“I think outcomes for a lot of people means meeting milestones. So hitting that next clinical milestone, CMC milestone, et cetera, and that’s, I think, one way of looking at it. Still, it’s also about the culmination of outcomes and achieving something greater than bringing together one discipline and one win.” ~ Adriana Valenciano, SVP, SSI Strategy
In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Adriana Valenciano discuss building an outcome-driven biotech company. The conversation focuses on three key themes: planning for globalization from the earliest stages of development, taking a multidisciplinary approach to defining milestones, and ensuring your team has the right skills at each growth stage.
Key Takeaways
- The importance of planning for global markets, not just focusing on the US (5:14)
- Strategic considerations when deciding which markets to prioritize (6:14)
- The advantages of taking a parallel global strategy approach (7:31)
- Why biotechs should build in flexibility for pivoting regulatory strategies (10:17)
- Tips for setting up global success early on (10:45)
- The downsides of siloed, function-specific milestones (11:43)
- Ways leaders can facilitate cross-disciplinary collaboration (13:17)
- An example of a company pivoting its strategy after regulatory feedback (14:45)
- The agility required when strategies change unexpectedly (16:52)
- Ensuring your team has the skills to handle changing milestones (18:31)
- Sourcing talent with multidisciplinary biotech experience (20:56)
Building an Outcomes-Driven Biotech
Achieving specific goals and milestones in biotech is crucial for organizations to thrive. This intentional results-oriented approach forms the foundational principle of being outcomes-driven. As Adriana explains, these outcomes go beyond clinical and CMC milestones; they encompass achieving regulatory buy-in, creating a straightforward patient-focused story, and ultimately moving the organization forward.
Planning for Global Success: A Multidimensional Approach
Regarding global success in the biotech industry, traditional paths may not always be the most efficient. While the default for many US-based companies is to run clinical trials in the US and seek FDA approval first, exploring other regions and countries as part of a global strategy can yield significant advantages.
Adriana highlights Canada’s excellent centers and patient populations as a strategic platform for specific disease areas. Moreover, Europe may favor companies targeting pediatrics due to different regulatory requirements. Understanding the global regulatory landscape and what regulators prioritize in different regions is essential for successful international expansion.
A parallel development approach can also be advantageous, such as having a leader and a follower or running programs in parallel. In addition, economic benefits and reimbursement incentives in other parts of the world can support biotech organizations with limited funding. By considering these factors and taking a global approach, companies can accelerate their drug development process and increase efficiency.
Break Silos With A Multidisciplinary Approach
The biotech industry is composed of multifaceted challenges that demand a multidisciplinary approach. It is not enough for individual functions to address their own problems and milestones independently; cross-disciplinary collaboration is essential.
In smaller organizations, there is often a high level of connectivity and collaboration across disciplines. However, it is essential to remember that cross-discipline collaboration doesn’t automatically account for organizational-wide planning. Influential leaders ensure that disciplines work together and collaborate seamlessly, allowing the team to build alternative strategies and adapt to new goals.
Adriana shares an example of a biotech company that had to reevaluate their strategy and bring the team together due to regulatory feedback. By involving different functions and data management, the team made necessary adjustments and successfully pivoted their approach. Motivation, collaboration, and good leadership were critical factors in adapting to new goals and adjusting plans.
The Power of Flexibility and Agility
Variables outside a biotech company’s control, such as regulators, payers, feedback from the medical community, patients, and investors, can significantly impact outcomes and milestones. A balance between defining critical outcomes and key milestones while allowing flexibility and agility is crucial to navigating these uncertainties.
Adriana emphasizes that outcomes and milestones must be clear enough to rally the team and enable future iterations and adaptation. The ability to pivot and adjust strategy is paramount for success in the biotech industry, especially when considering complex regulatory landscapes, securing funding, and responding to changes in the market.
Looking Ahead for the Biotech Industry
Despite the challenges the biotech industry faces, there is cause for optimism. Improved funding opportunities, increased interest from investors, and alternative sources of capital have enhanced the landscape for emerging biotech companies. Moreover, the development of innovative therapies continues to address unmet medical needs, offering hope for improved patient outcomes.
As we conclude this episode, I thank our guest, Adriana Valenciano, for sharing valuable insights on building an outcomes-driven biotech. Defining intentional goals, embracing a multidisciplinary approach, and staying agile in response to change is essential for success.
Join us in our next episode as we continue exploring captivating topics in the dynamic world of biotech.
Until then, keep pushing the boundaries of innovation and maximizing the value of your therapeutics.
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