Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Speakers

14^th Annual BioPharma & Healthcare Summit, Friday, September 4, 2020,

8 AM EST to 3-30 PM EST – Virtual Edition

• COVID-19 Pandemic is a Global crisis
• India can play a special role in R&D and in Manufacturing including Vaccine development

Opening comments: Dr Andrew Plump, President of R&D, Takeda Pharmaceuticals

• Global Summit around the World – JP Morgan of the East as we were called – it is Now a Global Conference vs East Coast
• Record number of Drugs approved as New Drugs with special quality
• explosion of modality of therapies to include Gene Therapy
• Billion underserved vs N-of-One drug
• India’s President Modi allow healthcare access to 1/2Billion
• collaboration across the World COVID Alliance in vaccine development
• Global effort, China recovery is remarkable
• India battle the infection and it is growing – Public Health
• Remarkable Speakers

Panelists:
Dr. Barry Bloom, Professor & former Dean, Harvard School of Public Health

• Testing – PCR expensive does not enable quick testing is expensive result come transmission occurred
• Antibody testing
• CRISPR test based
• Vaccine in clinical trials, public need to return for 2nd shot, hesitancy
• Who will get the Vaccine first? in the US  most vulnerable of those causing transmission
• Pharma takes risk when efficacious level is unknown
  Dr. George Yancopoulos, Co-Founder, President & CSO, Regeneron
• Repurpose – be careful
• Ebola vaccine development approach is been REUSED for COVID-19
• Existential threat by Disease – preparedness is ridiculous as size of investment – far where we need to be
• Untreatable disease burden COVID-19 cost of healthcare calls massive increases as a society and Private sector Moderna invested in new technology from Academe to the Industry
• Universal HealthCare will cripple the the healthcare systems
  Kiran Mazumdar-Shaw, Executive Chairperson, Biocon
• Safety in proof of concept
• Children focus for emergency use
• validation of repurpose drugs
• oral vaccine involve sequential processing, approval and TRUST,
• concerns about risks
• accelerate the process is the opportunity
  Dr. Rajeev Venkayya, President of the Global Vaccine Business Unit, Takeda
• Public confidence in COVID-19 Vaccine
• The Group with concerns at present is larger than 15 years ago due to the accelerate process od the development process
• political influences on CDC emergency authorization given prior to election
• hesitancy – influence of social media, conspiracies
• Transparency by Pharma and by Regulatory Agencies
• Independent reviews
  Dr. Richard Hatchett, CEO, Coalition for Epidemic Preparedness Innovations (CEPI)
• 78 countries ready to participate, Healthcare workers priority to be ready end of next year

Moderator:
Dr. William Chin, Professor of Medicine, Emeritus, Harvard Medical School

Dr. Mandeep Bhandari, Joint Secretary, Ministry of Health & Family Welfare, India

• COVID related – support for Clinical Trials support to the Industry, innovators, processes and infrastructure is in place

Dr. V G Somani, Drug Controller General of India, Central Drug Control Organization

• partnership, time line, transparency
• interaction online with regulators
• 30 days approval pre and post approval – progress achieved
• Online presubmission very useful to both sides
• Ecosystems on early development: Gene therapy

Moderator:
Muna Bhanji, Senior Vice President,  Merck & Co.

• India’s preparedness

Kenneth Frazier, Chairman of the Board and Chief Executive Officer, Merck & Co.

Strategies of Merck = “Medicine is for the People not for Profit”

• AntiViral – nucleocide – orally bioavailable
• Vaccine in early development – BSV Vaccine used in EBOLA – attenuated virus vector platform experience – 1 single doze, deployed Globally
• Vaccine modified Measles Vaccine, novel platform – out patient and Hospital
• Antibiotic research at Merck – no market incentives on pricing for Merck to invest in antibiotics
• people will die from bacterial resistance infection and next pandemic will be bacterial not viral

Moderator:
Dr. Stelios Papadopoulos, Chairman of the Board, Biogen

• Most important comments on urgency in investment in drug development by multiple constituencies made by
• Dr. George Yancopoulos, Co-Founder, President & CSO, Regeneron
• Access to therapy

Panelists:
Amitabh Kant, Chief Executive Officer, National Institution for Transforming India (NITI)

• Innovation in drug discovery collaboration for clinical trial infrastructure
• BioEconomy BioSimilar the largest number approved anywhere
• Incentives for size and scale
• Ingredients manufacturing to become India’s priority
• Investment in R&D and Human Capital in the BioEconomy

Hari Bhartia, Founder & Co-Chairman, Jubilant Bhartia Group

• US history of innovations cluster and infrastructure: Academe, VC, small medium Biopharma, Government involvement
• India: Contract research – 20 years history, lagging the ability to take risk
• Changing, pricing of drug increased, innovating drug for local consumption, and it can be taken to US for a better price
• Cancer immunology in India under development
• India was Leading Chemistry Research – China’s government invested and took the market
• Indian companies bigger in size – free on requirement imposed on China
• India will be a great supplier to US Market to build high capacity raw materials

