INDIA BIOPHARMA

READERS CONCLAVE
20-21 May
Organized by Bluetech Media
Ajoy Kumar, Country Head, JSS Medical Research India Pvt Ltd.
Special Address:
● Under reporting done throughout the system.
● We should start looking at data without religious and political bias, we don’t want to
venture and do study as a country, we are tech savvy but lack in science and research.
● if we want to leap in science, we need excellent educational hub (to reimagine Indian
healthcare).
● India is lacks in infrastructure, especially in tier 2 and tier 3 cities,
● We need to stop being seduced by whatsapp forwards.
● Companies will have to reimagine their setups, how to change with the work getting
virtual.
Ashok Bhattacharya, Former Executive Director,
Takeda Pharmaceuticals

● Last few decades Indian pharma has grown considerably.

● There is rise in health consciousness in people, increase in health insurance
participation, specialist and super specialist doctors and nurses.
● Indian Pharma has been a highly regulated industry with lot of mergers and
acquisitions.
● India 3rd in terms of volume, 14th by value with over 3,000 drug companies and
3,500 manufacturing units.
● In 2021 Economic Survey domestic market to grow 3 times, today valued at 41
billion US dollars predicted to reach 130 billion us dollars by 2030.
● 12% CAGR needs to be achieved in 2020-2030 which is currently at 9%.
Ashok Bhattacharya, Former Executive Director,
Takeda Pharmaceuticals

● India stands to be one the largest patient pool, intellectual hub for scientists, we have
a capacity of low cost high quality medicines with a recent example being vaccines.
● There is a change in mindset after pandemic, redefining roles and practices, benefit
policies, culture of teamwork, robust business contingency plan, ethics, resilience,
fast response to stimulus and Health science innovation coming into large focus.
● There are certain challenges like logistics and distribution, education, clinical trials,
manufacturing, taxation rules, funding etc and yet we need to be ambitious.
Panel discussion: Innovation in Biopharma and India’s
role in the global ecosystem
Panel Members:
Dr. Mukesh Kumar, Vice President & Head, Clinical R&D, Cipla
Subhojit Mukherjee, SBU Head Sales & Marketing, Akumentis
HealthCare Ltd
Prof P. Reddanna, Executive President – FABA, Senior Professor (Retd.)
School of Life Sciences, University of Hyderabad
Moderator: Dr. Uday Saxena, Chief Ideator & Co-Founder, Reagene
Biosciences
Panel discussion: Innovation in Biopharma and India’s role in
the global ecosystem
Dr. Mukesh Kumar, Vice President & Head, Clinical R&D, Cipla
● We are on that path to develop innovative product with deeper understanding of
disease, target and efficiencies. Our journey with value chain is very long with 8-10
years for innovative products.
● 3 major challenges in front of us: 1.Time, 2.Collaboration of sciences and 3.Huge
investments
● Cipla being a generic company not focuses on innovation hense needs more time for
this.
● We need to do partnerships of companies with universities with consistent focus of
management, keeping the goal of innovative pharma.
Panel discussion: Innovation in Biopharma and India’s role in
the global ecosystem
Dr. Mukesh Kumar, Vice President & Head, Clinical R&D, Cipla
● Doing science innovation together and making products available, we need to focus
on both.
● There has to be a policy and strategy for long term in innovation, for eg. there is
proper financial support in countries like US.
● Just a mandate will not help, need to create an ecosystem, infrastructure, start from
talent, science, innovation and then rewards will follow.
● US govt has some policies on creating this ecosystem at all levels, framework for
clinical research, regulatory framework and funding academic institutions.
● To improve Biopharma- Creating an ecosystem, long term strategy and framework.
Panel discussion: Innovation in Biopharma and India’s role in
the global ecosystem
Subhojit Mukherjee, SBU Head Sales & Marketing, Akumentis HealthCare Ltd
● We are a booming Pharma Industry.
● India is more into bio similar and by 2025 we will take over 1/3rd that of world
market.
● Expenses are on a higher side, access is a big problem, insurance coverage may cover
bio similar and not cover biologics.
● As of now we are top 10 in bio similar market and driving Indian market to more and
more expansion.
● There are so many regulations to get it passed for biologics than biosimilars.
● We need to be self sufficient.
Panel discussion: Innovation in Biopharma and India’s role in
the global ecosystem
Subhojit Mukherjee, SBU Head Sales & Marketing, Akumentis HealthCare Ltd
● Govt has to step forward in a big way, EBITA needs to be achieved in the companies
so if govt give required support and leverage they can rise.
● We have 70 biosimilars approved in India and only 18 in US, we are not coming with
biologics.
● Indian companies have risen to the occasion. Corporate flexibility is there for
keeping aside profits and they can rise to the occasion surely for eg. CSR.
● To improve Biopharma- Affordability (key pricing strategies)
Panel discussion: Innovation in Biopharma and India’s role in
the global ecosystem
Prof P. Reddanna, Executive President – FABA, Senior Professor (Retd.) School of Life
Sciences, University of Hyderabad
● There are no buyers for innovation as our industry are shy of taking the risks.
● They are happy with biosimilars and generic market is huge which relies on them.
● Many institutions are capable of doing innovation and they need to be extracted with
lots of effort.
● Problem is from both sides, no challenge to these education products for innovations
and no innovation in academics.
Panel discussion: Innovation in Biopharma and India’s role in
the global ecosystem
Prof P. Reddanna, Executive President – FABA, Senior Professor (Retd.) School of Life
Sciences, University of Hyderabad
● In Academics, faculty have complete freedom to do their projects.
● Faculty research is driven by national interest and if funding is coming it will be
great encouragement.
● To improve Biopharma- Need good channels for innovative academics, including
clinical research in medical institutions.
Sandeep Majumdar, Vice President (Bio Pharma Division), Intas
Pharmaceuticals Ltd.
● There are certain challenges to develop biosimilars as you have to be as similar as
possible to the innovator.
● Clinical trials phase 1&3 scale and everything needs to be organized.
Dr. Sanjeev Gupta, Sr. GM & Head-Advanced Biotech (Biosimilar R&D), Ipca
Laboratories
● Sustenance in the market is essential as many molecules are available in the market.
● We need to foresee what will happen after 10 years.
● We have to focus on technology and not be in hurry.
Dr. Arani Chatterjee, Senior Vice-president, Clinical Research, Aurobindo
Pharma

