These tests past two years. Our deep understanding of the
help physicians determine the presence or absence organisation’s process and development chains
of a disease in patients, and their findings are allowed us to reduce the process development
crucial to making treatment decisions. The spread timeline to just two months – down from the
of COVID-19 has demonstrated the importance usual timeline of six to 12 months. By speeding
of diagnostics and will have a lasting impact up the large-scale manufacturing process, we
on a national and global level, reshaping how ensured that Jenner Institute would be in the best
governments and healthcare players deal with possible position to quickly and safely roll out their
future pandemics.

38 SPEAKING WITH

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

vaccines to patients, once approved. development effort?
The role we play is by finding cost-effective Due to the complexity and diversity of vaccine
modalities, there is no single standard
ways to accelerate the vaccine development and manufacturing template or process which makes
manufacturing process and supply chain. We production a challenge for every organization
also support emerging economies by sharing racing to develop a safe and effective COVID-19
our expertise, helping to streamline their vaccine. The close collaboration of the global
manufacturing processes, driven by our mission to scientific community, regardless of region or
help the life science community solve the toughest nationality is more important than ever to
problems and make healthcare accessible to all. accelerate the discovery of a vaccine or treatment.

Merck is currently supplying key products What role Merck playing from virus detection
and services to more than 45 COVID-19 vaccine and characterisation, to vaccine and therapy
programmes around the world. In light of social production?
distancing measures and travel restrictions, The products and services we offer to
we provide both on-site and remote services, customers supporting the global COVID-19
including consulting on regulatory and Good effort include:
Manufacturing Process guidelines to validate the
robustness of critical unit operations for these ● More than 25 testing solutions (including
organisations. RT-PCR and serological diagnostics for both high-
throughput centralized and distributed point-of-
What are the operational challenges faced by care settings) including eight of the top 10 In-Vitro
governments and pharmaceutical firms along Diagnostic (IVD) market leaders
this journey?
There are three main challenges to consider ● Bioprocessing manufacturing platforms
namely (1) safety, (2) scaling-up and (3) supply. for more than 45 different vaccine candidates,
including DNA, inactivated virus, viral vector,
As scientists race to develop a life-saving protein subunit and Messenger RNA (mRNA)
vaccine in record time, safety remains the foremost vaccines
priority. Due to the highly unusual circumstances
surrounding this pandemic, there has been strong ● More than 20 monoclonal antibodies, plasma
pressure to expedite the development process and products and antivirals
scale-up production within a short period of time.
However, vaccines are used on healthy individuals We are working around the clock to
and therefore it is incredibly important that the ensure critical products and services, such as
purity, efficacy and yield of the vaccine process are biomanufacturing platforms and biosafety testing
not compromised by tight timelines. services are readily available to accelerate mass
manufacturing at the scale required to control this
Scaling-up is another crucial factor in pandemic.
expediting the response. Many pharmaceutical
firms have been trying to quickly bring commercial What is the advice / suggestions / offerings
scale manufacturing capabilities online. Currently, Merck can extend to pharmaceutical and
production capability as well as the capacity to fill clinical units in similar ventures
and supply vaccines are concentrated in developed
nations with emerging regions having insufficient Our unique position in the pharmaceutical
on-ground production capacity. ecosystem is like the engine that powers the global
response to the health crisis. Through our strong
As local and regional governments across the partnerships with the global scientific community
world implement social distancing and travel we are helping bring to life the treatments and
restrictions to reduce the spread of the virus, therapies plaguing our healthcare system today.
supply chains are ultimately affected hindering
the speed of production. To address this, Merck With our extensive experience and global
has been working closely with local officials network of technical experts, we stand ready to
and raw material suppliers to ensure that the help researchers and pharmaceutical firms in their
essential services our customers provide are not efforts to accelerate the vaccine and treatment
compromised. process, from optimising the research, testing,
process development to scaling the production of
What are some of the best practices in vaccines and treatments.
effective coordination of the global vaccine
Hithaishi C Bhaskar
[email protected]

SPEAKING WITH 39

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

“COVID-19 crisis has brought together

the scientific community like never before”

