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Articles by Kimberly Benton
Detroit CoC Awarded $40 Million in HUD CoC Competition — Homeless Action Network of Detroit
We’re excited to share that the Detroit Continuum of Care (CoC) has been awarded $40 million in the U.S. Department of Housing and Urban Development’s (HUD) annual CoC Program Competition! This funding will support vital programs and services aimed at preventing and ending homelessness in Detroit, Highland Park, and Hamtramck. A huge thank you to our partners and providers who work tirelessly to support our community.
07.31.24 -- What Does FDA's Platform Guidance Mean For ATMP Companies?
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.
07.16.24 -- Do You Know Your QMM? Moderna Might Some Day
The Sponsor's Clinical Development Handbook For Gene Therapy Clinical Trials Gene 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.
06.27.24 -- How Generative AI Could Change Pharmaceutical Manufacturing
FOCUS ON ANALYTICS & QUALITY Despite the hype, pharma has been slow to integrate artificial intelligence. Other industries have shown how it adds value by simplifying tedious tasks. Digitalizing Biopharma Manufacturing Step-By-Step: Part II Explore a modular approach to digitalization involving the development of electronic logbooks and procedural guides, weigh and dispense processes, and Master Batch Records/Electronic Batch Records.
06.26.24 -- What Does FDA's Draft Platform Guidance Mean For CGT Companies?
Discover WuXi Advanced Therapies. Take a virtual tour of our 400,000 ft2 campus conveniently located in Philadelphia, PA with four facilities dedicated to process development, on-site analytical testing, clinical manufacturing, and commercial production. Our team of more than 900 experienced cell and gene therapy professionals has the experience and know-how to expertly handle a wide variety of advanced therapies. Get in touch today.
What Does FDA's Draft Platform Guidance Mean For CGT Companies Original
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.
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