Advisory Board

Scientific Advisory Board 

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    Nigel J Titchener-Hooker, Ph.D. CHAIRPERSON

    Nigel J Titchener-Hooker Ph.D. CHAIRPERSON 

    Dean of Engineering and Professor of Biochemical Engineering, University College London (UCL)

    Nigel is a process economics and systems expert and currently the Dean of the world-renowned faculty of Engineering at UCL, covering a wide range of engineering disciplines. In addition to his academic credentials he worked as biochemical engineer at Glaxo. He is a consultant for a broad range of international companies while serving on the editorial board of several journals and acting as expert witness on key patent issues recognizing of his pioneering work on biopharmaceutical manufacturing.

    He is an Adjunct Professor University of Monterey, Mexico, Fellow of the Royal Academy of Engineering/Institution of Chemical Engineers, and member of American Institute of Chemical Engineers. He has a PhD in Biochemical Engineering from UCL.

     
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    Steve M.Cramer, Ph.D.

    Steven M.Cramer, Ph.D. 

    William Weightman Walker Professor at the Department of Chemical and Biological Engineering, Rensselaer Polytechnic Institute, Troy, New York.

    Steven Cramer is the William Weightman Walker Professor of Chemical and Biological Engineering at Rensselaer Polytechnic Institute, Troy, New York. Prof. Cramer is a bioprocessing downstream expert whose research focuses on applying fundamental understanding of biomolecular interactions towards the development of novel chromatographic and precipitation protein separation processes. He served as the Editor-in-Chief of the International journal Separations, Science and Technology for 20 years.

    Professor Cramer was the awarded the Alan S. Michaels Award for the Recovery of Biological Products (ACS Division of Biochemical Technology) and the 2016 ACS National Award in Separation Science and Technology.He was also awarded Rensselaer’s School of Engineering Outstanding Professor Award and the Research Excellence Award. Dr. Cramer was given a Presidential Young Investigator award from the National Science Foundation, the Early Career Award from Rensselaer Polytechnic Institute as well as several teaching awards.

    Professor Cramer has been elected a fellow of the American Institute of Chemical Engineers, the American Chemical Society and the American Institute for Medical and Biological Engineering.He has chaired several prestigious meetings including 2 International HIC/RPC Bioseparation Conferences, 2 ACS Recovery of Biological Products Meetings and the Gordon Conference on Reactive Polymers. Prof. Cramer is a consultant for several biopharmaceutical and bioseparation companies. He is also serving on the FDA panel for biosimilars. Prof.

    Cramer has published over 176 papers in peer-reviewed journals and has 10 patents. Importantly, he has produced 41 Ph.D. students who have gone on to leadership positions in the biotechnology industry and academia.

     
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    Howard Levine, Ph.D.

    Howard Levine, Ph.D. 

    Founder, President & CEO at BioProcess Technology Consultants

    Howard is a pioneer and thought leader in the biopharmaceutical industry with extensive strategic and operational experience in biopharmaceutical product development and commercialization. As CEO of BioProcess Technology Consultants, Howard leads a team of 20 consultants who provide value-added business, technical, regulatory, and operations consulting to the biopharmaceutical industry, enhancing the overall value of companies and bioproducts through the design and implementation of effective product development and commercialization strategies.

    His team advises clients in every phase of biopharmaceutical development and manufacturing providing specialized skills derived from an integrated team of knowledgeable consultants with the experience and skills in all aspects of bioprocessing. In his more than 35 years in the biopharmaceutical industry Howard has assisted numerous companies in developing biological products, provided strategic input in the development of new manufacturing technologies, and participated in the successful commercialization of several of these products.

    Prior to founding BioProcess Technology Consultants in 1994, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation and previously held positions of increasing responsibility in process development and manufacturing at Genentech, Amgen, and Xoma.

     
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    Wenyan (David) Shen, Ph.D.

    Wenyan (David) Shen, Ph.D.

    David is well recognized as an expert in developing biopharmaceutical products (biosimilars, biobetters, innovative biologics) working in projects from discovery to proof-of-concept, to clinical stage and regulatory filing. He is a leader working in top biotech and pharmaceutical companies such as NGM Biopharm, Teva, Merck and Amgen successfully leading discovery research, preclinical, process development, Chemistry, Manufacturing, and Control (CMC) activities and bioanalytical organizations.

    In addition, David headed the Teva-Lonza Joint Venture for biosimilar antibody development generating products meeting both EMA and FDA requirements. In his tenure at Teva, David led his organization that achieved the FDA approval of filgrastim and EMA approval of Ovaleap, the first FSH biosimilar approved in the EU and lipegfilgrastim, a biobetter for pegfilgrastim. He discovered new products and technologies (with more than 20 patents or applications) of significant industrial and commercial application.

    Furthermore, he serves in the Scientific Advisory Board and Steering Committees for several start-up biotech companies guiding their research and development while acting as reviewer of manuscripts for several peer reviewed publications. He has a Ph.D. in Biochemistry from the University of Toronto and postdoctoral training in Protein Engineering at MIT’s Whitehead Institute.

     
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    Eli Keshavarz-Moore, Ph.D.

    Eli Keshavarz-Moore, Ph.D

    Eli is Professor of Bioprocess Science & Enterprise in the Department of Biochemical Engineering and Vice-Dean for International Affairs for the faculty of Engineering Sciences at UCL, UK.

    Her research interest is in the bioprocessing of complex macromolecules with therapeutic promise including fusion proteins, antibody fragments (monoclonal and polyclonal), artificial chromosomes and phages; and cells including microbial, mammalian and fungal systems as well as transgenic materials. One particular aspect of her work addresses how to control and manipulate the upstream processing including fermentation and cell engineering in order to facilitate the whole processing sequence with the ultimate aim of creating a step change in design and operation of the entire process. She is a Chartered Chemical Engineer and a fellow of the IChemE.

