IMMUNO-ONCOLOGY INSIGHTS

Modelling the I-O manufacturing facilities of tomorrow

Guest Editor:
John Lunger, Chief Patient Supply Officer at Adaptimmune Ltd
John Lunger
Chief Patient Supply Officer at Adaptimmune Ltd
John Lunger has been Adaptimmune’s Chief Patient Supply Officer since August 2019. John leads the teams responsible for producing and delivering products to patients, accelerating supply execution, and optimizing the supply chain to be ready for commercialization. Previously, John was Head of Supply Chain and Commercial Product Supply at Merrimack Pharmaceuticals where he led clinical and commercial supply chain as well as the cross functional supply team for Merrimack’s first commercial product launched in October of 2015. Earlier in his career, he held various senior manufacturing, operational, and strategy roles with VWR International, Pfizer and Wyeth Pharmaceuticals. In his nearly 10 years with Wyeth he held a number of leadership positions, including operations and supply chain strategy, supply management, procurement and strategic sourcing, business systems implementation, generic pharmaceutical business management, and site operations management in a pharmaceutical manufacturing plant in Ireland. John began his career serving as a nuclear trained officer on a U.S. Navy submarine followed by strategic consulting with Accenture. John holds a Bachelor of Science degree (with distinction) in Ocean Engineering from the U.S. Naval Academy and an MBA in economics and operations management from the University of Chicago’s Booth School of Business.

How to increase I-O manufacturing efficiency, flexibility,...

J Lunger,
John Lunger
Chief Patient Supply Officer, Adaptimmune
John Lunger has been Adaptimmune’s Chief Patient Supply Officer since August 2019. John leads the teams responsible for producing and delivering products to patients, accelerating supply execution, and optimizing the supply chain to be ready for commercialization. Previously, John was Head of Supply Chain and Commercial Product Supply at Merrimack Pharmaceuticals where he led clinical and commercial supply chain as well as the cross functional supply team for Merrimack’s first commercial product launched in October of 2015. Earlier in his career, he held various senior manufacturing, operational, and strategy roles with VWR International, Pfizer and Wyeth Pharmaceuticals. In his nearly 10 years with Wyeth he held a number of leadership positions, including operations and supply chain strategy, supply management, procurement and strategic sourcing, business systems implementation, generic pharmaceutical business management, and site operations management in a pharmaceutical manufacturing plant in Ireland. John began his career serving as a nuclear trained officer on a U.S. Navy submarine followed by strategic consulting with Accenture. John holds a Bachelor of Science degree (with distinction) in Ocean Engineering from the U.S. Naval Academy and an MBA in economics and operations management from the University of Chicago’s Booth School of Business.
V Yabannavar,
Vijay Yabannavar
Executive Vice President and Manufacturing and Technical Operations Officer, Gritstone Oncology
D Rill
Donna Rill
Chief Technology Officer, Triumvira Immunologics USA, Inc
Ms. Rill is currently serving as the Chief Technical Officer of Triumvira Immunologics, USA, Inc. She has extensive manufacturing, clinical and translational research laboratory experience in cell and gene therapy, monoclonal antibody production, and protein production. She has setup and managed core development laboratories covering a large range of testing services to facilitate research, core drug development activities as well as manufacturing and quality control laboratories. With her expertise in the areas of laboratory construction, project management, development and operations, cGMP, cGTP, and GLP regulatory compliance, quality control/assurance system, database development,  and clinical standards of practice, she has designed and qualified cGMP Cell & Gene Therapy Laboratories, cGMP Vector Production facilities, core service laboratories, and Translational Research Labs. Ms. Rill has previously held the positions of Vice President of Manufacturing for Cell Medica, Chief Development Officer for Opexa Therapeutics, Laboratory Director of Cell and Gene Therapy, Translational Research Laboratories for Cell and Gene Therapy, Baylor College of Medicine; Associate Scientist/Lab Manager of the Bone Marrow Transplant Research Laboratory, and the GMP Cell & Gene Therapy Laboratories, St. Jude Children’s Research Hospital; Education Coordinator and Clinical Instructor, Department of Clinical Laboratory, LeBonheur Children's Medical Center and University of Tennessee Center for the Health Sciences.  
23 April 2021
Expert Roundtable

