Alahari Arunakumari, Senior Director
Medarex USA
Dr. Alahari Arunakumari is currently working at Medarex, NJ as Senior Director of Process Development Department, focusing on the development and transfer of cell culture and purification processes to internal manufacturing as well as outside CMOs. She has held different corporate positions in Biotech and Pharmaceutical companies in US for the past 16 years. She has extensive and collective experience in microbial fermentation, mammalian cell culture and purification of biologics at Enzon Inc., BMS and Medarex. At Medarex she has been conducting process research and optimization for Humab integrated process designs with CHO cell culture processes in combination with non-ProteinA platform technologies to reduce manufacturing timelines and improve the production economics.
Ansbert Gadicke, Founder & General Partner
MPM Group, USA
Dr Gadicke originally trained as a physician and subsequently held post-doctoral research positions at Harvard University and MIT. To gain business experience, Dr Gadicke then spent three years as a consultant with the Boston Consulting Group (BCG), where he worked with top management from pharmaceutical, diagnostic, biotechnology and health
insurance companies, in the areas of business strategy, pharmaceutical product development, marketing, company valuation and acquisitions.
In 1992, Dr Gadicke left BCG & founded MPM. For some time, MPM continued part of the work Gadicke had done at BCG, ultimately recruiting one of its clients, Dr. Michael Steinmetz, the global head of Biotechnology at Hoffmann-LaRoche, to join the firm and to help raise the first venture fund, BioVentures I, in 1997. Nobel laureate, Dr. David Baltimore, was then recruited as the chair of the medical and scientific advisory board.
MPM capital is now one of the world's largest dedicated investors in life sciences with committed capital of more than $2.5 billion. MPM is uniquely structured to invest globally in healthcare innovation. In addition to its BioVentures family of venture capital funds, MPM invests in the public markets through its BioEquities hedge fund.
Anthony V. Sollazo, Industry Solutions Manager - Life Sciences Asia Pacific
Rockwell Automation, Hong Kong
Anthony Sollazo has been an employee of Rockwell Automation for nearly 15 years. He began his career as an application engineer and since has held several positions of increasing responsibility in engineering, marketing and sales.
His experience in Life Sciences in the company began 8 years ago focusing on helping the global Life Sciences Companies develop manufacturing strategies towards achieving manufacturing excellence.
Over the last 5 years he was a Global Account Manager for one of the world's largest pharmaceutical companies. In June of 2008 he assumed a new role in Asia as Rockwell Automation's Life Sciences Industry Solutions Manager for Asia Pacific based in Hong Kong.
Christophe Tournerie, Executive Director, Clinical Research-Asia,
PharmaNet, Singapore
Dan Slone, Senior Director, Manufacturing Purification
Celltrion Korea
Dr Slone has spent over 30 years in licensed commercial scale protein purifications. The past 20 years in Mab purification. His experience includes design, process fit, technical transfers in new and established facilities. He has held positions in US, Europe and currently in Celltrion, Inc. in So. Korea. Former companies are Coulter Immunology, Biogen-Idec, Biotest AG, Merieux Institute. His purification experience spans processing milliliter to 15K Liters scale from human mammalian, and plant origin. Currently he is responsible for Celltrion’s downstream operations as a CMO that evolved from a construction site to first FDA licensed facility So. Korea, this in under 36 months.
Dr Slone has, in addition, responsibilities in assisting in the design and process fit for the 2 new Celltrion facilities 4 x 4.5K and 6 x 15K that are in final modes of construction. His experience includes all levels of validation from equipment through process including virus validations and cell culture operations.
David Glover, Director, Bioprocess R&D
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.
David Mashaal, Vice President of Global Business Development
SciGen Ltd, Singapore
David Zhao, Technical Director for Media Development
Invitrogen USA
Donald F. Gerson, COO & President, Technology & Manufacturing Divisional Group
Celltrion Korea
George Lovrecz, Project Leader, Fermentation Group
CSIRO Molecular and Health Technologies, Australia
Dr George Lovrecz is a Senior Principal Research Scientist at CSIRO Molecular and Health Technologies with 25+ years experience in fermentation, specialising in mammalian cell cultures. His early projects involved the development of an on-line computer-linked control for bioreactors using novel techniques and the scale-up and GMP production of human growth hormone (hGH) at the University of New South Wales in conjunction with Commonwealth Serum Laboratories (CSL) and the Garvan Institute. Later he become responsible for the operation of the Recombinant Products Laboratories at UNSW. He joined CSIRO in 1995 as the Head of the Fermentation Group in Parkville. George provides expertise in the area of large-scale production, optimisation, development and characterisation of recombinant proteins for internal and external research collaborators such as programs from CSIRO, WEHI, LICR, PHI, Agenix, etc. He had an integral role in the development of a large-scale production system for mammalian cell receptor glycoproteins, as part of a collaborative effort. The resulting achievements of this work included the 3D structure of hIR and EGF receptor fragments the first published instance from this receptor family. George also has been involved in several patents/publications and teaching and training and various organisations.
Gerhard Klement, CEO & President of Biopharmaceuticals
Reliance Life Sciences India
Gerhard F. Klement currently serves as CEO & President for Reliance Biopharmaceuticals. Reliance Biopharmaceuticals is part of Reliance Industries, the largest company in India. He is with Reliance since July 2006. The main goal of Reliance is to establish a global Biotechnology company. Within his role he is responsible for the production of recombinant Proteins and MAB, Blood Plasma Products, Vaccines and API’S.
Prior to joining Reliance he served as VP Manufacturing & Technical Operations for ALTUS Pharmaceuticals. Within this role he was leading the manufacturing, process development, formulation and analytical operations for ALTUS.