● Some advantages and disadvantages are associated with the trials.

● No need to follow the patient throughout lifetime in biosimilar, very large sample
sizes are often there.
● Biosimilar and innovator need to be on one-to-one basis, choosing right indications,
you can get away with approving product tested on small sample sizes but outside
India you will not get the approval, so for long term it is not useful.
Fire Side Chat: Biosimilars: Global Regulatory
Perspective: Strategies & Challenges
Panel Members:

Suma Ray, Sr. Vice President, Intas Pharmaceuticals Ltd.

Sadiq Basha, Associate Vice President, Regulatory Science, Biocon Pharma Ltd.

Dakshesh Mehta, AVP & Head Process Development, Wockhardt Research Centre

Moderator: Dr. Udaykumar Rakibe, Founder, PharmaMantraTM

Dakshesh Mehta, AVP & Head Process Development, Wockhardt Research Centre

● Getting innovator molecule and analyzing it, start process structure, design the dna,
generate a clone which will give the final product, then standard process
development begins process of a drug.
● Biologics from generic, difference is size of molecule, derived from different sources.
● National or international filing can be done, standardized process has been accepted
in most of the countries.
● Numbers are increasing based on the patient need, need for any such biosimilar
increases then agency will be helping in regulating the process more efficiently.
Suma Ray, Sr. Vice President, Intas Pharmaceuticals Ltd.
● Convalescent plasma therapy is nothing new and is being used in SARS, MERS,
Spanish flu etc.
● There should be harmonized approach as there is a need to rush for donor, quantity of
antibodies also an issue.
● Transportation an issue to tier 2 and tier 3 cities, fridges for transportation not
available.
● Government stopped the use but some will continue the practice.
Sadiq Basha, Associate Vice President, Regulatory Science, Biocon Pharma Ltd.

