COVER

CGT MANUFACTURING - Scaling CGT Manufacturing Inside the US: The New Regulatory Paradigm

John Tomtishen says amid shifting FDA priorities as well as developing geopolitical considerations, US companies are entering a new regulatory era, one that will define how CGTs are scaled, distributed, and delivered domestically.

FEATURES

CGT MANUFACTURING - Scaling CGT Manufacturing Inside the US: The New Regulatory Paradigm

John Tomtishen says amid shifting FDA priorities as well as developing geopolitical considerations, US companies are entering a new regulatory era, one that will define how CGTs are scaled, distributed, and delivered domestically.

SPECIAL FEATURE - Excipients: Innovation in a Shifting Pharma Landscape

Cindy H. Dubin speaks with several companies and highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.

FORMULATION FORUM - Orally Disintegrating Tablets

Shaukat Ali, PhD, and Jim Huang, PhD, say as more NCEs are being discovered, the industry is weighing all options for evaluating those molecules in different dosages to improve solubility and oral bioavailability. With requirement for taste-masking of bitter drugs with commercially available ODT excipients, it poses additional challenges for improving taste-masking and performance of molecules for the intended usages.

PRECLINICAL SCREENING PLATFORM - From Preclinical Screening to Clinical Optimization: Accelerating Poorly Soluble Drug Development

Andrew Parker, PhD, John McDermott, and Sandeep Kumar, PhD, believe the development of poorly soluble drugs remains a significant challenge in pharmaceutical R&D. However, by adopting an adaptive approach that integrates services from preclinical screening to clinical optimization, developers can achieve significant time- and cost-saving benefits.

LIPID FORMULATION DEVELOPMENT - Why Softgels Are the Technology of Choice

Dipanwita De, PhD, and Kaspar van den Dries say solubility and bioavailability in OSD formulations remain major challenges within the early stages of drug development. While technological innovations have allowed the pharmaceutical industry to make progress in solving this hurdle, choosing formulations that help achieve desirable solubility and bioavailability can help speed up development of the most promising molecules.

CONTAINER SELECTION - Why Container Selection is Key to Overcoming Sterile Fill & Finish Challenges for Next-Gen Biologics

Vincenza Pironti explores the importance of container selection for sterile injectable drug products and outlines key factors to consider to optimize the performance, quality, and efficacy of biologics.

EXCIPIENT TECHNOLOGY - Driving Oral Drug Delivery Innovation With Safe, Reliable Lipid Excipients

Nick DiFranco, MEM, says amidst the uncertainty of novel ingredients and formulation techniques, lipid excipients provide a safe, proven platform for enhancing in vivo formulation performance, enabling innovation without sacrificing scalability or regulatory confidence.

CLINICAL TRIALS - Keeping Pace With Shifting Drug Development Paradigms for Multi-Indication Therapies

Simon Bruce, MD, and Jack L. Martin, MD, indicate that as developers increasingly embrace multi-indication development, the success of multi-indication therapies will stem not merely from pipeline adjustments, but also from development strategies designed with multi-indication objectives at their core.

EXECUTIVE INTERVIEW - Intensity Therapeutics: Providing Cancer Patients With Treatments That Work

Lew Bender, Founder and CEO of Intensity Therapeutics, discusses the company’s science, clinical program, the drug development process, and more.