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A Faster, Clearer Path from Discovery to the Clinic
Early development has never been more important - or more challenging. Biotechs are under pressure to generate high quality human data earlier, with fewer resources, tighter timelines, and greater expectations from investors and partners. At the same time, clinical programmes are becoming more complex, regulatory standards are rising, and traditional early phase models often rely on fragmented vendors and inconsistent data.
Katsuhiro Mihara, Site Leader/Head Clinical Development at Venn Life Sciences Photo by:
The newly unified hVIVO was built to solve these challenges. By bringing Venn Life Sciences, CRS and hVIVO together under one organisation, we have created a fully integrated early‑phase partner - combining consulting, clinical trials, human challenge trials, and specialist laboratories into a single, coherent pathway from preclinical strategy to clinical proof‑of‑concept.
For biotechs, this means a faster, clearer, and more capital‑efficient route to the clinic.
An integrated accelerator‑to‑clinic model
Early development succeeds when strategy, science, and execution are aligned from the outset. Our model connects these elements under one accountable partner, reducing disruptive handoffs, shortening timelines, and improving the quality of decision‑enabling data.
This integrated approach spans:
Preclinical and clinical consulting to shape the right development strategy
CMC, non-clinical and regulatory support to prepare assets for first‑in‑human studies and alongside further clinical development
Phase I/II clinical trial delivery across our European sites
Human challenge trials (HCTs) for rapid, controlled efficacy readouts
Specialist laboratories providing biomarker solution, real‑time virology and immunology analysis
By combining these capabilities, we help biotechs move from discovery to first‑in‑human and onward to proof‑of‑concept with greater speed and confidence.
Decision‑enabling data, delivered earlier
In early development, clarity is everything. Investors, partners, and internal teams all need decisive CMC, non-clinical and human data to determine whether an asset should progress, pivot, or pause.
Our model is designed to generate that clarity sooner.
Human challenge trials (HCT) - an area where hVIVO is the global leader - provide controlled, high‑fidelity efficacy data months or even years earlier than traditional field studies. With 15 characterised challenge models and more than 50 studies completed, we offer a proven route to early efficacy insights that strengthen regulatory packages and support investor‑ready milestones.
Beyond HCTs, our owned Phase I/II clinical sites and specialist laboratories ensure consistent execution, predictable timelines, and high‑quality data across all early‑phase studies.
Recruitment certainty and operational reliability
Recruitment remains the single biggest cause of delays in clinical development. Our proprietary recruitment platform, FluCamp, and our continuously screened volunteer database give biotechs a level of recruitment certainty that traditional sites cannot match.
This infrastructure enables:
Faster study start‑up
Reliable timelines
Access to niche or hard‑to‑find populations
Higher retention and data completeness
For biotechs managing tight budgets and investor expectations, this reliability is a strategic advantage.
Built for the next generation of biotech
The unification of Venn Life Sciences, CRS and hVIVO strengthens our ability to support biotechs across therapeutic areas including infectious disease, respiratory, cardiometabolic, immunology, and dermatology. It also brings together decades of scientific leadership with industry-leading Key Opinion Leaders, operational expertise, and regulatory insight under one organisation.
The result is a purpose‑built early‑phase partner designed for today’s development environment—one that helps biotechs generate the evidence they need, when they need it, with greater speed, clarity, and confidence.
As the industry continues to evolve, our mission remains simple: accelerate the path from discovery to the clinic and help bring important new therapies to patients faster.
To find out more please visit www.hvivo.com
About Katsuhiro Mihara
Katsuhiro Mihara, RPh, PhD is a registered pharmacist and with a PhD in pharmaceutical sciences from the University of Tokushima.
He joined Venn in 2016 to lead the Clinical Development department and is currently also leading Venn’s business in the Netherlands.
Before joining Venn, he held leadership and senior scientist positions in clinical development and pharmacology at Abbott, Merck Sharp and Dohme, Schering Plough and Organon, giving him over 25 years of experience in preclinical/early clinical drug development in big pharma, biotech and provider alike.
He has been involved in numerous drug development projects as project leader, clinical trial manger and/or study director in multiple therapeutic areas, including, but not limited to, oncology, immunology, dermatology, urology, gynaecology and CNS from early discovery to marketing.
His experiences also include due diligence of various drug development projects with primary focus on risk assessments including evaluation of regulatory documents at major milestones (e.g. pre-IND, End of Phase I/II meetings) for investors.
