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    Strategic notes on biotech fundraising, venture design, and life sciences market entry.

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    Italy Gateway

    regulatory

    CE-IVDR: what it means for your diagnostics market entry strategy

    CE-IVDR changed European diagnostics market access in 2022. For US and Asian companies planning EU entry, it is a commercial planning variable, not just a compliance step.

    6 min read
    market entry

    For oncology diagnostics, Italy is the logical first market in Europe

    CE-IVDR changed the rules. Italy's IRCCS network, ageing demographics, and single-payer structure make it the most direct route to European market leadership for cancer diagnostic companies.

    12 min read
    market analysis

    Selling diagnostics as Research Use Only (RUO) in Europe: a go-to-market strategy that works, if you respect its boundaries

    Research Use Only is a legitimate go-to-market lane for diagnostics waiting on CE-IVDR, but it has hard regulatory boundaries. The strategy and the limits.

    12 min read
    market entry

    Opening a life sciences subsidiary in Italy: three mistakes that international companies keep making

    Italy is not one healthcare market. It is twenty-one. Most international companies discover this too late.

    10 min read

    Pharma and exit strategy

    pharma strategy

    Five conditions a pharma company needs before it buys

    Pharma BD teams are not VCs. They evaluate assets against a completely different set of criteria — and most biotech founders have never been told what those criteria are.

    10 min read
    commercial

    VCs aren't your buyer. Pharma is.

    In European biotech, the most probable exit is not an IPO. It is a pharma acquisition or licensing deal. That fact should shape every slide in your deck.

    9 min read
    BD&L

    When is the right time to out-license your biotech asset?

    Out-licensing too early destroys value. Too late, and the window closes. The framework for knowing when your asset is ready for a pharma conversation.

    7 min read
    exit

    License or launch: the game theory behind the choice

    The decision is not about preference or ambition. It is about which path creates more value per euro of risk retired, and for whom.

    6 min read

    Theory requires execution.

    Reading the map is not driving the road.
    If you need strategic support to implement these frameworks in your venture:

    Worth reading. Worth keeping.

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