BioSpectrum India 20th Anniversary Special

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52 POCD BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY WHY POINT-
OF-CARE
HASMUKH RAWAL DIAGNOSTICS
Managing Director, IS BOOMING
Mylab Discovery Solutions
The POCD market is poised for
Point-of-care diagnostics significant growth due to the increasing
(POCD) play a pivotal role in the prevalence of chronic diseases which
need long-term care and frequent
healthcare sector. Over time, it monitoring, and rapidly growing
has gained significant attention demand for cost-effective and innovative POC
diagnostic products. Furthermore, the COVID-19
for rapid diagnosis of various pandemic has created a paradigm shift in the POC
life-threatening or infectious testing scenario in India. It has driven research
diseases like cancer, diabetes and focused on the development of testing strategies
infectious diseases, as well as which can be rapid and economical, and can be
for monitoring patients’ health implemented in the community as a point-of-
care testing. The pandemic has accelerated the
conditions. POC devices are decentralisation trend in testing. Reaching closer
regarded as efficient diagnostic to patients outside of laboratories, hospitals,
homes enables a faster response to clinical needs.
options to prevent delays in
treatment, a crucial aspect in The developing healthcare infrastructure,
preventing high mortality rate the rising focus towards product innovation and
and transmission of infectious efficient POC diagnostics kits for patients, and the
increasing patient population along with growing
agents. cases of chronic disease will promote growth of the
market. We believe this market can grow near to 18
per cent year-on-year.

Recently, ‘The Lancet Commission on
Diagnostics’ report mentioned that globally,
nearly half of the population does not have
access to essential diagnostics for many common
diseases such as diabetes, hypertension, HIV, and
tuberculosis. POC diagnostics, which are often
characterised by being independent of laboratory
infrastructure and being highly affordable, can
greatly improve the accessibility of diagnostics.

In India, where there is an uneven distribution
of healthcare resources and infrastructure, the use
of POC tests is growing as an important tool to
increase diagnostic coverage of the population. In
our country, we face major challenges in assessing
rural and underserved patients’ healthcare
needs and in providing them with timely quality
healthcare at the point-of-care. This is also a
critical challenge in metropolitan areas where

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com POCD 53

the hospital and primary healthcare facilities are ANNIVERSARY
overburdened. Hence, POC diagnostics are vital
for a quick and affordable way to reach larger There is a growing recognition that
populations for better healthcare. POC diagnostics can help in the
reduction of burden on healthcare
Advancements in POC devices systems as they are designed to have
applications in the clinical settings
There is a growing recognition that POC as well as in remote places. While
diagnostics can help in the reduction of burden innovative point-of-care diagnostic
on healthcare systems as they are designed to devices hold great promise to
have applications in the clinical settings as well as improve quality of and access to
in remote places. While innovative point-of-care primary healthcare delivery in India.
diagnostic devices hold great promise to improve
quality of and access to primary healthcare of test results without the need for expert
delivery in India, it is imperative to introduce new technician
innovations that have scale-up potential. ● The ability to manufacture PoC diagnostic tests
at scale, respond to rapid rises in demand like
POC diagnostic devices used for monitoring pandemics, and keep the cost of manufacturing
Glucose, ECG, blood pressure, etc. have low are crucial
tremendously aided clinical and personalised ● Use of technologies such as AI and Machine
healthcare. Technological advancements have Learning to make POCT cheaper, faster, and
led to the development of several innovative POC easier to check for quality control.
diagnostic devices for different applications. Recent ● Connected POC diagnostic devices to ensure
advancements in the field of biosensing technology, flow of data from devices to national health grid
microfluidics, and paper-based diagnostics will The successful developments in POC testing
improve the quality and efficiency of diagnostics. will continue to hasten the diagnosis of many
Scientists and entrepreneurs have made a huge critical diseases. However, the POC diagnostic
impact on the development of next-generation devices need to be integrated within the health
POC diagnostic devices, which are based on the system and need to be more personalised data-
latest technologies such as Artificial Intelligence centric, which can benefit the primary healthcare
(AI), Internet of Things (IoT) etc. POC technologies system and place India on the course for attaining
with smart Information and communications full universal health coverage.
technology (ICT) hold tremendous hope for
sustainably managing resources and improving
healthcare delivery in rural areas. Further, these
technological advances can make diagnostic tools
affordable and accessible in India.

Some companies are developing POC tests
and machines, but most are importing them from
China and other countries. Mylab has a dedicated
centre of excellence for POC testing and we are
constantly endeavouring to raise the game by
introducing high quality diagnostics through point-
of-care. Towards this, we have recently launched
CoviSwift, which is the world’s first point of care
high throughput solution for COVID-19. It is
the first POC testing solution that can be used at
small labs, in-hospital labs, airports, villages and
allow gold standard testing at high throughputs
anywhere. We have also partnered with Hemex
Health in the US to develop POC for diagnosis
of a large number of infectious and vector borne
diseases.

Key growth drivers
● Development of indigenous rapid point of care

tests with better sensitivity and specificity
● Software and algorithms for interpretation

54 MEDICAL DEVICES BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY HOW
PROMISING
RAJIV NATH IS INDIA’S
Forum Coordinator, MEDICAL
Association of Indian Medical DEVICES
Device Industry (AiMeD) INDUSTRY?

A major boost to the neglected The Government of India through its
Medical Devices industry is flagship ‘Make in India’ initiative relied
the only silver lining to the heavily on the Indian manufacturers
to meet the rising demand of essential
pandemic; resulting in import- healthcare equipment for the country,
friendly policies and negligible pushing the Indian medical devices sector to
become self-reliant especially for approximately 50
duties. Sometimes a crisis essential COVID-19 Critical Medical Devices.
helps to come out with bolder
decisions. Healthcare stands to When imports got disrupted, specific devices
gain tremendously with PM’s detailed with quantified production shortages and
Atmanirbhar Swasth Bharat a focused Inter-Ministry Group coordinating with
domestic manufacturers via AiMeD had addressed
Yojana, PLI Scheme, Health production bottlenecks and challenges so that
Infra allocation, a focus on new not only capacity got utilised but also ramped up
rapidly. Manufacturers were allowed to sell higher
and emerging diseases and than L1 prices in some cases or given target pricing
health labs that will address to achieve with assured volumes.
major accessibility gaps. A quick
analysis of this crucial sector is in COVID-19 has changed the scenario of doing
business. It has opened massive opportunities for
order. the healthcare sector in tele-consultation, AI-based
diagnostics and remote healthcare management.
The Healthcare sector has become more focused
on innovation and technology over the past two
years of change. 80 per cent of healthcare systems
are aiming to increase their investment in digital
healthcare tools in the coming five years.

While in 2020 the Non-Covid care demand
fell sharply it rebounded in 2021. According to
government estimates, the current market size of
the medical devices industry in India, 4th largest
in Asia after Japan, China and South Korea, is
estimated at about $15 billion and has been growing
at a CAGR of 15 per cent over the last three years.
The market is expected to grow in the coming years
to reach a size of $50 billion by 2025.

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com MEDICAL DEVICES 55

The Indian Medical Device Manufacturing ANNIVERSARY
industry is at the cusp of a great opportunity.
Manufacturing growth in China has been India’s indigenous production
challenged by many countries resistance to buy would not grow unless imports were
Chinese Medical Devices. Another opportunity minimised and exports encouraged.
is the current Indian Public Procurement Policy. In the current environment, it will
Due to geopolitical reasons global investors have be difficult to make the dream
begun to show renewed interest in India. Our of Making in India a reality. To
government has also seized the initiative and in enhance the local production the
a series of measures has reformed the country’s Indian Medical Devices Industry is
foreign investment policy to allow higher levels looking forward for 5 changes in the
of investment from abroad in diverse sectors. As regulations.
a result India has become one of the most open
economies in the world and rightly positioned to encouraged. In the current environment, it will
attract large-scale foreign investments. The Indian be difficult to make the dream of Making in India
Government with Invest India spearheading the a reality. It is important to remember that Covid
initiative has already chalked out plans intending is not over yet. In the future, medical devices
to remove all roadblocks and offer tailor-made may be required. In India, there are more than
solutions to attract investment to make India a 20 such devices on which there are zero import
manufacturing hub for medical devices. duties, which is the main reason for the increase in
imports.
Unlike the 2021 Budget which stated Healthcare
as one of the 6 Pillars of Economy, sadly the Union To enhance the local production the Indian
Budget 2022 announced recently has no strategic Medical Devices Industry is looking forward for 5
stated measures to boost the healthcare sector changes in the regulations such as 1. Predictable
and domestic manufacturing. It is frustrating that tariff policy linked to Global Competitiveness;
against our expectations, the government has not 2. Graded increase of custom duty to 10-15 per
included any measures to help end the 80-85 per cent from current zero to 7.5 per cent; 3. Reduced
cent import dependence forced upon India and an GST on 18 per cent where being applied to 12 per
ever increasing import bill of over Rs 46000. cent as Medical Devices are not luxury goods; 4.
Health Cess applied on some Medical Devices
Imports from China of price sensitive Medical to also applied on other medical devices and 5.
Devices went up steeply by 75 per cent from Rs R&D related tax breaks to motivate indigenous
5208 crore in 2019-20 to Rs 9112 crore r in development.
2020-21. This is a lost opportunity for Indian
Manufacturers to grow and compete globally but The positive announcement for Medical Devices
saw with dismay dumping of Chinese imports when was on Public Procurement by allowing prompt
duties were slashed to zero per cent at the behest of payments of 75 per cent value invoiced and bringing
Importer dominant lobbies for Covid-critical items. in a weighted price preference on account of quality
which is especially critical in healthcare related
These are the same domestic manufacturers, medical devices. Supporting policies are needed
when imports got disrupted during COVID-19 so that Indian Medical Devices Industry can make
crisis, the government relied heavily on them to quality healthcare accessible and affordable for
meet the rising demand of essential Covid items common masses, aim to place India among the Top
for the country pushing the Indian medical devices 5 Medical Devices manufacturing hubs worldwide
sector to become self-reliant. and help end the 80-85 per cent import dependence
forced upon us and an ever increasing import bill of
The Indian government discussed establishing over Rs 46000 crore.
four major medical device parks in the country last
year. A fund of around Rs 100 million was to be A correct policy environment and support
allocated to each of these parks. The devices were will help India emerge as a medical device
to be created by indigenous companies in these manufacturing superpower, a global manufacturing
parks, furthering the mission of self-sufficiency and hub, a dependable manufacturer of quality products
manufacturing in India, but there is nothing in this in the global supply chain, and a global hub for
budget for fiscal year 2022-23 to indicate that the providing skilled manpower to other nations.
government wants to develop indigenous medical
device manufacturing industry.

India’s indigenous production would not
grow unless imports were minimised and exports

56 DIAGNOSTICS BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY WHAT’S
PROPELLING
SURESH VAZIRANI INDIAN IVD
Founder Chairman, INDUSTRY
Transasia-Erba International
Group of Companies Globally, the In vitro diagnostics (IVDs)
market is projected to reach $118.5
The COVID-19 pandemic has billion by 2027, growing at a CAGR of
brought diagnostics to centre- 7 per cent. On the other hand, though
stage and proved its importance the domestic IVD Industry is still at a
nascent stage, estimated at $9 billion, it is expected
in the healthcare system of to grow at a CAGR of ~15 per cent in the next 5
the country. Diagnostics is years. As a result, there have been several positive
important not only for COVID trends in the Indian IVD Industry.
but also for each and every
disease. Interestingly, over the Manufacturers of IVD devices have kept
last few decades there has been pace with the increasing demand for testing volumes
a steady transformation in the with innovative diagnostic solutions that are driving
testing space, from a simple the growth of the industry:
blood test and manual slide
review, to testing a wide range Newer technologies: Superior diagnostic
of parameters and integration technologies such as molecular and Nex-Gen
of digital microscopy for better Sequencing are witnessing fast-paced growth.
Companies like Transasia are investing in research
patient outcomes. for the development of novel technologies for
infectious diseases such as TB, HIV, Hepatitis, etc.

