2017 All Hands Meeting
October 17 Session
Life Sciences Track Agenda

9:00AM-10:00AM   Room 201
FDA Update

Nancy Stade
Sidley Austin LLP

This presentation will provide an overview of a number of different FDA initiatives announced since the change in administration, and a general discussion of changes that can be expected under new FDA Commissioner Scott Gottlieb.

10:30AM-12:00PM   Room 201
Life Sciences Open Forum: Leading a Small Legal Department

Alan Dow Ph.D./Julie Brooks/Ethan Knowlden/Brian Schar
Kilpatrick Townsend & Stockton LLP/Accela, Inc./Dextera Surgical Inc.

Join in this panel discussion about the challenges of running a small legal department. Drawing on their in-house experience as leaders of the legal function at a number of small companies, the panelists will take turns discussing how they work with and meet the needs of various stakeholders:
  • Board of Directors, senior management, founders, shareholders
  • Purchasing department and in-house sales and marketing team
  • HR, employees and independent contractors
  • In-house attorneys, outside counsel, litigation, and U.S. and foreign government
Panelists include: Alan Dow, Ph.D., Counsel at Kilpatrick Townsend & Stockton, LLP; Julie Brooks, former EVP, General Counsel, Chief Compliance Officer, Veracyte, Inc.; Ethan Knowlden, SVP, General Counsel, Accela, Inc.; and Brian Schar, General Counsel, Director of IP, Chief Compliance Officer, Dextera Surgical Inc.

1:30PM-2:15PM   Room 201
Licensing and Deploying Digital Health Solutions

Jennifer Geetter & Daniel Gottlieb/David Wallace
McDermott Will & Emery LLP/Johnson & Johnson Services, Inc.

This session will discuss the opportunities and constraints on licensing and deploying digital health solutions in the health care sector, including the following key business and regulatory issues:
  • Building the case for digital health solutions to health sector customers already bombarded with IT demands and emerging technology pitches
  • Developing and branding your solutions consistent with health care research norms and consumer protection laws
  • Impact of current private and government health insurance environment on need for particular solution features and implications for sales pitch to health care provider and health plan customers
  • Designing user-friendly security controls to comply with HIPAA security standards
  • TCPA compliance requirements for solutions that enable mobile calls and text messages to engage patients and other consumers
  • HIPAA requirements for aggregation of consumers’ personal information both to serve customers and also for secondary data business

2:20PM-3:05PM   Room 201
Getting What's Due: Life Science Licensing Disputes

Greg Call & Mark Jansen/Ronald Beaton
Crowell & Moring LLP/Trial Behavior Consulting

IP licenses can be of significant value. When the licensed inventions or works have commercial value, they can return millions or even billions of dollars. But licensing language can pose big problems. And small changes to the language can have big impacts. How do judges and juries sort through these kinds of issues? This presentation, based on significant experience in the life sciences sector, will share important advice with biotech and med device companies, research universities, and other institutions that invest significant resources in the development and maintenance of their intellectual property assets.

3:30PM-4:30PM   Room 203/204
Managing Anti-Corruption Compliance

Pamela Davis/Michael Ward
Orrick, Herrington & Sutcliffe LLP/Juniper Networks, Inc.

In-house efforts -- compliance plans, global ethics codes, due diligence -- to meet FCPA and other anticorruption responsibilites are forced to track moving targets, with evolving rules, court challenges and shifting government enforcement priorities. This update will review key trends for technology and life science companies, with an eye towards practical options for an uncertain, budget-constrained environment.

Please Note: Program details are subject to change without notice

2017 Participating Law Firms & Companies