BioSpectrum Asia October 2022

The 25th edition of Bengaluru Tech Summit - Asia’s largest IT, Deep Tech & Biotech event is
organized by the Dept. of Electronics, IT, Bt and Science and Technology, Govt. of Karnataka
is scheduled from 16th to 18th November 2022, with the theme, ‘Tech4NexGen’. The event
will be an in-person event at Bangalore Palace, Bengaluru.

Hon’ble Prime Minister Shri. Narendra Modi ji is intended to inaugurate the Summit along with heads of the Global Leaders.

The event will be attended by global technology leaders, India grown IT heads, Biotech, Deep tech and start-ups. BTS 2022

will provide the platform to access the best innovations, new products and cutting-edge ideas for building a collaborative,

global tech community. The theme for IndiaBio@Bengaluru Tech Summit is Leading the New Normal

BIOTECHNOLOGY BioPharma | BioAgri | BioIT | BioIndustrial | BioServices

CONFERENCE FOCUS 

EVENT SPECTRUM

• Multi-Track Conference • Global Innovation Alliance • Smart Bio Awards • Bio Posters

• International Exhibition • India Innovation Alliance • Unicorns Conclave • Bio Partnering

• India USA - Tech Conclave • R&D - Lab2Market • Biotech Quiz • B2B Meetings

HIGHLIGHTS OF BTS2022 Session Highlights

50+ 70+ 350+ • Towards 100$ Human Genome: Implications
• Smart Supply Chains in Biopharma
COUNTRIES SESSIONS SPEAKERS • Gene Editing and Agriculture
• One Health and Pandemic Preparedness
10000+ 400+ 1000+ • The Future of Genomic Medicine
• Bio Industrial and Bio Manufacturing
BUSINESS ATTENDEES EXHIBITORS START-UPS • Big data in Drug Discovery
• Bioinvesting
2500+ 50000+

ORGANISATIONS VISITORS

Contact: Ambika Kiran | [email protected] | +91 95359 99435 @blrtechsummit

www.indiabio.in | www.bengalurutechsummit.com

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directly with
Life-Science
Leaders and
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4 BIO EDIT

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Dr Milind Kokje MAN-MADE MUTANT MENACE

Chief Editor As the COVID-19 pandemic has started subsiding, healthcare experts are turning
their attention to the ‘silent pandemic’ of Antimicrobial Resistance (AMR).
[email protected] The BBC has recently reported that the occurrence of sepsis in newborns is
becoming more dangerous due to AMR. As it is, neonatal sepsis is estimated to be 1.8
times higher in middle income countries and 3.5 times higher in poor countries. Rising
cases of AMR in developing countries is exacerbating the neonatal sepsis, experts say.

Even the Access to Medicine Foundation has expressed concern over the faster than
expected rise of AMR. Such infections have claimed 1.27 million lives worldwide in
2019. The figure is significantly more than previously thought and it is more than deaths
caused by HIV and malaria together. The figure of 1.27 million deaths is mentioned
in an AMR report published in The Lancet in January, based on the data from 204
countries and territories. More serious part of the report is that these were the deaths
for which AMR was directly responsible. But AMR is associated with 4.59 million more
deaths. Previous estimates had predicted 10 million deaths annually from AMR by
2050. But, by now it has reached almost half of that more than 25 years before.

However, when it comes to tackling AMR, different organisations seem to have
contradictory opinions and strategies. About four months back, Access to Medicine
Foundation released its ‘2021 AMR Benchmark’ report. It attributed this ‘superbug’
spread to non-accessibility of antibiotics and antifungal medicines. Though 80 per cent
of the antibiotics are off-patent, access to them in low and middle income countries
is not improving. The report indicates that their better access to patients in these
countries will slow down the drug resistance spread. Drug producers have been asked
to adopt innovative approaches to increase the accessibility of antibiotics. Increasing
accessibility in low and middle income countries is ‘urgent’ as they are carrying the
major burden of lack of accessibility of antibiotics.

An estimated 5.7 million people, mainly from lower and middle income countries,
currently die each year from lack of access to antibiotics. Due to non-availability of
appropriate medication patients receive suboptimal treatments giving pathogens an
opportunity to develop resistance, the Foundation warned.

Access strategies by pharma companies for 166 antibacterial and antifungal
medicines and vaccines were examined in the report and it has been found out that only
26 per cent of off-patent generic medicines are covered by access strategies, compared
to 46 per cent of the on-patent medicines. Thus, the Foundation has put the onus on
drug manufacturers to improve the accessibility.

In the healthcare field generally it is true that the desired effect to overcome a
disease globally will not be possible if certain areas continue to have patients suffering
from that disease due to lack of access to the required medicines.

If lack of accessibility of antibiotics is causing the problem, several other
organisations say that overuse of antibiotics by doctors and patients’ habit to leave the
treatment in between are considered to be two major reasons for AMR. Scientists had
been warning for a long time that heavy use of antibiotics was turning into a problem.

The World Health Organisation (WHO) had said that due to decades of careless
exposure to antibiotics, superbugs are now widespread and represent a global crisis
that threatens a century of progress in health. It had also warned that none of the 43
antibiotics in development or recently approved medicines were enough to combat
AMR. One key recommendation from global health authorities is to cautiously avoid
antibiotics in the first place. Tackling disease-causing bacteria selectively, without
killing them is the way forward, opine some experts. This is possible because most
bacteria don’t need to cause disease to survive. If the treatments are not aimed at
killing them, the selection for resistance mutants will be weak, a claim that is proving
effective. One can only hope that experts across the world, even with diverging views,
might have a Eureka moment and end this menace for good.

BIO MAIL 5

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Acknowledgements/Feedback meticulous way of working, reviewing
our articles and presenting them so
Thank you BioSpectrum Asia for the well. The topics covered are innovative
great collaboration and the feature on and informative. New technologies and
Eppendorf in the September edition. applications from other pharma and
biotech industries is what makes this
- Sabrina Stock, Germany publication really stand out. It is always
a pleasure working with you.
The interview feature with Univercells
Technologies looks beautiful in - Arun Kedia, India
the September edition. Thank you
BioSpectrum Asia. BioSpectrum is a great platform to reach
healthcare innovators and stakeholders
- Beth Willers, US in Asia. It allows us great exposure
amongst decision-makers in the
VAV Life Sciences appreciates industry.
BioSpectrum for publishing our articles
over many editions. We have been - Terng Shing Chen, Singapore
very happy with your methodical &

Vol 17; Issue 10; October 2022 MM Activ Singapore Pte. Ltd. Taiwan
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6 BIO CONTENT

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

COVER STORY 18

Can Technology Efface

SLEEP DISORDERS?
The world is wide awake. Sleep disorders are on the rise globally and the Asia Pacific is no
different. There are numerous studies documenting how sleep loss is rampant and becoming an

epidemic. Approximately 45 per cent of people worldwide don’t get enough sleep. Asians have
the shortest average sleep time, according to researchers from Flinders University, Australia. To
combat these, firms are now turning to technology. The emergence of wearables, smart devices,
trackers, and patches has made widespread remote sleep monitoring possible. Insights gained
from the data collected by these devices are used to improve understanding of sleep and create

preventative sleep loss strategies. Let’s look at how healthcare firms are trying to unlock the
science of sleep disorders diagnosis and treatment by leveraging new tech.

21 22 24

“Wearable tech “AI-based tech services Sleep disorders
itself isn’t very will change diagnosis are a growing burden
and treatment of sleep
crucial, but in all countries
algorithms are’’ disorders”

Masayuki Asano, Christine Kwon, Sowmya Srinath,
Executive Officer, ACCELStars Director, HoneyNaps Director,

Healthcare & LifeSciences,
Frost & Sullivan, Singapore

BIO CONTENT 7

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

CLIMATE CHANGE

26 Scan
QR code
Big Pharma’s Green Ambitions to access
BioSpectrum
SPEAKING WITH
Asia
29 Digizine

“Our drug is now an LIFE SCIENCES
important treatment for
HIV patients in China” 41

Dr Changjin Wang, Why Life Sciences
CEO and board member, sector is Soaring in China
Frontier Biotechnologies
Yong Sin Peh,
31 Principal Consultant,
EPM Scientific
“Creation of reference genomes
will set up baseline on larger REGULARS
scale of genetic research”
BioEdit.........................................................................04
Dr Roy Tan, BioMail........................................................................05
General Manager, Policy and Regulatory News...................................08
MGI Asia Pacific Company News........................................................10
Finance News............................................................12
EVENT REPORT Start-Up News...........................................................14
World News...............................................................15
33 WHO News.................................................................17
Academics News......................................................43
Mölnlycke opens surgical glove People News..............................................................44
plant at Malaysia’s Kulim Hi-Tech R&D News..................................................................46
Park with an investment of RM233M Supplier News...........................................................48
Lets Talk Health........................................................50
35 BIO Asia–Taiwan 2022 showcases
innovation, market, supply and investment

38 Thailand LAB INTERNATIONAL,
Bio Asia Pacific & FutureCHEM INTERNATIONAL

3 Day Mega Event brings together
200+ speakers, 500 global brands,
2700 delegates, 8500 visitors to Bangkok

8 REGULATORY NEWS

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Australia approves new treatment
for rare cancer cholangiocarcinoma

A new targeted therapy to treat duration of response (DOR). cent of patients diagnosed with
a rare bile duct cancer called Continued approval of cholangiocarcinoma. PEMAZYRE,
cholangiocarcinoma has been this indication depends
approved for use in Australia. on verification and developed by US-
PEMAZYRE (pemigatinib) has description of benefit based Incyte and
been provisionally approved by the in confirmatory partnered with
Therapeutic Goods Administration trial(s). This means independent
(TGA) for the treatment of adult it will be available pharmaceutical
patients with locally advanced or to Australian company
metastatic cholangiocarcinoma patients with Specialised
with a fibroblast growth factor cholangiocarcinoma Therapeutics
receptor 2 (FGFR2) fusion who have been tested
or rearrangement that has for an abnormal gene (ST), in Singapore, for
progressed after at least one prior change in their tumour called an commercialisation in Australia,
line of systemic therapy. The FGFR2 fusion or rearrangement, New Zealand and Singapore,
decision to approve this indication a defect that can drive cancer belongs to a class of drugs called
has been made on the basis of growth. This defect is estimated kinase inhibitors and works by
overall response rate (ORR) and to be present in around 15 per blocking the abnormal FGFR2
protein in bile duct tumour cells
and preventing cell growth.

China gives nod to Singapore launches
inhaled vaccine as
COVID-19 booster dose national registry to

CanSino Biologics Inc. has announced that the National fight global severe
Medical Products Administration of China (NMPA)
has granted the company approval for its Recombinant asthma battle
COVID-19 Vaccine (Adenovirus Type 5 Vector) for
inhalation (Convidecia Air) to be used as a booster dose. A research network formed by Nanyang
Utilising the same adenovirus vector technological Technological University, Singapore’s
platform as the intramuscular version Convidecia, (NTU Singapore) Lee Kong Chian School of
Convidecia Air provides a non-invasive option that uses Medicine (LKCMedicine), Changi General
a nebulizer to change liquid into an aerosol for inhalation Hospital (CGH), Singapore General Hospital
through the mouth. Convidecia Air is needle-free and (SGH), and Tan Tock Seng Hospital (TTSH)
can effectively induce comprehensive immune protection has set up the Singapore Severe Asthma
in response to SARS-CoV-2 after just one breath. In Registry (SSAR), the first of its kind in the
addition, Convidecia Air can be stably transported and country. This national registry also joins the
stored between 2 and 8 degrees, making it more accessible International Severe Asthma Registry (ISAR),
and contributing to large-scale vaccine distribution and making it the largest international research
building broad immune protection globally. CanSino BIO collaboration in the history of respiratory
received the approval of its clinical trial application for medicine in Singapore. The SSAR is the first
Convidecia Air in March 2021. Studies published in The multi-centre, large-scale registry of severe
Lancet indicated that Convidecia Air can asthma patients in Singapore. It aims to
induce strong humoral, improve understanding of severe asthma,
cellular and mucosal collect evidence of treatment effectiveness and
immunity to achieve triple safety, and identify predictors of treatment
protection and effectively contain success. The registry will be managed by
the infection and spread of the virus. The Academic Respiratory Initiative for
Pulmonary Health (TARIPH), a research
network spearheaded by NTU’s LKCMedicine.

REGULATORY NEWS 9

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

India to set up Export Korea focuses on easier
access to medical services
Promotion Council
South Korea Health Industry Development Institute
for medical devices (KHIDI), a government-affiliated institution operating
under the Ministry of Health and Welfare of the Republic
As a big boost to the Indian Medical of Korea, has revamped the official website of Medical
Devices Manufacturing, the long sought Korea, featuring information
and requested Medical Devices Export related to the use of Korean
Promotion Council (EPC) is finally medical services. Information
sanctioned to be created under the aegis on operations and treatment
of Department of Pharmaceuticals (DoP), of medical specialties,
Government of India. This strategic step is including oncology, cardiology
expected to go a long way in accelerating and organ transplantation,
the exports and manufacturing growth of are available on the Medical
the medical devices sector. According to the Korea website, which has a
government’s notification, the EPC shall be list of clinics and hospitals
established with headquarters at Yamuna designated to treat foreign
Expressway Industrial Development patients. It also offers various
Authority (YEIDA), Greater Noida and other essential information
regional offices in Andhra Pradesh and for visiting Korea, such as the
Telangana. For setting up the headquarters, types of medical visas, visa
YEIDA will provide an initial funding of processing, and tax refund
Rs 3 crore. The regional office at Andhra for cosmetic surgery. It also details health guidelines for
Pradesh will be set up by 2023, while the severe diseases, such as cerebral infarction, breast cancer
Telangana office will be ready by 2025. The and respiratory diseases, as well as daily activities for
Chairman & Vice Chairman of the Council enhancing immunity and concentration. Medical Korea’s
shall be elected from members who are official website is supported in four languages: English,
manufacturers or processors of medical Chinese, Japanese, and Russian.
devices.

AstraZeneca’s Evusheld for COVID-19
treatment receives approval in Japan

AstraZeneca’s Evusheld COVID-19. In prevention, Japan’s in those whom SARS-CoV-2
(tixagevimab and cilgavimab, Ministry of Health, Labour vaccination is not recommended
formerly AZD7442), a long- and Welfare (MHLW) granted and who may have an inadequate
acting antibody combination, Evusheld Special Approval response to a COVID-19 vaccine
has been approved in Japan for for Emergency for adults and due to immunodeficiencies.
both prevention (pre-exposure Recipients of Evusheld for
prophylaxis) adolescents (12 years prevention should not be
and treatment of age and older currently infected with or have
of symptomatic weighing at had recent known exposure to
disease caused least 40kg). a person infected with SARS-
by SARS-CoV-2 Evusheld is CoV-2. The Japanese government
infection. The approved for has agreed to purchase 300,000
decision marks use units of Evusheld (150mg each of
the first global tixagevimab and cilgavimab), and
marketing AstraZeneca is working with the
approval for government and partners to make
Evusheld as a first doses available as soon as
treatment for possible.

10 COMPANY NEWS

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

GE Healthcare to revamp Thailand’s
Srisawan Hospital with digital care solutions

Thailand’s Srisawan Hospital has process management and patient its kind for Srisawan Hospital, an
collaborated with GE Healthcare flow; and an integrated user- established name in tertiary care
with a Memorandum of friendly solution that supports in central Thailand. Scheduled
Understanding (MoU) to leverage in the management of workforce to open in November 2022, the
digital solutions to improve resources and quality of care as new facility will offer an extended
patient-care outcomes and well as reduction of error risks range of specialties, including
increase staff productivity while and healthcare related costs in cardiac catheterisation, oncology,
reducing intensive care unit (ICU)- the ICU. The MoU is the first of and a dedicated stroke unit with
related healthcare costs. Under the mechanical thrombectomy. In
MoU, GE Healthcare will seek to addition to upgrading its Hospital
support Srisawan Hospital with Information System (HIS) for
two advanced digital solutions- the new facility, the hospital also
A secure asset maintenance and plans to implement a complete
management software tool which Electronic Medical Records
simplifies the monitoring of patient (EMR) system, which will enable
and examination-related volume it to digitalise the majority of its
trends to optimise productivity, operations.

Olympus unveils new Juniper Biologics
surgical visualisation
platform for endoscopy establishes global

Olympus Corporation, based in Japan, has announced headquarters in
the launch of VISERA ELITE III, its newest surgical
visualisation platform that addresses the needs of Singapore
healthcare professionals (HCPs) for endoscopic
procedures across multiple medical disciplines. VISERA Juniper Biologics, a science-led
ELITE III offers various imaging functions, all supported specialty healthcare company focused
on commercialising novel therapies, has
in one system enabling minimally invasive established its Global Headquarters in
therapies such as Laparoscopic Colectomy Singapore. This announcement is supported
and Laparoscopic Cholecystectomy. by the Singapore Economic Development
Future software upgrades will advance Board (EDB) & the company is backed by
surgical imaging technology and allow The Sylvan Group, an independent private
for individual configurations that equity investment firm focused on deep value
facilitate seamless support of various companies with strong ESG-compliance.
surgical applications leading to a reduction in Juniper Biologics aims to build a patient-centric
investment costs. VISERA ELITE III will be presence throughout key markets in Singapore
available in Europe, Middle East and Africa & around the globe. The unit is set to carry out
(EMEA), parts of Asia, Oceania, and Japan. a full range of activities for its fast-growing
In developing VISERA ELITE III, Sony international business for its portfolio of
Olympus Medical Solutions, a joint venture medicines in oncology & oncology supportive
company of Sony and Olympus, optimised care, rare diseases & gene therapy, with a goal of
each technology and image processing expanding access of its pharmaceutical portfolio
function specifically for medical applications to patients across the emerging markets. The
to create the most advanced, open, and facility is furnished with active management &
versatile surgical visualisation platform coordination around medical affairs, regulatory
Olympus has ever brought to market. affairs, commercial & business development as
well as all finance & invoicing activities.

