Innovations Shaping the Future of Cell and Gene Therapy

The Biotech Connector is a quarterly networking and speaker series, hosted by the FNL and Frederick County Chamber of Commerce, to bring together life science professionals for an inside look at local advances and to network.  

Please join fellow biotech and bioscience professionals for our last event in 2025. The speakers for the event are Vinay Vyas, PhD, Associate Director, Biopharmaceutical Development Program (BDP), Frederick National Laboratory for Cancer Research; Brian Paszkiet, M.S., Principal Clinical Specialist, Miltenyi Biotec; and Jon A. Rowley, PhD, Founder and Chief Product Officer, RoosterBio Inc.

Speakers

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Engineering Hope: FNLCR's Cutting-Edge CAR-T and TCR-T Therapies

Abstract

The Frederick National Laboratory for Cancer Research (FNL) is at the forefront of groundbreaking research in cancer immunotherapy, particularly in the realm of CAR-T and TCR-T cell therapies. This talk will provide an accessible overview of the innovative projects currently underway at FNL, showcasing how these cutting-edge approaches are reshaping the landscape of cancer treatment. This talk will explore the diverse range of CAR-T cell therapy projects, which involve genetically modifying a patient's own immune cells to target and destroy cancer cells. The presentation will highlight how the Biopharmaceutical Development Program is working with other cancer researchers to enhance the effectiveness of these therapies, improve their safety profiles, and expand their application to a broader range of cancer types. 

Additionally, the talk will delve into the exciting developments in TCR-T cell therapies at FNL. These therapies, which harness the power of T cell receptors to recognize cancer cells, are being refined to tackle solid tumors and hematological malignancies that have proven challenging for conventional treatments. A significant portion of the presentation will focus on the crucial advancements in viral vector production at FNL. These vectors are essential tools for delivering genetic modifications to T cells. By the end of this talk, attendees will gain a comprehensive understanding of how FNL's multifaceted approach to cell therapy research is paving the way for more effective, personalized cancer treatments. This overview will demonstrate the potential of these therapies to transform patient care and improve outcomes in the fight against cancer.

Bio

Vinay is an Associate Director at the Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory, where he heads the Development Group in the process development and clinical manufacture of ADCs, vaccines, cytokines, viral vectors, and cell and gene therapy products. More recently, he spearheaded the establishment of BDP’s cGMP CAR/TCR-T Cell Therapy Facility enabling FNL to rapidly become a leading manufacturing site for NCI’s clinical trials. 

Prior to joining FNL, he was a Visiting Scientist at the Center for Advanced Research in Biotechnology (CARB/IBBR), University of Maryland and a Senior Scientist at the Biochemical Engineering Research and Process Development Center at the Institute of Microbial Technology, CSIR, India. He graduated with degrees in Chemical Engineering and Chemistry followed by a PhD in Biotechnology and Biochemical Engineering. He has over 30 years of progressive experience in bioprocess development and translational research.

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Scaling the Future Advanced Therapy Products - The importance of manufacturing and supply chain

Abstract

Advanced therapy products hold transformative potential, but their success hinges not just on innovation, but on execution. As the field accelerates toward commercialization, scalable, efficient, and reproducible manufacturing is becoming a non-negotiable foundation. In this talk, we’ll explore why the cellular supply chain, starting with mesenchymal stromal cells (MSCs), must be designed with speed, consistency, and scalability in mind. We’ll highlight how plug-and-play bioprocess platforms are enabling rapid translation of MSC product concepts from idea to clinic, and why robust manufacturing solutions are essential to realizing the full promise of cell and gene therapies.

Bio

Jon A. Rowley is the Founder and Chief Product Officer of RoosterBio Inc and has a personal goal of making significant contributions to the commercial translation of living cellular technologies. Jon holds a PhD from the University of Michigan in Biomedical Engineering and has authored over 40 peer reviewed manuscripts and 20 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy manufacturing. He is an alumnus of BD, Aastrom, and Lonza, and currently resides in Walkersville, MD with his wonderful wife and their 3 awesome children. Jon is also on the Board of Directors of FITCI, Frederick’s local technology incubator.

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Automation of Cell and Gene Therapy Manufacturing Processes on the CliniMACS Prodigy® Instrument

Abstract

Automating cell and gene therapy processes is critical to improving efficiency, consistency, and scalability in advanced medical treatments. The CliniMACS Prodigy®, an integrated, closed-system platform, offers end-to-end automation for manufacturing cell and gene therapies. It streamlines complex workflows, such as cell isolation, genetic modification, expansion, and final formulation, while maintaining sterility and reducing manual interventions. This automation minimizes variability, enhances reproducibility, and reduces contamination risks. The platform's adaptability supports diverse therapeutic applications, including CAR-T cell production, hematopoietic stem cell processing, and virus-specific T cell generation. By automating these labor-intensive processes, the CliniMACS Prodigy® accelerates the production timeline, enabling broader clinical application and reducing costs. This abstract highlights the potential of the CliniMACS Prodigy® to transform cell and gene therapy manufacturing, paving the way for more accessible and reliable advanced therapies for patients worldwide.

Bio

Brian Paszkiet is an experienced scientist specializing in cellular processing, gene therapy, and automation. With a master’s degree in microbiology from the University of Illinois and over two decades of experience, he has held pivotal roles at Miltenyi Biotec, Inc., Thermo Fisher Scientific, and other leading organizations. At Miltenyi Biotec, Inc., Brian excels in creating and testing automated processes for the CliniMACS Prodigy® and supporting customers across the U.S. in automating their complex processes. His expertise spans cell separation, cell engineering, and lentiviral vector development. A seasoned innovator and collaborator, Brian has contributed to numerous publications, patents, and product launches in the cell and gene therapy field.