Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. Innovative therapies are moving from university laboratories to clinical trials to regulatory approval at an unprecedented pace, which is changing the traditional role that academic centers play in drug development and technology transfers. Campus clean room and pilot plants are increasingly manufacturing drug products and starting materials and drawing the eye of regulators. Institutional investments also are reshaping traditional approaches to conflict management in the clinical research enterprise. Below we summarize three key areas where General Counsel must assure that growth in an institution’s research portfolio does not outpace compliance infrastructure.
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.
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.
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.
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