Next Generation Dx Summit

Regulatory Compliance in Drug Diagnostic Co Development 

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TUESDAY, AUGUST 21

7:30 am Registration and Morning Coffee

 

Case Studies of Recent Combined Drug and Diagnostic Approvals 

8:30 Chairperson’s Opening RemarksErling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, Pfizer, Inc. 

8:40 XALKORI & ALK FISH Test Approval: Pharmaceutical Perspective

Erling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, Pfizer, Inc.

The simultaneous submission and approval of Pfizer’s XALKORI (crizotinib) and Abbott Molecular’s ALK break-apart FISH companion diagnostic in 2011 presented unique clinical development and regulatory challenges, requiring novel approaches as well as close collaboration between Pfizer, Abbott, CDER, and CDRH. XALKORI was approved only five years after entering clinical trials on the strength of its clinical data in ALK-positive NSCLC patients and unique regulatory strategy.

9:10 XALKORI & ALK FISH Test Approval: Diagnostics Perspective

Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc.

The simultaneous submission and approval of Pfizer’s XALKORI (crizotinib) and Abbott Molecular’s ALK break-apart FISH companion diagnostic in 2011 presented unique clinical development and regulatory challenges, requiring novel approaches as well as close collaboration between Pfizer, Abbott, CDER, and CDRH. The Abbott Molecular ALK Break Apart FISH test development timeline was accelerated from three years to two years and FDA approval was achieved in just five months.

9:40 Paving the Way for Contemporaneous Diagnostic Co-Development and Health Authority Review: The Zelboraf Story

Linda Burdette, Ph.D., Director, Drug Regulatory Affairs, F. Hoffmann-La Roche, Inc.

Co-development of the BRAF-targeted therapy, ZELBORAF™ (vemurafenib) with its companion diagnostic, the cobas® 4800 BRAF V600 Mutation Test highlights aspects of the regulatory pathway described in FDA’s 2011 draft guidance, In Vitro Companion Diagnostic Devices, and the resulting accelerated process for contemporaneous approval of a drug and companion diagnostic test. The ZELBORAF story also demonstrates the need for an integrated global regulatory strategy for marketing approval in a targeted population.

10:10 Coffee Break

11:00 Paving the Way for Contemporaneous Diagnostic Co-Development and Health Authority Review: The Cobas 4800 Braf Mutation Test Story

Lesley Farrington, Senior Manager, Regulatory Affairs, Roche Molecular System

An overview of the regulatory interactions and lessons learned on the road to contemporaneous review and approval of the companion diagnostic, cobas® 4800 BRAF V600 Mutation Test, with the selective BRAF inhibitor, ZELBORAFTM (vemurafenib) for the treatment of unresectable or metastatic melanoma with the BRAF V600E mutation. The accelerated Dx/Rx approval also demonstrates the ability to accelerate diagnostic development and registration timelines in coordination with drug development programs, while maintaining compliance and quality.

11:30 PANEL DISCUSSION: What’s Past is Prologue: A Regulatory Perspective on Contemporaneous Diagnostic Co-Development

Moderator: Janet Jenkins-Showalter, Senior Director, Regulatory Group, Intelligence and Policy, US Pharamceutical Development Regulatory, Genentech - A Member of the Roche Group

 

A Panel of Experts will discuss:

  • Lessons learned from contemporaneous diagnostic co-development successes
  • The current and future regulatory environment
  • How the most recent “poster-child” success stories, along with the regulatory environment and interested stakeholders, will shape the future of personalized medicine.

Panelists:

Erling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, Pfizer, Inc.

Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc.

Linda Burdette, Ph.D., Director, Drug Regulatory Affairs, F. Hoffmann- La Roche, Inc.

Lesley Farrington, Senior Manager, Regulatory Affairs, Roche Molecular System

Jeff Allen, Ph.D., Executive Director, Friends of Cancer Research

 

12:30 Enjoy Lunch on Your Own 

 

Working With Regulators 

1:45 Chairperson’s RemarksMaham Ansari, M.S.,Senior Associate, Regulatory Affairs. US Strategic Regulatory Services, OptumInsight
 

1:50 FDA Draft Guidances: Overview, Key Messages and Impact

Debra Rasmussen, RAC, MBA, Senior Director, Regulatory Affairs, Johnson & Johnson

2:20 Demystifying Bridging Studies

Marina V. Kondratovich, Ph.D., Associate Director for Clinical Studies, Personalized Medicine, OIVD, CDRH, U.S. Food and Drug Administration

In a “bridging study”, clinical samples tested initially with a clinical trial assay (CTA) are re-tested with a market ready assay (MRA) to support approval/clearance of the MRA. We discuss why high levels are required for positive and negative agreement of MRA with CTA and various challenges with such studies (e.g., unavailable samples, missing re-test results, impact of discordance between the two assays on drug efficacy).

2:50 Q&A with Speakers

Laboratories' Perspective 

3:20 FDA Approved Laboratory IVD Assays as Companion Diagnostics: A New Paradigm?

C. Donald Kafader II, Director, Regulatory Affairs, Esoterix Clinical Trials Services, a Division of LabCorp

IVD manufacturers have little incentive to seek and obtain FDA approval for some assays unless there is a substantial potential market for them to sell into. An alternative exists where centralized testing can support the need for a companion diagnostic assay. Laboratories are seeking FDA approvals for assays run only within their facilities. This new paradigm brings new concerns to the diagnostic laboratory and to the FDA.

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing

4:10 Laboratory Developed Tests and Their Place in the Genomic Medicine Era: A CLIA Laboratory Perspective on Companion Dagnostics

Elaine Lyon, Ph.D., Medical Director, Genetics Division; Co-Medical Director, Pharmacogenomics; Co-Director, Clinical Molecular Genetics Fellowship Program, ARUP Laboratories

Clinical laboratories may develop and validate their own methods following CLIA regulatory requirements as laboratory-developed tests (LDT). They may also validate FDA-cleared products for an off-label use (such as additional sample types) as LDTs. This presentation will discuss factors CLIA-certified laboratories consider in deciding to use an FDA-cleared IVD, an off-label use or an in-lab developed assay. The role of LDTs and clinical validations is put into an historical, as well as a near-future genomic medicine, perspective

4:40 CLIA, CAP, GCLP and the FDA: Clinically Certified Lab Processes Enable New Approaches to Therapeutic Compound and Companion Diagnostic Development.

Tera Eerkes, Ph.D., CSO, iGenix, Inc.

High-throughput genotyping, massively parallel sequencing (NGS) and other high-complexity techniques have made it possible to design clinical trials to maximize compound efficacy, minimize toxicity, and pre-segregate patient populations. However, there is a dearth of specific guidance on how these new data and techniques should be incorporated and utilized for FDA submissions. This talk will explore joining these revolutionary techniques and data with existing “best-in-class” regulatory certification processes, as well as future regulatory guides, to maximize successful FDA application potential.

5:10 Wine and Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing

6:10 Close of Day



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