COMPANY NEWS 11

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Neovii, Fosun Pharma Alkem Labs, Stempeutics
launch treatment for knee
ink agreement osteoarthritis in India

for bringing Indian pharmaceutical firm Alkem Laboratories has
announced that regulatory approval has been received
transplantation from the Drug Controller General of India (DCGI) for
the launch of StemOne in India. The product is indicated
medicine to China for the treatment of knee osteoarthritis (OA). It is the
first allogeneic cell therapy product
Neovii Pharmaceuticals, a Swiss based global to be approved for commercial
specialty-care biopharmaceutical company, use in India for knee OA. The
and Shanghai Fosun Pharmaceutical have product has been developed by
entered into an exclusive agreement, under Stempeutics, a group company of
which Neovii has granted Fosun Pharma Manipal Education and Medical
Industry an exclusive licence to develop and Group, for over twelve years.
commercialise Neovii’s Grafalon (rabbit anti- The company’s proprietary
human T-lymphocyte globulin, ATLG) in technology platform provides for
Chinese Mainland, Hong Kong SAR, Macau an efficient manufacturing process
SAR and Taiwan region. Under the Agreement thereby enabling the product to
Neovii is entitled to receive upfront, regulatory be made accessible to patients at
and commercial sales milestones as well as an affordable cost. More than one
proceeds from supplying Grafalon to Fosun million doses can be produced from
Pharma Industry. The parties’ aim is to firstly a single set of master cell banks,
strengthen Grafalon’s position in the field of which is unique in regenerative
transplantation medicine in China, in which it medicine, thus providing consistent
is already approved for marketing and included products to patients. StemOne has the potential to
in China’s National Reimbursement Drug provide best-in-class pain reduction, improve quality
List. Further, the agreement entails clinical of life, to maintain cartilage quality and to stall further
development to expand Grafalon’s regulatory disease progression in Grade 2 & Grade 3 Osteoarthritis
approval in China to the prevention of Graft patients. It has anti-inflammatory & immunosuppressive
versus Host Disease following allogeneic properties which reduce inflammation in the knee joint.
stem cell transplantation (SCT), so as to align
its approved usages in China with those in
Europe and other countries worldwide.

Twist Bioscience to accelerate
synthetic biology research in Australia

US-based Twist Bioscience and synthetic pathways, aiding in the benefits of such a partnership.
the Australian Research Council development of novel organisms As the CoESB continues to ramp
(ARC) Centre of Excellence in that will provide a cleaner and up its research and assist startup
Synthetic Biology (CoESB) have greener future. This is one of the companies by allowing the usage
announced a partnership that of CoESB facilities, having Twist
will enable CoESB members and as a partner ensures that access
partners to order a wide range to DNA is not a barrier to success.
of Twist products that facilitate The ARC Centre of Excellence in
research and development. Synthetic Biology was established
Twist Bioscience’s proprietary in 2020 with the goal to provide
DNA manufacturing process, 21st century solutions to global
quality control and scale will agricultural, food production,
play an increasingly important manufacturing, healthcare and
role in the development of new environmental challenges.

12 FINANCE NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Celltrion inks Advanced MedTech
deal worth Holdings acquires China’s
$1.75B for market-leader in urology
cancer-based
bispecific Integrated urology leader Advanced MedTech Holdings (AMTH) has
antibody announced the acquisition of a majority interest in WIKKON, the
Chinese market leader in urology and shock wave therapy devices.
US-based biotech firm Abpro Singapore-based AMTH expects to acquire the remaining shares of
has announced a strategic WIKKON by the end of 2022. Based in the tech hub of Shenzhen,
partnership with Celltrion, a also known as China’s Silicon Valley, WIKKON specialises in the
biopharmaceutical company development and manufacturing of solutions to treat urological and
headquartered in South Korea, orthopaedic conditions such as
for its cancer molecule ABP kidney stones, erectile dysfunction
102, an antibody therapy and joint, muscle or tissue pain.
for patients suffering from Established in 1996, WIKKON has
HER2+ cancer, including the largest installed base of over
breast, gastric, and pancreatic 6,000 urology treatment devices
cancer. Through this global in China and strong relationships
partnership, Abpro will receive with healthcare professionals. The
payments from Celltrion of up acquisition will significantly strengthen AMTH’s direct presence
to $1.75 billion, including an in China. Combining the German engineering strength of Dornier
equity investment, development MedTech, AMTH’s wholly owned subsidiary, with the innovative
and commercial milestone capabilities of WIKKON, AMTH will be able to offer physicians access
payments and worldwide profit to an expanded product portfolio and build up a high potential platform
sharing. Celltrion will be in for the development of a global value segment in urology.
charge of the development
of ABP 102 following the Everstone buys controlling stake
completion of in vitro studies in India-based Softgel Healthcare
by Abpro and will have world-
wide commercialisation Singapore-headquartered Everstone Capital, the private equity arm of
rights. HER2+ type cancer the Everstone Group, has announced the acquisition of a controlling
is implicated in up to 30 per stake in Softgel Healthcare (SHPL), a specialised niche dosage form-
cent of all cases in breast, focused manufacturing player catering to the global nutraceutical,
gastric, pancreatic, and other pharmaceutical and OTC segments. The partnership aims to
forms of cancer. Abpro’s transform SHPL into a scaled, diversified, and globally recognised
ABP 102 molecule has shown contract research, development, and manufacturing organisation
preliminary data of better in India with the support of the strategic resources of Everstone.
efficacy and less toxicity SHPL is part of the Madras Pharma Group, a leading pharmaceutical
compared to other therapies contract manufacturing organisation in southern India, with eight
treating the same indication. manufacturing facilities covering all dosage forms. SHPL specialises
in the research, development and manufacturing of soft gelatin
capsules and probiotics. Its customers span across the Americas,
Africa, and Asia with over 80 per cent of its sales being in exports.

PARTNER CONTENT 13

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Agilex Biolabs expands GLP Toxicology
capacity with the commissioning of its
new purpose designed testing facility

Australia’s leading provider of toxicology and to receive the best in the industry with forethought,
bioanalytical contract services, Agilex Biolabs has and results that can be backed by the Agilex brand
expanded its capacity to better serve the biotech, to the level of accepted regulatory requirements and
pharmaceutical and animal health industry with evaluations of innovative therapeutics and vaccines.
the opening of its new in-vivo testing facility.
The increased capacity empowers the renowned
After over 25 years of continued support to its toxicology team to continue its track record for
industry, the wealth of experience gained by Agilex will groundbreaking successes and scientific acumen. As
now be shared with an even more increased number of the premier Australian bioanalytical partner for COVID
sponsors from around the globe as a direct result of a vaccine development, Agilex completed multiple SARS-
500% increase in capacity subsequent to the addition CoV-2 fast-track programs on behalf of its sponsors in
of a new purpose built GLP toxicology facility, making the last two years, including mRNA, adenovirus, and
Agilex undoubtedly the largest Good Laboratory molecular clamp stabilized protein subunit vaccines. In
Practice (GLP) Toxicology service provider in the region. addition, Agilex is the only toxicology study provider
in Australia to accommodate CAR-T therapy programs
“We are thrilled to add more talented people to with immunocompromised models.
the team, shorten lead times further, be more agile,
and enhance our superior level of safety assessment Services performed at the new testing facility will
service to the global biotech, pharmaceutical and continue to be compatible with IND-enabling packages
animal health industries.” said Holly Stefl, Agilex’s Chief for FDA review and/or other international regulatory
Commercial Officer. agencies, per mutual acceptance of data (MAD)
agreements. In addition to the new Brisbane facility,
The new custom-built toxicology facility has over Agilex’s Adelaide campus houses multiple bioanalytical
10,000 ft2 of laboratory space and is equipped with facilities for new chemical entities (NCEs) small molecules,
state-of-the-art individually ventilated, environmentally peptides, biologics, cell and gene therapy, vaccines, and
monitored, high tech enabled systems scheduled for other modalities. The breadth of instrumentation and
accreditation by Australia’s National Association of experienced leadership enables Agilex to deliver robust
Testing Authorities (NATA) as a Biosafety Level (BSL) 2 and reliable data to a wide spectrum of drug developers
facility. The already installed modern industry systems in nonclinical and clinical phases.
and standards ensures that our sponsors will continue

14 START-UP NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Singapore Taiwan’s Brain Navi expands
to Middle East and Egypt
launches
Brain Navi, a surgical robot manufacturer in Taiwan, has announced
S$15M a strategic partnership with distributor, Medtreq Medical Equipment,
to expand the distribution of the Surgical Navigation Robot, NaoTrac,
BioMedtech throughout the region of GCC region, Jordan, Egypt plus other countries
in the Middle East and Philippines, Indonesia, Malaysia, and Singapore
incubator which will be covered by
Medtreq branch in Philippines.
To facilitate the clinical NaoTrac, a CE-certified and
adoption of new technologies local government approval
that will create value neurosurgical navigation robot
for patients, Nanyang from Brain Navi Biotechnology, is
Technological University, embedding dissimilar technology
Singapore (NTU Singapore), named SMART Technology
Agency for Science, Technology which combining the machine
and Research (A*STAR), and vision and in-house algorithm
National Healthcare Group to perform robot-assisted
(NHG) have launched co11ab surgery, to streamline surgical
Novena (co11ab), an incubator procedures with real-time imaging and minimal invasive outcomes. The
to support biomedical collaboration and partnership between Brain Navi and Medtreq enables
technology (BioMedtech) greater innovative outcome in the Middle East neurosurgery, such as
startups making the leap from Saudi Arabia, UAE, Egypt, Jordan, and some of the other countries on
research and development into progressing, to streamline the surgical procedure, improve the surgical
commercialisation of their accuracy and pass-on knowledge to shorten the learning curves.
innovations. co11ab is the first
such outfit to be embedded Bugworks, Cytecare
in Health City Novena, an collaborate for
integrated community of immuno-onco therapies
healthcare, medical education,
and translational research. Indian startup Bugworks Research and Cytecare Cancer Hospitals,
Located in NTU Singapore’s also in India, have announced first-of-its-kind collaboration.
Lee Kong Chian School of Bugworks develops best-in-class, novel therapies for cancer and
Medicine (LKCMedicine), the infectious diseases and has set up a dedicated research centre within
S$15 million incubator aims to
be a national innovation and Cytecare, which is committed
translational hub that brings to excellence in treating cancer
together research, clinical, and patients. Bugworks’ current
venture creation activities, research in immuno-oncology
creating an environment that centres around modulating the
spurs knowledge sharing, tumour microenvironment that
innovation, and collaboration. includes adenosine antagonism - an
co11ab is expected to be area of research with applications
fully operational in the first across many solid tumours. The
quarter of 2023. It will drive drug candidates from this research
new BioMedtech startups will undergo translational testing
by providing entrepreneurs on patient-derived tumours in the
access to industry expertise, ex vivo laboratories at Cytecare, before progressing to first-in-human
mentorship, and funding clinical studies. The outcome of this translational research will guide
support to develop their ideas the first-in-human trials, expected to commence in early 2024.
and concepts into products.
The startups will also be guided
to implement viable growth
strategies to expand overseas.

WORLD NEWS 15

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

US launches programme to expand AI use
in biomedical and behavioural research

The National Institutes of Health approaches. At the same time, the or ethical problems that may occur
(NIH) in the US will invest $130 programme will ensure its tools and during data collection and analysis.
million over four years, pending data do not perpetuate inequities Through extensive collaboration
the availability of funds, to across projects, Bridge2AI
accelerate the widespread use researchers will create guidance
of artificial intelligence (AI) by and standards for the development
the biomedical and behavioural of ethically sourced, state-of-the-
research communities. The art, AI-ready data sets that have
NIH Common Fund’s Bridge to the potential to help solve some
Artificial Intelligence (Bridge2AI) of the most pressing challenges in
programme is assembling team human health such as uncovering
members from diverse disciplines how genetic, behavioural, and
and backgrounds to generate tools, environmental factors influence
resources, and richly detailed a person’s physical condition
data that are responsive to AI throughout their life.

Rift Valley fever vaccines Bill & Melinda
to advance with new $50M
funding from Europe Gates Foundation

Norway-based Coalition for Epidemic Preparedness Innovations announces
(CEPI) has launched its second phase of funding to advance the
development of innovative vaccine programmes against the $1.27B to improve
mosquito-borne viral disease, Rift Valley fever. Including EUR 35
million financial support provided by the European Union Horizon healthcare
Europe programme, up to EUR 50 million in total will be made
available by CEPI to support promising Rift Valley fever vaccine The Bill & Melinda Gates Foundation
candidates through Phase I and has announced commitments
II clinical trials in endemic areas. totalling $1.27 billion to improve and
Since its first identification, Rift save millions of lives. About $912
Valley fever outbreaks have million has been pledged to the Global
typically occurred in 4–15-year Fund to fight AIDS, tuberculosis
climatic cycles, linked to periods (TB) and malaria. The funding will
of rainfall surges creating more help accelerate efforts to end HIV,
breeding sites for infected TB, and malaria by 2030 and build
mosquitoes. During the last two resilient health systems needed to
decades, the virus has continued protect against future pandemics. It
to expand its range across Africa also will be instrumental in reducing
and into new regions within the disproportionate impact of these
endemic countries. There is diseases on women and girls. The
concern that further climate funding will address overlapping
change and extreme weather events could create the necessary global crises that have reversed
conditions to expand the number and size of regions affected. the progress already made toward
Despite veterinary vaccines being available, no vaccines are achieving the UN Sustainable
currently approved for human use. CEPI has, to date, supported Development Goals (Global Goals).
two programmes with Wageningen University and Colorado State The foundation’s sixth annual
University to advance human Rift Valley fever vaccines. Goalkeepers Report notes that nearly
every indicator of the Global Goals
is off track at the halfway point for
achieving them by 2030.

16 WORLD NEWS

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Strengthening Nigeria launches
rotavirus vaccine under
malaria genomics national immunisation
programme
workforce in East Africa
In partnership with Gavi, the Vaccine Alliance, World
The Africa Pathogen Genomics Initiative in Health Organisation, UNICEF and other partners, the
collaboration with Infectious Diseases Research Federal Government of Nigeria, through the National
Collaboration in Uganda, the University of Primary Health Care Development Agency, has
California, San Francisco, and Johns Hopkins introduced the rotavirus vaccine into the country’s
University recently concluded a one-week routine immunisation programme. The launch is a
hands-on training on Malaria Genomic critical first step in a push to reach children across
Epidemiology and Data Analytics in Kampala, the country with the rotavirus vaccine, which protects
Uganda. The emergence and spread of drug- against rotavirus infections, the leading cause of
resistant malaria, mutated parasites that skip severe diarrhoea in young children worldwide.
detection by commonly used rapid diagnostic Childhood diarrhoea is the third leading cause of
tests, and the resurgence of malaria transmission childhood mortality in Nigeria, accounting for 15 per
in multiple countries are major threats to the cent of all deaths in children aged under five. The
control and ultimate elimination of malaria. vaccine will initially be available in 19 states and the
A recent expansion of malaria genomics in federal capital territory (FCT), starting with zones
Africa has enormous potential to help tackle with lower vaccination coverage, and will later be
these problems, but there is an urgent need rolled out to the remaining 17 states, with the aim
to expand the workforce for the generation, to reach seven million children within the first 12
analysis, interpretation and utilisation of months. The rotavirus vaccine will be administered
malaria molecular surveillance (MMS) data orally to infants at 6, 10 and 14 weeks of age.
to fully realise this potential. To fill this gap,
experts collaborated to develop and deploy
an interactive, hands-on workshop, bringing
together programmatic and research personnel
to understand the uses of malaria genomics in
augmenting public health surveillance, discuss
the challenges in implementing such technology,
and work together across institutions and
countries to identity practical solutions.

