Session Synopsis: Firms that develop companion diagnostics face numerous challenges. Among them are attracting a pharma partner, FDA procedures and regulations, reimbursement and engaging labs to run their tests. This panel will discuss those challenges as well as the incentives for developing and selling companion diagnostics.
Session Chair Profile
Editor in Chief, GenomeWeb
Edward Winnick is the Editor in Chief of GenomeWeb, an independent online news organization focused on the genomics research industry and the translation of that research into clinical practice. He has been at GenomeWeb for the past 12 years, serving as a reporter and editor covering the business, regulatory, and policy issues affecting the genomics research and genetic testing industries. He assumed the role of Editor in Chief in March 2013 after running GenomeWeb’s Daily News operations for several years, and now also oversees 360Dx, GenomeWeb’s recently launched diagnostics-focused news site. Prior to joining GenomeWeb, Ed was executive editor of the Reuters Health Industry Briefing, where he led Reuters Health’s coverage of the pharmaceutical, biotech, and healthcare industries. He began his journalism career in 1991 at Windhover Information, covering the diagnostics and managed care industries.
VP, Regulatory, Clinical and Medical Affairs, Illumina
Mya has extensive experience in gaining regulatory approvals for novel IVDs in the United States and Europe. This work has included PMAs, 510(k)s and de novo 510(k)s in the United States for both kit and lab-based products. In the European Union, Mya has experience with working with Notified Bodies and Competent Authorities on List A, List B and self-certified products. Certified by the Regulatory Affairs Professional Society (RAPS) since 1994, Mya also received the FDA Commissioner’s Special Citation in 2009 as a member of the rRt-PCR Flu Panel Team for exceptional performance and dedication in addressing complex regulatory and scientific issues in the clearance of a CDC test to diagnose human influenza infection.
J.D., CEO & Founder, Goldbug Strategies LLC
Sheila D. Walcoff, J.D., provides strategic advisory counsel to companies and investors engaged in diagnostics, digital health technologies, life sciences, and precision medicine. She is the CEO of Goldbug Strategies LLC, a professional services company providing strategic FDA regulatory and reimbursement consulting and analysis related to LDTs, in vitro diagnostics, companion diagnostics, targeted therapeutics, quality systems, compliance, NGS platforms, CDS software, and other cloud-based digital precision medicine tools. Previously, Ms. Walcoff was Associate Commissioner at the FDA, a senior science and public health official in the immediate office of the Secretary at HHS, partner in a large international law firm, and majority counsel to a congressional committee.
VP, Director PharmaDx Program, ARUP Laboratories Adjunct Associate Professor of Pathology, University of Utah School of Medicine
Dr. Heichman’s role involves both developing and managing scientific and business collaborations, with a special emphasis on those involving the pharmaceutical industry. Dr. Heichman led the team that developed and received FDA approval for ARUP’s two companion diagnostic tests in support of Novartis’ Gleevec rare diseases program. She has >25 years of scientific experience in both corporate and academic institutions. Prior to ARUP, she spent several years at Myriad Genetics where she was the VP of Proteomic Research and three years at the Huntsman Cancer Institute as the Director of Cancer Systems Biology and Resources. Dr. Heichman holds an AB in genetics from UC Berkeley, a PhD in Biological Chemistry from UCLA School of Medicine and conducted postdoctoral training from the Fred Hutchinson Cancer Research Center.