Cell & Gene

As the 🧬RNA landscape continues to evolve, many of the CDMOs are entering the space tailored to large-scale, linear mRNA—leaving next-gen modalities like saRNA, circRNA, and others at a crossroads. Join us for an exclusive panel discussion with industry experts who will dissect the state of the outsourcing industry. We will show mRNA and next-gen RNA modalities companies how to evaluate CDMO partners' platforms and technical capabilities and where the capabilities gaps still exist. Save your spot (free): https://lnkd.in/eSdynQQk 📅 Tuesday, January 21, 2025 🕚 11:00 AM EST 🎙️ Expert Speakers: 🔹Andy Geall, CTO, Replicate Biosciences 🔹Alexander Aust, MS, MBA, CEO, Consultant, Aust Business Solutions 🔹Qian Ruan, SVP of Technical Operations at Arcturus Therapeutics, & Board of Directors at ARCALIS, Inc. Sponsored by: Cytiva #mrna #saRNA #circRNA

Join Us for "2025 CGT Regulatory Outlook" As the cell and gene therapy landscape evolves rapidly, join me and two of the field’s top regulatory experts—Dr. Kimberly Benton, with over two decades at the FDA, and Bambi Grilley, RPh, CIP, CCRC, CCRP, RAC, a pioneer in clinical research—to explore the regulatory challenges shaping our industry in 2025. When: Thursday, January 16, 2025, at 11:00 AM ET Duration: 1 hour This is a unique opportunity to gain forward-looking insights into FDA processes, regulatory strategies, and their impact on clinical trials and manufacturing. Registration is free—don’t miss it! https://lnkd.in/eCc2xFZV

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