Clinical trial manufacturing & FDA compliance

Universities are creating more spaces and opportunities for faculty to develop experimental treatments on campus. Modular clean rooms, pilot-plants, and fermentation centers allow researchers to bring treatment concepts from faculty laboratories into a pharmaceutical manufacturing environment. But as products move into clinical trials, FDA regulations for product manufacturing increase. Universities providing space and oversight need to ensure that manufacturing investigational products for human use is performed under appropriate Good Manufacturing Practice controls, even when clinical trials involve only a handful of research subjects. Lax oversight or inadequate process controls can result in FDA enforcement, impacting all projects at a University facility.

New partnership arrangements with industry

As drug development moves to university facilities, academic institutions are taking on responsibility for supplying products and components for use in clinical trials. When products are developed in partnerships with industry or university laboratories provide key components, supply and license agreements may create unforeseen liability if supply is interrupted or a batch of product is rejected. University entities acting as contract manufacturers need to assure that appropriate agreements are in place for determining acceptability and quality of products. And when University-developed materials — such as specialized gene therapy vectors or biologically active peptides — are licensed to industry for further product development, it may restrict other research uses. Careful planning and well-structured agreements are key to limiting liability and avoiding research constraints.

Conflicts of interest

Universities and hospitals are taking a more aggressive approach to investment in biomedical startup companies with university-licensed intellectual property, but are conflict of interest policies adapting? Management of institutional and individual financial conflicts increasingly draws public scrutiny and regulator interest. With greater financial entanglements comes greater reputational and legal risk. A clear, consistent process for evaluating and managing conflicts is imperative, but fostering innovative research may require innovative conflict management solutions.

As changes to the landscape continue to accelerate and regulators increase scrutiny, a proactive approach to regulatory compliance is crucial to the public health mission of academic institutions.