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.”
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.
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.
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.”
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.
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.
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.
Dr. Patrick Brady, Vice President of Regulatory Affairs at Bayer, chaired the DIA 2018 Global Annual Meeting session “The Future of PharmaTech” that explored how new technologies such as artificial intelligence, block chain, cloud computing, and “the internet of things,” are impacting the entire healthcare ecosystem. Dr. Brady discusses these technologies and their impacts with Dr. Sudip Parikh, Senior Vice President and Managing Director for DIA Americas, in the following podcast. Watch the video of this podcast interview.
In 2016, a young boy was accepted as a patient in a clinical trial designed to develop a cure for DMD. A few months later, Nicholas Bullers and his family delivered to the FDA Pediatric Committee and Pediatric Ethics Subcommittee a presentation about the anguish that Nicholas faced in this trial. The Bullers family shared this journey in the DIA Global Annual Meeting session “Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Pediatric Trial,” and in the following interview conducted after that session. Watch the video of this podcast interview.
June Wasser is the Executive Director of the Reagan-Udall Foundation for the FDA, established by Congress for the purpose of advancing regulatory science. At the DIA 2018 Global Annual Meeting, she chaired the session titled "IMEDS, or Innovation in Medical Evidence and Development Surveillance: A Collaboration Based on the FDA's Sentinel Initiative," and was interviewed thereafter by DIA Senior Scientist Raleigh Malik. Watch the video of this podcast interview.