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TSA Snared in GAO Protest Jurisdiction

Client Alert | less than 1 min read | 03.19.10

In General Dynamics One Source, LLC, GAO rejected TSA's jurisdictional challenge, holding that Congress revoked TSA's exemption from GAO protests effective June 22, 2008, and that TSA's Phase II solicitation issued in December 2008 could not relate back to the exemption that previously existed for the Phase I competition. On the merits, GAO sustained the protests due to TSA's failure to evaluate price realism when (1) the awardee proposed mismatched staffing approaches in the technical and cost proposals, and (2) the awardee's proposed staffing depended upon hiring incumbent staff at rates well below current incumbent salaries.

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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 .  ...