Chad Green, Ph.D.

Chad is an accomplished Ph.D. level bioengineer, Lean Six Sigma Black Belt, and leader of design, development, scale-up, and cGMP manufacturing of cell therapy, gene therapy, and combination products. At Dark Horse Consulting, he specializes in critical areas of development including process development and improvement, CMC, risk management, root cause investigation and Quality by Design. He partners with clients across a broad range of technologies, including autologous and allogeneic cell therapy, biologic/device combination products, gene therapy and medical devices.

Inventor on over 25 issued patents, Chad most recently served as the Senior Director of Technical Operations at Fate Therapeutics where he led process development, technology transfer activities and CMC for an adaptive NK cell product. At Fate Therapeutics, Chad was also responsible for regulatory submissions, cGMP manufacturing strategy, and cGMP readiness for a broad range of iPSC-derived immunotherapy products.

While at ViaCyte, Inc., serving as Director of Product Engineering, Chad managed the design, development, verification/validation and transfer to manufacturing activities for all macroencapsulation devices, delivery systems, disposables and ancillary surgical tools for the first-in-human cell therapy combination product. Chad was also responsible for development of scalable methods for differentiation of stem cells in 3D culture. With over 14 years of experience collaborating with academic and industry partners, Chad brings first-hand knowledge and leadership of engineering and technical teams developing cell and gene therapy products.

EXAMPLES OF RECENT WORK

• Technology transfer of cell therapy products to cGMP manufacturing
• Development of quality systems and regulatory submissions for cell and gene therapies
• Provided risk analysis and risk modeling of cGMP manufacturing systems for adult and iPSC-derived cell therapies
• Quality by Design and process characterization for cell therapies
• Performed technical assessments of facilities for cGMP manufacturing of cell and gene therapies
• Executed statistical mining and characterization of clinical manufacturing data to support comparability
• Design and development of medical devices and medical instrumentation for cell therapies
• Verification and validation for medical devices and combination products
• Due diligence on novel cell and gene therapy products

SELECTED PATENTS

• Martinson, Laura; Green, Chad; Kroon, Evert; Agulnick, Alan; Kelly, Olivia; Baetge, Emmanuel E.  Encapsulation of Pancreatic Cells Derived from Human Pluripotent Stem Cells. US Patents 8,278,106, 8,425,928, 9,132,226, 9,764,062, 9,913,930.
• So, Vincent; Martinson, Laura; Green, Chad; Scott, Michael; Zamarippa, Mario. 3-Dimensional Large Capacity Cell Encapsulation Device Assembly. US Patent 9,562,880.
• Green, Chad; Yu, Xiaojie; Bang, Anne; Brandon, Eugene; Kelly, Olivia; Agulnick, Alan; Baetge, Emmanuel E.; D’Amour, Kevin A.; Schulz, Thomas C.; Robins, Allan J.  Stem Cell Aggregate Suspension Compositions and Methods of Differentiation Thereof.  US Patents 8,008,075 and 8,445,273.
• Green, Chad.  Cell Encapsulation Device.  US Patents D734847, D728095, D726307, D726306, D747467, D747468, D747798, D750769, D750770.
• Green, Chad; So, Vincent; Martinson, Laura; Scott, Michael.  Cell Encapsulation Device.  US Patents D720469, D755986
• So, Vincent; Martinson, Laura; Green, Chad; Scott, Michael.  3-Dimensional Large Capacity Cell Encapsulation Device.  US Patents D718472, D718471, D718470, D718469, D718468, D718467, D718466, D714956.

PAST EXPERIENCE

Fate Therapeutics
Senior Director, Technical Operations

ViaCyte, Inc.
Director, Product Engineering
Director, Device Engineering and Manufacturing

Novocell, Inc.
Senior Scientist

EDUCATION

University of California, Davis
Ph.D. Biomedical Engineering — emphasis in Biotechnology

California Polytechnic State University
M.S. Engineering — Biochemical specialization

California Polytechnic State University
B.S. Biochemistry
B.S. Microbiology