The UK headquartered Cytiva is a $3.3 billion «
global life sciences leader with nearly 7000
associates operating in 40 countries dedicated Francis Van Parys,
to advancing and accelerating therapeutics. As a Vice-President
trusted partner to customers that range in scale Commercial, Asia-
and scope, Cytiva brings speed, efficiency and Pacific, Cytiva
capacity to research and manufacturing workflows, (Formerly GE Life
enabling the development, manufacture and Sciences), Seoul,
delivery of transformative medicines to patients. South Korea
Cytiva announced the collaboration with Takara
Bio to develop DNA vaccine to confront the virus How do you plan to enhance your growth within
in Japan, on May 21. BioSpectrum Asia spoke to the APAC region?
Francis Van Parys, Vice-President Commercial, Asia’s Economies are seeing rapid growth in past
Asia-Pacific, Cytiva (Formerly GE Life Sciences), decades meanwhile it suffers for the increases in
Seoul, South Korea, who is responsible for providing cardiac disease, cancer and diabetes are subsequently
transformational technologies in biopharmaceutical anticipated, driven by increased life expectancy
research, manufacturing and diagnostics to Cytiva and lifestyle changes. Biotherapeutics are, and will
customers and partners in the life sciences industry remain, in the forefront of curing many of these
in China, India, Japan, Korea, ASEAN and Australia diseases and improving the quality of lives across
& New Zealand, for his major plans in store and his Asia. Cytiva is well positioned to support the growth
plans to enhance growth within the APAC region for in protein-based therapeutics and future treatments,
the company. Edited excerpts; such as cell and gene therapies. Additionally, as the
global healthcare system rapidly moves toward more
What are the major plans in store for Cytiva? personalized medicine, Cytiva will work with our
Any new segments to be explored? customers to ensure we are developing the right tools
Cytiva offers the same high-quality services as we did and technologies to ensure efficient manufacturing of
when we were part of GE Healthcare Life Sciences. novel therapeutics.
It shouldn’t be overlooked that we are already a life
sciences global leader and we expect our significant How is Cytiva contributing to this fight against
growth of recent years to continue. We have been COVID-19?
at the forefront of innovation and development The COVID-19 crisis has brought together the
of areas such as protein purification, single-use scientific community like never before. Our global
technology and cell and gene therapies. Cytiva will team is helping to accelerate the work of researchers,
benefit from being a newly-created organization developers, and manufacturers of diagnostics and
that is already a global life sciences leader. We have vaccines, to bring access to much-needed solutions
market leading brands such as ÄKTA, Amersham, for COVID-19. In Asia, we just announced the
HyClone and Whatman, among others. We also have collaboration with Takara Bio to develop DNA
more than 100,000 systems in use globally. We will vaccine to confront the virus in Japan, on May 21.
continue innovating from within and working with Genedrive: PCR assay to detect SARS-CoV-2; Sona
our customers to develop next generation solutions. Nanotech: rapid response lateral flow test; Avacta:
One area where we want to and must do better is Affimer-based point-of-care rapid screening test and
sustainability. This is a challenge and opportunity University of Queensland: vaccine
for any organization operating today and one that
Cytiva takes very seriously. We don’t want to be just What will be the impact of this pandemic on the
compliant in sustainability terms, we want to lead global economy? How is Cytiva preparing itself?
the industry. We will be focusing on areas such as Cytiva’s number one priority is the health and
GHG emission, use of plastics, packaging, water safety of our employees and our customers. We
management and societal impact among other areas.

40 SPEAKING WITH

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

are working closely with «
local governments, and
world health authorities to Roberto Polakiewcz,
actively monitor the outbreak Chief Scientific
and take all necessary Officer, Cell Signaling
precautions. We are prepared Technology, Danvers,
to walk alongside our United States
customers to help ensure
continuity of business, “CST is committed
stay connected virtually to developing new
for support, and provide rigorously validated
solutions in this time of need. antibodies and
protein tools”
The pandemic should
not derail us from our key The United States based Cell Signaling Technology (CST) is a
mission, which is to support global, private, family-owned company founded by scientists in
the world’s development of 1999. CST supplies the highest quality antibodies and reagents
new technologies and the to enable researchers to discover the mechanisms of disease. It didn’t
manufacturing of existing believe in compromising science for profits. That’s why it produces
drugs, which are so much and validate its products in-house. BioSpectrum Asia spoke to Roberto
important to the diabetes Polakiewcz, Chief Scientific Officer, Cell Signaling Technology (CST),
patient, or the cancer patient, Danvers, United States, who drives research, product, and technology
or the young child that needs innovation, facilitating the creation of CST’s most valuable products,
a vaccine. To achieve this technologies, and intellectual property on the company’s contributions
mission, you have to shuffle, in tacking COVID-19 and plans for expansion in Asian region?
because suddenly you have to Edited excerpts;
prioritize particular initiatives
that you didn’t have in mind How is CST contributing towards tackling the COVID-19
at all two months ago. We pandemic?
have a task force with special Cell Signaling Technology (CST) has and is rapidly expanding a
focus on the COVID-19 portfolio of research use antibodies, proteins, and tools to build assays
coronavirus, like we did when that can be used for creating viral and serological tests and studying
Ebola and SARS were global mechanisms of SARS-CoV-2 infection and host-immune response.
pandemics. This allows us to These products enable researchers around the globe to understand
rapidly respond to the needs the biology and pathology of the virus, so their efforts to develop
of our customers. reliable serological tests, therapeutic treatments, and vaccines can
move forward quickly. There has been an incredibly rapid effort to
Cytiva has comprehensive build tests to help fight the COVID-19 pandemic. Unfortunately, as we
crisis management and read in the news, speed often comes at the expense of quality. Global
security of supply programs research efforts have to move fast, but the scientific and medical
in place. We are committed community can’t afford to waste time on assays and experiments that
to fulfilling customer orders
and regularly adjust our
manufacturing output to
respond to market demands,
while ensuring our operations
and service capabilities
continue safely. We are also
in regular contact with our
suppliers regarding their
business continuity plans to
help minimize disruption of
the flow of materials into our
manufacturing facilities.

