Paul Miller, Vice President, Business Development for Europe and Asia Pacific
As we near the midpoint of 2023, emerging biotech companies are facing an evolving clinical research and development landscape in which time and money are proving to be both scarce and critical. Cautious investors are focusing their resources on therapies for specific indications, and a precipitous drop in investment capital has biotech companies competing aggressively against one another for continued funding. What's more, the collapse of Silicon Valley Bank has resulted in continued vigilance from both investors and biotech leaders; forcing some companies to delay development timelines as they try to secure additional funding.
The resulting climate is tight, risk-averse, and leaves little margin for error — all of which demonstrates the need for a flexible, collaborative clinical research partner who can deliver high-quality data and achieve tight milestones. A proper clinical research partner can help mitigate risk and reduce timelines by getting it right the first time, eliminating the need (and expense) for multiple change orders, protocol changes, or revised enrollment targets.
Getting it right the first time: Importance of the right clinical research partner
With the flow of capital so constricted, biotech companies realistically have only one opportunity to develop and commercialize a drug successfully. It is incumbent upon them, therefore, to choose a clinical research partner who understands the sponsor’s goals and exit strategy, then uses that knowledge to build a plan that includes all elements needed to achieve the study’s milestones. Many biotech companies are keen to fast-track development, but most of them can only proceed at a pace that matches their present cash status. By choosing a clinical research partner with flexible operational and contract models, sponsors can be confident that their development strategy balances cash-on-hand with achievable study timelines.
Perhaps the most critical element of a successful clinical research partnership is for the partnership to be truly collaborative. Smaller biotech companies don't always feel as though they’re a priority for large contract research organizations (CROs), and many both crave and need individualized attention to execute their development goals successfully. With venture capital realities now dictating development timelines, it’s more important than ever for CROs to be flexible and creative, with a dedicated leadership team that looks for creative ways to best support the sponsor’s exit strategy and long-term goals.
For example, a skilled clinical research partner can drive the feasibility assessment and help build the optimal strategy to support the best protocol for Investigational New Drug (IND) applications, commencing with the trial only when green-lighted by regulators. This approach not only gives confidence to investors but also to sponsors, who can breathe a little easier with both financing and the initial regulatory hurdles behind them.
Flexibility in a CRO partner is critical to the feasibility of being funded
Another key consideration for choosing a clinical research partner is flexibility as a CRO must be able to change direction with as little red tape as possible. Changes in protocols, unforeseen errors, new sites in new countries, or any additional change in the trial must all be facilitated by the CRO smoothly and quickly, which underlines the need for ongoing collaboration, operational leadership, and the willingness to explore new models.
A flexible outsourcing model is one such increasingly attractive option for emerging or late-stage biotech companies. As more companies freeze headcounts and focus on lean, project-based operations, a flexible outsourcing model can help fill talent gaps strategically, without a long-term commitment or any additional overhead. By working with a provider to supply the right talent at the right time, biotech companies can reduce risk, reduce costs, and increase the chances of a successful study.
There’s no doubt that the current economic climate presents significant challenges for emerging biotech companies seeking to bring innovative therapies to market. The scarcity of investment capital and cautious investors have created a risk-averse environment that demands a flexible and collaborative approach to clinical research and development. Flexibility in both outsourcing models and clinical research partnerships is critical for biotech companies to reduce costs and increase the chances of success. By working with a partner who understands their goals and exit strategy, biotech companies can navigate this challenging landscape, continue their development of innovative therapies, and emerge stronger than ever.