Massachusetts General Hospital/Harvard Medical School, Boston, USA
Dr. Crowley is the Daniel K. Podolsky Professor of Medicine at Harvard Medical School where he also serves as the Chief of the Reproductive Endocrine Unit of the Department of the Medicine at Massachusetts General Hospital. He also serves as the Director of the Harvard-wide Reproductive Endocrine Sciences Center, one of the National Institute of Child Health & Human Developments’ eight Centers of Excellence in Translational Research. He served as the Director of Clinical Research for the Massachusetts General Hospital (MGH) for 17 years.
Dr. Crowley’s research accomplishments include pioneering the research use and FDA approval, and commercial use of long acting GnRH agonists as the treatment for children with precocious puberty and pulsatile GnRH therapy for men and women with Isolated GnRH Deficiency (Kallmann Syndrome and normosmic Idiopathic Hypogonadotropic Hypogonadism) and hypothalamic amenorrhea. He and his team were also responsible for the discovery of the kisspeptin signaling system and its control of GnRH secretion and most recently elucidation of several genes controlling sexual maturation at puberty.
During the time he served as the Director of Clinical Research at the MGH, Dr. Crowley founded and served as the first Chair of The Clinical Research Forum, a national consortium of the top 60 academic medical centers engaging in clinical and translation research. This group represents the recipient institutions of greater than 70% of NIH’s funding for human research in the U.S.
In recognition of these scientific accomplishments, Dr. Crowley has received several academic awards among which are the Fred Conrad Koch Award (the Endocrine Society’s highest scientific award), the IBSEN Foundation’s International Juried Prize in Endocrinology, and the Clinical Research Awards of both the NIH and the Endocrine Society. In addition to being a member of the American Society of Clinical Investigation and the Association of American Physicians, Dr. Crowley also served as the President of the Endocrine Society from 2000-2002.
Founding principal, Endo-Rheum Consultants
Former Vice President of Women’s Health & Bone Repair Medical Research, Wyeth Research
Dr. Ginger Constantine has over 18 years of management experience in the pharmaceutical industry, including research, and global pharmaceutical affairs, and is a licensed rheumatologist. She is the founding principal of Endo-Rheum Consultants, a medical/clinical consulting firm.
During her ten year tenure within the Wyeth Pharmaceuticals and Wyeth Research organizations, Dr. Constantine held various management positions of increasing responsibility in the therapeutic areas of rheumatology, metabolism and bone repair. She ultimately served as Vice President of Women’s Health & Bone Repair Medical Research at Wyeth Research until its acquisition by Pfizer in 2010, guiding her staff to the completion of numerous Investigational New Drug Applications and more than ten New Drug Applications and European dossiers in the areas of contraception, osteoporosis, menopausal symptoms, endometriosis, and osteoarthritis.
Prior to joining Wyeth, Dr. Constantine was a practicing physician specializing in Rheumatology and Internal Medicine.
Dr. Constantine has authored more than 100 articles, posters, abstracts, and presentations in the areas of rheumatology and arthritis for peer-reviewed publications and medical society meetings. She is currently a Scientific Advisor to multiple pharmaceutical companies, and served on the board of directors of Savient Pharmaceuticals (specialty biopharmaceuticals) from 2009 to 2013.
Dr. Constantine obtained her medical degree from Temple University and completed her Rheumatology Fellowship at the University of Pennsylvania. She is a member of the North American Menopause Society, a member of and has been a committee member for The Endocrine Society, and the Association of Reproductive Health Professionals.
Professor of Biomedical Surface Chemistry , University of Nottingham School of Pharmacy, Nottingham, UK
Dr. Martyn Davies has over 30 years’ experience in the pharmaceutical, biopharmaceutical and drug delivery fields. He serves as chairman of Juniper’s Scientific Advisory Board and as an Advisor to its Board of Directors.