Mr. Klement served as Chief Technology Officer for the worldwide Biologics and Chemicals Group at Lonza, where he was responsible for new technologies and business development. From 2003 to 2005 Mr. Klement was the Head of Operations, USA and Chief Operating Officer Biopharmaceuticals, Worldwide at Lonza Biologics.
Previously, Mr. Klement held various positions in manufacturing and engineering at Serono and Centocor. Mr. Klement also serves on the Scientific Advisory Board of the New Hampshire Chamber of Commerce and the Scientific Advisory Board of Laureate Pharmaceuticals. He served as well on the board of directors for the New Hampshire. Mr. Klement holds a B.SC. from the University of Agriculture in Vienna, Austria. He received executive training in general management and leadership from IMD and Babson College.
Gordon Binder, Managing Director, Coastview Capital, USAFounder & former CEO, Amgen Inc, USA
Gordon Binder, founder and former CEO of California-based Amgen, is among biotech’s most respected business minds, owing to his shepherding of Amgen to the world’s largest biotech today. Under his leadership, the breakthrough recombinant human erythropoietin (Epogen), treatment for anemia in kidney disease patients, became the biotech industry’s blockbuster product with sales surpassing $2 billion in 2001.
Mr Binder has been chairman of both BIO and Pharmaceutical Research and Manufacturers of America (PhRMA), and he is currently on the boards of Massachusetts Institute of Technology, the California Institute of Technology and the American Enterprise Institute. In 2000, Mr Binder retired from Amgen but his clear biotech vision combined with his sharp financial mind led him to another new chapter in his career as he founded Coastview Capital, a venture capital firm that invests in biotech companies, where is he is currently Managing Director. In recognition of his outstanding achievements in the biotech business, he won the 2005 Global Leadership Award by Biotechnology Roundtable.
Günter Jagschies, Director Customer Applications R&D,
GE Healthcare LifeSciences, Sweden
Harish Iyer, General Manager R&D
Biocon India
Harish Iyer is the Head of R&D at Biocon where he has been since 2001. He has worked on numerous projects at Biocon including recombinant human insulin, BioMAb EGFR antibody and is currently working on discovery development projects such as oral insulin and other novel biologics in the Biocon R&D pipeline. Prior to joining Biocon, Harish worked in Process Sciences at Genentech, South San Francisco and Biogen-IDEC, San Diego. He graduated in 1995 with a Ph.D. in Chemical Engineering from the Rensselaer Polytechnic Institute, Troy, New York. He also has a Bachelor’s degree in Chemical Engineering from the Indian Institute of Technology, Madras.
James Miller, VP & GM, Singapore Product Operations
Genentech Singapore
James Miller, 49, joined Genentech in December 2005 as vice president, South San Francisco Biochemical Manufacturing responsible for the production of clinical and commercial proteins using recombinant and bacterial cell technology. He has recently accepted a new assignment as vice president and general manager, Singapore Product Operations. He and his family will be relocating to Singapore in 2008.
Miller joined Genentech from Centocor Biologics, a division of Johnson & Johnson, where he served as General Manager. Miller has held several other executive level positions in the BioPharma industry as Managing Director at Wyeth and Chiron Corporation, as well as a variety of manufacturing leadership positions at Invitron Corporation, UniLever, Schering-Plough Corporation, and Emerson Electric.
Jim brings 26 years of leadership experience in manufacturing and engineering to Genentech. His experience in all aspects of biotech manufacturing will benefit the company’s clinical and commercial protein production operations. He is well versed in Design Excellence, Six Sigma and Lean Manufacturing.
Miller is past Chairman of the Board of Directors of the Center for Emerging Technologies in St. Louis Missouri and was Board Member of the Missouri Biotechnology Association.
James Garner, Vice President of Clinical & Medical Affairs
Progen Pharmaceutical, Australia
Jason Gale, Team Leader, Health and Science Asia
Bloomberg Singapore
Jason Gale, a Bloomberg News team leader, is responsible for coverage of health care and science in Asia. Jason, a University of Adelaide graduate, has been with Bloomberg News since 2000, covering health care, agriculture, mining, companies, markets and general news from Melbourne and Singapore. He currently oversees a team of reporters in New Delhi, Tokyo, Jarkarta and Singapore covering pharmaceutical and biotechnology companies across Asia as well as public health issues and emerging infectious diseases.
Jason started his career writing for the Australian Holstein Journal. He later held positions as a regional correspondent for the Stock Journal, where he won the South Australian Rural Media Association's Best Human Interest Story award, and then as an editor of Alternative Farming and The Grower magazines at Rural Press Ltd. In 1998, he worked in the Australian Barley Board's communications office in Adelaide before joining Bloomberg in Melbourne.
Joseph Tarnowski, SVP, Biologics Manufacturing & Process Development
Bristol-Myers Squibb USA
In 2006, S. Joseph Tarnowski, Ph.D., joined Bristol-Myers Squibb in the newly created position of Senior Vice President, Biologics Manufacturing and Process Development, Technical Operations. In this role, Joe has responsibility for continuing to build the manufacturing capabilities needed to supply the company’s current and future biologic medicines to worldwide markets, including the construction of the Company’s new large-scale multi-product bulk biologics manufacturing facility in Devens, Massachusetts.
Joe has extensive experience in biologics. Prior to joining Bristol-Myers Squibb, he was at ImClone Systems, Inc, where he was Senior Vice President, Manufacturing Operations and Product Development. At ImClone Systems he was a member of the Executive Steering Committee and served as the chairperson of the company’s Biologics Operations Steering Committee. Joe joined ImClone Systems in 1999 as Vice President, Product and Process Development.
