BioSpectrum India October 2021

4 BIO CONTENT BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

COVER STORY 21

How academic-industry

SYNERGY ASSUAGES

DRIISSINOGRBDREARINS
With an ageing population globally, the burden of
neurological disorders is rapidly increasing, posing COVER
a challenge to the sustainability of health systems. DESIGN BY:
The burden of neurological disorders such as stroke, DOMINIX STRATEGIC
headache disorders, epilepsy, Alzheimer’s disease, DESIGN PVT. LTD.
Parkinson’s disease, multiple sclerosis, encephalitis,
meningitis, traumatic brain injuries, among others, is 24
also expected to increase in India due
to the rapid demographic and Patient-focused
epidemiological transition approach to
occurring in the country. combat
To add to it, factors such neurological
as shortages in the disorders
neurology workforce, Dr Kausik Maiti

inadequate MD (Psychiatry),
research funding, Senior Medical Director,
Parexel India, Hyderabad
limited supply
of drugs, and
scarcity of basic

healthcare
amenities,
are making the
situation worse. Let’s
try to unearth the
practicable solutions
and innovations
stemming from the
industry and academia.

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com Top Video BIO CONTENT 5

At-Home Diagnostics Padmakumar Nair,
Co-founder & Chief
28 Executive Officer,
Ennoventure,
Home diagnostics turn inevitable necessity Bengaluru talks about
how technology can
IVD Industry address the alarming
issue of counterfeiting
31 in India across the
pharmaceutical
Indian IVD industry displays industry.
resilience with 30% CAGR
Scan the QR Code »
Speaking With
Hitesh Goswami,
33 Co-founder and
Chief Executive
“Our new focus areas to Officer, 4baseCare,
offer services related to Bengaluru points
mRNA, plasmid development, out the evolution of
GMP manufacturing” personalised care
Mahesh Bhalgat, and genomics in
India.
Chief Operating Officer,
Syngene International, Hyderabad Scan the QR Code »

35 Adarsh Desai,
Founder, Infinita
“There is further scope Biotech, Vadodara
for developing the clinical speaks about the
research ecosystem, including growth of the Indian
regulatory pathways in India” enzyme industry.
Ajay Tandon,

Managing Director,
Veeda Clinical Research, Ahmedabad

SARS-CoV-2

37

Looking beyond
vaccines to fight
SARS-CoV-2
Dr Ashok Kumar,

President, Centre for Research and
Development, Ipca Laboratories Ltd, Mumbai

Regulars WHO News..................................20 Scan the QR Code »
Academics News.......................39
BioEdit .........................................06 People News...............................40
BioMail ........................................08 R&D News...................................44
Policy and Regulatory News....10 Supplier News............................48
Finance News.............................12 Let’s Talk Health & Science......50
Company News.........................14
Start-up News............................16
World News................................18

6 BIO EDIT BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

Carrot and stick

The Indian pharma sector is likely to be adversely India was prominent in API production and
affected by the regime change in Afghanistan supplied them to the world prior to 2000. But the
and the ever-meddling antics of China. The situation started changing thereafter with APIs and
pharmaceuticals exports showed a growth of 4.58 intermediates production and export moving to China.
per cent in the first quarter (April-June 2021) of the It not only increased the production capacity of APIs to
FY-22 at $5.78 billion as against $5.53 billion during very high quantities but started making them available
the corresponding period the previous year. In rupee at half of the price of India. Chinese companies could
terms, the growth is 1.71 per cent. The prospects of do it due to the Chinese government’s support of
exports in the second quarter (July-September 2021) low-interest loans, long term moratorium on debt
are also estimated to be good. Drugs and pharma is payment, proactive R&D support, market and export
also a major contributor to the year-on-year 41.5 per promotion incentives and low-cost electricity.
cent growth of India’s exports from special economic
zones (SEZs). The main reason for the growth is As a result, Indian companies found it difficult
the good performance of pharma in the April-June to compete with Chinese companies due to the price
quarter. The CARE Ratings predicts a 11 per cent difference and started losing the export market
growth in the next two years, to reach over $60 billion to them. Many of them were forced to stop the
from the current $45 billion. production of some APIs. The Chinese companies
could, thus, establish monopoly and raise rates once
But, the Talibani regime is an obstacle to Indian companies stopped production of those APIs.
smooth pharma exports to the country. The target The situation not only endangered pharma production
to export medicines to Afghanistan in 2021-22 is in the country but threatened to jeopardise the sector’s
$126.22 million. The export items consisted mainly export potential.
of formulations and vaccines. In the previous two
years – 2019-20 and 2020-21 - India exported $90 The Indian government has initiated steps to
million and $97 million worth of pharma products reverse the situation by launching Production Linked
respectively. Considering that the current target of Incentives (PLIs) plan to promote API production in
$126 million is achievable. the country once again. But promoting API production
once again would require many more steps and support
The apprehensions of the exporters are mainly from the government in different forms and ways.
due to the doubts over the payments. Even the
Federation of Indian Export Organisations (FIEO) Unfortunately, in its Remission of Duties and Taxes
has asked exporters to be cautious, particularly on Exported Products (RoDTEP) scheme, announced
regarding payments, due to the political developments in mid-August with retrospective effect from January
in Afghanistan. If the Taliban regime fails to build up 1, 2021, the government has excluded the pharma
confidence sooner, particularly related to payments, sector. Two prominent pharma industry associations –
there could be a major dent in the actual exports of the Indian Pharmaceutical Alliance (IPA) and Indian Drug
year. Manufacturers’ Association (IDMA) – have pointed
out that the exclusion would adversely impact the
The issue related to the growing Chinese sector’s competitiveness. IPA has said that the pharma
control over the Active Pharmaceutical Ingredients industry deserves 3 to 6 per cent benefit for APIs and
(APIs) affecting the Indian pharma industry has formulations. The pharma sector’s exclusion from the
been discussed time and again. It was once again scheme by the government is much like not offering the
prominently discussed when the Indian pharma carrot as reward for its good export performance, and
industry feared an imminent shortage of APIs to encourage its API manufacturing prowess.
imported from China when the Chinese industries
downed shutters at the beginning of 2020 due to the Dr Milind Kokje
COVID-19 outbreak . Chief Editor

[email protected]



8 BIO MAIL BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

Vol 19; Issue 9; September 2021 of fatal and chronic diseases. Thank you
Acknowledgements BioSpectrum for addressing the current
Thank you BioSpectrum for the video scenario of the molecular diagnostics space.
byte opportunity and the coverage on our
startup Leucine Rich Bio, and to share our - Sriram Natarajan, Goa
message that microbiome can play a big role
in not only diagnostics but prognosis and Thank you for filing stories on the Indian
therapeutics too. Institutes of Technology (IITs). Much
appreciated. We look forward to collaborating
- Dr Debojyoti Dhar, Bengaluru with BioSpectrum in the future as well.

Thank you for the coverage and interaction - Akhil Vaidya, New Delhi
with Sartorius Stedim India in the
September edition of BioSpectrum India. BioSpectrum is an excellent hub for all
things in biotech. Thank you for sharing
- Divya Bishnoi, Bengaluru extensive information and analysis on
business and industry trends with such
As per reports, the Indian Molecular detail. Keep up the good work.
Diagnostics Market is projected to grow
predominantly on account of rising cases - Manni Kantipudi, Hyderabad

Vol 19; Issue 10; October 2021 MM Activ Sci-Tech Communications

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10 POLICY AND REGULATORY NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

CIL signs MoU North East gets Rs 80 Cr
with Assam allocation to boost Ayurveda
to strengthen
infrastructure In a major boost to the initiatives to promote traditional medicinal
practices in the Northeast (NE), Sarbananda Sonowal, Union Minister of
Coal India Ltd (CIL), under Ports, Shipping & Waterways and AYUSH, has announced a slew of major
the Ministry of Coal, has initiatives. Sonowal has announced that in order to boost the education
signed a Memorandum of and training of Ayush medicinal experts, financial provision of Rs 70
Understanding (MoU) with crore, under National Ayush Mission (NAM) support, is to be provided
the Department of Health & for the establishment of a new
Family Welfare, Government Ayurvedic College at Dudhnoi in
of Assam for strengthening Goalpara, Assam. “The Ministry
the health infrastructure at of AYUSH has also decided
the Silchar Medical College to upgrade the Government
& Hospital, Silchar, the only Ayurvedic College in Guwahati
Medical College and Hospital and develop it as a Centre of
in Barak Valley Region, Excellence and a sum of Rs 10
Assam. In this new CSR crore as a financial grant is to
initiative, CIL will contribute be provided in this regard,”
Rs 5 crore towards setting up he added. Sonowal has also
an ICU facility and medical announced that as many as 1000 new Health & Wellness Centres (HWC),
gas pipeline in the Silchar as part of the National Ayush Mission (NAM) Scheme, will be opened in
Medical College & Hospital the NE states for growth and development of Ayush systems. With an aim
which will benefit over 40 to boost the popularity of traditional medicines provided by Ayush, the
lakh people of the state. minister also announced the setting up of 100 Ayush dispensaries under
The MoU was signed in the NAM in the North Eastern Region (NER).
presence of Dr Himanta
Biswa Sarma, Chief Minister Zydus receives EUA for the world’s
of Assam and Health Minister first plasmid DNA vaccine for COVID-19
Keshab Mahanta. CIL and its
subsidiaries have undertaken Ahmedabad-based pharma firm Zydus Cadila has announced that the
several high-investment, company has received the Emergency Use Authorization (EUA) from the
high-impact projects to help Drug Controller General of India (DCGI) for ZyCoV-D the world’s first
improve medical facilities Plasmid DNA Vaccine for COVID-19. ZyCoV-D is a three-dose vaccine
across the country. Notable
projects being the Medical that will be administered first on day zero, day 28th
College cum Hospital at and then on the 56th day. With this approval, India
Talcher in Odisha for Rs 492 now has its first COVID-19 vaccine for adolescents
crore, ‘Premashraya’, a home in the 12-18 age group, besides the adult population.
for children and their families ZyCoV-D, is a needle-free vaccine administered using
seeking cancer treatment The PharmaJet a needle-free applicator, which ensures
at Kolkata for Rs 41 crore, painless intradermal vaccine delivery. This is for the
Support for Bone Marrow first time that a technologically advanced vaccine
transplants of children has been successfully developed on the Plasmid DNA
suffering from Thalassemia platform for human use. The platform because of its
for Rs 40 crore and a Cardiac rapid plug and play technology can be easily adapted
Care Centre at Jharsuguda, to deal with mutations in the virus, such as those
Odisha for Rs 75 crore. already occurring. The company plans to manufacture 10-12 crore doses
of ZyCoV-D annually. The company also plans to seek approval for the
two-dose regimen of the vaccine. The main advantage of DNA vaccines
is their ability to stimulate both the humoral and cellular arms of the
adaptive immune system. They are a valuable form of antigen-specific
immunotherapy, as they are safe, stable and can be easily produced.

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com POLICY AND REGULATORY NEWS 11

DCGI approves Sports Minister releases
Truenat diagnostic
kit for Nipah Fit India mobile app

Truenat, an innovative point of care Real- To celebrate the second anniversary of the Fit India
Time PCR platform manufactured by Goa- Movement and as part of Azadi ka Amrit Mahotsav, the
based Molbio Diagnostics, has received Minister of Youth Affairs and Sports, Anurag Singh Thakur
Emergency Use Authorisation by the Drugs launched the Fit India Mobile Application
Controller General of India (DCGI) for at Major Dhyan Chand National Stadium,
their Nipah test. This is the first kit in India New Delhi. The unique feature of the Fit
to receive regulatory approval to conduct India App is to empower each individual to
tests for Nipah. Truenat is an indigenous check his/her fitness score based on a set
portable, battery-operated and IoT- of age-specific fitness tests and get specific
enabled point of care RT-PCR platform. recommendations on how to improve their
Leveraging the large footprint of Truenat fitness level through physical activities
machines deployed across the country for including yoga protocols. Animated Videos
diagnosis of infectious diseases such as have been provided to make individuals
TB, COVID-19, Hepatitis, etc., testing for understand the procedure for conducting
Nipah Virus can now be performed rapidly, the fitness tests themselves. These features
on-demand and closer to the affected are based on the Age-appropriate fitness
people, resulting in early and fast diagnosis protocols launched by the Prime Minister. The ‘Fitness
for effective management of the disease Protocol’ feature allows the user from different age groups to
and containment of the spread of the virus. do various exercises which help them in being able to keep
up with basic fitness levels. The protocol covers exercises that
are universally followed and duly ratified by health experts.

Efficient and reproducible results for all your
transfection applications

For India contact information: Phone: +91 124 6052900 | Email: [email protected] | Website: www.bioscience.lonza.com

12 FINANCE NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

HCG divests stake in Strand Lifesciences to Reliance

Bengaluru-based HealthCare cash inflow of Rs 83 crore for specialised oncology space, which
Global Enterprises (HCG) has HCG in addition to the take- also led to HCG becoming the
announced the acquisition of over of the labs and clinical single largest shareholder in
oncology hospital labs and research business. In Jan 2018, Strand. Subsequently, the newly
clinical trials business from HCG had executed a business combined Strand entity had
Strand Lifesciences as well as combination of its hospital labs raised capital from PE investors
simultaneous divestment of its and clinical trials business, which and also acquired Quest Labs
approximately 38.5 per cent stake operated under Triesta brand, India business, which was later
(on a paid-up capital basis and with Strand’s clinical diagnostics divested during onset of the
34.5 per cent on a fully diluted vertical to jointly focus on pandemic.
basis) in Strand to Reliance
Industries group company.
HCG received consideration of
about Rs 157 crore for sale of its
ownership in Strand and acquired
labs and clinical research
business through a Business
Transfer Agreement (BTA) from
Strand for a consideration of
Rs 81 crore with a set-off of Rs
7 crore towards receivables.
The transactions resulted in net

SII acquires 50% stake Dr. Reddy’s sells
rights to anti-
in SCHOTT Kaisha cancer agent E7777

Pune-based Serum Institute of India (SII) has Hyderabad-based Dr. Reddy’s Laboratories, along
bought a 50 per cent stake in the Indian joint with its subsidiaries has entered into a definitive
venture SCHOTT Kaisha from former co-owners agreement with US-based Citius Pharmaceuticals
Kairus Dadachanji and Shapoor Mistry. The pursuant to which it sold all of its rights to E7777 (an
joint venture is the leading Indian manufacturer engineered IL-2-
of pharma packaging products such as vials, diphtheria toxin
fusion protein)
syringes, ampoules and and certain related
cartridges used to package assets. Under
life-saving medications. the terms of the
With this acquisition, agreement, Dr.
Serum is securing its Reddy’s will receive
supply of high-quality $40 million upfront
pharma packaging upon the closing of the transaction, followed by
amid rising global approval milestone payment of up to $40 million
demand. Working related to the CTCL (cutaneous Tcell lymphoma)
together in the joint indication approval and up to $70 million for
venture opens a new additional indication approvals. Further, Dr. Reddy’s
chapter in the successful will receive certain sales-based milestones and tiered
earn-out payments. In March 2016, Dr. Reddy’s had
partnership of Serum and acquired the exclusive global rights (excluding Japan
SCHOTT. The companies have and Asia) to the investigational anti-cancer agent
had a strong business relationship – and both E7777 from Eisai Co. Ltd.
have been playing a crucial role during the
pandemic. On the packaging end, SCHOTT has
already exceeded its target to deliver vials for
more than 2 billion vaccine doses through 2021.