Ankit Kankar
[email protected]

SPEAKING WITH 41

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used poorly validated reagents, or worse yet come How was the FY19 for CST? How is CST
to an erroneous conclusion. So, CST is committed planning to enhance its growth in the coming
to developing new rigorously validated antibodies years?
and protein tools to important targets of COVID-19 CST has been fortunate to experience double-digit
pathology and immunology. Validation is always growth globally for several years. We continue to
important, but it is especially crucial now to ensure invest in innovation to develop new products and
that reagents are accurate and reliable. At CST, we services that researchers need to propel scientific
are stepping forward in solidarity with the scientific discoveries forward. Novel, relevant, and reliable
community to fight this disease the best way we research tools and reagents are needed now more
know how, based on quality and scientific rigor. than ever, and we will continue to provide them for
our fellow scientists.
What will be the impact of this pandemic on
the bioservices sector? Is CST planning to establish more presence in
As is the case for many companies right now, India?
priorities are and will continue to shift as businesses CST welcomes the opportunity to support the work
adjust to the needs of clients and adapt to potential of scientists in India by providing relevant and
limitations that arise during the pandemic. Details trustworthy products, resources, and exceptional
are evolving as we speak, but it’s possible that there support as researchers there continue to drive
may be an increase in demand for Asian CRO services novel research. India is an important scientific and
from multinational biopharma clients as they look cultural contributor of global research, in both the
to move their discovery work forward while labs in academic and industrial sectors. We look forward to
the United States and Europe are closed. Currently, growing our relationship with key opinion leaders
it is unclear if this trend will be temporary or more in both of these areas to further understand specific
long-term. needs of new research areas and technologies in
India. Additionally, we are continuing to improve
How is CST planning to overcome this impact processes across our distribution channels.
of COVID-19? Especially now, during this global health crisis, CST
CST is well-prepared to continue to support is ready to provide essential high-quality validated
researchers by providing services, reagents, and antibodies, products, and services to support
antibodies for key targets, not only for areas of important immunology, viral, and vaccine-related
COVID-19 pathology, but also for many other research in India.
important diseases. We look forward to supporting
researchers in many different disease areas as labs Ankit Kankar
reopen to continue ongoing research and begin to [email protected]
ramp up for more.

Some of our pharma and biopharma customers
have expressed concerns about the continuity and
supply of critical reagents. We understand how
disruptive it can be to a project if a key component
becomes unavailable. Since we manufacture more
than 95 per cent of our products in-house, we
have been able to continue operating and shipping
throughout this difficult period.

While we work towards developing new high-
quality products for our fellow researchers, we are
also keenly aware that the health and safety of our
employees and colleagues are our top priority. We
have already implemented multiple measures to keep
our employees and business partners safe, while
minimizing any disruption to our customers. We
are monitoring the situation closely and following
the guidance of the Centers for Disease Control and
Prevention (CDC) and governmental authorities
around the world.

42 SPEAKING WITH

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

“We can make 13M doses per week
without expanding our current capacity”

« pandemic, we have developed a series of new
rules and actions that is targeted at protecting our
Max Rossetto, colleagues’ health, decreasing the chances of viral
General Manager transmission within the workplace and ensure
- Business business continuity during these challenging times.
Development, We follow the Queensland Government official
Luina Bio, Australia guidelines. Furthermore, we monitor our colleagues’
temperatures, limit the amount of people in each
Luina Bio is a Brisbane, Australia based, drug room to a minimum, observe social distancing, ensure
development and contract manufacturing hygiene is kept at a very high level, have substituted
organization (CMO) serving the pharmaceutical, most meetings with teleconference and have
biotechnology and veterinary industries. Utilising implemented a work from home policy where feasible.
its TGA/APVMA licensed facilities operating to
international cGMP standards, it can provide What could be the impact of this pandemic on
comprehensive manufacturing solutions for both the industry?
biological and small molecule drugs. BioSpectrum Asia We work in the biopharmaceutical contract
spoke to Max Rossetto, General Manager - Business development and manufacturing organization
Development, Luina Bio, Australia on different issues (CDMO) industry. We have started to see a short
including strategies that are in place/ being planned to term rise in business due to the large influx of
tackle the COVID-19 outbreak and what needs to be done funding available to combat the pandemic. This will
to make Australia COVID-19 free? Edited excerpts; be concentrated in vaccines and testing, with some
investment in cures. Long term, I think this will show
the advantages of having a fast responding vaccine
development capability and platform, such as the one
we are supporting at Griffiths University. Funding will
be directed to these technologies.

