Biopharmaceutical Startup’s Need of a Regulatory Strategy

Authors

  • Julia Schueler
  • Tobias Ostler Dr. Regenold GmbH

DOI:

https://doi.org/10.5912/jcb675

Keywords:

drug development, regulatory, approval, venture capital, investor, startup

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.

Author Biographies

  • Julia Schueler

    Julia Schueler
    heads a think tank named BioMedServices. She has followed the biotech industry for more than 20 years. Nearly ten years of that time she spent with EY as a senior industry analyst where she was author of the yearly published German Biotechnology Report. In addition, she was involved in the production of EY’s Beyond Borders (Global Biotechnology Report). Her latest publication is a book (German language) on the history and situation of the biotech industry, especially in Germany and the US. She holds a MS in biology and a PhD in business administration from the University of Erlangen-Nuremberg in Germany. Further, she graduated as Certified Biotechnology Analyst and completed a training in public relations.

  • Tobias Ostler, Dr. Regenold GmbH

    Tobias Ostler

    is Senior Manager Scientific Affairs Biopharmaceuticals at Dr. Regenold GmbH.

    He received his degree in pharmaceutical chemistry at the University of Tübingen and his degree in biology at the University of Freiburg. Tobias holds a PhD in immunology of the Max-Planck-Institute of Immunobiology, Freiburg.

    Tobias Ostler started his industrial career in 2004 in a Swiss contract research organization. In 2008 he became head of research at Thermo Fisher Scientific in Freiburg and Uppsala, Sweden responsible for bioanalytics in clinical biopharmaceutical development programs. 

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Published

2016-05-05

Issue

Vol. 22 No. 1 (2016)

Section

Article