Core Team Members
Toxicology - Dr. Ronald Marler
Pharmacology - Dr. Richard Adamson
Clinical – Dr. Karen K. Church, Dr. Doris Chernik
Regulatory - Dr. Ann H. Rose
Biostatistical - Dr. Janet Wittes
Patenting/Licensing - Mr. William Bundren
Competitive Intelligence - Dr. Elisabeth Hefti
Chemistry, Manufacturing, Controls - Ms. Cynthia Green
Reimbursement - Ms. Leah Amir
*There are over 150 professionals in the Consortium covering all specialties from electronic/computer driven devices to nanotechnology
Core Team Member Bios:
Richard Adamson, Ph.D.:
Dr. Adamson has held positions with the U.S. Public Health Service at the National Institutes of Health (NIH) and the National Cancer Institute, NIH, where he rose to Director, Division of Cancer Etiology and Scientific Director. He also served as a Senior Policy Analyst in the Office of Science and Technology Policy, Executive Office of the President. In addition, Dick was the V.P. for Scientific and Technical Affairs with the American Beverage Association for a decade. Adamson holds an undergraduate degree in chemistry from Drake University and an M.S. and a Ph.D. in pharmacology from the University of Iowa. He also earned an M.A. in International Affairs from The George Washington University .He has published over 200 peer-reviewed papers and book chapters, serves on numerous editorial boards and has won many awards, including a Fulbright Award and the Presidential Meritorious Executive Rank Award and in 2006 the Phillipe Shubik Distinguished Scientist Award from the Toxicology Forum. He consults actively to industry, trade and professional associations, and government.
Leah Amir, MS, MHA:
Leah Amir, MS, MHS Executive Director of The Institute for Quality Resource Management, CEO VantageLinks is a Healthcare Economist and Medical Product Regulatory Strategist.
Leah Amir is an expert across the continuum of new product development, regulatory approvals, and commercialization harmonizing health economics, healthcare finance, and patient outcomes to demonstrate the cost effectiveness of a novel intervention. Her team utilizes information technology expertise to aid product development and to drive revenue in support of new medical technologies. For more than 25 years, Ms. Amir has engaged in commercializing new medical technologies, guiding process improvement in hospitals, obtaining FDA regulatory approval for new products and CPT codes for CMS reimbursement for procedures, coupled with a deep understanding of the need to improve point of care diagnostics to address the high volume of patients needing medical management of chronic disease. Ms. Amir has a portfolio of companies who have experienced regulatory/reimbursement success guiding their pathway for commercialization.
William J. Bundren, J.D.:
William Bundren is currently a sole practictioner with 25+ years experience specializing in developing and implementing global intellectual property strategies for start-up and emerging companies primarily in the medical, biological, biotechnical biochemical fields. He has held partner positions in several law firms in the Washington, D.C. area. Most notable of his achievements are 1) organizing and developing the domestic and foreign patent portfolio for the biomedical division of a Fortune 500 corporation, and 2) authoring and prosecuting 90% of NIH's AIDS-related patents from 1984-1987. The core patents presently generate the largest license fees of any U.S. government-owned patents. Bundren received his law-degree from Washington & Lee University and holds a MS degree in biotechnology from John Hopkins University. In addition he completed the NIH graduate degree program in organic chemistry; biochemistry; genetics; biochemical aspects of gene replication, transcription and translation; microbiology; biology of bacterial plasmids; immunology and hypersensitivity; and medical virology. He is admitted to practice in VA and DC and registered before the U.S. Patent & Trademark Office.