Rapid testing: While there will always be a
demand for advanced technologies in the large-scale
labs, Point-of-care testing (POCT) is proving to be
a boon in resource-limited settings. Worldwide, the
market is expected to grow at a 11.9 per cent CAGR
upto 2023.

From diabetes and pregnancy tests to testing for
infections such as Transfusion transmitted infections
(TTIs), dengue, malaria and most recently COVID-19,
manufacturers are expanding their product portfolio
to include POCT devices. Transasia offers rapid
test kits for dengue and malaria with a unique dual
colour advantage for easy interpretation. Besides this
Transasia has also recently introduced rapid tests for
critical infections such as hepatitis, HIV, HBSAg and
Syphilis and COVID-19.

Efficient after-sales services in Tier II, III and IV
cities of India: In the last few years, manufacturers
have expanded their role beyond just providing
quality solutions to providing seamless service.
Leading companies like Transasia Bio-Medicals
operate with a well-knit network of service and

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com DIAGNOSTICS 57

applications specialists to reach out to labs in ANNIVERSARY
remote-settings lacking a strong infrastructure. In
fact, Transasia has the largest team of sales and An outlay of Rs 64,000 crore towards
service personnel in the industry that caters to some healthcare in the current fiscal
locations not catered by any other company. year budget is giving an impetus
to this sector. Additionally, certain
At Transasia, on one hand we focus on providing policy changes such as the Medical
excellent after-sales and application support, on Device Regulation 2017 and the
the other hand, we offer value-based service by Production Linked Incentive (PLI)
identifying the customer needs and then upgrading scheme are good start-points to
the current technologies to meet these needs. engage manufacturers in high value
As an example, Transasia has integrated some production and incentivise domestic
unique parameters in its hematology range, as manufacturing.
preliminary indicators of cancer. Another example
is of providing open systems which enable the pharmaceutical companies and large corporate
use of reagents from any source, thereby offering chain hospitals in the diagnostic arena as laboratory
convenience to lab owners. service providers, is enabling greater accessibility.
Needless to say, this opens up a plethora of
Automation: With an increasing demand for opportunities for IVD manufacturers as well.
tests, laboratories are looking at ways to handle the
huge workload. And this is where manufacturers Government initiatives: An outlay of Rs
come into the picture, to provide solutions that meet 64,000 crore towards healthcare in the current
the rising demand for speed, quality, affordability fiscal year budget is giving an impetus to this sector.
and accuracy. Labs are now inclined to switch from Additionally, certain policy changes such as the
semi to fully automated analysers. Another step in Medical Device Regulation 2017 and the Production
this direction is Total Laboratory Automation (TLA). Linked Incentive (PLI) scheme are good start-points
to engage manufacturers in high value production
Digitisation: In a bid to get closer to the and incentivise domestic manufacturing.
end user, manufacturers are leveraging data and
building intelligence into their products. Integration Make in India: The government too has risen to
of automated systems with Internet of things (IoT) the occasion and identified the medical device industry
is helping manufacturers provide the advantage as a sunshine sector in its Make in India mission.
of 24x7 remote access, predictive maintenance
and inventory management. Further, Artificial Setting up of medtech parks: The
intelligence (AI) based diagnostic devices are Government’s collaboration with the industry has led
enhancing the lab workflow efficiencies by offering to the setting up of medtech parks. However, most of
a shorter turnaround time (TAT) thereby allowing these parks provide no other support other than land.
more samples to be tested. AI also aids in more Medtech parks should consider themselves as an
accurate image analysis, thereby enhancing the integral part of the eco-system and should hand hold
accuracy. In the long run this reduces the need for the industrial units to help them get all necessary
repetition, leading to cost-effectiveness. Government approvals in a short time.

Industry initiatives: In recent times, Government e-Marketplace: In the current
collaborative efforts of the industry and the era of e-commerce, the Government e Marketplace
government have led to opening up of new avenues (GeM) is a good platform to encourage local
for the IVD industry: manufacturers to reach out to government entities
for public procurement.
Quality certifications: For a long time,
the diagnostic industry was in need of its quality NITI Aayog in its recent report has stated that
assessment system. Introduced in 2018, Indian diagnostic and pathology centers will expand in the
Certification for Medical Devices (ICMED) is times to come and the sector has a promising future.
the country’s first indigenous quality assurance More and more people are opting for preventive
system for India manufactured medical devices. It diagnosis. Moreover, with people being aware of
is proving to be a boon for IVD manufacturers, in health concerns and importance of early detection
bringing down the substantial time and monetary of diseases, the onus is on manufacturers to provide
investment to obtain globally accepted quality technologically advanced systems for labs and
certifications and in-turn it is helping in assuring home-testing.
standardised products. Transasia is India’s first IVD
Company to receive this certification.

Entry of pharma sector: The entry of

58 PARTNER CONTENT BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

FRAN DEGRAZIO

Chief Scientific Officer, West Pharmaceutical Services, Inc.

Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and
delivery industry with extensive expertise in injectable drug products, including vial
container closure systems and prefillable systems for combination products. Fran has
held numerous technical roles at West, including R&D, Quality & Regulatory, Technical
Customer Support, Analytical Laboratories and Scientific Affairs. In her current role

as Chief Scientific Officer she is responsible to leverage scientific and regulatory
understanding across the enterprise. Fran received the Philadelphia Business Journal

2018 Healthcare Innovators of the Greater Philadelphia Region Award and the
Healthcare Business Woman’s Association Luminary Award for West in 2017.

De-Risking Biologic Drugs
and Injectable Drug-Device

Combination Products

RISK CONSIDERATIONS SPECIFIC prefilled syringe (PFS) barrels led to protein
TO COMBINATION PRODUCTS aggregation in Neupogen® (filgrastim) and several
other biologic drugs.2
Growth in biologic drugs in the development pipeline Research conducted has shown that due to
of products has led to growth in the use of injectable the presence of certain tungsten residuals,
drug-device combination products. A combination their concentration and the pH of the drug
product is a product comprised of two or more solution, aggregation formation can occur. It was
differently regulated constituent parts – for example a determined that this protein aggregation mainly
drug and a device. occurred through electrostatic interactions where
the conformation of the proteins remained
Looking at history, there are several clear examples unchanged.2
that justify why special considerations must be given to It is clearly evident through an assortment of
biologics and combination products. Risks specific to examples that there are various challenges that must be
each component must be understood because a system considered and overcome throughout the component
is only as strong as its weakest link, however, typically selection and system characterization and optimization
issues occur at the intersection of various components processes. This is why a holistic understanding that
of a system. considers the uniqueness of the molecule and drug
formulation, the primary package and its delivery device,
Several examples are: the patient/user, and the manufacturing process to
1. Leachables from an elastomeric component make it all happen is critical.

interacting with polysorbate 80 was one of UNIQUE CONSIDERATIONS FOR
the factors in the Eprex® drug product to lead BIOLOGIC-BASED DRUG PRODUCTS
to the increased occurrence of pure red cell
aplasia in patients as reported in The Increased There are sets of risks that must be considered
Incidence of Pure Red Cell Aplasia with an based on the fact that protein-based drug products
Eprex® Formulation in Uncoated Rubber Stopper have unique challenges that are different from
Syringes. Kidney International, Vol 67 (2005). traditional small molecule chemical drug products.
2. Silicone oil distribution issues that led to the Understanding this allows appropriate de-risking
autoinjector stalling and delivering an incomplete measures to be taken.
dose of Enbrel® (etanercept). Recalls occurred in
various geographic regions of the globe due to Risks such as incorrect folding, aggregation, amino
the potential of the glass syringe breaking within acid modification, and proteolytic cleavage can affect
the autoinjector.1 The root cause was the poor the bioactivity of the protein itself. In addition to this,
silicone oil distribution within the glass syringe drugs based on proteins are typically a higher viscosity
used within the autoinjector – resulting in higher- because they are larger in physical size (25,000 atoms
than-expected syringe extrusion forces. versus 100 atoms) compared to chemically derived
3. Tungsten residuals from the staked needle
insertion process used in glass forming of

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com PARTNER CONTENT 59

drug products. This leads to higher milligram per ANNIVERSARY
milliliter (mg/mL) concentrations. As the concentration
increases so does the viscosity which leads to additional MANUFACTURING PROCESS
challenges, especially in relationship to packaging and Processing steps can impact certain characteristics
delivering the drug product.
of the biologic leading to issues such as aggregation
The interface of the biologic, delivery device, and the and particle generation. Steps such as fermentation/
patient brings together all of the risk considerations. An expression, unfolding/refolding, purification, freeze–
example of this that may not routinely be considered is thaw, filtration, pumping, pressurization and drying,
the bioavailability of a drug. among other processes, can lead to aggregation.

Bioavailability is defined as the proportion of a drug Many of these steps may lead to shaking and
that enters the circulation when introduced into the shearing of the protein during production or
body, so it can have an active effect.3 distribution. This can induce protein aggregation
although the extent of impact depends both on
When a drug is administered intravenously, its the intensity and duration of exposure to such
bioavailability is 100%. When an injectable combination stresses. Shaking can create air/water interfaces. The
product is being used the drug is typically administered hydrophobic property of air relative to water induces
subcutaneously or intramuscularly, so the bioavailability protein alignment at the interface, maximizes exposure
is critical and can depend on aspects such as the depth of the hydrophobic residues to the air, and initiates
of needle injection, etc. aggregation. Shearing can also potentially expose
the hydrophobic areas of proteins and may cause
DEVELOPMENT PROCESS aggregation.6
A development process for a combination product
All significant risks must be considered and mitigated
always starts by defining the end targets that need in process development.
to be met. This means combining the drug target
product profile (TPP) and the device/system user RISK IDENTIFICATION FOR PACKAGE/DEVICE
requirements (URS). A methodical process to identify Once the individual risks in these areas are
risks and causes of failures should occur. Tools such
as Ishikawa diagrams and failure modes and effects understood, there must be consideration taken for the
analysis (FMEAs) are commonly used in this process. interactions of all these aspects.
It is critical that cross functional teams work together
to identify and prioritize the risks of not only the final An example of this type of risk is the fact that
combination product, but its constituent parts and proteins will have different affinities for various
critical components. surfaces. Adsorption can be affected by solution pH,
salt concentration, and temperature. Container closure
The physical characteristics of the drug will play a systems have been shown to induce surface-related
major role in delivery performance. Aspects such as protein aggregation. This has been exhibited with
viscosity, inherent particle size and thermal sensitivity, contact of metal containers/surfaces or the indirect
among others of the drug along with characteristics effect of a leachable or process aid from the container
such as the injection time, activation forces, physical closure system.6
discomfort, and dose accuracy must be understood and
managed.4 Part of this development process is the work Extractable and leachable studies should be
to identify the essential performance of the combination performed to evaluate the potential for the container
product. closure materials to interact with and modify the biologic
product. Change in product quality attributes should
ESSENTIAL PERFORMANCE REQUIREMENTS (EPRS) be realized in respect to component extractability,
EPRs are intended to be a subset of design controls physicochemical compatibility and safety. Reactive
species present at levels lower than the analytical
related to assuring that clinical performance of the evaluation threshold (AET) could have a negative impact
device meets the combination product’s intended use on biological product quality or lead to a potential
and be proven safe and effective. The FDA generally patient safety issue. The amount of work completed
considers EPRs as being the performance attributes for these studies should be commensurate with the
responsible for the clinical performance of the device phase of development.7 Over time, knowledge and
at the point of use (dosing/administering) and include understanding will build, and this should continue
the device’s performance attributes relating to the user through active lifecycle management.
interactions required to administer the dose.5
An understanding of the potential risks of the
These EPRs are identified within the combination package and delivery system is critical as they will form
products market application to the regulatory agency, the basis for potential issues with the final combination
therefore, any change that may occur that could have product. It is thought that a prefilled syringe system is a
an impact to the EPRs must be communicated to the relatively straight forward product to develop. In Figure 1
regulatory agency. below, there is a visual example of some of the risks that
should be considered early in the combination product
development process.