How is Luina Bio contributing toward tackling How to make Australia COVID-19 free?
the COVID-19 pandemic? Personally, I am not a virologist nor an epidemiologist.
Luina Bio brings its wealth of contract manufacture However, I feel that at the moment the Australian
capabilities and experience to the table, an invaluable States and Federal Governments are reasonably
component in advancing a potential COVID-19 vaccine successful in limiting the outbreaks of COVID-19
candidate. Luina Bio is involved in several ways: We in the population. A vaccine seems to be the most
are currently manufacturing a potential comedication effective way of limiting the reach of the virus.
for patients affected by the infection for preclinical
trials. We are supporting the early development of How can Australia be more prepared for a similar
a vaccine based on technology developed by Griffith outbreak in the future?
University in Brisbane. This vaccine should enter I think there is a lot of learnings and work will come out
preclinical trials later this year and has the potential of of this from Government and Science and Technology
being less expensive than other vaccines and relatively specialists to review learnings (what went well and
easy to produce as it is a bacterially expressed what can be done better) and revise action plans for
vaccine. We are supporting three different new tests any future pandemics. With regards to this specific
for COVID-19. These tests will be extremely fast and case, Luina Bio would hope the Griffiths vaccine is
reliable and would also have the advantage of having a success as we can make 13 million doses per week
a faster and more cost-effective manufacturing. This without expanding our current capacity. However, our
would allow poorer nations to be able to afford them. limitation is we don’t think Australia has the resources
to formulate and fill finish these quantities.
What strategies are in place to tackle COVID-19?
Following the recent developments of the COVID-19 Ankit Kankar
[email protected]

COVID-19 43

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

Face-lifting biopharma industry image

Emerging markets are gaining more importance «
than ever, led by China, considering the scales of
volumes they offer. With time and cost of development Dr Neel Fofaria,
significantly reduced, the pharma companies can Partner, MP Advisors,
launch the products at affordable prices. India

According to a market research expert, most with companion diagnostics to select the patients. A
people do not have any real opinion on the tailor-made phase I study in pre-selected patients will
biopharma industry, for them it just exists; and establish the safety and a further continuation of the
the ones who have an opinion, it is not a positive one. same set of patients for a phase II study will establish
This is counter-intuitive, especially for an industry the efficacy at an acceptable level. Therefore, it is now
that works on the premise of saving lives and impacts possible to approve the drugs based on phase II, while
each and every individual several times throughout combining phase III and phase IV post approval. Of
their lifetime.One reason for the negative opinion course, not all the drugs will qualify, but a robust
is the growing distrust due to high costs of available framework will enable the selection.
therapies and lack of transparency in the market place
and the overall healthcare system, contributed by cost Combining this approach with IT platforms
intensive new drug development and conservative to ensure the recall of every packet within 48-72
regulatory guidelines. hours will ensure further risk mitigation in case of
any unexpected adverse events. This will lead to a
With all negative impacts, COVID-19 pandemic significant reduction in the overall time and cost
gives an opportunity for the biopharma industry to taken to put a drug to the market. The patients will
transform its image. It is the only industry that can ultimately benefit from more number of available
deliver a solution and the timing of the pandemic is and customized therapies, that too with affordable
propitious as the science has substantially matured and cost. Data sharing between the pharma companies
put into practice. The scale of such a united response and the regulatory agencies will not only reduce the
from biopharma against COVID-19 is something that failure rates at an early stage, but also the burden of
has never been witnessed in history. clinical development, of course, within the boundaries
of protecting the IP.
At least 240 new or repurposed drugs are under
various stages of development, involving more than Every patient can access and afford the therapies.
50 companies across the US, EU, China, Japan and Emerging markets are gaining more importance than
India. Biopharma has demonstrated a collaborative ever, led by China, considering the scales of volumes
approach with ~90 deals announced between January they offer. With time and cost of development
and April 2020 for COVID-19 therapies, involving significantly reduced, the pharma companies can
~120 groups across a dozen countries, the highest launch the products at affordable prices. Active
one has ever seen in a single quarter. The deals aim collaborations with government and public health
towards expediting the drug development, leveraging organizations will maximize the market penetration.
key expertise of various partners from pre-clinical Moreover, data sharing at a public health level will
discovery, to clinical development to manufacturing. be the ultimate testimony to the drug’s efficacy and
will increase its overall acceptance. Such a pioneering
At the end of this pandemic, biopharma will initiative from a set of key stakeholders in one part of
emerge as one of the most important industries the world will ultimately have a ripple-effect on the
critical to the sustenance of mankind. An intelligent global biopharma landscape. With the patient at the
consortium of key stakeholders, the government, centre of the ecosystem, biopharma will be known as
regulators, biopharma and healthcare, combined the industry that does the right thing and the society
with IT tools has the potential to transform the future will embrace it with open hands.
drug developments, of course, with a patient-centric
approach.

