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Substantial Changes To CAS Administration Regulations

Client Alert | 1 min read | 03.16.05

Final rules, effective April 8, 2005, concerning proposed changes to CAS administration requirements that have been pending since April 2000 were promulgated on March 9, 2005 (70 Fed. Reg. 11743-61). The new regulations will be discussed in detail at the upcoming OOPS/WOOPS programs on March 31-April 1/April 14-15, but some of the highlights include:

  • When there is a CAS noncompliance, contract price adjustments may be required for closed contracts and closed years,
  • Improvement in the definition of "desirable" and "required" changes may permit contractors to avoid price adjustments,
  • Retroactive accounting changes are permitted in limited circumstances,
  • Widely criticized proposals to prohibit offsets between FFP and flexibly-priced contracts were abandoned, and
  • Estimates to complete rather than original cost estimates must be used to determine cost impact on FFP contracts.

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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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