Services
Bringing a gene or cell therapy to patients takes more than great science - it requires clear strategy, sound analytics, and steady guidance through development milestones.
At Brenna Consulting, I help teams navigate AAV, lentiviral vector, and other delivery programs with pragmatic, tailored support in CMC, analytics, manufacturing, and regulatory planning - so you can focus on advancing therapies that matter.
Smart Development Strategies
Gene delivery is never one-size-fits-all. Choosing the right system and development path can make the difference between a smooth regulatory submission and costly delays.
I help teams refine their approach to AAV, lentiviral, or other delivery platforms - aligning vector design, development plans, and regulatory expectations from the start. With a virology background, I bring scientific insight that keeps programs on track and tailored to their goals.
Analytics That Work
Robust, phase-appropriate analytics are essential to understand your vector and satisfy regulators. I work with teams to design assays, troubleshoot methods, and build analytical strategies that generate the right data at the right time.
For organizations that need leadership without expanding headcount, I can step in as a fractional Head of Analytics - bringing decision-making, coordination, and a clear roadmap forward.
Manufacturing & Regulatory Guidance
For small or virtual teams outsourcing viral vector manufacturing, critical details can easily slip through the cracks. I provide oversight during tech transfer and CDMO engagement, making sure deliverables meet specifications, timelines stay realistic, and challenges are addressed early.
I also support regulatory submissions by reviewing or drafting CMC sections for INDs and BLAs, ensuring alignment with your data and strategy. When needed, I can act as a fractional Head of CMC, keeping manufacturing, analytics, and regulatory workstreams moving in sync.
Getting in Touch
Have a question or want to explore working together?