Leaders in Pharmaceutical Business Intelligence (LPBI) Group

LIVE 13th Annual BioPharma and Healthcare Summit, Thursday, May 9, 2019, Marriott Hotel, Cambridge, MA

Reporter: Aviva Lev-Ari, PhD, RN

 

http://www.usaindiachamber.org

8:40 AM – 9:10 AM	Registration and Networking
9:10 AM – 9:20 AM	Welcome address: Karun Rishi, President, USAIC Opening comments: Dr Andrew Plump, President R&D and Director, Takeda Pharmaceuticals
9:20 AM – 9:40 AM	Fireside Chat Mark Abdoo, Acting Deputy Commissioner, U.S. Food and Drug Administration Dr Eswara Reddy, Drug Controller General of India, Central Drug Control Organization Moderator: Sanat Chattopadhyay, President, Merck Manufacturing Division; Merck & Co.
9:40 AM – 10:00 AM	Presentation on CAR (chimeric antigen receptor) T-cell Therapies Dr. Carl June, Director of Translational Research, Abramson Cancer Center University of Pennsylvania Moderator: Dr. Raju Kucherlapati, Professor of Genetics, Harvard Medical School
10:00 AM – 10:50 AM	Panel Discussion: Oncology – The Emperor of BioPharma Development Panelists: Dr. Arjun Surya, Co-Founder & CSO, Curadev Pharma Dr. Christopher Arendt, Head- Immunology Unit and Oncology DDU, Takeda Dr. David Meeker, President & CEO, KSQ Therapeutics Dr. Marcela Maus, Director of Cellular Immunotherapy, MGH Cancer Center Dr. Sanjiv Patel, President & Chief Executive Officer, Relay Therapeutics Moderator: Dr. Christiana Bardon, Managing Director, MPM Capital
10:50 AM – 11:20 AM	Networking Break
11:20 AM – 12:10 PM	Panel Discussion: Future of Clinical Trials and Drug Development Panelists: Dr. Alise Reicin, President, Global Clinical Development, Celgene Dr. Bruce Chabner, Director of Clinical Research, Mass General Hospital Cancer Center Dr. Mace Rothenberg, Chief Medical Officer, Pfizer Dr. Michael Rosenblatt, Chief Medical Officer, Flagship Pioneering Dr. Rob Scott, Chief Medical Officer, Abbvie Moderator: Dr. William Chin, Professor of Medicine, Emeritus, Harvard Medical School
12:10 PM – 1:00 PM	Panel Discussion: Manufacturing in the Future Panelists: Hari Bhartia, Founder and Co-Chairman, Jubilant Bhartia Group Mark Abdoo, Acting Deputy Commissioner, U.S. Food and Drug Administration Dr. Paul McKenzie, Executive Vice President, Pharma Operations & Technology, Biogen Sanat Chattopadhyay, President, Merck Manufacturing Division; Merck & Co. Vinay Ranade, Chief Executive Officer, Reliance Life Sciences Moderator: Professor N. Venkat Venkatraman, Boston University Questrom School of Business
1:00 PM – 1:50 PM	Lunch
1:50 PM – 1:55 PM	Video message from Suresh Prabhu, Hon’ble Minister of Commerce & Industry, Gov. of India
1:55 PM – 2:45 PM	Panel Discussion: One in a million – Emerging trends in Rare Diseases Panelists: Dr. Daniel Curran, Head of the Rare Diseases Therapeutic Area Unit, Takeda David Lucchino, Co-Founder and CEO, Frequency Therapeutics Dr. Dhaval Patel, Executive Vice President  and Chief Scientific Officer, UCB Dr. James Wilson, Director- Gene Therapy Program, University of Pennsylvania Dr. Timothy Yu, Assistant Professor in Pediatrics, Harvard Medical School Moderator: Dr. Samarth Kulkarni, Chief Executive Officer, CRISPR Therapeutics
2:45 PM – 3:20 PM	Networking & Tea Break
3:20 PM – 3:50 PM	Fireside Chat: Value and Access – The ongoing debate Christopher Viehbacher, Managing Partner, Gurnet Point Capital Dr. John Maraganore, Chief Executive Officer, Alnylam Pharmaceuticals Dr. Stelios Papadopoulos, Chairman, Biogen Moderator: Dr Andrew Plump, President R&D, Takeda Pharmaceuticals
3:50 PM – 4:10 PM	India update on Clinical Trial Regulations Arun Singhal, Additional Secretary, Ministry of Health & Family Welfare, India Dr Eswara Reddy, Drug Controller General of India, Central Drug Control Organization
4:10 PM – 5:00 PM	Panel Discussion: Research and Development Strategies and Trends Panelists: Dr Andrew Plump, President R&D, Takeda Pharmaceuticals Dr. James Bradner, President, Novartis Institutes for BioMedical Research Dr. Mathai Mammen, Global Head of R&D, Janssen Pharmaceutical Companies of J&J Moderator: Dr. Martin Mackay, Co-Founde, Rallybio
5:00 PM – 5:05 PM	Closing Remarks
5:05 PM – 6:15 PM	Cocktails & Networking Reception

