For early-stage biotech companies, securing funding marks a critical transition point, but the real challenge lies in turning plans into action.
Ray Sison, Managing Partner at SCxCMC, who has worked with over 75 different clients since 2011, offers a practical framework for navigating the crucial first 90 days after funding, with a focus on initiating drug product development.
The Goal: Reaching Your First CDMO Kickoff Meeting
The primary objective in the first 90 days is to progress from planning to execution.
As Sison emphasizes, “Getting to the kickoff meeting with a qualified and capable CDMO as quickly as possible is the goal.” This meeting represents the true transition point from strategy to implementation, marking the moment when theoretical plans begin transforming into tangible progress.
The integrated development timeline (below) includes indicative costs.
Critical Components for Success
The journey to successful execution rests on three fundamental pillars: document refinement, team building, and partner agreements. “Moving from planning stages to execution requires finalizing key documents, such as the TPP and the Drug Product Development Strategy in order to update RFPs, proposals, and contracts that we need to put in place with CDMOs,” Sison explains.
Living Documents: The Blueprint for Success
Two key documents require immediate attention post-funding. The first is the Target Product Profile (TPP), which Sison argues is often overlooked: “The target product profile exercise is not formalized and done frequently enough at biotech companies. Even though it might be done early on, I think that we sort of calcify into a certain strategy and we don’t seem to come back and review it enough.”
The TPP should be developed through a collaborative effort involving all key disciplines. As Sison notes, “You need to have everybody sitting at the table to have a fulsome discussion on the target product profile. In other words, what each discipline requires from the drug product in its characteristics, description, or performance in order to meet the requirements for that discipline.”
The second crucial document is the Drug Product Development Strategy. This strategy must consider various factors, including technical complexity levels, budget constraints, exit strategy timeline, and regulatory pathway choices. Sison points out a particularly relevant consideration for modern drug development: “More oncology and gene and cell therapy drugs are being evaluated on a fast track. And that typically means you need a formulation that is more commercial ready than traditionally developed products.”
Building Your Team: From Founding to Scale
The transition from a small founding team to an organization capable of managing multiple CDMOs requires careful consideration of team structure and composition. Sison advises, “Know what you’re great at. Know where as an organization your gaps or your weaknesses lie. Know what functionalities need to be required to be in house and which ones would create more value if outsourced or delegated.”
When it comes to hiring, Sison emphasizes the importance of balancing specialists and generalists: “As a small company, it would be great if everybody could do everything. Yet somehow, especially I would recommend when you’re developing strategy, you probably want something higher level that has a good feel and the experience in early stage drug development.”
Strategic Budget Management: Finding the Right Balance
The relationship between strategy and budget requires careful navigation. As Sison succinctly puts it, “Does budget drive strategy or does strategy drive budget? Well, the answer is budget drives strategy until it doesn’t.” He explains that in drug product development, “you’ve got competing priorities from CMC, clinical, regulatory, and the business and the budget. And for those reasons, there’s a healthy friction among these different disciplines.”
Implementation and Ongoing Management
Successful implementation requires regular review cycles of key documents and strategies. “Monitor budgets on CDMOs frequently as programs evolve and strive to provide adequate resources to manage the CDMOs themselves,” Sison advises. He emphasizes that “drug product development is a team exercise” that requires careful attention to leadership, processes, communication, and governance.
The Path Forward
The journey from funding to execution requires careful attention to detail and strategic thinking. As Sison concludes, “Working with CDMOs will require a team of talented cross functional SMEs and support staff working together with the CDMO towards common goals and objectives.” The development strategy significantly impacts CMC budget and spending timing, making it crucial to maintain flexibility while ensuring alignment with investor commitments.
By following this framework, early-stage biotechs can create a solid foundation for executing their development plans and fulfilling their commitments to investors. The key lies in maintaining a balance between thorough preparation and swift action, ensuring that the momentum from successful fundraising translates into effective drug development progress.
Ray Sison will be chairing an Outsourcing Excellence roundtable on Continuous Manufacturing at CDMO Live 2025. Download the agenda here.
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