Guidelines To Bring Your Biologic To Market: Are You Prepared?

Realizing the vision and avoiding common pitfalls: key considerations and questions to ask

You are determined to find an effective therapy for a particular disease. You’ve learned a lot, determined a possible mechanism of action, and selected the most promising biologic molecule from several good candidates. Perhaps you have already completed some pre-clinical work, and determined efficacy in animal models. You’ve even got investors who agree that this is worthy of a go-to-market run.

So, what now? Are you up to the task of bringing a biologic drug to market? Do you have the talent and resources you need? You know what the steps are, but how can you develop a strategy and plan for moving forward?

Here we explore, from a biopharma process development and drug manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.