BioSpectrum Asia October 2021

www.biospectrumasia.com S$ 5.00

Volume 16 | Issue 10 | October 2021

Heartening
upsurge in

Cardiac

Medtech

R&D

Life Science Incubator stirs international
startup interest in Singapore – 25
Marvels of Gene-edited Meds Unleashed – 30
Virtual Reality: A major healthcare influencer – 33

“Stem cell-based therapeutics poised to
become mainstream option”
-Dr Koji Tanabe, Founder & CEO,
I Peace, Inc., USA/Japan – 37





4 BIO EDIT

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Dr Milind Kokje UNTENABLE PROFITEERING

Chief Editor Malaysia has recently co-sponsored a proposal to the World Trade Organisation
(WTO) to suspend Intellectual Property Right (IPR) rules on COVID-19 vaccines,
[email protected] medicines and diagnostics. With this, it has become one among the over 60
countries supporting the waiver, which will help other countries produce their own vaccines
and therapeutics for COVID-19. At the same time, by his recent comment, “If you take away
the IPR, it is difficult to motivate scientists to do their research,” the German Ambassador
to India has tried to provide a base for those countries which are opposing the waivers.

The move for demanding waiver began almost a year back as India and South Africa
had initiated it back in October 2020 by submitting a proposal suggesting a waiver for all
WTO members on the implementation of certain provisions of the agreement regarding
prevention, containment or treatment of COVID-19. The relaxations were sought to
ensure quick and affordable access to vaccines and medicines for developing countries.
The waiver was sought from the implementation, application and enforcement of
specific provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS)
agreement. The proposal was amended in May 2021 to seek a waiver for limited years.
The TRIPS Council is instrumental in negotiating the number of years for the waiver
to be in effect. However, there has been no agreement over the waivers and the whole
issue appears to be caught up in a web, despite two meetings being held in June and
September. In June, the EU forwarded a counter proposal suggesting the use of the
existing flexibilities in TRIPS to help end the COVID-19 crisis.

Japan and several other countries supported the proposal and even the US changed its
earlier position to support it. Still, the UK, Switzerland, Canada, and the European Union
are opposed to it. By opposing the waivers, in a way, they are blocking ways to help poor
countries produce vaccines. On the other hand, some of these countries have apparently
not shared promised vaccine doses. The waivers will enable vaccine producers across the
world to initiate and/or increase vaccine production. This will help in more and easier
accessibility as well as affordability.

This is crucial as the vaccine inequality is widening with each passing day. High
income countries have 20 times more access to vaccines than low income nations. Same
is true about testing, (which stands at 92 times more than that of low income nations),
Oxygen and treatments.

Human Rights Watch and Equal Access to Health and Medical Services for All from
Japan have written to the leaders of Quadrilateral Security Dialogue (QSD/ QUAD)
nations - a strategic dialogue between the United States, India, Japan and Australia.
Amnesty International, too has expressed a similar opinion in its report and blamed
six major pharma companies for “causing human rights harm by refusing to share
technology. While wealthier countries have started vaccinating children and offering the
additional booster doses, only 0.3 per cent of the six billion doses administered globally
have been given to the poorest nations. This has resulted in 55 per cent people in rich
countries being fully vaccinated while less than 1 per cent in lower income countries.

Considering the huge investments that are made in research with no guarantee of
success, there is no doubt that securing IPRs is important for vaccine manufacturers.
But, experts have countered this argument by pointing out that for COVID-19 vaccine
research huge amounts of funding was provided by governments and payments for
advance orders were also made. This had considerably reduced the risk of investment.

India has, now, also offered to collaborate with East Asian countries for producing
off-patent medicines and vaccines to fight COVID-19. At the recent East Asia Summit
Economic Ministers’ Meeting, the reason cited by the Indian minister is both apt and
important. As the minister said, “What those opposing waivers need to understand, is
that in an interconnected and globalised world no one is safe until everyone is safe.”

While the world is limping back to the so called ‘new normal’, profiteering in health
crisis, with disregard for lives of those in underprivileged nations, is untenable.

BIO MAIL 5

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Acknowledgements Looking forward to collaborating again!
- Tabea Wanninger, Singapore
The team is appreciative that BioSpectrum
Asia’s topic of interest is aligned to that of This is the third time we have co-operated
what Alcatel-Lucent Enterprise (ALE) is keen with BioSpectrum Asia. Through the e-blast
to speak on – specifically digital continuity of our event and event report, thank you for
and transformation in the healthcare sector. encouraging more delegates and boosting the
The turnaround from securing the interview, brand image of BIO Asia-Taiwan.
developing and submitting responses, and
publishing of article, was seamless. We - Daisy Tsai, Taiwan
look forward to collaborating further with
BioSpectrum on future opportunities. There remains huge potential for research to
enhance our understanding of the role the
- Tan Hui San, Singapore gut microbiome plays in health and disease
states. Microba Life Sciences is thankful to
Agilent and Weber Shandwick are very BioSpectrum Asia for putting across this
happy to collaborate with BioSpectrum team. message through our interview feature.
Greatly appreciate that you guys picked up the
write-up on ‘Resisting & Adapting to Infectious - Mel Raassina, Australia
Diseases to Prevent Future Pandemics’.

Vol 16; Issue 10; October 2021 MM Activ Singapore Pte. Ltd. Taiwan
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6 BIO CONTENT

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

COVER STORY 18

Heartening upsurge

IN CARDIAC
MEDTECH R&D

Cardiovascular disease (CVD) remains the world’s number one killer, resulting in 18.6
million deaths a year. The global focus on the pandemic, neglecting the real numbers
of patients dying due to heart disease, among other life-threatening disorders, is
illogical and staggering, to say the least. ‘Harnessing the power of technology to
improve awareness, prevention and management of CVDs’, globally, is the goal
for World Heart Day 2021, observed on September 29 every year. Moreover, the
increasing cases of CVDs within the APAC region have, in turn, pushed the growth of
the cardiovascular devices market as it currently offers a range of stents, catheters,
cardiac rhythm management devices, pacemakers etc. An increasing number of
startups and medical innovations in the APAC countries are projected to take the
medtech ecosystem to the next level in cardiac care.

BIO CONTENT 7

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com SPEAKING WITH

INCUBATOR 39

25 “Aiming for Australia-India
synergistic collaboration in
Life Science Incubator stirs Life Sciences Sector”
international startup interest in Singapore
Abdul Ekram,
GENE EDITING Trade Commissioner, Australian Trade
and Investment Commission, South Asia, Australia
30
41
Marvels of Gene-edited Meds Unleashed
“Securing interoperability
VR from cyber threats in
healthcare orgs”
33
Vincent Goh,
Virtual Reality: A major healthcare influencer Senior Vice President, CyberArk
(Asia Pacific and Japan), Singapore
SPEAKING WITH
CANCER
35
42
“We’re actively tackling
issues concerning trade, Therapeutic approaches
investment and health” for the Treatment of
Hepatocellular Carcinoma
Chris Humphrey,
Executive Director, Dr Lim Chun Sen,
EU-ASEAN Business Council, Singapore Head of Radiotherapy and
Oncology Department, Hospital Sultan Ismail, Malaysia
37
REGULARS
“Stem cell-based
therapeutics poised to BioEdit.........................................................................04
become mainstream option” BioMail........................................................................05
Policy and Regulatory News...................................08
Dr Koji Tanabe, Company News........................................................10
Founder and CEO, I Peace, Inc., USA/Japan Finance News............................................................12
Start-Up News...........................................................13
World News...............................................................15
WHO NEWS...............................................................17
People News..............................................................44
R&D News..................................................................45
Academic News........................................................47
Supplier News...........................................................48
Lets Talk Health........................................................50

8 REGULATORY NEWS

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Australia improves hepatitis C diagnosis with new funding

To help improve the able to provide the testing and fingertip. This blood
treatment times of treatment all in one visit is a real is analysed on site,
those with hepatitis game-changer for people who with a result ready
C, the Australian would normally have to wait for the patient within
government will several weeks for a test result. an hour. If the result
fund a new national This technology can test for active comes back positive,
point-of-care testing hepatitis C infection by taking treatment can begin
(POCT) programme a small amount of blood from a during that same visit.
that can confirm active Under the programme,
hepatitis C infections testing will be available
within an hour and nationally at 65 sites
allow treatment to with a high prevalence
begin immediately. The Kirby of hepatitis C infection, including
Institute at the University of drug treatment clinics, needle and
New South Wales (NSW) and syringe programmes, and prisons.
the International Centre for The programme will also include
Point-of-Care Testing at Flinders the development of standard
University will be provided operating procedures, logistics,
with $6.5 million combined to deployment, operator training,
establish the programme. Being and external quality assurance.

China updates Japan buys 150 M
epidemic prevention
directions for doses of Novavax
medical institutions
COVID-19 vaccine
China’s health authority has released updated
directions for controlling and preventing the spread Japan’s Ministry of Health, Labour and Welfare
of COVID-19 in medical institutions. Medical (MHLW) is purchasing 150 million doses of
institutions are key locations for COVID-19 diagnosis US-based Novavax’ vaccine candidate (TAK-
and treatment and face continuous risk of epidemic 019 in Japan) manufactured in Japan by
outbreak, say the directions, urging them to stay on Takeda Pharmaceutical, subject to licensing
the guard and strictly implement epidemic prevention and approval. As part of a previously announced
measures. The directions require all medical workers, agreement with Novavax, Takeda is establishing
newly-accepted patients and those in their company to
undergo regular nucleic acid tests. Medical institutions the capability to manufacture
are required to immediately report any positive result TAK-019 (known outside
to local epidemic control and prevention departments, Japan as NVX-CoV2373) at
so as to block the spread of the virus as early as possible. its facilities in Japan and aims
The directions emphasize that medical workers at to begin distribution in early
fever outpatient departments receiving patients calendar year 2022. Novavax
from abroad or high-risk and medium-risk areas is licensing and transferring
in the country should be put under strict close-loop manufacturing technologies to
management, and their contact with people outside enable Takeda to manufacture
the hospital be restricted. The same requirements the vaccine antigen and is
apply to all personnel working in quarantine wards of supplying the Matrix-M TM
designated COVID-19 treatment medical institutions, adjuvant to Takeda for fill/finish together with the
say the directions. antigen. Takeda is responsible for the Japanese
clinical trial and regulatory submission to the
Pharmaceuticals and Medical Devices Agency
(PMDA) and will distribute TAK-019 in Japan
should it be approved by the MHLW.

REGULATORY NEWS 9

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Singapore gives nod Korea fully approves first
mAb treatment for COVID-19
to new therapy for
The Korean Ministry of Food and Drug Safety (MFDS)
advanced small-cell has approved regdanvimab (CT-P59), a monoclonal
antibody (mAb) treatment for COVID-19 for the extended
lung cancer use in elderly patients aged 50 years and over, or with
at least one underlying medical condition (the obese,
Patients in Singapore with an aggressive form cardiovascular disease, chronic lung disease, diabetes,
of lung cancer (metastatic small cell lung chronic kidney disease, chronic liver disease, and patients
cancer) can now access a new therapy that with immunosuppressive agents) with mild symptoms of
may improve outcomes. The drug ZEPZELCA COVID-19, and adult patients with moderate symptoms
(lurbinectedin) has been provisionally of COVID-19. This marks
approved by Singapore’s Health Sciences the first time a monoclonal
Authority (HSA) for the treatment of adult antibody treatment for
COVID-19 has received
patients with metastatic a full approval to treat
small cell lung cancer patients with COVID-19
(SCLC) who have from the Korean MFDS. In
progressed after prior February, the Korean MFDS
platinum-containing granted a Conditional
chemotherapy. This Marketing Authorisation
means patients who (CMA) to Celltrion Group
have failed other for the emergency use of
existing treatment regdanvimab (CT-P59) and allowed the use of CT-P59 in
options will now have adult patients aged 60 years and over, or with at least one
a further therapeutic option. ZEPZELCA is underlying medical condition (cardiovascular, chronic
the first new therapy approved by the HSA respiratory disease, diabetes, high blood pressure) with
to treat second-line SCLC in more than two mild symptoms of COVID-19, and adult patients with
decades and is the third oncology drug in the moderate symptoms of COVID-19. The administration
Specialised Therapeutics (ST) portfolio to time for the recommended dosage of regdanvimab (CT-
receive HSA approval. The Singapore approval P59), a single intravenous (IV) infusion of 40 mg/kg, has
follows on from approvals by the US Food and been reduced from 90 minutes to 60 minutes.
Drug Administration (FDA) decision, as well
as the Therapeutic Goods Administration
(TGA) in Australia.

India launches USAID-supported interactive
Vaccine Knowledge Management platform

The Ministry of Health and such as an interactive web- immunisation, and monitoring
Family Welfare and NITI Aayog based knowledge portal, best and supervision. As part of the
in India have launched a United practices compendium, and initiative, 15 Indian and global
States Agency for International organise virtual forums for cities will initially participate to
Development (USAID)-supported cities and countries to learn engage with more cities in the
‘City-to-City COVID-19 from each other’s experiences. future. COVID-19 vaccination
Vaccination Learning Exchange The discussion topics will range strategies have the potential to be
(CoVLEx) initiative to build a from vaccine procurement, a game-changer in strengthening
global COVID-19 vaccination governance, digital innovations national routine immunisation
knowledge management platform planning, and management, programmes, which in turn will
and initiate an exchange of ideas vaccine supply chain, contribute to delivering effective
and learnings on pandemic communications and social primary healthcare services and
response. The CoVLEx platform mobilisation, capacity building, accelerate progress towards
will develop knowledge products adverse events following achieving universal healthcare.

10 COMPANY NEWS

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US-based CRO firm Regencell Bio offers
traditional medication
Advanced Clinical in ASEAN countries

continues APAC expansion Regencell Bioscience Holdings has announced that
Regencell Bioscience, the company’s wholly-owned
Advanced Clinical, a global clinical research subsidiary in Hong Kong, has entered into a joint
services organisation (CRO), has announced that venture agreement with Honor Epic Enterprises.
the company’s global expansion into the Asia The joint venture (JV) is expected to offer COVID-19
Pacific (APAC) region continues with the opening related treatments to patients in ASEAN countries,
of a new office in Tokyo, Japan. The new office India, Japan, Australia and New Zealand. In March
will place Advanced Clinical in a better position 2020, Sik-Kee
to reach and respond swiftly to the ever-growing Au, Regencell’s
needs of their regional clientele as well as other strategic partner
international clients planning projects in Japan. TCM practitioner,
To lead clinical research efforts, Makoto Nishida started to develop a
has been appointed as the General Manager for Traditional Chinese
Japan. Nishida brings 25 years of experience in Medicine (TCM)
the pharmaceutical industry. He has previously treatment formula
worked as a Country Manager, focusing on targeting COVID-19
regional project management, APAC clinical and patients. So far, 12
regulatory strategy, and clinical development. He patients (suspected or confirmed COVID-19 cases)
holds a master’s degree in Pharmaceutical Science, have been treated, and their health records showed
Biochemistry and a Japan Pharmacist license. improvements after an average treatment period
Advanced Clinical will continue its APAC expansion of 5 days. Regencell will own 60 per cent of the JV
efforts in subsequent months with plans to add with a customary drag-along option. The principal
additional locations in Australia, South Korea, and business of the JV shall be to trade, manufacture,
Taiwan. In addition to Japan, Advanced Clinical market and distribute TCM formulae products,
has a Singapore hub for the APAC region. procure, enable, provide or support the treatment
of COVID-19 using TCM in the ASEAN countries,
India, Japan, Australia and New Zealand.

Australia’s Rhinomed makes first nasal swab for children

Australian firm Rhinomed has The trial, known as The Diagnosis respiratory viruses in children
completed development of the of Respiratory Disease in with Rhinoswab Junior, which
world’s first nasal swab designed Children with Rhinoswab Study is designed to collect a nasal
specifically for children. The (DIY Rhinoswab Study), will sample from children without
Rhinoswab Junior has been investigate the diagnosis of the discomfort and distress often
designed to deliver all the benefits associated with the combined
of the existing Rhinoswab but throat and deep nasal (CTDN)
with several novel features that swabs. The study will aim to
reduce the fear, anxiety and recruit 250 children at the
trauma associated with the use Respiratory Infection Clinic at the
of the existing standard of care RCH for a SARS-CoV-2 test. The
nasal swabs. The company has CTDN sample will be collected
received Human Research Ethics by a healthcare worker (HCW);
Committee (HREC) approval to however, children will self-collect
commence a clinical trial of the the Rhinoswab sample under
Rhinoswab Junior at The Royal the supervision of a healthcare
Children’s Hospital Melbourne. worker.

