Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate).

Autor: Baran SW; Emerging Technologies, Novartis Institutes for BioMedical Research, Cambridge, MA, USA., Brown PC; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Silver Spring, MD, USA., Baudy AR; ADME & Discovery Toxicology, Merck & Co., Inc., Kenilworth, NJ, USA., Fitzpatrick SC; U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of the Center Director, College Park, MD, USA., Frantz C; Translational Sciences, Seagen, Seattle, WA, USA., Fullerton A; Safety Assessment, Genentech, South San Francisco, CA, USA., Gan J; Pharmaceutical Candidate Optimization, Bristol-Myers Squibb Research and Development, Princeton, NJ, USA., Hardwick RN; Translational Safety Sciences, Theravance Biopharma US, Inc., South San Francisco, CA, USA., Hillgren KM; Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA., Kopec AK; Drug Safety Research & Development, Pfizer, Inc., Groton, CT, USA., Liras JL; Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc., Cambridge, MA, USA., Mendrick DL; U.S. Food and Drug Administration, National Center for Toxicological Research, Office of the Center Director, Silver Spring, MD, USA., Nagao R; Translational Sciences, Seagen, Seattle, WA, USA., Proctor WR; Safety Assessment, Genentech, South San Francisco, CA, USA., Ramsden D; Global Drug Metabolism and Pharmacokinetics, Takeda Pharmaceuticals International Co., Cambridge, MA, USA., Ribeiro AJS; U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, Division of Applied Regulatory Science, Silver Spring, MD, USA., Stresser D; Drug Metabolism, Pharmacokinetics and Bioanalysis, AbbVie, Inc., North Chicago, IL, USA., Sung KE; U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Tissues and Advanced Therapies, Division of Cellular and Gene Therapies, Silver Spring, MD, USA., Sura R; Global Preclinical Safety, AbbVie Inc., North Chicago, IL, USA., Tetsuka K; Analysis & Pharmacokinetics Research Labs., Astellas Pharma Inc., Tsukuba-shi, Ibaraki, Japan., Tomlinson L; Global Pathology, DSRD, Pfizer WRD, Cambridge, MA, USA., Van Vleet T; AbbVie, Inc., Chicago, IL, USA., Wagoner MP; Drug Safety Research & Evaluation, Takeda Pharmaceuticals International Co., Cambridge, MA, USA., Wang Q; Drug Safety Research & Evaluation, Takeda Pharmaceuticals International Co., Cambridge, MA, USA., Arslan SY; BioAnalysis, Applied Research Management & Biomedical Science (AMS), Astellas Pharma Inc., Northbrook, IL, USA., Yoder G; Aimmune (Nestlé Health Sciences), Brisbane, CA, USA., Ekert JE; In Vitro In Vivo Translation, Research, Pharmaceutical R&D, GlaxoSmithKline, Collegeville, PA, USA.

Publikováno v: ALTEX [ALTEX] 2022; Vol. 39 (2), pp. 297–314. Date of Electronic Publication: 2022 Jan 21.

mTORC1-Dependent Metabolic Reprogramming Underlies Escape from Glycolysis Addiction in Cancer Cells.

Autor: Pusapati RV; Department of Discovery Oncology, Genentech Inc, South San Francisco, CA 94080, USA., Daemen A; Department of Bioinformatics and Computational Biology, Genentech Inc, South San Francisco, CA 94080, USA., Wilson C; Department of Discovery Oncology, Genentech Inc, South San Francisco, CA 94080, USA., Sandoval W; Department of Protein Chemistry, Genentech Inc, South San Francisco, CA 94080, USA., Gao M; Department of Translational Oncology, Genentech Inc, South San Francisco, CA 94080, USA., Haley B; Department of Molecular Biology, Genentech Inc, South San Francisco, CA 94080, USA., Baudy AR; Department of Biomedical Imaging, Genentech Inc, South San Francisco, CA 94080, USA., Hatzivassiliou G; Department of Translational Oncology, Genentech Inc, South San Francisco, CA 94080, USA., Evangelista M; Department of Discovery Oncology, Genentech Inc, South San Francisco, CA 94080, USA. Electronic address: evangelista.marie@gene.com., Settleman J; Department of Discovery Oncology, Genentech Inc, South San Francisco, CA 94080, USA. Electronic address: settleman@calicolabs.com.

Publikováno v: Cancer cell [Cancer Cell] 2016 Apr 11; Vol. 29 (4), pp. 548-562. Date of Electronic Publication: 2016 Mar 24.

The power of FDG-PET to detect treatment effects is increased by glucose correction using a Michaelis constant.

Autor: Williams SP; Department of Biomedical Imaging, Genentech, Inc,, 1 DNA Way, South San Francisco, CA, 94080, USA. williams.simon@gene.com., Flores-Mercado JE, Baudy AR, Port RE, Bengtsson T

Publikováno v: EJNMMI research [EJNMMI Res] 2012 Jun 27; Vol. 2 (1), pp. 35. Date of Electronic Publication: 2012 Jun 27.

Restoring dystrophin expression in duchenne muscular dystrophy muscle progress in exon skipping and stop codon read through.

Autor: Hoffman EP; Research Center for Genetic Medicine, Children’s National Medical Center, 111 Michigan Ave NW, Washington, DC 20010, USA. ehoffman@cnmcresearch.org, Bronson A, Levin AA, Takeda S, Yokota T, Baudy AR, Connor EM

Publikováno v: The American journal of pathology [Am J Pathol] 2011 Jul; Vol. 179 (1), pp. 12-22. Date of Electronic Publication: 2011 May 23.

A robust in vitro screening assay to identify NF-kappaB inhibitors for inflammatory muscle diseases.

Autor: Baudy AR; Research Center for Genetic Medicine, Children's National Medical Center, Washington, DC 20010, USA., Saxena N, Gordish H, Hoffman EP, Nagaraju K

Publikováno v: International immunopharmacology [Int Immunopharmacol] 2009 Sep; Vol. 9 (10), pp. 1209-14. Date of Electronic Publication: 2009 Jul 21.