Panel #1:  Anatomy of a Products Liability Case

This panel will encompass a practical discussion of a products liability lawsuit, from the basic building blocks of products claims to real life examples. The first part of the discussion will include a primer on the types of claims and defenses typically asserted in a products case.  In the second part of the discussion, we will examine how a single products liability case can mushroom into multidistrict litigation, class action lawsuits, coordinated proceedings, and even relator qui tam and attorney general lawsuits focused on the company\’s marketing of a product and consumer fraud claims. Finally, in the third part of our discussion we will examine newsworthy products liability cases that exemplify the types of claims discussed in the first two parts of the discussion. The panelists will also discuss how documents and other evidence created during the development phase of a product can be used years later by plaintiffs or governmental entities to support their claims.

Speakers:

Anand Agneshwar, Arnold & Porter

Barry Boise, Pepper Hamilton

Jimmie McMillian, Barnes & Thornburg

Robyn Maguire, Nutter, McClennen & Fish (moderator)

Panel #2:  Biologics, Diagnostics and Biosimilars – Oh My!

This panel will discuss biologics and molecular diagnostics in terms of the science, their different regulatory framework, and their litigation risks. These speakers will provide background on the nature of biologic products, differences from traditional small molecule drugs and complexities in the manufacturing processes as well as explain how genetic and molecular testing is changing the practice of medicine. Regulatory and litigation issues for biologic products will be addressed including the anticipated abbreviated approval pathway for \’biosimilar\’ drugs as well as the anticipated increase in diagnostic regulations.

Speakers:

Krista Cosner, ABA Pharmaceuticals

Elizabeth Ann Lewis, Takeda Pharmaceuticals

Debra Dunne, Shook, Hardy & Bacon

Karen Lucas, Ph.D, Biotech Primer

Amy Judge Prein, Faegre Baker Daniels (moderator)

Panel #3:  What You Can Do Now to Prepare for Future Litigation

A discussion about what in-house counsel should be doing/thinking about to limit exposure, and best practices for preparing for or mitigating future litigation.

Speakers:

Erik Frick, Biogen Idec

Ron J. Hedges, Ronald J. Hedges LLC

Damon Hart, Littler Mendelson, PC

Benjamin Hsing, Kaye Scholer LLP (moderator)

In this session, we will explore the career journey of our panelists, key lessons learned, career goals, and the things they do to create strategic value for the companies they serve.  It is the goal of this discussion to provide the audience sightlines into the priorities, challenges, and self-investments that contribute to success for today\’s biotech general counsel.

Speakers:

Albert Parker II, Sunovion Pharmaceuticals

Luba Greenwood, Pfizer, Inc.

Tamara Joseph, InVivo Therapeutics Corporation

Werten Bellamy, Stakeholders, Inc. (moderator)