Regulators can justify accelerated new product
development cycles. Advances in science have enabled
next generation therapies to target a specific gene
or a mutation, with minimal off-target effects along

44 PEOPLE NEWS

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

Dr Gurjot Kaur receives
Microsoft grant for
COVID-19 research

A team of scientists led by Dr Gurjot Kaur, Associate

CANbridge Professor, School of Pharmaceutical Sciences,
appoints acting CSO
Shoolini University, Himachal Pradesh has been
China based CANbridge Pharmaceuticals Inc.,
a biopharmaceutical company developing offered a grant through Microsoft to conduct research
innovative drug candidates to treat underserved
medical conditions in China and other markets, on finding drugs to cure and prevent COVID-19.
has appointed Richard J. Gregory, PhD to the
position of Acting Chief Scientific Officer (CSO). This project will directly influence the anti-viral
Dr Gregory has a long and distinguished career
in research and discovery and pharmaceutical drug development.
industry leadership. Most recently, he was
Executive VP and Chief Scientific Officer at The team will
ImmunoGen Inc., where he was responsible for
research leading to new antibody-based cancer perform much-
therapeutics. Prior to joining ImmunoGen, Dr
Gregory was Head of the Sanofi-Genzyme R&D needed screening
Center, in Cambridge, where he oversaw R&D
in rare diseases, multiple sclerosis, immune of phytochemical
disorders and tissue protection/regenerative
medicine. He started his professional career at constituents for
Genzyme Corporation as a Research Scientist in
Molecular Biology, where his group was the first anti-viral activity
to express the cystic fibrosis transmembrane
conductance regulator (CFTR) and determine through interaction
the molecular defect caused by the most common
mutation of CFTR. with COVID-19

specific targets using

molecular modeling

studies. Dr Gurjot has

worked as a Post-Doctoral fellow from University of

Konstanz, Germany and has a PhD in Pharmaceutical

Sciences from University of Innsbruck, Austria

and a M.S. Pharm in Biotechnology from NIPER,

S.A.S Nagar. Her current research interests include

delineating molecular mechanism important for

air pollution in Indian population and improving

toxicity profiling of indigenous Himalayan plants

used as traditional medicine. She is actively involved

in in leadership roles in Society of Toxicology and

loves to blog about science.

Tessa Therapeutics announces new executive leadership

Singapore based Tessa joined Tessa as an independent john. Dr Ando joined Tessa as an
independent Board director in
Therapeutics, a clinical-stage cell Board director in March 2019. April 2018, bringing over 35 years
of experience as one of the most
therapy company developing next- He has led a distinguished experienced and respected leaders
in the global pharmaceutical
generation cancer treatments, career in the biopharmaceutical industry. Dr Ando currently serves
as the Chairman of the Board for
has announced that Jeffrey H. industry, spanning over 30 years. Eyepoint Pharma and has been a
Senior Adviser to leading specialist
Buchalter will assume the role He previously served in various healthcare investment group,
Essex Woodlands, since 2007. He
of Chief Executive Officer, and chairmanships and as Chief is also the retired Chairman of the
Board of Global Pharmaceutical
Dr Göran A. Ando will become Executive Officer of both private & Company, Novo Nordisk A/S.

Chairman of the Board, with publicly listed companies, including

immediate effect. Current Archimedes Pharmaceuticals,

Chairman of the Board Teo Ming Enzon Pharmaceuticals, and

Kian has stepped down with effect Ilex Oncology, Inc. Prior to

from May 1, 2020 and Co-Founder, that, he served as Group VP/

Andrew Khoo will remain as a Head of Worldwide Oncology

member of the Board. Buchalter Franchise at Pharmacia & Up

PEOPLE NEWS 45

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

Prof Diana Sarfati takes charge Dr Harsh
at Cancer Control Agency
Vardhan steps
The Deputy State Services Commissioner has announced the
appointment of Professor Diana Sarfati as Chief Executive, Cancer in as WHO
Control Agency. She is responsible for leading, prioritising, and
coordinating cancer care in New Zealand and is the government’s Executive
principal advisor on cancer. Prof. Diana is a public health physician,
cancer epidemiologist and health services researcher with Board Chairman
a world-leading reputation in cancer
control strategy and research. A focus Dr Harsh Vardhan, Union
of her career to date has been
advocating for systemic change to Minister of Health & Family
address cancer-related inequities
and to improve cancer care and Welfare, Government of India has
outcomes. In her substantive
role as Professor and Head of been appointed as World Health
Department, Department of Public
Health, University of Otago, Prof. Organisation (WHO) Executive
Diana is responsible for strategic
oversight and governance of Board Chairman. The Chairman’s
the department, leading
about 100 staff and post is held by rotation for one
PhD students in active
research and teaching year among regional groups.
programmes, and for
engagement with a range The Executive Board of WHO
of cancer and health
sector stakeholders. comprises 34 executives related

to the field of health, each

representing a member country.

