2013 Archived Content
Global Strategies for
November 4-5, 2013 | Boston Marriott Cambridge | Cambridge, MA
Cambridge Healthtech Institute’s Inaugural Global Strategies for Companion Diagnostics meeting will explore the strategies and decision making involved in developing companion diagnostics on a global scale, including international regulatory, reimbursement, and commercialization strategies, managing global drug-diagnostic co-development partnerships, and addressing technological and clinical companion diagnostic development from exploratory biomarkers alongside therapeutic development.
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Monday, November 4
7:30 am Conference Registration and Morning Coffee
8:30-8:40 Welcome Remarks from Conference Director
8:40-8:45 Chairperson’s Opening Remarks
8:45-9:10 The National Biomarker Development Alliance: An Incubator for Standards-Based Best Practices with an End-to-End Approach
Carolyn Compton, M.D., Ph.D., Professor, School of Life Sciences, Arizona State University
9:10-9:35 Presentation to be Announced
9:35-10:05 Overview of Novel Strategies to Improve Drug Discovery and Development in the Era of Precision Medicine
Harry Glorikian, Managing Director, Precision for Medicine
This talk will review current efforts and approaches within industry to streamline drug development and discovery – including target selection, validation, clinical trial patient selection and monitoring.
10:05-10:45 Coffee Break
10:45-11:10 Global Regulations and Their Impact on Genetic Data/Testing
Amelia Warner, Ph.D., President, Gentris Corp.
Global regulations for human specimen testing, specifically genetic sample testing and data usage, are rapidly changing. Specimens collected for assay development or diagnostic development have additional requirements for consent and management. There is a growing conflict between the goals of medical research and provisions for protections for patient privacy. This talk will focus on the balance of protection of subjects while advancing the goals of biomedical research for the benefit of patients now and in the future.
11:10-11:40 Meeting the Clinical Utility Needs of Regulators and Payers for Diagnostics
David Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine
Judi Smith, Vice President, in vitro Diagnostics & Quality, Precision for Medicine
Increasingly payers and the FDA are requesting clinical utility evidence as part of their approval or acceptance processes for both CDx and IVDs. Precision will explore the implications for clinical utility evidence development including the type of diagnostic test, regulatory status of the test, inclusion into the associated therapy’s label and how it will be used to guide decision making. We will take a deeper dive into considerations to for account as you plan your study – ensuring proper integration of regulatory and payer needs and ultimately, how the design will meet those needs and how it can affect the ROI on evidence development.
11:40-12:05 pm Forthcoming and Current EU Regulations Surrounding Companion Diagnostics
Sylvie le Gledic, Director, Personalized Medicine, Voisin Consulting
It is generally recognized that the current European In Vitro Diagnostic (IVD) Directive presents a certain number of weaknesses, and more particularly an inadequate classification system (based on positive lists) that leads to an insufficient level of scrutiny for many medium- to high-risk IVD tests. On September 26, 2012, the European Commission released the first draft of the new EU regulation for in vitro diagnostic medical devices. Companion diagnostics (CDx) will be classified as high-risk devices and specific requirements will be added to get these products CE marked. This presentation will describe the anticipated additional requirements that will apply to CDx and the practical implications for IVD and drug developers.
12:05 -1:30 Enjoy Lunch on Your Own
1:30-1:35 Chairperson’s Opening Remarks
1:35-2:00 Leveraging Partnerships to Deliver Precision Medicine
Morten Sogaard, Ph.D., Executive Director and Head, Biotechnology and Precision Medicine, External R&D Innovation, Worldwide R&D, Pfizer
Healthcare and pharmaceutical R&D today is expensive, reactive and often ineffective. We need to more precisely measure disease progression and treatment outcomes in patients to increase therapeutic index by treating only those patients likely to respond, or excluding those most likely to experience side effects. This talk will give examples of how precision medicine is applied in Pfizer R&D projects leveraging diagnostics, genetics and real-world data with a particular emphasis on innovative partnerships.
2:00-2:25 From Policy to Process: FDA Expedited Programs and Precision Medicine
Federico Goodsaid, Ph.D., Vice President, Strategic Regulatory Intelligence, Vertex Pharmaceuticals
PDUFA V and FDASIA legislation in 2012 required the FDA to issue a guidance document on expedited programs. The draft for this document, issued shortly after the Final Rule on Orphan Drugs, discusses fast track designations, breakthrough therapy designations, accelerated approval and priority review designations. Some questions about these programs are addressed by these two documents, such as the similarities and differences between fast track and breakthrough therapy designations. Other questions about surrogates in accelerated approvals remain open. The impact of this document on the development of therapies in precision medicine will be the subject of this talk, with a focus on the impact for the development of rare disease therapies.
2:25-2:50 Use of Biomarkers towards Understanding and Implementing Personalized Medicine in the Rare Disease Setting
Chetan Lathia, Ph.D., Executive Director, Clinical Pharmacology, Alexion Pharmaceuticals
2:50-3:50 Refreshment Break in the Exhibit Hall with Poster Viewing
3:50-3:55 Chairperson’s Opening Remarks
3:55-4:20 Personalized Medicine and Shrinking Patient Populations: Rethinking the Value of Companion Diagnostics
Alan T. Wright, M.D., MPH, CMO, Roche Diagnostics Corporation
Despite the critical role diagnostic tests play in personalized medicine, they are significantly undervalued, and the disparity that exists between current investment models and reimbursement policies for diagnostics is not tenable long-term. As science helps define the uniqueness of each person’s condition, the potential volume for specific tests will be less. To maintain investment from the private sector in diagnostics—which contributes significantly to medical innovation and helps demonstrate the clinical utility of FDA-approved tests—a more attractive path to market is needed.
4:20-5:00 Panel Discussion: Making Precision Medicine More "Precise"
Panelists to be Announced
5:00-6:00 Welcome Reception in the Exhibit Hall with Poster Viewing
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