Executive Director, Coalition Against Major Diseases
Director, Contracts and Legal Services
Chief Operating Officer
President and CEO
Executive Director and Scientific Lead Pediatric Trials Consortium
Executive Director, Patient-Reported Outcome Consortium
Director, Electronic Patient-Reported Outcome Consortium, Assistant Director, Patient-Reported Outcome Consortium
Executive Director, Critical Path to TB Drug Regimens Regulatory Science Consortium
Executive Director of European Office
Chief Science Officer; Executive Director, Multiple Sclerosis Outcome Assessments Consortium and International Neonatal Consortium
Executive Director, Duchenne Regulatory Science Consortium
Chief Technology Officer and Director, Data Collaboration Center
Executive Director, Type 1 Diabetes and Therapeutic Transplant Consortia
Director, Consortia Scientific Support
Director, Clinical Pharmacology
Executive Director, Predictive Safety Testing Consortium
Executive Director, Critical Path for Parkinson's Consortium
Director, Regulatory Strategy & Submissions
President Emeritus; Former Chairman of the Board
D. Craig Brater, MD, is Vice President of Programs at both the Walther Cancer Foundation and the Regenstrief Foundation both of which are based in Indianapolis. Dr. Brater served as the ninth dean of the Indiana University School of Medicine for 13 years before retiring from that position in 2013, at which time he was presented with the university’s highest honor, The University Medal, by IU President Michael McRobbie, for his visionary leadership. He is a nationally known expert on the effects of diuretics and of non-steroidal inflammatory drugs on renal function. Upon joining Indiana University in 1986, he established the Division of Clinical Pharmacology in the Department of Medicine. In 1990, Dr. Brater became chairman of the Department of Medicine, the largest department at Indiana University. He serves as a board member of BioCrossroads, and is President of the Alliance for Academic Internal Medicine. He has also been a member of the United States Olympic Committee ethics committee and on the editorial board for the American Journal of Medicine, and serves on the National Institutes of Health National Advisory Council for Complementary and Alternative Medicine. Dr. Brater received his BA degree in Chemistry and his MD from Duke University in Durham, North Carolina. He is also the recipient of numerous awards and honors, including the Lifetime Award for Distinguished Service in Years of Health Advancement from the Indiana Public Health Foundation and the Oscar B. Hunter Award from the American Society for Clinical Pharmacology and Therapeutics.
Dr. Peter Corr is Co-founder and General Partner of Auven 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. Missouri.
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. is a founding partner of Cooley LLP’s San Diego office and leads the firm’s 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.
Dr. Timothy R. Franson is Chief Medical Officer for YourEncore, responsible for the strategy and development of their clinical, regulatory, pharmacovigilance, and quality program offerings. He has extensive clinical and regulatory experience in all pre- and post-approval phases of pharmaceutical development relating to interactions with the FDA for policy and product issues, as well as with global regulators. He also serves as the current president of the U.S. Pharmacopeial Convention and on the Executive Committee of its Board of Trustees.
Dr. Franson was the founder and president of Franson PharmAdvisors LLC, a clinical and regulatory pharmaceutical development consulting firm that merged with FaegreBD Consulting. Prior to this, Dr. Franson was Vice President of Global Regulatory Affairs at Lilly Research Laboratories (Eli Lilly and Company) after serving as their Vice President of Clinical Research and Regulatory Affairs-U.S.
Dr. Franson was co-chair of the joint FDA-industry working group addressing clinical aspects of the FDA Modernization Act of 1997, including the Prescription Drug User Fee Act (PDUFA) renewal. He also co-chaired an FDA-industry safety interventions working group, was a member of the AAMC-PhRMA Clinical Trials Forum and of the Regulatory Advisory Board for the Centre for Medicines Research International. He recently served on the NIH-NCATS Treatment of Rare and Neglected Diseases (TRND) review panel, and currently serves as President of the United States Pharmacopeial Convention.
Dr. Franson has authored more than 50 articles in the fields of infectious disease, epidemiology, pharmacoeconomics, and antibiotic utilization, as well as four book chapters relating to innovation policy topics. He also served as a member of the Board of Directors for Myrexis (formerly Myriad) Pharmaceuticals from 2010 to 2013.
Dr. Franson received his BS in Pharmacy from Drake University, his MD from the University of Illinois College of Medicine, Internal Medicine training from the University of Iowa, and completed a Fellowship in Infectious Diseases and Epidemiology at the Medical College of Wisconsin.
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 for increasing both its staff and budget by nearly 50 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.
Peter Barton Hutt is a Senior Counsel in the Washington, DC law firm of Covington & Burling LLP, specializing in Food and Drug Law. He began his law practice with the firm in 1960 and, except for his four years in the government, has continued at the firm ever since. From 1971 to 1975 he was Chief Counsel for the Food and Drug Administration.
