PT. Enigma Saintia Solusindo’s Post

[PODCAST] The new frontier: regulatory implications for cell and gene therapies! Tune in and decode some of the key factors involved in regulatory approval, common barriers experienced getting these to market and Kimberly's insight for the next generation of CGTs to come through regulatory approval >>> https://hubs.ly/Q02mpr840

Hear from QPS Holdings, LLC's, Kimberley Buytaert-Hoefen, in the first episode of the ‘The new frontier’ podcast series and unravel the regulatory implications for bringing cell and gene therapies to market >>> https://hubs.ly/Q02mppZC0

Check out Episode 4 of CTI’s Moving Medicine Forward Podcast at https://lnkd.in/g7bUDhfX or connect with Katie on LinkedIn to learn how we are advancing the field of CGT. Meet Katie Westerkamp | Associate Director, Therapeutic Strategy Lead CTI is a leader in Cell and Gene Therapy (CGT) with experts like Katie driving innovative healthcare solutions. - What got you into CGT Research? “My first gene modified cellular therapy program was with beta thalassemia patients. The passion, particularly from Study Coordinators, made a lasting impact on driving my career in Cell and Gene research. I’m proud to pave the operational plan for CTI’s Cell and Gene Therapy studies, along with heading our Cell and Gene Therapy Center of Excellence.” - Where do you see the future of CGT? “The safety profile for Cell and Gene Therapy products has become more manageable based on knowledge we have gained. Traditionally, approved therapy centers sat within academic institutions. With an improved safety profile and consistent FDA approvals, there is a need for those products to move into regional and community hospitals. With the correct training protocols, this increases access to patients who otherwise wouldn’t have these products available to them within a reasonable radius of their home.” #MovingMedicineForward #AdvancingHealthcareSolutions #CRO #ThinkGlobalActLocal #CRC #CellTherapy #GeneTherapy #EmployeeSpotlight #CTIFamily 

Cell & gene therapies: How can market growth be sustained to maximise on opportunities? In this webinar, hosted by DDW and sponsored by Astrea Bioseparations, you will learn about how market growth can be sustained to maximise on opportunities in cell and gene therapy (CGT). You will hear from Doug Danison, Head of Commercial Strategy and Operations for Bayer CGT, Mark Treherne, Commercial Research Scientist and Chairperson at Spliceor, as well as Ian Scanlon, DSP Lead ATMP Purification at Astrea Bioseparations. Doug Danison will discuss transitioning innovative science into commercial success in the areas of CGTs. Mark Treherne will talk about advanced therapies and the development of RNA gene therapy for aggressive cancers which is being carried out at Spliceor. Ian Scanlon will discuss bottlenecks in advanced therapeutic delivery and how novel technologies can improve patient access and deliver sustainable processes. What you will learn: • Global opportunities created by advanced therapies in drug discovery • How sustainable growth is in this area and what the research sector should be focussing on for future success • The challenges this sector faces • Key trends for this sector. An audience Q&A session with the presenters will follow the webinar presentation.   Wed, Feb 28, 2024 3:00 PM - 4:00 PM GMT Register for this webinar and get your certificate of attendance! https://lnkd.in/eN-AKj-Y #CellandGeneTherapy #CGT #DrugDiscovery

https://lnkd.in/gWZQSnZx Cell and gene therapy overview and trends in China A lot of manufacturing and research capabilities How to bring that science to clinical and to successful marketing to global markets are critical topics to address? One key issue is the lack of human knowledge and capabilities that highly need improvement. #cellandgenetherapy #CART #Genetherapy #CDMO #Manufacturing #Regulations #Drugdevelopment

To continue to the discussions from the American Society of Gene & Cell Therapy conference, check out CTI's Podcast "Moving Medicine Forward," highlighting the work we conduct in Cell and Gene Therapy: 1. Bret Marshall discusses CTI's involvement in Cardiac gene therapy trials, exploring our impact, goals, and industry trends 2. Michael Schmidt and Nicole Sparshott discuss Chain of Custody best practices 3. Joana Lancastre discusses feasibility considerations for Cell and Gene Therapy Trials 4. Jaclyn Guillory shares CTI's experience with enrolling patients to trials with targeted therapies #CTIPodcast #MovingMedicineForward #CRO #ASGCT24 #CellTherapy #GeneTherapy

