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.

Challenges and Opportunities for South Africa’s New Regulatory System

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.

Clinical, Data, and Quantitative Science Now Converging

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.

Realizing the Full Potential of CRISPR: Is the Hype Getting in the Way of Progress?

Clinical applications of CRISPR have matured very fast, promising to deliver precise gene therapy solutions to inherited genetic conditions and new approaches to cancer treatment. But the path to new CRISPR-based cures won’t be smooth sailing. Rachel Haurwitz, President, CEO, and Co-Founder of Caribou Biosciences discusses this technology and the biggest roadblocks to CRISPR-based therapies.

Tackling Ethical Questions in Clinical Research and Drug Development

Navigating ethical challenges is in the job description of anyone who works in clinical research and drug development. In the May 2018 issue of Therapeutic Innovation & Regulatory Science, a group of experts in research ethics published a special section on this topic, taking a closer look at four distinct aspects of clinical research that raise ethical questions for drug development teams. Dr. Lindsay McNair, Chief Medical Officer at the WIRB-Copernicus Group and co-author and editor of the special section discusses the findings and the standards we might need to revisit.

WHO 2030 Framework for Efficient, Effective Regulation

Dr. Petra Doerr, Deputy Executive Director of Swissmedic, and Dr. Murray Lumpkin, Deputy Director of Regulatory Affairs and Lead for Global Regulatory Systems Initiatives for the Bill and Melinda Gates Foundation, explain the World Health Organization’s Essential Medicines and Health Products Strategic Framework for 2016 to 2030.