The FDA Is Watching


The FDA Is Watching

Your office, Feb. 11, 2014


Meet your instructors

Timothy Ayers is a principal of Porzio, Bromberg & Newman in the Life Sciences Compliance, Commercialization and Regulatory Counseling Department. With a background as in-house counsel in the pharmaceutical/healthcare industry, he is familiar with the business challenges faced by members of corporate legal and compliance departments.  As Vice President, Chief Compliance Officer for Dendreon Corporation from January 2012 through June 2013, Mr. Ayers created, developed and implemented a companywide compliance program in the United States and in Europe.  Prior to that, he served as Associate General Counsel for pharmaceutical, biotech and other life sciences companies, where he established and implemented compliance programs and provided legal counsel in the areas of commercialization, research and development, global issues and corporate issues.  Mr. Ayers counsels pharmaceutical, medical device and biotechnology companies on a variety of compliance-related issues, including healthcare fraud and abuse, FDA advertising and promotional law, FCPA, research and development/licensing, supply chain/distribution agreements, intellectual property, employment agreements and compliance investigations. 

Mr. Ayers is also a vice president of Porzio Life Sciences, the firm’s subsidiary, which offers a range of marketing and sales compliance products and services to pharmaceutical, medical device and biotechnology companies.

Michelle Axelrod is a principal at Porzio, Bromberg & Newman.  Drawing from her in-house experience, Ms. Axelrod offers valuable insights to Porzio, Bromberg & Newman clients on corporate dynamics and provides innovative ideas to support business goals while effectively protecting companies and reducing organizational risk.

Previously Assistant General Counsel at Sepracor, Inc., from 2004 through 2010, Ms. Axelrod successfully managed and supervised a team of attorneys and administrative personnel, supporting all commercial business units, including sales, marketing, commercial analytics, new products planning, contracting and pricing, institutional trade, managed markets, clinical research and medical affairs.  During that time, she acted as lead counsel on the development and/or commercialization of seven products.