Client
Accomplishments
Client Benefits
“Intrapreneurial” drug development unit of an established industry company
Crafted the initial clinical strategy for a novel dosage form product
Participated in the creation of regulatory strategy; presented its clinical aspects at pre-IND meeting
Clinical/regulatory foundation for all phases of product development
Credible development strategy that facilitated a strategic outlicensing arrangement
Privately held biotechnology company
Using Phase I data and expert panel input, crafted a Phase II-III program for a novel vaccine-based therapeutic agent
Coherent registration program that integrated basic science, clinical need, regulatory expectations, and market realities
Global provider of healthcare products and services
Advised on collaborative drug development opportunity with a leading medical device manufacturer
Sound scientific and business basis for entering into a unique proprietary co-development project with a world-class leader