Earlier, Joe was Chief Technical Officer and Senior Vice President of Research, Development, and Engineering for CellPro, Inc. Before that, he was Director, Process and Product Development at Scios, Inc. Prior to joining Scios, Joe was Director, Process Development and Improvement at Interferon Sciences, Inc., and before that he held various roles of increasing responsibility at Hoffmann-La Roche, Inc., including Research Section Chief, Bioprocess Development, Technical Operations, where he was involved in the scale-up and process development of proteins.
Joe earned a BS degree in Chemistry from Southeast Missouri State University and a Ph.D in Biochemistry from the University of Tennessee, Center for the Health Sciences.
Jun Yamaya, Vice President, CMC R&D Laboratories, Production Division
Kirin Pharma Japan
Jun Yamaya is the general manager (Vice President) of Kirin Pharma’s CMC R&D Laboratories, which are responsible for all CMC-related R&D activities for Kirin including the manufacture of investigational products both in-house and on contract. The facility in Takasaki, Japan, has a 2,000L GMP-compatible fermenter producing antibody APIs for clinical studies.
Before taking the current position, Dr. Yamaya’s professional experiences
include: the head of regulatory audit group, the head of overseas clinical development activities, and the President of Gemini Science, Inc., a US subsidiary of Kirin Pharma. He negotiated the antibody technology tie-up deal with Medarex, which resulted in the creation of KM-Mouse(r) and provided opportunities for Kirin to commercialize its proprietary
TC-Mouse(r) technology. He received a Ph.D. in molecular biology from Tokyo University and an executive MBA from San Diego State University. He speaks Japanese and English, but, unfortunately, not Chinese.
Kirin Pharma is the pharmaceutical business arm of Kirin Holdings (formerly Kirin Brewery). In April 2008, Kirin acquired a majority share of Kyowa Hakko Kogyo, another strong biotechnology company in Japan, and will merge Kirin Pharma into Kyowa to create a new global biotechnology-based pharmaceutical company, Kyowa Hakko Kirin, in October 2008.
Lorraine Hahn, Journalist & TV presenter, Former TV Talk show host & Anchor
CNN and CNBC, Hong Kong
Ms. Hahn is based in Hong Kong having spent her journalist career focused on Asian business issues. Her reputation developed over 20 years as a prominent journalist, presenter and talk-show host, most recently with CNN. Ms Hahn is an experienced moderator, interviewing business leaders, heads of state and other personalities. She was named "highly commended news presenter/anchor" at the Asian TV Awards in December 1999
Ms. Hahn was host of CNN International's regional chat show, Talk Asia until November 2006. She previously anchored CNN’s long-running Asia TV programme, CNN's Biz Asia (1998 -2000). Ms Hahn also spent 3 years at CNBC hosting its flagship program, Business Tonight, as well as The Winners, Talk of Asia and NBC Asia Evening News. She also covered the historic Hong Kong 1997 handover.
Before CNBC, she was a senior producer and anchor in Hong Kong for Television Broadcasts Ltd. (TVB). Ms. Hahn entered television broadcasting as a senior reporter and anchor for TVB's general and financial news units in 1988 before moving on to the English-language, daily program, The Financial Report. Her career in broadcasting began with Hong Kong's Commercial Broadcasting Corporation. She has lectured at Hong Kong University and gives talks on journalism and media. Ms Hahn also holds a degree in Business and English Literature from the University of British Columbia, Vancouver. She was born in Singapore & subsequently emigrated to Canada.
Michael Brown, VP Operations and Site Manager
Lonza Biologics Singapore
Michael Brown is VP of Operations and Site Head for Lonza Biologics in Singapore, responsible for the new commercial manufacturing site under construction in Tuas. Mike recently relocated from the Lonza UK site where he was Site Head responsible for small scale clinical and commercial GMP manufacturing of recombinant proteins and therapeutic monoclonal antibodies. Previous roles within Lonza have been based in Research and Development specialising in fermentation optimisation of mammalian cell cultures, primary separation technologies, process transfer into manufacturing and scale-up of processes from 200 to 20,000 L. Once a microbial physiologist, Mike had several roles in R&D at Celltech Biologics and has a Ph.D. in Microbiology from the University of Surrey, UK.
Murali K. Prahalad, Vice President, Molecular Biology Essentials
Invitrogen Corporation, USA
Dr. Prahalad currently holds the title of Vice President, Molecular Biology Essentials at Invitrogen Corporation (Nasdaq: IVGN), a global leader in reagents and tools for life science and biomedical research. In this role, he is responsible for the general management of Invitrogen’s Transfection and Selection, Nucleic Acid Separations, Cloning and Competent Cells, Custom Primers and Bioinformatics businesses. Dr. Prahalad joined Invitrogen in April of 2005 as a Director in the Corporate Development Group where his primary responsibilities focused on mergers and acquisitions. Prior to assuming his current role in July of 2007, Dr. Prahalad coordinated all of Invitrogen's in-licensing activities for nearly two years.
Prior to joining Invitrogen, Dr. Prahalad was the Vice President of Business Development for Sequenom Inc., a San Diego, CA-based biotechnology company. His professional experience also spans management consulting and information technology. He was a consultant with The Advisory Board Company in Washington, D.C. and later was a Co-Founder of zGraffiti, Inc., a McLean, Virginia based software firm specializing in CRM solutions for online retailers. Dr. Prahalad completed his B.Sc. with Honors from the University of Michigan in1992. He went on to complete his Masters in Medical Sciences and Doctorate in Biochemistry & Molecular Pharmacology from Harvard University in 1995 and 1998, respectively.
