DIA: Driving Insights to Action

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.