Representative Projects: Product Development Strategy

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