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.
Medical Affairs professionals in India work in uniquely challenging, constantly changing clinical research and clinical practice landscapes. “They walk on a tightrope with that balance between what the company needs and at the same time what is acceptable in the eyes of the medical community,” explains Dr. Viraj Suvarna, an independent consultant and expert in medical affairs in India who served on the faculty for DIA India’s Crafting Sound Medical Affairs Professionals 2018 workshop, in this Global Forum podcast.
Various data sources are used to evaluate patient safety throughout the healthcare product lifecycle, but the strengths and limitations of these sources can vary widely. In their most recent research published in Therapeutic Innovation & Regulatory Science, the Safety Working Group of the Biopharmaceutical Section of the American Statistical Organization focused on statistical strategies for obtaining reliable evidence from sources of safety data. This podcast discusses these strategies with three members of the working group: Dr. Richard Zink, Director of Statistical Services at TARGET PharmaSolutions; Dr. Olga Marchenko, Head of Therapeutic Area Statistics at Bayer, and Dr. Qi Jiang, Executive Director of Global Biostatistical Science, Head of Therapeutic Areas in Oncology, Inflammation, and Nephrology at Amgen.
Dr. Robert Nelson is Senior Director, Pediatric Product Development, for Johnson & Johnson, and previously served as Deputy Director and Senior Pediatric Ethicist in the FDA Office of Pediatric Therapeutics. At the DIA 2018 Global Annual Meeting, Dr. Nelson led discussions about “Regulatory and Ethical Considerations with Placebo Administration Using a Central Venous Access Device in a Clinical Trial” which is investigating therapies for a pediatric rare disease. Watch the video of this podcast interview.
Dr. Lode Dewulf serves as Chief Patient Officer for Servier and as Patient Engagement Co-Editor for the DIA Global Forum. At the DIA 2018 Global Annual Meeting, Dr. Dewulf chaired the session titled “Patient-Focused Medicines Development: Where It has Led Us to Today, What Challenges Remain, and What Do We Still Need to Do to Achieve Success?” He was interviewed after this session by Global Forum Editor Dr. Alberto Grignolo for the following podcast. Watch the video of this podcast interview.