CHI's Regulatory Compliance in Drug-Diagnostics Co-Development Conference, August 21-22, 2012, DC

This conference is part of the Next Generation Dx Summit: Moving Assays to the Clinic (August 21-23).
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Drug Approval
Diagnostics Approval
In Vitro Diagnostics


Needham - Massachusetts - US

May 14, 2012 - PRLog -- Cambridge Healthtech Institute (CHI) will host its inaugural Regulatory Compliance in Drug-Diagnostics Co-Development conference on August 21-22, 2012 at the Hyatt Regency Washington on Capitol Hill, Washington, DC. This conference is part of CHI’s Next Generation Dx Summit: Moving Assays to the Clinic. This conference is designed to help all parties involved in the process of drug-diagnostics co-development to learn how to navigate the regulatory reefs and bring their product to the market in the most effective and timely manner. The speakers include regulatory teams that brought to life Xalkori/ALK test approvals (Pfizer and Abbott) and Zelboraf/BRAF test approvals (Genentech and Roche Molecular), FDA experts, European experts, representatives from J&J, LabCorp, Illumina, ARUP, etc.

- Case Studies of Recent Combined Drug and Diagnostic Approvals
- Working with Regulators
- New Paradigms in Regulatory Approaches

Plenary Keynote Session:
Regulation of LDTs and RUOs

Alberto Gutierrez, Ph.D., Deputy Director, Office of in vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration
Moderated by: Franklin R. Cockerill, III, M.D., Ann and Leo Markin Professor of Microbiology & Medicine; Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine; President and CEO, Mayo Medical Laboratories and Mayo Collaborative Services, Inc.

Plenary Keynote:
Position of IVDs on Regulatory Issues

Alan Mertz, President, American Clinical Laboratory Association (ACLA)

Diagnostic Manufacturers: Key Regulatory Issues
Andrew C. Fish, Executive Director, AdvaMedDx

Distinguished Speaker Faculty:

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

Melina Cimler, Vice President, Quality & Regulatory Affairs, Illumina, Inc.

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

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

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

Alberto Gutierrez, Ph.D., Office of in vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration

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

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

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

Gene Pennello, Ph.D., Team Leader and Mathematical Statistician, Division of Biostatistics, OSB, FDA

Debra Rasmussen, RAC, MBA, Senior Director, Regulatory Affairs, Johnson & Johnson
Janet Jenkins-Showalker, Director, Regulatory Affairs, FDA Liason, F. Hoffman- La Roche

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

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

As part of the Next Generation Dx Summit (Enabling Point-of-Care Diagnostics, Emerging Molecular Markers of Cancer, Molecular Diagnostics for Infectious Disease, Companion Diagnostics, Commercialization of Molecular Diagnostics, Mass Spec for the Clinic), this event will bring together all of the major players in the evolving areas of diagnostics.

Those that register by June 1 will save up to $350.

To register and view the full agenda, visit

To inquire about sponsorship/exhibit opportunities, contact Joseph Vacca at 781-972-5431,

Writers and editors are invited to attend.  To request a press pass, email

About Cambridge Healthtech Institute (

CHI is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Cambridge Marketing Consultants, Barnett Educational Services, Cambridge Meeting Planners and CHI’s Media Group, which includes news websites and e-newsletters including Bio-IT World and eCliniqua. Founded in 1992, CHI strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments.


James Prudhomme
Cambridge Healthtech Institute
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Tags:Drug/diagnostics, Regulatory, Fda, Xalkori, Zelboraf, Drug Approval, Diagnostics Approval, In Vitro Diagnostics
Industry:Biotech, Science, Medical
Location:Needham - Massachusetts - United States
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