Mastering Clinical Trial Design: Will FDA’s Latest Guidance on Master Protocols Encourage Increased Adoption?

By Sugato De (VP, Regulatory Strategy, Head of Medtech) and Michelle Hoffner O’Connor (Clinical Strategy Scientist II)  On December 21, 2023, the Food and Drug Administration (FDA) issued a draft guidance entitled “Master Protocols for Drug and Biological Product Development.”  Master protocols originated as an efficient mechanism to determine which therapies may drive the most […]

Balancing Act in Preclinical Development: Strategies for Assessing and Managing Neurotoxic Risks in CNS Therapeutics

By Marcus Delatte (VP, Regulatory Strategy), Alison Wakeford (Scientist), Devin Welty (VP, Clinical Pharmacology), and Rachel Rozakis (Sr. Clinical Pharmacologist) Background Central Nervous System (CNS) disorders are typically severe and may produce various behavioral, anatomical, and physiological changes in millions of patients, which complicates developing effective therapeutics and managing product-related neurotoxicity.  Therefore, careful attention should […]

Cell & Gene Therapy Advancements: Early-Stage CMC Strategies for Exosome Innovation

By Marites T. Woon (Associate Director, Nonclinical), Mialy Ramaroson (Director, CMC), Jessica Lee (Principal, Global Head Cell & Gene Therapy) Welcome back to our exploration of the transformative world of exosomes in the second installment of our blog series. In our initial dive, we uncovered the intriguing potential of exosomes as dynamic messengers in intercellular […]

Navigating the Challenges of Clinical Trial Design 

Industry Featured Article Effective clinical trial design and execution play crucial roles in the successful introduction of a drug to the market.  However, the journey toward a meticulously planned clinical trial is fraught with challenges, capable of ensnaring even the most seasoned sponsors. Crafting an efficient recruitment strategy, formulating the trial’s design, and maintaining clear […]

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 […]

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 […]

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 […]