BioSpectrum Asia November 2019

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4 BIO EDIT

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Milind Kokje DIGITAL VULNERABILITY

Chief Editor The recent warning by US FDA about the cybersecurity vulnerabilities posing risks
for certain medical devices and hospital networks aptly explains how susceptible
[email protected] the healthcare records systems and medical equipment are in the digital age.
Just prior to the warning, information of University of Alabama (UAB) Medicine’s
nearly 20,000 patients was exposed to hackers following a data breach executed by
them posting a fake email. The hackers were successful despite training given to the
employees, who received a mail supposedly from their superior asking them to complete
a survey. The hackers’ intention was to divert the employees’ payroll to a different bank
account. That attempt was foiled but in the process some information of the patients
reached the hackers.

One Indian healthcare website experienced such an episode when Chinese hackers
stole 68 lakh records of patients and doctor information from a webiste. A cyberattack
in Singapore in 2017 impacted 1.5 million patients. A global ransomware attack in 2017,
known as WannaCry crippled the healthcare industry holding life-saving information
hostage. The attack affected over 20,000 computers in 100 countries. According to
Maryland University, a cyber-attack occurs every 39 seconds and more than 31 million
patient records have already been breached in the first half of 2019.

Though on one hand the new technology and digitisation has helped improving the
healthcare sector in various ways making it more efficient to the growing satisfaction of
the patients, on the other it suffers from the vulnerability caused by cyber-attacks. As
pharma manufacturing units rely more and more on internet connected technologies
they become more susceptible to cyber-attacks disrupting the manufacturing processes.
Hackers will be more interested in stealing information from pharma and healthcare in
view of the sensitive nature of the data they gather.

As a result, ERIC Institute, an internet-based digital library of education research
and information sponsored by the Institute of Education Sciences (IES) of the U.S.
Department of Education, among its list of top 10 health technology hazards for 2020,
puts at the seventh position cybersecurity risks in the connected home healthcare
environment. The institute believes that these hazards “warrant the greatest attention
for the coming year.” The problem of vulnerability is compounded in healthcare because
companies in the sector outsource more business functions and connect their network
with a large number of other organisations making more parties getting exposed to
personal health information.

The data will be even much more feared to be compromised in the near future. This
is because as per one prediction by 2025 most hospitals will have the ability to connect
more than 90 per cent of their devices and at the same time data security systems in
several hospitals seems to be not yet adequately robust. Attempts of cyber-attacks will
naturally increase as the data in the health sector is a gold mine. One can understand
the importance of health data when it is known that the breach in the Indian healthcare
website was detected when its stolen data was found to be available for sale in the
underground market.

Though the hackers have been using different methods to hack the information,
attacking server is the key part of many of the hacking cases. The US Department of
Health and Human Services’ office found out that 54 per cent of all individuals affected
by an information breach of healthcare organisations were impacted by breach involving
the servers. This is supported by Clearwater’s cyber intelligence institute which said
that 90 healthcare breaches in last one year involving 9 million patients were related to
servers. Its survey found out that 63 per cent of all critical and high risks were as a result
of some inadequately addressed security vulnerability in servers. Hence, protecting the
servers is the key aspect for protecting the information. It has listed dormant accounts
and excessive user permission as two most important reasons for security weakness and
unauthorised access.

BIO MAIL 5

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Acknowledgements The article by Dr Ayaaz Hussain Khan,
Global Head- Generics, Managing
Thank you so much for a great feature Director – Ecron Acunova (now under
of our interaction at Bio-Asia Taiwan Navitas Life Sciences) looks great. Thank
2019 in the October edition, much you
appreciated. The interview titled “US and
China together can dramatically improve - Deepti K, India
human health” has come out well.
Thank you so much for featuring
-Katherine Anderson, US the article by Frost & Sullivan,
titled ‘Digital Transformation in
The rfxcel team is very happy with the Pharmaceutical Industry’ in the
the coverage of our article by Victoria October edition.
Kozlova, General Director, rfxcel, Russia
in your latest edition. - Priya M George, India

- Santiago Cálad, Colombia

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6 BIO CONTENT

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

NEEDS
MUCH
MORE FOR
WORLD
WITHOUT
DIABETES

COVERStory 22

Diabetes is on the rise across the globe as reported in the most recent 8th edition of the
International Diabetes Federation (IDF) Diabetes Atlas 2017. As Diabetes is a lifestyle disease,
it can be prevented by adopting appropriate lifestyle. This is what the evidence from studies
conducted in the USA, Finland, China, India and Japan have proved. However, the pharma
industry has been investing on R&D and launching new products but needs much more. From
January 2019 to October 31, 2019, the US FDA has approved three products for type 2 diabetes
(two drugs Rybelsus and Victoza from Novo Nordisk and one drug – Farxiga from AstraZeneca).

27 BIOSPECIAL 29 SPEAKING WITH

Merging “We need treatments that
minds are easy to administer and
to effective with minimal risks”

monitor Dr Ben Ng,
diabetes Endocrinologist, ARDEN Endocrinology Specialist Clinic,
in APAC
Mount Elizabeth Novena Specialist Centre, Singapore

17 ANALYSIS 19 BIOSPECIAL

Merck’s Ranitidine
vaccine controversy

offers brings bad
hope for news for

Ebola pharma firms

BIO CONTENT 7

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

31 TECHNOLOGY CONNECT
ENGAGE
Hacked medical devices - SHARE
big security nightmare
Connect with us
36 TECHNOLOGY twitter.com/

Japan, China are leading the BioSpectrumMag
APAC healthcare AI market facebook.com/
BioSpectrumMagazine
Benjamin Low, https://goo.gl/QY4nUp
Vice-President, Asia Pacific, Milestone Systems, Singapore
/BS-LinkedIn
37 SPEAKING WITH www.biospectrumasia.com

“Our technology can clot all blood
samples in less than 5 minutes that
makes it a game changer”

Michael Grant,
Chief Executive Officer, Q-Sera Pty Ltd, Australia

39 COUNTRY REPORT

Drive for ‘Innovation Thailand’

41 HEALTHCARE

Raising bar to mitigate growing
health and economic impact of SSIs

Dr Charles E. Edmiston,
Emeritus Professor of Surgery, Medical College of Wisconsin, the USA

REGULARS

BioEdit.........................................04 World News...............................16
BioMail........................................05 R&D News..................................44
Regulatory News......................08 Academics News......................45
Company News........................10 Supplier News...........................46
Finance News............................12 People News..............................48
Start-Up News...........................13
WHO News.................................15 Bio Event...............................50

8 REGULATORY NEWS

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

India collaborates with WHO to re-design NHSRC

The Ministry of Health and Family initiative, National Dialysis on development of technical
Welfare, Government of India, in Program and other technology specification of Blood pressure
collaboration with World Health intensive services. In collaboration measuring devices, In vitro
Organization (WHO) has formally with WHO’s country’s office, diagnostics and devices for cancer
announced the re-designation of NHSRC has developed a guidance and cardiovascular diseases.
National Health Systems Resource document for the Ministry’s free Future collaboration includes work
Centre (NHSRC), as the WHO diagnostics initiative to further on International Classification and
Collaborating Centre for Priority strengthen the agenda of Universal Nomenclature for Medical Devices,
Medical Devices and Health access to affordable diagnostics. which would improve access to
Technology Policy. The mandate NHSRC also works with WHO affordable health technologies.
of the Division of Healthcare
Technology at NHSRC is to draw
up technical specifications for
technologies procured under
National Health Mission, draft
policies for medical device
maintenance and management,
undertake evaluations of health
product innovations, conduct
Health Technology Assessments
(HTA), and support the Ministry
of Health and Family Welfare
on issues related to diagnostics

South Korea Malaysia to begin
plans to bolster pneumococcal vaccination
biotechnology
The Health Ministry in Malaysia is committed to kick-start
South Korea intends to task a new the pneumococcal vaccination for children next year, with the
pan-government team to foster allocation of RM60 million proposed under the Budget 2020.
biotechnology into one of the country’s Elaborating on the pneumococcal vaccination programme,
next growth engines. The team, which Health Director-General Datuk Dr Noor Hisham Abdullah has
will be led by a vice minister, will look observed a need
at policy measures to help the industry to pre-prioritise
with participation from ministries and pre-negotiate
overseeing commerce, health, the pricing.
science and financial regulation. The Pneumococcal
government plans to announce the diseases include
set of policies to support the biotech lung infections/
industry within six months. inflammation
(pneumonia),
meningitis
(inflammation of
the membrane
surrounding the spinal cord or brain), sepsis (an infection in
the blood), sinusitis (infection of the sinuses) and otitis media
(middle ear infection). Also, an allocation of RM31 million
announced in Budget 2020 for upgrading and maintenance
of information and communication technology services, will
include a pilot project for hospital electronic medical records.

REGULATORY NEWS 9

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Taiwan recalls illegal
bone plates, screws

The Food and Drug the company had received the Australia to
Administration of the Ministry necessary GMP certification. The fund research
of Health in Taiwan has ordered incident is a manufacture violation on medicinal
the recall of more than 70,000 because the company had cannabis
bone plates and screws illegally distributed the products before
sold to hospitals by a Kaohsiung- receiving the GMP certification Australian Health
based company. The recall affects required to manufacture medical Minister has announced
81 hospitals and potentially products. The medical materials provision of $2.03
thousands of patients who are classified as patient-funded, million for research on
received the surgical implants and the health ministry has the use of cannabis to
between January and July this recommended that if patients are help cancer patients.
year. The titanium alloy plates worried they should talk to their While legal in most
and screws were manufactured doctor or seek compensation from of Australia, such
and sold by Shicheng Precision the illegal manufacturer according products are allowed
Technology Co., Ltd. before to the consumer protection law. only to patients on the
prescription of a doctor,
China approves and a license is required
Eisai’s antiepileptic drug to grow and make
medicinal cannabis.
Tokyo headquartered Eisai its significant clinical benefits According to the
Co., Ltd. has received a New compared to existing treatments, minister, there have only
Drug Approval for its in-house and was approved in about 12 been a limited number
discovered and developed months since the submission of well-designed clinical
antiepileptic drug (AED) Fycompa in September 2018. Fycompa is studies on medicinal
(perampanel) from the China a first-in-class AED discovered cannabis, and the country
National Medical Products at Eisai’s Tsukuba Research intends to increase the
Administration (NMPA) for use Laboratories. Administered orally evidence base to support
in an adjunctive treatment of once-daily, it is a highly selective, medical professionals.
partial onset seizures (with or noncompetitive AMPA receptor Health ministry data
without secondarily generalized antagonist that reduces neuronal shows 78 companies
seizures) in epilepsy patients 12 hyperexcitation associated with now licensed to grow
years of age and older. Fycompa seizures by targeting glutamate and harvest medicinal
was designated for Priority activity at AMPA receptors on cannabis, up from one in
Review by the NMPA due to postsynaptic membranes. March 2017.

10 COMPANY NEWS

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

AstraZeneca Hydrix introduces heart
India receives attack alerting technology
approval for
type 2 Australia based Hydrix Limited Coronary Syndrome (ACS) event,
diabetes drug has secured the exclusive rights to which includes heart attacks
distribute the AngelMed Guardian and unstable angina. The faster
AstraZeneca India has System in Australia and a number a heart attack is diagnosed and
announced that it has of significant Asian countries treated, the greater the chance of
received Import & Market including Singapore and Japan. a full recovery by the patient. The
permission for QTERN The Guardian is the world’s first Guardian identifies ACS symptoms
(Fixed dose combination FDA-approved, implanted cardiac with more certainty than the
of Dapagliflozin 10mg + monitoring device that can alert patient alone and alerts them to
Saxagliptin 5mg) in India patients of an impending Acute immediately seek medical help.
by the Drug Controller
General of India (DCGI). Simcere, JW Pharma join hands
This permission paves way for anti-gout drug candidate
for the launch of QTERN in
India, subject to the receipt China based Simcere commercialization of URC-102
of further related statutory Pharmaceutical Group and in China. Under the terms of
approvals and licenses. Korea headquartered JW the agreement, JWP will receive
QTERN is indicated as an Pharmaceutical (JWP) have upfront payment, milestones
announced a collaboration and and sales royalties from
adjunct to diet and exercise exclusive license agreement commercialization in China.
to improve glycaemic for anti-gout drug candidate Gout is a serious, progressive
control in adults with URC-102 in China (including and debilitating form of
type 2 diabetes mellitus Chinese Hong Kong & Macao). inflammatory arthritis. In most
(T2DM). QTERN combines According to the agreement, cases, it is caused by inefficient
two anti-hyperglycaemic Simcere will be responsible for excretion of uric acid, resulting in
agents with complementary the clinical research, hyperuricemia and the formation
mechanisms of action in a registration and of crystal deposits of uric acid.
once-daily tablet. The drug URC-102 is a selective inhibitor
comprises sodium-glucose of uric acid transporter (URAT-
cotransporter 2 (SGLT2) 1). It is currently under Phase
inhibitor- dapagliflozin and IIb clinical evaluation in patients
a dipeptidyl peptidase-4 with gout in South Korea.
(DPP-4) inhibitor
saxagliptin. SGLT-2
inhibitors help patients
achieve improved glycaemic
control by reducing the
reabsorption of glucose
from the blood and
enabling its removal via
the urine.

COMPANY NEWS 11

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Biocon, Mylan launch Semglee in Australia

Biocon Ltd and Mylan N.V. aged six years and above and
type 2 diabetes mellitus in
have announced the launch adults. Therapeutic Goods
Administration (TGA) approval
of Semglee (insulin glargine of Semglee, co-developed by
Biocon and Mylan, was based on
solution for injection 100 IU/ robust data that demonstrated
that Semglee is highly similar to
mL in a 3mL pre-filled pen), the the reference insulin glargine,
with no clinically meaningful
first insulin glargine biosimilar differences in efficacy, safety,
purity and potency. Mylan
in Australia available on the and Biocon’s insulin glargine
biosimilar is currently approved
Pharmaceutical Benefits in more than 40 countries
around the world.
Scheme (PBS). Insulin glargine

is a long-acting basal insulin

analogue, given once daily to

help control the blood sugar

levels of those with diabetes. It

is indicated for the treatment

of type 1 diabetes mellitus in

adults, adolescents and children

STA to market Eisai, Nichi-Iko
sarcoma drug in explore generic
Australia, NZ, SE Asia pharma biz in China

Independent pharmaceutical company Specialised Japan headquartered Eisai Co., Ltd. and Nichi-
Therapeutics Asia (STA), headquartered in Iko Pharmaceutical have announced that they
Singapore, has signed a new license deal, enabling have entered into a comprehensive collaboration
it to provide a global advanced sarcoma therapy to agreement for the generic pharmaceutical business
patients in Australia, New Zealand and throughout in China. Under this agreement, Eisai and Nichi-Iko
South East (SE) Asia. Under the terms of the aim to enhance their pharmaceutical businesses in
agreement, STA will provide the marine-derived China by introducing the high quality generic drugs
compound YONDELIS (trabectedin) to patients which Nichi-Iko maintains the marketing approval
throughout Australia, New Zealand and in South in Japan. Eisai and Nichi-Iko specifically select the
East Asia under exclusive license from Spanish appropriate products for the Chinese market needs,
company PharmaMar. YONDELIS, which has and Eisai’s subsidiary in China sells the products
been shown to improve progression-free survival after Nichi-Iko obtains the approval for import and
when used as second-line therapy for patients with sales in China. Eisai and Nichi-Iko will select the first
unresectable or metastatic liposarcoma (LPS) or two products in this fiscal year, and subsequently
leiomyosarcoma (LMS), is already approved and prepare to launch one to two products every year for
has been available to patients in the United States the continuous launch from FY2024.
since 2015, and in Europe since 2007.

12 FINANCE NEWS

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Admedus inks A$36.2M deal for Patch biz

Australia based Admedus Limited The CardioCel product range is to treat congenital heart defects,
announces the sale of its CardioCel the only one to have achieved vessel and cardiovascular
and VascuCel patch business to ten years without calcification or repairs, and peripheral vascular
U.S based LeMaitre Vascular degradation in man - a significant reconstruction. VascuCel is used
Inc., for up to A$36.2 million benefit to patients otherwise forced as a patch in great vessel repair,
in cash payments to Admedus. to undergo recurrent operations. peripheral vascular reconstruction
These products originated from Surgeons use CardioCel products and suture line buttressing.
the company’s proprietary, Under the agreement terms,
regenerative bio-scaffold platform Admedus receives A $22.8 million
technology, being used to upfront followed by deferred
address multiple cardiovascular payments of A$1 million each
procedures and repairs. LeMaitre at 12 months and at 36 months.
is a global provider of implants Additionally, the company may
and devices for the treatment of receive up to A$11.4 million in
peripheral vascular diseases. earn-out payments.

