Posts Tagged ‘Exploratory Development Submission’

LIVE 3:15PM – 5:00PM US-India BioPharma & Healthcare Summit, June 2, 2016, Marriott Cambridge, MA



Leaders in Pharmaceutical Business Intelligence (LPBI) Group

will cover in Real Time using Social Media the

10th US-India BioPharma & Healthcare Summit,

June 2, 2016

Aviva Lev-Ari, PhD, RN will be streaming LIVE from the 

Marriott Cambridge, MA







3-15 PM – 4-05 PM Panel Discussion: Cardiovascular and Metabolic Diseases- Matters of the heart and the body

Dr. Michael Rosenblatt, Executive Vice President & Chief Medical Officer, Merck & Co.

  • What are the trends
  • Hoe Genomics affects
  • Effect behavior by data from Devices like FitBit
  • Gene Editing
  • COllaboration potential with India


  • Neil McDonnell, PharmD, Chief Executive Officer, Metacrine
  • Dr. Anthony Muslin, Vice President, Head of the Cardiovascular & Fibrosis Unit, Sanofi
          1. Area of study: insulin sensitizers
          2. NASH — effects of insulin sensitizers on
          3. CVD — effects of insulin sensitizers on
          4. CNS — effects of insulin sensitizers on
          5. Genomic in Metabolic: Blocking hormone
          6. Two drugs that showed effect on CVD
          7. Antidiabetics inn NASH
          8. Diabetes and Renal
          9. Collaboration with India: VC, Pharma, Seizened Management Teams
  • Dr. Robert Plenge, VP and Head of Translational Medicine, Merck Research Labs
  1. Cholesterol – gene editing vs drug for the mutation
  2. Data analytics of big data — build Teams with al capabilities
  • Dr. Arthur Tzianabos, President & CEO, Homology Medicines
  1. Genomics and Genetics – few have been studied yet,
  2. genes to be targeted for editing
  3. In CVD – Gene Editing – cure disease at the origin: repair the gene transcription
  4. Ittalia, Editas
  5. In vivo genetics: Viruses and nanoparticles
  • Dr. Murali Vemula, Founder & President, Nivarta
  1. CVD
  2. Small molecule

Questions from the Floor

  • Burden of disease is high in India and CHina, Lovostatin, Metformin, Anti-Hypertensive — Decrease the burden og the disease
  • India has capabilities in IT — Harness that to Genomics?
4-05 PM – 4-55 PM Panel Discussion: Regulatory Policies to foster R&D Innovation

Dr. William Chin, Executive Vice President, PhRMA

  1. Regulatory – Roadblock and barriers
  2. Regulatory – Catalist
  3. This is a Bias: Partners with Academia, Industry Cell therapy, CRISPR
  4. Biomarkers – Approval by Regulator is not forthcoming


  • Dr. Ariz Ahammed IAS, Joint Secretary, Department of Pharmaceuticals, Govt. of India
  • Dr. Christopher Corsico, Chief Medical Officer, Boehringer Ingelheim GmbH
  1. If benefit is clear – Regulatory will act fast to accelerate
  2. Gov’t vs Regulators that are TOO much partnering with Companies applying for approval
  • Rajiv Kaul, Portfolio Manager, Fidelity Investments
  1. Intellectual Capital from all over the WOrld arrive to Cambridge
  2. Gov’t and industry to come together otherwise the Cost of Capital is too high
  3. Regulatory is necessary for Public Safety
  4. Regulatory is a barrier if a company stock depends 100% on Approval  – Colatico – approved in 3 Month
  5. Speed is important to Patients and to investors and to Patients
  6. New classification Noval Inventions: Fast approval – investors like this class of drugs
  • K.L. Sharma, IAS, Joint Secretary, Ministry of Health & Family Welfare, Govt. of India
  1. Public Health is of concern
  2. safety and efficacy is of great importance
  3. sociopolitical factors affect various States in India – Harmonization need be accomplished across States
  • Dr. Tsutomu Une, Corporate Advisor, Daiichi Sankyo Co., Ltd.
  1. Understanding he Patient and the family
  2. Priorities for patints vs Industry selfishness

Questions from the Floor

  1. Drug – device not fast approve – WHAT need to be done to accelerate this process
  2. Exploratory Development Submission —  New Scientific Concept  – concept and the Science behind and value – educate the Regulator – harmonize among regulatory agencies
  3. Concept presenented to Investors EARLY before we have the data
4-55 PM – 5-25 PM Participants comments
5-25 PM – 5-30 PM Closing Remarks

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