BRADLEY S. DAVIDSEN is an Associate in the Health Care and Life Sciences practice, in the Chicago office of Epstein Becker Green.
- Advises clients on the research, development, and approval of pharmaceuticals, biologics, and medical devices
- Provides counsel on state and federal licensure requirements for health care providers and facilities;
- Counsels clients in the establishment of telehealth/telemedicine practices
- Develops clinical trial agreements, vendor agreements, informed consent documents, and related materials for clinical research sponsors, and negotiates agreements with clinical research institutions and investigators and with providers of clinical trial services
- Counsels clients on compliance issues associated with pharmaceutical and medical device development and marketing activities, including reporting obligations and fraud and abuse laws and regulations
Mr. Davidsen’s recent engagements include:
- Assisting in the due diligence review of health-related licensure and other regulatory compliance of various target companies, including a clinical research organization, a contract manufacturer, a chain of restaurants, a group of prison commissaries, and groups of professional practices
- Assisting a small pharmaceutical company build a system for negotiating consulting agreements with health care professionals and complying with disclosure laws regarding payments to those professionals
- Establishing CLIA waivers and laboratory licensure for concierge physician practices
- Reviewing telehealth licensure and prescriber laws for a telebehavioral health company
- Researching corporate practice laws for a group of optometry practices
In addition, Mr. Davidsen is a contributing writer to Epstein Becker Green’s Health Law Advisor blog. His articles have discussed the 21st Century Cures Act, telehealth, generic manufacturer product liability, and civil monetary penalties, among other things. He also coauthored the 2017 appendix to the firm’s 50-State Survey of Telemental/Telebehavioral Health (2016), detailing the rapid growth of telemental health (mental health care delivered via interactive audio or video, computer programs, or mobile applications) and the increasingly complex legal issues associated with this trend.
Professional and Educational Background
Prior to joining Epstein Becker Green, Mr. Davidsen was responsible for clinical trial outsourcing arrangements at an international pharmaceutical company specializing in hematology, oncology, and immunology. He served in a strategic management role with oversight on contract, budget, and informed consent development, review, and maintenance for more than 30 clinical trials for several oncology franchises before, during, and after FDA approval. He began his health care career negotiating clinical trial agreements at one of the largest pharmaceutical companies in the world to support cardiovascular, neurological, pediatric, and oncology studies.
During law school, Mr. Davidsen received the Mary Franzese Humanitarian Achievement Award for Public Leadership, Community Service, Integrity, and Vision. He was a co-founder and co-president of the law school’s Health Law Advocates and a junior editor of Health Law Outlook. Upon graduating from law school, Mr. Davidsen served as a Judicial Law Clerk for the Honorable Thomas M. Moore of the Superior Court of New Jersey and then became a Special Deputy Attorney General (Department of Health and Senior Services and Department of Human Services) to the State of New Jersey Office of the Attorney General in Trenton.
- Seton Hall University School of Law (J.D., 2009)
- Concentration in Health Law
- Michigan State University (B.A., 2002)
- New Jersey
- American Health Lawyers Association
- Regulatory Affairs Professionals Society