BUFFALO, N.Y., April 8, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) announced today the appointment of key clinical development and regulatory affairs executives to optimally position the company for successful development of its drug candidates. Jean Viallet, M.D., has joined the Company as Chief Development Officer, reporting to the Chief Executive Officer, and will be responsible for overseeing CBLI's clinical strategy, trials and operations, regulatory affairs and preclinical development. The Company also announced the appointment of Gillian Miller, Ph.D., as Senior Director of Regulatory Affairs and Judith Schnyder, MBA as Director of Clinical Operations.
Dr. Viallet brings more than 20 years of experience as a medical oncologist and senior executive at both large and small pharmaceutical companies. Most recently, Dr. Viallet established Viallet Oncology Consulting, LLC after serving as the Chief Medical Officer of Precision Therapeutics, Inc. Prior to this he guided clinical and preclinical development at Gemin X Pharmaceuticals, Inc., as their Executive Vice President and Chief Medical Officer, culminating in a successful strategic acquisition of Gemin X by Cephalon, Inc. Before joining Gemin X, Dr. Viallet held senior clinical oncology development positions at GlaxoSmithKline PLC and Sanofi. He has extensive experience with all phases of drug development and has been involved in multiple successful Investigational New Drug applications, New Drug Applications, Biologics License Applications, European Medicines Agency submissions and U.S. Food and Drug Administration Advisory Committees. Dr. Viallet has also served in several clinical and academic posts at Hospital Notre Dame, Montreal General Hospital, McGill University and the Universite de Montreal.
Dr. Viallet noted, "As a clinical oncologist and scientist, I am grateful for the opportunity to guide CBLI's drug candidates derived from world-class science into established therapeutic advances for cancer patients and victims of potentially lethal radiation exposure. The company's spirit of innovation, their commitment to developing breakthrough treatments for oncology and acute radiation syndrome and the promising 'trial-ready' drugs in their pipeline are what attracted me to CBLI."
Dr. Miller's 15 years of regulatory affairs and clinical development experience in both the U.S. and Europe give her significant insight and experience in product registration and development strategies for novel and marketable small molecules and biologics for oncology and other therapeutic areas. Most recently, Dr. Miller worked as a consultant with SciLucent, LLC, providing regulatory, product development, and project management services for small and large companies with agents at various stages of readiness for approval in the U.S. and Europe. From 2004 to 2006, she was Associate Director of Regulatory Affairs at MedImmune and prior to that served in regulatory affairs roles at Shire Pharmaceutical Development and the Otsuka Maryland Research Institute. Dr. Miller started her career as a scientist at Becton Dickinson Technologies and then Cato Research Ltd. and was a Post-doctoral Fellow at Johns Hopkins Medical School.
Ms. Schnyder is a 15 year clinical research veteran with extensive oncology trials experience gained through a variety of positions at biotechnology and pharmaceutical companies and with a Clinical Research Organization. Most recently, Schnyder consulted on Phase I–IV oncology trials through her own firm, JAS Clinical Consulting, LLC. From 2008 to 2011, she worked alongside Dr. Viallet at Gemin X Pharmaceuticals, Inc., as their Senior Clinical Development Manager, where she managed a global phase I/II Small Cell Lung Cancer trial in 10 countries and a phase II Non-Small Cell Lung Cancer trial testing a novel bcl-2 inhibitor. Ms. Schnyder started her career at Medimmune Oncology, Inc., then worked at Cephalon, Inc. and Pharmanet, Inc. and was a Lead Clinical Oncology Development Scientist for GlaxoSmithKline PLC from 2002 to 2005.
Yakov Kogan, Ph.D., MBA, Chief Executive Officer commented, "We are very excited to welcome our new team members. They have extensive expertise in oncology clinical development, and a track record of success. We believe that the team's decades of experience and their prior leadership appointments will enable us to form and execute a strong trial strategy."
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a clinical-stage biotechnology company leveraging deep mechanistic understanding of the cell death process, apoptosis, to develop a robust pipeline of compounds primarily focused on oncology applications and mitigation of radiation injury. The Company's lead compound is being developed as both a radiation countermeasure and a cancer treatment. The Company has two operating subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's Cancer Institute Australia and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the Company's website at http://www.cbiolabs.com.
This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully obtain regulatory approval for our therapeutic product candidates; statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; the conduct and results of our various clinical trials; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These factors include, among others, the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's failure to develop new products; the Company's collaborative relationships and the financial risks related thereto; the risks inherent in the early stages of drug development and in conducting clinical trials. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.
Contact:
Rachel Levine, Director Investor Relations
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com