Philippe Kourilsky, Chair of Molecular Immunology, College de FranceFormer Director General, Pasteur Institute, France
An eminent scientist and expert in molecular immunology and tumor immunity, Professor Kourilsky had a rapid scientific career both in the academic and corporate setting. He is the Chair of Molecular Immunology at the College de France and was formerly Director General of the prestigious Pasteur Institute.
Professor Kourilsky was also a co-founder of Transgene, a gene therapy company based in France and was the President of Research of Pasteur Merieux Connaught (today Sanofi Pasteur) from 1993 to 1996. A winner of several scientific awards, he has published over 300 publications, including two reports for the French government and two scientific reference books. He is a member of the Academy of Sciences and l'Academia Europea.
Swapnil Ballal, Head of Biopharmaceutical Bulk Manufacturing
Intas Biopharmaceuticals India
Mr Ballal is currently heading India’s only EMEA approved biopharmaceutical plant at Intas Biopharmaceuticals Ltd where the manufacturing set up included two independent suites for microbial and mammalian cell culture based products. He is also heavily involved in manufacturing microbial and mammalian cell culture based biotherapeutics.
Mr Ballal has been associated with the Indian biotechnology industry for the last 12 years and has served in the area of R&D followed by manufacturing of biotherapeutics. He joined Intas in 2000 to start up the Biotechnology Division and has played a key role in the set up of the R&D division followed by the manufacturing plant for biologics. He is also involved in development of the contract manufacturing business at Intas. Prior to Intas, he was working in the R&D Division of Wockhradt Ltd.
Mr Ballal received his Master of Science in Marine Biotechnology from Goa University in 1995 and currently holds professional membership at PDA and ISPE.
Thibaud Stoll, Head of Global Biopharmaceutical Operations
Norvatis Pharma Switzerland
Thibaud Stoll is Head Global Biopharmaceutical Operations at Novartis. In this function, he manages 6 large-scale facilities around the world, which are in charge of late-stage technical development, clinical and commercial manufacturing of biopharmaceutical and biosimilar active ingredients, using both cell culture and microbial fermentation technologies.
Dr Stoll joined Novartis in 2000 to participate to the start-up of a new large-scale cell-culture facility in Huningue (F), from construction to FDA approval. He became then the Site Head of this facility. In this function, he was responsible for the worldwide manufacturing of Xolair®. Prior to joining Novartis, Thibaud held positions in biotechnology technical development at Genentech, Inc., in California, and in chemical production at Firmenich SA, in Switzerland.
Thibaud Stoll has a Master’s Degree in Chemical Engineering from the Massachusetts Institute of Technology (MIT) and a PhD in Biotechnology from the Swiss Federal Institute of Technology (EPFL) in Lausanne.
Uwe Gottschalk, Vice President, Purification Technologies
Satorius Stedium Biotech Germany
Dr. Gottschalk is Group Vice President, Purification Technologies, with a global responsibility for bioseparation products at Sartorius Stedim Biotech. He worked in different capacities for Bayer Health Care from 1991-2004 and became head of the GMP protein purification facility in Wuppertal (Germany). He was responsible for the production of monoclonal antibodies and other recombinant proteins using various expression systems.
Dr. Gottschalk holds a Ph.D. in Chemistry from the University of Münster. He is member of BioPharm International’s editorial advisory board and has written one book, five book chapters and many other publications in the areas of biotechnology and somatic gene therapy. In academia Dr. Gottschalk is Head Lecturer at the University of Duisburg–Essen (Germany) and also lectures at the Ecole Polytechnique Fédérale de Lausanne EPFL (Lausanne, Switzerland).
Dr. Gottschalk is board member of the VBU Association of German Biotech Companies.
Vincent Hingot, Project & Site Director
GSK Biologicals Singapore
Vincent Hingot is the Project & Site Director for the future GlaxoSmithKline Biologicals Bulk Manufacturing Site in Singapore.
He joined GSK Biologicals in 1991 for antibiotic production, first as Shift Supervisor then as Process & Automation Engineer. In 1997, he became Production Manager for Meningitis bulk vaccines production. In 2000, he was involved in the concept, design, construction and validation of a new bulk manufacturing facility in Wavre (Belgium). He was responsible for process transfer and the start-up of this worldwide supply bulk facility.
In 2005, he was also in charge of a large scale cell culture process scale-up including upstream and downstream processes.
Before joining GSK Biologicals, Vincent worked some years for petrochemical company, Petrofina, as Process Engineer and for IBM as software Developer and Analyst. Vincent holds a Degree in Biotechnology from Meurice Chimie Institute and is Bachelor of Chemical Engineering from University of Bruxelles (ULB).
William Downey, President
HighTech Business Decisions USA
Mr. Downey is president and managing director of HighTech Business Decisions, a consulting company that specializes in market research for business-to-business biotechnology, pharmaceutical manufacturing, medical and electronic products. HighTech Business Decisions has been serving the biopharmaceutical contract manufacturing industry for over ten years. Mr. Downey has over 25 years of industry experience, and he has held various positions in marketing, sales, strategy and finance for both private and public companies. Mr. Downey has a Masters in Business Administration from Washington University in St. Louis and Bachelors from the University of Michigan in Ann Arbor.
Xiaoqiang Li, General Manager
Tasly Jenner Biotech (Tianjin) China
Dr Li has combined experiences in clinical medicine and pharmaceutical biologics. Graduated from medical school in early 80’s in China and finished residency training in the United States. He’s practiced medicine and was responsible for residency training and clinical management. He’s also trained in Molecular Biology and Business Management in US. After 10 years of clinical practice, he came to China to set up his company, engaging in developing vaccine and biologics. He has been responsible for developing one vaccine and three recombinant protein drugs. He was also the general manager of Tianjin Tasly Biotech Venture Capital management Company between 2003 and 2005, and had extensive experiences in valuating and investing in biotech projects.. He is currently the managing director for Tasly-Jenner Biotechnology Co., a company in manufacturing subunit influenza vaccine. He is also the director of Tasly Biopharm Research Institue and Executive VP for Shanghai Tasly Pharmaceutical Co., a company engaging in mammalian cell culture and recombinant protein manufacturing. His main interest is in large scale manufacturing of biologics.
