Advisiory Panel

ourteam

Kelly Mehrer, PhD

Dr. Mehrer handles Global Drug Development Experts’ Business Development & Marketing. He holds a Ph.D. in Health Sciences Research from Barrington University, Florida; a Ph.D. in Business Marketing from California Coast University, California; and a BA in Biology from California State University, Fullerton.

During a career in Business Development, Sales & Marketing, Kelly has grown organizations focused in Biotech, Medical Devices, Clinical Trial Management, Pharmaceuticals, and Pharmaceutical Development. Most recently, Kelly was the Vice President of Strategic Accounts at PRA where he built an infrastructure to help PRA achieve critical milestones. His role was particularly focused on the top 25 global pharmaceutical companies. Prior to PRA, Kelly was Executive Vice President/Business Development & Marketing at Medifacts International, a mid-sized CRO with operations in Europe, China, and South America. Just prior to this role, Kelly held the role of Senior Director/Global Business Development for Cardinal Health’s Pharmaceutical Therapeutics Services Division. In this role, he was responsible for global growth in Europe, the U.S. and Asia. Kelly has held senior positions in sales and marketing at Johnson & Johnson, Eli Lilly, and Pfizer.

Prior to his business career, Kelly served in the US Army as an Intelligence Officer and as an Aviator with the 82nd Airborne Division, Fort Bragg, North Carolina. Kelly lives in North Carolina with his wife of 14 years and his four children. He enjoys traveling, reading, martial arts (holding a black belt in Tang So Doo and Hapkido), motor-cross riding, flying, diving and horseback riding. He is also involved with the Jacques Cousteau Society with his brother and the California Public School System as a Shark Naturalist helping to tag sharks to aid in their conservation off the coast of California.

Doug Cowart, Pharm D., FABCP, RAC

Dr. Cowart has broad expertise in both drug and device development. During his career of over 25 years as a clinical researcher/clinical trialist he has been involved in clinical program design, strategic planning, corporate operations and pharmaceutical business activities. His experience has been gained through a career encompassing positions in academia, private business, major pharmaceutical companies and the contract clinical research arena.

Dr. Cowart is board certified in Clinical Pharmacology, with broad expertise in Cardio-Renal Medicine. He has planned and initiated over 50 clinical studies in phases I-IV. As a consultant to the pharmaceutical and device industry, he has planned and carried out pivotal trials ultimately leading to the registration of several products. He has served U.S. and foreign companies as a liaison with the Food and Drug Association as well as the EMEA. He has both US and international clinical trial expertise, and has lead large-scale clinical development programs.

He has specific extensive expertise in the development of therapies for acute and chronic heart failure, hypertension, pulmonary arterial hypertension, atrial arrhythmias, antianginal agents, and diuretics and in therapies for the treatment of patients undergoing hemodialysis. In addition he has worked in development programs involving novel anti-inflammatory agents, and in CNS related therapies such as Attention Deficit Disorder, Alzheimer’s disease and in Immunological areas such as Arthritis, and Asthma. He has served as a consultant to oncology programs for both biological and small molecule therapeutic agents. He has published his work in major peer reviewed journals.

During his career, Dr. Cowart has gained extensive experience in planning and leading US and Global drug development programs, interfacing with the FDA, and other regulatory international agencies. He is certified by the U.S. regulatory affairs professional’s society.

Dr. Cowart has a proven track record of effective leadership; team building, organizational, communication and the social skills and business skills necessary to bring new pharmaceutical and device products to the market.

Our Team of Consultants

Gil Price, MD

Dr. Gil Price is a clinical physician trained in Internal medicine with a long-standing interest in the study of adverse drug reactions, drug utilization, drug development and regulation. He is an accomplished senior level manager with over 18 years of diverse therapeutic drug development experience. His responsibilities have included pharmacovigilance, competitive intelligence, and clinical development. Dr. Price was previously the Director of Clinical Development for Oncology at MedImmune Inc. He previously worked in the CRO sector at ClinTrials. Dr. Price began his pharmaceutical career at Glaxo Inc. in Research Triangle Park, NC, where he worked for nearly nine years on both the commercial and research sides of the company. Dr. Price is a member of the American Medical Association the Academy of Pharmaceutical Physicians and the American Society of Microbiology. Further details on Dr. Price can be found at http://www.drugsafety.biz

Michael Ryan, PhD

Dr. Mike Ryan, a senior pharmaceutical executive, assists clients to resolve complex organizational and business problems. With 25 years in leadership positions he is experienced in Profit & Loss, Strategic Planning, Turn-Around Management, Restructuring, Staff Building, and Business Development. He served as a global Marketing Director with the world’s largest pharmaceutical company and was a director of clinical research with another major firm. In addition, Mike was a Sr. Vice President with two international clinical research organizations. As a consultant he has worked to: re-engineer an international pharmaceutical company; design clinical development programs; establish complex SOPS for manufacturing and clinical operations. Mike received a B.A. in Chemistry from the University of Delaware, and his Ph.D. in Biochemistry and Physiology from the University of Louisville Medical School, and conducted post-doctoral research at Indiana University. Further details on Dr. Ryan can be found at http://www.silverbackgroup.net

