DT-168
Design Therapeutics
IND filed and cleared with no preclinical inquiries raised, on a construct class with no established regulatory precedent.
Regulatory record
Submissions that clear, and the discipline behind them.
Anticipating what a reviewer will ask before they ask it is not a stylistic preference. It is the difference between a filing that proceeds and one that returns with questions attached to a timeline.
The record
Filings, submissions, and agency interaction
DYNE-251
Dyne Therapeutics
IND cleared for a dystrophin-targeted antibody-oligonucleotide conjugate, supported by a nonclinical package completed to program timeline.
4 LDT reports
Pfizer
Lab-developed-test reports submitted to the FDA as IND amendments supporting phase 1b oncology trials.
INDs, NDAs, IBs
Sarepta Therapeutics
Nonclinical sections prepared across investigational and new drug applications and investigator brochures.
Global inquiries
Sarepta Therapeutics
Authored and reviewed responses to health-authority questions across jurisdictions, defending safety positions directly.
Agency representation
Multiple
Represented preclinical safety in regulatory interactions without intermediaries or external consultants.
Why it matters
A preclinical inquiry is a timeline, not a question.
For a development-stage company, an IND that returns with preclinical questions costs months and burns runway that was allocated to clinical work. The cost is rarely the science; it is usually a submission that did not answer the question a reviewer was always going to ask.
Two INDs — DT-168 and DYNE-251 — cleared under Marc's authorship, the first on a construct class with no regulatory precedent to draw on.
Program ledger
Every named compound
DYNE-251
Dystrophin-targeted conjugate. Completed the nonclinical package substantiating safety on the program's timeline.
IND cleared
DT-168
Novel trinucleotide-repeat-binding construct with no established regulatory precedent to draw on.
IND cleared — no preclinical inquiries
DT-216
Held safety and pharmacology accountability across the preclinical portfolio.
Safety & pharmacology owned
SRP-1001
Study strategy and endpoint selection through to data interpretation and internal risk position.
Nonclinical safety owned
SRP-1003
Run in parallel with AAV work, requiring separate toxicology judgement per modality.
Nonclinical safety owned
SRP-9010
Authored the preclinical safety content underpinning the program's regulatory progression.
Regulatory advancement supported
STX-001
One of four candidates on a lipid-nanoparticle mRNA platform.
IND documentation authored
STX-003
Design choices matched to both the scientific question and regulatory expectation.
GLP & non-GLP program delivered
STX-004
Platform-level safety agenda rather than candidate-by-candidate response.
GLP & non-GLP program delivered
STX-005
Submissions kept to schedule across the candidate set.
GLP & non-GLP program delivered
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