Ya-Jun Guo, Director
Shanghai Cell Engineering and Antibody Centre, China
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.
Suma Ray, Process Development Scientist
Sartorius-Stedim Biotech, India
Dr. Suma Ray is a Process Development Scientist responsible for Viral Clearance and Cell Line Development technologies at Sartorius-Stedim Biotech. She is an active member of the Global Purification Technology Group at Sartorius, focusing on Viral Clearance technology and applications, and also acts as a cell culture specialist. Prior to joining Sartorius, Dr. Ray was responsible for setting up and conducting Viral Clearance studies at Biocon, in India and has expertise in different mammalian cell culture technologies for production of recombinant therapeutic antibodies. Dr. Ray holds a PhD degree from 'All India Institute of Medical Sciences’, New Delhi, followed by post doctorate fellowships from ‘University of Virginia’ and ‘Stanford University School of Medicine’.
Pre and Post Conference Summits
Speaker Line up
Anand Tharmaratnam, Head of Clinical Development, Asia Pacific & CEO, S.E.A.
Quintiles East Asia Singapore
Dr Anand Tharmaratnam graduated in medicine from University College London, UK in 1992, he specialised in anesthesia and is a member of the Royal College of Anesthetists, UK. He joined Quintiles in April 1997 as a clinical pharmacologist at Guys Drug Research Unit, having spent the last 5 years working in anesthesiology and critical care medicine in London.
He was a Medical Director in Quintiles Europe from 1999 to 2001, following when he set up the first global ECG lab outside Europe and the US, in Mumbai in India in 2002, QECG. In 2003 he joined Quintiles Japan and helped set up Quintiles Japan international businesses in Hawaii, Brazil and Peru.
In August 2004 he moved to Singapore as CEO of Quintiles SE Asia, Taiwan and Korea based in Singapore and in 2006 took responsibility for the Quintiles business in Asia Pacific. This is today the largest clinical research organization in the region and it represents the single largest clinical development employer in Asia.
Bruce Register, CEO & President
Trusgen USA
Dr. Register is currently the founding President and CEO of Trusgen, LLC, headquartered in Sparta, New Jersey, USA. His career started at the Salk Institute Biotechnology Industrial Associates when the science of mammalian gene transfer and gene expression was just emerging. In the mid-1980’s, Merck Research Laboratories recruited Dr. Register specifically for his expertise in these new technologies. At Merck, he embarked on a distinguished 17-year research career, which focused on the cloning and expressing of multiple therapeutic gene targets—culminating in numerous scientific breakthroughs, publications, and patents.
In 2002 he transitioned into Merck’s US Human Health sales and marketing division as a scientific liaison for Vioxx. After its withdrawal, Dr. Register joined Bayer HealthCare, as International Medical Director, Global Marketing for OTC analgesics. Dr Register developed and implemented health care professional global marketing strategies and managed global key opinion leaders. In addition, he organized and led Bayer HealthCare’s scientific symposia and advisory boards in the U.S. and Europe. In September 2007, he merged his successful scientific and marketing careers by forming a new company, Trusgen LLC, which creates biologics outsourcing partnerships between biotech and pharmaceutical companies in the U.S. and Europe with CRO/CMOs in Asia.
Fidela Moreno, Senior Director, Global Development Operations
Asia and Latin America, Amgen USA
In her current role, Fidela is responsible for the oversight of Amgen’s clinical trials conduct in Latin America, India, East Asia and Japan. She joined Amgen in 2005, following a successful 12-year career in pharmaceutical medicine at Pfizer in Connecticut and an 8-year academic career as Assistant Professor of Medicine at the University of Utah. While in academia, she was involved in several national and international trials as a clinical investigator, and has more than 80 publications to her name, mostly in first line international medical journals.
Fidela joined Pfizer in 1993 and had increasing responsibilities for several major programs. In 1995, she co-managed Pfizer’s Erectile Dysfunction Program for ViagraTM, wrote the first six clinical trial protocols for the U.S.A. and subsequently managed those studies. In 1996 she served as Asian Medical Director for ViagraTM and CelebrexTM and was based in Hong Kong for 3 years. In 1999, she joined Pfizer’s International Clinical Research Group and was based in Mumbai as Vice-President for Clinical Research, Pfizer-India. She returned to the U.S.A. in June 2000 as Director for Clinical Education, and in January 2001, became Executive Director and Site Head, Development Operations, with responsibilities for Pfizer’s clinical trials in the USA, Canada, Latin America, India and Asia. She retired from Pfizer in mid-2005, but rejoined industry in late 2005 to work on Amgen’s international expansion efforts.
Fidela completed her medical education at the University of Santo Tomas Faculty in Manila, Philippines, Residency in Internal Medicine at the V.A. Hospital, Fellowship in Adult Cardiology at the Philippine Heart Center for Asia and Fellowship in Noninvasive Cardiology at the University of Utah, School of Medicine in Salt Lake City.
