FDA Grants QIDP and Fast Track Designations to Cidara Therapeutics’ Rezafungin Prophylaxis Development Program

René Russo, PharmD, BCPS

President and Chief Executive Officer

Arsanis, Inc.

René Russo, PharmD, BCPS, has spent more than 15 years in anti-infective R&D and has leadership experience across all phases of drug development, including global commercial launches for five novel antibacterial agents and clinical development and registration of several antiviral, antibacterial, and antifungal therapeutics. Her work has spanned the earliest phases of in vitro and animal work to clinical pharmacology, clinical development, and post-marketing clinical outcomes research. Prior to Arsanis, Dr. Russo served in various roles over an 11-year period at Cubist Pharmaceuticals (Cubist). As Vice President of an 80+ person global team, Dr. Russo oversaw the clinical microbiology program (including extensive in vitro and animal work to support dose selection and PK/PD analyses), contributed to the design of multiple Phase 1 to Phase 3 clinical studies, and directly managed the oversight of several global burden of disease programs, including urosepsis and nosocomial pneumonia, to understand the outcomes and unmet medical needs in these infectious diseases. In her role at Cubist, she was also responsible for the oversight of more than 140 studies designed to further understand Gram-positive and Gram-negative infections, including epidemiology, resistance patterns, and the study of various treatments (including combination therapies) across nonclinical and clinical studies. Dr. Russo directly oversaw investigator-initiated research for a broad portfolio of anti-infectives, including daptomycin, fidaxomicin, ceftolozane/tazobactam, and tedizolid. Prior to her time at Cubist, Dr. Russo held roles of increasing responsibility at Bristol-Myers Squibb where she started her industry career as a Postdoctoral Fellow in Industrial Pharmacy Infectious Diseases. She also held clinical positions at Robert Wood Johnson University Hospital and Princeton Hospital before joining the biotechnology industry. Dr. Russo received her PharmD and Bachelor of Science in Pharmacy from Rutgers University and holds a Board of Pharmacy Specialties Pharmacotherapy Certification (BCPS).

Michael N. Dudley, Pharm.D.

President and Chief Executive Officer
Qpex Biopharma, Inc.

Dr. Dudley has over 30 years of experience in antiinfective drug research, development, and commercialization. In 2018, he co-founded Qpex Biopharma which raised $33M in Series A financing and acquired the preclinical infectious disease programs from The Medicines Company. He has overseen the development and regulatory approval of 3 antibiotics, most recently a beta-lactamase inhibitor combination product from a new chemical class (vaborbactam) discovered in the company laboratories. The antibiotic product Vabomere™ advanced from discovery to FDA approval in 2017 in less than 8 years. He lead the negotiation for multiple contracts from public-private partnerships (e.g., BARDA of the US Government; Innovative Medicines Initiative for the EU) for a combined total of over $190 million funding to advance antimicrobial agents in development in the US and Europe. Prior to co-founding Qpex, he was Chief Scientific Officer and co-founder of Rempex Pharmaceuticals that was acquired by the Medicines Company (MDCO) in 2013, where he remained as the co-leader of the Infectious Disease Business Unit of MDCO. Prior to Rempex, he held VP/SVP/CSO positions of increasing responsibility at the biotech companies Mpex Pharmaceuticals (acquired by Aptalis in 2011), Diversa Corporation, and Microcide Pharmaceuticals. Prior to his career in pharmaceutical industry, he held full-time academic appointments that included Professor of Pharmacy and Chairman of the Department of Pharmacy Practice at the University of Rhode Island College of Pharmacy (URI), and Adjunct Professor of Medicine, Brown University School of Medicine at Roger Williams Medical Center in Providence, RI. As an academic researcher, he conducted preclinical and clinical research in antibacterial, antifungal, and antiviral agents, including pioneering work on PK-PD approaches for several classes of antiinfectives. Dr. Dudley has published over 130 scientific papers and book chapters describing the evaluation and clinical use of antiinfective agents and treatment of infectious diseases. He has served as an invited speaker at several FDA and EMA workshops, international meetings on infectious diseases, and advisor to several companies. He has served as an Editor for the journal Antimicrobial Agents and Chemotherapy and numerous other editorial and advisory boards. He completed undergraduate work at Pepperdine University and his Doctor of Pharmacy (PharmD) from the University of California San Francisco (UCSF), completed at residency at UCSF, and a fellowship in infectious diseases at Hartford Hospital.

FDA Grants QIDP and Fast Track Designations to Cidara Therapeutics’ Rezafungin Prophylaxis Development Program

René Russo, PharmD, BCPS

René Russo, PharmD, BCPS

Roger J. Pomerantz, M.D., F.A.C.P.

Christine Ann Miller

Graham G. Lumsden

Marco Taglietti, M.D.

Ankit Mahadevia

Jeffrey Stein, Ph.D.

Evan Loh, M.D.

Michael Dunne, M.D

Ciara Kennedy, Ph.D.

Ted Schroeder

Kevin Finney

Manos Perros, Ph.D.

David Roblin

Stephen Conafay

Christopher J. Burns, Ph.D.

Michael N. Dudley, Pharm.D.

Ramani Varanasi

Corey Fishman

Felix Faupel

Adrian Nivoliez