1. Home
  2. |Insights
  3. |GAO Sides With COFC In Continued Battle Over Hubzone Set-Aside Priority

GAO Sides With COFC In Continued Battle Over Hubzone Set-Aside Priority

Client Alert | less than 1 min read | 05.21.10

GAO in DGR Assocs., Inc.(May 14, 2010), relied on "unambiguous" statutory language instead of a contrary 2009 opinion letter from DoJ's Office of Legal Counsel to hold that a procuring agency must first consider whether the conditions for a HUBZone set-aside exist before proceeding with an 8(a) set-aside. With this decision, GAO falls into line with (and cites with approval) the recent Court of Federal Claims decision, Mission Critical Solution v. U.S (Mar. 2, 2010), appeal docketed (Fed. Cir. Apr. 2, 2010), to the effect that set-asides to HUBZone contractors are mandatory whenever the criteria in 15 U.S.C. 657a are met.

Insights

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 .  ...