Kimberly Benton

Jul 31, 2024 | advancingrna.com | Kimberly Benton |Antony Hitchcock |AGH Bioconsulting |Louis Garguilo

There’s been great progress in establishing platforms for linear mRNA vaccines — but where does this current know-how fall short for those exploring linear and next-gen RNA constructs for non-vaccine products? Secure your spot for Advancing RNA Live’s next digital panel discussion on the current known unknowns (and unknown unknowns) about our mRNA therapeutics candidates that make adopting the traditional QbD approach complicated. Registration is free thanks to the support of Roche Custom Biotech.

Jul 16, 2024 | outsourcedpharma.com | Louis Garguilo |Kimberly Benton |A Focus |GC Cell

The Sponsor's Clinical Development Handbook For Gene Therapy Clinical TrialsGene therapy has existed for decades, but the field is not as mature as it may seem. Its unique pace, structure, and funding dynamics present distinct challenges. Discover essential insights and strategies for overcoming gene therapy development challenges. Don’t panic if you aren’t familiar with the above acronym, which stands for Quality Management Maturity.

Jun 17, 2024 | cellandgene.com | Kimberly Benton

By Kimberly Benton, Dark Horse Consulting Group The U.S. FDA released the much-anticipated draft guidance Platform Technology Designation Program for Drug Development1 on May 28, 2024. This guidance was issued to establish a program for designation of platform technologies as required by the PREVENT Pandemics Act2 and provides information on how FDA intends to implement the program. Comments may be submitted to the public docket3 until July 29, 2024.