DIA: Driving Insights to Action

Statistical Strategies for Using Sources of Safety Data

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.

Regulatory & Ethical Considerations in a Pediatric Trial

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.

Patient-Focused Drug Development: What Must We Still Do?

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.

Interchangeable Biosimilars: A Global Perspective

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.

Game Technology Opens New Path to Clinical Endpoints

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.