Welcome to the DHC Regulatory Roundup, a new feature courtesy of our stableful of Regulatory experts. For this quarter’s inaugural edition, we’ve got a 2-for-1 content drop in which:
In late October 2022, FDA announced a new program called the CMC Development and Readiness Pilot, or CDRP (see the Federal Register notice dated October 31, 2022). The purpose of the CDRP is to increase CMC-focused communication between FDA and …
During Phacilitate’s Advanced Therapies Week ’23 in Miami last week, our former-FDA panel of regulatory experts got together to answer audience questions about both early- and late-stage regulatory concerns during the DHC Lunch & Learn activities. We’ve compiled the questions …
By Dan StantonBioProcess International
“With cell and gene therapies coming of age, experts at Advanced Therapies Week looked to reducing COGs, novel payer models, and even biosimilars to tackle their spiraling price tags…
Read entire article here:https://bioprocessintl.com/bioprocess-insider/therapeutic-class/10-cgt-approvals-in-2022-brings-gottliebs-math-close-to-realization/…
If you wish to reach out to us with comments or questions regarding this paper, please direct all correspondence to rAAV@darkhorseconsultinggroup.com, until April 15, 2023. If you have ideas or requests concerning DHC guidance, please write to us at thoughtleadership@darkhorseconsultinggroup.com.…
Dark Horse Consulting’s Sean O’Farrell recently published “Harnessing the power of design of experiments for cell therapy research & process development” with Cell & Gene Therapy Insights 2022; 8(11), 1487–1495. DOI: 10.18609/cgti.2022.217
The complexity and cost of producing cell therapies, …
Dark Horse Consulting’s Nate Manley and Sam Blackford coauthored this publication on the subject of “Expanding the analytical toolbox to address complex cell-based therapies” with Cell & Gene Therapy Insights 2022; 8(10), 1355–1369; DOI: 10.18609/cgti.2022.197.
Today’s innovators of cell-based therapies …
You are reading the beginning of the May 15th DHC Proposed Draft Guidance for FDA Consideration document itself. If you’re looking for the DHC press release on the same subject, click here. If you wish to reach out to us …
In early April, Endpoints News published “Avoiding Cell Therapy Manufacturing Gridlocks — a Do’s and Don’ts Guide,” in which guidance by our CEO, Anthony Davies, figured prominently. (One of his many quotes is above in the header on this page.)…
5 New Year’s Resolutions For Advancing The CGT Manufacturing Paradigm
By Anna Rose Welch, Director, Cell & Gene Collaborative
As I began plotting this article series following my conversation with Katy Spink, COO and Managing Partner of Dark Horse Consulting, …
From the Canadian Journal of Chemical Engineering via the Wiley Online Library comes an article authored by Dark Horse Senior Consultant Sara Mills in tandem with Elizabeth Csaszar and Peter Zandstra.
Access the full article, “Process evolution in cell and …
Principal Nate Manley was interviewed by Insights Bio this month for a Cell and Gene Therapy Insights raw and starting materials spotlight article entitled, “Emerging trends in control and regulation of immunotherapy cellular starting materials.”
Read the full article, including …
