Biopharmaceutical Startup’s Need of a Regulatory Strategy

Julia Schueler
Tobias Ostler
Dr. Regenold GmbH

DOI:https://doi.org/10.5912/jcb675

Abstract:

Human drug development and approval is a risky process. To assess the importance of the regulatory part, especially for startup’s or not yet established companies, we gathered some evidence by a survey amongst European venture capital investors. We asked: how do regulatory issues in biopharmaceutical development impact young companies’ development and their financing? In addition to the survey an intensive literature research and analysis on drug failures and refusals was undertaken. Overall the expectations of involved venture capital investors identified were very congruent to the regulators views.

The most striking insight was that developing companies looking for first and follow on financing rounds should prepare to have a regulatory strategy or plan available already during the first contact. Regulatory issues are an important part of the risk/value evaluation and therefore investment decision.

Keywords:drug development ,regulatory ,approval ,venture capital ,investor ,startup ,Swiss Biotech Association ,en ,