Waters (India) Pvt. Ltd.

36A, II Phase, Peenya Industrial Area, Bangalore - 560 058, India
Tel : 080 - 49292200-03, Fax : 080 - 49292204 E-mail : [email protected]

Mumbai : Tel : 022-25170127, Fax : 022-25170616, E-mail : [email protected]
New Delhi : Tel : 011-40194100 - 4149, Fax : 011 - 40194115, E-mail : [email protected]
Kolkata : Tel : 033-22828338, Fax: 033-22828384, Email : [email protected]
Hyderabad : Tel : 040-27901532, Telefax : 040-27901586, Email : [email protected]
Chandigarh : Tel : 0172-4234900, Telefax : 0172-4234901, Email : [email protected]
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Chennai : Tel : 044-22350336

14 COMPANY NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

Morepen Labs hives-off India’s first mRNA-
medical devices biz into
wholly-owned subsidiary based vaccine moves

New Delhi-based Morepen Labs plans to carve out the into Phase II/III trial
medical devices business into a separate wholly-owned
subsidiary both for building teams to manage the scale Pune-based Gennova Biopharmaceuticals,
of operations of large and fast-growing businesses and working on the nation’s first mRNA-based
unique features of point-of-care (PoC) business. It also COVID-19 vaccine, recently submitted the
plans to bring in fresh capital that makes it imperative to interim clinical data of the Phase I study
to the Central Drugs Standard Control
have a separate subsidiary to Organisation (CDSCO), the Government
undertake this fast-expanding of India’s National Regulatory Authority
point-of-care (PoC) business. (NRA). The Vaccine Subject Expert
The proposed segregation will Committee (SEC) reviewed the interim
give clarity to the working Phase I data and found that HGCO19
teams, trade customers and was safe, tolerable, and immunogenic in
other stakeholders. Post this the participants of the study. Gennova
spin-off, the company will be has submitted the proposed Phase
able to put the entire focus II and Phase III study entitled “A
on its core business of active Prospective, Multicentre, Randomized,
pharmaceutical ingredients Active-controlled, Observer-blind,
(API) and formulations. After Phase II study seamlessly followed by a
hiving off medical devices business into a wholly-owned Phase III study to evaluate the Safety,
subsidiary company, separate dedicated management will Tolerability, and Immunogenicity of the
work for the development of Medical Devices Business candidate HGCO19 (COVID-19 vaccine)
in a separate independent entity. In the second phase in healthy subjects” which was approved
post hive off, the medical devices company would go for by the office of the DCG(I), CDSCO.
CE Certification of its manufacturing facilities to become The study will be conducted in India at
the hub for PoC manufacturing in India. The new entity approximately 10-15 sites in Phase II and
plans to deploy more resources on the R&D, backwards 22-27 sites in Phase III. Gennova plans to
integration of core technologies like making enzymes / use the DBT-ICMR clinical trial network
proteins and develop a data lab for connected devices. sites for this study.

Medtronic, Stasis partner to redefine patient monitoring in India

India Medtronic, a wholly-owned remotely monitor their patients. monitors, the Stasis connected
subsidiary of Medtronic, has The Stasis Monitor is used in care monitoring system includes
announced a strategic partnership Emergency lCUs, surgical lCUs, - a bedside monitor that monitors
with Stasis Health, a wholly- high dependency units, step down six vital signs, a tablet that
owned subsidiary of US-based units, and private patient rooms. enables intuitive monitoring,
Stasis Labs, for scaling up and Unlike conventional disconnected and the Stasis app that allows for
expanding access for their bedside remote monitoring across devices.
state-of-the-art Stasis Monitor, Equipped to provide patient data
a connected care bedside multi- to any device through the cloud,
parameter monitoring system. the system is appropriate for
The addition of Stasis Monitor data-driven insights. It includes
to the Medtronic portfolio
expands the company’s battery backup to move patients
ability to serve between different areas of
patients inside care and provides 24-
the hospital while hour vital-sign trend
offering physicians data along with AI-
the option to powered proactive
alerts.

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com COMPANY NEWS 15

Sai Life Sciences opens discovery Cipla, Kemwell
biology facility in Hyderabad Biopharma
announce JV
Sai Life Sciences, full-service contract research, development and for respiratory
manufacturing organisation (CRO-CDMO), has announced the opening biosimilars
of a new biology facility at its integrated R&D campus in Hyderabad.
The new state-of-the-art facility houses expanded in vitro and in vivo Mumbai-based pharma firm
biology services, DMPK, toxicology and a vivarium. The facility augments Cipla and Bengaluru-based
both, its capabilities and capacity, to deploy cutting-edge platforms and contract development and
manufacturing organisation
technologies for accelerating (CDMO) Kemwell
integrated drug discovery Biopharma have announced
programmes. The new facility the execution of a joint
culminates the company’s venture (JV) agreement to
journey of unifying its develop, manufacture and
discovery, early and late commercialise biosimilars
phase development and for global markets. For
clinical supply capabilities this purpose, a joint
in a single 13-acre campus venture company shall be
housing over 1000 scientists, incorporated with an aim
delivering integrated value to enter the respiratory
at scale. The company’s biosimilars space. Under
discovery services support a the terms of the agreement,
wide range of global innovator companies from startups to large pharma the joint venture will
companies, across a diverse set of therapeutic areas including oncology, leverage Cipla and Kemwell’s
CNS, antivirals, and inflammation among others. complementary strengths
for end-to-end product
Wipro GE Healthcare launches first development, clinical
GE-SonoSim Simulation CoE Lab development, regulatory
filings, manufacturing
Wipro GE Healthcare has conditions. The collaboration and commercialisation of
launched its first-ever GE- focuses on providing enhanced biopharmaceutical products.
SonoSim Simulation Centre Of education services to medical Cipla’s respiratory prowess
Excellence (CoE) Lab in the South professionals who aspire to combined with Kemwell’s
Asia Region at MGM Institute of learn ultrasonography from expertise in biologics will
Health Sciences, Navi Mumbai. women’s health and cardiology accelerate bringing these
SonoSim provides scalable to point of care and primary essential products to market.
technology that will train medical care. The SonoSimUltrasound
professionals and students in Training Solution is a portable
ultrasonography, using real and comprehensive laptop-based
patient cases spanning a broad ultrasound training platform
that offers a curriculum of 60-
spectrum of plus cloud-based courses, image
normal and acquisition and interpretation
pathologic training using the SonoSimulator

and performance tracking
respectively. The
platform allows cases
to be obtained from real
patients for an on-demand,
hands-on authentic
scanning experience for
ultrasound learning.

16 START UP NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

5th edition of NBEC 2021 brings opportunities worth Rs 8.5 Cr

Dr Renu Swarup, Secretary, attract, identify and nurture deep as a part of BREC – the
Department of Biotechnology, science-driven business ideas that Biotechnology Industry Research
Government of India recently break new ground in addressing Assistance Council (BIRAC)
announced the launch of the societal challenges. Conducted Regional Entrepreneurship
fifth edition of the National Bio Centre, established at C-CAMP
Entrepreneurship Competition in partnership with BIRAC,
(NBEC). The competition, now NBEC 2021 has in store an
in its fifth year, is a nationwide unprecedented Rs 8.5 crore
search for exceptional ideas in in cash prizes and investment
the life sciences domain with opportunities this year for
potential for both social impact winners. 30+ industry and
and commercial success. NBEC investment partners have come
is held by Bengaluru-based forward to encourage and support
Centre for Cellular and Molecular bio-entrepreneurship in India
Platforms - C-CAMP every year to through this competition.

TechInvention BeatO acquires
offers single dose
COVID-19 vaccine Novique to provide

TechInvention Lifecare, a biotech startup company based scientifically-driven
out of Mumbai, has claimed positive outcomes of its
recombinant subunit SARS-CoV-2 vaccine (CoviTech) diabetes reversal
in a single dose preliminary study. The company is
now advancing further development of the vaccine. New Delhi-based startup BeatO has
In CoviTech, the antigen is expressed in yeast Pichia announced the acquisition of Pune-based
pastoris, one of the most desirable expression platforms Novique Health for an undisclosed amount.
in recombinant technology to produce cost-effective BeatO provides a full-stack solution for
products with high yield and easy scale-up process. diabetes management and, with Novique,
Products like the Hepatitis B vaccine manufactured using will now also provide a science-backed
the same platform technology are being administered diabetes reversal programme. Through
even to newborns with exceptional safety, according to the this acquisition, BeatO will augment its
company sources. While CoviTech is being positioned as services of combating diabetes through
an affordable, effective and safe vaccine for the masses, clinically proven management, reduction,
the startup is also exploring another vaccine candidate and reversal of diabetes by addressing the
targeting the conserved and immunogenic regions of the condition’s root cause. The funds will be
virus. This vaccine may have the potential to address the utilised to grow its subscriber base across
burning issue of mutations. multiple channels and geographies as well
as for product enhancement to provide
care for other cardio-metabolic conditions.
The company has currently expanded to
650,000 registered members, out of which
300,000 are paid members serviced across
3,000 cities in India.

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com START UP NEWS 17

Digital health startup 4baseCare
Navia Life Care raises $1M unveils
India’s largest
Navia Life Care, a digital health startup based in New Delhi, population-
has raised $1 million in funding en route to their Series A specific tumour
raise. The investment was led by Anicut Angel Fund, the equity gene panel
arm of Anicut Capital, with participation from 9Unicorns and
other notable angel investors, including the Healthcare and 4baseCare, a precision oncology
Life Science practice lead of a top tier strategy consulting firm, startup in Bengaluru, has launched
Strategic partnerships lead at Google India, and the CEO of its product - TARGT Indiegene,
a renowned global pharma company. The fresh funds will be India’s largest and first population-
focused on strengthening the company’s position as one of the specific tumour gene panel derived
fastest-growing digital health startups in India, which is helping from Whole Exome and Whole
in reducing information asymmetry and increasing access to Transcriptome data of over 1500
quality health information across the ecosystem. It will further cancer patients across 28 different
allow the company to use the capital for technology, business cancer types. Most of the cancer
development, product innovation and development, strategic panels currently available in the
hiring, and expansion across all healthcare hubs of India, metro market are based on data from
cities along Tier 2 and 3 cities. The digital health startup is the caucasian population, and
aiming to close a $5 million Series A in the next 3-4 months. The the same panel is used for testing
company has developed a connected care platform that facilitates across all the geographies. For
seamless transmission of information across various stakeholders example, the TARGT Indiegene ‘
of the healthcare industry while generating real-world evidence cancer panel is based on insights
which is valuable to these stakeholders in increasing their generated from tumour tissues of
understanding through actionable insights. Indian cancer patients resulting in
better success rates using precision
StanPlus gears up medicine in the management of
to launch air ambulances cancer. The insights from research
have helped build the largest
Hyderabad-based startup StanPlus announced its foray into the resource of mutational signatures
air ambulance space. While the company has been operating air identified in cancer patients in
ambulances during the COVID-19 pandemic amid the increased India. 4baseCare had already
demand for transferring critical patients, StanPlus will now partnered with Wipro in July to
systematically pursue it as a new vertical. The company’s air build a framework of efficient,
ambulances offer COVID-19, non-COVID-19, emergency, neonatal, streamlined, and well-regulated
ECMO (extracorporeal workflows to develop advanced
membrane oxygenation) gene panels and to ensure the
and cargo transfers. It highest data quality, data security
also offers options like and regulatory compliance.
chartered aircraft or Similarly, 4baseCare and ACTREC-
customised economic Tata Memorial Centre join hands
flights, among others. in the development of an AI-based
Each cutting-edge clinical interpretation platform.
ambulance is equipped
with the best quality monitors, ventilators, oxygen, and emergency
boxes, etc. The air ambulance space in India exists with glaring gaps
that have hindered adoption in the past. Services are expensive,
regions monopolised, and transparency negligible. Customer
knowledge and awareness are also lacking. The differentiation being
offered by StanPlus air ambulances, apart from its technological
superiority, lies in its competitive prices along with an unwavering
focus on quality, to bridge the specific gaps.

18 WORLD NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

Europe Africa CDC and IFRC
ramp up COVID-19 response
considers
The Africa Centres for Disease Control and Prevention (Africa CDC) and the
booster International Federation of Red Cross and Red Crescent Societies (IFRC)
have launched a new collaboration to strengthen community resilience
doses of and response to public health emergencies at the community level. The
two institutions have signed a Memorandum of Understanding to ramp
COVID-19 up pandemic response including testing support to countries; community
mobilization; advocacy and scaling up of contact tracing. In addition
vaccines to COVID-19, the collaboration includes other areas of public health.
Africa CDC and IFRC will strengthen investments in locally-led action
Based on current evidence, for prevention and response purposes while working with governments
there is no urgent need to ensure they intensify efforts to roll out the COVID-19 vaccination.
for the administration of Additionally, Africa CDC and IFRC will scale up advocacy against vaccine
booster doses of vaccines to wastage. This new initiative comes at a time Africa continues to face
fully vaccinated individuals major vaccine shortages, amid a high level of community transmission
in the general population, in countries such as Botswana, Burundi, Eswatini, Cabo Verde, Namibia,
according to a technical Seychelles, South Africa, Zambia and Zimbabwe.
report issued by the
European Centre for Disease US invests $185M in
Prevention and Control human genome research
(ECDC). The report also
notes that additional doses The US-based National the results and approaches used
should already be considered Institutes of Health is providing in their studies. All information
for people with severely approximately $185 million generated by the consortium
weakened immune systems over five years to the Impact of will be made freely available to
as part of their primary Genomic Variation on Function the research community via a
vaccination. The European (IGVF) consortium, initiated web portal to assist with future
Medicines Agency (EMA) and funded by NIH’s National research projects. Because there
is currently assessing data Human Genome Research are thousands of genomic variants
on additional doses and will Institute (NHGRI). NHGRI will associated with disease, and it
consider whether updates fund 25 awards across 30 US is not possible to manipulate
to the product information research sites. IGVF consortium each variant individually and
are appropriate. EMA will investigators will work to in each biological setting,
also be assessing data on understand how genomic variation
booster doses. While EMA alters human genome function, consortium researchers
assesses relevant data, and how such variation will also develop
Member States may consider influences human computational
preparatory plans for health and disease. The modelling
administering boosters and IGVF consortium approaches to
additional doses. The ECDC will develop a predict the impact
will update its technical catalogue of of variants on
report as ECDC and EMA
continue to work together genome function.
to collect and assess data
that are becoming available
on boosters and additional
doses. Close monitoring
of vaccine effectiveness
data and breakthrough
infections, particularly
among vulnerable groups at
risk of severe COVID-19 and
among those living in closed
settings, would be continued.

