Meet our speakers
VP, Corp Development,
Kalobios, USA
Dr. Alfenito was previously Vice President of Corporate Development at Dyax Corp (DYAX; NASDAQ), a company that makes peptide and antibody therapeutics via phage display. Previously, Dr. Alfenito served as President of Target Quest, a human antibody therapeutics company that subsequently merged with the then privately held Dyax Corp. Prior to joining Target Quest, Dr. Alfenito served as Associate Director of Corporate Development at Hyseq, Inc. (NUVO; NASDAQ) He holds a B.S. from Cornell University and an M.S. and a Ph.D. from Harvard University, and did his postdoctoral work at Stanford University.
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Professor of Immunology & Chief Scientific Officer,
Micromet AG
Dr. Baeuerle has served as Micromet's Chief Scientific Officer since October 1998. From February 1996 to September 1998, Mr. Baeuerle headed the drug discovery activities of Tularik Inc. in South San Francisco, CA, as Director, Drug Discovery. From October 1994 to February 1996, Mr. Baeuerle served as a full Professor and Chairman of Biochemistry at the Medical Faculty of Freiburg University, Germany. According to a survey by the Institute for Scientific Information (ISI, Philadelphia, PA, USA), Mr. Baeuerle was Germany's most frequently cited biomedical scientist of the past decade, and 38th worldwide, and published more than 200 scientific papers. Mr. Baeuerle performed his Ph.D. work at the Max Planck Institute for Psychiatry in Martinsried and at the European Molecular Biology Laboratory (EMBL) in Heidelberg, obtained a Ph.D. degree in biology from the University of Munich, and performed his post-doctoral research with David Baltimore at the Whitehead Institute of the Massachusetts Institute of Technology (MIT), Cambridge, MA.
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President, Biologics,
Glenmark Pharmaceuticals
Dr. Michael Buschle has over 15 years experience in the pharmaceutical/biotech industry in areas such as drug research and development and biopharmaceuticals manufacturing. He joined Glenmark in 2006 and is responsible for leading the Glenmark group’s initiatives in the area of biopharmaceuticals. In the meantime the company has established a pipeline of 5 NBE's in pre-clinical studies, with two of them expected to reach clinics in the very near future. He was one of the co-founders of Intercell AG, a successful biotech start-up which is now listed on the Vienna Stock Exchange. He was previously associated with Boehringer Ingelheim as well as leading academic institutions in the United Kingdom, USA and Austria.
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Founder, Director of Biologics Research,
Antitope Ltd
Dr Frank Carr has been at the forefront of antibody engineering technologies for over 20 years, and has an extensive publication record in peer-review journals and over 20 patents including co-inventor of germ-line humanization and DeImmunization™ technologies. Prior to Antitope, Frank has held senior management positions in Astra Zeneca and GE Healthcare (formerly Amersham Biosciences) and has founded/co-founded a number of successful companies (including Biovation and Antitope). These companies have an established track record in applying proprietary technologies, such as DeImmunization™, EpiScreen™ and Composite Human Antibodies™ to assess and remove immunogenicity from protein therapeutics, and as a result have produced a number of therapeutics that have been used to successfully treat a variety of indications in the clinic.
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Director, Cell Engineering Research Centre / Department of Cell Biology, Fourth Military Medical University ,
Fourth Military Medical University
Academician of Chinese Academy of Engineering, Professor and director of Cell Engineering Research Centre & Department of Cell Biology, National Key Discipline of Cell Biology, the Fourth Military Medical University. Doctoral tutor and national excellent teacher. Chief expert of Vaccine & Antibody Stress Project, HTRDP of China, principal investigator of State Key Laboratory of Cancer Biology, standing council of Chinese Association of Cancer, director of Chinese Society of Tumor Marker Oncology, standing syndic of Chinese Society of Cell Biology, director of committee of Cell Engineering & transgenic Organism, vice director of Committee of Biochemistry & Biopharmaceutical, CPA.
