This webinar will feature updated definitions of point of care (POC) manufacturing and feature two leading innovators in POC manufacturing to offer real-world examples of – and insights from – successful POC programs. Real-life experts will speak about their experience of building a point-of-care manufacturing program at a clinical laboratory. They will discuss the challenges, the potential solutions, and the regulatory aspects of in-house manufacturing, and provide perspective from the different vantage points of their respective roles.

Unlock the pathway to successful cell therapy approval in Australia with our ISCT exclusive webinar, "Getting Your Cell Therapy Product Approved: Some Dos and Don'ts." Hosted by experts from the Therapeutic Goods Administration (TGA), this event is your guide to navigating the intricacies of regulatory processes. Learn firsthand the crucial dos and don'ts that can make or break your cell therapy product's approval journey. Our distinguished speakers will delve into the nuanced requirements of the TGA, providing invaluable insights into crafting robust submissions, avoiding common pitfalls, and streamlining your approval process. Stay ahead of the curve by gaining a comprehensive understanding of Australia's regulatory landscape for cell therapies. Whether you're a seasoned professional or new to the regulatory realm, this webinar equips you with practical knowledge to optimize your strategy and enhance your chances of a successful approval. Seize this opportunity to engage directly with TGA officials, ask questions, and network with fellow industry professionals. Don't miss out! Register now for a transformative experience in advancing your cell therapy product through the regulatory maze Down Under.

Join us for an insightful webinar on the "Emerging Techniques in Cell Replacement Therapy for Pancreatic Diseases." This session will dive deep into cutting-edge methodologies revolutionizing pancreatic disease treatments. Highlighted topics include state-of-the-art hPSCs protocols to derive beta-like cells—a promising avenue in regenerative medicine. Exploring innovative horizons, the webinar will also feature discussions on Decellularized Extracellular Matrix (ECM) used in the bioengineering of islets. Discover the significance of ECM in recreating a nurturing environment for islet development and functionality. Additionally, explore the frontiers of Islet Transplantation Sites, and their impact on successful transplantation outcomes. Don't miss this exclusive opportunity to expand your knowledge and understanding of these ground-breaking approaches in the field of pancreatic disease management.

AusBiotech and Medicines Australia have partnered to co-lead a new Cell and Gene Catalyst initiative. This national joint venture is a collaborative effort between the two peak industry bodies. The Catalyst aims to accelerate the development and commercialisation of cell and gene therapies in Australia and strengthen Australian capabilities across the entire value chain.

Join our webinar, "CAR-T: Historical Perspectives, Manufacturing, and Clinical Applications," to uncover the revolutionary world of CAR-T cell therapy. Discover the historical journey and core principles that led to this cutting-edge treatment, and explore the intricacies of its manufacturing process. Delve into its diverse clinical applications, showcasing its potential in transforming patient

Thailand is strategically poised to establish itself as a prominent medical hub in the Asian region, boasting an exceptional medical infrastructure, skilled healthcare specialists, and a multitude of internationally accredited medical facilities. Consequently, Thailand's medical services have garnered global recognition.

Automated CGT manufacturing process will provide the potential solutions to reduce cost and burden in data management/integration on both manufacturing data and clinical data. There are 3 stories on such topics as the up-to-date/practical cases by 1) Hitachi - Decentralized Manufacturing Module/Value Chain Control, 2) Vision Care - Automated Manufacturing Process-Manufacturing Systems, and 3) Cyto-Facto - Automated Manufacturing Process based upon Quality by Design (QbD) initiatives. It is highly valuable to hear such stories and to introduce their activities into your manufacturing process, which will contribute to the successful business practice in CGT product development and commercialization.

Targeted Cellular Collections have been successfully used as the cell procurement method for HPC-A transplants for several years. These starting material products are becoming standard products for further manufacturing into novel biological medicines. With this change, the procurement of standardized, high quality and consistent product yields becomes essential to the manufacturing process. The donors may have underlying medical issues that complicate the apheresis procedure. The underlying disease may affect the approach to automated product collection. As the market is shifting to more licensed products, the manufacturing records and other clinical care documentation now begin with donor selection, qualification and collection. These processes and procedures are now part of the GMP manufacturing process and regulated by federal requirements for drug manufacturing. This session will review the experience of a collection facility with shifting the mindset from service delivery to manufacturing in a regulated environment as well as sharing best practices for collections for Cellular Therapy products.

Learn about: What is the ethical protocol of approaching patients for early-stage clinical trials i.e. determining what is the reasonable ratio between risks and benefits, and the role of the FDA and EMA? What are the key differences between CGT clinical trials compared to the traditional model? How has COVID-19 changed accessibility, resource planning and management of CGT trials and what are the best practices for working lean? What is the clinical perspective of the most forceful challenges posed by COVID-19 when conducting Clinical Trials? How has patient advocacy and support changed in the face of COVID-19?

Join leading experts in the cell and gene therapy sector for an expert look at the use of mesenchymal stem cells (MSCs) to treat COVID-19. This 75-minute webinar will cover the science and potential therapeutic benefit of MSCs to treat COVID-19; what patients and patient groups should understand about these therapies; and finally, the ethical and safety concerns for companies and clinics promoting therapies outside of a recognized regulatory process or prior to the conclusion of a clinical trial.