Leaders in Pharmaceutical Business Intelligence (LPBI) Group

11:00AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

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

11:00 Keynote Speaker – Past, Present and Future of Personalized Medicine

Past, Present and Future of Personalized Medicine

PM in the UK

Clinical evidence and cost effectiveness needed for PM

UK Government life sciences policy

Scale of PM:

2013 – 10 million pound

2020 – 60 million pound

Innovative healthcare to promote economic growth

• Genomics England 100,000  – new scientific discovery and kick start the UK genomics industry
• BIS – accelerate Skills & Training for the Genomics Industries
• UK Precision Medicine Catapult development of tests and commercialization of innovation in diagnostics

1 Billion Pound NIHR in UK

• tissue banks – Biobank
• Farr Institute – “big data”
• develop methodologies for starter research

National Institute Care Excellence

– standards for NP

Benefits of PM

• right treatment
• responding subgroups
• earlier treatments
• dosing
• reduce side effects

Companion Diagnostics in NICE – Technology Appraisals

• elevate a test like evaluate a drug ad part of Diagnostics
• Treatment: GIST — >>Biomarker: KitCD117

Diagnostics assessment Program

• 9 EGFR-TK – mutation testing –
• Mutation Analysis Services

NICE support to Companies – Company engagement

• discuss product pipeline and value proposition
• orientation to the process
• Scientific Advice on Clinical Trial Design
• workshops for Pharma and for Diagnostics — are different
• online tool being developed – standardize the Advise for Fee — get Accredited Advisors in the Fields of Genomics, Diagnostics
• Post guidance – evidence gaps, clinical utility and economic evidence
• Update guidance – research questions guiding Guidance for the industry
• Indirect Research facilitation: protocol external funding identify clinical context ethics +GCP leading to Publication within 2 years

UK and Genetics: Kirk and Watson on DNA

UK – 60 million patients under one National Universal Health Care System

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

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