The Personalized Medicine Conference

Educational and Networking Events for the Life Sciences Industry

 

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GenomeWeb offers the most comprehensive news source for personalized medicine, diagnostics, genomics, and more. We cover the latest research, scientific partnerships, merger and acquisition activity, and technology and business trends. Check it out at www.genomeweb.com. Registration is free.

 

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      AGENDA (go to Day Two)

      Monday, April 11, 2011

      7:45 - 8:30 Registration/Continental Breakfast

      8:30 - 8:40 Chair's Opening Remarks

      Charlie Raffin
      Consulting Partner
      CJR Advisors, LLC
      former Vice President Commercial Assessment
      Ortho Clinical Diagnostics, Johnson & Johnson

      8:40 Assessing the Evidence for Genomics: Focus on the Patient

      This presentation will cover the following subjects:

      • Overview of Blue Cross Blue Shield Association's Technology Evaluation Center
      • Overview of evidence assessment criteria
      • Evaluation of direct vs. indirect evidence
      • Case Studies
      • Conclusions

      Margaret Piper, Ph.D., M.P.H.
      Director, Genomics Resources, The Technology Evaluation Center (TEC)
      Blue Cross Blue Shield Association

      9:15 Almac’s Partnership Models for the Discovery and Development of Novel Biomarkers

      This presentation will cover the following:

      • Almac's diagnostics business model
      • Diagnostic-Pharmaceutical partnership models
      • Fee for service
      • Creation of joint IP
      • Utilizing Almac's background IP

      Michael Sloan
      VP Business Development
      Almac Diagnostics

      9:50 Forging Win-win Relationships to Improve Patient Outcomes: The Novartis Molecular Diagnostics (MDx) Approach to Partnering

      This presentation will:
      • Explore key drivers for pharma and diagnostic companies to ensure a shared vision can be achieved
      • Identify guiding criteria in partner company selection
      • Provide a case study illustrating NVS MDx’s fully integrated Rx-Dx partnering approach

      Yves Dubaquie, Ph.D
      Director, Business Development & Licensing
      Novartis Molecular Diagnostics

      10:25 Morning Refreshment Break

      10:45 Commercializing a Gene-expression Test Which Competes Against Your Prospective Customers: Personalized Medicine vs. Fee for Service

      This presentation will cover the following

      • Heart transplantation care and endomyocardial biopsies (EMB)
      • AlloMap Development, Regulatory, Reimbursement
      • AlloMap vs. EMBs
      • Transplant cardiologists as customers and competitors
      • Comparative Effectiveness Research studies
      • Selling to all customers (Physicians, nurses, hospitals, payers, patients)

      Matthew J. Meyer
      VP Corporate Business Development
      XDx

      11:20 Expanding Personalized Medicine from a Niche Market to Standard of Care: Clinical Utility, Cost Effectiveness and Education of Diagnostics in Real World Settings

      The presenter will discuss the following:

      • A PBM's perspective on the clinical utility of health care innovations
      • A novel approach to lower barriers to entry for clinical useful diagnostic tests
      • Physician and patient uptake of pharmacogenetic tests

      Gabriela Lavezzari, Ph.D.
      Senior Manager, Extramural R&D
      Medco

      11:55 Luncheon

      1:05 Rx/Dx Partnering: Two Products Towards One Goal: Delivering the Prospect of Personalized Medicine

      Rx and Dx companies differ in business models that support product development and commercialization. Solid strategies and flexible interactions are essential for productive Rx/Dx collaborations. The discussion will focus on considerations for successful partnerships dedicated to developing different products that, together, bring benefit to all-especially the patients.

      Andrea Lauber, Ph.D.
      Head, Transactions for Clinical Biomarkers and Pharmacodiagnostics
      Bristol-Myers Squibb

      1:40 Workshop: The Drivers and Financial Benchmarks of Personalized Medicine (all speakers and delegates welcome)

      A personalized or targeted therapy is not the same as a one-size-fits-all therapy, often requiring different drivers and financial metrics to ensure successful launch and adoption. This workshop aims to address the drivers necessary to ensure the successful launch of a personalized or targeted therapy and how to optimize resources behind those drivers. The workshop will begin by looking at a suggested model of drivers necessary to ensure optimal net present value of a personalized medicine is achieved.

