Scott Seibel Email and Phone Number

Made key contributions to identify CDX-0158 back-up. As part of a cross-functional team spanning 4 sites, working to characterize back-up antibodies in cell-based potency, agonist and binding assays that have generated high quality data which will be critical to the program’s decision-making process. In support of the CDX-0158 program, retrieved information from fragmented sources to reestablish the clinical plasma SCF pharmacodynamic biomarker assay. Significant improvements were made that enabled the complete evaluation of samples with improved reliability and reproducibility. During acquisition, several critical reagents for clinical PK and immunogenicity assays passed their expiration dates. As an experienced user of MSD technology and PK assay development, was charged with performing activity assays for quality control. Completed characterization of reagents and re-established protocol for KTN0158 human PK assay. All components were recertified, CoAs issued and as a result pK analysis of clinical samples continues at CRO. Similar reagent characterization was completed that allowed the CDX-3379 team to complete the PK and ADA analysis for the Phase 1 study. Characterization also provided stability and storage information

Supported CMC efforts for the KTN0158 Development Program by reformatting the KTN0158 potency assay to assess relative potency of drug substance and drug product for stability studies. Developed and qualified a quantitative (ECL) immunoassay method to measure phosphorylation of tyrosine residues in the cytoplasmic domain of human KIT after stimulation with the KIT ligand, SCF. With minor modifications, protocol was qualified and is in use at contract GMP testing lab.Performed troubleshooting, identified new reagents and established a revised protocol for the KTN0158 cynomolgus monkey and human PK assays for toxicology and human clinical trials. Wrote protocol and worked with CRO to assist validation and implementation of assay. Assay in use for analysis of clinical samples. Qualified and utilized assay to assess study samples and issued bioanalytical report for Covance Study 8316301.Contributed to preclinical data package supporting the KTN0158 program. Established protocol for differentiation of mouse mast cells from bone marrow, established growth conditions, flow cytometry and degranulation characterization. Contributed to efforts to identify an in-house anti-mouse KIT antibody for in vivo studies. Utilized ForteBio’s Blitz technology to evaluate protein binding properties of antibodies. Work supported a pending publication and a poster presentation at AACR 2016 that concluded inhibition of KIT in vivo modifies immune cell populations to improve the efficacy of checkpoint inhibitors in syngeneic mouse tumor models.Refined and performed studies with KTN3379, Cetuximab and combination on seven head and neck cell lines(SCCHN) including proliferation assays, flow cytometry evaluation for presence of ErbB1-4, ELISA based secretion assay for detecting presence of Nrg1 and western blot analysis for presence of phospho/total ErbB1-4 and down-stream signaling proteins. These studies resulted in a pending publication and a poster presentation at AACR 2015.

Member of core team responsible for directing research on Gram(-) specific antibacterial program. Responsible for the oversight, direction, resourcing and performance of project related efficacy, pK/pD and safety related in vivo research.Coordinate resources necessary to accomplish project specific studiesWorked actively at bench 80% of work week.Collaborate with Microbiology, Chemistry, Toxicology, PDM & PharmSci to accomplish team goals needed to progress to Phase IIn a collaborative effort brought a difficult and project critical radioactive receptor-ligand assay on board for the project team.Authored and presented macrolide work as a poster at 2009 ICAAC

Independently lead the in vivo pharmacology assessment of a biologic in-licensing opportunity. Involved the development of novel efficacy models of Gram (+) infection. Managed relationships with offsite researchers so that collaborations were conducted seamlessly allowing for the on time achievement of project goals.Successfully developed a novel rat respiratory infection model with H. influenza exhibiting robust growth over 72 hours. The ability of this model to evaluate several relevant tissue compartments for CFU burden and drug concentrations provides a better pharmacokinetic /pharmacodynamic understanding and aids in the prediction of antimicrobial efficacy against pulmonary infections in humans. The model was used to successfully evaluate a novel Phase I macrolide against 3 macrolide standards of care.Produced project critical in vitro/in vivo toxicity and in vivo efficacy data package providing the project team with the information necessary to reach a stand down decision on a long standing program Provided in vivo efficacy & in vitro toxicity data to multiple project teams contributing to progression of program milestones

Developed, executed and analyzed acute interarticular cytokine induced canine osteoarthritis model. Provided novel model for assessment of mmp inihitors.Supported establishment, execution and analysis of chronic interarticular and surgical menisectomy models of OA Studied effects of nonspecific mmp inhibitors in canine in vitro cartilage degradation assay.

Completed work for publication and patents associated with Rimadyl and its competitors and associated licensing opportunitiesSupervision of cell-based Canine Cox ½ assay system.Development/execution of canine in vitro cartilage degradation assayEvaluated therapeutic index of p38 series in canine Cox ex vivo modelReestablishment of FACS based assay for CD11-b up regulationCo-development of Cox ½ databases. Co-development of Canine whole blood ex vivo Cox ½ assay systemsNegotiated for and facilitated design of laboratory space and coordinated efforts in group move in 2000 and 2002

Canine Cox ½ asssays established Rimadyl’s favorable selectivity allowing the business unit to move forward marketing the productCo-development of Canine whole blood in vitro Cox ½ assay system.Development of Cell-based Canine Cyclooxygenase ½ assay systems.Study of evolution of multiple drug resistance in livestock pathogens.

Characterization of Bicyclomycin Resistant E. coli mutants.Development of 7 secondary antimicrobial screens and databases.Maintenance of 8 aerobic/4 anaerobic antibacterial screens and databases providing SAR data for multiple project progression strategies.Established communications with chemistry dept. for SAR discussions.Completion of Serpulina hyodysenteriae high through put screen.