Dr. Dudley has over 30 years of experience in anti-infective R&D and commercialization. In 2018, he led the Series A financing for Qpex and acquisition of the preclinical programs from The Medicines Company. He has overseen R&D and regulatory approval of multiple anti-infectives, including most recently vaborbactam that progressed from discovery to FDA approval in < 8 years. He was CSO of Rempex when it was acquired by the Medicines Company (MDCO), where he remained as co-leader of the Infectious Disease Business Unit. He has lead negotiations for multiple public-private partnerships (e.g., BARDA; Innovative Medicines Initiative) for over $190 million to advance the development of antimicrobial agents in the US and Europe. Before Rempex/MDCO, he held leadership positions of increasing responsibility at Mpex, Diversa, and Microcide. Prior to his career in industry, he held academic appointments at the University of Rhode Island College of Pharmacy and Brown University School of Medicine. He has published over 140 scientific papers/book chapters on the evaluation and clinical use of antiinfectives. He completed undergraduate work at Pepperdine University, his PharmD and residency from the University of California San Francisco (UCSF), and a fellowship in infectious diseases at Hartford Hospital.
Michael Dudley, PharmD
Jeff Loutit, MBChB
Chief Medical Officer
Dr. Loutit is responsible for global clinical development, and medical and regulatory affairs. Dr Loutit has 19 years of experience in anti-infective and pulmonary drug development. Prior to Qpex, he was Chief Medical Officer at Mpex, Rempex, and The Medicines Company where he was responsible for the global Phase 1 through 3 clinical development and post-approval studies in the US and/or Europe of inhaled levofloxacin, oritavancin, intravenous minocycline, and meropenem-vaborbactam. Prior to working at these companies, he held positions of increasing responsibility at Intermune overseeing the global clinical development of oritavancin and pirfenidone. He received his medical training at Otago University in New Zealand and completed his Residency in Internal Medicine at Cleveland Metropolitan General Hospital. Following a year as Chief Resident, he completed an Infectious Disease Fellowship at Stanford University, and then joined Infectious Disease faculty at Stanford and was Chief of Infectious Disease at the Palo Alto VA Hospital. During this time he was Director of the Infectious Disease Fellowship training program and Assistant Director of the Internal Medicine training program.
Dr. Lomovskaya has over 25 years of experience in antibiotic R&D as a world-recognized expert in the field of antimicrobial resistance. Her industry career started at Microcide where she pioneered the field of understanding multi-drug resistant efflux pumps and potential therapeutic use of inhibitors. At Mpex, she oversaw key microbiology studies for Quinsair (inhaled levofloxacin) approval in cystic fibrosis. Following Mpex, she joined Rempex (later acquired by The Medicines Company) and led the efforts to discover novel beta-lactamase inhibitors and oversaw critical microbiology studies that supported the development and regulatory approval of Vabomere (meropenem-vaborbactam). Dr. Lomovskaya is an inventor on over 20 patents and patent applications, authored over 50 original papers, review articles and book chapters. In 2018 Dr. Lomovskaya was elected as a fellow of American Academy of Microbiology. She received her Ph.D. in molecular genetics from the Institute of Molecular Genetics, Russian Academy of Sciences and her M.S. in molecular biology from Moscow State University, with post-doctoral research appointments at MIT, Cal Tech and Stanford.
Senior Vice President,
Discovery and Clinical Microbiology
Olga Lomovskaya, PhD
Mr. Griffith brings over 25 years of experience in drug discovery and development and led the teams responsible for non-clinical/clinical pharmacology, toxicology and CMC that supported multiple INDs/IMPDs and resulted in regulatory approvals for Quinsair (inhaled levofloxacin for cystic fibrosis), Minocin IV (new formulation), and Vabomere (meropenem-vaborbactam) at Mpex and Rempex/The Medicines Company. Mr. Griffith has extensive experience in the determination and application of pharmacokinetics and pharmacodynamics (PK/PD) of antibacterial agents from discovery through drug approval. Prior to Mpex, Mr. Griffith held positions of increasing responsibility in clinical and non-clinical pharmacology and drug product/formulation development and manufacturing at CovX, and Microcide. Mr. Griffith is an inventor on 22 issued patents and has authored over 40 original research papers. He received his BA in Biology from the University of California at Santa Cruz.