Professor Chen has been engaged in research on the cancer cell biology, cell engineering, antibody & biopharmaceuticals etc for long-term and obtained many advanced and creative fruits, especially in the fields of monoclonal antibody HAb18 with its target molecular CD147 and the extracellular matrix. From 1994, Professor Chen began to apply antibody target drug, named Iodine (131I) Metuximab Injection (LICARTINTM), obtained Certificate of New Drug in April 2005, certificate of GMP in January 2007 and came into the market.
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COO and VP Business Development,
Arana Therapeutics
Rob Crombie joined Arana in April 2004 and was instrumental in the acquisition of US company Absalus in the following year, firmly focusing the combined company in the antibody therapeutics sector. Rob was responsible in securing several multi-product Pharma partnerships that Arana has ongoing, including those with GlaxoSmithKline and CSL Pharmaceuticals. In August 2007 EvoGenix merged with Peptech to form one of Australia’s largest Biotech companies - Arana Therapeutics, where his role continues to focus in the marketing and alliance management of the company’s many technology partnerships.
Rob has over 10 years of senior business development experience specifically in the antibody sector. He previously managed a technology development team at Cobra Therapeutics Ltd and was responsible, at UK public company ML Laboratories PLC, for licensing antibody manufacturing technologies to several top pharmaceutical and biotech companies
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Senior VP Corp Development, Chief Business Officer,
Affitech, USA
Dr. Das has about 25 years of experience in the pharmaceutical and biotechnology industry, with emphasis in the biotherapeutics sector in general, and therapeutic antibody area, in particular. He has held research management positions at Bayer Corporation in the United States and at Bayer AG in Germany. In addition to his drug discovery and product development background, Dr. Das’ expertise includes business and corporate development, technology and product licensing, market research and alliance management. Dr. Das has been working for Affitech since 2000, and immediately before that he was the Vice President of Business Development of Etiogen Pharmaceutical, a Bay area biotechnology company. He is also the Editor of the biotechnology trade publication, American Biotechnology Laboratory, and is the author or co-author of D&MD Publications’ international market research volumes, Display Technologies, Antibody Engineering, and Antibody Therapeutics. Dr. Das has a PhD in bioorganic chemistry, post-doctoral training in cell and molecular biology, as well as an Executive MBA with focus in international marketing.
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COO & President, Technology & Manufacturing Divisional Group,
Celltrion, Inc.
Dr. Gerson received his Ph.D. in Biophysics from McGill University in Montreal in 1972. Dr. Gerson then established and ran the Biotechnology Department as a contract manufacturing facility at the Alberta Research Council and was VP of Manufacturing and Process Development for Human Vaccines at Connaught Laboratories and moved on to become the VP of Research & Development at Apotex Fermentation, Inc. where he developed a new patented process for the production of Lovastatin and built a manufacturing plant in Canada and established a subsidiary Joint-Venture for manufacturing in China. As Managing Director of Vaccine Manufacturing at Wyeth-Lederle Vaccines, he was responsible for the production of DTP, OPV, Pnu-Imune, Hib-Titer and the transfer from Development to Manufacturing, and launch, of Prevnar, a Pneumococcal-conjugate vaccine for pneumonia in children. As VP Manufacturing and Development of Acambis, he developed the process for and manufactured more than 200 million doses of Smallpox Vaccine for the United States Government. He later became the Managing Director of Manufacturing and Development at the International Aids Vaccine Initiative, (IAVI), responsible for manufacturing clinical trial materials, process development, and planning for eventual worldwide manufacturing of a vaccine against HIV. At present, he is COO and President of the Technology and Manufacturing Division of Celltrion, Inc., a contract manufacturer of mammalian cell produced protein biopharmaceuticals in Seoul, Korea.
