Director, Cell & Gene Collaborative Subscribe to my blog Wednesday, October 25, 2023 Here, Haskett and Graskemper walk me through the different nuances of risk-sharing in the current CGT outsourcing space and how they identify the best partner, platform, and intellectual property (IP) strategy when reviewing and (re)negotiating an MSA ..read more

Director, Cell & Gene Collaborative Subscribe to my blog Monday, October 2, 2023 We can’t just talk broadly about our need for more advanced capabilities from our outsourcing partners without closely examining the current maturity of CDMOs' AAV-based gene therapy and LVV-based cell therapy platforms. Lucky for us, Haskett and Graskemper shared their top tips and tricks for evaluating the seaworthiness of current CGT platform offerings.  ..read more

Director, Cell & Gene Collaborative Subscribe to my blog Friday, September 8, 2023 There are a few must-know details about the why & how of Sarepta’s comparability exercise, which I’ll outline for you here. But it wasn’t the facts and figures underpinning the comparability assessment itself that I found the most noteworthy; rather, this adcom served as an important reminder about the overall role comparability can and likely will play in the regulation of our advanced therapies moving forward ..read more

Director, Cell & Gene Collaborative Subscribe to my blog Monday, September 18, 2023 As we continue progressing beyond the COVID (i.e., the seller’s) economy, both Haskett and Graskemper agree we’re steadily seeing biotechs taking on a much more empowered role in negotiating with and securing CDMO partners. But they also see several shifts in the CGT development landscape that could impact both biotechs and their outsourcing partners equally — for the better, or if we’re not careful, for the worse ..read more

Director, Cell & Gene Collaborative Subscribe to my blog Monday, August 21, 2023 Though we cling to — and simultaneously despair over — the fact that regulatory experiences are product-specific, the hurdles/debates Sarepta faced remind us of the scientific and clinical complexities our future CGT products will no doubt be faced with during their own BLA reviews ..read more

Director, Cell & Gene Collaborative Subscribe to my blog Monday, August 7, 2023 The mRNA industry is an exciting place to be, and I have no doubt we will celebrate some significant triumphs in the future. But there are three critical realities (or perhaps difficult truths) I was reminded of during the mRNA Therapeutics Summit worth reiterating to keep us grounded through all our uninhibited dreaming ..read more

Director, Cell & Gene Collaborative Subscribe to my blog Monday, July 10, 2023 We tend to think of sustainability predominantly in terms of environmental/social initiatives. However, the 2023 AGC CDMO Summit presentations also shed light on three additional types of sustainability — and the mindsets underpinning them — that are essential for establishing an efficient business without placing our manufacturing and quality initiatives at risk ..read more

Director, Cell & Gene Collaborative Subscribe to my blog Friday, July 21, 2023 The eventual shape of our industry became increasingly top-of-mind as I listened to the final expert panel at the PDA ATMP conference, during which several experts shared the industry challenges currently keeping them up at night. Not surprisingly, many of these experts’ concerns revealed the tenuous relationship we as an industry have with our (often vastly different) assessments of risk in the CGT manufacturing paradigm.  ..read more

Director, Cell & Gene Collaborative Subscribe to my blog Thursday, June 15, 2023 Though the word “flexible” will inevitably appear in any conversation about a manufacturing facility, paradigm, or platform, we rarely stop to flesh out what such flexibility can mean and/or may look like. Here, in part two of this series, Abe Maingi of Inceptor Bio and Jason C. Foster of Ori Biotech help me chisel out how they are thinking about flexibility in tech provider partnerships in the heterogenous ATMP space.  ..read more

Director, Cell & Gene Collaborative Subscribe to my blog Wednesday, June 7, 2023 In part 1 of this two-part article, Jason C. Foster, CEO and executive director of Ori Biotech, and Abe Maingi, VP of business development and co-founder of Inceptor Bio, share their perspectives on how partnerships must evolve to mitigate the unique scientific and financial risks facing autologous cell therapies.  ..read more