Karen K. Church, Ph.D., RAC
Dr. Church is a regulatory professional for 30 + years ; currently , V P of Regulatory Affairs and Q A at Ocera Therapeutics and Lead/ Principal Clinical Affairs/Regulatory Sciences with ViCro LLC. She previously served as Sr V.P, and other executive and management positions responsible for regulatory affairs, quality assurance, clinical affairs, and project management for Pfizer Global Research and Development, Ancile Pharmaceuticals, Advanced Bioresearch Associates, InSite Vision, Gensia, Inc., Hoffmann-La Roche, Abbott Laboratories, and Astra Pharmaceuticals. Karen has worked with most every FDA Reviewing Divisions and has had regulatory oversight for 27 N DA's and over 150 INDs/CTAs. She earned a doctorate degree from Canbourne University in Regulatory Sciences, graduating summa cum laude and holds graduate degress in Food & Drug Law from Northeasters U., John Marshall Law School and Rutgers U.
Karen has served as Pres & Sec of the Drug Information Association (DIA) Board of Directors, on the DIA Training Course and Strategic Planning Committees, and as Chair for the Steering Committee for the Americas. She helped develop and serves as instructor for the DIA Regulatory Affairs training courses and has received the DIA Outstanding Service Award. She is a guest lecturer for the doctorate degree program in Regulatory Sciences at the University of Southern California and was also an adjunct professor for the Masters Degree program in Regulatory Affairs at San Diego State University. Her other professional affiliations include the American Medical Writers Association (AMWA), the Regulatory Affairs Professionals Society (RAPS), and the Food and Drug Law Institute (FDLI).
Doris Chernik, Ph.D.:
Dr. Chernik has held professorship positions at the University of Pennsylvania, School of Medicine, where she was also Director of the Sleep Laboratory; the University of Medicine & Dentistry, New Jersey Medical School and was the Clinic Director @ the Gestalt Center for Psychotherapy and Training, N.Y. In the private sector she worked for Hoffmann-LaRoche for over 20 years where she rose to Assistant Medical Director. She has over 30 years of experience in all phases and levels of clinical research (Phases I to IV) preparing NDA's, IND's and IDB's where she has worked on neuroleptic molecules, anti-parkinson medications, hypnotics, antibiotics, benzodiazepine antagonists, etc. She developed and managed national and international clinical programs, wrote protocols, monitored clinical studies, reviewed statistics, trained study center staff and rescued programs in crisis. Chernik received her doctorate in experimental psychology from the University of Texas and her undergraduate degrees from California State University. She is well published in peer-reviewed journals and at scientific meetings and has received numerous awards including the fellowship award from the National Institute of Mental Health/ NIH. Currently, she consults actively to industry and foundations.
Cynthia Green, RAC:
Cindy Green has been in the chemistry, manufacturing and controls (CM&C) field for some 30 years holding senior manager positions in regulatory/QA/QC area for several biotech and device companies as well as President of her own consulting company. She has over 25 years of technical, regulatory, quality control/assurance experience and over 4 years of "hands on" research and development expertise. She has organized and established quality control departments, as well as GMP/GCP/GLP compliance programs, wrote and/or reviewed a full range of regulatory submissions for medical devices and biologic products; international submissions and export applications; validation plans (both master plans and method validation); clinical documentation systems and manufacturing plans for multi-use areas. In addition, she has conducted an extensive number of internal, supplier, and contract manufacturing audits worldwide. Ms. Greene holds a Bachelor of Science degree in bacteriology and public health from Washington State University and was certified in Regulatory Affairs in 1993. She is a member of numerous professional associations and an Editorial Board Member of the Institute of Validation Technology (IVT).
Elisabeth Hefti, Ph.D, MBA:
Dr. Hefti has a thorough understanding of life sciences and has over 20 years business experience evaluating the commercial potential of scientific discoveries. She held corporate positions directing biotechnology R&D efforts and assessing related investment opportunities at institutions such as Swiss Bank Corp in N.Y. , where she rose to V.P, Corporate Finance and CPC International, as Director of the Biotech Division and coordinator of international R&D programs. As an independent consultant to life sciences companies and financial institutions, she assists them gain a better understanding of competitive scientific discoveries and/or ongoing product developments through providing fact-based knowledge, verified by primary sources, to assist and guide critical business decisions. Elisabeth holds a Ph.D. in Biochemistry from Rutgers University and a MBA in Finance from the University of Chicago. She has authored numerous reports on pharmaceutical industry trends in the U.S. and Europe and frequently presents at international conferences.
