RES' QSP modeling helped Solid Biosciences in determining and justifying the dosage leading to the FDA approval of the IND application for Solid Biosciences' SGT-003, a gene therapy for Duchenne Muscular Dystrophy. November 14, 2023. https://lnkd.in/gGa78pmb
RES Group, Inc
生物技术研究
Needham，Massachusetts 289 位关注者
Mechanistic modeling & simulation services to accelerate R&D in drug development
关于我们
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.
- 网站
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https://resgroupinc.com/
RES Group, Inc的外部链接
- 所属行业
- 生物技术研究
- 规模
- 11-50 人
- 总部
- Needham，Massachusetts
- 类型
- 私人持股
- 创立
- 2003
- 领域
- Mechanistic Quantitative Systems Pharmacology (QSP) Modeling、MIDD (Model Informed Drug Development)、FIH (First-in-Human) Dosing、IND (Investigational New Drug) Support、Physiologically-Based Pharmacokinetic (PBPK) Models、Gene Therapy Models、Immuno-Oncology Models、Protein Degrader Models、Lysosomal Disorder Models、Hematological Toxicity Models、Disease-Progression Models和Antibody-Drug Conjugates Models
地点
RES Group, Inc员工
动态
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RES' QSP modeling helped Takeda determine the dosage leading to FDA approval of Takeda’s ADZYNMA (ADAMTS13, recombinant-krhn), the first and only FDA-approved recombinant protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme. November 9, 2023 https://lnkd.in/gfssCYP2
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The following RES' works were cited in a white paper on regulatory QSP submissions to the U.S. FDA report by Bai et al., 2024: ???????????????? ?? (?????????????? ??????????????) - ????? ?????? ?????????? ?????? ???????????????? ???? ?????????????? ?????????????? ?????????????? ?????????????????????? ???? ?????????????? ????? ??????????????????'?? ?????????????????????????? ???? ???????????? ??????????????'?? ???????????? ???? ???????????????? ????????????????. ????? ?????????????? ???????????????? ???????? ?????????????? ??????? ????? ????????? ?????? ???????????????? ???? ?????????? ???? ????? ?????????????????????????? ???? ???????????????? ?? ??????????????????????????????? (????) ?????? ???????????????? ?????????????? ???????????????? ???????????????????? ?????????? ?????? ???????????????? ?????? ???????????????????? ???????????? (??????) ????????????. ?????????????????? ?????????? ?????? ???????????????????? ???????????? (??????) ???????????? ????????????????? ?????????????????????????? ?????????????? ???????????? ???????? ???????? ???? ????? ???????????????? ?????? ???????????????????? ???????????? ???????????????????? ???????????????? ???????????????????????? ???????????? ????? ?????????????????? ????????. ????????????????????????, ?????????????? ?????????????? ?????????????????????? ???????? ???????????????? ???? ?? ???????????? ???????????????????? ???????? ???? ???????????????? ????? ?????????????????? ???????????? ????????. ????????? ?????????????????????? ???????? ???????????????? ???? ?????????? ????????????? ???????????????????? ???????????????? ?????? ????? ???????????????????? ???? ???????????????? ??, ?????????????????????????? ????? ???????????????? ????????????????????????. ? In addition, RES' papers on Gaucher's disease and another on Nieman-Pick disease are also referenced in this whitepaper. Bai JPF, Liu G, Zhao M, et al. Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report. CPT Pharmacometrics Syst Pharmacol. 2024;13:2102-2110. doi:10.1002/psp4.13208 https://lnkd.in/gGX5y9UE
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Join RES Group at ACoP 2024 – Booth 30 and Poster W0920! We're excited to invite you to visit us at Booth 30 during ACoP 2024! Our team will be showcasing our latest advancements in mechanistic QSP modeling and regulatory support services. Poster Presentation: Don’t miss our poster session on Wednesday, where we’ll dive into "Incorporating Computational Fluid Dynamic Modeling into Pharmacometrics Models for Applications in Gene Therapy, Anti-Inflammatory Treatments, and Transdermal Patch Drug Delivery" (Poster W-0920). We look forward to connecting and exploring new collaborations! RES Team
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RES Group members contributed to Chapter 4 - Quantitative Systems Pharmacology Modeling of Adeno-Associated Virus Gene Therapies: Mechanistic Identification of Species-Translation Using Preclinical and Clinical Data. https://lnkd.in/gkyJUWDu
?? ???The big day is finally here! Development of Gene Therapies: Strategic, Scientific, Regulatory, and Access Considerations is now available. This book was years in the making, and has chapters from a broad array of thought leaders across industry and academia. Table of Contents, contributor list, and index is attached, and you can find physical copies and the e-book from the publisher here: https://lnkd.in/gMHVSH2a Alex Sverdlov Jeff Palmer Sury Somanathan Page Bouchard Deepa Chand Francis Tukov Mark Milton Satya Rao Cynthia J. (CJ) Musante Nessy Tania Petra Kaufmann, MD Amanda Haidet-Phillips, Ph.D Mimi C. Lee MDPhD Matthew Meriggioli Akos Herzeg Tippi MacKenzie Scott Galasinski Hannah Bare Erik Barton Aili Cheng Seoan Huh, PhD Vanessa D'Souza Arun Balaji Hans-Juergen Fuelle Reena Kartha Paul Orchard Nayla Mumneh, MD John Shoffner, MD, FACMG Iulian Alecu Mohamed Hassanein Kelly Fader, PhD Jessica LeClair David Beidler Kasem S Akhras
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If you are attending #ASGCT come by our booth anytime (2050) or our poster on Friday where we demonstrate how mathematical modeling can test, in silico, various infusion conditions for optimum gene therapy targeting in the parenchyma.