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GAO Teaches Course in Cost Realism 101

Client Alert | less than 1 min read | 06.06.07

In Magellan Health Services (Jan. 5, 2007, http://www.gao.gov/decisions/bidpro/298912.pdf), GAO sustained a protest of HHS's award of a cost-plus-fixed-fee contract for employee assistance program services when the agency's cost realism evaluation was unreasonable for several reasons, including a failure to account for insufficient levels of effort and labor rates in the awardee's cost proposal. After chiding the agency for not adjusting the awardee's cost proposal in accordance with the recommendations of the agency's own cost analyst, GAO found the adjusted costs were still lower than the protestor's but the smaller delta required the agency to take another look at its unsupported conclusion that the offerors were "technically equal."

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Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...

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