A separate platform from the clinical decision support OS — built for the medicinal chemists, ASO designers, gene-editing scientists, regulatory specialists, and CMC leads who design and shepherd individually-tailored therapies through IND-track development.
Different users. Different regulatory posture. Different risk surface. Different sales motion. We chose to build the Studio as its own product — separate codebase, separate auth, separate revenue model — because the work it does is fundamentally different from clinical decision support.
Decision support for licensed clinicians at the chart. Genomic, lab, medication, wearable, and EHR signals — surfaced as evidence-linked recommendations for clinician review.
Therapy candidate design + IND-track development for ultra-rare and individually-variant disease cases. Specialist teams design ASO, CRISPR, mRNA, AAV, and protein-replacement candidates with named-specialist review at every gate.
Modality-agnostic core (case, safety, CMC, IRB/IND, monitoring) shared by modality-specific design modules. The same case can carry multiple candidate modalities under simultaneous review.
A single per-program record carrying patient context, variant, phenotype, prior treatments, candidate roster, document vault, and IRB/IND IDs. Phase tracking from intake through clinical monitoring.
Variant → mechanism mapping with evidence linkage (ClinVar, OMIM, GeneReviews, literature). Required-evidence gate before candidate design can be finalized.
Splice modulation, knockdown, steric blocker, uORF strategies. Chemistry selection (2'-MOE, cEt, LNA, PMO, PS/PO). Off-target, immunogenicity, and toxicity screens. Delivery + dose precedent linkage.
SpCas9, SaCas9, base editor, prime editor selection. Guide RNA candidates with on/off-target scoring. Edit outcome modeling, bystander risk, AAV/LNP/electroporation delivery planning.
Codon-optimized sequence design with UTR + cap selection, modified nucleoside choice, LNP composition, secretion signals, and dose-from-precedent estimation.
Cargo packaging, promoter selection, capsid choice, tissue-targeting evidence, manufacturing yield notes, immunogenicity precedent.
Cross-modality pre-IND screening: in-silico off-target panels, immunogenicity motifs, predicted toxicology endpoints, integrated tool outputs (BLAST, CRISPRme, etc.).
Manufacturing route selection, batch record templates, release-spec authoring, stability-program tracking. eCTD-friendly section content rather than free text.
Protocol authoring, consent tracking, IND module assembly, signed-document control. 21 CFR Part 11-style audit log from day one.
The boundary between clinical OS and Studio is enforced. Studio outputs do not appear in clinician-facing CDS workflows unless a structured publish event crosses the boundary.
The Studio is an enabler for qualified specialist teams. Every artifact is reviewed and signed by a named human; institutional review gates wet-lab, manufacturing, IND, and patient activity.
Every construct, delivery plan, dose, and protocol is a draft for named specialist review. The software does not autonomously synthesize, manufacture, dose, or administer therapy.
Version control, provenance, signature trails on every artifact. eCTD-friendly content, 21 CFR Part 11-style audit, IRB-aware from the first wireframe.
A shared core (case management, safety screens, CMC, IRB/IND, monitoring) supports modality-specific design modules. The same case can carry multiple candidate modalities under simultaneous review.
Workflow + artifact management surfaces are lowest-risk. Decision-support and ranking are mid-risk. Future regulated software claims have per-module pathways. Public claims today are scoped accordingly.
If you're a clinician practicing personalized medicine, the clinical OS is your surface. The Studio is for the people one layer behind the chart — the teams designing the therapies the chart will eventually monitor.
ASO design specialists
Gene-editing scientists (CRISPR / base / prime)
mRNA + protein-replacement designers
AAV / viral vector specialists
Translational pharmacologists
Regulatory affairs (IND, expanded access, IRB)
CMC + GMP manufacturing leads
Clinical pharmacologists + PIs
The Studio is in active build. We share the architecture brief, modality coverage, regulatory posture, and N-of-1 program partnership terms under NDA with academic medical centers, ultra-rare disease foundations, and small biotech sponsors.