Bukwang Pharma Takeda divests select
invests $5M in OTC to Acino for $200M
JV with ASLAN
Japanese firm Takeda Pharmaceutical Company
Singapore based ASLAN Pharmaceuticals, Limited has announced that it has entered into an
a clinical-stage oncology and immunology agreement to divest a portfolio of select over-the-
focused biopharma company, and Bukwang counter (OTC) and prescription pharmaceutical assets
Pharmaceutical, a leading R&D focused Korean in a number of Near East, Middle East and Africa
pharmaceutical company, have announced that (NEMEA) countries within its Growth and Emerging
they have established a new joint venture to Markets Business Unit to Acino for a total value in
develop preclinical aryl hydrocarbon receptor excess of $200 million. This is the third transaction
(AhR) antagonists from ASLAN’s early stage in FY19 that furthers Takeda’s strategy to focus on
pipeline. The independent company, JAGUAHR business areas core to its long-term growth and
Therapeutics, will focus on developing new facilitate rapid deleveraging following its acquisition
immuno-oncology therapeutics for global markets of Shire. Under the terms of the agreement, Acino
targeting the AhR pathway and will be based in will acquire the rights, title, and interest to the
Singapore. Under the terms of the agreement, products in the portfolio exclusive to these countries.
ASLAN will transfer the global rights to all of It is anticipated that primarily sales and marketing
the assets related to AhR technology, originally professionals supporting the portfolio will transition
discovered and developed by ASLAN and its to Acino at closing of the transaction. The parties will
collaborator Dr Mark Graham, into JAGUAHR. also enter into a multi-year manufacturing and supply
Bukwang will invest $5 million in JAGUAHR agreement, under which Takeda will continue to
in two tranches to fund the development of the manufacture the products on behalf of Acino.
assets, identify a lead development compound
and file an Investigational New Drug application.

START-UP NEWS 13

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Japanese AI startup Ansun
secures $42.9M funding Biopharma
receives
AI Medical Service Inc., one of the the company to approximately $57 $80M in
world’s first real-time endoscopic million raised since its founding in Series B
artificial intelligence (AI) developers 2017. The company intends to use funding
based in Japan, has announced that the latest funding for the promotion
it has raised approximately $42.9 of clinical trials, to further the China based startup
million in Series B funding from development pipeline, acquisition Ansun Biopharma,
Globis Capital Partners, World of expert personnel, investment in which is committed
Innovation Lab (WiL) and Sony equipment and overseas expansion. to developing first-
Innovation Fund by IGV (Innovation Through further development of in-class innovative
Growth Ventures), as well as its technology, the company hopes biopharmaceuticals for
additional third-party allocations. to accelerate towards regulatory the most urgent and
Following the last funding round approval and contribute to the unmet clinical needs in
in August 2018 of over $9 million development of endoscopic medical the field of respiratory
from the Incubate Fund, this brings care worldwide. infections, announced
the completion of
Bayer G4A partners $80 million Series B
with Wellthy Therapeutics round of financing.
This round of financing
Wellthy Therapeutics to improve was led by Haisong
the latter’s product, regulatory and Capital, Dawan
commercialization capabilities while District Common
exploring areas of collaboration. Home Development
Bayer’s G4A team is present in Fund, Jiachen Capital,
over 34 countries, working towards KIP and existing
enabling positive disruption in the shareholders Yuanming
digital health and care industry, Capital, Lilly Asia Fund,
through new business opportunities Jingwei China, Materia
and partnerships with Bayer. Bayer Medica Capital, and
recognizes Digital Therapeutics Jifeng Capital. Huaxing
(DTx) as an important category of Capital acted as the
health care, delivering evidence- exclusive financial
based therapeutic interventions built advisor for this
with high quality software programs financing. The proceeds
to prevent, manage, or treat specific from this round will be
chronic conditions. used primarily for the
ongoing PIV Global
Multicenter Phase III
clinical trial and the
expansion of other
indications.

Indian health tech startup Wellthy
Therapeutics has announced its
partnership with Bayer through
its G4A partnership initiative.
As part of the partnership, the
German lifesciences group’s G4A
team will be working closely with

14 START-UP NEWS

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Lucence, TTSH to reduce MedTech
risks of liver cancer surgery Innovator
picks deep
Tan Tock Seng Hospital (TTSH) decision support. Among major tech startups
and oncology startup Lucence cancers in Singapore, liver cancer
Diagnostics based in Singapore has the highest mortality rate MedTech Innovator,
are developing a next-generation when compared to the incidence the premier nonprofit
decision support tool for liver rate. Surgery is the primary accelerator in the medical
cancer patients, which aims therapeutic option for liver technology industry, recently
to reduce the risks associated cancer. This innovation is the first picked NDR Medical as the
with liver cancer surgery. The project to result from a Research winner and Inochi Care
tool, which TTSH and Lucence Collaboration Agreement between as the runner-up of 2019
have been collaborating on TTSH and Lucence, a collaboration Asia Pacific Grand Prize,
since April this year, seeks to facilitated by the Centre for out of four finalists, 20
develop machine learning models Healthcare Innovation and her showcase companies and
based on radiology images of partner NHG Centre for Medical 170 applicants. Attendees of
liver cancer patients for clinical Technologies and Innovations. The MedTech Forum, hosted
by the Asia Pacific Medical
NTU startup unveils Technology Association
robot with human-like grip (APACMed), voted for
the Grand Prize winner of
A robotics technology startup from Nanyang Technological University, $150,000 in Singapore.
Singapore (NTU Singapore) named Eureka Robotics, has unveiled a new Four finalist companies
robot that can pick up delicate optical lenses and mirrors with care and viz., Crely Healthcare,
precision, just like a human hand. Named Archimedes, the robot is developed Inochi Care, NDR Medical,
by the same NTU team behind the “IKEA Bot” and Nesa Medtech made
last year which attracted international headlines it to finals and competed
when it assembled an IKEA chair autonomously for the title of 2019 Asia
in less than 9 minutes. Archimedes can slot Pacific Grand Prize winner.
lenses and mirrors of different sizes into a NDR Medical and Crely
custom loading tray, to get them ready for Healthcare are Singapore
coating. This will be a boon to the manufacturers based whereas Inochi Care
for optical products such as cameras, medical and Nesa Medtech are
imaging and eyewear, as it eliminates defects based out of India from
in production and improves productivity. This the cities of New Dehli and
built-in-NTU innovation was supported by the Bengaluru respectively. The
SMART (Singapore MIT Alliance for Research four finalist companies are
and Technology). Its development from a lab developing transformative
concept into a prototype that is now going out to market is one fine example medical technology
of technological translations taking place at the NTU Smart Campus. innovations in the areas of
precision medicine, surgical
advancements, and critical
care. NDR Medical, based
in Singapore, is developing
a robotic system that
uses artificial intelligence
and image processing to
automate the targeting of
lesions and expedite the
diagnosis of critical illnesses.

WHO NEWS 15

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

WHO welcomes vital addition to Global Funds

The World Health Organization resistance and other threats.
(WHO) has elcomed new funding It is expected that the Global
commitments made at the Global Fund will continue to invest a
Fund’s Sixth Replenishment good proportion of this money
Conference in Lyon hosted by to strengthen health systems,
the Government of France, on including building diagnostics
October 9, 2019. The pledges, capacities, surveillance systems
amounting to $14.02 billion and supply chains. WHO and
will cover a three-year period the Global Fund have worked
(2020-2022) to finance the fight closely together since the Global
against HIV, TB and malaria. The Fund was set up in 2002 to help
renewed commitment to replenish countries establish and sustain
the Global Fund will mean that nationally-driven programmes
over 110 affected countries will to fight HIV, TB and malaria. It
receive critical financial support provides vitally needed funding,
for health allowing them to scale while WHO supplies technical
up infectious diseases responses expertise and guidance at both
and to fight back against drug global and country level.

WHO launches app to WHO releases first
improve elderly care world report on vision

The World Health Organization (WHO) has launched a 1 billion people worldwide are living with vision
package of tools, including a digital application to help impairment because they do not get the care
health and social workers provide better care for older they need for conditions like short and far
people. The innovative interactive digital application sightedness, glaucoma and cataract, according
known as WHO ICOPE Handbook App provides practical to the first world report on vision issued by the
guidance to address priority conditions including World Health Organization. The report found
mobility limitations, malnutrition, vision and hearing that ageing populations, changing lifestyles and
loss, cognitive decline, depressive symptoms and social limited access to eye care, particularly in low- and
care and support. Used in conjunction with a package of middle-income countries, are among the main
tools including a new handbook, the app will accelerate drivers of the rising numbers of people living
training of health and social workers to better address with vision impairment. According to the report,
the diverse needs of older people. The Integrated Care stronger integration of eye care is needed within
for Older People package of tools is the result of two national health services, including at primary
years of extensive consultations with leading experts and health care level, to ensure that the eye care
stakeholders including civil society representatives. needs of more people are addressed, including
through prevention, early detection, treatment
and rehabilitation.

16 WORLD NEWS

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Ethiopia focuses Kenya
on traditional launches cervical
medicine research cancer vaccine

Ethiopia’s Ministry of Health has released a five Kenya’s Health Ministry has launched cervical
years’ traditional medicine research roadmap. cancer vaccine for the first time in the country
Among the goals that government eye are to verify targeting 800,000 girls. The Human Papilloma
the effectiveness of traditional medicine and utilize Virus (HPV) vaccine will be offered nationally
them in modern medicine. The existing traditional alongside other Routine Infant Vaccines through
medicine policy will be revised, regulations and an existing network of over 9,000 public and
legislation will be enacted so as to reinforce the private health facilities. The vaccine will be given
existing regulatory regime in the sector. Inclusion free of charge to earmarked 800,000 girls who
of traditional medicine in the education system and are currently 10 years old and subsequently to
training traditional medicine practitioners are also all girls as they turn 10 years old in future. The
identified as relevant steps for the health sector. government has earmarked 800 million shillings
The five year’s roadmap also emphasizes on the to the introduction of the vaccine this year.
importance of preserving indigenous traditional According to the World Health Organization,
medicine knowledge and plants. The government cervical cancer is the third leading cause of
also intends to coordinate with the pharmaceutical deaths among women in Kenya after infectious
industry so as to enable proven traditional medicines and cardiovascular diseases.
to enter the production process.

Germany to assist Nigeria’s health sector

German government has vocational training and
agriculture. Already five
reached agreement with the hospitals were to be given
technical support to have a
Federal Ministry of Health ‘train the trainer’ concept
and have a cooperation
in Nigeria to offer financial between the hospitals.
Both countries are already
and technical assistance working in the area of
polio eradication where
towards improving the a funding of 30 million
euros has been provided
country’s healthcare by Germany.

delivery system. According

to Germany’s Minister of

Health, Jens Spahn, both

countries had discussed on

how to partner in several

areas, including health,

ANALYSI S 17

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

MERCK’S
VACCINE

OFFERS
HOPE FOR

EBOLA

Ebola get attention only when there is a crisis, but this time Ebola
is in news for the right reasons. Merck’s Ebola Vaccine (V920) got

green signals from the US and European regulators.

On September 17, 2019, the U.S. Food and Drug therapeutic advantage over existing treatments, or
Administration (US FDA) had accepted the benefit patients without treatment options. These
Biologics License Application (BLA) and granted medicines are considered priority medicines by
priority review for Merck’s investigational Ebola vaccine EMA. To be accepted for PRIME, a medicine has
(V920), under review for the prevention of disease caused to show its potential to benefit patients with unmet
by the Ebola Zaire virus. The Prescription Drug User Fee medical needs based on early clinical data.
Act (PDUFA), or target action date, is set for March 14,
2020. In parallel, and in close collaboration with FDA Merck also got green light from the European
and European Medicines Agency (EMA), submissions regulator on October 18, 2019. Committee for
have also been made to the World Health Organization Medicinal Products for Human Use (CHMP)
(WHO) to achieve prequalification status and to African of the EMA has adopted a positive opinion
health authorities in collaboration with the African Vaccine recommending a conditional marketing
Regulatory Forum (AVAREF). authorization for V920 Ebola Zaire vaccine
(rVSVΔG-ZEBOV-GP, live). If affirmed by the
On July 25, 2016, Merck announced that the FDA had European Commission, the vaccine will be
granted the vaccine candidate Breakthrough Therapy authorized under the brand name ERVEBO
Designation, and that the EMA had granted PRIME (pronounced UR-VEE-BOH) and indicated for
(PRIority MEdicines) status. active immunization of individuals 18 years of age
or older to protect against Ebola Virus Disease
The FDA’s Breakthrough Therapy Designation is (EVD) caused by Zaire Ebola virus.
intended to expedite the development and review of a
candidate that is planned for use, alone or in combination, “This positive opinion from CHMP represents
to treat a serious or life-threatening disease or condition important progress towards licensure of a vaccine
when preliminary clinical evidence indicates that the drug to provide protection from Ebola virus disease to
may demonstrate substantial improvement over existing people in areas affected by the Ebola Zaire virus,”
therapies on one or more clinically significant endpoints. said Dr. Roger M. Perlmutter, president, Merck
Research Laboratories. “Our work would not have
PRIME is a process from the EMA to enhance support been possible without the efforts of countless
for the development of medicines that target an unmet numbers of people, especially those from the World
medical need. PRIME is intended to optimize development Health Organization and many other government
plans and speed up assessment of the medicine’s application and non-governmental organizations, who have
so these medicines may potentially reach patients earlier. worked tirelessly on the development of this
PRIME focuses on medicines that may offer a major

18 ANALYSIS

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Major Ebola outbreak: Laboratory and subsequently licensed to a subsidiary
of NewLink Genetics Corporation.
● Ebola was discovered in 1976 near the Ebola
River in what is now the Democratic Republic In late 2014, when the Ebola outbreak in western
of Congo. Since then, the virus has emerged Africa was at its peak, Merck licensed V920 from
periodically from its natural reservoir (which NewLink Genetics. Since that time, the company has
remains unknown) and infected people in worked closely with a number of external collaborators
several African countries. to enable a broad clinical development program with
partial funding from the U.S. government, including the
● The 2014–2016 outbreaks in West Africa was Department of Health and Human Service’s Biomedical
the largest Ebola outbreak since the virus Advanced Research Development Authority (BARDA)
was first discovered in 1976. The outbreak and the Department of Defense’s Defense Threat
started in Guinea and then moved across land Reduction Program (DTRA) and Joint Vaccination
borders to Sierra Leone and Liberia. Acquisition Program (JVAP), among others. Merck’s
V920 investigational supply replenishment activities
● As of May 8, 2016, the World Health are supported by partial Federal funding from BARDA.
Organization (WHO) and respective
governments reported a total of 28,646 Merck is responsible for the research, development,
suspected cases and 11,323 deaths (39.5%), manufacturing and regulatory efforts in support of
though the WHO believes that this V920. The company has committed to working closely
substantially understates the magnitude of with other stakeholders to accelerate the continued
the outbreak. development, production and, if licensed, distribution
of the vaccine. Another Ebola vaccine licensed by
● The current 2018-2019 outbreak in Merck from Canada’s Public Health Agency – rVSV-
Democratic Republic of the Congo is highly ZEBOV – is said to be the first vaccine brought to the
complex, with insecurity adversely affecting market against the Ebola Zaire virus.
public health response activities. As of
October 13, 2019, a total of 3228 cases were Johnson & Johnson is among the other companies
reported, of which 3114 confirmed and 114 developing Ebola vaccines. Earlier, GlaxoSmithKline
probable, of which 2123 deaths (case fatality (GSK) was also developing the Vaccine, but now it has
rate 66%). transferred the rights to Sabin Vaccine Institute. To
further develop the Vaccines, Sabin has entered into
● In the 21 days from 23 September to 13 a Research Collaboration Agreement with the Vaccine
October, the number of affected health Research Center (VRC) at the National Institute of
areas has reduced, with 22 health areas Allergy and Infectious Diseases (NIAID).
and 10 health zones reporting new cases,
predominated by Mandima, Mambasa and Apart from this, two other drugs have shown
Kalunguta. positive results in the clinical trials. According to a
report in Nature journal, one of the drugs, REGN-
important vaccine. Our top priority is the achievement EB3, is a cocktail of three monoclonal antibodies
of registration of our German ERVEBO manufacturing against Ebola made by Regeneron Pharmaceuticals of
site, so that licensed supply can be used to support Tarrytown, New York. The second, mAB114, is derived
global public health preparedness.” from a single antibody recovered from the blood of a
person who survived Ebola in the DRC in 1995, and
Lack of regulatory approval didn’t deter the company was developed by the US National Institute of Allergy
to start using it on the patients. Since May 2018, Merck and Infectious Diseases (NIAID).
has donated and shipped more than 245,000 1.0mL
investigational V920 Ebola vaccine doses to the World According to Centers for Disease Control and
Health Organization (WHO) in response to requests by Prevention (CDC), one of the major operating
the WHO. Beyond doses already delivered, more than components of the Department of Health and Human
190,000 additional 1.0mL investigational doses are Services in the USA, while the spread of EVD in
currently available and ready to ship to the outbreak West Africa has been controlled, additional cases
region at WHO’s request. may continue to occur from time to time. However,
because of ongoing surveillance and strengthened
The Journey of Merck’s Ebola vaccine response capabilities, the affected countries now have
the experience and tools to rapidly identify cases and
V920, Merck’s investigational Ebola Zaire vaccine, limit the spread of the disease.
was initially engineered by scientists from the Public
Health Agency of Canada’s National Microbiology Ayesha Siddiqui
[email protected]

BIOSPECIAL 19

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Ranitidine controversy
brings bad news
for pharma firms

Online pharmacies are usually met with the skepticisms, often considered to be the
hotbed of fake drugs, but this time around an online pharmacy has helped unearthed a
potential that could have harmed people.

