DIA: Driving Insights to Action

DIAmond Session 303: Value-Based Health Care Decision Making: The Quest for Smarter Spending

Discussions around value are not new, but health care spending based on value decisions and assessments is. Implementation of providing value in health care, particularly around the dollars and cents needed to do so, varies greatly worldwide. At DIA2016, an esteemed panel addressed this issue through Value-Based Health Care Decision Making: The Quest for Smarter Spending. “What’s different today than what we’ve seen in the past is this notion of transparency in how people are making these value decisions,” suggested Jennifer Snow. Facilitator: Jennifer Snow, MPH, Director, Reimbursement Policy Insights, Xcenda. Featured Speakers: Professor Sarah Garner, PhD, BPharm, Associate Director, Science Policy and Research, NICE, UK; Richard Willke, PhD, Chief Science Officer, International Society for Pharmacoeconomics & Outcomes Research; Newell McElwee, Merck & Co.; and Benjamin Heywood, Co-Founder, President, & Chief Privacy Officer PatientsLikeMe Inc.

DIAmond Session 302: Europe and the US: Making Outcomes-Based Health Care Possible

At DIA2016, a panel discussion with experts from regulatory, academic research, industry and information technology explored the health care industry’s next beachhead: Europe and the US: Making Outcomes-Based Health Care Possible. Panelists focused on the topics of clinical data, real-world data, and their relationships to evidence that more adequately address questions of value to support this value-based wave of change. “I would argue that randomized clinical trials, our so-called ‘gold standard,’ will only show you the tip of the iceberg,” said DIA 2016 Co- Chair Dr. Hans-Georg Eichler. Moderator:  Duane Schulthess, Managing Director, VitalTransformation. Featured Speakers:  Dr. Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU; Dr. Gigi Hirsch, Executive Director, MIT Center For Biomedical Innovation; Richard Bergström, Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA); and Steve Rosenberg, Senior Vice President and General Manager, Health Sciences Global Business Unit, Oracle Health Sciences.

DIAmond Session 203: “Innovation is Clearly Happening”: Next Generation Collaboration: Transforming the Industry

The DIA2016 panel discussion Next Generation Collaboration: Transforming the Industry focused on convergence, collaboration and cooperation in drug development. These activities, performed early and often amongst all stakeholders, can drive greater innovation, reduce time to market and increase efficacy in product development: There are 560 drugs currently in development for rare diseases; HIV, once a death sentence, is now a chronic disease; Hepatitis has a cure; and Melanoma, long considered untreatable, is now managed by a number of new drugs. In 2015, the FDA approved 51 new drugs, all new class agents, the largest number of approvals over the past 66 years. Featured Speakers: Dr. Dalvir Gill, CEO of TransCelerate BioPharma, Inc.; Dr. Christopher Austin, Director, National Center for Advancing Translational Sciences, National Institutes of Health; Dr. C. David Nicholson, Allergan Executive Vice President, Brand R&D; Dr. Jonathan Jarow, Senior Medical Advisor to the Center Director, CDER, FDA; Margaret Anderson, Executive Director, FasterCures, A Center of the Milken Institute; and Drew Schiller, Co-Founder and Chief Technology Officer, Validic.

DIAmond Session 201: International Regulatory Convergence, Collaboration & Cooperation

The DIA2016 DIAmond session International Regulatory Convergence, Collaboration, and Cooperation, convened a senior panel of global regulators to share with attendees the challenges in their respective jurisdictions, domestically and internationally, and discuss mutual reliance activities, including and especially the emerging International Coalition of Medicines Regulatory Authorities (ICMRA). Featured Speakers: Part I:  Emer Cooke, Head of International Affairs, EMA; Dr. Tatsuya Kondo, Chief Executive, PMDA, Japan; and Dr. Robert Califf, Commissioner, FDA. Part II: ICMRA Chair Anil Arora, Health Products & Food Branch, Health Canada; ICMRA Vice-Chair Dr. Lorraine Nolan, Health Products Regulatory Authority, Ireland; Jonathan Mogford, Medicines & Healthcare Products Regulatory Agency, UK; Dr. John Skerritt, Department of Health, Australia; and Dr. Jarbas Barbosa (Agência Nacional De Vigilância Sanitária, Brazil).

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.

TransCelerate Moves Clinical QMS from Vision to Conceptual Framework

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).

Executive Director Shares New CTTI Strategic Plan to Improve Clinical Trials

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.