IRC Staff

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Donald F. Grabarz     Managing Director - Member

Donald F. Grabarz is a co-founder and Managing Director International Regulatory Consultants, a Limited Liability Company, established in 1989. He was the founder and President of DFG & Associates, Inc., Salt Lake City, Utah, a consulting practice established in 1986 dedicated towards serving manufacturers of medical devices and related projects on regulatory and quality matters.

Mr. Grabarz is a Pharmacist by profession having received his degree from St. John's University in New York City. He has also studied at Pace University and attended courses provided by the Wharton School of Business. Prior to establishing DFG & Associates, Mr. Grabarz has had over twenty plus years of industry experience with significant management responsibilities in major corporations such as Johnson & Johnson, Becton Dickinson, C.R. Bard and Symbion.

Having had extensive and intimate involvement in the evolution of the Medical Device Amendments of the US Federal Food, Drug, and Cosmetic Act as well as being active in the development of Safe Medical Devices Act, and those implementing regulations. Mr. Grabarz has lectured extensively throughout the U.S., Europe and Asia on a variety of related subjects. He has conducted seminars and lectures on regulatory and quality matters for such organizations as the Pharmaceutical Training Institute, HIMA (Advamed), RAPS, the Institute for Applied Technology, the Center for Professional Advancement and St. John's University. He has provided his expertise in conference sponsored by Ernst & Young and Adams, Harkness & Hill. Mr. Grabarz was instrumental in the development and conduct of a course on Regulation and Marketing of Medical Devices at Fairleigh Dickinson University in their Pharmaceutical MBA Program and is an adjunct professor in curriculum development and teaching at Salt Lake Community College.

His extensive experience includes acting as technical advisor to the HIMA (Advamed) produced training film, the "INSPECTION" and as editor to their "RECALL" training program. Mr. Grabarz has also contributed both feature and topical articles to various domestic and international professional trade publications. His experience also has included work on DEA, EPA, HCFA and OSHA matters.

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R. Tyler McCabe, Ph.D.   Associate Senior Consultant / Clinical and Regulatory

Dr. McCabe has over 20+ years of experience in the biopharmaceutical biotechnology industry. He is President and CEO of MyGene International, a biotech company with leading edge in-vitro diagnostic devices. Dr. McCabe is also President and CEO of ViroPan, Inc. a company involved in the development of product for the prevention and treatment of sexually transmitted diseases. He co-founded and was VP of R & D and a Director of Pharmaceutical Discovery Corporation (PDC) (now MannKind, NASDAQ: MNKD), a biopharmaceutical company focused on drug delivery, diagnostics, and CNS therapeutics. At PDC, Dr. McCabe developed and patented several novel drug discovery and clinical diagnostic technologies presently marketed worldwide, and gained significant regulatory experience through U.S. FDA approval of diagnostic devices. He also discovered the mechanism of action of the novel anti-epileptic and neuroprotectant drug felbamate (Felbatol®) and developed and patented new compounds for the treatment of CNS disorders. Subsequently, he was instrumental in starting and functioned as VP, R & D at Cognetix, a company focused on developing therapeutic agents from the venom of the predatory marine cone snail. He has helped lead four drugs into and through the clinic, interacted with FDA, and was fortunate to have substantial involvement with several large and small pharmaceutical and biopharmaceutical companies.

Dr. McCabe received his B.S., MSPH (public health, epidemiology) and Ph.D. (pharmacology and toxicology) degrees from the University of Utah. Before embarking on his biopharmaceutical and device career, he was awarded a Postdoctoral Research Award Training (PRAT) Fellowship and Staff Fellowship at the National Institutes of Health. He has published over 100 scientific articles. He has over 13 issued U.S. patents on biopharmaceutical products and technologies.

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Anne T. Carter, RAC     Associate Senior Consultant / Clinical and Regulatory

Anne Carter has 20 plus years experience in clinical development and regulatory affairs for products in the pharmaceutical, biotechnology, and medical device industries. Anne received a Bachelor of Science degree in Health Education from the University of Utah, and a Bachelor of Science degree in Nursing from Westminster College. She is Regulatory Affairs Certified by the Regulatory Affairs Professional Society (RAPS), the Drug Information Association (DIA) and ETA Sigma Gamma..

Preceding her services to IRC, Ms. Carter's career experience includes being a co-founder of G.R.S.A. of Utah, LLC, a small clinical and regulatory CRO which serves pharmaceutical, medical device and biotechnology companies. Prior to her consulting career Anne Carter held significantly important positions within the healthcare industry for such companies as UroQuest Medical Corporation, IOMED, Inc., Himedics, Inc., Microprobe Corporation, Research Industries Corporation and, ICN Pharmaceuticals.

Ms. Carter is highly experienced, possessing expertise in the preparation and submission of IND's and NDA's for pharmaceuticals as well as IDE's, PMA's and 510(k)'s for medical devices. This experience extends to providing professional services for preparation of standard operating procedures for manufacturers; clinical trial monitoring; clinical and GMP audits; international dossiers and, technical file preparation to support ISO certification and CE Mark for products.

Her career includes the direct involved and responsibility for approvals of a various drug device combination products, drug delivery systems, DNA probe in vitro diagnostic kits and, various cardiovascular and urology devices. She has successfully managed and coordinated animal and human clinical studies for Phase I through IV as required by the FDA new drug application process. Ms. Carter is experienced as acting as the liaison for manufacturers with the FDA and other government regulatory agencies.

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Duck Joo Lee, M.D., Ph.D., MPH Senior Consultant / Medical Advisor /Clinical

Dr. Lee served as CEO of MyGene Co, Seoul, Korea as well as Chief Medical Officer for ViroPan, Inc. and member of the Board of Directors. He has over 20 years of experience as a practicing physician and researcher in leading University Hospitals in Seoul, Korea. Dr. Lee is Professor at the Fortune Jungmun University School of Medicine. He specialized in aging health care concentrated on the chronic debilitating diseases. He has also conducted research in the U.S. at the University of Minnesota and the University of Utah. Of the most recent ongoing clinical research, a Phase III global study on new SERM drug for the treatment of osteoporosis is the first of its kind conducted in Korea. Among Dr. Lee's numerous degrees, he received M.D. and M.S. degree from the Yonsei University Medical School, an M.P.H degree from the University of Minnesota, and a Ph.D. degree from the Korea University School of Medicine. He received The Minister of Health and Welfare Award and The Young Investigator Award of International Osteoporosis Foundation.