60 PARTNER CONTENT ANNIVERSARY BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

Figure 1 to tissues, and a drive system to deliver the appropriate
drug volume. An adhesive is used to attach the device to
PATIENT/USER CONSIDERATION the patient’s skin.
All drug and device work is important and
The benefits to the patient can be many because
ultimately benefits the patient. The FDA has made it of the ability to deliver greater drug volume by a
clear that human factors considerations are a must in subcutaneous injection over extended time periods. This
developing any combination product. Ultimately, the type of product provides an avenue to move treatment
design validation testing (DVT) that occurs at the end from a hospital/clinical environment to the home. It can
of development is completed to assure that the right enable self-administration in a safe and effective manner.
product was developed. The objective of human factors
is to consider the users, their environment, and the SUMMARY
interface with the device to assure safe and effective use. As the many benefits of biologic drugs being

Formative human factors work should be conducted delivered as part of a combination product platform
while the combination product is still under development are realized, this trend toward self-administration will
– including misuse considerations. This process is continue to grow. Understanding the various risks and
iterative and should provide feedback into the design being positioned to mitigate those risks is not an option
so that improvements can be applied. A risk mitigation but a must in development and commercialization. The
strategy should be documented to de-risk the identified use of a risk-based approach is foundational from a
hazards to an acceptable level. Retesting should occur to regulatory perspective and should be at the center of all
demonstrate effectiveness.8 The design verification and work that is being conducted. It is imperative that the
validation processes at the end of combination product unique challenges of biologic drugs and the intersection
development should assure the correct product has been of various components of the system be considered at
developed for the targeted user and therapeutic need. the center of these programs for them to be successful.

BIOLOGIC FORMULATION AND PATIENT/USER REFERENCES
CHALLENGES CAN BE MITIGATED THROUGH 1. Government of Canada Recalls and Safety Alerts.
INNOVATIVE DEVICE PLATFORMS
Enbrel SureClick Autoinjector (September 18, 2009).
As mentioned, these biologics are sensitive to their https://healthycanadians.gc.ca/recall-alert-rappel-
environment and formulations may come with physical avis/hc-sc/2009/9736r-eng.php
challenges such as larger volumes and higher viscosities 2. Jiang Y., et.al. Tungsten-Induced Protein Aggregation:
with a broader range in injection rates. An alternative Solution Behavior. J Pharm Sci, Vol. 98 No. 12, (2009),
way of addressing some of these challenges is through pp 4695-4710. https://doi.org/10.1002/jps.21778
the use of on-body injector systems. These systems can 3. National Center for Biotechnology Information (NCBI).
typically hold a larger volume that can be delivered over https://www.ncbi.nlm.nih.gov/books/NBK557852/
a period of minutes versus “seconds,” which are typical 4. DeGrazio F, Paskiet D. Injectable Combination Product
of autoinjector systems. Development: Facilitating Risk-Based Assessments
for Efficiency and Patient Centric Outcomes. J Pharm
Wearable injectors adhere to the body to deliver Sci, Vol. 109 No. 7, (2020), pp 2101-2115. https://doi.
larger volumes of drugs subcutaneously. Several org/10.1016/j.xphs.2020.03.020
pharmaceutical and medical device companies have 5. Lipman J, Stevens A. Essential Performance
developed wearable injectors. The device consists of a Requirements – Latest FDA and Industry Insights on
reservoir for medicine, a cannula for substance delivery Identification and Control Strategies. Xavier Health
Combination Products Summit (September 13, 2019)
6. Wang W, Nema S, Teagarden D. Protein Aggregation
– Pathways and Influencing Factors. International
Journal of Pharmaceutics Vol 390, Issue 2 (2010), pp 89-
99. https://doi.org/10.1016/j.ijpharm.2010.02.025
7. Paskiet D. Safety Thresholds and Best Demonstrated
Practices for Extractables and Leachables in
Parenteral Drug Products. PharmEd Extractables and
Leachables Virtual Summit. (June 2021)
8. Follette Story M. Human Factors Considerations for
Combination Products. RAPS. (2011) https://www.fda.
gov/media/81986/download

Eprex is a registered trademark of Johnson & Johnson Corporation.
Enbrel is a registered trademark of Immunex Corporation.
Neupogen is a registered trademark of Amgen Inc.

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com FUNDING 61

NITIN DESHMUKH ANNIVERSARY
Sr Advisor,
HOW VC
Kotak Investment Advisors FUNDING FOR
India’s life sciences industry INDIAN LIFE
journey over the past three decades SCIENCES GREW
PHENOMENALLY
has been transformational,
moving from strength to strength. The Indian Venture capital industry began
its journey in 1988 as part of divisions
It was the 1970 Patent Act, which or subsidiaries of these development
triggered an era of reverse financial institutions and included
Technology Development and Investment
engineering in the Indian pharma Corporation of India (TDICI ) now known as ICICI
sector with a number of pharm Ventures Ltd, IFCI Venture Capital Ltd, Gujarat
Venture Capital Finance Ltd, Canbank Finance
companies setting up businesses. Ltd. Soon there were a number of private VC funds
Most of these were family owned and global institutions such as Credit Capital,
20th Century Finance, UTI Ventures, Pathfinders,
companies with subsidy and Warburg Pincus, HSBC Bank, Standard Chartered
debt-funding support from Bank, JP Morgan, CDC, Indocean Fund, Schroeder’s
setting up shop in India in the early 90’s.
national development financial
institutions like ICICI, IDBI and While the 90’s decade (1990-1999) was pretty
IFCI, besides the respective state much dominated by IT Services companies
sponsored development financial attracting bulk of the venture capital funding in
the country, a few select Venture Capital (VC)’s
institutions. The development took bets on small, mid-size pharma companies
of COVID-19 vaccines is just the for introducing new drugs and formulations and
most compelling example of the expanding capacities and domestic market networks.
potential of life sciences. We could Beneficiaries of such VC funding included today’s
see global disease burden being very successful companies like Sun Pharmaceuticals,
addressed with capabilities such Gland Pharma, Neuland Laboratories, Ajanta
as gene-editing technologies to Pharma, Intas Pharmaceuticals, Medicorp
curb malaria, cellular therapies Technologies (since acquired) Orchid
to repair or even replace damaged Pharmaceuticals, Divi’s Laboratories. The 1990s also
cells and tissues and new kinds of saw Indian pharmaceutical companies accessing
vaccines for NCDs. Let’s explore global markets with generic drugs and formulations
which provided rapid scale to these pharmaceutical
further. companies besides providing successful exits
through initial public offering (IPOs) to VC investors
like ICICI Ventures which gained prominence as the
most dominant and successful player in the Pharma
/ Life Sciences investing space in the country in this
decade.

While a large part of life science investing by
VC’s in the 90’s went to pharmaceutical companies,
innovation funding was largely led by ICICI’s R&D
/Technology Funding programmes which funded
the early stage vaccine development in companies
such as Serum Institute, Bharat Biotech, Shantha

62 FUNDING BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY Biotech among others. A few university Biotech spin
outs such as Bangalore Genei, Strand Genomics
Kotak’s investment strategy too attracted funding during this period besides
in life sciences evolving startup’s like Vimta Labs, Penpol, Monozymes,
Advanced Enzymes and Gangagen however they
In light of some outstanding innovation were very few and far between.
happening through the BIRAC startup
incubation and funding ecosystem, the The 2000’s decade (2000-2009) saw an
team at Kotak having led over 40 plus increased level of activity in the life sciences with
investments in very successful pharma, many VC/ Private equity (PE) funds besides ICICI
biopharma, biologics and enzyme companies Ventures initiating investments in this sector.
over the past 3.5 decades has launched Besides pharmaceuticals, VC/PEs ventured
an early stage investment programme in into newer areas such as biopharmaceuticals,
2019 to support new age businesses and contract & clinical research organisations (CRO’s),
differentiated innovations in the biotech / drug discovery and agri biotech. Beneficiaries
medtech/ healthtech sector in the country. included companies such as Biocon, Syngene,
The strategy is to invest in transformational Intas Biopharmaceuticals, Lambda Therapeutic
healthcare companies developing and Research, Veeda Clinical Research, Bharat Serums
commercialising novel therapeutics, medical &Vaccines, VLife Sciences, Novalead, Rubicon
devices and services that address unmet Research, Glenmark Pharmaceuticals, Shasun
medical needs through innovation. We Pharmaceuticals, Natco Pharma, GVK Biosciences,
are pursuing investment opportunities in Sai Life Sciences, Metahelix, ReaMetrix, Sphaera
companies that are attempting to solve Pharma, Molecular Connections, Bharat Biotech,
some of the most important unmet medical Perlecan Pharma (JV of ICICI Venture with Dr.
needs in the areas of oncology, immunology, Reddy’s) and others. Interestingly many of these
ophthalmology, infectious diseases, metabolic investments were early stage and those with
diseases, neuroscience and dermatology manufacturing and service led business models,
space leveraging on extensive relationships which demonstrated scale enabled good exits
with pharmaceutical companies and medical and returns for their investors. This was the most
institutions to advance delivery of affordable difficult period for early stage drug discovery and
patient care with determination to positively biotech companies though as they had to deal with
impact society. significant delays in regulatory approvals whether
be it for clinical trials or even manufacturing. Add
Over the past 2.5 years the team has to this were challenges in fund raising as there were
already built an early stage biotech/medtech only 2-3 investors whom they could go to and there
/healthtech portfolio of 15 companies so was general reluctance from investors too given the
far. Some of the companies where Kotak disorganised state of regulatory approvals during
has commitments to date include Myvax that time. It was the most frustrating period for
(Influenza and Covid Vaccines), Pandorum early stage discovery companies as well as investors
(bioengineered corneal tissue), Eyestem (cell who invested in such companies. Most therefore
therapy for age related macular degeneration), failed to progress on their discovery programmes
Ahammune (drug candidate for Vitiligo), and faded out.
Bugworks (drug candidates for AMR and
Immunotherapy), Immuneal (CAR-T Cell The last decade (2010-2019) has been the most
cancer immunotherapy ), Niramai (breast transformational for the life sciences industry. This
cancer screening device), Epigeneres decade saw VC/PE investment activity across all
(early stage cancer detection), Healthians stages – early, mid, late, and buyouts. This was
(Healthcare Diagnostics), Fullife (consumer also the decade of secondary transactions where
wellness products), Meddo (chain of OPD for the first time VC/PE’s were not dependent on
clinics), NeuroEquilibrium (chain of vertigo IPO’s or strategic exits but were able to offer their
clinics), Medfin (virtual hospital model for day stake to other VC/PE players through secondary
care surgeries) among others. transactions to accomplish successful exits. This
was the decade where pharmaceutical companies
This is in addition to our growth/ such as Intas Pharmaceutical, Eris Pharmaceuticals,
structured /pre-IPO investment strategy in Advanced Enzymes, Emcure Pharmaceuticals, Strides
this space which we will continue to scale Pharmaceuticals, Bharat Serums& Vaccines, Shilpa
up further (recent past investments include Laboratories, Laurus Labs, Mankind Pharma, Akum
Omniactive and PharmEasy).

