New York Academy of Sciences Conference to Explore Biomarker-Based Personalized Medicine

April 21, 2014, NEW YORK - On April 28 - 29 the Companion Diagnostics: From Biomarker Identification to Market Entry conference will explore the recent growth in complex biological data, which has enabled a paradigm shift in healthcare away from "one-size-fits-all" approaches towards customized, patient-tailored therapies.

Biomarker-based companion diagnostics (CDx), designed to identify responsive patient sub-populations or those likely to experience adverse drug effects, lie at the heart of this personalized, precision medicine movement. The conference will provide a neutral forum for international scientists and clinicians from academia, industry, and government-as well as healthcare policy makers, regulatory experts, and insurance sector representatives-to discuss strategies that will facilitate CDx development and integration into clinical care. Strategies, and challenges, will be discussed from research, financial, and regulatory points of view.

"There is tremendous (and fully justified) excitement surrounding the growing use of next generation DNA sequencing technologies in clinical practice, but the academic community is not prepared for the tsunami of data that will ensue. Medical institutions and their patients will need to share genomic and clinical data at unprecedented levels to make sense of the findings and realize the benefits of precision medicine," says keynote panelist Charles Sawyers, MD, Chair, Human Oncology and Pathogenesis Program; Marie-Josee and Henry R. Kravis Chair, Memorial Sloan-Kettering Cancer Center.

Presentations will illustrate successes and failures based on case studies; evaluate emerging applications of technologies such as epigenetics, bioinformatics, and nanotechnology; analyze diverse therapeutic target areas beyond cancer including inflammatory, infectious, cardiovascular, metabolic, and neurodegenerative diseases; and recognize regulatory hurdles.

"FDA has a policy that requires the co-approval of a diagnostic with a therapeutic product when the diagnostic is essential to the safe and effective use of the therapeutic product. FDA has been working on a number of processes to manage this co-development model. To date, the policy has been working well for 'one drug, one test' co-approvals," says keynote panelist Reena Philip, PhD, Director, Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA.

"With the rapid development of new diagnostic technologies, FDA understands that this approach may not apply to all development programs and are committed to science-based approaches that bring the greatest benefit to patients," Philip adds, underscoring the need for multi-sector exploration and discussion of emerging technologies.

"There are many favorable environmental forces driving the field of precision medicine forward, however the challenge of turning this positive momentum into tangible opportunity for pharmaceutical and diagnostics players remains," says keynote panelist Mikael Dolsten, MD, PhD, President, Worldwide Research & Development, Pfizer Inc. "Meaningful partnerships resulting in pharmaceutical and diagnostic co-development can enable the development of novel drugs more precisely targeted at the biologic underpinnings of disease. Therapies resulting from a precision medicine approach have the potential to meaningfully improve the lives of the patients we seek to treat by enabling optimal treatment and positive clinical outcomes."

Additional keynote panelists Elaine Collier, MD, National Center for Advancing Translational Sciences / NIH, and Michael Kolodziej, MD, FACP, Aetna, will speak about promoting personalized medicine through policy strategies and the insurer's perspective on integrating CDx in the healthcare setting, respectively.

For a full conference agenda, including a list of speakers and panelists, visit www.nyas.org/CDx2014. For media inquiries, including press pass requests, contact Diana Friedman (dfriedman@nyas.org; 212-298-8645). 

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The New York Academy of Sciences

The New York Academy of Sciences is an independent, not-for-profit organization that since 1817 has been committed to advancing science, technology, and society worldwide. With 22,000 members around the world, the Academy is creating a global community of science for the benefit of humanity. The Academy's core mission is to advance scientific knowledge, positively impact the major global challenges of society with science-based solutions, and increase the number of scientifically informed individuals in society at large. Please visit us online at www.nyas.org.