Senior Vice President,
Nonclinical and Clinical Development
Ms. Morgan has more than 30 years of experience in the biotechnology and pharmaceutical industry being well versed in all stages of drug development with a proven track record in recruiting, training, and managing clinical, regulatory and quality departments. Ms. Morgan has been involved in the successful filing of over 25 INDs, 5 NDAs and 1 PMA. Recent experience includes NDA/MAA approval of Vabomere™, Minocin , Quinsair ™ , and Dermagraft ™ . She has experience running over 50 Phase 1-4 clinical trials in multiple indications in respiratory infections, infectious diseases, autoimmune disorders, asthma/allergy, cardiovascular and skin replacement. She has lead inspection-readiness activities and participated in several successful FDA inspections. Ms. Morgan has held executive positions at The Medicines Company/Rempex, Mpex, Nereus Pharmaceuticals, Hollis Eden, and The Immune Response. Prior to that, she held clinical, regulatory and quality positions of increasing responsibility at Advanced Tissue Sciences and Dura. Ms. Morgan received her B.S. in Biology from San Diego State University.
Senior Vice President,
Clinical and Regulatory Operations
Scott Hecker, PhD
Dr. Hecker has over 30 years of industry experience in leading medicinal chemistry and manufacturing in antibiotic drug discovery and development. He began his industrial career at Pfizer as a medicinal chemist in antibacterial drug discovery and then joined Microcide/Essential Therapeutics, where he led teams in the discovery of novel anti-infective drug candidates. He then moved to Metabasis Therapeutics where he oversaw the discovery and early development of drug candidates for diabetes, hyperlipidemia and hepatitis C in programs that advanced in development under partnerships with Merck and Roche. He later joined Mpex/Rempex Pharmaceuticals, where he was a founding member of the beta-lactamase inhibitor program that discovered the now FDA-approved agent vaborbactam, and continued at the Medicines Company following acquisition of Rempex to oversee the API manufacturing and early discovery programs. Dr. Hecker has over 40 publications and over 55 U.S. patents. He holds a B.A. in Chemistry from Wesleyan University and a Ph.D. in Chemistry from the University of California, Berkeley.
Senior Vice President,
Chemistry and Chemical Development
Ms. Linfesty has over 20 years of combined executive leadership experience in soliciting/securing, implementing and directing research programs focused in infectious diseases. These responsibilities included oversight of the fiscal and scientific milestones of large research studies and programs in biotechnology/pharmaceutical Industry, government, academia, healthcare systems, and not-for- profit organizations. Prior to joining Qpex, she was at Rempex/The Medicines Company where she was responsible for installing and executing contracts with BARDA, Innovative Medicines Initiative (IMI) in the EU, and NIAID. Prior to joining industry, Ms. Linfesty held positions of increasing responsibility associated with clinical research and administration at the Navel Health Research Center (San Diego), Infectious Disease Clinical Research Program of Uniformed Services University of the Health Sciences, i3 Research, and UC San Diego. Ms. Linfesty received her BA in Psychology/emphasis in Experimental Research Methodology from California State University, San Marcos.
Ms. Roos has over 30 years of experience in financial reporting, accounting, human resources, information technology management and operations for public and private companies. Prior to Qpex, Ms. Roos served as a consultant for Qpex and several other biopharmaceutical companies including Gossamer Bio, The Medicines Company, Rempex Pharmaceuticals, and Chimerix. Previously, Ms. Roos served as Executive Director, Finance and Corporate Controller at LMA North America, a medical device company, held various financial management positions at Gensia (a public biopharmaceutical company), and served as an auditor at PricewaterhouseCoopers. Ms. Roos has a bachelor’s degree in Accounting from Boston College.