Each Therapy and Disease Area is an Opportunity to Create Tailored Solutions
Led extensive emerging trends analysis on the future of oncology practice, driving key commercialization decisions as well as policy and political strategies to support assets. Worked closely with key thought leaders in oncology.
Effectively identified and executed tandem regulatory and reimbursement strategy across FDA and CMS for re-launch of orphan oncology asset, allowing for new pricing and commercialization strategies to significantly raise market value to reflect new investment in the product.
Successfully developed strategies for expedited review and preferential reimbursement for opioid abuse deterrent formulations and built a payer strategy in anticipation of an indication.
Achieved fastest ever quality measure change upon product approval, significantly driving uptake in inpatient vaccine sales.
Advanced new narrative for identifying and treating pain with key government officials to successfully ensure review of ICD-9/10 codes, opioid overutilization programs and implementation of the IOM Report on Pain. Worked across IOM, FDA, NIH, CMS, and CDC.
Successfully created and negotiated adoption of new emerging health risk standard for expediting vaccines CPT codes, removing enormous barrier to provider uptake and reimbursement for a vaccine even before FDA approval. Worked closely with patient groups, FDA, NVPO, HHS, CDC and the AMA.
Ensured broadest possible vaccine use recommendation at ACIP/CDC and advanced timely reimbursement change at CMS to reflect recommendation, ensuring physician payment and expedited use. Worked closely with CMS leadership, FDA, NVPO, CDC, HHS, and the White House.
Positively amended CMS coverage policy of weight loss therapies if used for treatment of diabetes, metabolic syndrome, and related diagnoses in anticipation of an FDA approval. Worked with payer and pharmaceutical trade associations and CMS.