Three Ways to Accelerate from Trial to Market

Clinical development success rates across the drug industry are becoming increasingly more difficult. According to Pharma Intelligence: Clinical Development Success Rates 2011-2020, only 52 percent of Phase I assets move to Phase 2. Without solid planning and execution, valuable resources can be wasted. And in a day and age of fewer investment dollars needing to go farther, it is incumbent upon the sponsor company to quantify risk and differentiate its assets, to accelerate the time from trial to market.

For companies who are pre-IND, speed to market and proof of principle are critical stages in their lifecycle. For some companies, the finish line is investor attraction, while for others it is probability of success that leads them to an exit strategy (possibly selling off their assets to a larger company, better equipped to take on the Phase 1 to 3 clinical studies).

There are three ways to create your successful pathway to market.

1. To move from pre-IND to IND, the sponsor company should de-risk itself with early onset planning to prepare for regulatory interactions. Selecting a partner with deeply rooted experience with FDA meetings and ability to aggregate data into a succinct Pre-IND meeting request and meeting package, thereby ensures meaningful FDA feedback. Engaging company leadership, attending in-depth development meetings, and providing directional leadership and technical expertise are key critical aspects of an end-to-end solution.
2. Another hurdle to master is the qualification of a Contract Research Organization (CRO). Not all CROs are created equal and nor do they come to the table inexpensively. Begin the process by identifying a select group of candidate CROs based on stringent performance criteria. Create a set of standardized specifications to enable direct comparisons and meticulously evaluate budgets, experience, data solutions, technology infrastructure, and other relevant factors. Understand the impacts of negotiating budgets and scopes to prevent future surprises, incorporating risk-sharing incentives and penalties where feasible.
3. Lastly, de-risk your data from the onset! As clinical development sponsor companies increasingly embrace technology, they engage numerous vendors and services, resulting in a complex data ecosystem. However, many lack clarity on data integrity requirements and regulations, jeopardizing their development programs. Statistics show five to 15 percent of Phase I studies fail due to data integrity issues. Data integrity violations are often flagged during audits or inspections, which may not lead to outright trial failure but can delay progression to subsequent phases or require remediation. Our advice: don’t let data integrity undermine the validity of the entire study and regulatory acceptance.

Hiring an end-to-end solutions consulting firm like Halloran offers sponsor companies advisory services that de-risk programs from planning to execution. Having access to a team of experts is critical to avoiding and resolving regulatory and data integrity issues. Our highly skilled consultants are well-versed in the regulatory process and have expertise in modality and therapeutic offerings which is often seen as an extension of your team.

If you want to learn more about our capabilities, contact us or check our additional Insights.