Cell & Gene

What can the cell therapy space expect to see in 2025? I asked three biotech leaders this question, and they candidly shared their predictions and optimism for the new year (and beyond). We discuss the effects of a changing political landscape (namely, bipartisan support of the BIOSECURE ACT), exciting advancements on the horizon for cell therapy manufacturing, and how biotech leaders should prepare for a potentially harsh funding environment in 2025. I would like to sincerely thank Kevin Caldwell, CEO, co-founder, and president of Ossium Health, Hamid Khoja, Ph.D., CSO of FibroBiologics, and Robert Williamson president and acting CEO of Triumvira Immunologics, for their participation in this roundtable discussion. To the rest of my LI friends -- please comment anything you agree with, disagree with, or found particularly insightful from this conversation. I always look forward to hearing your thoughts!

How will regulatory shifts impact cell and gene therapies in 2025? Join us for the 2025 CGT Regulatory Outlook on Thursday, January 16, 2025, at 11:00 AM EST. Hear from Dr. Kimberly Benton, former FDA leader and regulatory expert, as she shares strategies for navigating FDA processes, addressing challenges, and shaping successful development pathways. This free, one-hour session is your guide to the year ahead. Register now - https://lnkd.in/eK66iT4A

In this edition of Cell & Gene "In Focus": TRENDING CONTENT - Catch Up #1. The Complex Regulatory Landscape Of Flow Cytometry For Cell Therapy #2. Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why #3. CD70 & Autoimmune Diseases #4. Improving TCR T-Cell Persistence and Efficacy with Adaptimmune's Dennis Williams #5. October 2024 — CDMO Opportunities And Threats Report #6. Developing An mRNA-Encoded Antibody Platform To Accelerate Therapies To Clinic

How will regulatory changes shape cell and gene therapies in 2025? Find out at the 2025 CGT Regulatory Outlook on Thursday, January 16, 2025, at 11:00 AM EST. Gain expert insights from Bambi Grilley, RPh, CIP, CCRC, CCRP, RAC—a leader in clinical research and regulatory innovation—on navigating FDA processes, overcoming challenges, and driving successful trials. This free, one-hour session is your chance to stay ahead in this dynamic field. Register now - https://lnkd.in/eZ3VZSSv

Last month, #FDA (#CDER) issued a #draftguidance, "Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics (ONT)," to support clinical development and marketing of these products. Here, Peter Calcott provides a thoughtful summary and analysis of the guidance. https://lnkd.in/e9-nVTcz

Are you prepared to navigate the rapidly evolving regulatory landscape of cell and gene therapies? Join us for the 2025 CGT Regulatory Outlook on Thursday, January 16, 2025, at 11:00 AM EST. In just one hour, you’ll gain essential insights into the regulatory trends that will shape the industry’s future, including: ◼️ Strategies to address key regulatory challenges in 2025. ◼️ Perspectives on potential changes to FDA approval processes. ◼️ Updates on how recent regulations impact clinical trials and manufacturing. Led by distinguished experts Dr. Kimberly Benton, Bambi Grilley, RPh, CIP, CCRC, CCRP, RAC, and Erin Harris, this live event is your opportunity to stay ahead in a field projected to see 50 approvals by 2030. Registration is free, and this session will leave you equipped to thrive in this dynamic space. 👉 Secure your spot today - https://lnkd.in/ea8yCFpE

Count On Data Integrity Auditors Making These 10 Requests https://lnkd.in/eibp42y6 - By Dr. Eva Kelly, ERA Sciences Whether your company is navigating new manufacturing operations, launching a product in a new market, or adopting a risk-based approach for the first time, understanding what auditors look for is essential.

Quick reminder that Episode 91 of Cell & Gene: The Podcast featuring BlueRock Therapeutics' Amit Rakhit, MD, MBA is available. Tune in wherever you #podcast to listen to our conversation. Episode 92, out 12/19, will feature my in-depth discussion with Asklepios BioPharmaceutical, Inc. (AskBio)'s Lothar Roessig, MD about developing #genetherapies for #cardiovascular diseases, specifically congestive heart failure (CHF). This is another informative episode showcasing how the #CGT space is rapidly expanding beyond #oncology. #cellandgenetherapy #celltherapy #genetherapy #parkinsons #parkinsonsdisease https://lnkd.in/eGFcxZUq

Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides? https://lnkd.in/ebec7Dwu - By Kishore Hotha, PhD, MBA, Dr.Hotha's Life Sciences LLC Artificial intelligence (AI) is revolutionizing biomanufacturing by addressing critical challenges, especially in scaling production.

Great to see Benita Nagel CEO Nuntius Therapeutics and Albert Kwok CSO quoted in this article in Advancing RNA: Over the past year, mRNA-based therapies have delivered impressive clinical results, showing their promise well beyond infectious diseases. For example, BioNTech’s pancreatic cancer vaccine kept 40% of patients cancer-free for at least three years — an extraordinary outcome. With mRNA cancer vaccines on the cusp of commercialization, we expect interest and investment in this field to grow significantly. Advances in gene editing are also promising. Intellia’s Phase 2 mRNA-based CRISPR treatment for hereditary angioedema achieved majority complete responses. These breakthroughs make us incredibly excited for what lies ahead - Benita Nagel https://lnkd.in/ga_JAdpQ