Wiley Rein LLP


Events & Speeches

Wiley Rein's attorneys regularly speak before legal and industry groups on a wide variety of issues, and often serve as panelists, keynote speakers and moderators for law-related events, seminars, symposiums and workshops.  If you are interested in having a Wiley Rein attorney share their expertise with your group, please contact Patricia O'Connell at poconnell@wileyrein.com.

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  • Enter the Drones: Using Unmanned Aircraft in Disaster Recovery

    Katy M. Ross, Speaker
    2015 National Hurricane Conference
    April 2, 2015 | Austin, TX | More Information
  • In-House Panel on Fiduciary Liability: Underlying Exposures and Coverage Issues, Placing and Underwriting Insurance, Future Needs, and Strategic Litigation and Settlement Considerations

    Kimberly M. Melvin, Speaker
    ACI's 9th National Forum on ERISA Litigation
    April 14, 2015 | Chicago, IL | More Information
  • Delving into the Mechanics of the USFDA Biosimilars Approval Process and Section 351(k) Applications Under the Pathway

    James N. Czaban
    Overview of Event
    • Going over important definitions in the Act including "biological" and "biosimilars" and "reference product"
      - Exploring key provisions in the Act
      - Criteria for biosimilarity and interchangeability
      - Clinical trials and safety studies
      - Exclusivity provisions
      - Patent litigation and exchange provisions: Understanding the major differences between small molecule Hatch-Waxman litigation and biosimilars litigation as outlined in the statute
    • Recapping the statements and guidance issued by USFDA post-BPCIA: what are the open questions?
      - February 2012 three-part guidance pertaining to scientific and quality considerations in demonstrating biosimilarity to a reference product
      - March 2013 guidance regarding closed-door meetings and biosimilars user fees
      - May 2014 Guidance on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
      - August 2014 Guidance on Reference Product Exclusivity for Biological Products
      - Submitting an application under 351(k): what must be included in its content?
      - Examining the specific provisions for patent resolution under the statute
      - Certification procedures
      - Procedures for patent identification
      - Mechanisms of negotiation and engaging in good faith negotiations
      - Settlement processes
      - Calculating data and patent exclusivities under the Act
      - Comparing and contrasting the biosimilars pathway under the statute to 505(b)(2) and BLA pathways
      - Breakdown of relevant considerations with each route including timing, costs, IP litigation considerations, and exclusivities
    ACI's Summit on U.S. Biosimilars
    April 20, 2015 | Munich, Germany | More Information
  • Global Issues : An Analysis of International Approval and Promotion Processes

    Sonali P. Gunawardhana
    Overview of Event

    This session will analysis and discuss key issues in international food and drug law, focusing on approval processes and promotion guidelines around the world. Speakers will cover Asia, North America, South America and European markets for food, drugs, and medical devices. 

    2015 FDLI Annual Conference
    April 20, 2015 | Washington, DC | More Information
  • Surviving a Congressional Investigation and Practical Guidance for State Legislative Investigations

    Dorthula H. Powell-Woodson, Speaker
    2015 Blue National Summit
    April 20, 2015 | Phoenix, AZ | More Information
  • Minimizing the Uncertainty Surrounding the Pathway: Insights Into USFDA's Current Initiatives Regarding the First Wave of Biosimilars Applications

    James N. Czaban
    Overview of Event

    Topics covered include:

    • Understanding the USFDA's "totality of the evidence" and case-by-case approach to biosimilar approval
    • Update on the closed-door meetings between manufacturers and USFDA
    • Meeting USFDA's standards for biosimilarity and the heightened standard for interchangeability: how are companies moving forward in light of lingering open questions from draft guidance?
    • Demonstrating biosimilarity: What exactly will a company need to show?
      - Putting together a step-wise approach
      - Showing safety and efficacy through clinical trials: Looking to innovators' trial design and endpoints
      - Extrapolating data: what will be acceptable? (i.e. between populations within indications? Across unrelated indications?)
      - To what extent will bridging studies of ex-US data be acceptable?
      - What are companies doing in the absence of final guidance?
    • Anticipating when final USFDA guidance regarding biosimilarswill be issued in light of the first applications being public
    • Substituting the biosimilar at the pharmacy level: what will it take to make interchangeability a reality and how can manufacturers maintain this over time?
    ACI's Summit on U.S. Biosimilars
    April 21, 2015 | Munich, Germany | More Information
  • The New Paradigm for Health Care Privacy & Why It Matters to You

    Kirk J. Nahra
    2015 Blue National Summit
    April 21, 2015 | Phoenix, AZ | More Information
  • Top Ten Healthcare Privacy and Security Developments to Watch

    Kirk J. Nahra
    2015 Blue National Summit
    April 21, 2015 | Phoenix, AZ | More Information
  • The Wild Wild West: Cyber Risks, Data Security and Privacy

    Kirk J. Nahra
    2015 PLUS Professional Risk Symposium
    April 28, 2015 | Atlanta, GA | More Information
  • Domain Name Registry and Registrar Liability: Recent Developments, Cases and Best Practices

    David E. Weslow, Moderator
    INTA Annual Meeting
    May 4, 2015 | San Diego, CA | More Information
  • The New Paradigm for Health Care Privacy

    Kirk J. Nahra, Moderator
    Third Annual Medical Informatics World Conference 2015
    May 4, 2015 | Boston, MA | More Information
  • The Coming New World Order on Health Care Privacy and Data Security

    Kirk J. Nahra, Speaker
    Third Annual Medical Informatics World Conference 2015
    May 5, 2015 | Boston, MA | More Information
  • Effective Advocacy and Management in Arbitration

    Sandra Tvarian Stevens, Speaker
    Program Co-Sponsored by the American Arbitration Association, the College of Commercial Arbitrators, the District of Columbia Bar and JAMS
    May 14, 2015 | Washington, DC
  • Can Our Company Do This? What Is and Isn't Allowed Under the Russian and Ukrainian Sanctions Regime

    D. Scott Nance, Speaker
    9th Annual Forum on Economic Sanctions for the Corporate Sector
    May 19, 2015 | Amsterdam, Netherlands | More Information
  • Drones are Coming: Are You Ready for Unmanned Aircraft?

    Benjamin C. Eggert, Speaker
    PRIMA 2015 Annual Conference
    June 7 - June 10, 2015 | Houston, TX | More Information
  • M&A in Government Contracting: How to Navigate a Transaction, Before and After with a Focus on 'What Matters'

    Kay Tatum
    GWSCPA's 11th Annual Government Contractors Conference
    June 11, 2015 | Tyson's Corner, VA | More Information
  • State of Existing Allocation Law, With a Focus on Asbestos, Environmental, and Other Long-Tail Claims

    Laura A. Foggan, Panelist
    ACI's 2nd National Forum on Insurance Allocation
    June 25 - June 26, 2015 | Chicago, IL
  • PLI's Corporate Political Activities 2015: Complying With Campaign Finance, Lobbying and Ethics Laws

    Jan Witold Baran and Caleb P. Burns
    September 10 - September 11, 2015 | Washington, DC

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