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Director, Bioprocess R&D, UCB Celltech,
UCB Celltech, UK
David held positions in the veterinary vaccine and enzyme production industries prior to completing a PhD in Biochemistry at the University of Birmingham, UK in 1997. He moved to Celltech as Group Leader, Fermentation where he worked on the establishment of Celltech’s microbial production and Fab’-PEG technology platforms, taking several products through clinical development. In 2003 David moved to GlaxoSmithKline as Process Development Manager with responsibility for monoclonal antibody projects. After 2 years at GSK he returned to the ‘new’ UCB Celltech to take up the position of Director, Bioprocess R&D. His department is responsible for early stage process and analytical development activities in support of UCB Celltech’s biologicals pipeline. However, David has also played a leading role in developing CMC components of MAA and BLA filings in Europe and the US for UCB’s lead biological, Cimzia. David sits on the UK’s BioIndustry Association Manufacturing Advisory Committee and the steering committee of the BioProcessing Research Industry Club, a UK Government/Industry funding body for industrially relevant research in bioprocessing.
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Business Development Director, Asia , Roche Pharma Partnering,
Roche
Frank has been instrumental in setting up the newly formed Shanghai office of Roche Pharma Partnering. The office will further strengthen Roche’s presence in the region and will be mainly responsible for partnering activities in Korea, Singapore and China, as well as Taiwan and Hong Kong. Prior to taking up this post, from 2006 Frank was Global Head, Drug Delivery Partnering, responsible for both the strategic and life-cycle management activities related to drug delivery partnering. Frank was a Global Alliance Director from 2002, managing pivotal research alliances such as Chugai, Evotec, SGX, Syrrx and Biotie. During the time of these two positions, he concluded more than 80 research and technology transactions.
Frank joined the Roche Pharma Partnering team as Head of Opportunity Surveillance in July 2001, having previously worked in various research functions in Roche and at Boehringer Mannheim GmbH.
Frank has a degree in chemistry from the University of Heidelberg and a Ph.D. from the Technical University of Munich within the group of Nobel laureate Robert Huber (Max-Planck-Institute for Biochemistry at Martinsried).
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Director,
Shanghai Cell Engineering and Antibody Centre
Dr. Yajun Guo graduated from the Third Military Medical University in China in 1978 and received his Ph.D. from the Shanghai Second Military Medical University. He did his post-doctoral training in Shanghai Institute of Biochemistry, Academy of Sciences of China. He went to Harvard School of Medicine in 1989 as a visiting professor and then, joined the faculty of Case Western Reserve University as an assistant professor in 1993. In 1996, Dr. Yajun Guo became a professor in Sidney Kimmel Cancer Center in San Diego. Starting from 1998, Dr. Yajun Guo established the Shanghai Zhangjing Biotechnology Center as an R & D research center for therapeutic antibody and in 2005， he enlarged the center into the present Shanghai Cell Engineering and Antibody Center in which two academic institutions, SMMU and SJTU, and three companies, CPGJ, LSGJ and ZJBC are consisted of. Dr. Yajun Guo’s program focuses on experimental immunotherapy and immunogenetherapy. The ultimate goal of their research will be further developing the novel strategy for generation effective cellular cancer vaccines and monoclonal antibody-based immunotherapy protocols such as it can be translated into clinical treatment for human cancers. Currently, He is also a PI of the National Key Basic Research program Project “Structure and function of antibody” and is conducting five therapeutic antibody clinical trials in China. As a co-director, Dr. Guo is also conducting a project of antibody large scale production which consists of a total 50,000L capacity for mammalian cell culture.
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Head of New Technologies, Roche Pharma Research,
Roche
After studying biology and chemistry at the University of Regensburg, Germany, Dr Anton Haselbeck received his PhD in 1982, before undertaking a post-doctoral fellowship at the University of California in Berkeley. Dr Haselbeck was Assistant Professor at the University of Regensburg for two years before joining Boehringer Mannheim, Germany, in 1988. His major activities within Boehringer/Roche have included the analysis of erythropoietin, and he directed as team leader all anaemia-related pre-clinical activities, including the development of CERA. As technical expert for erythropoietin he has played a major role in many legal and patent related activities world-wide. Besides his involvement in anaemia research and development, Dr Haselbeck was also responsible as Program Director for Oncology in Penzberg for in-licensing of products and technologies. Currently he is as Head of New Technologies responsible for external access to technologies in the area of protein therapeutics at Roche Pharma Research in Penzberg, Germany.
