2013 All Hands Meeting
December 5th Main Session
Life Sciences Track Agenda

Life Sciences IP Portfolio Management - Maximizing the Value of IP Assets

Atulya Agarwal & Mark Kresnak
Dickstein Shapiro LLP

Intellectual property can be a life science company's most valuable asset - the bedrock that underlines a company's long-term success. Being able to strategically leverage the full value of those assets while navigating complex third party IP landscapes is absolutely essential for success in the biotechnology, medical device, diagnostics, and pharmaceutical sectors. This session will discuss strategies for maximizing the commercial value of a life sciences IP portfolio and will review significant considerations for developing and implementing successful IP procurement, protection and enforcement programs to maximize revenue and to accomplish a wide variety of other business objectives.

Life Science Corporate Update/Life Science IP Litigation Update

Jake Handy, Matthew Rossiter, Michael Shuster, David Tellekson and Claire O'Callahan
Fenwick & West LLP

A checklist of the most important corporate and IP issues facing life science companies as they "clean up" in preparation for pending or potential acquisition (and, conversely, the most important issues for acquiring companies).

FDA Update: Social Media Use By Life Science Companies

Joy Liu & Kellie Combs
Ropes & Gray

The promotion of prescription drugs and medical devices has been revolutionized in recent years not only by the advent of direct-to-consumer advertising, but also by the proliferation of social media tools such as message boards, chat rooms, Facebook, and Twitter. Now as never before, product manufacturers have a direct link to users and potential users of their products, and equally important, users have access to a wealth of product information and the ability to communicate with each other about their experiences in real time. Although FDA’s advertising and promotion regulations apply broadly to companies’ social media initiatives, they were developed decades ago and fail to address the unique issues associated with social media promotion; nevertheless, the Agency has directed several enforcement activities toward companies that have utilized social media tools to communicate about their products. This session will address the regulatory challenges posed by social media tools, explore FDA’s approach to enforcement in this area, and provide practical advice for companies to consider when developing their compliance strategies

Product Liability Update for Life Science Companies

Cheryl Sabnis
King & Spalding

Product liability litigation continues to be a substantial threat to a life science company’s most valuable assets. While the war over pre-emption rages on, it is your company’s marketing efforts and sales representatives that are guiding plaintiffs and their attorneys around the defenses manufacturers traditionally have used to avoid liability for product-associated injuries. This session will discuss current trends in product liability litigation relevant to manufacturers of devices, pharmaceuticals, and biologics and offer practical advice for companies seeking to minimize liability and maximize their ability to defend against product liability claims.

Privacy Update for Life Science Companies

W. Reece Hirsch
Morgan, Lewis & Bockius LLP

The compliance date for the HIPAA Final Rule has arrived, marking a new phase in healthcare privacy and security regulation and enforcement that will have a profound impact on a wide range of health care industry contractors and vendors, known as “business associates,” including many life sciences companies, health care technology companies and research organizations. This presentation will review what business associates need to know to operate in this new regulatory landscape, including: (i) steps to comply with new privacy and security obligations under the HIPAA Final Rule; (ii) who is and isn’t a business associate under the new rules; (iii) negotiating business associate agreements with customers; (iv) managing liability risks associated with security breaches; and (v) understanding new agency liability principles applicable to business associates and covered entities.

FDA-Related Investigations

Daniel Dwyer
Kleinfeld, Kaplan & Becker, LLP

How can a life science company prevent its name from appearing on an FDA warning letter or a Department of Justice press release? This presentation will review the legal basis and remedies for a number of recent enforcement actions, and ways to steer clear of potential liability for: Failure to Correct Defects; Anti-Kickback Violations; GMP Violations; Off-Label Promotion; and Data Reporting Violations.

Please Note: Program details are subject to change without notice

Participating Law Firms & Companies