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Pharmaceutical companies face the need to adjust their strategies, starting from target identification and validation, through clinical trials, approval processes, and marketing, in order to fit into the new concept of personalized medicine. Successful collaboration with diagnostics partners has become a cornerstone in the efforts to bring tailored therapies the market. The Third annual Personalized Medicine conference will present solutions and case studies for successful implementation of personalized medicine principles throughout the entire process of bringing a safe and effective drug to the market.
RECOMMENDED PRE-CONFERENCE SHORT COURSES ON SEPTEMBER 6TH *
(SC1) Fit-for-Purpose Biomarker Assay Development and Validation
(SC3) Novel Cancer Biomarkers
*Separate registration required.
WEDNESDAY, SEPTEMBER 7
7:00 am Registration and Morning Coffee
8:00 Chairperson’s Opening Remarks
Joshua P. Cohen, Ph.D., Research Assistant Professor, Tufts Center for the Study of Drug Development
Keynote Presentation
8:10 A Model for Developing Companion Diagnostics in Pharma
Werner Verbiest, Head of the Companion Diagnostics Center of Excellence, Johnson & Johnson
The formation of a Companion Diagnostics Center of Excellence in the Janssen Pharmaceutical companies of Johnson & Johnson will be discussed. The important linkages that have been created with the therapeutic areas, the functional groups, and other stakeholders within J&J will be presented. In addition, the importance of connecting the product development, regulatory, partnering and commercial strategies will be highlighted. Lessons learned from case studies will be presented.
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8:40 Driving Personalized Medicine Approaches into the Clinical Drug Development Pipeline
Amelia Warner, Pharm.D., R.Ph., Head, Clinical Pharmacogenomics and Clinical Specimen Management; Director, Late Stage Development, Merck Research Laboratories
9:10 Translational Informatics in Personalized Medicine
Eric D. Perakslis, Ph.D., Vice President, Research & Development IT, Johnson & Johnson Pharmaceuticals Research and Development
Realizing the utility of personalized medicine has proven quite elusive. At J&J, we are taking a very integrated approach to population science and personalized medicine that incorporates the disparate aspects of epidemiology, statistics, companion diagnostics and targeted therapies.
9:40 Delivering High Quality of Pharmacogenomics Data to Clinical Studies
Lei Li, M.D., Ph.D., Head, Clinical Pharmacogenomics Laboratory, Pfizer
Quality control (QC) and quality assurance (QA) are not novel to medical diagnostics and clinical practice. However, it has been challenging when we apply QA/QC of translational biomarkers into clinical trials. How can we translate good scientific research results into clinical practice and generate high quality of data to support drug-diagnostic co-development? In this presentation, we will use Pharmacogenomic assays as examples to identify quality control issues in clinical research, to provide examples of technology challenges in clinical studies, and to review regulatory and professional QC/QA monitoring system and guidance.
Sponsored by
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10:10 Designing Smarter Trials to Support Personalized Medicine
Kevin Vogelsang, Business Development, Clinical Technologies Group, Tessella Inc.
Personalized medicine offers great potential to society but poses new challenges to drug development. Developing personalized medicines efficiently means trials must incorporate biomarkers and sub-populations into their analysis. With this added complexity.
10:25 Networking Coffee Break in the Exhibit Hall with Poster Viewing
10:50 The Impact of Personalized Medicine on Benefit-Risk Planning and Management
Michael Forstner, Ph.D., Integrated Safety Risk Manager, PDS, Roche
The increasing importance of personalized medicine is changing our view on the comparative benefit-risk profile of medicines. While the advantage of identifying patients who would benefit most from a given treatment is obvious, there is also the additional benefit of finding patients who would experience inappropriate levels of harm. The technologies used and the type of data produced require a thorough impact analysis to provide an overall positive benefit-risk profile for as many patients as possible. The co-development of therapeutics and diagnostics is creating new risk factors that have to be appropriately analyzed and managed in order to ensure the best level of protection to the patient, and ensure the viability of the drug.
11:20 Investing in Personalized Medicine: A Payer’s Perspective
Richard K. Schatzberg, President and CEO, Generation Health
Understand how genetic benefit management (GBM) helps healthcare payers manage the increasingly complex field of genetic testing. The presentation will review how to gain meaningful diagnostic insights and provide clinical and economic benefits to patients, healthcare providers, and payers including;
• Analyzing current utilization of genetic testing and approaches to optimizing plan design and medical coverage policies
• Selecting the most effective and efficient testing technologies from the broad array of marketed tests & labs
• Identifying patients for whom a genetic test will provide actionable information
• Working with healthcare providers and patients to facilitate genetic testing
• Delivering clinical decision support to healthcare providers so that they can act on a patient’s genetic information
• Improving billing and payment practices
11:50 Clinical and Economic Challenges Facing Pharmacogenomics
Joshua P. Cohen, Ph.D., Research Assistant Professor, Tufts Center for the Study of Drug Development
Pharmacogenomics explores the ways in which genetic variations can be used to predict whether an individual patient will benefit from a drug, have a bad response, or no response at all. Accordingly, therapies may be tailored to certain genetic characteristics of individual patients or subpopulations, drawing on data gathered from a variety of sources, including tests for biomarkers. In this talk, I will examine the clinical and economic challenges that face developers of and payers for personalized drugs and companion diagnostics. First, I will review and summarize clinical, regulatory, and reimbursement issues with respect to eight high profile personalized medicines and their companion diagnostics. Second, I will examine Medicare Parts B and D reimbursement of the eight drugs. Third, I will discuss survey data I elicited from three key stakeholders - payers, drug and diagnostic developers, and pharmacogenomic experts – on i) reimbursement of diagnostics; ii) the role that different kinds of evidence play in informing prescribing and reimbursement decisions, and iii) the specific clinical, regulatory, and economic challenges that confront pharmacogenomics as it moves forward.
