To get a drug approved by the Food and Drug Administration, it may take 15 years and $1 billion, but the process is well-defined. However, as of now, there is no such pathway for diagnostic tests.
Board of Directors
J. Lyle Bootman, PhD, ScD
Dr. Bootman has served as Dean of The University of Arizona College of Pharmacy since 1987. Dr. Bootman is Professor of Pharmacy, Medicine, and Public Health, and a fellow of several professional associations, including the American Pharmacists Association, American Association of Pharmaceutical Scientists, and the American College of Apothecaries. He is the Founding and Executive Director of The University of Arizona Center for Health Outcomes and PharmacoEconomic (HOPE) Research, one of the first such centers developed in the world. He is former President of the American Pharmacists Association and President Emeritus of the Pharmacy & Therapeutics Society. Dr. Bootman received his pharmacy education at The University of Arizona and his doctorate at The University of Minnesota. He completed a clinical pharmacy residency at the National Institutes of Health, and received an honorary doctorate from the University of the Sciences in Philadelphia. He has received numerous outstanding scientific achievement awards, most notably from the American Association of Pharmaceutical Scientists and the Academy of Pharmaceutical Science and Research. Currently, he serves on several prestigious boards, including Critical Path Institute, Research Corporation Technologies, CMR Institute, and Madeira Therapeutics.
Dr. Craig Brater is Indiana University vice president with responsibilities for the life sciences and dean of the IU School of Medicine. Upon joining Indiana University in 1986, he established the Division of Clinical Pharmacology in the Department of Medicine, creating a partnership with Purdue University, which he has continued to advance over the past 20 years. In 1990, Dr. Brater became chairman of the Department of Medicine, the largest department at Indiana University. In 2000, he was selected to be the ninth dean of the IU School of Medicine. He serves as a board member of Indiana University Health, board and executive committee member of BioCrossroads and chairman of the board of Fairbanks Institute.
ShaAvhrée Buckman, MD, PhD
Liaison Advisory Member – Non-voting
ShaAvhrée Buckman is currently the Director of the Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). OTS is comprised of the Office of Biostatistics and the Office of Clinical Pharmacology. OTS provides oversight to CDER research involving human subjects as well as CDER regulatory science research. OTS is responsible for providing coordination for Critical Path initiatives across CDER in partnership with individual CDER offices. Dr. Buckman served as Deputy Director for OTS prior to accepting the position as Director. Before joining OTS, Dr. Buckman served as a medical team leader in the Division of Pediatric Drug Development, Office of Counter Terrorism and Pediatric Drug Development, CDER. Dr. Buckman received her MD and PhD degrees (with an emphasis on molecular cell biology) from Washington University School of Medicine. Dr. Buckman completed Pediatric specialty training at Baylor College of Medicine.
Peter B. Corr, PhD
Dr. Corr is Co-Founder and General Partner of Celtic Therapeutics Management LLLP. Dr. Corr retired from Pfizer, Inc., where he was Senior Vice President for Science and Technology. He also headed worldwide pharmaceutical research and development for Pfizer. Previously, Dr. Corr served as Executive Vice President, Pfizer Global Research & Development, and President, Worldwide Development. He also served as Senior Vice President, Discovery Research, at Monsanto/Searle, and then President of Pharmaceutical Research and Development at Warner Lambert/Parke-Davis. Dr. Corr, who received his doctorate from Georgetown University School of Medicine, spent 18 years as a researcher in molecular biology and pharmacology at Washington University in St. Louis. His research has been published in more than 160 scientific manuscripts. He is a Trustee of the Joyce Theatre Foundation in New York City, and a member of the National Academies' Institute of Medicine (IOM) Committee on Conflict of Interest in Medical Research, Education, and Practice, the IOM Forum on Drug Discovery, Development, and Translation, and the IOM Committee on Accelerating Rare Diseases Research and Orphan Product Development.
M. Wainwright Fishburn, Jr.
M Wainwright Fishburn, Jr. is a founding partner of Cooley LLP's San Diego office and leads the firms Wireless Health Group. Mr. Fishburn is an active community leader and has shaped many industry organizations. He is Chairman of the Sanford-Burnham Institute for Medical Research and serves on the Board of the Wireless-Life Sciences Alliance. He is on the Board of the Critical Path Institute, an independent institute created in part by the FDA, dedicated to improving the regulatory path for innovative medical therapies. He is also a founding member of the Corporate Directors Forum, as well as BIOCOM, where he serves as a member of the Executive Committee. Mr. Fishburn is a co-founder of six companies, two of which are public. Prior to law school, he worked in the corporate environment assisting with the divestiture of 12 operating companies.
He completed post-graduate work as a Senior Fellow at the Australian National University and received his J.D. degree from the University of California, Hastings College of the Law. He has served as President of the Hastings Board of Governors.