Dr. K. Vijay Raghavan, Principal Scientific Advisor, Government of India

Resources are necessary 30% from Industry vs Government and Academe with great students and labs

Indian context – Personalized Medicine – Telemedicine and IT infrastructure allowing innovation in a 1Billion Population- sheer volume of quality professional

Dr. Naresh Trehan, Chairman, Medanta – the Medicity

• Ecosystem ready for Government to promote innovations to conduct clinical trial with global acceptance standard
• diverse gene pool in population to innovate for new molecule to market
• Vaccine under development on Phase 1,2,3 – regulatory mechanism is in place
• genetic drugs, BioSimilar dominance in the market – biotech can do clinical trials in India vs abroad

Moderator:
Sanat Chattopadhyay, President, Merck Manufacturing Division; Merck & Co.

• Largest producer of generic drugs
• antiretroviral drug produced by Indian Pharma
• Biotech innovations growing middle class – how innovation , infrastructure and shift to research
• Diversify and become self reliance

Panelists:
Dr. Alise Reicin, Former President, Global Clinical Development, Celgene

• Clinical trial were impacted by association of patients to trials
• anti bacterial resistance requires investment – needs will be greater for antibiotics in the future
• Cancer mutation next therapy biomarkers for mutations to be developed

Dr. Laurie Glimcher, President & CEO, Dana-Farber Cancer Institute

• Dana Farber saw impact of COVID-19 on immunosuppressant population of patients coming in for Cancer Tx – switch from IV Tx to Oral
• 96% decrease in screenings due to Pandemic – increase with Cancer diagnosis in coming years
• No clinical Trials in Cancer were suspended – all continued
• Telemedicine and working at home very efficient
• Genomics of COVID-19 studies at Dana Farber same pathway identifies
• safety and efficacy must be achieved – not to approve drugs without phase I & Phase II endpoints

Dr. Philip Larsen, Global Head of Research, Bayer AG

• Repurposing drugs as antiviral from drug screening innovating methods
• Cytokine storm in OCVID-19 – kinase inhibitors may be antiviral  – dat of tested positive allows research of pathway in new ways
• Regulatory agencies in US and Europe for types of drugs vs single patient drugs

Rehan Verjee, President, EMD Serono

• entire volume of clinical trials at Roche went down same at EMD
• delay of 6 month, some were to be initiated but was put on hold
• Charities funding cancer research – were impacted and resources will come later and in decreased amount
• New opportunities support access to Medicine
• improve investment across the board
• Antibody cytotoxic with precision

Dr. Tony Ho, Head of Research and Development, CRISPR Therapeutics

• challenges overcome by testing at home

Moderator:
Dr. Raju Kucherlapati, Professor of Genetics, Harvard Medical School

• New normal as a result of the pandemic role of personalized medicine
• Cancer cure – what are the prospects

Panelists:
Christopher Viehbacher, Managing Partner, Gurnet Point Capital

• IPOs can have advantages in Pandemics – Travel curtails all deals done virtually in greater efficiency
• Drug pricing is a target by White house
• Dream of every Biotech – get Big Pharma coming to acquire and pay a lot
• Morph and adapt

Daphne Zohar, Founder & CEO, PureTech Health

• kill project early financial incentive not in line in the industry
• incentive to move resources among project and kill early project experiments to find which project to kill
• Innovations – pattern recognition, fast followers academic translation
• Disease focus, best science is the decision factors

Dr. Elias Zerhouni, Professor Emeritus, Johns Hopkins University

• Digital Health
• CVS opens clinics
• R&D – Capital is low
• Network of global innovation hubs vc investor channel like in the past
• Value of company driven by hits blockbusters

Dr. Stelios Papadopoulos, Chairman, Biogen

• Worst pandemic in our lifetime
• stock market if hot – in balance in supply and demand, interest rates low, excess supply of equities in entertainment, Travel, hospitality
• Healthcare was defensive therapeutics needed – opportunity to innovate in HC – shift money from entertainment, Travel hospitality to HC
• Recovery will shift money away from Healthcare
• IP Protection and patent expiration – biotech are cases not trends

Moderator:

Dr. Andrew Plump,

President of Research & Development, Takeda Pharmaceuticals

• Days of Genzyme please tell us about Christopher Viehbacher, Managing Partner, Gurnet Point Capital

Moderator Presenter: Dr. Michael Rosenblatt, CEO

ROI is not there, regulatory requirements reduced, Registry

Panelists:
Dr. Alfred Sandrock, Executive Vice President, Research & Development, Biogen

• Multiple Sclerosis therapy
• cost effectiveness is not there vs save a life
• Appeal opportunity is there and regulators are people