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com FUNDING 63

Drugs & Pharmaceuticals, Shasun Pharmaceuticals, ANNIVERSARY
Encube Ethicals, raised large sums from PE players
to accomplish scale. The enormous funding support has been a period of hostile adversity that spurred
from PE players and capital markets enabled the innovation and behavioural changes and helped
sector to emerge as amongst the key drivers in address some of the biggest problems.
achieving better health outcomes, domestically
and globally. During this decade, India gained Longstanding practices in the healthcare sector
strength in generic drugs, vaccine production and have been transformed, perhaps forever. Vaccine
biopharmaceuticals and got recognised as ‘the development usually took years or even decades.
pharmacy of the world’ , the world’s largest provider In just one year since the Covid pandemic started,
of generic drugs. This decade also witnessed a the world had several safe and effective vaccines
number of buyout transactions led by PE funds for including a few by Indian vaccine manufacturers.
the first time in the country of companies such as The regulators too demonstrated unprecedented
Gland Pharma, Bharat Serums & Vaccines, Rubicon flexibility in fast tracking clinical trials, reviews and
Research, Sutures India, Anjan Drugs, Veeda conditional approvals. Healthcare professionals
Clinical Research and most recently J B Chemicals & who have otherwise taken decades to adopt digital
Pharmaceuticals Limited and Avra Labs. technologies, shifted to providing tele- consultations
across the globe as in-person consultations dropped.
The last decade also saw the birth of The telemedicine guidelines launched by Indian
Biotechnology Industry Research Assistance Council regulators in the midst of the early 2020 lockdown
(BIRAC) as an institution, which has brought about boosted telehealth adoption among patients and
a transformational change in the innovation and healthcare providers. Pharma companies too
entrepreneurship ecosystem in the Life Sciences adopted digital modes for interacting with medical
sector in the country. Since it’s incorporation in 2012, professionals. Be it medical providers, insurance
BIRAC has initiated several funding programmes that providers or manufacturers, all rapidly transformed
has helped bridge the gap in the industry-academia their ways of working. E-commerce became the
innovation research and facilitate novel drug way of life for delivering healthcare diagnostics,
discovery, vaccine development, medical device and pharmaceuticals, devices and oxygenators. New
agri -component companies. BIRAC has funded over consumer behaviours will compel the continued
1000 startups, 60 Bio Incubators across the country transformation of healthcare delivery models.
at an enormous velocity. Several of these startups
have graduated to attracting third party investments In the midst of these challenges, astute
from angel investors, early stage VC‘s in the country startups in the healthtech /medtech space grabbed
and introduced innovative products and services in opportunities as they aimed to fill the gap in this
the markets. We will see many of these attracting sector bringing in tech-enabled innovations. Online
several rounds of funding from VC/PE players consultations / telemedicine, Online pharmacies,
over the next few years and gaining prominence in Diagnostic testing labs, Home testing and Home
domestic and global markets. A lot has improved on Healthcare for instance, caught the attention of
the Indian regulatory front too on the processes for consumers as well as investors in 2020 -21. With
approvals of clinical trials and grant of manufacturing focus shifting to health consciousness in the
licences over the past 6-7 years, which has helped the aftermath of COVID-19, wellness and fitness start-
innovation ecosystem reinforcing confidence amongst ups too gained prominence last year. Healthcare
Indian VC/PE Funds. analytics and artificial intelligence opened up
an entirely new spectrum of opportunities with
Life Sciences startup applications in drug discovery, clinical trials,
landscape in the coming years diagnosis, imaging diagnostics, treatment, health
records etc. The healthtech /medtech sector received
COVID-19 has spared none. Its scale and $2.2 billion funding across 131 deals in 2021. For
spread were underestimated and were beyond the first time in India, four health tech startups –
projections by scientific models. Amidst the turmoil, Pharmeasy, Curefit, Pristyn Care and Innovaccer
Healthcare-Pharma-Biotech industry rose to the became Unicorns during the year. The development
occasion to undertake an unprecedented initiative of COVID-19 vaccines is just the most compelling
to fight the pandemic. As we look back at the year example of the potential of life sciences. We could
gone by, the pandemic has offered many learnings see global disease burden being addressed with
to the Healthcare-Pharma-Biotech industry that capabilities such as gene-editing technologies to
potentially unlocks several opportunities in the curb malaria, cellular therapies to repair or even
coming year and decade. Clearly, this pandemic replace damaged cells and tissues and new kinds of
vaccines for non-communicable diseases, including
cancer and heart disease.

64 PARTNER CONTENT BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

Our focus is to accelerate biomarker
research to enable better disease

understanding and effective interventions

Biomarker research is crucial for understanding drug development efforts?
disease pathogenesis, identifying various Dr. Yadav: Finding novel ways to use
stages of the disease, monitoring disease
severity and therapeutic response, and predicting technologies that have been previously proven to
patient prognosis. Monitoring biomarkers in clinical work in vaccine development is one way to further
trial endpoints is critical for predicting the efficacy speed up. In vaccine development, safety and
of novel medications throughout the drug discovery efficacy are critical. Recent studies have shown
and development process. Merck has constantly that multiplex immunoassays offer a flexible way
been advancing the technologies for biomarker to monitor immune responses. The process of
research and validation. In a conversation with screening is necessary to ensure that only the best
Biospectrum, Dr. Pragya D Yadav (Scientist ‘E’ candidates are selected for further testing, but can
and Group Leader, ICMR-National Institute of be time-consuming and resource-intensive. Multiplex
Virology) discussed the integration of multiplexing immunoassays have been used throughout the
immunoassay technology in drug/vaccine vaccine research process to expedite screening.
development. Dr. Pankaj Kumar Joshi (Head of Requiring only small amounts of a clinical sample,
Commercial Marketing at Merck) also highlighted multiplex immunoassays can be applied at all
the recent advancements by Merck. stages of vaccine/drug development, including at
the preclinical stage, and is a proven tool to monitor
How will the Indian biopharma market evolve critical safety and efficacy of the process. Specifically,
along with the surge of cutting-edge technologies it helps in the precise understanding of the immune
in terms of precision medicine? status in terms of pathogen-specific cytokine and
antibody profile of the study participants.
Dr. Yadav: In the future, a key initiative should be
to develop a world-class pharmaceutical plant with With the increasing need for multiplexing
cutting-edge machines that manufacture products biomarker analysis, how does Merck enable
at high speed with precision and reliability that is access to these new technologies for the
consummate with quality and compliance standards. scientific community?
This will help accelerate indigenous vaccine research
in India. The newer technologies to be developed Dr. Joshi: “Prevention is better than cure” is
include multiplex immunoassay which enables an excellent metaphor for biomarker research.
the detection of as many analytes as possible in a Multiplex immunoassays help speed up disease
single assay all in all to reduce the overall number of research and biomarker discovery. We can help the
assays, as a way forward towards this step. scientific community to acquire data that they can
trust out of each sample, with little repetition to make
How can multiplex immunoassays support the the best next-step decisions. Whether one needs
development and clinical trials for vaccine and an ultrasensitive detection from an SMC™ assay,
robust ELISAs, or rich multiplex profiling data using
MILLIPLEX® and Luminex® xMAP® technologies,

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com PARTNER CONTENT 65

ANNIVERSARY

we pioneer in bringing the best solutions to enable candidates to market?
scientific research in the life science space. Merck Dr. Joshi: During the development of vaccine
has created two labs to enable easier access to
these state-of-the-art technologies: the Merck candidates, biomarkers can help anticipate adverse
Innovation Lab and the High-End Skill Development events. Understanding vaccination effectiveness
Lab. Both our labs are equipped with cutting-edge and safety are critical during clinical trials. To
technologies like the Luminex® systems, SMCxPRO™ find clinically useful biomarkers, patients must
for ultra-high immunoassays, SNAP i.d® 2.0 Protein be stratified to find the best prospects. Merck’s
Detection System, and the Auto2D® Automated 2-D MILLIPLEX® biomarker screening assays detect
Gel Electrophoresis Device. From antibodies to over 1,300 soluble analytes across 11 species,
enzymes to small bioactive molecules and custom making it the most comprehensive in the industry,
services, we have the solutions you need for any including the NHP (non-human primate) panels to
biomarker analysis. aid the COVID-19 vaccine developments.

How multiplex immunoassay contributes to A diverse portfolio facilitates the transition
serotyping and sero-surveillance studies? from animal models to clinical research. Along
with multiplex immunoassay solutions, our Single
Dr. Yadav: Serological data indicating the Molecule Counting™-based SMCxPRO™ can aid
presence and level of antibodies against infectious in the stratification of clinical trial participants and
disease antigens provide indicators of exposure and gain of insights into vaccine candidate efficacy. Our
transmission patterns in a population. Laboratory MILLIPLEX® assays aid the detection and exploration
testing for large-scale serosurveys is often hindered of biomarkers, whilst SMCxPRO™ enables the
by time-consuming immunoassays that employ detection of minute yet critical changes of the
multiple tandem steps. Serosurveillance is increasingly biomarkers level.
becoming an attractive and economical strategy for
multiple disease-specific public health programs How will the newly introduced xMAP®
in hope to gather information within a population INTELLIFLEX system support the acceleration of
regarding pathogen exposure or vaccination coverage. research?
The use of bead-based multiplex immunoassay
technology has been gaining recognition as a next- Dr. Joshi: The Luminex xMAP® INTELLIFLEX
generation screening tool in seroprevalence studies system, was introduced with our goal of providing
with high-throughput and timely collection of antibody the finest solutions for novel biomarker research.
data. Bead-based multiplex immunoassays contribute The system includes an integrated touch
to serotyping and sero-surveillance studies through screen with updated software and comes in two
simultaneous detection of multiple pathogen-specific configurations. A high-throughput RUO version with
antibody responses in a small volume (25ul or 50 ul) of all the advantages of bead-based multiplexing,
serum/plasma or other clinical samples. It also has the as well as a second variant (DRSE) with a dual
advantage of investigating a large number of clinical reporter and side eject variation that is more
samples in a high-thorughout manner in short period suited for automation. The dual reporter channel
of time. increases the number of data points acquired from
a single sample, which improves efficiency. With
How does Merck support the vaccine access to progressive tools, services and expertise,
development process, specifically in bringing the we are proud to be partners of researchers in
their scientific breakthroughs, solving the toughest
problems in life science.

66 HEALTHCARE BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY WILL
INDIA SHINE
SAMEER AGARWAL BRIGHTER IN
Group CFO, HEALTHCARE
DELIVERY
Manipal Hospitals SECTOR?