Dr. Davies is a Professor and former Head of School at the University of Nottingham School of Pharmacy, and cofounded the Laboratory of Biophysics and Surface Analysis (LBSA), the leading Research Division of the School. The LBSA has an international reputation and track record for the development and study of drug delivery and biomaterials and was the first grouping to receive the GlaxoSmithKline International Achievement Award (2003), given for “internationally recognized work on drug delivery and new techniques for surface and interface analysis”.
In 1997, Dr. Davies co-founded Juniper Pharma Services (f/k/a Molecular Profiles Ltd.), a successful spin-out from the LBSA, and served as its Founder-Chairman until its acquisition by Juniper Pharmaceuticals (f/k/a Columbia Laboratories) in September 2013, at which time he was appointed Advisor to the company’s Board of Directors. He played a key role in Molecular Profiles’ strategic development and also in leading and consulting on many technical projects for clients.
Dr. Davies holds a first class honours degree in Pharmacy from Brighton Polytechnic and a Ph.D. from King’s College, University of London. He has authored or co-authored more than 380 published scientific articles, has trained more han 100 postgraduate and research scientists, is a Fellow of the Royal Society for Chemistry (FRSC) and Royal Pharmaceutical Society of Great Britain (FRPharmS), the American Institute of Biological Engineering, the UK Association of Pharmaceutical Scientists, and the Controlled Release Society, and is a past President of the Controlled Release Society (2011-12). He also serves on the editorial
University of California, San Francisco, School of Medicine, USA
Dr. Linda Giudice is the Robert B. Jaffe MD Endowed Professor and Chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco (UCSF) School of Medicine. She is also Director of the UCSF Laboratory of Human Endometrial Biology, Functional Genomics, and Stem Cell Research.
A noted obstetrician, gynecologist and reproductive endocrinologist, Dr. Giudice specializes in endometriosis, implantation and ovulatory disorders, infertility and assisted reproduction. Her research focuses on endometrial biology and placental-uterine interactions as well as environmental impacts on reproductive health. Clinical interests include endometriosis, infertility, assisted reproduction, and implantation and ovulatory disorders.
Dr. Giudice has served on numerous NIH study sections, is former Chair of the Reproductive Health Drugs Advisory Committee to the FDA, and chaired the NIH Reproductive Medicine Network and Specialized Cooperative Centers Program in Reproduction and Infertility Research Steering Committees. Dr. Giudice was elected to the Institute of Medicine (now the National Academy of Medicine) in 2002; she served on the board of directors of the Society for Women’s Health Research; and is a past President of the Society for Gynecologic Investigation (SGI). She served on the board of directors of the American Society for Reproductive Medicine (ASRM) and was President of the ASRM in 2013.
The author of over 250 publications, Dr. Giudice earned her Ph.D. in biochemistry at UCLA and completed a postdoctoral fellowship at Rockefeller University, working under Nobel Laureate Gunter Blobel. She earned a medical degree at Stanford University and completed a residency in obstetrics and gynecology at Stanford and Washington University in St. Louis as well as a fellowship in reproductive endocrinology and infertility at Stanford. She served as director of the reproductive endocrinology and infertility division at Stanford before joining UCSF in 2005.
Dr. Giudice is the recipient of numerous awards including the 2008 SGI President’s Distinguished Scientist Award, the 2008 Women in Science Award from the American Medical Women’s Association, and the ASRM 2008 Distinguished Researcher Award. She was honored as one of the NIH Great Teachers and the NIH Perinatology Branch Wall of Honor. She is also the recipient of the American Infertility Association “Illumination Award” for her work on the environment and reproductive health. In 2011, Dr. Giudice was elected Co-Chair of the NICHD Director’s Reproduction Vision Workshop and named a fellow of the American Association for the Advancement of Science (AAAS).
