Speakers

George Lovrecz, Professor, CSIRO Manufacturing, Australia

Professor George Lovrecz is a Senior Principal Research Scientist at CSIRO. Manufacturing with over 30 years of experience in fermentation, specialising in the scale-up of mammalian cell cultures. George provides expertise in the area of large- scale production, optimisation, development and characterisation of recombinant proteins for internal and external research collaborators both for academic and industrial projects. His laboratory has ISO9001 and veterinary cGMP accreditations to provide quality material for pre-clinical, toxicology and up to Phase-I clinical trials. Read more..

Alois Jungbauer, Professor, Department of Biotechnology, University of Natural Resources and Life Sciences, Austria

Alois focussed on Protein Technology and Downstream Processing and Bioprocess Engineering. He also acts as area head and Dep. Director of Research in the Austrian Centre of Industrial Biotechnology. Read more..

Kara Calhoun, Head of I-Labs, PT Innovation, Technology, & MSAT, Genentech, USA

Kara Calhoun is a Director and Head of I-Labs in Roche’s Pharma Technical (PT) Innovation, Technology, and MSAT organization. Kara’s agile team create and manage shared use spaces for the Roche PT community to experiment with manufacturing technologies. Previously, Kara led a group of cell culture and purification bioprocess experts in Global MSAT focusing on network technical solutions and standardization. She was a member of the Drug Substance External Manufacturing leadership team overseeing numerous tech transfers to CMO partners for commercial products. Kara has 20 years’ experience in bioprocess technologies including cell culture process development, live virus vaccine development, cell-free protein synthesis, process impact on product quality (glycosylation), and approaches for accelerated CMC development and tech transfer. Kara received her undergraduate degree from Princeton University and her Ph.D. from Stanford University, both in Chemical Engineering. Read more..

Wen-Li Chung, Quality Control Scientist, Genentech, USA
David Smith, CCO, Healios KK, Japan

After working as pharmacist, David W. Smith experienced various roles in pharmaceutical industries. Since 2002 he has involved in a cell therapy contract manufacturing business, then served as the Vice President, Global Business Development for Lonza Corporation, one of the largest cell therapy manufacturing service organization in the industry. He became a Director and Chief Commercial Officer of Healios in 2018. Read more..

Li Jiangqing, Founder & CSO, HeBei Senlang Biotechnology Inc. Ltd, China

Li Jiangqing is currently the Founder and Chief Scientific Officer of HeBei Senlang Biotechnology Inc. Ltd. He is also serving as Adjunct Professor of Second Hospital of Hebei Medical University. He obtained his PhD in Immunology at University of Wuerzburg, Germany and M.Sc in Immunology from Peking Union Medical College, China. His main research focus areas are gene modified adoptive T cell therapy, in vitro expansion and gene editing of Hematopoietic stem cells and Transplant Immunology. Read more..

Chris Sweeney, Associate Director, Kalbio Global Medika, Indonesia

Chris Sweeney is a biopharma professional with over 30 years’ experience in the industry. He has worked in practically every aspect of the industry and can cover such diverse range of topics from cell line generation, cell bank generation, process development, facility design, process design, validation, quality management system generation and implementation, cell culture, bioreactors, roller bottles, purification and fill finish. In 2004, he was the EU GMP expert for ASEAN and trained the ASEAN Health Authorities in PIC/S GMP. These included Thai FDA, Philippine FDA, Indonesian BPOM and Vietnamese DAV. At present, he works for Kalbe (one of the largest independent pharma companies in SouthEast Asia), where he designed, built, validated and started up a multiple international award-winning facility. Read more..

