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Follow Up: White House Issues Order under Defense Production Act as Part of COVID Response

Client Alert | 1 min read | 03.23.20

In our March 19 alert, C&M summarized President Trump’s recent executive order invoking the Defense Production Act (DPA). In this follow-up, we provide three separate analyses. First, we provide a discussion of the Defense Production Act, and the implications of the executive order for U.S. businesses and the government in its efforts to reduce the impact of COVID-19. Second, we discuss the current Department of Health and Human Services (HHS) regulations implementing its priorities and allocations authority prior to the executive order. And third, we discuss the manner in which the government most frequently has exercised similar authorities under the DPA pursuant to the Defense Prioritization and Allocation System (DPAS).

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 .  ...