Africa CDC, Smart Africa accelerate digital healthcare

The Africa Centres for Disease screening, and diagnosis for rapid
case identification, interruption
Control and Prevention (Africa of community transmission, and
clinical care delivery. The digital
CDC) and Smart Africa have tools not only improve the public
health response but also generate
concluded an agreement to work vast amounts of data which,
when harnessed within national
together towards accelerating health information systems,
open avenues for advanced
the use of digital technologies analytics, disease modelling, and
forecasting. This reinforces the
to improve healthcare and capacity of health authorities and
policymakers to quickly detect,
strengthen health systems across notify and effectively respond to
public health threats.
the African continent. The

signed agreement will focus on digital health convenings to be
hosted by African Union Member
connecting all of Africa’s health States. The COVID-19 pandemic
has accelerated home-grown
facilities and workforce by 2030, innovation that resulted in a wide
range of solutions for public health
advancing health data protection, messaging, epidemic surveillance,

portability, interoperability,

and governance; and working

together in the organisation of

WHO NEWS 17

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com WHO puts

WHO inks framework forward new
agreement with Belgium
recommendations
On the sidelines of the 77th session of the United Nations General
Assembly in New York, a new framework agreement was signed for influenza
between the Wallon Government, Belgium and the World
Health Organisation (WHO), on September 21. The Framework vaccines for 2023
Agreement will, amongst others, facilitate financial contributions
to the work of WHO, with a focus on the technical cooperation The World Health Organisation
around health heeds in the priority countries in Africa which are (WHO) has announced the
at the centre of the efforts of the development cooperation of the recommended viral composition
Wallon Government. With the new agreement, it is expected that of influenza vaccines (both
joint cooperation around areas of mutual interest, which include quadrivalent and trivalent) for
immunisation, research and policy initiatives, could start as soon the 2023 southern hemisphere
as possible. The agreement focuses on particular areas where the influenza season. The
added value of the partnership will make the most impact. To this recommendations issued will be
end, joint action programmes will be developed to support the used by national vaccine regulatory
implementation of public health programmes and activities aimed agencies and pharmaceutical
at strengthening the health systems in Africa. companies to develop, produce,
and licence influenza vaccines for
WHO launches the following influenza season.
Healthy Ageing Collaborative The periodic update of viruses
contained in influenza vaccines
The World Health Organisation (WHO) has announced the is necessary for the vaccines to
launch of Healthy Ageing Collaborative, a multi-sectoral and be effective due to the constantly
multi-stakeholder network to advance implementation of the evolving nature of influenza
United Nations (UN) Decade of Healthy Ageing (2021–2030). The viruses. The recommendation is
Collaborative provides a new opportunity for State and non-State based on the advice of a group of
actors to work together, leveraging their respective strengths to experts from WHO Collaborating
address pressing issues that affect the lives of older people, their Centres and WHO Essential
families, and communities. Regulatory Laboratories that
The Collaborative will raise analyse virus surveillance data
awareness, strengthen generated by the WHO Global
international coordination Influenza Surveillance and
on healthy ageing, Response System (or GISRS).
support national level Around a billion people get
implementation while seasonal influenza every year
recognising the role of older and the threat of an influenza
persons, ensuring their pandemic is ever-present. For
meaningful engagement this reason, the need to monitor
and the application of circulating respiratory viruses,
human rights-based including influenza, continues
approaches. Members of to be critical. This monitoring
the Collaborative, aligned informs the vaccine composition
on aims and principles and recommendations that WHO issues
willing to learn from each other, will prioritise issues that will be twice a year.
addressed in working groups. Collaborative action will contribute
to the progressive realisation of the rights of all older people
everywhere to the enjoyment of the highest attainable standard
of health and harness the social and economic opportunities that
population ageing provides.

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Can Technology Efface

DISOSLREDEEPRS?
The world is wide awake. Sleep disorders are on the rise globally and the Asia Pacific is no
different. There are numerous studies documenting how sleep loss is rampant and becoming
an epidemic. Approximately 45 per cent of people worldwide don’t get enough sleep, according
to a McKinsey report. Asians have the shortest average sleep time, according to researchers
from Flinders University, Australia. To combat these, firms are now turning to technology. The
emergence of wearables, smart devices, trackers, and patches has made widespread remote
sleep monitoring possible. Insights gained from the data collected by these devices are used to
improve understanding of sleep and create preventative sleep loss strategies. Let’s look at how
healthcare firms are trying to unlock the science of sleep disorders diagnosis and treatment by

leveraging new tech.

On September 29, Pfizer, a global pharma on an Apple iPhone. It requires no accessories
company, announced the acquisition of or hardware other than an iPhone to make an
ResApp Health, Brisbane-based Australia’s assessment. ResApp plans to solicit 510(k) clearance
leading digital health company developing for Android devices in the future.
smartphone applications for the diagnosis and
management of respiratory disease for $179 million. The company noted that in an at-home clinical
trial of 220 patients comparing SleepCheckRx to
Founded in 2014, ResApp hit the Australia
Stock Exchange in July 2015 via an $11 million
backdoor listing. ResApp has developed two key
products SleepCheck, a smartphone application
which allows consumers to self-assess their risk of
sleep apnoea and ResAppDx, a smartphone-based
acute respiratory disease diagnostic test for use in
telehealth, emergency department and primary care
settings. Both products are CE Marked in Europe
and TGA approved in Australia.

On July 6, ResApp Health received
510(k) clearance for its SleepCheckRx
as a prescription-only software-as-
a-medical device from the US Food
and Drug Administration (FDA).
SleepCheckRx is an easy to use, at-
home sleep test that screens adults
for the risk of moderate to severe
obstructive sleep apnoea by analysing
breathing and snoring sounds recorded

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simultaneous polysomnography, the SleepCheckRx “One challenge though
algorithms correctly identified 89.3 per cent of common to all is the fact of
patients with moderate to severe obstructive sleep making sure these devices or
apnoea (AHI greater than or equal to 15/hour) tech are used correctly in the
and achieved a specificity of 77.6 per cent. This
product is going to play a key role in the health of patient/user journey.”
many Australians who have been affected with sleep - Quentin Soulet de Brugiere,
disorders.
Co-Founder and CEO,
According to the Deloitte Access Economics 2021 Dreem, France
report, published by the Sleep Health Foundation
1 in 10 Australians have a sleep disorder that can “Scientific and clinical
substantially affect their well-being, safety and investigations suggest
productivity. Apart from the personal distress these that precision medicine
problems cause, the report shows they have a large technologies can improve
economic downside. In the last financial year (2019- our sleep, much in the way
20) their estimated overall cost was $14.4 billion that precision medicine
in financial costs with a further $36.6 billion in technologies are improving
non-financial costs related to lack of well-being. The the diagnosis, treatment, and
financial component is equivalent to 0.73 per cent of management of a wide range
Australia’s gross domestic product. The nonfinancial
cost represents 3.2 per cent of the total Australian of diseases.”
burden of disease for the year. The financial costs are - Len Liptak,
dominated by productivity losses of $11 billion and Co-founder, and CEO,
costs associated with increased accident risk. These ProSomnus Sleep
costs were distributed across the three major sleep Technologies, USA
disorders – obstructive sleep apnoea (OSA), insomnia
and restless legs syndrome. “Lifestyle apps or gadgets
with high claims but poor
“What is striking about the results of this analysis
is the relatively small amount spent on identifying validity taint the image
and treating sleep disorders compared to the large of unobtrusive and easy
costs of living with their consequences,” observes methods that meet medical
Natasha Doherty, who leads the Deloitte Access
Economics Health and Social Policy team. standards.”
- Max Sieghold,
Looking at the issue there has been a flurry
Co-founder,
Sleepiz AG, Switzerland

“The other challenge is to
get the right algorithm for

the right set of patients,
this is more so as we now
know that sleep apnea can
manifest differently in males
and females and there is
also inter-person variability
which needs to be taken into
account. This is particularly
true when coming up with
the algorithm of different PAP

devices.”
- Dr Sibasish Dey,
Head - Medical Affairs,
South Asia, ResMed, USA

20 COVER STORY

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of activities in the sleep disorders space across in the sleep industry worldwide to combat sleep
Asia Pacific. On March 23, Singapore brand disorders. Growing at a 14.5 per cent CAGR between
BUZUD, Fosun Trade Medical Devices, a leading 2020 and 2030, according to ResearchAndMarkets.
manufacturer of medical appliances, announced com the global sleep tech devices market revenue
its next-generation BUZUD Smartwatch DM01 and is set to reach $49.99 billion by 2030 from $12.89
Smartwatch DM02 that can detect blood oxygen billion in 2020. Device sales will increase the fastest
levels and monitor sleep quality with its SpO2 in Asia-Pacific (APAC) due to the advancements
technology. The feature-rich smartwatches have in wearables’ technology and booming number of
highly sensitive sensors that provide accurate health elderly, especially in India and China, the report
data insights, for both consumers actively seeking noted.
to manage their wellness and health conditions, and
for fitness enthusiasts. The Asia Pacific (APAC) sleep tech devices
market size is poised to reach $8 billion by 2027,
Similarly on March 21, Pear Therapeutics, according to a latest by Graphical Research. Some of
the leader in developing and commercialising the well-known players operating in the Asia Pacific
software-based medicines called prescription sleep tech devices market include Beddit, Dodow,
digital therapeutics (PDTs), signed an agreement Dreem, Eight Sleep, Fitbit, Koninklijke Philips,
with SoftBank Corporation to develop a Japanese- Oura Health, ResMed, Sleep Shepherd, Xiaomi, and
language digital therapeutic for the treatment of others. These companies have undertaken numerous
sleep/wake disorders for the Japanese market. In the strategies including new product launches and
United States, Pear is marketing Somryst, the only acquisitions that have helped them to grow as major
FDA-authorised prescription digital therapeutic for market players.
the treatment of chronic insomnia.
Countering sleep loss
Pursuant to the agreement, Pear will develop
digital therapeutic applications for the treatment According to reports there are over 80 sleep
of sleep/wake disorders for the Japanese market disorders. The most common ones are insomnia,
and SoftBank will investigate the Japanese market obstructive sleep apnea (OSA), central sleep apnea
potential for those applications, and SoftBank has (CSA), restless legs syndrome, and narcolepsy. It’s
an option to negotiate an exclusive license for Pear’s worth noting that the majority of the research is
digital therapeutics for sleep/wake disorders in focused on insomnia and sleep apnea.
Japan.
The current gold-standard methodology
Even South Korean healthcare startup to diagnose sleep disorders is overnight
HoneyNaps announced the launch of SOMNUM, a polysomnographic (PSG) recordings, which is an
medical software to diagnose, predict, and prevent intensive, time-consuming, and laborious process.
diseases by automatically analysing data measured
by Polysomnography using Artificial Intelligence To overcome the challenges, a growing
(AI) algorithms in November 2021. HoneyNaps’ number of health tech firms are developing
SOMNUM software is Korea’s first deep learning- apps, wearables, patches, sensors, trackers, etc.
based analysis program that enables multi-channel for at-home sleep monitoring and diagnosis.
real-time large-capacity signal analysis. It is More recently, a new group of devices,
completely different from the AI software that has Electroencephalogram (EEG) headbands has
been released previously and will offer users far more emerged for home sleep monitoring.
insight.
Takeda, Japan’s largest drugmaker, is conducting
As sleep problems constitute a global epidemic clinical trials to wake and sleep state transitions on a
that threatens health and quality of life for up to 45 portable EEG device in Narcolepsy Type 1 (NT1) and
per cent of the world’s population, there is a large healthy participants. In a separate initiative, Takeda
opportunity for digital therapeutics globally to on 22nd September 2021, partnered with TREND to
address patient unmet needs. Most sleep disorders launch an initiative with the Narcolepsy community.
are preventable or treatable, yet less than one-third By using TREND’s artificial intelligence engine,
of sufferers seek professional help. Of all adults in real-world social media conversation data from
Japan, 20 per cent are chronically sleep deprived and narcolepsy patients are analysed to explore how real-
15 per cent feel excessively sleepy during the day, life stories and shared experiences have the potential
according to the Japanese Association of Preventive to enhance understanding of the disease’s impact
Medicine for Adult Disease. on daily life and reveal current unmet needs of the
patient community.
A variety of new technologies are being developed
SleepWell, a Japanese MedTech firm developing

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“Wearable tech itself isn’t very crucial, but algorithms are’’

Masayuki Asano, ACCELStars, a medical sleep tech startup from the
Executive Officer, ACCELStars University of Tokyo, Japan is developing the world’s
highest level of sleep measurement technology
and treatment support services for psychiatric disorders,
neurodegenerative diseases, and developmental disorders
that are known to be accompanied by sleep disorders.
In an email interaction with BioSpectrum Asia, Masayuki
Asano, Executive Officer of ACCELStars discussed more
about the company and wearable technology for the
diagnosis of sleep disorders. Edited excerpts;

How does ACCELStars approach the science of fully established. We have developed an algorithm,
sleep disorders? named ACceleration-based Classification and
Estimation of Long-term sleep-wake cycles (ACCEL)
You must undergo a PSG test (polysomnography) that classifies sleep and wake episodes using only
for one night in a hospital to detect sleep with 100 per raw accelerometer data, without relying on device-
cent accuracy. ECG, diaphragmatic and nasal breathing, specific functions. The algorithm uses a derivative of
as well as EEG measurement, are all included in PSG. triaxial acceleration (jerk), which can reduce individual
So our goal instead, is to use wearable technology on differences in the variability of acceleration data.
the wrist to detect sleep disturbances. Today, the most
precise sleep detection is available for home sleep How important are wearables in this space?
testing, health promotion, and diagnosing disorders The development of sleep, mental, and
that may affect sleep. Our device would monitor both neurodegenerative illness-related disease detection
the diagnosis and treatment of sleep and dyskinesia. took over fifty years. We might be able to strike in
We are also developing a device for sleep apnea the sleep field, though, now that the technology and
syndrome and schizophrenia. censors have been established. Additionally, wearable
technology itself isn’t very crucial, but algorithms that
Please give us an overview of the wearable go into it are.
technology that ACCELStars is developing to detect
sleep disorders and how they work. What are the challenges in developing such
solutions?
Arm acceleration data have been used to
measure sleep-wake rhythmicity. Although several One of the major challenges is applying it as a
methods have been developed for the accurate medical device for regulatory approval. The other one
classification of sleep-wake episodes, a method with is expanding outside of Japan.
both high sensitivity and specificity has not been

solutions for sleep disorders, has developed with an accuracy on par with human doctors.
SleepScope (SS), a single channel portable EEG Some of the AI based diagnostics solutions
device for sleep measurement.
from Asia include: ResApp Health’s SleepCheckRx,
Another leading firm is Dreem, a french startup, HoneyNaps’ SOMNUM and Asleep medical-grade
which has developed The Dreem 3 headband. It sleep monitoring AI software and personalised sleep
is registered as an FDA class II medical device. app.
For the rest of the world, the Dreem 3 headband
is usually used as an investigational device in Wearable devices and patches have been the
research studies. It also has a consumer CE biggest game-changer in the diagnosis of sleep
marking. disorders. One such device is onesleeptest by
ResMed, a disposable home sleep test, for OSA
Artificial Intelligence (AI) like in every sphere is diagnosis. The latest FDA-approved wearable
also making waves in sleep diagnosis and research. devices and patches include Acurable’s AcuPebble
In 2018, US researchers demonstrated that a deep SA100device for OSA diagnosis (the UK) and
learning algorithm could recreate diagnostic scores Wesper’s patch for mild symptoms of sleep apnea
for sleep staging, sleep apnea, and limb movements (USA).

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“AI-based tech services How does HoneyNaps approach the science of
will change diagnosis and sleep?
treatment of sleep disorders”
HoneyNaps is working on developing essential
Christine Kwon, technologies for sleep biosignal sensing, data
Director, HoneyNaps analysis, AI-based sleep disease diagnosis, and
digital therapeutic solution. The advanced platform
I n November 2021, South Korea’s HoneyNaps launched SOMNUM is Korea’s first deep learning-based analysis
SOMNUM software, Korea’s first deep learning-based program that enables multi-channel real-time large-
analysis program that enables multi-channel real- capacity signal analysis. It is completely different from
time large-capacity signal analysis for sleep diagnosis. the AI software that has been released previously and
HoneyNaps is a sleep-specialised biomedical company will offer users far more insight.
with non-contact bio-signal sensing technology, artificial
intelligence software that analyses, diagnoses real-time Can technology change sleep disorders
large-capacity bio-signals, and server and database diagnosis and treatment?
platform technology for personalised services. The
company is now preparing for the FDA approval of the According to a United States sleep market report,
software. In an email interaction with BioSpectrum Asia, more than 100 million people around the world
Christine Kwon, Director, HoneyNaps shared details about suffer from sleep disorders such as sleep apnea and
insomnia. Around 90 per cent of those individuals
the company and the importance of Artificial Intelligence do not receive medical treatment for the disorders,
(AI) in the sleep disorders space. Edited excerpts; however. A variety of new technologies are being
developed in the sleep industry worldwide to combat
sleep disorders. As of 2020, the market size is worth
more than $76 billion. On average, the annual growth
rate of the sleep industry is expected to grow 14 per
cent by 2026.

Sleep management and sleep metrics are a global
trend. Various sleep-related apps/technologies now
tell individuals how well they slept and allow for better

What’s new in treatment options first device used while awake that is intended to
improve tongue muscle function, which in time can
Sleep science has evolved a lot, and there has help prevent the tongue from collapsing backward
been a tremendous transformation in treatments and obstructing the airway during sleep.
for sleep disorders. There are a range of treatment
options available for treating OSA such as CPAP Implantable devices are another option for the
(Continuous positive airway pressure) therapy, oral treatment of sleep apnea. Inspire Medical System’
and implantable devices. Inspire is the only FDA-approved OSA treatment that
works inside the body to treat the root cause of sleep
Pioneered by ResMed, a global leader in sleep apnea with a single click. Respicardia’s Remedē is
technology in the early 1990s CPAP therapy is the the only FDA-approved implantable device for CSA.
most popular treatment option for OSA. ResMed Inspire and Respicardia are American sleep tech
originated in Australia and is now headquartered in companies.
the US.
Prescription digital therapeutics (PDTs) represent
An alternative treatment for OSA and snoring a new class of software-based medical devices
are intraoral devices. Some of the FDA-approved authorised by the USFDA to treat various diseases
intraoral devices include Oventus’ O2Vent Optima and a growing number of PDTs are targeted toward
(Australia), ProSomnus Sleep Technologies’ addressing sleeping disorders.
ProSomnus EVO sleep (USA), and snore device,
Vivos Therapeutics’ s mmRNA (modified Pear Therapeutics’ Somryst, is the first PDT for
mandibular Repositioning Nighttime Appliance) treating chronic insomnia and delivers cognitive
device (USA). behavioural therapy for insomnia (CBT-I) via a
mobile application.
In 2021, FDA cleared Signifier Medical
Technologies’, eXciteOSA, a new prescription-onlySo Regulators around the world are bullish on
device intended to reduce snoring and mild OSA. PDTs. German regulators have approved somnio,
Unlike devices used while patients sleep, this is the the country’s first and only permanently approved

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engagement with rest. The added emphasis on self- existing data. Data preparation, algorithm design, and
care and rest to improve mental health has added to data learning results review/improvement should all
the trend of sleep management. The sleep industry be done by humans.
is growing into a high-value-added sector, spawning
various new terms such as ‘Sleeponomics’ or ‘Sleep 2) Professional manpower: Deep learning-
Tech.’ based AI development requires a vast amount of
learning data, expensive IT systems for processing
HoneyNaps expect that AI-based technology the data, data processing, and algorithm design,
and services will change sleep disorders diagnosis and professional manpower for cloud service
and treatment. HoneyNaps also will start a digital development. In general, the cost of developing AI
therapeutic business for the treatment of insomnia increases in the order of rule-based systems, machine
in addition to monitoring, analysing, and diagnosing learning, and deep learning, and especially the
inter-sleep bio-signals. The platform consists of development of AI core technologies for sleep medical
SOMNUM, an AI software for diagnosing sleep data over 6 hours is entirely different from general AI
diseases, SOMNUM Scanning, a non-contact sleep technology development.
analysis, and coaching solution, and SOMNUM
Medella, a digital treatment for insomnia. 3) Inference error: AI has a significantly low ability
to cope with uncertain situations, so when applying AI,
What are the challenges in developing such apps/ it is necessary to give humans a role in verifying it or
solutions? intervening in case of abnormal processes as a safety
device.
The challenges pertain to:
1) Learning: Artificial intelligence (AI) does not How do you see the growth of the company and
learn things itself. To be exact, the concept of AI what plans do you have for the coming year ?
learning is different from that of humans, so the role
of humans is important in AI learning. AI is a program In 2021, despite the aftermath of COVID-19,
that finely classifies and predicts data, and its the company attained sales growth of more than
‘learning’ means the process of reducing the deviation 25 per cent compared to the prior year. We are
between the actual and predicted values by updating preparing for the FDA approval of SOMNUM, a
the weights used to derive results with the input of sleep disease diagnosis software that integrates
core technology.

