The drug development process is a long and winding road with opportunities and pitfalls alike. Drug developers navigating their compound’s preclinical testing, clinical trials and manufacturing are frequently under pressure to progress more efficiently and meet tight timelines. Additionally, when one step unexpectedly falters, the impacts are far-reaching across the planned development process.
Drug development can feel like a relay race at times, and if companies don’t coordinate each handoff precisely, they can fall behind. As companies make hypothetical strides around the track, they are always searching for ways to carefully compress and coordinate timelines to hit key financial and regulatory benchmarks.
Here are six ways drug development teams can keep programs on track and even accelerate the process.
Define goals before entering preclinical work
When beginning the preclinical phase, it is common to work with up to 10,000 compounds, which can be overwhelming and lead to distractions. Committing to a more detailed approach and keeping goals in mind with every decision can help teams gain momentum and stay laser-focused from the start. Setting goals and expectations at the program’s onset is critical to streamlining the process and advancing to first-in-human (FIH) trials.
Developers must set long-term goals to avoid unknowingly creating limitations, like insufficiently saving and archiving data that may not seem relevant at the time. The long-term application of data is central to successful drug development programs. Focusing solely on the task at hand, at whatever stage of the process, can keep a team from understanding how the new data will impact the next step. Every preclinical insight must be well documented to leverage results during other studies or clinical trials.
To ensure alignment, define and communicate goals with teams and partners. Having clear-cut goals in terms of regulatory pathways and target populations sets the stage for the rest of the development process, and any ambiguity can result in excess work and budget variances.
Consider dual filing early
If a company is considering entering additional markets shortly after commercialization and manufacturing, explore dual filing as an option. Although it might seem overwhelming to factor in multiple regions’ regulatory requirements, dual filing offers many efficiencies.
Submitting a global Investigational New Drug (IND) package to the U.S. Food and Drug Administration can minimize the need to conduct repeat studies, enable faster expansion into foreign markets and broaden the investigation of multi-ethnic populations. To capitalize on these benefits, companies should make this decision at the onset of a program. This choice allows laboratories to plan studies in adherence to the global Good Laboratory Practices (GLPs) and follow relevant regulatory body requirements. Beyond study conduct, each regulatory body has different reporting and archival standards. Recognizing and preparing for these differences can reduce the number of additional follow-ups and requests for information during or after submissions.
Focus on study preparation
Proving the safety and efficacy of a drug requires numerous studies, which are critical to capturing the data necessary for supporting an IND application. However, the value of the resulting data is contingent on the proper study set up. Often, laboratories cannot adjust study parameters after the fact, and any mid-study shifting could lead to retesting or data loss. Thorough planning is essential.
Companies should begin their planning and study program by running the test article through pre-formulation. This step focuses on selecting the right drug substance, excipients and packaging material for product development to ensure data demonstrates the materials’ stability under varied conditions. The next step is securing all necessary supplies, such as reagents or test systems for upcoming evaluations. A laboratory testing partner typically completes this portion of the preparation. It’s crucial to ensure that partners can meet these criteria without delays.
Because a study is only as strong as its documentation, drug developers must proactively identify the reporting and format needs for IND applications. For example, each regulatory body has different in vivo testing requirements. Accommodating the applicable reporting standards will help ensure that applications provide enough detail to justify each study during submission.
At this stage, development teams should document their findings and share this background information with their team and any testing partners. It can also be helpful to define descriptive terms and peer review requirements before beginning a study.
Study preparation establishes a foundation for studies, working relationships and the overall chance of a compound’s success. Meticulous study preparation can propel a program forward — or stop it in its tracks.
Identify key reporting criteria
Developing thorough reports is essential to minimizing delays and ensuring all the correct components are available when filing a submission. Reviewers will expect thoughtful and comprehensive reporting, so being aware and up to date on the latest requirements is essential. Here are a few key reporting components to consider:
Monitor schedules: Clearly define all timelines and ensure all parties are working towards the same deadline. If there are any changes to the submission schedule, communicate them immediately.
Scientist reports: When working with multiple laboratory testing partners, there may be varying approaches to documentation that should be synchronized. Companies may also consider submitting a Q&A statement with all contributing scientist reports.
Define descriptive terms: When reporting materials, minimize all ambiguity by defining all necessary terms, such as clinical signs and pathology.
Peer review requirements: Ensure that any peer review requirements are factored into the study timeline to avoid surprise setbacks when preparing the final reports.
SEND compliance: If submitting data to the FDA, companies must ensure their formatting complies with the Standard for Exchange of Nonclinical Data (SEND) procedures. Laboratory testing partners should be well versed in compiling SEND data packages, but it’s essential to inquire about their expertise in this area.
Pick the right partner
Kicking off the drug development process might feel overwhelming, but a laboratory testing partner can support and even serve as an extension of the team. A committed and reliable testing partner can keep a program on track by offering companies access to specialized methodologies, equipment and dedicated personnel. Additionally, leveraging a laboratory testing partner can introduce a third-party into the mix and eliminate the assumption of any bias in the studies and results.
However, testing partners can operate in highly unique ways. Before selecting a laboratory, be sure to ask the right questions and determine their competencies. Companies should investigate the laboratory testing partner’s familiarity with each region’s different expectations when considering global applications and their access to testing systems.
If a development team is spread thin, consider finding a laboratory testing partner that can provide the full spectrum of support, including translation services, regulatory planning/strategy, dossier preparation, communications with regulatory agencies and submissions on your behalf. Allowing a laboratory testing partner to focus on these details can free up your staff to handle other pressing items. Companies that take time identifying a laboratory that fits their program’s unique needs set themselves up for successful partnerships and IND applications.
Meet with regulators
Developers can reduce testing errors and ensure clear requirements by scheduling a pre-submission meeting with governing officials. These meetings can help identify what is important to each regulatory body when developing applications, potentially saving time by reducing regulatory feedback and the possibility of retesting. With the ever-changing regulatory guidelines, a pre-submission meeting can keep a program on track and allow teams to adapt to new expectations early on.
To get the most value out of these meetings, come prepared with specific questions that pertain to the compound’s intended testing plan. Including a testing partner in the conversation can help developers who want increased clarity on testing parameters and potential issues. Partners can help guide a compound and adjust plans based on regulators’ feedback.
Successfully completing the relay
The drug development process is complex, and each step in the process requires preparation, attention and expertise. Proactivity and proper planning can help minimize the risk of delays during handoffs and even accelerate the drug development process.
When a team broadens its perspective, invests in planning, remains curious and leans on the right partnerships, it can more seamlessly reach key benchmarks and move toward a medical solution.
