Posts Tagged ‘Regulatory and Clinical Research’

LIVE — 9AM-noon 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








9-15 AM – 9-30 AM Welcome address by Karun Rishi, President, USA-India Chamber of Commerce

Progress made in last two years, we need faster advancement. Thanks to all attendees and those who came for far away.

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

Biomedical field, important issues are covered today. Karun is a Force of Nature. Guests from India, welcome.

Innovation in BioTech and understanding Disease is exploding

  • Ability to attack disease is amazing
  • Pipelines synthetic, small molecule – THE Past — today new unconventional therapies

India’s role:

  • Innovation space in India – diversification in modalities
  • Partnerships
  • # of Rounds in Financing: 67 new start ups in 2015 in the US – Academic Start Ups
  • Models in India: we need to figure out which types will work best in India

Takeda and Japan

  • Strong academic science
  • rich history of productivity in R&D
  • Commercialization of R&D is not strong in Japan
  • Institute outside of Tokyo: Academia and Industry collaboration
9-30 AM – 9-55 AM India Regulatory and Clinical Research Update
K.L. Sharma, IAS, Joint Secretary, Ministry of Health and Family Welfare, Government of India

  • Ministry of Health and Family Welfare is keen to improve and progress
  • Federal funds will be distributed to 60 States for Reform, Actions
  • Good Laboratories Practices, Manufacturing Practices Processes, CMP, GMP,
  • Risk assessment based on data from Manufacturing and inspection
  • Regulatory aspects and validation – largest in the World quality effort of manufacturing, August 2016 – results will be sahred
  • Medical Devices: ISO – extensive cooperation to amend the Law and add New Lawsto provide compeling reason for rules and standards in Medical Devices and Prostesis
  • Biologics, Stem Cells
  • Collaboration between Medical Institutions, Academic Institution
  • Recruiting from industry to the Government
  • Toxicology studies
  • Acredidation process
  • Put in Public Domain: Information on products, all new regulation
  • International hamonization

Questions from the Podium

    • Academia: Collaboration
    • J-J: IF the doors are open – How we can connect to develop relations
    • How International hamonization can take place with each of the States
  • Committes from Laboratories, Central Govenrment and Industry
    • US -India collaborations: Improvements on the way
9-55 AM – 10-45 AM Panel Discussion: Neurodegenerative diseases – Matters of the mind

Dr. Ole Isacson, Professor of Neurology, Harvard Medical School

The most difficult field in Medicine, opportunities in Academia and in Industry — in last ten years these two groups merged in interest to solve the problem, Genetics work with Neuro to develop drugs, pathology and Neurologist discussions associations with immunology and oncology

  • 5 Millions in the US affected by Neurological Diseases
  • Role of Stem Cells
  • gene therapies


  • 5 – Dr. John Dunlop, Vice President & Head, Neuroscience, AstraZeneca
  1. Clinical Studies  – data on antibodies need to be sahred AZ invested in Amyloid Hypothesis
  2. ALS, MS, Parkinson
  • 3 – Dr. Douglas Feltner
  1. Antibodies made  – cause fight with inflammation
  2. MS, Parkinson, AZ – very complex diseases
  3. Longitudinal changes,
  • 4 – Philippe Lopes-Fernandes, Senior Vice-President, Merck KGaA

Adherence with medicine and treatment cause of 15 years

  • 2 – Dr. Alfred Sandrock, Executive Vice President and Chief Medical Officer, Biogen

DO belief in Beta-Amyloid hypothesis is causal hypothesis, In early patients – reduction of plaque by the drug very quickly, Early CLinical Trial, progression monitoring, TAU present and spread beyond temporal lobe, microglial cells can be protected, helpful to preserve neurons,

  1. Need to understand Pathways,
  2. know how to mitigate risk along the way, reduce risk of investment in a disease solution may not come by instead of investment on a drug for a disease curalble NEURO is more difficult
  3. How Indian Scientists can particiapte
  4. even with inheretance, protected by other factors
  5. Intracellular proteins
  • 1 – Dr. Rudolph Tanzi, Director, Genetics and Aging Research Unit, Mass General Hospital

Biology of Alzheimer’s Disease: Loss of synapses, 4 genes, Amyloid Hypothesis – debatable, head-concussions, genes for inflammation, Human models, C1-2, diet, Statin, APO-4 E2, E3 – lipid componenet – role in amyloid transport

  1. Cross -pathologies disease specifics
  2. mutations that protect us, plaque is present NO Ad, resilience
  3. Brain-Microbiome: Infections in th eBrain

Questions from the Floor

  • Etiology
  • Biomarkers
10-45 AM – 11-15 AM Fireside Chat with

  • Dr David Meeker, Head, Sanofi Genzyme


  1. How we build value
  2. specialty care business  – systemic growth
  3. Where is the probability the highest?
  4. Pay to Play – a start not an end game
  5. R&D effert internally must be very strong before acquision are to take place
  6. ecosystem is critically important
  7. Resource allocations remains important in strategy


  • Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries Limited – India based


  1. How innovations in India can impact positively the Cost of HealthCare
  2. 4 products at different stages
  3. Partnerships wiht International companies are needed in areas the expertise is not enough
  4. 50% of products are for international markets
  5. consistency and scalability
  6. Partnerships with Biotech are important for growth – joint value for bigger position
  7. In our strategy I am Seeking
  • partner in oncology,
  • other drugs to use out technology for drug delivery,
  • excaplulate our expertise in exosome lipidsome for other targets
  • Proof of Concept transfer to products the process id lengthy
  • BioSimilar – BioPharma — important sector for Pharma
  • Fear of failure

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

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