MedCity Influencers

Address FDA guidance on targeted therapies and companion diagnostics

The DIA 2013 49th Annual Meeting, to be held in Boston, Mass., from June 23-27, is the largest life sciences meeting in North America. Among the 250+ educational offerings across 22 tracks will be a session titled “Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges” within the Medical Devices, In Vitro Diagnostics, and Combination Products track.

This post is sponsored by DIA.

The FDA released a draft guidance in July 2011 that outlined requirements and recommendations for developing targeted therapies and companion diagnostics, but it left many questions unanswered. The DIA 2013 49th Annual Meeting will give attendees the opportunity to discuss potential approaches to address these remaining queries.

The DIA 2013 49th Annual Meeting, to be held in Boston, Mass., from June 23-27, is the largest life sciences meeting in North America. Among the 250+ educational offerings across 22 tracks will be a session titled “Co-development of Targeted Therapies and Companion Diagnostics: Identifying Regulatory Strategies to Overcome Challenges” within the Medical Devices, In Vitro Diagnostics, and Combination Products track.

Attendees in the session will identify a regulatory development strategy for diagnostically selected populations; learn to recognize approaches to defining the diagnostically selected population; and formulate strategies for multi-marker diagnostic development.

The session, to be held on June 25 from 1:45 – 3:15 p.m., will be chaired by Janet Jenkins-Showalter, Director, Regulatory Policy, Strategy and Intelligence, Genentech, A Member of the Roche Group. The panel will include Jeff Allen, PhD, Executive Director, Friends of Cancer Research; Erling Thor Donnelly, PhD, RAC, Manager, Worldwide Regulatory Strategy, Pfizer Inc; and Shayesteh Fuerst-Ladani, MBA, MS, Director, SFL Regulatory Affairs & Scientific Communication.

The DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science is the largest multidisciplinary event that brings together a global community of professionals at all levels and across all disciplines in the discovery, development, and life cycle management of medical products, all with a common goal to foster innovation that will lead to the development of safe and effective medical products and therapies for patients.

Returning to Boston, one of the strongest life sciences regions in the United States, this year’s event will feature 250+ educational offerings over 22 tracks on hot topics from key thought leaders from the life sciences industry.

The DIA Annual Meeting provides attendees with a valuable opportunity to meet professionals from around the world, share knowledge and experience, network, and build new relationships.

For more information about the DIA 2013 49th Annual Meeting visit www.diahome.org/DIA2013.

Register by May 17 to reserve your spot on the Advance Attendee List.

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