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com WORLD NEWS 19

Nepal to get 4 Mn Moderna vaccine doses through COVAX

Nepal is the second country globally safe and effective. The World Bank
to have completed agreements with has made available $104 million to
GAVI to procure 4 million doses of support the Government of Nepal’s
Moderna vaccines, financed by the health response to the pandemic,
World Bank, through the COVAX with $67.5 million earmarked to
cost-share option. This will diversify purchase and deploy COVID-19
and strengthen the country’s vaccines. Recently, 1,000 oxygen
COVID-19 vaccine portfolio. Delivery concentrators were brought in
of these vaccines is expected to start through the project while seven
by March 2022 and will contribute to oxygen generation plants are being
Nepal’s goal to vaccinate at least 72 established, one in each province.
per cent of its population, as well as These will help strengthen health
children 12-17 years of age for whom preparedness in the event of future
the Moderna vaccine is deemed waves of the pandemic.

Sri Lanka receives 2 Mn UNICEF provides
syringes from WHO for
COVID-19 vaccination $1.4 M worth

In its continued effort priority procurement Med-Aid to Pakistan
to support Sri Lanka’s of syringes. Moreover,
COVID-19 response, the reinforcing longer- The United Nations Children’s Fund
the World Health term perspective of the (UNICEF) has handed over 1000 oxygen
Organisation (WHO) partnership with donors concentrators and related accessories
has provided 2 million allows the organisation worth $1.4 million to the Ministry of
syringes urgently to build towards National Health Services, Regulations
needed for the ongoing sustainable recovery and Coordination in Pakistan. The
vaccinations. These were with Ministry of Health Special Assistant to the Prime Minister
delivered in two separate leadership. Sri Lanka has on Health, Dr Faisal Sultan received
consignments. This also recently received the life-saving medical devices used
procurement is a case a large consignment of for treating
in point whereby WHO AstraZeneca vaccines patients
has been able to make a from Japan via the suffering from
critical contribution to COVAX Facility, to help coronavirus
Sri Lanka’s ambitious with the vaccination infection, birth
vaccination drive through drive. asphyxia and
complicated
pneumonia.
Including the latest consignment,
UNICEF has so far provided a total
of 3065 Oxygen Concentrators to the
Government of Pakistan, during the last
twelve months. Earlier, UNICEF had
provided 525 Oxygen concentrators from
its own funds, 220 from funds received
from the Asian Development Bank and
1320 from the World Bank’s Pandemic
Emergency Funding. In addition, three
million doses of Pfizer COVID-19 vaccine
have been donated by the Government
of the United States and delivered by the
COVAX Facility to Pakistan recently.

20 WHO NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

WHO updates guidance WHO opens hub
for TB management in
children, adolescents for pandemic

A rapid communication released by the World Health and epidemic
Organisation (WHO) Global Tuberculosis Programme
has announced important updates to guidance on intelligence in Berlin
the management of tuberculosis (TB) in children and
adolescents. This includes new recommendations on The World Health Organisation (WHO)
diagnostic options, treatment regimens, as well as Director-General has recently inaugurated
treatment decision algorithms and optimal models of care the new WHO Hub for Pandemic and
for the delivery of child and adolescent TB services. The Epidemic Intelligence, based in Berlin.
rapid communication highlights key updates including The WHO Hub, which is receiving an
recommendation on the use of Xpert MTB/ RIF Ultra in initial investment of $100 million from the
gastric aspirate or stool specimens as the initial diagnostic Federal Republic of Germany, will harness
test for TB and the detection of rifampicin resistance, in broad and diverse partnerships across
children aged below 10 years with signs and symptoms many professional disciplines, and the
of pulmonary TB; and recommendation on the use of latest technology, to link the data, tools and
a shorter intensive regimen composed of 6 months of communities of practice so that actionable
isoniazid, rifampicin, pyrazinamide and ethionamide in data and intelligence are shared for the
children and adolescents with microbiologically confirmed common good. The WHO Hub is part of
or clinically diagnosed TB meningitis, presumed to WHO’s Health Emergencies Programme
be drug susceptible, as an alternative to the currently and will be a new collaboration of
recommended 12 month regimen. countries and partners worldwide, driving
innovations to increase availability of key
data; develop state of the art analytic tools
and predictive models for risk analysis;
and link communities of practice around
the world. Critically, the WHO Hub will
support the work of public health experts
and policy-makers in all countries with the
tools needed to forecast, detect and assess
epidemic and pandemic risks so they can
take rapid decisions to prevent and respond
to future public health emergencies.

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

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

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com COVER STORY 21

How academic-industry

SYNERGY ASSUAGES

DRIISSINOGRBDREARINS
With an ageing population globally, the burden of Neurological disorders,
neurological disorders is rapidly increasing, posing both fatal and non-
a challenge to the sustainability of health systems. fatal, are among the
The burden of neurological disorders such as stroke, leading contributors to the
headache disorders, epilepsy, Alzheimer’s disease, burden of non-communicable
Parkinson’s disease, multiple sclerosis, encephalitis, and communicable diseases
meningitis, traumatic brain injuries, among others, in India. In the past three
is also expected to increase in India due to the rapid decades, most studies in India
demographic and epidemiological have shown a high disease
burden for neurological diseases
transition occurring in the including Alzheimer’s disease,
country. To add to it, factors stroke, epilepsy, Parkinson’s
disease, and dementia, mostly
such as shortages in the
neurology workforce, reported for the urban Indian
population. On the
inadequate research other hand, neuro-
funding, limited infectious diseases
such as meningitis,
supply of drugs, encephalitis,
and scarcity of progressive multifocal
basic healthcare leukoencephalopathy,
amenities, are HIV-associated
neurodegeneration
making the etc. are also increasing
situation worse. heavily in number.
Let’s try to unearth Disability-adjusted
life years (DALYs) are
the practicable an important metric for
solutions and assessing the burden of
innovations neurological disorders,
stemming from and they continue to
increase year after year.
the industry and According to a study
academia.
published in the Lancet
in 2021, the contribution
of non-communicable

22 COVER STORY BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

“There is a need to address the shortage of neurological disorders was 4 per cent in 1990,
trained neurology workforce, and strengthen doubling to 8·2 per cent in 2019, while injury related
early detection and cost-effective management of neurological disorders contributed 0·2 per cent in
neurological disorders in the country.” 1990 and 0·6 per cent in 2019.
- DR VINOD PAUL
Member, NITI Aayog, New Delhi The study also revealed that among all
neurological disorders in India in 2019, stroke,
“The rise of non-communicable disease related headache disorders, and epilepsy contributed to the
risk factors, as leading contributors to neurological greatest disease burden in terms of DALYs. Except
disorders and resultant disability in India, is not for stroke, only small proportions of neurological
a surprise. We need policy, health system and disorder DALYs were attributable to known risk
personal level actions to achieve healthy ageing factors, implying that more research is needed to
across a long life course.” understand association with risk factors.
- PROF. K SRINATH REDDY
President, Public Health Foundation of India, For instance, smoking is a risk factor for
New Delhi Alzheimer’s disease and other dementias and
multiple sclerosis, but shows a protective effect for
“We can increase the number of neuroscience Parkinson’s disease. Likewise, alcohol use is a risk
research students in India by developing strong factor for stroke and idiopathic epilepsy, which is also
graduate and undergraduate programmes.” more prominent in males due to higher alcohol use
- KRIS GOPALAKRISHNAN among males in India. On the other hand, the leading
Chairman, Axilor Ventures, Bengaluru risk factors for stroke are high systolic blood pressure
and air pollution, followed by dietary risks, high
fasting plasma glucose, high BMI, and smoking and
secondhand smoke.

“The rise of non-communicable disease related
risk factors, as leading contributors to neurological
disorders and resultant disability in India, is not a
surprise. It reflects the demographic, socio-economic
transitions that have steered the shift in our
epidemiological profile over the past 30 years. What
is helpful is the recognition that much of this burden
of disease and disability is related to modifiable risk
factors which can be reduced at the population level
and corrected at the individual level. We need policy,
health system and personal level actions to achieve
healthy ageing across a long life course”, points out
Prof. K Srinath Reddy, President, Public Health
Foundation of India, New Delhi.

Further research is indeed required to fill the
knowledge gaps regarding the distribution, outcomes,
and determinants of neurological disorders across
the country. Given the poor availability of proper
neurology health services, lack of knowledge and
awareness, limited scientific projects, and the stigma
attached to these disorders in the country, efforts
are needed by all stakeholders to the understanding
of neurological diseases, with regard to diagnosis,
treatment and preventive approaches wherever
possible.

“Several government policies and initiatives
are in place to address the burden of neurological
disorders across India, however more focused
efforts are required for the planning of specific
neurology services in each state. There is a need to
address the shortage of trained neurology workforce,
and strengthen early detection and cost-effective

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com COVER STORY 23

management of neurological disorders in the “Our Percept PC Deep Brain Stimulation (DBS)
country”, reflects Dr Vinod Paul, Member, NITI system enabled with BrainSense technology
Aayog, New Delhi. allows for more personalised, data-driven neuro-
stimulation treatment.”
Technology governing neuro-management - RAHUL ARORA
Head of Neurosciences Therapy, Medtronic India,
With the rise in incidences of neurological diseases Hyderabad
in India, the adoption of technology for diagnosing
and managing these conditions has accelerated “We are now at an inflection point, where with
rapidly in the past decade. In particular, the growth data, lots of computing power, and artificial
of the Indian neurological devices market is being intelligence, we can cloud-enable complex
driven by an emphasis on developing superior neuroscience-based workflows.”
neuro-modulation and neuro-stimulation techniques, - LAINA EMMANUEL
leveraging minimally invasive procedures that benefit Co-founder and Chief Executive Officer,
patients. The market is currently dominated by global BrainSightAI, Bengaluru
players such as Medtronic, Abbott, Stryker, Boston
Scientific, to name a few. “Approximately hundred potential drugs for
treatment of Alzheimer’s disease have failed between
As a recent development, India Medtronic, a 1998 & 2011, which shows the gravity of the problem.”
wholly owned subsidiary of Ireland headquartered - DR VIBIN RAMAKRISHNAN
firm Medtronic, has launched the Percept PC Deep Professor, Department of Biosciences &
Brain Stimulation (DBS) system enabled with Bioengineering, IIT Guwahati
BrainSense technology to offer enhanced comfort for
patients with Parkinson’s disease, tremor, dystonia,
and epilepsy.

Providing more information on this development,
Rahul Arora, Head of Neurosciences Therapy,
Medtronic India, Hyderabad says, “The system
enabled with BrainSense technology is designed to
capture brain signals while simultaneously delivering
therapeutic stimulation, inside and outside the
clinic. With Percept PC, physicians can now track
patient brain signals and correlate these with patient-
recorded actions or experiences such as symptoms,
side-effects, or medication intake. This allows for
more personalised, data-driven neuro-stimulation
treatment.”

In addition, the company has partnered with
Apollo Hospitals Group to integrate artificial
intelligence (AI) for advanced stroke management
for the first time in India. The US FDA approved AI
platform for stroke diagnosis has been validated by
clinical trials. The AI software will provide automated
analysis in less than two minutes as against currently
accepted imaging practices for diagnosis of stroke
that takes up to one hour to complete, enabling faster
decision making in stroke where every second counts.

“AI can play a significant role in stroke care,
diagnosis, and management. Since every stroke
patient is different, we need to improve on
predicting recovery and rehabilitation and that’s
where technology can help. AI has the potential for
application not only in diagnosis and management
but also in prediction. Many affordable AI
technologies can be implemented in low and middle
income countries (LMIC) for stroke management”,
says Dr Jeyaraj Pandian, Vice-President, World

24 COVER STORY BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

Dr Kausik Maiti
MD (Psychiatry), Senior Medical Director,

Parexel India, Hyderabad

“The simultaneous assessment of nerve function Psychiatric and neurological disorders (PNDs)
and brain blood circulation can allow urgent represent a significant burden for public health
treatment decisions to be made quickly in cases of worldwide. The World Health Organisation
stroke and hypertension.” (WHO) estimates that at least 450 million people
- DR SHUBHAJIT ROY CHOWDHURY suffer from PNDs worldwide. Depression (322
Associate Professor, School of Computing & million affected), bipolar disorder (60 million),
Electrical Engineering, IIT Mandi schizophrenia (23 million), dementia and
Alzheimer’s disease (50 million), and anxiety (260
“AI has the potential for application not million) are the most prevalent PNDs in the world.
only in diagnosis and management but
also in prediction. Many affordable AI The burden of neurological disorders is rapidly
technologies can be implemented in low and increasing, posing a challenge to the sustainability
middle income countries (LMIC) for stroke of health systems, including developing countries
management.” like India. The COVID-19 pandemic and its
- DR JEYARAJ PANDIAN devastating outcomes have further highlighted
Vice-President, World Stroke Organisation, issues of mental health. This clearly suggests the
Ludhiana availability of a growing pool of potential study
participants for clinical trials to be conducted in
India.

In a recent estimate by the Association of the
British Pharmaceutical Industry (ABPI), 38 per cent
of global research and development is invested
in oncology and immuno-oncology, whereas
other areas, such as respiratory and nervous
systems attract 9.3 per cent and 7 per cent
respectively. This is largely due to the perception
that therapeutic development in psychiatry is risky,
time-consuming, and tedious.