James C. Greenwood is President and CEO of the Biotechnology Industry Organization (BIO) in Washington, D.C., which represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. Since his appointment in January of 2005, he has markedly enhanced the trade association's capacity â€“ increasing both its staff and budget by nearly fifty percent. BIO is now a world class advocacy organization playing a leading role in shaping public policy on a variety of fronts critical to the success of the biotechnology industry at the state and national levels as well as internationally. Mr. Greenwood represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005. A senior member of the Energy and Commerce Committee, he was widely viewed as a leader on health care and the environment. From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee's vast jurisdiction. He led hard-hitting investigations into corporate governance at Enron, Global Crossing and WorldCom; terrorist threats to our nation's infrastructure; and waste and fraud in federal government agencies. Prior to his election to Congress, Mr. Greenwood served six years in the Pennsylvania General Assembly (1981-86) and six years in the Pennsylvania Senate (1987-1992). Mr. Greenwood graduated from Dickinson College in 1973 with a BA in Sociology. From 1977 until 1980, he worked as a caseworker with abused and neglected children at the Bucks County Children and Youth Social Service Agency. Mr. Greenwood is married with three children and resides in Upper Makefield, Pennsylvania.
Jeffery E. Jacob, SM
Mr. Jacob is the principal of Tucson Pharma Ventures LLC, an Arizona-based biopharmaceutical development, consulting, and investment firm. Throughout his career, Mr. Jacob has created technology-based startup companies and supported the expansion of existing companies in both the physical and life sciences. He currently serves as the CEO of Cancer Prevention Pharmaceuticals, a development stage company pioneering preventative therapeutics in Oncology. Mr. Jacob is a founding Board Member and previously served as the Chief Program Officer of Critical Path Institute (C-Path); he was responsible for creating C-Path's business plan and initial programs. On behalf of C-Path, Mr. Jacob currently serves as Interim President of the National Biosignature Laboratory initiative, which aims to create analytical standards for biomarkers and assays used in Healthcare research. Between 1987 and 2004, Mr. Jacob worked with Research Corporation Technologies (RCT), most recently as its Senior Vice President. During this time, he led the transformation of the company from a patent development and licensing organization to an early-stage technology incubation and venture development firm. Mr. Jacob has a Master's degree in engineering and a Master's degree in Technology and Policy from Massachusetts Institute of Technology.
Michael Kasser, MBA, PhD
Michael Kasser is the CEO and President of Holualoa Companies, a real estate investment company with interests in residential and commercial real estate in the Northeast, Southwest, Hawaii and Europe. Mr. Kasser started Holualoa in 1985. His previous experience includes positions as financial analyst with WR Grace & Co.; as President of Technopulp, Inc., a pulp and paper consultant, and as CEO of Booher Lumber Company. Mr. Kasser's community activities have included: Chairman of the Salary Commission for the County of Hawaii; in addition, he has been a member of the board of the Kona Hawaii Family MCA, the Aloha Performing Arts Center, the American Hungarian Foundation, the National Museum of Women in the Arts, and the Kasser Art Foundation; and is presently a trustee or board member of the University of Arizona Foundation, the College of Science at the University of Arizona, the Tucson Museum of Art, and The Metropolitan Museum of Art Department of Scientific Research Visiting Committee. His outside business activities have included board memberships of: CyraCom, Inc., a language interpretation company; Protein Sciences, Inc., a biotech company; and West Maricopa Combine, Inc., a water company. He has also served as an Educational Counselor for M.I.T. and as a member of its Corporation Development Committee, and is presently a member of the M.I.T. Music and Theatre Arts Visiting Committee. Mike has a BS and an MS in Chemical Engineering from M.I.T., a Doctorate of Engineering from the University of Grenoble (France) and an MBA from Harvard Business School. He is fluent in French, German, Spanish, Italian and Hungarian.
Shaun A. Kirkpatrick, MA
Mr. Kirkpatrick is president and chief executive officer of Research Corporation Technologies (RCT) in Tucson, Ariz., and serves on the company's Board of Directors. Kirkpatrick oversees RCT's BioVentures investment portfolio and technology development and licensing activities in North America, Europe and Australia. In addition to overseeing company-wide matters, he manages a portfolio of technology investments and companies in the biomedical sciences for RCT. He also plays an active role in creating new companies around novel therapeutics and biomedical platforms, and serves as executive management during the incubation phase. Mr. Kirkpatrick received his master's degree in international economics and science/technology in international economics from Johns Hopkins University School of Advanced International Studies in Washington, D.C., and Bologna, Italy. He graduated summa cum laude from The University of Arizona in Tucson with a dual major in economics and ecology/evolutionary biology. He also studied at the London School of Economics, the University of Kansas and Eastern Michigan University. RCT is a technology investment and management company that provides early/seed-stage funding and development for promising biomedical companies and technologies originating in the world's universities and research institutions.
