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Corrective Action Needs Correcting

Client Alert | less than 1 min read | 08.12.05

In Resource Consultants, Inc. (June 2, 2004 http://www.gao.gov/decisions/bidpro/2930733.pdf), the GAO sustained a protest because the agency had "abandoned" one of the ground rules for the re-evaluation of proposals, a re-evaluation that had been conducted as corrective action in response to an earlier protest. According to GAO, while the terms of the re-evaluation permitted offerors to submit revised price proposals only, revisions to the awardee's staffing costs were so extensive as to constitute technical proposal revisions; therefore, the agency should have permitted all offerors to submit revised technical proposals.

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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 .  ...