Digital Health Application (DiGA) in the field of sleep “Having spent close to
medicine. two decades as a full-time
sleep researcher with good
The UK-based National Institute for Health and
Care Excellence (NICE) recommended the use of Big exposure to field studies
Health’s Sleepio digital therapeutic for the treatment as well as lab-based ones,
of insomnia. I’m excited about the next
5-10 years. In the same way,
Mixed bag of challenges and breakthroughs
smartphones disrupted
Developing clinically validated digital treatments and transformed daily
for such disorders is not without challenges.
living, CST(consumer sleep
“Challenges are very different from one to technologies) will alter the
another. Developing a virtual sleep clinic is very way we organise our time
different from an implantable medical device, and to allow for healthful sleep.
different from a sleep tracker or a CBT-App. One Finding solutions that enable
challenge though common to all is the fact of making this is a multi-billion dollar
sure these devices or tech are used correctly in
the patient/user journey,” said Quentin Soulet de question.”
Brugiere, Co-Founder and CEO, Dreem, France. - Professor Michael

Highlighting challenges, Len Liptak, Co-Founder Chee Wei Liang,
and CEO, ProSomnus Sleep Technologies, USA said, Director,
“The main issue is the validation of app/device data
for medical purposes. Many apps and devices collect Centre for Sleep and
health data. The next step is to demonstrate that this Cognition, NUS
health data is, in fact, medically useful for diagnosing
Yong Loo Lin School of
Medicine, Singapore

24 COVER STORY

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The most-significant players Sleep disorders
in the sleep tech devices market are a growing burden
in all countries
● Masimo Corporation
● Koninklijke Philips N.V. Sowmya Srinath,
● Fitbit Inc. Director,
● Samsung Electronics Co. Ltd Healthcare & LifeSciences,
● Xiaomi Inc., Apple Inc. Frost & Sullivan, Singapore
● Garmin Ltd.
● Fossil Group Inc. Did you know that it can cost an employer
● ResMed $3000 and more a year in healthcare costs
● Compumedics Limited for just a single employee with obstructive
● Nihon Kohden Corporation sleep apnoea? In countries like the US, with 70 per
● Huawei Technology Co. Ltd. cent of the population being sleep deprived it is not
● ASUSTeK Computer Inc. surprising that around 2.28 per cent of the GDP was
● Withings and Motorola Mobility LLC. spent as costs attributable to sleep deficiency in
2015, according to The Harvard Gazette.
Source: ResearchAndMarkets.com
Did the pandemic help in bringing awareness of
or managing sleep disorders. Fortunately, there is good sleeping habits, similar to the sudden surge
tremendous progress on this front. These innovations we witnessed in fitness activities? According to a
seem poised to rapidly increase awareness of sleep study report ‘How Have Sleep Habits Changed amid
disorders and expand access to care, which is COVID-19’? published in The American Journal of
exciting.” Managed Care; the answer is no. Clearly it hasn’t
improved, as 53 per cent of the population surveyed
ProSomnus Sleep Technologies develops mentioned that they spend less time sleeping than
intraoral devices for OSA and snoring. A recent study before the pandemic, which is a growing burden.
evaluated the performance of precision treatment
planning and ProSomnus’ precision intraoral medical Sleep is not a developed world disorder only.
device technologies. The study reported that 94 per It is a growing burden in emerging markets too.
cent of patients with mild to moderate sleep apnea Insomnia, a common disorder amongst healthy
were successfully treated, 85 per cent of patients said adults has a prevalence of 10-15 per cent in
they achieved their treatment goals, and 97 per cent Singapore currently and as high as 39.1 per cent in
reported a significant reduction in snoring.
Finding the proper algorithm for the right group of
Another thing is apps and devices designed for patients is another challenge.
the treatment of sleep disorders have to be FDA-
approved, certifying that the data and treatment are “The other challenge is to get the right algorithm
clinically validated and meaningful. There are many for the right set of patients, this is more so as we
products out there, but few have clinical data to show now know that sleep apnea can manifest differently
safety, work, and patients use and have regulatory in males and females and there is also inter-person
review and authorisation. variability which needs to be taken into account.
This is particularly true when coming up with the
“Having validated and accurate measurements algorithm of different PAP devices,” Dr Sibasish Dey,
that are comparable to the gold standard and Head - Medical Affairs, South Asia, ResMed, US.
accepted by the medical community. Especially new ResMed is a pioneer of CPAP therapy and also has
tech like radar and sound face challenges as these developed several diagnostics devices/ wearables in
are not well-established standards in the medical this space.
community despite their high potential. Lifestyle
apps or gadgets with high claims but poor validity In 2021, Australian researchers in a systematic
taint the image of unobtrusive and easy methods that review called for standardisation and consistency
meet medical standards,” said Max Sieghold, Co-
founder, Sleepiz AG, Switzerland. The company also
has a subsidiary in India and is currently running an
online sleep screening service in India and Europe
and observed very high acceptance amongst people
who would otherwise not seek early medical care.

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China during the pandemic. “I’m hopeful about the future
The growing prevalence, increases financial of wearables for sleep as these

burden both demand improvement in lifestyle or are a natural integration
at the least intervention to improve sleep cycles. with digital treatments and
But unfortunately we have had the statistics into peoples’ lives. We need
that showcase almost 90 per cent of obstructive
sleep apnoea cases are left undiagnosed, further the accuracy to improve
burdening the ecosystem. and make sure that they are
evaluated independently by
Clearly it’s just not drugs, but technology that is the USFDA before being used
required to support diagnosis and management to
improve sleep cycles. clinically.”
- Dr Yuri Maricich,
We have in the late part of last decade witnessed Chief Medical Officer and
a series of consumer grade devices and tools to Head of Development at
support diagnosis and management. But in this Pear Therapeutics, USA
decade we have seen a surge in US FDA approved
clinically graded solutions to support the same. technologies are improving the diagnosis, treatment,
and management of a wide range of diseases,” said Len.
The US FDA has approved eXciteOSA device
delivers electrical stimulation through a mouthpiece For PDTs several studies have demonstrated
from under the tongue to reduce snoring and mild patient use, clinical safety as well as benefit in clinical
sleep apnoea. As untreated obstructive sleep apnea trials and real-world use. Various other studies are
(OSA) can lead to serious complications such underway to clinically validate the digital treatments/
as heart attack, glaucoma, diabetes, cancer and diagnosis in this space.
cognitive and behavioural disorders, such devices to
improve quality of life and reduce healthcare costs “I’m hopeful about the future of wearables for
burden. sleep as these are a natural integration with digital
treatments and into peoples’ lives. We need the
EnsoSleep, an artificial intelligence-assisted accuracy to improve and make sure that they are
sleep test scoring solution supports home based evaluated independently by the USFDA before
total sleep time measurement, Inspire Upper Airway being used clinically,” said Dr Yuri Maricich, Chief
Stimulation’s new telemetry based solution are some Medical Officer and Head of Development at Pear
of the digital innovations in sleep management that Therapeutics, US.
have been launched in recent times.
Correct usage of technology coupled with the
With a stronger pipeline of innovative adoption of good lifestyle practices can help improve
technologies, sleep disorder growth can be plateaued sleep and treat sleep disorders.
in a decade. The next generation can tend to wake
up after a good 8 hours of sleep from the current 5-6 “Having spent close to two decades as a full-time
hours of sleep cycle. Good sleep can assure a healthy sleep researcher with good exposure to field studies
body that can build a better future. as well as lab-based ones, I’m excited about the next
5-10 years. In the same way, smartphones disrupted
in the use of best practice design approaches and and transformed daily living, CST (consumer sleep
implementation assessments for sleep apps. technologies) will alter the way we organise our time
to allow for healthful sleep. Finding solutions that
A tech paradox enable this is a multi-billion dollar question,” said
Professor Michael Chee Wei Liang, Director, Centre
The irony of using technology to combat sleep for Sleep and Cognition, NUS Yong Loo Lin School of
disorders isn’t lost though. Earlier tech was seen as Medicine, Singapore. His current research seeks to
the bane of sleep and is now being considered as a reduce the impact of degraded or restricted sleep on
potential armour in the fight against such disorders. cognitive performance, well-being, and health span.

This begs the question, how accurate and With a suite of new technology revolutionising
beneficial is tech for sleep disorders? Can technology the way we sleep, there’s no doubt that there will
actually help us improve our sleep? Experts seem to continuously be new interventions for sleep disorders
think so. and improvements in sleep quality. For all of these
technologies, integration into clinical practice is
“Scientific and clinical investigations suggest essential for these to be accessible for all.
that precision medicine technologies can improve
our sleep, much in the way that precision medicine Ayesha Siddiqui

26 CLIMATE CHANGE

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

BIG PHARMA’S
GREEN AMBITIONS

Pharma, like every other industry, has a negative impact on the environment and in the face of the
current climate crisis, owes a responsibility to find ways to mitigate this harm. The industry has
risen to the challenges, with a majority of big pharma firms aiming for carbon neutrality by 2030.
What steps are big pharma companies taking to improve sustainability and how much further do
they need to go to actually make a dent in carbon emissions? Let’s find out.

Climate change - what once felt like a faraway (AstraZeneca, Biogen, GSK, Johnson & Johnson,
threat has become an imminent crisis. The Merck, Novartis, Eli Lilly, Pfizer, Sanofi, and Takeda)
rise in the earth’s temperature can create and Schneider Electric launched the Energise
favourable conditions for the spread of vector-borne programme, to engage hundreds of suppliers
diseases such as malaria or increasing pollen-related in climate action and decarbonisation of the
allergies. The World Health Organisation (WHO) pharmaceutical value chain.
estimates that between 2030 and 2050 climate
change will cause an estimated 250,000 additional In June 2021, eight other pharma companies
deaths each year. In November 2021, a Canadian (Sharp, Harro Hofliger, Schreiner MediPharm,
woman in her 70s became the first person to be Körber Pharma Packaging Solutions, SCHOTT
officially diagnosed with ‘climate change.’ Pharmaceutical Systems, HealthBeacon, Datwyler
and Ypsomed Group,) have founded the Alliance to
The pharmaceutical sector is at the centre of this Zero. This is a non-profit membership association for
crisis. A 2019 study by Canada’s McMaster University pharma and biotech supply chain enterprises, that
which assessed emissions reported by big pharma aims to facilitate the transition of the pharma sector
companies found the industry emitted more, and was to compliance with net-zero emissions, in line with
more carbon-intensive, than the automotive industry. the goal of the Paris Climate Agreement.
Specifically, the 48.55 tonnes of CO2 (carbon dioxide)
equivalent that the sector emitted per million dollars Big pharma’s response to a changing climate
of revenue was found to be 55 per cent greater than
the emissions of the automotive sector. The industry Big pharma has announced initiatives to address
is now finding ways to undo the damage and big climate change by cutting carbon emissions,
pharma firms have set ambitious carbon reduction saving water, cutting waste, and incorporating
targets for themselves. environmentally stable manufacturing into their
products.
In November 2021, ten big pharma companies
In 2022, French firm Sanofi started constructing

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a new manufacturing site in Singapore that will be “Synthetic biology that
nearly carbon neutral, using green electricity from integrates metabolic
the site’s own solar panels. The site will enable
the manufacture of multiple vaccines, with just 12 engineering of various
days needed to switch from making one vaccine to biological hosts (e.g. bacteria,
another. It is expected to be fully operational by
2026. In 2020, Sanofi also joined RE100, a global fungi, and plant cells) and
initiative in which companies commit to 100 per cent enzyme engineering will be a
renewable energy by 2050 (in France, all of Sanofi’s
sites are already fully renewable-powered). The major solution that will lead
firm also reduced water withdrawals by 22 per cent to the next green revolution
between 2015 and 2020.
in the way future small-
Japan’s Takeda achieved carbon neutrality molecule pharmaceuticals
in 2020. One of the ways Takeda achieved this
milestone is through investment in more than 30 will be produced.”
renewable energy and carbon offset projects across - Dr Jing-Ke Weng,
12 countries. In May 2022, the firm announced Co-founder, DoubleRainbow
an accelerated goal to achieve net-zero GHG
(greenhouse gas) emissions related to operations, Biosciences, USA
including before 2035 and for its entire value chain
before 2040. To achieve climate-related goals, a “While drug companies
company-wide, cross-divisional programme has been manufacture life saving
established to increase renewable energy usage and medications, their production
drive energy efficiency. Takeda is also looking beyond is resource-intensive and
its own operations and is working with suppliers to requires a great deal of
help them establish science-based reduction targets energy-intensive production.”
and reduce GHG emissions.
- Henryk Badack,
In 2021, UK’s GlaxoSmithKline (GSK) announced Senior Vice President
a £50 million ($59 million) investment in renewable Technical Services and
energy and carbon reduction at major UK and US Internal Project Management,
manufacturing sites. Vetter Pharma, Germany

Swiss firm Novartis is committed to becoming renewable sources, and the firm has further
carbon neutral across its value chain by 2040. From committed to reaching the 100 per cent sustainable
2021, Novartis has avoided an average of 18,000 power target by 2025. The pharmaceutical giant has
shipments per year saving approximately 1,400 also set a goal of net-zero emissions across its vast
tonnes of CO2 annually. It has also started to use supply chain by 2045.
solvents at most of its manufacturing plants that are
recycled and can be reused. The other leading pharma giants from the US, Eli
Lilly and Merck aim to shift global transportation
In January 2020, UK’s AstraZeneca announced from air to sea freight, as this has a substantially
its ‘Ambition Zero Carbon’ plan to achieve zero lower carbon footprint. Both the drugmakers
carbon emissions by 2025 and to ensure the entire have also invested in renewables as part of their
value chain is carbon negative by 2030. The firm push towards net-zero. Merck has secured several
has committed to invest $1 billion over the next ten contracts with wind and solar power providers to
years to deliver these targets. Part of this ambitious accelerate its own goal of 100 per cent renewable
strategy includes moving toward an entirely global energy by 2025, while Eli Lilly entered a joint venture
fleet, operating solely on electric vehicles by 2025. with Enerpower in July 2021 to open the largest solar
farm in Ireland, UK which will power its nearby drug
In 2020, US based Biogen announced, ‘Healthy manufacturing plant.
Climate, Healthy Lives,’ a groundbreaking $250
million, 20-year initiative to eliminate fossil fuels Pfizer from the US, too, has pledged to go carbon
across its operations and collaborations with neutral by 2030 and will, among other strategies,
renowned institutions, aimed at improving the health reduce direct emissions by 46 per cent and purchase
of the world population. 100 per cent of its electricity from renewable sources.
Following a virtual power purchase agreement with
At Johnson & Johnson in the US, half of the Vesper Energy, Pfizer expects its North American
electricity the company uses already comes from operations to be 100 per cent solar-powered by the
end of 2023.

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SOME OF THE TOP PHARMS’ ENVIRONMENTAL harnessing the power of natural evolution through
INDICES MEASURED AGAINST THEIR PEERS, bioengineering to improve the quality of human
1 BEING THE WORST, 5 BEING THE BEST* health.

Company Carbon Pollution Water Manufacturing is another carbon-intensive
Footprint Prevention Conservation stage of a pharma company’s supply chain. One
of the most effective ways of reducing carbon
AbbVie 53 5 emissions associated with this is to adopt continuous
manufacturing, an efficient alternative to batch
Amgen 55 5 manufacturing, that combines multiple separate
production stages into one single, continuous
Biogen 55 5 production line.

Bristol Myers Squibb 5 1 2 Back in 2014, US-based biotech company Amgen
had opened a biomanufacturing plant incorporating
Eli Lilly 51 2 continuous purification methods in Singapore for
commercial production of biologic drug substances.
Gilead Sciences 2 1 3 Compared with the manufacture of the same amount
of product in a traditional facility, the plant has
GSK 55 5 demonstrated a 73 per cent reduction in energy
consumption, 54 per cent reduction in water use,
Johnson & Johnson 5 3 5 and 69 per cent reduction in carbon emissions. In
2018, the firm began building a new next-generation
Merck & Co. 5 4 4 biomanufacturing plant in Rhode Island, USA.