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Director, Therapeutic Antibody Research Center,
Korea Research Institute of Bioscience and Biotech, Korea
Hyo Jeong Hong is currently the Director of Therapeutic Antibody Research Center, Korea Research Institute of Bioscience and Biotech. She was educated at Seoul National University where she obtained her Master and Bachelor degree in Science. Upon completion, she went on to pursue Ph.D in Molecular Biology at University of Pittsburgh and at Korea Advanced Institute of Science and Technology. In 1988, she started her first professional career as Research Associate at Genetic Engineering Center at KIST and subsequently at Clinical Cancer Center of University of Wisconsin in USA. In 1990, she returned to Korea to join Protein Engineering Research Group at KRIBB as Senior Research Scientist. In 1995, she became the Head of Laboratory of Antibody Engineering and was promoted to become the Director of Protein Therapeutics Research Center of KRIBB. Dr. Hyo Jeong Hong is currently the Director of Therapeutic Antibody Research Center of KRIBB.
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Dr Normando Iznaga-Escobar, Head Of Division, Business and Development,
Cimab Sa
Dr Iznaga-Escobar received his master in physico-mathematical sciences degree from Moscow State University M. V. Lomonosov in 1989, followed by a training period from 1989-1991 at the Faculty of Science and Technology at the University of Havana. He received his PhD degree on Pharmaceutical Sciences at the University of Havana in 2004.
Dr Iznaga-Escobar joined the Center of Molecular Immunology in Havana, Cuba on February 1992. From February 1992 – September 1995 he served as Fellow Researcher at the Diagnostic Development System Group, from October 2005- December 1997 worked as Associate Researcher at the Division of Antibody Engineering, from January 1998 – February 2001, he was Associate Researcher, and Head of the Department of Product Development, and anti-EGF-R humanized monoclonal antibody h-R3 (nimotuzumab) project manager at the Research Direction, from February 2001- at present he is an Assistant Researcher, and Head of the Division of Business and Development. In July 2004 he became the Global Nimotuzumab project leader.
Dr Iznaga-Escobar is a member of CIMAB business and development team that has successful concluded agreements in the monoclonal antibody and cancer vaccines field in 2003 with Oncoscience AG (Wedel, Germany), in 2004 with CancerVax (Carlsbad, California, USA), Bioven ( Kuala Lumpur, Malaysia), Biocon Biopharmaceutical Ltd (Bangalore, India) and Biotech Pharmaceutical Ltd (Beijing, India), in 2005 with Kuhnil Pharmaceuticals Ltd ( Seoul, South Korea), and Innogene Kalbiotech ( Singapore), and in 2006 with Daiichi Pharmaceuticals Ltd (Tokyo, Japan) and InnoBiologicals ( Kuala Lumpur, Malaysia).
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He has more than 15 year’s experiences in Research, development, and clinical trial of novel biological therapeutics for the treatment of malignant cancer and autoimmune diseases. Together with his team in Shanghai MediPharm, a fully subsidiary of MediBiotech, he successfully launched the first recombinant Tumor Necrosis Therapy antibody for the treatment of malignant lung cancer on China market. He completed 10 key R&D biotech projects supported by Chinese national and local scientific foundations. He has received many academic awards from Chinese government and the city of Shanghai. He has published more than 40 papers in peer-reviewed international journals like Journal of Clinical Oncology, Cancer Research, and Gene Therapy, et al. He has invented more than 15 biotechnologies which are patented in China or United States. Currently he is also a professor of Medicine in College of Life Science, Tongji University, Shanghai, China.
