BayOConnect 2026: Regulatory Strategy Determines Biotech Success

Where the biotech scene meets

From June 30 to July 1, 2026, Munich was the meeting point of the biotech scene: BayOConnect 2026 brought founders, researchers, investors and established partners together at the Design Offices München Macherei. At the heart of it was one question: how do young biotech companies secure long-term market access and the value of their scientific breakthroughs?

This is exactly the interface addressed by Martina Schneider (Chief of Staff at CSL Innovation GmbH and co-founder of LOVEDIS) and Lena Pauli-Tzschirner (Principal Consultant at Entourage GmbH) in their exclusive live double interview. Their goal at the conference was to show founders and investors that market access and regulatory strategy are not downstream bureaucratic obligations but the strongest drivers of actual company value (valuation).

How the quality of regulatory decisions determines the speed, company value and fundability of innovation.

Four key topics in focus

The biotech ecosystem thrives on cooperation and strategic foresight. At the conference, the two experts explored how start-ups can navigate the typical cliffs of the early development phases:

• Company value and investor attractiveness (valuation): In BayOConnect's investor matching, financial viability counts above all. A coherent reimbursement path planned early gives start-ups the trust they need when raising venture capital.
• Anchoring reimbursement and HTA requirements early: Many developers focus primarily on the technology in the early phase. The double interview showed why considering payer evidence and HTA (health technology assessment) early on drastically reduces the risk of failing at the market threshold.
• TechBio, AI and regulatory sandboxes: The conference was strongly dedicated to digitalization in biotech. The discussion covered how AI in the R&D phase can be brought into practice faster through forward-looking regulatory spaces such as the IHI BRIDGE project.
• What start-up ecosystems need: Capital alone is not enough. Biotech start-ups need direct access to modern R&D infrastructures and incubators (such as the CSL incubator in Marburg) as well as experienced sparring partners for operational execution.

Entourage on site

Alongside the live double interview, co-founder and managing director Moritz Haucke represented Entourage GmbH on site at the Design Offices München Macherei. At the center of the exchange were market access roadmaps, regulatory approval questions and cooperation models at the interface of Entourage and SmartStep Consulting.

Want to set up a meeting, or have a question about our consulting work for biotech and start-up companies? We would be glad to talk.

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