Leaders in Pharmaceutical Business Intelligence (LPBI) Group

LIVE 11/16 3:15PM – 5:30PM – The 12th Annual Personalized Medicine Conference, HARVARD MEDICAL SCHOOL, Joseph B. Martin Conference Center, 77 Avenue Louis Pasteur, Boston

 

Leaders in Pharmaceutical Business intelligence (LPBI) Group

Covering in Real Time using Social Media this Event on

Personalized Medicine

Aviva Lev-Ari, PhD, RN, Founder LPBI Group & Editor-in-Chief

http://pharmaceuticalintelligence.com

Streaming LIVE @ HARVARD MEDICAL SCHOOL,

Joseph B. Martin Conference Center

@pharma_BI

@AVIVA1950

November 16

#PMConf

 

 

3:15 p.m. — Diagnostics Debate: Regulatory and Reimbursement Hurdles for Personalized Medicine Diagnostics

Nowhere are the regulatory and reimbursement challenges facing personalized medicine more evident than in the diagnostics industry, where the routes to market are often hampered by a lack of clarity regarding the possible changes to the regulatory pathway for laboratory-developed tests, ambiguity regarding the kinds of evidence that justify payment, and the need for large marketing budgets to sell low-cost procedures, all of which impede the development of sophisticated diagnostics with the power to transform medicine.

During this panel discussion, representatives from a diverse range of diagnostics companies, a payer and FDA will identify the most promising strategies to alter the landscape to encourage investment in personalized medicine diagnostic products, including the roles of other stakeholders such as the pharmaceutical industry and integrated health systems.

• Moderator: Ronnie Andrews, Founder and Principal, The Bethesda Group

 

• Suzanne Belinson, Ph.D., M.P.H., Executive Director, Center for Clinical Effectiveness, Blue Cross Blue Shield Association

1. Centralized Evidence review – Payers making coverage decisions
2. Blue Payers: Payers: can modify or use it as such
3. Value proposition of Evidence Review: Medical Specialties, Payer, Providers, Manufecturer of Diagnostics, Clinical Research
4. Where is the GAP, in evidence review
5. engagement with Blue and non Blue, Community based Hospitals
6. Test utilization – decision is made – withhold a treatment or modification of treatment — at the aggregate level – impact on outcome can be achieved
7. reduce number of test is a health outcome,
8. redude numbers of day in Hospital is a Health Outcome
9. Curate information for Payers to use the information for policy
10. Prime Therapeutics – PPM of 14 organization — are clients for Evidence Review by Center for Clinical Effectiveness, Blue Cross Blue Shield Association – 36 plans, IT issues, Patient is covered in IL, treatment is givrn in FL, different rules in FL.

 

• Brad Gray, CEO, NanoString

1. Seattle-based gene expression (emerged in academia), development of diagnosis
2. IN VITRO DIAGNOSTIC KIT – PREDICTION OF RESPONSE TO BREAST CANCER
3. Cengene – response to their druv
4. Medidiation – prospate cancer
5. Merck – response to Keytruda – multiple indications
6. Universal asset development: Diagnostics several parameters in ONE test
7. Policy change is not the focus bur the association of diagnostics with drugs

 

• Alberto Perez, FDA

 

• Michael Pellini, M.D., CEO, Foundation Medicine – had experience with Thermo Fisher Diagnostics
• Molecular diagnostics space, information comapny not Lab or Diagnostics
• Comprehensive tumor testing – ASSETS:

1. EXTRACT MOLECULAR information from tissue vs multiple biopsies
2. COMPEHENSIVE DB OF 1,000 PATIENTS – Genomic Profiling – Rows are cancer type Columns are Published studies providing evidence
3. Decision Support: MD, Pathologists – Testing Platform submitted to FDA to get regulatory standards
4. Biliary small tumor

 

4:30 p.m. — Visions of Value: Evaluating Evidence for Personalized Medicine

The fact that payers, providers, patients, industry representatives and regulators all define value differently makes it difficult for personalized medicine’s champions to contribute to and communicate about the body of evidence supporting the field. Participants in this panel discussion will bring the personalized medicine community closer to an accepted definition of value by identifying common elements in multiple stakeholders’ understanding of the concept.

• Moderator: Susan Dentzer, President and CEO, Network for Excellence in Health Innovation

1. Without Pricing adjustment Access can’t be accomplished
2. drugs for HPC – patient is not sick enough to qualify for the drug

• Donna Cryer, J.D., President and CEO, Global Liver Institute

1. societal impact of a diagnosis
2. Development of Value framework, development of he evidence that goes into Value frameworks, Outcomes desireable, Patient generated evidence
3. Health high functioning citizens and a fibrant Health Care industry
4. PM PARADIGM accepts Patients factors to be used in algorithm development
5. Restrictive Formulary for non avarage patients – access at time of need

 

• Michael Sherman, M.D., M.B.A., M.S., Senior Vice President, Chief Medical Officer, Harvard Pilgrim HealthCare

1. Pay for Service is not connected to Value
2. Charge the variable cost for testing
3. DECISION re driven by costs: delivering drug lowering cholesterol to avoid facing expenses of trating CVD
4. Higher price for success
5. Care about the total cost of Care
6. payment for innovations

• Peter B. Bach, M.D., M.A.P.P., Director, Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center

1. Oncology drugs and Priding to improve the decision making
2. US and specialty drugs
3. severe access problems for drugs to patient – colapse because of Pricing
4. out performing in cost of treatment per patient
5. Societal equation – drug prices
6. AMA embrassed Value based Pricing on 11/16/2016
7. Linking Price of Drug with what the drug does

 

• Randy Barkholder, PhRMA

1. consolidation Prices for Medicine and for Societal are different
2. add value to the Healthcare system
3. Performace and quality to measure value
4. Drug companies representation and SOcietal values vs HealthCare system value

 

5:30 p.m. — Elements Café Cocktail Reception

#PMConf

SOURCE

http://www.personalizedmedicinecoalition.org/Conference/November_16_Program