Know FDA expectations for your CGT program.
Your partner from INTERACT to IND.
Move phase to phase knowing what to expect.
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Pressure-test your INTERACT package.
Surface the questions and deficiencies the FDA is likely to raise at your earliest formal meeting — before you submit.
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Reviewed against FDA expectations.
Every package is reviewed by former CBER reviewers against current precedent and review posture for your product type.
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Build toward IND with confidence.
A clear read on CMC, pharmacology/toxicology, and clinical readiness — and the specific gaps to close before you file.
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Position for expedited programs.
RMAT, Breakthrough Therapy, and Fast Track strategy, with the evidence package that holds up the claim.
Johnny Lam, PhD
Nearly 12 years at FDA’s CBER with a focus on cell & gene therapy. Johnny reviewed 300+ submissions across INTERACT, IND, and Master Files, served on the Tissue Reference Group, and was policy lead on FDA guidances including Potency Assurance for Cellular and Gene Therapy Products.
Head of Regulatory Strategy at Deffai · former FDA CMC reviewer and Director for Policy.
More ways we help CGT teams.
Frequently asked
What product types do you cover?
Cell therapies, gene therapies, and other regenerative medicine products regulated by CBER’s Office of Therapeutic Products — including 351 HCT/Ps and combination products.
Which FDA interactions do you support?
INTERACT, Pre-IND, and IND submissions, plus expedited-program requests — RMAT, Breakthrough Therapy, and Fast Track.
Who is this built for?
Cell and gene therapy sponsors and their CMC, regulatory, and clinical teams preparing for FDA meetings and submissions.
Who built it?
Former FDA reviewers — including a former CBER CMC reviewer and Director for Policy with nearly 12 years of cell & gene therapy experience.
Do you use our data to train AI?
No. We never train AI on your data, and we don’t allow third parties, including foundation models, to either. Read more about security.