Off-Label Communication: Top Tips for Compliance

Click on Presentation Title to Download the Presentation


10:15 a.m. – 11:30 a.m.

FDA Guidance & Impact on Regulatory & Quality Professionals

  • Lisa M. Dwyer, Partner, King & Spalding LLP
  • Joshua Eizen, U.S. Chief Compliance Officer, Actellion
  • Kelly Goldberg, Vice President, Law & Senior Counsel for Biopharmaceutical Regulation, PhRMA
  • John Murphy, Deputy General Counsel, BIO


11:45 a.m. – 12:30 p.m.

Litigation Affecting Regulatory & Quality Professionals

  • Jeffrey S. Bucholtz, Partner, King & Spalding LLP
  • Don Bunnin, Executive Director, Senior Counsel - Litigation & Commercial Eye Care, Allergan
  • Sean Flynn, Associate General Counsel and Chief Compliance Officer, ABIOMED, Inc.
  • John Richter, Partner, King & Spalding LLP


12:30 p.m. – 1:30 p.m.

Luncheon Address (No slides for this session)

  • Ethan Davis, Deputy Assistant Attorney General, Consumer Protection Branch, DOJ


1:30 p.m. – 2:15 p.m.

Hypothetical Off-Label Communication Cases

  • Katlin Backfield, Attorney and Consultant, Backfield, PLLC; former Associate Chief Counsel for Drugs, FDA
  • Carolyn Bruguera, General Counsel,  MDMA
  • Pete Leininger, Counsel, King & Spalding LLP; former Associate Chief Counsel for Enforcement at FDA


2:15 p.m. – 3:00 p.m.

Drug & Device Manufacturers Communication with Payors, Formulary Committees & Similar Entities

  • David Bloch, Principal Legal Counsel, Medtronic
  • Nikki Reeves, Partner, King & Spalding LLP
  • Paul Savidge, General Counsel, Spark Therapeutics


3:15 p.m. – 4:15 p.m.

From Social Media to Soap Operas: Exploring New and Novel Advertising and Promotion Tactics in the Current Landscape

  • Heather Banuelos, Counsel, King & Spalding LLP
  • Gillian M. Russell, Counsel, King & Spalding LLP