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.
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.
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.
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.
Conversations about artificial intelligence in drug discovery and development are shifting from theoretical questions to practical implementation and impact. Detlef Hold, Global Strategy Lead, Knowledge Cycling (Genentech), and panelist for Exploring Use of Artificial Intelligence at DIA Europe 2018, discusses AI and machine learning in the workplace.
Dr. Shun Lu, Director of the Shanghai Lung Cancer Center at Shanghai Jiaotong University in China, discusses the importance of training doctors and nurses for clinical research in China’s fight against cancer and his experience on the Steering Committee for the 10th DIA China Annual Meeting. (Note: You may notice small gaps in audio due to transpacific connection.)
As Director of the Phase 1 Unit of the Clinical Pharmacological Research Center at Peking Union Medical College, Dr. Pei Hu has been a driving force in advancing model-based drug development in China. Dr. Hu discusses recent changes impacting clinical research in China and her service as co-chair of our 10th DIA China Annual Meeting in Beijing.
The US Centers for Disease Control and Prevention estimates that the annual "economic burden" from prescription opioid abuse–including the costs of healthcare, lost productivity, addiction treatment, and criminal justice–is $78.5B. Dr. Nora Volkow, Director of the National Institute on Drug Abuse (NIDA), US National Institutes of Health, discusses opportunities to turn back this tide and previews the Keynote Address she will deliver at our DIA 2018 Global Annual Meeting this June.
Dr. Shahid Hanif, Head of Health Data & Outcomes for the Association of the British Pharmaceutical Industry, discusses the IMI Big Data for Better Outcomes initiative in advance of the session Has the Time for Big/Real World Data Finally Arrived? which he will chair at DIA Europe 2018.