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Set-aside Determination Must Be Industry-Specific

Client Alert | less than 1 min read | 09.07.12

In DynaLantic Corp. v. U.S. Dep’t of Defense, a small business challenged on constitutional grounds a Navy set-aside for 8(a) small disadvantaged businesses of a simulator buy. The D.C. district court held that there is sufficient evidence of discrimination that limits minority business development for the 8(a) program to withstand a facial challenge, but that, without an agency determination of discrimination in the military simulation and training industry specifically, the Navy was enjoined from using an 8(a) set-aside procurement for the simulator.

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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 .  ...