Uwe Gottschalk, Chief Scientific Officer, Lonza, Switzerland

Uwe Gottschalk is Chief Scientific Officer (CSO) at Lonza since July 2017. Between 2014 and 2017 he served as a Chief Technology Officer where he established and led the global Research and Technology organization of Lonza Pharma/Biotech. Before joining Lonza, he served as Group Vice President at Sartorius Stedim Biotech between 2004 and 2014 with a global responsibility for all bioseparation-related process technology. He worked in different capacities for Bayer Health Care from 1991 to 2004, overseeing the process development and manufacturing of biopharmaceutical products such as monoclonal antibodies and other recombinant proteins. Uwe earned his M.Sc and PhD in Chemistry at the University of Münster, Germany and Nottingham, UK, delivering his dissertation on drug targeting with monoclonal antibodies. He has written extensively in the areas of downstream processing, industrial biotechnology and somatic gene therapy. In academia, Dr. Gottschalk is currently Head Lecturer at the University of Duisburg-Essen (Germany) and also lectured at the Ecole Polytechnique Fédérale de Lausanne (EPFL) in Lausanne (Switzerland). Dr. Gottschalk was board member of the VBU Association of German Biotech Companies between 2006 and 2010. He sits on the editorial advisory boards of Pharmaceutical Bioprocessing, Genetic Engineering News and BioPharm International. He is honorary member of the Society for BioChromatography and Nanoseparations, member of the Management Pool at the Institut of Marketing, University of St. Gallen (HSG) and member of the American Chemical Society (ACS). Read more..

Uwe Voelker, Site Head, Sterile Drug Product Manufacturing, , Roche, Germany
Garry Takle, Associate Vice President, Biologics and Vaccines Analytics, Merck & Co., USA
Yong Jick Kim, Vice Chairman, CTO, Polus Inc., Korea
Ravishankar Kasturi, Vice President - Operations and Process Development, Reliance Life Sciences, India

Ravishankar Kasturi is Vice President - Operations and Process Development at Reliance Life Sciences in Navi Mumbai, India. He manage all aspects of process development and GMP manufacturing to produce biosimilars for clinical and commercial supplies. The portfolio of products include proteins derived from microbial fermentation and mammalian cell culture covering cytokines, monoclonal antibodies, hormones and glyco proteins. His prior assignments were at Dr Reddy’s Biologics,. Hyderabad, and Uni- Sankyo ltd,. Hyderabad. He received his M.Tech in Bio-Chemical Engineering from Andhra University , Vishakhapatnam and his Bachelors in Pharmacy from Gulbarga University , India. Read more..

Cecie Jiang, Vice President of Quality, Shanghai Henlius Biotech, China

Cecie Jiang has over 20 years of leadership experience in the pharmaceutical, medical device, and biotech industries with strong knowledge in quality system management, manufacturing transfers, QC Laboratories, and validations. She has successfully led multiple global regulatory inspections and ISO audits for different companies. Cecie received her Master degree in Microbiology from the University of Wisconsin – Madison. She is the Vice President of Global Quality Operation in Henlius Biopharma. Prior to joining Henlius, she has served as the Vice President of Global Quality and Compliance for TWi Pharmaceuticals, Director of Quality for several companies including Boehringer Ingelheim, Stryker, Aphena Pharma Solutions. She also worked at Novartis, Perrigo and Bristol-Myers Squibb as QO Project Manager, QC Sr. Supervisor, and Process Engineer. Read more..

Jerry Dong, Vice President CMC Operations, Shanghai Henlius Biotech, China

Zhengyu (Jerry) Dong is Vice President, CMC Operations at Shanghai Henlius Biopharma, Inc. In this role, he is responsible for overall product development CMC strategy and oversees CMC project management from clinical stages to commercialization. Dr. Dong obtained his BS in Chemistry from Peking University in China and Ph.D. in Biochemistry from the University of Wyoming in US. He conducted his post-doctoral training at the Washington University School of Medicine in US. He has over 23 years of experience in biopharmaceutical CMC development. Dr. Dong previously worked in the areas of vaccine and biologics development at Merck Research Labs, Genentech Inc. and Gilead Sciences. He has extensive experience in the biologics analytical development and characterization, overall product control system , Quality Management System, process controls and validation, global pharmaceutical cGMP regulations as well as technology transfer and outsourcing management. In his professional career, Dr. Dong has contributed to the CMC development of multiple commercial biologics and played numerous leadership roles by leading both functional and cross-functional teams and has led many strategic initiatives to improve CMC development efficiency while maintaining product quality. Read more..