George Chen, Medical Director
GSK China/HK Pharmaceuticals China
Dr. Chen currently is GSK’sArea Medical VP and Chief Medical Officer responsible for clinical development , medical affairs, drug safety and medical governance for the GSK China/HK area pharmaceutical business. Prior to the current post, Dr. Chen was a SrCorporate Strategy Advisor responsible for corporate strategic asset management and business development, and a Global Medical Advisor responsible for global oncology product development at Eli Lilly (Indianapolis, USA), respectively. Prior to industry, Dr. Chen was a Principal Investigator at US National Institutes of Health at Bethesda, USA. Dr. Chen received his Medical Doctor from the Shanghai Medical University and his MBA from the Wharton School of the University of Pennsylvania. He had his post graduate medical trainings at Shanghai Cancer Hospital and New York Medical College, respectively. Dr. Chen specializes in Oncology and Immunology. Dr. Chen publish widely in the fields of oncology/immunology research in peer-reviewed international journals. Dr. Chen is a member of American Societyof Clinical Oncology, American Association of Cancer Research and American Association of ImmunologistsGeorge Z Chen, M.D., MBAArea Medical VP and Chief Medical OfficerGSK China/HK
Hajimu Sakamoto, Vice President, Business Development
Artisan Pharma USA
Mr. Sakamoto joined Asahi Kasei Pharma Corporation (formerly Asahi Chemical Industry Co., Ltd.) in 1978 where he first was a researcher in Asahi’s research laboratories. During this period, he developed biotechnology-derived products such as tissue plasminogen activator, tumor necrosis factor, and thrombomodulin. Mr. Sakamoto was also a member of an Expert Working Group of the ICH (International Conference on Harmonization) representing the Japan Pharmaceutical Manufacturers Association and worked for establishing ICH guidelines relating to biotechnology quality issues. He then moved to Licensing and Business Development of Asahi Kasei Pharma Corporation in 1994 where he was responsible for many deals with pharmaceutical companies, including those with GSK, Shering A.G., and Novartis. Most recently, he was the general manager of Licensing and Business Development. Mr. Sakamoto has a master degree in biochemistry and biophysics from Osaka University
Hiroko Tsukamoto, Marketing Director
Asahi Glass Japan
James Garner, VP Clinical & Medical Affairs
Progen Australia
Dr James Garner completed his medical studies at St Mary’s Hospital Medical School in London. He practiced hospital medicine for a number of years in the United Kingdom and in Australia. After several years as a corporate strategy consultant with Bain & Company in Sydney, James joined Biogen Idec (NASDAQ: BIIB) to assume medical responsibilities for the Asia-Pacific region. During his time with Biogen Idec, he advised on the commercial launch of several novel biologic therapies in nine Asian countries, and also participated in managing regional clinical research and business development activities. Currently, his primary area of responsibility is Progen's global clinical development program and he is also involved in providing medical input into activities such as business development and discovery research. In addition to his medical qualifications, James holds a Bachelor of Sciences (with First Class Honours) from University College, London, and a Master of Arts and a Master of Business Administration from the University of Queensland. He also holds a Graduate Certificate in Applied Finance and Investment from the Financial Services Institute of Australasia. He is a Young Fellow of the Royal Society of Medicine (UK) and a member of the Australian Pharmaceutical Physicians Association.
Jay Madan, Vice President of Business Development
Reliance Life Sciences India
Joseph Santangelo, Development Director
SingVax Singapore
Joe Santangelo is a founder, board member and Development Director of SingVax Pte. Ltd (incorporated in 2004), which is a privately held Singapore biotech company focusing on vaccines for human health. His responsibilities at SingVax include management of all development operations as well as defining the corporate product development strategies. Prior to this he served in R&D roles at Microscience Ltd. from its inception as a spin out from Imperial College of Science Technology and Medicine (UK) in 1997. His overall career in microbiology, infectious diseases and fermentation spans more than 25 years. Joe was born, educated and worked in the United States, before moving to South Africa, Germany, the United Kingdom and Singapore. He has worked in both academia and industry, and moved to the biotech sector 10 years ago.
Joe has a B.Sc. from the State University of New York, an M.Sc. from the University of Vermont and a Ph.D. from the University of Cape Town. He was awarded an Alexander von Humboldt fellowship (1993) and is a member of various Microbiology and Biotechnology Societies.
Kochung Lin, CEO
PharmaEssentia Corp. Taiwan
Dr. Ko-Chung Lin, a lead founder of PharmaEssentia Corp., is an accomplished scientist also an effective manger with more than 40 patents and more than 18 successful years of industrial experience including drug discovery and development. Dr. Lin, one of a number of high-profile overseas-based Taiwan bioscientists who returned to Taiwan in recent years to form the core of PharmaEssentia’s management team. PharmaEssentia Corporation established in 2003, by returning scientists from prestigious Big Pharma and biotechnology companies in the west, including Amgen, Aventis, Bristol Myers Squibb, Genentech, Merck, Procter & Gamble Pharmaceutical and FDA. Prior to establish PharmaEssentia Corp., Dr. Lin was a founding member and serving as the head of the drug discovery at Biogen, a prominent and successful biotech company in the US. He has been the lead inventor on many patent applications and is the inventor of their current breakthrough drug candidate, which is in the phase II clinical trial. He is also a co-inventor on numerous enzyme inhibitor patents at a major US pharmaceutical company. He also built a team to develop the chemical manufacturing process for a product at that is on the market Biogen.
Narinder Chopra, Director, Clinical Operations
CombinatoRx Singapore
Mr. Narinder Chopra is currently working at CombinatoRx Singapore as Director of Clinical Operations, focusing on clinical development in infectious diseases and supporting the US clinical operations. He has held a number of clinical operation positions within large and small pharmaceutical companies over the last 8 years developing, executing and reporting on phase II-IV global, regional and local clinical trials. He has worked on studies in rare diseases such as myasthenia gravis, pemphigus vulgaris and lupus nephritis as well as some more common disease areas like Asthma, rhinitis and COPD. He started his career in clinical development with the CRO industry for 3 years.
