11:00AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston
Reporter: Aviva Lev-Ari, PhD, RN
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
Mirella Marlow, M.A., M.B.A.
Programme Director, Centre for Health Technology Evaluation,
National Institute for Health and Clinical Excellence (NICE) @NICEcomms
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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