DIA: Driving Insights to Action

Executive FDA Leadership Reviews & Previews PDUFA Reauthorization

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?

“Biosimilars have at last come of age in the United States”

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.

Mission, History & Opportunity Attracts New DIA Americas Leadership

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.”

Clinical & Real-World Data: Is AI the Missing Link?

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.