● Product needs to be particular and same molecular profile and the biological property
with the licensed product.
● Last two decades were “setting the trend” and now, there will be “coming of
products”.
● Government should keep supporting and regulatory agencies should work efficiently.
● Plasma derived factorate is quite cheaper and hence cost effectiveness can make the
market.
Panel Discussion: Nuances on Biopharma Innovation,
Manufacturing Strategies & Market Development

Panel Members:

Dr. Ravetkar, Executive Director, Serum Institute

Mr. B N Manohar, CEO, Stempeutics

Dr. Subramananya Vangala, CEO, Reagene Biosciences

Dr. Parul Ganju, Founder & CEO, Ahammune

Mr. Mukesh Agarwal, CEO, Invati Creations

Moderator: Vishal Gandhi, Founder & CEO, BIORx Venture Advisors Pvt Ltd
Dr. Subramananya Vangala, CEO, Reagene Biosciences

● Had a good experience in innovative pharma and been observing that in India there is
only generic mindset.
● In India they only check the boxes but it is not a check box exercise so, innovation
needs to be there.
● Major gap in innovation, hence all people need to come together.
● Government should not compete with the private interests.
Dr. Subramananya Vangala, CEO, Reagene Biosciences
● For outsourcing, good options are not available.
● Laboratories are not only the answer but trained professionals who can make use to
those infrastructure is really important.
● Regulatory guidelines need to change with time and innovation. We don't have a real
AI approach. Mindset needs to change.
● Investors need to come forward, don’t depend on government only, collaborations are
necessary.
● Lot of money and technology is needed.
Mr. B N Manohar, CEO, Stempeutics
● For Stem cells it is a long journey with multiple clinical trials right from
development.
● Need to work with ICMR and DCGI, it has to be as per law as per regulations.
● Money is needed as well. Capital plays a very important role, filed patients, robust
manufacturing process, batch to batch consistency is a challenge as well.
● Making sources available upto -170 degrees , supply chain cold chain needs to be fit,
high shipment cost hence the product is costly.
● Large scale manufacturing is the biggest challenge with bringing down the cost.
Mr. B N Manohar, CEO, Stempeutics
● Innovation and regulatory framework is required, we need to work closely with
regulators.
● We are struggling to manufacture good labs, even if there are labs available, they are
not being used.
● We are going to import vaccines which is such a shame as india has 60% of pharma
industry of the world.
● Many innovations are coming many models are coming, some can mimic humans
whether they are safe or not for us.
● People are coming with 3D technology, scale up and reduce the cost.
● Focus on innovation tech manufacturing.
Dr. Parul Ganju, Founder & CEO, Ahammune
● Entire team is responsible for working efficiently in a startup.
● Startup has a lean team with razor sharp focus, you need to wear all the caps, capital
is also very important.
● I have been very fortunate to have good mentors.
● Science can't be outsourced and is a pillar of drug discovery innovation.
● We need learn good things from Boston Ecosystem, lot of communication between
people, framework, authorities, government and regulating authorities.
● India should not wait for a big drastic events such as pandemic. If not now, when?
Mr. Mukesh Agarwal, CEO, Invati Creations

● Ecosystem in india is short of many such things.

● There needs to be passion to play with data, good advisors and role models are also
necessary.
● We have a short memory, we have so much money to spend on unusual aspects but
we are not able to provide innovation for such pandemics as seen in the history.
Mr. Mukesh Agarwal, CEO, Invati Creations
● Ecosystem in india is short of many such things.
● There needs to be passion to play with data, good advisors and role models are also
necessary.
● We have a short memory, we have so much money to spend on unusual aspects but
we are not able to provide innovation for such pandemics as seen in the history.
● Invest in infrastructure on innovation and science.
Panel: Investment Trends in zThe Biopharma Ecosystem:
The Next Big Opportunity
Panel Members:

Dr. Mahesh Bhalgat, COO, Syngene International Ltd.

Sunita Sreedharan, Advocate & Patent Agent, SKS Law Associates

Ashwin Raguraman, Founding Partner, Bharat Innovation Fund

Dr. Mirage Singh, Project Manager, National Biopharma Mission, DBT BIRAC

Dr. Arvind Chari, Vice President, Eight Road Ventures

Nita Sachan, PhD, Vice President, Endiya Partners

Moderator: Vishal Gandhi, Founder & CEO, BIORx Venture Advisors

Dr. Mirage Singh, Project Manager, National Biopharma Mission, DBT BIRAC
● There have been many disruptive innovations in recent year, medical diagnostics and
other innovation are there.
● We have made good progress, homemade kits but lack of intent to go for novel
molecules.
● There are biosimilars but we need to focus in R&D in novel molecule.
● Startups need to develop innovative techniques. Major investment is needed and they
need to focus various areas such as raw materials and manufacturing.
● Future of Cell and gene therapy, monoclonal antibodies will be there.
● Biopharma needs high investment, shred facilities available, focus on proof of
concept.
Nita Sachan, PhD, Vice President, Endiya Partners

● MNCs need to take up their molecules on the investment side.