Valisure, an online pharmacy based in the US, by a third-party laboratory uses higher temperatures.
discovered the link of Zantac and its generics The higher temperatures generated very high levels
to the carcinogen N-nitrosodimethylamine of NDMA from ranitidine products because of the
(NDMA) during its routine testing of every batch test procedure. The FDA published the method for
of every medication, and first notified the United testing angiotensin II receptor blockers (ARBs) for
States of Food &Drug Administration (US FDA) of nitrosamine impurities. That method is not suitable
its initial findings in June of 2019. On September for testing ranitidine because heating the sample
13, 2019, Valisure filed a detailed petition with the generates NDMA. The FDA recommends using
US FDA asking the agency to recall all products an LC-HRMS testing protocol to test samples of
containing ranitidine. Valisure’s research, along with ranitidine. Its LC-HRMS testing method does not use
that of Stanford University and others, found that elevated temperatures and has shown the presence
NDMA was the result of the “inherent instability” of much lower levels of NDMA in ranitidine than
of the ranitidine molecule. This means that all reported by the third-party laboratory. International
manufacturers, brand or generic, and all lots of regulators using similar LC-MS testing methods have
ranitidine-containing medications are affected and also shown the presence of low levels of NDMA in
could generate very high levels of NDMA in the ranitidine samples.
human body.
The FDA will test ranitidine oral solution products
Following which the FDA issued a warning about and has begun testing samples of other H2 blockers
the NDMA (at low levels) presence in ranitidine. On and proton-pump inhibitors to help inform this
September 24, 2019, USFDA alerted health care ongoing investigation. To date, the agency’s early,
professionals and patients of a voluntary recall of 14 limited testing has found unacceptable levels of
lots of prescription ranitidine capsules distributed NDMA in samples of ranitidine. The agency will
by Sandoz Inc., The agency further issued an alert to provide more information as it becomes available.
health care professionals and patients to a voluntary
recall of over-the-counter (OTC) ranitidine tablets (75 The brand version of ranitidine is Zantac;
mg and 150 mg), labeled by Walgreens, Walmart, and originally developed by GlaxoSmithKline (GSK).
Rite-Aid and manufactured by Apotex Corp. Novartis’ generic-drug division, Sandoz, Sanofi, Dr
Reddy’s, GSK have recalled the drugs. However, the
The US FDA is continuing to test ranitidine FDA is not recommending individuals stop taking all
products from multiple manufacturers and is ranitidine medicines at this time.
assessing the potential impact on patients who have
been taking ranitidine. In addition, the agency has The FDA has been investigating NDMA and other
asked manufacturers of ranitidine to conduct their nitrosamine impurities in blood pressure and heart
own laboratory testing to assess levels of NDMA failure medicines called Angiotensin II Receptor
in their ranitidine products and to send samples Blockers (ARBs) since last year. In the case of ARBs,
of ranitidine products to FDA to be tested by its the FDA has recommended numerous recalls as it
scientists. discovered unacceptable levels of nitrosamines. This
issue surfaced in the summer of 2018, when the FDA
The agency has observed the testing method used was informed that API manufactured by Zhejiang

20 BIOSPECIAL

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What is NDMA consumer-facing recommendations regarding the
instance of a carcinogenic chemical in Zantac “highly
N-nitrosodimethylamine NDMA is classified questionable,” and are urging those who take Zantac
as a probable human carcinogen (a substance to consult with their doctors before continuing to take
that could cause cancer) based on results the medicine.
from laboratory tests. NDMA is a known
environmental contaminant and found in water The complaint also alleges that scientific testing
and foods, including meats, dairy products, and that employs the FDA’s own protocols shows that a
vegetables. single tablet of Zantac may react to form up to 26,000
times the FDA-approved limit of NDMA, a chemical
What is Ranitidine? which the FDA and World Health Organization
(WHO) classify as a carcinogen. Although the FDA
Ranitidine is an over-the-counter (OTC) has announced that it too found NDMA in Zantac
and prescription drug. Ranitidine is an H2 and generic ranitidine, albeit at lower levels, the FDA
(histamine-2) blocker, which decreases the has not urged companies to recall the drug, nor has it
amount of acid created by the stomach. Over- recommended that consumers stop taking Zantac.
the-counter ranitidine is approved to prevent
and relieve heartburn associated with acid According to the firm’s complaint, when one
ingestion and sour stomach. Prescription 150 mg tablet of Zantac is ingested, it undergoes
ranitidine is approved for multiple indications, a chemical reaction in the stomach to create more
including treatment and prevention of ulcers than 3,100 times the FDA-approved limit of NDMA.
of the stomach and intestines and treatment of The lawsuit, filed September 20, 2019, in the U.S.
gastroesophageal reflux disease. Ranitidine is District Court for the District of New Jersey, accuses
even on the World Health Organization’s List of Sanofi and Boehringer Ingelheim of knowingly
Essential Medicines, as one of 433 drugs deemed manufacturing and selling over-the-counter (OTC)
essential for addressing the most important Zantac containing a concealed carcinogen to millions
public health needs globally. in the U.S. suffering from heartburn and other
gastrointestinal issues, including sour stomach, acid
Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, reflux or gastroesophageal reflux disease (GERD).
Taizhou Zhejiang China for some generic valsartan-
containing medicines contained NDMA, posing a The FDA has established a permissible daily
potential safety concern.

In 2018, the FDA issued guidance to the industry
on how to assess and control the impurities. EMA
(European Medicines Agency) also issued new
manufacturing requirements for ARBs following
a review, stating that companies that make sartan
blood pressure medicines are being required to
review their manufacturing processes so that they
do not produce nitrosamine impurities. Companies
will have a transition period of two years to
make any necessary changes, during which
strict temporary limits on levels of these
impurities will apply.

Lawsuits against Sanofi and
Boehringer Ingelheim

Class-action law firm Hagens Berman has
filed a second lawsuit regarding Sanofi
and Boehringer Ingelheim’s intentionally
concealed cancer risks in its popular heartburn
medication, Zantac. Attorneys are also
calling the Food and Drug Administration’s

BIOSPECIAL 21

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intake limit of 96ng of NDMA, but recent testing Dr. Reddy’s recalls all Ranitidine
using FDA-approved methods detected more than products in the U.S. Market
2,500,000ng of NDMA per 150mg tablet of Zantac.
Each Zantac tablet has been found to contain 26,000 On October 23, Dr. Reddy’s Laboratories
times the FDA-approved amount of NDMA that can Ltd., Hyderabad based Indian multinational
be safely ingested daily. pharma company along with its subsidiaries,
had initiated a voluntary nationwide recall on
What other regulators are saying? October 1, 2019, (at the retail level for over-the-
counter products and at the consumer level for
At the request of the European Commission, EMA is prescription products) of all of its ranitidine
to start a review of ranitidine medicines after tests medications sold in US due to confirmed
showed that some of these products contained an contamination with N-Nitrosodimethylamine
impurity called NDMA. EMA’s Executive Director (NDMA) above levels established by the FDA.
has asked the human medicines committee (CHMP)
to provide guidance for avoiding the presence This recall follows the USFDA’s caution note
of nitrosamine impurities in human medicines alerting patients and health care professionals
containing chemically synthesized active substances. that NDMA was found in certain samples of
ranitidine. To date, Dr. Reddy’s has not received
The Singapore drug regulator the Health Science any reports of adverse events related to the recall
Authority, (HSA) said eight brands of ranitidine of Dr. Reddy’s Ranitidine products. The recall
medicines have been found to contain trace includes all quantities in the US that are within
amounts of a nitrosamine impurity, NDMA, which expiry. The company noted that its Ranitidine
are above the internationally acceptable level. As a products can be identified by NDC numbers on
precautionary measure, the HSA is stopping the sale the product label. All Ranitidine products with
and supply of the affected ranitidine medicines at expiration dated September 2019 to June 2021
clinics, hospitals and pharmacies. are being recalled. This recall is being executed
with the knowledge of the U.S. Food and Drug
The Drug Controller General of India (DCGI) Administration.
has directed manufacturers of ranitidine active
pharmaceutical ingredients (API) to verify their also prohibited the use of all the lots sold in Italy of
products and take appropriate measures to ensure ranitidine-containing medicines produced by other
patient safety. It has also asked them to ensure that pharmaceutical companies, pending their analysis.
the drug is sold only under prescription.
At Health Canada’s request, companies marketing
As a precautionary measure, Bangladesh has ranitidine products in Canada have stopped any
banned the import of raw materials, production and further distribution until evidence is provided to
sale of ranitidine until further notice. demonstrate that they do not contain NDMA above
acceptable levels. The request to stop distribution
Taiwan’s health authorities have also ordered the means that the existing stock of ranitidine products
recall of 38 stomach medications in a precautionary currently available in pharmacies or at retail stores
measure over alleged carcinogen contamination. may continue to be sold. This is different from a
recall, since products that are being recalled can
Australia’s TGA (the Therapeutic no longer be sold. This is an interim, precautionary
Goods Administration) is working measure as Health Canada continues to gather
information from companies and to assess the issue
with international regulators with other international regulators.
and medicine sponsors to
investigate this issue. The TGA Similar measures have been taken or are in the
has undertaken laboratory testing of process of being adopted in other EU countries and in
Australian ranitidine medications to several non-European countries. Ranitidine market
determine if these batches are affected. is expected to surpass $485.4 million by 2026, said a
The TGA will publish a detailed testing report report by Coherent Market Insights. This controversy
when the testing will be completed. For now will surely affect the market, but to what degree for
TGA has recalled all the ranitidine medicine that, will have to wait and watch.
from the market.
The Italian Drug Agency (AIFA) has ordered Ayesha Siddiqui
the withdrawal from pharmacies and from the [email protected]
distribution chain of all lots of medicines containing
the active ingredient ranitidine produced at
Saraca Laboratories Ltd - India pharmaceutical
workshop. As a precautionary measure, AIFA has

22 COVER STORY

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NEEDS MUCH
MORE FOR
WORLD WITHOUT
DIABETES

Diabetes is on the rise across the globe as Moreover, it was estimated that the number of
reported in the most recent 8th edition of adults with diabetes in the world had increased from
the International Diabetes Federation (IDF) 108 million in 1980 to 422 million in 2014 (28.5 per
Diabetes Atlas 2017. According to the IDF statistics, cent due to the rise in prevalence, 39.7 per cent due
presently every seven seconds someone is estimated to population growth and ageing, and 31.8 per cent
to die from diabetes or its complications, with 50 due to interaction of these two factors). Besides the
per cent of those deaths (4 million in total per year) growth and aging of the world population in general,
occurring under the age of 60 years. This is against the the global obesity epidemic has turned out to be a key
background of a global diabetes prevalence of 8.8 per factor for the rise of diabetes incidence together with
cent of the world population in 2017, standardized for the immense progress of multifactorial cardiovascular
the age group 20-79 years. risk management and successful revascularisation
therapy of people with diabetes also contributing to
The prevalence is expected to further increase to the expansion of the worldwide diabetes population.
9.9 per cent by the year 2045. In total numbers, this
reflects a population of 424.9 million people with In addition to overt diabetes, the IDF Atlas estimates
diabetes worldwide in 2017 with an estimate of a 48 another 352.1 million people worldwide to have a pre-
per cent increase to 628.6 million people for the year stage of diabetes, called Impaired Glucose Tolerance
2045. Global numbers of diabetes prevalence have (IGT), a figure which is anticipated to rise to 531.6
continuously risen from 151 million in 2000, when the million in 2045. In the latter group, the manifestation
IDF Diabetes Atlas first was launched, to 285 million of overt diabetes could actually be prevented in most
in 2009 and to 382 million in 2013. Disturbingly in people by appropriate measures, along with most of
this context, some 50 per cent of all individuals with the severe complications of diabetes at the heart, the
diabetes are undiagnosed, especially in developing brain, the eyes, the kidneys, and the feet.
countries.
On a global scale, diabetes hits particularly “middle-
According to report published in European aged” people between 40 and 59 years of age which
Society of Cardiology in April this year, the figures causes serious economic and social implications.
given in the IDF Atlas fit well with the estimates of an Furthermore, diabetes affects especially low and
international consortium reporting worldwide trends middle income countries, as 77 per cent of all people
in diabetes since 1980 based on a pooled analysis with diabetes worldwide live in those countries.
of 751 population-based studies with 4•4 million
participants. According to this group global age- Diabetes more or less equally affects both sexes
standardised diabetes prevalence increased from 4.3 with men having a small edge over women at younger
per cent in 1980 to 9.0 per cent in 2014 in men, and age groups and women surpassing men at higher age
from 5.0 per cent to 7.9 per cent in women. groups. Depending on age groups, global diabetes
prevalence is about 5 per cent for the age group 35-

COVER STORY 23

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Diabetes is on the rise across the globe

as reported in the most recent 8th edition

of the International Diabetes Federation

(IDF) Diabetes Atlas 2017. As Diabetes is

a lifestyle disease, it can be prevented by

adopting appropriate lifestyle. This is what

the evidence from studies conducted in

the USA, Finland, China, India and Japan

have proved. However, the pharma industry

has been investing on R&D and launching

new products but needs much more. From

January 2019 to October 31, 2019, the

US FDA has approved three products for

type 2 diabetes (two drugs Rybelsus and

Victoza from Novo Nordisk and one

39 years, 10 per cent for drug – Farxiga from AstraZeneca).
the age group 45-49 years,
15 per cent for the age group IDF Diabetes Atlas 8th Edition 2017
55-59 years, and close to 20 per cent Global fact sheet
starting at age group 65-69 years. Diabetes prevalence
numbers are largely determined by people with type2 ● Approximately 425 million adults (20-79
diabetes who comprise about 90 per cent of the total years) were living with diabetes; by 2045 this
population. These individuals are characterized will rise to 629 million
by various degrees of relative insulin deficiency in
conjunction with a wide spectrum of insulin resistance. ● The proportion of people with type 2 diabetes
is increasing in most countries
About five per cent of the total diabetes population
represents monogenic forms of diabetes, such as ● 79% of adults with diabetes were living in
various subtypes of MODY (maturity-onset diabetes of low- and middle-income countries
the young) and other rare genetic conditions, another
five per cent encompass sub-forms of immune- ● The greatest number of people with diabetes
mediated type 1 diabetes with a pronounced, if not were between 40 and 59 years of age
absolute insulin deficit in the long run. Reflecting the
enormous therapeutic progress in the last 30 years, ● 1 in 2 (212 million) people with diabetes were
many people afflicted with type 1 diabetes today are undiagnosed
able to live for almost a normal life span, although the
disease usually starts at a young age, i.e.in children ● Diabetes caused 4 million deaths
and adolescents. For the age group 0-19 years, the ● Diabetes caused at least $ 727 billion dollars
IDF Diabetes Atlas 2017 provides a global number of
1,106,500 people with type 1 diabetes with an annual in health expenditure in 2017 – 12% of total
incidence of 132,600 newly diagnosed cases. spending on adults
● More than 1,106,500 children were living
Mortality, though decreasing in the last 30 years, with type 1 diabetes
has remained at least two fold increased both in adult ● More than 21 million live births (1 in 7 births)
type 1 and type 2 diabetes compared with the general were affected by diabetes during pregnancy
population. Excessive death rates not only relate to ● 352 million people were at risk of developing
cardiovascular causes, but also to non-cardiovascular type 2 diabetes
causes such as cancer, renal disease, liver disease,
pneumonia, septicaemia and other infections. In
contemporary global cohorts of type 2 diabetes, e.g.

