C&G Editor in Chief, Erin Harris
Inside The ISCT Global Regulators Summit 2023
The ISCT Global Regulators Summit occurred on May 30, 2023. Immediately following the Summit, I attended a post-event press conference to learn the key highlights of the proceedings. Here's what I learned.
The Latest On Cell & Gene Live And Cell & Gene: The Podcast
April and May have been busy months for Cell & Gene: The Podcast and Cell & Gene Live. In case you missed it, here’s a look at just some of what we’ve covered including computational biology’s impact on gene therapy, the future of exosome science, and best practices for in-house CGT manufacturing.
The Potential Of Prime Editing
Ann L. Lee, Ph.D., Chief Technical Officer at Prime Medicine explains prime editing’s potential to make wholesale changes to DNA at one time.
Ocugen’s Modifier Gene Therapy Technology
Ocugen is the Malvern, PA-based biotech focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines. The company has achieved positive, preliminary data for OCU400, a therapeutic approach utilizing a modifier gene therapy platform with the potential to address significant unmet medical need for patients affected by Retinitis pigmentosa (RP) and Leber Congenital Amaurosis (LCA). I talked to Shankar Musunuri, Chairman of the Board, CEO & Co-founder of Ocugen to learn about next steps in the program.
Inside Atsena Therapeutics’ Gene Therapy To Improve Functional Vision
I caught up with Kenji Fujita, MD, Chief Medical Officer at Atsena Therapeutics to learn more about ATSN-101, the company’s investigational gene therapy for the treatment of GUCY2D-associated Leber congenital amaurosis (LCA1).
A Summary Of Cell & Gene Therapies Manufacturing Outlook Report: 2023 Edition
Industry Standard Research (ISR) just released Cell & Gene Therapies Manufacturing Outlook (2nd edition), and just like its predecessor, it’s chock full of valuable data. Here's a summary of their findings.
The Case For CGT In-House Manufacturing
With flexible and sustainable design strategies and best practices and contingency planning based on current market conditions and exit strategies, building an in-house facility is feasible.
The CureDuchenne, Sarepta Therapeutics Partnership
CureDuchenne is a non-profit located in Newport Beach, CA, that focuses on supporting translational research with the aim of getting promising therapies out of the labs and into human trials as fast and as safely as possible and has partnered with Sarepta from its earliest stages. I caught up with Michael G. Kelly, Ph.D., Chief Scientific Officer at CureDuchenne to learn more about the organization and its partnership with Sarepta.
CGT’s Highly Anticipated Regulatory Decisions
Time is flying, and as 2023 marches on, as many as 13 cell or gene therapies could be granted FDA approval by the end of the year.
A Breakdown Of Scaling Cell Therapies Part 2
Our Cell & Gene Live, Scaling Cell Therapies Part 2: Establishing Comparability in Manufacturing, aired last month and is now available on demand. Here is a breakdown of the full 60-minute presentation into smaller segments so you can learn at your own pace.