There are apprehensions that the underlying
science for psychiatric drug development

“It will take 10 years to build a world class Stroke Organisation, Ludhiana.
institution for ageing and neurological research”, Mumbai-based startup Qure.ai has leveraged
- ASHOK SOOTA
Chairman/Managing Trustee, SKAN, Bengaluru the growth of AI in this field, to develop a brain
computed tomography (CT) scan product called qER.
It covers both stroke and traumatic brain injury, and
provides support to physicians reading head CTs
in the emergency care setting to help radiologists
prioritise the most critical patients. It is the only
solution in the industry to detect every critical brain
abnormality on a head CT including five types of
intracranial hemorrhages, cranial fractures, infarcts,
midline shift, and mass effect (for tumor detection).

Going a step further, Bengaluru-based
startup BrainSightAI has designed a cloud-based
neuroscience workflow to enable greater precision

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com COVER STORY 25

Patient-focused approach to
combat neurological disorders

remains immature and the path to understanding With access to a huge population base
the very nature of mental disorders is too daunting. (approximately 18 per cent of the total world
The molecular and cellular underpinnings of most population), English speaking investigators
psychiatric disorders are complex and unknown (neurologists, psychiatrists and neuroscientists)
and psychiatric diagnoses still remain arbitrary. In along with the required infrastructure support
addition, drug candidates entering Phase III can fail systems such as the rapid extension of medical
at a rate of 40 to 50 per cent, where in most cases, infrastructure in Tier II and III cities, supportive
the cause of failure is lack of efficacy. government policies and use of technology,
all contribute to making international pharma
Over the last many decades, clinical development consider India for Phase II-III PND clinical trials.
in PNDs was restricted to ‘me too’ drugs rather than
any new biological target. While these drugs may Although the pandemic outbreak and the
have improved in terms of their safety and tolerability, ensuing lockdowns were a major blow to clinical
efficacy goals have somehow become unachievable. trials globally, it further spotlighted the importance
High placebo response, subjectivity associated of patient-centricity as the foundation for efficient
with rating scales, lack of objectively measurable studies and innovative drug development.
endpoints, high patient dropout, traditional preclinical
disease models that fail to accurately inform the There are already some promising startups
potential efficacy of compounds and changing or in India with research focusing on the use
unestablished regulatory requirements make this of technological innovation such as artificial
even more challenging. intelligence in the diagnosis and management
of neurological disorders. Also, a few Indian
Although researchers have identified biological biopharma companies are focused on discovering
pathways leading to neurodegenerative diseases and developing new chemical entities (NCEs) for
and developed promising molecular agents to target central nervous system therapies. Such innovations
them, delivering therapeutics across the blood-brain contribute to the overall ecosystem of R&D
barrier (BBB) and into the brain has been a challenge. associated with CNS therapeutic areas in India.

Despite these challenges, Indian clinical research In conclusion, in order to increase patient
has made noteworthy contributions in the Central participation, retention and study in the field of
Nervous System (CNS) drug development. Indian neurology and psychiatry, it is important for the
clinical trial data for drugs like safinamide and pharma and clinical trial industries to share expertise
apomorphine pump therapy are key for global and work to minimise the challenges that the sector
pharma to seek the United States Food and Drug currently faces. An innovative, agile, and patient-
Administration (US FDA) approval. focused approach is the right way forward.

in diagnosis and treatment planning of neuro- cloud-enable complex neuroscience-based workflows.
oncological and neuropsychiatric disorders. Now, doctors and researchers can focus on asking
questions and not on the mechanics of answering
Sharing her perspective Laina Emmanuel, Co- questions.”
founder and Chief Executive Officer, BrainSightAI,
Bengaluru says, “Neurodisorders, such as oncologic, Predictive diagnosis and therapeutics
trauma and psychiatric, are the third-leading
contributors to the global disease burden. To be Although technology adoption can play a vital role
able to address these potentially life-threatening in the management and treatment of the various
disorders better, the healthcare industry needs tools neurological diseases, we also need to develop a
to predict outcomes earlier, discover new clinical better understanding of their onset in order to build
and drug indications, and better understand drug preventive strategies. And this is where our scientists
and therapy responses. Such intuitive tools weren’t can help us out.
possible earlier. However, that is changing now. We
are now at an inflection point, where with data, lots of For instance, current treatments for Alzheimer’s
computing power, and artificial intelligence, we can only alleviate some of the symptoms of the disease,
while there is no disruptive therapeutic approach yet

26 COVER STORY BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

List of neuroscience that can treat the underlying causes. Thus, a team
research centres in India of researchers at Indian Institute of Technology
Guwahati (IIT-G) are exploring the use of low-voltage
● Indian Institute of Science (IISc), Bengaluru electric fields and Trojan peptides to delay the onset
● Indian Institutes of Technology (IITs) of the disease by at least 10 years.
● National Institute of Mental Health and
“Approximately hundred potential drugs for
Neurosciences (NIMHANS), Bengaluru treatment of Alzheimer’s disease have failed between
● Institute of Mental Health & Neurosciences 1998 and 2011, which shows the gravity of the
problem. Our research has provided a different path
(IMHANS), Kozhikode that may extend the onset of Alzheimer’s disease.
● National Centre for Biological Sciences (NCBS), However, it would take testing in animal models and
clinical trials before bringing in such new therapeutic
Bengaluru approaches into human treatment”, says Dr Vibin
● National Brain Research Centre (NBRC), Ramakrishnan, Professor, Department of Biosciences
& Bioengineering, IIT Guwahati.
Manesar
● Institute for Stem Cell Science and On the other hand, scientists at the National Brain
Research Centre, Manesar have developed a human-
Regenerative Medicine (inStem), Bengaluru based model that could help study how the brain
● University of Allahabad develops, particularly the neurons, and what goes awry
● University of Hyderabad during brain development leading to cognitive decline.
● Jadavpur University, Kolkata
● Indian Institute of Speech and Hearing, Mysuru Working on another interesting aspect,
● Birla Institute of Technology & Science-Pilani, researchers at the Indian Institute of Technology
(IIT), Mandi have invented a method to
Hyderabad simultaneously study the variations in nerve
● Rajiv Gandhi Centre for Biotechnology, functions and brain blood flow associated with brain
disorders such as Ischemic stroke. The new method
Thiruvananthapuram can help in locating and classifying damaged sites or
● Jawaharlal Nehru University, New Delhi lesions in the brain, brought about by, or leading to
● Sri Devaraj Urs Medical College, Kolar neurological diseases.
● Vellore Institute of Technology (VIT), Vellore
● Shri Chitra Tirunal Institute of Medical Sciences Dr Shubhajit Roy Chowdhury, Associate
Professor, School of Computing & Electrical
and Technology (SCTIMST), Trivandrum Engineering, IIT Mandi further explains, “The
● Shoolini University, Solan
● Raman Research Institute (RRI), Bengaluru
● Jawaharlal Nehru Centre for Advanced

Scientific Research (JNCASR), Bengaluru

List of neurological disorders in India

Non- communicable neurological disorders
● Stroke
● Headache disorders
● Epilepsy
● Cerebral palsy
● Alzheimer’s disease
● Other dementias
● Brain and central nervous system cancer
● Parkinson’s disease
● Multiple sclerosis
● Motor neuron diseases

Communicable neurological disorders
● Encephalitis
● Meningitis
● Tetanus

Injury-related neurological disorders
● Traumatic brain injuries
● Spinal cord injuries

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com COVER STORY 27

Facts

Stroke, headache disorders, and epilepsy are
the leading contributors to neurological disorders
burden in India.

Headache disorders comprising migraine and
tension-type headache were the most prevalent
neurological disorders in India in 2019, affecting
488 million people.

Source- Lancet study, 2021

simultaneous assessment of nerve function and Key global players in
brain blood circulation can allow urgent treatment neurology-devices market
decisions to be made quickly in cases of stroke and
hypertension. Our device can also help in identifying ● Abbott Laboratories, US
the progress of diseases such as Parkinson’s and ● B. Braun Melsungen, Germany
can in fact predict occurrence of these diseases even ● Boston Scientific Corporation, US
before presentation of symptoms.” ● Johnson and Johnson, US
● Medtronic, Ireland
To potentially accelerate therapeutic discoveries ● MicroPort Scientific Corporation, China
for neurological disorders, Indian Institute of ● Nihon Kohden Corporation, Japan
Technology, Madras (IIT-M) and Massachusetts ● Smith & Nephew, UK
Institute of Technology (MIT) scientists have recently ● Stryker Corporation, US
grown human brain tissues called organoids with
help of a 3D printed bioreactor. summer school to train master’s students in various
disciplines in neuroscience.”
With so many out-of-the box ideas emerging from
the scientific minds, one does get hopeful of finding Recognising these challenges, Ashok Soota,
a way out to combat these neurological diseases. former President of the Confederation of Indian
However, a major challenge that is facing the field of Industry (CII) has recently established probably
neurological research in India is dearth of funding. India’s first not-for-profit entity in the private sector
In the context of the country’s growing incidence of called SKAN, for neurological research with a fund
neurological disorders, the quantum of investment commitment worth Rs 200 crore. The projects will
in scientific research in the country is very minute. be done through reputed partners namely Centre for
As a result, India lacks foundational research Brain Research (CBR) at Indian Institute Science,
infrastructure, such as a comprehensive neuroscience Bengaluru (IISc).
data repository, which would serve as a critical
resource for future investigations into brain function “For problems related to both ageing and
and diseases. neurological disorders, the philosophy of the research
will include searching for kinder, gentler therapies;
According to Kris Gopalakrishnan, Chairman, delaying the onset and slowing down the progression
Axilor Ventures, Bengaluru, “We can increase of the disease and providing persons a better quality
the number of neuroscience research students in of life even as they live with the illness. It will take 10
India by attracting and ramping up the number of years to build a world class institution for ageing and
principal investigators, developing strong graduate neurological research”, says Ashok Soota, Chairman/
and undergraduate programmes and offering Managing Trustee, SKAN, Bengaluru.

As the neuroscience field evolves in the future,
and new needs and challenges emerge, it will become
imperative to fill the voids in knowledge and skill
sets. Thus, now is the time to strengthen partnerships
between the government, industry and academia
in order to develop a more tailored approach for
handling this growing burden in the country.

Dr Manbeena Chawla
[email protected]

28 AT-HOME DIAGNOSTICS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

Home diagnostics
turn inevitable necessity

With a change in people’s sentiment and expected to witness a high growth rate during the
armed with tech advancements, the home- forecast period. The Rest of the World accounts for a
based diagnostics sector is likely to sail small fraction of the market & it is expected to account
through smoothly. The recent great leaps in for more share during the later phase of the forecast
AI and IoT in healthcare, not to mention the period. India with a high population base offers a lot of
need to maintain ‘social distancing’ and lack opportunities for the home diagnostics market.
of workforce in the healthcare sector, as in
others as well, has become a driving force to Current trends
reckon with. Let’s explore this exciting new
phase in healthcare. The introduction of home-based diabetes testing kits
was the first to be introduced as a viable solution.
Gone are the days when one has to visit a Since then a lot of innovation has been made in
diagnostic centre, wait in a queue, and get home-based diagnostics.
tested for any ailment. Offering freebies, many
diagnostics players are in the fray to grab the market Gurugram-based Healthians has launched health
share. The COVID-19 pandemic has turned the home testing at home in 100 new cities in the country.
diagnostics market more lucrative with players in the For the expansion, Healthians is in the process to
sector going the extra mile to offer the best services recruit 1,500 support staff, including pathologists,
they can. phlebotomists, lab technicians and runners, over
the coming six months. According to Deepak Sahni,
The global at-home diagnostics market will CEO and Founder, Healthians, the second wave of
register to value over $6 billion by the end of 2026 COVID has made the entire nation understand the
and a CAGR of over 3 per cent during the forecast importance of diagnostics at home.
period of 2019-2026. According to a report from
Mumbai-headquartered Abbott launched its
FutureWise Research, North America and Europe Panbio COVID-19 Antigen Self-Test for the detection
dominated the global market due to high awareness of the SARS-CoV-2 virus. The Panbio COVID-19
among the general population. North America Antigen Self-Test. The kit contains all the materials
accounts for a 90 per cent market share due to high required including nasal swabs, test devices and
adoption. Europe, the UK, Germany and France reagent ampules. No additional instrumentation
dominated the global market due to high penetration is required to conduct the test. Sanjeev Johar,
among the general population. Divisional VP, Abbott’s rapid diagnostics business
in the Asia Pacific, Singapore says, “Self-testing is a
The Asia Pacific and Latin America portrays the proven tool that provides an added layer of defence
most opportunistic market for manufacturers due along with public health protocols and the vaccine
to the large patient population. Both the zones were rollout.”

“During the pandemic, the Lonavala, Maharashtra-based Mylab Discovery
demand has shifted from a Solutions’ COVID-19 self-test kit, CoviSelf is designed
treatment-based healthcare as the mid-nasal swab test and can detect positive
system to that of preventive results in just 15 mins, according to Hasmukh Rawal,
Managing Director, Mylab Discovery Solutions. Each
healthcare, largely due to unit contains a testing kit, instructions to use (IFU)
public awareness on health and leaflet and a bag to safely dispose of after testing.

prevention.” Gujarat-based Meril’s self-use Rapid Antigen Test
- Aishwarya Vasudevan, for COVID-19, CoviFind, provides accurate results in
just 15 minutes.
Group COO, Neuberg Diagnostics, Bengaluru
Redcliffe Life Diagnostics, headquartered out
of Noida, recently launched four new labs in Patna,
Indore, Raipur and Noida to respond to the new rise
in home comfort diagnostics prompted by post-Covid

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com AT-HOME DIAGNOSTICS 29

care. Bengaluru-based startup MyDiagnostics allows “The second wave of COVID-19
to book lab tests and offers health checkup packages
online. Partnering with NABL, ISO, CAP certified labs has made the entire nation
across the country, MyDiagnostics aims to provide
testing and diagnosis services at home. These are understand the importance of
some of the examples of home-based diagnostics.
The future of diagnostics will include the use of new diagnostics at home.” - Deepak Sahni,
technology such as medical implants that send data
to a smartphone and smartwatch to actively monitor CEO and Founder, Healthians, Gurugram
vital signs 24 hours a day, seven days a week.
“Self-testing is a proven tool
Technological innovations
that provides an added layer
Artificial Intelligence and Machine learning have
transformed the healthcare delivery system. The of defence along with public
diagnostics sector is no exception to this and with
the aid of technology has evolved to suit the need. health protocols and the vaccine
Discoveries like genomics and genetic testing will
make diagnostic services more personalised to the rollout.” - Sanjeev Johar,
needs of customers. Companies are investing heavily
in upgrading the technologies so that customers can Divisional VP, Abbott’s rapid diagnostics business,
get their tests done from the comfort of home.
Asia Pacific, Singapore
Aishwarya Vasudevan, Group COO, Neuberg
Diagnostics from Bengaluru says, “In the US, for “CoviSelf is designed as the
instance, the need for diabetes testing kits peaked mid-nasal swab test and can
during the surge in annual mortality rates from detect positive results in just 15
diabetes. During the pandemic, the demand has
shifted from a treatment-based healthcare system to minutes.”
that of preventive healthcare, largely due to public
awareness on health and prevention.” - Hasmukh Rawal,
MD, Mylab Discovery Solutions, Pune
Says Mumbai-based Sushant Kinra, COO,
Suburban Diagnostics, “Technological advancements “It’s an exciting space to be in,
and investments in a digital platform for in-vitro tests and we see a huge potential
will make the Indian IVD industry more accessible to for growth with advanced
clinicians and patients globally.” technological offerings.”

