Panel Title: Impact of Next Generation/Whole-Genome Sequencing on Companion Diagnostics

Location: Biomarker World Congress, Philadelphia, PA

Date: May 3, 2011, 11:45AM – 12:30PM

Co-Sponsor: NGS Leaders Community

Members (invited):

  • Richard Resnick, CEO, GenomeQuest (moderator)
  • Dr. Rick Wilson*, Professor and Director, The Genome Center at Washington University School of Medicine
  • Dr. Dom Spinella, Executive Director Translational Medicine, Pfizer
  • Dr. Michael Nohaile, Global Head, Novartis Molecular Diagnostics
  • Dr. Glenn Miller, Vice President and Head of Personalized Healthcare & Biomarker Strategy, Portfolio & Alliances, AstraZeneca
  • Colin Hill, CEO, Via Science

Background:

“I strongly advise pharma biomarkers groups to begin investing in whole-genome technology now, as the respective cost curves of whole versus partial methodologies will likely cross even before their new diagnostics products hit the market.”

- Dr. Mark Boguski, BIDMC, Harvard Medical School

“Whole-genome sequencing circumvents the limitations of conventional candidate gene testing by providing an unbiased survey of the genome and the ability to detect structural variants that are often missed with conventional assays.”

- JAMA, April 20, 2011, Preliminary Communication

“Perhaps the best hope for short-term impact of NGS data lies in the capacity to discriminate drug-responsive patients from nonresponders… this task should be comparatively easy because we don’t necessarily need to unravel causation; association may be sufficient.”

- Dr. Alexander Kamb, Executive Director Oncology, Amgen, Bio-IT World

Questions:

  • Will WGS-CDx be a practical/high ROI genomics investment for pharma and why/not?
  • Can WGS-CDx be transformational in drug rescue and how?
  • How will WGS-CDx affect the design/operation of clinical trials?
  • What practical steps/investments should pharma be making in this area?
  • What advances/benefits of WGS are creating these opportunities?
  • How will this affect the strategies of diagnostic companies and research labs?
  • Which therapeutic areas offer the most promise in the near-term?

* To share published study (JAMA, April 2011) with objective: “to determine whether whole genome sequencing can identify cryptic, actionable mutations in a clinically relevant time frame.” See: http://jama.ama-assn.org/content/305/15/1577.short.