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Head, Business Development and Licensing,
Kirin Pharma
Dr. Shiro Kataoka joined Kirin Brewery in 1985, where he was involved in research directed to the production of G-CSF that led to the establishment of a manufacturing plant for G-CSF for the Asian market. From 1991 to 1994, he studied oncology at the Institute of Molecular and Cellular Biosciences at the University of Tokyo, where he received his Ph.D. in pharmacology. He then returned to Kirin where he was in charge of drug discovery research, and in 1999 he began focusing on the evaluation of targets for human antibody development. From 2001 to 2007, he was the Research Head of the Human Antibody Group for the Pharmaceutical Research Laboratories of Kirin Brewery. From 2004 to 2008, He was Visiting Professor of Gunma University.
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Regulatory Leader,
Octoplus N.V, The Netherlands
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Research Director, Research Center,
Green Cross Corp, Korea
Se-Ho Kim received his B.Sc. from Seoul National University, Korea in 1983 and started his career at the Green Cross Corp., the largest biopharmaceutical company in Korea, where he worked for monoclonal antibodies for diagnostic kit development. Then he received his Ph.D. from the Immunology Department of the Weizmann Institute of Science, Israel in 1997, and after 2 years’ post-doctoral research at the Massachusetts General Hospital in Harvard Medical School he returned to the same company. His research area has been the application of antibodies and currently the focus of his research is therapeutic antibody development using antibody engineering technologies.
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Dr. Masamichi Koike was named President and CEO of BioWa, Inc. on April 1, 2007. For the past 16 years, Dr. Koike has been working on the development of several therapeutic monoclonal antibody (Mab) projects with Kyowa Hakko Kogyo Co., LTD. (Tokyo, Japan).
As a project leader with Kyowa Hakko, Dr. Koike has been instrumental in the discovery, planning and development of antibody programs such as the anti-IL-5 receptor and the anti-CCR4. He has worked alongside industry pioneers throughout the process of developing therapeutic antibodies, including the establishment of murine Mabs, the cloning of the genes, the encoding of Mabs, the pharmacological evaluation of Mabs, the development of bioanalysis method and manufacturing process, as well as GLP TOX study planning, development and administration. He joined BioWa, Inc. in March 2005 as Director, Department of Research and Development, and contributed in filing IND for the company’s anti-IL-5 receptor antibody.
Dr. Koike received his bachelor’s degree in Pharmaceutical Science from University of Tokyo and his doctorate in Immunology from University of Tokyo School of Medicine. Dr. Koike received postdoctoral training in the Program of Biochemistry and Biophysics at University of California, San Francisco, from 1998 to 1999. He holds issued US patents on anti-IL-5 receptor Mab and anti-GM2 Mab, which are in BioWa’s current product pipeline.
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Senior VP and Scientific Director,
Medarex, USA
Nils Lonberg received his Ph.D. from the Department of Biochemistry and Molecular Biology at Harvard University in 1985. He joined GenPharm International in 1990. At GenPharm, Dr. Lonberg’s research group developed a mouse with human antibody genes for the generation of fully human monoclonal antibodies. In 1997 GenPharm became a subsidiary of Medarex, where Dr. Lonberg is now Senior Vice President, Scientific Director.
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Vice President, Business Development,
Reliance Biopharmaceuticals
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Dr Ramakrishnan Maelarkode, Chief Scientific Manager, Research and Development,
Biocon
Ramakrishnan Melarkode completed his PhD in Biochemistry from the University of Mysore, Karnataka, India in 1995. He did his Post Doctoral research in University of Chicago between 1997 and 1999 and conducted research in Yeast Biochemistry. Ramakrishnan’s expertise lies in Protein Purification and Characterisation. He joined Biocon in 1999 and in the first six years co-ordinated projects in Process Development of Statins and immunosuppressants. He has also received training in fermentation, analytical characterization and cell based assays.