Since 1994, he has taught a full course on Food and Drug Law during Winter Term at Harvard Law School. He taught the same course at Stanford Law School during Spring Term in 1998. He is the co-author of Food and Drug Law: Cases and Materials (Foundation Press, 1st edition 1980, 2d edition 1991, 3d edition 2007, 4th edition 2014, and has published more than 175 book chapters and articles on Food and Drug Law and on health policy.
He has represented the national trade associations for the food, prescription drug, nonprescription drug, dietary supplement, and cosmetic industries. While at FDA he drafted the legislation that became the Drug Listing Act of 1972 and the Medical Device Amendments of 1976, and beginning in 1962 he has participated in the drafting of major legislation amending the Federal Food, Drug, and Cosmetic Act. He has testified before the House and Senate more than 100 times either as counsel accompanying a witness or as a witness.
Mr. Hutt has been a member of the Institute of Medicine (IOM) of the National Academy of Sciences since it was formed in 1971. He has served on the IOM Executive Committee and other NAS and IOM committees. He recently served as a member of the Working Group on Innovation in Drug Development and Evaluation for President Obama’s Council of Advisors on Science and Technology (PCAST). He served on the Science Review Subcommittee of the FDA Science Board to review the FDA science needs in order to perform its regulatory mission, and published a major analysis that resulted in Congress doubling FDA appropriations. He also recently served on the Panel on the Administrative Restructuring of the National Institutes of Health and on the Working Group to Review Regulatory Activities within the Division of AIDS of the National Institute of Allergy and Infectious Diseases. He is a member of the Board of Directors of the AERAS Global TB Vaccine Foundation, the Foundation for Biomedical Research, the California Healthcare Institute, and the Institute of Health Policy Analysis. He serves on a wide variety of other academic and scientific advisory boards, on the Board of Directors of venture capital start-up companies, and on the Advisory Boards of venture capital firms.
Mr. Hutt has served on the IOM Roundtable for the Development of Drugs and Vaccines Against AIDS, the Advisory Committee to the Director of the National Institutes of Health, the NAS Committee on Research Training in the Biomedical and Behavioral Sciences, the NIH Advisory Committee to Review the Guidelines for Recombinant DNA Research, the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS established by the President’s Cancer Panel of the National Cancer Institute at the request of President Bush, the Keck Graduate Institute of Applied Life Sciences, one of the Claremont Colleges, and five Office of Technology Assessment advisory panels. He was a member of the New Foods Panel of the White House Conference on Food, Nutrition and Health and authored the panel report. He has twice been a councilor of the Society for Risk Analysis and has served as Legal Counsel to the Society as well as the American College of Toxicology.
During the 1960s, Mr. Hutt litigated pro bono cases on behalf of homeless alcoholics and drug addicts. He co-argued the only alcoholism case ever heard in the United States Supreme Court, Powell v. Texas, and then drafted the legislation that created the National Institute of Alcohol Abuse and Alcoholism and the National Institute of Drug Abuse. Based on this work, two-thirds of the States have repealed their statutes that had made public intoxication a criminal offense.
He was named by The Washingtonian magazine as one of Washington’s 50 best lawyers (out of more than 40,000) and as one of Washington’s 100 most influential people; by the National Law Journal as one the 40 best health care lawyers in the United States; and by Global Counsel as the best FDA regulatory specialist in Washington, DC. Business Week referred to Mr. Hutt in June 2003 as the “unofficial dean of Washington food and drug lawyers.” In naming Mr. Hutt in September 2005 as one of the eleven best food and drug lawyers, the Legal Times also referred to him as “the dean of the food-and-drug bar.” In April 2005, Mr. Hutt was presented the Distinguished Alumni Award by FDA. In May 2005, he was given the Lifetime Achievement Award for research advocacy by the Foundation for Biomedical Research. The Best Lawyers of America selected Mr. Hutt as the 2013 FDA Lawyer of the Year for Washington, DC.
Mr. Jeffrey Jacob is the CEO of Cancer Prevention Pharmaceuticals, a development stage company pioneering preventative therapeutics in oncology. He is also 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. 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.
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 the Massachusetts Institute of Technology.
Dr. 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. Dr. Kasser started at 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. Dr. 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 and/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. Dr. Kasser has a bachelor of science degree and master’s of science 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.
Mr. Shaun Kirkpatrick is president and chief executive officer of Research Corporation Technologies (RCT) in Tucson, Arizona, 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 dual undergraduate degrees 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.
Alan Levin served as Executive Vice President & Chief Financial Officer of Endo Health Solutions Inc. from June 2009 until September 2013. Prior to joining Endo, Mr. Levin worked with Texas Pacific Group, a leading private equity firm, and one of their start-up investments. Before that, he was Senior Vice President & Chief Financial Officer of Pfizer Inc., where he worked for 20 years in a variety of executive positions of increasing responsibility. Mr. Levin received a bachelor’s degree from Princeton University and a master’s degree from New York University’s Stern School of Business. He is a certified public accountant and a member of the Advisory Board of Auven Therapeutics, a private equity fund, where he chairs the fund’s Audit & Risk Committee. In addition to Critical Path Institute, he is also a member of the Boards of Directors of Aceto Corp, a NASDAQ-traded company specialized in generics and pharmaceutical intermediate products, and Diffusion Pharmaceuticals LLC, a development stage oncology company.
