Each journey begins at a starting point, and we believe that few journeys are as exciting as developing a drug. In order to succeed and reach your destination, you need a solid roadmap, the drug development plan (DDP), this is the outline of your drug development strategy.
A comprehensive drug development strategy outlines each step for advancing a new compound from the lab through each stage of development, ultimately arriving at the envisioned marketed drug product.
This requires a multi-disciplinary project team of experienced experts in strategic planning, which outlines the chemistry, manufacturing, and controls (CMC) and formulation activities, key non-clinical studies, and Phase I-III clinical trials, regulatory submissions, and health authority interactions, market launch activities, and life-cycle management. A drug development strategy is a dynamic process that moves forward in defined stages. A carefully planned set of steps and action plans, progressing from non-clinical to the first-in-human Phase I to Phase II “proof of concept” and pivotal Phase III trials for registration.
The drug development process can be complex and involves various strategic steps that can reduce timelines and costs
A proper development strategy should answer the following:
Identifying these steps early is an essential part of a successful development. Our Venn experts can guide through your journey.
At Venn Life Sciences, our team of experienced consultants have the expertise to help with the various steps in drug development to ensure that you receive the support and direction required to formalise your drug development. We have integrated drug development partners offering a unique combination of drug development consultancy, clinical trial design and execution.
Learn more about our drug development services here.