Amit Jogi, Associate Director, Syngene International, India
Terence Teo, Business Development Manager, SEA, Pall Filtration Pte Ltd
Hendri Tjandra, Senior Staff Scientist, Bayer
Matthew Choo, Analytical Chemist and Data Scientist, Bioprocessing Technology Institute (BTI), A*STAR, Singapore
Lucas Chan, Chief Scientific Officer and Co-founder, CellVec Pte Ltd, Singapore

Lucas Chan co-founded CellVec private limited in August 2018 having spent 15 years at King’s College London. As Senior Investigator he developed the first bench-to- bedside clinical application of a gene-modified whole cell vaccine for Acute Myeloid Leukaemia. He became Head of Manufacture for Advanced Therapies at King’s, where he established the first GMP-compliant lentiviral vector manufacturing process in Europe and oversaw production of a range of Advanced Therapy Medicinal Products including multiple productions of clinical viral vector batches for early phase studies in Europe. He received his PhD in molecular biology and gene therapy from Imperial College London and is a Fellow of the Royal Society of Biology. Read more..

Horst Ruppach, Scientific Director Viral Pathogen Safety, Biologics Testing Solutions, Charles River, Germany

Horst Ruppach studied chemistry at the University of Cologne and the University of Marburg, Germany and earned his PhD in Virology (HIV). He has more than 25 years of experience in the field of virology and is a proven expert for technical and regulatory aspects of virus safety testing and virus/prion clearances studies. Read more..

Narasimha Rao Nedunuri, Managing Director, Clonz Biotech, India

Narasimha Rao Nedunuri is one of the founding members of CLONZ Biotech, an 8 year old Clinical stage Biosimilar Monoclonal Antibody start-up company based in Genome Valley, Hyderabad, India. He is currently serving the company as the Managing Director & CEO. Nedunuri, a Molecular Biologist turned Entrepreneur has 18 years of experience in the field of Life Sciences Research including Cancer Biology, Proteomics, and Molecular diagnostics. He also had business experience in a USA based company, with the responsibility of establishing the business for new product range for its Indian subsidiary. Nedunuri at CLONZ, along with the co-promoters coming from recognized leaders who launched complex Biosimilar MAbs, driving the company to emerge as a significant Global Biosimilar MAb company. Read more..

Andras Guttman, Senior Manager Applications, CE, SCIEX , USA

András Guttman, MTA-PE Lendület Professor of Translational Glycomics, is the head of the Horváth Csaba Memorial Institute of Bioanalytical Research in University of Debrecen, Hungary. He contributes to the separation/application efforts at Sciex. His work is focused on capillary electrophoresis and CE-MS based glycomics as well as glycoproteomics analysis of molecules of biomedical and biopharmaceutical interests. Dr Guttman had previous academic appointments at Northeastern University (Boston, MA) and at University of Innsbruck (Austria) holding the Marie Curie Chair of the European Commission. His former industrial affiliations included Novartis (La Jolla, CA), Genetic BioSystems (San Diego, CA), and Beckman Instruments (Fullerton, CA), where he developed high-resolution capillary electrophoresis and microfluidics based bioanalytical methods. Professor Guttman has close to 300 scientific publications, wrote 35 book chapters, edited 4 textbooks and holds 23 patents. He is a member of the Hungarian Academy of Sciences, past president of the American Chemical Society Hungary Chapter, on the board of the Society of Hungarian Academicians in America, associate director of CASSS and serves on the editorial boards of a dozen international scientific journals. Dr. Guttman graduated from University of Veszprem (Hungary) in chemical engineering, where he also received his doctoral degree. Professor Guttman has been recognized by numerous awards including the Analytical Chemistry Award of the Hungarian Chemical Society (2000), named as Fulbright Scholar of the US Department of State (2012), received the CASSS CE Pharm Award, the Arany Janos Medal of the Hungarian Academy of Sciences, the Pro Scientia award of University of Pannonia in 2013, and the Dennis Gabor Award of the Novofer Foundation (2014). Dr Guttman is also the recipient of the 2017 Dal Nogare Award of the Delaware Valley Chromatography Forum. Read more..