COMPANY NEWS 11

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Menarini APAC signs Biocon Biologics, SII
licensing agreement
with Daiichi Sankyo ink strategic alliance

Menarini Asia-Pacific (APAC) Holdings, part of Indian firms Biocon Biologics Limited (BBL),
the Italian global biopharmaceutical company a subsidiary of Biocon and Serum Institute
Menarini Group, has signed a multi-year exclusive Life Sciences (SILS), a subsidiary of Serum
licensing agreement to assume the registration, Institute of India (SII) have announced a
sales, marketing, and distribution of the orally strategic alliance. Under the terms of the
administered gabapentinoid, mirogabalin (TARLIGE), agreement, BBL will offer approximately 15 per
in the Philippines, cent stake to SILS, at a post-money valuation
Malaysia and of approximately $4.9 billion, for which it will
Singapore. TARLIGE get committed access to 100 million doses of
was developed vaccines per annum for 15 years, primarily
and is currently from SILS’s upcoming vaccine facility in
marketed in Japan Pune with commercialisation rights of the
by Daiichi Sankyo SILS vaccine portfolio (including COVID-19
and is indicated vaccines) for global markets. BBL will generate
for the treatment a committed revenue stream and related
of peripheral margins, commencing H2, FY23. In addition to
neuropathic pain vaccines, the strategic alliance will also develop
(PNP), including antibodies targeting several infectious diseases
diabetic PNP and post-herpetic neuralgia. The drug like Dengue, HIV, etc. The two companies will
binds to and modulates the α2δ-1 subunit of the enter Service Level Agreements (SLAs) for
voltage-gated calcium channels widely found in the manufacturing and distribution of the vaccines
nervous system in areas that mediate pain transmission and antibodies.
and processing. Neuropathic pain, which refers to pain
caused by a lesion or disease of the somatosensory
nervous system, has been shown to be prevalent in
the general population by as much as 7 to 8 per cent.
Patients with neuropathic pain are more susceptible to
high pain intensity with more comorbidities, such as
depression, panic/anxiety disorder, and sleep disorders.

Korean firms join hands for new cancer cell therapies

Daewoong Pharmaceutical therapeutic cell programme into
the clinic by the first half of 2022.
and Hanall Biopharma of SUPLEXA Therapeutic Cells are a
differentiated and non-engineered
South Korea are expanding autologous therapy made from
activated and reprogrammed
their global open collaboration peripheral blood mononuclear
cells (PBMC) - derived from
initiative by investing in Alloplex patient whole blood. SUPLEXA
cells are generated rapidly and in
Biotherapeutics, an emerging US- abundance through a robust ex vivo
manufacturing procedure during
based biotechnology company. which they acquire the capacity to
kill all tumour cells tested without
The Korean firms have announced affecting normal cells.

their investment in Alloplex

Biotherapeutics by purchasing

to support a potential long-term Alloplex to develop global networks
and communication with experts
collaboration for developing new in this domain. This investment
will allow Alloplex to advance
cancer cell therapies. Daewoong its first-generation SUPLEXA

Pharmaceutical and Hanall

Biopharma aim to collaborate with

12 FINANCE NEWS

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Beximco Pharma acquires 54.6% stake in Sanofi Bangladesh

Beximco Pharmaceuticals has & Baker, two of its shareholders and the Ministry of Industries,
finalised agreements to acquire based in the UK. The remaining 20 per cent and 25.4 per cent
54.6 per cent of stake in Sanofi shares are owned by Bangladesh respectively. Sanofi Bangladesh
Bangladesh for over Tk 400 crore. Chemical Industries Corporation generated Tk 303 crore in revenue,
The acquisition is set on expanding Tk 27 crore in profit before tax and
Beximco’s capabilities and product had Tk 640 crore in gross assets in
base offerings into new specialty the year ending on December 31,
therapy areas. This will also mark 2020, according to its last audited
the French pharmaceutical giant’s accounts. A part of Sanofi SA, a
exit from Bangladesh, ending global biopharmaceutical company
operations spanning for more than focused on human health, the
six decades. Earlier, Bangladesh Bangladesh operations were
Bank approved the Bangladeshi established in 1958 as a part of the
drug maker’s acquisition of the British chemical company, May &
Sanofi shares from Fisons and May Baker.

China’s Brii Bio Fujifilm sells
invests $100M more
for SARS-CoV-2 mAb radiopharma
combination therapy
biz to PeptiDream
Brii Biosciences is committing an additional $100 million
to advance global regulatory filings and commercial efforts for 30.5 B yen
for its investigational SARS-CoV-2 monoclonal antibody
(mAb) combination therapy, BRII-196/BRII-198. Japan-based Fujifilm Corporation
Following on the heels of a positive Phase III data readout has announced the transfer of the
from the ACTIV-2 trial, and as countries around the world radiopharmaceutical business of Fujifilm
continue to face a significant resurgence of COVID-19 Toyama Chemical, a consolidated
cases, the company is doubling down on its efforts to subsidiary of Fujifilm, to PeptiDream
bring BRII-196/BRII-198 to a broad range of patients as a Inc. Fujifilm has entered into a share
promising potential new treatment option for COVID-19. transfer agreement with PeptiDream,
BRII-196/BRII-198 is a SARS-CoV-2 neutralising under which all outstanding shares of
monoclonal antibody combination therapy. Interim the newly established company (the
results from Phase III of the NIH-sponsored ACTIV-2 new radiopharmaceutical company),
trial recently demonstrated that the combination therapy to which Fujifilm Toyama Chemical’s
achieved a statistically significant reduction, 78 per cent, radiopharmaceutical business is succeeded,
of relative risk in the combined endpoint of hospitalisation will be transferred to PeptiDream. Based
and death in non-hospitalised COVID-19 patients at high on this agreement, Fujifilm will receive a
risk of clinical progression. lump sum of 30.5 billion yen and potential
contingent payments based on the progress
of the business succeeded by PeptiDream.
The transfer date is scheduled for March
2022. Under its medium-term management
plan “VISION2023“, Fujifilm is accelerating
business growth in healthcare, identifying it
as one of its key business fields. Fujifilm is
currently expanding its healthcare business
in two areas, the Medical Systems business
that handles medical devices and medical
IT, and Life Sciences business that handles
Bio CDMO, drug discovery support, and
pharmaceutical products.

START-UP NEWS 13

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Australian Startups in China
startups explore
treatment for IBS-D push drug discovery

Australia-based startup Microba Life Sciences will work for neurodegenerative
with Anatara Life Sciences to complete microbiome
analysis for a much-needed therapeutic treatment for diseases
sufferers of Irritable Bowel Syndrome (IBS) that causes
increased diarrhoea (IBS-D). Anatara has commenced China-based startups Insilico Medicine and
recruitment for a Phase I/II clinical trial of their 4B Technologies have signed a strategic
Gastrointestinal Re-Programming complementary collaboration agreement in advancing the
medicine (GaRP) to address an unmet clinical need development of innovative small molecule
for IBS-D. Microba will apply its high-resolution gut therapies for amyotrophic lateral sclerosis
microbiome analysis platform to measure the effect of (ALS) and other major neurological diseases.
the treatment on the microbiome by comparing pre- ALS is a rapidly progressive and fatal
treatment specimens and specimens taken after eight neurodegenerative disease recognised by
weeks on the GaRP complementary medicine. One of the World Health Organisation (WHO) as
Anatara’s mechanisms of action addresses dysbiosis one of the five incurable diseases with no
(microbiome disruption) to rebalance a healthy effective treatments to date and an average
microbiome for sufferers of this condition. The trial surviving duration of 3-5 years. This strategic
would evaluate the safety and efficacy of GaRP for future collaboration will enable Insilico’s AI
use as complementary medicine for sufferers of IBS-D. technology to be widely applied in various
stages of R&D to speed up novel drug
discovery by combining 4B Technologies’
breakthrough science and cutting-edge
platform technologies in CNS drug discovery
and development. Both companies will work
together closely in an effort to discover novel
treatments for ALS through identifying
high-quality targets and therapeutic agents
with an aim of improving the efficiency and
probability of success to benefit patients
worldwide.

Everest Medicines advances mRNA therapies in Asia emerging markets

China-based startup Everest Greater China, Brunei, Cambodia, neutralisation titers against the
Medicines has inked two separate Indonesia, Laos, Malaysia, original strain of SARS-CoV-2
definitive agreements with Myanmar, Pakistan, Philippines, (G614) in an S protein-typed
Canadian biotech firm Providence Singapore, Thailand, Timor-
Therapeutics Holdings Inc., to Leste and Vietnam. Providence’s pseudovirus assay.
license rights to Providence’s lead mRNA COVID-19 vaccine Everest will also
mRNA COVID-19 vaccine candidate, PTX-COVID19-B, gain rights to
candidates in Asia emerging currently in Phase II clinical Providence’s next
markets, including Greater China, trials, has demonstrated that generation mRNA
Southeast Asia and Pakistan, and it is generally safe and well-
to establish a broad, strategic tolerated and that the PTX- COVID-19
partnership to develop mRNA COVID19-B dosed vaccine
products globally leveraging subjects have high candidates
Providence’s cutting-edge mRNA against
technology platform. Everest specific
gains rights to Providence’s variants of concern
mRNA COVID-19 vaccines in (VOC) which
are in preclinical
development.

14 START-UP NEWS

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EDGC Mylab to
strengthens position
in Korean precision establish POC
medicine market
testing labs in India
German firm Molecular Health GmbH is collaborating
with South Korean startup EONE-Diagnomics Genome Indian startup Mylab Discovery Solutions
Center (EDGC) to help its healthcare provider customers has acquired a majority stake in Sanskritech
identify personalised treatment options for cancer – the developer of Swayam- India’s first most
patients. The collaboration is intended to establish advanced Point-of-Care (POC) testing system
leadership in the fast-growing precision medicine with over 90 test parameters and telemedicine
market for liquid biopsy. Therefore, the two partners facility. Mylab will establish POC testing labs
combine two major proprietary technologies, Molecular at doctor offices, nursing homes, community
Health’s MH Guide and EDGC’s ONCOCATCH-CDx. health centres, airports, etc. through lab
This allows comprehensive genomic tumour profiling partners to enable patients to get test results
to guide treatment in solid tumours. As part of the faster, at a lower cost and without the need to
cooperation, EDGC aims to utilise Molecular Health’s wait for hours. Swayam is a portable diagnostic
MH Guide, analysis software that supports oncologists and telemedicine POC system that can be
and molecular pathologists in the interpretation of large used to create a small lab anywhere. Mylab
molecular datasets. Independent of the sequencing will use its expertise in diagnostic solutions
technology used, MH Guide can make complex datasets development, biosensors, robotics, liquid
readable, and automatically identify genetic variants handling to further expand the test menu
that are relevant for the treatment of cancer patients. and embed Artificial Intelligence which will
facilitate faster reporting and consultation with
the doctor and an even better experience.

JETRO partners with US accelerators to promote Japanese startups

The Japan External Trade foreign investors, and new by providing specific courses
Organisation (JETRO) is business partnerships. This in specialised areas such as
hosting an online acceleration year JETRO will select 100 B2B, bio-healthcare, Climate/
programme in partnership with top startups from innovation Cleantech, and University-based
the Cabinet Office of Japan hubs across Japan. JETRO will deep tech. The Bio/Healthcare
from October 2021 to March support their global expansion cohort will consist of startups
2022. In this programme, focusing primarily on health
JETRO will collaborate with 6 and biotech in verticals such as
major accelerators to cultivate digital health, medical devices,
the growth of Japanese startup healthcare services, life sciences
ecosystems - serving as an entry and pharmaceuticals. Cambridge
for Japanese startups within Innovation Center (CIC) will run
the global market. Startups will this course with its extensive
receive first hand mentorship, knowledge of the US medical and
matching opportunities with bio landscape.

WORLD NEWS 15

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

International orgs intensify cooperation for COVID-19 vaccination

The heads of the International low- and lower-middle-income in the aggregate, the doses are
Monetary Fund, World countries. The Task Force not reaching low- and lower-
Bank Group, World Health expressed concerns that without middle-income countries in
Organisation and World Trade urgent steps the world is unlikely sufficient amounts, resulting in
Organisation met with the CEOs to achieve the end-2021 target a crisis of vaccine inequity. The
of leading vaccine of vaccinating at least 40 per Task Force encouraged countries
manufacturing cent of the population in all that have contracted high
companies countries—a critical milestone to amounts of vaccine doses, and
to discuss end the pandemic and for global vaccine manufacturers, to come
strategies economic recovery. The Task together in good faith to urgently
to improve accelerate COVID-19 vaccine
the access to Force members noted that, supplies to COVAX and AVAT,
COVID-19 despite adequate two multilateral mechanisms
vaccines, total global that are crucial for equitable
especially in vaccine distribution of vaccines.
production

Global Infectious UK to curb
Diseases Index to track
pathogens worldwide overprescribing

The Future Investment Initiative (FII) Institute in the of medicines
US has launched the Global Infectious Diseases Index.
It uses a specially designed Artificial Intelligence (AI) The government will take action to prevent
tool designed to track pathogens around the world and medicines from being prescribed unnecessarily
provide key data to help prepare for, and fight infectious in England, as a new review highlights the
impact of overprescribing. The review revealed
diseases. Captured in near that 10 per cent of the volume of prescription
real-time, it was developed items dispensed through primary care in
in partnership with the England are either inappropriate for that
global pioneer in infectious patients’ circumstances and wishes, or could
disease risk solutions be better served with alternative treatments.
Metabiota and leading Around 1 in 5 hospital admissions in over-
technology consulting firm 65s and around 6.5 per cent of total hospital
Accenture. It tracks up to admissions are caused by the adverse effects of
60 pathogens, including medicines. The more medicines a person takes,
those behind COVID-19, the higher chance there is that one or more
Dengue and Measles and is of these medicines will have an unwanted or
designed to increase global awareness about infectious harmful effect. Some medicines, such as those
diseases including Tuberculosis, Malaria and HIV, as to reduce blood pressure, can also increase the
well as reduce threats and provide valuable insights risk of falls amongst the frail and elderly. The
to drive decision making. The Index will provide review sets out a series of practical and cultural
endemic disease burden and epidemic disease threat changes to make sure patients get the most
data in one platform. It includes the top five deadliest appropriate treatment for their needs.
global endemic diseases, across 204 countries and
territories, and tracks up to 60 pathogens, including the
Coronavirus. Integrated data also includes countries
ranked by Highest Healthcare Expenditure (as a
percentage of GDP), the number of people per country
vaccinated for each disease and in-depth information
on medical professionals and services.

16 WORLD NEWS

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

WB, UNICEF support health services
for children, women in South Sudan

The World Bank (WB) and areas, the states of Jonglei Ministry of Health in enhancing
United Nations Children’s and Upper Nile. This close its stewardship of the South
Fund (UNICEF) are Sudanese health system and its
collaborating to collaboration between capacity to plan and implement
implement a $53.5 the World Bank and programs. The development
million project UNICEF in partnership between the World
in South Sudan South Sudan Bank and UNICEF has also
that focuses on comes at a supported South Sudan’s Ebola
COVID-19 vaccine crucial time as and COVID-19 response in terms
deployment in the country of logistics and operations,
the country and continues to including screening at points
the provision of respond to of entry, risk communication
essential health the COVID-19 activities to create awareness, and
services for the pandemic the training of health personnel
most vulnerable populations in on effective infection prevention
two of the most hard-to-reach including the scaling up and control.
of its vaccination rollout efforts.
Both sides will also support the

African Union, Africa Argentina, Brazil to
create mRNA vaccine
CDC to usher in new development centres

paradigm in health To increase COVID-19 vaccine production capacities
worldwide and expand access in the Region of the Americas,
The African Union (AU) through the the Pan American Health Organisation (PAHO) has
African Centres for Disease Control selected South American countries Argentina and Brazil
and Prevention (Africa CDC), and the to create two centres for the development and production
European and Developing Countries of vaccines with messenger RNA (mRNA) technology.
Clinical Trials Partnership (EDCTP) have Sinergium Biotech in Argentina has been selected due to
signed a Memorandum of Understanding
(MoU) aimed at establishing a framework its extensive experience in the
to serve as a firm basis for cooperation production of vaccines and other
in their shared goals to promote a new biologicals, and its capacity
paradigm in health. Through the MoU, to develop complex products
the Africa CDC and EDCTP express their added to the experience in the
commitment towards joining efforts distribution of these products to
and maintaining a close and continuous national and international levels
relationship for the achievement of their in highly competitive countries.
common objectives. The scope of the Meanwhile, in Brazil, the
MoU is defined through the following company in charge of carrying
themes: Emerging and re-emerging out this development will be the Bio-Manguinhos Institute
infectious diseases, epidemic intelligence of Technology in Immunology, which is part of the Oswaldo
and capacity building for preparedness Cruz Foundation (FIOCRUZ). The installation of these two
and outbreak response. The MoU also centres seeks to create the basis for the implementation of a
covers implementation and public health regional collaboration that takes advantage of cooperation
research, the one health approach, and with the technology transfer centre located in South Africa,
data management. AU and EDCTP will as well as cooperation with other production actors in the
cooperate to implement a programme of region in order to expand the productive capacity that
work for the execution of activities within benefits the entire region.
these themes.

