Robert Langer, Sc.D.
Co-Founder and Board Member
David H. Koch Institute Professor, MIT
Robert S. Langer is the David H. Koch Institute Professor (there are 14 Institute Professors at MIT; being an Institute Professor is the highest honor that can be awarded to a faculty member). Dr. Langer has written over 1,100 articles. He also has approximately 760 issued and pending patents worldwide. Dr. Langer's patents have been licensed or sublicensed to over 220 pharmaceutical, chemical, biotechnology and medical device companies. He is the most cited engineer in history.
He served as a member of the United States Food and Drug Administration's SCIENCE Board, the FDA's highest advisory board, from 1995 -- 2002 and as its Chairman from 1999-2002.
Dr. Langer has received over 180 major awards including the 2006 United States National Medal of Science; the Charles Stark Draper Prize, considered the equivalent of the Nobel Prize for engineers and the 2008 Millennium Prize, the world's largest technology prize. He is the also the only engineer to receive the Gairdner Foundation International Award; 72 recipients of this award have subsequently received a Nobel Prize. Among numerous other awards Langer has received are the Dickson Prize for Science (2002), Heinz Award for Technology, Economy and Employment (2003), the Harvey Prize (2003), the John Fritz Award (2003) (given previously to inventors such as Thomas Edison and Orville Wright), the General Motors Kettering Prize for Cancer Research (2004), the Dan David Prize in Materials Science (2005), the Albany Medical Center Prize in Medicine and Biomedical Research (2005), the largest prize in the U.S. for medical research, induction into the National Inventors Hall of Fame (2006), the Max Planck Research Award (2008) and the Prince of Asturias Award for Technical and Scientific Research (2008). In 1998, he received the Lemelson-MIT prize, the world's largest prize for invention for being "one of history's most prolific inventors in medicine." In 1989 Dr. Langer was elected to the Institute of Medicine of the National Academy of Sciences, and in 1992 he was elected to both the National Academy of Engineering and to the National Academy of Sciences. He is one of very few people ever elected to all three United States National Academies and the youngest in history (at age 43) to ever receive this distinction.
Justin Hanes, Ph.D.
Co-Founder and Board Member
Professor at Johns Hopkins University and Director of the Center for Nanomedicine at JHU School of Medicine
Justin Hanes received a B.S. in Chemical Engineering from UCLA in 1991 and Ph.D. in Chemical Engineering from MIT in 1996. He did postdoctoral training in Oncology and Neurosurgery at the Johns Hopkins University School of Medicine in 1996-1998. He is a full Professor at Johns Hopkins University, with appointments in the Departments of Ophthalmology, Biomedical Engineering, Chemical & Biomolecular Engineering, Environmental Health Sciences, Neurosurgery and Oncology. He is the Director of the Center for Nanomedicine at the Johns Hopkins University School of Medicine, where he leads a laboratory of more than 40 scientists and engineers. He also serves on the Executive Committee and as Director of Therapeutics for the Institute for NanoBioTechnology at Johns Hopkins. He has published widely and is an inventor on more than 15 patent families, many of which have been licensed to industry. He has given more than 100 invited lectures and has received numerous honors and awards
, including being named among the "World's Top 100 Young Innovators and Leaders in Technology and Business," by the MIT Technology Review in 2003. He was also named a "Global Young Leader" by the U.S. National Academy of Sciences, and selected as a representative of the U.S. to attend the "Meeting of the New Champions" at the World Economic Forum in Tianjin, China in 2008. He currently serves on the scientific advisory board for Genentech, Inc.'s Drug Delivery Division and is a founder and director of Kala Pharmaceuticals, where he also serves as the Chair of the Scientific Advisory Board.
Colin R. Gardner, Ph.D.
Former Vice President of Global Pharmaceutical Development, Merck & Co., Inc.; Former CSO, Transform Pharmaceuticals/J&J
Dr. Gardner was born and educated in Scotland, receiving a BSc and Ph.D. in chemistry from the University of Glasgow. After post-doctoral studies at Harvard Medical School (Biophysics) and MIT (Chemical Engineering), he returned to Europe and spent 2 years in the chemistry department at the University of Aberdeen followed by 6 years in drug discovery at the Merrell International Research Center in Strasbourg.
Thereafter he joined Merck and Co. in the US, spending the first 4 years as a leader in a drug delivery group. He was then appointed to develop and lead a more effective interface between drug discovery and early pharmaceutical development; he pioneered the paradigm of early intervention which has become the standard in the industry. He progressed in the department to become VP and Global Head of formulation design and development for all Merck products - he was involved in the development of 16 small molecule NCEs whose combined maximum annual sales averaged $20Bn and three major vaccines.
In 2001, Colin took early retirement from Merck to become the CSO of a start-up formulation company (TransForm Pharmaceuticals) in the Boston area. Four years later TransForm was acquired by Johnson & Johnson and led to major changes in the way in which J&J integrated discovery and early development. Colin stayed on as the President and Site Leader of TransForm.
Colin retired from TransForm/J&J in June 2009 and is now an industry consultant.
Peter Hutt, LL.M.
