Accelerated Tox Offerings: A Recipe for Streamlining IND Applications

by Alejandro Fernandez-Martell, Ph.D.
Principal Scientist, Global Process Development

The IND Race: rapid tox material supply as a key to success

The current landscape of biotech is characterized by accelerated drug development and constant pressure to advance molecules from lab to clinical trials faster than ever before. For drug developers, reaching Investigational New Drug Designation (IND) and/or Clinical Trial Application (CTA) status is not only a significant milestone in drug development for initiating clinical trials, but also it is a crucial financial milestone that helps companies secure further funding to support their clinical development journey. As drug developers collaborate with Contract Development and Manufacturing Organizations (CDMOs) to expedite this process, the rapid toxicology (tox) material supply has emerged as a new critical path to IND.

Faster tox solutions maximize the impact of rapid DNA-to-IND timelines for faster drug development

Companies across the biopharma industry have reported a notable reduction in DNA-to-IND timelines for monoclonal antibodies (mAbs), where health authority applications for first-in-human (FIH) trials have been completed within months instead of years. Lonza’s Ibex® Design for mAbs is a clear example of such continuous efforts to expedite innovative molecules to the clinic. This program is fast enough to ensure our customers can reach DNA-to-IND readiness within 11 months.

Advancing to health authority applications with increasingly faster timelines can be overwhelming for drug developers, as accelerated IND applications require that toxicology animal testing, including data analysis and report generation, must be completed within four to five months, which is a pretty significant time constraint with no room for delays. With the pressure to advance into FIH trials rapidly, we have identified that the timely provision of toxicology study data is becoming the next bottleneck.

Lonza has recently launched two new rapid tox offerings to address this emerging bottleneck by accelerating the generation of toxicology material, which is essential for the initiation of toxicology studies, by up to 50% faster compared to typical IND timelines for mAbs. These new rapid tox offerings not only reduce tox material generation from 5 months to 2.5 months without impact on Chemistry, Manufacturing, and Controls (CMC) activities, but also ensure that we meet and exceed both customer expectations and evolving market demands.

Figure 1. Estimated timelines for our accelerated tox offering for mAbs, which can reduce timelines for tox material supply by 50 percent.

Harnessing industry expertise to enhance drug development with purpose

As a Principal Scientist of Global Process Development, I actively look to find better solutions for both Lonza’s customers and operations. I an passionate about science and technology and eager to find better ways to achieve operational excellence. Recently, I am proud to lead, and work with, a team of experts at Lonza aiming to modernize our drug material supply timeline for therapeutic proteins. Together, our team is pushing boundaries to speed up toxicology material delivery, the new critical path for FIH trials, for a wide range of protein modalities, while minimizing manufacturing risk and meeting market expectations.

Building new offerings is never a simple task, it requires collective expertise from multiple departments such as Process Development, Analytics, Operations, Business and Commercial Development, and Marketing. Each stage demands careful coordination, drawing specialized knowledge to ensure that the solution is not only scientifically sound but also aligned with the business goals and effectively meets the market demands.

The impact of collaboration in supporting customers on their path to the clinic

I have found the dedication of our team inspiring, and it’s an honor to witness how we strike a balance between collective and individual contributions to foster an environment where the expertise and unwavering commitment of every team member is amalgamated to provide solutions that meet our current customer demands. This led not only to improved development timelines and cost but also has helped me to enhance my understanding of the complexity of each journey our customers face when bringing life-changing treatments to clinical trials. 

For me, being a scientist at Lonza is a rewarding and fulfilling experience as I work and learn first-hand from diverse teams of experts across the global network. I have enjoyed channeling our expertise and passion to provide integrated offerings that speed up timelines while producing high quality products for use in clinical trials. Every step from accelerating toxicology material generation to reducing risk has been a collaborative effort. Personally, it has deepened my understanding of our business and the vital role we play in the industry.

Gaining extra time for thorough toxicology studies

Our rapid tox offerings deliver tox material sooner, which means that customers can initiate toxicology studies earlier than previously possible. In an industry where time is a scarce commodity, these new rapid tox offerings are not merely advantageous, but transformative, as this offering gives up to 2.5 months of additional time capacity to our customer to complete tox studies and comply with expedited IND timelines.