Mr. Rick Myers was named to the board after serving as Chief Operating Officer of C-Path, a position he held from January 2009 through March 2012. Rick was appointed to the Arizona Board of Regents (ABOR) in 2010, and currently serves as treasurer of the Board, chair of the Legislative Affairs Committee, and is a member of the Regents’ Executive Committee and the Health Affairs Committee. He recently completed two years as the ABOR Chair. Prior to C-Path, Mr. Myers retired from IBM Corporation after 25 years of service where he served as Vice President of Development for 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 1,600 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, the 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 degree in Mechanical Engineering at the University of Alabama.
Paula J. Olsiewski, Ph.D. joined the Alfred P. Sloan Foundation as a Program Director in 2000. Dr. Olsiewski created and directs the Foundation’s programs in Microbiology of the Built Environment and Synthetic Biology, for which grantmaking was concluded in 2014. Dr. Olsiewski led Sloan’s Biosecurity program until its conclusion in 2010. She also oversees the Sloan Public Service Awards, the Foundation’s Civic Initiatives, and the Sloan Awards for Excellence in Teaching Science and Mathematics.
Dr. Olsiewski serves on numerous advisory committees and boards, including serving as the Chair of the Board of Scientific Counselors Homeland Security Research Subcommittee at the U.S. Environmental Protection Agency. She previously served on the advisory board for the National Consortium for the Study of Terrorism and Responses to Terrorism (START), a Center of Excellence of the U.S Department of Homeland Security based at the University of Maryland (2005- 2012). She served on the Board of Advisors for the WMD Center’s Bio-Response Report Card in 2011 and was a member of the NRC Committee on Advances in Technology and the Prevention of their Application to Next Generation Biowarfare Threats, which produced the “Globalization, Biosecurity, and the Future of Life Sciences” report (2006).
Dr. Olsiewski serves as Board Chair of the Dominican Friars Health Care Ministry of New York. She also is a board member of the Spondylitis Association of America and is the Yale Alumni Fund Co-Chair of Agents for the Class of 1975. She was a member of the MIT Corporation (2003-2009), was President of the MIT Alumni Association (2003-2004), and served on the MIT Initiative on Faculty Race and Diversity Advisory Committee (2008-2009). Dr. Olsiewski also was a member of the Board of Trustees of Asphalt Green, Inc. (1997-2009) and served at Board Chair (2000-2005). Dr. Olsiewski has received awards for fundraising from Yale, MIT, and Asphalt Green.
Prior to joining the Foundation, Dr. Olsiewski served in many capacities in the biotech and biomedical community. She directed the New York City Biotechnology Initiative, a state-funded program under the auspices of the New York Biotechnology Association, to improve the region’s ability to grow biotechnology companies by fostering relationships between academia and industry. She established and directed the technology licensing office at the Hospital for Special Surgery, an affiliate of Weill Medical College of Cornell University. Dr. Olsiewski has served as a consultant on numerous projects, providing technical analysis of biomedical companies and technologies for investment banking groups and state economic development agencies. She worked for nine years at Enzo Biochem, Inc., a publicly traded biotechnology company, where she directed commercial development activities for a variety of in vitro diagnostic products.
Dr. Olsiewski received a Bachelor of Science in chemistry from Yale College and a Doctorate in biological chemistry from MIT.
Mrs. 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. She serves on a number of community and state and national boards including 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), and San Miguel High School. Prior to founding the Ara Parseghian Medical Research Foundation, Mrs. Parseghian worked for seven years as President, CFO and Controller of MCS Telecommunications in Tucson. She earned a bachelor of business administration degree in Accounting at the University of Notre Dame, and a master’s degree in Management from the J.L. Kellogg Graduate School of Management at Northwestern University. Mrs. Parseghian has also successfully passed the CPA exam.
Dr. Alastair 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 of 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 in 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.
Steve joined the Critical Path Institute in 2015 and leads the Coalition Against Major Diseases (CAMD) to build drug development tools with industry (14 members), academic, and key patient advocacy foundations (5 members), and qualify these tools with regulators such as the FDA & EMA to accelerate the delivery of foundational information required to deliver innovative medicines to treat Alzheimer’s disease and related neurodegenerative disorders with impaired cognition and function.