Rahul Fadnis, Head of Viral Testing Facility, Syngene International, India

Rahul S. Fadnis, PhD, is a biotech professional with over 15 years of industry experience in the areas of Viral Safety, Clearance and Vaccine Development. He heads the Viral Testing Facility at Syngene International Limited that offers the Viral Clearance and Safety studies to Indian and Global Biopharma Industry. Previously, he worked for Biocon Limited for over 7 years and was leading the Biosafety group at the R&D centre. His work focussed on conducting viral clearance studies on the downstream manufacturing process for recombinant proteins, novel as well as biosimilars. Rahul also holds experience of conducting the cell bank characterization studies on the mammalian cell banks expressing therapeutic recombinant proteins. Being virologist by profession Rahul was actively involved in the development of viral assays for in-vitro and molecular-based platforms for detection of retro and adventitious viruses from recombinant protein products expressed in mammalian systems. He has been instrumental in the development of sensitive assays for the detection of residual DNA from protein product intermediates of a manufacturing process. He has also worked with Ranbaxy and Serum Institute of India, Pune, India to work on bacterial vaccine manufacturing. He has completed his PhD from National Institute of Virology, Pune, India. Rahul has several publications in peer-reviewed journals and patent to his name. He is an active participant in viral safety forums held globally. Read more..

Paul Tan, Head of Manufacturing Excellence, Takeda, Singapore

Paul Tan is currently serving as the Head of Manufacturing Excellence at Takeda, Singapore and is leading Advate production in SN2 and working on the technology transfer of SHP655 to SN2. Prior to this, he was Manufacturing Manager of Manufacturing Suite 2 and had led the department to successful licensure of Rixubis. Prior to Shire, he held various Manufacturing roles in Lonza, Human Genome Sciences (now GSK), with 13 years of industrial experience. Paul is a key member in 3 startup biologics projects and has worked on more than 9 biologics products at commercial scale. He holds a B.Eng Chemical Engineering and M.Sc Industrial and Systems Engineering from the National University of Singapore. Read more..

Bryson Wilkes, Senior Global Product Manager, Thermo Fisher Scientific

Bryson Wilkes received his degree in Business Marketing from the Jon M. Huntsman School of Business, and is currently Sr. Global Product Manager for new product development at Thermo Fisher Scientifics’ Bioprocess Production group, Single Use Technologies Business. He has over 8 years of experience in the bioprocessing industry with 13 years in the medical industry. Read more..

Thomas Laue, Emeritus Professor, University of New Hampshire, USA

Tom Laue is the Emeritus Carpenter Professor of Molecular, Cellular and Biomedical Sciences, and Emeritus Professor of Material Sciences at the University of New Hampshire. He is the Founder and Emeritus Director of the Biomolecular Interaction Technologies Center. Tom received his bachelor’s degree in Natural Sciences from the Johns Hopkins University in 1971 and his Ph.D. in Biophysics and Biochemistry from the University of Connecticut in 1981. His post-doctoral studies were conducted at the University of Oklahoma. Between 1969 and 1975, he worked as a technician in the deep space program of NASA. His work has focused on instrument and method development for the analytical ultracentrifuge and analytical electrophoresis. Data from these instruments have contributed to over 3900 publications since 1980. Read more..

Wei-Chun (Wesley) Wang, Vice President of Biologics Process Development, WuXi Biologics, China

Dr. Wei-Chun (Wesley) Wang joined WuXi Biologics at 2015 as the Vice President of Biologics Process Development at Wuxi campus. Dr. Wang has more than 30 years of biopharmaceutical industry experience in the United States including 19 years at Amgen. At Amgen Dr. Wang had taken on roles with increasing responsibilities within the Process & Product Development function in Operations. Dr. Wang has extensive CMC leadership experience in overseeing cross- functional teams in successfully completing the drafting of CMC sections for BLA/BLAa of late phase and commercial stage mAb and Fc-fusion protein projects. He was also the key author in crafting many responses to RTQ questions from the FDA, EMA, PMDA and many other regulatory agencies around the globe. Dr. Wang is a recognized expert in analytical development and product characterization of mammalian expressed glycoproteins. Dr. Wang has a Ph.D. in Biochemistry from University of Georgia and was a Postdoctoral Fellow in the Glycobiology/Chemistry program at La Jolla Cancer Research Foundation, California (now Sanford-Burnham Medical Research Institute). He also worked at Bristol-Myer Squibb and Immunex before joined Amgen. Read more..

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