Nazlee Mohd Kamal, CEO
Inno Biologics Malaysia
Mohd. Nazlee Kamal became Chief-Executive-Officer of Inno Biologics Sdn. Bhd. In December, 2002. Prior to Nazlee’s employment with Inno Biologics, he was the Asean
Business Area Manager (Separation) for Amersham Biosciences. He was leading the sales and marketing effort for Separations product range in ASEAN. He was also responsible for technical issues surrounding the protein separation and purification for laboratory and manufacturing scale. Among his contribution was the product trial at Kirin Pharmaceutical, Japan for second generation Erythropoietin production. Before that he was the Business Development Manager at Sartorius in 2001 after B. Braun Biotech was bought-over by Sartorius. He was the Sales Manager at B. Braun Malaysia from 1997 to 2000. He was instrumental in the business development of B. Braun bioreactors sales and marketing effort in Malaysia. He was a Lecturer at the University of Technology Malaysia from 1986 to 1996.
Nazlee holds a PhD. in Chemical Engineering (Bioprocess) from Univ. of Queensland, Brisbane, Australia. He is a member of several societies including International Society of Pharmaceutical Engineering, Malaysian Biotechnology and Molecular Biology Society and Institution of Chemical Engineers. He is currently member of Advisory Council for Biotechnology Studies at International Islamic University Malaysia.
Nazlee was responsible for the development of Bioprocess Engineering programme at University Technology Malaysia when he was a member of the Bioprocess Engineering Department. He has written numerous papers for journals and presentation at Conferences. He was the inventor of the “External Spinfilter” now marketed by Sartorius BBI Systems.
Paul Anderson, Managing Director
Orthocell Pty Ltd Australia
Paul is CEO of emerging Australian start-up company OrthoCell Pty Ltd and has over 15 years of experience within the health care industry. His expertise lies in bridging the gap between research and clinical practice in the development of emerging medical technologies. This encompasses applying the regulatory framework to the product and the accompanying ‘grey area’ interpretation, rebating pathways, marketing, sales, developing Orthopaedic relationships, strategic planning and financial planning. His strengths also include excellent communication and presentation skills which are integral in the integration of these processes. Paul has a strong track record with his previous board position with Verigen Australia Pty Ltd a human cell therapies company having successfully commercialised Autologous Chondrocyte Technologies in Australian New Zealand And SE Asia. Paul oversaw the growth of the company through to its eventual acquisition in 2005 by Genzyme.
Raymond Chua, Managing Director & Regional Medical Director (Asia Pacific, Oceania & Middle East), Eisai Clinical Research Singapore
Rolf Werner, Corporate Senior VP
Biopharmaceuticals Boehringer Ingelheim, Germany
Prof. Dr. Dr. h.c. Rolf G. Werner is Corporate Senior Vice President of the Corporate Division Biopharmaceuticals at Boehringer Ingelheim GmbH and responsible for the strategic orientation and the worldwide business of biopharmaceuticals of Boehringer Ingelheim. He obtained his M.Sc. in biology at University of Tübingen in 1971. After his scientific work at the Max-Planck Institute for Molecular Genetics in Berlin he obtained his PhD at University of Tübingen in 1973.
In 1982 he became editorial consultant of the journal “Drug Research” and reviews more than 50 scientific publications a year. In 1990 he was appointed as professor at the Faculty of Biology at the University of Tübingen. In 1990 he also became member of the Scientific Board of Biotechnology at the University of Stuttgart and member of the Kuratorium of the Fraunhofer Gesellschaft in Stuttgart. In December 2003 he was appointed as a member of the Board of Trustees of the Boehringer Ingelheim Deutschland GmbH. In January 2004 he received an honorary doctor degree from the University of Chiang Mai in Thailand.
Rose Qiu, Head of Global Clinical Operation, Asia Pacific
Johnson & Johnson, China
Rose completed her training in clinical medicine in China and continued her study in pharmacology with a PhD and post-doc. in University of Toronto and Stanford University. Since entering pharmaceutical industry, Rose has gained extensive experiences in clinical R & D, regulatory affairs and pharmacovigillance. Rose is currently head of global clinical operation, Asia Pacific, Johnson and Johnson. She is responsible to lead the Asia Pacific GCO team to strengthen infrastructure and contribution to the global clinical development programs, ensure optimal resource planning and management of quality, speed and cost efficiency of clinical studies conducted in AP, drive regional strategy and ensure study placement, demonstrate therapeutic area and operation advantages in AP region.
Prior to that, Rose was the head of R & D with Xian-Janssen Pharmaceutical and global clinical organization of J & J, China. She has been instrumental in building the R&D functions, and in establishing the capability and credibility of Xian Janssen in the area of clinical research, regulatory affairs and drug safety.
Ross Horsburgh, Vice President, Global Clinical Development
Kendle, Singapore
Dr Horsburgh is a New Zealand trained physician with a background in general medicine and neuroscience research. Since joining the pharmaceutical industry 14 years ago he has set up and managed global clinical development units in a number of Asia Pacific countries. From 1993 to 1998 he was based in Beijing establishing clinical development units for two multinational companies
Since 1998 Dr Horsburgh has lived in Singapore, initially working for AstraZeneca as Asia Pacific Business Development Director before moving back into R&D mid-2002 as Regional Medical Director and Head, Clinical Research Region Asia Pacific.
