How to Accelerate IND-Enabling Toxicology Studies in Today's Drug Development Environment

The conversation today is quite different.

Across the pharmaceutical industry, development timelines are becoming increasingly compressed. Biotech firms are being pressured to show progress to investors, large pharmaceutical firms are looking for quicker portfolio development progress, and competition regarding first-in-class and best-in-class drugs has become more difficult. With just a couple of weeks delay, there can be major consequences in this world.

For this reason, activities that were once considered to be normal development activities are now being looked at more closely. Some of these include IND-enabling toxicology studies, which are becoming a critical aspect in the speed of a therapy to first-in-human testing.
The issue is not that toxicology has become less efficient. In many respects, scientific capabilities are stronger than ever. Rather, the challenge lies in the fact that modern drug development has changed dramatically.

Today's pipelines include therapeutic modalities that were rarely encountered just a few years ago. New modalities like cell therapies, gene therapies, antibody-drug conjugates, oligonucleotide based therapies and others have expanded scientists' options. Simultaneously, these innovations have raised new challenges on safety evaluation, study design and regulatory expectations.

This creates a development environment where toxicology programs must move faster while addressing increasingly complex scientific challenges.

A New Reality for Toxicology Programs

This is a lesson many development teams learn when starting to design toxicology studies for submission as an IND.

In theory, the way is simple.

Candidate selection is complete, manufacturing activities are progressing, and the regulatory strategy has been defined. Yet once toxicology timelines are incorporated into the broader development plan, the schedule can begin to tighten.

Study slots may not be available as quickly as expected. Additional analytical work may be required. Regulatory questions may emerge regarding study design or species selection. What initially appeared to be a manageable timeline can suddenly become more challenging.

These experiences are not isolated.

Demand for pharmaceutical toxicology testing has grown significantly across the industry in recent years. There's been an increase in the number of therapeutic candidates entering development as well as numerous ones needing specialized skills and infrastructure that can't be readily scaled up in one fell swoop.

Consequently, toxicology is increasingly being viewed as a strategic component of development planning rather than a box to be checked before submission.

Why Early Decisions Matter More Than Ever

One lesson emerging across the industry is that many toxicology delays originate long before a study actually begins.

At times, safety issues are added later to discussions around development. When toxicologists really get involved, important decisions about candidate selection, manufacturing schedules or regulatory decisions may have been finalized.

This can restrict flexibility and cause unnecessary pressure.

Organizations that consistently achieve aggressive development timelines often take a different approach. Toxicologists are brought into conversations earlier, allowing potential risks and study requirements to be identified while there is still time to adjust plans.

The benefits extend beyond scheduling.

Earlier engagement frequently improves communication between development functions and helps ensure that toxicology requirements are aligned with broader program objectives.

Capacity Constraints Are Only Part of the Story

When discussing toxicology bottlenecks, capacity is often the first issue mentioned.
It is certainly an important factor. At times, safety issues are added later to discussions around development. When toxicologists get engaged, important decisions – such as candidate selection, manufacturing schedules or regulatory approaches – may have been taken.

This reduces the flexibility and brings unnecessary pressure.

The complexity of the therapies themselves is changing what toxicology programs require. Novel mechanisms of action, unique delivery platforms, and emerging treatment modalities frequently demand customized study approaches.

A program involving a traditional small molecule may follow a familiar path. A gene therapy or advanced biologic may not.

As a result, success increasingly depends not only on securing study capacity but also on ensuring access to the right scientific expertise.

Industry Perspective

The focus of industry discussions on toxicology timelines is shifting toward finding a balance between speed, study quality, and regulatory expectations. Fewer seats available, changing treatment options, and shorter development timelines all contribute to increased complexity of IND-enabling programs. The interaction of these factors should be better understood to design more successful strategies for sponsors to promote more rapid development and keep science on track.

For additional insights, explore Breaking the Toxicology Bottleneck for IND Submissions.

The Expanding Role of Preclinical Toxicology Services

As development programs become more specialized, many sponsors are reevaluating how toxicology activities are resourced.

In some cases it might be suitable to build local capacity.In some organisations it may be appropriate to expand internal capacity. Others find that they need to work with external suppliers for more flexibility and to make use of expertise that they would not be able to develop themselves.

As a result, preclinical toxicology services are playing an increasingly important role across the industry.

In addition to the execution of the studies, seasoned partners can provide useful feedback on the regulatory expectations, study design considerations, and project planning. They can be very helpful in development teams to deal with uncertainty, especially when developing new therapeutic modalities.

It's not just about outsourcing activities. To develop strategies that both are scientifically sound and efficient for operations.

Looking Beyond Speed

Speed will be one of the first words in the minds of most when talking about how to get toxicology studies going faster for IND.

But the most successful organizations generally don't just concentrate on speed.
Rather, they concentrate on predictability.

An effective and predictable toxicology program enables development teams to develop more efficiently, set realistic expectations with stakeholders, and to make informed decisions throughout the development process.

Often as well as the need to avoid unexpected delays, it's important to avoid delays at all.
This is a vital balance to keep in mind, one that will become more and more significant as the drug development process evolves.

Toxicology will continue to be a key safety prong for patients. Meanwhile, it will have an impact on the pace of advancing promising treatments to the clinic.

In a competitive world, where organisations need to stay on top of things, getting to grips with the sources of toxicology bottlenecks and how to overcome them can often be as significant as the science itself.

Conclusion:

Drug development timelines are becoming more and more compressed, and toxicology is no longer a downstream process. The importance of early planning, cross functional collaboration, and having proper scientific expertise is becoming the critical factor for continuing development momentum. Companies that take a proactive approach to the toxicology issue stand a better chance of having the IND timeframe more predictable and advancing their potential drug candidates into the clinic more efficiently.