Leaders in Pharmaceutical Business Intelligence (LPBI) Group

7:45AM–9:15AM, January 27, 2015 – Risk, Reward & Innovation, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA

Real Time Conference Coverage with Social Media

@Computer History Museum by Dr. Aviva Lev-Ari, PhD, RN

7:45AM – 8:15AM Lee Hood, Institute for Systems Biology

Catalyzing a Revolution in Healthcare through a Longitudinal, Digital-Age Study of 100,000 Well Individuals

LIVE FROM THE PODIUM

Development of strategies for identification of early diagnosis, 24 different diseases, examined 700 families, genes related to neurotransmitter — diagnostics for Parkinson’s Disease, one cancer panel, sequencing of two chromosones

•  Drug discovery — does the drug work
• on which segment of the population, 7000 patients enabled aggregation
• Quantification of Wellness, definition of disease dependent
• longevity impact of Genomics 50% of the population will reach age 100
• Transcriptome, proteomics combined with life style and environmental variation
• Transformational relations with Patient – what he/she want out of therapeutic options available
• identification of two homozygotes – for research of Cardiac decompensation, diabetes
• Recommendation: Serum + Genomics, no one will do it all
• Genes and mutations, grafts, environmental perturbations, family history
• Physiological and Psychological transition point
• Digital devices: into one’s iPhone download information on disease transition
• Prototypical achievement 100,000 patients with predisposition to disease – identify the transition point: Pre-diabetes to diabetes
• Underdeveloped and Developed Nation: Global improvement of Health

Risk, Reward & Innovation

8:15AM – 8:30AM Ralph Snyderman, Duke University (Chair)

PM & Healthcare Delivery: Value & Cost of Innovation

LIVE FROM THE PODIUM

• Advantage to the Global Community
• Minority populations account for 80% of the cost
• Personalized Health Care – Start with state of Health which may even improve
• defining disease by the molecular basis, define risk, definition of what “CHronic DIsease is” vs State of Disease which may improve
• Real Impacts: Progress in decrease number of affected patients
• Drug Spending by Geography: Spending on R&D, Growth in Spending, Investment in R&D depends on drug profits
• Beyond Targeted Therapies – NEW therapeutics to cure not just treat disease
• WHO WILL PAY FOR INDIVIDUALIZED MEDICINE
• Pricing pressures are growing
• cost competition, patent of biologics, biosimilars between US and Europe – Cross competition for HepC Vaccine

8:30AM – 9:15AM  – Ed Abrahams, PMC (Moderator)

LIVE FROM THE PODIUM – PRICE, COSTS, REWARDS

Stephen Eck, Astellas

When drug is approved by FDA, Price need to reflect the cost and the expenses, future innovations are paid by the patients that will not use it in the future, since the value will be realized at too distant a future. Medicine is an important part of Culture. Ability to pay – Medicaid and Medicare – ability to pay is only partially realized in the pricing of the products consumed and services offered.

• predicting the outcome of tests need be related to how it is paid for  — diagnostics of a drug vs a Chemical of Genomics Test
• Value of drug

Steve Miller, Express Scripts

Q: CURE HEP C – COST EFFECTIVENESS

A: Burden of HepC is very great. Sustainable treatment: Pharma need to bring the drug to the market for biosimilars. Generics: effect on Pharma is negative, Consumer does not like Generic, Price disparity between US and Europe is enormous. Payers need to define copay acceptable not to over burden the patients.

• value of drug
• extract the therapy from the test result — Value of the Test

Paul Radensky, McDermott Will & Emery

Q. Payers pressure on Diagnostics

A. Chemistry test experience change in coding of Labs Test Chemistry tests, $30 -$40

• Price for tests, Payer – negotiates why the test is important
• Pharmacogenomics — new test not in Chemistry but in Genomics — New codes, pricing, margins
• Assay $10 – cost of Genomics Testing decreased exponentially
• pathways to commercialize tests, requires more data to be successful in the deployment of a test well examined in “trials” pre-deployment

Risa Stack, GE Ventures

• Biotech company, develops the drug, specific therapy like IMMUNOTHERAPY is differently approached by the investors
• Diagnostics are preferred to drugs.
• FoundationMedicine — shows the way in Diagnostics involved Genomics

Panel, Q&A

Summary by Dr. Abrams

Q – by Audience to Dr. Miller: Payments for Treatment without knowing the course of treatment

Dr. Miller: MD is interested in improving medicine via Diagnostics

Q – FDA and Payers are Gate Keepers, decrease cost of HealthCare

Paul: Test X-ray, diagnostics, lack of understanding of how to use the new diagnostics, evidence needed to piece together the information

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