Phases: Maximizing Clinical Efficiency
Venue: Westin Grand Hotel
|Event Date/Time: Oct 08, 2003||End Date/Time: Oct 10, 2003|
PhasesSM brings presentations from the following representatives of the Food and Drug Administration:
Mark B. McClellan, MD, PhD, Commissioner of the FDA, opens this conference with a keynote address on the current status of clinical trials. Dr. McClellan discusses his pledge to try to speed and reduce the costs of drug development and what the industry needs to do to accomplish this goal.
Karen Weiss, MD, the Acting Deputy Director for the Office of Therapeutics at CBER of the FDA explains the importance of knowing the agency's expectations when creating a sound clinical development plan and how to anticipate potential obstacles by learning from the agency's past experiences.
Alexandra Worobec, MD, Medical Officer, CBER of the FDA identifies what preclinical information is necessary to conduct an efficient phase I trial from the biologics perspective.
The following keynote speakers:
Robert G. Pietrusko, PharmD,Vice President,Worldwide Regulatory Affairs and Pharmacovigilence for Milliennium Pharmaceuticals provides details surrounding the rapid development and approval of VELCADE, which has been tagged the industry's fastest trip from bench to bedside.
Louis M. Sherwood, MD, FACP, Recently Retired Senior Vice President of US Medical & Scientific Affairs at Merck & Co., Adjunct Professor of Medicine at University of Pennsylvania and President of MEDSA, LLC, presents with an overview of the central challenges facing clinical development in relation to the challenges of clinical research.
Important featured speakers:
Lucy Wynohradnyk, Director EDC, Clinical Operations at Forest Laboratories presents the circumstances behind and expectations of Forest's conversion of all phases of studies and the entire organization to eClinical, a procedure started 2 years ago an hoped to be completed by the end of 2005.
Louis Morris, PhD, an expert consultant with 23 years of experience as an FDA Official addresses the development and implementation of marketing and risk management plans in Phase IV.
Educational sessions presented by senior executives:
Curtis L. Scribner, MD,Vice President Regulatory Affairs at Biomedicines, Inc., former Deputy Director, OBRR, CBER, FDA, discusses the expectations and requirements for the end-of-phase II FDA meeting.
Stephen Sainati, PhD,Vice President of Clinical Research at Takeda Pharmaceuticals discusses creative and alternative study designs to better integrate Phase II into all phases of clinical trials.
Robert De Jager, PhD,Vice President, Clinical Development at Daiichi Pharmaceuticals explains the utility of biomarkers to determine the safety and efficacy of your drug earlier in clinical trials.
Informative panel discussions:
The Use of Innovative Strategies in Patient Recruitment: Best Practices and Success Stories from Pharma and Biotech
Financing an International Trial: Can Only Large Pharma Afford to Conduct Trials Outside the US?
The first day of the conference,Wednesday, October 8th, consists of four workshops and a Full-day Phase IV Symposium. The workshops address the topics of biomarkers, CRO selection, pediatric trials and IT solutions. The phase IV symposium is divided into 4 sections, the uses of IT for data collection and analysis, site selection and training, the the development and implementation of marketing and risk management plans, and HIPAA guidelines.
On October 9th and 10th, PhasesSM offers you the unique opportunity to choose from different afternoon tracks, Phase I, Phase II, Phase III, and The Globalization of Clinical Trials. Please see Agenda Day 1 and Agenda Day 2 for an overview of the sessions and speakers being offered.
In addition to this unique three-track feature, PhasesSM also provides morning plenary, keynote and featured speaker sessions that address broader issues that are of concern across all phases. Sessions include a keynote address by the FDA Commissioner on his pledge to help reduce drug development times and costs, an overview of the central challenges facing clinical research and clinical development, a panel discussion on best practices and success stories for patient recruitment, and understanding the agency's expectations to create a sound development plan. Featured case studies include Millenium's VELCADE rapid approval process and Forest's decision to go completely eClinical.