24 COVER STORY

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IDF Centres of Education as studied in the TECOS trial, more
than 50 per cent of all deaths is due to
Western Pacific Region: cardiovascular causes with sudden death
● Diabetes Center, Taichung Veterans General being the most common cause, followed
by combined death from myocardial
Hospital - Taiwan infarction or stroke, and death from heart
● Philippine Center for Diabetes Education failure.

Foundation, Inc. - Philippines Prevention studies
● Siriraj Diabetes Center. Faculty of Medicine related to Type 2 diabetes

Siriraj Hospital - Thailand According to the National Institute
● Thai Association of Diabetes Educators – of Diabetes and Digestive and Kidney
Diseases Health Information Center,
Thailand USA diabetes can cause serious health
● The Chinese University of Hong Kong – problems, such as heart disease, stroke,
and eye and foot problems. Prediabetes
Prince of Wales Hospital Diabetes Centre - also can cause health problems. The
Hong Kong good news is that type 2 diabetes can be
South-East Asia Region: delayed or even prevented. One can prevent or delay
● All India Institute of Diabetes, Raheja Fortis type 2 diabetes by losing a modest amount of weight
Hospital - Mumbai, India by following a reduced-calorie eating plan and being
● Chellaram Diabetes Institute - Pune, India physically active most days of the week and taking
● Dr. Mohan’s Diabetes Education Academy - diabetes drug metformin (with recommendation of
Chennai, India doctor).
● Diacon Hospital (Diabetes Care & Research
Center) - Bangalore, India According to IDF there is overwhelming evidence
● Jothydev’s Diabetes Research Centre (JDC) - from studies in the USA, Finland, China, India and
Trivandrum, India Japan that lifestyle changes (achieving a healthy body
● M.V. Hospital for Diabetes & Prof. M. weight and moderate physical activity) can help prevent
Viswanathan Diabetes Research Centre - the development of type 2 diabetes in those at high risk.
Chennai, India
● Swasthya (Yash Diabetes Specialities LLP, All The Da Qing Study examined the effect of a 6-year
India Institute of Diabetes and Research) - diet and exercise intervention in Chinese individuals
Ahmedabad, India with Impaired Glucose Tolerance (IGT) and an average
● Sunil’s Diabetes Care n’ Research Centre Pvt. age of 45. The diet intervention alone was associated
Ltd. - Nagpur, India with a 31 per cent reduction in the risk of developing
● TOTALL Institute of Health Education - type 2 diabetes, while the exercise intervention alone
Indore, India showed a 46 per cent reduction. The combined diet
and exercise group had a similar 42 per cent reduction
IDF partners in the risk of developing type 2 diabetes during a
6-year follow-up period.
● Gold partners - Sanofi Diabetes
● Silver partners - Lilly Diabetes and Pfizer The Finnish Diabetes Prevention Study (DPS) was
the first randomized controlled trial to specifically
MSD Alliance examine the effect of a lifestyle intervention in
● Bronze partners – Allergan, Merck preventing type 2 diabetes. This study randomly
● Partners – AstraZeneca, Bayer, MSD, assigned 522 overweight or obese individuals with IGT
to either a lifestyle intervention or a control group and
Novartis, Servier, SunLife and i-sens followed them for approximately 3 years. The lifestyle
intervention provided individualised counseling
focused on achieving and maintaining healthy body
weight, reducing fat intake, increasing fibre intake
and increasing physical activity. After two years, the
incidence of type 2 diabetes in the intervention group
was less than half that observed within the control
group. The Diabetes Prevention Program (DPP) was
conducted in 3234 US adults with IGT. Unlike most

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previous studies, the cohort was diverse and included IDF SEA and WP regional fact sheet
a large proportion of women (68%) and ethnic
minorities (45%), and compared lifestyle intervention ● The International Diabetes Federation (IDF)
versus drug intervention (metformin) and a placebo is divided into seven regions, Africa, Eastern
control group over 2.8 years. The DPP reported Mediterranean and Middle East, Europe,
that both lifestyle intervention and metformin had North America, South and Central America,
positive effects on the prevention of type 2 diabetes South East Asia, Western Pacific, with the aim
and restoring normal glucose tolerance. The lifestyle of strengthening the work of national diabetes
intervention was more effective in preventing type 2 associations and enhancing collaboration
diabetes, particularly in older adults. between them. IDF’s network of members in
168 countries provides an authoritative global
The Indian Diabetes Prevention Program (IDPP) voice, working to ensure that the needs of all
was a prospective community-based study, that people affected by diabetes are met so that
examined whether the progression to type 2 diabetes each can live their lives as unhindered by the
could be influenced by interventions in native Asian disease as possible.
Indians with IGT who were younger, leaner and
more insulin resistant than in multiethnic American, ● The IDF South-East Asia (SEA) Region
Finnish and Chinese populations Results showed includes seven countries and territories,
that progression of IGT to type 2 diabetes is high in currently representing 11 diabetes
native Asian Indians. Both lifestyle modification and organizations in six countries. It is the second
metformin significantly reduced the incidence of type most populous IDF Region.
2 diabetes in Asian Indians with IGT.
● An estimated 82 million adults aged 20-79
The US FDA approvals years were living with diabetes in the SEA
region in 2017, representing a regional
Diabetes is a lifestyle disease. Hence it can be prevalence of 8.5%. About 45.8% of these
prevented by adopting appropriate lifestyle. This is diabetes cases were undiagnosed. Close to
what the above studies have proved. However, besides half (48.8%) of all adults with diabetes in the
prevention, the pharma industry has been investing region live in urban areas.
on research and development (R&D) and launching
new products. From January 2019 to October 31, ● The IDF Western Pacific (WP) Region
2019, the US Food and Drug Administration (FDA) includes 39 countries and territories,
has approved three products for type 2 diabetes (two currently representing 28 diabetes
drugs Rybelsus and Victoza from Novo Nordisk and organizations in 20 countries and 2
one drug – Farxiga from AstraZeneca). territories. It has the largest population of
all IDF regions and accounts for 37% of all
On September 20, the U.S. Food and Drug diabetes cases in the world.
Administration has approved Rybelsus (semaglutide)
oral tablets to improve control of blood sugar in adult ● An estimated 158.8 million adults aged 20-79
years were living with diabetes in the IDF
WP region in 2017, representing a regional
prevalence of 9.5%. Over half (54%) of these
cases are undiagnosed. Close to two-thirds
(63.8%) of adults with diabetes in the region
live in urban areas.

Source: IDF Diabetes Atlas 8th Edition

patients with type 2 diabetes, along with diet and
exercise. Rybelsus is the first glucagon-like peptide
(GLP-1) receptor protein treatment approved for use
in the United States that does not need to be injected.
GLP-1 drugs are non-insulin treatments for people
with type 2 diabetes. The approval of Rybelsus was
granted to Novo Nordisk.

Similarly on June 17, the U.S. Food and Drug
Administration has approved Victoza (liraglutide)
injection for treatment of pediatric patients 10 years

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The Growing Burden of the Diabetes Epidemic diabetes management, including continuous glucose
monitoring systems, insulin pumps and automated
Source: International Diabetes Federation insulin dosing systems. In the safety communication
issued the agency noted that the use of unapproved
or older with type 2 diabetes. Victoza is the first non- or unauthorized devices could result in inaccurate
insulin drug approved to treat type 2 diabetes in blood glucose (sugar) measurements or unsafe insulin
pediatric patients since metformin was approved for dosing, which can lead to injury requiring medical
pediatric use in 2000. Victoza has been approved to intervention or even death.
treat adult patients with type 2 diabetes since 2010.
The FDA granted this application Priority Review. The Working together
approval of Victoza was granted to Novo Nordisk.
To integrate glucose sensing and insulin delivery
On October 21, AstraZeneca announced that technologies that would help to further simplify how
the US FDA has approved Farxiga (dapagliflozin) people with diabetes manage their condition, Sanofi,
to reduce the risk of hospitalisation for heart failure the gold partner of IDF has partnered with Abbott
(hHF) in adults with type-2 diabetes (T2D) and on September 16. The two companies will take an
established cardiovascular disease (CVD) or multiple innovative approach to connected care by developing
cardiovascular (CV) risk factors. The approval is based tools that combine the revolutionary FreeStyle Libre
on results from the landmark DECLARE-TIMI 58 CV technology with insulin dosing information for future
outcomes trial (CVOT), the largest sodium-glucose smart pens, insulin titration apps and cloud software.
cotransporter 2 (SGLT2) inhibitor CVOT conducted
to date to evaluate T2D patients with multiple CV risk The non-exclusive collaboration will initially
factors or established CV disease. enable data sharing, at the consent of the user, between
Abbott’s FreeStyle Libre mobile app and cloud
In addition to drugs, the U.S. Food and Drug software and Sanofi’s connected insulin pens, apps
Administration on February 14, permitted the and cloud software that are currently in development.
marketing of new type of insulin pump, referred to as This data sharing will enable both people with diabetes
an alternate controller enabled (ACE) infusion pump, and their doctors to make better informed treatment
or ACE insulin pump, is the first interoperable pump, decisions around medication, nutrition and lifestyle.
meaning it can be used with different components that Sanofi noted that it is currently working to provide
make up diabetes therapy systems, allowing patients connected pens, apps and cloud software that will be
to tailor their diabetes management to their individual compatible with the FreeStyle Libre system and its
device preferences. compatible digital health tools. The two companies
aim to bring this to people with diabetes within the
The USFDA permitted marketing of the next few years, pending local regulatory approvals.
Tandem Diabetes Care t:Slim X2 insulin pump with
interoperable technology (interoperable t:Slim X2) Sanofi, the gold partner of IDF noted at the
for delivering insulin under the skin for children 78th Scientific Sessions of the American Diabetes
and adults with diabetes. Diabetes therapy systems Association in June last year that it is working with
may be comprised of an ACE insulin pump and other a goal to create a world without diabetes. Sanofi has
compatible medical devices, including automated been leading this quest for nearly 100 years, since it
insulin dosing (AID) systems, continuous glucose created one of the first insulin formulations. Yet even
monitors (CGMs), blood glucose meters or other as treatments for type 1 and type 2 diabetes have
electronic devices used for diabetes management. evolved and improved, much more work lies ahead.

At the same time the U.S. Food and Drug Having a vision of ‘Living in a world without
Administration on May 17, has warned patients and diabetes’, IDF, an umbrella organization of over 230
health care professionals of risks associated with national diabetes associations in 170 countries and
the use of unapproved or unauthorized devices for territories and leading the global diabetes community
since 1950, has partnered with 12 companies namely
Sanofi Diabetes (gold partner), Lilly Diabetes and
Pfizer MSD Alliance (silver), Allergan, Merck (bronze)
and AstraZeneca, Bayer, MSD, Novartis, Servier,
SunLife and i-sens (partners). All partners have been
working with IDF to fulfil its mission ‘Promoting
diabetes care, prevention and a cure worldwide’.

Narayan Kulkarni
[email protected]

BIOSPECIAL 27

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Merging minds to
monitor diabetes in APAC

More than 60 per cent of the people with blood glucose levels at regular intervals to adjust
diabetes live in Asia, with almost one-half the insulin dosing accordingly. This is done usually
in China and India combined. Globally, through a finger-prick test where a patient can see if
the number of people with diabetes has their blood sugar levels are too high or too low. Since
risen from 108 million in 1980 to 425 carrying out these tests multiple times a day can be a
million in 2018. Out of these, China has the substantial mental and physical burden for diabetics,
largest number of diabetes cases of 114 many companies are developing alternatives. The
million, followed by India with 74 million, leading players of APAC market in this area include
as reported in 2018 with type 2 diabetes Roche, Johnson & Johnson, Abbott, Medtronic, Novo
being the most common. According to the Nordisk, Ascensia, Tandem and Terumo. Regionally,
International Diabetes Federation (IDF), the China, India, Japan, and Korea are the leading
global number is expected to rise to 592 contributors in this space with large participation of
million by 2035. In response to the growing companies involved in manufacturing diabetes care
concerns about the escalating burden devices.
posed by diabetes, World Diabetes Day
(WDD) was created in 1991 by the IDF and With China being in the lead, prevalence of
the World Health Organization (WHO), on continuous glucose monitoring users is pretty low.
November 14. People usually consult the doctor’s advice when they
buy it. “Continuous glucose monitoring as a novel
With the increasing number of diabetes cases diagnostic technology is still under development in
every year, the diabetes market in the Asia- China. The Chinese clinical guideline for continuous
Pacific (APAC) region is expected to reach glucose monitoring has been last updated in 2018.
a value of $10.5 billion in 2020. According to GBI Although, these guidelines
Research, China will see the fastest expansion with a have substantially improved
CAGR of 11.1 per cent over the period from 2019-2024 the application of CGM, and
in comparison to other major APAC countries namely have increased comprehensive
India, Japan, Korea and Thailand. Within the diabetes glucose management in China,
market, the diabetes care devices segment has been the optimum utilization of this
valued at $2.75 billion in 2019 for the APAC region. technology is yet to be done
This market is majorly segregated into management constructively”, shares Weiping
devices (insulin pumps, insulin pens, syringes, and Jia, Director, Shanghai
cartridges) and monitoring devices (self-monitoring Diabetes Institute.
blood glucose- SMBG and continuous glucose
monitoring- CGM). In the monitoring space, SMBG Enhancing the concept of CGM in China, Swiss
segment including sensors and receivers occupies tech company Ascensia, one of the leading players
more than 93 per cent of the market share within the of the APAC diabetes care device market, has
APAC region. Although, CGM devices such as test collaborated with Zhejiang POCTech, a developer
strips, glucometers provide real-time data of blood and manufacturer of CGM systems based in China, in
glucose levels for patients, its adaptability is very low January 2019, to co-develop a next generation product
in APAC markets with the cost factor being a major for glucose monitoring.
concern.
On the other hand, the awareness of continuous
Typically, diabetic patients need to check their monitoring of glucose levels has increased widely in
India, and the market is expected to see a high growth
in the country with a CAGR of 10 per cent by 2024.
Abbott is one of the first players who revolutionized
diabetes management in India through its Flash
Glucose Monitoring System back in 2015. It is a small,
round sensor that can be applied on the back of the
upper arm of a person with diabetes, disregarding

