Cleveland BioLabs Культура компании

Dr. Ann Lenich Hards, Ph.D. serves as an Executive Vice President of Regulatory Affairs at Cleveland BioLabs, Inc., and served as its Executive Vice President of Regulatory Affairs and Quality Assurance. Dr. Hards served as the President of Pharmaceutical Development at Bridging Health-Matters. Dr. Hards served as a Vice President of Regulatory Affairs at Cleveland BioLabs, Inc. since May 24, 2010. Dr. Hards was responsible for development and ongoing implementation of Cleveland BioLabs's regulatory strategy and interactions with the U.S. Food and Drug Administration (FDA) and other regulatory agencies and she also provided strategic oversight of these activities on a consulting basis. She served as Executive Vice President of Regulatory Affairs of ARCA biopharma, Inc. ( Formerly Arca Discovery, Inc.) since July 2006 and responsible for all aspects of health authority interactions and regulatory strategy as well as management of the entire regulatory preparation process and staff. She has over fifteen years of experience in the pharmaceutical/biotechnology industry at Sanofi-Aventis, Somatix Therapy Corporation, Pharmacia Inc. and Parke-Davis Pharmaceuticals, with thirteen years of that experience in regulatory affairs. Most recently, she served as Vice President of Clinical Investigation Realization at Sanofi-Aventis from 1996 to 2006, with responsibility for ensuring that clinical development strategies and documentation addressed the current and future standards of regulatory approval. Prior to that, she held a number of senior regulatory-management positions including Vice President Worldwide Cardiovascular and Thrombosis Regulatory Affairs. Notably, Dr. Hards has played an integral part in the preparation, submission and prosecution of eleven new NDAs/major efficacy supplements, including the initial and subsequent approvals of Plavix(R), an anti-platelet agent with a $6.5 billion market. From 1990 to 1994, she was with the Parke-Davis Pharmaceutical Research Division of Warner-Lambert where she held several positions in Regulatory Affairs and Clinical Communications. Dr. Hards received her B.S. degree in Agriculture from Purdue University and Ph.D. degree in Biophysics and Genetics from the University of Colorado Health Sciences Center.

Dr. Langdon L. Miller, M.D. has been the Chief Medical Officer of Oncternal Therapeutics, Inc. since October 12, 2016. Dr. Miller has been the President and Chief Medical Officer of Cleveland BioLabs, Inc. since May 4, 2015. He served as a Strategic Medical Advisor to Cleveland BioLabs since February 2014. Dr. Miller has more than 25 years of experience designing and conducting successful translational and clinical drug development programs in oncology (hematological and solid tumors) and orphan diseases. Dr. Miller played major roles in the successful development of multiple anti-cancer agents, including filgrastim, sargramostim, irinotecan, exemestane, dexrazoxane, epirubicin, sunitinib and idelalisib. He has worked in all phases of drug development, from first-in-human studies through pivotal registration-directed trials to medical affairs programs and has filed multiple Investigational New Drug applications, Clinical Trial Applications, New Drug Applications and orphan drug applications. Dr. Miller has extensive experience in the generation, analysis, presentation and justification of drug development programs before regulatory authorities, advisory committees, investigators, investors and business development partners. He served as an Executive Vice President of Research & Development at Calistoga Pharmaceuticals, Inc. since August 1, 2010. He served as the Chief Medical Officer of PTC Therapeutics Inc., since July 2003. He joined PTC from Pharmacia Corporation, where he served as Vice President of Global Clinical Research in Oncology. He served as a Member of Advisory Board of Gloucester Pharmaceuticals Inc. He served as a Director of Pharmacia LLC. He served as a Senior Investigator at the National Cancer Institute (NCI) where he provided strategic direction for NCI-sponsored trials. He has authored over 100 regulatory documents and publications. Prior to establishing his consultancy in 2013, he held leadership positions in government and in large and small biopharmaceutical companies, including the National Cancer Institute, Pharmacia Corporation, PTC Therapeutics, Calistoga Pharmaceuticals and Gilead Sciences. He has held clinical positions at Stanford University and the University of California at San Francisco. Dr. Miller completed an Internal Medicine Residency at the University of Minnesota and a Medical Oncology Fellowship at Stanford University. Dr. Miller received his M.D. from Northwestern University Medical School in Chicago, Illinois.

Dr. Andrei V. Gudkov, Ph.D., D.Sci, is a Scientific Co-Founder of Cleveland Biolabs, Inc. and has also been its Chief Scientific Officer since June 2003. Dr. Gudkov serves as Chief Scientific Officer and Founder at Everon Biosciences, Inc. He co-founded Mega Biotech & Electronics Co., Ltd., and serves as its Chief Scientific Officer. Dr. Gudkov serves as Senior Vice President of Basic Science at Roswell Park Cancer Institute. He has over 25 years of experience in biomedical research. Prior to 1990, he worked with The National Cancer Research Center in Moscow (USSR), where he led a broad research program focused on virology and cancer drug resistance. In 1990, he re-established his lab at the University of Illinois at Chicago where he became a tenured faculty Member in the Department of Molecular Genetics. In 1999, he defined p53 as a major determinant of cancer treatment side effects and suggested this protein as a target for therapeutic suppression. In 2001, Dr. Gudkov moved his laboratory to the Lerner Research Institute at the Cleveland Clinic Foundation, where he served as Chairman of the Department of Molecular Biology and Professor of Biochemistry at Case Western Reserve University. He served as a Director of Cleveland Biolabs, Inc. since June 2003. He serves as a Director of Panacela Labs, Inc., Mega Biotech & Electronics Co., Ltd., Russian Pharmaceutical Company Incuron, LLC and Taiwan Indigena Botanica Co., Ltd. He serves as Member of Scientific Advisory Board at CytoLogic, Inc. He served as Senior Vice President of Research Programming and Development of Roswell Park Cancer Institute since May 2007. In Cleveland, he has continued developing his gene and drug discovery programs, extending them to new cancer areas and drug targets. Many aspects of Dr. Gudkov's work involved collaboration with several industrial partners, including Quark Biotech, PPD Discovery, Clontech and ChemBridge Corp. Dr. Gudkov's work with Quark Biotech resulted in the establishment of a unique long-term relationship between academic and industrial entities that generated millions of dollars of research support for the academic lab and new technologies and drug targets for the industry. He has more than 100 publications, including research articles and analytical reviews in top-level journals. He is an invited speaker at numerous international congresses. Dr. Gudkov holds 21 issued and 7 pending patents. Dr. Gudkov serves as Chairman of the Department of Molecular Biology at CCF, Principal Investigator on a series of NIH-funded programs, Author of over one hundred research papers and Inventor on 21 issued U.S. patents in the cancer area, including the patent for the first p53 inhibitor, pifithrin-alpha.

Rachel Levine serves as the Director, Corporate Development & communications for Cleveland Biolabs. Rachel started at Cleveland Biolabs in December of . Rachel is based in the Greater New York City Area.

Andrei Purmal serves as the VP, Chemistry for Cleveland BioLabs, Inc.. Andrei started at Cleveland BioLabs, Inc. in November of 2011. Andrei is based in the Buffalo/Niagara, New York Area.