How to Improve Interactions with the FDA to Achieve Higher Success Rates

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Ramsey is a founding member and editor of The RPM Report, a monthly magazine focused on the development of commercial strategies based on regulatory and policy realities. The RPM Report focuses its coverage on FDA, CMS and Congress as they impact biotech and pharmaceutical companies. Prior to The RPM Report, Ramsey was a contributing editor to The Pink Sheet and also covered the medical device and OTC drug industries.

Dr. Grau is the President and Chief Executive Officer of Lux Biosciences, Inc. Dr. Grau has 25 years of experience in the biotechnology and pharmaceutical industry. His extensive expertise in the healthcare field includes general and R&D management, corporate strategy and strategic alliances, and the development of new products and technologies for a variety of diseases.

Dr. Grau served as Enzon's Chief Scientific Officer from 2002 to January 2005. In this role, he upgraded Enzon's R&D capabilities and built a rich portfolio of projects in all stages of development, based on Enzon's macromolecular engineering technologies (Single Chain Antibodies [SCAs] and PEGylation) and based on partnering. The areas of therapeutic focus included oncology and immunology, as well as viral and fungal infections.

Prior to joining Enzon Dr. Grau served as President of Research and Development and member of the Executive Board at BASF Pharma/ Knoll where he directed a global R&D organization and significantly advanced and expanded the Company's product portfolio. This included therapies for autoimmune diseases, obesity, arrhythmia, sepsis, severe pain, and most notably, a human antibody directed against TNF-? (adalimumab, Humira?) for the treatment of rheumatoid arthritis and other autoimmune diseases.

Previously, Dr. Grau served as Senior Vice President and R&D Integration Officer of Aventis Pharma, and as SVP Global Product Realization at Hoechst Marion Roussel, where he directed the company's global late-stage product development activities with a portfolio of projects ranging from diabetes, infectious diseases, oncology, neurology, osteoporosis, cardiology, rheumatology, and hormone replacement therapies, and a budget of $940 million. During 1996-97, Dr. Grau was CEO of Hoechst Marion Roussel in the Netherlands, responsible for the entire commercial infrastructure of this subsidiary. Insulin Glargine (Lantus?) is based on his inventions at the beginning of his career at Hoechst.

Dr. Grau received his Ph.D. in chemistry and biochemistry from the University of Stuttgart and spent three years as a post-doctoral fellow at Purdue University in the field of protein crystallography.

Dr. Bryan began with BCG in February 2007. As a medical officer and team leader for FDA's CDER and CBER, Dr. Bryan was responsible for the clinical review of Investigational New Drug (IND) applications for drugs and biologics, including monoclonal antibody, cell, and gene therapies, for a wide range of neurologic indications, including cerebrovascular disease, multiple sclerosis, Alzheimer's disease, Parkinson's disease, other movement disorders (e.g., cervical dystonia), headache, amyotrophic lateral sclerosis and other neuromuscular disorders, insomnia and other sleep disorders, and a variety of other neurologic indications. As team leader, Dr. Bryan also ensured the quality and consistency of clinical reviews, actively participated in sponsor meetings, and was intimately involved with regulatory decisions and policy affecting the development and approval of numerous investigational products, primarily for neurology indications.

Tom Garvey is the President of Garvey Associates, Inc. (GAI), a medical/scientific consulting firm which works with pharmaceutical, medical device, and biologics firms worldwide. GAI designs clinical trials and programs of clinical trials for drugs and devices, analyzes, organizes, and presents data derived from clinical trials and composes New Drug Applications (NDAs). The firm has had a great deal of experience with a variety of practical and theoretical problems related to clinical trials, data analysis and interpretation and submissions to and interactions with FDA. The firm has also composed and submitted many IND's and has been involved in design, analysis, and presentation of clinical studies for NDA supplements, preparation and prosecution of submissions for OTC switches of major prescription drugs, due diligence (assessment of compounds for licensing or acquisition) and preparation of sponsors for various FDA interactions including advisory committee meetings. Dr. Garvey has also provided expert opinion in a number of legal cases involving drug and device labeling, failure-to-warn, and Lanham Act actions.