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GAO Repeats Protective Order Warning

Client Alert | less than 1 min read | 04.03.08

In denying the motion for reconsideration of its dismissal of the protest in PWC Logistics Servs. (Mar. 31, 2008) for breach of the protective order by the client retaining for a week protected material and distributing it within the company, GAO repeated that this case is to serve as a warning to other protestors: if the client receives from its attorneys any materials that are marked as subject to protective order, they are immediately to close and return or destroy the materials, and their attorneys are to provide prompt notice of the violation.

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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 .  ...