Christopher Sorge

Prepared scientific regulatory documents, including protocols, clinical study reports (CSRs), pharmacometric reports, biopharmaceutic summaries, clinical pharmacology summaries, and response documents for submission to global health authorities (HAs) Coordinated regulatory documentation activities, including kick-off and comment resolution meetings, interactions with contributing authors, formatting & editing, and documentation management

•Performed noncompartmental (NCA) pharmacokinetic (PK) analyses and provided clinical interpretation for Phase I & II clinical studies, communicated results and guided interdepartmental project teams & clinicians •Prepared detail-oriented and well-organized text, tables & figures to clinical study reports (CSRs), Investigator’s Brochures (IBs), internal memorandums & presentations, and journal manuscripts (MSS) •Provided PK sections to the successful regulatory submissions of suvorexant (orexin receptor antagonist for the treatment of insomnia) and vorapaxar (thrombin receptor antagonist for reducing atherothrombotic events) •Provided modeling & simulation support (Simcyp & NONMEM) for drug-drug interactions and dose ranging & selection studies •Prepared Programming Requirement Specification files for data merging & SAS Transport Files for regulatory submissions of CSRs & PK/PD modeling reports •Provided quality control (QC) review and remediation support to NONMEM datasets & control files, internal presentations, CSRs, and MSS •Participated in functional development initiatives for clinical data storage & regulatory submissions, and professional connectivity & team building

•Performed PK analyses supporting pre-clinical drug development, including cross-species dose-ranging & ADME, formulation, and human AME studies •Designed protocols and study plans, scheduled & managed internal and contract studies, and authored the final, technical study reports and updated IBs •Initiated and managed external studies with contract research organizations (CROs), including test article supply, sample analyses, and facilities inspections •Communicated PK results, discussion & study observations and supported cross-functional drug-development teams to achieve project milestones •Provided dose and sparse-sampling selection analyses for Toxicology, formulation support for Pharmaceutical Sciences, and stability of radiolabel testing for Radiochemistry

•Performed pharmacokinetic analyses supporting drug discovery & development, communicated results and guided interdepartmental project teams •Participated in the discovery and pre-clinical development of lidorestat (IDD-676), an aldose reductase inhibitor for the treatment of diabetic neuropathy •Conducted in vivo & in vitro DMPK studies in support of drug discovery, including rodent AME, microsomal metabolism, protein binding, and Caco-2 partitioning •Designed and performed Phase I & II microsomal metabolism assays, including enzyme induction & kinetics, reaction phenotyping, and drug-drug interaction •Designed and performed physical chemistry assays, including drug solubility, octanol-water partitioning, and aggregation liability

•Conducted in vivo & in vitro DMPK studies in support of drug discovery, communicated results and guided interdepartmental project teams •Screened & identified metabolic liabilities in discovery drug candidates •Prepared & phenotyped human liver microsomes for metabolism studies

Worked as a laboratory technician in various laboratories including: Basic Biology Teaching Laboratory under Charles E. Smith, PhD; Biochemical Pharmacology Research Laboratories under Drs. Gerda & Jack Klingman, PhD and Robert Hruska, PhD, and Pharmaceutical Sciences Research Laboratories under George B. Corcoran, PhD and Marilyn E. Morris, PhD.