Richard P. Schwarz Jr., PhD

Richard P. Schwarz Jr., PhD is an expert in the discovery and development of novel cardiovascular therapeutics. He has 30 years of experience in the pharmaceutical/ biotechnology industry and in government service. Dr. Schwarz held the position of Deputy Chief, Extramural Cardiology Branch, at the National Heart, Lung and Blood Institute (NIH) from 1979-1982, and served as Global Director of the Cardiovascular Clinical Development Program at the Sterling Research Group, Sterling Drug, Inc. from 1982-1990. He has also served as Senior Director, Clinical Development at Astra USA and as Vice President, Clinical Development and Regulatory Affairs at Texas Biotechnology Corporation during the 1990s. Since 1998, he has been the founder and President of a strategic consulting firm, CV Ventures, LLC. Dr. Schwarz has planned and directed numerous R&D programs in cardiovascular therapeutics, including: inotropic agents and neurohormonal modulators in CHF; thrombin inhibitors, IIb/IIIa inhibitors and thrombolytic agents in acute coronary syndromes; cardiovascular clinical genomics; antidyslipidemic agents; cardiac cell therapy; and thrombin inhibitors in arterial and venous diseases. He was the Program Director/Principal Scientist for two successfully commercialized cardiovascular drugs: PRIMACOR® (milrinone), a heart failure medication; and ARGATROBAN® (argatroban), an antithrombotic drug. Dr. Schwarz has been a strategic consultant, Scientific Advisory Board member, or part-time senior executive for numerous start-up and development-stage cardiovascular R&D companies, as well as for venture capital groups. He has also served as a scientific/technical reviewer for research grant applications for the Center for Scientific Review and the National Heart, Lung and Blood Institute (NIH). Dr. Schwarz has also served as an adjunct faculty member at several medical institutions, most recently as Adjunct Professor of Medicine (Cardiology) and Director of Translational Clinical Sciences, Interdisciplinary Stem Cell Institute, at the University of Miami Miller School of Medicine. His bibliography lists over 40 publications and two books.

Bert Spilker, MD, PhD, FCP, FFPM

Dr. Bert Spilker is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA (Pharmaceutical Research and Manufacturers of America) based in Washington, D.C.

He was President and cofounder (in 1993) of Orphan Medical, Inc., a public pharmaceutical company that develops and markets important medical products for patients with uncommon diseases. He is well known as the author of 15 books on clinical trial methods and the processes of drug discovery and development. These books are considered by many as the standard references on clinical trials and drug development.

He has worked at four major pharmaceutical companies for over 20 years (Pfizer, Philips-Duphar, Sterling-Winthrop, and Burroughs Wellcome) in medicine discovery, development, and management.

He served on the Steering Committee for the International Conference on Harmonization, or ICH, and has received numerous honors including the FDA Commissioner’s Special Citation for work in the orphan medicine area.

He is Clinical Professor of Pharmacy Practice at the University of Minnesota and Adjunct Professor of Medicine and Clinical Professor of Pharmacy at the University of North Carolina in Chapel Hill.

His medical training in pharmacology and internal medicine was at Cornell Medical College, State University of New York (Downstate Medical Center), University of California at San Francisco, University of Miami Medical School (Ph.D. to M.D. Program) and Brown University Medical School. Further details on Dr. Spilker can be found at http://www.bertspilker.com/

Michael Tansey. MD

Dr. Tansey had been Chief Medical Officer and Senior Vice President at Pharmacia Corp. until its acquisition by Pfizer Inc. in 2003. He has more than 25 years of experience working at major pharmaceutical companies where he has had increasing responsibility for all aspects of product development, including global clinical development plans, clinical and medical operations, regulatory affairs, and post-approval clinical marketing support.

From 1996 until 2003, Dr. Tansey was Chief Medical Officer of Pharmacia and Upjohn and then Chief Medical Officer and Senior Vice President of Medical Development and a member of the Chief Executive’s Operations Committee for Pharmacia Corporation. Previously, he held positions of increasing responsibility at Rhone-Poulenc-Rorer, Glaxo and Hoechst.

Dr. Tansey founded a consulting group, Competitive Drug Development LLC, in 2003 and has since guided more than 12 companies in the United States, Europe and Asia to optimize their development processes and plans. During this time, Dr. Tansey also worked part-time as Director of Clinical Operations for a contract clinical research organization and as part-time Chief Medical Officer for The La Jolla Pharmaceutical Company, a biotechnology company.

Dr. Tansey received a medical degree from Manchester University in the United Kingdom and a Doctorate from the University of Cape Town in South Africa for experimental and clinical studies into the metabolic aspects of myocardial infarction. He is an Associate Fellow of the American College of Cardiology and a Fellow of the Faculty of Pharmaceutical Medicine, Royal College of Physicians.

Bing Zhang, PhD

Dr. Bing Zhang has fifteen years of experience in statistical analyses for pharmacokinetic (PK) and Phase I-IV clinical trials as well as integrated summaries of safety (ISS) and efficacy (ISE) for new drug applications (NDA) in various therapeutic areas such as pain control, cardiovascular, respiratory, psychotic disorders, oncology, anti-viral, blood substitute, etc. Dr. Zhang was previously Associate Director of Biostatistics at a biotech company and held various leadership positions for statistics and SAS programming groups at a large pharmaceutical company, and Senior Statistician at a CRO. Dr. Zhang has extensive experience in the development of clinical development plans, clinical trial protocols, statistical analysis plans, and clinical trial reports; and in the preparation of multiple NDA submissions. Dr. Zhang is an expert on CDISC submissions and led a team that did one of the first CDISC SDTM submissions to the FDA. Dr. Zhang has a Ph.D. in Statistics and M.S. in Computer Science from the University of Kentucky.

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