Potency Assurance for Cellular and Gene Therapy Products FDA Draft Guidance. On December 28, 2023, FDA announced the availability of the draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. 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. For a high-level overview of this guidance document, please view the recorded webinar at: https://lnkd.in/gDwZcrPq This webinar features Dr. Matthew Klinker, Cell Therapy Branch 2 Chief, Office of Cellular Therapy and Human Tissues, Office of Therapeutic Products, CBER. #celltherapy #cellandgenetherapy #celltherapymanufacturing #genetherapy #gmp #fda #fdacompliance #fdaregulations

'CGT actors and process maps: Who does what in the supply of different cell and gene therapies', was published in April 2022. https://lnkd.in/eQYQj2yt This toolkit identifies and describes the organizational units, process blocks, and customer-critical paths for several CGT modalities and is an essential step in promoting understanding of the complexity of CGT delivery. It observes that, due to the customer-critical pathway on allogeneic and autologous cell therapy, there is a requirement for a control tower actor to coordinate delivery. Our new 'Cell and gene therapy outbound supply chain tool' picks up this journey by demonstrating the different value chains that CGTs have in the outbound supply chain, making it clear what different therapy classifications mean and their supply chain ramifications. https://lnkd.in/eKY6-dJj Both publications provide a common language, facilitate clear communication, and provide a better understanding of the challenges. Designed to help educate communities in this space whether just entering the CGT field or more established, they are tools by which industry can find common ways of working. #celltherapy #genetherapy #supplychain #biopharmaceuticals Information Technology BioPhorum

Cell & gene therapies: How can market growth be sustained to maximise on opportunities? In this webinar, hosted by DDW and sponsored by Astrea Bioseparations, you will learn about how market growth can be sustained to maximise on opportunities in cell and gene therapy (CGT). You will hear from Doug Danison, Head of Commercial Strategy and Operations for Bayer CGT, Mark Treherne, Commercial Research Scientist and Chairperson at Spliceor, as well as Ian Scanlon, DSP Lead ATMP Purification at Astrea Bioseparations. Doug Danison will discuss transitioning innovative science into commercial success in the areas of CGTs. Mark Treherne will talk about advanced therapies and the development of RNA gene therapy for aggressive cancers which is being carried out at Spliceor. Ian Scanlon will discuss bottlenecks in advanced therapeutic delivery and how novel technologies can improve patient access and deliver sustainable processes. What you will learn: • Global opportunities created by advanced therapies in drug discovery • How sustainable growth is in this area and what the research sector should be focussing on for future success • The challenges this sector faces • Key trends for this sector. An audience Q&A session with the presenters will follow the webinar presentation.   Wed, Feb 28, 2024 3:00 PM - 4:00 PM GMT To secure your place, register for FREE now. https://lnkd.in/gjh7wdYm #CellandGeneTherapy #AdvancedTherapies #DrugDiscovery

The #cellandgenetherapy market is expected to reach $36.92 billion by 2027, growing at a CAGR of 39.62% during the forecast period. This expansion represents tremendous potential for addressing previously incurable conditions by targeting the underlying causes at the #genetic or #cellular level. The patient journey to obtaining treatment, however, is often fraught with complexity at every touchpoint, providing ample opportunity for improvement. Our blog, “Delivering on the promise of cell and gene therapies: A patient-centric approach,” addresses the current long and nonlinear #patientjourney for individuals who could benefit from cell and gene therapies. It then explores how sponsors, in collaboration with their #CDMO partners, can find ways to streamline operating models for cell and gene therapy development, manufacturing, and delivery, ultimately enabling an optimal #patientexperience. Read the blog to learn more: http://spr.ly/6047n8kFf