Simone Colgan Dunlap is co-chair of the firm's Health & Life Sciences Industry Team and a member of the Health Law Group. Ms. Colgan Dunlap's practice is focused on regulatory compliance, related risk management, and corporate/contracting matters for a variety of clients, including: drug and device manufacturers, pharmacy benefits managers (PBMs) / third-party administrators (TPAs), health care insurers, discount medical plan organizations (including prescription discount card administrators), pharmacies, home health agencies, hospitals, physicians, pharmacists, and nurses. Her recent experience includes:
- Drafting and negotiating distribution agreements for drugs and devices, business associate agreements, group purchasing organization agreements, data use agreements, licensing agreements, pharmacy services agreements, specialty pharmacy services agreements, HUB agreements, marketing agreements, Risk Evaluation and Mitigation Strategies (REMS) consulting agreements, independent contractor agreements, and numerous other commercial contracts.
- Structuring and drafting agreements for novel products and services that leverage her understanding of health care regulatory issues and business needs.
- Providing strategic advice to clients on a diverse array of regulatory compliance issues, including investigations and enforcement actions; permitting and licensure; controlled substances distribution and prescription dispensing; FDA compliance; change-of-ownership / mergers and acquisitions; medication therapy management programs; federal and state fraud and abuse compliance (e.g., Anti-Kickback and Stark); clinical trials; and records retention.
- Advising clients regarding federal health privacy laws, including HIPAA/HITECH as well as state laws governing the confidentiality of health information, medical records, mental health records, and records containing other sensitive information.
- Serving as a seconded attorney for McKesson Corporation for six months. In this role, Ms. Colgan Dunlap coordinated drafting and regulatory review of contracts for three business units: McKesson Specialty Arizona Inc., Onmark, Inc., and McKesson Specialty Care Distribution Joint Venture L.P. In addition, she was responsible for identifying regulatory compliance issues associated with new products, supervising outside counsel, coordinating and developing discovery management strategies, and developing recommendations for process improvement.
- Developing template contracts and related procedures for review and negotiation.
- Coordinating and deploying attorney teams to provide short-term and long-term customized contracting support during peak work periods, emergencies, and for special projects in a manner that integrates the client's contracting preferences.
- Counseling a food manufacturer on regulatory strategies for a novel product and maintaining FDA compliance for marketed products.
- Health & Life Sciences
- Business Law for Health & Life Sciences
- Data Privacy & Security
- Health Information Technology, Privacy & Security
- FDA Regulatory Practice
Education and Honors
- University of Michigan Law School (J.D., cum laude, 2008)
- University of Michigan Journal of International Law, Business Development Editor
- Whitman College (B.A., with honors, 2002)
- U.S. District Court, District of Arizona, 2009
Professional and Civic Activities
- International Association of Privacy Professionals (IAPP)
- National Association of Specialty Pharmacy (NASP)
- Quarles & Brady Diversity Committee
- Quarles & Brady Phoenix Women's Forum (Chair)
- Ms. JD's Third Annual Conference on Women in Law: Avenues to Advancement (Conference Co-Chair)
- U.S. Department of State, Office of Legal Affairs at the United States Mission to the United Nations in Geneva (Legal Intern)
- Hon. Stephen M. McNamee, U.S. District Court, District of Arizona (Judicial Intern)
- Wills For Heroes (Attorney Volunteer)
- Maricopa County Volunteer Lawyers Program (Intern and Attorney Volunteer)
- American Health Lawyers Association (AHLA)
- National Association of Women Lawyers (NAWL)
- Maricopa County Bar Association (MCBA)
- Arizona Asian American Bar Association (AAABA)
- National Asian Pacific American Bar Association (NAPABA)
- Ms. JD
- Named "Top 50 Pro Bono Attorney" in 2010 by the Arizona Foundation for Legal Services & Education