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
Thorir D. Bjornsson, MD, PhD
Dr. Bjornsson has held academic appointments at Duke University Medical Center in Durham, North Carolina, and at Jefferson Medical College in Philadelphia, Pennsylvania. During his academic career, Dr. Bjornsson maintained an active research laboratory and clinical research unit, funded by federal and foundation grants, and industry support. In his biopharmaceutical industry career, Dr. Bjornsson led global early clinical development across all therapeutic areas, first at Bristol-Myers Squibb in Princeton, New Jersey, and subsequently at Wyeth Pharmaceuticals in Collegeville, Pennsylvania. At both companies, he led numerous cross-functional initiatives aimed at improving specific scientific, organizational, or operational issues, such as back-up compound strategies, translational medicine, biomarker laboratory, early development cycle times, and unmet medical need assessment. Dr. Bjornsson is the author or co-author of approximately 225 published papers, abstracts, and book chapters. He is the recipient of numerous awards and honors, including Nanaline Duke Scholar at Duke University, Samuel M.V. Hamilton Family Professor of Medicine at Jefferson, President's Award at BMS, and Team-of-the-Year Award at Wyeth. He has served on numerous national selection committees, including the NIH Pharmacology Study Section and the PhRMA Foundation's Clinical Pharmacology Selection Committee. Dr. Bjornsson is a graduate of the Medical School of the University of Iceland. After initial clinical training in hematology/oncology, he trained in clinical pharmacology at Stanford University Medical Center. Dr. Bjornsson's specialties include early clinical drug development; clinical pharmacology; translational medicine and therapeutics; experimental medicine; preclinical candidate assessment and selection; drug development; pharmaceutical predictivity; biomarker applications; quantitative pharmacology; dose range selection; clinical safety margins; biological/clinical knowledge representation; portfolio strategies; and unmet medical needs assessment.
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.
Craig Brater, MD
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.
Dr. Samuel Broder
Dr. Samuel Broder has served at the NIH and in the private sector as a scientist and clinician in medical oncology. He was a founding member of Celera in 1998, serving as Executive Vice President for Medical Research and Chief Medical Officer. He worked with the Celera Team that sequenced and assembled the human genome, with a special focus on applying new genomic discoveries to the evolving ideas of Personalized or
Targeted Medicine.
Before joining the company, in 1989 he had been appointed by President Reagan to serve as Director of the National Cancer Institute (NCI), a position he held for 6 years. His laboratory interests include anti-retroviral therapy, and also, the relationship between immunodeficiency disorders and cancer. His laboratory, within the intramural NCI, focused on the role of suppressor cells in various immunodeficiency states, neoplasms of immunoregulatory T cells, and the relationship between cancer and immunodeficiency disease. In the mid 1980s, the team he led developed the foundational drugs now widely used in the therapy of AIDS and its related disorders in adults and children, including dideoxynucleosides such as Retrovir® (AZT) and Videx®(ddI), which are still in use today.. He also oversaw the development of other anti-cancer agents, such as TAXOL®.
While serving as NCI Director, he helped launch a number of large-scale, randomized
clinical trials related to the prevention, diagnosis, and treatment of cancer & Women's
Health, and inaugurated the SPORE Program at the NCI. Several of these studies
required interaction and collaboration with trials groups across the USA and Europe and
other parts of the world. He implemented a number of programs focused on translating
basic science discoveries into practical clinical applications. He helped launch several
major randomized trials in the prevention of breast and prostate cancer. He is the author
or co-author of more than 340 scientific publications. He is a member of numerous
scientific organizations, including the Institute of Medicine (elected 1993) of the National
Academy of Sciences, and has received numerous scientific awards related to his
research in cancer and AIDS. His current interests relate to applying knowledge of the
human genome, DNA diagnostics, and proteomics to the development of new strategies
to diagnose and treat heart disease and cancer.
ShaAvhrée Buckman, MD, PhD
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.
John L. Carter, MBA
John L. Carter joined the IBM Corporation in 1956 at Owego, New York. He held various jobs within the company prior to becoming Plant Manager of IBM's Rochester, MN operation in 1974. He came to Tucson in 1977 as General Manager to start up a 5000-employee facility, and retired from IBM in 1987. He has continued in executive positions or board of directors roles since that time. Mr. Carter is a graduate of Purdue University with a Bachelor's Degree in Civil Engineering, and earned an MBA with a major in Finance from the University of Pennsylvania's Wharton School. Some of his current activities include being a member of the Tucson Airport Authority and The University of Arizona College of Science Dean's Board of Advisors. He is also on the Boards of Directors for Critical Path Institute, Unisource, Tucson Electric Power, the Thomas R. Brown Family Foundation, Research Park Development Corporation, and Global Solar, Inc. Previous board memberships include the University of Arizona Foundation, the Arizona Council on Economic Education, the Heard Museum in Phoenix, The Arizona State Chamber of Commerce, HealthPartners of Arizona, TMC Healthcare, the Arizona Bank, and the United Way of Tucson.
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 partner in the Cooley Godward Kronish Business department. He joined the Firm in 1992 as a founding partner in the San Diego office and currently serves on the Firm's Marketing Committee. Mr. Fishburn has been counsel to public and private companies operating in a variety of environments, including biotechnology, information technology, internet, computer hardware and software, communications, composite materials, retail, service and manufacturing industries. Mr. Fishburn received a J.D. degree in 1981 from the University of California, Hastings College of the Law and served as President of the Hastings Board of Governors. He received a B.A. from the University of Arizona and has served on the University of Arizona Technology Advisory Committee. Mr. Fishburn completed post-graduate study at the Australian National University and was appointed as a Senior Fellow of Bergmann College affiliated with the A.N.U. Mr. Fishburn is admitted to practice before the State Bar of Arizona and the California State Bar and is a member of the American Bar Association.
James C. Greenwood
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 – 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.
Cindy Parseghian
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
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.
Raymond L. Woosley, MD, PhD
Dr. Raymond Woosley is the founding President and Chairman of the Board of The Critical Path Institute (C-Path). Dr. Woosley is also the Director of the Arizona Center for Education and Research on Therapeutics that is funded by a grant to C-Path from the Agency for Healthcare Research and Quality. Prior to founding C-Path, Dr. Woosley was Vice President for The University of Arizona (UA) Health Sciences Center and Dean of the UA College of Medicine. He was Associate Dean for Clinical Research and Chair of the Department of Pharmacology at Georgetown University School of Medicine. Dr. Woosley was a professor at Vanderbilt University Medical School and the first US scientist for Glaxo's initial US operations. Dr. Woosley earned his Ph.D. in Pharmacology from the University of Louisville, his M.D. from the University of Miami and completed post-doctoral training in pharmacology, internal medicine and clinical pharmacology. His research has been published in over 265 peer-reviewed publications and 50 book chapters. He is a member of the National Academy of Science's Institute of Medicine's Drug Forum.