Sponsored by
12:20 pm CCCDx: Commercial Considerations for Companion Diagnostics; Will all these Cs help us SEE the Future?
Pia Gargiulo, Ph.D., Senior Director, Companion Diagnostic Partnerships, QIAGEN
QIAGEN has demonstrated its capability in the area of CDx by creating collaborations with the pharmaceutical industry to engage and explore development paths to deliver the promise of personalized medicine. Despite the rapid increase in CDx partnerships in industry there are few good commercial examples. A successful launch must address several critical factors: timelines, labelling, adoption, reimbursement, education and advocacy. We will explore the next phase of collaborations and what is necessary to achieve success.
12:50 Luncheon Presentation (Sponsorship Opportunity Available)
or Lunch on Your Own
Keynote Presentation
1:55 The Crizotinib/ALK Companion Diagnostic Partnership
Stafford O’Kelly, President, Abbott Molecular
Hakan Sakul, Ph.D., Senior Director, Translational Oncology Group, Oncology Business Unit, Pfizer
In 2009, Pfizer selected Abbott Molecular to develop a companion diagnostic for its non small cell lung cancer (NSCLC) therapeutic crizotinib. The FDA subsequently agreed to fast-track the approval of crizotinib, meaning the companion diagnostic would also need to be approved, in this case many months ahead of the original date. Pfizer began a rolling submission of the NDA to the agency in December 2010 while Abbott Molecular submitted the first of 4 modules of the PMA also in December 2010. This is a joint presentation between Pfizer and Abbott Molecular and will cover the challenges and process that led to a successful combination product submission. In particular, it will offer insights to the U.S. regulatory process that can sometimes govern selection of a companion diagnostic partner and touches on reimbursement and commercial readiness topics as well.
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12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own
1:50 Chairperson’s Remarks
Brian T. Edmonds, Ph.D., Director, Global External Research & Development, Eli Lilly
2:55 A Fork in the Road for the Co-Development of Companion Diagnostics: Partnering or Acquisition?
Brian T. Edmonds, Ph.D., Director, Global External Research & Development, Eli Lilly
The use of diagnostic assays to determine the optimum therapeutic regimen for a patient population is not novel to clinical practice. However, what is transformative is the use of molecular tests to identify those patients who are likely to respond to specific therapeutics, or are at risk of adverse events. It is likely the demand for such data will only increase over time from major stakeholders in health care; i.e., payors, providers, regulatory and patients. Pharmaceutical companies who wish to develop companion diagnostic products in support of their drug portfolio, but do not have diagnostic subsidiaries, have three basic options: invest to build up an internal group, partner with, or acquire existing diagnostic companies. This presentation will address the pros and cons of each and discuss why a mix of the three may be the best formula.
3:25 Networking Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Delivering Personalized Healthcare Through Successful Partnerships
Cecilia Schott, Ph.D., Business Development Director, Personalized Healthcare, AstraZeneca
Personalized Healthcare aims to create superior patient outcomes through the use of healthcare tools and diagnostics, achieving “right treatment, right patient, right dose, right time.” Building strong and effective partnerships between pharmaceutical and diagnostic companies is key to advancing drug development. This presentation will provide an overview of business models of collaboration for the co-development of drug and diagnostic and looking at the opportunities and challenges of individual deals.
4:30 Panel Discussion: Drug-Diagnostics Co-Development: Challenges and Solutions
Moderator: Brian T. Edmonds, Ph.D., Director, Global External Research & Development, Eli Lilly
5:00 Interactive Breakout Discussion Groups
Topic: Pharmacogenomics as a Tool to Personalized Therapy
Moderator: Scott D. Patterson, Ph.D., Executive Director, Medical Sciences, Amgen
Topic: The Personalized Medicine Adjustments to Pharmaceutical Operations
Moderator: Amelia Warner, Pharm.D., R.Ph., Head, Clinical Pharmacogenomics and Clinical Specimen Management; Director, Late Stage Development, Merck Research Laboratories
Topic: Pharma-Diagnostics Relationship: Various Paths
Moderators:
Brian T. Edmonds, Ph.D., Director, Global External Research & Development, Eli Lilly
Cecilia Schott, Ph.D., Business Development Director, Personalized Healthcare, AstraZeneca
- The various options for a pharma to develop a companion diagnostic test
- The pros and cons of each
- Case studies
6:00-7:00 pm Welcome Reception in the Exhibit Hall with Poster Viewing
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