Trk 02: Proj-Port Mgt-Strat Planning [
clear filter]
8:30am EDT
#104: Impact of Biologics, Vaccines, Oncology, and Breakthrough Therapy Designation on Traditional Global Drug Development Strategy
Chair
Director, Global Project & Alliance Management, Merck & Co., Inc.
Eva M. Finney, Ph.D., PMP, is Director, Global Project and Alliance Management at Merck, where she has been a Project Manager for 15 years. She has managed multiple development programs from early to late stage, including several NDA submissions leading to successful product approvals...
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Speakers DR
Principal Consultant, Robinson Vaccines and Biologics LLC
Independent consultant with 25 years experience in global vaccine and biologics product commercialization, process development and CMC regulatory strategy/execution (IND, BLA, PAS). Over 20 years at Merck, chaired the CMC development team that achieved approval of RotaTeq, an oral...
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Head of Regulatory Affairs Operations, Baxalta
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc...
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Head of Regulatory Affairs Operations, Shire
Dr. Susan Uptain is currently Head of Global Regulatory Operations at Baxalta, where she is responsible for operational excellence in execution of global regulatory strategy and tactics. Previously, she was Director of Project Management and Alliance Management at Merck & Co., Inc...
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Monday June 27, 2016 8:30am - 9:45am EDT
105AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 02: Proj-Port Mgt-Strat Planning,
Forum
- Credit Type ACPE, CME, IACET, PMI, RN
- Audience Advanced
- Featured Topics Approval Pathways, Design Thinking, Precision-Personalized Medicine-Targeted Therapy, Biologics-Biosimilars, Vaccines, Increasing Research and Development Innovation
- Interest Area Regulatory Affairs, R&D - Strategic Issues, Strategic Planning, Biotechnology, Rare - Orphan Diseases
- format json
- Interest Area Regulatory Affairs,R&D / Strategic Issues,Strategic Planning,Biotechnology,Rare / Orphan Diseases
- Featured Topics Approval Pathways,Design Thinking,Precision/Personalized Medicine/Targeted Therapy,Biologics/Biosimilars,Vaccines,Increasing Research and Development Innovation
- Credit Type ACPE, CME, IACET, PMI, RN
- Tags Forum
8:30am EDT
#105: Maximize the Value of Your Product by Beginning with the End in Mind
Chair JR
Director, Global Project Management, Merck & Co., Inc.
Jay has over 20 years of pharmaceutical industry experience and over 14 years of project Management experience. She is currently the cardiovascular franchise leader within the Project Management group at Merck.
Speakers
Manager, Clinical Trial Management, Eli Lilly and Company
Carrie is a Manager with Eli Lilly and Company overseeing Clinical Trial Managers on Oncology trials. She has over 10 years of drug development experience in clinical operations and project management. Carrie has led teams across multiple therapeutic areas and phases, which has provided...
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Chief Development Officer and Head of Global Regulatory Affairs, Covance Inc.
Dr. William Hanlon, PhD, is the chief development officer and head of global regulatory affairs for Covance. He has been with Covance for four and a half years, after spending 25 years in pharma in the discovery and the development side of developing drugs for global commercialization...
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Monday June 27, 2016 8:30am - 9:45am EDT
107AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA