The current clinical-evaluation process is fraught with inefficiencies, resulting in numerous compound failures and exploding development costs. To offset these obstacles, a number of pharmaceutical companies are employing novel clinical-trial models.
More than 80% of compounds that begin human clinical testing fail because of efficacy or safety issues, while many marketed drugs face withdrawal or severe use restrictions.
A New Paradigm for Clinical Development: The Clinical Trial in 2015, a recent report from AdvanceTech Monitor, discusses a strategy for reinventing clinical development.
Changing the Trial Paradigm
U.S. Clinical-Trial Spending Increases
Making A Case For Data Standards
Clinical Imaging: The Key To Reducing Drug-Development Costs
Fastest Drug Developers Outperform Their Peers
Alexis Borisy, A.M. President, CEO, and Founder, CombinatoRx Inc., Cambridge, Mass.; CombinatoRx is a biopharmaceutical company focused on developing new medicines built from synergistic combinations of approved drugs. For more information, visit combinatorx.com.
Joseph J. Brindisi. VP, Business Development, and General Counsel, Kyowa Pharmaceutical Inc., Princeton, N.J.; Kyowa Pharmaceutical is the U.S. development company of Kyowa Hakko Kogyo Co. Ltd., a life-sciences company with headquarters in Tokyo. For more information, visit kyowa-kpi.com.
Kenneth A. Getz. Senior Research Fellow, Tufts Center for the Study of Drug Development; Boston; CSDD is an independent, academic, nonprofit research group affiliated with Tufts University. For more information, visit csdd.tufts.edu.
Bernard Gilly, Ph.D. Cofounder, Chairman, and CEO of Fovea Pharmaceuticals SA, Paris; Fovea, with U.S. headquarters in New York, is a biopharmaceutical company dedicated to the discovery and development of innovation in products for ocular diseases. For more information, visit fovea-pharma.com.
Thomas P. Koestler, Ph.D. Executive VP and President, Schering-Plough Research Institute, Schering-Plough Corp., Kenilworth, N.J.; Schering-Plough is a global science-based healthcare company with leading prescription, consumer, and animal health products. For more information, visit schering-plough.com.
John Lawrie. VP, Process Solutions, Octagon Research Solutions Inc., Wayne, Pa.; Octagon Research is a leader in the electronic transformation of clinical R&D and offers a suite of regulatory, clinical, process, and IT solutions to the life-sciences industry. For more information, visit octagonresearch.com.
Jonathan E. Lim, M.D. CEO and President, Halozyme Therapeutics Inc., San Diego; Halozyme is a development-stage biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. For more information, visit halozyme.com.
John McKearn, Ph.D. CEO and President, Kalypsys Inc., San Diego; Kalypsys is a clinical-stage pharmaceutical company that is advancing the way drugs are discovered and developed. For more information, visit kalypsys.com.
William J. Newell, J.D. President, Aerovance Inc., Berkeley, Calif.; Aerovance is a privately held biopharmaceutical company exclusively focused on developing and commercializing breakthrough medicines for asthma, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), and eczema. For more information, visit aerovance.com.
James A. Schoeneck. CEO, BrainCells Inc., San Diego; BrainCells is a leading-edge neurogenesis-based drug discovery and development company targeting novel therapies for depression, mood disorders, and other CNS diseases. For more information, visit braincellsinc.com.
Rick Taranto. President, WorldCare Clinical LLC, Cambridge, Mass.; WorldCare Clinical (WCC), part of ProScan, is an imaging CRO, offering end-to-end imaging services in support of clinical trials for the pharmaceutical, biotechnology, and medical-device industries. For more information, visit wcclinical.com.
Arthur J. Tipton, Ph.D. President and CEO, Brookwood Pharmaceuticals, Birmingham, Ala.; Brookwood, a wholly owned subsidiary of Southern Research Institute, is a product-focused drug-delivery company. For more information, visit brookwoodpharma.com.