2014 Archived Content

Cambridge Healthtech Institute’s Fifth Annual

Personalized Diagnostics

Best Practices for Clinical Implementation

February 10-12, 2014 | Moscone North Convention Center | San Francisco, CA  


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Tuesday, February 11 

7:00 am Registration and Morning Coffee 

8:00 Plenary Keynote Session (Click Here For More Details) 


9:15 Refreshment Break in the Exhibit Hall with Poster Viewing


10:25 REGULATORY PANEL DISCUSSION: Late-Breaking News from the FDA that Impacts in vitro Diagnostic Tests

Moderator:Thomas F. Soriano, President & CEO, DOCRO, Inc.

This session will feature guest speakers from the FDA and industry who will discuss late-breaking news related to companion diagnostics (CDx), next-generation sequencing, (NGS), laboratory-developed tests (LDTs), including guidance documents. Coordination of the pharmaceutical and diagnostic components for approval will be discussed - questions having to do with the process for approval of drugs that require a CDx, what to do with the various data, and how to anticipate requirements during the clinical stages of development will be discussed.

Guest Speaker via Webex: Alberto Gutierrez, Ph.D., Director, Office of in Vitro Diagnostics (OIR), FDA

Richard Naples, Senior Vice President, Worldwide Corporate Regulatory Affairs, Becton-Dickinson

Michael Page, Ph.D., Senior Director, Oncology, Global Regulatory Affairs, Eisai, Inc.

Daniel J. O'Shannessy, Ph.D., Senior Director, Translational Medicine & Diagnostics, Morphotek

Joseph V. Ferrara, President, Boston Healthcare

12:00 pm Optimizing Evidence Development and Communication to Support Market Access for Molecular Diagnostics

Joseph V. Ferrara, President, Boston Healthcare

Learn how the landscape for molecular diagnostics is evolving in terms of market access pathways and clinical evidence requirements. Attendees will gain an understanding of the challenges of aligning evidence development programs to support clinical positioning, market adoption, and payer reimbursement and funding. Best practices for collaborations between clinical development and commercialization strategy teams will be reviewed and highlighted, as well as key elements of successful transitions from clinical development to commercialization and payer engagement.

12:30 pm Session Break

12:40 Luncheon Presentation I: Personalized Patient Therapy with Pharmacogenetics

Stuart A. Scott, Ph.D., Assistant Professor, Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai


1:10 Luncheon Presentation II: Washington Legal Update – Strategies for Navigating Key Reimbursement and FDA Issues for Diagnostics

Torrey Cope, J.D., Partner, FDA Regulatory, Sidley Austin LLP

Barbara Cammarata, J.D., M.P.H., Counsel, Health Care Regulatory/Reimbursement, Sidley Austin LLP

Dora L Hughes, M.D., M.P.H., Senior Policy Advisor, Government Strategies, Sidley Austin LLP

This session will feature an FDA lawyer, a health care reimbursement/CLIA/fraud and abuse lawyer, and a government strategies expert who will discuss some of the key legal and policy issues facing diagnostics companies in the current regulatory environment.  The panel will explain practical strategies companies may employ to address legal challenges related to commercializing and marketing their products under FDA and health care requirements, as well as strategies to obtain appropriate reimbursement and to comply with government and private payor reimbursement requirements.  It will also cover the industry’s role in developing law and policy to address the unique challenges in the emerging areas of in vitro diagnostics, companion diagnostics, molecular pathology and next generation sequencing.

1:40 Refreshment Break in the Exhibit Hall with Poster Viewing

2:15 STRATEGIC PANEL DISCUSSION: Recent Companion Diagnostic Drug Approvals

Moderator: Hakan Sakul, Ph.D., Executive Director and Head, Diagnostics, Worldwide R&D, Development Operations, Pfizer, Inc.

Overview on diagnostic commercialization, reading market forces and what it takes to make a success.

Ron Mazumder, Ph.D., MBA, Global Head, Research & Product Development, Janssen/J&J

Peter Collins, Ph.D., Vice President & Head, Diagnostics, GlaxoSmithKline

Jeremy Bridge-Cook, Ph.D., Senior Vice President, Research & Development, Luminex

Eric Lai, Ph.D., Senior Vice President & Head, Pharmacogenomics, Takeda Pharmaceuticals

Gregory Zdechlik, COO, Eli Lilly & Co.

3:50 Sponsored Presentations (Opportunities Available)  

4:20 Valentine's Day Celebration in the Exhibit Hall with Poster Viewing

5:20 Breakout Discussions in the Exhibit Hall

These interactive discussion groups are open to all attendees, speakers, sponsors, & exhibitors. Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

The Future of Prenatal Genomic Testing

Christopher Robinson, M.D., MSCR, Associate Professor, Maternal Fetal Medicine, Obstetrics and Gynecology, University of Virginia

  • Transitioning from high risk patients to global screening with NIPT
  • Is there potential for NIPT to achieve diagnostic capability in prenatal testing?
  • Cost effectiveness and outcomes following implementation of NIPT

Extracting Biological Information from WGS/WES

German Pihan, M.D., Director, Hematopathology Lab, Pathology, Beth Israel Deaconess Medical Center & Harvard Medical School

  • Searching for pearls in rough seas: Finding cancer genome sequence variants with predictable clinical impact.
  • Imagining cancer biology: In silico prediction and modelling of the biological impact of cancer genome variants.
  • Quo vadis cancer genome: What's next in the analysis of cancer genomes?

6:30 Close of Day 

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