Case Study I: Nimble and Cost-Effective Path to IND

Situation: A start-up, backed by a major research University and seasoned Board of Directors, was developing a first-in-class immune-oncology drug for patients with few existing treatment options. Unfortunately, the firm they had hired to prepare their FDA filing failed to assemble a package fit for review. This misstep was costly and time-consuming for the company. After securing Series-A funding, the company was at a critical juncture. A second failed attempt was not an option. The company turned to Spannerwerks.

Insight: Early-stage companies need an expert team to prepare for the IND filing. When the company is a start-up and has not yet hired the right talent, a consulting partner with proven expertise makes the difference.

Solution: We provided a team that flexed up and down, right-sizing expertise cost-effectively. Along with establishing the central project management capabilities to orchestrate pre-filing activities, Spannerwerks brought interim leadership to oversee technology transfer, contract manufacturing, and clinical operations. We also provided writers experienced in cell and gene therapies to restructure and simplify the IND application. While the team included the expertise of 8 people, the cost to the company was comparable to 2-3 full-time hires. Spannerwerks economically delivered experience and capabilities that are too costly for an early-stage company to hire and provided a depth and breadth of expertise that other consulting firms do not have.

Results: Spannerwerks completed the FDA filing in 9 months, including GMP tech transfer and final clinical protocol. It won approval without requiring re-work or schedule delays. The company achieved a successful validation of their ground-breaking therapy with their Series-A funding. They did not need to make expensive hires prematurely and could focus on the science while Spannerwerks concentrated on getting to IND.