#266: Perspectives on Expanded Access to Investigational New Drugs
Chair
Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
Dr. Bugin is an experienced pharmaceutical professional who has made significant contributions to drug development and regulatory science. He currently serves as the Deputy Director of Operations ,in this role, he plays a key leadership role in the evaluation of new drugs and ensures...
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Speakers
Vice President, Pfizer Inc
Anne Cropp has led the strategic planning and clinical development of several compounds in Cardiovascular and Metabolic diseases, Phases 2-4. Anne has led many business process improvements and has led several initiatives across the spectrum of clinical trial planning, design and...
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President, Marti Nelson Cancer Foundation
Robert L. Erwin is co-founder and President of the Marti Nelson Cancer Foundation, a cancer patient advocacy organization with a focus on access to experimental medicine. He has served as a member of the Cancer Policy Forum of the Institute of Medicine, a member of the Research Committee...
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Senior Medical Advisor, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology...
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Managing Partner, Salutramed Group, LLC
Mr. Moch is Managing Partner of The Salutramed Group, a strategic/operational advisor to life science companies. He has been co-founder or CEO of 4 firms developing therapies for life-threatening diseases and most recently was CEO of Chimerix. In August 2014, Mr. Moch and Arthur Caplan...
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Tuesday June 28, 2016 4:00pm - 5:15pm EDT
108A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 08: Reg Affairs,
Forum
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Patient Engagement, Agency Participation, Approval Pathways
- Interest Area Patient Engagement, Regulatory Affairs, Rare - Orphan Diseases
- format json
- Interest Area Patient Engagement,Regulatory Affairs,Rare / Orphan Diseases
- Featured Topics Patient Engagement,Agency Participation,Approval Pathways
- Credit Type ACPE, CME, IACET, RN
- Tags Forum