Dallas Hughes, Ph.D., President
Dr. Hughes has over 30 years of experience in preclinical research and development, microbiology, and drug discovery. His experience in natural products has resulted in the discovery and preclinical development of several novel drug candidates. Prior to joining NovoBiotic Dr. Hughes was a Sr. V.P. at Cetek Pharmaceuticals.
Aaron Peoples, M.S., M.B.A., Director of Chemistry
Mr. Peoples joined NovoBiotic after his graduate work at the University of Wisconsin–Madison, where he studied protein folding by synthesizing small peptidic model systems. His background in advanced NMR techniques and analytical separations are vital to the drug discovery process within the company. Mr. Peoples also has an extensive background in natural product isolation and characterization.
Kim Lewis, Ph.D., Co-founder
Dr. Lewis is a specialist in multi-drug resistance and drug discovery. He is University Distinguished Professor of Biology and Director of Antimicrobial Discovery Center at Northeastern University. Dr. Lewis is the co-inventor of the method for growing unculturable bacteria that forms the core of NovoBiotic's intellectual property.
Losee Ling, Ph.D., V.P. of Research & Dev.
Dr. Ling has extensive experience in pathogen genetics, microbiology, and screening for novel antimicrobial agents. She has led multi-disciplinary teams from assay development to lead optimization, screening both synthetic small molecules and natural products. Prior to NovoBiotic Dr. Ling was at Genome Therapeutics, Waltham, MA for over 10 years.
Amy Spoering, Ph.D., Director of Biological Research
Dr. Spoering is responsible for the development and evaluation of new methodologies and technologies at NovoBiotic Pharmaceuticals. She also supervises the fermentation facility including the production of teixobactin for research purposes. Her doctoral research investigated the molecular mechanisms of bacterial tolerance to antibiotics.
Slava Epstein, Ph.D., Co-founder
Dr. Epstein is a specialist in environmental microbiology. He is Professor of Biology at Northeastern University. Together with Dr. Lewis, Dr. Epstein co-invented the method to grow unculturable microorganisms. Dr. Epstein developed innovative methods for enumeration of marine microorganisms, their in situ study and their molecular diversity.
Robert J. McCormack, Ph.D., Creative Regulatory Solutions, LLC, Regulatory Consultant. Dr. McCormack has over 30 years in the pharmaceutical sector, and has gained a detailed understanding of drug development, which is substantiated by various positions he has held in the disciplines of nonclinical and clinical research, regulatory affairs and quality assurance. As Vice President of Regulatory Affairs and Quality Assurance at Cubist Pharmaceuticals, Dr. McCormack was responsible for establishing a cross-functional, team-oriented infrastructure in the Clinical, Regulatory, Nonclinical, Manufacturing and Quality Assurance and Control Departments. He acted as primary liaison with FDA/HPB on all issues of strategic importance related to the development of anti-infective compounds. He is providing strategic planning for teixobactin in the areas of nonclinical, clinical, and CMC development, FDA meetings, and IND filings.
Prabu Nambiar, Ph.D., M.B.A., R.A.C., Syner-G Pharma Consulting, LLC, CMC Consultant. Dr. Nambiar has over 25 years of industry experience including last 20 years in CMC Regulatory Sciences. His extensive CMC experience includes resolution of complex CMC/Quality and Compliance issues (regulatory starting materials, genotox impurities, specifications, QbD implementation, PAI responses) using science and risk-based approaches and leading NDA/Regulatory Teams. He has held previous positions as Vice President of Regulatory Affairs CMC at Vertex Pharmaceuticals and Senior Director, CMC Regulatory Affairs at Cubist Pharmaceuticals. He has led the filing and approval of 11 NDAs, numerous sNDAs, INDs and international filings. Dr. Nambiar and the Syner-G team is overseeing CMC management for teixobactin.
Carole Sable, M.D., CA Sable Consulting, LLC, Clinical Consultant. Dr. Sable is a widely-recognized expert in clinical development, having advanced multiple compounds from pre-IND through global regulatory approvals and commercialization. As Chief Medical Officer at Synexis, she designed the clinical development program for SCY-078, a novel antifungal compound. This included authoring a formal development plan for the program, designing the Phase 2 studies, and playing an instrumental role in the company’s IPO. As Chief Medical Officer at Novexel SA and President, Novexel, Inc. (US Subsidiary), Dr. Sable successfully advanced two antibacterial programs from IND filing through Phase IIb trials: ceftazidime avibactam (CAZ/NXL104) in complicated intra-abdominal infections and complicated urinary tract infections, and NXL103 in acute bacterial skin and skin structure infections. Both compounds were acquired by Astra-Zeneca. She provides clinical development advice for teixobactin as it advances through development.
Jules Selden, V.M.D., Ph.D., PreClin Strategies, LLC, Toxicology Consultant. Dr. Selden has over 37 years of experience spanning from preclinical development in rodents to regulatory affairs. He provides comprehensive safety assessment evaluation of candidate molecules from IND/CTA-enabling to NDA submission as well as drug metabolism and pharmacokinetics. Dr. Selden’s industrial experience includes Merck, Sepracor (now Sunovion), Microbia (now Ironwood), Luitpold, and Idenix. He is providing guidance on the preclinical toxicology assessment of teixobactin.
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