Presenters
James C. Shehan, JD
Of Counsel, Hyman, Phelps & McNamara, PC, United States
Kay Holcombe, MS
Senior Vice President for Science Policy , Biotechnology Industry Organization (BIO) , United States
Wendy Selig, MS
Founder and Chief Executive Officer, WSCollaborative, United States
Selig is CEO of WSCollaborative, which focuses on establishing winning cross-sector collaborations. She spent 5 years as President & CEO of the Melanoma Research Alliance and 10 years at the American Cancer Society/ACSCAN. She served 12 years on Capitol Hill and has held leadership roles in multiple advocacy coalitions and the NCI DCLG. She is a Magna Cum Laude graduate of Princeton University and holds an MSJ from Northwestern University.
Art Gertel, MSc
President and Principal Consultant, MedSciCom, LLC, United States
Dr. Gertel has more than 40 years of experience in the pharmaceutical industry in virtually all phases of pharmaceutical drug research and development, from preclinical pathology/toxicology to registrational clinical trials, post-marketing trials, project management, and market support. He has been involved in the development of standards in reporting clinical trial data, publications, and protocol development. He leads seminars and panels on drug development and bioethics.
Richard Klein
Director, Expanded Access Programs & Policy, Former FDA, Patient Liaison, GE2P2 Global Foundation, United States
Richard Klein is the director of the FDA’s Patient Liaison Program in the Office of Health and Constituent Affairs, the primary interface between the agency and patient and patient advocate communities. The program interacts with outside communities and within the agency’s scientific & policy offices to facilitate patient engagement, and to address issues and concerns of patients. The program ensures that patient communities are represented in approval and policy decisions at FDA.
Christina Sandefur
Vice President for Policy, Goldwater Institute, United States
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