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 officialsHelping companies navigate the regulatory pathway to market for novel technologiesAdvising companies on FDA marketing rules and labeling claimsCounseling clients during inspections and post-inspection matters, responses to Form 483s, untitled and warning letters, and other enforcement actionsApplying for appropriate product codes to facilitate tracking and future payment of FDA-regulated productsOrganizing and managing coalitions of healthcare stakeholders to secure policy objectives through representation before the U.S. Congress, Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), and other federal agenciesLobbying Congress on critical issues facing companies regulated by FDA and their trade associations.Providing analysis and strategies for reimbursement under Medicare (Part A and Part B) and Medicaid

• 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 institutions, and investors. • Lobby Congress, CMS, FDA, and other agencies; analyze legislative and regulatory proposals; assess the regulatory, legislative and political environment and develop strategic recommendations. Providing bioethics/compliance analysis and advice. Specific areas of focus include: reimbursement; Medicare; personalized medicine; follow-on biologics; drug safety; quality measurement and improvement; stem cell research and other bioethics issues.• 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.

• 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; and bioethics.• 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 employees and had approximately $13 million in budget.