CASE STUDIES

PROOF-OF-CONCEPT PROGRAM MANAGEMENT

Client with an organization in flux needed an executive level program manager to hit-the-ground-running for a Phase 2 drug-device therapeutic in the rare disease space during proof of concept trials.  Client's needs were met by seamless integration with an existing cross-functional team, identification of key gaps and guiding the team towards critical go/no-go criteria.

PLATFORM TECHNOLOGY ASSESSMENT AND STRATEGIC GUIDANCE

Client with a novel antibody program sought a broad base assessment and ranking of possible discovery programs with fast-to-clinic and fast-to-market potential.  Client's needs were met through a coordinate assessment of the technology capabilities, the various competitive landscapes, and strategic development plan opportunities.

COMMERCIAL STAGE INTEGRATED PROGRAM MANAGEMENT

Client with a Phase 4 stage marketed rare disease therapeutic enzyme needed an on-demand executive program manager to ensure alignment between development and product strategy during life cycle management. Client's needs were met by an "at-the-ready" approach to integrate with the team, leadership, and organizational stakeholders, maintain communications around critical activities, and provide frameworks for key decision-making.

PROGRAM MANAGEMENT DURING DRUG CANDIDATE SELECTION 

Start-up client with a novel oral semi-synthetic natural product therapy sought a hands-on program manager to help team develop practicable screening strategies and move quickly to a final candidate for IND enabling studies and beyond.  Client's needs were met by an embedded approach to working with the team and key CRO vendors, to move quickly to decision-making milestones.