Stephen Mcmillan Email & Phone Number

Washington, DC, US

Washington DC-Baltimore Area

Washington D.C. Metro Area

Providing legislative and regulatory strategies for established and emerging companies in the pharmaceutical, biotech and device industries. Available for retained consultant and project work. Feel free to start a discussion by contacting me at 202-207-5421, or s_mcmillan1@verizon.net.

Washington, District Of Columbia, United States

Creating and leading the US Government Affairs and Patient Advocacy function for a leading global device company.Coloplast develops products and services that make life easier for people with very personal and private medical conditions. Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We.

• Created the new function in Washington to proactively position a growing company in the public policy environment.
• Served as Interim Director of Government Affairs, providing timely briefings on key issues before Congress and working on development of access and budget priorities.
• Identified and prioritized key regulatory and reimbursement issues that coincide with the existing and emerging portfolio, as well as the commercial interests, of Eisai Inc. to enhance visibility and success with.
• Managed and filed several applications with CMS and USP on behalf of existing brands, securing optimized reimbursement in key markets.o Secured favorable reimbursement coding for breast cancer and antiemetic drug in.
• Developed collaborative working relationships with key internal customers, including Legal, Market Access, Health Economics Outcomes Research, and brand leadership, including management of Health Care Reform Committee.
• Assisted the Head of Office in Washington with developing strategies for the group, including the identification of potential resource issues and solutions, including development of goals, objectives and metrics to.

• Created the new position in Washington to position a growing company to proactively engage in the public policy environment.
• Developed functional descriptions for the Policy group in conjunction with the Head of Office.
• Identified and prioritize key issues that coincide with the existing and emerging portfolio, as well as the commercial interests, of Takeda Pharmaceuticals to enhance visibility and success with Congress and federal.
• Developed goals, objectives and metrics to more effectively identify areas of success.
• Assisted with efforts to launch a political action committee.
• Developed working relationships with key internal customers, including Managed Markets, brand leadership and State Government Affairs.

• Created position and function to position the company to successfully compete in a new Medicare market environment.
• Secured favorable outcomes from implementation of Section 641 demonstration language, ensuring significant uptake of current oncology brand portfolio.
• Secured favorable CMS recommendation to produce better health outcomes in the treatment of asthma, and significantly benefit a major brand.o Significantly increased brand revenues in all payer environments.
• Engaged CMS on behalf of two emerging brands, as well as new patient assistance programs.
• Managed cross-functional efforts to analyze numerous proposed regulations and development of corporate comments.
• Active participant with development of new Medicare account structure and reimbursement training programs and modules.

Washington, DC

• Directed and represented the interests of foreign-based major pharmaceutical company in Washington. Managed and directed policy analysis and strategic planning. Represented company in numerous policy development teams.
• Secured development and inclusion of language in the Medicare Modernization Act that positively influenced the company’s oncology portfolio.
• Provided regular updates and presentations to senior management and brand team on issues of direct impact to the business.

• Directed and represented the interests of a $3 billion industry in federal and state legislative bodies and regulatory agencies.
• Implemented major component of association’s strategic plan.
• Managed development and introduction of major industry legislative proposal.
• Increased industry involvement and visibility in Congress.
• Increased cooperation with allied trade associations, industries and Federal regulatory bodies.
• Modified internal decision-making processes for association committees and task forces.

Bachelor Of Arts - Ba, Political Science

Graduate Coursework, Public Administration