Dark Horse Consulting Announces Expansion of Quality and Device Engineering Teams

Campbell, CA, April 2018 — Dark Horse Consulting (DHC), a leading provider of consulting services for the cell and gene therapy industry, today announced the appointments of Christine Bui as Senior Consultant and Vince So as Consultant.

Christine Bui has been a part time Associate Consultant at DHC for the past 18 months, advising cell and gene therapy clients primarily on matters of Quality Management System design and implementation. She was most recently Senior Manager in Quality Systems and Manufacturing at Portola Pharmaceuticals where she developed the company’s data integrity and risk management programs, and matured the quality system prior to Portola’s first drug product approvals of an anticoagulant, Bevyxxaâ, and antidote Andexxaâ. She was also Person-in-Plant (PIP) to provide oversight of cell bank and drug substance manufacturing activities at multiple CMOs during critical registration and validation campaign batches. Additional responsibilities at the company were to establish policies and SOPs for compliant management of GxP quality system processes, and support regulatory inspections and internal audits. Prior to Portola Pharmaceuticals, Christine worked at Amgen and Boehringer Ingelheim, where she focused on manufacturing operations and compliance. Christine got her start at Geron Corporation, where she developed manufacturing protocols, trained manufacturing staff, and transferred a drug dose preparation process to multiple clinical sites in preparation for clinical trials of the company’s cell therapy products. She has a B.S. in Biological Systems Engineering from the University of California at Davis, and an M.B.A. from Santa Clara University.

Vince So has been a part time Associate Consultant at DHC for the past 6 months, advising cell and gene therapy clients primarily on matters of device design and engineering, and process engineering. Before joining DHC, Vince was a Senior Product Development Engineer at Symbient Product Development where he served as the lead engineer and project manager on multiple projects for a variety of clients. Previously, Vince was a Staff Engineer at ViaCyte, a company developing an implantable cell therapy-device combination product for diabetes. He has M.S. and B.S. degrees in Mechanical Engineering from the University of California at San Diego.

“The appointments of Christine and Vince expand our capabilities in the fields of Quality Management Systems and Device Engineering,” said Anthony Davies, Ph.D., CEO and Founder. “The ability to access high quality, technically sound support in these areas are critically important for our clients’ success. Both Christine and Vince have consistently delivered high quality work products for our clients as part time Associate Consultants; we are thrilled to now be able to welcome them to the full time DHC team.”

About Dark Horse Consulting

Dark Horse Consulting (DHC) specializes in providing strategic and operational support for the Cell and Gene Therapy industry. All of our consultants have deep Cell and Gene Therapy industry experience, spanning diverse functions such as process development, device development, manufacturing, quality, regulatory, program management, business development, strategy, and financing/investor relations. Many of our consultants also bring experiences from adjacent more mature sectors, including traditional biologics, small molecules, medical devices, and management consulting. As a result, we deeply understand the unique challenges faced by Cell and Gene Therapy developers and are able to apply best practices from other industries to address the needs of our clients.

Our team of Cell and Gene Therapy professionals brings deep technical expertise to help you tackle the unique challenges of our exciting young field.