2014 Archived Content
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Tuesday, February 11
7:00 am Registration and Morning Coffee
9:15 Refreshment Break in the Exhibit Hall with Poster Viewing
10:15 A Few Crisp Comments by a Former FDA Leader on the Current Need for More FDA Reform Similar to What We Did Before
John A. Norris, J.D., MBA, Chairman, Norris Capital, Inc. and FDDH, Inc.; Senior US Advisor to Kanagawa, Japan, Governor Kuroiwa and GCC; Former 2nd-in-Command of the US FDA
This presentation discusses the efforts of the Global Collaborative Center (GCC) in helping to reform the U.S. FDA’S review methods and standards relating to diagnostics and other medical solutions like drugs and devices.
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
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
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.
4:20 Late Breaking Presentation
4:35 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.
Real World Coverage and Reimbursement: Implications for Molecular Testing
William McGivney, Ph.D., Principal, McGivney Global Advisors LLC
- Coverage hurdles to the introduction, use, and payment for molecular tests
- Inside the coverage processes and considerations of public and private payers
- Impact of guidelines, pathways, electronic decision-assist tools, etc.
- The setting of reimbursement levels in an environment of change in payment methodologies
Taking the Cardiac Biomarker ST2 from Discovery to Clinical Adoption
James V. Snider, Ph.D., President, Critical Diagnostics
- Defining clinical utility for a novel test
- Developing and IVD test and technology options
- Regulatory, coding and reimbursement
How Do Diagnostic Providers Demonstrate Clinical Utility and Cost-Effectiveness?
Harry Glorikian, Managing Director, Strategy, Precision for Medicine
- How did you identify the clinical need you are aiming to address?
- Who is your customer and how will you demonstrate clinical utility to justify this additional step?
- How will you demonstrate cost-effectiveness to justify this additional cost?
- How will you drive adoption and reach your customer base?
Big Data's Big Role in Understanding Complex Diseases
Andreas Kogelnik, M.D., Ph.D., Founder and Director, Open Medicine Institute
- High performance platform for integrating molecular/genomic and clinical data
- Applying science and medicine to crowd-sourced data
- Enabling longitudinal outcomes studies with genomics and informatics
6:30 Close of Day
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