Expert Roundtable on immuno-oncology manufacturing: progress towards streamlined commercialization

Anthony Davies

Executive Chairman, Dark Horse Consulting; Guest Moderator

Anthony founded Dark Horse Consulting in 2014, bringing 20+ years of leadership experience in product, process and manufacturing development to cell and gene therapy companies in need. Anthony has a proven track record in managing pharmaceutical pipelines, is a skilled liaison with international regulatory agencies, and has an intense familiarity with a wide range of biologics, and cell and gene therapies. He is a highly sought-after keynote speaker and chair of national and international conferences and seminars, noted for his provocative, thoughtful and sometimes contrarian presentations.

Øystein Åmellem

Director of R&D at Thermo Fisher Scientific

Øystein is Director of R&D at Thermo Fisher Scientific. For more than 19 years, Dr. Åmellem has held different leadership positions in R&D, Product Management and Business in Thermo Fisher Scientific. In these roles he was responsible for development and commercialization of products and services, including for the cell therapy market. He received his PhD from the University of Oslo in the field of molecular cell biology. During his academic career, he focused on the study of physiological & molecular mechanisms of tumor cell growth and was involved in investigating the method of actions for a novel group of anti-cancer compounds developed by Norsk Hydro.

Knut Niss

Chief Technology Officer, Mustang Bio

Dr. Niss has served as Chief Technology Officer since March 2018. Dr. Niss joined Mustang in March 2017 as Vice President of Operations, where he initiated and oversees the establishment of Mustang’s cell therapy manufacturing facility. Prior to Mustang, Dr. Niss was Cell Therapy Asset Leader at Biogen, where he oversaw CMC-related activities for gene-edited hematopoietic stem cell and lentiviral gene therapy programs for sickle cell disease and hemophilia, respectively. Earlier in his career, Dr. Niss was Senior Technical Project Leader at Novartis’ cell therapy manufacturing facility in Morris Plains, New Jersey, where he directed the transfer and implementation of the CTL019 process from Penn to Novartis. He also served as Senior R&D Program Manager at EMD Millipore, where he established processes for the large-scale expansion of adult and pluripotent stem cells. Dr. Niss began his career in senior research positions in Pfizer’s Regenerative Medicine and Immunology groups. He holds a Ph.D. in molecular biology from Humboldt University of Berlin, and an M.S. in microbiology from the University of Göttingen in Germany. Dr. Niss completed his postdoctoral research at Boston Children’s Hospital and the Dana-Farber Cancer Institute.

Sanjin Zvonić

WindMIL Therapeutics

In his current role at WindMIL Therapeutics, Dr. Zvonić leads the development of WindMIL’s core technologies and pipeline products, while concurrently contributing to the organizational growth and development. In 2009, Dr. Zvonić joined PCT, where he focused on client engagement and technology transfer into PCT, giving him a comprehensive understanding of cell therapy development, manufacturing and commercialization requirements and strategies. In 2014, he joined Novartis Cell and Gene Therapy Unit, where he focused on the development and commercialization of Novartis C/GT pipeline products. In 2016 Dr. Zvonić returned to PCT, with a focus on driving the growth and development of PCT’s clinical and commercial manufacturing business lines while integrating into Hitachi Chemical.