Aviva Lev-Ari, PhD, RN & Leaders in Pharmaceutical Business Intelligence (LPBI) Group

will cover the event in Real Time

REAL TIME COVERAGE USING SOCIAL MEDIA

 

LIVE Images taken by @AVIVA1950

 

 

 

9:10 AM – 9:20 AM

Welcome address: Karun Rishi, President, USAIC

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

• tomorrow announcement @Shire
• India 1.3Billion in India, each person is a potential patient in the largest democracy in the World
• China – transformation takes place every day
• The Patient and the Pricing of Drugs the biggest issue missing the ball dialoguing on Panel today

9:20 AM – 9:40 AM

Fireside Chat

• Mark Abdoo, Acting Deputy Commissioner, U.S. Food and Drug Administration (FDA)
• Dr Eswara Reddy, Drug Controller General of India (DCGI), Central Drug Control Organization

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

9:40 AM – 10:00 AM Presentation on CAR (chimeric antigen receptor) T-cell Therapies
Dr. Carl June, Director of Translational Research, Abramson Cancer Center University of Pennsylvania Moderator: Dr. Raju Kucherlapati, Professor of Genetics, Harvard Medical School

• Video on child with recurrent twice of leukhimia
• T-cell HIV Virus infect

 

10:00 AM – 10:50 AM

Panel Discussion: Oncology – The Emperor of BioPharma Development

Panelists:

• Dr. Arjun Surya, Co-Founder & CSO, Curadev Pharma
• Dr. Christopher Arendt, Head- Immunology Unit and Oncology DDU, Takeda

1. solid vs blood tumors
2. T-Cells amplification microenvironment and biology
3. PD-1 in combination therapies thousand Trials
4. Biomarker allows to check response in conjunction with genomics data brings insights
5. Tumors World, Biomarkers in Immuno oncology respond to PD-1 no response to other drug
6. stratify patients

• Dr. David Meeker, President & CEO, KSQ Therapeutics

1. Protein experimental data compound design from simulations of VIRTUAL compounds,
2. how to incentivise to take on new innovations

• Dr. Marcela Maus, Director of Cellular Immunotherapy, MGH Cancer Center

1. more that one single administration by injection
2. response rates different even in one patient let alone among patients
3. detection gene
4. CAR-T glioblastoma
5. pancreatic cancer good responses in combination therapies
6. immunr repertoire biology so complex that biomarkers are limited

• Dr. Sanjiv Patel, President & Chief Executive Officer, Relay Therapeutics

Moderator: Dr. Christiana Bardon, Managing Director, MPM Capital

• 30% patinets with complete cure

10:50 AM – 11:20 AM Networking Break11:20 AM – 12:10 PM

Panel Discussion: Future of Clinical Trials and Drug Development

Panelists:

• Dr. Alise Reicin, President, Global Clinical Development, Celgene

1. endpoints need to be redefined it effect price of drug development
2. in Oncology – Basket and Umbrellas Trial – two stufies approval for melanoma, biomarker
3. Is response rate is 30% va 50% and Phase 3 is negative Kertuda when worked at Merck dose ranging last phase when response dropped from 60% to 30% in the case of Study C3
4. 30% of the cost of the study – 30% was translational
5. CRO model appropriate oversite vs douplication of tasks

• Dr. Bruce Chabner, Director of Clinical Research, Mass General Hospital Cancer Center

1. Old paradigm Phase 1,2,3 – off the board now, New drugs do not need the old paradigm
2. Phase i1 changed if genomics is involved multiple cohorts at same time
3. FDA play amazing role
4. patient selection is key
5. mutations in rare disease vs mutations in cancer
6. immunotherapy and endogenic drugs with chemo in RENAL cancer
7. check-points – lung cancer understood money spent to find responders
8. HOW to select which cheno therapy — no improvement today vs past
9. 40 drugs approved by accelerated approval one came back on the market
10. Financial burden of being in a clinical trial
11. Foundation gives money to Institutions to reimburse patients for flights, meals, acommodation, Pharma are reluctant to participants due to potential accusation of bias id Pharma pays Patients that participate in Clinical Trials

