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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Integrating Genetic Medicine into Clinical Care

August 27, 2018

CRISPR Therapeutics CEO Dr. Samarth Kulkarni spoke in the DIA 2018 Global Annual Meeting panel discussion session titled “Precision Medicine, Gene Editing, and Gene Therapy: Current Status and Regulatory Challenges of Integrating Genetic Medicine into Clinical Care.” He spoke after this session about the challenges of developing therapeutics involving gene therapy and gene editing with Session Chair Tshaka Cunningham, DIA Associate Director for Scientific Collaboration. Watch the video of this podcast interview.

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Regulatory Landscape of Drug-Device Combination Products

August 23, 2018

Demetra Macheras serves as Director, Regulatory Policy and Intelligence, in Regulatory Affairs for AbbVie, Inc. At the DIA 2018 Global Annual Meeting, Demetra served as panelist to provide the industry perspective in the session titled “Navigating the Regulatory Landscape of Drug-Device Combination Products” and was interviewed after this session for the following podcast. Watch the video of this podcast interview.

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Value-Based Assessment & Contracting: What Needs to Be Done?

August 21, 2018

While today’s contracting models prove unsustainable and many champion outcomes-based contracting models, much work remains to make these new models a reality. At the DIA 2018 Global Annual Meeting, Dr. Michael Rosenblatt, DIA Director and Chief Medical Officer at Flagship Pioneering, chaired the session “Value-Based Assessment and Contracting: What Needs to be Done to Make it a Best Practice?” and subsequently discussed innovative contracting models with DIA Global Chief Executive Barbara Lopez Kunz. Watch the video of this podcast interview.

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