Modelling the I-O manufacturing facilities of tomorrow

J Lunger
Chief Patient Supply Officer, Adaptimmune
John Lunger has been Adaptimmune’s Chief Patient Supply Officer since August 2019. John leads the teams responsible for producing and delivering products to patients, accelerating supply execution, and optimizing the supply chain to be ready for commercialization. Previously, John was Head of Supply Chain and Commercial Product Supply at Merrimack Pharmaceuticals where he led clinical and commercial supply chain as well as the cross functional supply team for Merrimack’s first commercial product launched in October of 2015. Earlier in his career, he held various senior manufacturing, operational, and strategy roles with VWR International, Pfizer and Wyeth Pharmaceuticals. In his nearly 10 years with Wyeth he held a number of leadership positions, including operations and supply chain strategy, supply management, procurement and strategic sourcing, business systems implementation, generic pharmaceutical business management, and site operations management in a pharmaceutical manufacturing plant in Ireland. John began his career serving as a nuclear trained officer on a U.S. Navy submarine followed by strategic consulting with Accenture. John holds a Bachelor of Science degree (with distinction) in Ocean Engineering from the U.S. Naval Academy and an MBA in economics and operations management from the University of Chicago’s Booth School of Business.
23 April 2021
Foreword

How to increase I-O manufacturing efficiency, flexibility,...

J Lunger,
John Lunger
Chief Patient Supply Officer, Adaptimmune
John Lunger has been Adaptimmune’s Chief Patient Supply Officer since August 2019. John leads the teams responsible for producing and delivering products to patients, accelerating supply execution, and optimizing the supply chain to be ready for commercialization. Previously, John was Head of Supply Chain and Commercial Product Supply at Merrimack Pharmaceuticals where he led clinical and commercial supply chain as well as the cross functional supply team for Merrimack’s first commercial product launched in October of 2015. Earlier in his career, he held various senior manufacturing, operational, and strategy roles with VWR International, Pfizer and Wyeth Pharmaceuticals. In his nearly 10 years with Wyeth he held a number of leadership positions, including operations and supply chain strategy, supply management, procurement and strategic sourcing, business systems implementation, generic pharmaceutical business management, and site operations management in a pharmaceutical manufacturing plant in Ireland. John began his career serving as a nuclear trained officer on a U.S. Navy submarine followed by strategic consulting with Accenture. John holds a Bachelor of Science degree (with distinction) in Ocean Engineering from the U.S. Naval Academy and an MBA in economics and operations management from the University of Chicago’s Booth School of Business.
V Yabannavar,
Vijay Yabannavar
Executive Vice President and Manufacturing and Technical Operations Officer, Gritstone Oncology
D Rill
Donna Rill
Chief Technology Officer, Triumvira Immunologics USA, Inc
Ms. Rill is currently serving as the Chief Technical Officer of Triumvira Immunologics, USA, Inc. She has extensive manufacturing, clinical and translational research laboratory experience in cell and gene therapy, monoclonal antibody production, and protein production. She has setup and managed core development laboratories covering a large range of testing services to facilitate research, core drug development activities as well as manufacturing and quality control laboratories. With her expertise in the areas of laboratory construction, project management, development and operations, cGMP, cGTP, and GLP regulatory compliance, quality control/assurance system, database development,  and clinical standards of practice, she has designed and qualified cGMP Cell & Gene Therapy Laboratories, cGMP Vector Production facilities, core service laboratories, and Translational Research Labs. Ms. Rill has previously held the positions of Vice President of Manufacturing for Cell Medica, Chief Development Officer for Opexa Therapeutics, Laboratory Director of Cell and Gene Therapy, Translational Research Laboratories for Cell and Gene Therapy, Baylor College of Medicine; Associate Scientist/Lab Manager of the Bone Marrow Transplant Research Laboratory, and the GMP Cell & Gene Therapy Laboratories, St. Jude Children’s Research Hospital; Education Coordinator and Clinical Instructor, Department of Clinical Laboratory, LeBonheur Children's Medical Center and University of Tennessee Center for the Health Sciences.  
22 April 2021
Expert Roundtable Video

Outlook on manufacturing adoptive cell therapies for cancer...

