Becky

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AspireBio provided us with the Regulatory CMC support we needed to get our gene therapy IND over the finish line with the FDA. We are a small start-up working on an ultra-rare disease that needs fit-for-purpose solutions that strike the right balance between Regulatory guidance and what makes sense for an ultra-rare indication.  Aspire Bio helped us develop creative solutions that meet guidelines without making over the top commitments. We have always felt that the Aspire Bio consultants are fully embedded on our teams and work down in the trenches with us, helping us to design creative solutions to ultra-rare gene therapy problems.