Anti-Depression Medication: Current Landscape and Product Development Trends
Alison Wakeford, PhD, Scientist, Allucent Marcus S. Delatte, PhD, VP Regulatory Strategy, Allucent Background According to the World Health Organization, depression is a common mood disorder, affecting approximately 280 million people globally.1 Depression is characterized by persistent feelings of sadness and loss of interest, occurs across almost all age groups, and manifests in various forms […]
Advancing Oncology Drug Development: The Importance of Single-Arm Trials
By Marites T. Woon, PhD (Associate Director, Nonclinical) and Jessica Lee, MD, PhD (Principal, Global Head Cell & Gene Therapy) According to a report by the American Society of Gene and Cell Therapy, oncology remains one of the top areas of focus for investigational cell and gene therapy (CGT) products in Q1 of 20231, underscoring […]
Inroads To Approval: Navigating Formal FDA Meetings to Optimize Your Drug Development Program
Matthew Hight, PhD, RAC, Associate Director, Regulatory Affairs, AllucentJoshua Taylor, PhD, RAC, Senior Director, Regulatory Affairs and Head of Clinical Strategy, Allucent Marcus Delatte, PhD, Vice President, Regulatory and Drug Development Consulting, Allucent Welcome to our comprehensive five-part blog series where we will seek to guide you through the intricate world of formal meetings between the […]
Exosomes: Unveiling Their Potential in Cell and Gene Therapy
By Marites T. Woon (Associate Director, Nonclinical), Mialy Ramaroson (Director, CMC), Jessica Lee (Principal, Global Head Cell & Gene Therapy), William Lee (Vice President, Regulatory Affairs), and Richard Stewart (Vice President, Nonclinical) Welcome to our three-part blog series on exosomes, the fascinating messengers of the cellular world. In this captivating exploration, we delve into the […]
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 […]