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Mobile apps have the potential to transform clinical investigations of medical products by enabling data collection from a large and geographically diverse subject population. Increasingly, companies are using mobile apps not only to recruit and enroll subjects for clinical trials, but to collect data to support clinical trial endpoints. This article discusses the regulatory status of mobile apps used to collect data in investigations and evaluates the pathways for using such apps in studying drugs and devices.

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Sidley is pleased to present its third annual year-in-review addressing developments in securities class actions brought against life sciences companies in 2016.

In this publication, we provide an overview and analysis of trends in decisions involving life sciences companies with products at two distinct stages of development—pre- and post-FDA approval. Next, we provide summaries of the 41 federal court and appellate court decisions surveyed. Finally, we catalog the new securities class action complaints filed against life sciences companies in 2016.

Bad news and stock price declines can occur at any stage of a company's development, but in the life sciences sector—given particular issues relating to drug development, regulatory approval, and continued regulatory oversight of manufacturing, marketing and sales activities—the setbacks are clustered in a few obvious stages of a company's life cycle. Accordingly, we analyze legal developments by reference to the stage of drug or device development at issue in the decisions. Looking at the case law and new complaint filings by phase of development yields useful insights and may assist you in your risk mitigation.

We hope you enjoy the Securities Class Actions in the Life Sciences Sector: 2016 Annual Survey.

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Bay Area Life Sciences Roundtable