Cell and Gene Therapy Clinical Trials: How to Successfully Operationalize a Trial of Prolonged Duration
Cell and Gene therapies hold revolutionary potential for treating a wide range of diseases however, operationalizing trials of such duration and complexity is a significant task. Their development demands meticulous planning and expertise across multiple disciplines. View this webinar to hear from Allucents operational A-Team as they share insights and strategies on how to successfully […]
Translational Clinical Pharmacology in Cell and Gene Therapy
Learn more about the accelerating growth caused by transformative, curative and durable effects for unmet medical needs. The challenges that come along when growth happens so rapidly. As well as translational clinical pharmacology in AAV and CAR-T therapies. Presented by Vice President of Clinical Pharmacology – Devin Welty. Watch Here
Cell and 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 […]
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 […]
Operationalizing Cell and Gene Therapy Trials
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 […]
Long-Term Follow-Up for CGT Trials: Best Practices to Operationalize
By Desmond Cabrera, Project Director, Cell and Gene Therapy With today’s cutting-edge technology, we are on the cusp of developing truly magnificent therapies using cell and gene science. However, as with any new therapy, we must always consider the patient first. Guidelines to Ensure Patient Safety As far back as 2001, as new cell and […]
A Regulatory Perspective on Cell and Gene Therapy in Oncology
By Jessica Lee, VP, Regulatory Strategy, Head, Cell/Gene Therapy The past decade has produced many promising innovative cell and gene therapies (CGTs) to treat human diseases. CGT products, which use genetic material to modify cells in vitro or in vivo to treat, prevent, or potentially cure diseases, have great potential to address unmet medical needs. […]
Developing Oligonucleotide Therapies
Oligonucleotides are short strands of DNA or RNA molecules that contain a small number of nucleotides. Each nucleotide consists of a nitrogenous heterocyclic base (or nucleobase), a five-carbon pentose sugar (deoxyribose in DNA or ribose in RNA), and a phosphate group. The development of nucleotide and oligonucleotide therapeutics has been growing in importance over the […]
Expediting Treatments to Oncology Patients in Need: Understanding the FDA’s Accelerated Pathways
By Jessica Lee, VP, Regulatory Strategy, Head, Cell/Gene Therapy In recent years, we have observed a significant increase in use of expedited programs offered by the U.S. Federal Drug Administration (FDA). These programs are specifically intended to facilitate the development and review of novel drugs that address unmet medical needs in treating serious or life-threatening […]
Navigating Regulatory Strategies for Cellular & Gene Therapies
While any drug development program can face regulatory hurdles, developing cellular and gene therapies often presents unique challenges. Small and midsize biotech and pharma companies developing cellular and gene therapies should begin to understand critical nuances for successful regulatory meetings and submissions and how they impact strategic decisions during the product development lifecycle. At the […]