Leaders in Pharmaceutical Business Intelligence (LPBI) Group

LIVE 11/17 8AM – 1:45PM – 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 17

#PMConf

 

Joseph B. Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115

7:00 a.m. — Registration and Continental Breakfast

8:00 a.m. — Opening Remarks

• Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

8:15 a.m. — Fireside Chat

• Moderator: Meg Tirrell, Reporter, CNBC

1. How did the the Economics changed

• Daniel O’Day, CEO, Roche Pharmaceuticals – Joined Roche at 1989

1. Roche  – 60% of investments goes to Cancer with embedded diagnostics, 20-30% of the market
2. Hypothesis in the Lab starts an innovation – Phase I, Phase II is extension of Phase I – continue understanding of the Biology of the Disease
3. Treat only patient that will benefit – PM – transformational benefit
4. Early stage of discovery – protection of IP – work inside ONE company — less of an issur the protection of IP
5. Diagnostics area – Roche collaborates with other Pharma
6. Setting infrastructure for testing
7. Diagnostics and Pharma are coming together – availability of big data – discover and develop with Foundation Medicine – Deep analysis of Molecular Medicine, decide o better hypothesis, do it in shorter time – 2015 – Commercialize the platform around the Globe, One standard for Clinical Trials – in China hard to move Clinical Trials Data out of China –
8. Harnessing Global Data in Oncology – Clinical Trials
9. Data accuracy
10. Genentech, Foundation Medicine and Roche capabilities – FDA
11. Comprehensive Genomics side – has needs yet to be developed for Payers to participate
12. Foundation One – 30% more positive Lung Cancers found vs standard of testing
13. Over simplification is dangerous, technology/diagnostocs/histology/genomics – sequencing ENHANCES not replaces
14. Data of Phase III – robust genomics profiling: no diagnostics and wrong diagnostics
15. In the next five years, Cancer immunotherapy, when and how resistance occur.
16. Blood based assay – Patient journey  – fine tuning the Science tissue based sample
17. Biomarkers: Tumor microenvironment
18. Diagnostics is not rewarded appropriately, genetics, CMS,
19. Outcome value for TX and Dx
20. Mission of Roche will not Change with change of Gov’t, public Sector in the US, FDA – requires being faster a respondent,
21. ” I am optimistic”

Questions from the audience

• Democratizing access to sequencing data
• accuracy of test results, Oncologist and PCP ordering genomics tests, value added
• PM after medicine SOC (biopsy, tissue histology)
• Reimbursement: Diagnostics vs drugs

8:45 a.m. — Coverage is King: Identifying the Evidence That Leads to Reimbursement

Many innovators in personalized medicine are unclear on the kinds of evidence that inform the coverage and payment decisions of payers. That lack of clarity can have negative financial consequences for personalized medicine companies with products and services that are on the market but not paid for. During this panel, payer representatives will help define the reimbursement landscape for the field by providing examples of the evidence they consider appropriate for coverage and payment. Confirmed panelists include:

• Moderator:Amy M. Miller, Ph.D., Executive Vice President, Personalized Medicine Coalition

1. What each of the companies does in PM
2. Targeted therapeutics: 25% are targeted,
3. Value of Diagnostics

• Kristine Bordenave, M.D., Lead Medical Director, Humana

1. Clinical perspective, how much it cost to patient, clinician, Pharma – both need to be paid,
2. Population Health, 100% of GDP to go to HealthCare — can’t be
3. Humana Perspective: How to cover – organized criming: Charges for Testin – several month doen in one day, sharing drugs, expired drugs, repackaged and sold, drugs resold
4. Independent Research Department: MS, Pharmacists, Statisticians — Looking at the Value of Test in Population context
5. Large Medicare, Small managed care company, Value-based contracts: working with Pharma – early on at Phase II stage
6. Testing: genetics, radiographic — 60 gene panel – done by two labs,
7. Duplication in ordering genetic testing: optometrists, Physical therapist, ordering genetic profiling

