Representative Experience

Life Sciences Government Strategies - Biosecurity

Provided strategic counsel to a coalition of leading venture capitalists in support of Congress’ passage of the All-Hazards Preparedness Act, creating BARDA

Life Sciences Government Strategies - Biosecurity

Advised an innovative early-stage company on obtaining a $102 million contract with the U.S. Department of Health and Human Services to develop an influenza neuraminidase inhibitor for the treatment of pandemic influenza

Life Sciences Government Strategies - Coverage and Reimbursement

Advised a genomic test company on lab billing and payment rules

Life Sciences Government Strategies - Coverage and Reimbursement

Successfully argued for unique coding and payment for single-source drugs

Life Sciences Government Strategies - Coverage and Reimbursement

Worked successfully with CMS to expand coverage of a previously non-covered therapy for the treatment of age-related macular degeneration

Life Sciences Government Strategies - Coverage and Reimbursement

Represented a leading cancer center in obtaining a DRG reclassification for hospital inpatient reimbursement for an anti-cancer therapy for renal cell carcinoma and melanoma

Life Sciences Government Strategies - Coverage and Reimbursement

Advised a coalition of leading academic medical centers and medical device manufacturers in the development of one of the first data registries under CMS’s Coverage with Evidence Development policy

Life Sciences Government Strategies - Food and Drug

Represented a company regarding combination product issues with respect to a medicinal product used in conjunction with a medical device, which was subject to the Medical Devices Directive

Life Sciences Government Strategies - Food and Drug

Engaged the FDA and Congress, on behalf of a national coalition of innovative medical technology companies, regarding the appropriate regulation of break through genetic and molecular diagnostic tests

Life Sciences Government Strategies - Food and Drug

Devised a strategy to persuade an FDA review division to accept a medical technology company’s proposed development plan, after the company had reached an impasse with the review division over its data requirements

Life Sciences Government Strategies - Legislative

Represented leading pharmaceutical and biotech companies in connection with the enactment of the MMA

Life Sciences Government Strategies - Legislative

Advocated on behalf of a national civil rights organization to assure the timely reauthorization of the Ryan White CARE Act, the largest publicly funded program dedicated to providing people with HIV/AIDS in the United States with a wide range of community-based health and support services

Life Sciences Government Strategies - Legislative

Advised industry trade associations in connection with the reauthorization of the Prescription Drug User Free Act and the Public, Health, Security and Bioterrorism Preparedness and Response Act