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A Fast Lane Approach to Investigational New Drug (IND) Applications
Shorten your development timelines
Drug development is a complex and time-consuming process, typically taking 10-12 years from initial discovery to regulatory approval. This is due to the rigorous safety and efficacy testing required to ensure that new drugs are safe and effective for patients. While this testing process is essential, it can also delay the availability of life-saving treatments to patients who need them most. The Fast Lane and Fast Track IND paradigms can help save valuable time.
Michael V. Templin, PhD Senior Scientific Director for Charles River's Scientific Advisory Services, emphasizes the importance of balancing speed and safety in drug development. "It often comes down to making a choice," he says. "Things can be done faster, but ultimately it is a balance between speed and the need for sufficient, accurate data." Templin provides drug development expertise and guidance to clients, helping them plan their safety strategies. "Since these drugs are going into humans, we want them to be as safe as possible," he says.
Reduce IND Timelines Without Compromising the Quality and Scope of the Studies
The Fast Lane and Fast Track IND paradigms are designed to address this time challenge. By providing clients with expedited reviews and access to FDA expertise, as well as making decisions on data rather than with documents, the paradigms can help streamline the development process and bring new drugs to the clinic faster. Fast Lane and Fast Track IND paradigms were developed in response to client demand for accelerated investigational new drug applications. The paradigms challenge the traditional notion that speed, and integrity are mutually exclusive and demonstrates that it is possible to significantly reduce timelines without compromising quality.
The Fast Lane and Fast Track IND paradigm was developed in response to demand from clients who wanted to accelerate and decrease their investigational new drug application timelines. The paradigms challenge the traditional notion that speed, and integrity are mutually exclusive and demonstrates that it is possible to significantly reduce timelines without compromising quality.”
Steven J. Bulera, CVP, Chief Scientific Officer, Safety Assessment
What are the Fast Lane and Fast Track investigation new drug paradigms?
Fast Lane is a single study reporting strategy that removes “white space” from the reporting timeline using a very disciplined approach to reporting milestone using dedicated staff and a partnership between Charles River and the clients in order to meet the aggressive IND milestones and the overall report timeline.
Fast Track is an approach for an entire IND program (PK studies, DRFs, and/or needed definitive GLP studies) where stage gate decisions are made using data rather than reports and sub-reports. Decisions are made quickly as the next study activities progress at risk (protocols/study plans written at risk, animals already ordered prior to dose selection being completed, etc.,). The paradigm is designed to remove “white space” between the studies of an IND program in order to accelerate and decrease the overall time it takes to complete the studies needed for an IND submission. The Fast Lane approach to individual studies can also be coupled with the Fast Track paradigm for even faster completion of the IND package.
How do the Fast Lane and Fast Track IND paradigms achieve unprecedented speed?
The Fast Lane and Fast Track IND paradigms achieve unprecedented speed by removing time from the process wherever possible, while still maintaining integrity and managing risk. This is done through extensive planning, coordination, and collaboration with clients.
One key element of the paradigms is the requirement that clients be fully committed to supporting the aggressive milestones and timelines. This means being responsive to requests for information and documentation, being willing to work closely with study personnel, and making decisions within the targeted time frame.
Another key element of the program is the use of efficient tools and processes. The Fast Lane and Fast Track IND team(s) use a variety of tools and processes to streamline the IND submission process, including electronic document management systems and automated workflows.
The Fast Lane and Fast Track IND paradigms have achieved impressive results, reducing the time taken to complete reports and an IND program by more than half. In numerous occasions, Fast Lane has reduced definitive IND reporting timelines from the standard 11 weeks (with peer review) to 32 business days. Additionally, in two cases an IND package timeline was decrease by approximately 56%.
The Fast Lane and Fast Track IND paradigms offer unique and innovative approach that helps accelerate drug development timelines. The program is achieving unprecedented speed by removing time from the process wherever possible, while still maintaining integrity, quality, and managing risk.
Contact us today to learn more about the Fast Lane and Fast Track IND paradigms and how we can help you accelerate your IND timelines.