Novartis 14 4 Sanofi followed suit in 2019, opening its first
digitally-enabled, continuous manufacturing facility
Novo Nordisk 2 2 2 in the US.

Pfizer 51 2 However, some experts feel it’s virtually
impossible for the industry to avoid emissions
Roche 22 2 entirely.

Sanofi 53 4 “While drug companies manufacture life saving
medications, their production is resource-intensive
* Source: Censible and requires a great deal of energy-intensive
production, for example, operations involving
Path to net-zero automated air circulation and high water and
electricity usage. Combined with the required high
The industry has set ambitious targets and is standards that result from strict, ever-increasing,
making larger strides in achieving this task, but and absolute binding regulations by healthcare
there’s a lot that it has to do to actually make a dent authorities, it is very difficult to avoid residual
in carbon emissions. emissions entirely,” said Henryk Badack, Senior
Vice President Technical Services/Internal Project
Getting energy from renewable sources, investing Management, Vetter Pharma, Germany.
in greener fuels for shipping and using more eco-
friendly and less wasteful forms of packaging are all Vetter is a global CDMO (contract development
steps in the right direction. and manufacturing organisation) with an enduring
commitment to sustainability.
Another way to reduce emissions is to use
synthetic biology for the production of APIs He added, “It is not always possible, for example,
(Active Pharmaceutical Ingredients) and other raw to integrate recycled materials into production. In the
materials. Current small-molecule intermediate/ case of waste management, biopharma companies
API manufacturing almost entirely relies on cannot recycle many substances as they have been
unsustainable, petroleum-industry-derived in contact with active ingredients. This would be too
precursors. dangerous for humans and the environment alike.”

“The growing need to quickly move away from Perhaps net-zero emissions are somewhat
fossil fuel amid the threat of climate change creates ambitious, but not unattainable and the industry
urgent demand for novel sustainable approaches to should take all necessary steps to be more
replace the current supply chain of small molecule sustainable, to maintain a healthy ecosystem.
drug production. Other than sporadic uses of
biocatalysts in specific steps of some pharmaceutical Ayesha Siddiqui
synthesis, truly sustainably produced synthetic small-
molecule pharmaceuticals are very rare. Synthetic
biology that integrates metabolic engineering of
various biological hosts (For example, bacteria,
fungi, and plant cells) and enzyme engineering
will be a major solution that will lead to the next
green revolution in the way future small-molecule
pharmaceuticals will be produced,” said Dr Jing-Ke
Weng, Co-founder, DoubleRainbow Biosciences,
USA.

Double Rainbow is a sustainable biotech company

SPEAKING WITH 29

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

“Our drug is now an important

treatment for HIV patients in China”

High-potency active pharmaceutical «
ingredients (HPAPIs) like small molecules
have been the longtime essentials for Dr Changjin Wang,
drug development. Small molecules constitute
90 per cent of drug sales being the primary active CEO and
substance choice for pharmaceuticals. Frontier
Biotechnologie is one such China-based global firm board member,
specialising in the accelerated R&D, development,
and manufacture of complex small molecules for Frontier
pharmaceuticals and biotechnology. Dr Changjin
Wang, CEO and board member of China-based Biotechnologies
Frontier Biotechnologies, spoke with BioSpectrum
Asia about emerging research and market prospects treatments that would benefit patients.
at small molecules for infectious diseases like
anti-COVID and anti-HIV. Edited excerpts; What is your approach to small molecule
innovation and application?
How do you describe Frontier’s relentless
efforts in antiviral therapeutics? How have Based on our collective expertise and experience
the market trends and prospects been in this in developing antiviral protease inhibitors, we
arena? decided to develop an antiviral drug for COVID-19 –
FB2001 (bofutrelvir), as we believe that it is a more
For the past 20 years or so, we have seen many effective treatment option versus antibody therapy,
viral outbreaks across the globe. From SARS and especially against the different COVID-19 variants.
MERS to the recent COVID-19, there aren’t that In September we announced positive results from
many antiviral drugs available to help patients the Phase 1 clinical trial of our drug candidate,
overcome these diseases. Based on our experience FB2001 – a small molecule inhibitor of coronavirus
and expertise in developing our HIV treatment, we main protease (Mpro) – in healthy adult volunteers.
decided to expand into developing a treatment for Clinical studies have shown FB2001 to be safe and
COVID-19 as well as other infectious diseases, though well tolerated among trial participants.
many are still in the early stages of development.
We believe that there is a huge unmet need in this FB2001 has demonstrated in vivo antiviral activity
area due to the difficulty in developing appropriate in the lung and brain tissue of the SARS-CoV-2
drugs for each type of disease. We are always open to mouse model without the need for pharmacokinetic
learning and educating ourselves about new clinical boosting. Therefore, it holds great promise as a
challenges and seek to use our scientific expertise to treatment for acute COVID-19 as well as long-COVID,
address unmet needs in medicine via the expansion both of which will be evaluated in further follow-up
of our therapeutic portfolio. studies. Frontier Biotechnologies is also developing
a pulmonary formulation of FB2001 that could be
What is your outlook for the infectious used in outpatient settings for the treatment of mild
disease diagnosis and treatment market in COVID-19, as well as for post-exposure prophylaxis.
China or the APAC region? When inhaled directly into the respiratory tract and
lungs, the tissue concentration of FB2001 is much
We view infectious diseases as a major disease higher than that in plasma; hence, the onset of action
area and there is a growing need for more antiviral and viral clearance could potentially be faster than
treatments, not only in this region but globally as that of oral therapy. Additionally, we hypothesise that
well. There are still tremendous opportunities in the a pulmonary formulation might be more effective
diagnosis and treatment of infectious diseases and we in outpatient settings as an inhaled drug can reach
are constantly trying to enhance our understanding the respiratory tract and lungs directly, resulting
of these new diseases in hope of developing new in a faster onset of action and viral clearance. This
is currently in development, and we hope that our

30 SPEAKING WITH

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

programme’s success may help decrease the disease Our efforts paid off as our drug is
burden and improve patient outcomes in the long now an important treatment for
run. For hospitalised patients who are receiving HIV patients in China. We are
many drugs at the same time, we strived to develop a seeking marketing authorisation for
single-agent drug that can achieve effective treatment Albuvirtide from health authorities in
doses without the use of a ‘booster’ component to many countries and have already received
reduce the risk of drug-drug interactions. Bofutrelvir approval from Ecuador, Cambodia,
is currently in Phase II and III trials, involving Malaysia, and Azerbaijan. We hope to
around 1,200 hospitalised patients in clinical centers expand commercialisation to many
worldwide. countries in Asia, Europe, South
America, and Africa.
Could you shed some light on your efforts
What is your stake in Asia for
in developing the first long-acting anti-HIV Active Pharmaceutical Ingredient
(API) synthesis and preparation,
fusion inhibitor and subsequent market especially in the development of new

penetration? long-acting peptide drugs?

Frontier Biotech started off with the idea of We have recently built two large-
creating albuvirtide, which is our first product on the scale manufacturing facilities in
market. This was made possible with the help of Dr Nanjing and Chengdu. The Chengdu
Dong Xie, one of our co-founders, who has extensive plant allows us to have one of the biggest peptide
experience in HIV drug discovery development. API manufacturing capabilities in China, with a
production capacity of 250 - 1,000 kg of API peptide
We believed that long-acting injectables would drugs annually. These facilities support not only the
be key to helping patients as they could reduce production of our own approved products but also
pill burden and improve treatment adherence, at future pipeline molecules. Other companies can
a time when most treatments were in the form of also work with us to leverage our manufacturing
oral pills. It took us a really long time to develop our capabilities.
HIV treatment, but we persevered, and our drug
was approved for use in 2018 by China’s National What’s your current innovative drug product
Medical Product Administration. Once approved, we pipeline for FY 22-23?
began our commercialisation efforts in China with
a specialised team of about 100 people, who had We have a number of products that are currently
to do a lot of market education with the healthcare in our drug development pipeline:
community and patients owing to unfamiliarity with
long-acting injectables at that point in time. ● In the HIV space, we have the FB1002
combination drug (Albuvirtide + 3BNC117) that is
undergoing three Phase II trials in the United States
and China.

● For COVID-19, we have FB2001 which is
currently undergoing Phase II and III clinical trials
globally.

● We also have FB3001, a novel topical patch for
the management of pain and inflammation that is
about to enter a Phase III trial.

● FB6001, a therapeutic peptide vaccine targeting
PCSK9, is an anti-hypercholesterolemia / low-
density lipoprotein agent, currently in preclinical
development.

We are constantly leveraging our expertise to
discover and develop new drugs that help ease
patients’ disease burden. We are aiming to grow our
presence globally, with the hope of attracting new
talents and taking our capabilities to the next level.

Hithaishi C Bhaskar
[email protected]

SPEAKING WITH 31

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

“Creation of reference genomes

will set up baseline on larger

scale of genetic research”
Indonesia has established its first national
integrated biomedical programme, the «
‘Biomedical and Genome Science Initiative
(BGSi)’ in Jakarta designed to foster precision Dr Roy Tan,
medicine in the country by integrating the potential
of genomics into healthcare services. The government General Manager,
of Indonesia is committed to developing population
genetic databases as part of its biomedical innovation MGI Asia Pacific
and public health initiatives. Supporting the
initiative, a leading bioscience technology provider neurodegenerative diseases, metabolic diseases,
in Shenzhen (China), the MGI Tech Co. Ltd. (MGI), genetic disorders, and aging.
is on its mission to leverage cutting edge sequencing
techniques to assist Indonesia’s extensive venture In conjunction with BGSi, what are the
to combat health concerns via developing more implications of this national initiative? How
effective therapeutics in the country. The BGSi will MGI contribute to creating a credible and
genome and biomedical research initiative will accountable population database?
have a profound impact on Indonesia for the next
five years. In an interaction with BioSpectrum MGI is honoured to have this opportunity to
Asia, Dr Roy Tan, General Manager of MGI Asia support Indonesia’s National Genome Project
Pacific elaborated on the cutting-edge automation by providing our cutting-edge automation and
and sequencing technology shaping Indonesia’s sequencing technology to improve human health.
National Genome Project. Edited excerpts; Based on its proprietary technology and the market
trend of genetic sequencers, MGI has developed a full
Which are the project initiatives that MGI range of genetic sequencers from small to medium-
will support as technology providers for throughput benchtop genetic sequencers, to high-
Indonesia’s National Genome Project? and-ultra-high-throughput genetic sequencers in
order to accommodate different sequencing needs.
Budi Gunadi Sadikin, Minister of Health, MGI’s DNBSEQ-T7RS can produce up to 1~6 TB
(Kemenkes), government of Indonesia officially of high-quality data per day and is well suited for
launched the BGSi on August 14, 2022. BGSi is the national genome projects as well as whole genome
first national initiative programme created by the sequencing, deep exome sequencing, epigenome
Ministry of Health to develop more appropriate sequencing, transcriptome sequencing, and tumour
treatment for the community. The method used relies panel. It supports multi-sequencing modes with
on the technology of collecting genetic information increased accuracy, reduced duplicates, and reduced
(genome) from humans and pathogens such as index hopping, making it a competitive platform
viruses and bacteria or commonly referred to as for scientific research, clinical research, and disease
whole genome sequencing (WGS). prevention.

Regarded as a scientific breakthrough and the MGI’s automation systems, MGISP-NE384
first of its kind in Indonesia, the project targets to high-throughput automated nucleic acid extractor
collect biological samples and curate the unique and MGISP-960 high-throughput automated
genome data of 10,000 Indonesians in the next two sample preparation system will greatly automate
years to develop insights into and map variants from labour-intensive and time-consuming procedures
the local population with pre-determined priority such as DNA/RNA extraction and library prep for
diseases. The results will contribute to the research high throughput sequencing, thus contributing to
and development of treatment in six main disease
categories: cancer, infectious diseases, brain and

32 SPEAKING WITH

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

improving the overall efficiency and productivity in research. The collaborations among the local
NGS laboratories. MGI will provide its ultra-high- researchers and aboard experts, education, and
throughput genetic sequencer, automation systems training programmes help Indonesian researchers
and data processing platform to help this programme to improve their genomic science and research
creating a total workflow and solution and making a programmes that will strengthen their biotech
more effective lab, with the help of its strategic local capabilities. Like China or other countries, as the
partner PT Bakti Energi Abadi. local genomics talents developed, not imported, a
new industry with many startups combined with vast
Are there any collaborative efforts involved in local biodiversity will come and spur.
the project?
How does MGI build therapeutics and
MGI, with the help of its strategic local partner PT
Bakti Energi Abadi, will create a total workflow based disease prevention strategies in Asia Pacific
on ultra-high-throughput genetic sequencer DNBSEQ-
T7RS, the MGISP-960RS and MGISP-NE384RS while optimising the efficiency of NGS
automation systems, and ZTRON data platform to
support the BGSi initiative. Budi Gunadi Sadikin, laboratories?
Minister of Health, Indonesia, explained that the
Ministry of Health will expand the sequencing capacity With a strong focus on the upstream of the
which will be supported by the Global Fund. Until sequencing industry, MGI is mission-oriented
December 2022 there will be 56 genome sequencing to develop more advanced life science tools to
machines spread across 43 laboratories in Indonesia. empower downstream customers in reproductive
health, precision cancer diagnosis and treatment,
How is MGI planning to strengthen infectious diseases, food security, agriculture,
Indonesia’s biomedical sector and its global forestry, fishing, consumer genomics, etc. MGI’s
competitiveness in life science innovation? automation systems improve sample extraction,
processing and sequencing procedures to dissect
With the implementation of precision medicine the genetic disparities for understanding the disease
through the use of genetic technology, MGI, with genesis and profilaxis. The introduction of MGI
the help of its strategic local partner PT Bakti sequencing and automation systems aligns with
Energi Abadi, will help this programme create a Indonesia’s national strategy - Biomedical and
total workflow based on its ultra-high-throughput Genomics Science Initiatives for Precision Medicine.
genetic sequencer, automation systems, and data It is the key to understand the genetic information
processing platform. With the large-scale of genomic such as mutation and diversity to have an earlier
data collected during the 10,000 whole genome screening or monitoring programme based on
sequencing, bioinformatics talents are needed to ctDNA/RNA circulating tumor genetic materials in
analyse these data. The creation of the reference one’s blood, to detect or diagnose earlier and treat
genomes for Indonesia will set up a baseline on the earlier for cancer prevention, to stratify the different
larger scale of genetic research. Comprehensive diseases and design the individualised treatment for
training from MGI will help to cultivate talents personalised medicine. All diseases related to cancer
needed for Genomics science and biomedical are due to changes of genetics in our aging process.
Understanding the genetic variations will aid in better
control over precision medicine and technology.

In addition to collaborating with Nalagenetics,
MGI has, lately, partnered with MiRXES, a
Singapore-headquartered biotechnology company,
to accelerate spatio-temporal transcriptomics and
multi-omics research in human development and
diseases. Based on MGI’s leading DNBSEQ-T10×4RS
sequencing system, MiRXES aims to build an ultra-
high-throughput, high-resolution spatial genomics
pipeline in Singapore to give local researchers
access to cutting-edge capabilities to generate novel
biological insights into complex diseases such as
cancer and allow for discovery of new biomarkers and
pathways for targeted drug development.

Hithaishi C Bhaskar
[email protected]

EVENT REPORT 33

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Dignitaries attending the Opening Ceremony of Mölnlycke’s new facility at Kulim Hi-Tech Park, Kedah, Malaysia.

