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PODCAST: Announcing Crowell & Moring’s Regulatory Forecast 2018

Client Alert | less than 1 min read | 03.01.18

On February 28, Crowell & Moring published its fourth annual Regulatory Forecast, exploring how technology is driving the future of business across industries – and how Washington, as well as state and global regulators, is forging the appropriate balance between fostering innovation and protecting consumers.

The publication’s editors, Richard Lehfeldt and Dan Wolff, both partners in the firm’s Administrative Law and Regulatory Practice, sat down to discuss the forecast. In this 8 minute podcast, Richard and Dan discuss what you will find in our Regulatory Forecast 2018, including both topics and authors new to the forecast this year.

Click below to listen or access from the link:
SoundCloud

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 .  ...