Getting an Oncology IVD to Market Faster
What Founders Underestimate Early On
In this 60-minute session, Egbert Smit (CEO of MLA Diagnostics) and Annelies Rotthier (QbD Group) unpack the clinical evidence decisions that trip up oncology diagnostic startups — and how to get them right the first time.
¿Qué aprenderás?
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Why clinical evidence decisions made in the first months can lock you into the wrong regulatory path
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How to design a study when your samples are limited, expensive, and irreplaceable
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Where founders most often misalign intended use, performance claims, and study endpoints
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What a first-time-right clinical evidence strategy looks like under IVDR — and why it matters to investors too
Aprende de los mejores
Ponentes
Egbert Smit
CEO, MLA Diagnostics
Life sciences leader with 20+ years of science and business experience. (Co-)founder of several IVD businesses and currently leading oncology IVD venture MLA Diagnostics (Maastricht) and cardiovascular disease IVD venture PERSUASIVE (Utrecht).
Annelies Rotthier
QbD Group
IVD Clinical Evidence and Medical Writing. IVD Product Development and IVDR Compliance. Strategic leadership & Consultancy.
¿Es para ti?
¿A quién va dirigido?
Founders and CEOs of early-stage IVD/diagnostic companies
Regulatory affairs professionals in oncology diagnostics
Clinical evidence and study design leads
Quality managers at emerging medtech/IVD companies
Business development professionals in the IVD space