KelleyIn 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/…
At this year’s Advanced Therapies Week in Miami, DHC is going to be doing something unprecedented. We’re convening our full panel of ex-FDA regulatory experts together at the Dark Horse Lounge (booth #700) for four events. Stop by to meet …
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 …
Walnut Creek, CA and Boston, MA—Dark Horse Consulting Group (“DHC”), the leading global consultancy to the cell and gene therapy (“CGT”) industry, and WestView Capital Partners (“WestView”), a Boston-based growth equity firm, are pleased to jointly announce that WestView has …
by Katy Spink, DHC’s COO and Managing Partner
Welcome to the end of Q3’22, a time that feels like an excellent opportunity for an update on my thoughts from earlier this year regarding what 2022 could mean for cell and …
By Dark Horse Principal Kevin Whittlesey, Ph.D.
In the field of cell and gene therapy we’re seeing more excitement and growth each year, and the recent ZYNTEGLO® approval adds to that. The significance of the new approval is due to …
