Our Leadership Team
Timothy R. Coté, MD, MPH
Principal & Chief executive officer
Dr. Timothy R. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal service at the FDA, NIH, and CDC, Dr. Coté recently served as the Director of the FDA Office of Orphan Products Development (OOPD) from Sept 2007 – May 2011. In this role he implemented the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications. An anatomic pathologist and medical epidemiologist, he has published 80 peer-reviewed articles on areas as diverse as HIV/AIDS-related malignancies, typhoid fever epidemics, and the impact of bicycle helmet laws on injury statistics. Dr. Coté is founder and CEO at Cote Orphan; he directs and trains staff to create compelling regulatory submissions that are finely tuned to each client's business strategy and to the unwritten rules within the FDA.
Dr. Coté received a bachelor's degree from Syracuse University, a medical doctorate from the Howard University College of Medicine and a master's degree in Public Health from Harvard School of Public Health.
Erin Lawless Miller, JD
Chief Operating Officer
Erin Lawless Miller has experience in law, finance, and operations management. In her current role as a member of the Senior Leadership Team, Lawless Miller functions as the Chief Operating Officer and is responsible for the operations of Human Resources, Finance, Marketing, and Strategic Planning. She was a member of the government and regulatory practices at Venable, LLP and the boutique FDA law firm of Buc & Beardsley, LLP, both in Washington, DC. As a contributing editor at the New York State Science and Technology Law Center, Lawless Miller wrote numerous articles on regulatory issues affecting patent, intellectual property, and technology transfer law for journal publication.
Lawless Miller has a law degree from Syracuse University College of Law and graduated Magna Cum Laude from Syracuse University’s prestigious S.I. Newhouse School of Public Communications. She holds certificates in contract negotiation and finance from Harvard Law School’s Program on Negotiations and the National Labor College. She earned a Black Belt in Lean Six Sigma. Lawless Miller is a 2009 recipient of the Hermes Award for outstanding contribution in the area of communications law and policy.
JOSEPH KISZKA, MBA
VICE PRESIDENT OF BUSINESS DEVELOPMENT
Joseph Kiszka has experience in business development and strategy in both the medical device and biotech markets. In previous roles, Kiszka has worked closely with medical device executives and physicians on market development, product development, as well as medical education and training. In his current role at Coté Orphan, Kiszka manages the West Coast. He earned his Master’s in Business Administration from Mount St. Mary's University, his Undergraduate Bachelor’s Degree in Science from George Washington University, and Six Sigma Lean and Green Belt from Villanova. Kiszka also served 11 years in the U.S. Navy.
Robert Anderson, PhD
Director of Regulatory Affairs Science
Robert Anderson has experience in translational science, regulatory affairs and program management. At Coté Orphan he is Director of Regulatory Affairs Science and his major responsibilities include coaching and mentoring clients and internal teams of regulatory scientists on submission strategy, product development planning and Chemistry, Manufacturing and Control (CMC) challenges. He has a extensive expertise in vaccines, and biotherapeutics, including cellular and gene transfer products. Prior to joining Coté Orphan, Anderson served as Senior Principal Regulatory Affairs Scientist at Leidos, Inc. Previously, Anderson was a Product Reviewer (CMC) and Regulatory Project Manager at CBER/FDA. His portfolio of projects included novel viral vectors, cell therapies, cytokines and monoclonal antibodies and immunoglobulin like molecules. Anderson earned a B.Sc. in Biology/Microbiology from University of the Sciences in Philadelphia (USP; nee PCPS), a Ph.D. in Microbiology from the Pennsylvania State University College of Medicine, and completed doctoral and post-doctoral research in viral immunology and antigen processing. Anderson also completed post-doctoral work at Yale University School of Medicine.