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.
FDA has approved 11 biosimilars, but 41 biosimilars have been approved for use in Europe. The DIA 2018 Global Annual Meeting session “Interchangeable Biosimilars: A Global Perspective” explored the circumstances behind this difference and ways and reasons to close this gap, led by Session Chair Nielsen Hobbs (Executive Editor, US Policy & Regulatory, The Pink Sheet/Scrip), who was interviewed by DIA Senior Digital Copy Editor Chris Slawecki for this podcast. Watch the video of this podcast interview.
Dr. Bill Byrom, Vice President, Product Strategy and Innovation, for CRF Health, Vice Director of the C-PATH ePRO (electronic Patient Reported Outcomes) Consortium, and a member of the DIA Study Endpoints Community, discusses the future of ePRO, mobile accelerometry, and other mobile devices, in clinical trials. Attend Advancing the Science of Study Endpoints to learn more.
A study published in the July 2018 issue of Therapeutic Innovation & Regulatory Science (TIRS) evaluates the current South African regulatory review process within the MCC, identifying regulatory milestones and review times prior to the establishment of the new South Africa Health Products Regulatory Authority (SAHPRA). Sam Salek, Professor of Pharmacoepidemiology at the School of Life and Medical Sciences, University of Hertfordshire, UK, and co-author of the study discusses the main findings as well as the challenges and opportunities for enhanced regulatory practices in South Africa.
Dr. Tony Guo (Executive Director and Head of Biometrics, China, BeiGene) and Dr. William Wang (Executive Director for Clinical Safety, Risk Management Statistics, Biostatistics, and Research Decision Sciences at Merck Research Laboratories) preview the intersections of clinical science, health data science, and other pathways that will converge at the DIA Quantitative Science Forum 2018.