WHO NEWS 17

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WHO proposes WHO opens Hub for
Pandemic and Epidemic
stepwise improvement Intelligence in Berlin

in global air quality levels The World Health Organisation (WHO) Director-
General has recently inaugurated the new WHO
New World Health Organisation (WHO) Global Air Hub for Pandemic and Epidemic Intelligence,
Quality Guidelines (AQGs) provide clear evidence of based in Berlin. The WHO Hub, which is receiving
the damage air pollution inflicts on human health, at an initial investment of $100 million from the
even lower concentrations than previously understood. Federal Republic of Germany, will harness broad
The guidelines recommend new air quality levels to and diverse partnerships across many professional
protect the health of populations, by reducing levels disciplines, and the latest technology, to link the
of key air pollutants, some of which also contribute to data, tools and communities of practice so that
climate change. Since WHO’s last 2005 global update, actionable data and intelligence are shared for the
there has been a marked increase of evidence that common good. The WHO Hub is part of WHO’s
shows how air pollution affects different aspects of Health Emergencies Programme and will be a new
health. For that reason, and after a systematic review collaboration of countries and partners worldwide,
of the accumulated evidence, WHO has adjusted driving innovations to increase the availability
almost all the AQGs levels downwards, warning of key data; develop state-of-the-art analytic
that exceeding the new air quality guideline levels is tools and predictive models for risk analysis; and
associated with significant risks to health. At the same link communities of practice around the world.
time, however, adhering to them could save millions Critically, the WHO Hub will support the work
of lives. The goal of the guideline is for all countries of public health experts and policy-makers in all
to achieve recommended air quality levels. Conscious countries with the tools needed to forecast, detect
that this will be a difficult task for many countries and and assess epidemic and pandemic risks so they
regions struggling with high air pollution levels, WHO can take rapid decisions to prevent and respond to
has proposed interim targets to facilitate stepwise future public health emergencies.
improvement in air quality and thus gradual, but
meaningful, health benefits for the population.

WHO pushes innovative tech for COVID-19, other priority diseases

The World Health Organisation already commercially available emergencies decked out in a
(WHO) has compiled a in countries, while the rest are shipping container. Some of
compendium of 24 new still at the prototype stage. The these technologies are already
technologies that can be used compendium includes simple in use and have proven their
in low-resource settings amidst items ranging from a colourised value through pilot programmes.
the COVID-19 pandemic. The bleach additive, which allows For example, the solar-powered
compendium’s main objective the naked eye to identify non- oxygen concentrator has been
was to select and assess sterilised surfaces and objects, highly effective in treating
technologies that can have an to more complex though easy-to- pneumonia, which kills 900,000
immediate and future impact use equipment such as a portable children a year, in a regional
on COVID-19 preparedness and respiratory monitoring system children’s hospital in Somalia’s
response, potentially improve and ventilators with an extended Galmudug state. The information
health outcomes and quality battery that can be used where is vital to help governments, non-
of life, and/or offer a solution electricity is not available or governmental organisations and
to an unmet medical need. unstable. The list also includes funders decide which products to
15 of these technologies are a deployable health facility for procure.

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Heartening upsurge

IN CARDIAC
MEDTECH R&D

Cardiovascular disease (CVD)
remains the world’s number one

killer, resulting in 18.6 million
deaths a year. The global focus
on the pandemic, neglecting the
real numbers of patients dying

due to heart disease, among
other life-threatening disorders,
is illogical and staggering, to say
the least. ‘Harnessing the power of
technology to improve awareness,
prevention and management of

CVDs’, globally, is the goal for
World Heart Day 2021, observed

on September 29 every year.
Moreover, the increasing cases
of CVDs within the APAC region
have, in turn, pushed the growth of
the cardiovascular devices market
as it currently offers a range of
stents, catheters, cardiac rhythm
management devices, pacemakers

etc. An increasing number of
startups and medical innovations
in the APAC countries are projected
to take the medtech ecosystem to

the next level in cardiac care.

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The burden of cardiovascular diseases (CVDs) risk factor for CVD. According to UN Population
such as ischaemic heart disease, coronary Division data, between 2020 and 2030, Singapore,
artery disease, angina, stroke, rheumatic South Korea, Hong Kong, Taiwan, and Thailand will
heart disease, congenital heart disease, peripheral become the fastest ageing societies in the world. Japan
arterial disease, aortic aneurysm and dissection, already has the world’s oldest population and will
deep vein thrombosis, across Asia Pacific (APAC) continue to age faster than the global pace.
varies by country, but is nonetheless substantial.
Collectively CVD is the leading or second-leading In Japan, where the world’s oldest population
cause of death across the region and the prevalence has seen the largest increase in the incidence of
continues to rise. Further, shifting demographics in ischaemic heart disease and stroke, medical experts
the region, with both an increase in younger people are speaking openly of an impending cardiovascular
experiencing CVD and ageing populations with disease pandemic. The estimated annual direct
multiple comorbidities, are putting health systems costs of ischaemic heart disease and stroke in Japan
under increasing pressure. accounts to $5.7 billion and $6.5 billion, respectively.

Age is arguably the most important non-modifiable As for Mainland China, CVD has, in just two
decades, moved from a relatively uncommon

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“Advanced AI “As cardiologists
methods, such continue to move away
as deep-learning from traditional imaging
convolutional neural
networks, have methods such as
enabled rapid, human- angiography, emerging
like interpretation of technologies are pivotal

the ECG.” to determine the best
- Dr Konstantinos Siontis, course of patient care.”

Cardiac Electrophysiologist, Department of - Dr Nick West,
Cardiovascular Medicine, Mayo Clinic, Chief Medical Officer and
Divisional Vice President, Global Medical Affairs,
USNational University Heart Centre Singapore Abbott- Vascular Business, US

condition to an epidemic in the country. It US$bn18
is estimated that 4 million deaths are due to 16
cardiovascular diseases each year in China, closely 14 Japan
followed by India. 12
10 5.5
Adding on, numerous studies have repeatedly
shown that individuals experiencing CVD events 8
have a significantly elevated risk of further events. 6
For instance, a Singapore-based study estimates 4
that around 7 per cent of those with a heart attack 2
suffer another one within a year. Meanwhile, another 0
study from Australia shows that of those discharged
from hospitals with acute cardiac syndrome, which Thailand Taiwan South Singapore Hong Kong Australia Mainland
includes both infarctions and unstable angina, 57 per Korea China
cent are readmitted within a year.
Indirect 0.5 1.0 1.9 2.8 3.2 4.1 5.6
Dr Tee Joo Yeo, Director, Cardiac rehabilitation
unit, National University Heart Centre Singapore Direct 0.2 0.2 0.8 1.2 1.4 0.9 2.4 6.5
explains, “Simply put, there are more people who are
now survivors of heart attacks and strokes. The more Fig 2- Estimated annual direct and indirect costs of stroke in
survivors there are, the more likely it is that there will
be recurrence.” selected APAC economies ($ billion) Source- The Economist- Intelligence Unit

In short, an ever-growing part of the population Medtech market dispensing better care
is known to have a CVD and may well survive a heart
attack or stroke. This demands urgent attention but CVDs have in turn pushed the growth of the
also represents an eminently realisable opportunity cardiovascular devices market over the years within
to ensure these individuals receive appropriate care. the APAC region. The rising healthcare expenditure
of the countries along with the huge R&D investment
US$bn 18 by major medical devices companies of the region
16 are anticipated to further promote the growth of the
14 Japan APAC cardiovascular devices market by 2026.
12
10 10.6 China contributed the major share in APAC
cardiovascular devices market in 2019 and is
8 expected to retain its position in the coming years.
6 The dominance of China is mainly due to the
4 presence of a substantial CVD workforce in the
2 country, followed by India.
0
Some of the global players dominating the
Thailand Taiwan South Singapore Hong Kong Australia Mainland APAC cardiovascular devices market are Abbott
Korea China Laboratories, Biotronik, Boston Scientific
Corporation, GE Healthcare, Hill-Rom Holdings,
Indirect 0.2 0.8 1.2 1.4 1.4 2.8 5.1 Inc., Medtronic PLC, MicroPort Scientific, Schiller
AG, to name a few. Moreover, new product launches,
Direct 0.4 1.3 1.9 2.2 2.2 4.5 4.6 5.7 mergers, acquisitions, public-private partnerships,
startup funding, and technological advancements
Fig 1- Estimated annual direct and indirect costs of ischaemic such as artificial intelligence, machine learning,
heart disease in selected APAC economies ($ billion) deep technology, 3D-printing etc. are making a
considerable difference in this space.

“Although the electrocardiogram (ECG) has

COVER STORY 21

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“Potential applications of “There are more people
the eko.ai platform and tools who are now survivors
of heart attacks and
range from expanding the strokes. The more
use of echocardiography in survivors there are,
clinical care to improving the the more likely it is
performance of cardiovascular that there will be
clinical trials, especially for the recurrence.”
early detection and prediction - Dr Tee Joo Yeo,
Director, Cardiac rehabilitation unit,
of heart disease.” National University Heart Centre
- James Hare, Singapore

Chief Executive Officer & Co-founder,
eko.ai, Singapore

long offered valuable insights into cardiac and and healthcare reimbursements, commencing with
non-cardiac health and disease, its interpretation Australia and Singapore. Hydrix is the exclusive
requires considerable human expertise. Advanced distributor of the AngelMed Guardian in eight Asia
AI methods, such as deep-learning convolutional Pacific countries including Australia, Singapore,
neural networks, have enabled rapid, human-like Japan, Malaysia, Hong Kong, Thailand, Indonesia,
interpretation of the ECG, while signals and patterns and New Zealand.
largely unrecognisable to human interpreters
can be detected by multilayer AI networks with Biotronik, based in Germany, is another global
precision, making the ECG a powerful, non-invasive player dominating the APAC cardiovascular devices
biomarker”, says Dr Konstantinos Siontis, Cardiac market. The company has recently launched its new
Electrophysiologist, Department of Cardiovascular injectable cardiac monitor (ICM) in Japan. The novel
Medicine, Mayo Clinic, US. device is designed to help patients with irregular
heart rhythms by documenting unexplained syncope
Quoting a recent development, US-based Abbott with increased clarity.
has received the Food and Drug Administration (FDA)
clearance for its latest optical coherence tomography In addition, Japanese firms Astellas Pharma Inc.,
(OCT) imaging platform powered by the company’s Nitto Denko Corporation, and M. Heart Co., have
new Ultreon Software. This innovative imaging recently joined hands to develop and market a portable
software combines OCT with AI to provide physicians ECG, for promoting early detection and appropriate
an enhanced, comprehensive view of coronary blood treatment of atrial fibrillation, a condition estimated to
flow and blockages to assist physician decision-making affect approximately 700,000 patients in Japan.
and provide the best pathway for treatment. Opening
more avenues for the APAC market, the Ultreon The Indian market too has seen the entry of
Software has recently received approval in Japan. many revolutionary cardiovascular devices by global
players in the last one year. For example, Abbott has
“As cardiologists continue to adopt OCT and launched its Amplatzer Piccolo Occluder in India,
move away from traditional imaging methods such the world’s first medical device that can be implanted
as angiography, emerging technologies are pivotal to in the tiniest babies (weighing as little as 700 gms).
determine the best course of patient care. AI enables The company has also launched a minimally invasive
Ultreon Software to automatically detect calcium and heart valve repair device to treat mitral regurgitation,
vessel diameters allowing doctors to put stents exactly and new implantable cardioverter defibrillator (ICD)
where they are needed,” says Dr Nick West, Chief
Medical Officer and Divisional Vice President, Global DIFFERENT PRODUCTS OF THE
Medical Affairs, Abbott- Vascular Business, US. CARDIOVASCULAR DEVICES MARKET

On the other hand, Angel Medical Systems Inc has ● Defibrillators
recently received the FDA approval to upgraded ● Catheters
battery of its Guardian device, the world’s only ● Angioplasty devices
implantable cardiac monitor intended to detect and ● Pacemakers
alert patients of a potential heart attack including a ● Artificial heart valves
silent heart attack. This approval has paved the way ● Stents
for the company’s exclusive distributor Hydrix, based ● Ventricular assist devices
in Australia, to submit applications for regulatory

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“SingValve was developed as and cardiac resynchronisation therapy defibrillator
a heart valve implant that is (CRT-D) devices in India.
made for the individual patient.
It belongs to the highest class of US-based Medtronic has released the world’s
implants in regulatory terms, and smallest pacemaker to treat heart block in the
constitutes a Class III implant, Indian market this year. Further, in order to help
which is the first of its kind reduce infections associated with the use of cardiac
globally, made in Singapore.” implants, Medtronic has introduced an absorbable,
single-use, antibacterial envelope that can be used
- Dr Theodoros Kofidis, with any implantable defibrillator, pacemaker, or
Associate Professor, Head and Senior Consultant, neurostimulator in India recently.

Department of Cardiac, Thoracic and Vascular “The medtech industry is a sunrise sector and
Surgery, National University Heart Centre, Singapore there is huge potential to improve patient lives. Some
of the research on new materials, mRNA technology
“We hope that we can application and innovative minimally invasive devices
create a new medical development will create a new horizon of improving
technology enterprise patient lives in near future”, says Ganesh Sabat, Chief
Executive Officer, Sahajanand Medical Technologies,
within Australia India. The company is currently in the process of
through world-leading setting up Asia’s largest stent manufacturing facility
multidisciplinary research with an investment of approximately $35 million.
and development to reduce
the burden of heart failure.” Startups set pulse racing

- Dr Shaun Gregory, Apart from the global players, a number of domestic
Senior Research Fellow, startups have set the pulse racing for the APAC
Department of Mechanical and Aerospace cardiovascular devices market with a range of
Engineering, Monash University, Australia novel products. For instance, Singapore-based eko.
ai has developed a machine learning platform to
“Some of the research automate the slow, manual and error-prone process
on new materials, mRNA of measuring and interpreting echocardiograms,
or ultrasound images of the heart. The startup has
technology application recently raised $4 million worth funding to grow
and innovative its development team and accelerate commercial
operations in the US and Europe.
minimally invasive
devices development “Potential applications of the eko.ai platform
will create a new horizon and tools range from expanding the use of
of improving patient echocardiography in clinical care to improving the
performance of cardiovascular clinical trials, especially
lives in near future.” for the early detection and prediction of heart disease.
- Ganesh Sabat, We have ongoing commercial and academic research
collaborations with multiple partners, including
Chief Executive Officer, AstraZeneca, Brigham and Women’s Hospital,
Sahajanand Medical Technologies, India Samsung Medical Center’s Heart, Vascular and Stroke
Institute, and the University of Alberta, with more
“We are to be announced soon”, shares James Hare, Chief
now able to Executive Officer & Co-founder, eko.ai, Singapore.

customize Then there is South Korea-based healthcare startup
3D-printed SkyLabs that has successfully commercialised its ring-
heart valves that type heart rhythm monitoring device, CART-I. The
will fit exactly to device monitors patients’ cardiac signals and helps
the dimensions detect atrial fibrillation, an irregular heartbeat that can
of the patient’s lead to heart-related complications.

heart.” Adding on, there is NewMed, a Shanghai-based
- Dr Sanjay Cherian, startup that is developing interventional artificial
heart valve systems. The startup now has three
Consultant - Cardio Thoracic and Vascular
Surgeon, Frontier Lifeline Hospital, India

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artificial heart valve replacement products under RECENT BREAKTHROUGHS IN
clinical trial, one of which has been selected to enter R&D AT APAC CARDIAC MEDTECH
the Chinese drug regulator’s fast-track registration SPACE ATTACHED
process for innovative medical devices and is
expected to become the first approved domestically Startup/ Institute Latest innovation
made mitral valve replacement product in China.
eko.ai, Singapore Machine learning-based
Another China-based startup, Hanyu Medical has platform to detect heart
developed a mitral valve interventional device that SkyLabs, South Korea diseases
is expected to become the second mitral valve repair
system marketed in China after Abbott’s MitraClip. NewMed, China Ring-shaped heart rhythm
monitoring device
Adding to the list is US-based startup CB Scientific Nanyang Technological
that has targeted the start of cardiac lab services University, Singapore Artificial heart valve
operations in Thailand last year. It has developed National University Health replacement products
a novel cardiac monitor to help in the detection of System, Singapore
abnormal heart rhythms. The startup has tied up with Monash University, AI-powered tool to detect
local distributors Mango Wellness and My Cardia Australia heart diseases
Thailand to establish its products in the country. Pohang University of
Science and Technology, Personalised heart valve
Medical innovations getting stronger South Korea bioprosthesis

