Dr. Jacqueline M. Wolfrum is the Codirector of Biomanufacturing@MIT-CBI at the MIT Center for Biomedical Innovation. She also directs BioMAN, an industry-academic consortium focused on innovations and best practices in biomanufacturing, and she manages research activities focused on data analytics in biomanufacturing, continuous manufacturing, and cell therapy manufacturing.
Dr. Delfi Krishna has 10 years of biologics and 10 years of cell and gene therapy experience. During her Ph.D., she designed efficient and targeted retroviral and lentiviral vectors for gene delivery in human cells.
Dr. Stacy Springs is the Executive Director at the MIT Center for Biomedical Innovation (CBI). The Center integrates the Institute’s technical, scientific, and management expertise to solve complex biopharmaceutical challenges. Dr. Springs is a principle investigator on several research programs in biologics manufacturing, from application of data analytics and PAT in the continuous production of monoclonal antibodies, viral vectors and vaccines, to development of innovative rapid sterility tests and new approaches to adventitious agent contamination through long read sequencing.
Anthony J. Sinskey is a professor of microbiology within the Department of Biology at MIT. Professor Sinskey's research focuses on establishing an interdisciplinary approach to metabolic engineering. He is a recipient of a 2015 J-WAFS Solutions Grant for his project, "A Multiplex, Nanosensor Platform for the Real Time Monitoring or Food and Water-Borne Contaminants" as well as a recipient of a 2015 J-WAFS seed grant for his project, "A Bioassay-Based Approach to Food Safety in China."
Cell therapy is revolutionizing healthcare and is bringing life-changing treatments to patients. Are you ready to become a leader in bringing the most complex medicinal modality to market? Do you believe in the power of cells to treat devastating diseases? This three-day course will cover the entire cell therapy process development life cycle and provide actionable strategies to accelerate the manufacturing process, regulatory review, and market launch. Ultimately, you will learn how to take cellular therapies out of the lab and into the hands of patients in need.
Dr. Jacek Cieslak is a product quality team leader in the Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality (OPQ), CDER, FDA. Between 2005 and 2014, Dr. Cieslak has been working at FDA as a researcher/reviewer in the Division of Therapeutic Proteins in OBP where he gained review experience including protein therapeutics and biosimilar products. Dr. Cieslak joined the FDA in 2001 where he conducted his postdoctoral research on chemical synthesis and modifications of oligonucleotides. Prior to joining the FDA, he earned his Ph.D. degree in Chemistry from the Polish Academy of Sciences. He has authored and co-authored over 40 peer-reviewed publications in the area of oligonucleotide synthesis.
Dr. Pin-Kuang Lai is an assistant professor in the department of chemical engineering and materials science at Stevens Institute of Technology
Dr. Ryan E. Holcomb is employed as a Principal Scientist for Legacy BioDesign LLC, a contract research organization specializing in the formulation of therapeutic proteins and peptides.
