Developing a life science asset from early discovery through clinical development to commercialization requires a clear clinical and regulatory strategy, adequate funding, relentless rigor, and most of all, an experienced and dedicated team. It is the people who drive progress, and it is the people that investors consider the most in their decision-making. Though this concept may sound dated, when leaders miss this core tenant, they may struggle to acquire the funding they need to meet their milestones to achieve clinical development success, and, as a result, they may risk seeing their progress dwindle.
This important takeaway was also echoed during the MassBio State of Possible event and shared during the panel, “Science Moment: Rewriting What is Possible.” The panel discussed what enabled their success even in this choppy fundraising environment. Panelist Abe Ceesay, CEO of Rapport Therapeutics, noted, “Investors follow teams. If your team has a great track record, investors will take note and follow you. There must be a balance between great science and great teams.”
We cannot agree more. Life science development companies must ensure they have the right people with the right expertise across key functional areas to ensure their success. Otherwise, they will be left with talent gaps that have significant consequences, including a lack of progress that may result in reduced funding opportunities and other downstream impacts.
But what does the right expertise look like across an organization? In this article, we highlight a few leadership examples that showcase the value and importance of these key players to enable successful outcomes, creating a positive track record for future investments.
Successfully Moving from Clinical Development to BLA Through Strategic Advising
There are many circumstances that make or break clinical development success. Considering all the potential roadblocks, a small biotechnology company focused on immuno-oncology approached Halloran requesting a Development Program Manager to assist in their first Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA).
In this example, the company had lost its Development Program Manager, cycled through multiple Vice Presidents of Regulatory Affairs, and very few team members held that critical BLA experience. Considering their personnel gaps, the company was poorly aligned, lacked proper planning, had insufficient executive support, requirements, and expectations were unclear, lacked resources, and their choice of technology did not enable them to achieve their internal goals.
Halloran engaged the company by addressing the infrastructure challenges that prevented them from meeting submission goals. Halloran stepped in as the Development Program Manager and pivoted in essential ways. Halloran identified the following issues, and then worked efficiently to find appropriate solutions:
Once Halloran fixed these challenges, the company’s efficient and organized infrastructure propelled them to a successful filing of their BLA with the FDA. This model became the gold standard for future development candidates in their portfolio.
Enhancing Efficiencies and Reducing Risk with Clinical Development Leadership
A small biotech developing an innovative therapy needed to retain a clinical trial leader as they launched their multi-center trial sites. The company experienced two cycles of leadership turnover, resulting in lagging strategy and operations. They needed to immediately hire an expert to drive progress forward, while they mindfully sought their full-time replacement.
The company faced a tight timeline, minimal resources, and numerous inefficiencies. They chose to work with Halloran because of our expertise and ability to jump into operations and quickly get up to speed. They needed to slow down and focus on finding the right replacement, knowing an expert could stabilize and enhance their clinical operations and infrastructure to meet their next development milestone.
Halloran provided the company with a step-by-step approach:
As the short-term engagement ended, the client’s operations improved and noted enhanced and streamlined processes to propel the clinical trial strategy and observed better internal and external relationships with sites and vendors. While their clinical development program was back on track, their leadership had the time and space to find the right full-time replacement without rushing or risking their trial.
Though there are many other examples to offer, these two come to mind because our team enabled progress for these companies to further drive clinical development success.
Positive Impact of Collective Leadership Progress
When a company leader hires the right functional leaders, the collective progress and momentum builds and continues to have a lasting positive impact on the company. As we’ve seen with investor behavior, the long-tail impact of that progress can be significant.
If you have leadership and expertise gaps in any of your functional areas – clinical, quality, regulatory, and data and technology – please examine the pitfalls of those gaps and don’t delay these critical discussions. Halloran is here to support your goals and guide you through the intricate journey of bringing your product to market with confidence and strategic foresight. We understand the importance of a team and the significant impact that the right team can have on a company’s success.