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October 3, 2022

EXTRACELLULAR VESICLES – Engineering Extracellular Vesicles to Create Next-Generation Therapeutics October 3, 2022

David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.

April 1, 2019

RISK MANAGEMENT – FDA’s Quality Risk Management Approach to New Drug Applications April 1, 2019

Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.

August 27, 2018

DRUG DEVELOPMENT – Cell & Gene Therapies Calling for Innovation in Drug Development August 27, 2018

Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.