● Need domain specific people and private investors.
● How can we make it a risk-free debt for the companies?
● We need deep funding, government should help.
● Supportive environment should be provided, Indian regulators should be effective.
● Risk covering funding should be given to startups.
Dr. Arvind Chari, Vice President, Eight Road Ventures
● India needs to work in other innovations with generic scenes.
● Domain specific work needs to be followed with these investors.
● In India startup needs a balanced team, clinical talent is needed, business focused
CEOs should lead these technical startups.
● Funding in India is on the rise, super early stage companies are in abundant, after 6
months they do not get far.
● Regulators are doing a fair job.
● Build our ecosystem step by step, no reason why we shouldn’t be thriving.
● Benchmark clearly, judge business viability for startups.
Ashwin Raguraman, Founding Partner, Bharat Innovation Fund
● Monoclonal antibodies, they are playing in extremely interesting and innovative area
and there are only a few global players.
● From commercial startups standpoint it was an essential point, scientific team was
really great.
● Focus on taking startups through the final steps.
● Making sure you have an early differentiator.
Dr. Mahesh Bhalgat, COO, Syngene International Ltd.
● Indian bio pharma startup ecosystem ranking in 2020 we were 23rd, ecosystem for
startups to flourish but still not good enough.
● Startups need to make themselves attractive. It is not about pure science but about
what you put on the table.
● Sales, marketing and supply chain can be worked upon collectively as a unit.
● More than focusing on pure sciences but needs to be good as a whole, all teams need
to be effective, role of govt is very important as well.
Sunita Sreedharan, Advocate & Patent Agent, SKS Law Associates
● Clients file for patients and they often don’t come for IP management at the right
time.
● Trademarks are very important, clauses need to be looked carefully, IPR team needs
to be updated.
● IPR is one thing but due diligence on IPR is something else and patent and
trademarks area are other things which need to be taken care of.
● Novelty search should be done efficiently before “reinventing the wheel”.
● There should be better communication between the systems.
Panel: Emerging Areas in Biopharma
Panel Members:

Pirthi Pal Singh, Associate Vice President & Head, Dr Reddy's Laboratories

Shailendra Rathi, Sales Director, South & West, Eli Lilly & Company

Amrut Medhekar, Senior Vice President, Zydus Cadila

Moderator: Ranjit Barshikar, CEO, Qbd International, (Quality by Design/CGMP

Consulting) United Nation Adviser, MPP Geneva
Pirthi Pal Singh, Associate Vice President & Head, Dr Reddy's Laboratories
● Highly challenging process development of biosimilars.
● Step 1: Cloning (most critical step), Step 2: Expression, Step 3: Post translational
modifications (involves glycation fragmentation etc) and Step 4: Process
development (ensuring the stablility and safety of the product).
● Aim 0 defect product for interest of patients.
● More automation, more accuracy of data, more data points available hence additional
innovative challenges are resolved.
Amrut Medhekar, Senior Vice President, Zydus Cadila
● Boosting market more of diagnostics in terms of penetration reaching Class C towns.
● Reaching cost efficiency with poor patients.
● Digitization changed, online retail, telemedicine.
● Bigdata is going to help out us in future.
● NDHM aimed to support digital health space, history of patient available for research
and easier for doctor to trace the diseases.
● 7-10 times increase in Class B and C towns due to digitalization in patients reach.
Shailendra Rathi, Sales Director, South & West, Eli Lilly & Company
● India is certainly the pharmacy of global world and yet many innovations not
available for Indian population.
● MNCs have their own global brands.
● Market needs to be penetrated and this trend is coming up really well.
● New channels have been adopted over the course of pandemic i.e. digital adaptation,
move from product centric promotion to disease focused promotion.
Vaccine Manufacturing to Last Mile Delivery
Panel Members:

Pradip Patel, COO & Director - Chiron Behring Vaccines (A group company Bharat
Biotech International Limited)

Kapil Sood, Senior Director, Life Sciences Solutions, South Asia, Thermofisher Scientific