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finger-prick calibration. Leading players of diabetes
Over the past few years, many established and care devices market in APAC

new players have developed innovative ways of ● Roche ● Novo Nordisk
diabetes monitoring and management in the form ● Johnson & ● Ascensia
of connected devices, digital solutions etc. At the ● Tandem
forefront of healthcare innovation, Roche Diabetes Johnson ● Terumo
Care India came out with its latest Integrated Diabetes ● Abbott
Management Solution (IDMS) with the launch of the ● Medtronic
mySugr app and Accu-Chek Instant blood glucose
monitoring system in May 2019. The mySugr app Top 5 diabetes afflicted APAC countries
provides bluetooth connectivity with Accu-Chek
Instant, enabling the automatic uploading of data. The ● China ● Thailand
app provides easy access to blood glucose monitoring ● India ● Korea
data to caregivers and doctors, enabling dynamic ● Japan
therapy modification. Through this app, users will also
have access to diabetes coaching at their fingertips. Making a significant contribution towards tackling
As another recent development, Eris Lifesciences the increasing diabetes scenario in Japan, Tokyo
and India Medtronic are jointly launching Guardian based medical device manufacturer Terumo initiated a
Connect device in India in 2020. It is a cutting edge collaboration with US based DexCom in February 2019
device that stands out with built-in mechanisms for to distribute the company’s CGM devices exclusively
sending out alerts predicting high and low blood in Japan. Dexcom’s system is the global market leader
sugars 10-60 minutes in advance. in real-time CGM. The products are equipped with a
safety mechanism that automatically issues an alert
“Lack of awareness and limited patience adherence when blood glucose is low or high.
are the key factors contributing towards poor
management of diabetes in India. Disease managers The number of diabetes cases are catching up on
must create holistic personalized offerings that help Thailand as well with the prediction that one out of
patients manage diabetes. Disease management five people aged over 60 years will have diabetes
companies thus need to focus essentially on the by 2025. The IDF projects that the number of Thai
customer-centric aspect of the value chain, which is people with diabetes in 2040 will increase to 5.3
commercialization and product uptake by the patients. million. As a result, Novo Nordisk Thailand is working
They need to equip patients with tools that improve to collaborate with the Royal Thai government for
drug adherence and the overall customer experience. enabling proactive management of diabetes.
The end result will be simple yet
robust platforms that can engage With Korea being no exception in this list of APAC
and empower patients. The data countries afflicted with diabetes, the leading company
originating from these platforms of the Korean domestic market Handok has signed
will also enable physicians to an agreement with Medtronic Korea in June 2019 to
optimize patient care”, points market and distribute two of the latter’s continuous
out Sriram Shrinivasan, glucose monitoring (CGM) device, Guardian Connect
Partner, Global Emerging and iPro 2, to local medical institutions. Guardian
Markets Leader, Life Connect and iPro 2 is a CGM system that measures
Sciences, EY. glucose levels every five minutes through sensors
attached to the skin.
Another Asian country showing increasing levels of
diabetes cases is Japan. According to a national health On the whole, the blood glucose monitoring
survey conducted by the Ministry of Health, Labor, market in APAC is highly fragmented with few
and Welfare in 2018, 20 million people in Japan manufacturers having a presence in major countries
had either contracted or were at risk of contracting within APAC, while the remaining manufacturers
diabetes. Addressing this concern, Novo Nordisk stay confined to the local or region-specific markets.
announced its partnership with the Taiwanese AI However, mergers between players in the recent past
engine Health2Sync in March 2019, to provide digital is the key element helping companies strengthen
diabetes management. The company aims to wirelessly their market presence and making a difference in the
connect its insulin delivery devices, enabling auto space of diabetes care.
data recording of self-injected insulin for continuous
glucose monitoring for the Japanese population. Dr Manbeena Chawla
[email protected]

COVER STORY /SPEAKING WITH 29

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“We need treatments that
are easy to administer and
effective with minimal risks”
World Diabetes Day is marked on November 14
by International Diabetes Federation (IDF) «
and World Health Organisation (WHO) in
response to growing concerns about the escalating Dr Ben Ng,
health threat posed by diabetes. The estimated Endocrinologist,
diabetes mellitus prevalence worldwide for 2011 was ARDEN Endocrinology
366 million people and is expected to increase to 552 Specialist Clinic,
million by 2030. With over half of the global diabetic Mount Elizabeth
population residing in Asia Pacific (APAC) region, the Novena Specialist
prevalence rates put a considerable financial burden Centre, Singapore
on the healthcare budget of each country. Increasing
evidence shows that the progression from impaired diabetes-related complications such as eye, kidney,
glucose tolerance (IGT) to type 2 diabetes occurs nerve and heart disease.
more frequently in Asians compared with Caucasians.
Furthermore, IGT is independently associated with an What are the latest developments in diabetes
increased risk of cardiovascular disease, and should prevention and cure in APAC?
be managed at the earliest. Pharmaceutical industries Particularly in Singapore, there are many recent
are rigorously working to combat the prevalence and initiatives that are designed to help prevent diabetes,
the control of diabetes due to its increasing concerns. on both the individual and national level. For instance,
Dr Ben Ng, Endocrinologist, ARDEN Endocrinology as part of Singapore war on diabetes, there has been
Specialist Clinic, Mount Elizabeth Novena Specialist a recent ban on advertisements promoting packaged
Centre, Singapore, outlines on the diabetic epidemic, drinks with high sugar content. There are also
prevention, and treatment in conjunction with launch numerous health apps now available to help people
of Sanofi’s latest breakthrough drug for uncontrolled monitored your overall exercise and food consumption
diabetes, SOLIQUA. Edited excerpts; making them more health conscious and aware of the
diet and exercise. Unfortunately, diabetes is a chronic
How do you address Asia’s fast-growing diabetes disease and can progress over time. Although in
epidemic?
I think it’s important to appreciate that diabetes World Diabetes Day
can potentially be a devastating condition if not November 14
picked up or treated correctly. However, with proper
management, evaluation and therapy, the majority
of diabetes-related complications can be avoided and
its risks potentially reduced. The earlier the condition
is detected and treated, the better the outcome.
Therefore, when it comes down to type 2 diabetes,
prevention is always better than cure and hence, early
detection and timely intervention is critical in dealing
with this condition. The challenge with many patients
who are diagnosed at a later stage of diabetes, despite
being adherent to lifestyle and dietary intervention
including taking the regular medication and insulin, a
significant proportion of this patient remained poorly
controlled putting them at high risk of developing

30 COVER STORY /SPEAKING WITH

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Soliqua Phase 3 results Singapore to help adults with type 2 diabetes have
significantly lowered better control over their blood sugar levels in a simple,
blood sugar levels single daily injection. It is a powerful agent which
is indicated adults with type 2 diabetes to improve
In a Phase 3 study evaluating adults with their sugar control particularly when oral therapy is
type 2 diabetes inadequately controlled by insufficient. SOLIQUA is made up of two treatments
GLP-1 receptor agonist (GLP-1 RA) treatments, which are effective in managing diabetes – a long acting
Soliqua/Suliqua (insulin glargine 100 Units/mL insulin and a GLP-1 RA [receptor agonist]. These two
and lixisenatide) met the primary study objective parts have been shown to have a complementary mode
by demonstrating a statistically superior of action which keeps blood sugar within the patient’s
reduction of average blood sugar level (HbA1c) target levels.
after 26 weeks, compared with continuing GLP-1
RA treatment, according to a release from Sanofi. How advantageous is SOLIQUA over
conventional Insulin to patients suffering from
The LixiLan-G study included either a daily or uncontrolled diabetes?
once-weekly GLP-1 RA treatment as comparator. SOLIQU is a powerful agent which offers excellent
More patients who switched to Soliqua achieved sugar reducing capabilities. It is injected once a day
HbA1c levels below 7%, a target recommended which makes it easier for patients to manage.
by the ADA, compared with those who stayed
on previous GLP-1 RA therapy. More patients How do you project your future ventures in
who switched to Soliqua also achieved the treating diabetes?
composite endpoint of HbA1c below 7% without I think increasingly, people are getting more aware
documented symptomatic hypoglycemia (low of diabetes and its associated complications. The
blood sugar levels). recognition of the Singapore government on the
severity of this condition and its efforts in providing
The study showed a safety profile consistent practical and effective support in lowering the risk is
with the established profiles of the treatments extremely welcomed by the medical community as a
studied: the most common classes of adverse whole. However, moving forward, I think more normal
event were gastrointestinal events (i.e., nausea, therapy is clearly required. Diabetes can be a lifelong
diarrhea and or vomiting) and hypoglycemia. condition and as people continue to live longer, we
need treatments which are both easy to administer,
“We are committed to providing people living effective with minimal risks to the patient’s with
with diabetes a broad range of options that can regards to side effects and ensure side effects on other
help support personalized care,” said Rachele organs. Furthermore, as food technology develops,
Berria, Global Head of Diabetes Medical Affairs food alternate is which are healthier, cost effective
at Sanofi. “As the first comparison between need to be developed to enable the community to
Soliqua and both daily and weekly GLP-1 RA better choose the right kind of food which can for a
treatments, this study provides physicians with lower risk of diabetes and have less impact on your
new data that they could use when considering blood sugars.
Soliqua as a part of a personalized treatment
plan.” What would be your message on account of
World Diabetes Day on November 14?
The full Phase 3 data results were The theme for world diabetes day 2019 is again “the
presented on June 9 for the first time as an oral family and diabetes “. The aim of this will be to raise
presentation at the 79th Scientific Sessions of the awareness of the impact of diabetes on the family and
ADA in San Francisco. the need for effective network for all dose affected. I
would encourage anyone who is at risk of diabetes or
recent years, metabolic surgery has been advocated has a family member with diabetes to be aware that
for a selected group of patients to halt or reversed the diabetes can be a long-term condition and support
condition, medication and lifestyle therapy remains from all the family and community is required
by far the most common method of treating diabetes. if you ever going to be able to tackle this disease
One of the latest therapies available on Singapore to successfully.
help combat the diabetes burden is SOLIQUA.
Hithaishi C Bhaskar
Can you briefly share the efficacy, safety and [email protected]
tolerability of SOLIQUA as seen in clinical trials?
SOLIQUA is the first-of-its-kind treatment in

TECHNOLOGY 31

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Hacked medical devices -
BIG SECURITY NIGHTMARE

Cybersecurity was considered the purview of IT (Information Technology) till the
security breaches in the medical devices forced us to look at safeguarding the devices
again such cyber-attacks. Just like IoT (Internet of Things) , the concept of IoMT
(Internet of Medical Things) has gained momentum. The internet enabled medical
devices such as insulin pumps, defibrillators are as vulnerable to a cyber attack like as
any normal internet connected device.

On June 27, the U.S. Food and Drug SingHealth’s (Singapore’s largest group of healthcare
Administration (FDA) has issued warning institutions) database containing patient personal
notice to patients and health care providers particulars and outpatient dispensed medicines had
that certain Medtronic MiniMed insulin pumps are been the target of a major cyber-attack. About 1.5
being recalled due to potential cybersecurity risks million patients who visited SingHealth’s specialist
and recommended that patients using these models outpatient clinics and polyclinics from May 1, 2015
switch their insulin pump to models that are better to July 4, 2018 have had their non-medical personal
equipped to protect against these particulars illegally accessed and copied.
potential risks. And the FDA noted
that it is not aware of any confirmed Who could have forgotten the 2017’s
reports of patient harm related ransomware attack - WannaCry which affected
to these potential cybersecurity
risks. more than 300,000 machines in 150
countries including UK’s
The potential risks are related National Health Service
to the wireless communication (NHS). WannaCry attack
between Medtronic’s MiniMed that is still active after
insulin pumps and other being attributed to
devices such as blood glucose shutting down more
meters, continuous glucose than 60 hospitals
monitoring systems, the remote in the UK and more
controller and CareLink USB than $100 million
device used with these pumps. dollars in damages.
The FDA is concerned that, due But in addition to
to cybersecurity vulnerabilities WannaCry,
identified in the device, someone there are
other than a patient, caregiver new
or health care provider could
potentially connect wirelessly to
a nearby MiniMed insulin pump
and change the pump’s settings.
This could allow a person to
over deliver insulin to a patient,
leading to low blood sugar
(hypoglycemia), or to stop insulin
delivery, leading to high blood
sugar and diabetic ketoacidosis (a
buildup of acids in the blood).

Similarly in July 2018,

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vulnerabilities discovered all the time. Here is repay its debts. Such potential
a partial list: Urgent/11 running on VX Works, manipulation of the devices
NotPetya based on the same EternalBlue package is one of the major risks
as WannaCry, Sodinokibi malware running on apart from the loss of
Microsoft Win 7-10, and SACK Panic that resides in privacy and data thefts,”
the TCP stack of the Linux kernels, said Rahul Rastogi,
Co-founder and CEO,
The threat is real Agatsa, India.

Emerging technologies such as the cloud, IoT, The potential impact of a
artificial intelligence, machine learning and hacked device could be as scary as the death of a
blockchain are transforming the way healthcare is patient. “It can potentially impact the safety and
delivered. While, no doubt, these technologies are effectiveness of the device. With medical devices this
revolutionizing patients care, they are also increasing could carry immediate consequences, there could
the growing cybersecurity risks inherent in the be a possible risk of patient safety issues, injury or
expansion of connected devices. death. The devices can malfunction, there could
be incorrect assessments, and the threats could
“Patient monitors, IV pumps, MRI machines, and
infusions pumps all behave like computers with the affect the continuity of care,” said
ability to monitor patient conditions in real-time, Himanshu Baid, Manging
share data and even automatically adjust dosages. Director, Poly Medicure,
Although all of these innovations India and Chairman,
are improving in-patient care, Confederation of
their ability to communicate Indian Industry,
over internal computer Medical Device
networks has introduced Committee, India.
new vulnerabilities to There have been instances
cyber attacks,” said Leon
Lerman, co-founder and where medical devices in
CEO, Cynerio, Israel. hospitals, as well as those implanted in a patient’s
body such as pacemakers, have been compromised
Cynerio provides medical by the hackers. At times, the hackers have managed
device and Internet of Medical Things (IoMT)
security solutions. “One of the results of a cyber
attack is that electronic health records are no
longer accessible, so hospitals can be faced with
having interruptions in medical services which can
cause harm to patients. Hackers can also exploit
vulnerabilities to interrupt treatments, tamper with
doses, and modify test results resulting in incorrect
diagnoses. There is also the potential cost of paying
off hackers due to a ransomware attack, and the
potential loss of business due to having a tarnished
reputation,” he added.

The patient data breach is just one of the various
risks that the modern connected healthcare devices
are vulnerable to, but there are a number of risks
apart from data theft. For instance, in the year
2017, Abbott faced a major scare with its internet-
connected pacemakers and had to recall 465,000 of
the devices. The company found out that there was a
vulnerability that could potentially have given access
to a hacker to alter the pacing commands or to make
the device battery drain quickly.

“Such an exploitation of the device would have
not only threatened the lives of patients but also
damaged the financial ability of the company to

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THERE IS A NEED FOR CONSTANT MONITORING.
FORTUNATELY, UNTIL NOW THE VULNERABILITIES HAVE
BEEN SPOTTED AND CORRECTIVE MEASURES ARE
BEING TAKEN WITHOUT ANY CATASTROPHIC ACTION BY
POTENTIAL HACKERS. VARIOUS SOLUTIONS SUCH AS
SIGNAL ENCRYPTION AND PASSWORD PROTECTION ETC.
ARE BEING WORKED OUT. HOWEVER, THERE IS A NEED
TO BE ON GUARD CONSTANTLY IN THE SAME WAY THAT
THE DATA CENTRES MONITOR AND ELIMINATE ANY
POTENTIAL THREAT TO THEIR SYSTEMS. THERE IS A
NEED FOR CONSTANT PERIODIC UPGRADES OF SYSTEM
SECURITIES. PRESENTLY, VARIOUS BODIES, AS WELL
AS END-USERS, ARE MONITORING THE SITUATION AND
TAKING ALL POSSIBLE STEPS TO PREVENT ANY MAJOR
BREACH OR MISCHIEF BY CRIMINALS OR HACKERS. THE
MEDICAL DEVICE MAKERS ARE CONFIDENT OF BEING
ABLE TO HANDLE ANY CYBERSECURITY CHALLENGES
THAT MIGHT EMERGE IN THE YEARS AHEAD.

to disrupt patient care operations across facilities in This highlights the importance
the United States and at various other places in the of having strict security
world. It has been found that by gaining access to measures in place,” said
pacemakers, the hackers can alter the heartbeat of a Alwin van den Broek,
person or even stop it altogether, thus causing harm data protection officer,
to the user. Factory-CRO Group,
Netherlands.
“All the medical devices using software and radio
frequencies which are connected to hospitals and Challenges in securing
other healthcare networks are vulnerable. However, medical devices
it is possible to proactively guard against breaches.
In other cases, constant monitoring and timely Healthcare is somewhat less likely than other
corrections are needed,” said Dr industries to implement a full range of security,
KK Aggarwal - President- firms are often hesitant to install advanced security
Elect- Confederation of systems due to the fear of slow or block access to
Medical Associations critical care information.
in Asia and Oceania
(CMAAO), President “Most of the healthcare organizations have gone
Heart Care Foundation through a digital transformation from a connectivity
of India, Editor-in-Chief perspective. The basic cyber hygiene is missing
IJCP Group. in many cases, imagine the devices those have
longer operating life; endpoint security is often
“Cyber attacks can have missing in such case, and are differently managed
several goals, such as 1) holding data for ransom by a low skilled operator, this poses a challenge in
with the goal to make money like the relatively recent safeguarding the devices,” said Baid.
WannaCry attack, 2) exploiting data by gaining
unauthorized access to the data, or 3) denying service Another challenge is the visibility, feels Lerman.
or denial-of-service (DoS) attacks. Medical devices “The first step is having visibility into medical
have often not been targeted deliberately, but the devices. There may be hundreds or thousands of
appliances of medical devices are linked to hospital smart medical devices, such as patient monitors,
networks which are more vulnerable to such attacks. IV pumps, MRI scanners, infusions pumps, and
ventilators but there is rarely an up to date inventory