Just like in Amazon, where a very large portion - Vijender Singh,
of technology and investment is done to power CEO, Metropolis Healthcare, New Delhi
the Amazon experience, Metropolis is similarly
approaching at-home diagnostics. widened and enhanced the role of diagnosis.”

Vijender Singh, CEO, Metropolis Healthcare COVID impact
based out of Delhi opines, “In terms of innovation,
this means re-imagining the entire value-chain of India saw an unprecedented demand for home-
diagnostics very differently. We are now solving based tests with the start of COVID-19. The epidemic
processes like routing and scheduling of our exposed the flaws in the health systems and was an
collection agents, chat-bot based ordering systems eye-opener. People had to queue for hours to get the
for WhatsApp and integration of external health data tests done at the diagnostic centre and getting the
like IoT devices. It’s an exciting space to be in, and
we see a huge potential for growth with advanced
technological offerings.”

Dheeraj Jain, Founder, Redcliffe Life Diagnostics
says, “Monitoring and care are shifting from diagnostic
and healthcare facilities to the home, leveraging
technologies such as connected devices, IoT and
wearables. Especially with the advent of easy-to-use
medical equipment for self-diagnosis like sugar, BP
monitor, oximeter, and AI technologies, has drastically

30 AT-HOME DIAGNOSTICS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

HOME DIAGNOSTICS MARKET the main vehicle for detection. The availability of kits
PROJECTS CAGR OF 5% THROUGH 2030 has encouraged more people to test themselves at
home, increasing the demand for rapid test kits.
A report on the home diagnostics market
projects a substantial annual increase, reaching Aishwarya opines. “The COVID-19 pandemic
an impressive valuation in 2021 over 2020. With made ease of getting tested important, around the
an increasing proportion of patients opting for world. With RT PCR testing becoming mandatory
homecare, the market’s outlook is anticipated for travel, more people are getting tested, repeatedly.
to remain strong over the next 10 years, with Intercity lockdown restrictions have decreased
a projected CAGR of approximately 5 per cent visits to hospitals and clinics, in turn increasing the
through 2030. demand for diagnostic tests, in general.”

Source: Fact.MR report Says Jain, “Diagnostics is back in the spotlight,
thanks to a three-fold increase in testing,
“Monitoring and care are emphasising the urgent need for more well-equipped
facilities with qualitative testing capabilities.
shifting from diagnostic and
Tech steps
healthcare facilities to homes,
Tests done from the comfort of home are likely to
leveraging technologies such make a change in attitude in the common man’s
mind. With a highly populated country like India, the
as connected devices, IoT and healthcare need is going to rise and providers need to
find innovative ways to tackle the ever-growing need.
wearables.” - Dheeraj Jain,
Metropolis has been making all tests as a part of
Founder, Redcliffe Life Diagnostics, Gurugram home-collection and inching towards the goal. In
parallel, the diagnostics major wants to redefine the
“Technological advancements home-diagnostics experience at par or even ahead of
what people get from Zomato, Flipkart etc.
and investments in a digital
“The future of at-home diagnostics is now
platform for in vitro tests will largely dependent on the supply chain, which has
been stressed throughout the pandemic. With new
make the Indian IVD industry government initiatives towards healthcare and the
foray of strong private healthcare providers, many
more accessible to clinicians operational challenges can be circumvented with the
right synergies,” says Aishwarya.
and patients, globally.” - Sushant Kinra,
Kinra adds, “Leveraging technology to consolidate
COO, Suburban Diagnostics, Mumbai lab and testing services and improving the logistics
and supply chain will help to harness those
report took another three to four days. Many were opportunities. Investments for maintaining quality
reluctant to move out of the house which resulted in a standards and upgrading the skills and knowledge of
delay in starting the treatment. staff will also heighten activity and enhance skill sets
to match the technological advances.”
A joint statement by the Federation of Indian
Chambers of Commerce and Industry (FICCI) and A greater emphasis on drive-through testing
Ernst and Young (EY) states that the diagnostics stations, mobile vans for COVID sample collection,
sector saw a steep fall in volumes due to COVID-19. home collection, telemedicine, and telehealth services
On the other hand, the sale of home monitoring will aid in the growth of the home diagnostics sector.
devices and services such as sample collection from
home, online availability of reports and doorstep Promising future
delivery of medicines saw a rise.
Experts believe that the future of diagnostic
According to US federal data, the number of laboratories will favour more testing at the point of
lab tests increased by 6X in the last two months. In care (or near to the patient). This depends on the
mid-August 2021, the number of tests per day rose to supply chain, which was stressed throughout the
1.5 million, from 250,000 tests per day in July 2021. pandemic. With the help of government initiatives,
With plans to reopen schools across the world, the good technology, AI and machine learning, the future
demand for home-based diagnostics services is going of the home diagnostic segment looks promising.
to see a surge with rapid test kits for COVID-19 being
Sanjiv Das
[email protected]

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com IVD INDUSTRY 31

Indian IVD industry displays
resilience with 30% CAGR

2020 has been a catastrophe and a revelation at the «
same time. A disaster in the sense that COVID-19
spread to almost every country worldwide and the Thomas John,
World Health Organisation, declared it a public
health emergency. And, a revelation because the Managing Director,
diagnostic industry, like every entity on this planet,
adapted, evolved and survived this global health Agappe Diagnostics,
crisis by boosting indigenous manufacture.
Ernakulam
The pandemic has dramatically reduced the
walk-in patients to the hospital and standalone threat. In the context of COVID-19, IoT-enabled/
labs in view of unexpected infection controls linked devices/applications are utilised to reduce the
and scare. Reducing the risk of transmitting the possible transmission of COVID-19 to others by non-
virus to either patients or healthcare workers within contact, early diagnosis, timely monitoring of patients,
their practice, patients were deferring elective and and practising defined protocols after patient recovery.
preventive visits and regular check-ups. Wherever
possible, the majority was shifting from in-person IoT is increasingly becoming a vital technology in
visits to telemedicine visits. healthcare systems with cost-effective better solutions
and services. Processes like tracking, identification
Further, patients were also avoiding appointments & authentication and data collection, the exponential
because they do not want to be away from their growth of IoT in healthcare is expected to rise to $188
homes and risk exposure. So, there was a considerable billion in 2025 ($72 billion in 2020). In other words,
drop in healthcare utilisation from March 2020 and IoT technology during the COVID-19 pandemic has
patients tried to avoid interactions with the health proven its convenience and advantages in helping
professionals anticipating contracting the virus, patients, healthcare providers, and authorities to
including in outpatient appointments. The trend a greater extent. The global point of care (POC)
was the same in immunisations, cancer check-ups, diagnostics market size is projected to reach $50+
wellness services, all. There was a heavy drop at the billion by 2025. Technological advancements in POC
beginning of March 2020 and later the trend has devices, sky-rocketing instances of infectious diseases,
improved a bit. and big leaps in the investments by key players are
pivotal driving forces assisting the growth of the POC
During the pandemic era, the IoT (Internet of diagnostics market.
Things) sector, which is an advanced technology that
links all smart gadgets together within a network with COVID-19 impact
no human interactions, developed far & wide, owing to
the scare of people to travel to healthcare institutions. The COVID-19 pandemic has significantly supported
Any equipment which can be connected to the internet the POC diagnostics market after a short dip. The
for further monitoring or transferring data to another outbreak of COVID-19 has multiplied the global
device can be an IoT device. demand for diagnostic kits to rapidly detect the
disorders. However, countries across the globe are
In recent years, IoT has gained convincing research facing a severe dearth of laboratory-based molecular
ground as a new research topic in a variety of academic assays. Thus, many players are bent on supporting the
& industrial disciplines, especially in healthcare. The required supply of tests worldwide.
IoT revolution is reorganising healthcare systems from
conventional to more personalised healthcare systems The POC diagnostics market witnessed significant
through which patients can be consulted, diagnosed, growth in 2020, owing to the increasing usage of POC
treated, and monitored easily. tests that can rapidly diagnose COVID-19. With the
sharp rise in the demand for faster diagnostic results,
Since the pandemic commenced, there has been the acceptability of POC testing is thriving high.
ample effort in different research forums to exploit a
wide variety of technologies to combat this worldwide

32 IVD INDUSTRY BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

Supporting the call of the Prime Minister The test strip contains highly specific and
to support Atmanirbhar, from immediate sensitive COVID-19 monoclonal capture antibodies
development of all required COVID-19 and colloidal gold conjugated detector monoclonal
test kits to manufacturing millions antibodies which react with the nucleocapsid antigen
of tests, the Indian IVD Industry was present in the nasopharyngeal swab sample. The
the solution provider in the biggest sandwich structure formation and aggregation due to
healthcare crisis of our nation. From the the interaction between the antibodies and antigen
production capacity of 5,000 tests a day, will result in the colour band formation in the test
manufacturers could scale up their efforts and control line with the COVID-19 positive sample.
to produce more than 1,00,000 tests per The Self/Home test can offer 100 per cent specificity
day. IVD industry recorded a growth of and 70-80 per cent sensitivity as compared to the
30 per cent in the year 2020, with double RT-PCR assay (Ct value up to 38) if the procedure is
the rate at which the industry had been strictly followed. India has rightly emerged with self-
growing in the past decade. sufficiency to fight the COVID-19 crisis because Indian
in-vitro diagnostic devices (IVD) manufacturers
The multiplying number of COVID-19 cases and relentlessly worked to address the crisis with rapid
the alarming concern on governments to improve scaling up of testing for COVID-19. Testing and
patient management has boosted the demand for isolation were considered most important to contain
rapid antigen testing kits that can be effectively used the pandemic. The ever-increasing demand for
in point-of-care settings. Such fast-detecting tools are COVID-19 diagnostic tests has given a big boost to the
vital in providing accurate and effective treatment IVD industry.
strategies.
The government of India, through its flagship
Moreover, the increasing burden of other ‘Make in India’ initiative supported the Indian
respiratory illnesses across the globe, the shift towards manufacturers very much to meet the rising demand
decentralised diagnostics, and the easy availability to for essential healthcare equipment for the country,
POC devices through online platforms are the other pushing the Indian medical devices sector to epitomise
key factors likely to boost the long-term growth of the Atmanirbhar Bharat theory or self-reliance.
POC diagnostics market in the coming decade.
Supporting the call of the Prime Minister to support
COVID-19 Antigen Self-Test, currently the nucleic Atmanirbhar, from immediate development of all
acid-based polymerase chain reaction, is used as the required COVID-19 test kits to manufacturing millions
standard for COVID-19 diagnosis and Rapid Antigen of tests, the Indian IVD Industry was the solution
Test (RAT) is considered as the reliable platform for provider in the biggest healthcare crisis of our nation.
mass screening of COVID-19. Worldwide 60 per cent All IVD products like reagents, equipment and systems
of the COVID-19 disease diagnosis is dependent on used to diagnose and monitor COVID-19, cardio-
RAT and the remaining 40 per cent stake is held by vascular diseases, diabetes and other comorbidities
RT-PCR. Based on the high spreading rate and low were surging high. All players of IVD were meeting
testing pace, several countries have liberalised the RAT an increasingly supportive regulatory landscape
testing strategy for Self/Home testing by the patients. for product development and commercialisation.
In India, the Indian Council of Medical Research Indigenous development RT LAMP-based molecular
(ICMR) has given permission for COVID-19 self-test testing for COVID-19 was another milestone in our
by May 2021 in order to increase the testing rate in history. From the production capacity of 5,000 tests
rural areas. The laboratory-based COVID-19 antigen a day, manufacturers could scale up their efforts
testing has been modified as a self-test by altering to produce more than 1,00,000 tests per day. IVD
the testing protocol and by making the raw materials industry recorded a growth of 30 per cent in the year
like nasopharyngeal swab, prefilled lysis buffer user 2020, with double the rate at which the industry had
friendly. been growing in the past decade.

Benefits are ready to use COVID-19 antigen test IVD industry in the year 2019 was Rs 7500 crore
card, a patient can perform the test without any which was expected to grow at a CAGR of about 15 per
external help, required only nasal sample, easy sample cent before the pandemic crisis. COVID-19 has helped
collection, prefilled lysis buffer with dropper head for to boost the rate of growth to 30 per cent compared
direct sample addition to the cassette, result within 15 to 15 per cent expected. There is no room for second
minutes & the result can be synchronised with ICMR thoughts that Aatmanirbhar Bharat will take the
website also through the mobile app. medical devices industry to enviable horizons in the
coming years where quality and affordability will be
our bottom line.