India encompasses a massive Over the years, India has become a
healthcare system, but there popular destination for medical
tourists, given the relatively low
remain many differences in costs and high quality of its private
quality between rural and urban hospitals with advanced medical
care. India was placed 10th in the Medical Tourism
areas as well as between public Index for 2020-21 out of 46 destinations by the
and private healthcare. The Medical Tourism Association. We have evolved
- not only providing world-class facilities to our
healthcare industry has been citizens but also the neighboring countries, the
boosted by the strides made in African continent, UAE among others.
technology and the advancement
of medical science in the country. Enter private players
The healthcare sector has become
one of the largest sectors of the Indian Healthcare, over the past few years,
economy in India, both in terms has been largely driven by private healthcare with
government spending still around 1.2 per cent
of revenue and employment. of GDP. In the 1980s, private health providers
An ageing population, rising entered the market. The chief factors influencing
lifestyle diseases, an increased the growth of health expenditure were new
medical technology, increasing competition,
emphasis on public-private restrained public funding and growth in health
partnerships, faster adoption of manpower.

digital technologies, including Soon, came the private healthcare chains - the
telemedicine, heightened interest big players who played a vital role in developing
healthcare, and helping the life expectancy of the
from investors, and increased average Indian move up from 32 years in 1947 to
foreign direct investment (FDI) 69.66 years in 2019.
inflows have driven the healthcare
sector to where it stands today. When it comes to the pharmaceutical market,
India is the largest manufacturer and provider
Let’s explore further. of generic drugs globally. With a large pool of
scientists, engineers steering the industry, India
supplies over half of the global demand for various
vaccines, 40 per cent of generic demand in the
United States, and at least a quarter of all medicine
in the UK.



68 HEALTHCARE BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY have also taken to telemedicine and virtual
consulting in a big way. The rise of telemedicine
The future of healthcare is evolving and virtual consulting has built confidence
with the advent of Technology, amongst patients as a healthcare delivery
method. There is now a belief among patients
Artificial Intelligence (AI), connected that they do not need to rush to large cities
devices and is rapidly changing during emergencies as hospitals can now cover
given the pandemic. There has them with the best of their medical services
been increased acceptance and remotely.

adoption of technology whether it The future of healthcare is evolving with the
is video consultation, monitoring advent of Technology, Artificial Intelligence
(AI), connected devices and is rapidly changing
thru connected devices, using AI and given the pandemic. There has been increased
this has taken healthcare to tier II, acceptance and adoption of technology whether it
III cities that did not have access to is video consultation, monitoring thru connected
healthcare. devices, using AI and this has taken healthcare
to tier II, III cities that did not have access to
The jobs created through this manufacturing healthcare.
export allows a great number of foreign
exchange into our economy. While many western Today, over 60 per cent of the country has
counterparts deride India as a copy-cat drug access to smartphones and internet access.
maker, without India, the world would be in a Healthcare is increasingly reaching the doorstep
dire need of generic drugs. The recent Production for sample pick up, delivery of pharmacy gaining
Linked Incentive (PLI) schemes, foreign popularity. The benefit of technology like
investment, over-the-counter medication, vaccines, Artificial intelligence and big data would not
and the growth of diagnostic and pathology centers only help better prediction and prevention of
will only take India to greater heights when it diseases in the future but also has the potential
comes to the manufacturing and producer of to improve diagnosis and treatment of patients
generic drugs. as well.

Increasing insurance coverage IoT (Internet of things) and Electronic
Intensive Care Unit (EICU) could help smaller
With the advent of Ayushman Bharat, there nursing homes to be connected to larger
is a renewed focus on the creation of primary healthcare establishments and the command
health centers across the country and also to give center can also help better monitor and also
insurance to the citizens. Currently, only about bridge the skill gap and get Tier II, III towns
300 million Indians have health-related insurance connected as well. Private Hospitals have also
cover which is around 25 per cent of the population invested in world-class infrastructure like
as compared to 90-95 per cent of the population in Robots for minimally invasive and complex
western and developed nations. surgeries, Tomography (for Radiation in Cancer
care) is also reducing the time of the patients in
Increasing coverage of health insurance will Hospital.
help reduce out-of-pocket spending by around 60-
65 per cent. While the government is achieving it Colloborative effort
through the Ayushman Bharat mission, the private
sector aims to address it through technology. I am sure that with government policies,
Thanks to the higher penetration of information collaboration and support there would be an
technology and social media platforms, there is integration of healthcare across the various towns
better awareness about healthcare and insurance and villages. This will potentially enhance the
throughout the country. Recent reports have seen quality of healthcare in the country.
an increase in online health insurance customers
from smaller cities. The government’s projection of spending close
to 2.5 per cent of GDP on healthcare by 2025-26
New tech interventions helps bridge the gap of last-mile delivery that
presently exists similar to the sterling role that the
Similarly, people, especially the millennials, Government of India did for the vaccine rollout.
India has become a case study, as over 1,700
million doses have been administered across the
country.



70 AUTOMATION BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

AMIT MOOKIM HOW
Managing Director, AUTOMATION
CAN
IQVIA South Asia TRANSFORM
ENTERPRISE
With the explosion of data around & PATIENT
us and the increasing ability JOURNEY

through advanced analytics and From the lens of healthcare, I would bucket
machine learning to be able to use data into three parts - Data relating
to Population Health, Patients and
data for better patient outcomes, pertaining to the supply chain.
there cannot be a more exciting
time to be in healthcare. The Population health data

importance of more relevant data India’s experience through the pandemic has
on value and outcomes is being highlighted the importance of and need for accurate
validated by manufacturers, and updated data relating to population health.
While there is a huge amount of data available,
researchers, and even regulators. it is patchy and not current as we are still heavily
And it’s all coming together in a dependent on census data that is collected every
10 years. Efforts underway through the National
more precise understanding of the Digital Health Mission to build the backbone and
human experience in healthcare. digital pathways necessary for the country’s health
Let’s explore further. infrastructure, so as to be able to capture timely
health data, will go a long way in addressing this
lacuna.

Patient health data

While we have an emerging innovation
ecosystem and a lot of innovation has happened
in drug development and building the healthcare
infrastructure, not much innovation has taken place
in care delivery and patient data sets. But now,
as more clinics and hospitals are being digitised
and more programmes are focusing on disease
management, particularly chronic disease, we are
beginning to see a mindset shift in how data is being
utilised to design better health outcomes, both at
an aggregate level and at a deidentified patient
level. This mindset shift is being supported by both,

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72 AUTOMATION BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY Of the one million odd chemists in India today,
while there is rapid automation taking place at the
Of the one million odd chemists chemist level, only around 10 per cent of chemists
in India today, while there is rapid use any kind of a digital platform so there is huge
opportunity for automation at the chemist level
automation taking place at the too. Digitisation will help drive more consolidated
chemist level, only around 10 per data that will be incredibly important for every
cent of chemists use any kind of stakeholder, whether it’s the pharma company or
a digital platform so there is huge the wholesaler or the chemist.
opportunity for automation at the
chemist level too. Digitisation will I believe the healthcare industry in India could
help drive more consolidated data learn lessons in automation from three industries
that will be incredibly important for - telecom, financial services and retail. Telecom is
most important as it followed the same route to
every stakeholder. building an analytics-driven mindset and model to
completely disrupt cost to access. Fintech, because
government as well as the private life sciences sector it has brought down the transaction cost and
since it impacts the whole ecosystem. Having said digitised the customer interaction, while it has also
that, we still have a long way to go compared to understood how to provide security at the individual
other emerging markets, because there are black level to protect data and privacy. And retail because
spaces in the road to digitisation. Only 5-7 per cent it has worked through a lot of digitisation, using
of our country’s prescribers use any kind of digital technology for precision segmentation and targeting
platform and less than 5 per cent of our population of customers and channel partners.
have digital patient records, while only around
10-15 per cent of hospitals use an EMR (electronic When it comes to innovation, we can also
medical record) or clinical platform. But we have learn a lot from entrepreneurs and startups
started on the digitisation journey and the data working in geospatial intelligence for logistics,
it generates will be incredibly valuable to make retail and financial services that could be relevant
our healthcare system more accessible as well as for healthcare, because our ability to tap and
efficient. understand different micro markets and segments
from a geographical perspective could help build a
Supply chain data stronger supply chain and access points. There are
also many startups who are working to bring down
One of the early disruptions in countries like the cost of healthcare acquisition and ease of access
China and Indonesia which embarked on large to delivery, building platforms and marketplaces
universal health programmes was the consolidation to create greater customer experiences that we can
of the supply chain. We see the same starting to learn from. Finally, I think we should also tap into
happen in India today. We have more than 55,000 ecosystems and communities that are being built
– 60,000 thousand distributors and stockists, and for user generated content and opinion where we
there is a whole digital ecosystem that is building have an opportunity to listen to patient and doctor
up at two to three times the growth rate of the communities.
traditional channel.
As we evolve and build a more data-centric
During the pandemic waves, we saw what the healthcare system, and as important it is to share
lack of a robust digital supply chain network could data to drive better insights and patient outcomes,
result in with supply chain bottlenecks, lack of we need to make sure we use data responsibly
visibility on endpoints, inventory pile ups. That and understand the implications of how we collect
continues to happen in parts even today because we and share data. The government and regulatory
have a fragmented supply chain. Access to supply authorities need to play an important role in
chain data will help curb wastage and ensure that ensuring and steering discussions towards such
drugs are available at chemists where demand issues so that there is greater awareness across the
is generated. Track and trace systems will have healthcare ecosystem.
a particularly strong impact in identifying and
weeding out fake drugs which is a very important As we go through the automation journey in
requirement for India given the huge geography we India, we need to look at automation as a process to
cater to. transform the enterprise and patient journey, and
not just to generate revenue. The world is counting
on us for innovations and scientific breakthroughs to
improve societal health.

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com PARTNER CONTENT 73

ANNIVERSARY

Women in STEM shattering
gender stereotypes

Creating gender equity and providing leadership opportunities for women scientists and researchers
has been central to the vision at UPES School of Health Sciences and Technology.