    She has pioneered the development and implementation of innovative enterprise training at the bioprocessing/life sciences interface to help commercialization of research. The training program encompasses a range of courses at undergraduate, postgraduate levels extending to and including leadership courses for industry in the healthcare and biotechnology sectors. She is an industrial bioprocessing consultant, and has been advisor to the UK’s Sector Skills Council for Science. In her Vice- Dean role, she interacts with engineering institutions at a global level.

     
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    Nathan E. Lewis, Ph.D.

    Nathan E. Lewis, Ph.D. 

    Assistant Professor in the Department of Pediatrics at the University of California, San Diego.

    Nathan Lewis is an Assistant Professor in the Department of Pediatrics at the University of California, San Diego. Professor Lewis is a leading expert in the use of novel genomic tools and big data analytics for mammalian cell culture design and optimization in an effort to increase the safety, efficacy, and affordability of biopharmacueticals.

    In his work he helped lead early efforts to sequence the genomes of the Chinese hamster and diverse cells lines, and has led efforts to map out the cellular pathways regulating cell growth and protein production. Using these resources he has developed intellectual property regarding computational design of cell lines and feeding strategies, along with the identification of modalities to engineer cells to obtain desirable bioprocess and protein attributes.

    Professor Lewis received his Ph.D. in Bioengineering from UC San Diego, after which he received postdoctoral training at Harvard Medical School and served on the faculty at Brigham Young University.

     

Regulatory and Clinical Advisory Board

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    Dr. Hoss Dowlat

    Dr. Hoss Dowlat

    Dr. Hoss is a thought leader in biosimilars, and heading an international team of drug development Principal Consultants at his self-owned PHARMABIO CONSULTING from Germany. His experience encompasses strategic regulatory support and due diligence to circa. 90 client Pharma companies and international management consulting and pharmaceutical service companies from across Europe, America, Canada, China, Korea, Taiwan, Japan, and India. Dr. Hoss was 2000-2010 Vice-President, Technical, Drug Development and Regulatory Global Strategy Services, at the leading CRO Parexel International providing direct strategic consulting. Prior to this he managed drug development programs and registrations in several major Pharma companies.

    Dr. Hoss is British-Canadian educated throughout in England and was awarded a Post-doctoral European Royal Society Fellowship researching at the CNRS, France, with a Nobel Laureate. He has more than 33 years of drug development experience in over 15 therapeutic areas in the EU and North American pharmaceutical industry, 23 years of which have been in regulatory affairs. His strength is in therapeutic proteins such as novel and biosimilar monoclonal antibodies.

    He has extensive experience with FDA and EU Meetings and is a pioneer in European biosimilar approvals beginning with regulatory lead to one of 2 EU Biosimilar somatropin, hGH, approvals in April 2006. Hoss has published five milestone articles and book chapters on EU/US/Global biosimilars development and registration in 2012-2013, and the latest two articles in 2016 providing expert insights and opinions of the hot topics of biosimilar interchangeability and biosimilar orphans.

     
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    Dr Gilberto Lopes

    Dr Gilberto Lopes

    Gilberto Lopes is Chief Medical and Scientific Officer for the Oncoclinicas Group, the largest Oncology provider in Latin America with 34 clinics and more than 290 physicians. He holds a concomitant position as faculty member at the Johns Hopkins University in Baltimore, Maryland. Trained in Brazil and the United States, Dr. Lopes has published more than 100 papers and book chapters in journals such as the Journal of Clinical Oncology, Cancer, Nature Reviews, Lancet Oncology and Health Affairs. He has been an Investigator in more than 100 studies and clinical trials covering breast, gastrointestinal, genitourinary and thoracic cancers.

    He founded the Singapore Chapter of the “International Society for Pharmaco-economics and Outcomes Research” and “Cancer Control in Low and Middle Income Countries”, an NGO. He was the Chairman for the Health Care committee at the American Chamber of Commerce in Singapore and a member of the executive committee for the Singapore Society of Oncology and a board member for the Chapter of Medical Oncologists at the Singapore Academy of Medicine. 

    Dr. Lopes is currently a committee member for the International Association for the Study of Lung Cancer (IASLC) and the American Society of Clinical Oncology (ASCO) and Associate Editor for ASCO University and the society´s Journal of Global Oncology. He has also served as an expert for the International Atomic Energy Agency and the World Health Organization in official missions and advised governments, professional societies and industry partners on issues related to cancer control and treatment.

     
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    Dr David Kerr 

    Dr David Kerr

    Dr David Kerr is a founder of OCB and Professor of Cancer Medicine at the University of Oxford, where he has worked with colleagues to build a new Institute for Cancer Medicine and Cancer Hospital. Dr Kerr has an international reputation for the treatment of, and research into, colorectal cancer and the quality of his work has been recognised by the award of several international prizes and the first NHS Nye-Bevan award for innovation.

    He has made a significant contribution to reforming the NHS as a Founding Commissioner for Health Improvement, Chair of the National Cancer Services Collaborative, instigator of the Department of Health’s networked approach to clinical cancer research and he developed a 20 year plan for the future of the NHS in Scotland, the “Kerr Report”. Dr Kerr was elected Fellow of the Academy of Medical Sciences in 2000, Honorary Fellow of Royal College of General Practitioners in 2007, appointed Commander of the British Empire in 2002 and was elected President of the European Society of Medical Oncology in 2010.