Prof. V. S Chauhan, EC Chairman, NAAC, Govt. of India

Udit Mangal, Vice President- Business Development, Pluss Advanced Technologies

Moderator: Tarun Walia, Founder & CEO, Artixio

Prof. V. S Chauhan, EC Chairman, NAAC, Govt. of India
● COVID19 vaccine came early because SARS had similar genome and were known so
designing of vaccine was time tested.
● Hence, bringing them to human was very quick.
● Huge amount of money was invested.
● Many huge scientific collaborations were made possible.
● No company compromised with the safety of the people.
● New vaccines are just waiting to be approved by regulators and we might see 10-15
vaccines in just a few months.
Kapil Sood, Senior Director, Life Sciences Solutions, South Asia, Thermofisher
Scientific
● We have been part of a lot of conversations and hence knowledge has been passed on
on a much higher pace, authorities and regulators have played their role quite
effectively.
● We worked on 250+ projects, on all aspects, providing products to cell culture media
and other technologies.
● What really helped is that scientists work together the results are much faster.
Udit Mangal, Vice President- Business Development, Pluss Advanced Technologies

● Developing vaccine in 6 months is a tremendous scientific achievement.

● More than 30% of vaccines go waste in the last stage, primarily due to low
maintenance of temperature.
● Traditional ways of keeping cold vaccines is not appropriate.
● Ice Packs, gel packs are used due to which freezing of vaccine happens and largest
cause of vaccine wastage.
Pradip Patel, COO & Director - Chiron Behring Vaccines (A group company Bharat Biotech
International Limited)

● India among top 12 destination bio technology industry.

● Valued at 70 billion, dedicated CIO technology department In india.
● AI and precision medicine is there gene sequencing tissue engineering etc.
HR Panel Discussion
Panel Members:

Dev Tripathy, Vice President & Head HR, Glenmark Pharmaceuticals

Kaushik Ray, Vice President - Human Resources, HR Head, Dr. Reddy’s Laboratories

Benjamin James, HR Leader Asia Pacific at Cytiva

Moderator: Pritika Kalra, COO, BSLA

Dev Tripathy, Vice President & Head HR, Glenmark Pharmaceuticals
● First quarter was chaos and uncertainty with lot of worry in business, airports closed
shipping closed.
● But second quarter was bit settled and everyone was kind of prepared.
● Thankfully demand all over the world didn’t go drastically down.
● Employees safety one area of core importance, now more departments interconnected
with better communication.
Benjamin James, HR Leader Asia Pacific at Cytiva
● Situation is far more critical and today HR is more critical than any other day.
● More unseen collaborations have been possible due to pandemic.
● We need talent who can handle the demand.
● Digital technology is the changing factor, AI has been helping like never before.
Kaushik Ray, Vice President - Human Resources, HR Head, Dr. Reddy’s Laboratories

● We had to improvise as the safety along with that we had to bring medicines to the
country.
● R&D had to work in shifts like never before, and people rose to the occasion.
● There was infection, stress and had no safety standards meanwhile we had to come
up with safety standards for people.
● Employee engagement and keeping a distance was also important.
Panel: Role of Technology, Artificial Intelligence and
Analytics in Pharma
Panel Members

Dr. Kavita Lamror, Value Evidence Expert, Sanofi

Anjani Kumar, Chief Information officer & Digital Transformation Leader, Strides

Dr. Antonio Feraco, Managing Consultant Industry 4.0, Vice President, Digital Service,
TÜV SÜD

Moderator: Dr. P Ratnakar, Vice President & Practice Head- Life Sciences, Tech Mahindra
Dr. Kavita Lamror, Value Evidence Expert, Sanofi

● We need to tap into data and see how much of it is usable.

● Before allocating time and investment, AI helps reading the data more efficiently.
● AI has been the game changer, very effective in identifying new targets.
● Blockchain also very essential technology in drug discovery and intellectual property
identification, data storage and transparency.
Dr. Antonio Feraco, Managing Consultant Industry 4.0, Vice President, Digital Service, TÜV
SÜD

● In the next 3 years we are expecting smart sensors using less electricity which are
capable of getting more data.
● Need to be more into R&D.
● First to be digital enough with customer centric drug manufacturing.
● AI helps read data to the optimum level.
Anjani Kumar, Chief Information officer & Digital Transformation Leader, Strides

● Everybody out here working their hearts out.

● Data is the new oil with all sorts of devices coming in.
● Digitization leads to more data generation, sensors are also giving data and ultimately
there is data flood and need to get insight out of it.
● Data is waste if not processed.
● Cloud data warehouses is changing the game.
● New drug delivery system is being bought up in the near future.
● Digital pills segment is also something in sight.