I DR. SNIGDHA MISHRA I DR. VANIKA GUPTA

The year 2020 was exemplary for women laureates UPES takes pride in the achievements of its women-led
in STEM. Emmanuelle Charpentier and Jennifer faculty, charting path-breaking initiatives in STEM.
Doudna won the Nobel Prize in Chemistry for their
revolutionary research on CRISPR and Andrea Ghez the Department of Microbiology, has Dr. Smriti Arora,
shared the crown with Reinhard Genzel in Physics expert in the area of Host-Pathogen Interactions,
for discovering the supermassive black hole. Despite Ribosome Biology, and Genomics. Other bright minds
under-representation, under-valuation, gender bias and in the team are devising strategies and investigating
professional inequity, women researchers have come candidates for development of future therapeutics
a long way in the last century. However, the task of against enteric pathogens, understanding the molecular
addressing these challenges is mammoth and calls for a basis for insulin resistance, respiratory and age-
dedicated effort from the society as a whole. UPES, as associated ocular diseases in humans. And finally,
a progressive institution of higher learning, is defiantly research in the stream of Biotechnology has Dr. Nishu
committed to offer equal opportunities to its women Goyal as an expert in the areas of metabolic network
scientists, researchers and students and harness their modeling and optimization of cellular network and
potential as future leaders in science and technology. Systems Biology. Dr. Vanika Gupta and Dr. Snigdha
Mishra, with expertise in reproductive ailments and
School of Health Sciences and Technology immune-response, are working on establishing widely-
(SoHST) at UPES has a cohort of exceptionally employed invertebrate models Drosophila melanogaster
proficient and talented women as faculty. About 50 to and Caenorhabditis elegans, in addition to the existing
60 per cent of students pursuing STEM and higher ‘animal house’ facility that would expedite therapeutics
studies at SoHST are women. Individual excellence assessment and help explore human disease targets.
and coordinated team brilliance shines through under Additionally, Zebrafish facility would also be introduced
five unique verticals. First, the Food, Nutrition and to study complex neurological disorders such as autism.
Dietetics Department, focusing on areas investigating Together, these five verticals establish SoHST as a
interactions between diet, health and diseases, is unique trans-disciplinary school with women in key
helmed by Dr. Shuchi Upadhyay and Dr. Divya Rawat. leadership positions.
Second, the Department of Pharmacology has Dr.
Jyoti Upadhyay with expertise in the area of Clinical (The authors are academicians at
Pharmacy and Pharmacovigilance. Other faculty UPES School of Health Sciences and Technology)
members have considerable research experience in
the area of Pharmaceutics, Novel Drug Delivery and
Targeting Systems, Nanotherapeutics, Pharmokinetics,
Pharmacognosy and Process Engineering. Third, the
areas of Structural Bioinformatics, computer-aided
Drug Design and Medicinal Chemistry are being led by
academicians with global exposure and experience.
Ms. Monika is a medicinal chemist in this team, working
on QSAR-inspired designing and synthesis of novel
medicinal compounds against dermal cancers. Fourth,

74 DIGITAL HEALTH BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY healthcare. Digital health is not just limited to doctors
providing consultation over the telephone or video
DR K HARIPRASAD call but also includes maintaining digital health
President, records for treatment continuity, integrating data
from wearable devices and mobile applications for
Apollo Hospitals monitoring and reporting critical updates directly
to the caregiver and choosing the most suitable
A DIGITAL treatment based on an AI-enabled clinical research
FUTURE FOR module.
HEALTHCARE
Artificial Intelligence (AI) is set to revolutionise
Healthcare has seen an evolution not just and redesign medicine and healthcare. From
in the technology used for treatment traditional image processing techniques covering
but also in the delivery of care and a limited number of diseases in 1993 to assistive
well-being. One reason for this is the software like IBM Watson and predictive apps like
advances in digital technology over the the Apollo AI-powered Cardiovascular Disease
last two decades that have impacted every industry. Risk tool, the potential of AI in healthcare is set to
While the digital transformation of healthcare had explode. There is a huge amount of information
already begun before the pandemic, the pace was that is generated regarding medical conditions,
steady but slow. Five years ago, projections had treatment protocols from medical records. One of the
indicated that 40 per cent of Internet of things applications of AI is in managing this Big Data.
(IoT)-related technology would be health-related by
2020. Driven by artificial intelligence and machine AI and ML (Machine Learning) capabilities in
learning, innovation in digital health technologies digital healthcare have equipped providers to deliver
was increasingly taking place, but a major impact customisable treatment and services directly to
on the delivery of care was yet to be visible. The patients’ homes, after analysing a plethora of use
pandemic forced the delivery of care to rapidly adapt cases fed into the clinical R&D systems daily. Just
to a new digital normal encompassing health records, like Google Maps uses traffic information and data to
doctor consultations, smart wearables and digital show us the best route to a destination, AI can help by
therapeutics. using all the medical data to show the doctor the best
tests based on the symptoms to reach a diagnosis or
Since the pandemic, the emphasis has been the best treatment methods to reach a cure.
on a smooth integration of digital technology into
Digital Healthcare in India is evolving by
the day and enabling the healthcare industry to
further improve patient diagnosis, treatment and
management and work towards preventive and
predictive care and well-being. The continuing
transformation of healthcare delivery platforms and
the advent of high-speed connectivity will ensure that
more patients from Tier-II and Tier-III cities in India
get the same quality of treatment as in the metros.

Technology will also help build a larger and
stronger pool of talent through remote learning and
continuous skilling. Over time, this will help improve
the doctor-patient and nurse-patient ratio.

This is just the beginning! National public
health initiatives like Ayushman Bharat and the
National Digital Health Mission, India have already
taken a major step forward to digitise healthcare.
With technology powered by AI and ML enabling
integration of health data across platforms, digital
health will ensure a seamless delivery of care.
Digitisation will also enable accessibility and
expansion of reach thus adding value to the health
economy and a long-term positive impact on the
growth of the healthcare sector. A digital future for
healthcare awaits us in 2022 and beyond!

ANNIVERSARY Women Special

Of Pathfinders
and Pathbreakers

Call to Action for
Gender Diversity in
Sci-Tech & Innovation

Dr Renu Swarup
Former Secretary to Govt of India,

Department of Biotechnology,
Ministry of Science &Technology

76 WOMEN SPECIAL BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY

Of Pathfinders
and Pathbreakers

Women continue to sustain the quest to make a mark in the workplace and balance their
personal life. Pandemic or not, woman power has not diminished one bit, and it shows
in their exemplary achievements in India and the rest of the world. On the occasion of

Women’s Day and for the completion of its 20 years in March 2022, BioSpectrum salutes
20 inspiring leaders of the life sciences industry, for motivating others around them,
breaking the glass ceiling and paving their own paths in 2021. These 20 women are

powerhouses in their respective fields, inspiring not just their employees and the people
around them, but other women and the next generation of women leaders.

In spite of the challenges of the COVID-19 positions in supporting the people on their teams.
crisis, women’s representation improved
across all levels of the corporate Also, compared with men in similar
pipeline in 2020 and 2021. This
is an encouraging sign and positions, women managers are
worth celebrating after an incredibly
difficult time across the globe. As a taking more consistent actions to
result, the theme for International
Women’s Day, March 8, 2022, revolves promote employee well-being
around - ‘Gender equality today for a
sustainable tomorrow’, recognising including checking in on their team
the contribution of women and girls
around the world to build a more members, helping them
sustainable future for all.
manage their workloads,
According to the ‘Women in
the Workplace 2021’ report by and providing support
McKinsey, women are rising to
the moment as stronger leaders for team members who
and taking on the extra work
that comes with stress and are dealing with burnout
exhaustion. Compared with
men at the same level, women or navigating work–life
are doing more to support their
teams and advance diversity, challenges.
equity, and inclusion efforts.
Over the past 18
For instance, women are
doing more than men in similar months, companies have

embraced flexibility.

More than three-quarters

of senior HR leaders say

that allowing employees

to work flexible hours is one

of the most effective things

they’ve done to improve employee well-

being. However, many companies are

missing a crucial piece i.e. without clear

boundaries, flexible work can quickly

turn into “always on” work and that is

affecting a lot of women lately. Maybe

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com WOMEN SPECIAL 77

even leading them to leave their jobs, since ANNIVERSARY
they have less time in-hand for the family.
Another prominent name is Dr Soumya
As per the State of Working India 2021 Swaminathan, currently serving as the Chief
report by the Azim Premji University, the Scientist at the World Health Organisation.
number of women who have had to quit the A paediatrician and a globally recognised
workforce has been alarmingly high over researcher on tuberculosis and HIV, Dr
the last one year, irrespective of their nature Soumya has 30 years of experience in clinical
of employment. Almost 50 per cent care and research and has worked throughout
of the women exited compared
to only 11 per cent of men. The her career to translate research into
number of women exiting from impactful programmes. She was
any work arrangement is at Secretary to the Government of
least twice their share in India for Health Research and
that arrangement in the Director General of the Indian
pre-pandemic period. Council of Medical Research
from 2015 to 2017.
On the brighter Likewise, we have Dr
side, more women have Renu Swarup, former
entered the workforce Secretary, Department
as ‘freshers’ than men. of Biotechnology (DBT),
Also, women are taking up Government of India.
different kinds of jobs as compared to Through biotechnology
men. A study of the men and women
who remained employed in 2021 translational research and industry-
reveals that women seem to stick academia partnerships, she has
around in the same job more. In supported more than 1000 startups
other words, women have displayed and entrepreneurs and nearly 500
higher determination in the last one
year. small companies for innovative
research and product development.
Raising a toast to ‘Women Dr Renu served in the DBT for
Leaders in Life Sciences’ nearly 29 years. She was the Senior
Advisor and Scientist- H at DBT
The Indian life sciences sector has a deep pool before taking over as Secretary in 2018.
of talented women who have made a mark for The list would be incomplete without mentioning
themselves by doing exceedingly well in their careers Dr Chandrima Shaha, a biologist and professor
and by setting up great examples. To start with we at the National Institute of Immunology (NII) in
have Kiran Mazumdar Shaw, Executive Chairperson New Delhi, who became the first woman to head
at Biocon. A first-generation entrepreneur and the prestigious Indian National Science Academy
global business leader with over four decades of (INSA) in 2019. She has previously served the INSA
experience in biotechnology, Kiran is fueled by her as vice-president and director of the NII.
passion. She started her biotech journey in 1978 Every year, many women are joining the
from her garage in India and today, that journey is leadership list and carving a niche for
changing lives for the better across the globe. She is themselves in this male-dominated
regarded as an unconventional thinker with many industry. On this note, BioSpectrum
firsts to her credit. Under her aegis, Biocon delivers brings to you 20 inspiring leaders of the
on the promise of making medicines accessible and life sciences industry, for motivating
affordable to millions of patients worldwide. others around them, breaking the glass
ceiling and paving their own paths
Following suite is the recent Padma Bhushan in 2021. These 20 women
awardee Suchitra Ella who is the Joint Managing are powerhouses in their
Director of the vaccine company Bharat Biotech, respective fields, inspiring
which she co-founded with her husband Dr not just their employees
Krishna Ella in 1996. With experience in customer and the people around
operations, finance, marketing and business them, but other women
development, Suchitra is a strong pillar of support and the next
and guidance at Bharat Biotech, overseeing a wide generation
range of operations in the company. of women
leaders.

78 WOMEN SPECIAL BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY DR PRIYA ABRAHAM

DR BHARATI PRAVIN PAWAR Director, National Institute of Virology

Minister of State for Health and Strong commander
Family Welfare, Government of India
At the centre of a critical juncture of
Spearheading healthcare genomic studies of SARS-CoV2 in India
throughout 2021 has been Dr Priya
Adoctor by profession who had been Abraham, Director, ICMR- National
working since the last 7 years through Institute of Virology (NIV). She has been
Zilla Parishad to eradicate malnutrition at the forefront of the fight against COVID-19 by
and providing clean drinking water being involved in several research
in Nashik district, Dr Bharati Pravin activities. Dr Priya led the NIV
Pawar stepped into Prime Minister Narendra teams that made India proud
Modi’s cabinet as the Minister of State for Health right from the standardisation
and Family Welfare in 2021. With keen interests of the COVID-19 real-time PCR
in reading and singing, Dr Bharati has been to the development of the first
indigenous COVID KAWACH
actively participating in a number of IgG ELISA to the achievement of
healthcare related programmes contributing to India’s first indigenous
and launches across the country vaccine against COVID-19, (COVAXIN), in a very
since the past few months. short time span.

“WE ARE MOVING AHEAD TO MEET “I FEEL PROUD TO BE PART OF A GREAT TEAM THAT
THE GOAL OF UNIVERSAL HEALTH HAS DEMONSTRATED ITS EXPERTISE IN MANAGING
THE ONGOING COVID-19 PANDEMIC SO WELL.”
COVERAGE WITH ‘WHOLE
OF SOCIETY’ APPROACH
WITH SAHBHAGYATA AND
SANKALP.”

