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20-F
BIOLINERX LTD. filed this Form 20-F on 03/10/2016
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The following table sets forth information for our oncology Scientific Advisory Board members.
 
Name
 
Position/Institutional Affiliation
     
J. Aaron Ciechanover, M.D., Ph.D.
 
Professor Ciechanover is a Distinguished University Professor at the Rappaport Faculty of Medicine of the Technion and the co-director of the Technion Integrated Cancer Center. He shared the 2004 Nobel Prize in Chemistry with Professors Avram Hershko and Irwin Rose for the discovery of ubiquitin-mediated protein degradation. Among his many other prizes are the Israel Prize in Biological Research (2003) and the Albert Lasker Award for Basic Medical research (2000).  He is a member of numerous learned societies, among them the Israeli Academy of Sciences and Humanities and the National Academies of Sciences and of Medicine of the USA (Foreign Associate). Professor Ciechanover was also a member of our original Scientific Advisory Board.
     
Jorge Eduardo Cortes, M.D.
 
Dr. Cortes is Professor of Medicine, Deputy Chair, and Chief of the CML and AML Sections of the Department of Leukemia at The University of Texas, MD Anderson Cancer Center (MDACC). Dr. Cortes has authored hundreds of peer-reviewed manuscripts, abstracts, book chapters, and other medical publications. He is an associate editor for the medical journal, Blood and serves on the editorial board of other journals such as the Journal of Clinical Oncology, the American Journal of Hematology and Clinical Cancer Research. In addition, Dr. Cortes serves on the Board of the International CML Foundation. Dr. Cortes has received numerous awards including The Service to Mankind Award from the Leukemia and Lymphoma Society and the Faculty Scholar Award from the MDACC for clinical research and for education.
     
Debasish Roychowdhury, M.D.
 
Dr. Roychowdhury is a leader in the pharmaceutical industry with a strong background in oncology research and development, and regulatory and commercial operations, having previously served in key senior leadership roles at Sanofi, GlaxoSmithKline and Eli Lilly. Dr. Roychowdhury has a distinguished track record in the field of oncology having been involved in the approval of nine oncology drugs, including Almita, Tykerb and Jevtana. Currently, he is President of Nirvan Consultants, LLC and in this capacity he serves in senior advisory roles for biotechnology companies to help advance their pipeline of therapeutic medicines. Dr. Roychowdhury also serves as a member of the Board of Directors for Lytix Biopharma AS and Radius Health, Inc. In his academic career, Dr. Roychowdhury served as a faculty member at the University of Cincinnati.
     
Yosef Yarden, Ph.D.
 
Professor Yarden is The Harold and Zeda Goldenberg Chair of Molecular Cell Biology of the Weizmann Institute of Science. He is a member of the Israel Academy of Sciences and Humanities and Past President of the Federation of the Israel Societies of Experimental Biology. Among his many awards, he has received the Susan G. Komen for the Cure® Brinker Award for Scientific Distinction in Basic Research, and the Ernst W. Bertner Memorial Award of the MD Anderson Cancer Center. Professor Yarden is also a member of the European Molecular Biology Organization, the European Cancer Academy and the Asia-Pacific International Molecular Biology Network. Professor Yarden was also a member of our original Scientific Advisory Board.
 
Manufacturing
 
Our laboratories, which are located in our headquarters in Modi’in, Israel, are compliant with both current good manufacturing practices, or cGMP, and certified Good Laboratory Practices, or GLP, and allow us to manufacture drug products for our current clinical trials. The suppliers of the drug substances used for our current clinical trials have the necessary approvals as well. See “— Property, Plant and Equipment.” If we decide to perform any Phase 3 clinical trial with respect to, or commercialize, any therapeutic candidate on our own, we anticipate that we will rely on third parties to produce the therapeutic supplies. We have limited personnel with experience in drug or medical device manufacturing and we lack the resources and capabilities to manufacture any of our therapeutic candidates on a commercial scale.
 
Under our out-licensing agreement with Bellerophon with regard to BL-1040, we have the option to manufacture at least 20% of BL-1040 products pursuant to the terms of a supply agreement to be negotiated in good faith with Bellerophon. See “— Other Out-Licensing Agreements — Bellerophon.” Under our collaboration agreement with Panmed and Genoscience with regard to BL-8020, we have agreed to supply, at the licensors’ request, the drug needed for a clinical trial to be administered by the licensors, subject to the parties agreeing to commercially reasonable supply terms. There can be no assurance that our therapeutic candidates, if approved, can be manufactured in sufficient commercial quantities, in compliance with regulatory requirements and at an acceptable cost. We and our contract manufacturers are, and will be, subject to extensive governmental regulation in connection with the manufacture of any pharmaceutical products or medical devices. We and our contract manufacturers must ensure that all of the processes, methods and equipment are compliant with cGMP, for drugs or QSR for devices on an ongoing basis, mandated by the FDA and other regulatory authorities, and conduct extensive audits of vendors, contract laboratories and suppliers.