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of all these devices making it difficult to respond improve safety measures where necessary,” said van
when a vulnerability is discovered. Many medical den Broek.
devices are likely managed by bio-engineering, and
they may or may not be visible or accountable to IT.” Making medtech hack proof

He added, “Even when IT is aware of medical Cyber attack on medical devices is extremely risky.
devices, using traditional IT or even generic IoT Education initiatives for clinicians and nurses to
cybersecurity approaches isn’t good enough. A raise cyber attack awareness from the manufacturers,
medical device security solution needs to take proactive role of the government to promote
into account the medical context of the device guideline for secure medical devices and regular
communications including the role of the devices in monitoring of the devices and providing patches as
the medical workflows to apply the necessary controls soon as anything malicious discovered are some of
to ensure patient safety and protect sensitive data. the steps which can put a dent in hacking the devices.
Standard IT security systems are not designed to However, they cannot fully be safe from cyberattack,
capture this information.” says Lerman, “Medical devices can’t be cyber attack
proof, just like windows based PC cannot be cyber-
One of the biggest challenges is the lack of attack proof, but steps can be taken to increase the
encryption of the signals that the medical devices security of the devices. Manufacturers can build
emit. This gives hackers an opportunity to break into devices with security in mind, and the healthcare
the devices and cause potential harm. Developing providers can use automation to have full visibility
devices that can contain the radio signals emitted into medical devices and the potential risk of attacks.
by the implanted devices will effectively deny the They can apply security controls such as access
hackers any opportunity to access the signals. control rules and micro-segmentation to decrease the
cyber risk associated with medical devices.”
“It is important that medical devices are
safeguarded by design (privacy by design) by Most of these connected devices emit unencrypted
implementing technical safeguards and careful radio signals through which a potential hacker can
handling of (personal) data in the early stage of the gain access to the device and manipulate it. One of
development of the medical device. When developing the most effective ways to make them cyber attack
a medical device, the challenge is to be the best and proof would be to encrypt the radio signals.
the fastest, but manufacturers cannot forget the
safeguards. In other words, the competition between “The most vulnerable devices are usually those
the technology to secure the devices and the hackers that regulate heartbeat by sending an electrical
who will try to break in will be a continuous battle. impulse to the lower chamber of the heart. These
So, it is important to apply continued vigilance and are remotely monitored and calibrated by external
computers that also extract information from the
devices and implants. These devices emit radio
frequency signals which can be noted in an area of
several meters around the patient. If these signals are
unencrypted then a hacker can jam, alter or record
the signals. Hence, it is important to encrypt these
signals to make the devices fairly cyber attack proof,”
said Rastogi.

It is important that hospitals and medical device
manufacturers accord as much value to cybersecurity
as top IT companies and computer hardware
manufacturers do. In the absence of effective safety
measures, the hackers can access these devices and
steal patient data as well as make the machines
malfunction.

“When it comes to hospital systems, greater
emphasis must be laid on integrating stronger
password mechanisms or the modern bio-metric
identification facilities can be integrated. Such
measures will significantly reduce the vulnerability
of connected medical devices. There is also a need
for a constant monitoring of threats and periodic

TECHNOLOGY 35

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evaluation of the efficacy of cyber security measures. protocols in compliance with the local regulations
Further enhancement of technology that cuts down and the GDPR. Manufacturers can improve their
on the signal emission from the medical devices security system by mapping their field of work
would also help in improving the safety of such and identifying potential risks by conducting Data
devices,” said Dr Aggarwal. Protection Impact Assessments. As an organization
that does not manufacture medical technology, we
“With the global increase in awareness regarding have been able to observe the changing landscape
value of personal data and thus also an increase in evolving around the GDPR and how it will continue
the need of a good protection framework, regulations to evolve,” said van den Broek.
are becoming more stringent. Adhering to the
existing regulations and guidelines regarding the What happens next?
security of data is a good starting point; this includes
the EU 2016/679 General Data Protection Regulation There is a need for constant monitoring. Fortunately,
(GDPR) and the guidance provided by the US FDA on until now the vulnerabilities have been spotted and
cybersecurity in medical devices and organizations,” corrective measures are being taken without any
said van den Broek. catastrophic action by potential hackers. Various
solutions such as signal encryption and password
Can manufacturer ensure safe device? protection etc are being worked out. However, there
is a need to be on the guard constantly in the same
In the wake of these attacks, it has become imperative way that the data centres monitor and eliminate any
for medical device manufacturers to take steps to put potential threat to their systems. There is a need
in place adequate safeguards. They need to constantly for constant periodic upgrades of system securities.
monitor the risks and threats pertaining to their Presently, various bodies, as well as end-users, are
medical devices. monitoring the situation and taking all possible steps
to prevent any major breach or mischief by criminals
Security must be a central concern starting right or hackers. The medical device makers are confident
from the very beginning of system architecture and of being able to handle any cybersecurity challenges
continuing through the entire product development that might emerge in the years ahead.
lifecycle. Conducting a thorough risk assessment,
properly developing a structured procedure, and then Cyber vulnerabilities are often overlooked
closely following it can be critical to mitigating cyber due to insufficient forethought or expertise. In
risk at the manufacturing level. today’s hyper-connected world, if the companies
are able to take effective measures to handle cyber
“Security features need to be given a higher vulnerabilities, they are better positioned to earn
priority in the product design process. Often customer trust, and that can be a major competitive
security is overlooked or manufacturers rely on advantage in future.
third-party components that may include their own
vulnerabilities. Manufacturers need to make sure “Yes, we are already seeing attacks becoming
they use newer and less vulnerable operating systems, more mainstream. Medical devices are so vulnerable
implement more secure communication protocols that they are affected by “every day” attacks, there is
which support encryption and authentication, make no need for a sophisticated nation sponsored attack
sure they streamline their patch release process - to shut down hospitals - as we saw with WannaCry
to be able to respond quickly to newly identified 18 months ago. However, we are seeing the industry
vulnerabilities. taking steps in the right direction. Healthcare
providers are taking more control, implementing
The FDA has become more active inspecting and automatic medical device monitoring solutions like
requiring more security features, but since these Cynerio to have full visibility into their network,
devices can have a long development cycle, it may analyze the risk and proactively detect anomalies
take some time before we see results,” said Lerman. to ensure patient safety and data protection,” said
Lerman.
With the advancement in technologies and further
proliferation of connected devices, these cyber In the near future, a lot of patients will rely on the
attack threats will grow. It is up to medical device safety and security of these devices. In healthcare,
manufacturers, to understand that each connected there is a lot more on stake than any other industry,
device opens another pathway for threat actors, from business loss to product recall to patient safety
it’s incumbent upon device manufacturers to keep and the regulatory risk.
security foremost throughout the development life
cycle. Ayesha Siddiqui
[email protected]
“Manufacturers should ensure security of their
devices by developing and adhering to cybersecurity

36 TECHNOLOGY

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Japan, China are leading the
APAC healthcare AI market

« hospitals, which are slated to be ready by 2022, in a
bid to tackle challenges such as the lack of medical
Benjamin Low, personnel and increasing medical expenses with a
more than $100 million investment.
Vice-President,
A key contributor to the success and leadership
Asia Pacific, of countries such as Japan within the field of
technological development, is a result of their national
Milestone Systems, culture, which is deeply ingrained in the concept of
collaboration. This mindset is key to creating a society
Singapore that is forward-looking, as well as a community that
can effectively utilize technological solutions to solve
There has been an unprecedented increase in pertinent challenges such as the shortage of healthcare
healthcare costs within Southeast Asia. Driven workers. That is why more countries in APAC can
by factors like ageing populations, unhealthy greatly benefit from adopting and adapting a stronger
diets and increasing rates of diseases like diabetes, the culture of collaboration and innovation.
total healthcare spending by the ASEAN six nations —
Indonesia, Malaysia, Philippines, Singapore, Thailand In fact, studies have found that culture and skills
and Vietnam – are expected to rise to $740 billion by are among some of the key barriers that are keeping
2025 from the current figure $425 billion. Singapore based organisations from succeeding in
AI adoption. More than half of the business leaders
With such an exponential demand for healthcare and workers surveyed believe that cultural traits, such
services, this will continue to take a toll not only on the as risk-taking, proactive innovation, as well as cross-
region’s economy, but also on the already stretched function partnerships among teams, are not pervasive
supply of healthcare workers and professionals in Asia. in their work culture. Businesses must create the right
However, this is a key space where investments in AI organisational culture, in order to progress along their
and analytics can play a critical role in circumventing digital journey.
the ever-growing strain on resourcing.
On the other hand, India is blessed with a large
Investments in analytics or other integrations, such pool of well-trained medical professionals and is
as access control, can dramatically increase efficiency significantly cost competitive compared to countries
in medical settings by intelligently monitoring with in Asia and the West. The healthcare industry has
real-time video and recording activities for review evolved into being one of India’s largest sectors, both
and analysis. Decision makers in the healthcare sector in terms of revenue and employment, due to increased
are increasingly seeing the need for analytics. It has expenditure and services by public and private players.
been found that the percentage of new roles enabled According to the India Brand Equity Foundation, the
by technological adoption will rise from 16 per cent in healthcare market will triple in size by 2022 to reach
2018 to 27 per cent in 2022. an estimated $ 133.44 billion.

It has also been encouraging to see the growth of India is ushering in technological breakthroughs
technology adoption across Asia. For technologies such and with an ever-changing landscape for health-tech.
as AI within the APAC healthcare sector, the APAC A recent example can be seen in India’s healthcare
market had witnessed a five-year compound annual coverage scheme, dubbed Modicare – being the world’s
growth rate of close to 56 per cent from the period of largest healthcare coverage scheme, the initiative
2013 to 2018, with Japan and China leading the pack. has opened up the flood gates towards technological
adoption in India’s healthcare sector.
In 2018, Japan contributed the highest revenue
in the APAC healthcare AI market, followed closely Technological adoption is here to augment the
by China. Notable countries such as Thailand and human capability and enable people to do more
Malaysia were the third largest revenue contributors, qualitative work, thus further enabling the healthcare
followed by Australia, India and Singapore. Japan’s industry to maximise its resources and provide quality
lead can be seen in its setting up of 10 AI-based coverage for patients.

SPEAKING WITH 37

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“Our technology can clot all blood

samples in less than 5 minutes

that makes it a game changer”
Australian-based Q-Sera’s blood clotting
technology, RAPClot was recently granted «
patent in the US. It is the latest in a growing
list of countries where the patent has now been Michael Grant,
granted which include the EU, China, Japan and Chief Executive
Australia. In an email interaction with BioSpectrum, Officer, Q-Sera Pty Ltd,
Michael Grant, CEO, Q-Sera tells us about the Australia
company, working of this unique technology, and
future plans of the company. Edited excerpts:

Please tell us about your patented blood In acute situations where speed matters
clotting tech? such as emergency departments, blood tests are
When venous blood is taken for testing, it is usually commonly used to assist the accurate diagnosis
collected into evacuated plastic tubes. These tubes of medical problems. Having access to a tube that
can either clot the blood followed by centrifugation to universally clots all blood samples within 5 minutes
remove the clotted cells, producing a serum sample will contribute to improved patient outcomes and
or are just centrifuged to remove unclotted cells, reduced healthcare costs.
producing a plasma sample which contains remnant
cells and clotting factors. Serum is the gold standard Q-Sera’s technology seeks to improve laboratory
for biochemical analysis. However current tubes efficiencies by firstly reducing time for sample
are not able to produce high quality serum from all analysis (contributing to a reduction in turn-around
samples and are not able to clot samples, which have time of results). Standard serum tubes which are
been anti-coagulated, for example, in a hospital setting based on silica not only require up to 30 minutes to
with heparin or in a community setting with warfarin clot blood, but can clot poorly leading to laboratory
or one of the newer oral anticoagulants. Q-Sera aims issues and are unable to clot anticoagulated blood
to provide a competitively priced ‘universal’ serum from patients treated with blood thinners such as
tube to replace current serum and plasma tubes, warfarin, heparin or the newer oral anticoagulants.
rapidly producing high quality serum from all samples Thrombin-based serum tubes are faster than a
including those which are highly anticoagulated. standard serum tube. However these tubes can cost
up to five times more, and are still unable to clot
To achieve this, Q-Sera uses pro-coagulants anticoagulated blood at high levels. In addition to
called prothrombin activators found in the venom of rapid clotting, Q-Sera RAPClot tubes can produce
some of the world’s deadliest snakes, including the high quality serum from all samples, potentially
Australian Coastal Taipan, to clot blood samples and reducing equipment downtime due to poorly clotted
produce serum for analysis. These unique proteins serum samples and associated resourcing and time.
are able to bypass the inhibitory mechanisms in RAPClot tubes then represent an unmet market need.
the mammalian blood clotting cascade and clot
blood samples to completion, even in the presence When you will be commercializing the product/
of high dose anticoagulants. Q-Sera is now able to technology and which countries it will be made
produce the cost-effective RAPClot protein from available?
modified cell lines using standard bio-pharmaceutical Q-Sera is actively working with a number of
manufacturing processes. multinational companies to commercialise this
technology and take it to the market. Following a deal
The ability to clot all blood samples in less than five being announced, launch in major markets is expected
minutes, including those containing anti-coagulants, as early as 2023 as significant development work has
which affect around 10 per cent of hospital patients, been completed to date. In terms of potential markets,
make the technology a game changer.

38 SPEAKING WITH

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Q-Sera has its primary patent family granted or to get the blood results quickly as patients were in
approved in the US, the EU, China, Japan, Australia, desperate need of intervention, his thought was “if
Canada, Mexico, Russia and South Africa with other only I could coagulate the blood quicker.” At that
markets to follow. This patent covers the use of moment, he thought of the Brown snake that nearly
these unique actives including naturally-derived and bit him. With colleagues and expertise from around
recombinantly produced versions in blood collection Australia, a five-year quest started to understand
tubes. A second patent family covering formulations and extract the pro-coagulant from the venom and
to stabilise the patented actives in blood collection confirm its suitability for use in blood collection
tubes is progressing through National Phase. These tubes. This in turn led to the development and testing
combined patent families will provide commercial of RAPClot, manufactured recombinantly using
advantage through 2034. industry standard techniques.

What led to the setting up of Q-sera? The Q-Sera technology was licensed to Q-Sera
Q-Sera was founded on IP from the University by UniQuest, UQ’s commercialisation company
of Queensland (UQ) and is based on decades of and has received investment from two of Australia’s
experience with snake venom proteins by inventors premier innovation sector investors, the Medical
who include Haematologists and the Chief Scientist Research Commercialisation Fund (MRCF), managed
of a major Australian hospital Pathology Department. by Australia’s largest venture capital firm Brandon
In Australia, we have snakes that coagulate their Capital Partners, and Uniseed, who along with other
prey’s blood which is different to many other snake institutional investors have funded Q-Sera’s activities.
venoms which usually contain anti-coagulants.
The clotting powers of snake venom prothrombin What were the challenges in the development
activators were well known to these scientists. of this tech?
Significant work has been done to stabilise RAPClot
A kick-start to the project was an incident where in standard plastic blood collection tubes when
the pathologist was riding his bike to work one hot, produced using industry standard production
sunny day in Queensland. His heart was pumping fast processes. Production of blood collection tubes
and as he turned a corner he noticed an Australian includes spraying and high temperature drying
Brown snake on the ground. As he cycled past, the followed by gamma irradiation to sterilise the product.
snake tried to strike him and just missed his leg. As As blood collection tubes are high volume and high
he continued on to work, he thought, “I wonder what throughput, it was important that RAPClot tubes were
would have happened if it had actually got me?” As able to be manufactured under similar conditions and
he was working very hard and his blood was running efficiencies as current tubes. These formulations form
fast, he thought he could have potentially died had it the basis of Q-Sera’s second patent family.
struck him.
Additionally, it’s sometimes challenging getting
Later at work, he was trying to take patients’ patents approved in the US, China and Japan, Q-Sera
blood for serum samples. As he was under pressure now having successfully granted patents in these
key jurisdictions. This is important for the Asian
region as the use of rapid serum tubes is growing,
particularly in China, with an increasing focus on
laboratory efficiency and turn-around time. Japan on
the other hand has been using thrombin-based rapid
serum tubes as standard for many years and could
benefit significantly from a rapid serum tube that also
clots anticoagulated samples.