S.K. Gupta, Director General & Dean
Institute of Clinical Research, India
Dr S K Gupta is currently Dean, and Director General Institute of Clinical Research (India), which is one of the premier and pioneering Institute in the country. He was formerly Head of the Department of Pharmacology at All India Institute of Medical Sciences, New Delhi and is the founder of National Pharmacovigilance center at AIIMS. In recognition of his outstanding contributions in the field, Dr. Gupta has been nominated as expert-member of a number of committees of DST, DBT, CSIR, ICMR and Ministry of Health and Family Welfare; Govt. of India is a member of governing body of the Central Council of Research in Ayurveda. He has been conferred with prestigious Fellowships of International Society of Eye Research USA and International Academy of Cardiovascular Sciences, Canada. He has been visiting Professor to several prestigious universities in UK, USA, Germany etc. Dr. Gupta has been recipient of prestigious awards and was recently conferred the ‘Distinguished Services Award in Cardiovascular Science, Medicine and Surgery ’ by International Academy of Cardiovascular Sciences, Canada. and Dr. Gupta has several patents to his credit and one of his ophthalmic formulations is being commercialized. At present, Dr. Gupta has been the President of the Indian Society of Pharmacology, Secretary General of International Academy of Cardiovascular Sciences and Member, Executive Committee of the International Society of Heart Research. Dr. Gupta has published more than 250 research papers and edited seven books and have guided more than 150 postgraduate students. Elected fellow of the Indian Pharmacological Society.
Satish Totey, CSO
Stempeutics India
Satish Totey is Director, Manipal Institute of Regenerative medicine and Chief Scientific Officer, Stempeutics research Pvt. Ltd. He did his DVM and MS in Veterinary Medicine and PhD from Jawaharlal Nehru University, New Delhi. He carried out postdoctoral research at University of Wisconsin, Madison and National Institute of Health, Bethesda, Maryland. He spent around 20 years at National Institute of Immunology, New Delhi and his research interest was molecular signaling during pre-implantation embryos. He is pioneered in transgenic research in India and developed more than 17 transgenic mice lines for several human diseases. He also worked on gene knockout and studied TGF beta knockout animals. He was also working on human and ovine growth hormone and expressed these proteins in E.coli and achieved highest ever yield in fed batch culture.
He was among a small number of researchers who pioneered the isolation and characterization of pluripotent stem cells from human embryo, which provided an important framework for the development of human embryonic stem cells
His derived human embryonic stem cells lines have been listed in NIH stem cell registry. He has also developed up-scaling of mesenchymal stem cells and currently conducting phase-I and II clinical trials for myocardial infarction, leg ischemia, cerebral stroke and Multiple Sclerosis.
He has 90 research papers to his credits and 12 US patents.
His research group currently focuses on the extrinsic factors involved in maintenance of the pluripotent state in human embryonic stem cells, and those factors that drive their commitment into progenitor cells representative of the three embryonic germ layers.
Scott M Wheelwright, President
Strategic Manufacturing Worldwide, Inc. USA
Scott M. Wheelwright, Ph.D. is founder and president of Strategic Manufacturing Worldwide, Inc., a consultancy focused on bringing products to market. SMW provides technical expertise to biotech and related industries in the areas of manufacturing, process development, compliance, facilities, and business development, with particular emphasis on strategic planning and projects in Asia.
Dr. Wheelwright has over 20 years experience in solving the challenges companies encounter when bringing biotech and other medical products out of research and into the commercial marketplace. Dr. Wheelwright has led the development of products for cancer, wound healing, infectious diseases and cardiovascular therapy.
Previous employment includes positions at Scios, Chiron and Abbott. Dr. Wheelwright obtained his Ph.D. degree in chemical engineering from the University of California at Berkeley and performed post-doctoral studies at the Max Planck Institute in Germany. Dr. Wheelwright is the author of a book on protein purification and has published many papers on process design and manufacturing for biotechnology.
Stefan Borgas, CEO
Lonza Biologics Switzerland
Stefan Borgas has been the President and Chief Executive Officer of Lonza since June of 2004. Prior to joining Lonza, he held various senior positions for BASF Group, most recently as Group Vice President, Regional Business Unit Fine Chemicals North America (2003-2004). Other positions included Group Vice President, Regional Business Unit Fine Chemicals Europe, Africa, Middle East (2001-2003), Director Strategic Marketing Animal Nutrition, Fine Chemicals (1998-2001), and Group Logistics Manager, Engineering Plastics (1995-1998). He holds a degree in Business Administration from the University of Saarbruecken and a Master of Business Administration from the University of St. Gallen.
Werner Katzmann, Regional Medical Director
Schering-Plough Research Institute Asia, Singapore
Werner Katzmann is currently the Regional Medical Director of the Schering-Plough Research Institute in Singapore. In this position he is in charge of all clinical trial activities of Schering-Plough in phase 1, 2 and 3 in Asia outside Japan. He started this operation “from scratch” in 1999 and has built it into a major clinical R&D centre for the company. In 2005 he was also responsible for the company’s research activities in Australia. Werner graduated in medicine from the University in Tübingen, Germany, and received his doctorate (PhD) in clinical epidemiology from the same institution. He is an oncologist by training and a member of the American Society of Clinical Oncology (ASCO). Werner joined the pharmaceutical industry in Janury 1984 and has worked in different roles and responsibilities for three major pharma companies over the past 24 years (Roche, Rhone-Poulenc Rorer [now Sanofi-Aventis], and Schering-Plough). He has been involved in drug development and clinical trials in Asia since 1990, i.e. for 18 years, when he was Regional Medical Manager for Roche. He is well familiar with global drug development and the specific requirements for regulatory approval in the various Asian countries and Australia. His personal interest is in the area of new drug therapies for oncology, hepatitis
and cardiovascular diseases.
Back to top
|
