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COFC Reverses Another Cica Stay Override

Client Alert | less than 1 min read | 05.10.04

Although the protester’s incumbent contract (and the 6-month extension) had expired, in Keeton Corrections, Inc. v. U.S., (March 17, 2004), the Court of Federal Claims rejected as arbitrary and capricious an override decision that was premised on the purported necessity of using the awarded contract to deliver necessary correctional services to the Bureau of Prisons. The court found that the agency had not explained why sole source purchase orders could not be used to obtain the necessary services pending GAO’s protest decision, and held that such sole source orders (issued either to the protester or the awardee) would be permissible under the circumstances, and would be less harmful to competition than an override of the CICA stay.

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Client Alert | 9 min read | 10.21.26

Artificial Intelligence in Life Sciences: Reliability of AI-Generated Evidence in Drug Discovery and Development

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 .  ...