Series on Cannabis and Cannabis-Derived Products for Therapeutic Development, Part One
Sources of Cannabis and Cannabis-Derived Compounds Alison Wakeford, PhD, Scientist, Regulatory and Drug Development Consulting, Allucent Laura L. Erwin, PhD Marcus S. Delatte, PhD, VP Regulatory Strategy, Regulatory and Drug Development Consulting, Allucent FDA Issues Final Clinical Research Guidance on Cannabis The Food and Drug Administration (FDA) issued a final guidance on 24 January […]
The Office of Therapeutic Products (OTP): A New Way Forward for Cell and Gene Therapies
By Marites T. Woon, Associate Director, Nonclinical, and Jessica Lee, Principal, Global Head, Cell and Gene Therapy Cell and gene therapies (CGT) represent a growing subset of products that do not follow a traditional development journey, fraught with various challenges from inception to manufacturing and further on to commercialization. And yet, the curative potential these […]
Nonhuman Primates (NHPs): FDA Issues Guidance for Use in Nonclinical Safety Studies
By Alison Wakeford, PhD, Scientist, Allucent Richard Stewart, PhD, VP Nonclinical, Allucent Marcus S. Delatte, PhD, VP Regulatory Strategy, Regulatory and Drug Development Consulting, Allucent The Food and Drug Administration (FDA) issued a final guidance on 4 February 2022 to address the constrained supply of nonhuman primates (NHPs) for nonclinical safety assessments. As part one […]
Stepwise Paediatric Investigation Plan — Evolutionary or Revolutionary?
A New Initiative of the European Medicines Agency to Support Paediatric Medicines’ Development. HsinYi van Eekelen, Senior Clinical Strategy Scientist, and Richard Veselý, VP Regulatory Strategy Introduction At the time of the Paediatric Regulation introduction in 2006 [(EC) No 1901/2006], many products administered to children were prescribed by physicians based on their off-label experience instead […]
FDA Clarifies Policy on Post-COVID Meetings
Joshua Taylor, PhD, RAC, Senior Director, Regulatory Affairs and Head of Clinical Strategy, AllucentMatthew Hight, PhD, RAC, Associate Director, Regulatory Affairs, AllucentMarcus Delatte, PhD, Vice President, Regulatory Strategy, Allucent The Food and Drug Administration (FDA) issued an update on 30 January 2023 that clarifies the Agency’s position on and plan for face-to-face meetings. Prior to the March […]
Let’s Extrapolate!
Global regulators set scientific principles for using adult data in pediatric medicine development Simone Langeveld, Clinical Strategy Scientist, Allucent and Richard Veselý, VP Regulatory Strategy What connotations does “extrapolation” conjure for you? Something mathematical, obscure, suspicious? Or something liberating, connecting your rational brain with freedom and fantasy? You may not realize, but we continuously extrapolate […]
Overcoming Patient Recruitment Difficulties in Acute Ischemic Stroke Trials
Gilad Rosenberg, MD, MSc, Executive Medical Director, Therapeutic Area Medical Lead in Neuroscience Acute ischemic stroke (AIS) is a common and often devastating illness. Each year close to 700,000 persons experience new or recurrent ischemic stroke in the US alone. While the development of effective treatments for AIS is a priority of neurological research, clinical […]
Lessons Learned as Early Adapters of the EU’s Clinical Trials Regulation
By Marita Kruskopf Osterberg, PhD and Bernarde Bau, BSc, MSc The European Union’s Clinical Trials Regulation (CTR) has harmonised the process for authorisation and supervision of clinical trials in EU and the European Economic Area (EEA). Originally deployed on 31st of January 2022, the new process makes it possible to submit one online application to gain […]
Diversity in clinical trials: Optimizing drug development strategy, leveraging data and increasing efficiency with modeling and simulation.
By Lisa Benincosa and Katy Moore Clinical trials have evolved over the years with inclusion of broader patient populations; yet, additional efforts are needed to better understand the safety and efficacy across the diversity of patients who will be using the medicine. Factors such as race, gender, preexisting conditions, and age can all impact how a […]
How to Overcome Challenges in Combination Immunotherapy Clinical Trials
Immunotherapy has quickly become a major focus in the world of cancer research and treatment. In recent years, there has been a surge in the number of biotech companies conducting clinical trials for combination immunotherapies. What are Combination Immunotherapies? The combination immunotherapy approach involves the use of two or more different types of immunotherapies in […]