Trk 17: Rare-Orphan Diseases [
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8:30am EDT
#121: Rare Disease Clinical Trials: Coping with Unique Challenges
Chair
Patient Advocate / Secretary, Canadian Organization For Rare Disorders (CORD)
Maureen Smith’s M.Ed. (Educational Psychology) interest in patient advocacy stems from a rare disease diagnosis at the age of 8. She is the Secretary of the Canadian Organization for Rare Disorders (CORD), co-chair of the Rare/Orphan Disease program track for the Drug Information...
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Speakers LM
President and Founder, KMR Group Inc.
Linda Martin is a founder and President of KMR Group, a firm specializing in biopharmaceutical R&D performance, data and analytics. Her areas of expertise include the measurement and evaluation of R&D productivity and clinical development, including subspecialties of enrollment and...
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Chief Medical Advisor, Synteract HCR
Dr. Stephan de la Motte serves as Chief Medical Advisor at SynteractHCR. With nearly 30 years of experience, he is renowned for his scientific and medical expertise and clinical trial knowledge of Phase I, II and III studies. Over the course of his career, he has served as coordinating...
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Chief Medical Advisor, Synteracthcr
Dr. Stephan de la Motte serves as Chief Medical Advisor at SynteractHCR. With nearly 30 years of experience, he is renowned for his scientific and medical expertise and clinical trial knowledge of Phase I, II and III studies. Over the course of his career, he has served as coordinating...
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CEO, Farmacon
Sara Tylosky, President & CEO at Farmacon has > 20 years of experience in strategic management & global marketing in the pharmaceutical & biotech industries. Farmacon works with sponsors, from large pharmas to start-up biotechs, from market intelligence to project manage enrollment...
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Monday June 27, 2016 8:30am - 9:45am EDT
103A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#143: Priority Review Vouchers: Past Experiences, Legislative Reform, and Tips for Sponsors
Chair AR
Director, Global Regulatory Policy, Merck & Co., Inc.
Andrew S. Robertson works in Global Regulatory Affairs at Merck & Co., focusing on regulatory policies concerning vaccines, biologics, biosimilars, in vitro diagnostics, mobile medical apps and software medical devices. He has over 13 years of experience spanning academia, industry...
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Speakers
Vice President, Regulatory Services, Mapi
Ms. Anderson has covered many aspects of drug development during over 30 years in the pharmaceutical and biotechnology industry. Ms. Anderson has held several positions which have included the areas of regulatory affairs, drug development, and due diligence for licensing. She has...
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Associate, Goodwin Procter LLP
Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity...
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Monday June 27, 2016 10:45am - 12:00pm EDT
103C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA