2014 All Hands Meeting
November 7th Main Session
Life Sciences Track Agenda
FDA UPDATE: Essential Knowledge Pharmaceutical and Medical Device Companies Need for 2015
Ellen Darling & Carol Pratt
K&L Gates LLP
Recent developments at the FDA have implications for pharmaceutical and medical device companies that make preparation for 2015 absolutely necessary. This FDA update session will cover key topics of interest to a diverse range of medical device and pharmaceutical companies.
- The Internet and various social media platforms have increasingly enabled drug and device manufacturers to more actively engage with consumers and healthcare professionals. These communications are still subject to FDA oversight. We will discuss keeping your company apprised on the FDA’s recent guidance on communications using social media and some recommended best practices.
- Learn about recent cases addressing the preemption of FDA regulations and how they impact your safety department’s policies and procedures, as well as your labeling and litigation strategy.
- The FDA has adopted new views on the regulation of software used in the healthcare IT industry (medical devices used to manage medical data and/or images and mobile medical applications). Knowing whether your software is or is not a medical device is critical for budgeting development costs and ensuring regulatory compliance.
- Lastly, we will discuss FDA’s proposed regulation of laboratory developed tests (LDTs) and how that could affect current LDTs and the development of new LDTs.
Life Science Corporate & IP Update
Gabriel Gross, Judith Hasko & Mark Roeder
Latham & Watkins LLP
This double update on corporate and IP developments and trends affecting life science companies will discuss:
- 2013-2014 trends in biotech collaborations, IPOs and M&A
- Equity considerations in collaborations
- Change of Control considerations
- Patentable Subject Matter in Life Sciences
- Challenging Life Sciences Patents at the Patent Trial and Appeal Board
They Said Our Drug or Biologic is “Suspect” What Now?
Christina Markus & Elaine Tseng
King & Spalding
Effective January 1, 2015, the Drug Supply Chain and Security Act (“DSCSA”) places new obligations on pharmaceutical and biopharmaceutical manufacturers and distributors to quarantine and investigate “suspect” products, and to notify both regulators and trading partners about “illegitimate” products identified in the supply chain. This panel will lead a case study to help in-house counsel advise on the new regulatory obligations, evaluate whether operating systems are structured to support compliance, and consider whether contractual relationships and business terms should be updated to streamline communications, coordinate activities, and allocate risks.
LS Privacy Update
Morrison & Foerster LLP
A discussion of privacy, behavioral advertising, cyber-security, and many other topics related to information management by life science companies.
Cross-Border Considerations in Life Sciences: Canada
Canada is open for life sciences business! In this fast-paced hour, participants will hear about the current regime for life sciences investments in Canada. The session will cover:
- Key "Canadian" points to watch out for in cross border life sciences transactions
- Current trends in venture capital investment in Canada
- The regulatory regime for therapeutic approvals
- Employment standards in Canada
- Venture capital term sheets and deal terms
- Key issues in mergers and acquisitions
Please Note: Program details are subject to change without notice