2016 All Hands Meeting
November 16 Session
Life Sciences Track Agenda
Product Liability Update for Life Science Companies
Sandra Edwards & Karen Kimmey
Farella Braun + Martel LLP
Hope for the best, plan for the worst. Adverse incidents, during and after development of life science products, can lead to individual and class action claims stemming from research, design, manufacture, distribution or marketing. Product liability litigation is constantly evolving, and this presentation will update in-house counsel at life science companies about recent developments and trends for avoiding future claims and defending current ones.
FDA Update/IP Update for Life Science Companies
Fish & Richardson, P.C.
This double-header session will update in-house counsel at life science companies on: (1) recent FDA developments affecting pharmaceutical and and medical device approvals (Hatch-Waxman, biosimilars, digital health technologies, etc.); and (2) current IP portfolio management strategies (and their implications for due diligence, patent prosecution, licensing, etc.).
Crowell & Moring LLP
Healthcare IT continues to grow explosively, and with it the need to stay current on evolving HIPAA issues, including audits, privacy notices, cybersecurity, breach notification, OCR investigations, documentation and corrective action. This presentation will review recent developments and responsive strategies for life science companies.
Life Science Sector Collaborations
When would it be beneficial to expand a clinical trial beyond the traditional model of characterizing the safety and efficacy of a particular study drug? How can we best arrange such a clinical study using drugs from multiple pharmaceutical companies, in order to maximize our understanding of the uses of various drugs for a particular disease, protection the intellectual property for each pharma participant, but also to minimize the likelihood of intellectual property ownership overlap? We will explore these questions through a recent case study.
International Corruption Enforcement: Recent Development, Trends and Strategies
Brendan Cullen & Laura Oswell
Sullivan & Cromwell LLP
The stakes have never been higher for global companies active in emerging markets. The U.S. Foreign Corrupt Practices Act (FCPA) has led to more than 400 SEC and DOJ enforcement actions involving more than 100 countries but with particular focus on critical markets like China. To address evolving demands of the FCPA and similar laws, in-house counsel must be prepared to develop strategies and respond to these complex issues. This session will discuss worldwide anti-corruption enforcement, recent policy developments and trends and strategies for implementing robust compliance programs and responding to alleged compliance breaches.
Please Note: Program details are subject to change without notice