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consultations will feature advice on what to expect from the
regulatory review process and point participants to resources
for managing their particular challenges. Conversations will be
centered on where and how to interact with the FDA around various
points of interest (e.g. biomarker validation, data collection guidelines,
IND/NDA tracking, clinical trial protocols, communication with
industry). |
Mary Dwight - Vice President of Government
Affairs, Cystic Fibrosis Foundation
As vice president of government affairs for the Cystic Fibrosis (CF) Foundation, Mary Dwight directs the foundation’s public policy agenda and grassroots activities. She has been a catalyst for accelerating efforts to remove barriers to clinical drug development. Dwight also leads the strategic development of the foundation’s efforts to enable and expand access to CF care, integrating the organization’s public policy, advocacy, strategic communications, and medical research and care delivery programs. Prior to coming to the foundation, Dwight was a vice president at Spitfire Strategies where she crafted successful policy strategy for clients such as the David & Lucile Packard Foundation, Robert Wood Johnson Foundation, First Focus, and the Juvenile Diabetes Research Foundation. Dwight began her career with Representative Diana DeGette (D-CO), a member of the House Energy and Commerce Committee. Dwight graduated cum laude from Williams College.
Michael Werner - Partner,
Holland & Knight
Michael Werner has 26 years of healthcare law, lobbying, regulatory, and policy development experience in Washington. He advises biotechnology/pharmaceutical companies, research institutions, patient groups, and investors with a particular emphasis in regenerative medicine, personalized medicine/genetics, and matters pertaining to orphan drugs. His work with clients includes: FDA issues, obtaining federal funding, conflicts of interest analysis, physician payment "sunshine" rules, alliance development and patient registries, review of Material Transfer Agreements, and bioethics issues. Werner is the co-founder and executive director of the Alliance for Regenerative Medicine, an organization whose members are research institutions, life sciences companies, patient advocacy groups, and investors that advocate for federal policies to advance regenerative medicine research and product development. Before joining Holland & Knight, Werner was president of The Werner Group, a Washington, D.C.-based consulting firm. Prior to that, he was chief of policy for the Biotechnology Industry Organization. Werner is a founding member of the board of directors of the Coalition for the Advancement of Medical Research, an organization of more than 100 nationally-recognized patient and science organizations and universities. Werner is a heavily sought-after speaker for meetings and conferences, and the author of more than 50 published articles.
DISCLAIMER
The Expert Consultations at Partnering for Cures are informal sessions
intended to be informational in nature. The individuals serving in the role
of experts are providing their advice pro bono, and before acting upon any
such advice you should consult with your own experts or consultants who
are more familiar with your particular organizations. Neither the consultants
nor the sponsors of Partnering for Cures shall be liable in any manner with
respect to the outcomes or consequences that may result from any actions
taken based upon the guidance offered in these sessions. |
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Terms
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