Prior to joining the Critical Path Institute, Steve was an accomplished pharmaceutical scientist and leader with a proven track record to deliver differentiated therapeutics. Experience spanning more than 25 years of large pharma (Abbott, Lilly, Pharmacia, & Pfizer), biotechnology (DuPont Pharmaceuticals, Neuromed Pharmaceuticals), and academic service (University of Iowa, Cornell Medical College, Southern Illinois University School of Medicine) resulted in 30+ drug candidates entering into clinical development to treat pain, neurological, psychiatric, and urological diseases. Dr. Arnerić has demonstrated his ability to lead complex cross-functional matrix organizations of 100+ staff, and effectively manage budgets within target. His Ph3 or Launched Product Development experience includes the following: Exalgo™(Oros-hydromorphone for OA & CLBP), Esreboxetine (DPNP), Dynastat™(acute pain), Lyrica™(neuropathic pain), Cymbalta™ (musculoskeletal pain, fibromyalgia, DPNP), Mirapex™(Parkinson’s Disease, RLS) and Detrol™(overactive bladder). He is a leader that leverages global alliances and cross-organizational strengths to maximize organizational efficiencies (Merck, Recordati, Covance, NeuroSearch, RaQualia, Jubilant, Noxxon, Arteus, PsychoGenics, AnaBios, Chorus, Scripps, Univ of Pittsburgh, University of Colorado, University of Geneva, ORCATECH, Univ. of Arizona, Univ. of British Columbia, etc.). Dr. Arnerić is a medical educator experienced in teaching medical students, graduate students, and neuroscience medical liaisons – he currently holds a position as Adjunct Professor of Pharmacology, SIU School of Medicine, and Research Professor of Medicine, The University of Arizona. He has authored 146 peer-reviewed articles, 201 abstracts, 17 chapters, 1 book, numerous IND submissions, as well as being a co-inventor/author of 15 patents.
Lewis Barbieri graduated from St. John’s University, School of Law, in 1994, and was admitted to the New York Bar in 1995. He then worked at Pfizer Inc in Manhattan for twelve years. During his time at Pfizer, Lew worked in the Contracts and Outsourcing group, negotiating, then managing others who negotiated, clinical trial agreements with academic sites, and service agreements with Contract Research Organizations (CROs) who were selected through a competitive bidding process to perform management and monitoring activities in support of Pfizer’s clinical trials. In 2006, Lew moved from New York City to Tucson and began nine years of employment as the Director of the Office of Research and Contract Analysis (ORCA) at The University of Arizona. In this role, Lew managed a department of seventeen people in their efforts to bring research funding into the university through the negotiation of all manner of agreements. Lew joined C-Path July 1, 2015.
Mr. Steve Broadbent is responsible for the daily operations of the organization as well as developing and implementing C-Path’s strategy and goals. He manages the organization’s finances, human resources, facilities, information technology and personnel. In addition, he also oversees C-Path’s consortia efforts to ensure successful qualification of safety and efficacy biomarkers, disease progression models, patient-reported outcome instruments and other drug development tools.
Before joining C-Path, Mr. Broadbent was an IBM executive with nearly 31 years of experience in storage product development. He managed over 400 engineers in four countries with responsibility for architecting, developing, testing and supporting IBM’s largest and most complex disk storage systems—those used by top businesses and government agencies to store their most important data.
He earned a bachelor of science degree in electrical engineering from the University of Idaho and a master’s of business administration from the Eller College of Management at the University of Arizona. He is also a certified Project Manager.
Dr. Martha Brumfield is President and Chief Executive Officer of the Critical Path Institute, an Arizona-based non-profit (501(c)(3)). In this role, Brumfield leads the institute in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science, which is accomplished by leading teams that share data, knowledge, and expertise resulting in sound, consensus-based science. Brumfield assumes the role of CEO after most recently serving as Critical Path Institute’s Director of International and Regulatory Programs. In that position, she helped guide international program development and provided regulatory expertise to consortia. She is also a Professor at College of Pharmacy, The University of Arizona.
She also has her own consulting practice (Martha A. Brumfield LLC) focusing on concordance in global regulatory initiatives and regulatory science qualification programs. Other areas of focus in her practice include excellence in clinical trial conduct and pharmacovigilance, facilitation of scientific consortia, and programs supporting patient access to medicines.
Brumfield brings 20 years of experience from Pfizer Inc., most recently, as senior vice president of worldwide regulatory affairs and quality assurance. There, she led a global team that supported lifecycle pharmaceutical research, development, and commercialization through creation and implementation of regulatory strategies and quality assurance oversight. Brumfield also played a key role in managing the broader company relationships with global regulators, trade associations, academics, and others on regulatory policy issues. She served on corporate governance initiatives including the planning and implementation of mergers and acquisitions, and led her departments through these periods of significant change.
She is Chair of the Board of Directors for the Regulatory Affairs Professional Society, and chaired the Global Curriculum Coordinating Committee with FDA’s Office of International Policy, which oversaw the development of a competency framework for regulators in developing countries. She is also active with global nonprofits, including the Regulatory Harmonization Institute and GlobalMD, where she delivers educational workshops on regulatory and clinical trial topics in Asia. She has served on and contributed to the Institute of Medicine consensus committees, which were commissioned by U.S. FDA focusing on global regulatory systems and on falsified and substandard drugs. She also serves on the Steering Committee of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard.
