Erin Lawless Miller, JD
Chief of Staff
Erin Lawless Miller joins Coté Orphan Consulting with years of experience in law and operations management. Previously, she worked in the government and regulatory practices at Venable, LLP in Washington, DC and a boutique FDA law firm, where she preformed legal and health/medical research. As a contributing editor at the New York State Science and Technology Law Center, Lawless Miller wrote numerous articles on regulatory issues effecting patent, intellectual property, and technology transfer law for monthly publication in an electronic journal.
Lawless Miller has a law degree from Syracuse University College of Law and graduated Magna Cum Laude from Syracuse University’s S.I. Newhouse School of Public Communications. She holds certificates from Harvard Law School’s Program on Negotiations and the National Labor College in contract negotiations. Lawless Miller is a 2009 recipient of the Hermes Award for outstanding contribution in the area of communications law and policy.
Harry Cook, MBA, RPh
Director of Clinical Operations
Harry Cook has over 36 years of experience in the pharmaceutical industry performing a variety of functions including: clinical strategy development, project leadership, clinical operations process ownership, related financial/resource management, CRO contracting/management and pharmaceutical sales. Mr. Cook’s experience includes major exposure to the NDA process and hands-on oversight of the clinical function including clinical trial design, budgeting, investigator selection, site initiation, monitoring, data analysis, report writing and pharmacovigilance. He has interacted effectively with thought leaders and company personnel at all levels. Mr. Cook has either led or been instrumental in more than 14 major drug submissions in the United States and abroad in a variety of therapeutic areas.