Massachusetts Institute of Technology, Boston, USA
Dr. Robert S. Langer is the Massachusetts Institute of Technology Department of Chemical Engineering David H. Koch Institute Professor; being an Institute Professor is the highest honor that can be awarded to a faculty member. Dr. Langer has authored over 1,300 articles and holds nearly 1,070 patents worldwide. His patents have been licensed or sublicensed to over 300 pharmaceutical, chemical, biotechnology and medical device companies. He is the most cited engineer in history.
Dr. Langer served as a member of the United States Food and Drug Administration’s SCIENCE Board, the FDA’s highest advisory board, from 1995 until 2002 and as its Chairman from 1999 to 2002.
Dr. Langer has received over 220 major awards. He is one of four living individuals to have received both the United States National Medal of Science (2006) and the United States National Medal of Technology and Innovation (2011). He also received the 2002 Charles Stark Draper Prize, considered the equivalent of the Nobel Prize for engineers; the 2008 Millennium Prize, the world’s largest technology prize; the 2012 Priestley Medal, the highest award of the American Chemical Society; the 2013 Wolf Prize in Chemistry; the 2014 Breakthrough Prize in Life Sciences; the 2014 Kyoto Prize; and, the 2015 Queen Elizabeth Prize for Engineering. He is also the only engineer to receive the Gairdner Foundation International Award; 82 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), the Prince of Asturias Award for Technical and Scientific Research (2008), the Warren Alpert Foundation Prize (2011) and the Terumo International Prize (2012). 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, and in 2012 he was elected to the National Academy of Inventors.
Forbes Magazine (1999) and Bio World (1990) have named Dr. Langer as one of the 25 most important individuals in biotechnology in the world. Discover Magazine (2002) named him as one of the 20 most important people in this area. Forbes Magazine (2002) selected Dr. Langer as one of the 15 innovators worldwide who will reinvent our future. Time Magazine and CNN (2001) named Dr. Langer as one of the 100 most important people in America and one of the 18 top people in science or medicine in America (America’s Best). Parade Magazine (2004) selected Dr. Langer as one of six “Heroes whose research may save your life.”
Dr. Langer has received honorary doctorates from Harvard University, the Mt. Sinai School of Medicine, Yale University, University of Western Ontario (Canada), the ETH (Switzerland), the Technion (Israel), the Hebrew University of Jerusalem (Israel), the Université Catholique de Louvain (Belgium), Rensselaer Polytechnic Institute, Willamette University, the University of Liverpool (England), Bates College, the University of Nottingham (England), Albany Medical College, Pennsylvania State University, Northwestern University, Uppsala University (Sweden), Tel Aviv University (Israel), Boston University, Ben Gurion University (Israel), Drexel University and the University of California – San Francisco Medal. He received his Bachelor’s Degree from Cornell University in 1970 and his Sc.D. from the Massachusetts Institute of Technology in 1974, both in Chemical Engineering.
Clinical Drug Development & Regulatory Consultant
Past Deputy Director, Division of Reproductive and Urologic Drug Products
Dr. Marianne Mann, a pulmonologist and intensivist by training, is an independent pharmaceutical development and regulatory consultant with extensive experience in regulatory affairs. Her nine year tenure at the U.S. Food and Drug Administration (FDA) spanned senior roles in multiple divisions, including three years as Deputy Director of the Division of Reproductive and Urologic Drug Products.
Since 2004, Dr. Mann has consulted on multiple projects across dozens of therapeutic areas for products in various stages of development. Her work extends from pre-IND meetings through approval and post-approval commitments. She has served on many drug advisory and drug safety boards, has helped prepare sponsors for FDA advisory panels including serving on mock advisory panels, and in May 2013 presented findings of adjudicated anaphylaxis events for a testosterone product at an FDA panel meeting.
From 1994 to 2003, Dr. Mann was at the FDA Center for Drug Evaluation and Research (CDER). In her role as a Medical Officer of the FDA’s Divisions of Antiviral Drug Products and Special Pathogens and Immunologic Drug Products from 1994 to 1998, Dr. Mann reviewed clinical protocols from the early phases of drug development through post-marketing for numerous therapeutic products.
