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 | 9 min read | 10.21.26
The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .
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