Leaders in Pharmaceutical Business Intelligence (LPBI) Group

8:20AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

Reporter: Aviva Lev-Ari, PhD, RN

REAL TIME Coverage of the Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

8:20 a.m. Special Guest Keynote Speaker – The Future of Personalized Medicine

The Future of Personalized Medicine

How to ask the right question is what HMS taught me best 

Increasing the knowledge of Biology, response to disease, preventive strategies.

2004 — Monumental year — One year after completion of sequencing the Genome

2008/9 – Breast Cancer – pharmacotherapy approved, a protein involved in triggering the disease.Target therapy – risk of disease identified

WHAT FDA is doing on Genetics Information as PARTNERS in Medicine

25% of drugs approved are Targeted therapies

LABELING drugs on genetic information

diagnostics test — identify good respondents

Companion Diagnostics – should be used in Targeted therapies. IGF1, HER2 expression and amplification

PM more important in ONCOLOGY , HepB, Cystic Fibrosis, differential response, CVD – expansion, more to be done

In 2002 — a Program to discuss Genetic information VSDS – New Genomics Program, National Center for Toxicology Research a participants

Translational Scientist are added.

Completion Genome sequencing — push to PM 2011 – Genomics evaluation Team for Safety.

Challenge – Drug, Biologics – interaction need coordination by Agency to discuss challenges and collaboration with out side Group.

Developers of Targeted therapies: Orphan Drugs, Biomarkers – expedited review to promote innovations, fast track breakthrough therapies. Opportunities of Scientist to engage discussion with FDA

 – ALL hands on Deck Approach at FDA – making products available, i.e. SCLC (small cell lung cancer)

Since 2005 – 25 Guidance Reports, i.e., Orphan Drugs and on Companion Diagnostics to be developed in tandem with drug development.

Companion Diagnostics – 3 month review, enforcement and direction – in the framework

FDA — needs to keep up with development in the Diagnostics and in the disease ares.

Illumina – Assays using SNIPS – FDA assesses a shared curated DB on mutation, reduce the review time significantly

FDA – NGS – reference libraries, Genomics Reference and Storage of genomics data

Tools and Capabilities  – support regulatory and science, statistical methods of analysis — implemented for Breast Cancer — signaled the way of new Partnerships and New Clinical Trials formats and methods in its development.

New diagnostics – AMP Program Alzheimer’s Disease, rheumatoid arthritis (RA), inflammatory bowel syndrome (IBS)

What Science is needed for the Regulators to effectively HELP spar innovation.

Pharmacogenomics, Pharmacogenetics — MAPPING the Human Genome and all other areas of “OMICS” – moving from Lab to bedside — requires expertise in Disease prevention, Difference in patients life, Standard medical practice

• Biology and Pathways
• Biomarkers
• New diagnostics
• Increased communication Universities, new paradigms models and continual effort of SHARING and coordination of shared resources

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

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