Navigating the Investigational New Drug (IND) submission process for your drug development program can be a complex process, especially when filing with various regulatory agencies and pursuing multiple markets. However, dual, or globally filing an IND package can open doors for drug developers if done correctly and proactively.
Knowing what it takes to file globally, regulatory details to consider, and some of the challenges can help fast track your program to first in human trials. Drug developers that discover how to effectively navigate this process have an avenue toward cost efficiencies, condensed timelines, access to larger markets and more.
Thinking of Filing Globally?
Many developers opt to file IND packages globally because required studies can overlap amongst agencies, reducing the number of necessary studies and ultimately saving money and time. For instance, when filing with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), it’s possible to conduct studies that fulfill both agencies’ requirements, rather than running studies twice.
Drug developers looking to file IND packages to multiple regulatory bodies must first decide in which markets they want to initiate clinical work. This decision process must materialize before IND-enabling studies begin in order to tailor the studies to specific requirement differences between agencies. If this choice is delayed, changing program parameters can be costly or not entirely possible.
Whether you conduct preclinical testing in-house or with an outsourced laboratory testing partner, ensuring that the right expertise is at the table is crucial to any submission. Once a developer decides which markets and agencies to pursue, enlisting the right partner is vital to work through the necessary GLP testing and IND submission. To understand the complexity of the task at hand, start by identifying gaps between submission requirements.
Regulatory Details for a Global Reach
While dual filing reduces the number of studies due to the overlap in requirements, there are critical differences between agencies. These differences need to be assessed and accounted for during timeline formulation, budgeting and study design.
Attention to detail is essential when pursuing global submissions. Differences in regulatory requirements could seem minor but are still imperative to the success of the submission, such as providing specifics on gender representation and reproductive toxicology studies. Having a team of qualified regulatory experts and a well-versed laboratory testing partner is helpful during this planning stage. For example, your partner can identify unique reporting formats or tabulation elements, such as Electronic Common Technical Document or eCTD tables.
Typically, dual filing requires more testing systems and studies to fulfill requirements than what is generally needed when submitting to a single agency. When looking for requirement contrasts between countries of submission, pay attention to terminology, necessary personnel, study design and reporting. Developers need to identify these variations and plan for the investment to ensure a successful submission.
Common Pitfalls and Keys to Success
The most common challenges for drug developers pursuing global IND submissions typically revolve around insufficient planning. Acting too late on initiating your global IND submission can leave you vulnerable to rushed timelines, gaps in expertise and miscalculated regulatory requirements. Overlooked details, no matter how small, can greatly affect the acceptability of an application.
Too often, companies decide to file globally after initiating key studies. This approach can make it difficult and costly to reassess the palpability of dual filing at this stage in the process. For instance, suppose that a laboratory has started a significant toxicology study. The decision is then made to file with another governing body that requires distinct variances in testing system representation. In this case, the laboratory will have to conduct this study twice in order to meet the requirements set forth by the second regulatory agency. Duplicating studies is costly, inefficient and can lead to delays in the submission process.
Many drug developers find that globally filing IND packages is cost-effective and saves valuable time and resources. When considering if a global submission is right for your drug development program, ensure that you understand the process, the regulatory requirements and challenges to plan for or avoid. Gain insights from your laboratory testing partner’s expertise and inquire about how they would effectively take your program to the global stage.
Established in December 2000, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 4,100 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated”.