Brumfield earned a Bachelor of Science degree and a Master of Science degree in Chemistry from Virginia Commonwealth University, a Ph.D. in Organic Chemistry from the University of Maryland, and served as a post-doctoral fellow at The Rockefeller University.
Dr. Connor (Clinical Research Alliance, LLC) is Executive Director and Scientific Lead for the Pediatric Trials Consortium at the Critical Path Institute and Emeritus Professor of Pediatrics, Microbiology, Immunology and Tropical Medicine at George Washington University and Children’s National Health System. He holds an MD and Masters Degree in Bioethics from the Perelman School of Medicine at the University of Pennsylvania and did postgraduate training in Pediatrics at Northwestern and Pediatric Infectious Diseases at the University of Rochester. He has more than 30 years of experience in drug and biologics development in academia and the biotechnology industry. He was PI of the Pediatric AIDS Clinical Trials Unit at New Jersey Medical School, Chairman of the national NIAID-ACTG Pediatric Research Committee, and PI of ACTG 076 that led to FDA approval of zidovudine for prevention of mother-to-infant transmission of HIV. Dr. Connor served as an advisor to NIH, FDA, CDC, WHO and other authorities and led initial efforts to establish standards of care for HIV-infected children and pregnant women.
Subsequently Dr. Connor was the Executive Vice President and Chief Medical Officer at MedImmune, directing clinical development programs, including ones leading to regulatory approval of products for prevention of serious Respiratory Syncytial Virus disease and a live attenuated intranasal influenza vaccine. He was also responsible for Medical Affairs, Product Safety, and Clinical Operations, including Biostatistics/Data Management and was Co-Chair of the company’s product development committee. In 2008, Dr. Connor returned to academia as Director of the Office of Innovation Development at Children’s National Health System; Professor of Pediatrics, Microbiology, Immunology and Tropical Medicine at George Washington University School of Medicine and Health Sciences; and member of the executive team at the Clinical and Translational Science Institute at Children’s National in Washington DC.
Prior to joining C-Path, Dr. Stephen Joel Coons was a professor in the College of Pharmacy and the Mel & Enid Zuckerman College of Public Health at The University of Arizona. In addition, Dr. Coons served as co-director of the Arizona Cancer Center’s Behavioral Measurements Shared Service. For over two decades, the primary focus of his research has been the measurement of patient-reported outcomes, including health-related quality of life.
After receiving a BS in pharmacy from the University of Connecticut, Dr. Coons completed a hospital pharmacy residency at the VA Medical Center in Phoenix, Arizona and earned an MS in pharmacy, an MEd in higher education, and a PhD in pharmacy (administrative and behavioral sciences) at The University of Arizona. His post-doctoral training in health outcomes research was completed at the University of California, San Diego (UCSD). Previous academic appointments have been in the colleges of pharmacy, medicine, and allied health professions at the University of Kentucky and in the Division of Health Care Sciences at the UCSD School of Medicine. Dr. Coons is an emeritus professor at The University of Arizona and a fellow in the American Association of Pharmaceutical Scientists.
Mabel Crescioni is currently Director, Electronic Patient-Reported Outcome (ePRO) Consortium, and Assistant Director, Patient-Reported Outcome (PRO) Consortium at the Critical Path Institute. Mabel is also an Instructor at the Mel & Enid Zuckerman College of Public Health, The University of Arizona (UA), where she teaches Public Health Policy and Management. Prior to joining C-Path, Mabel was an Assistant Professor at the UA College of Medicine. She completed a post-doctoral fellowship at the UA College of Medicine’s Department of Ophthalmology, where she worked on a longitudinal study of refractive error among Native American children validating PRO measures for children who receive spectacle correction. In addition, she has served as consultant to state and tribal health departments, health centers, and other health-related non-profit organizations. After completing her Bachelor of Arts degree in Communications at Rutgers University, Mabel earned a JD at Interamerican University of Puerto Rico, an LLM in Health Care Law at Saint Louis University, and a Doctor of Public Health (DrPH) at the UA. Prior to joining the UA, she also served as Health Policy Advisor to the Governor of Puerto Rico.
Debra Hanna, PhD, is the Executive Director of the Critical Path to TB Drug Regimens (CPTR) initiative led by the Critical Path Institute and funded by the Bill & Melinda Gates Foundation. In her role as Executive Director, Debra coordinates this global, multi-sector partnership that is driven by the contributions of 260+ members and partners. She leads the expanding tuberculosis (TB) data collaboration initiative and multiple program teams focused on accelerating the development of novel drug regimens and rapid drug susceptibility tests for TB. This work is accomplished by facilitating the advancement of innovative regulatory science approaches, qualification of novel drug development tools and biomarkers as well as the development of TB clinical trial modeling and simulation tools.
