TRACK C - Biopharmaceuticals & Drugs:
Autologous Cell Manufacturing:
Current Challenges & Prospective Paths Forward
Of the many recent innovations in personalized medicine, perhaps none is so intimate and potentially impactful as the use of autologous cells. Yet broad dissemination of this treatment modality requires a rethinking of manufacturing approaches. The cells come from an individual patient and are delivered back to the same patient, yet in the intervening time: where they go, how they are treated, and how they are tested and released are open questions. This panel will seek to explore these unique manufacturing considerations.
Nathanael McCurley, PhD
Licensing Associate, Georgia State University
Leveraging 20 years of experience in academic science and industrial R&D, Nathanael works with investigators at Georgia State University to move their innovations from academic labs into the world of commerce. Trained as an experimental immunologist and cell biologist, Nathanael began his research career in Becton Dickinson’s Molecular Diagnostics R&D division, resulting in 510(k) Premarket Notification and successful commercial launch of a clinical-grade molecular diagnostics device (BD ProbeTec ET). In graduate studies, he investigated cellular mechanisms of antigen processing by dendritic cells in the laboratory of Ira Mellman, PhD at Yale, followed by postdoctoral studies of cellular immunology in the laboratory of Max Cooper, MD at Emory. Prior to joining GSU, Nathanael worked in two Atlanta-based biotech startup companies that licensed immunology-related technologies from Emory (Haplomics, Inc and GeoVax, Inc) and was pivotal in raising $5.6M in non-dilutive funding for the firms. Nathanael holds PhD, MS, and MPhil degrees in Immunobiology from Yale University and BS degrees in Philosophy, Molecular Biology, Biochemistry, and Bioinformatics from Towson University.
Jim Braun, MPH
Vice President of Innovation, Point A Center for Supply Chain Innovation at Georgia Power
Jim Braun leads innovation at Point A where leading global companies, start-ups and academic institutions come together to solve complex supply chain challenges. Point A Members bring together diverse capabilities and expertise as a foundation for identifying and tackling supply chain issues to drive outcomes that create lasting value for Point A Members. The Point A ecosystem is an interconnected network of diverse thinkers, innovation hubs, and cross-industry collaborators that are shaping the digital supply chain of the future.
Before joining Point A in 2018, Jim worked in Materials Management and Supply Chain at Genentech, a member of The Roche Group. During his 10-year tenure at Genentech, he led Procurement throughout the start-up and licensure of a new state-of-the-art Drug Product Fill-Finish plant in Hillsboro, Oregon. In 2013 Jim additionally led the Genentech/Roche Global Tank Management supply chain business that was responsible for transporting work-in-process inventory between 20+ biologics manufacturing sites spanning from Singapore, across Europe, to California. This global supply chain operation released thousands of Quality Approved cryovessels annually to support both clinical work and high volume manufacturing where operational and shipping validations were integral to securing global drug licenses.
Jim holds a B.S. in Biology from Wayne State University and a Masters of Science in Public Health from The University of Michigan. Jim began his career at Intel Corporation’s R&D Campus in Hillsboro, Oregon. He earned an MBA from the University of Washington during his 7 years at Intel.
Krishnendu Roy, PhD
Director, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT)
Dr. Krishnendu (Krish) Roy received his undergraduate degree from the Indian Institute of Technology (India) followed by his MS from Boston University and his PhD in Biomedical Engineering from Johns Hopkins University. After working for two years at Zycos Inc., a start-up biotechnology company, Dr. Roy left his industrial position to join the Biomedical Engineering Faculty at The University of Texas at Austin in 2002, where he was Professor and Fellow of the Cockrell Chair in Engineering Excellence. He left UT-Austin in July of 2013 to move to Georgia Tech. He is currently the Robert A. Milton Chaired Professor in Biomedical Engineering, and serves as the Director of the newly established NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT) and The Marcus Center for Cell-Therapy Characterization and Manufacturing (MC3M) - as well as the Director of the Center for ImmunoEngineering. He is also the Technical Lead of the NIST/AMTech National Cell Manufacturing Consortium (NCMC), a national public-private partnership, focused on addressing the challenges and solutions for large scale manufacturing of therapeutic cells. Dr. Roy’s research interests are in the areas of Immuno-engineering, scalable cell manufacturing, stem-cell engineering and controlled drug and vaccine delivery technologies, with particular focus in biomedical materials. In recognition of his seminal contributions to these fields, Dr. Roy has been elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and Fellow of the Biomedical Engineering Society (BMES). In addition, Dr. Roy has received numerous awards and honors including Young Investigator Awards from both the Controlled Release Society (CRS) and The Society for Biomaterials (SFB), NSF CAREER award, Global Indus Technovator Award from MIT, the CRS Cygnus Award etc. He is also the recipient of Best Teacher Award given by the Biomedical Engineering Students at UT-Austin and the best advisor award given by bioengineering students at Georgia Tech. He serves as a member of the Editorial Boards of the Journal of Controlled Release, the European Journal of Pharmaceutics and Biopharmaceutics, and the Journal of Immunology and Regenerative Medicine. He is a member of the Forum on Regenerative Medicine of the National Academies of Science, Engineering and Medicine (NASEM) and a Board Member of the newly established Standards Coordinating Body (SCB) for Cell and Regenerative Therapies.
Senior Director - Operations, Dendreon Pharmaceuticals LLC
Dwayne joined Dendreon nearly 4 years ago following a 23 year manufacturing career in Big Pharma. As the Head of Operations at Dendreon’s Union City facility, Dwayne oversees the manufacture of Provenge, an immunotherapy for the treatment of prostate cancer. While his career has weaved its way through stints in Manufacturing, Technical Operations, Quality Operations, External Manufacturing, and Change Management, Dwayne’s true passion is coaching people to achieve goals they never thought possible. Dwayne and his family enjoy being outdoors, whether embarking on an aggressive hike or casual walk, challenging one another to board/card games, and giving back to the community.
Process Engineer and Associate, CRB
Emily Thompson is a Process Engineer and Associate at CRB, specializing in biological process and facility design. Over the last 17 years working in the biotechnology industry, she has gained expertise in designing facilities for monoclonal antibodies, vaccines, and cell and gene therapy production, both in stainless steel and single-use. Emily’s facilities experience includes all phases of process design, including master planning, conceptual and detailed design, construction services and equipment procurement. Emily is a specialist in process simulation and modeling and experienced in a number of different software programs. A graduate of North Carolina State University, Emily holds two degrees: a Bachelor of Science in Chemical Engineering and Bachelor of Science in Biochemistry. She is also a licensed Professional Engineer in the state of North Carolina.