On 5 March 2020, the “Adım Adım Biyogirişimcilik” (Step by Step Bioentrepreneurship) session at StartHUB featured Prof. Dr. Elif Damla Arısan and attorney Erdem Mümtaz Hacıpaşaoğlu (Vircon Legal) as speakers.
Building a company inside a regulated field
Life-science ventures invert the usual startup sequence. Where a software company can ship and correct, a biotech or health-tech founder has to know from the outset which side of a regulatory boundary the product sits on — a wellness application and a medical device look similar in a pitch deck and are governed very differently, and a diagnostic feature driven by a model may also be a high-risk AI system. That classification determines the evidence, the documentation and the timeline.
Two other things behave differently here. Research data is often health data, which means informed consent and purpose limitation constrain what the company may later build on it. And the asset base is usually a patent family plus trade secrets that may sit with a university rather than the company — worth resolving before a grant such as TÜBİTAK BiGG or a milestone-based round. See Intellectual Property and KVKK & GDPR Compliance.
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