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Federal Circuit Reaffirms Deferential OCI Standard

Client Alert | 1 min read | 05.06.09

The Federal Circuit in Axiom Resource Mgmt., Inc. v. U.S. (May 4, 2009) reversed the CFC decision granting a protest on the basis of an organization conflict of interest ("OCI"), and, in doing so, reaffirmed that, when the CFC reviews an OCI determination by a CO, including, in this case, the adequacy of a mitigation plan, it must apply the deferential "arbitrary and capricious" standard of the Administrative Procedure Act. In addition, the appellate court criticized the CFC for accepting litigation affidavits and relying on them when there was no need to supplement the administrative record, along the way casting doubt on the vitality of the Esch factors commonly used by the CFC in deciding whether to supplement an agency record in a bid protest case.

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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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