Drug Development Project Management
Venn Project Management Team consists of senior project managers with at least a 10-year+ track record in innovative Pharma industry and often an additional PhD-level expertise in specific drug development areas. Each project manager has proven to be able to set up and manage complex tailor-made drug development programs outsourced to Venn and is able to anticipate to unexpected findings. They are well aware that these development programs need to be executed under high time pressure and sometimes with limited resources while maintaining the highest quality level. These project leaders not only have a broad view on drug development, but also have excellent communication skills and client focus, making sure that the client experience is as if he/she is running the program on internal resources.
A typical drug development program outsourced to Venn starts with a thorough review of the available data (a gap-analysis or due diligence) followed by the design of a ‘roadmap’ or drug development plan that outlines the minimal required nonclinical and clinical studies including possible biomarker development (‘need-to-haves’ vs ‘nice-to-haves’), the drug formulation requirements , the regulatory requirements, the timelines, risks and costs that are associated with the development of the product up to a certain milestone. In a next step, Venn multi-disciplinary project managers can assist in a timely execution of the drug development plan making use of Venn validated network of CROs and CMOs, thereby carefully guiding its clients through the different phases of drug development and (international) registration. This results in an accelerated and efficient (faster and cheaper) drug development program, an increased product value and a shorter route to commercialisation.
Johan te Koppele, Ph.D.
Managing Director Venn Early Development