Ronald Marler, D.V. M., Ph.D.
Dr. Marler has over 27 years of pharmaceutical R&D experience for top level global pharmaceutical companies, such as Marion Merrell Dow, where he rose to the position of V.P. of Global Drug Safety and Covance Laboratories, where he was Division V.P. for North America Toxicology Services. His experiences include project team management of early stage pharmaceutical portfolios, preclinical pharmaceutical development. In addition, he consults extensively to virtual and small biotech/pharma companies developing for them preclinical and proof-of-concept development programs. He has extensive experience with the FDA and foreign regulatory authorities in support of pre-IND, IND and NDA submissions. Dr. Marler also rose through the academic ranks to become Dean and Professor, College of Veterinary Medicine, Kansas State University. He also holds several positions at Mayo Clinic, College of Medicine. Dr. Marler received his D.V.M and Ph.D. from Kansas State University and is a Diplomate of both the American College of Veterinary Pathologists and the American Board of Toxicology. In addition he is a graduate of the Harvard Institute of Education Management, Harvard University and a graduate of Senior Business Management , Darden School of Business, University of Virginia. He has published extensively in peer-reviewed journals on pathology and infectious diseases as well as authored numerous proprietary scientific reports and position papers in support of product development.
Ann H. Rose, Dr.PH.;
Dr. Rose is founder, CEO/President of ViCro, a company founded in 1998. She has over 20 years experience in drug/device/OTC development from a regulatory, clinical and business development aspect both in government and the private sector. During her government experience in the Congress of the U.S. (OTA) and the Department of Health & Human Services (Office of the Secretary and Assistant Secretary for Health) she rose to the position of Deputy to the Science Advisor. Dr. Rose was a principal in several key pieces of legislation affecting the PHS, e.g. the Orphan Products Act of 1983 and the Technology Transfer Act of 1986 and instrumental in licensing the first AIDS invention @ NIH to the private sector. She rose to senior corporate executive positions in major pharmaceutical e.g. AKZO and biotech companies e.g. OSI Pharma providing leadership and guidance for drug development and regulatory affairs. Rose received her doctorate in epidemiology and public health from the University of Texas. She has published numerous articles in peer-reviewed journals on these topics and speaks extensively at professional meetings. A recipient of several awards from the National Science Foundation, the University of Texas and the Sigma Xi Award for Outstanding Research. She also serves on the Boards of several organizations.
Janet Wittes, Ph.D.;
Dr. Wittes is a co-founder of ViCro. She has held positions with the Dept. of Veterans Affairs Cooperative Studies Program, NIH/National Heart Lung and Blood Institute as Chief, of the Biostatistics Research Branch, and the City University of New York. She is the founder and President of Statistics Collaborative, Inc. Dr. Wittes is a member of many advisory committees, including a large number of Data and Safety Monitoring Boards (DSMBs) for randomized clinical trials sponsored by both industry and government. She chairs the DSMBs for several large multi center trials sponsored by NIH. She has been a member of several FDA advisory panels. Wittes holds an undergraduate degree in mathematics from Radcliffe College and a Ph.D. from the Department of Statistics of Harvard University. She is an author of numerous publications in statistical methods and applications. Her publications have appeared in Biometrics, Journal of American Statistical Association, American Statistician, Statistics in Medicine, Controlled Clinical Trials and a variety of medical journals. She was Editor in chief of Controlled Clinical Trials and has served on the Editorial Advisory Committee for the journal for ten years. She is currently an Associate editor of Clinical Trials. Dr. Wittes is a Fellow of the American Statistical Association and the American Association for the Advancement of Science and an elected member of the International Statistical Institute. She holds membership and elected positions in several U.S. and international biostatistical professional societies.
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