• Dr. Mace Rothenberg, Chief Medical Officer, Pfizer

1. FDA recognizes approval process – systems involved AFTER approval for reimbursement and monitoring after market
2. regulatory by countires are different
3. which factors are sacrifiable in the long tern in clinical trial design

• Dr. Michael Rosenblatt, Chief Medical Officer, Flagship Pioneering

1. Safety – benefit risk is what physicians work with every day
2. Drugs paradign of small molecules does not hold is you have a drug that deliver entire organelle – how you dose for half life how you prive the rate of replication in the body
3. Surrogate markers
4. Taking a drug off the market ->>  conditional approvals [approval can be taken back or require additional studies] not a favorable view of Pharma in the present to support Conditional approval vs accelerated approval

 

• Dr. Rob Scott, Chief Medical Officer, Abbvie

1. speed
2. differentiation from competition
3. drug development in crisis is CVD not cancer, US and the rest of the world – lowest investment in drugs is CVD
4. Studies designed by Physicians using SAME design
5. need to create experts to use ML in the course of clinical trial design
6. regulators as Partners not as Barriers
7. Proof of efficacy is a burden on the developers of the drug not on the Regulatory
8. Increase use of advertising to recruit
9. 70% OF PATIENTS WILLING TO PARTICIPATE  lives to far from site of trials
10. Telecommunication between administrators of study ans clinical Trials participants
11. Back when I was at Pfizer, designing study – patients burden relieved more willingness to participate
12. Preferrs to run studies in house vs use CRO they are not effective in monitoring like study run in house

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

• Probability of success to clinic has not changed
• challenge is design and execution in clinical trials
• changes in drug modalities: RNA, DNA,
• which combination to use
• how to find the many patients needed
• Basket and Umbrellas Trial

12:10 PM – 1:00 PM

Panel Discussion: Manufacturing in the Future

Panelists:

• Hari Bhartia, Founder and Co-Chairman, Jubilant Bhartia Group

1. supply change
2. blockchain
3. quality by design
4. CPK
5. productivity will go up variability will decrease
6. manufacturng must happen in India
7. Genetics price selection
8. Secure system, data quality the data logic and the analytics
9. infrastructure in manufacturing is not completed yet
10. Training by augmented reality Turnover high in India
11. cyber security – digitization and central control
12. demonstration data offense

• Mark Abdoo, Acting Deputy Commissioner, U.S. Food and Drug Administration

1. next 10 years India and China will improve regulatory activities and match better the US requirements
2. review foreign hosts
3. skills and location of hosts:
4. India: Standards and unannounced inspections and
5. China: same
6. Blockchain is experienced as experimentation at FDA across each all parts of the Agency

• Dr. Paul McKenzie, Executive Vice President, Pharma Operations & Technology, Biogen

1. raw material to patients: Pharma very slow than other industries Reliable needs be very high, relationships
2. Hurrican in PortoRIco affected supply chain
3. Reality, every one HAVE to be in China
4. Platforming for each modality for Scaling out vs Scaling up
5. diversify vs modality x
6. build capacity and capabilities customization of ultra filtration different in two plants lowers standardizations
7. Training on Demand, Virtually, documnetation needs to change to electronic
8. Continueous manufacturing Academic contribution

• Vinay Ranade, Chief Executive Officer, Reliance Life Sciences

1. Pharma was slow in India the manufacturing
2. infantile diarreha vaccine 70,000 in 4 years needs that drug,
3. massive intellectual capital in India
4. How to implement and make best use of data to improve processes
5. cyber security was not experiences

• Sanat Chattopadhyay, President, Merck Manufacturing Division; Merck & Co.

1. Phase 1 scaling out vs up – it is different in vaccine field
2. ML, Block chain, supply chain and manufacturing will be adapted in supply chain
3. Apply analytics and relationships in manufacturing
4. obsolescence and upgrades
5. capture data electronically
6. cyber security can be a hazard hard to mitigate when all systems are down
7. significant challenges in manufacturing and data security

Moderator: Professor N. Venkat Venkatraman, Boston University Questrom School of Business

• How can Pharma become leaner
• heterogenuious environment for production
• cyber security

1:00 PM – 1:50 PMLunch1:50 PM – 1:55 PM Video message from Suresh Prabhu, Hon’ble Minister of Commerce & Industry, Gov. of India1:55 PM – 2:45 PM