Prior to joining Critical Path Institute, Dr. Hanna spent 11 years in the Antibacterial Research and Development Unit of Pfizer Global Research and Development. She was the Research Project Leader for multiple Antibacterial Drug Development programs and also led an innovative translational research team focused on understanding pharmacodynamics and pharmacokinetic relationships for novel antibacterial agents spanning early discovery to Phase 2 development. She has contributed to 40+ peer-reviewed publications in 16 high-impact journals, most notably, three journal supplements focused on TB drug development tools, diagnostics, and regulatory approaches in Clinical Infectious Diseases and Journal of Infectious Diseases.
Debra received her doctorate in Microbiology from North Carolina State University and her Bachelor of Science degree in Microbiology and Immunology from Colorado State University. Dr. Hanna’s passion for tuberculosis research began with her postdoctoral fellowship at the University of California, San Diego, and motivated her to pursue a career in antibiotic drug development. As Executive Director of CPTR, she has expanded the reach of C-Path partnerships with key stakeholders in the global health community and positioned the organization as a global leader in data collaboration and consensus-based science approaches designed to deliver outcomes.
Graham Higson has spent over 35 years in the pharmaceutical industry and, since January 2014, is Managing Director and owner of GCH Pharma Consulting Ltd, specialising in the provision of strategic regulatory advice, drug development, regulatory outsourcing and organizational development. He is also a member of the NDA Regulatory Advisory Board, comprising former senior European regulators and industry experts.
Prior to establishing his own consulting company, he was Managing Director of NDA Advisory Services where he was accountable for the organization’s Regulatory and HTA Advisory Boards. Earlier in his career he was Global Head of Regulatory Affairs for the Medical Diagnostics division of GE Healthcare and previously he spent five years at AstraZeneca as Vice President and Global Head of Global Regulatory Affairs leading the regulatory organisations across six R&D sites in the UK, Sweden, US and Japan. This followed a number of senior regulatory positions both in the UK and USA during his 11 year tenure at Pfizer. Prior to that he worked at Gensia, Sandoz, Ciba-Geigy, Synthѐlabo and Baxter Healthcare.
He has also been a member of both the EFPIA and PhRMA regulatory affairs committees, the CMR Regulations Advisory Board and the TOPRA Regulatory Advisory Council.
Dr. Lynn Hudson serves as the Chief Science Officer for the Critical Path Institute and Executive Director of both the Multiple Sclerosis Outcome Assessments Consortium and the International Neonatal Consortium. She also co-chairs the Scientific Advisory Committee of CFAST. She received a Bachelor of Science degree in Biochemistry at the University of Wisconsin, a doctorate in Genetics and Cell Biology at the University of Minnesota, and post-doctoral training at Harvard Medical School and Brown University. Combining science and policy, Dr. Hudson conducted research in the National Institute of Neurological Disorders and Stroke (NINDS) intramural program and directed the Office of Science Policy Analysis at the National Institutes of Health (NIH) from 2006 to 2011. As a major source for policy analysis within the NIH’s Office of the Director, her office covered a wide spectrum of sensitive and emerging issues and oversaw a number of programs, including the AAAS/NIH Science Policy Fellowship program, NIH’s contract with the National Academy of Sciences, and the Public-Private Partnership Program. Her policy team’s awards cite contributions to NIH’s Congressional Justification, Biennial Report, implementation of the NIH Reform Act, Stem Cell Guidelines, and Comparative Effectiveness Research.
As Chief of the Section of Developmental Genetics, Dr. Hudson received the NIH Merit Award for her discovery of the causative mutations in the neurologic disorder Pelizaeus-Merzbacher disease (PMD), and an NINDS Award for educational outreach efforts. Dr. Hudson’s research focused on defining the network of genes involved in the development of glial cells, with the goal of designing strategies to overcome glial dysfunction in inherited or acquired neurological diseases. She served as an elected officer for the American Society for Neurochemistry, an officer on the scientific advisory board of the PMD Foundation, and as an advisor for a number of granting agencies and disease foundations, including the National Multiple Sclerosis Society. Presently, Dr. Hudson serves on the National Academies of Science (NAS) Forum on Drug Discovery, Development, and Translation. She has a Research Professor appointment in the College of Medicine at the University of Arizona. She is also a board member of BIOSA, the BioIndustry Organization of Southern Arizona, and was honored by AZBIO as the 2015 Arizona Bioscience Leader of the Year.
Jane Larkindale, DPhil, is the Executive Director for the Duchenne Regulatory Science Consortium at the Critical Path Institute in Tucson, Arizona, concurrently serving as the Vice President for Research Development at the Friedreich’s Ataxia Research Alliance. She is a molecular biologist by training, having completed her DPhil (PhD) in the department of plant sciences at Oxford University in 2001, which she attended on a Rhodes scholarship. In the laboratory, she did research in areas as diverse as molecular biology, biochemistry, genomics, plant science, medical physics, marine biology, and industrial chemistry. In the course of this research, she published numerous original research papers and review articles in several disciplines. Her experience in drug development and neuromuscular diseases started at the Muscular Dystrophy Association, an international non-profit covering over forty neuromuscular diseases, where she worked from 2007 to 2014, finally as Vice President for Research. Dr. Larkindale was instrumental in the startup of MDA Venture Philanthropy (MDA’s drug development arm), which invested in 21 drug development projects, of which ten are in or about to start clinical trials, and several of which have been licensed by large pharmaceutical companies. She led an organization-wide strategic planning process for research, and initiated and organized MDA’s annual meeting series, which attracts over 500 participants annually. In her free time, Dr. Larkindale is a volunteer for the Southern Arizona Rescue Association, taking part in search-and-rescue missions across Pima County. She enjoys all outdoor activities, particularly trail running and backpacking.