As Deputy Director of the Division of Reproductive and Urologic Drug Products from 1998 to 2000. Her role there included managing several important safety issues, such as the cardiovascular concerns that arose for Viagra in the post-market setting, and the risks of administering terbutaline in the home setting to pregnant women.
From 2001 to 2003, Dr. Mann served as Deputy Director of the Division of Pulmonary and Allergy Drug Products, where her broad understanding of drug development was a critical asset in the evaluation of clinical trial designs for their ability to demonstrate effectiveness and maintain patient safety.
Dr. Mann was a member of numerous FDA working groups and committees, including the Oncology Coordinating Committee (2001-2003) and the NICHD-FDA Newborn Initiative Group (2002-2003).
Her work garnered many FDA awards including the FDA Award of Merit (1998), the Department of Health and Human Services Secretary’s Award for Distinguished Service (1998), and the CDER Excellence in Communication Award (2002).
After leaving the FDA in 2003, Dr. Mann served as Chief of the Respiratory Disease Branch of the Division of Microbiology and Infectious Diseases of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) until establishing her consultancy in June 2004. Dr. Mann concurrently volunteered as a Staff Pulmonologist at the National Naval Medical Center from 1996 to 2004.
Prior to joining the FDA, Dr. Mann was a practicing pulmonologist and internist, and held positions at Fort Meade’s Kimbrough Army Community Hospital and the Hospital for Special Care in New Britain, CT.
Dr. Mann earned her Medical Doctorate with Honors in Otolaryngology, Ambulatory Medicine and Urology, at the Medical College of Pennsylvania in conjunction with Lehigh University in an accelerated six-year combined Bachelor’s and Medical Doctorate program. She is Board Certified in Internal Medicine and has authored numerous scientific papers published in peer-reviewed journals.
President, Daniel A. Shames Consulting, Inc.
Past Director, Division of Reproductive and Urologic Drug Products
Past Deputy Director, Office of Drug Evaluation III, U.S. Food and Drug Administration Center for Drug Evaluation and Research
Dr. Daniel A. Shames is an experienced clinician with extensive experience in pharmaceutical development and regulatory affairs. During his twelve year tenure at the U.S. Food and Drug Administration (FDA), Dr. Shames served as Deputy Director, Office of Drug Evaluation III/Center for Drug Evaluation and Research (CDER) from 2006 to 2008, as well as a member of the Senior Management Team of the Office of New Drugs and the Drug Safety Oversight Board. Since 2008, as President of Daniel A. Shames Consulting, Inc., he has been an independent clinical/regulatory consultant on a wide range of pharmaceutical issues.
Dr. Shames began his career with the FDA in 1996 and held positions as Primary Medical Officer, Team Leader and Deputy Director in the Division of Reproductive and Urologic Products (DRUP). From 2001 to 2006, he served as Director of DRUP and reviewed therapeutic products for clinical areas including contraception, infertility, obstetrics, menopause, and urinary incontinence, for which he received the CDER Leadership Excellence Award (2004). He later received the FDA Outstanding Service Award for outstanding leadership as the Acting Director of the Division of Gastroenterology Products (2008).
Prior to joining the FDA, Dr. Shames was in private urology practice and on the clinical faculty at the University of South Carolina School of Medicine and, while at FDA, Georgetown Medical School.
Dr. Shames has authored numerous scientific papers published in peer-reviewed journals, and has received many distinguished awards and honors over the course of his career. He currently serves on the Scientific Advisory Board of Agile Therapeutics (transdermal contraceptive products for women).
Dr. Shames earned his medical degree from Georgetown Medical School, and completed his specialty training in the Urology Residency Program at the University of Pennsylvania and a Post-Doctoral Fellowship in renal research from the National Institutes of Health. Dr. Shames is a Fellow of the American College of Surgeons.