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Speaker Biographies

Optimizing Cell Culture Technology

Thomas Ryll, Ph.D., Director, Cell Culture Development, Biogen Idec, Inc.

Dr. Ryll completed his Ph.D. in Biochemistry and Biotechnology in 1992 at the Technical University of Braunschweig, Germany. After a year of PostDoc work in Germany he joined Genentech in 1993 and was part of the development of the first generation of large scale manufacturing processes for antibodies and recombinant proteins in the 1990s. In 2000 Thomas joined Abgenix as Senior Scientist and Associate Director, Cell Culture Development. His contributions included the establishment of a cell culture development organization, the development of Abgenix's proprietary expression system based on cell:cell fusion and an efficient medium and fed-batch process format for antibody production. Other accomplishments included support of design, construction and start-up of a new Process Sciences and Manufacturing facility.

Thomas joined Tanox in 2003 as Director and Senior Director of Process Development and member of the management team. Responsibilities included all bioprocess activities from cell line generation, culture process, purification and formulation development and analytical support as well as project team leadership. Thomas joined Biogen Idec in 2006 and currently serves as Senior Director of Cell Culture Development in charge of cell line, culture process, scale-up, technology transfer and manufacturing support activities. Thomas scientific interests focus around combining biological and engineering aspects for maximizing process efficiencies and product quality.

Yuval Shimoni, Ph.D., Principal Engineer, Manufacturing Sciences, Bayer HealthCare LLC

Dr. Yuval Shimoni is a Principal Engineer with Bayer HealthCare. His diverse responsibilities range from leadership of process development projects to commercial manufacturing operations support activities. Yuval brings over a decade of cell biology and process engineering experience in the biotech industry, both established and start-up. Before that, Yuval was awarded prestigious fellowships under which he conducted post-doctoral research at UC Berkeley. Yuval holds Ph.D. and M.Sc. degrees, both from the Weizmann Institute of Science. He has been an invited speaker at renowned conferences, is an inventor on patent applications and has authored research papers published in high impact peer-reviewed scientific journals.

Patrick Hossler, Ph.D., Senior Scientist III, Process Sciences, AbbVie Bioresearch Center

Patrick Hossler has worked in early-stage cell culture process development in the Process Sciences department of AbbVie (and formerly Abbott) in Worcester, MA for over 5 years.In this time he has contributed to multiple projects that have advanced to late-stage clinical testing and commercialization. Before employment at AbbVie, he worked in late-stage cell culture process development in the Technical Operations group of Bristol-Myers Squibb in East Syracuse, NY for 1.5 years. His interests and research work encompass the relationship between cell culture process and media conditions and the resulting impact on process performance and product quality.

Sofie Goetschalckx, Manufacturing Cell Culture Science Lead, Technology Division, Genzyme

Sofie graduated Biochemistry Sciences at University of Antwerp, Belgium in 2000. Her professional carrier started at Pharming N.V. where she was a member of R&D organization. Shortly after Genzyme's acquisition; Sofie became responsible for start-up of cell culture team and to establish the new laboratories. She played pivotal role in the technical transfer, scale up and validation of the cell culture processes for Myozyme and Campath. Her team has developed and qualified small scale models for various large scale cell culture processes and it is still providing Global support to Genzyme's Manufacturing Sites. The important part of Sofie's work is exploring innovative tools and processes and evaluation towards at scale manufacturing processes.

Alan Dickson, Ph.D., Director, Centre of Excellence in Biopharmaceuticals (COEBP); Professor, Institute of Biotechnology, University of Manchester

Alan Dickson is currently Director of the Centre of Excellence in Biopharmaceuticals and is Professor of Biotechnology in the Faculty of Life Sciences at the University of Manchester. Alan undertook his BSc and PhD at the University of Edinburgh, before moving to a Research Fellowship at the University of Kent and, subsequently, to the University of Manchester. His research has focused on the regulation of cell function (in terms of metabolic, protein and gene targets) in mammalian cells. The early 1990's saw the start of series of fruitful collaborations with commercial partners in relation to mammalian cell hosts for protein harvest and this continues today through the Bioprocessing Research Industry Club and via individual collaborations. The CoEBP acts to co-ordination all of the University of Manchester's activities with the bioprocessing sector. Alan has been part of the senior management team of the Faculty of Life Sciences, as Dean for Graduate Education and, subsequently, Dean for Communications.

Shirley Peters, Ph.D., Research Scientist, Protein Expression and Purification Group, UCB Celltech

Shirley Peters is a molecular biologist that has worked at UCB since 2006. She works in the Protein Expression and Purification department. Her role involves the development and characterisation of mammalian expression platforms and of antibody and novel antibody formats. She holds a Ph.D. in Biochemistry from the University of Kent that focussed on IgG4 and investigating its unique characteristics. She completed an M.Sc in Biomedical Science at the University of Leiden, Netherlands and a B.Sc at the University of Stellenbosch, South Africa.