What are your future plans?
Q-Sera is actively working with a number of
multinational companies to commercialise this
technology, however would welcome interest from
tube manufacturers or medical device companies
looking to enter this large volume sector with a highly
differentiated product.

Ayesha Siddiqui
[email protected]

COUNTRY REPORT 39

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Drive for ‘Innovation Thailand’

The aim is to generate 5 per cent of GDP or to TCELS section in Thailand Lab exhibition
add 1.5 trillion Thai Baht to the economy in a
decade. And the medium to reach the target The BIOTEC has six research pillars. They include
is innovation. After establishing itself firmly as a medical devices & implants, biopharma, biotech for
‘manufacturing hub’ for over a decade, Thailand industry & agriculture, and nanotechnology.
now aims to be an ‘Innovation hub’ with majority
of activities going on in life sciences, medical and The Thailand Bioresource Research Center at
biotechnology areas. The government is emphasizing the Thailand Science Park provides high quality
innovation as a part of its 20-year old national repository and services for vast arrays of biomaterials
development strategy. to strengthen R&D. It provides safe deposit facility
of strains, their isolation and identification, freeze
Several agencies and research & development drying and liquid drying, training and consultancy.
organisations are working towards reaching the TBRC has a storage of 90,000 strains.
destination. Thailand Science Park at Phatum
Thani, just on the outskirts of Bangkok, houses “TCELS’s GMP production unit for Cell and Gene
many of them with some other spread to Bangkok Therapy Products at the park provides R&D leased
and some other cities in the country. These include space, clean rooms of B, C and D grade, analytical
the National Science and Technology Development equipment of cell and gene manufacturing and
Agency (NSTDA), National Center for Genetic quality assurance. Even private companies can
Engineering and Biotechnology (BIOTEC), Thailand take advantage of these services”, said Kamchorn
Center of Excellence for Life Sciences (TCELS), GMP Balangura, Adviser, TCELS, while showing the clean
Production unit for Cell and Gene Therapy products, rooms and other facilities.
Center of Medical Genomics, Thailand Bioresource
Research Center (TBRC), Eastern Economic Corridor One such private company utilising these facilities
of Innovation (EECi), and the National Innovation is Cryoviva Thailand, promoted by Indorama
Agency (NIA). Even some private companies are ventures of India, Cryoviva India and RJ Corp India.
a present in the Thailand Science Park using the “It is a private cord blood and cord tissue bank
facilities provided for innovation. started since 2007, giving access to stem cells, the
futuristic therapy with unlimited possibilities,” said
The state-of-the-art facilities set up at the Dr Ornnuthchar Poungpair, Project Manager and
innovation cluster of the Thailand Science Regulatory Affairs, Cryoviva Thailand. Number of
Park include clean rooms providing ultra-clean families storing the stem cells of their new born is
environment, sensitive labs for sophisticated research growing in Thailand, she added.
and testing labs equipped with high-performance
equipment for advanced research. TCELS’s Center of Medical Genomics, set up
15 years back, is working in the area of precision
Among the various projects they all are working medicine and allied topics. “Twenty genomes can be
on and the success stories they share, an important
one is of P218, a new anti-Malaria drug developed by
BIOTEC’s Protein-Ligand Engineering and Molecular
Biology Laboratory. The development is crucial when
two studies recently published in Lancet Infectious
Diseases warn of Malaria drugs failing at an
“alarming rate” as drug-resistant malarial parasites
are spreading rapidly across South East Asia.

“Phase II clinical trials for the new drug P218 are
on,” said Dr Chairat Uthaipibull, Director, Medical
Molecular Biotechnology Research Group at BIOTEC.
The group is also doing research on a new diagnostic
technique and a new vaccine for TB and developing
a new vaccine for dengue. They are trying many
possibilities of protein or DNA combinations.

The research is being done in many other areas.

40 COUNTRY REPORT

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Lower-Extremity Exoskeleton for Paraplegic Patients developed TBRC’s storage of strains
by Mahidol University

sequenced at the center each week,” said Nareenart robotics aided equipment for surgeries, diagnostics
Iemwimangsa, Clinical Scientist at the center. and rehabilitation. It was displayed by the centre at
the Thailand Lab International 2019 expo held at
One of the important projects being implemented BITEC, Bangkok in September.
through the center is Yothi Medical Innovation
District (YMID). “Stretching from Victory Monument Thailand imports medical items worth 200 billion
to Rama VI Road in Bangkok, the 170-hectare known Baht annually. When YMID will be successful it is
as Yothi area is being eyed as a test bed for research expected to contribute 7 billion Baht to the GDP every
into medicines and health-related technologies,” said year. The Eastern Economic Corridor of Innovation
Dr Sirasak Teparkum, Deputy CEO, TCELS. (EECi) is another project, a hub of industrial research
and innovation, being developed to foster innovation
The area is home to many hospitals and medical capability. Located in Wangchan valley in Rayon
departments. It has more than 30 medical and province, EECi provides translational research
specialised institutions, nearly 12,000 medical facilities and quality infrastructure to support
personnel and research institutes of over 2.5 million scaling-up of research work. The ambitious $45
square meters supporting more than 7,000 patients. billion project is part of Thailand 4.0, a new economic
Thus, it has a potential to be a prototype for the model aimed at transforming Thai industries from
development of medical innovation district. Now, it manufacturing-based to high-tech. Thailand plans to
is being developed into a medical innovation center do this by promoting innovation in different sectors.
within 10 years under the country’s plan to make
Thailand a medical hub for Southeast Asia. “It is the Thailand’s efforts are being paid in rich dividends
first area-based innovation in Thailand focusing on as the World Intellectual Property Organization
medical innovation making into a medical Silicon ranked Thailand sixth out of 17 countries in Asia
Valley”, said Dr Teparkum. in its Global Innovation Index 2018 published in
conjunction with Cornell University. It has moved up
One of the institutions which is part of YMID is seven positions reaching the 44th place on a global
Mahidol University. Students from its Center for scale.
Biomedical Engineering and Robotics Technology
(BART) Lab have developed Lower-Extremity (Milind Kokje was in Thailand on the
Exoskeleton for Paraplegic Patients to help them invitation from the organizers of Thailand
walk. It is also in the process of several other such
Lab International 2019)

HEALTHCARE 41

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Raising bar to mitigate growing
health and economic impact of SSIs

Approximately 313 million surgeries are «
undertaken globally each year, and most of these
procedures are successful and result in improved Dr Charles E.
health for patients. The keyword here is most. Edmiston,
While majority of surgical procedures are a Emeritus Professor
success, it is important not to overlook those that of Surgery, Medical
are not. What important lessons can we learn College of Wisconsin,
from these small but significant incidents? What the USA
more can we do? What must change?

Surgical site infections (SSIs) remain a pertinent The impact of this is two-fold. The first is
healthcare problem globally, despite advances additional costs associated with an extended
in medical technology and surveillance systems. hospital stay, as well as the considerable fees from
In fact, SSIs are becoming the most common reoperation. The economic burden of SSIs is not only
healthcare-associated infection (HCAI) today, limited to the duration of a patient’s stay in hospitals,
contributing significantly to the rising morbidity and as they may still have to rely on assistance from other
mortality rates among affected patients. community care services following their discharge.
Those who experience delayed wound healing (i.e.
The situation is particularly dire in Asia Pacific diabetic patients) as a result of an infection are more
and I had observed throughout my visits to the vulnerable to secondary complications, which may
region, that there was a general lack of awareness require additional healthcare resources and lead to
around this issue. Many countries in the region have further issues. The second is opportunity cost. Not
higher rates of HCAIs than other developed nations only do SSIs require the use of additional healthcare
in the world, and SSIs in some selective surgical resources, the resulting opportunity cost to hospitals
procedures have been associated with mortality rates is also substantial as it leads to the displacement of
approaching 46 per cent. This is due in part to the manpower and equipment that would otherwise be
fact that many of these patients at the time of surgery used elsewhere. It also has an impact on subsequent
present with significant co-morbid risk, resulting procedures that may be delayed.
in post-operative complications, increased hospital
length of stay, escalating cost and death. The total financial cost associated with post-
operative SSIs can easily run into the millions of
Mitigating the prevalence of SSIs requires dollars for healthcare systems across Asia Pacific,
identifying underlying patient risk factors and putting placing a significant economic burden on countries
into place appropriate evidence-based interventional with limited resources.
strategies designed to improve outcomes.
The often-overlooked impact of SSIs
Mounting financial burden of SSIs
With the spotlight on SSIs and their financial impact,
The financial burden of SSIs is frequently discussed, a crucial consideration that is often neglected is its
since in the current economic environment, a greater effect on a patient’s physical and mental well-being.
emphasis is now placed on obtaining more value Some of the indirect costs of SSIs include patient
from healthcare dollars amidst rapidly rising medical morbidity and mortality, the inability to work and
costs in an economy with limited resources. In some loss of income, which should not be ignored since
Asia Pacific countries, an SSI infection can extend the they play a significant role in one’s recovery process.
length of a person’s hospital stay by 20 or more days. Furthermore, loss of financial independence has a
Many of these patients will also require a second detrimental impact on the well-being of the patient’s
operation (i.e. orthopaedic) which places additional family.
burden and stress upon the patient and his family.

42 HEALTHCARE

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Urgent need for evidence-based practices minimise the risk of complications. Such initiatives
signify a step in the right direction as we strive to
The pathway to improve surgical outcomes require encourage further action at national and local levels
embracing effective evidence-based processes. to prevent undesirable surgical outcomes.
Although the major variables of SSIs are not always
easily controlled, evidence-based surgical care Advancing preventive measures
bundle interventions are imperative in minimising
the relevant risk factors. It is estimated that more New research and advancements in surgical
than half of SSIs (55 per cent) is preventable using technology have improved SSI prevention practices
evidence-based strategies. and most importantly, patients’ health. Over
the years, several multidisciplinary prevention
In late 2016, the World Health Organization programmes based on evidence-based guidelines,
(WHO) publish the first-ever evidence-based global surgical site care bundles and checklists have been
guidelines on the prevention of SSIs, with the goal developed at both global and national levels.
of tackling the growing burden of HCAIs on both
patients and healthcare systems. This document Evidence-based interventions for consideration
focuses on a wide range of issues relating to today include normothermia; weight-based
SSIs while also addressing inconsistencies in the antimicrobial prophylaxis; supplemental oxygen,
interpretation of recommendations across countries. oral antibiotics/mechanical bowel prep, and wound
edge protector (colorectal surgery); staphylococcal
Significantly, the WHO guidelines take into decolonization (orthopaedic and CT surgery);
account existing scientific research and covers preoperative antiseptic showers; separate wound
evidence-based interventional strategies that focus closure trays; smoking cessation; intraoperative
on the pre-, intra-, and post-operative environment. irrigation with 0.05 per cent chlorhexidine gluconate;
The guidelines recommend the use of triclosan- glove changes prior to fascia and subcuticular wound
coated sutures in all types of surgical procedures to closure; innovative device-related procedures, and
reduce the incidence of SSIs. This recommendation traffic control in operating rooms.
falls in-line with other global and societal guidelines
recommending the use of triclosan-coated sutures Despite the obvious process, there is still a
as part of an inclusive evidence-based process lack of emphasis placed upon the engagement of
to reduce the risk of surgical site infections. The patients in preventing SSIs, who are already playing
Plus Antibacterial suture technology by itself has an increasingly active role in the decision-making
been reported in peer surgical literature to provide process relating to their health. On the other hand,
a 28 per cent risk reduction benefit. Combining institutions that have been successful in reducing
the triclosan-coated suture technology with other their SSI rates have in tandem developed an effective
evidence-based interventional strategies affords a system to measure compliance to the bundle process.
significant risk reduction and economic benefit to the
surgical patient population. Recently, I attended the The implementation and adoption of evidence-
first-ever Care+ Masters Symposium in Singapore, based practices in hospitals remain an issue in today’s
where international experts were brought together to rapidly evolving healthcare landscape. Without
discuss SSI prevention strategies across Asia Pacific, question, recommended guidelines can be highly
and they similarly advocated the use of innovative effective in improving post-op patient outcomes, but
technologies such as antimicrobial-coated sutures to there is still a lack of institutional and governmental
support in translating such initiatives within some
developing nations. In this regard, leaders in the
surgical community must play a crucial role in
advocating for change to reduce the risk of SSIs. If
prominent surgeons champion the cause, it will be
less challenging for those in authority to embrace and
implement these effective evidence-based processes.

All in all, the multifactorial nature of SSIs means
no single measure can completely eliminate risk
factors. However, growing economic presence and
a need for social change has become the catalyst
for research and collaboration between policy
makers and healthcare professionals, representing
an effective pathway for improving surgical patient
outcomes in a dynamic and diverse world.

Bias ectrumBIO INTERACTION 43

BBIOIOSPEICNTRTUEMR|ANCOVTEMIOBENR 2019 | www.biospectrumasia.com p ASIA EDITION

How Health Care Innovation Is Challenged
by Cyberattacks

Alwin van den Broek Factory a Factory-CRO
Group
MSc company
Data Protection Officer,
Factory-CRO Group CRO for Medical Devices & JVDs

"Cyberattacks can have several goals, improve safety measures where necessary,"
such as said van den Broek.

I) holding data for ransom with the goal to "With the global increase in awareness
make money like the relatively recent regarding value of personal data and thus also
WannaCry attack, 2) exploiting data by gaining an increase in the need of a good protection
unauthorized access to the data or 3) denying framework, regulations are becoming more
service or, denial-of-service (DoS) attacks. stringent. Adhering to the existing regulations
Medical devices have often not been targeted and guidelines regarding the security of data is
deliberately but the appliances of medical a good starting point; this includes the EU
devices are linked to hospital networks which 2016/679 General Data Protection Regulation
are more vulnerable to such attacks. This (GDPR) and the guidance provided by the US
highlights the importance of having strict FDA on cybersecurity in medical devices and
security measures in place," said Alwin van organizations," said van den Broek.
den Broek, data protection officer
Factory-CRO Group. FactorY--CRO GrouP-
�\�-�_.-... BBA e:�C•'-•
"It is important that medical devices are Fa.ctor�y
safeguarded by design (privacy by design) by
implementing technical safeguards and careful "Manufacturers should ensure security of their
handling of (personal) data in the early stage of devices by developing and adhering to
the development of the medical device. When cybersecurity protocols in compliance with the
developing a medical device, the challenge is local regulations and the GDPR.
to be the best and the fastest, but manufacturers Manufacturers can improve their security
cannot forget the safeguards. In other words system by mapping their field of work and
the competition between the technology t� identifying potential risks by conducting Data
secure the devices and the hackers who will try Protection Impact Assessments. As an
to break in will be a continuous battle. So, it is organization that does not manufacture
important to apply continued vigilance and medical technology, we have been able to
observe the changing landscape evolving
around the GDPR and how it will continue to
evolve," said van den Broek.

44 R&D NEWS

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Singapore creates world’s largest Asian genetic databank

Researchers in Cell. The team from
the Genome Institute
Singapore have created of Singapore (GIS)
of the Agency for
the world’s largest Science, Technology
and Research (A*Star)
genetic databank of collected the blood
samples of close to 5,000
Asian populations, which Singaporeans, 2,780
Chinese, 903 Malays
could help scientists and and 1,127 Indians. The
samples were sequenced
doctors better diagnose over two years by several
healthcare institutions
rare diseases, find including the National
University Hospital,
the causes of chronic Khoo Teck Puat Hospital
and the Singapore Eye
ailments and help us Research Institute.

better understand

the country’s history.

The study contains

the completed whole-

genome sequencing

data of around 5,000

Singaporeans, and has

been published in top

biomedical journal

Australia one step close Korea reveals
to cervical cancer cure
technology to build
Australian researchers are cervical cancer tumours
one step closer to finding in mice, using stealth 3D medical devices
a cure for cervical cancer nanoparticles. These
having killed off tumours nanoparticles were used to A group of engineers at Daegu Gyeongbuk
in mice using gene-editing target a gene called E7 that Institute of Science and Technology
technology, as part of a is found in cancer which (DGIST) has developed a technology
world-first study. The is caused by the human to produce flexible 3D medical devices.
scientists from Griffiths papillomavirus (HPV). The It is expected to be used in developing
University used CRISPR- study revealed 100 per cent various devices with embedded electrical
Cas9 technology that survival and no tumors functionality or soft robots. According
changes the sequence of for the treated mice. The to the engineering group, since this
DNA in cells to correct the scientists are now working technology can manufacture 3D flexible
mutation. The researchers towards human trials of devices more easily than the existing
used the technology the gene therapy in the methods, it is expected to have a
to target and treat the next five years. positive impact on the future research.
It is expected to be widely applied, for
instance, for pressure measurement
inside the body including the cranium,
devices with electrical stimulation and
detection functions, and soft robots.

