Jerome Workman’s Post

Specialized CGT therapies require distinct manufacturing capabilities, so we advise all our clients to choose their consultants and manufacturing partners carefully.  In what ways will increased efficiency boost your efforts to bring new assets to market? #processdevelopment #drugdevelopment #productdevelopment

Speed and flexibility are critical for success in #biotherapeutics and cell and gene therapy. John Litz from ILC Dover explains why these factors are essential for a seamless supply chain and how they impact manufacturing efficiency. Watch the video to learn more. #Biopharma #Biopharmaceuticals

Development of therapies is costly and challenging so many drop out leaving underserved patient communities without treatment. At #worldorphanusa Peter Marks, Director of the Center for Biologics Evaluation and Research talked about the need for removing barriers to keep researchers moving forward: -Unique production for small batch gene therapy -globalization of research approach to take varying regulatory requirements into consideration -streamlining process with the START program to get meetings in front of the FDA faster #onehavas making a #meaningfuldifference in #raredisease

💡 Want to navigate the complexities of Cell and Gene Therapy development? Our webinar series has you covered! Learn how to create a holistic CMC plan and optimize your process for success. Register today! https://buff.ly/4dWVyMS #GeneTherapy #Pharma #BioTech

+++ Pipeline #News +++ Fast Track Designation for Heart Failure Gene Therapy Asklepios BioPharmaceutical, Inc. (AskBio)'s gene therapy program for congestive heart failure has been granted U.S. FDA Fast Track Designation, emphasizing the need to rapidly advance new therapeutic modalities such as gene therapy for people living with congestive heart failure. Learn more: https://lnkd.in/ekY-krjA #TeamBayer

Exciting news from the Europe cell & gene therapy market! The increasing array of potential investigational cell and gene therapy products are promoting many companies to strategically embrace acquisitions to solidify their market presence. The market is currently dominated by major players such as Novartis, Gilead Sciences, Spark Therapeutics, Inc., Amgen, and Orchard Therapeutics. For more industry insights, check https://bit.ly/3S7hiv7 #europecellandgenetherapymarket #cellandgenetherapymarket #focusreportsbyarizton #ariztonresearchreveals #marketresearch #researchreport #marketinsights #markettrends #marketsize #marketshare #marketgrowth #marketforecast #marketexpansion #healthcareandlifesciences

Potency Assurance for Cellular and Gene Therapy Products "A potency assurance strategy is a multifaceted approach that reduces risks to the potency of a product through manufacturing process design, manufacturing process control, material control, in-process testing, and potency lot release assays. The goal of a potency assurance strategy is to ensure that every lot of a product released will have the specific ability or capacity to achieve the intended therapeutic effect." #FDA #celltherapy #cellandgenetherapy #manufacturing

AMT Guidance Would Hinder Cell and Gene Therapy Progress, Commentators Charge: The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) pathway would be restrictive to manufacturers in the cell and gene therapy spaces, the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy said in filed comments. #fda #financial #lifesciences

Alliance for Regenerative Medicine has released the newest sector snapshot. The cell and gene therapy sector go-to for all the statistics from our sector. Includes an update 2024 clinical pipeline, financing, industry trends and clinical trial landscape. 2,762 developers, 1,920 clinical trials and $11.7B in investment. #celltherapy #genetherapy #regenerativemedicine #advancdtherapies #cellandgenetherapy Tim Hunt Rita Johnson-Greene, MBA #geneediting #CARt #therapies #therapeutics #sectorupdate #biotech #biotechnology #healthcare #lifesciences #engineeredcelltherapies #Pharma #pharmaceuticals #regulatorypipeline #approvals #financing #clinicaltrials #investment #drugdevelopment #clinicalpipeline #cellengineering

📺 During the #BEYONDExpo2024 Healthcare Summit, we hosted a panel on “Challenges and Innovative Solutions in the Development of Cell and Gene Therapy Drugs”. During this panel discussion, they highlighted challenges such as high costs, and breakthroughs aimed at overcoming these obstacles and discussed the safety concerns and their solutions to these advancements. 🙏 Special thanks to the following panelists for their valuable insights: Zhenhua Wu, Founder and CEO, Exegenesis Bio Wang Shiyu, Co-Founder and Chief Scientific Officer, SanegeneBio Shin-Shay Tian, SVP, Discovery Research, Shanghai Vitalgen Biopharma Yarong Liu, Founder and CEO, Grit Biotechnology 👉 Don’t miss the full video at: https://lnkd.in/gNHTjmaG #Technology #Healthcare #Biotechnology #Pharmaceuticals #Innovations #HealthcareSummit