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GAO Protest Jurisdiction Covers Concession Contracts

Client Alert | 1 min read | 03.22.04

In Shields & Dean Concessions, Inc. (Feb. 23, 2004), GAO took jurisdiction over the protest of a concessions contract awarded by the National Parks Service ("NPS"), stating that, because the concession contract at issue involved the delivery of goods and services to the government, as well as certain groundskeeping and construction services, the contract was a "procurement" within the meaning of CICA, and, therefore, was within GAO's bid protest jurisdiction. Notwithstanding its reliance on CICA to assume jurisdiction, GAO noted that, pursuant to statute, for concession contracts NPS is not bound by the provisions of CICA and the FAR that govern the conduct of procurements, and GAO therefore reviewed the award decision to determine whether it was consistent with the specific statute and regulation governing NPS concession contract and the terms of the solicitation and otherwise reasonable, and sustained the protest.

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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 .  ...