Challenge:
Our client is an innovative, publicly-traded, lean biotechnology company focused on developing potential cures for infectious diseases and cancer utilizing cell therapies and proprietary platform technologies. The primary infectious disease target is Human Immunodeficiency Virus (HIV). There are numerous cancer targets, focused on hard-to-treat solid tumor indications where, currently, Chimeric Antigen Receptor (CAR) technologies have faced numerous challenges.
Alacrita was engaged to provide regulatory affairs support for Chemistry, Manufacturing & Controls (CMC), and Pharmacology & Toxicology to help support and accelerate client Research & Development (R&D) activities.
Solution:
Alacrita's regulatory affairs specialist has over fifteen years' experience in the field, both with the FDA as a senior regulatory specialist and subsequently within the pharmaceutical industry developing novel cell therapies. Our regulatory affairs team worked with the client to develop a regulatory strategy for its lead cell therapy product, as well as additional products in the pipeline.
Other members of our team were then integrated into the client R&D Team and their external contract organizations to ensure a smooth implementation and oversight of the strategy. For the lead drug, Alacrita's regulatory affairs expert supported the client with the management of contract manufacturing organization relationships, strategic support and implementation of manufacturing process and analytical method development and optimization, strategic support and implementation of Investigational New Drug (IND)-enabling in vitro and animal studies, as a regulatory liaison for first-in-human clinical trial design and associated information client education on FDA requirements, meetings/interactions and submissions for cell and gene therapies.
Cell & Gene Therapy Support
Alacrita frequently supports clients on projects involving advanced cell and gene therapies. For more information on our background and experience in this field, please click here.
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