DIA: Driving Insights to Action

Novel Approaches to PV Collaboration

Dr. José Vega is Vice President, Global Clinical Safety and Pharmacovigilance and Chief Safety Officer at Merck Research Laboratories. He also serves as Executive Sponsor of the TransCelerate Pharmacovigilance initiatives and as Merck's representative on the Clinical Trials Transformation Initiative Steering Committee. At the DIA 2018 Global Annual Meeting, Dr. Vega chaired the session Novel Approaches to Pharmacovigilance Collaboration and was interviewed after this session by Global Forum Editor Dr. Alberto Grignolo. Watch the video of this podcast interview.

Advancing the Science of Study Endpoints

“The relationship between an endpoint and an outcome is similar in many ways to the relationship between data and evidence,” explains Michael Lees, Head of Value, Evidence and Portfolio for Europe and Canada at Takeda Pharmaceutical Company Limited, and a program committee member for DIA’s Advancing the Science of Study Endpoints conference. “You can take a similar approach if you’re a clinical or regulatory expert: The transformation of the endpoint that’s measured in a clinical study into something that has meaning when you’re making a decision.”

Analyzing Innovation’s Progress in Gottlieb Era

At the DIA 2018 Global Annual Meeting, Dr. Nancy Bradish Myers, President and Founder of Catalyst Healthcare Consulting, Inc., chaired the panel discussion Analyzing Innovation's Progress in the Gottlieb Era, which brought together thought leaders from FDA, industry, and the venture capital world to discuss FDA’s modernization plan and its impact on development of innovative treatments. Dr. Myers was thereafter interviewed by DIA Global Chief Executive Barbara Lopez Kunz to discuss the key takeaways of the session. Watch the video of this podcast interview.

Comparing Generic Safety Profile with Branded Cousin

Howard Chazin serves as Director of Clinical Safety Surveillance Staff in the Office of Generic Drugs for the FDA Center for Drug Evaluation and Research. At the DIA 2018 Global Annual Meeting, Dr. Chazin chaired the session titled Generic Drug Products: Comparison of Safety Profile With Branded Cousin. He was interviewed after this session by Mr. Thomas Bols, Senior Vice President & Managing Director for DIA Europe, Middle East, and Africa. Watch the video of this podcast interview.

Defining Unmet Need Critical to Determining Value

Recent efforts to bring about agreement on the meaning of “unmet medical need” include a series of Unmet Medical Need sessions at the DIA 2018 Global Annual Meeting. This podcast, recorded after one such session, features DIA Senior Scientist Inka Heikkinen with two experts in this field: Dr. Kenneth Kaitin, Professor and Director of the Tufts Center for the Study of Drug Development at Tufts University School of Medicine; and Dr. Luca Pani, former Director General of the Italian Medicines Agency and current Executive Director for Global Medical Innovation at NeuroCog Trials, and Professor of Clinical Psychiatry at the University of Miami. Watch the video of this podcast interview.

Triple-A RWE: Adequate Data, Appropriate Designs, Actionable Evidence

Dr. Gregory Daniel, Deputy Director and Clinical Professor in the Duke-Robert J. Margolis Center for Health Policy, served as panelist in the DIA 2018 Global Annual Meeting session about real world evidence titled Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence. He was interviewed after this session by Mr. Thomas Bols, Senior Vice President & Managing Director for DIA Europe, Middle East, and Africa. Watch the video of this podcast interview.

US REMS Requirements for NDAs and BLAs

Nina Alexandria Johnson is a PharmD Candidate at Western New England University College of Pharmacy. At the DIA 2018 Global Annual Meeting, Nina claimed third place in the Student Poster Session for her poster titled Assessment of the United States REMS Program Requirements for NDAs and BLAs. Nina was interviewed shortly after receiving this award by DIA Science Writer Sandra Blumenrath. Watch the video of this podcast interview.

Epoietin Biosimilars: Qualitative Study of Patients' Views

Nicole Tsao is a PhD Candidate at the University of British Columbia in Canada. At the DIA 2018 Global Annual Meeting, Nicole claimed second place in the Student Poster Session for her poster titled Like We Have a Choice: A Qualitative Study of Patients' Views on Epoietin Biosimilars for Anemia of Chronic Kidney Disease. Nicole was interviewed shortly after receiving this award by DIA Science Writer Sandra Blumenrath. Watch the video of this podcast interview.

Disparities Between FDA/EMA Review Processes

Bijan Motamedi is a Doctor of Pharmacy Candidate at the University of Southern California School of Pharmacy. At the DIA 2018 Global Annual Meeting, Bijan claimed first place in the Student Poster Session for his poster titled Disparities Between FDA and EMA Regulatory Review Processes. Bijan was interviewed by DIA Senior Digital Copy Editor Chris Slawecki shortly after receiving this award. Watch the video of this podcast interview.

DIA Japan's Focus in Fall 2018

Dr. Akio Uemura, Senior Vice President and Managing Director, previews DIA Japan’s fall event calendar and explains the need to reduce clinical research complexity, and the need to develop both clinical and economic measures of patient outcomes, to enable innovative healthcare product development in Japan. “Clinical trial costs have increased to a much greater level, and that becomes a problem that makes the drug very expensive,” he explains. “There are many efforts being made to streamline those processes and make the cost as accessible as possible.”