Small molecule and Biologics - Brand and Generic Rx - Oral and Parenteral Products
Company A - 2024 - Project leader on 505(b)2 oncology injectable product development. Market research, FDA meetings, clinical trial design and site selection, Orphan Drug application, CRO engagement for PK assay development.
Company B - 2024 - Consulting engagement with leading injectable pharmaceutical company to evaluate new products for development via 505(b)2/NDA regulatory pathway. Activities include licensing of developed products to partners.
Advisor to CEO and COO on go-to-market strategies for blockbuster generic pharmaceutical. Evaluation of product development and formulation projects for new to market products.
Advisor to CEO of biologics manufacturer. Evaluated and recommended contract manufacturing expansion opportunities to support growth.
Advisor to publicly traded pharmaceutical company CEO and CCO to create streamlined distribution and development of contemporary trade agreements for in-line products.
Consultant services to Private Equity organizations exploring investment in private pharma company businesses. Includes product and pipeline assessments, technology assessement, contract analysis, strategic fit and synergy development.
Community and Hospital
Responsible for leading product strategy initiatives for a start-up SaaS business which provides innovative patient care management solutions to community pharmacies.
Business Development advisor to start-up SaaS business with clinically development software for detecting drug diversion activities in hospitals.
Contracting and Pricing
Pharmaceutical contracting responsibilities for emerging specialty distributor focused on supplying oncolytic products to independent physician groups throughout the USA.
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