ESQlabs: the MIDD partner for biotechs that have to prove value with less capital

Most biotechs arriving at BIO Japan carry the same three pressures: one or two lead assets, a narrowing financing window, and partners, investors and regulators asking quantitative questions your data package cannot yet answer. Model-Informed Drug Development (MIDD) is how you close that gap. ESQlabs is a MIDD specialist of around 60 scientists, built on the open-source Open Systems Pharmacology Suite. We also run a human-relevant safety and new-approach-methods practice, but MIDD is our core.

The problems we solve for biotech:

• No in-house clinical pharmacology function. You do not need to hire a modelling team. We act as your virtual clinical pharmacology and PBPK/QSP department, from discovery through filing, scaled to the question in front of you.

• First-in-human dose is still a judgement call. Translational PBPK and QSP turn preclinical data into a defensible human dose, exposure and schedule prediction, with the uncertainty quantified rather than hidden.

• The data room cannot answer BD and investor questions. We build the model-supported value story: dose rationale, exposure and target-engagement predictions, virtual trials, competitor benchmarking and differentiation. This is the evidence licensing partners and VCs probe in due diligence, prepared before they ask.

• Every additional study is capital you do not have. PBPK supports waivers and replaces dedicated studies for drug-drug interactions, hepatic and renal impairment, pediatrics, geriatrics, pregnancy and food effect. PBBM supports formulation and bioequivalence decisions.

• Japan is on the roadmap but the cost is unclear. We address ICH E5 and E17 ethnic-factor and bridging expectations with PBPK and population PK. Since PMDA's December 2023 revision, a dedicated Japanese Phase 1 study is not required in principle where a robust ethnic-sensitivity assessment is provided, which can remove a study and a year from your Japan plan.

• A six-figure software licence is not justifiable. ESQlabs is the leading contributor to the open-source OSP Suite (PK-Sim and MoBi). You pay for expertise and results, not perpetual licences: no vendor lock-in, full transparency for regulators, lower total cost than the closed commercial stack. Our work is aligned with ICH M15, effective in the EU on 23 July 2026.

About: Founded 2017, Saterland, Germany. Deloitte Technology Fast 50 Germany. Founder and CEO Stephan Schaller chairs the OSP Management Team. We serve global pharma under master service agreements and biotechs on focused, milestone-sized engagements. Meet us at BIO Japan 2026, Pacifico Yokohama.