Mölnlycke opens surgical glove

plant at Malaysia’s Kulim Hi-Tech

Park with an investment of RM233M
Malaysia has been actively promoting and
implementing sustainable development In addition to production lines, the site includes
initiatives aligning with the National an administrative building housing R&D and
Investment Aspirations (NIA) and Sustainable laboratories facilities.
Development Goals (SDG) principles. In line with
this, Mölnlycke, a leading medical product and This new plant will expand Mölnlycke’s glove
solution company from Sweden, is committed manufacturing capacity by 60 per cent and help
to contributing to Malaysia’s sustainability goals meet future demand for high-quality surgical gloves.
through its shared value creation WeCare roadmap, The current initial production capacity is around 50
while creating innovative infrastructure to grow the million pairs of surgical gloves per year. Once the
local economy. production capacity reaches full capacity in 2026, the
target will be 200 million pairs of surgical gloves per
With this goal, Mölnlycke, operating in over 100 year.
countries worldwide leveraging essential products
range to healthcare professionals, has set up its Talking about the facility, JC
fourth surgical gloves manufacturing facility in Guillou, Vice President Global
Malaysia at Kulim Hi-Tech Park, built with a total Operations, Mölnlycke
investment of EUR 50 million (RM233 million). Gloves, Malaysia, said “Our
new plant in Kulim, Kedah
Speaking about the facility Zlatko is a significant milestone for
Rihter, CEO, Mölnlycke, Mölnlycke, as it is part of our
Sweden said “The new plant transformative journey towards
is a key part of our future plans becoming a global leader in sustainable healthcare.”
for sustainable growth within
the surgical gloves business. We “Malaysia is very honoured that Mölnlycke,
will achieve this in a less resource- who has a long-term presence in Kedah, continues
intensive way, while creating a state- to expand in the Kulim Hi-Tech Park (KHTP).
of-the-art working environment for our colleagues in The establishment of Mölnlycke’s new production
Malaysia.” facility in Malaysia is a mark of confidence in the
continuous sustainable growth of the Malaysian
With a total area of 29,164 square meters and a economy and will be a boon for Malaysia to
building footprint of 14,620 square meters, the newly maintain its leadership position in the glove
constructed production facility is fully equipped with manufacturing sector. Once implemented, the
an automated glove production and packaging line. company’s state-of-the-art automated plant in
Malaysia which has incorporated sustainable

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BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Breach detection indicator gloves Partnerships for Sustainability

Studies indicate that as much as 92 per cent As part of its commitment to reduce the operational
carbon emissions by 50 per cent by 2030 (baseline
of surgical glove punctures go unnoticed during 2016), and in support of Malaysia’s national agenda
to achieve net-zero emissions by 2050, Mölnlycke is
surgery with single gloving. Using double gloves focused on driving continuous energy efficiency to
transition to 100 per cent renewable electricity across
reduces the risk of surgical staff perforating an all its sites globally. The company intends to optimise
the new plant’s energy consumption by tapping
inner glove by 71 per cent. Thus, Mölnlycke’s digital energy management to monitor how energy is
being used and where it is being lost. This increased
double gloves strategy reduces the risk of blood transparency will help us optimise our efforts to
reduce consumption. The new manufacturing plant is
contamination by 65 per cent, compared to single constructed in partnership with global sustainability
solutions providers, ENGIE and Veolia Water
gloves. It also reduces the risk of needlestick Technologies. Veolia’s state-of-the art solutions will be
assisting in improving the plant’s water and wastewater
injury by up to 82 per cent. On this background, management, effectively recycling water, and further
improving the discharge quality to achieve a circular
Mölnlycke has created an indicator glove which economy and to reduce waste in manufacturing
processes. In addition, with Veolia’s digitalised system,
can significantly detect perforations during water consumption at the plant is expected to be
reduced to 50 per cent.
surgery by colouring the punctured area, from 23
Olivier Estienne, Country
per cent in the single glove group to 36 per cent in Director for Malaysia, Veolia
Water Technologies said “Veolia
the combination glove group. Further to 90.2 per is firmly committed to championing
ecological transformation.
cent in the indicator glove group. Using indicator Mölnlycke seeks to establish
sustainable practices and integrate a
double gloving will significantly detect glove green mindset into their business. Our team is proud
to be part of Mölnlycke’s expansion plans in Malaysia
punctures. and we look forward to more avenues to support their
endeavour for greater sustainability and improved
practices, would be exporting performance.” ENGIE, a global leader in providing
100 per cent of its production low-carbon energy, will support Mölnlycke’s production
for the global market, making operations by providing sustainable energy solutions to
Malaysia part of their key the new Kulim plant under a long-term power-purchase
value chain internationally” agreement spanning over 15 years.
said Arham Abdul Rahman,
CEO, Malaysian Investment Expressing happiness on
Development Authority (MIDA). collaborating with Mölnlycke,
Thomas Baudlot, CEO, Energy
Hailing the development, Solutions APAC, Country Head
Muhammad Sanusi bin Md for Southeast Asia, ENGIE,
Nor, Chief Minister of Kedah Singapore said “ENGIE is proud to
said, “Having Mölnlycke’s new be the chosen long-term sustainability
state-of-the-art factory in Kedah partner to Mölnlycke in accelerating their low-carbon
complements right prerequisites journey in Malaysia. This project exemplifies how industry
for sustainable production of high- players can reap economic benefits by accelerating their
quality surgical gloves”. energy transition with low-carbon solutions.”

Speaking about the new facility Hithashi C Bhaskar
from Mölnlycke, Mohamad [email protected]
Haris Kader Sultan, Chief (The correspondent attended the Opening
Executive, Northern Ceremony at the invitation of Mölnlycke)
Corridor Implementation
Authority (NCIA), said “NCIA
is proud to facilitate Mölnlycke’s
expansion in the medical devices
sector as it will accelerate the development of
the high-technology and digitalisation ecosystem
in Kulim Hi-Tech Park, which is classified as
Northern Corridor Economic Region (NCER)
Special Promoted Area. Mölnlycke’s expansion on
innovative and advanced products is in line with
the government’s efforts to create 500 high-skilled
employment opportunities in the science and
technology field, for the benefit of the rakyat.”

EVENT REPORT 35

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Dignitaries at the Opening Ceremony of BIO Asia-Taiwan Exhibition 2022.

BIO Asia–Taiwan 2022 showcases

innovation, market, supply and investment
BIO Asia–Taiwan 2022 jointly organised by the
Taiwan Bio Industry Organization (Taiwan the Asian Value Chain’ explored Asian CDMOs key
BIO) and the global Biotechnology Innovation role in strengthening bio business while enhancing
Organization (BIO) under the theme ‘Connecting market proximity, advancing service quality, local
the Asian Value Chain’ at the TaiNEX 2 Exhibition incentives, and lowering operation and shipping
Center in Taipei, showcased the latest achievements costs.
in the industry, academia, and research institutes,
with 100,000 visitors making it to the five day The conference has sessions entitled CDMO
international conference and exhibition. business for small molecules, biosimilars, cell
therapy, regenerative medicine, precision medicine,
Talking about the event Johnsee Lee, Chairman genetic testing, medical materials, services, smart
of the BIO Asia–Taiwan Organizing Committee. medicine, pharmaceutical industry equipment,
said “BIO Asia–Taiwan 2022 showcases innovation, medical instruments and more. Furthermore, the
market, supply and investment value linkages to and event exemplified cell lines, biopharmaceutical drug
within the Asian biomedical ecosystem.” development, clinical testing and API production
processes along with smart technologies which
The active involvement of government research can optimise biologics product development and
institutes like Academia Sinica, the Ministry of manufacturing. Exclusive global CDMO’s featuring
Health and Welfare, the National Health Research enhanced capabilities were also the highlights of the
Institutes, the Institute of Nuclear Energy Research, exhibition.
the Development Center for Biotechnology (DCB),
and the Ministry of Economic Affairs’ Biotechnology Speaking on the supply chain
and the Biotechnology and Pharmaceutical Industries during the pandemic times John
Promotion Office (BPIPO) were the major highlights A Murphy, III, Chief Policy
of the event. Officer and Healthcare
Deputy Counsel, at
Connecting the Asian Value Chain Biotechnology Innovation
Organisation (BIO), says “With
When the global pandemic emphasised supply the COVID-19 pandemic straining
chain cruciality, CDMO (Contract Development and global supply chains to breaking point, the US
Manufacturing Organisation) mobilisation became a government and other relevant authorities stepped
significant enabler to endure exponential growth in up early and supported the pharmaceutical and
next-generation therapies and biologics. Reflecting biotech sectors to enable the rapid development
this scenarios, the theme of the event, ‘Connecting and rollout of vaccines and medicines to meet the

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BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Visitors at the TaiNEX 2 Exhibition Centre. leading international industry experts held in the
‘Company Presentation’ and the ‘Entrepreneur
unprecedented public health need. Supply problems Pitch’ programme. Insightful sessions explored
at least for vaccines are no longer an issue. But faced post-pandemic strategy, advanced therapies, digital
with the next pandemic, including the possible global health, supply chain considerations, investment,
spread of the monkeypox virus, whether the global regional cooperation and more. Around 88
supply chain will remain resilient will require a global presentations from regional and international
effort to maintain it”. biotech, pharma, materials, devices, and diagnostics
companies enriched the sessions.
Sharing his views, Lee-Cheng
Liu, Founder, Chairman& The conference has covered many areas such
as Innovation- covering precision health, AI and
President at EirGenix Inc. digital health, and more; Market & Supply -including
explains, “With global easing of biosimilars, vaccines, contract development &
pandemic conditions, industry manufacturing, APIs, and generics, among others
stakeholders, policy makers, and and Investment – covering early-stage financing,
investors in Taiwan and the rest of cross border investment, capital markets, and more.
Asia have been discussing the future
of biomedical supply and value chains, in particular Plenary sessions covered global
identifying where existing Asian production facilities biotech development, and featured
might fit into the global biomedical ecosystem. a keynote presentation from
Taiwan looks well placed to play a major role in this Nobel Prize Laureate Dr
regard”. Shinya Yamanaka of Japan
on ‘Top iPS Cell Technologies at
Enthralling sessions Affordable Prices’.

The BIO Asia–Taiwan 2022 conference was In his presentation, Dr Shinya
jointly held by PwC Taiwan, Taiwania Capital, the Yamanaka described his latest research on iPS cells
DCB, the Industrial Technology Research Institute to make cell lines and related technology more
(ITRI), the Ministry of Health and Welfare, Academia affordable for future applications. He described the
Sinica, Taipei Medical University, EirGenix, Formosa current protocols for stem cell treatments and other
Laboratories, Quanta Computer, the Taiwan Digital rejuvenation technologies as being expensive and
Health Industry Development Association, and the time-consuming, and how an alternative technology
Precision Medicine Industry Association of Taiwan. is more cost-effective.

BIO Asia–Taiwan 2022 featured over 22 To add on, Dr Yamanaka who is also the
sessions comprising over 100 presentations by Representative Director at Japan’s CiRA Foundation
said, “It’s a pleasure to announce the signing of a new
Japan-Taiwan collaboration, a research agreement
between National Yang Ming Chiao Tung University
(NYCU) and the CIRA Foundation at Kyoto
University, that aims to automate various processes
in iPS cell manufacturing, This will contribute to our
goal of a more affordable iPSC solution”.

Meanwhile, Prof. Yoshiaki
Tsukamoto, The Executive
Director of ‘Japan Bio
Industry Association’
provided an overview of japan’s
bioeconomy strategy and greater
Tokyo biocommunity, aligning
with Japan’s latest Bioeconomy
Strategy to promote open innovation, R&D activities,
partner alliances and networking among Japan’s
biocommunity.

Continuing to examine global development
trends, the forum further prospected ‘International
Collaboration Strategy’, ‘Exit Strategies for Early

EVENT REPORT 37

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Stage New Drug Companies’, ‘New Modalities to development process; from the improved screening
Cure’, ‘Advances in Cell and Gene Therapy’ sessions of drug targets to the optimising and speeding up
delving some of the latest promising therapeutic of clinical trials. The result is the enhancement of
techniques. efficiency and the improved chance of a successful
drug launch”.
Furthermore, a key BioMed Commercialisation
Center, comprising 13 research teams from the Connecting international participation
“Research Center for Epidemic Prevention Science’’
demonstrated some of Taiwan’s most promising Simultaneously, BIO One-on-One Partnering
license-ready technologies. In addition, the National platform encouraged international participation
Science and Technology Council led the Hsinchu through the online meeting scheduling system to
Science Park, the Central Taiwan Science Park, connect with potential partners, collaborators,
the Southern Taiwan Science Park, the Taiwan and investors along with in- and out-licensing
Instrument Research Institute, and 36 other opportunities. Potential investors and collaborators
industry players showcased their innovations in drug engaged with onsite and online participants
discovery, medical materials, telemedicine, medical triggering endless possibilities.
cosmetics, and carbon net zero firms. Similarly, the
conference witnessed an independent session on Furthermore, exclusive ‘The International Zone’
Novel Platforms for Biopharma Discovery headed by featured biomedical ventures from 10 international
Taiwan’s Biomedical Translation Research Center pavilions corresponding to the USA, the UK, Canada,
(BioTReC) of the Academia Sinica. Poland, Switzerland, Australia, Malaysia, the
Philippines, Belgium, and Italy.
Booming biotech industry
In his address Wallace Lin,
BIO Asia–Taiwan 2022 collated global Secretary-General, Taiwan
biotechnology and pharmaceutical executives and BIO said “With biotechnology
investors exploring business opportunities with being a global industry, market,
Taiwan’s emerging biotech sector. The event hosted regulations, and products
around 1,500 participants from over 30 nations at the need to be compliant with
exhibition and more than 100,000 engaged virtually. international standards and aligned
with international requirements. BIO Asia–Taiwan
The exhibition brought together offerings from 15 provides the platform for Taiwan to engage with the
participating countries with more than 1,500 booths. global biomedical community to help meet these
It was a perfect pitch to demonstrate the pulse requirements. We aim to cement Taiwan’s role as an
and achievements of more than 550 bio-industry essential player in the international value chain.”
manufacturers including over 50 publicly-listed
companies. The collaboration among government Speaking about the success of the
entities, academic research institutes, and industry- event held from July 27-31, 2022,
university was the highlight at the event. Johnsee Lee, Chairman, Bio
Asia- Taiwan 2022 said, “BIO
A variety of biomedical technologies, biotech- Asia–Taiwan has become the
pharmaceutical-medical devices, advancements in platform of choice to connect Asia
precision medicine, as well as AI applications, IoT to the global biotech community.
technology, and unique investment opportunities In spite of the lingering effects of the
were exclusive features of the event corroborated by pandemic, more than 100,000 participants from
the engrossing sessions, which emphasised Taiwan’s 30 countries utilised onsite and online platforms
growing digital advantage in the Biomed sector. to experience the exhibition and conferences. Once
Taiwan’s borders open up completely, we expect next
Addressing the delegates year’s BIO Asia–Taiwan to witness an even greater
Chung-Hsiun Wu, President, success.”
Development Center for
Biotechnology (DCB), BIO Asia-Taiwan 2023 is preparing to strike back
who is also the Chairman from July 26- 30, 2023. With the ease in border
of Taiwan BIO, says With restrictions, the event is expected to attract more
Taiwan’s recent rapid progress in participants and international visitors by next year,
the fields of Big Data, AI, genomics stimulating greater business opportunities in and
and biomarkers, companies in our emerging around Taiwan.
biotech and pharmaceutical industry space are
taking advantage of these tools to optimise the drug Hithaishi C Bhaskar
[email protected]

38 EVENT REPORT

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Thailand LAB INTERNATIONAL,

Bio Asia Pacific & FutureCHEM

INTERNATIONAL

3 Day Mega Event
brings together
200+ speakers,

500 global brands,
2700 delegates,
8500 visitors
to Bangkok

With a strong presence of over 200 The inauguration function was marked by the
companies and organisations Thailand ceremony of signing of MoU between TCELS and
LAB INTERNATIONAL, Bio Asia Pacific for mutual cooperation in the field of research. The
and FutureCHEM INTERNATIONAL, exhibition MoU was signed by Prof Chutima Eamchotchawalit,
show of the laboratory, life science, biotechnology and Governor of TISTR and Dr Chairat Uthaipibull, Deputy
chemical industry, was back in full splendour, live after CEO and Acting CEO of TCELS. It was witnessed by
a gap of two years in Bangkok in September. The event Sayan Tanpanich, Deputy Governor of R&D Group
showcased over 500 global brands from 10 countries. for Bio-Industries, TISTR and Patcharaporn Wongsa,
Program Director - Nutraceuticals & Cosmeceuticals,
The theme of the show was ‘Integration of TCELS. Describing the purpose of the show, Igor
Technology and Innovation Platforms for Laboratory, Palka, Managing Director of VNU Exhibition Asia
Life Sciences and the Chemical Industry in the Asia Pacific, in his welcome address at the inaugural
Pacific Region’. Organised jointly by VNU Exhibitions function, said “We aim to provide the perfect platform
Asia Pacific and Thailand Center of Excellence for for business collaboration and investment through
Life Sciences (Public Organisation) (TCELS), the our business matching programme, the hosted buyer
three-day exhibition, yet again, was held on the 14000 programme and our networking night.”
Sq meter floor area of the Bangkok International
Trade and Exhibition Centre (BITEC) at Bangkok. Dr Chairat Uthaipibull, Deputy CEO of TCELS,
It was inaugurated by Dr Suwit Khunkitti, former and Yongyut Gidadhanapon, President of Science and
Deputy Prime Minister of Thailand on September 14, Technology Trade Association (STTA), also spoke on
2022 amidst the presence of industry and academic the occasion. Dr Uthaipibull later told BioSpectrum
organisations stalwarts. Asia, “We have so many research products displayed
here. We try to help them in standardisations and
Dr Khunkitti said, “The Thai government policy regulations. Hopefully we will push some innovation
focuses on an innovation-driven economy in 10 and research to the market.” He added, “TCELS has
targeted industries. As per the policy, Thailand LAB brought trend setters, industry leaders and investors
INTERNATIONAL, Bio Asia Pacific and FutureCHEM from around the world to participate in the event’.
INTERNATIONAL, are able to connect research
from the laboratory to product development and Talking to BioSpectrum Asia Gidadhanapon said,
distribution to the market.” He hoped that this trade “STTA is ready to support and drive the Thai economy
fair would further stimulate research, especially in with laboratory equipment investment from now on.”
the medical and health sectors, to get new products
on the shelf faster.Thailand Institute of Scientific and The Thailand Lab Asia showcased all laboratory
Technological Research (TISTR). equipment and instruments in the area of analytical,
testing, calibration, metrology, clinical, safety, research

EVENT REPORT 39

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Dignitaries and
honored guests at
the Thailand LAB
INTERNATIONAL,

Bio Asia Pacific
and FutureCHEM
INTERNATIONAL

conference and
exhibition.

and diagnostic. The showcasing organisations were whole range of products, she added. Due to the two-
divided into groups lab tech, lab chem, lab safety, year gap in the exhibition caused by COVID-19 and
lab automation, medtech and life sciences. Bio Asia subsequent lockdown, Sastra Kimkitikulvilai, Field
Pacific is a platform for biotechnology, life sciences, Account Manager of Sartorius Thailand felt this year’s
digital health, precision medicine, biopharma and exhibition as a reunion. “It creates more opportunities
smart health focussing on innovative therapeutics and for face-to-face meeting with a customer and we can
healthcare services. discuss and continue to build up our relationship with
customers,” he added. Another exhibitor felt the show
India and Korea had country pavilions with links researchers and investors to actively help grow
companies from both the countries showcasing their research in medical and health at the industrial level.
cutting edge technologies, innovations and products.
Besides, there were genomics, medtech and TLSC During the networking event, the VNU exhibitions
pavilions. Prominent companies like ThermoFisher, recognised some of the companies by giving them
Danaher, Agilent Technologies, Eppendorf, Sartorius, awards for booth design and as best supporter.
Mettler-Toledo, IKA, Merck, Perkin Elmer and more. Eppendorf, Bara Scientific and Agilent were presented
Furthermore, the key local distributors such as Best booth design awards and Bara Scientific, Bio
Gibthai, Bara Scientific, Bio Active, Geneplus, DKSH,
Becthai, Science Tech, Sithiporn Associates displayed “The Thai government policy
their products. Some companies launched new focuses on an innovation-
products with demonstrations by professionals. driven economy in 10
targeted industries. As per
“This year, we can bring back the potential buyers the policy, Thailand LAB
and exhibitors from the Philippine Association of INTERNATIONAL, Bio Asia
Medical Technologists, Inc. (PAMET), Cambodian Pacific and FutureCHEM
Entrepreneurs Association (CEA), MSME India, as INTERNATIONAL, are able
well as exhibitors from China, Korea, Singapore, to connect research from
Italy, Malaysia, Finland, Hongkong, Japan and other the laboratory to product
countries, said Anucha Parnpichate, Senior Project
Manager, VNU Asia Pacific. Over 8500 visitors from development and distribution
28 countries visited the exhibition. to the market”.