A major pioneering initiative

of Dr Harsh Vardhan was his

act of implementing WHO’s

Essential Drug Programme, which

revolutionised governments’

attitudes on public health care.

Under the concept, maximum

budgetary outlay was apportioned

to those drugs most needed by the

people. His life-long commitment

Australia hires first deputy CMO to polio eradication continues

notwithstanding his being in

power or not. To this end, he also

wellbeing. Her new role will served the South-East Asia office of
strengthen the coordinated
medical and mental health WHO as an Advisor. He is the first
response and decision-making
to the COVID-19 pandemic, Indian to have been nominated
and support the delivery of
mental health system reforms to the prestigious WHO body,
for all Australians. Dr Ruth is
a consultant psychiatrist with the Strategic Advisory Group of
more than 25 years’ experience
at a senior level in community Experts (SAGE), in which capacity
and hospital based mental
health services, community he counseled the international
based aged persons’ mental
health services, mental health body on developing policies on
short stay in Emergency
Departments, homeless vaccines and biologicals.
people with mental illness,
Former chief psychiatrist of and working with police about
Victoria, Dr Ruth Vine has been mental health.
appointed as the country’s first
deputy chief medical officer
(CMO) for mental health. Dr
Ruth’s appointment recognises
the importance the Australian
Government is placing on
Australia’s mental health and

46 R&D NEWS

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

Australia reveals findings on drug resistant bugs

Bacteria are becoming resistant Organisation (CSIRO), may

to treatment faster than new have found an effective

antibiotics are being developed, treatment to combat this health

causing experts to fear there challenge. The team has been

could be a slower pandemic, researching antimicrobial

the drug-resistant superbug. polymers, an up-and-coming

Researchers from the University new class of anti-infectives that

of South Australia (UniSA), can be used as an alternative

as well as collaborators from to antibiotics. Building on

the University of Melbourne, previous work between UniSA

Monash University and and CSIRO, the team worked

Australia’s national science to create polymer mimics

agency, Commonwealth of antimicrobial peptides,

Scientific and Industrial a diverse class of naturally

Research Organisation occurring molecules that act as

Commonwealth Scientific the first line of defense for all

and Industrial Research multicellular organisms.

Korea screens FDA- Japan creates model to
approved drugs study COVID-19 effects
against SARS-CoV-2
A scientific team at University of Tsukuba
Researchers at the Institut Pasteur Korea have
screened 48 Food and Drug Administration (FDA) in Japan has observed that comprehensive
-approved drugs against SARS-CoV-2, and found
that two, that are already FDA-approved for other implementation of COVID-19 infection
illnesses, seem promising. The FDA approval for
other uses would greatly reduce the time needed prevention measures boosts their effectiveness,

to gain FDA approval while partial implementation compromises
of use in COVID-19. An
anti-helminthic drug it. The team has developed an agent-based
called niclosamide
demonstrated very computer model to estimate the effects of
potent antiviral activity
against SARS-CoV-2. A staggered commuting times, telecommuting,
downside of niclosamide
is low absorption, which school closures, social distancing, self-isolation,
undercuts the drug’s
power by reducing the and the various other measures being used in
dose that reaches the target tissue. However, further
development or drug formulation could enable an an effort to halt the spread of COVID-19, the
effective delivery of this drug to the target tissue.
Despite substantially lower antiviral potency, novel coronavirus. Simulations conducted using
ciclesonide, an inhaled corticosteroid used to treat
asthma and allergic rhinitis, also showed promise this model showed that implementing measures
against SARS-CoV-2. Its anti-inflammatory activity
might play a critical role in dampening or preventing either individually or in partial combinations
the cytokine storms, an immune inflammatory
overreaction that can kill COVID-19 patients. yields limited results. The findings provide hints

for estimating the combinations of measures most

effective in preventing the spread of infection.