For the last three years, he has been working on Process and Drug Development pathways for monoclonal antibodies focusing on disease indications in Cancer and Rheumatoid Arthritis. Ramakrishnan Melarkode is currently the Chief Scientific Manager for Research and Development at Biocon.
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Chief Business Officer,
Avesthagen
Bruce has over 30 years of experience in the fields of General Management, Marketing and Corporate M&A within the global pharmaceutical industry. Since 1975 he has held a number of Senior Management positions with Rhone-Poulenc, AstraZeneca, Pharmacia and Schering-Plough within UK and Asian markets including Japan. He was also involved in the early entry of the pharmaceutical industry into China with a number of joint-ventures.
Since 2002 he has been based in UK and has set up his own pharmaceutical/healthcare consulting business called NMR Ltd, assisting companies and small enterprises enter the UK market. He has been involved as a Non-executive Director of Thermascan Medical Services Ltd, which is now merged into The Chiron Clinic. He also part of the original founding group who set up BiOracle, which is a “Point of Care” diagnostic company founded in 2003.
From 2004 he was Senior Vice-President of Bioaccelerate Inc in London and CEO of a small biotechnology start-up company called GENADERM Ltd. In 2006 Bruce joined Avesthagen Pvt Ltd , a Systems Biotechnology company based in Bangalore, India as Chief Business Officer. They are currently developing a number of “Biosimilars” for the world markets. ( see www.avesthagen.com) He graduated from Nottingham University in 1971 with an Honours Degree in Biological Sciences with Statistics. He has been Chairman of various Pharmaceutical branches of IFPMA and PhRMA. He is currently a member of the Institute of Directors in UK.
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Pharmaceutical Assessor,
MHRA
Liz holds a PhD in Viral Immunology from University of Leicester, and completed postdoctoral studies at the Institute of Virology, University of Glasgow. Liz transferred to government agencies and spent time inspecting laboratories and production facilities before moving to MHRA. Liz is currently an accredited pharmaceutical assessor at the MHRA involved in reviewing and assessing the pharmaceutical component of applications to market biological medicinal products such as monoclonal antibodies, vaccines, blood products and advanced therapies. Liz regularly provides companies with scientific advice and has acted as the UK representative for EMEA Gene Therapy Expert Working Party.
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Co-founder and Chief Medical Officer,
Ganymed Pharma
Ugur Sahin is an expert in oncology and tumor immunology. He studied medicine in Cologne and served as a physician in the hemato-oncology departments at the Universities of Cologne, Hom-burg/ (Saar) and Mainz, Germany. He has a 20 year research experience in the fields of tumor im-munology and molecular oncology. He has pioneered a range of novel approaches for discovery of cancer specific targets and developed several improved methods for antigen specific cancer immu-notherapy. Since 2006 he is professor for experimental and translational Oncology at the Johannes Gutenberg University, Mainz, responsible for the development and clinical translation of novel ap-proaches for cancer immunotherapy. Ugur Sahin is co-founder and chief medical officer of Gany-med Pharmaceuticals, which focusses on the development of therapeutic monoclonal antibodies directed against novel, highly cancer specific targets.
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Director, Epitope Mapping and Protein Mimicry,
PepScan, Netherlands
Did a PhD in Biology studying neuropeptides in snail brains. Directly following his PhD in 1992 he joined the group of Prof. Rob Meloen who is co-inventor of the pepscan method, a now standard tool to map linear B-cell epitopes of antibodies. He co-developed the pepscan technology to what it is today, a powerful tool to map linear, conformational and discontinuous epitopes. Today he is responsible for the socalled CLIPStm epitope mapping, to map complex binding sites and to develop CLIPStm-based immungens that induce functional antibodies against novel target proteins such as GPCR’s.
