Comparing Generic Safety Profile with Branded Cousin

September 10, 2018

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.

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Defining Unmet Need Critical to Determining Value

September 7, 2018

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.

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

September 6, 2018

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.

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US REMS Requirements for NDAs and BLAs

September 4, 2018

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.

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Epoietin Biosimilars: Qualitative Study of Patients’ Views

September 4, 2018

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.

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Disparities Between FDA/EMA Review Processes

September 4, 2018

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.

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DIA Japan’s Focus in Fall 2018

September 4, 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.” 

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FDA Leadership on Future Biologics and EMA/FDA Cooperation

August 30, 2018

In the following podcast from the DIA 2018 Global Annual Meeting, Sudip Parikh, Senior Vice President and Managing Director, DIA Americas, is joined by Dr. Sandra Kweder, Deputy Director and Liaison to the EMA, Office of International Programs, FDA; and by Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research; to discuss EMA/FDA bilateral cooperation and related regulatory issues. Watch the video of this podcast interview.

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Global Perspectives on Patient Engagement

August 30, 2018

Jan Nissen, Vice President of Patient Innovation for Merck & Co., Inc., joins Deborah Collyar, Global Forum Patient Engagement Co-Editor and Founder of Patient Advocates In Research (PAIR), to discuss the importance and value of engaging patients in innovative research and product development at our DIA 2018 Global Annual Meeting. Watch the video of this podcast interview.

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DIA Board Chair Discusses DIA Now and Digital Tomorrow

August 28, 2018

On July 1 2018, Dr. Joseph Scheeren (Senior Advisor, R&D, Bayer) became Chair of the DIA Board of Directors. “In this time of great change, it is great to be part of an organization like DIA, which wants to bring stakeholders together in order to discuss and foster the development of new products and new technologies,” he explains. “We have a unique opportunity not only to bring these stakeholders together but also to serve as a platform for information for our members and even beyond our members.” 

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