The exhibition offered an opportunity “to form - Dr Suwit Khunkitti,
partnerships with many distributors of Thailand,” Former Deputy Prime
said Loh Sook Yee, senior director of VWR of Avantor
group. Due to the show the customers know our Minister of Thailand

40 EVENT REPORT

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

“STTA is ready to support in implementation of artificial intelligence setting
and drive the Thai economy – accuracy and readiness’ by Bio Asia Pacific; ‘Lab
with laboratory equipment of the future – a Labware perspective’ by LabWare
Asia Pacific; ‘Southeast Asia pharmacogenomics
investment from now on.” research network’; ‘Lessons learnt from COVID-19
- Yongyut Gidadhanapon, – Innovations for the next pandemic’; ‘Global trend
of future food and potential of Thai food industry
President of Science in the world market’ and ‘Cannabiz Asia’ by VNU
and Technology Trade Exhibitions. Bara Scientific had set up a special
Cannabis and Kratom pavilion giving scientific
Association information to the visitors.

“We have so many research While making a presentation in a conference on
products displayed here. ‘Lessons learnt from COVID-19 – Innovations for
We try to help them in the next pandemic’, Dr Nirutti Pradubyti, Medical
standardisations and Director, Pfizer Thailand Ltd., narrated the efforts
done by Pfizer in developing COVID-19 vaccine. The
regulations. Hopefully we will company developed 11 billion doses and distributed
push some innovation and them in 201 countries, he pointed out. It is also
research to the market.” advancing work on a potential next-generation oral
- Dr Chairat Uthaipibull, treatment, he said. Pfizer is also testing different
Deputy CEO and versions of the COVID-19 vaccine which are Omicron
Acting CEO of TCELS based, multivalent (delta/alpha) and monovalent
(delta). In a conference session on ‘Global trend of
“We aim to provide the future food and potential of Thai food industry in
perfect platform for business the world market’, Lalana Thiranusornkji, Head –
collaboration and investment Innovations and new product development, CPF Food
Research and Development Center Company, said
through our business the personalised food trends were assessment based,
matching programme, the genetics based, microbiome based and biomarker
hosted buyer programme and based. Product customisation allows for creation of
specific nutrients and texture. She narrated a case
our networking night.” study of a Ukrainian startup that develops consumer
- Igor Palka, nutrigenetics solutions. It offers to consumers genetic
tests analysing which vitamins and minerals are easy
Managing Director of VNU to process for them. Accordingly, it recommends
Exhibition Asia Pacific personalised healthy diets based on the genetic
composition. That is going to be the global trend of
Active and Gibthai were presented Best Supporter future food, she added.
awards. Beside the product showcases, intensive
conferences on various topics with 51 academic and 13 Explaining the need for plant-based foods, she
technical sessions were conducted by industry experts, said 23 per cent water is consumed to grow livestock,
supporting associations, and academic institutions. 45 per cent land is occupied by livestock. She said
Over 2000 onsite delegates and 1700 online delegates that innovation in food is essential and people matter
were addressed by 200 speakers from 11 countries. in innovation. The conference on cannabis took an
overview of the progress being done in the area in
Some of the topics and the organisers of the various Asian countries and how the laws are getting
conferences included ‘Quality assurance of laboratory amended for the use of Cannabis and hemp for
for food safety to strengthen global market’ organised medical purposes.
by Metrology Society of Thailand; ‘Review of ISO/IEC
17025/2017’ organised by Innolab Forum; ‘Roles of Dr Milind Kokje
polymers in meeting the net zero target’ by Polymer [email protected]
Society of Thailand; ‘Nutrigenomics for better health
and wellbeing’, ‘2022 Thailand life sciences industry attended the three day long Thailand LAB
updates’ and ‘Medtech trends to watch in 2022’ by INTERNATIONAL, Bio Asia Pacific and FutureCHEM
Bio Asia Pacific; ‘Biopharma process improvement –
Enhancing your fluid handling experience’ by VWR; INTERNATIONAL conference and exhibition held at
‘Toxicology and safety of natural and innovative Bangkok International Trade and Exhibition Centre
products’ by Thai Society of Toxicology; ‘Challenge (BITEC) in Bangkok, Thailand from September 14-16 on

the invitation of VNU Exhibitions Asia Pacific.

LIFE SCIENCES 41

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Why Life Sciences

sector is Soaring in China
According to research conducted by Invesco, Life
Sciences as a sector has been growing annually «
between 15 and 20 per cent (2015-2018),
with more than 370 listed healthcare companies in Yong Sin Peh,
China and Hong Kong. The Life Sciences market in
China is expected to continue to develop, becoming Principal Consultant,
one of the most diverse and expansive sectors in the
country. The demand for top talent is across many EPM Scientific
different functions within the Life Sciences sector,
including Research & Development (R&D), Clinical,
Manufacturing and Commercial.

Hot healthcare job opportunities which struggle to keep up with demand. While
investment in digitalisation was already increasing,
A variety of factors have contributed to the the COVID-19 pandemic dramatically accelerated the
booming Life Sciences industry in China. Previously, uptake of digital technology.
the pharmaceutical sector in China was primarily
focusing on the replication of generic drugs, leveraging Challenges in hiring
on the success of global off-patent medicines and
driving commercial success. However, the approach Despite the optimistic outlook for Life Sciences
has changed in recent years and has shifted more and China’s healthcare industry as a whole, the lack
towards vaccine development, innovative drugs of Life Sciences talent threatens the entire growth
and biotechnology. Particularly due to COVID-19, of the booming sector if left unresolved. One of the
it resulted in a huge shift towards pharmaceutical biggest challenges facing the industry is the ability
innovations. In 2021, Shanghai Fosun Pharmaceutical to attract and retain mid-senior level professionals
agreed to form a $200 million joint venture with amidst a limited local talent pool. To cope with
German partner BioNTech to build a plant in China increasing headcounts due to expansion, intense
to supply up to 1 billion doses of coronavirus vaccine competition is rife between companies to ensure
a year. On the other hand, Sinovac Biotech Ltd, a they snap up the talent available. The shortage of
biopharmaceutical product provider in China and one talent has also resulted in companies having to target
of the first few companies to develop a vaccine for the Chinese nationals from overseas who are looking to
Coronavirus, unveiled its plans to construct a vaccine return home, causing reverse brain drain around the
quality research centre in Beijing. world. Apart from remuneration packages, there are
other areas that Life Sciences talent will assess before
Globalisation and digitalisation key to growth committing to a decision. Some of these include
the stability of the organisation, job title, ongoing
Globalisation has propelled multinational projects within the company, location where the job
corporations (MNCs) to actively target the Chinese is based within China and other benefits provided
market for next generation biologics, which has by the company. It is clear that the ability to manage
created opportunities for Chinese contract research these expectations is key to whether a company is
organisations (CRO) / contract development and able to attract and retain its talents.
manufacturing organisations (CDMO). Pharma
companies remain unfazed by the disruption brought Overcoming hiring challenges
upon by the pandemic, and continue to maintain a
positive outlook on the booming health-care market in As mentioned, higher compensation is a big driver
China. Digitalisation of the industry is another major for Life Sciences professionals to consider a new
trend that is transforming the hiring landscape in role, so those hiring must be offering a competitive
Life Sciences. Accessibility has been a long standing package, to attract but also retain talent. Firms
issue in China as resources are disproportionately need to ensure they give top talent new challenges
concentrated in the large hospitals of major cities and projects, as well as training and learning

42 LIFE SCIENCES

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Over the last decade, China’s Life investment in innovation by significantly reducing
Sciences industry has grown into a the price (and therefore profitability) of generic
RMB 6.8 trillion market capitalisation medicines and introducing tax incentives for
industry and is one of the largest sectors innovative companies to invest in research and
in the A share market. With regards to development. A number of legal and regulatory
healthcare innovation, China’s share of changes have also been implemented as part of
the global R&D pipelines rose to 13.9 per Healthy China 2030. Two key reforms are the
cent in 2020, up from 4.1 per cent in 2015, implementation of the Revised Drug Administration
showing its increasing commitment to Law (rDAL) in 2019 and the associated revised Drug
innovation. And it’s not just about China. Registration Regulation (rDRR) in 2020. Under the
new rDAL, the rules have been streamlined so that
opportunities, to keep them engaged and excited both domestically manufactured drugs and imported
about their role, otherwise they might walk. Talent drugs are subjected to the same requirements –
is also much more open to relocation, with the cost which promotes innovation by accelerating the
of living around the world in many places increasing review and approval for drugs that treat severe, rare
and the rise in remote work. Employers may need or clinically urgent illnesses. China has more than
to also be open to talent potentially moving, or even 100 Life Sciences parks dotted across the country,
open to talent from afar. run by local governments which attract companies
with tax breaks and subsidies. It is estimated that
Collaboration crucial to attracting talent more than $100 billion has already been invested in
the Life Sciences sector by state, provincial or local
Given the cultural and regulatory challenges faced governments.
by healthcare providers, it is often desirable to work
with a local partner, either as a domestic advisor China and beyond
or joint venture partner. Brii Biosciences Limited,
a multi-national company developing innovative Over the last decade, China’s Life Sciences
therapies for diseases with significant unmet medical industry has grown into a RMB 6.8 trillion market
needs and large public health burdens, announced its capitalisation industry and is one of the largest
partnership with TSB Therapeutics (Beijing) Co., Ltd. sectors in the A share market. With regards to
a joint venture majority-owned by the Company and healthcare innovation, China’s share of the global
China Resources Pharmaceutical Commercial Group R&D pipelines rose to 13.9 per cent in 2020, up
Co., Ltd. to advance stockpiling, channel distribution from 4.1 per cent in 2015, showing its increasing
and hospital access for the company’s long-acting commitment to innovation. And it’s not just
neutralising monoclonal antibody (mAb) therapy, the about China. Founded in Beijing 2010, BeiGene,
amubarvimab/romlusevimab combination. The two a biotechnology company that specialises in the
parties are working together to ensure timely drug development of drugs for cancer treatment, now has
supply that supports the pandemic prevention and a global team of over 8,000 colleagues across five
control efforts in China. The collaboration will also continents. Recently, it has announced the opening
explore other opportunities to enable expanded access of a new regional office in Basel, Switzerland and this
to combination therapy in China. Such partnerships new location will serve as a hub for the company’s
can also attract talent, both local and international, operations within the European region.
by combining their expertise and providing more
opportunities to work on innovative projects – a key A continued expansion
attraction for many Life Sciences professionals.
Looking ahead, we expect to see the Life Sciences
Govt. support for better job opportunities industry in China continuing to expand, with more
companies from the western world entering the
Healthy China 2030 sets out China’s long-term market. China’s biotech industry is still young and
approach to healthcare and shows its commitment needs time to mature, but we do foresee an increasing
to participating in global health governance. The number of companies being able to compete on the
Healthy China 2030 initiative included innovation global stage in time to come. Local competitors will
as one of its four core principles. As part of this also be competing for fresh talent as they aim to
initiative, the government aims to promote develop novel technologies. Either way, there is a
great amount of opportunity for professionals to tap
on to grow their careers and ride the expansion wave
of this burgeoning industry.

ACADEMICS NEWS 43

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com SK Bioscience

MGRC to collaborate on announces
genetics, regenerative and
alternative medicines research scholarships

Leading genomics and biopharmaceutical specialist Malaysian Genomics to support
Resource Centre (MGRC) Berhad has signed a letter of intent (LOI) with
the Faculty of Science and Natural Resources, Universiti Malaysia Sabah local bio-talent
(UMS) and Rinani Genotec Sdn Bhd (Genotec) to collaborate on research
and development (R&D) in genetics, and regenerative and alternative South Korean firm SK
medicines. Under the LOI, MGRC, which owns a high-throughput Bioscience has been striving
sequencing lab, advanced microarray facility, and new state-of-the-art to nurture local talents to lead
cell processing lab, as well as Genotec, which specialises in biomedical the Korean bio industry. For
treatments using stem cells, will assist in strengthening the teaching and this, the company has decided
research activities of the undergraduate programme at UMS’ Faculty of to provide scholarships to
Science and Natural Resources. This cooperation will enable the exchange Korea Polytechnic University,
of research resources and ideas to enhance the quality of research at UMS, Andong Science University,
as well as create opportunities for students from the Faculty of Science and Catholic Sangji University,
Natural Resources to serve their internship period at MGRC or Genotec. and Youngjin Junior College.
Andong is the area where
5C Network launches academy ‘ Andong L House ‘, a
for training radiographers, vaccine production facility
radiologists in India of SK Bioscience, is located.
Activities to foster local
Focused on providing advanced practical training for radiographers and talent and create jobs are also
radiologists, Bengaluru-based startup 5C Network has launched the 5C underway. SK Bioscience aims
Academy. The need for this kind of institutionalised, professional training to complete the development
stems from the fact that in the radiology domain that is continuously of a new plant by the end of
witnessing technology and domain advances, there is a long-felt need for 2024 on a new site in Andong.
a forum that can help radiographers and radiologists stay up-to-date on The company is accelerating
domain knowledge, learn new best practices, benefit from the experience the development of human
of experts in the domain, and also get mentored on improving on their resources by establishing
own skills on the job. The academy launches the first-ever certification an industry-university
programme for practising radiographers specialising in CT and MRI cooperation system with local
scans. As part of the curriculum, the participants will experience universities to nurture talents
interactive workshops on CT and MRI best practices with live case demos. tailored to vaccines. The
The workshops will be followed by question and answer sessions, and major objective is to support
assessments to ensure a complete understanding of each module. Each human resource development
module when completed grants one credit to the participant. Subject to so that Korea can grow into a
the participant successfully completing all the modules, the 5C Academy global bio hub.
will grant a diploma in practical radiography to them.

44 PEOPLE NEWS BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Everest Dr Catherine Mohr joins
Medicines Board of Aroa Biosurgery
appoints Rogers
Yongqing Luo New Zealand-based soft tissue regeneration company Aroa
as new CEO Biosurgery has announced the appointment of award-winning
medical researcher and inventor, Dr Catherine Mohr as a Non-
China-based Everest Medicines, Executive Director to the board. Dr Catherine’s experience spans
a biopharmaceutical company several areas, including surgery, medical
focused on developing and technology, engineering, product
commercialising transformative development and design, healthcare,
pharmaceutical products to alternative energy, automotive, aerospace,
address critical unmet needs global entrepreneurship, Intellectual
in Asia Pacific markets, has Property litigation, US Food & Drug
appointed Rogers Yongqing Administration (FDA) compliance and
Luo as Chief Executive Officer education. She has been involved with
(CEO) of the company, effective several successful emerging companies
immediately. Luo will also serve in medical technology and other areas,
as an Executive Director on notably co-founding VeriSure, where she
Everest’s Board of Directors. invented the LapCap, the first of a new
Luo brings to Everest more category of laparoscopic surgery enabling products. She is currently
than 25 years of experience the President of the Intuitive Foundation, the corporate Foundation
in the healthcare industry of Silicon Valley based Intuitive Surgical, pioneers in the robotic-
with an extensive leadership assisted surgery field and maker of the da Vinci surgical robot system.
track record across clinical
development, regulatory Ami Lifesciences appoints
affairs and commercialization. Amit Kaptain as CEO
Previously, Luo served as
President and General Manager, India-based Ami Lifesciences, a pure-play manufacturer and exporter
Greater China at Brii Biosciences of Active Pharmaceutical Ingredients (APIs) and intermediates to
and CEO of TSB Therapeutics leading pharmaceutical companies of the world, has announced the
where he spearheaded the rapid appointment of Amit Kaptain as Chief Executive Officer (CEO) of
registration approval, GMP the company. As part of the Ami Lifesciences senior management
certification and successful team, Kaptain will be responsible for building business strategy
commercialisation of the and longstanding global partnerships with leading pharmaceutical
amubarvimab/ romlusevimab companies (including Big Pharma and Innovators) by developing
combination, the first COVID-19 products in niche therapeutic areas, and thereby becoming a reliable
neutralising antibody treatment partner of choice from India. With 20+ years of experience in the
in China. API industry, Kaptain is a seasoned professional in driving sales,

marketing and operations across global markets and
has worked with large Indian MNCs such as Dr.
Reddy’s, Ranbaxy, and Sun Pharma. Prior to
joining Ami Lifesciences, he worked as COO
at Aurore Lifesciences. Prior to that, Kaptain
worked at Dr. Reddy’s (DRL) for 7 years in
various leadership roles. At Ranbaxy, Kaptain
was Head of Global API Sales & Marketing
and was responsible for driving new product
development. He spent around 6 years with
Sun Pharma where he was responsible for
sales & marketing in India, Far &
South-East Asia.