A team of researchers from Nanyang Technological Dr Sanjay Cherian, India World-first durable total
University, Ngee Ann Polytechnic, Singapore, and the artificial heart
National Heart Centre at Singapore has invented an University of Auckland,
AI-powered tool that could speed up the diagnosis New Zealand Atherosclerotic coronary
of cardiovascular diseases. They have devised the artery using 3D-printing
diagnostic tool by using an AI machine learning system
algorithm called Gabor-Convolutional Neural
Network (Gabor-CNN), which mimics the structure India’s first 3D-printed
and function of the human brain, enabling computers heart valve
to learn from past experiences like a human.
Electroceutical-based
Using the algorithm, they trained their tool to heart device
recognise patterns in patients’ ECGs by inputting
examples of ECG signals that reflect cardiovascular MAJOR PLAYERS OF THE APAC
diseases. The team will be working with local hospitals CARDIOVASCULAR DEVICES MARKET
to conduct further trials to validate the clinical use of
their new AI tool with a larger database of patients. ● Medtronic (Ireland)
● Boston Scientific Corporation (US)
Another team of scientists at Singapore’s ● Abbott (US)
National University Health System has developed a ● Edward Lifesciences Corporation (US)
naturally-designed human-like personalised heart ● Cardinal Health (US)
valve bioprosthesis. Named SingValve, it mimics the ● iVascular (Spain)
appearance, form and physical properties of a human ● B. Braun Melsungen (Germany)
mitral valve. The first-inhuman trials which entail ● Terumo Corporation (Japan)
about 15 human implantations in two to three different ● Biosensors International Group (Singapore)
countries are expected to be conducted by 2023. ● Biotronik (Germany)
● GE Healthcare (US)
“In this advanced age of precision medicine ● Hill-Rom Holdings, Inc. (US)
and technology, we wanted to produce something ● MicroPort Scientific (China)
closer to the natural anatomy and function of the ● Schiller AG (Switzerland)
mitral valve. SingValve was developed as a heart
valve implant that is made for the individual IN FACTS
patient. It belongs to the highest class of implants
in regulatory terms, and constitutes a Class III ● More than 75 per cent of CVD deaths occur in
implant, which is the first of its kind globally, made low- and middle-income countries
in Singapore. SingValve creates a precedent in the
local manufacturing of a high-value implant, which ● 85 per cent of all CVD deaths are due to heart
will further strengthen Singapore’s MedTech scene”, attacks and strokes

Source- WHO

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mentions Dr Theodoros Kofidis, Associate Professor, University of Science and Technology (POSTECH)
Head and Senior Consultant, Department of Cardiac, in South Korea has succeeded in mimicking the
Thoracic and Vascular Surgery, National University atherosclerotic coronary artery using a 3D-printing
Heart Centre, Singapore. system. They have developed a customised occluder
that mimics an atherosclerotic coronary artery with an
Setting another example, a consortium of approximately 20 per cent blocked condition. It can be
universities, hospitals and industry, led by Monash used to mimic other ischemic cardiovascular diseases
University in Australia and US-based firm Bivacor such as chronic heart failure for further studies.
has received $1 million in Australia’s Federal
Government funding to develop and commercialise a A team of experts in India has also recently
world-first durable total artificial heart. explored the benefits of 3D-printing and in turn has
developed India’s first 3D-printed heart valve. This
“This project aims to significantly reduce the new 3D-printed heart valve could actually be the
burden of heart failure in Australia, and globally, future of cardiac surgery, since it overcomes most of
through ground-breaking multidisciplinary the disadvantages or complications associated with
research that will lead to the development and the currently available artificial heart valves.
commercialisation of cutting edge devices that
support or replace the heart. We hope that we can “An added advantage of this 3D-printed
create a new medical technology enterprise within heart valve is that its design was developed using
Australia through world-leading multidisciplinary specialised computer-aided design software and
research and development, building the capacity and modeling techniques, based on the MRI scan images
capability for translational research of Australia’s of the human heart, as a result of which, we are now
health and medical research sector,” says Dr Shaun able to customise 3D-printed heart valves that will fit
Gregory, Senior Research Fellow, Department of exactly to the dimensions of the patient’s heart. Also,
Mechanical and Aerospace Engineering, Monash since it is ‘Made in India’, the cost of this novel heart
University, Australia. valve could be much lower than that of the imported
heart valves that are currently used in India”, says
Another grant amount of $1 million is being Dr Sanjay Cherian, Consultant - Cardio Thoracic and
utilised by the researchers at the University Vascular Surgeon, Frontier Lifeline Hospital, India.
of Auckland in New Zealand (NZ) to develop
‘electroceuticals’- devices that stimulate or block Although the rising cases of CVDs across the
neural activity and which offer an attractive APAC region is a cause of major concern, the surge of
alternative to drug-based therapies for heart disease. startups and growing medical innovations is likely to
They can be more precisely controlled, and also have take the cardiac medtech ecosystem to the next level
fewer side effects. in the future.

Utilising the opportunities being offered by Dr Manbeena Chawla
3D-bioprinting, a group of researchers at Pohang [email protected]

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Life Science
Incubator stirs
international startup
interest in Singapore

Singapore has become a biomedical sciences hub at the heart of Asia by being the choice
location for companies to develop and create new products that meet Asia’s healthcare
needs. Singapore is home to more than 60 multi-national Medtech companies, undertaking a
range of activities from manufacturing to research and development. Since the launch of the
Biomedical Sciences Initiative in 2000, Life Sciences has been developing as a key economic
pillar in Singapore. The government recognises Biomedical Science as an area with significant
economic potential. We take a closer look at Life Science Incubator (LSI), a novel venture by
the Singapore government that promises to accelerate the startup ecosystem in the region,
aiming to spread across the ASEAN and beyond.

According to Singapore government reports, in representatives of educational institutions, ecosystem
2016, the Government invested S$4 billion, or builders, industry accelerators and partners from
one-fifth of the national R&D five-year budget, Singapore and Germany in a hybrid setting. These
into health and biomedical research. With these included representatives from Enterprise Singapore,
investments Singapore’s commitment to developing Economic Development Board (EDB), SGInnovate,
into a world-class biomedical hub is evident. Despite National University of Singapore (NUS), Nanyang
the economic headwinds from COVID-19 and other Technological University (NTU) and Agency for
geopolitical events, the country demonstrated Science, Technology and Research (A*STAR). The
resilience through robust and persistent performance German accelerators, teams at the German Embassy,
by biomedical clusters. Singapore’s Biomedical and the German Chamber of Commerce (AHK)
cluster employs about 25,000 workforces and were among the elites along with several partner
contributed almost 18 per cent of manufacturing the organisations.
GDP in 2020.
Life Science Incubator was founded by Tako
On September 22, 2021, Singapore launched Life
Science Incubator (LSI) at its German Centre located
at the International Business Park. The novel venture
will brace the growing pool of startup ecosystems
while also attracting German and European
companies looking to access and accelerate in the
region.

The launch was officiated by Alvin Tan, Minister
of State, Ministry of Trade and Industry (MIT),
Singapore and Dr Norbert Riedel, Ambassador to
German Embassy in Singapore, in association with

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“Partnerships between Ventures LLP and is a joint venture with Acromec
Singapore and German Engineers Pte Ltd. Tako Ventures is a Singapore-
companies are expected to incorporated limited liability partnership focused
grow further as both countries on investing in scientific enterprises, whose three
deepen business ties. The founders are active in the life sciences and critical
number of business missions to environment design, supply, and building.
Germany increased from 13 in
2018 to 22 in 2019, benefitting Launch-pads and catalyst
over 150 companies across
sectors such as advanced for life science ventures
manufacturing, Medtech and
healthcare, future of mobility, Life Science Incubator is set to fully fill the agile
and e-sports. This is a dynamic demand at a thriving startup pool with equipped and
location for tech startups affordable facilities to resource the ecosystem. The
looking to scale up globally, facility will leverage local accelerators, universities
and LSI has prepared a most and polytechnics to engage in their missions,
conducive environment for stimulating entrepreneurship and providing external
startups to ideate, thrive and resources to support the spin-out efforts of these
internationalize. We continue institutions.
to welcome the global flows of
trade, investment, and talent The novel shared laboratory concept at Life
including from Germany.” Science Incubator has a clear mission to create
accessible and affordable launch-pads for life science
- Alvin Tan, companies catering to a diverse range of startups
Minister of State, Ministry of Trade and working across the biotech, biopharma, food tech and
Medtech space while acting as a melting pot for local
Industry (MIT), Singapore and international talents looking to scale and grow in
Singapore.
“Life Science Incubator is a
state-of-the-art BSL Level 2 Speaking about the involvement of the network
coworking laboratory that exists of Venture Capital companies, Niamh Madden,
to facilitate Biotech, Foodtech General Manager at Life Science Incubator said,
“The VC partners of LSI will play an integral role for
and Medtech companies the startups that decide to locate themselves within
to develop and grow in an
accessible, agile and affordable

facility and to be a space
conducive to collaboration and
cross-pollination. LSI creates a
space where multinationals and
leaders in technologies, services

and equipment can join the
conversation. Where these

companies can support and
engage the burgeoning startup

ecosystem that Singapore has
fostered and that Life Science
Incubator will attract. We will
supplement and support the
population of startups and mid-
sized companies, both local and
international, with a move-in

ready ‘plug and play’ lab.”
- Niamh Madden,

General Manager, Life Science Incubator, Singapore

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LIFE SCIENCE INCUBATOR
MEMBER COMPANIES

● Cellivate Technologies Pte Ltd,
● Wasna Pte Ltd, Haemetrics Pte Ltd
● Haemetrics Pte Ltd
● Big Idea Ventures

Dr. Norbert Riedel has a well-established network around startups
ecosystems. The government policies and schemes
and Mr Alvin Tan foster a culture of nurturing and boosting life sciences
biomes and entrepreneurship across regional
at the Life Science superlative universities, research organisations and
industrial R&D. Singapore is well positioned as a hub
Incubator Launch in the region by being a perfect base for many global
investors and entrepreneurs. LSI aims to connect
the facility. They will act as the first point of contact these dots and become an ecosystem of research and
for potential pre-seed/series A investment when development with potential spread across ASEAN
these startups are ready to go to market. There will and beyond.
be regular workshops from various members of the
VCs to assist the startups in preparing for their first Singapore-Germany bilateral cooperation
and second rounds of investment. These VC partners
bring a huge network throughout South East Asia and Since its inception in 1995, The German Centre
Europe which we hope the LSI startups will be able to Singapore has supported more than 600 companies
leverage and network through”. in entering and doing business in Southeast Asia.
Currently, 150 companies call the German Centre
“LSI strives to become a scientific community their “home away from home”. The German Centre
where startups can grow, learn and cross-pollinate. delivers the ecosystem for businesses from co-
At the same time, providers of services and working areas for temporary use up to permanent
equipment in the scientific industry have a space to private sectors that allow expansion over time. The
launch, test and develop their products to make them German Centre Singapore is a member of Landes
suitable for the local markets. Both are surrounded bank Baden-Württemberg (LBBW). With deep
by a support network of advisors, lawyers, VCs, etc. roots in Germany, LBBW is present in a number of
to foster their growth and make use of Singapore as a economic and financial hubs worldwide and runs
strategic location in ASEAN,” she added. German Centres in Singapore, Beijing, Moscow,
and Mexico. A large number of partner companies
Speaking at the event, Singapore’s Minister of in LSI are German-headquartered and are utilising
Trade and Industry, Alvin Tan said, “LSI’s mission LSI to showcase their technology in this region. LSI
is to attract and support local and international provides the ability to position equipment/technology
startups in Singapore. Startups play a pivotal in a German infrastructure lab environment.
role in unlocking the commercial value of our
research and development efforts. They bring novel Besides its significance as a space for
solutions to market and complement the efforts collaborations and developments in the life sciences,
of larger companies to enhance the vibrancy and LSI’s presence at the German Centre creates a
competitiveness of our biomedical and food tech gateway to Germany and Europe for its members who
industries”. share Singapore’s goals to develop SMEs and Biotech
startups. LSI will facilitate many German scientific
Singapore with its thriving startup scene along equipment SMEs an opportunity to exist in Singapore
with a skilled local and international workforce without massive investment and thus leveraging
the advanced German technology on the Singapore
market.

Niamh says, “The German Centre has been an
integral part of LSI’s journey and an incredibly
valuable partner over the last 14 months. The
German centre is already the focal point for German

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“Merck focuses on accelerating
access to better health,

from advancing genome
editing technologies,

providing intelligent lab
solutions, to optimising the
research discovery, testing
and manufacturing of new
molecules and more. As the
platinum partner to LSI, we
will provide our solutions in
protein research, cell biology,

drug discovery, genomics,
bioprocessing and purification

systems.”
- Rajeev Nair,

Senior VP & Head of Asia Pacific,
Merck Lifescience, Singaporethe Pacific, Singapore

commerce in Singapore, with a particular focus Lab Tour at Life Science Incubator Launch
on high tech SMEs. LSI now complements that
cluster and provides a platform for local as well as emulating Operation Theatre (OT) for an accelerated
international companies to set up and grow”. valuation cycle. Speaking on the inclusion of the
Operating theatre in LSI, Niamh says, “The demand
In October 2020, Germany-Business Forum for operating spaces in Singapore’s hospitals is
Connect (GSBF Connect), was launched to support incredibly high and exorbitant. For most medical
discussions and deepen business ties between device manufacturers there is no need to work on
German and Singaporean companies. The series an actual human or a cadaver, the device can be
of year-long events focused on developing faster, showcased effectively on carrions or vegetables. With
digital, and more industry-relevant connections that in mind, a showcase operating theatre without
between the two nations. Policymakers and industry conventional enrolment procedures will add value to
heads discussed Southeast Asian collaborations, the scientific and start-up community”.
sustainability, and open innovation.
Foodtech venture
The Primary Focus
LSI initiated its Foodtech connection with a plant-
Life Science Incubator’s primary focus is to support based meat startup. Foodtech research is usually
Biotech, Biopharma, Medtech and Foodtech carried out between a BSL2 facility and an industrial
companies. The facility includes a large open kitchen. The facilities cater to advanced food
laboratory with shared equipment, six private suites technologies and applications. Additional access
for research confidentiality and a host of shared to an industrial kitchen in the German Centre will
support rooms including a pilot plant and demo be complimenting the overall industry needs and
operating theatre. requirements, as and when needed.

Biotech and Medtech ventures The Minister of State (MTI) Alvin Tan said, “For
the Foodtech industry, the past 18 months of COVID-
With the growing number of Medtech startups related supply chain disruptions have put it in the
emerging in Singapore, Medtech vertical has begun spotlight. As a small and open country that imports
as an integral part of LSI with a functioning demo over 90 per cent of food, Singapore is vulnerable to
operating theatre. Currently, onboard startup
members and companies at LSI are working
on ground-breaking innovations and exploring
everything from alternative protein or cell-based
meat to female fertility.

Medtech companies can create, evaluate and
demonstrate their innovative tool or procedure in an

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“Singapore has invested
heavily in life sciences

over the past decades and
has created an excellent

ecosystem for research and
commercialisation. The newly

established Life Science
Incubator is a highly valuable
addition to this system that will
allow it to tap the vast potential
of bilateral cooperation in this

area.”
- Dr Norbert Riedel,

German Ambassador, Regional Director for Asia and
the Pacific, Singapore

the global food market and supply chain volatility. technology to assist in their research.
Hence, Singapore Food Agency is shoring up local Merck has been supporting startups in the Life
food production capabilities to help meet Singapore’s
nutritional needs”. Science Incubators through collaboration or funding
programmes to support their research discovery,
He further explained, “Singapore is leading scale-up and implementation. Merck’s offers
internationally in the clean meat industry. We are the numerous initiatives and inspires entrepreneurs at
first country to grant regulatory approval for cultured the Life Science Incubator to utilise some of Merck’s
‘labgrown meat’ to be sold commercially. Such programmes.
solutions represent new possibilities for us as we
build greater food resilience in Singapore. A resource ● The Accelerator programme: Encouraging
like the Life Science Incubator can offer a crucial startups to work with Merck’s business sectors for co-
launchpad for the growing population of startups development of innovative products.
working on innovative solutions and tech in the lab-
grown protein sphere, as well as other niches within ● M Ventures: Backing entrepreneurs through
the Foodtech sector”. equity investments for translating innovative
technologies and products into commercialisation.
Merck’s Support Towards
LSI Research Innovation ● The Future Insight Prize: A monetary
reward of up to 1 million Euros every year to honour
Multinational pharmaceutical company Merck ground-breaking innovation in science & technology.
has partnered with LSI while sharing mutual The focus in 2022 will be on Energy-CO2 conversion.
values of empowering the scientific community in
creating a strong trust and alignment to a long and Working with EDB, Merck has also brought in
successful partnership. Merck will be assisting LSI the BioReliance Biosafety Testing Lab, with a new
by supporting the startup community in accelerating capability in the areas of biosafety testing services, a
research and innovation. Merck partnership with LSI critical step in drug development process to ensure
will add value in terms of the best equipment and sterility and safety.

With all the progressive developments, LSI is
looking forward to thriving partner companies,
state agencies, institutions and ecosystem builders
to support small and medium (SME) businesses to
evolve. Aiming to strengthen collaborations, LSI
is facilitating valuable dialogue between partner
companies and a growing cohort of members to
establish LSI as a world-class space for science
innovations. Adding value to Singapore’s network of
companies, LSI will rejuvenate the next generation of
Life Science Leaders to further solidify Singapore as a
leading destination for Life Sciences innovations.

Hithaishi C Bhaskar
[email protected]

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MARVELS OF GENE-EDITED
MEDS UNLEASHED

In June 2021, US-based Intellia Therapeutics announced first-ever clinical data supporting safety
and efficacy of in vivo CRISPR genome editing in humans, a pivotal moment in the gene editing
landscape, offering hope for genetic disorders. BioSpectrum explores the latest in the field of gene
editing and what the future holds for this technology.

