RES Group, Inc

RES Group Inc, an MIT spin-off and a pioneer in QSP (Quantitative Systems Pharmacology) modeling since 2001, is dedicated to accelerating and de-risking drug development. Utilizing mechanistic QSP modeling, we offer a range of services including First-in-Human (FIH) dose projections for IND applications, toxicity projections for regulatory submissions, and support for early-stage drug development. With a track record of successfully collaborating on over 100 new drug developments, we have earned the trust of biotech and pharmaceutical companies alike, as demonstrated by the following examples: Our MIDD (Model Informed Drug Development) approach for Takeda’s application for ultra-rare blood clotting disorder was recently approved by FDA: November 9, 2023 Takeda’s ADZYNMA (ADAMTS13, recombinant-krhn) Approved by U.S. FDA as the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP). Our human dose projection was recently accepted in the IND clearance in treating Duchenne muscular dystrophy: November 14, 2023 Solid Biosciences Announces IND Clearance by FDA for Duchenne Muscular Dystrophy Gene Therapy Candidate SGT-003.