Leaders in Pharmaceutical Business Intelligence Group, LLC, Doing Business As LPBI Group, Newton, MA

1:30 pm – 2:20 pm 3/26/2015, Precision Medicine: Who’s Paying? @ MassBio Annual Meeting 2015, Cambridge, MA, Sonesta Hotel, 3/26 – 3/27, 2015

Reporter: Aviva Lev-Ari, PhD, RN

Dr. Aviva Lev-Ari will be in attendance on March 26, 2015, 8:00AM to March 27, 2015, 2:00PM

Leaders in Pharmaceutical Business Intelligence are Covering the Event in REAL-TIME using Social Media

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1:30 pm – 2:20 pm    Precision Medicine: Who’s Paying?    

Moderator: Jeff Elton

1. Avoid using Cost do use Value
2. System scale
3. moving from 2015 clinical setting with Genome required interpretation
4. one launch of drug per month, catalyst to accelerate
5. data accessibility

• David Altshuler, Executive Vice President of Global Research and Chief Scientific Officer, Vertex Pharmaceuticals

Definition: PM

1. Targeting the root cause of disease symptom, Cystic Fibrosis, mutation in gene, medicine improve alveolar performance
2. Develop a medicine for a foundation of disease beyond gene variance
3. Academic Centers play a unique role – information flowing, genetic relationships, diagnosis – process understood
4. Simplistic thinking on Sequencing wound lead to therapy
5. Value to families like Cystic Fibrosis — family impact is Value
6. Expense in Clinical Trials that do not succeed, small trials, new design of the process of the clinical Trial design
7. FDA put forward pathway to facilitate PM
8. Imaging device measure of efficacy recognized by regulatory
9. Value Added by President Initiative on PM
10. Interoperability piece – In UK Biobank and genotyping – foundation in the US
11. Other places more advanced than the US
12. Not all Diagnostics tests are same – Diagnostic Company A provide eligibility to Herceptin and Diagnostic Company B does not provide the eligibility — DEVICES/LABS CAN’T HAVE VARIABILITY BEYOND A SMALL %.
13. Physician need to drive the innovations, FDA, Foundation — vs 2015 – taking the word of an MD as the verdict

• Walter Carney, Chief Scientific Officer and General Manager, Nuclear Diagnostics

1. Diagnostics and therapies – Primary tumor – RIGHT TEST AT THE RIGHT TIME not at metastatic state, groups of women triple negative on breast cancer, Not eligible for Herceptin, estrogen receptor negative, women receive target therapy are resistance surface.
2. Better biomarker like the “blood test for bacteria” – diagnostics for Cancer to be built by Pharma and used trial
3. Companion Diagnostics developed the Marker by Pharma for Phase III
4. IBD – diagnostics require monitor disease over time
5. IP required involved showing benefits from the lab to the clinic
6. Genetic mutations  more quickly to get results than in the past
7. Immunology principles are applied in diagnostics
8. FDA has very good Science — in need for additional infrastructure
9. Understanding the disease for PM — will change course of disease transform — t will take time
10. Next generation will have the value — we are chartering the course with commitment for the long term

• Susan Hagar, Vice President, Communications and Government Affairs, Foundation Medicine

1. Cancer is a disease of the Genome – one Test will give mD the Genomic profile matched with drug therapies, recommend the Clinical Trial for the patient
2. Genomic DB 35000 FoundationCore – Genomics Drives for clinical Trials to bring drugs to market  – Patient-centric Approach, Predic the unique market to be used to enable quality of life of the Cancer Patient
3. Obama’s Initiative for PM very promising
4. Combination of Private and Public Companies to leverage information for Patients.
5. MD needs information stratified for patients, actionable by MD in rural area NOT at MGH in Boston
6. Integration of information for the Clinical Setting
7. Regulatory need to change – lab diagnostics tests, Now FDA requires to regulate Diagnostics
8. Reimbursement – Innovating Payers are need to think out of the box
9. Investors found query DB for diagnostics at the same time of identification of the Biomarkers to be used for an indication
10. President initiative is DB building to leverage Cost of HealthCare — In the US – Privacy Debate in hindering information sharing and foundation for data creation
11. Family needs education can take more that 3 weeks a patient has for the task
12. Empower Patient and family by Genomic drivers to be able to go back to the MD to discuss options
13. Changing Paradigm requires resources, the Initiative from the Administration very positive
14. do not guess a TEST — every tumor is unique, what is the genomics drivers

From the Audience

The public is not homogeneously informed on the TREATMENT OPTIONS