There are three commonly acknowledged Dublin-based ERS Genomics Limited, was
gene editing technologies, namely, Zinc formed to provide broad access to the foundational
Fingers, Transcription Activator-Like Effector CRISPR/Cas9 intellectual property co-owned by Dr
Nucleases (TALENs), and Clustered Regularly Emmanuelle Charpentier. This could be the reason
Interspaced Short Palindromic Repeats (CRISPR). CRISPR is having its moment.
While all three enable gene editing, it was the advent
of CRISPR in 2012 that has led to widespread use of In June 2021, US-based Intellia announced the
gene editing technology within life sciences research. first clinical data in history to demonstrate potent
reduction of disease-causing proteins with a single-
Scientists Dr Jennifer Doudna (UC Berkeley, dose infusion of CRISPR genome editing therapy.
USA), Dr Emmanuelle Charpentier (Max Planck, They were able to directly deliver lipid nanoparticles
Germany) and Dr Feng Zhang (MIT, USA) are the containing Cas9 mRNA and gRNA to liver cells
pioneers of CRISPR gene editing. The trio and the to correct ATTR amyloidosis. This is the first case
respective institutions backing them have founded of direct gene editing in humans and appeared to
companies to commercialise the CRISPR-Cas system. be safe and very effective. These landmark data
Dr Jennifer Doudna and Dr Emmanuelle Charpentier represented a momentous milestone for the patients
share the 2020 Nobel chemistry prize for their and the biotech industry.
discovery of gene-editing technique.
“Over the last years, the field has begun to
Dr Doudna has founded Caribou Biosciences and transform the potential of CRISPR into medicine;
Intellia Therapeutics, while CRISPR Therapeutics, however, technical challenges remain. Realising
ERS Genomics and Casebia Therapeutics are the full potential of CRISPR and the benefits of in
associated with Dr Charpentier. Editas Medicine was vivo genome editing requires the ability to deliver
launched by Dr Zhang and Dr Doudna. the treatment to the right cells in the body and to
the right location in the genome. Intellia is the only
“Gene editing with CRISPR is a relatively simple company that has produced clinical data indicating
process, allowing scientists at any level to easily apply our ability to achieve both these criteria – a highly
the technology. Reagents can be obtained in days significant scientific and technical
(versus several weeks for the other technologies) and achievement. This is critical
generally come at a considerably lower cost. CRISPR for establishing the broadest
is flexible enough to be used in any of the three main potential for patients across a
forms of gene editing - deleting, inserting, or editing wide range of diseases,” said
DNA. A huge advantage of CRISPR is that it can be John Leonard, President
used in a ‘library’ format wherein thousands of gene and Chief Executive Officer,
edits can easily be made simultaneously and then Intellia Therapeutics, USA.
the results are shifted to find specific target genes
with interesting results. This has enabled scientists Until now, scientists have used CRISPR ex vivo
to begin untangling the vast collection of genomic where editing occurs in cells outside the body and
data which has been amassed over those edited cells are transferred into patients. That’s
the last 10 years, and use that why Intellia’s results represent a step forward for
information to better understand CRISPR.
the complexities of biological
processes and disease,” said Eric “Presently, there are many active clinical trials
Rhodes, CEO, ERS Genomics, employing some level of gene editing. These include
Ireland. random integration using lenti-based systems and
targeted editing using CRISPR and TALEN-based

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technologies. Most of the current work is ex vivo LATEST DEVELOPMENTS
where cells are modified outside the body and then
delivered back for therapeutic effect. ● In January 2020, Irish-firm ERS Genomics
We are getting very good results in
disrupting a gene using CRISPR licenses CRISPR gene editing technology to
or TALENS where more than
90 per cent editing is becoming Japan’s Daiichi Sankyo to support internal
common”, said Jason Potter,
Director of Genome Editing, research and development
Thermo Fisher Scientific, USA. ● In June 2020, US’ Vertex and CRISPR

Though CRISPR is the toast of the town at Therapeutics’ investigational CRISPR/Cas9
the moment, there’s scope for other gene editing
technologies too. US’ Sangamo’s Therapeutics is gene-editing therapy showed promise in more
using its proprietary Zinc Finger (ZF) platform to
develop therapies for a wide variety of diseases. patients with sickle-cell disease
● In June 2021, US’ Beam Therapeutics, Apellis
French firm Cellectis uses TALEN to develop
therapies for cancer as does Bluebird bio of the USA. inked a deal deal to apply base editing to

Ethical concerns discover novel therapies for complement-driven

In 2018, when Chinese scientist Dr He Jiankui, diseases
announced that he had created the world’s first gene- ● In June 2021, Swiss-American firm CRISPR
edited babies using CRISPR, it sparked a controversy
and raised ethical concerns about the use of such Therapeutics has partnered with Capsida
technologies.
Biotherapeutics to discover and develop new
Since then, the World Health Organisation
(WHO) has banned the germline cell editing and in gene-editing therapies for Friedreich’s ataxia
June 2021 issued new recommendations on human
genome editing for the advancement of public health. (FA) and familial amyotrophic lateral sclerosis

The reports deliver recommendations on the (ALS)
governance and oversight of human genome ● In June 2021, US’ Gene editing startup Verve
editing in nine discrete areas, including human
genome editing registries; international research Therapeutics to raise $267 million in Initial
and medical travel; illegal, unregistered, unethical
or unsafe research; intellectual property; and Public Offering (IPO)
education, engagement and empowerment. ● In July 2021, US’ Prime Medicine launches with
The recommendations focus on systems-level
improvements needed to build capacity in all $315 million financing to deliver on the promise
countries to ensure that human genome editing is
used safely, effectively, and ethically. of prime editing
● In July 2021, US based Caribou Biosciences
A CRISPR Future
raised $304 million in one of gene editing’s most
By virtue of its ease of use and low cost, CRISPR
has already opened up the use of genome editing to lucrative IPOs
disciplines that had previously not even considered it
as a possibility. The biggest barrier to overcome in gene editing is
to demonstrate its effectiveness and safety. Current
“It is likely to become a major player in the trials reveal that the process can be safe and long
treatment of genetic diseases. Perhaps much in the lasting. However, most applications are still focused
same way that software has evolved to manipulate on untreatable orphan diseases and very sick people
computer and robotic hardware, so too will gene so the affected populations are small.
editing serve as a ‘coding tool’ for exploring and
exploiting the biological hardware of living systems. “As gene editing is proven safe and as we better
The ethics surrounding gene editing are also understand how to deliver it for best effect, it will be
becoming an important topic as the technology applied to more common diseases, like some forms
evolves and applications expand”, said Dr Rhodes. of diabetes, where there are currently established
therapies. A lifetime of being on a drug could be
replaced by a single gene editing treatment to
cure the disease. Debilitating childhood diseases
could be cured early, allowing for a more normal
development”, added Potter.

Ryan Donnelly, Senior
Product Manager, Gene
Editing Reagents, Horizon
Discovery, UK, outlines how
gene editing will evolve in the
future. From research to therapy,
Horizon Discovery drives the
application of gene editing and gene modulation. “The

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KEY PLAYERS “The type of cells being manipulated will continue
to expand. While immortalised cell lines are relatively
● US-based Intellia is a pioneer in the development easy to edit and therefore great for proof-of-principle
of CRISPR/Cas9 genome editing and is rapidly work, they are limited in how similar they are to
moving experimental therapies towards the non-cancerous cells found in vivo. As such, groups
clinic will look to work with cell types that more accurately
represent cells found in vivo e.g., differentiated
● CRISPR Therapeutics AG is a Swiss-American induced Pluripotent Stem Cells (iPSCs), primary
firm, transforming CRISPR/Cas9 technology cells, 3D cell models and organoids, as to have
into breakthrough human therapeutics. Its stronger confidence in results. It will continue to
lead programme targeting the blood diseases evolve beyond gene editing. ‘CRISPR without the
β-thalassemia and sickle cell disease has cut’ systems use deactivated or ‘dead’ Cas9 (dCas9)
entered clinical testing, as has its allogeneic which utilises guide RNAs to target the CRISPR-
CAR-T program targeting B-cell malignancies dCas9 complex to a specific DNA region but instead
of cutting the DNA, the dCas9 is linked to additional
● US’ Editas Medicines is using CRISPR, to protein(s) e.g., activators, inhibitors, epigenetic
research and develop both in vivo and ex vivo modifiers, affinity tags, or fluorophores, the options
gene edited medicines for wide variety of are endless”, added Donnelly.
diseases. Its main focus is on ocular diseases
Therapies using CRISPR will revolutionise
● US’ Caribou Biosciences Caribou is a clinical- medicine. Early success stories on the use of CRISPR
stage biopharmaceutical company focused to correct disease causing mutations in humans show
on developing genome-edited allogeneic cell that CRISPR-based therapies are a reality. However,
therapies for devastating human diseases targeting these therapies to difficult-to-access organs
such as the brain may continue to pose issues.
● South Koreas’ ToolGen, Inc. is a publicly traded
biotechnology company focused on the Gene editing is advancing so rapidly that next-
development and application of genome editing generation technologies are already on the heels of
technologies. It creates, and holds intellectual CRISPR-Cas9. One such example is base editing.
property rights for essential tools and US’ Beam Therapeutics is pioneering the use of
technologies for editing the genetic information proprietary base-editing technology to develop
in microbial, plant, animal, and human cells powerful, uniquely precise genetic machines that
rewrite genetic code.
● US’ Sangamo Therapeutics is using its
propriety genome regulation technology, zinc Another American firm Editas Medicines recently
finger protein transcription factors (ZFP-TFs), released data on a new gene editing technology
to develop therapeutics for wide variety of termed SLEEK (SeLection by Essential-gene Exon
diseases Knock-in). SLEEK enables high efficiency, multi-
transgene knock-in of iPSCs, T cells, and Natural
● French firm Cellectis, a clinical-stage Killer (NK) cells.
biotechnological company employing its core
proprietary technologies to develop products Although still in the research and development
based on gene-editing with a portfolio of phase, gene-edited medicines will inevitably transform
allogeneic chimeric antigen receptor (CAR) the lives of millions of patients and transform the
T-cells in the field of immuno-oncology and industry when they are launched in the market.
gene-edited hematopoietic stem cells (HSC) in
other therapeutic indications Ayesha Siddiqui

● US’ Beam Therapeutics is pioneering the use of
base editing — a potential new class of precision
genetic medicines — with a vision of providing
life-long cures to patients suffering from serious
diseases

scale and number of experiments and/or edits made
will rapidly increase. Instead of interrogating a single
gene, experiments could be set up to investigate an
entire network of pathways, or to engineer cell models
capable of mimicking polygenic diseases with multiple
causative mutations”, said Donnelly.

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VIRTUAL REALITY: A MAJOR
HEALTHCARE INFLUENCER

The time is finally ripe for a meaningful utilisation of Virtual Reality (VR) and Augmented Reality
(AR) in healthcare. Major leaps in software development and equally reliable hardware has made
applications of VR in complicated surgeries a complementary tool. Visualisations to improve patient
outcomes, helping physicians and students interact in the VR world to effectively recreate realtime,
stressful and life-threatening scenarios is being increasingly deployed across the world. We shall
enter this new promising world in healthcare to examine its impact thus far.

Virtual reality (VR) is mostly seen as the with Healthcare IT News, Australian VR startup
domain of the gaming industry. The Vantari VR said four tertiary hospitals have been
increasing penetration of connected devices using its VR training platform in critical care.
in the healthcare sector, increased investment, and
the growing need to reduce the healthcare cost are Mental health
the major drivers of virtual reality in the healthcare
market. According to Facts and Factors market While VR has been used successfully to treat post-
research report, the global virtual reality healthcare traumatic stress disorder (PTSD), it has also been
market is expected to grow from $2.70 billion in proven to manage other mental health problems such
2020 to reach $40.98 billion by 2026. as depression, phobias, addiction, stress, and anxiety.
By providing new ways to keep the body relaxed and
While still in the early stages of adoption, there calm, VR helps with anxiety and stress. In a method
are various possibilities for VR in the healthcare known as therapeutic VR, users wear a VR headset and
sector, including medical education, surgery, and experience a simulation designed to calm their mind.
managing mental health.
A study published in the Complementary
Medical training Therapies in Medicine in August 2020, found that
in anxiety/phobias, virtual reality can be used as
The most obvious and widespread application of supportive therapy, not a replacement for traditional
VR has been in the space of medical education. One treatments. VR is being used more and more often
study published in the journal of Advances in Medical as a therapeutic tool in psychology or psychiatry.
Education & Professionalism in 2018 found that However, there has yet to be a comprehensive
48 per cent of students have used virtual education synthesis and critical review of the literature to
technology for laparoscopic surgery training. Using identify future directions to advance the field in this
virtual reality has improved learning in 74 per cent area, the study mentioned.
of the students. Higher accuracy of almost 87 per
cent, has been reported in medical practice by those Surgery
trained through VR medium.
Another application of VR is in the field of surgery.
Virtual reality provides real-life scenarios via Several companies have created platforms that use
the simulated environment, making it easier to gain VR to help surgeons practice their skills. Virtual
practical knowledge that would otherwise be difficult reality also assists surgeons in planning upcoming
to comprehend in a real environment. operations and educating patients. It helps doctors
in the operating room, guiding them in a three-
COVID-19 pandemic has accelerated this further. dimensional space.
Japanese VR medical device maker Jolly Good,
together with the Nippon Medical School, a university US-based OssoVR, the leading virtual reality-
in Tokyo, has developed a cloud-based clinical based surgical training company, has launched
education platform that uses VR for medical students the world’s first VR-based multimodal assessment
who are unable to attend clinical practice due to the experiences. In addition to adding this capability
spread of COVID-19. within its platform, Osso’s platform has also launched
in multiple new languages in addition to English,
Hospitals in Australia are starting to utilise VR in including Japanese, Spanish, German and French
practising life-saving procedures, cutting down the to broaden access in more than 30 countries where
training time from months to days. In an interview

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VR IN ACTION VR in the healthcare system, Asia isn’t far behind
either. There has been a flurry of activities in the
● In 2015, doctors at Miami’s Nicklaus Children’s recent past in this space. Perhaps the most notable
Hospital, USA used Google Cardboard and an one is South Korea’s electronics giant Samsung
app called Sketchfab to map a baby’s heart in which, in 2017, has developed a new application of its
VR, prior to surgery. VR headset, the Gear VR, to enable doctors to better
diagnose mental disorders. The firm developed it in
● In 2016, VR view of surgery live-streamed for partnership with FNI, Seoul’s Gangnam Severance
the first time to audience worldwide when UK Hospital and content maker.
doctors used VR technology during a surgery to
show the operation. In 2018, Travelers Companies, Samsung
Electronics America, Cedars-Sinai, Bayer and
● In 2019, VR headsets were being worn for the AppliedVR announced that they would commence
first time by patients at St George’s Hospital, a new study to explore the effectiveness of a digital
London, UK to change the way they experience pain-reduction kit that uses therapeutic VR and
anxiety during wide-awake surgery. The wearable technology as a non-pharmacological
headsets were being offered to patients having supplement to managing pain associated with
regional anaesthetic for upper limb surgery as acute orthopaedic injuries of the lower back and
a way of helping them to relax ahead of and extremities. In 2016, Taiwanese smartphone
during surgery. manufacturer HTC entered the field with the HTC
Vive, a VR device. Since then, the device has been
● In Aug 2021, a study showed that VR can used for surgery simulation and medical training
decrease pain and anxiety in children undergoing around the world.
intravenous (IV) catheter placement. VR works so
well that Children’s Hospital in Los Angeles USA In 2018, HTC’s healthcare division, DeepQ,
now offers it routinely for blood draws. announced the completion of the world’s largest VR
anatomy lab in collaboration with Taipei Medical
it is currently utilised. OssoVR is the first surgical University. In 2019, HTC Vive partnered with
training platform to take a multi-modal approach to SimforHealth, a French VR surgical simulation
assessment in a milestone-based training model. This firm to train medical personnel around the world.
approach, for the first time, allows users to assess Japanese startup HoloEyes is making VR surgery
their knowledge of specific workflows, including what a reality in the country. Its software converts two
to do when things go wrong (as they unfortunately dimensional CT (computed tomography) and MRI
sometimes do during surgery). (magnetic resonance imaging) scans into 3D images
for use in VR platforms and has already been in use
Singapore-based Kyalio and the Endoscopic and at several Japanese hospitals for procedures like
Laparoscopic Surgeons of Asia (ELSA), developed the orthopaedic and liver surgeries.
day-to-day endo-laparoscopic VR surgical library. A
first in Asia, the multi-platform VR surgical library, Risk assessment
which utilises real-scene VR, addresses the importance
of continuous surgical training and enables cross- Healthcare traditionally has been slow to adopt
border surgical education to be sustained even in digital technologies and with good reasons. While VR
the face of COVID-19. The library also supports provides exceptional opportunities to transform the
long-distance surgical training for young surgeons in healthcare sector, it’s not without challenges.
developing countries and remote areas.
While cost and data privacy remain the topmost
Making inroads in Asia concern, there are other challenges too. Simulation
sickness, perceptuomotor, headaches and eye strain
While the USA leads the way in terms of integrating are some of the side effects of VR therapy.