R&D NEWS 47

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com India-Singapore
conduct
Hong Kong discovers new treatment predictive
for nasopharyngeal cancer studies on
COVID-19
A research team led by Hong Kong Baptist University (HKBU)
has developed a novel anti-Epstein-Barr virus (EBV) drug that Researchers from the Indian
can selectively disrupt a viral protein produced by EBV, leading Institute of Technology- Guwahati
to the shrinkage of tumours caused by the virus. It is the first (IIT-G), India, and the Duke-
known agent to successfully target the virus and disturb its latency NUS Medical School, Singapore,
in tumour cells in this way. The strategy of reactivation of EBV have used data science models
from its latency is a new trend in nasopharyngeal carcinoma to analyse and predict the total
(NPC) therapy, and number of infected people for
some non-specific, different states in India. The
anti-viral drugs have researchers have considered the
recently entered phase exponential, the logistic, and the
1 or phase 2 clinical Susceptible Infectious Susceptible
trials. The new drug (SIS) models, along with the
represents the first model-free daily infection-rate
specific targeted agent (DIR) using open-source data.
to disrupt a single viral They have interpreted the results
protein and to potently jointly from all models rather
reactivate EBV from its than individually. Their report
latency. These research results were published in the international is based on the growth of active
journal Proceedings of the National Academy of Sciences. Patents cases in recent times, along with
have been filed for the new drug and its previous generation. the daily infection-rate (DIR)
Based on these patents, HKBU researchers have established values for each state. They label a
a HKBU spin-off company, called BP InnoMed Limited, with state as severe if a non-decreasing
startup support from the Technology Start-up Support Scheme trend in DIR values is observed
for Universities, and the new company aims to further develop the over the last two weeks along
drug and carry out clinical trials. with a near exponential growth in
active infected cases; as moderate
Singapore offers hope to patients if an almost decreasing trend in
with underactive bladders DIR values is observed over the
last two weeks along with neither
Individuals with an underactive bladder, for example following increasing nor decreasing growth
a spinal cord injury, often cannot sense bladder fullness or are in active infected cases; and as
unable to empty the bladder completely. This distressing symptom controlled if a decreasing trend in
can seriously affect one’s quality of life. Dr Faezeh Arab Hassani, the last two weeks’ DIR values is
observed along with a decreasing
a researcher from the National growth in active infected cases.
University of Singapore (NUS),
has recently invented a device
that can monitor bladder volume
in real time and effectively empty
the bladder. This innovation may
open up a new treatment option for
patients with underactive bladders
in the near future. The novel system comprises a sensor integrated
with an actuator. The soft and thin sensor monitors the bladder
volume continuously while the actuator is equipped with strong
emptying force to clear the bladder. The actuator contains a shape
memory alloy (SMA) spring, which keeps the sensor in contact with
the surface of the bladder at all times for precise volume detection.

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

Chugai inks Peking University strengthens
research response to COVID-19
agreement with
A*STAR Since the COVID-19 outbreak, and control of COVID-19 into
China based Peking University Arabic, and released Counter
Japan based Chugai has been at the forefront of COVID-19 Documents (Arabic
Pharmaceutical has announced the battle against the novel Version). Furthermore, as part
that Chugai Pharmabody coronavirus. While the of the efforts to help foreigners
Research (CPR), a research pandemic
centre of the Chugai Group is gradually better
in Singapore, has begun joint brought understand
research on a therapeutic under control medical
antibody to fight COVID-19, in China, terms that
with the Agency for Science, countries they might
Technology and Research across the come across
(A*STAR) in Singapore. This world are still in a struggle to in notices
joint research project focuses on contain it. In light of this, the and news written in Chinese,
a potential therapeutic antibody School of Foreign Languages faculty and students from
for COVID-19 that was discovered (SFL) at Peking University SFL have put together a
by a research team led by Senior translated China’s official multilingual COVID-19
Principal Investigator Dr Cheng-I documents on the prevention terminology handbook in 21
Wang at A*STAR’s Singapore different languages.
Immunology Network (SIgN).
Candidates were isolated from a NTHU used big data
high diversity synthetic human to counter COVID-19
antibody library and showed
high potency in neutralizing National Tsing Hua University (NTHU) in Taiwan is collaborating
live coronavirus which causes with Facebook and Harvard University in using big data to study
COVID-19. CPR will lead the the potential spread of coronavirus in Taiwan. This international
antibody optimization with its collaboration is being led by Assistant Professor Hsiao-Han Chang
world-leading antibody research of the Institute of Bioinformatics and Structural Biology at NTHU.
capability, and by applying The preliminary results indicate that the risk of local transmission is
Chugai’s proprietary antibody higher than long-distance transmission between counties and cities.
engineering technologies, create The team also found that local movement plays a more important role
a clinical candidate antibody. in the potential spread of
coronavirus than long-
distance movement.
This runs counter to the
widespread perception
that distance traveled is
the most important risk
factor; what matters most
is actually the number
of people contacted and
the length of time one
is in close contact with
them. Based on the results of another study recently conducted using
mathematical modeling to assess the impact of wearing face masks,
the team strongly supports the Central Epidemic Command Center’s
(CECC) decision to set up a system for distributing masks, since it
prevents the hoarding of an item important for limiting the spread
of the epidemic.

SUPPLIER NEWS 49

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

Shimadzu increases production of mobile X-Ray systems

As the COVID-19 pandemic immediately displayed on its
continues to spread throughout built-in monitor within about
the world, moving the infected two seconds. Therefore, the
or potential patients to X-ray systems are considered especially
examination rooms shall be effective for judging the patient’s
strictly restricted, therefore the condition and deciding whether
demand for mobile X-ray systems or not ventilator is necessary.
that can be used to diagnose The systems can also transmit
pneumonia in the isolated images to the in-hospital
patient rooms or intensive network server. To quickly
care units (ICUs) is sharply meet the needs of such medical
increasing. Digital Mobile X-ray facilities and workers, Japan
systems are to be moved to the based Shimadzu is making every
bedside of patients and enable effort to increase production
radiography just there on-the- of its mobile X-ray systems as
spot, then X-ray images can be much as possible.

