ARTICLES BY BRIAN CLARK
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![Signed Agreement]( "Beyond The FDA Guidance: Practical Considerations For Quality Agreements")
Beyond The FDA Guidance: Practical Considerations For Quality Agreements5/19/2017Many sponsors, particularly small to midsize organizations, opt to use their CMO’s boilerplate quality agreement. These agreements in many cases are compliant with the standards, but they usually lack many of the practical details to ensure an effective relationship with clear expectations.
Brian Clark
Brian Clark is principal at GMP Operations Consulting LLC, a CMC consulting firm founded in 2006. He has more than 25 years of experience in the development, manufacturing, and quality management of biologics, drugs, and medical devices, with specific expertise in advanced technology medicinal products such as cell therapies, regenerative medicine, and antibody-drug conjugates. Previously, he served in executive and senior leadership roles at ImmunoGen Inc., Altus Pharmaceuticals, Alkermes, Therion Biologics, Antigenics (now Agenus), and Genzyme Tissue Repair. Brian has a bachelor’s in biology from the University of Massachusetts, Boston, and an MBA in general management from Boston University.