• Matthew Fontana, M.D., Vice President and Chief Medical Officer, Pharmacy, Health Care Service Corporation

1. WHY REFERE TO US AS PAYERS – BUSINESS MODEL: MULTIPLE CUSTOMERS MEDICAID, BIG PROVIDERS, MANAGED CARE INDUSTRY
2. Cost and Revenue
3. FDA is been pushed to ignore the science (DMD), lack of coordination in HealthCare
4. Pay for diagnostics if not linked to Therapeutics – morbidity
5. elaboration of Diagnostics
6. Accuracy of testing – expensive  – misinterpretation

• Elaine Jeter, M.D., MolDx Medical Director, Palmetto GBA

1. Access of Patients – 25 of 50 States are participants in MOlDx — NOT New England States
2. All molecular assays to register for code specificity – to be able to control appropriate coding – Panel matched to unit of service issue between Genome Profiling and assay
3. Reimbursement – Lung Cancer – Clinical utility  – genomic profiling ONLY IF THE DATA IS IN A REGISTRY — IF PROVED UTILITY AND THE REGISTRY SHOULD BE IN PUBLIC DOMAIN
4. Analytical minimal standard accepted
5. Developed Assessment meetings – Labs come to receive guidance  – clinical utility information, as a contractor – Central Office allowed PM vs Lab developing tests – assist Lab – pay for service obtain end points
6. Assays for Prostate Cancer – innovative – high disease demand, define endpoints
7. Paying premium for FDA approved genetic testing – onlu 2% of molecular assays — 98% are not FDA approved
8. 65,000 molecular tests in the market in the Registry only 10,000, every day 2-3 new molecular assay tests are introduced
9. By statue, no screening covered by Medicare for Genetic testing – congress need to act upon that – change coverage of Medicare. Memogram and colonoscopy, lung X-ray – are by statue – covered by Medicare

Questions from the Audience

• Why premium paid if FDA approved a test?
• Screening and early detection

9:45 a.m. — Networking Break

10:15 a.m. — Harvard Business School Case Study Presentation

DNA-editing technologies have been hailed as revolutionary with the possibility to edit out mutations that cause disease.  Yet the CRISPR-Cas system is currently locked in a legal dispute between two great research institutions involving, as one journalist put it, “who owns molecular biology.”  The CRISPR technology in short raises the broader issue of whether these new techniques should be privately owned or placed in the public domain. The technology also raises serious ethical issues. The case study will serve as the point of departure for our discussion of these issues.

• Leader:Richard Hamermesh, D.B.A., Senior Fellow and Former MBA Class of 1961, Professor of Management Practice, Harvard Business School

1. Ethical issues in the case
2. Stacks are very high

11:15 a.m. — Keynote Speaker

• Introduction:William Chin, M.D., Chief Medical Officer, Executive Vice President, PhRMA
• Keynote:Victor Dzau, M.D., President, National Academy of Medicine (ex-IOM) – part of NIH