      This discussion will lay the foundation for consideration of resource requirements necessary to power those drivers to guarantee achievement of the targeted therapies goals for return on investment without loss of resource.

      Program Outline:

      Drivers of Personalized Medicine

      • Introduction to Benchmarking Model
      • Consideration of Why Targeted Therapies Require Different Drivers
      • Explanation of Model Drivers
      Financial Metrics
      • Introduction to Financial Metrics in Personalized Medicine
      • Consideration of Necessity of Differential Resource Requirements
      • Explanation of Financial Metrics

      Workshop Hosts:

      Peter Keeling
      Chief Executive Officer
      Diaceutics

      Mollie Roth, Esq.
      Chief Operating Officer
      Diaceutics

      3:25 Speaker Meet and Greet / One-to-One Meeting Break (special space reserved)

      4:10 Oncotype Dx: How Lessons Learned in the US and Internationally Have Informed the Next Generation of Development and Commercialization

      This presentation will cover the following:

      • The Genomic Health story and key drivers of success
      • Lessons learned from commercialization of breast vs. colon Oncotype Dx in international and domestic markets; how this has impacted their pipeline of development products (including additional test in colon cancer)
      • What they believe are major influencers going forward (e.g., regulatory, pharma) and how they are reacting and positioning themselves
      • Why they believe pharma/Dx partnerships are not just needed, but essential in the marketplace going forward and their vision of what these look like
      • How their capabilities in diagnostics can be leveraged by multiple healthcare stakeholders to better serve the patient

      Kathy Hibbs
      Senior Vice President, General Counsel
      Genomic Health

      4:45 Personalized Medicine in a Changing Regulatory Environment: Lessons Learned and the Challenges that Lie Ahead

      Personalized medicine promises to introduce a new, substantially higher standard of healthcare – one in which patients and their physicians can more quickly and definitively determine best treatment options, avoiding those that may be unnecessary, unbeneficial or harmful.

      Current regulatory frameworks in the US and EU contain no clear incentives or structure to support diagnostics R&D, treatment pairing, and clinical adoption. Sponsors can obtain approval of targeted products under the current regulatory system, but the challenges are significant and a more streamlined regulatory scheme would incentivize development of these products. The presenter will discuss both regulatory history as it pertains to personalized medicine as well as future regulatory challenges.

      Debra Rasmussen, RAC, MBA
      Worldwide Executive Director, Regulatory Affairs
      Companion Diagnostics Center of Excellence
      Johnson & Johnson

      5:20 Evening Reception (all speakers and delegates welcome)

      ________________________________________________________________________________________________________________


      Tuesday, April 12, 2011

      7:30 - 8:15 Continental Breakfast

      8:15 Chair's Opening Remarks

      Keith F. Batchelder, MD
      CEO and Founder
      Genomic Healthcare Strategies

      8:25 Partnering to Integrate Genetic Benefits Management into Personalized Medicine

      This presentation will cover the following:

      • Introduction to Generation Health/CVS Caremark's partnership in personalized medicine
      • How the partnership will advance the field of personalized medicine
      • Logistical and commercial challenges of genetic benefit management
      • How Generation Health/CVS Caremark will be working with CVS clients to integrate Generation Health’s expertise and services

      Troyen A. Brennan, M.D., M.P.H.
      Executive Vice President & Chief Medical Officer
      CVS Caremark Corporation

      Rick Schatzberg
      Co-Founder, President & CEO
      Generation Health

      9:15 A Stakeholder-Driven Approach to Improving the Evidence Base for Molecular Diagnostics in Cancer

      While a significant and growing number of molecular diagnostic tests are available for use in practice, there is little consensus regarding what types of studies provide adequate evidence for clinical and reimbursement decisionmaking. There is also considerable uncertainty about how such evidence can be generated in an efficient and timely way. The Center for Medical Technology Policy (CMTP) is currently working through a structured process of consultation with stakeholders to develop a methodological framework to improve the evidence base for these tests. The CMTP's approach targets the information needs of end-users, including product developers, clinical researchers and research sponsors.

      This talk will present an overview of the lessons learned to date in their efforts to develop methods for conducting comparative effectiveness studies in molecular diagnostics for cancer therapy, the goal of which is to produce better evidence for post-regulatory decision makers.