Richard Liwski is the Chief Technology Officer and Director of Critical Path Institute’s Data Collaboration Center. Richard is responsible for aligning C-Path’s Information Technology strategy with the organization’s goals, ensuring the security and privacy of data, as well as the architecture and development of data sharing initiatives in support of C-Path consortia and other Data Collaboration Center projects.
The Data Collaboration Center was founded to provide large-scale data-sharing solutions in a neutral, noncompetitive environment for stakeholders from industry, global regulatory agencies, government agencies, non-governmental organizations, patient advocacy groups, and academia.
Prior to joining Critical Path Institute, Richard spent 26 years at IBM that included roles in storage product development, department and functional area management, program management, brand/marketing management, and customer relationship management. His IBM experience included assignments working with major US pharmaceutical companies and healthcare providers as the technical focal point for their data storage needs.
Richard received his Bachelor of Science degree in Electrical Engineering from New Mexico State University.
Inish M. O’Doherty, PhD, is Executive Director of both the Type 1 Diabetes (T1D) and Therapeutic Transplant (TTC) Consortia at C-Path. Specifically, his work focuses on the collaborative selection and development of prognostic biomarkers that can be qualified as Drug Development Tools (DDT) and Novel Methodologies (NO) with the FDA and EMA respectively.
Prior to C-Path, Dr. O’Doherty spent a number of years implementing chemical biology target validation methodologies in the drug discovery and development process at Pfizer Inc. During his tenure at Pfizer, his work spanned both the chemistry and biological sides of early-stage drug discovery. He worked at both the Worldwide Medicinal Chemistry Oncology branch in La Jolla, CA, and the Cardiovascular Metabolic and Endocrine Disease (CVMED) Research Unit in Cambridge, MA. As well as leading in-house target validation and target-engagement studies, Dr. O’Doherty was the Pfizer scientific lead for an academic collaboration with the University of California San Francisco to advance the understanding of quantitative in-cell target engagement assays in complex cellular environments.
Dr. O’Doherty received his PhD from Cornell University, Ithaca, as part of the Tri-institutional training Program in Chemical Biology (TPCB) which encompasses Weill Cornell Medical College, The Rockefeller University, and Memorial Sloan-Kettering Cancer Center. Inish worked on a variety of interdisciplinary projects, which focused on the design and application of chemical probes for the deconvolution biological signaling pathways, with collaborators across serval institutions, resulting a number of publications.
Dr. Amy Porter is the Director of Consortia Support at C-Path. A pharmacologist by training, Dr. Porter has over 10 years of experience in the pharmaceutical industry leading programs in Neuroscience drug discovery in Psychiatry, Neurodegeneration, and Pain at Eli Lilly and Company and Amgen.
Amy received her Bachelor of Science degree in Biochemistry and her Doctorate degree in Pharmacology and Toxicology from the University of Arizona. As a post-doctoral fellow at Eli Lilly and Company, Amy led a team of researchers from multiple disciplines that discovered a novel endogenous cannabinoid, Virodhamine.
Prior to joining C-Path, Amy ran an in vitro pharmacology laboratory at Eli Lilly and Company with a focus on the role of the endogenous cannabinoid system and cholinergic receptors in brain diseases. At Amgen San Francisco, Amy’s laboratory in the Neuroscience division led efforts from target validation to clinical development and cross functional drug development teams in pain and psychiatry.
Amy’s experience also includes scientific and regulatory writing as a consultant for non-profits and government agencies. Amy also worked as an independent in vitro pharmacology consultant for a pharmaceutical company.
Dr. Klaus Romero is a clinical pharmacologist and epidemiologist by training, with 12 years of experience in clinical research. He is a fellow of the American College of Clinical Pharmacology, a founding member of the International Society of Pharmacometrics, as well as a member of the American Society for Clinical Pharmacology and Therapeutics and the International Society for Pharmacoepidemiology. He has conducted research on endemic channels for non-steroidal anti-inflammatory drug-related gastropathy, antibiotic-related dysglycemia, drug-induced QT prolongation, pharmacoepidemiology, and patient education. Dr. Romero has been with C-Path since January 1st, 2008, where he has led clinical pharmacology, pharmacoepidemiology, and modeling and simulation projects for the Coalition Against Major Diseases, the Polycystic Kidney Disease Outcomes Consortium, and the Critical Path to TB Drug Regimens Consortium, achieving major milestones such as the first regulatory endorsement by the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) of a clinical trial simulation tool for mild and moderate Alzheimer’s Disease. He is fluent in English, Spanish, German, and Portuguese, and has published in the areas of clinical pharmacology, pharmacometrics, cardiovascular drug safety, and pharmacoepidemiology.
