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 […]
Accelerating Drug Development of Innovative Oncologic Agents: Master Protocols
By Marites T. Woon, Associate Director, Nonclinical, and Jessica Lee, VP, Regulatory Strategy, Head, Cell / Gene Therapy Exponential advancements in oncology continue to drive personalized medicine and biomarker-driven therapeutics into reality. The development of innovative therapies to treat serious diseases remains a frontrunner across drug and cell and gene therapy (CGT) pipelines, with oncology […]
Benefits of Bayesian Dose Escalation Designs for Oncology Studies
As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods for dose escalation to support identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label Early Phase or First in Human studies. Bayesian dose escalation designs have also coincided with advances in oncology therapy […]