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Final Rule Requires Technical Interchange for IR&D Cost Allowability

Client Alert | 1 min read | 11.14.16

On November 4, 2016, DoD issued a final rule requiring contractors performing IR&D projects initiated in FY2017 or later to engage in a technical interchange with DoD, and report the occurrence of this interchange, before the costs for such projects may be deemed allowable (a topic previously discussed here). Although the rule is stated to be intended to promote DoD awareness of IR&D projects and provide feedback to contractors, it is likely to impose an administrative burden on contractors and DoD alike and could have a chilling effect on IR&D investment, particularly because it is silent regarding the allowability of IR&D costs if DoD fails to engage.

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Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...

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