Sriram Sriram Gunda
Staff Fellow Clinical Pharmacology Reviewer @FDA
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WORK HISTORY
Staff Fellow Clinical Pharmacology Reviewer @FDA
EDUCATION
University of Missouri-Kansas City
Ph.D., Pharmaceutical Sciences
SKILLS
ABOUT SRIRAM SRIRAM GUNDA
Experience in clinical pharmacology and clinical Pharmacokinetics:OCP/CDER/FDA- clinical pharmacology review of INDs, BLAs and NDAs.Pharma/CRO- clinpharm lead, study PK team management, budgets, timelines, CRO/external contractor identification and selection-protocol design, SAP development, hands-on NCA & pop-pk analysis in phoenix and nonmem, TLFs, authorship in CSRs, IBs, IND packages, M2 and M5, review of PMRs/PREA/iPSPs, and review bio-analytical methods and reports-experience leading phase-1 SAD/MAD, FE, TQT, hepatic and renal impairment studies, DDIs, 505(b)(2)s, biosimilars, BE studies etc-hands-on PK M&S experience (beginner-intermediate level)- experience working with small and large molecules-experience collaborating with CROs and consultants for PK/PD, clinpharm, pop-pk modeling & bioanalytical work-designed and led cross-over, parallel, replicated, adaptive, single and multiple sequence designs-provided technical input in FIH, POC, RP2D and EOP2 dose selection-communication skills- scientific and regulatory writing, inter-department/client presentations-products-oral solids, liquids, IV bolus/infusion, IM, ocular, dermal/topical, inhalations etc, including complex products.Skill set-PK: NCA, Cmpt modeling, pop-pk modeling and simulations-PD: Emax, indirect models-Dosing simulations/prediction-BE analysis, convolution/deconvolution and IVIVC analysis-BootstrappingWorkshops and Courses-phoenix certifications in pop-pk-Population Modeling with Phoenix NLME and Connect” at ACoP 2011-New and Advanced features of NONMEM 7 and PDx-POP 4” at ACoP 2011-Metrum\'s MI210-IS: Essentials of Population PK-PD Modeling & Simulation-classes in metrics at UMBSoftware-Phoenix WinNonlin & NLME-R & NONMEM(PDx-POP/pirana)- beginner to intermediate level proficiency;Research in Ph.D-PK, drug transporters, prodrugs, microdialysis/animal models, in vitro/ex-vivo drug transport, & bioanalytical.
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