DR NITA PATEL DR GAGANDEEP KANG

Executive Director- Immunology, Professor, Department of Gastrointestinal
Vaccine development- Novavax Sciences, Christian Medical College

Determined and diligent Force to reckon with

One of the lead vaccine scientists Voicing out her opinion and expertise on
at Novavax, a US-based biotech the development of COVID-19 vaccines
company that has developed a and monoclonal antibody therapy
COVID-19 vaccine in 2021, Dr Nita throughout 2021, Dr Gagandeep
Patel in Maryland often works Kang has been at the forefront in
for 18-hours a day in the lab. She worked at tackling the pandemic. An elected Fellow of the
MedImmune for almost 25 years on various Indian Academy of Sciences and the American
Academy of Microbiology, she became the first
projects including tuberculosis. She later Indian woman to be inducted as a Fellow of the
moved to Novavax in 2015 where her Royal Society (FRS) in London by joining the likes
team has been working tirelessly to of Isaac Newton and Charles Darwin
develop the COVID-19 vaccine. to be elected to the almost
360-year-old scientific body.
“THIS IS THE FASTEST THAT I HAVE
WORKED FOR ANY VACCINE “THERE IS SO MUCH STILL TO
THROUGHOUT MY CAREER. ONE LEARN ABOUT IMMUNE RESPONSES
THING I KNEW WAS THAT AND PROTECTION FROM DISEASE,
WE DID NOT HAVE MUCH BUT THERE HAVE NEVER BEEN
TIME THAT NORMALLY OPPORTUNITIES LIKE THIS
IT TAKES TO DEVELOP A BEFORE.”
VACCINE.”

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com WOMEN SPECIAL 79

DR ARADHANA SARIN ANNIVERSARY

Chief Financial Officer, AstraZeneca PRIYA GANDHI

Effortless navigator Executive Director, Hester Biosciences

Adoctor from India, and an MBA from Strategic planner
Stanford Business School, Dr Aradhana
Sarin stepped in as the Chief Financial Priya Gandhi joined Hester Biosciences
Officer at AstraZeneca in 2021, a in the year 2016 and has worked since
company that has a market cap of then from being an officer to a Deputy
$175.54 billion. Dr Aradhana was earlier serving Director, before being inducted in the
as the CFO at Alexion before it was acquired by board and appointed
AstraZeneca in 2020. She has also served as a as the Executive Director of
Managing Director at Citi Global Banking in New the company in 2021. She
York, where she advised clients in the life sciences is currently part of the
and biopharmaceutical sectors. She has relocated team which is involved
from the US & is now based in the UK. in designing Hester’s
strategic direction besides
“THE CHALLENGE IS ALWAYS being involved in day-to-
BALANCING THE SHORT-TERM NEEDS day business operations.
FROM INVESTORS & STAKEHOLDERS Priya has played an active role in setting up
& INVESTING LONG-TERM IN THE the manufacturing plant and the business
BUSINESS & TAKING THE RIGHT activities in Hester Africa. Notably, she is a trained
RISKS.” Bharatnatyam dancer.

DR SHOBHANA KAPOOR “THE LIFE SCIENCES SECTOR IS FULL OF INFINITE
POSSIBILITIES AND SO IS THE FUTURE FOR WOMEN
Assistant Professor, LEADERS. BOTH MAKE A POWERFUL COMBINATION.”
Indian Institute of Technology (IIT) Bombay
DR PARUL GANJU
Biology explorer
Co-founder & Chief Executive Officer,
Dr Shobhna Kapoor, Assistant Professor Ahammune Biosciences
at IIT Bombay, studying the roles
played by lipids in infectious diseases A Path- finder
at molecular level and
inventorying the For Dr Parul Ganju, 2021 was full of
pathogenic lipid-induced development as her team at Ahammune
effects in host cell membrane Biosciences filed the first Investigational
properties, received the New Drug Application with the Drug
Science and Engineering Controller General of India for approval
Research Board Women to conduct human studies with its lead drug
Excellence Award for 2021, instituted candidate for vitiligo, with freshly infused capital
by Department of Science and Technology. With raised in a Pre-Series A round. Besides
the COVID-19 pandemic creating a massive push vitiligo, through her startup Dr
to develop effective anti-infective therapies, Dr Parul is aiming to target multiple
Shobhna is pursuing an exciting paradigm for dermatological indications with
broad-spectrum, anti-infective intervention that a deep pipeline of IP-based
relies on targeting the lipid membrane. molecules that modulate
cellular pathways underlying
“OUR GROUP IS INTERESTED IN EXPLORING LIPID skin health and immunity.
MOLECULES AS CHEMICAL BIOLOGY TOOLS TO
STUDY CELLULAR SIGNALING PATHWAYS INVOLVED “EMBRACE THE CHALLENGES
IN INFECTIOUS DISEASES.” IN LIFE, THEY JUST MIGHT
BE THE TRIGGER FOR
YOUR NEXT INNOVATION.”

80 WOMEN SPECIAL BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY NIDHI JAIN

DR NEETU SINGH Founder & Chief Executive Officer, KareXpert

Associate Professor, Digital expert
Indian Institute of Technology, Delhi
An engineer from the Indian Institute of
Nano looker Technology Roorkee, Nidhi Jain is the
founder of an artificial intelligence-led
Awinner of Janaki digital healthcare platform KareXpert,
Ammal-National funded by Reliance Industries.
Women Bioscientist KareXpert has emerged as Asia’s first and only
Award 2021 by the company to digitise hospitals’ 100 per cent
Department of workflow with a single solution. For Jain, 2021
Biotechnology, Dr Neetu Singh is was challenging and fruitful as she was able to
currently establishing a research programme digitise the healthcare infrastructure in several
at IIT-D that explores systematic probing into tier-2 and tier-3 cities, empowering them to
nanomaterials biological activity and formulates
‘design rules’ for developing biosystems encounter the ongoing medical
for specific bio-medical and technological challenges including COVID-19,
applications. Her work is published in very through her venture.
high impact journals and also gathered a lot of
attention and featured in Faculty of 1000 Prime “THE GOOD PART IS LIFE SCIENCE
(identifies top research in biology and medicine) AND THE HEALTHCARE SECTOR
and several other science media outlets. IS ALREADY WELCOMING WOMEN
IN TERMS OF NURSES, DOCTORS
“A RATIONAL APPROACH IS NECESSARY FOR
SYSTEMATICALLY ADVANCING NANO-MATERIALS AND IN OTHER PROFILES.”
AND BIOMEDICAL TECHNOLOGIES OF THE FUTURE.”

RUNAM MEHTA SUMITA MITRA

Chief Executive Officer, HealthCube Partner, Mitra Chemical Consulting

The go-getter Elegant designer

Aphysiotherapist by profession, Runam The European Patent Office (EPO) has
Mehta is the Chief Executive Officer honoured the Indian-American chemist
(CEO) of HealthCube, a well-funded Sumita Mitra with the European
health-tech startup in the arena of Inventor Award 2021 in the
diagnostic devices. Much elated after ‘Non-EPO countries’
winning the ‘Startup of The Year’ title at the category. Sumita was the
Smart Bio Awards during the Bengaluru Tech first to successfully integrate
Summit 2021, Runam is now aiming to lead the nanotechnology into dental
company into its next round of funding as well as materials to produce stronger
greater market expansion in the next 24 months. and more aesthetically
Prior to joining HealthCube as its Chief pleasing fillings, which are
Growth Officer Runam spent close now used by dentists around the
to 7 years at Portea Medical. world. Her innovation has since been successfully
commercialised and used in more than 1 billion
“NO ONE MAKES IT ALONE. tooth restorations. Sumita is a partner at Mitra
SURROUND YOURSELF WITH Chemical Consulting, LLC, a company she set up
PEOPLE – PEERS, MENTORS, with her husband after leaving 3M in 2010.
FRIENDS, AND FAMILY WHO ARE
INVESTED IN YOUR SUCCESS.” “I ALWAYS TELL YOUNG PEOPLE, ‘BELIEVE IN
YOURSELF, SEEK HELP WHEN NEEDED, AND
NEVER GIVE UP’.”

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com WOMEN SPECIAL 81

ASHVINI DANIGOND ANNIVERSARY

Chief Executive Officer, DR PRAKRITI TAYALIA
Manorama Infosolutions
Assistant Professor,
Embracer of technology Indian Institute of Technology (IIT) Bombay

Ashvini Danigond is a successful first Dimension changer
generation global Indian entrepreneur
and tech-innovator pioneering path- An Assistant Professor at the
breaking innovations in the health- Department of Biosciences and
tech sector. Under her able guidance, Bioengineering in Indian Institute
Manorama Infosolutions has been awarded a of Technology (IIT)
prestigious country automation project from Bombay has been
the Ministry of Health (MoH), the awarded the Merck Young
Republic of Seychelles in 2021. It is Scientist Award -2021 in
a one-of-its-kind project that will the Biological Sciences
directly benefit the citizens of category. Her work revolves
the nation by providing digital around engineering immune
solutions for the government- cells via 3D matrices for cancer
run hospitals. immunotherapy and developing semi-synthetic
hydrogel matrices for studying differences in
“KEEP YOURSELF UPDATED cell behaviour in 2D and 3D micro-environment.
OR GO OUTDATED. YOU HAVE Dr Prakriti is a PhD in Applied Physics and
TO ADAPT TO CHANGING Bioengineering from Harvard University.
TECHNOLOGY.”
“SCIENTIFIC PROBLEMS CAN BE SOLVED IN TWO WAYS;
EITHER SOLVE A COMMON PROBLEM IN A UNIQUE
WAY, OR A UNIQUE PROBLEM IN A COMMON WAY.”

DIVYA SRIRAM KHUSHBOO SANDHU

Co-Founder, D-NOME Customer Experience Manager, Janani

Habit breaker Perfect manager

Divya Sriram, was adjudged the winner Khushboo Sandhu is the driving
of the Cytiva co-sponsored reward force behind the unique focus on
for the Best Domain-Specific Startup reproductive health for the Bengaluru-
Prize of Rs 5 lakh, and Rs 2 lakh prize based startup Janani, incepted by her
sponsored by Syngene, to support the fiancé Nilay Mehrotra. In
next generation of entrepreneurs, at the National 2021, Khushboo along with her
Bio Entrepreneurship Competition (NBEC) team launched a number of
2021. Divya is a PhD in cancer biology from novel services such as home
CSIR- Centre for Cellular & Molecular Biology semen collection kit, do-it-
in Hyderabad. Her work has been published yourself semen testing kit
internationally in prestigious journals, including etc., alongside securing Rs 8
Nature Journal’s scientific reports. crore worth of seed investment.
Her expertise lies in innovating the Having studied aviation from the Frankfinn
diagnosis of infectious diseases Airhostess Training Institute, Khushboo has
using molecular biology. worked with Jet Airways and IndiGo.

“I HAVE ALWAYS BEEN IN “YOU’RE ALL SHEROES, AND YOU’RE SETTING A
PURSUIT OF BRIDGING BREATHTAKING EXAMPLE FOR ALL THE WOMEN OUT
ACADEMIA AND ITS THERE. EVEN IF THE ODDS ARE STACKED AGAINST
APPLICATION IN THE YOU, KEEP GOING.”
INDUSTRY.”

