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Academia‐industry alliances for biomedical innovation ő what can we do better? (1053.1)
Author(s) -
Seymour E
Publication year - 2014
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.28.1_supplement.1053.1
Subject(s) - business , repurposing , scrutiny , alliance , pharmaceutical industry , resource (disambiguation) , medicine , pharmacology , engineering , political science , computer science , computer network , law , waste management
Research conducted at academic medical centers significantly contributes to discovery, development, or repurposing of drugs and biologics. Industry partnerships can be a vital component to the initiation and translational success of such research. The financial benefits to both parties are considerable, but industry directly and indirectly assumes additional risk due to less control over the research program and from increased safety reporting burden to regulatory authorities. As a result, industry “external R&D” divisions are increasing their selection scrutiny and regulatory oversight of these partnerships. Academic investigators can improve opportunities for success by adopting Good Laboratory Practice in alliance with industry requirements, but these practices are uncommon in academic labs. In addition, with the support of industry, investigators can submit their own Investigational New Drug application (IND) to FDA to begin clinical research. This IND should be in electronic Common Technical (eCTD) format to align with industry practice. Finally, safety reporting should comply with industry needs, but industry should resource the investigator to help them meet their corporate regulatory requirements. Academia‐industry alliances are an increasingly important source of biomedical innovation, but should be carefully vetted to maximize benefit and minimize risk.