Key insights from hVIVO’s recent webinar on IND readiness and early clinical success
Early‑phase research is defined by uncertainty. The safety profile is still emerging, the protocol is being tested for the first time, and the smallest decision can influence the entire trajectory of a programme.
In this blog, hVIVO’s consultancy team, lead by Katsu Mihara, Head of Clinical Development & PK/PB, outline why early‑phase development is one of the most exciting - and unforgiving - stages of drug development. For startups, the path to IND and first‑in‑human studies is filled with scientific promise, but also operational, regulatory, and strategic pitfalls that can derail timelines and erode investor confidence.
During hVIVO’s recent webinar, Fast‑Tracking First‑in‑Human: A Startup‑Focused Guide to IND Readiness and Early Clinical Success, our consultancy experts from clinical development, CMC, non‑clinical development, and regulatory affairs shared the most common challenges they see across early‑stage biotech. Despite their differing specialties, their advice converged around a single theme: most early‑phase failures stem from planning gaps, not scientific ones.
Here are the five biggest takeaways for any startup preparing for IND‑enabling activities:
1. Strong science isn’t enough — early‑phase success requires integrated planning.
One of the clearest messages from the discussion was that startups often excel scientifically but fall short in operational and strategic planning. Founders typically understand their molecule deeply, but early‑phase development requires a coordinated plan that aligns CMC, non‑clinical, clinical, and regulatory activities from the start.
Too often, companies generate data before defining a regulatory strategy or a coherent development roadmap. This leads to gaps, rework, and delays that could have been avoided with early cross‑functional alignment.
2. CMC timelines are almost always underestimated — sometimes dramatically.
The panel emphasized that CMC is one of the most common sources of delay. Startups frequently fail to define the actual clinical product early enough—not just the molecule, but the intended formulation, presentation, and analytical profile.
Manufacturing timelines are routinely underestimated, especially when relying on CDMOs. Analytical readiness, stability programs, and scalable processes must be addressed earlier than most teams expect. Without this, even promising programs can stall before reaching the clinic.
3. Regulatory engagement should start early - and be used strategically.
A recurring theme was that startups often avoid early meetings with regulators or treat them as a formality. This is a missed opportunity. Regulators do not expect a perfect package at the pre‑IND stage, but they do expect phase‑appropriate data, clear questions, and a well‑reasoned development position.
Early engagement helps prevent misaligned studies, unnecessary repeat work, and late‑stage surprises. The experts stressed that regulatory interactions should be used to validate assumptions, clarify expectations, and de‑risk the development plan—not simply to “check a box.” Properly approached regulatory engagement will also help gain the confident level of investors during the due diligence phase.
4. Non‑clinical planning must be driven by the intended clinical design.
Non‑clinical strategy is often developed in isolation, which leads to avoidable issues. The panel highlighted several common pitfalls: insufficient test material, inappropriate formulations for animal studies, unrealistic timelines, and uncertainty around dose selection.
Crucially, non‑clinical planning must be dictated by the intended clinical study—dose, route, formulation, and endpoints. Without that alignment, programs risk regulatory pushback or the need to repeat studies. Early coordination between non‑clinical, CMC, and clinical teams is essential.
5. Investors want to see a coherent roadmap — not fragmented data.
From an investor‑readiness perspective, the message was clear: investors gain confidence when startups demonstrate integrated thinking. A clear Target Product Profile (TPP), a realistic development plan, and a cross‑functional roadmap signal maturity and readiness.
Venture capitalists increasingly expect expert guidance, not trial‑and‑error planning. Startups that seek experienced support early—and can articulate a cohesive IND strategy—are far more likely to secure funding and maintain investor confidence through early‑phase execution.
The bottom line
Early‑phase development is where timelines slip, budgets expand, and promising assets can lose momentum. But the challenges are predictable—and avoidable—when startups plan early, integrate disciplines, and engage experts before gaps become bottlenecks.
The message from the webinar was clear: success in first‑in‑human studies isn’t just about strong science—it’s about strong strategy.