Our Team
Munish Mehra, PhD
Dr. Mehra serves Global Drug Development Experts as Managing Director. He holds a Masters in Mathematics from the prestigious Indian Institute of Technology, Kanpur, India and a Masters in Computer Science and PhD in Biostatistics from the University of Kentucky.
During a career in clinical research spanning 20 years, Dr. Mehra helped grow two contract research organizations into global players, one of which was the first CRO to go public in 1991. More recently, he led Clinical Research operations at a mid-size CRO focused on cardiovascular research. He has served as VP of Clinical Research, CIO, Director of Data Management and Biostatistics, and as Director of Business Development. Dr. Mehra has helped several sponsors ensure studies are designed optimally and executed efficiently. He has "rescued" several clinical trials and NDA submissions that were delayed and needed strong leadership and depth of experience to get back on track. His global experience spans working in Europe, China and India, and has focused on assisting companies accelerate drug development with global strategies for rapid enrollment, optimized clinical data management, and addressing FDA submission issues. Dr. Mehra developed a "Method and system for remote electronic monitoring and mentoring of computer assisted performance support" for the conduct of clinical trials, for which he received a patent.
Dr. Mehra has represented several Sponsors at the FDA and regularly serves as principal Biostatistician on clients’ behalf. Dr. Mehra has authored several publications in peer reviewed journals, as well as SOPs, SAPs, CSRs, ISSs, and ISEs and various sections of NDAs.
He is actively involved in analyzing new ways to brings drugs to market sooner, and is currently working with the Association of Clinical Research Organizations (ACRO), CDISC, NIH and FDA on aspects of the Critical Path Initiative. He is involved in an ongoing effort to help develop guidance’s for standardizing data collection in clinical trials. Dr. Mehra is a frequent speaker at numerous industry meetings including the DIA Annual meetings and recently served as the chair of the Drug Information Association (DIA) Information Technology Special Interest Area Communities (SIAC) as well as the Advisory Council for North America.
Dr. Mehra led the development of an offshore Biometrics unit in China and recently worked with a team on submitting an electronic submission to the FDA (hybrid eCTD with CDISC SDTM 3.1 datasets) that allowed the NDA to be submitted electronically and the data loaded into the FDA’s data warehouse for immediate review. As CIO, Dr. Mehra previously helped a mid-size CRO build a global, scalable, and fault tolerant 21CFR11 compliant IT infrastructure. Munish’s inspiration for clinical research is his great-grand father Dr. Sir RN Chopra, one of history’s leading pharmacologists and widely considered the father of modern drug development in India. Dr. Chopra was knighted for his work and as Physician to the King of England. Munish resides in North Potomac, Maryland with his wife Sangeeta, teenage son Avnish, and daughter Sunaina. Munish enjoys reading and traveling and regularly contributes his time and resources to removing illiteracy and disease around the world.
James Krejci
James Krejci is President of Global Drug Development Experts. Mr. Krejci has over 15-years experience in international corporate leadership positions, both with Fortune 500 companies and with smaller firms. He has extensive experience in both the U.S. and, in emerging markets around the world.
He held the role of Chief Financial Officer with Medifacts International, a global CRO, from 2001-2004. Over this period, he was instrumental in increasing Medifacts’ corporate valuation by 800% and oversaw the company’s global expansion. Prior to Medifacts, he lived in Russia for five years where he was the founding CFO TV3 Russia, a nationwide TV network that today operates in over 100 cities across Russia. While with TV3, James worked with private institutional investors to raise Series A financing of $25m from U.S. and British investors. Prior to TV3, James led financial operations for Burson-Marseller’s Emerging Markets Practice and was based in Moscow. James has extensive experience in private equity capital raising both in the U.S. and abroad, debt financing, international tax, establishing corporate operations in foreign countries, and training foreign nationals.
James holds a Bachelor of Arts Degree in History and Economics from Denison University, and an MBA in International Finance from the American Graduate School of International Management (Thunderbird). He speaks Russian and German, and is a citizen of the United States and Switzerland.
Jim is an avid skier and is a frequent supporter of childrens’ education and microfinance programs in the developing countries of Asia, Latin America, and Eastern Europe.
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. Further details on Dr. Zhang can be found at http://www.macrostat.com/