Grant Support Services

Translating complex AI/ML biomarker science into compelling, fundable grant applications for academic and clinical researchers.

NIH R01/R21 Support

Active

End-to-end strategic development of Specific Aims, Research Strategy, and Innovation sections. We align your AI/ML biomarker hypotheses with current NIH study section priorities.

Rare Disease Foundation Grants

Active

Tailored grant writing for specific patient advocacy groups and rare disease foundations. We excel at translating complex multi-omic science into compelling patient-impact narratives.

Biostatistical Plan Development

Active

Rigorous statistical methodology sections including sample size justification, power calculations, and advanced ML validation protocols required by stringent review panels.

FDA Biomarker Qualification

Active

Strategic alignment of early-stage research grants with long-term FDA Biomarker Qualification Program (BQP) requirements, ensuring data collected today supports regulatory submission tomorrow.

Grant-Ready Biostatistics Checklist

NIH study sections penalise vague analytical plans. Our team ensures your proposal meets the highest standards of statistical rigour before submission.

Study Design

  • OKClear delineation between discovery and validation cohorts
  • OKJustification of multi-omic platform selection (e.g., RNA-seq vs targeted proteomics)
  • OKMitigation strategies for batch effects in multi-center retrospective data

Power & Sample Size

  • OKSimulation-based power calculations for high-dimensional ML feature selection
  • OKFDR (False Discovery Rate) control methodology clearly stated
  • OKAttrition rate estimates included for longitudinal endpoints

Analytical Rigour

  • OKPre-specified handling of missing data (e.g., multiple imputation)
  • OKCross-validation strategy (k-fold, leave-one-out) explicitly detailed
  • OKIndependent hold-out test set secured and sequestered
Timeline

Key Milestones

Platform development, patent activity, STTR submissions, and validation milestones from the source program roadmap.

May 2026
KIF7-CilioPanel™ PPA Filed · MCGEN-002-PROV
US Provisional Patent Application covering the 11-gene tiered panel, BFD Module, and JCiloScore™ ML composite. Patent Pending.
May 31, 2026
SarcoActivity™ PPA Filed · US 63/078,909 ✅
US Provisional Patent Application covering 7 components and 16 claims for the race-calibrated sarcoidosis monitoring platform. Filed as micro entity. Patent Pending.
September 5, 2026
NIH STTR Phase I Submissions
SarcoActivity™ STTR (NHLBI + NIMHD, $299,800) with Prof. Sweiss / UIC STAR Center. KIF7-CilioPanel™ STTR (NICHD, $300,000) with KAU Jeddah.
May 31, 2027
NPPA + PCT International Filings
Non-Provisional Patent Applications + PCT designating US, EPO, Japan, India, China, Canada, Saudi Arabia (GCC) for both platforms.
2027–2028
Platform Validation and Pharma CDx Partnerships
STAR Center registry validation (SarcoActivity™); KAU + Indian cohort validation (KIF7-CilioPanel™); first pharma Letter of Intent (aTyr Pharma, Ultragenyx, Ionis Pharmaceuticals).