Panel Discussion: One in a million – Emerging trends in Rare Diseases

Panelists:

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

1. worked with Academic community on how to treat rare disease in the future

• David Lucchino, Co-Founder and CEO, Frequency Therapeutics

1. Show clinical benefit and impact multiplemyeloma
2. patients becoming activists
3. access
4. foundation by patients
5. Patient to get cloud

• Dr. Dhaval Patel, Executive Vice President  and Chief Scientific Officer, UCB

1. if a modality will cure a disease justify innovation Model for payment: Mortgage Model
2. Access INDEX pricing – US will benchmark the price in other parts of the world
3. Gene therapy is not only got monognenic diseases but for
4. decrease work involved in development of drugs

• Dr. James Wilson, Director – Gene Therapy Program, University of Pennsylvania

1. tension between physicians and development of the perfect drug.
2. AV
3. Protein replacement therapy repeated infusion gene therapy infrastructure develop in China for China, Develop in India for India vs develop in US for India or China
4. Cost of manufacturing to decrease

• Dr. Timothy Yu, Assistant Professor in Pediatrics, Harvard Medical School

1. Scalability beyond the one case: the mechanism for the drug has generability for other aptients iwth same mutation the method has no limit
2. Molecular type of mutation Spice Switching strategy, just-in-time manufacturing

Moderator: Dr. Samarth Kulkarni, Chief Executive Officer, CRISPR Therapeutics

1. Rare diseases, potential for cure
2. Academia, Hospitals, biotech
3. commercial model of the disease

2:45 PM – 3:20 PMNetworking & Tea Break3:20 PM – 3:50 PM

Fireside Chat: Value and Access – The ongoing debate

• Christopher Viehbacher, Managing Partner, Gurnet Point Capital

1. since 2003 testify in the House, against Canadian  David Brenner was asked about importation from Canada of breast cancer tamoxiphen at a lower price than in the US.
2. From importation crisis to Obama Care – stable system Medicare Part D – drug coverage for Olderly
3. After Obama – Price is part of doing business REBATES $100Billion the valur of REBATES
4. Co-Insurance

• Dr. John Maraganore, Chief Executive Officer, Alnylam Pharmaceuticals

1. right for innovation will be preserved
2. price increase
3. give and take
4. Co-pay – We need lower co-pay
5. with current administration, sink finding the Well instead of Well funding the sick
6. CHange is coming, co-pay will change

• Dr. Stelios Papadopoulos, Chairman, Biogen

1. Genzyme days vs 2019
2. changes how drugs are priced?
3. Flaws of the system:Gevernment induce prices that will change
4. $800,000 drug is now $80 [ala Regeneron] – R&D was $2Billion
5. CO-pay for hospital stay is lower than co-pay on drugs – 10% twice a year

Moderator: Dr Andrew Plump, President R&D, Takeda Pharmaceuticals

3:50 PM – 4:10 PM

India update on Clinical Trial Regulations

• Arun Singhal, Additional Secretary, Ministry of Health & Family Welfare, India

1. Each patient deserve access to healthcare in India
2. experimenting

• Dr Eswara Reddy, Drug Controller General of India, Central Drug Control Organization

1. Time line for Application approval for drugs, if approved in another country 60 days
2. Gov’t hospitals can import New drugs which have not been permitted in India

4:10 PM – 5:00 PM

Panel Discussion: Research and Development Strategies and Trends

Panelists:

• Dr Andrew Plump, President R&D, Takeda Pharmaceuticals

1. Neuroscience – Pharma understand biomarkers and now genetics
2. Vaccines – across species in the animal WORLD

• Dr. James Bradner, President, Novartis Institutes for BioMedical Research

1. Attempt not to tweak the PIPELINE: CVD, NEUROSCIENCE AND CANCER
2. 485 Teams doing R&D convluence of interests to develop cure
3. Modularity – BioMolecule — multimodality biophysical biochemical protein degradation – rewire disease cells with biomolecules combing propertitie of permiability of small molecules
4. PHARMACOLOGICAL PREVENTION – biotech is inspiring only Pharma can solve

• Dr. Mathai Mammen, Global Head of R&D, Janssen Pharmaceutical Companies of J&J

1. immunooncology – mutation signature – marker protein signature — that group of diseases respond to
2. colon cancer and multiple myeloma — understanding of the biology was deep

Moderator: Dr. Martin Mackay, Co-Founder, Rallybio

5:00 PM – 5:05 PM Closing Remarks

5:05 PM – 6:15 PM Cocktails & Networking Reception