Dr. John-Michael Sauer is a toxicologist by training with over 15 years of experience in drug discovery and development. He has been responsible for leading multiple functional areas across several pharmaceutical companies. He is dedicated to bringing quantitative translational science approaches to safety assessment, as well as transforming the way we use nonclinical safety data to drive clinical study design and data interpretation.
John-Michael has over 100 scientific publications in the areas of toxicology, drug metabolism, clinical pharmacology, pharmacokinetics, and pharmacology.
Prior to joining C-Path in 2013, Dr. Sauer had the opportunity to play an individual contributor role at Eli Lilly where he participated in the development, registration, and commercialization of Strattera for the treatment of ADHD in children and adults, as well as supported many other discovery and development teams. He also played a pivotal leadership role in the transformation of Elan Pharmaceutical’s discovery and development strategies, including the incorporation of several quantitative translational science approaches. John-Michael also gained operational and management experience in the Contract Research Organization (CRO) environment as the Site Scientific Head for the Covance Chandler site in Arizona.
John-Michael received his undergraduate and Master’s degrees in Biomedical Sciences at Western Michigan University, and his Doctorate degree in Pharmacology and Toxicology from The University of Arizona.
Currently, John-Michael is the Executive Director of the Predictive Safety Testing Consortium at the Critical Path Institute and an Adjunct Research Professor in the Department of Pharmacology at the University of Arizona, College of Medicine.
Diane Stephenson is a neuroscientist by training with 30 years’ combined experience in academic neuroscience and drug discovery. She is passionate about translational science and has a long-time dedication to the discovery of therapies to treat diseases of the nervous system.
Diane received her undergraduate degree in Biochemistry at University of California, Santa Barbara, and her Ph.D. in Medical Neurobiology from Indiana University. In her academic career, Diane focused her research on Amyotrophic Lateral Sclerosis and Alzheimer’s disease (AD), and while in industry, drug discovery initiatives for Alzheimer’s disease, stroke, Parkinson’s disease, and Autism Spectrum Disorders represented key themes.
From 1981-1989, Diane was an associate research scientist at the ALS and Neuromuscular Research Foundation in San Francisco. During her career in industry, focus included animal model characterization, biomarker discovery and development, and evaluation of drug candidates for brain diseases.
As an ambassador for public-private partnerships, she has initiated numerous external academic collaborations, including worldwide alliances. Diane joined Critical Path Institute as Director of the Coalition Against Major Diseases (CAMD) in 2011 with specific emphasis on Alzheimer’s disease.
In her current role leading the Critical Path for Parkinson’s (CPP) Consortium, Diane leads a multidisciplinary global team comprised of academic experts, industry scientists, patient advocacy groups, and regulatory experts collectively aimed at accelerating treatments for Parkinson’s disease. She is an ambassador for advancing regulatory science across multiple types of brain diseases.
Dr. Liz Walker joined Critical Path Institute as Assistant Director of the Predictive Safety Testing Consortium in January, 2008. Her professional experience includes preclinical program development and oversight of biologic drugs for auto-immune and oncology indications; design and interpretation of mechanistic toxicology, combination safety, and GLP toxicology studies; and medical writing in support of regulatory submissions. Other scientific interests include biomarkers, validation of animal and alternative in vitro models, developmental toxicology, molecular signaling in cell cycle control, and systems biology approaches to toxicology. Dr. Walker received her doctorate in Toxicology from the University of Washington focusing on mechanisms of low-dose toxicant impact on cell fate during neurodevelopment.
Prior to founding Critical Path Institute in 2005, Dr. Raymond Woosley was Vice President for the University of Arizona (UA) Health Sciences Center and Dean of the UA College of Medicine. He also served as Associate Dean of 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 GlaxoSmithKline’s initial US operations. Dr. Woosley earned his doctorate in Pharmacology from the University of Louisville and his medical degree from the University of Miami. He completed post-doctoral training in pharmacology, internal medicine and clinical pharmacology. Dr. Woosley’s 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.
Dr. ShaAvhrée Buckman-Garner 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-Garner served as Deputy Director for OTS prior to accepting the position as Director. Before joining OTS, Dr. Buckman-Garner served as a medical team leader in the Division of Pediatric Drug Development, Office of Counter Terrorism and Pediatric Drug Development, CDER. Dr. Buckman-Garner received her medical degree and doctorate (with an emphasis on molecular cell biology) from the Washington University School of Medicine. Dr. Buckman-Garner completed Pediatric specialty training at Baylor College of Medicine.
Dr. Janet 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 of the Office of Therapeutics Research and Review, and Acting Deputy Director of the Center for Biologics Evaluation and Research. Dr. Woodcock received her medical degree from the Fienberg School of Medicine from Northwestern University 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.