1. Global Landscape of PM: Integration into HealthCare — Cost effectiveness
2. Evidence for PM
3. better health and well being
4. high value health care
5. strong science & technology – 150 papers in JAMA ans NAS
6. Precision Medicine: patient/public engagement, NGS: omics, biomarkers, collection of clinical & research data, integration of omics, EHR
7. Challenges: Tests & Therapies
8. efficacy of PM AFTER actually being used in clinical practice
9. Evidence of PM efficacy for implementation in Practice
10. Regulatory and Reimbursement for utility
11. Reward Value vs cost
12. Aligning Results: 10% incidence reduction vs 50% incidence reduction
13. Evidence generation:
14. Modeling could be used to assess the potential economic impact of PM approaches
15. Final regulatory & Payment Pathwaysand payer approval
16. Analytic Validity — clinical validity — economic impact analysis– Assess Clinical Utility
17. Strength of evidence Low to High
18. investigational experiment
19. Assess cost effectiveness: initial experimentation — Economic analysis — provisional approval — validation — final approval
20. Integration with clinical Practice: Clinician Educatuin, integration pathways
21. Genomic Medicine:guideline and care pathways — Clinical DSS —
22. Data infrastructure and sharing: EHR (DIGITize) – genomics – GA4GH
23. PATIENT/PUBLIC ENGAGEMENT – concern of Privacy and Data Ownership – Fear of discrimination  — consent — education of Patients
24. Future needs: data, National scale learning system, Global collaboration G2GH
25. Support Data infrastructure
26. PM – quality, access, cost, improve clinical outcomes, inequality mitigate
27. PRECISION PUBLIC HEALTH – ZIKA, EBOLA,
28. GENOMICS and Population Health Action Collaborative
29. working Groups: Evidence generation

11:45 a.m. — Bag Lunch

12:45 p.m. — Personalizing Care: Strategies for Integrating Personalized Medicine into Health Care

Personalized medicine lacks sufficient literature on how health care providers can integrate personalized medicine into clinical care, which makes it difficult for providers to take advantage of the growing number of personalized medicine products and services now available to them. During this session, panelists who have spearheaded integration efforts will share the strategies they found most useful for speeding the pace of personalized medicine’s adoption in clinical settings. Confirmed panelists include:

• Moderator:Howard McLeod, Pharm.D., Medical Director, DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center

1. Awareness & education
2. Patient empowerment
3. value recognition
4. IT and Information Management
5. ensuring Access to Care: Case if Neuropathy than 15 more visits causing 8 other Patients to be pushed in the queue

 

• Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Senior Vice President, Oncology, Flatiron Health

1. Family and Care givers need to understand as well
2. More Advocacy in Washington

 

• Dax Kurbegov, M.D., Physician Vice President, National Oncology Service Line, Catholic Health Initiatives – CHI (103 Hospitals) and DIgnity ospitals – Community system

1. Provide speed of service
2. Permeate piece by piece by each institution, economics – problematic IT infrastructure for Genomics is expensive, centralized system needed
3. broader beyond Oncology
4. complex Patients with polypharmacy
5. If physician needs to write a special note for service , patients are lost in the way for testing
6. as NGS become accessible in labs — CHI provide infrastructure to LINK Patients with Experts and Labs outside the system

• Lincoln Nadauld, M.D., Ph.D., Executive Director of Precision Genomics, Intermountain Healthcare, UT (22 Hospital 107 physicians – Molecular Tumor Board)

1. Pilot Project approach implemented in 3 hospitals, built lab, implement by Molecular Tumor Board placed on the report
2. Barriers: getting drug is difficult – mutation exists, drug exists — How to get the drug ordered, approved and shipped
3. Patients want to know that their oncology is up to date the care is best, Patient advocate for themselves, Patient empowerment
4. Barriers to PM – Physician compensated better for next line IV chemo vs Targeted Genomic-based therapy
5. Tumor Board
6. Get Genomics EARLY not late – it will max the course of treatment
7. MOST PATIENT CAN’T TRAVEL FOR CARE because it is expensive
8. Utility and Value asked by Payors, cost saving need be demonstrated not only efficacy vs SOC – reduce cost must be demonstrated

 

• Peter H. O’Donnell, M.D., Assistant Professor of Medicine and Associate Director for Clinical Implementation, Center for Personalized Therapeutics, The University of Chicago

1. Lab Testing, way to long, system for Physician to look at Genomic data,
2. If Physician is buying in shared decisions with Patient easier
3. all tests are bundled and results are presented to PCPs – they love that
4. Drugs fail because Patients do not take them vs Pharmacogenomics – more likely to help Patients

#PMConf

SOURCE

http://www.personalizedmedicinecoalition.org/Conference/November_17_Program