Gene therapy CMC and analytics consulting

Delivering better viral vector for gene and cell therapy patients.

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Services

Solutions tailored to the unique challenges of gene and cell therapy products.

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Executive Leadership, Strategy & Vector Design

  • Viral vs. non-viral gene delivery strategy

  • Vector system selection (AAV, lentiviral or other platforms)

  • Early-phase gene therapy development planning

  • Support for bespoke and rare-disease therapy programs, including patient foundations

  • Fractional Head of CMC or Analytics for gene therapy programs

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  • Design of analytical strategy roadmap for viral vector development

  • Assay design, optimization & troubleshooting

  • Phase-appropriate analytical strategies for AAV and lentiviral vectors

  • Support for analytical method transfer to CDMOs or internal teams

Viral Vector Analytics

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  • Tech transfer oversight for viral vector manufacturing

  • CDMO project management & troubleshooting

  • Regulatory submission support (review/drafting of technical sections) for gene therapy CMC

  • Alignment of manufacturing, analytics and regulatory efforts

  • Fractional Head of CMC for gene therapy programs

Manufacturing & Regulatory Support

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  • First-in-human viral vector drug products

  • In vivo and ex vivo CAR-T therapeutics

  • Executive leadership of a multi-million dollar program, including analytical strategy design and launch of governance & decision-making framework

  • Expert witness in viral vector intellectual property disputes

Example Projects

Scientist performing gene therapy analytics

Why work with Brenna Consulting?

Developing a gene or cell therapy means navigating complex science and high-stakes decisions. I help teams find clarity at those critical points - bringing the perspective of a Harvard-trained virologist with over 15 years experience in viral vector development.

My background includes senior leadership in biopharma, where I guided programs in AAV and lentiviral vector analytics and process development. Now, I work directly with teams to shape strategies that are practical, scientifically sound, and built to move programs smoothly toward IND and beyond.

At every stage, my focus is the same: to offer clear, tailored solutions that strengthen your science, reduce risk, and help promising therapies reach patients faster.

Getting in Touch

Have a question or want to explore working together?