The Honorable James T. Kolbe
Mr. Kolbe currently serves as a Senior Transatlantic Fellow for the German Marshall Fund of the United States. Mr. Kolbe advises on trade matters as well as issues of effectiveness of US assistance to foreign countries, on US-EU relationships, and on migration and its relationship to development. He is co-chair of the Transatlantic Taskforce on Development with Gunilla Carlsson, the Swedish Minister for International Development Cooperation. He also serves as an adjunct Professor in the College of Business at The University of Arizona, and serves on a part time basis as strategic consultant with McLarty Associates. For 22 years, Mr. Kolbe served in the United States House of Representatives, elected for eleven consecutive terms (1985 to 2007). He represented the Eighth congressional district, comprising the southeastern part of Arizona with Tucson as the main population area. While in Congress, Jim served for 20 years on the Appropriations Committee of the House of Representatives. He was Chairman of the Treasury, Post Office, and Related Agencies subcommittee for four years, and for the last six years in Congress, he chaired the Foreign Operations, Export Financing, and Related Agencies subcommittee. Kolbe graduated from Northwestern University with a BA degree in Political Science and then from Stanford University with an MBA with a concentration in economics.
Rick Myers has been named to the Board after leaving his role as Chief Operating Office of Critical Path Institute, a position he held from January 2009 through March 2012. Rick is currently starting his third year of an eight-year term serving as a Regent with the Arizona Board of Regents. Prior to C-Path, Mr. Myers retired from IBM Corporation after twenty-five years of service where he served as Vice President of Development, Storage Systems and was a member of the Chairman's Senior Management Group. An engineer by training, Mr. Myers led a research and development facility with 1600 scientists creating innovations in mass data storage and retrieval technologies. Mr. Myers is very active in the state and local communities as a member of several other boards, including Science Foundation Arizona, Tucson Airport Authority, Women's Foundation of Southern Arizona, National Advisory Board for The University of Arizona Science Center, and the Arizona State Commerce Global Network Board. He is the immediate past Chair of the Southern Arizona Leadership Council, an association of local CEOs focused on improving Tucson and Southern Arizona. Mr. Myers is recognized for his leadership and team building skills, as well as his expertise in creating and managing organizational systems. He earned his Bachelor of Science in Mechanical Engineering at the University of Alabama.
Cindy Parseghian is President of the Ara Parseghian Medical Research Foundation. Along with her husband, Michael, she is co-founder of the Ara Parseghian Medical Research Foundation, which they started in 1994 in an effort to find a cure for Niemann-Pick Type C disease, a rare and fatal genetic disorder that struck three of their four children. As President, Mrs. Parseghian has spearheaded a successful fundraising campaign raising more than $36 million in 16 years. Of the more than 400 rare disease organizations in America, the Parseghian Foundation has raised more funds than perhaps any other. Cindy Parseghian serves on a number of community and state and national boards including among others the National Institute of Neurological Disorders and Stroke Advisory Council, University of Notre Dame College of Science Advisory Council, Translational Genomics Inc. (TGen), The Critical Path Institute (C-Path), San Miguel High School. Prior to founding the Ara Parseghian Medical Research Foundation, Mrs. Parseghian worked for 7 years as President, CFO, and Controller of MCS Telecommunications in Tucson. She earned a BBA in Accounting at the University of Notre Dame, and a Masters of Management from the J.L. Kellogg Graduate School of Management at Northwestern University. Mrs. Parseghian has also successfully passed the CPA exam.
Alastair J.J. Wood, MB, ChB
Dr. Wood received his medical degree from St Andrew's University and Dundee Medical School in Scotland. He joined the Faculty at Vanderbilt University School of Medicine in 1978 where he became tenured Professor of both Medicine and Pharmacology, and Attending Physician at Vanderbilt Medical School. He was Assistant Vice Chancellor for Clinical Research (1999-2004), and Associate Dean, Vanderbilt Medical School (2004-2006) before being appointed Emeritus Professor of Medicine and Emeritus Professor of Pharmacology in 2006. His current academic appointments are Professor of Medicine and Professor of Pharmacology at Weill Cornell Medical College, New York. Dr. Wood has served on a number of Editorial Boards. He was a member of The New England Journal of Medicine Editorial Board (2004-2006); he was the Drug Therapy Editor of The New England Journal of Medicine from 1985 to 2004, and is currently on the Editorial Board of The British Journal of Clinical Pharmacology and The Scientist. He has previously served on the Editorial Boards of Clinical Pharmacology and Therapeutics and Biopharmaceutics and Drug Disposition. He authored the Chapter in Harrison's Principles of Internal Medicine on Adverse Drug Reactions from the 9th through the 15th edition.
Janet Woodcock, MD
Liaison Advisory Member – Non-voting
Dr. Woodcock is the Director of the Center for Drug Evaluation and Research within the United States Food and Drug Administration. Dr. Woodcock has served the FDA as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. In these roles, she oversaw scientific and medical regulatory operations. Dr. Woodcock served as Director of the Center for Drug Evaluation and Research from 1994 to 2005. She previously held other positions at the FDA including Director, Office of Therapeutics Research and Review, and Acting Deputy Director, Center for Biologics Evaluation and Research. Dr. Woodcock received her MD from Northwestern Medical School, and completed further training and held teaching appointments at Pennsylvania State University and the University of California in San Francisco. She joined the FDA in 1986.