LIVE 11th US-India BioPharma & Healthcare Summit, Thursday, May 18, 2017, Boston Marriott Cambridge, 50 Broadway, Cambridge

Reporter: Aviva Lev-Ari, PhD, RN

Opening comments by – Dr Andrew Plump, Chief Medical & Scientific Officer, Member of the Board of Directors, Takeda Pharmaceuticals

1. Value and Access in Healthcare vs Innovations, Patients,
2. Value in HealthCare is relative to time and location
3. massive underserved population
4. Access: whoever Patients are and whereever they are
5. In India 1.3 Billion people, 70% of World population and HealthCare spending is 1% of World cost of HealthCare – need for investment ans development of infrastructure

1. Immunotherapy – Tumor cells, necrosis, mutation, Response to T-Cell therapy and Tumor shrinkage
2. What is the mechanism to enable Oncology drugs in China and India
3. Oncology Drug are two expensive
4. Melanoma gets best response to PD-1
5. We might not have found the right Checkpoint molecule, new agonist therapies, new antigens
6. Oncolytic Viruses – for tumors that do not respond to immuno therapy
7. Combination therapy, increase in Toxicity
8. Toxicity – Cerebral edema during clinical trials of immunotherapy
9. Upregulation and Downregulation dependent on dosing in immuno-therapy

Panelists:

• Dr. Edward Benz, President & CEO Emeritus, Dana Farber Cancer Institute

1. 1. Durable response, immuno-suppression, biological role in tumor surveillence, Checkpoint opens up the use of vaccines
   2. Block of 50 molecules
   3. How can we learn more on the Translational and Clinical level – getting smarter – HOW
   4. Screening Patients: Immuno-phynotyping, predicting markers,

• Dr. Rakesh Jain, E.L. Steele Laboratory of Tumor Biology,  MGH Cancer Center/ Harvard Medical School
• Dr. Timothy Clackson, President R&D and CSO, Ariad Pharmaceuticals
• Dr. Chandru, Chairman, Strand Life Sciences

1. Licensing HepC will be very important

• Dr. Jeffrey Engelman, Global Head of Oncology Research, Novartis Institutes for BioMedical Research

1. PD-1 is $50,000 a year therapy, In India affordable pricing
2. Collaboration: PACK –  few companies and Academic – focus on immunotherapy,
3. Foundation Medicine biomarkers Platform
4. What is the mutation burden which will predict the response to PD-1

Moderator:
Dr. Vijay Kuchroo, Director- Evergrande Center for Immunologic Diseases, Brigham & Women’s Hospital/ Harvard Medical School

• Dr. Richard Moscicki, ex-Genzyme, Deputy Director (Science Operations), Center for Drug Evaluation and Research, USFDA and

1. Since 2004, 40 Public-Private Partnerships, relationships with NIH
2. External relationships, where are the Scientists going,
3. Toxicology, Biomarkers, Lexicon,

• Dr. Chris Austin, Director, National Center for Advancing Translational Sciences, NIH

1. Academic and Biotech companies relations: Toxicity testing, new clinical trial design, increase efficiency
2. Knowledge of disease increased vastly
3. HealthCare not at the same rate
4. Rare disease tested on 5,000 patients, Genomics combinatories
5. Clinical Trial Templets: FDA & NIH working together on
6. FDA & DARPA – Tissue engineering
7. mainatin Statistical Robustness yet change the process

• Dr. R.K. Vats , IAS, Additional Secretary, Ministry of Health and Family Welfare, Government of India

• Moderator:
  Dr. William Chin, Executive Vice President and Chief Medical Officer, PhRMA

1. Efficiency of Clinical Trial needs improvement
2. Gene therapy in US: Interaction between NIH and FDA – how is it going

Panelists:

• Dr. Stephen Caddick, Director of Innovation, Wellcome Trust

1. management health in decline
2. scientific complexity
3. Science, Technology and Understanding Human Behavior neede NOT to fail society

• Dr. Johan Van Hoof, Global Therapeutic Head- Infectious Diseases & Vaccines, Janssen Pharmaceutical Companies of Johnson & Johnson
• Dr. Gagandeep Kang, Executive Director, Translational Health Science & Technology Institute (THISTI)

1. Clinical Trial Design in India, integrated IRB system for evaluation

• Michael Nally, President, Merck Vaccines, Merck & Co.

• Dr. Niranjan Sardesai, Chief Operating Officer, Inovio Pharmaceuticals

Moderator:
Dr. William Chin, Executive Vice President and Chief Medical Officer, PhRMA

1. Necessary expertise on emerging infectious agents
2. Affordability of Vaccine
3. More discussion needed on Vaccines

• Sanat Chattopadhyay, President, Merck Manufacturing Division, Merck & Co.;
• Dr. R. K. Vats, IAS, Additional Secretary, Ministry of Health and Family Welfare, Government of India; Alok Kumar, Advisor, Niti Aayog*

Moderator:
Dr. Amrit Ray, Chief Medical Officer, Janssen Pharmaceutical Companies of Johnson & Johnson

Panelists:

• • Dr. Richard Moscicki, Deputy Director (Science Operations), CDER, USFDA
  • Dr. Petra Kaufmann, Director, Office of Rare Diseases Research & Director, Division of Clinical Innovations – NCATS, NIH
  • Dr. G.N. Singh, Drug Controller General of India, Central Drugs Standard Control Organization, Ministry of Health
  • K.V. Subramaniam, President, Reliance Life Sciences

• Dr. William Chin, Executive Vice President and Chief Medical Officer, PhRMA

1. Patient’s Compliance, control investigation
2. Value to Patient, what value do they ask for

Moderator:
Dr. Michael Rosenblatt, Chief Medical Officer, Flagship Pioneering

Panelists:

• Dr. Chris Austin, Director, National Center for Advancing Translational Sciences, National Institutes of Health

• Dr. Jim Burns, President and CEO, Casebia Therapeutics
• Dr David Meeker, Executive Vice President & Head, Sanofi Genzyme
• Dr. Wim Parys, Head of R&D- Global Public Health, Janssen Pharmaceutical companies of Johnson & Johnson
• Dr. Alfred Sandrock, Executive Vice President & Chief Medical Officer, Biogen

Moderator:
Dr. Steve Uden, Head of Research, Alexion Pharmaceuticals

Panelists:

• Dr. James Bradner, President, Novartis Institutes for BioMedical Research
• Dr. William Hait, Global Head- Research & Development, Janssen Pharmaceutical Companies of Johnson & Johnson
• Dr Andrew Plump, Chief Medical & Scientific Officer and Director, Takeda Pharmaceuticals

1. Clinical Partnerships important, last molecule developed in house in 1999, Partnershiip in Stem Cells, development for Ciliac disease

• Dr. David Nicholson, Chief R&D Officer, Allergan

1. R&D is small Intell Group to identify opportunities is large, 2,500

Moderator:
Dr. Martin Mackay, Executive Vice President and Global Head of R&D, Alexion Pharmaceuticals