2015 All Hands Meeting
October 28 Session
Life Sciences Track Agenda
Successfully Navigating the Business Imperative to Demonstrate and Communicate Product Value
Torrey Cope, Meena Datta/Hae-Won Min Liao
Sidley Austin LLP/Gilead Sciences, Inc.
Drug and device manufacturers are facing greater-than-ever pressure to demonstrate the value of their products to payors, to providers, and to patients. At the same time, there are many Healthcare- and FDA-related obstacles that complicate execution of this business imperative. This session will explore how these dynamics are currently playing out with respect to patient assistance programs (PAPs) and value-added services, and address recent First Amendment developments that have potential to completely redefine the ways companies engage in value-focused communications. The session will focus on practical ways in which these and other value-related tactics can be executed in an effective and compliant manner.
Life Sciences IP Update: Unique Challenges for the Life Sciences in PTAB Litigation
Steven Carlson & Jonathan Waldrop/David Ruschke
Kasowitz, Benson, Torres & Friedman LLP/Medtronic Cardiovascular
The Patent Trial and Appeal Board (PTAB) has become a critical patent litigation forum. Initially favored in "tech" cases, we are now seeing an increasing share of medical device, pharma, and biotech cases heading to the PTAB. We will discuss the features of PTAB litigation that pose particular challenges and opportunities for the life sciences. This session provides practical advice for choosing among the potential PTAB forums (IPR, CBM, PGR), preparing a petition and defense (including how far expert testimony may be allowed), and navigating the pitfalls with copending litigation.
Is Your Policy Panacea or Placebo? The In-House Lawyers’ Guide to Safe and Effective Use of Insurance Coverage
The life sciences and high tech industries are rapidly innovating, evolving and expanding. In those fast-paced industries, risks are also rapidly changing and increasing. It is essential for in-house counsel to understand what risks insurance policies cover, what they exclude, and how to maximize benefits. This discussion will focus on issues of particular importance to the life sciences sector, as well as those affecting all technology-driven companies. Key topics to be addressed include:
- Privacy and cybersecurity
- Product liability
- Product defect
- Directors’ and officers’ coverage
- [Surprise!] impact of merger
Munger Tolles & Olson LLP
What happens when a criminal or civil enforcement investigation arises in a foreign jurisdiction and potential transnational litigation ensues? What are the practical consequences of such an investigation and how does a company defend its interests both abroad and in the United States? This session provides practical advice regarding coordinating defenses to transnational criminal and civil enforcement investigations and developing cost-effective and nuanced strategies to address these complex problems.
Please Note: Program details are subject to change without notice