Accelerating Biotech Success: Early-Stage Development Strategies to Secure Funding
New rules and strategies for emerging biotech and pharma to secure funding for tailored early-stage solutions.
The biotech landscape is demanding a more integrated approach to early-stage asset development. In an era where clinical data and a compelling commercial story are non-negotiable, companies need strategies that not only accelerate development but also resonate with investors and stakeholders. These strategies require a unique approach that bridges the gap between science and commercialization to deliver tailored early-stage solutions.
A recent Financial Times-hosted biotech roundtable in Palo Alto underscores a critical shift in funding dynamics. Gone are the days, says Matthew Krenicki, Senior Director of New Offering Development at Syneos Health, when a promising scientific or clinical concept could secure millions in funding.
Today’s investors have a new set of rules:
- Assets with validated clinical outcomes attract more funding than those in preclinical stages.
- A compelling commercial narrative, aligned with market needs, de-risks investment decisions.
- Venture capitalists are increasingly selective, favoring companies with a well-articulated plan for market access and profitability.
For early stage biotechs, this means integrating commercial strategy early to avoid fundraising roadblocks and maximize asset value.
Combine Clinical, Medical and Commercial for a Fully Integrated Strategy
Addressing challenges with a fully integrated model that combines clinical, medical and commercial expertise is key to unlock the full potential of biotech assets, explains Andy Tincu, Vice President of Solutions Development at Syneos Health. Some areas of focus to make this possible, include:
- Asset Direction and Viability: Early-stage decisions can set the tone for long-term success. Biotechs that prioritize indications by evaluating patient population size, competitive landscapes, and medical feasibility help identify “where to play,” ensuring resources are directed toward the most promising opportunities.
- Commercial Target Product Profile (TPP) Development: Differentiating a product in a crowded market requires precise positioning. By engaging stakeholders, including healthcare providers and payers, companies can refine the TPP to align with market and/or stakeholder needs, emphasizing safety, efficacy and HCP/patient adoption potential. “This validation ensures a strong foundation for downstream development,” says Vik Chawla, Managing Consulting Director at Syneos Health.
- Market Access and Payer Strategy: Navigating payer landscapes is one of the biggest hurdles for early stage biotechs. By evaluating formulary dynamics, reimbursement trends and competitive pricing to craft strategies it is possible to optimize payer engagement and accelerate market access. This approach strengthens investor confidence by addressing commercialization risks head-on.
- Sizing Market Opportunity and Scenario Planning: Understanding the size and dynamics of your target market is critical for crafting a winning strategy. Scenario planning helps biotechs anticipate a range of possible outcomes, such as shifts in competitive landscapes, regulatory changes, or variations in adoption rates. By leveraging predictive modeling and data-driven insights, companies can make informed decisions and remain agile in a constantly evolving market. This ensures resources are allocated effectively while maximizing potential ROI.
- Customized Development Roadmaps: To streamline the path to market, it is important to develop detailed roadmaps outlining activities, timelines and costs from preclinical stages through launch. These plans provide companies with clarity on financial and operational milestones, helping them secure funding and maintain momentum.
What are the new rules to obtain seed round funding?
Exemplified by a recent engagement with a preclinical biotech company preparing for a seed round, following these new rules and recommendations makes success possible. Key outcomes included:
- The most viable indication was identified through a structured evaluation of clinical feasibility, market dynamics and stakeholder feedback. This approach ensured prioritization of the indication with the highest likelihood of clinical success and commercial viability.
- Integrated insights from HCPs and payers helped optimize the TPP and refine the value proposition.
- A step-by-step plan with financial projections helped the company secure funding and align stakeholders was delivered.
- Insight that selecting indications with clear commercial viability leads to greater focus.
- A clearly defined market opportunity that makes partnerships possible.
- Investors rewarded the company based on their disciplined use of capital.
The result? A well-articulated commercialization strategy that enabled successful fundraising and enhanced corporate valuation. By addressing gaps, early-stage biotechs can align their science with market realities, enhancing their appeal to investors and strategic partners.
In today’s biotech landscape, a compelling commercialization strategy is as important as strong science. Integrated solutions provide the expertise and tools necessary for early stage biotechs to maximize asset value and secure funding. For companies navigating the complexities of asset development, combining clinical insights with commercial strategy is key to unlocking success.
Explore how Syneos Health's integrated clinical, medical and commercial expertise can accelerate your journey from lab to life. Learn more about our tailored solutions for early-stage asset development and commercialization.
Contributors
Andy Tincu | Vice President, Solutions Development
Matthew Krenicki | Senior Director, New Offering Development
Vik Chawla | Managing Director, Consulting