      Patricia Deverka, M.D.
      Senior Research Director
      Center for Medical Technology Policy (CMTP)
      Research Associate Professor
      University of North Carolina at Chapel Hill

      9:50 Pioneering Partnerships: Business Models for Successful Companion Diagnostic Co-development

      This presentation will cover the following topics:

      • The companion diagnostic wish list – what Pharma look for in a diagnostic partner
      • Plotting a course to commercialization – QIAGEN’s experiences in the development and launch of the therascreen® KRAS PCR Kit and the therascreen® EGFR PCR Kit companion diagnostics for oncology
      • Looking ahead – where now for companion diagnostics? New potential therapeutic areas to explore

      Richard Watts
      Director of Business Development for Companion Diagnostic Partnerships
      QIAGEN

      10:25 Morning Refreshment Break

      10:50 A Therapeutic Company’s Perspective on Successful Companion Diagnostic Partnering

      Therapeutic companies have an increasing need for companion diagnostics, particularly in oncology, yet may not have the capabilities necessary to develop, obtain regulatory approval and commercialize diagnostics. Availability of an FDA-approved diagnostic may at times be necessary in order for the therapeutic company to obtain regulatory approval of the desired indication for their therapeutic. In addition, the weight of evidence that triggers such a decision may come late in the development program and create challenging timelines for the diagnostic partner. The types of companion diagnostics are broad, e.g., immunoassays, immunohistochemistry, molecular tests. Some therapeutic companies are employing a preferred partner strategy in which they are developing a network of potential partners to collaborate with to develop a companion diagnostic to meet their specific needs.

      This presentation will cover from the therapeutic company’s point of view the key capabilities of a preferred diagnostic partner and elements of a successful partnership.

      John O'Connor
      Executive Director, Technnology Licensing
      Amgen

      11:25 The Use of Population Based Health Care Information to Create Personalized Health Care Delivery

      This presentation will cover the following:

      • Electronic Health Records (EHRs) - What are the benefits and obstacles?
      • Optimized Care Delivery using e-Health Services in Primary & Specialty Care
      • The future of medicine "Wired" and "Personalized"
      • How can we manage populations and patients efficiently - TECHNOLOGY & INFORMATION which are useful to clinical practice, changing the process of care

      Scott Taylor, RPh, MBA
      Executive Director, Industry Relations
      Geisinger Health System

      12:00 Luncheon

      1:15 Commercialization of Companion Diagnostics: The Perspectives of a Leading IVD Company

      The speaker will discuss bioMerieux's strategy for successful commercialization of companion diagnostic tests. The talk will focus on various options for commercialization of CDx tests and the evolving commercial landscape with reference to bioMerieux's co-development alliances with pharmaceutical partners.

      John Beeler, Ph.D.
      Director, Theranostics and Business Development
      Biomerieux

      1:50 Pricing & Market Access Strategies for Companion Diagnostics

      This presentation will cover the following:

      • Strategic decisions on using companion diagnostics
      • Pricing scenarios for companion diagnostics
      • ROI Partnerships: Development, Delivery, Transactional Pharmacoeconomics and utility for target product profiles
      • Integrating the value chain and patient to maximize revenue capture
      • US, European, and Emerging Economy Approaches

      Patrick Terry
      Principal, Pricing & Market Access Group
      Scientia Advisors LLC

      2:25 Panel Session: Companion Diagnostic Partnering: Case Studies and Best Practices

      Yves Dubaquie, Ph.D., Director, Business Development & Licensing, Novartis Molecular Diagnostics

      John O'Connor, Executive Director, Technnology Licensing, Amgen

      John Beeler, Ph.D., Director, Theranostics and Business Development, Biomerieux

      Chair: Keith F. Batchelder, MD, CEO and Founder, Genomic Healthcare Strategies

      3:15 Companion Diagnostics: FDA's Current Thinking

      This presentation will provide an overview of FDA's current thinking on how "companion diagnostics" are defined, and introduce the regulatory requirements for them. Critical issues in understanding companion diagnostic validation and oversight will be discussed.

      Elizabeth Mansfield, Ph.D.
      Director, Personalized Medicine
      Office of In Vitro Diagnostics, Center for Devices and Radiological Health
      FDA

      3:50 End of Conference

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