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com SPEAKING WITH 33

“Our new focus areas to offer
services related to mRNA, plasmid
development, GMP manufacturing”

Bengaluru-based contract research, «
development and manufacturing
organisation Syngene International has Mahesh Bhalgat,
recently expanded its biomanufacturing capacity
to address the growing demand for outsourced Chief Operating Officer,
biologics manufacturing and encouraging
growth in the biologics business. In addition, Syngene International,
the company has adopted a multipronged
approach to attract the right talent as a part of its Hyderabad
expansion plans. Mahesh Bhalgat, Chief Operating
Officer, Syngene International, Hyderabad capabilities for bulk drug substance to meet the
shares more in this regard during a detailed growing requirements from our expanding client
interaction with BioSpectrum. Edited excerpts; base for end-to-end cGMP clinical and commercial
manufacturing.
The company has recently expanded its
biopharma-manufacturing capacity at the In the first quarter of FY 22, we signed a
Bengaluru centre. Could you elaborate on five-year agreement with IAVI, a USA-based,
the units added and how it is aligned with non-profit, scientific research organisation, to
its strategic focus on biologics as one of its manufacture three anti-HIV monoclonal antibodies
future growth drivers? for use in Phase I and II clinical trials. As the
development and manufacturing partner, Syngene
We have made investments in both mammalian will provide an integrated solution including cGMP
and microbial manufacturing. On the mammalian manufacturing of the drug substance and drug
side, we have added additional 2000 L single-use product. Our new focus areas to offer services
bioreactors to further enhance capacity to serve the related to mRNA and plasmid development and
needs of molecules such as monoclonal antibodies. GMP manufacturing gives us a unique position in
Recently, we also announced the completion of the market.
our new 500 L microbial facility which further
enhances our suite of offerings. Along with being Take us through your talent acquisition
a multiproduct facility, this facility is set up to strategies for expanding the overall
manufacture protein products and is also suitable headcount.
for manufacturing mRNA vaccines by producing
the plasmid DNA and the mRNA material. We Talent is one of the most critical assets for a
have also started offering cell banking services for research-focused innovation-driven organisation
biologics clients and are in the process of increasing such as Syngene and acquiring the right talent pool
the capacity in our GLP-certified viral testing is an essential part of our overall growth strategy.
facility, which is a unique facility in the country. We have adopted a multipronged approach to
attract the right talent. Firstly, we recruit young,
Other aspects of investment in biologics have fresh minds from various scientific-educational
been focused on increased digitalisation and institutes across the country and they then undergo
automation tools such as electronic lab notebooks, rigorous training through the Syngene Training
training records, and quality management systems Academy (STA). The objective of this training is
tools. These moves are geared towards our to prepare them for the practical job requirements
transition to paperless ways of working and help of the organisation as well as to develop their soft
avoid the risk of human errors, but also decrease skills. Secondly, given the global clientele that
operational costs and improve time-to-market. The we work with and the cutting-edge science that
recent investments have increased our production

34 SPEAKING WITH BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

happens in our labs, Syngene is the first choice for and predicting toxicity endpoints through an in-
Indian scientists who are based in the west and silico tool. Such tools help significantly reduce the
are looking at returning back to India. Not just time for drug discovery.
Indian scientists in the middle levels, we are also
able to attract senior expat talent from the west to Our scientific solutions benefit not only the
be a part of our leadership team. In recent times, life sciences sector but also the animal health,
we have recruited a number of senior leaders consumer goods, nutrition, agro-chemicals and
who have worked at various reputed and diverse specialty chemicals sectors. We work for 8 out of
organisations. They bring with them not only the top 10 pharma companies, our clients include
leadership skills but also a deep understanding Amgen, Abbvie, GSK, Merck, BMS, J&J, Sanofi
of the work culture and operating rhythm of our amongst others.
clients from a cross-company and cross-industry
perspective. What is the company’s growth projection for

We currently employ 5400 people, of whom the next five years?
4700 are scientists based in our laboratories in
Bengaluru and Hyderabad working on discovery, The pandemic has been a game-changer for many
development and manufacturing of small industries and particularly the pharmaceutical
molecules, large molecules, oligonucleotides and industry. The trend of outsourcing has only
specialty chemicals. increased with a lot more small biotechs coming
up and traditional pharma companies looking at
With the ongoing expansion of capacity in ways to diversify and de-risk. While we do not
our Hyderabad facility, which is mainly focused give forward-looking projections, suffice to say
on Discovery Chemistry, we have laid a strong that the fundamentals of the global biopharma
foundation by growing our laboratory footprint industry remain strong. There is good momentum
beyond Bengaluru. Last financial year, we expanded for new chemical entities and new biological entity
the facility and added capacity for 90 scientists. approvals by regulators underpinned by a strong
We have now launched Phase-III of the expansion, pipeline of drugs in the early stages of discovery
which will allow us to build additional capacity for and development. The continuing drive to reduce
300 scientists in addition to the 300 scientists who the cost and cycle times associated with drug
are already working there. discovery while driving productivity is expected
to increase outsourcing further, with significant
What are the fields of drug research that interest in the integrated drug discovery and
development model.
Syngene is currently focused on?
On the manufacturing side, growing demand
As a strategic partner to our clients, often working for biologics, huge capacity consumption
as an extension of their internal scientific teams, from vaccines, the capital-intensive nature of
we bring them the flexibility and efficiency to the business, and the complexity involved in
scale up rapidly and respond to challenges and biopharmaceutical manufacturing is driving
opportunities in a result-oriented, safe, and demand for outsourcing. We believe Syngene is
compliant manner. The scientific breadth and depth well-positioned to capture many of these market
of our portfolio are contributing to the development opportunities. Our Dedicated R&D Centres are
of new therapies for a wide range of diseases, with seeing good growth on the back of the expansion
each offering the prospect of making a meaningful of ongoing collaborations. The Discovery Services
difference to the lives of people living with such business is driving Syngene’s focus on integrated
conditions for example - we are proud of our work drug discovery (IDD) projects which give us the
to help Albireo Pharmaceuticals develop a new opportunity to extend our relationship with our
treatment for a genetic liver disease that affects clients to every stage of the value chain. In biologics
children. Our scientists also work on research manufacturing, we have expanded our mammalian
projects that focus on leukaemia, Parkinson’s and microbial capacity.
disease, inflammatory disorders, and fibrotic
disorders, demonstrating our growing capabilities Our investment plan primarily focuses on
across complex therapies. We are also using expansion across all divisions, capability additions
technology more effectively and have introduced and increased digitisation and automation. We
ways to improve toxicological analysis using data believe all these dimensions of growth contribute
analysis based approaches. As an example, we are to a positive growth environment in the next few
now able to reduce weeks-worth of work down to years.
a few mins by avoiding the synthesis of molecules
Sanjiv Das
[email protected]

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com SPEAKING WITH 35

“There is further scope for developing
the clinical research ecosystem,
including regulatory pathways in India”

As per the latest Clinical Research «
Organisation (CLRO) Market Report
by Frost & Sullivan (India), India is Ajay Tandon,
becoming an attractive destination for clinical
and preclinical research outsourcing supported Managing Director,
by quality scientific capability, the emergence
of the biosimilars industry, increased demand Veeda Clinical
for complex generics and availability of a large
number of patient volunteers. A key player of Research, Ahmedabad
the Indian CLRO market, Ahmedabad-based
Veeda Clinical Research is all set to capitalise and geographical markets to cross leverage our
on the growing R&D budget of the global capabilities and offer customised integrated
pharmaceutical firms. In conversation with research solutions for our clients. We are working
BioSpectrum, Ajay Tandon, Managing Director, towards further aligning our capabilities, systems,
Veeda Clinical Research, Ahmedabad reveals processes and people to realise the full potential of
the company’s future plans. Edited excerpts; our combination.

What strategies have been carved out for What are the recent clinical research
the company’s growth in the CLRO market? activities undertaken by the company?

We continue to see strong growth year-on-year as The clinical research industry is a highly competitive
we execute our strategic plan. While operations landscape where the key factors for success are
in the last quarter were impacted by the second time, experience, efficiency and high-quality
wave of the COVID-19 pandemic, this has begun science. We answer these needs by executing an
to normalise now. We recently raised $16 million iterative, interdisciplinary approach that is robust,
from Sabre Partners and a group of eminent HNI agile and efficient. As a reliable and trustworthy
investors, including Pranab Mody of JB Chemicals, partner to pharmaceutical and biopharmaceutical
Havells India Family Office, Nikhil Vora of Sixth companies, we believe in delivering quality services,
Sense Ventures and Arjun Bhartia of Jubilant. positive outcomes and experiences to its customers.
These distinguished investors chose to partner We plan, execute and work towards delivering value
with Veeda in realising the company’s vision to our customers through customised research
of becoming the preferred research partner for services, solutions and support. We maintain a
innovative pharmaceutical and biopharmaceutical close relationship with our customers and work
companies globally. The funds raised in this last in partnership with them. As a team, working
round were deployed primarily for the acquisition collaboratively and strategically responding to
of Bioneeds India, a leading preclinical research change, as it arises, allows us to explore multiple
organisation, besides ongoing investment in pathways to market.
capability enhancement in our clinical and
biopharma research services. Veeda’s investment Veeda’s clinical research facilities, resources and
in Bioneeds has been driven by our mission to offer scientific expertise offer the fastest turnaround time
a comprehensive portfolio of drug development with end-to-end clinical research support. Engaging
services spanning clinical, preclinical and in partnership enhances operational success and our
analytical services to innovative pharmaceutical ability to deliver quality research data as efficiently
and biopharmaceutical companies globally. Our and quickly as possible. We believe in supporting
capabilities are distinct with multiple adjacencies clients throughout their development journey,
and we see significant synergies across our clients responding to challenges with agility focused on a

36 SPEAKING WITH BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

successful outcome. patent expiries and we have been strengthening our
Together with clients, we build solution-driven capabilities to fully service this segment, including
the development of dedicated laboratories under
partnerships based on mutual trust and reliability. Ingenuity Biosciences and Bioneeds. We also see
Veeda partners and supports the drug development increasing potential for conducting late phase
process of leading pharmaceutical MNCs across clinical trials in India across a spectrum of drug
Europe, North America, India and China, Asia. products and therapeutic areas, as discussed earlier,
Veeda’s portfolio of services includes a set of clinical and have been investing in our team, processes and
research studies and ongoing trials for different technology to support our global clientele in these.
therapeutic areas and segments which include:
Oncology (Injectables & Oral Formulations); We believe that cross leveraging the capabilities
Ophthalmology; Psychiatry; NCE Molecules; and clientele across Veeda and Bioneeds will
Biosimilar Molecules; and COVID-19 (Vaccines, augment our growth potential in the coming years.
Oral Capsule & Tablets). In terms of clients and markets, we continue
to see significant potential in deepening our
Are you conducting any trials for COVID-19 engagement with our existing clients through a
vaccines right now? broader offering of services as well as enhancing our
penetration in some of the key global markets to
We are at different stages of the design and service more clients. In particular, we are relatively
execution of clinical trials involving vaccines and underweighted in the US in the context of the
other drug therapies targeted at COVID-19. market potential for our services and we would
focus on addressing this.
What safety measures are you following
while conducting the clinical trials? What is India’s position in clinical research

Veeda has a skilled team of scientists, investigators, when compared to its global counterparts?
research associates, quality assurance and other
support staff who are experienced in conducting Over the years, India has established itself as one
diverse trials of varying complexities over the years. of the leading pharmaceutical hubs and a preferred
They are critical to ensuring the rights, safety and destination for outsourcing research, leveraging
wellbeing of the volunteers and the integrity of the our strong industry ecosystem that includes
data generated in the trials we conduct. scientifically skilled human resources, global
quality infrastructure and compliances, and cost
Ensuring safety begins with the initial feasibility competitiveness. Within clinical research, India
of the proposed trial when we do thorough literature is a leading service provider supporting the global
research of the drug to understand its safety profile generic industry but we currently lag in global
including the reported side effects. This enables clinical trials for new and novel drug products.
us to establish appropriate study protocols and
screening criteria, with the support of the sponsors, As per recent reports published by market
and be prepared for the management of possible research firm GlobalData, in 2020, the Indian
adverse events. Our clinical staff assigned for the CLROs accounted for around 8.3 per cent of the
studies are duly qualified and fully trained in these global clinical trials. For a country that accounts for
study-specific requirements. 16 per cent of the global population and 20 per cent
of the global disease incidences, there is a case for
During the COVID-19 pandemic, we furthering global clinical trials in India.
implemented further screening criteria and safety
procedures to ensure the safety and wellbeing of the The New Drugs and Clinical Trials Rules of 2019
subjects during the trial period. in India have created a more robust regulatory
framework for conducting clinical trials in the
What are your growth plans for the next five country and especially during the COVID-19
years? pandemic, we have demonstrated the ability to
conduct large scale clinical trials in the country on
We will continue to invest, organically and accelerated timelines to generate dependable data
inorganically, in broadening and deepening our to support approvals of the required drugs and
service capabilities to support the development of vaccines. There is further scope for developing the
complex and novel generics and innovative drug clinical research ecosystem, including regulatory
products globally. We continue to see significant pathways, to support more global clinical trials in
growth potential in generics with the long pipeline India.
of products scheduled to go off-patent in the near
to medium term. There is a significant development Sanjiv Das
pipeline in biosimilars as well given scheduled [email protected]

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com SARS-CoV-2 37

Looking beyond vaccines
to fight SARS-CoV-2

It is difficult to predict how much protection vaccines «
will confer us against the new and future variants,
but we should avail the full benefits from them, Dr Ashok Kumar,
because they may reduce the disease severity &
deaths from the infections. A foolproof treatment to President – Centre
restrict it from proliferation or killing may take time
because new drug development is time-consuming for Research &
and also unpredictable.
Development, Ipca
We are all aware of the re-infections people
are experiencing after having been fully Laboratories Ltd.
recovered once from SARS-CoV-2, and
also the severe infections and eventually deaths of Mumbai
people who had taken the full course of the vaccines,
developed based on the knowledge available on 3, 2021, estimates that the true number of COVID-19
the genome sequencing of the spike protein; thus death toll may be more than 15 million, and the
suggesting that the seroconversion provided by recent surge in infections in the US, Australia, China,
natural infection or vaccines does not confer the South East Asia etc., is mainly due to Delta-variant,
desired long-term protection. These findings are which is equipped to evade the protection confer
further substantiated by recent reports concluding by existing vaccines. The UK, where more than 50
that not all who got infected develop neutralising per cent of the population is fully vaccinated, is also
antibodies to SARS-CoV-2. For example, the studies going through a similar threat.
conducted by scientists in Germany confirmed
that 85 per cent of people who came in contact The strong selective pressure created by an
with SARS-CoV-2 positive individuals did not infection acquired as well as vaccine-induced
develop antibodies against the virus. A similar immunity is the known factor for the emergence
study from Israel finds that 5 per cent of of the new, yet more infectious, variants and it is
COVID-19 patients, confirmed by RT-PCR, reasonable to accept that the new variants, namely
did not seroconvert. So, the million-dollar Delta or Mu will not put full stop on the emergence of
question is: Are the existing vaccines
redundant? yet more infectious versions. The increased
infectiousness and also the capacity of
More recent studies conducted by the evading the human immune system
Centre for Disease Control & Prevention confirms that there is more than spike
(CDC) have suggested that even younger protein mutations, which made Delta-
people with lower detectable levels
of virus, are unlikely to seroconvert variant different from its predecessors,
instilling doubts about the and this is the subject of the present
vaccination as a foolproof note!
approach to curb the pandemic
and pushing the need for a The understanding so far
long-term remedy to protect
the masses from serious We know that the mutation called
infection and eventually E484K in spike protein, which binds
deaths due to SARS-CoV-2. ACE-2 is present in all three variants,
namely α, β and gamma and is due to
A report published in
The Economist on August the substitution of glutamic
acid by a lysine residue at
position E484K in the spike’s
amino acid sequence. The
Delta variant (B.1.617),
creating havoc worldwide
had two sub-variants

