View, browse and sort the list of CPhI North America Conference sessions and show floor programming by pass type, track, and format. Seating is first come, first serve, so please arrive early to sessions that you would like to attend. Sessions are subject to change.
Bryan J. Coleman (Senior Director, Pharmaceutical & Device Consulting Services, EAS Consulting Group)
Date: Tuesday, April 24
Time: 3:30pm - 4:15pm
Pass Type: Conference Pass, VIP Attendee - Get your pass now!
Track: Drug Manufacturing
Vault Recording: TBD
New drug development presents a myriad of challenges, particularly when a choosing to work with a CMO. Critical decisions will ultimately affect your ability to produce a therapeutic agent that delivers high quality results on time and on budget.
Will the CMO produce only Phase 1 or 2 product or will it be able to meet the demand of Phase 3 and beyond (commercialization)? Can they compliantly scale-up operations for anticipated growth? Are they in compliance with strict government and regulatory requirements, producing to USFDA requirements of cGMP standards? Is the CMO able to adequately track key performance measures to support your product?
Learn the important questions to ask and how to assess competencies as potential CMO partners are assessed to ensure your needs are met across the spectrum of compliance, production, quality, communication and more. Preparation, teamwork and planning will determine the success of your CMO partnership.