Dr. Daniel Curran, Head of the Rare Diseases Therapeutic Area Unit, Takeda

• Takeda collaborates with Grace Science Foundation

Dr. David Meeker, Chairman & CEO , Rhythm Pharmaceuticals

• Cystic Fibrosis 

Dr. John Orloff, Head of Research & Development, Alexion

• ALS
• Duchenne Muscular Destrophy
• HUS
• ASO
• gene therapy – one time therapy: Valuation for the industry of long term therapy: US (long term non existence) vs Europe and Japan (much appreciated

Matt Wilsey, Co-Founder & Chairman, Grace Science Foundation

• Ultra-rare (500 Patients) vs Ultra Ultra-rare (50 Patients)
• 70 patients in the World, Grace disease, Parent drive the search for drug
• Manufacturing cost comes down
• Price is dynamic

Moderator:
Dr. Steve Uden, Co-Founder, Rallybio

• Regulators are people

Dr. Roy Vagelos, Chairman of the Board, Regeneron Pharmaceuticals

• Congratulate Big Pharma for taking the challenge on COVID-19
• Vaccine, Antibody and anti-viral
• Government funding
• Merck was independent from Government – to be independent and be able to set the price
• HIV-AIDS: reverse transcriptase converted a lethal disease to a chronic disease, tried hard to make vaccine – the science was not there
• Industry role: Competition of drug discovery capacity is been built, global needs, price need be low for global reach
• Government is a already a player hoping without a control on pricing
• 300Million people were treated FREE by Merck’s Family Program HepC
• 9% in China immunize the newborn with HepB 1994 100% babies immunized – no profit to Merck – eradication of HepB in China
• Neuro degeneration – science supports drug development
• Role of R&D Scientists in Drug discovery?

Moderator:
Dr. Mathai Mammen, Global Head of Janssen Research & Development, Johnson & Johnson

• COVID-19 drug development: Response by Big Pharma
• Industry role in Access to medicines, biologics, antibodies, vaccines
• Role of R&D Scientists in Drug discovery?
• PAHTN – use Machine Learning on top of data collected routinely,

Panelists:
Dr. Anne Heatherington, Head of Data Sciences Institute, Takeda Pharmaceuticals

• Reliance on Data – AI and Data in Pharma alliance with MIT
• collaboration of Data for COVID-19
• Women need education in STEM and in Data Science

Arpa Garay, President, Global Pharmaceuticals, Commercial Analytics, Merck & Co.

• Data on Patients and identification who will benefit fro which therapy
•  cultural bias risk aversion
• Invest early on in STEM

Dr. Maya Said, Chief Executive Officer, Outcomes4Me

• Cancer patients taking change of their care
• Digital Health – consumerization of Health, patient demand to be part of the decision, part of the information
• FDA launched a Program Project Patient Voice

https://www.fda.gov/about-fda/oncology-center-excellence/project-patient-voice

• Women should not undersell themselves

Dr. Najat Khan, Chief Operating Officer, Janssen R&D Data Sciences, Johnson & Johnson

• Validation
• Deployment of algorithms
• embed data by type early on in the crisis to understand the disease
• Compare the Big IT-Data and Pharma where are the barriers?
• STEM and Women in Pharma – the opportunity must be right

Nina Kjellson, General Partner, Canaan

• Data science is a winner in Healthcare
• Women – Data Science is an excellent match

Moderator:
Sastry Chilukuri, President, Acorn AI- Medidata

• Opportunities in Data Science in Pharma
• COVID-19 and Data Science
• STEM and Women in Pharma

Panelists:
Dr. Andrew Plump, President of Research & Development, Takeda Pharmaceuticals

• Enter for Plasma and for manufacturing vs discovery
• Change how pharma behaved inefficiently in the past – with COVID-19 new behaviors in the industry
• End of Century most diseases could be cured

Dr. David Reese, Executive Vice President, Research and Development, Amgen

• Interaction with regulator was most favorable

Dr. Hal Barron, Chief Scientific Officer and President R&D, GlaxoSmithKline

• Cytokine storm – few approaches
• Control molecule GSK owned
• GWAS not easy to find which gene drives the association
• Functional Genomics gene by gene with phenotypes using machine learning significant help

Dr. Mathai Mammen, Global Head of Janssen Research & Development, Johnson & Johnson

• Neuro-modulation: Symptomology Outcomes – no correlation
• Vaccine platform used in the past for several vaccines: Selection process from several candidates, cell line enter Clinical waiting for data
• Using same platform with several proteins – great communality in the development
• Regulator deepen trust relationship which will carry for the future
• Pulmonologists and cardiologist in the COVIS-19 Patients – remove drugs monitoring on drugs

Moderator:
Duval Patel presented the Moderator

Moderator:

Martin Mackay, Co-Founder, RallyBio

• Every year it is getting better
• India – innovate and make drugs for every country and for India
• Diversity and inclusion
• Leadership in Pharma Industry in all Panels
• Massive impact can be made