In collaboration with the NC Biotechnology Center and Life Sciences Law and through their Clinical Trial Lunch Series, we invite you to join us for a presentation and panel discussion regarding the statistical principles around controlling Type I errors for primary and key secondary efficacy endpoints. The seminar will provide a conceptual overview of this topic and will focus on strategies to optimize the chances of achieving ‘wins’ on the endpoints that will drive approval and commercialization.
Registration: For more information and to RSVP, please go to the NC Biotechnology Center events page.
Title: Mapping the Maze of Multiplicity: Statistical Strategies for Managing Primary and Key Secondary Endpoints in Late-State Clinical Trials
Panelists (See bios below):
Dr. Anthony Segreti, Head of Biostatistics, RTI Health Solutions
Ms. Anne McKay, Senior Director of Regulatory Affairs, RTI Health Solutions
Dr. Heyward Hull, Clinical Professor, Division of Pharmacotherapy and Experimental Therapeutics,
UNC School of Pharmacy
Date: Monday, June 25th
Time: 11:30 to 1:30
Location: NC Biotechnology Center, 15 T.W. Alexander Drive, Research Triangle Park, NC 27709 Map and Directions
Anthony Segreti, PhD, Head of Biostatistics, RTI-HS
Dr. Anthony Segreti is Head of Biostatistics at RTI Health Solutions. He has 27 years of experience in the pharmaceutical industry at Burroughs Wellcome Co., Glaxo Wellcome, and GlaxoSmithKline as a project statistician, manager, and director of statisticians supporting Phase 1-4 clinical trials. He has extensive experience consulting on the design of clinical trials and has interacted with the FDA on regulatory submissions. Dr. Segreti is a member of the American Statistical Association, the Biometrics Society, Sigma Xi, and Delta Omega. He has been active in the Biostatistics Section of the Pharmaceutical Researchers and Manufacturers Association and organized a training course for New Clinical Statisticians, which is still taught annually under the auspices of PERI, the Pharmaceutical Education and Research Institute. He served on the Steering Committee of the Biostatistics Section from 1988-1998, was vice-chair in 1992, and was chair from 1993-1994. He served on the Steering Committee for the Midwest Biopharmaceutical Statistics Workshop as a workshop chair in 1997 and a program co-chair in 1994 and 1997 and is active on the steering committee for the BASS (Biopharmaceutical Annual Statistics Symposium) meeting.
Anne McKay, Senior Director, Regulatory Affairs, RTI-HS
Anne McKay is Director, Regulatory Affairs at RTI Health Solutions. She joined RTI HS in March of 2007 providing strategic regulatory support both internally and to external clients. She has over 30 years of experience in the regulatory affairs and quality assurance divisions of the pharmaceutical industry. Since the acquisition of Triangle Pharmaceuticals by Gilead Sciences in 2003, she has been consulting primarily to biotech start-up companies in the areas of regulatory, compliance, strategy, and project management. For 6 years prior to that, she served as Executive Vice President of Regulatory Affairs and Quality Assurance at Triangle Pharmaceuticals. While at Triangle, Ms. McKay oversaw all regulatory and quality activities for the start-up company focused on the development of antiviral compounds. In the second half of 2002 Ms. McKay managed the successful filings of the New Drug Application (NDA) in the US and the Marketing Authorization Application in Europe for Emtriva® (FTC) for HIV. Both applications were approved in 2003. Prior to Triangle, Ms. McKay served as Director of Regulatory and Quality Assurance for Medco Research. During her one year at Medco, Ms. McKay managed the successful filing of 2 NDAs. Prior to that, Ms. McKay spent fifteen years in positions of increasing responsibility at Burroughs Wellcome, with her last position being Director of Regulatory Affairs, North America. While at Burroughs Wellcome, Ms. McKay was responsible for the management of over 80 INDs and 80 NDAs. During her tenure, she oversaw the NDA submission and approval of Retrovir®(AZT), Zovirax®(acyclovir), Wellbutrin®, Lamictal®, Exosurf®, Navelbine® and many other novel new chemical entities. Development of the first products to treat genital herpes and HIV infection prompted new regulations allowing for early access to life saving medicines, including Subpart E designation and Treatment INDs. Ms. McKay was also the primary contact with FDA for all biological applications including interferon, TPA, and Campath®.
Heyward Hull, PharmD, MS, Clinical Professor, Division of Pharmacotherapy & Experimental Therapeutics, School of Pharmacy, University of North Carolina-Chapel Hill
Prior to joining the UNC School of Pharmacy in fall 2006 on a part-time basis, Dr. Hull was Senior Vice President, Development and Regulatory Affairs, at Icagen, Inc. A pharmaceutical scientist, Dr. Hull has over 28 years of pharmaceutical industry experience in clinical drug development, including management positions at Quintiles, Inc (Group Vice President, Therapeutic Area Group 2) and at Burroughs Wellcome Co. (Director of Cardiovascular Medicine). Dr. Hull has been involved in all phases of clinical drug development from initial human studies to product registration and post-marketing studies, across a variety of therapeutic areas. Dr. Hull’s current teaching responsibility includes graduate-level courses in experimental design and applied biostatistics.