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Since 1990, Philippe has been active in antibody engineering projects, immunology and bioinformatics research at the University of Brussels. After working as IT-Manager for PE Genscope (curr. Applera, CA), he joined the team for the creation of AlgoNomics. Philippe holds an M.S.E. in biotechnology, a Master in Information Technology and is chairman of the Belgian Association of Bioindustries bio.be
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Director of Research and Development,
MorphoSys AG
Dr. Weidmann joined MorphoSys AG in 2002 as scientist. Since then he had held various positions with increasing responsibility within the R&D department. From 2003 until 2004 Dr. Weidmann was Laboratory Head Protein Supply. In this role Dr. Weidmann was responsible for expression and purification of antibodies in different scales as well as for the technology development in the area of protein expression and purification. In his current position as Director R&D, Dr. Armin Weidmann is responsible for the generation and characterization of therapeutic antibodies in customer related projects. Additional responsibilities include the management of Quality Assurance for the company’s proprietary development programs.
Before joining MorphoSys Dr. Armin Weidmann did his post-doctoral training at the Department of Microbiology and Immunology of the Emory University in Atlanta, GA, USA on molecular virology studying the role of different viral proteins in the pathogenesis of HIV and SIV. He received his PhD in Biochemistry at the University of Würzburg, Germany focusing on the interaction of viral glycoproteins with lympho- and monocytic cells
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Executive Vice President and Chief Scientific Officer,
Dyax Corp, USA
Clive R. Wood, Ph.D. is Executive Vice President and Chief Scientific Officer at Dyax Corp.
He joined Dyax in 2003, after 17 years at Genetics Institute and Wyeth Research. Prior to GI, he spent four years at Celltech Ltd., UK. His research has focused on immunology, inflammation and antibody technologies. Dr. Wood also serves as an adjunct Professor in the Department of Pharmacology and Experimental Therapeutics of Boston University School of Medicine. He received his Biochemistry B.Sc. in addition to his Ph.D. from Imperial College, University of London in 1982 and 1986, respectively.
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Head,
Biologics Consulting Group
Trained as an immunologist and medical doctor and have been working for years as a reviewer for monoclonal antibody division and division of biological oncology product in Center for Drug Evaluation and Research, FDA, the instructor has accumulated lots of expertise in development of biological therapeutic protein drug and knowledge, and experience in regulatory issues associated with biological therapeutic protein drug development. The instructor reviewed antibody-based therapeutic proteins for treatment of varieties of diseases including tumors, autoimmune diseases. In the Division of Monoclonal Antibodies, the instructor was responsible for reviewing pre-BIND, BIND and BLA and performed cGMP facility audit for BLA pre-approval inspection, therefore, gained expertise in regulatory issues as well as scientific and technical issues related to development and manufacturing of therapeutic protein, including characterization of the therapeutic protein, establishment of rational specification for lot release, process validation and process modification, assay validation, virus/pathogen clearance, comparability and stability study. As an excellent immunologist with strong research ability, the instructor is particularly good at assay development for therapeutic protein that is extremely critical for biologic drug development. Every step of the biologic drug development in pharmacology, toxicology, CMC or clinical field involves development of rational assays that meet the scientific and regulatory requirement.
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Nils Lonberg
SVP & Scientific Director
Medarex, USA
Ya Jun Guo
Director
Shanghai Cell Engineering & Antibody Centre, China
Patrick Baeuerle
Chief Scientific Officer
Micromet, Germany
Rob Crombie
COO & VP of Business Development
Arana Therapeutics, Australia
Clive Wood
Executive VP & Chief Scientific Officer
Dyax, USA
Michael Buschle
President, Biologics
Glenmark Pharmaceuticals, India
Dianwu Ju
CEO
MediPharma Biotech, China
Masamichi Koike
President & CEO
BioWa, Kyowa Hakko, Japan
Armin Weidemann
Director, R&D
Morphosys, Germany
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sponsorship opportunities
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Target your market
For details contact Colin Zheng on 65 6322 2763 or send an email
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