Leica Biosystems brings
next-gen digital pathology
scanner in APAC

FDA approves Agilent US based Leica healthcare organizations
PD-L1 assay as Biosystems, the global to scale up digital
companion diagnostic leader in pathology pathology so they can
workflow solutions, meet ever-increasing
Agilent Technologies Inc. has announced that announced that it has demands without
the U.S. Food and Drug Administration (FDA) launched the Aperio sacrificing quality. The
has approved the company’s PD-L1 IHC 28-8 GT 450 DX, its next Aperio GT 450 DX
pharmDx for expanded use in non-small generation digital System was rigorously
cell lung cancer (NSCLC). Agilent developed pathology scanner, in tested by technicians
PD-L1 IHC 28-8 pharmDx in 2016 through the APAC region. With and pathologists in
a collaboration with Bristol Myers Squibb, continuous loading, Asia, including at Seoul
and it has been previously approved as a no-touch operation, and National University
complementary in vitro diagnostic for non- 32 second scan time Hospital (SNUH), a
squamous non-small cell lung cancer, as well at 40x magnification, leading digital pathology
as other forms of cancer, including, squamous the Aperio GT 450 hospital in South
cell carcinoma of the head and neck, and DX, registered as CE Korea, to determine the
urothelial carcinoma. Now, physicians will IVD and TGA, allows workflow impact.
be able to use the PD-L1 IHC 28-8 pharmDx
assay as an aid in identifying patients with
metastatic NSCLC for treatment with the
dual immunotherapy combination of Opdivo
(nivolumab) and Yervoy (ipilimumab),
manufactured by Bristol Myers Squibb.

50 SUPPLIER NEWS

BIOSPECTRUM | JUNE 2020 | www.biospectrumasia.com

Thermo Fisher collaborates Beckman
with WuXi Diagnostics
Coulter
Thermo Fisher Scientific Inc., the Thermo Scientific OmniPath
world leader in serving science, COVID-19 Total Antibody ELISA launches RNA
announced it will expand its test will detect Immunoglobulin
response to the COVID-19 M (IgM) and Immunoglobulin extraction kit
pandemic by developing a total G (IgG) to help clinicians
antibodies test in collaboration determine if a patient has been Beckman Coulter Life Sciences
with China based WuXi exposed to SARS-CoV-2. The has announced the launch of
Diagnostics and US based Mayo test is designed to run on an RNAdvance Viral XP, a new
Clinic. The new test is the result open instrument platform, and RNA extraction kit validated
of ongoing collaboration between the determination of antibody for use in infectious disease and
all three organizations, including status will aid in the diagnosis of real-time PCR virus research.
clinical evaluation and support the disease during the acute and The kit is now available for
from Mayo Clinic. Thermo recovery stages of infection. purchase as high-throughput
Fisher will seek U.S. Food and laboratories worldwide ramp
Drug Administration (FDA) up RNA extraction capabilities.
Emergency Use Authorization RNAdvance Viral XP is intended
(EUA) and international for use in high-throughput
regulatory authorizations for research workflows to extract
the test over the next few weeks. viral RNA from swab samples,
Once approved for use, the an essential step in the overall
workflow. After RNA extraction,
Eurofins unveils RT multiplex the collected RNA is used in qRT-
PCR test for COVID-19 PCR kits to test whether the RNA
from a virus is present, yielding
Eurofins Technologies announces the launch of its RT-PCR a positive or negative result. The
(polymerase chain reaction to reverse transcriptase chain reaction) development team has worked
CE-IVD marked multiplex for direct qualitative detection of the closely with global research
pathogen of the new coronavirus (SARS-CoV-2). The development of partners during the past several
the test was led by the affiliated companies Gold Standard Diagnostics months to provide customers with
a high-performing, validated viral
Inc., VIROTECH Diagnostics extraction solution during this
GmbH and Nova time of increased need.
TecImmundiagnostica GmbH.
These specialized diagnostic
technology companies are
well-established providers of
testing solutions, which are
strongly focused on scientific
excellence in infectious disease
testing. They work closely with
Eurofins scientists around
the world to design and
validate the new product. The
GSD NovaPrime SARS-CoV-2 is a real-time multiplex PCR for the
direct qualitative detection of the SARS-CoV-2 pathogen. The assay
simultaneously detects two target sequences within the N gene.
Multiplex PCR provides a streamlined workflow in a reaction and
provides results in approximately two hours of PCR. An extraction or
inhibition control and a positive control are included in the reagents.