Academic cGMP clinical trial batch suites: From grant application success to construction

Mark A. Paskanik, NCARB, LEED AP BD+C
Sr Architect, Lab Design Expert
Amy Caparoni, BS, MS
Assistant Director, GMP Operations
Steven Triggiano, AIA, LEED AP BD+C
Senior Project Manager

The demand for CGMP clinical batch trial suites are on the rise at academic institutions, and rigorous grant application and facility design and construction requirements must be navigated with precision. Mark Paskanik, Amy Caparoni and Steve Triggiano use a case study from the Duke Human Vaccine Institute to chart the steps and techniques used to coordinate stakeholder input and meet regulatory guidelines while staying true to project vision, budget, and schedule. They present a fly-through video of the space, highlight cGMP construction techniques, and highlight unique university organization strategies to increase speed to market.

Continuing Education
American Institute of Architects (AIA)
Professional Development Hour (PDH)