Dr. Abrouk is Founding Partner and Exec. Sr. VP of Biostatistics, Clinical Trials Innovations, LLC. With his extensive experience as a biostatistician in biopharmaceutical drug development, he has contributed to multiple global regulatory strategy and filings as well as business development strategies. He has served as world-wide Biometrics expert (Statistics, Programming & data management) on safety monitoring committees of numerous clinical programs. His development areas of experience include: Oncology, Pain, Cardiovascular, Anemia, Diabetes, Hepatitis C, and Alzheimer Disease. Successful NDA/BLA submissions include: Aranesp (Darbepoietin alfa, chronic renal insufficiency anemia), Aranesp (chemotherapy-induced anemia), Neulasta (Neutropenia due to chemotherapy), Jurnista (OROS Hydromorphone, Chronic Pain), Ionysys (Fentanyl, chronic pain) and Priligy (Dapoxetine).
Alan Ashworth is President of the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, a role he began in January 2015. He was previously Chief Executive of the Institute of Cancer Research (ICR) in London, United Kingdom. Dr. Ashworth's research focuses on understanding breast cancer genetics and applying what he learns to change the way patients are treated. He was a key part of the team that identified the BRCA2 breast cancer susceptibility gene, which is linked to an increased risk of some types of cancer. Dr. Ashworth found a way to kill off BRCA1- and 2-related tumor cells by treating them with PARP inhibitors, which amplifies the damage caused by the broken DNA repair machinery in those cells. This exemplifies the genetic principle of synthetic lethality in cancer therapy.
Dr. Ashworth is an elected member of EMBO and the Academy of Medical Sciences and a Fellow of the Royal Society. He has been the recipient of a number of scientific prizes and awards including The European Society of Medical Oncology Lifetime Achievement Award, the David T. Workman Memorial Award of the Samuel Waxman Cancer Research Foundation and the Meyenburg Foundation's Cancer Research Award and was the inaugural winner of the 2013 Basser Global Prize. He is the recipient of the 2015 Genetics Society Medal.
Dr. Benet has been a Professor since 1969 of, and has also served as Chairman of, the Department of Biopharmaceutical Sciences, University of California, San Francisco. Dr. Benet has been Chairman, President and/or Chief Executive Officer of AvMax Inc., since 1995. Dr. Benet received his A.B. (English), B.S. (Pharmacy), and M.S. from the University of Michigan, and his Ph.D. from the University of California. Dr. Benet's research interests, more than 470 publications, and 11 patents are in the areas of pharmacokinetics, biopharmaceutics, drug delivery, and pharmacodynamics.
Dr Joeseph Bertino is University Professor of medicine and pharmacology, UMDNJ-Robert Wood Johnson Medical School and is interim director of the school's Cancer Institute of New Jersey Bertino in New Brunswick. He was named interim director of the Stem Cell Institute of New Jersey in 2007. He has been an American Cancer Society professor since 1976. Dr. Bertino joined The Cancer Institute of New Jersey in 2002 as associate director and was appointed chief scientific officer in 2004. Prior to joining The Cancer Institute of New Jersey at Robert Wood Johnson Medical School, Dr. Bertino served as chair of the Molecular Pharmacology and Therapeutics Program, and member and co-head of the Program in Developmental Therapy and Clinical Investigation at Memorial Sloan-Kettering Institute for Cancer Research. From 1973 to 1986, Dr. Bertino served as director of the Yale Comprehensive Cancer Center, including director of the center and associate director for clinical research. Dr. Bertino has been internationally recognized for his role in finding curative treatments for leukemia and lymphoma.
Dr. Peter Houghton received his bachelor's in Pharmacy from the University of Bradford, and his Ph.D. in Biochemistry/Pharmacology from the University of London, Institute of Cancer Research, Surrey, England. In 2014, Dr. Houghton became Director of the Greehey Children's Cancer Research Institute (GCCRI), and holder of the Greehey Distinguished Chair for the Children's Cancer Research Institute. Previously, he was Director of the Center for Childhood Cancer holding the Elizabeth M. & Richard M. Ross Endowed Chair in Pediatric Research. Prior to Nationwide Children's Hospital, Dr. Houghton held various positions at St. Jude Children's Research Hospital, Memphis, TN. Dr. Houghton's research has been focused on developing relevant models of rare childhood cancer that have been useful in identifying novel drugs (e.g. camptothecins) and understanding the biology of these tumors. Dr. Houghton serves as a member of the Steering Committee, Phase I Consortium, and the Developmental Therapeutics Committee, of the Children's Oncology Group.
Dr. Langkecker has over 25 years of experience in academic and industry-sponsored oncology/hematology clinical research and development Phase I to Phase IV, including the past 5 years at Clinipace as Medical Monitor and Executive Medical Director Global Oncology. Peter's Pharmaceutical company experience includes Novartis, Schering-Plough, SUGEN (acquired by Pfizer) and several biotech companies. He contributed to the clinical development of Femara®, Eulexin®, Intron A®, Temodal®, Bexxar®, and Sutent® and is co-author of over 50 publications and posters.
