From discovery to IND: the critical success factors for an efficient preclinical development phase

Early alignment prevents costly delays

Many delays arise not because experiments fail, but because critical decisions are made too late or are insufficiently aligned.

When CMC, toxicology, regulatory affairs and project management become involved only at a late stage, additional studies may prove necessary or documentation may need to be revised. This not only increases costs, but can also significantly delay the start of clinical trials.

Leading organisations therefore invest in early multidisciplinary decision-making. By establishing priorities collectively and identifying dependencies, they can recognise risks earlier and execute development programmes more efficiently.

Regulatory thinking begins before submission

A common mistake is to view regulatory affairs primarily as the final step before submitting an IND dossier. In reality, a successful regulatory strategy begins during the preclinical development phase.

Regulatory authorities expect a compelling and coherent narrative in which safety, quality and scientific evidence are logically aligned. This requires decisions to be documented and substantiated consistently throughout the development pathway.

By incorporating regulatory expectations into the development strategy at an early stage, organisations can prioritise studies more effectively, avoid unnecessary work and strengthen the quality of their submission dossier.

Project governance as an accelerator of innovation

As development programmes become more complex, effective governance becomes increasingly important. Decision-making should not depend on individual disciplines, but take place within a clear framework in which responsibilities, decision points and escalation procedures are explicitly defined.

Strong project governance provides several benefits:

• Better alignment between scientific and operational teams;

• Greater transparency regarding timelines, budgets and risks;

• Faster decision-making when new insights emerge;

• Clear priorities across multidisciplinary teams;

• Better preparation for investment and portfolio decisions.

  
  

For organisations managing multiple development programmes in parallel, this also provides an important foundation for effective portfolio management.

Quality and speed do not need to conflict

The pressure to shorten development timelines is increasing. Competition, investors and patients all demand the rapid introduction of innovative therapies. Speed, however, must never compromise the quality of the underlying data.

The most successful development organisations do not look for ways to omit essential steps, but for ways to organise processes more intelligently. Standardised working methods, digital collaboration, integrated data analytics and clear decision criteria make it possible to work more efficiently without compromising scientific quality or patient safety.

Operational excellence is therefore achieved not by working harder, but by making better decisions.

Experience makes the difference

Although technology and data play an increasingly important role, experience remains one of the most critical success factors in preclinical development.

Senior professionals recognise patterns that may not be immediately apparent in research results. They understand which risks are likely to emerge, how different disciplines influence one another and how to translate complex decisions into a realistic development plan.

This experience is particularly valuable for innovative modalities such as cell and gene therapies, RNA technologies and advanced biological medicines. The scientific challenges are not purely technical. They also require strategic insight into regulation, manufacturing, quality and future clinical development.

A strong foundation for clinical success

The transition from discovery to IND is far more than an administrative milestone. It is the point at which years of scientific research are translated into a clinical development programme that must be safe, scientifically substantiated and operationally feasible.

Organisations that invest in integrated collaboration, early regulatory strategy, strong project governance and experienced specialists establish a robust foundation for the next phase of drug development. This increases not only the likelihood of a successful IND submission, but also the prospects of a more efficient development pathway and better clinical outcomes.

In a sector where time, quality and innovation are inseparably linked, a well-structured preclinical development phase is a decisive factor in sustainable success.