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My Expertise

Cell & Gene Therapy Development

With >12 years of deep expertise and understanding of the latest cell and gene therapy advancements (1-5), I can help your team innovate forward in these areas:

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  • CAR-T cell therapy 

  • Gene therapy 

  • Oncolytic virotherapy

  • Genetic engineering (CRISPR & TALEs)

  • LVV/AAV vector systems 

  • Preclinical & IND-enabling study design

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CAR-T Cell Manufacturing & CMC strategy

Not sure how to convert your small-scale cell manufacturing process into a clinic-ready process? I was there once and in 2020, I worked closely with my academic partners and the FDA to perfect a new CAR-T cell manufacturing process for people living for HIV (3). Leaning in to those early challenges, my goal is to position your CMC strategy and CAR-T cell manufacturing process for a successful launch into clinical trials.

Fractional Leadership

The Fractional Consulting model allows companies to access high-level expertise without the overhead costs associated with permanent hires. Particularly in the biotech sector, where speed and adaptability are crucial, fractional consultants can fill gaps in knowledge, drive strategic initiatives, and help navigate the intricate landscape of CGT discovery, clinical trials and regulatory processes. As an experienced Fractional Director, I apply my high-performance mindset coupled with proven CGT expertise to help organizations advance their CGT pipelines to the clinic.

Biotech & Clinical Trial Startup

Whether it's launching a new cell and gene therapy startup or establishing multiple clinical trial sites in the US with your CRO partners, let's work together to accelerate your organization goals through high-performance consulting & fractional leadership. 

My Approach

My Track Record

I turn bold ideas into tangible successes

© 2025 by Kim Gonda, Ph.D. 

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