Since the widespread adoption of such technology
is still in its nascent stage, there are no regulations in
place. For it to successfully integrate in the healthcare
system and to avoid its misuse, robust regulatory
policies are a must. The Healthcare industry is at a
tipping point. The COVID-19 pandemic and emerging
technologies such as VR will help shape the future of
the healthcare industry.

Ayesha Siddiqui

SPEAKING WITH 35

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

“We’re actively tackling issues

concerning trade, investment and health”
The EU-ASEAN Business Council (EU-ABC),
a primary and sole voice for European «
business in the ASEAN region, enhances
trade, commerce and investment between Europe Chris Humphrey,
and ASEAN. It is recognised by the European Executive Director,
Commission and the ASEAN Secretariat and is EU-ASEAN Business
an accredited entity under Annex 2 of the ASEAN Council, Singapore
Charter. Independent of both bodies, the Council
has been established to help promote the interests in Southeast Asia and called for an urgent and
of European businesses operating within ASEAN. greater focus on the implementation of life-course
It works on a sectorial and cross-industry basis to immunisation. The EU-ABC is the only pan-ASEAN
help improve the investment and trading conditions business body for European business.
for European businesses in the ASEAN region by
influencing policy and decision-makers. The EU- How is EU-ABC promoting healthcare
ABC’s membership consists of large European capabilities, trade, and investment between
Multinational Corporations and the nine European Europe and the ASEAN region?
Chambers of Commerce from around Southeast Asia.
We have produced a number of policy position
In September, EU-ABC held a health papers over the last year aimed at opening debates
summit in Singapore bringing together business with policymakers and other key stakeholders on
leaders, members of the diplomatic corps, and a range of health-related matters. These include
academics across Southeast Asia and Europe to a paper on Sustainable Health Financing and
discuss and deep dive into emerging trends and one on the need for the promotion of self-care in
transformative healthcare industry solutions, ASEAN. We have also run a number of workshops
addressing the unprecedented circumstances on these issues and on the Healthy Ageing topic
posed by the global health crisis on healthcare across the ASEAN region as well as webinars on
systems. BioSpectrum Asia had an opportunity topics involving both industry and government
to converse with Chris Humphrey, Executive representatives. These are in addition to our recent
Director of EU-ASEAN Business Council, Singapore Summit focused purely on health issues that
in an insightful discussion. Edited excerpts; involved a range of sector experts and Ministers from
across ASEAN. Regular dialogue with government
What’s the standing of the EU-ASEAN bodies, Ministries of Health, Finance and Trade/
Business Council (EU-ABC) in the ASEAN Commerce are key planks of our ongoing efforts
region? to promote both health issues and those related to
trade and investment.
EU-ABC represents the voices of EU-businesses
in ASEAN by promoting their interests through Can you elucidate sustainable healthcare
the frequent release of advocacy papers, high- financing in ASEAN and the Asia Pacific?
profile dialogues with the ASEAN government and
various ASEAN sectoral bodies as well as through EU-ABC’s Insurance Paper released in March this
gauging the sentiments of its members through the year, is focused on improving the affordability of
annual business sentiment survey. The advocacy insurance protection using tax policies, intelligent
papers address issues in the ASEAN region, where automation and investments. It emphasises
relevant stakeholders from the private sector improving the accessibility of insurance with digital
come together to recommend changes towards the solutions, and providing integrated digital health
ASEAN government. For example, the Healthy solutions to ensure the protection of individual
Ageing and Lifetime Immunisation Advocacy Paper, wellness. Additionally, our Sustainable Health
contributed by KPMG in Singapore, and Sanofi, with
the support of the Western Pacific Pharmaceutical
Forum (WPPF) unveiled healthy ageing barriers

36 SPEAKING WITH

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Financing paper published last year developed a towards prioritising healthcare economies
number of recommendations to help the countries of
the region make the aim of universal health coverage and funding to address preventative care?
more affordable.
Governments and society at large, cannot take
These included resolving the inefficiencies in the healthcare for granted. Therefore, investing in
existing system through elements such as: health, in all aspects, is vital for society. This does
not just mean more hospitals, doctors, clinics
● Establishing a more regular routine of driving or nurses (though in some cases more are truly
healthcare issues across multiple ministries needed), but it also means the right policies to
(Ministry of Finance, Ministry of Health, Ministry of encourage healthier living, allowing access to
Education, etc.); products and services for people to look after
themselves better, promoting education on healthier
● Bringing preventative concepts into reality, living, vaccinations, etc., and advancing more
for example through promoting life-course modern elements such as digital health tools.
immunisation, promoting healthy lifestyles and
introducing more early diagnosis techniques; How can the ASEAN region come together to

● Promotion of self-care through increasing tackle the spread of counterfeit drugs in the
access to OTC products, vitamins and minerals and
leveraging digital health tools region?

● Augmenting the roles of nurses and EU-ABC’s advocacy paper, ‘Tackling Anti-illicit
pharmacists Trade in ASEAN’, highlights recommendations
across different areas of concerns:
● Revisiting the core financing model to upgrade
the system: Counterfeit Drugs
● Develop a comprehensive framework
How significant is public-private partnership pertaining to the implementation and protection of
and collaboration in leveraging life-course lot codes.
immunisation and improving access to ● Define serialisation and Track and Trace laws,
quality healthcare? mandate serialisation of products.
● Form a regional Public-Private working group
To establish life-course immunisation as a core for Illicit Trade to share market intelligence and
part of healthy ageing policies, a whole-of-system investigative techniques with customs authorities.
and society approach is needed, both top-down and E-commerce
bottom-up approaches are equally important. ● Collaborate with online platforms to promote
online to offline enforcement.
The government will have to recognise life-course ● Develop an ASEAN-wide MoU between law
immunisation as part of healthy ageing policies; enforcement, platform owners, and brand owners to
leverage the influence of healthcare providers make the identification and takedown of illicit sellers
by engaging their expertise and knowledge on easier.
increasing vaccination uptake; develop robust ● Promote the adoption of better due diligence
data collection infrastructure where information processes for online intermediaries including social
can be captured and stored in a central location to media platforms.
monitor, track and convey information about current ● Develop national government frameworks for
epidemics, continuously evaluate and improve governing advertising and promotion of products,
current efforts; improve public access to vaccination compatible with OECD guidelines.
points and; increase the affordability of adult Free Trade Zone (FTZ)
vaccines through free or subsidised vaccines. ● Form comprehensive and specific definitions
of permissible activity in FTZ’s with implementation
The private sector can provide annual influenza policies and periodic checks.
vaccination as part of employee benefits and ● Incorporate digital solutions to ease reporting
introduce insurance products to cover vaccination requirements, track and trace requirements.
costs. ● Ensure authorities have access to
aggregated data on goods entering and exiting
Lastly, citizens can contribute to the efforts the FTZ with correct tariff classification and
by supporting the elderly to bridge the digital gap owner information
to access information and online bookings for
vaccination. Grassroots can also share information Hithaishi C Bhaskar
on vaccine safety and efficacy with the wider [email protected]
population.

How do you elaborate on EU-ABC vision

SPEAKING WITH 37

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

“Stem cell-based therapeutics

poised to become mainstream option”
To make the trial investments more meaningful
and to avoid ambivalence in animal models,
medical science is adopting novel in vitro
models of specialised human pluripotent cell lines. «
Pluripotent stem cells (PSCs) have the agility to

expand indefinitely and differentiate into almost Dr Koji Tanabe,

any organ-specific cell type. iPSC-derived organs Founder and CEO,

and organoids are currently being evaluated in I Peace, Inc.,

multiple medical research arena. Innovative USA/Japan

pharmacovigilance methodologies are preferring

induced pluripotent stem cells (iPSCs) for pre-clinical

and clinical investigational studies. Global Induced

Pluripotent Stem Cell (iPSC) market is expected a challenge. Entry into this venture is no easy task.

to reach $2.3 billion by 2026. The iPSC market in As a contract development and manufacturing

Asia Pacific is estimated to witness fast growth due organisation (CDMO), I Peace is geared to tackle that

to increasing R&D projects across countries like challenge and become the pioneer of mass production

Australia, Japan and Singapore. technology of clinical grade cell products.

I Peace, Inc. a Palo Alto-based global biotech

company with its manufacturing base in Japan, Can you elaborate I Peace’s cost-effective

has succeeded in developing and mass-producing proprietary stem cell synthesis solution and

clinical grade iPS cells through its proprietary its manufacturing scale?

iPS cell manufacturing services. The human iPSC The key advantage of iPSCs is the ability to create

(hiPSC) lines at I Peace leverage differentiated cells pluripotent cells from an individual’s own cells.

across clinical research and medical applications. Furthermore, iPSCs can multiply indefinitely and

BioSpectrum Asia discovered more about Japan’s evolve into any type of cell, making iPSCs an ideal

stem cell manufacturing ecosystem with Dr Koji tool for transplant and regenerative medicine and

Tanabe, Founder and CEO, I Peace, Inc., The drug research. However, clinical applications of

United States of America/Japan. Dr Tanabe iPSCs to date, utilise heterogenic transplantation.

earned his doctorate under Dr Shinya Yamanaka, It is because manufacturing of just one line of

a Kyoto University researcher who received the iPSCs requires a cost intensive clean room to be

2012 Nobel Prize in Physiology or Medicine for occupied for several months. Manufacturing process

discovery of reprogramming adult somatic cells complexities also pose a barrier to cost reduction and

to pluripotent cells. I Peace is focusing on this mass production.

Nobel Prize-winning iPSCs technology where Dr In contrast, I Peace has developed a proprietary,

Tanabe had played a key role in generating the fully automated closed system for iPS manufacturing,

world’s first successful human iPSCs as one of the enabling cost-effective production of multiple lines

team members and is currently industrialising of iPSCs from multiple donors in a single room.
it in the US and Japan. Edited excerpts;
Within a few years, we expect to manufacture

several thousand lines of iPSCs simultaneously in

a single room. With this technology, I Peace can

How do you define Japan’s Stem cell efficiently generate an ample supply of various iPSCs

manufacturing dynamics aligning with for heterogenic transplant, while also fostering a

regional and APAC market potential? society where everyone can bank their own iPSCs for

We believe that human cells play a pivotal role in potential medical use.

next-generation drug therapy. Clinical trials of iPSC

applications are in full swing not only in Japan, How does I Peace position its businesses

but worldwide as well. In the US, the momentum objectives and go-to-market strategies?

of clinical trial research is astounding. Yet, mass I Peace’s manufacturing facility and its processes

production of GMP compliant cell products remains have undergone rigorous audits and are certified

38 SPEAKING WITH

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

At I Peace, we envision a world in which of heart disease, and neurocytes for neurological
everyone would possess their own disease.
iPSCs and if needed, receive autologous
transplant medication using their own What is your outlook around boosting public-
iPSC. We believe in the importance private stakeholder’s initiatives to encourage
of raising awareness of Nobel Prize awareness on stem-cell-based therapeutics?
winning iPSC technology and we think
much more needs to be done. We need iPSC research has advanced tremendously over the
to enlighten the public about iPSCs - past 16 years, and even more so since Dr Shinya
what they are, how they are created, Yamanaka’s Nobel Prize award in 2012. The
and how they play a role in next- acceleration of applied research is paving the way for
generation medical therapies. stem cell-based therapeutics to become a common
treatment modality in the near future. As human cell
to be in compliance with GMP guidelines of the manufacturing requires specialised professional skills
US, Japan, and Europe. We have the capacity to and knowledge, it is important to promote functional
manufacture clinical-grade iPSCs and iPSC-derived specialisation. These specialisations include donor
cells for clinical use in the global market. Our recruiting, cell manufacturing (where I Peace is
manufacturing staff have unparalleled expertise in the key player), and implementing cell transplant
the manufacturing of iPSCs, and their knowledge as a medical practice. We believe that creating a
and experience make it possible to mass produce systematic industry structure will build awareness
high quality clinical-grade iPSCs in the shortest and further drive the growth of stem cell-based
possible time. Additionally, we streamlined the therapy.
iPSC use licensing scheme to expedite collaborative
ventures with downstream partners. We believe these Can you brief Japan’s licensing key notes to
strategies position I Peace as a global leader in iPSC manufacture and process clinical-grade cells
technology. in the region?

How do you outline the concept Japan enacted three laws to promote the use of
of ‘democratising access to iPSC regenerative medicine as a national policy:
manufacturing’?
1) The Regenerative Medicine Promotion Act --
At I Peace, we envision a world in which everyone representing the country’s determination to promote
would possess their own iPSCs and if needed, regenerative medicine; 2) The Pharmaceuticals,
receive autologous transplant medication using their Medical Devices, and Other Therapeutic Products
own iPSC. We believe in the importance of raising Act (PMD Act); and 3) The Act on the Safety
awareness of Nobel Prize winning iPSC technology of Regenerative Medicine (RM Act). The U.S.
and we think much more needs to be done. We need also has various tracks such as the Regenerative
to enlighten the public about iPSCs - what they are, Medicine Advanced Therapy (RMAT) Designation,
how they are created, and how they play a role in Breakthrough Therapy designation, and Fast Track
next-generation medical therapies. We also need to designation.
underscore the benefits of early banking one’s own
iPSCs, such as autologous transplant and the fact that Of significance, the PMD Act enables a fast-track
cells taken in the early stages of life are preferable for regulatory approval of regenerative medical
over cells collected later in life. products in Japan. In compliance with the RM Act,
I Peace was audited by the PMDA and licensed
To democratise iPSC access, it is also important to by the Ministry of Health, Labour, and Welfare to
expedite application research. We work closely with manufacture specific cell products.
downstream partners, and support their iPSC-derived
drug therapy development efforts by providing Because cell product manufacturing regulations are
iPSCs to meet their needs. We also collaborate not standardised globally, cell therapy developers are
with downstream partners in the development of forced to source GMP iPSCs for each market. I Peace
promising therapies including the use of T-cells for however, has overcome this hurdle. We have built in
cancer therapy, cardiomyocytes for the treatment compliance with global GMP regulations, including
FDA’s cGMP regulations per 21 CFR 210/211 in our
operation. As a result, we can provide cells for global
use in multiple markets, accelerating both product
development and regulatory approval.

Hithaishi C Bhaskar
[email protected]

SPEAKING WITH 39

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

“Aiming for Australia-India synergistic

collaboration in Life Sciences Sector”
To advance trade and investment links
with India, the Australia India Business «
Exchange (AIBX) 2021 programme has been
launched. AIBX is the Australian Government’s Abdul Ekram,

flagship business exchange programme aimed at Trade Commissioner,

growing two-way business literacy and commercial Australian Trade

partnerships between Australia and India. In and Investment

the healthcare sector, there are opportunities for Commission,

Australian and Indian providers to collaborate South Asia, Australia

in the areas of training and skills development,

digital health and joint research and development.

To find out more in this regard, BioSpectrum Asia

spoke to Abdul Ekram, Trade Commissioner, explore collaboration in India?

Australian Trade and Investment Commission, Australian medical technologies are making a
South Asia, Australia. Edited excerpts;
global impact. Solutions such as the cochlear

implant (bionic ear) and continuous positive airway

pressure (CPAP) devices for sleep apnea are just two

What role is the AIBX Programme playing in Australian inventions that have transformed the lives

the healthcare and pharma sector? of people around the world.

AIBX is a response to the ‘India Economic Strategy’, The Australian medical devices and diagnostics

an ambitious plan to transform Australia’s economic industry has pioneered niche products such as 3D

partnership with India. Australian Trade, Tourism customised titanium implants, non-invasive blood

and Investment Minister Dan Tehan launched the glucose monitoring systems, long-wearing night and

AIBX 2021 programme in Melbourne early this day contact lenses, melanoma detection devices,

year, alongside Australian and Indian business transdermal insulin delivery devices, and diagnostic

leaders. This is a four-year strategy to enhance both technologies for sleep disorders, neurophysiology and

way business engagements and increase bilateral cardiology.

trade and investment between Australia and Australia has embraced digital health to

India. AIBX is a digital-first programme that will provide new ways of delivering services and to

provide actionable market insights and partnership radically transform current processes, and increase

strategies, directly connect companies on both sides efficiencies, creating opportunities for collaboration

to foster commercial engagement through industry and investment. We have a National Digital Health

roundtables, dialogues and masterclasses. Healthcare Strategy, with pioneering initiatives co-produced

is one of the five priority areas in AIBX. between consumers, governments, researchers,
Healthcare initiatives include:
providers and industry. This includes a framework

 Launching a digital health report highlighting for secondary data use.

the Indian digital health value chain and Australia is one of the few developed economies

opportunities for Australian digital health companies located in the tropics and has extensive research

to engage, expertise in medicines to tackle diseases like dengue,

 Innovative health boot camp (in partnership malaria, and tuberculosis. This creates collaboration

with AstraZeneca) to foster collaborations for the opportunities for Indian companies for their home

startup to scale-up companies and create a digital markets. The Australian government actively

value chain integration between India and Australia, supports R&D tax incentives and a robust yet flexible

 Partnering with major health and life sciences regulatory regime that protects intellectual property

events in Australia and India to increase market (IP) and enables research to be undertaken in a

literacy. timely and efficient manner.

