The UNTHSC Pre-Clinical Services group conducts fixed-term contract services for the evaluation of antibacterial agents, including established models of both acute and chronic bacterial infections in several different animal species. In addition, pharmacokinetic studies and bioanalytical analysis are performed in-house in multiple species for submitted compounds. Infection models or protocols other than those currently performed and detailed at our website, may also be established and adapted as required to meet the more specific needs of interested sponsors:• Establish and perform contract services for the evaluation of antibacterial agents, including existing models of both acute and chronic bacterial infections in multiple animal species, develop and validate new in vivo models for specific therapeutic area, pharmacokinetic studies, bioanalytical support and pharmacodynamics for external pharmaceutical companies, biotechs and academic institutions in the US and worldwide.• Support sponsor’s research and development activities as required for the evaluation of proprietary molecules through consultation, guidance, presentations and publications.• Responsible for the overall planning and conduct of non-clinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice.• Design and write protocols, conduct and coordinate research studies for Sponsors in accordance with the United States Food and Drug Administration (FDA) Good Laboratory Practice (GLP) Regulations, 21 Code of Federal Regulations Part 58.• Write, review and implement Standard Operating Procedures (SOPs) for the conduct of GLP studies.

• Responsible for directing all in vivo evaluations through animal model development as well as pharmacokinetic / pharmacodynamic testing and analysis of novel compounds in all medicinal chemistry projects from discovery through and including pre-clinical. models, pharmacokinetics / pharmacodynamics and toxicology.• Project leader for biofilm anti-bacterial discovery and development program (including in vivo model development of device related infections).• Direct pre-clinical development, toxicology and safety pharmacology evaluation including outsourcing of IND enabling studies: in vitro and in vivo.• CRO and Phase I facility visits and evaluation for site selection of pre-clinical and clinical studies. Coordinate Phase I pharmacokinetic sample analysis.• Preparation of: pre-IND briefing documents and materials; efficacy and pharmacokinetic sections of IND submission, Toxicology and Safety Pharmacology IND edit / review.

• Responsible for in vivo bacterial and viral efficacy models for all infectious disease discovery programs.• Direct pharmacokinetic studies of antibiotics and antiviral compounds for structure / activity relationships, dose scaling and lead selection.• Coordinate studies with outside investigators and laboratories for evaluation of compounds in animal infection, efficacy models and pharmacokinetics.• Supervise in vitro discovery bacterial evaluations and antiviral screeninggroups performing enzyme and cell based assays.• Initiate and establish pharmacodynamic determinations for lead antibiotics.• Collaborate with clinical, commercial and marketing groups to advance discovery projects into pre-development and development.• Establish working relationship and coordinate test procedures with Drug Metabolism and Drug Safety groups for bacterial and viral programs.• Biology team leader for novel β-lactamase inhibitor discovery and pre-development team.

• Performed in vitro evaluations on new penems and other novel antibiotics for antibacterial activity determinations against a broad spectrum of bacteria and testing conditions.• Worked extensively with anaerobic organisms, identification and susceptibility test procedures.• Participated in a world-wide clinical isolate program to determine emerging resistance patterns as related to aminoglycoside antibiotic usage.• Performed procedure using high-pressure liquid chromatography to identify aminoglycoside modifying enzymes in bacterial cell extracts.• Worked extensively with in vivo test procedures for determination of antibiotic efficacy and toxicity in mice and rats.• Antifungal research involving a variety of infections and in vivo protocols in the mouse, hamster and guinea pig.