PEOPLE NEWS 45

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com EDGC recruits

Aevice Health names Dr David Sam Martin as
Van Sickle as Board Advisor
VP of Overseas
Aevice Health, a Singapore-based medtech company developing
novel wearables to enable remote management of chronic respiratory Business
diseases, has announced the appointment of Dr David Van Sickle,
as Strategic Advisor. Dr Van Sickle, who served as the co-founder Development
and former Chief Executive Officer of Propeller Health, has over 15
years of experience in digital health. As Aevice Health continues to South Korean firm EDGC (Eone
transform the landscape of home management of chronic respiratory Diagnomics Genome Center),
diseases such as asthma and chronic obstructive pulmonary a company specialising in
genomic analysis and precision
disease, he will assist the team in developing medicine, has announced that
its US commercialisation strategy. He Sam Martin has been hired
will also support the company’s efforts as the Vice President (VP) of
to build clinical evidence for its remote Overseas Business Development.
monitoring solutions. Dr Van Sickle By recruiting Martin, who has a
led Propeller Health through the 2019 wealth of experience and network
acquisition of the company by ResMed in the overseas genome market,
and continued to run the company as a EDGC will make a full-scale
standalone business until 2021, when he entry into overseas markets and
became an Entrepreneur in Residence solidify its status as a global bio
at the San Diego-based medical company. Martin has recently
equipment manufacturer. He worked for Invitae and Ambry
was recently appointed Non- genetics, two of the top US
Executive Director by Closed genetics companies specialising
Loop Medicine. in personal genomic medicine. He
also has clinical experience as a
Dr Taiyin Yang joins genetic counsellor, working eight
Board at Brii Biosciences years at Beth Israel Hospital in
New York City. EDGC is a public
Brii Biosciences, with operations in the US and China, has genomics company listed on the
announced the appointment of healthcare industry veteran Dr KOSDAQ in 2018. The company
Taiyin Yang, to the company’s Board of Directors as co-chair of the is receiving great attention in
newly expanded Audit and Risk Committee, effective September the global market for its liquid
1, 2022. Dr Taiyin Yang is the former Executive Vice biopsy, a core technology for
President of Pharmaceutical Development and cancer and prenatal diagnosis.
Manufacturing at Gilead Sciences. She directed The ‘ONCOCATCH’ for early
operations of process, device and formulation cancer screening and precision
development, manufacturing, packaging, diagnosis, EDGC’s representative
analytical operations, laboratory information liquid biopsy technology, is a
systems and data science, to name a few. third-generation innovative
Under her leadership, Gilead developed the technology.
world’s first HIV single tablet regimen and
advanced numerous compounds from early-stage
development to market, reaching millions of
people around the world. Prior to joining
Gilead in 1993, she worked at Syntex
Corporation for more than a decade,
where she contributed to the development
and commercialisation of more than 10
medicines.

46 R&D NEWS

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

South Korea uses 3D bioprinting to engineer organs at scale

A research team at Pohang organs to function like real engineer the tissues similar to
University of Science and tissues. To overcome these issues, real tissues. In particular, the
Technology (POSTECH) in South the research team from South assembly method allows the
Korea has developed a method Korea summarised and presented possibility of creating engineered
for engineering organs at scale a new bioprinting technology to organs bigger than the previous
using bioprinting. The findings size limit. If technologies such as
from the study were recently bioprinting, new materials, and
published in the international stem cells are combined, more
journal Trends in Biotechnology: realistic engineered organs can be
Cell Press. The limitations of produced. In combination with
previously published studies were robotics or artificial intelligence
that only a single tissue could (AI), more automatised and
be fabricated at a time, and the elaborate methods for generation
size of the tissue was very small. of organ substitutes would be
Moreover, additional elements possible in the future, according
were required for the 3D printed to the researchers.

India develops new method Australia designs
for TB vaccine delivery
using gold nanoparticles molecule chip

Researchers from the Indian Institute of Science (IISc) have for modern
designed a new method to deliver a vaccine candidate for
tuberculosis (TB), caused by Mycobacterium tuberculosis. It manufacturing
involves using spherical vesicles secreted by bacteria coated
on gold nanoparticles which can then be delivered to immune of drug, vaccines
cells. This can potentially trigger an immune response and offer
protection against the disease. While the BCG vaccine works Australia’s University of Queensland
(UQ) researchers have pioneered a
well in children, it is not as effective new chemical process to manufacture
at protecting adolescents and adults. the molecules that are the building
This prompted the researchers at IISc blocks for lifesaving medicines
to develop a potential subunit vaccine and vaccines. Prof. Matt Trau
candidate that contains only parts of from UQ’s Australian Institute for
the infectious bacterium to stimulate Bioengineering and Nanotechnology
an immune response. They decided to (AIBN) has been awarded an ARC
use Outer Membrane Vesicles (OMVs) Laureate Fellowship worth $2.9
that are spherical membrane-bound million to further understand and
particles released by some bacteria, and develop the process. The researchers
contain an assortment of proteins and have been able to accelerate and
lipids which could induce an immune control chemical reactions on a tiny
response against the pathogen. Mycobacterium-derived OMVs nano-scaled chip. This could enable
are usually unstable and come in different sizes, making them on-demand, miniaturised, remote
unsuitable for vaccine applications. But the OMVs coated on manufacturing in a much more
gold nanoparticles were found to be uniform in size and stable. economical and environmentally
In future studies, the team plans to develop gold-coated OMVs friendly way. Much like 3D printing
derived directly from Mycobacterium tuberculosis and test has disrupted manufacturing on a
them on animal models to take the results forward for clinical larger scale, this could change modern
applications. Such efforts could open up new avenues for the manufacturing on the molecular
development of vaccines for other bacterial diseases as well. scale. According to Prof. Trau, the
technology could be applied to the
production of life-saving products.

R&D NEWS 47

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

NZ offers improved China explores
alternative to screen
patients with poor gut health new technology

Non-invasive sensors laid on the skin’s surface to measure for early diagnosis
bioelectrical activity could offer a better alternative for
patients suffering with poor gut health. Researchers at the of glaucoma, optic
Auckland Bioengineering Institute (ABI) in New Zealand
and the Faculty of Medical and Health Sciences’ Department neuropathies
of Surgery have employed a novel device using a sticky
patch of sensors and a recording device and associated A research team led by the Department of
techniques to create a new and reliable non-invasive tool Ophthalmology, School of Clinical Medicine,
to map electrical waves from the stomach. Coined as Body LKS Faculty of Medicine of The University of
Surface Gastric Mapping (BSGM), the method has proven Hong Kong (HKUMed), with collaborators
a reliable detector of gastric slow wave activity and has now from the Faculty of Medicine of The Chinese
led to an exciting and unexpected discovery identifying two University of Hong Kong (CU Medicine)
distinct disease subgroups in chronic nausea and vomiting and local and international partners, has
syndromes. With this bio-electrical information on hand to developed a new technology ROTA (Retinal
inform clinical guidance or treatment, people experiencing nerve fibre layer Optical Texture Analysis) to
chronic vomiting or nausea may be directed to different unveil the optical texture and trajectories of
pathways and may receive diagnosis and more appropriate the axonal fibre bundles on the retina. ROTA
treatment options sooner. outperforms the current clinical standards,
attaining 15 per cent to 28.4 per cent higher
in sensitivity in detecting early optic nerve
damage in glaucoma, the leading cause
of irreversible blindness. The next steps
include enrolling patients from Queen Mary
Hospital, Grantham Hospital, and Hong
Kong Eye Hospital for longitudinal studies
to examine the effectiveness of ROTA for
detection of glaucoma progression, as well as
working with optical coherence tomography
(OCT) industrial partners to deploy ROTA in
clinical care.

Singapore brings quick test to detect
immunity against COVID-19 & variants

A team of scientists from the produced during a COVID-19 care test kit is a serology test that
Singapore-MIT Alliance for infection to determine if a person measures antibodies made by
Research and Technology is infected, this rapid point-of- the patient. It requires a drop of
(SMART), MIT’s research blood and takes just 10 minutes
enterprise in Singapore, to show results, as compared to
and Nanyang Technological the 24 to 72 hours required for
University, Singapore (NTU conventional laboratory testing.
Singapore) has developed a The test kit detects the levels of
quick test kit that can tell if a neutralising antibodies against
person has immunity against SARS-COV-2, the virus causing
COVID-19 and its variants, based COVID-19, and its variants such
on the antibodies detected in a as Delta and Omicron, and can be
blood sample. Different from easily adapted for new variants of
ART test kits, which look for concern and other diseases in the
the presence of viral proteins future.

48 SUPPLIER NEWS

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

Thermo Fisher Sony Electronics
unveils new generation
invests $160M to of 4K HDR 3D/2D
surgical displays
expand bioproduction
Sony Electronics is expanding its line-up of surgical LCD
capacity in US displays with two versatile options, the LMD-XH550MT
(55-inch) and LMD-XH320MT (32-inch). The new models
Thermo Fisher Scientific has opened can be paired with surgical endoscopes, microscopes, and
a new biomanufacturing facility in surgical robots for precise visualisation in operating rooms,
Chelmsford, Massachusetts. The $160 surgery centres and training and education environments.
million, 85,000-square-foot facility will The monitors combine detailed 4K resolution, HDR (High
help meet growing demand for the biologic Dynamic Range), and Sony’s unique Local Dimming Panel
materials needed to produce vaccines and Technology, improving visibility through increased control
breakthrough therapies for cancer and and precise reproduction of highlights and shadows along
other diseases. This new site is part of with support for 3D and 2D images. Powerful functionality
Thermo Fisher’s $650 million multi-year includes improved picture quality to experience more
investment to expand its bioprocessing contrast and reduced halation of blood and tissue structures,
production capabilities. The technologies new interface options, upgraded image enhancement
produced at the Chelmsford site are used technology and an integration-friendly design. Medical
in the purification process of developing and Engineering Group is a division company under Sony
biotherapeutics and vaccines. These Electronics (Singapore). It markets Sony’s leading medical
products help save time and reduce costs digital imaging products in Asia Pacific besides Japan.
so that new treatments can reach more
patients faster. With the opening of the site
in Chelmsford, Thermo Fisher continues
to bring its capacity investments online to
support customers as they grow and scale.
When fully staffed, the Chelmsford site will
employ up to 250 people in roles across
manufacturing, engineering, procurement,
quality, warehousing, site leadership and
more.

BD launches next-generation prefillable vaccine syringe

BD (Becton, Dickinson and Effivax Glass Prefillable Syringe will
Company) has introduced a next- further help customers meet the
generation glass prefillable syringe stringent demands of today’s vaccine
(PFS) that sets a new standard in manufacturing through design
performance for vaccine PFS with enhancements focused on fill/finish
new and tightened specifications and container reliability. Through
for processability, cosmetics, improved quality specifications,
contamination and integrity. The BD BD Effivax is designed to
new BD Effivax Glass Prefillable reduce the risk of line stoppage and
Syringe has been designed improve the total cost of ownership,
in collaboration with leading manufacturing capacity and supply
pharmaceutical companies to availability. The BD Effivax Glass
meet the complex and evolving Prefillable Syringe will benefit from
needs of vaccine manufacturing. the $1.2 billion, four-year investment
Approximately 70 per cent of the top that BD announced in late 2020 to
100 biopharmaceutical companies expand and upgrade manufacturing
rely on BD for supply of PFS. BD capacity and technology for PFS.

SUPPLIER NEWS 49

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

HiMedia develops Monkeypox
RT PCR and viral DNA/RNA extraction kits

India-based HiMedia for detection of the virus. that is based on the
Laboratories is geared Swab samples from suspected silica column format
up to face a possible individuals can be processed and aids in quick and
outbreak of monkeypox using HiPurA Viral DNA/ simultaneous extraction
virus with extraction RNA purification kit (MB582) of the viral DNA and
and RT PCR detection RNA from the sample.
kits. Running ahead Subsequent detection
of time, HiGenoMB, by Hi-PCR Monkeypox
the molecular biology Virus Multiplex Probe
section of HiMedia PCR kit (MBPCR269),
Labs is prepared for a Taq Man based Probe
what can become the PCR kit, can accurately
next pandemic – Monkeypox. It detect the virus with utmost
is amongst the first few Indian sensitivity and specificity; even
multinationals to come up 3.31 copies/µl of the viral gene.
with the viral DNA extraction These kits are available for
and monkeypox RT PCR kits research use right now.

MGI introduces ultra-high Agilent collaborates
speed gene sequencer in China
with METTLER TOLEDO
China-based MGI Tech has launched DNBSEQ-G99,
the latest model of the gene sequencer with mid to low to reduce errors in
range throughput. As one of the sequencers with the
fastest speed among those with the same throughput sample preparation
in the world, DNBSEQ-G99 is especially suitable for
targeted gene sequencing and small genome sequencing, Agilent Technologies has collaborated with
delivering rapid and high- METTLER TOLEDO to address error-prone
quality data output. Based sample preparation. This integrated solution
on MGI’s DNBSEQ allows the automatic & seamless transfer of
core technology, weighing results & the associated metadata
DNBSEQ-G99 for from METTLER TOLEDO LabX Balance
the first time adopts software to Agilent OpenLab software. Sample
triangular matrix signal preparation is a critical part of many laboratory
spots on sequencing workflows. It is a time-consuming bottleneck
flow cell, reaching & a frequent source of errors & inaccuracies
higher density of data that often leads to costly quality investigations
output, with an overall or rework. The solution from Agilent &
throughput of 8-48 METTLER TOLEDO, launched in Munich at
Gb per run. In China, Analytica 2022 in June, offers a fully automated
where DNBSEQ-G99 & digitalised LC or GC workflow designed to
was first launched, a number eliminate common errors in the weighing
of early users had already conducted trial runs which process. The complete solution automatically
were met with excellent performance. This model will transfers weighing results to the latest release
be available for reservation overseas starting early of Sample Scheduler for Agilent OpenLab
2023. As the ninth sequencer model launched by MGI, CDS. Sample Scheduler retrieves the sample
DNBSEQ-G99 continues to take the lead in innovation by & weight data from the METTLER TOLEDO
focusing on three source core technologies. LabX software & allows users to seamlessly
route sample & weighing information to any
instrument in the laboratory.

50

BIOSPECTRUM | OCTOBER 2022 | www.biospectrumasia.com

CommittingtoMentalHealthandWellbeing
Around 1 in 7 people live with a mental health
condition in the WHO South-East Asia Region prevent negative work situations and cultures and
(Region). The personal and economic distress offer much-needed mental health protection and
and disruptions caused by the COVID-19 pandemic support for working people. For the first time, the
have widened the gaps in addressing mental health World Health Organisation (WHO) recommends
challenges, which include scarcity of human resources, manager training, to build their capacity to prevent
low investment, stigma, inadequate prevention and stressful work environments and respond to workers
promotion programmes, paucity of data, and lack of in distress.
services in primary care settings.
WHO noted that an estimated 12 billion workdays
To address the issues and to promote mental are lost annually due to depression and anxiety costing
health, the member countries of the Region adopted the global economy nearly $1 trillion. WHO and the
the Paro Declaration committing to Universal Access International Labour Organization (ILO) have called
to People-centered Mental Health Care and Services. for concrete actions to address mental health concerns
The Paro Declaration was adopted at the Ministerial in the working population.
Roundtable on addressing mental health through
primary care and community engagement on day two In its World Mental Health Report, published in
of the 75th Session of the Regional Committee Session June 2022, WHO noted that of one billion people
held in Paro, Bhutan on September 6. living with a mental disorder in 2019, 15 per cent of
working-age adults experienced a mental disorder.
As part of the Declaration, member countries People with severe mental health conditions die
agreed to develop country-specific targets to achieve on average 10 to 20 years earlier than the general
universal primary care-oriented mental health services population, mostly due to preventable physical
and mainstream mental health in policy planning, diseases. Work amplifies wider societal issues
implementation, and evaluation. that negatively affect mental health, including
discrimination and inequality. Bullying and
The Paro Declaration also calls for increased psychological violence (also known as mobbing) is
funding for community-based mental health networks a key complaint of workplace harassment that has a
and continuous supply of medicines and rehabilitation, negative impact on mental health. Yet, discussing or
including occupational therapy for everyone who disclosing mental health concerns remains a taboo in
needed them, and strengthening of data gathering and work settings globally.
reporting, implementation research and performance
monitoring, to ensure context-sensitive improvement It may be noted that COVID-19 triggered a 25
of mental health systems. per cent increase in general anxiety and depression
worldwide, exposing how unprepared governments
Several member countries in the Region have were for its impact on mental health, and revealing a
already taken action to strengthen policies, plans, chronic global shortage of mental health resources. In
laws and services to improve the mental health of 2020, governments worldwide spent an average of just
populations. Replicating and scaling up successful 2 per cent of health budgets on mental health, with
models and innovative interventions, harnessing lower-middle income countries investing less than 1
digital technologies and telemedicine to improve per cent.
access to services and capacity-building of health-
care workers, and using evidence and data for Observing October 10 as World Mental Health
programme improvement will help make the Region Day on this year’s theme ‘Making mental health and
withstand future mental health impacts exacerbated wellbeing for all a global priority’, drawing on the
by humanitarian emergencies, climate change and latest evidence available, showcasing examples of good
economic downturns. However, the WHO Mental practice, and voicing people’s lived experience, WHO
Health Atlas found that only 35 per cent of countries calls on all stakeholders to work together to deepen
reported having national programmes for work-related the value and commitment given to mental health,
mental health promotion and prevention. reshape the environments that influence mental health
and strengthen the systems that care for people’s
To help member countries on the issue WHO, on mental health.
September 28, published two publications - WHO
Guidelines on mental health at work and a derivative Narayan Kulkarni
WHO/ILO policy brief. The new guidelines can help Editor

[email protected]