Australia is well known for its capability in

In which areas can Australian life sciences training, especially in the healthcare education sector.

companies provide their expertise and There are examples of offering joint programmes

40 SPEAKING WITH

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

for infectious diseases, wound care to paramedics an ethics application.
training, partnering with leading hospitals and The Australian government supports stronger
corporates in the market.
engagement with the Indian pharmaceutical industry
How are Australian companies planning to to strengthen Australian supply chain resilience.
enhance their presence in the life sciences India is one of the top 10 sources of medicine
sector in India? imported to Australia. Several leading Indian
pharmaceutical companies have a strong marketing
In recent years, Australian research institutions presence in Australia. Eligible Indian pharmaceutical
have focused on building relationships with Indian companies can benefit by conducting R&D
universities and corporates to develop products for including clinical trials (such as Bio Availability/Bio
the Indian and other international markets. On the Equivalence studies) in Australia and avail generous
business side, besides the strong presence of two R&D Tax Incentive offered by the Australian
known major Australian companies Cochlear and government.
ResMed, we have seen the partnership grow with
successes like Australia’s Wollongong University Will pharma innovation in India benefit from
partnering with India’s first integrated medical tech
zone to develop 3D bioprinting. Australia’s Griffith this association?
University and Indian Immunologicals Ltd (IIL)
came together to develop COVID-19 and Zika vaccine Australia provides an end-to-end solution from
research. Under this agreement, the project will research and development and clinical trials,
be funded by the vaccine manufacturer, IIL, while through to commercial production with a growing
Griffith University will provide its technical expertise. and multi-faceted health and life sciences
The George Institute for Global Health, a subsidiary industry. Australia has a successful history of
of Go8 UNSW, has been active in India for over achieving breakthroughs in biotechnology and
a decade. It has built expertise in both Australian ranking among the top 5 in the world for biotech
and Indian primary healthcare delivery efficiently innovation. Australia’s track record in discovery and
and affordably through frugal innovation. These commercialisation includes developing penicillin
translational research outcomes can be rolled out in as medicine for civilian use, discovering the link
both countries. between Helicobacter pylori and gastric ulcers,
spray-on skin for burn treatments, influenza
Synapse Medicals has a successful footprint in treatment (Relenza), and the cervical cancer
India with a model of integrated service delivery vaccine.
for Australia and the Indian healthcare sector.
With a presence in India for over five years, FBE We see a growing shift in India towards
offers biomedical maintenance services to a large innovative novel drug development, moving up to the
number of hospital equipment in the country. QIMR pharmaceutical value chain. Some companies like
Berghofer Medical Research Institute from Brisbane Biocon, Dr. Reddy’s, Indian Immunological, Bharat
has numerous collaborations with Indian research Biotech are actively seeking to collaborate with
institutes and organisations, latest with IIT, Bombay Australian research institutes to access promising
using infra-red technology to analyse which patients biotech assets and co-development of novel
are most at risk of becoming severely unwell from therapeutic products.
COVID-19.
We believe there is strong potential for
How can Australia support India’s bio- collaborative research between top tier universities,
pharmaceutical sector to conduct clinical research institutes and industry, especially Indian
trials of global standards? biopharmaceutical companies. We can certainly
create strong synergy through collaboration
Australia is regarded as one of the best places in between Australia and India in the life sciences
the world to conduct clinical trials. According to a sector. Australia’s strong reputation for incubation
recent report, Australia hosts around 5 per cent of and acceleration in the biotechnology sector can
global clinical trials. Considering a country with be well complemented by India’s strong capability
only around 24 million population, we are certainly and capacity to support commercialisation. We
‘punching above our weight’ in this sector globally. like to position Australia as India’s trusted partner
Australian competitive advantage is based on high in intelligent health solutions and learn from each
quality, speed and cost-efficiency. An early-phase other to make healthcare accessible, affordable, and
trial can start as little as 6-8 weeks after submitting efficient to our citizens.

Dr Manbeena Chawla
[email protected]

SPEAKING WITH 41

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

“Securing interoperability from

cyber threats in healthcare orgs”
Healthcare is becoming one of the major targets
of cyber-attacks with the increase in adaptation «
of Infocomm network-driven technologies.
The enablement of remote monitoring tools and Vincent Goh,
frequent data maneuvers is prompting the ransomware
and cyber-attack risks on confidential healthcare data. Senior Vice President,
Tackling this will leverage unlimited possibilities
in advanced medical technology and healthcare CyberArk (Asia Pacific
innovations. Vincent Goh, Senior VP at CyberArk (Asia
Pacific and Japan), Singapore provides more insight and Japan), Singapore
on multi-layered cybersecurity threats and solutions
for healthcare organisations. Edited excerpts; In 2020, a ransomware attack invaded 30 servers
of the Düsseldorf University Hospital, resulting in a
What are the common ways attackers use to disruption of its treatment and emergency services,
enter a company’s network to steal their data? where a patient who had to be transferred to another
hospital died from treatment delays. The incident is
Phishing remains one of the top forms of social-driven the first known death due to a cyberattack.
breach. Attackers nearly always take the path of least
resistance by using this tried-and-true approach: What can the security team in hospitals do to
start with a phishing scam targeting a user’s endpoint secure themselves against such attackers?
then crack weak passwords to access credentials
in the device. Using these credentials, the attacker Firstly, hospitals and other private healthcare
can move from one workstation to another to steal organisations should focus on electronic patient health
sensitive data and privileged credentials (such as information (ePHI) records, which includes personally
local admin rights) to easily escalate to higher-value identifiable information (PII). These records must
assets and information. In addition, the attack surface be compliant with global and local regulations and
has expanded dramatically as connected devices standards. As hospitals and healthcare ecosystems
proliferate, including computers for medication, continue to grow in size and complexity, providers face
treatment and surgical procedures. ever-increasing challenges in protecting highly targeted
ePHI. Secure interoperability – or the safe sharing of
What are the implications faced by an ePHI – would not be possible without the use of privileged
organisation if it is attacked by cyber criminals? access management. Managing access to privileged
information is an effective way to limit the moves of
Damage may stem from the disruption of a healthcare an intruder throughout the network after a breach.
organisation’s business operations by making To combat today’s multi-layered threats, healthcare
workstations, software and servers inoperable and/ organisations must ramp up employee cybersecurity
or extorting the victim with threats. Cyber-attacks do training, back up data regularly and adopt an Identity
not stop at the endpoint but seek to propagate deeper Security approach to their cyber defences, whereby
for more valuable data. It is imperative for healthcare the organisation assumes that any identity – whether
institutions to demonstrate regulatory compliance, IT admin, remote worker, third-party vendor, device,
not only to avoid financial penalties, but also to avoid or application – can become privileged under certain
unwanted, severe repercussions. Once in, attackers conditions, creating an attack path to an organisation’s
will disable endpoint security and security monitoring most valuable assets. Tools are put in place to ensure
wherever possible. Their next objective is to harvest that all these identities are authenticating accurately,
credentials for an even higher privilege escalation, allocated proper permissions allowing them access to
to look for more machines and valuable data. As privileged assets in a structured way.
they propagate, they disrupt backups, delete shadow
copies and unlock files to maximise the impact of Hithaishi C Bhaskar
the attack. In some cases, it can lead to loss of lives. [email protected]

42 CANCER

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Therapeutic approaches for the
Treatment of Hepatocellular Carcinoma

« resection or local ablation, which offer promising
5-year survival rates of up to 75 per cent. However,
Dr Lim Chun Sen, less than 15 per cent of patients are eligible for the
Head of Radiotherapy potentially curative treatments as the majority of
and Oncology them present with advanced disease.
Department, Hospital
Sultan Ismail, Malaysia If the cancer is detected too late for a curative
resection to be feasible, then there are various
Whether or not late stage patients have treatment options to try and control the cancer and
access to the latest therapies or only cytotoxic prolong survival.
chemotherapy; the treatment options are still only
palliative and symptomatic. Symptomatic care For more advanced stage B which are
refers to therapies intended to ease the symptoms multinodular but still localised to the liver, and
and improve the patient’s quality of life (QoL) preserved liver function, treatments are basically
without addressing the basic cause of the disease. palliative and revolve around chemoembolization
which is typically performed by a hepatobiliary team
Hepatocellular carcinoma (HCC) is one of the and intervention radiologist.
leading causes of cancer death globally. In
Malaysia, HCC is the eighth most common There are now loco-regional therapies like
cause of cancer across both genders. Although it radiofrequency ablation (using heat to destroy
is the fifth most common cause of cancer among the cancer), chemotherapy directed into the liver
males, it is responsible for the second highest (TACE) or radiation directed into the liver (radiation
number of cancer deaths among men after lung beads released directly into the liver tumour). These
cancer. Whether or not late stage patients have therapies are used to slow the cancer’s progression,
access to the latest therapies or only cytotoxic stabilise and/ or shrink it.
chemotherapy; the treatment options are still only
palliative and symptomatic. Symptomatic care Chemoembolisation achieves > 2.5-year survival
refers to therapies intended to ease the symptoms rates of up to 75 per cent. For most stage B cancers
and improve the patient’s quality of life (QoL) these therapies are palliative but occasionally with
without addressing the basic cause of the disease. a stage B cancer presenting just a single nodule but
with compensated liver function, the tumour can
Therapeutic approaches for the treatment of HCC be reduced to an operable size that makes resection
can be classified into three categories: potentially viable. However, these therapies are very expensive
curative, palliative, and symptomatic. At the Hospital and not widely available in Malaysia, even in the
Sultan Ismail, the Barcelona Clinic Liver Cancer private sector.
(BCLC) staging system is used, which classifies
patients according to tumour status, liver function Sadly, almost 85 per cent of all patients are
(by Child– Pugh (CP) category), and performance already stage C or D by the time the cancer is
status (PS), as either: 0 (very early stage), A (early discovered, and they are not suitable for curative
stage), B (intermediate stage), C (advanced stage), or surgery or even loco-regional therapies, as their
D (very advanced/end stage). cancer is too far advanced.

Disease staging and treatments HCC is often detected at a late stage as it is largely
asymptomatic and patients simply do not show
The early-stages (0 and A) of HCC can be treated any signs of illness such as fever, pain or swelling
with potentially curative therapies such as surgical in the early stages. Very often HCC is only detected
by chance, when patients are being treated and/or
examined for something else. These are the patients
which are referred to me; the earlier stage patients
are usually seen to by the hepatobiliary team.

The treatment options for late stage patients
are basically palliative for stage C, with the aim
of extending life as long as possible. For stage D,
treatment is basically symptomatic, best supportive
care (BSC), to try and make them as comfortable as

CANCER 43

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possible, with the best possible quality of life (QoL) Today we can hope to keep patients alive
we can manage. with cancer for much longer than was
the case 15 years ago, but we need the
Palliative care patients to be willing and able to cope
with the treatments that are keeping
Since the early 2000s when the first tyrosine kinase them alive. The best way to do that is to
inhibitor (TKI) drug that was effective for HCC give them the best QoL we can.
called sorafenib was developed, it has been the
recommended standard of care for late-stage HCC. If patients can afford the treatment, they can
access all the approved medications available for the
TKI drugs have been used to treat other types treatment of advanced HCC. Currently, I am only able
of cancer since the 1980s. They are also called to offer older, traditional cytotoxic chemotherapies to
molecular-targeted drugs or targeted therapy, as they most of my public sector patients.
target and inhibit particular proteins or enzymes that
promote cancer. Unfortunately, for decades, none Whether or not late stage patients have access to
had worked for HCC. the latest therapies or only cytotoxic chemotherapy;
the treatment options are still only palliative and
That changed in 2005 when the US Food and symptomatic. Symptomatic care refers to therapies
Drug Administration (FDA) approved oral sorafenib, intended to ease the symptoms and improve the
a multi-kinase targeted therapy, which had been patient’s quality of life (QoL) without addressing the
shown to prolong patients’ survival in HCC; this basic cause of the disease.
meant we finally had a palliative treatment to offer
late-stage HCC patients. Although the drug was The patient’s QoL is an important consideration
approved in Malaysia within a couple of years of as the effects of the illness and the side effects of
the FDA, it is not covered by government schemes treatments are often hard to bear. Many patients
here and are only available to patients who have with HCC report suffering from pain and fatigue, as
comprehensive insurance or can afford to cover the well as experiencing side effects from the medication
cost themselves. such as diarrhoea, lethargy, palmar-plantar
erythrodysesthesia, hypertension, nausea, vomiting,
After a decade or more with no new TKI drugs etc., making symptomatic care crucial for patients’
coming to market, the last three or four years have QoL.
produced several new TKI-targeted therapies.
Today we can hope to keep patients alive with
The latest second-line option to be approved cancer for much longer than was the case 15 years
in Malaysia in early 2021, is cabozantinib. As ago, but we need the patients to be willing and able to
each patient and cancer is a unique case, not all cope with the treatments that are keeping them alive.
are suitable for cabozantinib. Cabozantinib offers The best way to do that is to give them the best QoL
significant survival benefits for patients who meet we can.
the inclusion criteria for the CELESTIAL trial; i.e.
they have progressive disease on one or two systemic Fortunately, there are some promising
therapies, as well as well-preserved liver function. therapeutic developments on the horizon. Ongoing
trials combining targeted TKIs like cabozantinib
The median survival time for advanced liver with immunotherapies show promise and may soon
cancer before we had a second-line therapy was less improve the prognosis and extend the life expectancy
than a year, and for many Malaysians around six of patients with HCC, perhaps significantly.
months. Now, with second-line therapy options, we
can routinely achieve significant improvement on
survival for this group of patients. The addition of
cabozantinib to our pharmacology has increased the
treatment options for HCC.

Management of patients

with advanced HCC

The Pan-Asian adapted ESMO Clinical Practice
Guidelines for the management of patients with
advanced HCC recommend targeted TKI therapies
like sorafenib and cabozantinib as the standard of
care for late stage HCC. However, permission is
rarely given for their use in government hospitals in
Malaysia.

44 PEOPLE NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Jubilant Biosys Dr Steve Lee takes charge
picks Giuliano as CEO of Eden Biologics
Perfetti as CEO
Taiwan-based Eden Biologics, Inc. has announced the appointment of
Indian contract research
organisation Jubilant Dr Steve Lee, an accomplished biotech executive with broad experience
Biosys has announced the
appointment of Giuliano and entrepreneurial leadership, as the new Chief Executive Officer (CEO)
Perfetti as its Chief Executive
Officer (CEO). Perfetti and Director of the Board. Dr Lee is a global business leader with a
has more than 20 years of
experience across diverse distinguished track record in biologics research, bioprocess development,
businesses and global
markets with expertise in technical operations, business
strategy, sales, marketing and
business development. He has development, strategic
led business transformation
and expansion programmes planning, and commercial
working in reputed names
including Accenture and manufacturing in a highly
AstraZeneca among others.
Before joining Jubilant regulated environment
Biosys, Perfetti was associated
with Fabbrica Italiana and emerging markets for
Sintetici (F.I.S) as Chief
Commercial Officer and was over 30 years. Specifically,
responsible for strategising
and executing the company’s Dr Lee has led changes in
growth plan and ramping
up the global scale-up and transforming companies
commercial service business.
Jubilant Biosys is a part of the into high-performance organisations in biotech startups and large
Jubilant Pharmova family of
companies with R&D centres biopharmaceutical groups in the United States and Asia. Previously
in India and business offices
in Asia and North America. the CEO and Founder of BioGENEXUS, Dr Lee developed disruptive

innovation and breakthrough manufacturing technology platforms

while providing biotech consulting services globally. Now he brings his

extensive biotech industry experience, strong leadership and passion to

Eden Biologics with hopes of expanding Eden’s innovative, cost-effective

biologics development platform and commercial manufacturing alliances

in both Asia and the US.

Dr Eichenfield heads Scientific
Advisory Board of Aslan Pharma

Singapore-based Aslan States, Canada, Europe, and Asia.
Dr Eichenfield is Chief of Pediatric
Pharmaceuticals has announced and Adolescent Dermatology at
Rady Children’s Hospital-San
the appointment of Dr Lawrence Diego, Distinguished Professor
of Dermatology and Pediatrics
Eichenfield, as chair of its Scientific and Vice Chair of the Department
of Dermatology at University
Advisory Board, comprising of California San Diego School
of Medicine. He has served as
experts in dermatology and lead author and co-chair of the
committee for the American
allergic disease from the United Academy of Dermatology
Guidelines for Atopic Dermatitis
and sits on the editorial boards
of multiple other journals and
periodicals. In addition to his
extensive clinical experience,
he has authored over 400
publications on inflammatory
skin disease.

