Therapeutic Workshop
Opportunity in Osteoporosis and Bone Metabolism Disorders is Spurring Pipeline Growth
Thursday, October 30, 2008
5:00pm - 6:15pm
Sea Cliff
Osteoporosis is significantly under-diagnosed worldwide, and for patients with either osteoporosis or bone metabolic disorders, treatment options are limited, especially for those addressing bone metabolism. Difficulty with patient compliance, even with the newer products, requires treatment regimens that are easier to use and require less frequent administration. With baby boomers driving the size of the aging population, 2007 sales in excess of $10B, and the top-selling drugs starting to face generic competition, how will new agents in the pipeline transform the fast-growing osteoporosis and emerging bone metabolic disorder markets? A panel of industry and clinical experts will discuss the current and future therapeutic classes of drugs in the pipeline for treating osteoporosis and the metabolic disorders related to this disease, including recent clinical data, therapeutic characteristics and patient compliance factors that will drive eventual adoption and success.
Moderator
- Liana Moussatos, PhD, Senior Healthcare Research Analyst, Pacific Growth Equities LLC
Panelists
Industry:
- Brian MacDonald, MB, ChB, PhD, Chief Executive Officer, Zelos Therapeutics
- James P. Gilligan, PhD, MSIB, Vice President Product Development, Unigene Inc.
Clinician:
- Michael McClung, MD, Founding Director of the Oregon Osteoporosis Center
- John Bilezikian, MD, Chief of the Metabolic Bone Diseases Unit, Chief of the Division of Endocrinology, Professor at the College of Physicians and Surgeons, Columbia University
Who's Who
Liana Moussatos, PhDDr. Moussatos came to Pacific Growth Equities from UBS Global Asset Management where she was director and portfolio manager of the UBS Global Biotech Funds for five years. Previously, Liana was with Bristol-Meyers Squibb where she was a manager in University and Government Licensing, External Science and Technology. Liana has also worked with Sloan-Kettering Cancer Institute in the office of Industrial Affairs and the National Cancer Institute in the Office of Technology Development. Liana received her BS in Entomology and her MS in Zoology and Biochemistry from Clemson University, her Ph.D. in Plant Pathology from the University of California, Davis and completed a postdoctoral research fellowship in cellular and molecular Physiology at the Yale School of Medicine.
Michael McClung, MD Dr. McClung is an endocrinologist and Founding Director of the Oregon Osteoporosis Center in Portland. He has been involved with metabolic bone diseases as a clinician, educator, and a clinical investigator for over 25 years. Dr. McClung has experience in designing, conducting, and reporting clinical trials for osteoporosis and related diseases. He has extensive experience with current and investigational treatments for osteoporosis. Dr. McClung is a member of the Council of Scientific Advisors of the International Osteoporosis Foundation and has been a member of FDA Endocrine and Metabolic Advisory Board. He is involved in clinical guideline development regarding osteoporosis for several societies.
John Bilezikian, MD Dr. Bilezikian is Chief of the Metabolic Bone Diseases Unit, Chief of the Division of Endocrinology and Professor at the College of Physicians and Surgeons, Columbia University. Dr. Bilezikian carries on an active program of basic and clinical research in metabolic bone diseases, including osteoporosis and primary hyperparathyroidism. He has been involved in many of the major clinical trials of new therapies. Dr. Bilezikian is a past President of ASBMR and ISCD and currently is Editor in Chief of the Journal of Clinical Endocrinology and Metabolism. He is on the Board of Governors of the International Osteoporosis Foundation and has edited or co-edited four major textbooks on bone metabolism. He is a Distinguished Physician of the Endocrine Society and a recipient of the Fred Bartter Award from ASBMR. He has published over 400 articles and papers in his areas of expertise.
Brian MacDonald, M.B., Ch.B., Ph.D. Dr. MacDonald joined Zelos as Chief Executive Officer in 2005. From 2003 to 2005, he served as an R&D strategy consultant to the biotechnology industry, with projects that included Head of Clinical and Regulatory Affairs for Gentara Corporation. In 2002, Dr. MacDonald joined 3-Dimensional Pharmaceuticals as Head of Development and a member of the corporate management team, until the acquisition of that organization by Johnson & Johnson in 2003. Prior to that, he held a variety of positions in Clinical R&D at SmithKline Beecham, finally assuming worldwide responsibility for osteoporosis and rheumatology, a role that, following the merger to form GlaxoSmithKline, was expanded to include a range of therapeutic areas including dermatology and analgesia
Dr. MacDonald received his Ph.D., M.B., and Ch.B. from the University of Sheffield in the UK after which he undertook specialty clinical training in metabolic bone disease and rheumatology.
James P. Gillagan, PhD, MSIB Dr. Gilligan has over 25 years experience in the pharmaceutical and biotechnology industry. He received his Ph.D. in Pharmacology and Toxicology from the University of Connecticut during which time he completed a special research fellowship at the Cleveland Clinic Foundation’s Atherosclerosis Research Unit. He performed his post-doctoral training at the Roche Institute of Molecular Biology. He also holds a Masters of Science in International Business degree from Seton Hall University.
Dr. Gilligan is Vice President of Product Development at Unigene Laboratories Inc. Boonton, NJ, a biopharmaceutical company. He was a founding member of Unigene in 1981. His responsibilities include coordination of all US and International pre-clinical research, toxicology, and regulatory filings as well as design and management of clinical studies. Dr. Gilligan was involved with the successful 505(b)(2) registration of Fortical Nasal Spray with the FDA in 2005. He is also responsible for the current Clinical Programs for oral sCT and PTH. Dr. Gilligan’s responsibilities also include identifying new applications for Unigene’s technology and negotiations with prospective partners.