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 […]

Guide to CTIS Workspace Organization

Looking to understand the Clinical Trials Information System (CTIS) workspace organization better? Our newly released Guide to CTIS Workspace Organisation provides detailed insights into the management approaches of CTIS, including the organization-centric and trial-centric methods. The guide also offers a thorough examination of the authority workspace and its related tasks regarding clinical trial applications. This […]

Why Multinational Clinical Trials are Key to Bringing Novel Therapies to Patients

Originally published by BioPharmaDive Small and mid-sized biotech companies face unique challenges when bringing novel therapies to market. While many large pharmaceutical companies have the knowledge and in-house talent to clear regulatory hurdles and conduct efficient clinical trials, smaller companies often do not. That’s why small and mid-sized biotechs need to THINK BIG when working to […]

Defining the Regulatory Roadmap for Product Success

Originally published by BioPharmaDive Small and mid-sized biotech companies face unique challenges when bringing novel therapies to market. While many large pharmaceutical companies have the knowledge and in-house talent to clear regulatory hurdles and conduct efficient clinical trials, smaller companies often do not. That’s why small and mid-sized biotechs need to THINK BIG when working […]

Focusing on smaller biotechs to have a big impact on society

Originally published by PharmaVoice.com Marcus Delatte spent over 10 years as a senior pharmacology and toxicology reviewer with the U.S. Food and Drug Administration (FDA). Today, he leverages his expertise to help small and mid-sized biotech companies develop scientific, technical and regulatory strategies at the specialized Clinical Research Organization (CRO) leader, Allucent. Here he discusses how and […]

A Guide to Scientific Advice

A positive outcome for your marketing authorization application (MAA) is not guaranteed. As a result, it is imperative to employ methods to maximize the potential of your MAA and set yourself up for success.    Can asking the right questions increase the chances of your trials success?  The European Medicines Agency (EMA) provides valuable scientific advice […]