R&D NEWS 45

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Australia brings world- Hong Kong develops
targeted osteoarthritis
first 3D imaging for pain reliever

melanoma detection Researchers at The Hong Kong Polytechnic University
(PolyU) have developed a groundbreaking, imaging-
Australia has the highest rates of melanoma guided nanoparticle photothermal treatment for
(skin cancer) in the world with an average osteoarthritis pain, utilising the concept of targeted
28,000 Australians diagnosed with the disease cancer therapy but instead applied to the protein that
every year. They can now have skin cancer initiates pain signalling along the nervous system. The
diagnosed earlier using world-first 3D scanning novel targeted osteoarthritis pain theranostics, which
technology with the launch of the Australian offer both diagnostics and therapeutics, are made of gold
Cancer Research Foundation- Australian nanorods coated with a two-dimensional nanomaterial,
Centre of Excellence in Melanoma Imaging and molybdenum disulfide. The coated nanorods are
Diagnosis, at the University of Queensland. further fused with antibodies directed against the nerve
growth factor (NGF), the pain-triggering protein. The
The technology novel technique enables new and accurate diagnostics
enables researchers approaches like osteoarthritis pain imaging; tracking
to track moles and injured joints using localised nanorods for photoacoustic
skin spots over time imaging; as a new non-invasive imaging modality that
using full-body combines high contrast and good specificity of optical
mapping, making it imaging; delivers the high resolution and penetration
a game-changer for depth offered by ultrasound imaging; can avoid
melanoma detection. expensive knee replacement surgeries, non-targeted
For the first time, painkillers and their significant side effects.
medical researchers
can access a national database of up to
100,000 patient images taken by 3D full-body
imaging systems located in Queensland, New
South Wales and Victoria, as part of the world’s
largest melanoma imaging trial, which aims to
develop more efficient and effective screening
for the early detection of skin cancer. Using
algorithms created by artificial intelligence,
the 3D imaging systems are able to analyse the
images and produce a full-body skin spot map,
which transforms the way we will monitor
patients in the future.

Removing mutant DNA key to treating
mitochondrial diseases: iCeMS, Japan

Mutant DNA sequences normal DNA co-exist. This state the impacts of the mutant DNA,
is called heteroplasmy and to without addressing the core
inside cellular mitochondria cure mitochondrial diseases, mutation. The researchers have
we need to be able to remove developed a compound made
can be eliminated using a mutant mitochondrial DNA of a mitochondria-penetrating
from cells. Current approaches peptide (MPP) bound to a
bespoke chemical compound. for such mitochondrial diseases polymer, called a pyrrole-
are problematic. Some involve imidazole polyamide (PIP), which
The approach, developed by injecting genetic material into can be modified to target a specific
cells, which could lead to unwanted DNA sequence. These were then
scientists at Kyoto University’s alterations. In others, antioxidant attached to an existing anti-
drugs are administered to reduce cancer drug, called chlorambucil.
Institute for Integrated Cell-

Material Science (iCeMS) in

Japan, could lead to better

treatments for mitochondrial

diseases. In some mitochondrial

diseases, mutated DNA and

46 R&D NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

BRICS Singapore deploys
AI for glaucoma screening
to study
Scientists from Nanyang Technological University, Singapore (NTU
overlap of Singapore), in collaboration with clinicians at Tan Tock Seng Hospital
(TTSH) in Singapore have developed a novel method that uses artificial
SARS-CoV-2 intelligence (AI) to screen for glaucoma, a group of eye diseases that can
cause vision loss and blindness through damage to the optic nerve at the
with TB
back of the eye. The AI-enabled method
Department of uses algorithms to differentiate optic nerves
Biotechnology (DBT), with glaucoma from those that are normal
Ministry of Science and by analysing ‘stereo fundus images’ – multi-
Technology, Government angle 2D images of the retina that are
of India in collaboration combined to form a 3D image. When tested
with BRICS countries on stereo fundus images from TTSH patients
(Brazil, Russia, India, undergoing expert examination, the AI
China, and South Africa) is method yielded an accuracy of 97 per cent
implementing SARS-CoV-2 in diagnosing glaucoma. The team is now
NGS-BRICS consortium and testing their algorithms on a larger dataset of
multi-centric programme patient fundus images taken at TTSH. They are also looking at how the
to study the impact of software can be ported to a mobile phone application so that, when used
severe COVID-19 conditions in conjunction with a fundus camera or lens adaptor for mobile phones, it
on tuberculosis (TB) could be a feasible glaucoma screening tool in the field.
patients. The SARS-CoV-2
NGS-BRICS consortium Korea unveils handheld cancer
is an interdisciplinary diagnostic sans radiation exposure
collaboration to advance
COVID-19 health- A team of scientists at the Pohang University of Science and Technology
relevant knowledge and to (POSTECH) in South Korea has developed a handheld photoacoustic finder
contribute to improvements that can help examine lymph node conditions without radiation exposure.
in health outcomes. The Cancers such as breast cancer and melanoma metastasise primarily
consortium will accelerate through the lymphatic system, so knowing the condition of the lymph
the translation of genomic nodes is essential in accessing the
data leading to clinical and stage and prognosis of cancer. The
public health research and handheld photoacoustic finder
interventions from clinical (PAF) is equipped with a solid-
and surveillance samples state dye laser and a transparent
by utilising the high-end ultrasound transducer (TUT).
genomic technologies, Unlike conventional gamma
and epidemiologic and probes, this non-radioactive PAF
bioinformatics tools for eliminates the risk of exposure to
future use in diagnostic radiation and the need for special
assays and tracking facilities and allows repeated usage
transmission dynamics which is cost-effective. In general, a sentinel lymph node (SLN) biopsy
of COVID-19 and other around the cancer is performed to assess the metastasis in breast cancers
viruses. The collaborative and melanoma. This is because the SLN is the first gateway for tumours
study is expected to provide to travel to the lymph nodes. However, since conventional biopsies use
valuable co-morbidity radioisotopes to find the SLN, patients and physicians are inevitably
data about pulmonary TB exposed to radiation and the procedure requires a special facility to access
patients with or without radioactive materials. The photoacoustic finder (PAF) system is the first
COVID-19 co-infection portable photoacoustic sensing tool for SNL localisation.
that is expected to be
generated for better disease
management.

ACADEMICS NEWS 47

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

India, Australia to appoint
Academic Chair in Ayurveda

All India Institute of Ayurveda under the Ministry of Ayush has signed

a Memorandum of Understanding (MoU) in coordination with the

National Institute of Complementary Medicine (NICM) - Western

Sydney University Australia to appoint an Academic Chair in Ayurveda.

The new Academic Chair will undertake academic and collaborative

research activities in Ayurveda, including

herbal medicine and yoga, as well as design

academic standards and short-term/ South Korea’s

medium-term courses and educational Pohang slated

guidelines. This Chair will also conduct to become

workshops/seminars/conferences on world-renowned

Ayurveda, advocate the safe and effective use medical city

of Ayurveda Systems in Australia, identify Pohang University of Science and
Technology (POSTECH) in South
in academic and research programmes on Korea has recognised the bio
sector as a key future industry
Ayurveda their strengths and gaps, provide ever since President Moo Hwan
Kim took office in September
tutorials to students, including the promotion of research activities 2019. Early this year, President
Kim presented the plans to build
and innovations in Ayurveda in India. This Ayurveda Academic Chair a medical school and a hospital,
emphasising the need for both
will be based at Western Sydney University’s NICM Health Research institutions. These plans picked
up speed with the COVID-19
Institute, with tenure for a period of three years. The appointment pandemic, and are being realised
with the opening of the Graduate
of the Chair is jointly funded by the Ministry of Ayush and Western School of Medical Science and
Engineering. Joon Won Park,
Sydney University and is anticipated to commence early in 2022. former president and chemistry
professor at POSTECH, who has
China to build AI-based led a boom in the biodiagnostics
research centre for market with nanocon technology
improving public health in 2006, is currently leading the
project. With the introduction of
The Institute for AI Industry Research, Tsinghua University (AIR) a medical school and a hospital,
and the Beijing Academy of Artificial Intelligence (BAAI) in China Prof. Park wants to position
have announced that they would be building a research centre on Pohang as a world-renowned
the coordinated development of all sectors in the health industry medical city in the long run.
with the help of artificial intelligence. Like the University of Texas MD
The move aims to create a new Anderson Cancer Center – one
pattern featuring early prediction, of the world’s most respected
active prevention, personalisation centers for cancer treatment – he
and active participation, and to offer wants Pohang to be recognised
more intelligent personal health as an epicenter for treating
management and more effective public certain diseases in the future.
health governance. The new research
centre will create a personalised health
management system for individuals,
connect software with intelligent hardware through a healthy diet
and lifestyle, and build an ’AI + health’ management ecosystem
that covers scientific research, technical breakthroughs, platform
construction, product development and business incubation.
Through a multimodal neural symbol AI, combined with correlation,
attention mechanisms and causality, the centre will enable different
expressions and models to be trained and learned from each other.

48 SUPPLIER NEWS

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Sartorius opens new UK-based Bunzl
application and service
hub in Shanghai buys medical

Sartorius has officially opened its new, significantly supplies distributor
expanded Application and Service Hub in Zhangjiang
Science City in Shanghai, China. Equipped with the latest in Australasia
innovative instrumentation and offering cutting-edge
professional expertise, this Hub covering over 3,000 square Bunzl plc, based in London, has entered
metres accommodates the Sartorius Application Center into agreements to acquire a US-based
3.0, the Confidence Validation Services Laboratory 2.0 and safety business and a medical supplies
APAC Service Hub. This combined facility is designed as distributor with operations in Australia
an integrated solution platform to empower and accelerate and Singapore. MedShop is an online
progress in areas ranging from research to process distributor of medical supplies and devices
development to production in the Chinese life sciences and to a diverse range of healthcare customers,
biopharmaceutical industries. The latest innovations in predominantly
bioanalytic, continuous processing and digitalisation are in Australia.
now going live in the upgraded Application Center 3.0, where The business
the new Sartorius process solutions will be showcased and has a strong
experienced as their first point of entry. More importantly, digital platform
early-stage monoclonal antibody (mAb) and virus-based and operations
therapies can be discovered, and their process applications in Melbourne
can be custom developed, tested, and verified. and Singapore.
MedShop generated revenue of AUS$22
million in 2020. The acquisition was
completed in early September. MedShop
is a complementary business that builds
on Bunzl’s capabilities in the Australian
healthcare sector, allowing the company
to target an expanded customer base. The
strength of the digitally focused leadership
team supports the significant potential to
grow the business in Australasia.

Cytiva expands capacity for bioprocessing
single-use consumables in China

Cytiva continues to expand the end of 2021; with the other flexibility for customers. These
its manufacturing capacity six lines scheduled in Q3 2022. It expansions are part of the recently-
for bioprocessing single- adds 1300 square metres (sq m) announced $1.5 billion investment
use consumables in China. to the manufacturing area of the by Cytiva and Pall Corporation. In
In collaboration with Wego ISO Class 7 cleanroom and also addition to the increased capacity,
Pharmaceutical, the two includes a 1200 sq m warehouse to Cytiva also brings new products,
companies are expanding an further save lead time and increase 100L to 1,000L Xcellerex mixer
existing facility jointly launched bags, to the expanded facility’s
in 2018. These newly added manufacturing portfolio. The
manufacturing lines will triple new products will incorporate
the supply capacity of single-use Fortem technology - Cytiva’s
consumables in the Asia Pacific materially advanced, single-use
region. The planned expansion characterised film, and its local
will consist of an additional eight manufacture enhances our ability
new manufacturing lines, two of to provide business continuity for
which are expected to launch by our customers.

SUPPLIER NEWS 49

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

Shimadzu, HORIBA release LC-Raman
System for multi-R&D applications

Shimadzu technologies. Combining LC by detecting unknown
Corporation and separation technology with components. Markets
HORIBA have Raman visualisation technology involved in ensuring
released a new not only significantly increases the safety and
LC-Raman system measurement accuracy and health of people,
that combines a efficiency, but it is also expected such as healthcare,
Shimadzu high- to offer new measurement value pharmaceuticals,
performance liquid and life sciences, and
chromatography markets involved in
(HPLC) with a developing advanced
HORIBA Raman spectrometer materials, have been changing
for the Japanese domestic at a rapid pace in recent years.
market. The product is the For research and development
result of joint development in such fields, it is important to
work that started in August have measuring methods that
2020 and represents the world’s are as accurate and efficient as
first system to combine these possible.

Thermo Fisher enables scalable Mycenax
gene therapy workflows
Biotech builds
Addressing the need to make adeno-associated virus (AAV)
production more efficient and scalable, Thermo Fisher Scientific first continuous
has launched the integrated Gibco AAV-MAX Helper Free
AAV Production System, a complete, optimised solution that bioprocessing
simplifies the AAV vector production workflow. The all-in-one
AAV-MAX system increases productivity and cost efficiency lab in Taiwan
by delivering high viral titers using Viral Production Cells 2.0,
a new, clonally documented, Cytiva has partnered with Mycenax
293F-derived mammalian cell Biotech Inc to launch Taiwan’s
line. AAV is crucial to the field of first continuous bioprocessing lab.
gene therapy; more than 1,300 Built within Mycenax’s Research
unique gene therapy products are Center, the new lab will enable
currently under development, the company to expand the
and nearly half are reliant commercial manufacturing for
on AAV. The ability to scale their first biosimilar project. In
production is critical to bringing this new lab, Cytiva will provide its
down costs and accelerating comprehensive product portfolio,
the process from research to including Xcellerex XDR single-
commercialisation. The AAV- use stirred-tank bioreactors,
MAX system has been developed to scale from shake flasks to ReadyToProcess WAVE bioreactors,
bioreactors. Coupled with the active development of regulatory- ÄKTA Protein Purification Systems,
compliant reagents, the system is designed to streamline the etc., to complete both the continuous
transition from research to commercial manufacturing. On process platform and the scale-up
average, the system can save viral vector researchers and manufacturing platform. In addition,
developers 25 per cent on plasmid DNA usage and 50 per cent OptiRun, Cytiva’s data-driven
on production costs compared to polyethyleneimine (PEI)- advisory services will further help
based mammalian production systems. Mycenax implement an integrated
strategy to optimise its entire
continuous bioprocess workflow.

50

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumasia.com

A United Front against COVID-19
As on September 29, 2021, 44.9 per cent
of the world population has received at the COVAX Advance Market Commitment
least one dose of a COVID-19 vaccine (AMC). This is enough to protect 20 per cent
with 33.04 per cent share of people fully of the population, or 40 per cent of all adults;
vaccinated against COVID-19. 6.2 billion doses in all 92 AMC economies with the exception of
have been administered globally, and 26.02 India. Over 200 million doses will be allocated
million are now being administered each day. to self-financing participants. The key COVAX
Only 2.3 per cent of people in low-income milestone of 2 billion doses released for
countries have received at least one dose. delivery is now expected to be reached in the
first quarter of 2022.
In Asia, as of September 28, Singapore
is the leading country with 79.39 per cent Responding to the global need, leaders
share of people vaccinated against COVID-19 from across the world attended the Global
(76.59 per cent fully vaccinated) (September COVID-19 Summit on September 22, hosted
26) followed by China 76.22 per cent (70.78 by Joe Biden, President of the United States of
per cent) (as on September 18), Japan 69.98 America. The leaders have again underlined
per cent (59 per cent), India 46.07 per cent their commitment to ensuring equitable
(16.61 per cent), Indonesia 32.04 per cent access to COVID-19 vaccines for all countries
(17.97 per cent), Vietnam 31.52 per cent (8.44 through COVAX – noting that equitable
per cent) (September 26), Pakistan 25.94 per access is essential to end the acute stage of the
cent (12.17 per cent), the Philippines 22.69 pandemic.
per cent (14.53 per cent) (September 9) and
Bangladesh 14.96 per cent (9.98 per cent), The commitments made at the Summit
according to Our World in Data. offer the promise of reaching the targets
that the World Health Organisation and its
Realising the need to support the partners have set to vaccinate 40 per cent
low- and lower-middle-income countries, of the population of all countries by the end
on September 8, 2020, the world came of 2021 and 70 per cent by the middle of
together to support COVAX, a multilateral next year. Responding to the global support,
initiative aimed at guaranteeing global Tedros Adhanom Ghebreyesus, Director-
access to life-saving COVID-19 vaccines. In General, World Health Organisation (WHO)
the last two months, COVAX has already said “To reach this year’s target, we need
achieved significant progress: more than 2 billion doses for low- and lower- middle
$10 billion has been raised; legally-binding income countries now. To quote President
commitments for up to 4.5 billion doses Biden, “we can do this.”
of vaccine; 240 million doses have been
delivered to 139 countries in just six months. President Biden in his remarks pointed
Yet the global picture of access to COVID-19 out “We will work with global vaccine
vaccines is unacceptable. Only 20 per cent manufacturers to expand global and regional
of people in low- and lower-middle-income manufacturing for mRNA, viral vector, and/
countries have received a first dose of vaccine or protein subunit COVID-19 vaccines and to
compared to 80 per cent in high- and upper- enhance transparency of data on production
middle income countries. and projections for dose manufacturing.”

According to COVAX’s latest Supply But it is clear that commitments alone
Forecast, it expects to have access to 1.425 won’t save lives, stop transmission, immunise
billion doses of vaccine in 2021, in the most people, scale up manufacturing capacity, and
likely scenario and in the absence of urgent prepare the world to prevent future health
action by producers and high-coverage emergencies. What is needed now – finally –
countries to prioritise COVAX. Of these doses, is for commitments to turn into immediate
approximately 1.2 billion will be available for actions to equitably end the pandemic.
the lower income economies participating in
Narayan Kulkarni
Editor

[email protected]