Situation:
Small virtual biotech with transdermal delivery system and no experience in the drug development process.
Solutions:
- Gap analysis revealed no experience in drug development and approval and limited understanding of expectations . No vendor management competency existed within the team.
- Over the course of the initial process, Halloran set vendor expectations for the first trial, managed Vendor timeline, budget, and quality, and saved 25% of a $2MM budget and tightly managed scope.
- During the interim phase, Halloran managed the transition of data management and statistical analysis to an Indian CRO to increase capital efficiency.
- During the final phase, Halloran managed the full clinical program for an OTC NDA, managed new partnership with a big pharma licensor, designed additional marketing and supportive studies, provided regulatory, clinical, and strategic input, and represented the client's best interest in the co-development of the asset.
Value:
Revised the client's management processes, clarified roles, and introduced project management. As a result, there was increased productivity and a reduction in timelines by an average of 30%, as well as a decrease in project expenses from 20-30%. Successfully guided client through three FDA meetings with strong and positive relationship with agency resulting in removal of a clinical hold, and represented client's development interests ultimately resulting in a $100MM licensing deal.