January 22, 2008

Baker & Daniels' FDA Team Brings Decades of Regulatory Experience

From foods and pharmaceuticals to biologics and medical devices, Baker & Daniels LLP has developed a versatile team with decades of experience in FDA law. The firm's practice group members have extensive experience derived from working at the Food and Drug Administration, for the U.S. Department of Justice and at major Fortune 500 companies, including Eli Lilly and Company, the Novartis Group, Guidant Corporation and Procter & Gamble Company, where many served in leading roles in the law divisions of those companies.

In today's world of stricter government regulation and growing risks, Baker & Daniels' professionals work closely with clients to develop regulatory strategies that enable innovative, cutting edge technologies to navigate through the very complicated maze of FDA regulations and procedures. The firm's team represents start-up companies, large corporations and research institutions on a broad spectrum of regulatory matters affecting the development and marketing of drugs, medical devices, diagnostics, combination products and foods.

"We are proud to have established what we believe to be the largest FDA regulatory law practice between the two coasts," said Pat Cross, Baker & Daniels' life sciences practice group leader. "Life sciences companies operate in a very sophisticated environment, and our FDA professionals have the hands-on experience and creativity to help our growing list of life sciences clients meet their needs. Our practice will support not only the rapidly expanding life sciences businesses in Indiana, but clients throughout the country."

At Baker & Daniels, lawyers strategize, counsel, problem solve and, as necessary, litigate on the full range of FDA matters. They can guide a company from start to finish, laboratory to marketplace.

Baker & Daniels' FDA team includes:

  • Suzanne M. O'Shea, regulatory counsel for 21 years with the FDA where she worked with drug, device, biologic, human tissue and combination products.
  • James T. O'Reilly, associate general counsel with Procter & Gamble for 24 years who is also a professor in FDA law at the University of Cincinnati College of Law.
  • Ralph F. Hall, former litigation and compliance counsel with Guidant and past chief environmental counsel with Eli Lilly and Company who is also a distinguished visiting practitioner and professor at the University of Minnesota Law School.
  • Daniel P. Carmichael, who joined Baker & Daniels in 2000 after serving as an attorney with Eli Lilly and Company for 28 years, most recently as deputy general counsel.
  • Erin Reilly Lewis, former Assistant U.S. Attorney for the U.S. Department of Justice where she investigated violations of the False Claims Act, Anti-Kickback Statute, Stark Act, HIPAA, Controlled Substances Act and others.
  • Amy Judge-Prein, who served as counsel at Eli Lilly and Company where she was lead counsel for development and marketing of portfolios of products and clinical trials spanning thousands of patients and dozens of countries.
  • Lee M. Tumminello, who has over 17 years of experience in the area of FDA law as counsel for Eli Lilly and Company working on commercial and regulatory legal issues related to a variety of disease state areas including oncology.
  • Joan Antokol, former vice president and global head of privacy for Novartis Group who has experience in international privacy and data protection, medical and clinical research, health authority inspections and drug safety.
  • Amy K. Cornell, who joined Baker & Daniels as an associate after serving as a graduate assistant in the National Agricultural Law Center in Fayetteville, Ark., while earning an LL.M. degree at the University of Arkansas School of Law.
  • Elizabeth Baney, an honors graduate from Indiana University who joined Baker & Daniels as an associate   in the firm's office in Washington D.C. where her practice involves health regulatory policy, bioethics and government relations.

"Life sciences is one of the fastest growing legal practice areas across the country," said Tom Froehle, Chair and Chief Executive Partner at Baker & Daniels. "We're very excited to have such a deep and experienced group of professionals on our team. The combination of our FDA practice based in Indianapolis and the public policy and reimbursement professionals working in our Washington D.C. office allows us to integrate FDA legal, business and reimbursement strategies to better serve our clients' needs in this important sector."

In addition to their work experience, Baker & Daniels' lawyers have authored articles on FDA law for the Food and Drug Law Journal; Journal of Health Care Compliance; Food and Drug Law Institute Update;   Journal of Nursing Law; and American Bar Association Press. Jim O'Reilly has authored several books on FDA law and was referred to as an "expert" on FDA approvals when one of his publications on FDA was quoted by the U.S. Supreme Court. Expertise also extends to testimony in hearings before the U.S. Senate and House of Representative on FDA issues and presentations to a variety of industry groups.

Founded in 1863, Baker & Daniels LLP is one of Indiana's largest law firms. With more than 370 lawyers and consulting professionals, Baker & Daniels serves clients in regional, national and international transactional, regulatory and litigation matters from offices in Indiana, Washington, D.C. and China. For more information about Baker & Daniels, visit www.bakerdaniels.com.

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