82 WOMEN SPECIAL BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY DR MAMTA MURTHI

DR PRITI V WARKE Vice President-Human Development,
World Bank
Director - Cell Biology, Head -
Regulatory Affairs, HiMedia Laboratories System supporter

Passionate leader To respond to the largest crisis the world
has ever seen, Dr Mamta Murthi played
Dr Priti V Warke has been passionately an instrumental role in providing a
involved in R&D, operational and package of $12 billion by the World Bank
administrative activities of the cell to help countries respond to vaccines,
biology wing of Mumbai-based HiMedia testing, and even treatments
Labs. When the second COVID-19 in 2021. Dr Mamta started as
wave surged in 2021, she swiftly managed the Vice President for Human
entire supply chain and increased workload with Development at the World
a limited staff. Her R&D team worked overtime, Bank on July 1, 2020. In this
developing media for vaccine production & many role she oversees the Global
other products related to antibody testing kits. She Practices for education;
encouraged proper & continuous communication health, nutrition, and population;
externally with customers and gender; social protection and jobs – as well as the
internally with her team. Human Capital Project.

“WOMEN ARE INHERENT “THE PANDEMIC HAS EXPOSED WEAKNESSES IN
LEADERS AND INFLUENCERS, HEALTH SYSTEMS WORLDWIDE AND SET BACK
IT’S JUST THAT THEY NEED PROGRESS TOWARDS SDG3.”

TO RESTRUCTURE THEIR
PERSPECTIVES OF SELF-
BELIEF.”

DR TANUSHREE DEVI LAISHRAM ANURADHA GUPTA

Co-Founder, CyGen HealthTech Deputy Chief Executive Officer- Gavi, the
Vaccine Alliance
Mindful entrepreneur
Vision maker
Awinner of the Meity NASSCOM Women
Entrepreneur Award 2021 in the Anuradha Gupta, who is more than
healthcare category, Dr Tanushree a little invested in India’s COVID-19
Devi Laishram from Manipur is vaccination journey, having spent long
playing a pivotal role in preventing years strengthening public health in
lifestyle-related diseases through India before she joined Gavi, has played
her startup venture CyGen a key role to ensure equitable access to COVID-19
HealthTech. A medical doctor vaccines across the world through the Vaccine
and a clinical cardiologist Alliance in 2021. Prior to Gavi, Anuradha served as
by profession, Dr Tanushree Mission Director of the National Health Mission of
has developed a cloud-based India, where she ran the largest, and possibly most
preventive healthcare platform complex, public health programme in the world
that helps various channels with an annual budget of $ 3.5 billion.
diagnose patients earlier with higher accuracy.
Her startup has recently collaborated with South “THE PANDEMIC HAS
Korean firm Seegene for distribution of COVID-19 HIGHLIGHTED THE NEED TO
testing kits in India. MAKE HIGHER AND LONGER-
TERM INVESTMENTS. THERE
“BEING MINDFUL OF THE NEEDS AND EXPECTATIONS HAS BEEN A LONG-STANDING
OF THE CUSTOMERS AND MY TEAM IS MOST COMMITMENT IN INDIA
IMPORTANT.” TO INCREASE PUBLIC
FINANCING FOR HEALTH.”

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84 WOMEN SPECIAL BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY CALL TO
ACTION FOR
DR RENU SWARUP GENDER
Former Secretary to DIVERSITY IN
Government of India, SCI-TECH &
Department of Biotechnology, INNOVATION
Ministry of Science &Technology
The recent UNESCO Science Report 2021
Gender Diversity is critical has highlighted some very important
for Science,Technology and matrices for assessing the progress
Innovation (STI), as for nearly countries make in mainstreaming policies
all other sectors. It is today and programmes on Gender Diversity,
well recognised that complete some key ones are - number of women researchers
inclusivity and gender parity especially in future technology sectors, number of
are essential to make economic women inventors in Patent applications, number
of women entrepreneurs, access to Venture funds
progress and drive the by Women entrepreneurs, number of women in
developmental agenda. In recent academics, number of women in Science academies,
number of women in Corporate Boards etc.
years there has been a special
focus on Women Empowerment Globally numbers are progressing, with women
and on women led development researchers moving to ~33 per cent in 2018 from
in our Policy and Programmes. ~28 per cent in 2015, in India the percentage of
women investigators across sectors is approx 30 per
Globally also there has been a cent. We also see more women entrepreneurs - in
special focus on trying to address India, it is today over 35 per cent. Globally over 60
per cent of all patent applications in Biotech had
the issues related to Women women inventors, although in Engineering it was
In STEM (science, technology, less than 15 per cent. There is however a major
engineering and mathematics) gap in the numbers when it comes to women in
and framing key policies which leadership positions especially in future technology
support the development of world sectors. The concern is the representation of women
class talent in STEM to reduce this in National Academies - even in biological sciences
which has a higher representation, globally it is just
Gender Gap. around 15 per cent.

In India it is heartening to note that we have
had a fairly good representation and India has also
had Women as Presidents of Academies. We are
also seeing an increase in numbers of our Women
achievers – from Nobel Prize globally to the Shanti
Swarup Bhatnagar Awards in the country to other
awards and fellowships, a marginal increase in
numbers is being noted. It is however imperative, to

BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com WOMEN SPECIAL 85

see how these numbers translate to an increase in ANNIVERSARY
the number of women in leadership positions.
In India it is heartening to note
Key actions required that we have had a fairly good
representation and India has
It is important to institutionalise Gender also had Women as Presidents of
Equality Policies at organisational, national and Academies. We are also seeing an
international level. increase in numbers of our Women
achievers – from Nobel Prize globally
We need to focus on Policy, Programmes and to the Shanti Swarup Bhatnagar
People. We need to frame the right policies to help Awards in the country to other
us to implement the key strategic decisions. Once awards and fellowships, a marginal
the policies are in place, we need to develop a increase in numbers is being noted.
strategy to implement these - for this a set of well
designed programmes are a key to success. Then of schemes provide opportunities to women scientists
course we need the right people to help us achieve who have had a career break to come back into
our targets and goals. the mainstream. Alternate career options from
Intellectual Property (IP) management to Science
What we need to do is create a level playing Communication to Legal affairs are opportunities
field for women and girls in research and which are made available through Technology
entrepreneurship. The key to success is three- Information Forecasting and Assessment
pronged: Council (TIFAC) and other organisations.
Women Entrepreneurship is promoted by DBT-
The first is to build a strong base of women in Biotechnology Industry Research Assistance
science for the nation’s success, by providing access Council (BIRAC), DST-Technology Development
to science education for our girls at all levels specially Board (TDB), NITI Aayog-Atal Innovation Mission
focussing on the remote districts, tier 2 and 3 cities. (AIM) and other agencies which provide access
to mentorship, finances and technical resources,
The second is to build a vibrant ecosystem that special incubators, awards etc. We have some very
encourages the girl child and women scientists vibrant Women Incubators and Parks which are
to constantly up-skill themselves, build their nurturing women startups and entrepreneurs.
leadership skills, and evolve as leaders in driving
scientific innovation and progress. Women scientists and entrepreneurs have
demonstrated their strong presence, and we have
The third is to empower them financially and many success stories. We should now work to
socially – we need to ensure that we have Policies ● Create policies and partnerships which harness
which enable gender participation at the workplace
and handle the socio - economic, cultural and the economic potential of women for sustainable
behavioural aspects. This is imperative for sustained and inclusive growth.
and long term careers of women in science. ● Attract Women to Science Research and develop
a sustainable framework to retain them for long
We still have a significant distance to cover. We term research.
need to build a strong foundation and ensure equality ● Scale up women entrepreneurial activities to take
in numbers at the base — we cannot have an inverted it from the informal to formal sector.
pyramid, a strong base is essential to tap the potential ● Overcome internal and social barriers to market
of our girls in science education, and this requires access to bring women entrepreneurs to the
consistent and concerted effort from a variety of center stage of economic development.
stakeholders - including families, school systems, the As countries frame STI Policy, it is imperative
corporate sector, and of course, women themselves. that the issues of Gender Diversity continue to
occupy centre stage, with National and International
Government of India through Ministry of Science partnerships also explicitly including this in their
& Technology, (Department of Biotechnology (DBT), agreements. It is imperative to continue this
Department of Science and Technology (DST), momentum to ensure that we succeed in this very
Council of Scientific and Industrial Research (CSIR) important Global Challenge of Gender Equality.
has created some very important enabling policies
and programmes to attract young girls and women
to science and empower them – special science
education programmes for young girls – Vigyan
Jyoti and Vigyan Pratibha which gives the girl
students a level playing field to take examinations
for engineering colleges and builds their skills to
take up other educational options.

From KIRAN to BioCARE, a number of grant

86 WOMEN SPECIAL BIOSPECTRUM | MARCH 2022 | www.biospectrumindia.com

ANNIVERSARY Incubation Centre, at the park, provides cost-effective
opportunities to budding entrepreneurs who would
PROF. P M MURALI like to set-up a startup. Mentors associated with the
Chairman, Golden Jubilee park help the incubatees from prototype to product
launch. On the occasion of International Women’s
Biotech Park for Women Day, Chairman of the Golden Jubilee Biotech Park for
Women, Prof. P M Murali, shares his views on what
“WOMEN MUST women must do to become successful entrepreneurs.
BELIEVE IN
THEIR IDEAS How many women entrepreneurs are
AND THE housed at the Golden Jubilee’s incubation
SURROUNDING centre?
ENVIRONMENT
MUST BE There are currently 23 women entrepreneurs.
SUPPORTIVE” The whole business model is to serve the women
entrepreneurs of the park. Eighty per cent of all the
Established two decades ago with income goes into facility and manpower costs to
the support of the Department of ensure that there is a lot of traction. In addition, the
Biotechnology, Government of India, park operates two seed funds. The administration of
Government of Tamil Nadu and this is also done by the park.
with technical support from the M S
Swaminathan Research Foundation (MSSRF), the Any word of advice to women
Golden Jubilee Biotech Park for Women encourages contemplating entrepreneurship?
and empowers women entrepreneurs in the
life sciences sector. The MS Swaminathan Bio- Women entrepreneurs have a bigger challenge
than men as their lives are quite interlined with
their family obligations. Also, they need a big
support system if they have to dedicate time to
their business objective without interruption. The
good side is because of this, women have greater
time management skills. This is something that
is quite noticeable. Other challenges include
marriage, relocation, children’s studies and career,
providing care for the elderly, etc. All these come
into a woman’s domain and she has to manage
this, along with her work. This, sometimes, is a
serious challenge. Some hesitate on account of such
constraints. However, women are now demonstrating
higher efficiency to offset these hurdles. The bottom
line is that women have to believe in their ideas and
the environment around her has to be supportive to
make her dream come true.

On the occasion of International Women’s
Day, what message would you like to convey
to the women in the biotech industry?

Women are laser focused. They are better at
time management and have greater empathy while
building teams. This works to their advantage.
They have to believe in themselves and build an
environment where all others buy into her belief
system. Think they have a very bright future in the
startup ecosystem and also in leading from the front.
Most women-led organizations have a ‘human face’
and there is a lot of emotional connection. “Believe in
yourselves and we can do it must be the motto”.

Anusha Ashwin



RNI TC No. MAHENG14628 RNI NO. DELENG/2004/13061
Date of Publication - 28/02/2022 Date of Posting - 01/03/2022

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