Former Chief Legal Counsel, FDA
Peter Hutt, LL.M. is Senior Counsel, Covington & Burling; Former Chief Legal Counsel, Food & Drug Administration Mr. Hutt has been leading figure in food and drug law for 50 years. He joined the law firm of Covington & Burling in 1960 and, except for four years as Chief Counsel of the Food and Drug Administration, has continued to serve at the firm. While at FDA he drafted the legislation that became the Medical Device Amendments of 1976, and beginning in 1962 he has participated in the drafting of most of the major legislation amending the Federal Food, Drug, and Cosmetic Act. Mr. Hutt is a member of the Institute of Medicine of the National Academy of Sciences. He co-authored the casebook used to teach Food and Drug Law and has published numerous papers on the subject. Mr. Hutt is a member of the board of directors of Ista Pharmaceuticals, Inc., Xoma Ltd., Celera Genomics, and Momenta Pharmaceuticals and several other privately-held life science companies. Mr. Hutt received his B.A., magna cum laude, from Yale University, his L.L.B. from Harvard University and his L.L.M.
from New York University
Ronald Lee Krall, M.D.
Former Chief Medical Officer, GlaxoSmithKline
Dr. Krall is Associate Fellow, University of Pennsylvania Center for Bioethics, and Former Chief Medical Officer for GlaxoSmithKline (Retired). He is a member of the Executive Board of the Observational Medical Outcomes Partnership and of The Institute of Medicine Forum for Drug Discovery, Development and Translation.
Dr. Krall holds a B.A. in mathematics from Swarthmore College, an M.D. from the University of Pittsburgh and completed his training in neurology and a fellowship in Clinical Pharmacology at the University of Rochester.
Over 25 years in the pharmaceutical industry, Dr. Krall worked for four companies (Lorex Pharmaceuticals, Abbott Laboratories, Zeneca/AstraZeneca and GlaxoSmithKline), holding a variety of positions responsible for drug development, and safety of medicines. He concluded his career as Senior Vice President and Chief Medical Officer for GlaxoSmithKline. Over his career he has overseen in some capacity the development of over 20 medicines, including Ambien, Hytrin for Benign Prostatic Hypertrophy, Depakote for Migraine and Bipolar Disorder, Nolvadex, Arimidex and Faslodex for breast cancer, Seroquel, Accolate, Diprivan, Iressa, Tykerb, and Entereg.
Dr. Krall currently makes his home in Steamboat Springs, Colorado, where he and his wife own and operate Off the Beaten Path, an independent bookstore, coffeehouse and bakery café (www.steamboatbooks.com).
Howie Rosen
Former President of ALZA Corporation/J&J and Former Vice President, Commercial Strategy at Gilead Sciences, Inc.
Howie is an independent consultant and serves on the board of directors of AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), CNS Therapeutics, Inc., PaxVax, Inc. and Pearl Therapeutics, Inc., where he served as interim President and CEO from June 2010 to March 2011. From 2004 to 2008, he was Vice President, Commercial Strategy at Gilead Sciences, Inc. where his responsibilities included strategic marketing, global brand management, health economics, competitive intelligence, market research and Gilead's overall portfolio and business planning. Prior to joining Gilead, Mr. Rosen was President of ALZA Corporation where he was responsible for all aspects of managing ALZA as an independent 1000-person operating company within the Johnson & Johnson Family of Companies. Previously at ALZA as Vice President, Product Development, he was responsible for product development activities, portfolio management and corporate and new product planning. Over his 10 years at ALZA, Mr. Rosen also had responsibilities for mergers and acquisitions, R&D planning, and technology ventures. Prior to joining ALZA, Mr. Rosen managed the west coast practice of Integral, Inc., was Director, Corporate Development at GenPharm International, Inc. and was a consultant in the San Francisco office of McKinsey & Co. Mr. Rosen is a member of the Stanford University Advisory Council on Interdisciplinary Biosciences and was a member of the Stanford School of Engineering Advisory Council from 2004 to 2007. Mr. Rosen is also a member of the Biomedical Engineering Advisory Board at City College of New York and the BOD of the MIT Club of Northern California. Previously he was a member of the BODs of CoTherix, Inc and Pharsight Corporation. Mr. Rosen is a lecturer in the Department of Chemical Engineering at Stanford and teaches entrepreneurship at the Stanford Graduate School of Business. He is also a member of the National Academy of Engineering and co-inventor on 7 US patents. Mr. Rosen received an MBA from the Stanford Graduate School of Business, where he graduated first in his class as the Henry Ford II Scholar. Mr. Rosen has an MS in Chemical Engineering from MIT and he graduated with distinction from Stanford University with a BS in Chemical Engineering.
Bennett Shapiro, M.D.
Former Executive Vice President & Head of Research, Merck & Co., Inc.
Dr. Shapiro was most recently Executive Vice President, Worldwide
Licensing and External Research for Merck. He joined Merck Research Laboratories in 1990 as Executive Vice President, Worldwide Basic Research where he was responsible for all basic and preclinical
research activities at Merck. Dr. Shapiro led the research program that resulted in FDA registration of approximately 25 drugs and vaccines, including Vioxx, Arcoxia, and Emend, and stretching as far
back as the A2 antagonist Cozaar, the hepatitis A vaccine VACQTA, and many others.From 1999-2003 Shapiro oversaw all in-licensing activities for Merck. Previously, he was Professor and Chairman of the Department of
Biochemistry at the University of Washington. He is the author of over 120 papers on the molecular regulation of cellular behavior and the biochemical events that integrate the cascade of cellular activations at fertilization. He is a Senior Partner and Chairman of the Board at
PureTech Ventures. Dr. Shapiro has served on many institutional advisory boards and scientific review panels, and is currently a member of the board of various life science companies, including VBL, Protein Forest, Celera, Momenta, Elixir, Satori, and Ikaria. He also
sits on the boards of the Drugs for Neglected Disease Initiative and the Mind and Life Institute. Dr. Shapiro received his MD from Jefferson Medical College.
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