ABA Biotech Regional Workshop
Thursday, June 12 2014
1:00 pm – 5:30 pm
Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA
Please join us for the inaugural ABA Biotech Regional Workshop on June 12, 2014 from 1:00 p.m. to 5:30 p.m. at Massachusetts Biotechnology Council (MassBio) in Cambridge, Massachusetts. This program is geared towards in-house and outside pharmaceutical and biotechnology attorneys who are interested in learning more about biotechnology products and products liability litigation. Whether you are new to the world of pharmaceutical litigation, or an experienced lawyer, this program has something for you. The various panels will address the anatomy of a products liability case, key concepts, regulations and litigation risks of biologic/biosimilar products and preparation for future litigation. The program will be capped off with a panel discussion of general counsels from area biotech companies discussing lessons learned, their career journeys and the creation of strategic value for their companies. End the afternoon at a networking reception with counsel from the heart of the Cambridge Biotech industry. We look forward to seeing you there.
The cost is $65.00 for ABA members, $125.00 for non-members, and will be offered free of charge to in-house counsel.
Welcome & Introduction
- Kendalle Burlin O'Connell, Massachusetts Biotechnology Council, Cambridge, MA
- Guled H. Adam, ARIAD Pharmaceuticals, Inc., Cambridge, MA
- Jessica Benson Cox, Faegre Baker Daniels LLP, Indianapolis, IN
1:00-2:00pm Anatomy of a Products Liability Case
- Robyn Maguire, Nutter, McClennen & Fish, LLP, Boston, MA
- Anand Agneshwar, Arnold & Porter, LLP, New York, NY
- Barry Boise, Pepper Hamilton, LLP, Philadelphia, PA
- Jimmie McMillian, Barnes & Thornburg, LLP, Indianapolis, IN
This panel will consist of 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 clinical development of a product can be used years later by parties to a litigation or an investigation involving injuries allegedly caused by the product.
2:00-3:00pm Biologics, Biosimilars and Beyond: Key Concepts, Regulatory Issues and Litigation Risks
- Amy Judge-Prein, Faegre Baker Daniels, LLP Indianapolis, IN
- Elizabeth Ann Lewis, Takeda Pharmaceuticals, Cambridge, MA
- Debra Dunne, Shook, Hardy & Bacon, LLP Philadelphia, PA
- Karin Lucas, Ph.D., Biotech Primer, Towson, MD; Sarepta Therapeutics, Cambridge, MA
- Krista Cosner, ABA Pharmaceutical Subcommittee Co-Chair, San Francisco, CA
This panel will discuss biologics and biosimilars in terms of the science, their different regulatory framework, and their litigation risks. The 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 these products are changing the practice of medicine. Regulatory and litigation issues will be addressed including the anticipated abbreviated approval pathway for biosimilar drugs as well as anticipated changes to traditional litigation defense strategies.
3:15-4:15pmPreparing for Future Litigation: A Discussion of Strategies for In-House Counsel In the Current Litigation Climate
- Benjamin Hsing, Kaye Scholer LLP, New York, NY
- Erik Frick, Biogen Idec, Cambridge, MA
- Ron J. Hedges, Ronald J. Hedges LLC, Hackensack, NJ
- Damon Hart, Littler Mendelson, PC, Boston, MA
This panel will discuss how in-house counsel can best prepare for or mitigate future litigation by conducting early risk assessment and pre-suit investigation, understanding the proposed changes to the Federal Rules regarding discovery and preservation of information, and learning lessons from the In re Actos case. The speakers will reflect expertise in preparing for a diverse array of litigation, including claims and investigations relating to IP, employment, white-collar, transactional, and other disputes affecting the biotech industry.
4:15-5:15pmThe General Counsel Reality: A View of the Leadership and Career Journey
- Werten Bellamy, Stakeholders, Inc., Pennsylvania
- Albert Parker II, Sunovion Pharmaceuticals, Marlborough, MA
- Luba Greenwood, Pfizer, Inc., Cambridge, MA
- Tamara Joseph, InVivo Therapeutics Corporation, PC, Cambridge, MA
The biotech general counsel operates at the intersection of the company's most important commercial, operational, and strategic priorities - as the GC's leadership responsibilities extend well beyond known 'risks' and 'legal issues.' 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.
5:15pm Closing Remarks
5:30pm Cocktail Reception
LAW FIRM SPONSORS
Kaye Scholer, LLP
Nutter, McClennen & Fish, LLP
Faegre Baker Daniels, LLP
Pepper Hamilton, LLP
Barnes & Thornburg, LLP
Products Liability Biotech Subcommittee Chairs:
Lori B. Leskin, Kaye Scholer, LLP, New York, NY
Chris Johnson, Shook, Hardy & Bacon, LLP, San Francisco, CA
Products Liability Pharmaceutical Subcommittee Chairs:
John A. Camp, Carlton Fields Jorden Burt, PA, Miami FL
Krista L. Cosner, San Francisco, CA
Products Liability Committee Co-Chairs:
Sarah Grider Cronan, Husqvarna Professional Products, Charlotte, NC
Richard Gaal, McDowell, Knight, Roedder, & Sledge, LLC, Mobile, AL
Lara White, Adams & Reese, LLP, New Orleans, LA
The ABA directly applies for and ordinarily receives CLE credit for ABA programs in AK, AL, AR, AZ, CA, CO, DE, GA, GU, HI, IA, IL, IN, KS, KY, LA, MN, MS, MO, MT, NM, NV, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, VI, WA, WI, and WV. These states sometimes do not approve a program for credit before the program occurs. This course is expected to qualify for 4.0 CLE credit hours in 60-minute states, and 4.5 credit hours in 50-minute states. This transitional program is approved for both newly admitted and experienced attorneys in NY. For more information about CLE accreditation in your state, visit http://www.americanbar.org/cle/mandatory_cle.html or contact Katie Peternell at firstname.lastname@example.org or 312.988.6714.