38 SARS-CoV-2 BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

It is difficult to predict how much protection observed in the α-variant, in large amounts (Chem.
vaccines will confer us against the new World, 10, Aug. 2021). It is important to remind here
and future variants, but we should avail the that the vaccines developed so far for COVID-19 work
full benefits from them, because they may by eliciting antibodies against the spike protein of
reduce the disease severity & deaths from the original, so-called, Wuhan Virus strain, and may
the infections. The permanent solution, not yield immune response against the viral proteins
however, will be possible only when we present in the new variants and also those produced
have a method to detect the infection at its in abnormal amounts for securing its survival and
outset, well before the virus travels down making it more infectious!
to infect vital organs. A foolproof treatment
to restrict it from proliferation or killing may A vaccine that is made from attenuated or
take time because new drug development is deactivated virus, such as COVAXIN, developed by
time-consuming and also unpredictable. Bharat Biotech or CoronaVac developed by Sinovac
may also not be effective, if the virulence is either
namely B.1.617.1 and B.1.617.2. The double mutant because of overproduction of a particular viral
B.1.617.1 has two mutations, known as L452R and protein, such as Orf 9 b, or Orf 6 or N, observed in
E484Q, and triple has an additional V382L in the the case of α-variant!
spike protein. On the other hand, B.1.617.2 has spike
protein substitutions at 19R, (G142D), 156del, 157del, Krogan believes “It’s not just that we vaccinate
R158G, L452R, T478K, D614G, P681R, D950N and & we are done; we need many parallel strategies to
these mutations have been correlated with its much combat it.” He feels that the way new variants are
higher infectiousness. finding ways to remain relevant by becoming more
infectious, the best approach could be to shift the
What’s new? focus to the host and target one of our proteins that
the virus needs, making viral mutations irrelevant
The studies carried out by Krogan’s group at the as far as the protection from this infectious virus is
University of California brings a new knowledge that concerned, but is easier said than done!!
> 50 per cent greater infectiousness of α-variant
is not the result of a mutation in the spike protein, The Way Forward
as one might have thought, but due to Orf 9 b, the
protein present in large amounts and has high affinity It is difficult to predict how much protection
for one of the host proteins; Tom 70. The latter vaccines will confer us against the new and future
is vital for triggering the human innate immune variants, but we should avail the full benefits from
system. Tom 70 also interacts with a mitochondrial them, because they may reduce the disease severity
membrane to initiate the desired antiviral response, & deaths from the infections. The permanent
if infected by SARS-CoV-2. The inactivation of Tom solution, however, will be possible only when we
70, as the result of its interaction with Orf 9 b, gives have a method to detect the infection at its outset,
the virus an opportunity to grow uninhibitedly in well before the virus travels down to infect vital
the infected host cells. The raised levels of two more organs. A foolproof treatment to restrict it from
proteins, identified as Orf 6 and N, in the virus are proliferation or killing may take time because new
known to antagonise host immunity and may be drug development is time-consuming and also
supportive to its increased infectiousness. unpredictable.

With the absence of Orf 9b and also the Mutations are the key especially for RNA viruses
understanding that only 7 out 18 mutations known to sustain the evolving human immune environment;
so far in eight proteins of SARS-CoV-2 are in spike however, since virus persistence also depends on a
protein, one can easily infer that the cause for the host to survive, there is a limit to go. On the other
high virulence of Delta-variant is due to something hand, some of the mutations may prove detrimental
different than observed in α-variant and also lies to viruses, thus giving us a hope that sooner or later
outside of the spike protein. SARS-CoV2 will either get redundant or slow down,
as happened with other viruses in the past. However,
Based on the knowledge developed by his team, our immune system is strong enough to give complete
Krogan hypothesised that it could be simply because protection (Cell, May 2021), as substantiated by
of some changes in the regulation of the expression uncountable numbers of senior citizens emerging out
rates, rather than the viral protein sequences as winners against COVID-19.
themselves, producing proteins similar to Orf 6&N,
We can trust and keep in good shape by simply
modifying our lifestyle, behaviour and habits to
continue living a healthy life, even though this virus is
likely going to cohabit with us forever.

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com ACADEMICS NEWS 39

ASU’s School of Pharma Sciences IIT-G inks R&D
joins hands with PHDCCI collaboration
with Amrita
Gurugram-based Apeejay Stya up and technology transfers, Vishwa
University (ASU)’s School skill development and other Vidyapeetham
of Pharmaceutical Sciences areas. Apart from knowledge
and apex industry chamber dissemination through national The Indian Institute of
PHDCCI (PHD Chamber of and international guest lectures, Technology, Guwahati
Commerce and Industry) have workshops, conclave and (IIT-G) is collaborating with
recently signed a Memorandum seminars, it seeks to ensure Amrita Vishwa Vidyapeetham
of Understanding (MoU) industry readiness, internships (AVV), a private, deemed-
facilitating collaboration in and faculty development university based in
the incubation of ideas, new programmes. Among other Coimbatore, in Education
product development, two-way things, it will be of major benefit and Research activities.
knowledge-sharing, scale- to the students to enhance This will help in enriching
their skills and knowledge. academic programmes
Industry-academia interface and promote an exchange
has always been a focus area in of students between two
ASU’s approach to education. institutions. A Memorandum
The MoU with the PHDCCI of Understanding (MoU)
would provide a formal basis for towards this collaboration
collaboration between industry was signed by Prof. T.G.
and academia to develop Sitharam, Director, IIT
required skills in a path towards Guwahati, and Prof. Venkata
excellence. Rangan, Vice-Chancellor,
AVV, recently. IIT Guwahati
Global Dental Academy and AVV will encourage
opens in India cooperation between
their faculty members,
In a major leap, the Global Healthcare Academy (GHA) - India’s first Med departments, and research
Ed Tech company founded by Dr B S Ajaikumar, Executive Chairman centres including visits of
of HCG Hospitals in Bengaluru, along with Dr Girish Rao and Dr faculty members to deliver
Anand Krishna (maxillofacial surgeons of repute from Bengaluru) have lectures, conduct seminars,
launched the Global Dental Academy (GDA). The Global Dental Academy discussions, research and
will initially offer courses such as digital supervise student studies.
dentistry, smile designing, implantology, Students’ visits to attend
infection control in dental surgery, medical courses and jointly develop
emergencies in dentistry, to name a few. teaching programmes would
Besides online Courses, GDA will also also be encouraged along
conduct workshops and hands-on practice with collaboration in research
courses. The future oral implantology has projects.
developed and progressed into a central
core of the art and science of dentistry.
This field, over the course of its existence,
has transformed from a modality on the
fringes of the profession to being embraced
by virtually every component and aspect of
our discipline. Oral Implantology is a discipline filled with complexity.
The field demands its practitioners to have a high level of expertise in
a vast array of areas, many of which evolve at a fast rate. These courses
aim to introduce its participants to a fascinating subspeciality whilst
understanding its core concepts.

40 APECOAPDLEEMNIECWSSNEWS BBIOIOSPSEPCECTRTRUUMM || OACUTOGBUESRT 2021 | www.biospectrumindia.com

Dr Renu Swarup Portea Medical elevates
takes additional Meena Ganesh as Chairperson
charge as DST
Secretary The Founder and Chief Executive Officer (CEO) of Bengaluru-
based startup Portea Medical, Meena Ganesh has now been
The government has approved elevated to the position of Chairperson. Vaibhav Tewari has now
the assignment of the additional taken charge as the company’s CEO. In her new capacity, Meena
charge of the post of Secretary, will be building strategy, mergers and
Department of Science & acquisition (M&A), driving advocacy
Technology (DST) to Dr Renu and relationships with stakeholders
Swarup, currently serving as such as institutional partners,
the Secretary, Department government bodies, investors and
of Biotechnology (DBT) with external communication. Till February
immediate effect and till the 2013 before she founded Portea, Meena
appointment of a regular was a promoter and board member of
incumbent or until further TutorVista, and CEO and MD of Pearson
orders, whichever is earlier. She Education Services, which included
recently received an extension in innovative and successful brands such
her tenure as DBT Secretary for as leading online tutoring company, TutorVista, and Edurite, a
a period of six months beyond provider of technology-based solutions and digital content. Prior to
April 30, 2021; upto October 31, her stint with Pearson, Meena set up the Tesco Hindustan Service
2021, until further orders. She Center, Tesco’s outsourced IT services and analytics operation in
has served in the Department of India, and served as the CEO.
Biotechnology for nearly 29 years
and was holding the position of Mansukh Mandaviya steps
Senior Advisor/Scientist ‘H’ till in as Chairperson of Stop
she was appointed a Secretary TB Partnership Board
to the Government of India on
April 10, 2018. With a PhD in Union Minister for Health and Family Welfare Mansukh
Genetics and Plant Breeding, Mandaviya has taken charge as the Chairperson of Stop TB
Dr Renu Swarup has also been Partnership Board. The minister will hold the responsibility
closely involved in programmes until 2024. He will lead the efforts of the Stop TB Partnership
and activities related to Women
and Science. She was responsible Secretariat, partners, and the TB community at
for getting implemented the large, towards reaching the UN TB targets by
DBT Scheme on Biotechnology 2022, a milestone moment in the effort to
Career Advancement for Women end TB by 2030. Former Union Minister
Scientists – Bio CARE. She was for Health and Family Welfare Dr Harsh
also a member of the Task Force Vardhan was earlier appointed as the
on Women in Science constituted Chairman of the Stop TB Partnership
by the Scientific Advisory Board. Soon after the cabinet reshuffle,
Committee to the Prime Minister. this change was announced. The Stop
TB Partnership is a unique international
body with the power to align actors all
over the world in the fight against TB.
The participation of a wide range
of constituencies gives this global
body the credibility and the broad
range of medical, social and
financial expertise needed to
defeat TB. The Partnership’s
vision is a TB-free world.

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com 41

TICEL BIO PARK LIMITED

TICEL BIO PARK Ill - The cradle of life science enterprise is a joint venture of
Tamilnadu Industrial Development Corporation Ltd (TIDCO) and TIDEL Park which
spreads across a sprawling 10 acres and is strategically located right next to Anna
University. The ambitious project is spread across G+13 floors and offers cutting
edge facilities for Biotech, Pharma and IT / ITES Companies. High end lab spaces
stand out as unique value propositions of the facility.

TICEL BIO PARK – Phase III -The tallest building in Coimbatore
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42 APECOAPDLEEMNIECWSSNEWS BBIOIOSPSEPCECTRTRUUMM || OACUTOGBUESRT 2021 | www.biospectrumindia.com

American Association of Atul Soneja joins
Neurological Surgeons
honours Dr BK Misra CitiusTech as

Dr BK Misra, Head of the Department of Surgery and President- Operations
Division of Neurosurgery & Gamma Knife Radiosurgery,
PD Hinduja Hospital & Medical Research Centre, Healthcare technology solution provider
Mumbai received the International Lifetime Achievement CitiusTech, with operations in India and the
Award from the American Association of Neurological US, has announced the appointment of Atul
Soneja as President - Operations. Soneja will
Surgeons (AANS) at its focus on strengthening CitiusTech’s delivery
Annual Scientific Meeting organisation, including its proficiency teams
2021 in Orlando recently. He and corporate functions, to drive operational
is the first Indian ever to be quality, scalability, and service delivery
bestowed with this award. excellence. Based out of Bengaluru, Soneja
Dr Misra is the Honorary has over 26 years’ experience in building and
President of Asian Australasian scaling technology products and services
Society of Neurological organisations across the globe. Before
Surgeons (AASNS), is joining CitiusTech, he was the Global Head
the first Vice President of of EdgeVerve, a subsidiary of Infosys that
the World Federation of focused on AI and automation products and
Neurosurgical Societies platforms. Prior to EdgeVerve, he handled
(WFNS), and President of the multi-billion-dollar IT services businesses at
World Federation of Skull Infosys, across multiple industry verticals like
Base Societies, all leading Financial Services, Manufacturing and Retail.
international neurosurgical
societies. Dr Misra was the first to execute Image-Guided
Aneurysm Microsurgery globally and the first in South
Asia to perform Gamma Knife Radiosurgery. Acoustic
Neuroma Surgery, Vascular Neurosurgery (Aneurysm,
AVM), Skull Base Surgery, Pituitary Surgery, Gamma
Knife Radiosurgery, Awake Craniotomy, Minimally
Invasive Neurosurgery, and Surgery of Complex Brain
and Spine Disorder are among Dr BK Misra’s areas of
expertise in neurosurgical patient care.

Jubilant Biosys appoints Giuliano Perfetti as CEO

Bengaluru-based contract among others. Before joining
research organisation Jubilant Jubilant Biosys, Perfetti was
Biosys has announced the associated with Fabbrica
appointment of Giuliano Perfetti Italiana Sintetici (F.I.S) as Chief
as its Chief Executive Officer Commercial Officer and was
(CEO). Perfetti has more than responsible for strategising and
20 years of experience across executing the company’s growth
diverse businesses and global plan and ramping up the global
markets with expertise in scale-up and commercial service
strategy, sales, marketing and business. Jubilant Biosys is a
business development. He has part of the Jubilant Pharmova
led business transformation and family of companies with R&D
expansion programmes working centres in India and business
in reputed names including offices in Asia and North
Accenture and AstraZeneca America.



44 R&D NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

IIT-B develops low-cost sensors to detect pulse rate variability

A research team from the can coat several substrates with monitor the pulse waveform of
Indian Institute of Technology, support from the Advanced a human radial artery in real-
Bombay (IIT-B) has developed Manufacturing Technologies time is aligned with the ‘Make in
low-cost soft, flexible, and programme of the Department India’ initiative, and researchers
wearable sensors that can be of Science & Technology (DST), have applied for 3 national
used for the diagnosis of pulse Government of India. The patents for these sensors. The
rate variability in humans. technology which can be used to sensors have been tested for
Being a high sensitivity flexible their different levels of strains
pressure/strain sensor, it can like micro and large scale motion
also be used for small and monitoring and have potential
large scale motion monitoring, applications in biomedical
with potential applications in devices, skin electronics, and
robotics, prosthetics, as well minimally invasive surgery. This
as minimally invasive surgery frontier technology for wearable
and identification of tumour/ and robotic devices applications
cancerous cells. The team has is in the third stage of the
fabricated these tactile (pressure Technology Readiness Level,
and strain) sensors using low- and the team further plans to
cost polyurethane foam and develop a prototype for an array
nanomaterial-based inks that of sensors in the future.