ACADEMICS NEWS 45

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

University of Auckland joins hands with Japan

A newly signed Memorandum aims to build a framework to
of Understanding (MoU) encourage close cooperation
between Auckland Services at between students and
the University of Auckland and researchers, and collaboration
Japan’s National Institute of through exchanges and joint
Advanced Industrial Science research projects. AIST will
and Technology (AIST) will reap provide vital experience and
benefits for New Zealand (NZ) contacts in the local market
entrepreneurs and research. The to give NZ entrepreneurs an
agreement will enable the two edge when trying to leverage
parties to significantly increase opportunities in Japan and
technological cooperation other international markets, in
in robotics and artificial the areas of engineering, science,
intelligence (AI). The MoU and medical and health science.

Thammasat University
inks MoU for
marijuana research

JNU, ICMR Thammasat University University in order to
announce education, in Thailand has signed find extraction process
research collaboration a Memorandum by using liquid carbon
of Understanding dioxide. Then, the
India based Jawaharlal Nehru University (JNU) (MoU) with JSP company will associate
has signed a Memorandum of Understanding Pharmaceutical with the medical
(MoU) with Indian Council of Medical Research Manufactory to undergo sector to manufacture
(ICMR) for institutional collaboration in mutual research modern drug rather
education and research. The main objectives of the and develop study than traditional or
MoU are to promote and enhance the interaction of marijuana and herbal medicine. Both
and collaboration between faculty, staff and perform marijuana parties also intend to
students of JNU with ICMR institutions through research for a medical grow a cannabis tree
visits and exchange programmes, joint academic use in future. JSP will in closed environment,
and research programmes. The MoU is aimed be working with the and conduct a training
at enhancing the technological collaboration in Faculty of Engineering course for personnel
the areas of national interest. The cooperation at Thammasat and students.
will focus on faculty and student exchange
programmes, increasing the opportunities for
interaction among members of faculty and
students between Schools/Centres of JNU and
ICMR institutions as well as creating Visiting/
Adjunct Faculty positions and short visits.

46 SUPPLIER NEWS

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Waters introduces new Eurofins,
range of TA instruments UgenTec to
employ AI for
Waters Corporation has introduced the new TA Instruments MSF16 molecular
Multi-Specimen Fatigue Instrument. The MSF16 extends the capability testing

of accelerated cyclic testing by loading 16 specimens Eurofins GeneScan
simultaneously, rapidly delivering insights into the Technologies GmbH and
failure limits of materials, components and products UgenTec have announced
under repeated loading. The durability of materials a collaboration on the
and their construction is critical for the longevity development of assay
of products that experience repetitive forces. plugins for Eurofins
From aircraft and automobiles to medical devices, GeneScan Technologies’
understanding durability can be lifesaving. Fatigue portfolio of molecular
testing of component materials or final assemblies biology kits on UgenTec’s
involves repetitive mechanical loading (stress and real-time PCR analysis
strains) that measure when and how they fail. Failure software platform,
quantification requires ten to one hundred specimens FastFinder. FastFinder
be tested for millions, even hundreds of millions analysis is a software
of cycles. TA’s MSF16 instrument, equipped with module that uses artificial
industry leading motor technology and 16-sample intelligence (AI) to
support the analysis and
capacity, significantly accelerates fatigue analysis and interpretation of qPCR data.
provides users a competitive edge by reducing their time-to-market. Trained on over a billion
data points across hundreds
Thermo Fisher expands clinical of assays, FastFinder takes
trials capabilities in China any assay on any common
PCR device and minimizes
Thermo Fisher Scientific, the solutions for customers and hands-on time. It allows
world leader in serving science, their patients. The facility will diagnostic companies to
has announced an expansion of support the growth of clinical trial standardize the way their
its integrated clinical trials supply studies for customers in China assay is used in the field or
and distribution services network, and provide emerging biotech by their service laboratories,
in Suzhou, China. To align with companies with the resources making interpretation
China’s effort to encourage to develop and commercialize operator-independent and
drug innovation, the newly new drug candidates. The reducing time-to-result.
expanded Suzhou facility will nearly 7,000-square-meter
address the growing demand for addition in Suzhou offers a
drug development supply chain full suite of services, including
services and focus on high quality materials storage, packaging and
primary and secondary packaging distribution.

SUPPLIER NEWS 47

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

Qiagen, Illumina accelerate NGS adoption

Illumina, Inc. and QIAGEN Both partners are also exploring genomic profiling of tumor
N.V. have announced a 15- opportunities for QIAGEN to samples in immunotherapy.
year partnership intended develop and market companion Illumina and QIAGEN will
to broaden the availability diagnostics based on Illumina’s cooperate to commercialize a
and use of next-generation TruSight Oncology (TSO) assays menu of clinically validated
sequencing NGS-based in-vitro that enable comprehensive workflows that combine
diagnostic (IVD) kits, including QIAGEN’s proprietary content
companion diagnostics, for and bioinformatics solutions.
patient management. The The partnership will initially
agreement grants QIAGEN focus on commercializing
non-exclusive rights to develop oncology IVD kits to support
and globally commercialize patient management and may
IVD kits to be used together with expand in the future to include
Illumina’s MiSeq Dx and NextSeq additional clinical diagnostic
550Dx Systems. The agreement fields, such as cardiology,
also includes rights for expansion hereditary diseases, infectious
of the partnership on future diseases, as well as inflammatory
Illumina diagnostic (Dx) systems. and autoimmune diseases.

Merck acquires acoustic CNMPA approves
Agilent’s PD-L1
technology developer Companion Diagnostic

Merck, a leading science and technology company, Agilent Technologies has announced that the
has announced it has acquired FloDesign Sonics National Medical Products Administration of
of Wilbraham, Massachusetts, USA, developer China (CNMPA, formerly the China Food and
of a unique acoustic cell processing platform for Drug Administration) has approved its PD-L1 IHC
the industrialization of cell and gene therapy 22C3 pharmDx assay for use in China. The assay
manufacturing. Merck is the first company is now approved as a companion diagnostic to
to make acoustic technology available for cell identify patients with locally advanced or metastatic
therapy manufacturing. Acoustic cell processing non-small cell lung cancer (NSCLC) whose
is a disruptive technology that allows for the tumors express PD-L1 for first-line treatment with
manipulation of cells with ultrasonic waves. single-agent KEYTRUDA, an anti-PD-1 therapy
FloDesign Sonics’ acoustic cell processing platform manufactured by Merck & Co., Inc. Kenilworth,
allows enhanced cell washing and concentration NJ, U.S.A. PD-L1 IHC 22C3 pharmDx is the first
for manufacturing cell therapies. The acquisition and only NMPA-approved companion diagnostic
is a strategic fit for Merck, strengthening the that has been clinically validated to aid in the
ability alongside pharmaceutical manufacturers to identification of NSCLC patients for treatment with
advance cell-based therapies to patients. KEYTRUDA.

48 PEOPLE NEWS

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

IPA announces Dr Satish Dr Vincent
Reddy as President
Chang steps
Satish Reddy, Chairman of Dr Reddy’s
Laboratories has been appointed as into TLC
President of the Indian Pharmaceutical
Alliance (IPA) for 2019-2021. As an active Taiwan based clinical-stage
member of major industry associations and specialty pharmaceutical
governmental panels, Reddy played a key company dedicated to
role in shaping policies concerning the development and
the pharmaceutical sector as well commercialization of novel
as the economy, such as policy nanomedicines designed to
formulation on India’s patent target areas of unmet medical
law, drug pricing and important need in pain management,
amendments to the Drugs & ophthalmology and oncology,
Cosmetics Act. He was a past Taiwan Liposome Company
president of IPA (2013-2015), (TLC) has announced the
a member of the Drugs appointment of Dr Vincent
Technical Advisory Board of Chang, PhD, as TLC’s Vice
India, the Chairman of the President of Manufacturing
Andhra Pradesh Chapter of Development. With over
the Confederation of Indian 35 years of experience
Industries (CII) and head of attained at Abbott, Roche,
its National Committee on GlaxoSmithKline and
Pharmaceuticals. Bayer, Dr Chang will serve
as a member of the TLC
Ascletis hires new Management Team and
Chief Scientific Officer guide the company in affairs
related to the chemistry,
Ascletis Pharma, China based innovative R&D driven, commercial- manufacturing and controls
stage biotechnology company addressing unmet medical needs in of its products. Prior to
therapeutic areas including anti-viral, cancer and fatty liver diseases joining TLC, Dr Chang
has announced that Dr Handan He joins Ascletis as Chief Scientific ran a consulting firm that
Officer, reporting to Dr Jinzi J. Wu, Founder, Chairman and CEO of performed quality audits
Ascletis. Dr Handan He was a former Global Head of Computational, and worked with clients on
Biopharmaceutics and Translational quality improvement and
PK/PD at Novartis Pharmaceutical various CMC issues. Before
Corporation, New Jersey, USA. She that, he had been with Abbott
managed scientific teams across Novartis for 25 years. In his last role,
global sites in USA and Switzerland. he was responsible for the
Her main responsibilities included in quality assurance of contract
silico ADME predictions, human PK/ manufacturing from API
PD projections, translational PK/PD, to a wide range of dosage
in vitro and in vivo correlations, and clinical Physiologically Based forms of drug products. Dr
Pharmacokinetic modeling for drug absorption, drug interaction, Chang received numerous
organ impairment and pediatrics. She joined Novartis, New Jersey in Presidential Awards for
1997. Over her 22 years tenure at Novartis, she authored more than outstanding achievement
30 INDs and 3 NDAs (Galvus, Indacaterol and Midostaurin), and during his time at Abbott.
supported all disease areas in both preclinical and clinical stages at
Novartis. She conducted 15 due-diligence evaluation projects (phase I
through phase III) to help strengthen the Novartis pipeline.

PEOPLE NEWS 49

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

3 scientists share George
medicine Nobel 2019 Clinical
names Sean
The Nobel Prize 2019 for Physiology or Medicine has been awarded to Hart as CBO
three scientists for discovery of how cells sense and adapt to oxygen.
William G. Kaelin Jr, Sir Peter J. Ratcliffe and Gregg L. Semenza have George Clinical, a global
been jointly awarded the Nobel for their work of identifying molecular scientifically-driven clinical
machinery that regulates the activity of genes in response to varying research organization
levels of oxygen. The fundamental importance of oxygen has been (CRO) headquartered in
understood for centuries, but how cells adapt to changes in oxygen levels Australia, has announced
has long been unknown. This year’s Nobel Prize awarded work reveals the promotion of Sean
the molecular mechanisms that underlie how cells adapt to variations in Hart to the new role of
oxygen supply. The discoveries made by the three men have fundamental Chief Business Officer
importance for physiology and have paved the way for promising new (CBO). Hart, who joined
strategies to fight anemia, cancer and many other diseases. George Clinical through
the acquisition of Vector
AGC Biologics appoints Oncology in 2017, will now
new GM for Japan lead business development
functions globally for
AGC Biologics, a global leader in clinical and commercial manufacturing the organization. In this
of therapeutic proteins, has announced the appointment of Naofumi expanded capacity, Hart
Kagami as Site Head/General Manager of the Chiba, Japan facility. will lead the U.S. and
Kagami will provide leadership and site management to ensure Asia Pacific business
the continued execution of world-class contract development and development teams as an
manufacturing services. He will support the continuous growth of the integrated global function
Chiba facility while working closely with colleagues in Copenhagen, to drive the organization’s
Heidelberg and Seattle to ensure the business leverages and integrates business development
AGC Biologics combined global capabilities. Kagami brings 25 years strategy in a concerted
of industry experience to his role. Prior to joining AGC Biologics, he manner across all regions.
worked for Roche Diagnostics, Lonza and Sartorius Stedim in Japan in He will also direct global
R&D, marketing and sales roles of increasing leadership responsibility marketing and public
for the life science and bio-manufacturing markets. He holds a Master relations efforts for George
of Science degree in Biochemistry and Biophysics from the University of Clinical. Hart will continue
Tokyo Graduate School. to lead the U.S. team as
Managing Director as well
as provide leadership for
global late phase activities.

50 BIO EVENT

BIOSPECTRUM | NOVEMBER 2019 | www.biospectrumasia.com

ICNDT-2019

“Neurological disorders pose great challenge
to healthcare in developing countries”
The Minister for Shipping and Minister of
State for Chemicals & Fertilizers, government The Minister for
of India Mansukh Mandaviya has said that Shipping and Minister of
Neurological disorders pose a great challenge to the State for Chemicals &
healthcare in developing countries in view of limited Fertilizers, government
resources and manpower that are in adequate to of India Mansukh
tackle the increasing burden. He was addressing Mandaviya speaking
three day International Conference on Neurological at the ICNDT-2019
Disorders and Therapeutics (ICNDT-2019) organized organized by NIPER-
Ahmedabad at
Gandhinagar, Gujarat,
India on October 24.

by National Institute of Pharmaceutical Education

and Research (NIPER)-Ahmedabad at Gandhinagar, Radiologist, Harvard Medical School, USA and Dr

Gujarat, India on October 24. Dileep R. Yavagal, Clinical Professor of Neurology and

Mansukh Mandaviya hoped that the conference Neurosurgery at the University of Miami of Medicine,

would help to explore and encourage approaches to USA spoke at the conference.

stimulate new ideas for research and treatment that Dr M.V. Padma Srivastav, speaking on “ Restoring

will be beneficial across the spectrum of neurological the Post Stroke Brain: Drugs, Devices and Robotics”

disorders. This will create a cross fertilization between said “Restorative therapies aim to improve outcome

basic neuroscientists and clinical neurologists who by salvaging threatened brain, as with reperfusion or

rarely see each other and get people thinking about how neuroprotective drugs and also by promoting plasticity

both can help society by contributing to a common aim within surviving neural tissue. Restorative therapies

of treating different neurological disorders effectively. typically have a therapeutic time window measured in

Today India is largest exporter of generic drugs globally days-weeks and so have the potential to be assessed by

and it has been predicted that the number is going to a large fraction of patients with a new stroke.”

rise in coming periods, the minister said. Dr Karen Chen, speaking on “Challenges of

The minister pointed out that Global Burden of intracranial drug delivery: new frontiers in a long

Disease study by the World Bank and the Harvard history of false starts” said Chemotherapeutic agents

School of Public Health, drew the attention of the for malignant disease take advantage of the tumor’s

international health community to the burden of increased metabolism resulting in cell death. For

neurological disorders. This study found that the intracranial disease, systemic drug administration

burden of neurological disorders was seriously is challenged by the blood brain barrier, resulting in

underestimated by traditional epidemiological and lower target drug concentrations. Early trials of intra-

health statistical methods that consider only mortality arterial chemotherapy demonstrated were notable for

rates but not disability rates. On one hand clinical high rates of hearing loss in platinum-based agents

treatment of such diseases are important, on the other and blindness due to infusion below the ophthalmic

hand lifestyle changes & naturopathy &traditional artery. These concerns along with advances in

Indian ayurvedic system of yoga may also provide catheter maneuverability has prompted safe and

solutions, Mandaviya said. repeated super selection of segments of the anterior

ICNDT-2019 was held to foster cross-disciplinary and posterior circulation.“

exchange of ideas and expertise to help in deciphering Dr Dileep R. Yavagal, Clinical Professor of

different unexplored mysteries of neuroscience. Neurology and Neurosurgery at the University of Miami

During the three day conference researchers, public of Medicine, USA speaking on “Translating cell therapy

health professionals, scientists, industry and scholars for ischemic stroke: Intra-arterial and other routes

exchanged ideas of novel research and technologies in of delivery of cells for enhanced stroke recover” said

circumventing different unexplored mechanisms of “Stroke is the leading cause of disability worldwide with

neuroprotection. a staggering burden of over 17 million strokes resulting

Many speakers from USA, Japan, Germany, in 6 million deaths per year. Of the stroke survivors, 2/3

Italy, Malaysia and India including Dr M.V. Padma have a significant disability. 1 in 4 people above the age

Srivastav, Professor & Head of the Department of of 25 will have a stroke in their lifetime and there are 80

Neurology, AIIMS, New Delhi, India, Dr Karen Chen, million stroke survivors globally.”