Michelle Rohrer, PhD is Associate Director of Regulatory Affairs of Genentech. She has 10 years of experience in the biotechnology industry. As a Clinical Scientist and International Clinical Team Leader, she was responsible for clinical development of biologics for a variety of indications, including AIDS wasting, diabetes, neuropathy, nephropathy, congestive heart failure, and obesity. She has managed and monitored clinical trials in all phases of development and led several international development programs with corporate partners, such as Roche and Serono. In her current position, she leads the development of the Regulatory strategies for Genentech's Biotherapeutic products targeting such indications as psoriasis, age-related macular degeneration, acute coronary syndrome, rheumatoid arthritis and diabetic wounds. She has facilitated preIND, End of Phase II and preBLA meetings with the Food and Drug Administration's CBER and CDER divisions. Most recently, she led the filing of the Biologics Licence Application in the Common Technical Document format of Genentech's monoclonal antibody Raptiva for the treatment of psoriasis.

Dr. Jackson is the Chief Medical Officer of Endovasix, Inc a venture funded medical device startup developing a laser catheter system for treatingstroke. He is responsible for the clinical aspects of product design and testing as well as the development and medical monitoring of the clinical trials. Dr. Jackson earned a degree in chemistry from Stanford University and went on to study medicine and neuroscience at Harvard Medical School. He completed a Ph. D. in neurobiology focusing on ion channel electrophysiology and cell volume regulation. He graduated with an MD/Ph. D. in 1996. Following medical school, Dr. Jackson trained in neurosurgery at the Brigham and Women's Hospital in Boston, Massachusetts.

Kari Nadeau, MD, Ph.D., is Vice President, Chief Scientific & Medical Officer. She has over 12 years experience in academia and industry. As a medical director of global clinical trials at Biogen, Coulter Pharmaceuticals and Roche Pharmaceuticals, she gained broad experience in developing clinical development plans in therapeutic areas in Oncology, Autoimmune Diseases, Infectious Diseases and Transplantation. Kari has overseen and monitored many clinical trials in Phase I through Phase IV development. Through interactions with business development and marketing departments, she has implemented overall strategy plans for biologics, vaccines, gene therapies and small-molecule therapeutics. Kari received both her Ph.D. in Biological Chemistry and Pharmacology and her MD from Harvard Medical School. She trained in Oncology and Hematology and completed her residency at the Dana Farber Cancer Institute. She is a member of the American Society of Clinical Oncology, the American Society of Hematology, the American College of Rheumatology and the American Society of Transplantation.

Larry Kleinman, is a founder and Vice President of Development for Pacific BioDevelopment, a San Francisco based consulting firm since 1995, where he has assisted several companies gain market approval for their products. He has participated in every type of FDA interaction from Pre-IND meetings to advisory committee presentations and also Pre-approval Inspections of facilities. Prior to founding Pacific BioDevelopment, he held the position of Senior Director, Regulatory Affairs, at Genentech where he was responsible for the guiding the regulatory strategies for a number of molecules including the approval of several marketing applications. Mr. Kleinman retired from the US Public Health Service where he held positions at the National Cancer Institute and the Food and Drug Administration where he served on the licensing committee for Genentech's Tissue Plasminogen Activator-Activase. He is a licensed pharmacist.