IIT-M, VIT build air Joint study by IIT-H
sanitisation tech for
COVID-19, TB prevention to enhance sperm

Indian Institute of Technology, Madras (IIT-M) and Vellore competence for IVF
Institute of Technology (VIT), Chennai, have collaborated
with Queen Mary University of London (QMUL), the A group of researchers from the Indian
UK, to develop India-centric air sanitisation technologies Institute of Technology, Hyderabad
and guidelines to prevent the spread of coronavirus and (IIT-H), Mangalore University,
tuberculosis (TB). The system is aimed at deployment in Kasturba Medical College, Manipal,
confined indoor places such as offices and hospitals. The and Manipal Academy of Higher
Education, has designed a small organic
joint research aims to develop molecule mPTX which improves the
a robust low-cost bio-aerosol sperm functional competence required
protection system to suppress for in vitro fertilization (IVF). The
air-transmitted diseases studies have demonstrated that mPTX,
in indoor locations. In a pentoxifylline derivative, was able
collaboration with Magneto to increase sperm motility, prolong
Cleantech, a pioneering in vitro sperm survival, improve
industry startup based sperm fertilisation potential, without
in Delhi, the testing and adversely affecting the development
of the embryos at a much lower
implementation will be done with concentration compared to the
real-time applications in various widely used pharmacological agent -
Indian environments. The target geographies for this project pentoxifylline in IVF technology. mPTX
are India and its adjacent countries. The major factor can be a potential drug candidate
working with this area is the high population and heavy for aiding viable sperm selection in
urban pollution. The joint consortium will develop products patients having immotile or poor motile
that would be commercialised through Magneto along with spermatozoa in the ejaculate or from
the academic institutions. This will pave the way for many the testicular biopsy, and for increasing
new job openings for young budding engineers. sperm motility before IVF.



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

IISER Bhopal BRICS to study overlap of
identifies SARS-CoV-2 with tuberculosis
mechanism of
breast cancer Department of Biotechnology (DBT), Ministry of Science and Technology,
progression Government of India in collaboration with BRICS countries (Brazil,
Russia, India, China, and South Africa) is implementing SARS-CoV-2
Researchers at the Indian NGS-BRICS consortium and multi-centric programme to study the impact
Institute of Science Education of severe COVID-19 conditions on tuberculosis (TB) patients. The SARS-
and Research (IISER), CoV-2 NGS-BRICS consortium is
Bhopal have shown the an interdisciplinary collaboration to
mechanism by which breast advance COVID-19 health-relevant
cancer cells proliferate and knowledge and to contribute to
spread. Their findings have improvements in health outcomes.
important implications The consortium will accelerate the
in designing therapeutic translation of genomic data leading
interventions for breast to clinical and public health research
cancer. The IISER team and interventions from clinical and
studied the regulation of surveillance samples by utilising the
one particular gene called high-end genomic technologies, and
‘ESRP1’ in breast cancer. epidemiologic and bioinformatics
The researchers found that tools for future use in diagnostic
there is a difference in the assays and tracking transmission dynamics of COVID-19 and other viruses.
expression of the ESRP1 gene The collaborative study is expected to provide valuable co-morbidity data
between normal and tumour about pulmonary TB patients with or without COVID-19 co-infection that
tissues of breast cancer is expected to be generated for better disease management.
patients. The researchers
explored the regulatory INST designs bio-nanocarrier
mechanism behind ESRP1 to treat visceral leishmaniasis
upregulation in breast
tumour tissues. According A group of researchers at the Institute of Nano Science and Technology
to the researchers, the (INST), Mohali has developed a non-invasive, easy to administer, cost-
finding that such intelligent effective, and patient compliant potential therapeutic strategy against
regulatory mechanisms Visceral Leishmaniasis, a neglected tropical disease. Their strategy based
exist in cancer cells to on nano carrier-based oral drugs coated with vitamin B12 enhanced
alter the expression of
essential genes as and oral bioavailability and efficacy of
when required, resulting in the therapy by more than 90 per
cancer progression, lays the cent. Visceral Leishmaniasis (VL)
foundation towards a better is a complex infectious disease
understanding of a complex transmitted by the bite of female
disease and for improved Phlebotomine sandflies. It is a
therapeutic strategies. neglected tropical disease that
affects millions annually, making
it the second most common
parasitic killer after malaria. The
researchers have developed a smart
and intelligent nanocarrier utilising
the natural intrinsic vitamin
B12 pathway present in the human body that can mitigate stability
challenges and drug-associated toxicity. Anchoring vitamin B12 on the
surface of solid lipid nanoparticles augmented the stability and targeted
delivery of the poorly soluble drugs and also enhanced the therapeutic
efficiency with reduced risks of off-target actions.



48 SUPPLIERS NEWS BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

Sciex unveils capillary electrophoresis solution BioPhase 8800 system

Sciex has launched the latest throughput, sensitive CE-SDS scientists can quickly understand
capillary electrophoresis (CE) and Capillary isoelectric focusing molecular liabilities and
solution, the BioPhase 8800 (CIEF) analysis, resulting in ensure the development and
system. This is the only multi- uncompromised accuracy for manufacture of robust, stable
capillary system for capillary large sample sets. With this biologics. Parallel processing
electrophoresis sodium dodecyl of eight samples dramatically
sulfate (CE-SDS) that processes system, accelerates analysis and shortens
eight samples simultaneously, new therapy development; while
retaining sample integrity and experiment design speed can
delivering consistent, accurate increase from 1 month to as quick
results. The development of
increasingly sophisticated as 1 week. High-throughput,
biopharmaceutical therapies precise quantitation of
requires the ability to critical quality attributes for
measure and monitor critical large sample sets delivers
quality attributes consistent, comparable
in short timelines. data throughout the
The BioPhase 8800 pipeline, from
system enables high bioprocessing to
R&D to QA/QC.

Fusion Antibodies, Agilent reveals
development of
Eurofins focus on COVID-19 severity
screening method
preclinical drug
Agilent Technologies Inc. has announced that
discovery research researchers at the Indian Institute of Technology
Bombay (IIT-B) and the QIMR Berghofer Medical
UK-based contract research organization Research Institute in Australia have developed a
Fusion Antibodies has entered into a rapid method for differentiating COVID-19-positive
commercial collaboration with Eurofins, a patients expected to
leading supplier of products and services to show severe symptoms
the drug discovery industry. The collaboration from those likely
between Fusion Antibodies and Eurofins to experience only
Discovery will last for an initial two-year mild symptoms.
period and is a commitment to provide world- The classification
class scientific expertise, next-generation algorithm, published in
technology, and guidance to accelerate the the journal Analytical
delivery of the best possible antibody against Chemistry, is based
a broad range of targets and therapeutic areas on infrared spectra of
into the clinic. Under the agreement, Fusion blood plasma, acquired on an Agilent Cary 630 FTIR
Antibodies will provide comprehensive pre- Spectrometer. In the study, the researchers collected
clinical antibody development services from infrared spectra of blood plasma from 160 COVID-
discovery, engineering, and critical reagent positive patients from Mumbai (130 as a training set
supply to Eurofins so that together they for model development and 30 as a blind test set for
can provide a complete workflow solution model validation). The spectra, collected on a Cary
for busy researchers. This includes Fusion 630 FTIR spectrometer equipped with a diamond-
Antibodies services for antibody generation, attenuated total reflectance (ATR) sampling module,
characterisation, sequencing, engineering and revealed slight but observable differences between
expression, and Eurofins Discovery’s in vivo severe and non-severe COVID-19 patient samples.
and in vitro services, such as efficacy models,
bioanalytical services, biomarker development,
phenotypic assays and safety assessment.

BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com SUPPLIERS NEWS 49

HMD achieves Thermo Fisher,
production capacity of
over 1 Bn AD syringes AstraZeneca to

Hindustan Syringes & Medical Devices Ltd (HMD), New co-develop NGS-
Delhi-based manufacturer of disposable and auto disable
(AD) syringes has achieved the target committed to based companion
create capacities to produce over 1 billion AD syringes for
COVID-19 vaccination per diagnostics
year to support the massive
vaccination campaign to Thermo Fisher Scientific’s clinical
eradicate the disease and help sequencing business and AstraZeneca
make India Atmanirbhar. are co-developing next-generation
It has also achieved the sequencing (NGS)-based companion
milestone of producing over diagnostics (CDx) to support
1 crore pieces of assorted AstraZeneca’s expanding portfolio of
size of syringes daily. Last targeted therapies. The companies will
year in December, HMD had collaborate under a multiyear, global
already dispatched 14 crore agreement. NGS-based companion
AD syringes to the COVAX diagnostics are increasingly used to
stockpile facility created in match patients with new therapies for
anticipation of supporting a cancer and other diseases. More than
global worldwide vaccination 90 per cent of AstraZeneca’s clinical
drive. At HMD, the machines pipeline, across all main areas from
crank out more than 4.2 lakh oncology, cardiovascular and renal to
syringes of various types per metabolic and respiratory disease, are
hour at the factories spread targeted precision medicine therapies.
over 11 acres in Faridabad industrial district in Haryana. Thermo Fisher currently offers the only
HMD has the capacity to produce over 250 crore assorted globally distributable NGS CDx solution
syringes of various types and sizes per year. The company is approved and reimbursed by government
investing over Rs 100 crore from its own resources, to scale and commercial insurers in more than
this up to 300 crore and more. 15 countries, including the US, multiple
European nations, Japan, South Korea
and the Middle East, and covering more
than 550 million lives globally.

Avantor buys Masterflex bioprocessing biz for $2.9 B

Avantor has entered into a pumps and aseptic single-use platforms including monoclonal
definitive agreement to acquire fluid transfer technologies with antibodies (mAbs), cell and
the Masterflex bioprocessing estimated 2022 revenues of gene therapy and mRNA,
business and related assets of approximately $300 million. The and supports both therapy
Antylia Scientific, a privately acquisition strengthens Avantor’s and vaccine manufacturing
held, portfolio company of offering across all bioproduction including COVID-19. Masterflex
investment firms GTCR and has business characteristics
Golden Gate Capital. The all- common to Avantor including
cash transaction is valued at its premium brand, stringent
$2.9 billion, subject to final quality standards, specification-
adjustments at closing. Given driven model and highly recurring
anticipated tax benefits from the revenue. Avantor will leverage
transaction structure, the net its differentiated channel and
purchase price is approximately deep biopharma customer
$2.7 billion. Headquartered in relationships to enhance growth
the US, Masterflex is a leading opportunities in both research
global manufacturer of peristaltic and production environments.

50 LET’S TALK HEALTH & SCIENCE BIOSPECTRUM | OCTOBER 2021 | www.biospectrumindia.com

Prostate cancer eludes
effective diagnosis-prognosis

It is undoubtedly hard to hear the news of a cancer prostate, a major issue is that it’s often hard to tell
diagnosis, but that’s what an estimated 34,540 how quickly the cancer is likely to grow and spread.
men heard in India when new cases of prostate This can affect whether cancer needs to be treated
cancer were reported in 2020. Prostate cancer is the right away, as well as which types of treatment might
most frequently diagnosed cancer in 112 countries, be good options.
followed by lung cancer in 36 countries, and colorectal
cancer and liver cancer each in 11 countries. The widespread use of prostate-specific antigen
(PSA) screening has led to earlier detection and
Although the actual incidence of prostate a dramatic down-staging of prostate cancer at
cancer in India is lower than that in the Western diagnosis but also has resulted in overdiagnosis and
populations, the incidences are now considerably overtreatment of this indolent disease. For instance,
increasing in the urban population. But for a disease most men with an elevated PSA level turn out not to
as common as prostate cancer, relatively little is have prostate cancer; only about 25 per cent of men
known about its aetiology. Established risk factors who have a prostate biopsy due to an elevated PSA
are limited to advancing age, family history of level actually are found to have prostate cancer when
this malignancy, and certain genetic mutations in a biopsy is done. But then possible side effects of
tumour suppressor genes called BRCA1 and BRCA2. biopsies include serious infections, pain, and bleeding.
Mutations in a few DNA repair genes might also be
responsible for some hereditary prostate cancers. Traditionally, prostate cancer is diagnosed using
needles inserted into the prostate gland in several
Now some gene mutations can be passed from places under the guidance of transrectal ultrasound
generation to generation (inherited), while some (TRUS) imaging to collect samples of tissue. This
genes mutate during a person’s lifetime, and the approach is called a systematic biopsy.
mutation is not passed on to the next generation.
Most gene mutations related to prostate cancer seem However, ultrasound does not generally show
to develop during a man’s life rather than having the location of cancer within the prostate. It is
been inherited. For instance, exposure to radiation or mainly used to make sure the biopsy needles go into
cancer-causing chemicals can cause DNA mutations the gland safely. Therefore, biopsy samples using
in many organs, but so far these factors haven’t ultrasound guidance can miss cancer altogether, or
been shown to be important causes of mutations in identify low-grade cancer while missing areas of high-
prostate cells. grade, potentially more aggressive cancers.

Further, studies have revealed that people who Of late, colour doppler ultrasound is being used
are obese may have a higher risk of prostate cancer that may make prostate biopsies more accurate
compared to people considered to have a healthy by helping to ensure the right part of the gland is
weight. In obese people, the cancer is likely to be sampled but further studies are still required in this
more aggressive and more likely to return after initial space.
treatment.
As a result, clinical imaging research needs to be
Moreover, distinguishing the lethal from non- done to address the clinical management problems in
lethal is the overarching problem in the clinical prostate cancer. New serum tissue biomarkers with
management of prostate cancer. Many men who greater sensitivity and specificity can be developed
develop prostate cancer never have symptoms or and validated. In addition, novel imaging techniques
undergo therapy and eventually die of other causes. can be explored for their potential in detecting
The natural history of prostate cancer is remarkably early disease, guiding tissue biopsy, and planning
heterogeneous and still not completely understood. treatment.

Particularly for men with prostate cancer that is Dr Manbeena Chawla
localised i.e. not thought to have spread outside the Executive Editor

[email protected]