X Wang,
Xiuyan Wang
Associate Director, Michael G. Harris Cell Therapy and Cell Engineering Facility
Dr. Wang was trained by Dr. Adolfo García-Sastre and received her Ph.D. in Biomedical Sciences from the Mount Sinai School of Medicine in New York. She joined Dr. Peter Cresswell’s laboratory in the Department of Immunology at Yale University as a Howard Hughes Medical Institute fellow, and later as a Cancer Research Institute postdoctoral associate.Dr. Wang joined Memorial Sloan Kettering Cancer Center in 2007, and is currently the Associate Director of the Michael G Harris Cell Therapy and Cell Engineering Facility, and an Associate Lab Member in the Department of Molecular Pharmacology. Dr. Wang is in charge of the R&D, process development and manufacturing.She has overseen the successful manufacturing of all the CAR T cell products used in 13 phase I/II clinical trials, over 20 batches of cGMP grade viral vectors, as well as tech transfers to multiple industrial partners. She served in the translational science and product development committee in the American Society of Gene and Cell Therapy (ASGCT). She is currently a member for the National Heart, Lung and Blood Institute (NHLBI) independent external expert panel and a committee member for the Alliance of Regenerate Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).
I Riviere
Isabelle Rivière
Director, Michael G. Harris Cell Therapy and Cell Engineering Facility
Dr Rivière received her PhD in Cellular and Molecular Biology from the University of Paris. She initiated her graduate studies at the Institut Curie in Paris and completed her thesis in the laboratory of Dr.Mulligan at the Whitehead Institute in Cambridge, MA. During this time, she developed novel retroviral vectors for in vivo long-term expression of transgenes in hematopoietic cells using MFG/SFG-based retroviral vectors that are widely used in clinical studies for the treatment of genetic and acquired disorders. She is currently the Director of the Michael G. Harris Cell Therapy and Cell Engineering Facility where she investigates the genetic modification of hematopoietic cells to increase or retarget the immune response against tumors. Her laboratory has developed cell manufacturing platforms under cGMP conditions for several Phase I/II clinical trials and currently supports 8 CAR-T cell based clinical trials under 5 INDs at MSK. She actively participated in the National Cell Manufacturing Consortium Workshop that has led to the establishment of the Technology Roadmap to 2025 for Achieving Large Scale, Cost effective, Reproducible Manufacturing of High-Quality Cells.
21 April 2021
Editorial

Future-proofing cell therapy manufacturing capability:...

A Welch,
Anthony Welch
Biological Resources Branch, DTP/ DCTD/NCI
M Ernstoff,
Marc Ernstoff
ImmunoOncology Branch, DTP/ DCTD/NCI
J Yovandich
Jason Yovandich
Biological Resources Branch, DTP/ DCTD/NCI
20 April 2021
Commentary

Key considerations in delivering tomorrow’s biopharma manufacturing...

E Huang
Edwin Huang
University of Technology Sydney
Edwin Huang has over 15 years of research and commercial experience in bio-processing technology, covering microbial, plant cell and mammalian cell systems for various bio-production purposes, with a strong focus in mammalian application for biologics production to support pre- to early stage of clinical studies. Edwin has held various technical and managerial positions with local and oversea, private and publicly-listed start-ups, like Acyte (Sydney), Apollo Life Sciences (ASX:AOP), Biosceptre International (UK), and brought therapeutic antibody products into first in human use. A cross discipline background in engineering, life science and commerce has enabled Edwin to provide sound business and investment consulting in areas of biopharmaceutical and life science to management, existing and prospective investors and other research firms. Edwin is currently managing the $11.5M Biologics Innovation Facility at UTS, and also a retained expert with multinational patent law firms to work with global biopharmaceutical companies.
19 April 2021
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