Michael Werner Email & Phone Number

Washington, DC, US

Miami, Florida, US

Advising companies on premarket and postmarket FDA regulatory strategies, including product classification, application filings, GMP requirements and manufacturing issues, and compliancePerforming "regulatory or reimbursement due diligence" for investors in biotechnology and medical device companiesRepresenting companies in meetings with FDA.

• Responsible for all operations of this lobbying, regulatory analysis, public policy, and bioethics consulting firm for biotechnology and pharmacuetical companies, patient advocacy groups, physicians, research.
• Lobby Congress, CMS, FDA, and other agencies; analyze legislative and regulatory proposals; assess the regulatory, legislative and political environment and develop strategic recommendations. Providing.
• Help companies and organizations liase, establish partnerhips, and develop collaborations with government agencies, patient advocacy groups, BIO, physician groups, and others.
• Provide legal advice/strategic consulting to help companies and organizations identify and address bioethics challenges.

Washington, DC, US

• Led all of BIO’s policy development, research, legislative, regulatory, bioethics, alliance development, and legal activities to achieve BIO’s priorities.
• Led BIO’s policy development efforts on key industry issues including: Medicare; reimbursement/demonstrating the value of medical innovation; drug safety; follow on biologics; stem cell research; intellectual property.
• Managed all facets of preparation and presentation for BIO Executive Committee and Board of Directors meetings.
• Managed BIO policy and advocacy departments (Federal Government Relations; State Government Relations; Science and Regulatory Affairs; Bioethics; Office of General Counsel; and Policy). These departments contained 38.

Philadelphia, PA, US

Doctor Of Law (J.D.), Law

Bachelor Of Applied Science (B.A.Sc.), Pre-Law Studies; Political Science