Martin List, Ph.D. Martin received a Pharmacy degree in 1984 from Julius Maximilian, University in Wurzburg and a Ph. D. in Pharmaceutical Technology in 1987 from the University of Basel, Switzerland. He worked at Sandoz from 1984 to 1996 where he was involved with various programs in dosage form and analytical development. In 1997, he joined Roche, Basel, where among other positions he was Department head, dosage form development and Department head, global Product Supply Chain Leaders. In 2012, Martin became engaged in supply chain project management.
Dr. David Parkes has more than 28 years of experience in scientific discovery and drug development in the fields of diabetes, obesity, NAFLD/NASH and cardiovascular disease. He has held senior level roles in both Discovery Research and Medical Affairs at Amylin Pharmaceuticals Inc., following his extensive training in globally-recognized medical research institutes. David most recently served as Senior Director of Discovery Research at Amylin Pharmaceuticals, where he led the preclinical development of exenatide, culminating in the approval and global commercialization of two “standard of care” drugs (Byetta and Bydureon) for the treatment of diabetes. He played a pivotal role in global scientific education for exenatide, pramlintide and metreleptin, three first in class drugs for the treatment of metabolic diseases. David has played a lead scientific role on alliance teams with partners including Eli Lilly, Takeda and Psychogenics, and is currently a senior scientific consultant for companies including Astra Zeneca, Profil, Novartis, Spitfire and Renova. David received his PhD in Pharmacology from the University of Melbourne, Australia, and has published over 90 scientific articles in high-impact journals.
William J. Rutter, PhD is an investor in and strategic advisor to Prolynx. Currently, Rutter is Founder, Chairman and CEO of Synergenics, LLC, which's controls a consortium of companies with different but complimentary approaches to diagnosis, prevention and treatment on a worldwide basis. Previously, Dr. Rutter was co-founder and chairman of Chiron Corporation, a major biotechnology company which is well known for the development of recombinant DNA-based vaccines, including Hepatitis B, and for the discovery of Hepatitis C, the first sequencing of the HIV-AIDS virus. Chiron pioneered the development of quantitative DNA-based diagnostic tests measuring viral load, which has played a major role in protecting the blood supply, and also in developing drugs for treatment of these diseases. Chiron was acquired in two stages by Novartis and its antecedent company Ciba-Geigy. Dr. Rutter has served on boards of Novartis and several Biotech companies. Dr. Rutter is a member of the National Academy of Sciences and the American Academy of Arts and Sciences. Dr. Rutter has published 381 scientific articles and holds 26 patents and patent applications. Previously, Dr. Rutter served as Chairman of the Department of Biochemistry and Biophysics at UCSF. His lab made key contributions to biotechnology and recombinant DNA technology, including cloning of the human insulin gene and the production in yeast of a virus-like particle for Hepatitis B, which was eventually used in the manufacture of a Hepatitis B vaccine.
Roland Thieme, Ph.D. Roland Thieme recently retired from heading small molecule development of Roche Basel. He was a member of the small molecule development leadership team located in Basel, Switzerland and of several technical governance committees.
Roland received his Master of Science in 1982 and his PhD in 1986 from the Albert-Ludwigs-University in Freiburg, Germany. He joined Roche in 1986 and in 1992 built a group for analytical development. From 1999 until 2001 he was technical team leader and responsible for CMC activities of early phase development and supply chain management activities of several projects. In 2001 he became head of the clinical Supply Center Basel with responsibility for scale-up and GMP manufacturing of the small molecule API portfolio. From 2002 to 2016 Roland was responsible for the global API development at Roche Basel, Tech Center Boulder/Colorado and the chemical development group in Florence/South Carolina. He served as Head of Process Research and Technical Development incl. Analytical Development & Clinical supply.
Dr. Venook is Professor of Clinical Medicine and the Madden Family Distinguished Professor of Medical Oncology and Translational Research at the University of California, San Francisco (UCSF). Dr. Venook hails from Metuchen, NJ; he received a BA in Biological Sciences from Rutgers College in 1976. He received his MD Degree in 1980 from UCSF, completed his internship at UCSF in 1981, then spent two years at an Urban Indian clinic in Sacramento, California and then completed a residency in Internal Medicine at the University of California, Davis. He returned to UCSF as a Hematology/Oncology Fellow in 1985, joining the faculty in 1988. The Gastrointestinal Oncology Program was started through a collaboration with surgeon Dr. Robert Warren in 1991 and the program now has ten physicians and physician/scientists in medical oncology. One of two UCSF MD's to become affiliated with the Cancer and Leukemia Group B in 1988, Dr. Venook has chaired and/or authored six major studies within the cooperative groups and he now Chairs the GI Committee of the Alliance for Clinical Trials in Oncology (formerly CALGB.) He has also been an Associate Editor of the Journal of Clinical Oncology since 2009.