EDUCATION
Dan Gipe MD
1992 Bachelor of Arts, Liberal Arts Westminster College, Fulton, MO
1997 Doctorate of Medicine - University of Missouri School of Medicine, Columbia, MO
EXPERIENCE
09/2010 – Present Regeneron Pharmaceuticals, Inc., Tarrytown, NY
Director, Clinical Sciences, Cardiovascular & Metabolism Therapeutics
* Defines clinical trial-related Clinical Development Program (CDP) goals and objectives
* Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSC) based on thorough scientific review and consultation with internal and external experts.
* Reviews and finalizes clinical study concepts for presentation to TA Head and Sr. Management
* Reviews and finalizes the medical and scientific portions of clinical trial protocols derived from CSCs
* Accountable, along with CTM, for timely clinical trial execution and quality of deliverables
* Leads and supervises the work of Clinical Team to produce high quality program deliverables on schedule
* Identifies program risks, creates and implements mitigation strategies
* Maintains and develops relationship with key program investigators
* Organizes clinical advisory boards, steering committees and data safety monitoring boards as required
* Reports to TA Head and senior management on clinical trial milestones
* Responsible for the medical content of clinical study reports
* Reviews all medical/scientific publications related to clinical trials
* Establishes the benefit/risk ratio of a therapeutic candidate in CDP-defined indications
* Responsible for the analysis of clinical data, including safety monitoring
* Responsible for all activities and procedures that ensure patient safety
* Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines
* Is the primary clinical contact for communications with regulatory agencies and
IRBs/ethics boards
* Identifies and recommends resource allocation for CDP execution
* Identifies changes to established practices/policies if appropriate
Establishes and monitors CDP budget
12/2008 – 11/2009 Shionogi USA, Inc., Florham Park, NJ
Medical Director, Clinical Development
• Participated in the design and implementation of phase 1-2 clinical trials, ensuring that the overall scientific and medical content of medical programs were sound
• Supported product development and research programs with respect to safety and risk management issues
• As Medical Safety Officer, provided medical support to the Director of Drug Safety for all medical safety activities and provide medical and safety assessments following review and analysis of Serious Adverse Events, adverse event reports and specified safety inquires and investigations as directed by the Project Leaders
• Assisted in preparation and review of FDA MedWatch Forms, Periodic Safety Update Reports, and other regulatory reports
• Worked closely with CROs and Shionogi Clinical Development and Regulatory Affairs staff to provide medical leadership and scientific guidance both 1:1 and in team meetings
• Developed and maintained strong relationships with both internal and external customers, including Key Opinion Leaders, in order to lead company’s interests from a medical perspective
• Remained current with clinical and drug development information relevant to assigned programs through the review of literature, attendance at medical/scientific meetings
• Provided coaching and subject matter expertise to colleagues
• Responsible for the development of research protocols for phase 1-2 clinical trials in dermatology, hematology, and metabolic therapeutic areas
• Worked closely with Business Development colleagues to out-license and/or co-develop a product with other pharmaceutical firms
04/2008 – 11/2008 Ferring Pharmaceuticals, Inc., Parsippany, NJ
Director, Medical Affairs, Orthopedics
•Participated in the design and implementation of phase 1-2 clinical trials, ensuring that the overall scientific and medical content of medical programs were sound
•Worked with Medical Science Liaisons to ensure progress of Investigator-initiated trials
•Provided support to Managed Care Department by presenting clinical data to managed care organizations
•Responsible for the close-out of a large phase 4 trial in orthopedics
•Worked closely with CROs and Ferring Clinical Development and Regulatory Affairs staff to provide medical leadership and scientific guidance both 1:1 and in team meetings
•Developed and maintained strong relationships with both internal and external customers, including Key Opinion Leaders, in order to lead company’s interests from a medical perspective
•Remained current with clinical and drug development information relevant to assigned programs through the review of literature, attendance at medical/scientific meetings
•Provided coaching and subject matter expertise to colleagues
05/2006-04/2008 Reliant Pharmaceuticals, Inc., Liberty Corner, NJ
Director, Clinical Research, Clinical Development
•Primarily responsible for the Clinical/Regulatory assessment of all product candidates for potential in-licensing or co-promotion.
•Worked closely with Business Development team on various stages of due diligence of product candidates
•Prepared Clinical/Regulatory presentations for product candidates for the Development Portfolio Review Committee (DPRC)
•Presented Clinical/Regulatory assessment of product candidates to the Development Portfolio Review Committee
•Worked with Marketing team to develop product concepts for product candidates for Qualitative and Quantitative Market Research
•Supported the feasibility analyses of various Phase 2 development projects
•Supported the feasibility analysis of a large Phase 4 outcomes study
•Identified and formed relationships with KOLs in various therapeutic areas to develop KOL support for various Phase 2 and Phase 4 projects
•Responsible for the development of an Advisory Board for the assessment of a Phase 2 development project in Osteoarthritis
•Responsible for the development of a non-clinical program in Osteoarthritis