Project Farma (PF)的动态

"It's great to see a willingness to learn and a willingness to take some risk. We should take advantage of this partnership because we're all learning together and delivering value to patients." - Miguel Forte, Kiji Therapeutics The clinical development roadmap for cell and gene therapy is ever-changing. How can we prepare for a more integrated approach to clinical trial design and execution? Brought to you by Precision For Medicine and hosted by Endpoints News. WATCH NOW: https://hubs.ly/Q02ybr8t0 #CGTx #CGTxDay2024 #CellTherapy #GeneTherapy #transformativemedicine

"It's great to see a willingness to learn and a willingness to take some risk. We should take advantage of this partnership because we're all learning together and delivering value to patients." - Miguel Forte, Kiji Therapeutics The clinical development roadmap for cell and gene therapy is ever-changing. How can we prepare for a more integrated approach to clinical trial design and execution? Brought to you by Precision For Medicine and hosted by Endpoints News. WATCH NOW: https://hubs.ly/Q02xXpMD0 #CGTx #CGTxDay2024 #CellTherapy #GeneTherapy #transformativemedicine

??Day one at the ?????? ???????? ?????????????? ?????????????? ?????????? ???????????? in Boston and the Cellply team, Massimo Bocchi and Marco Fadda, are joining the many discussions about the challenges of potency assay development for these therapeutics. They are joining the many analytical, QC, and regulatory experts who are sharing insights into the real-world issue and assessing the impact of the FDA’s draft guidance “Potency assurance for cellular and gene therapy products”. ? With VivaCyte now available commercially, there is a ?????? ?????????????????? ???????????? ?????? ???????? ???????????????????????????????? ???? ?????????? ???????????????? ?????????????????? that offers novel insights to enhance understanding of these vital cell therapy products. ???????????? #?? #CellCharacterization #PotencyAssay #CellTherapy

Things are now really starting to accelerate in this space - bring it on ..

Today Ocugen announced that the Data and Safety Monitoring Board approved enrollment in Cohort 3 as well as Phase 2 initiation in the Phase 1/2 ArMaDa clinical trial for OCU410—a modifier gene therapy candidate being developed for geographic atrophy. We are very enthusiastic about the potential of OCU410 as a potential one-time treatment for GA with a single sub-retinal injection. The currently approved treatments for GA target only the complement pathway and require approximately 6-12 intravitreal injections annually. OCU410 addresses multiple pathways causing dAMD, including complement, lipid metabolism, inflammation, and oxidative stress, potentially providing long-term benefit to patients. Read the full press release here: https://bit.ly/4aLjz6H

Pediatric cell and gene therapy trials: there's a LOT to consider. Get to know the regulatory requirements and more in this Institute for Advanced Clinical Trials for Children (I-ACT for Children) webinar on June 25 (featuring Advarra's Executive Director of Biosafety Services Dr. Daniel Eisenman):

I'm excited to share that I'm speaking at PRIM&R as part of session A05:?"The Ethical Conduct of Cell and Gene Therapy Research: Novel Challenges for Industry and the IRB"! #advarra, #clinicaltrials, #clinicalresearch, #genetherapy, #cellandgenetherapy, #mrna, #mrnavaccines, #ABSA, #SBA, #MABION, #SEBSA, #researchethics

Pediatric cell and gene therapy trials: there's a LOT to consider. Get to know the regulatory requirements and more in this Institute for Advanced Clinical Trials for Children (I-ACT for Children) webinar on June 25 (featuring Advarra's Executive Director of Biosafety Services Dr. Daniel Eisenman):

Thank you Lung-I Cheng for facilitating this robust discussion at Reuters Events Pharma about the value of #patient engagement in #cell and #gene therapy development. Key takeaways included: *Innovative study designs, such as leveraging #RWE, is needed to develop treatments for rare diseases which often have small patient populations. *Leveraging information from #FDA's patient focused drug development meetings is important to understanding the patient experience. *The rapid development of #CGTs is a paradigm shift for many regulating bodies, and risk-based flexability is needed to ensure timely #patient #access. *Long-term patient follow up remains a challenge, but the value of capturing patient #data remains a priority. Fellow Panelists: Olga Granaturova, Co-founder, President,?PriveBio Jeffrey Meckler, Chief Executive Officer,?Indaptus Therapeutics Jason Lott, MD MSHP MHS FAAD, VP, Global Integrated Evidence Generation, Specialty Medicine, Integrated Care, and Cell-Gene Therapy,?Bayer Special thanks to my colleagues American Society of Gene & Cell Therapy for supporting my participation at events on this important topic. #ASGCT #ASGCTadvocacy #CellTherapy #GeneTherapy

Hoping to see you soon at our upcoming webinar!