The current US Prescription Drug User Fee Act, commonly referred to as PDUFA V, will sunset at the end of 2017. At the first Public Meeting on PDUFA Reauthorization, Center for Drug Evaluation and Research Director Dr. Janet Woodcock said, “PDUFA has been generally considered successful. We continue to meet or exceed nearly all our application review goals…And these accomplishments are, in part, made possible by the resources provided by this program.” In this exclusive podcast, Dr. Woodcock and Dr. Theresa Mullin, Director of FDA’s Office of Strategic Programs, discuss PDUFA, the need for reauthorization into PDUFA VI, and its progress since the initial 1992 legislative authorization. Update: Dr. Woodcock will also share her expert regulatory insights through her Keynote Address at Advancing the Science of Study Endpoints; she will be joined by Dr. Mark McClellan, Director, Duke-Robert J. Margolis Center for Health Policy, Duke University, to share their perspectives on the development of study endpoints, Where Are We Now and Where Are We Going?
While they do not present new treatment options, biosimilars make tried and trusted, highly effective but very expensive biological cancer therapies more widely available at a more affordable price. With their potential for improving access to effective biological therapies through reduced costs, biosimilars have garnered great interest among industry, regulators, patients and payers. Program Chair Cecil Nick, who has worked for more than three decades in clinical development and regulatory affairs, explores the science, global regulatory pathways, clinical evidence for and other aspects of biosimilars that will be discussed at DIA’s Biosimilars 2016 Conference.
In August 2016, DIA welcomed Dr. Sudip Parikh as Senior Vice President and Managing Director for the DIA Americas region. Dr. Parikh previously served as Vice President and General Manager of Health and Consumer Solutions at Battelle; he has also served as senior liaison for the US Senate Appropriations Committee in budget negotiations with the pharmaceutical and biotechnology industries, and research universities, centers and hospitals. What was the most important lesson he learned while working on Senate Appropriations? “At the biggest level, it’s never let the perfect get in the way of the good,” he explains. “There are many, many stakeholders at the table, and the perfect IS the enemy of the good.”
The world's first regulatory-approved artificial pancreas proves the powerful potential of machine learning, as it informs the algorithm regulating real-time insulin delivery as a function of the patient's blood sugar level. Where else can machine learning or artificial intelligence (AI) help to drive health care innovation? Dr. Joelle Pineau, Associate Professor at the School of Computer Science at McGill University, Co-Director of the Reasoning and Learning Lab, and member of the Centre for Intelligent Machines, explains how AI can improve the operational and scientific efficiency of clinical trials, advance personalized medicine and cancer research, and previews the Keynote Address, The AI Revolution: Perspectives on Health Care in the Information Age, that she will deliver at DIA's Canadian Annual Meeting 2016.
Pre-competitive collaboration among pharmaceutical companies is leading to advances in critical aspects of drug development. This podcast delivers expert discussion of TransCelerate's Clinical Quality Management Systems, based on their article TransCelerate's Clinical Quality Management System: From a Vision to a Conceptual Framework in the July 2016 issue of Therapeutic Innovation & Regulatory Science (TIRS).
Dr. Pamela Tenaerts serves as Executive Director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership of more than 60 organizations working together to identify and promote practices that will increase the quality and efficiency of clinical trials. In this exclusive podcast, Dr. Tenaerts reviews CTTI’s antibacterial drug development program, previews her session Opportunities for Improving Informed Consent of Clinical Research Volunteers at our DIA 2016 Annual Meeting in Philadelphia, and shares highlights of CTTI’s new strategic plan, with DIA Global Forum Deputy Editor Dr. Alberto Grignolo.
Who determines how much society and/or patients should pay for a medicine? And how are those determinations made? Dr. Alberto Grignolo, Deputy Editor for DIA’s Global Forum, discusses these and related questions with Professor Sarah Garner, Associate Director, Science Policy & Research, for the UK's National Institute for Health and Care Excellence (NICE), and a pharmacist with special expertise in the interface between Health Technology Assessment (HTA) and regulation. Professor Garner will participate in a panel discussion on Value-Based Health Care Decision Making: The Quest for Smarter Spending at our DIA 2016 Annual Meeting in Philadelphia.
Dr. Gigi Hirsch is the Executive Director of the MIT Center for Biomedical Innovation (CBI). As part of her mission to innovate the drug development process, Dr. Hirsch will serve as Co-Chair of the DIA 2016 Annual Meeting in Philadelphia, where she will also participate in a panel discussion on Europe and the US: Making Outcomes-Based Health Care Possible. “DIA provides an incredibly powerful platform for engaging globally around some of the most important innovations that are happening in real time and need to continue to evolve,” she explains in this exclusive interview with DIA Global Forum Deputy Editor Dr. Alberto Grignolo.
Effective engagement between patients and industry, regulatory agencies, and other stakeholders, requires organizational cultures that place high priority and focus on patients. As Associate Director, Diversity & Patient Engagement, for Bristol-Myers Squibb Company, Mary Stober Murray builds relationships with advocacy organizations, patient communities, and provider communities, to keep them informed, educated, and prepared to support clinical development of BMS compounds. Mary will contribute her voice to the panel discussion on Changing Cultures to Advance Patient Engagement during the DIA2016 Annual Meeting in Philadelphia, and shares her experiences in this exclusive interview with DIA Global Forum Deputy Editor Dr. Alberto Grignolo.
Dr. Yves Juillet, Secretary General of the Academy of Medicine Foundation in France, is one of the persons most responsible for DIA’s first formal steps into patient engagement. For more than two decades, Dr. Juillet has been deeply involved with DIA, serving on the Advisory Council of Europe, the Board of Directors, and as DIA President. In 2013, he was named Honorary President of the French Academy of Pharmacy and was also named a DIA Fellow, the organization’s highest honor. In this exclusive Global Forum interview, Dr. Juillet shares what inspired these first steps and reflects on DIA’s subsequent journey into patient engagement.