Jamey D. Young, Ph.D., Assistant Professor, Chemical and Biomolecular Engineering, Molecular Physiology & Biophysics, Vanderbilt University

Dr. Jamey D. Young is an Assistant Professor of Chemical and Biomolecular Engineering and Assistant Professor of Molecular Physiology and Biophysics at Vanderbilt University. He received his Ph.D. from Purdue University and was awarded an NSF Graduate Research Fellowship in the laboratory of Doraiswami Ramkrishna. Dr. Young continued his training at MIT as an NIH Ruth L. Kirschstein postdoctoral fellow with Gregory Stephanopoulos. The central theme of his research is metabolic engineering: the application of engineering, biochemistry, and molecular biology to analyze and redirect cellular metabolism. In particular, his lab uses13C metabolic flux analysis (MFA) to investigate research questions of relevance to medicine and biotechnology. He was awarded the NSF CAREER Award in 2010 and the DOE Early Career Award in 2012. He has authored numerous papers involving the application of mathematical modeling and MFA to a variety of research topics, including bacterial physiology, liver metabolism, cancer cell metabolism, photosynthetic metabolism, and cell culture engineering.

Kate Strathearn, Ph.D., Cell Applications Scientist, Corning Life Sciences

Kate Strathearn is a Cell Application Scientist at Corning Life Sciences.  She received her Ph.D. from Purdue University in Medicinal Chemistry and Molecular Pharmacology.  Since joining in 2011 Kate has been involved in various projects, ranging from supporting customers to developing technical white papers on up-stream bioprocessing methodologies.  Her most recent efforts have been focused on creating technical documents and protocols focused on viral production using the HYPER and Microcarrier-based technologies.

Ulrike Rennefahrt, Ph.D., Senior Research Scientist, Data Interpretation Health, metanomics GmbH (a BASF company)

Ulrike Rennefahrt received her M.Sc in Microbiology and Biotechnology, and obtained her Ph.D. in Tumor Biology from the University of Wuerzburg (Germany). After completion of postdoctoral training at the Fox Chase Cancer Center in Philadephia, she joined metanomics GmbH in 2008. At metanomics GmbH she is working with commercial clients to apply metabolomics in bioprocessing approaches (using bacterial and mammalian host systems), as well as in the identification of mode of action and off-target effects of drugs, or the understanding of disease mechanism. In addition, she has worked on multiple in-house biomarker research projects together with colleagues from Metanomics Health GmbH.

Lam Raga Anggara Markely, Ph.D., Scientist I, Biogen Idec, Inc.

Raga Markely received his BS in Chemical Engineering from University of Wisconsin-Madison in 2006, and PhD also in Chemical Engineering from Massachusetts Institute of Technology in 2011. At UW-Madison, he did several undergraduate research projects on mathematical modeling of biological systems, fluid dynamics, and reaction kinetics in Chemical Engineering and Mathematics Department. At MIT, he worked with Prof. Daniel I.C. Wang in developing a new high-throughput sialic acid assay, optimization of cell culture conditions to improve sialylation, and high-throughput analysis of intraclonal variability in glycoprotein sialylation. After finishing his PhD thesis, he joined a High-Throughput Analytical Group at Biogen Idec in 2011. Since then, he has been developing new assays for high-throughput small-scale protein purification and product quality analysis, as well as performing routine support for these assays and other product quality analyses.

Jeffrey J. Chalmers, Ph.D., Professor Department of Chemical and Biomolecular Engineering, The Ohio State University

Jeffrey J. Chalmers is a Professor in the Department of Chemical and Biomolecular and Director of the Analytical Cytometery Shared Resource at the Ohio State University. He has received a National Science Foundation Young Investigator Award, was elected a Fellow of American Institute for Medical and Biological Engineering in 2001, and in 2005 was elected a fellow of the AAAS. He has published over 130 peer reviewed articles, book chapters, a book in bioengineering, and nine issued patents; a majority of which involve magnetism and magnetic cell separation. Professor Chalmers received his Ph.D. from Cornell University in 1988 and his B.S. in Chemical Engineering from U.C. Berkeley and a B.A. from Westmont College in 1983.

Lada Laenen, Ph.D., Managing Principal Scientist, Head, Cell Culture and Microbiology, Technology Division, Genzyme, a Sanofi Company

Dr. Laenen graduated Biotechnology Sciences at University of Zagreb, Croatia in 1998 and obtained her doctoral degree in Natural Sciences in 2001 at University of Kaiserslautern, Germany. Her professional carrier started at PLIVA Inc., Zagreb Croatia, and continued at MIXIS Genetics, Paris, France, in different development roles focusing on bacterial metabolism and antibiotic production. Moving to Belgium, her first challenge was at Flen Pharma, where she established research and quality departments with main focus towards tissue cultures and wound healing processes. Afterwards, she moved to Johnson & Johnson for its Tibotec/Virco branch where she was worked in the HIV field leading multidisciplinary teams. In 2007, she joined Genzyme where she is currently heading the Cell Culture and Microbiology departments, with a focus on process development and validation, regulatory submissions, providing support towards commercial manufacturing as well as exploring innovative tools and processes.

Mark DeCoster, Ph.D., Associate Professor, Biomedical Engineering, Louisiana Tech University

Dr. DeCoster is currently the James E. Wyche III endowed Associate Professor in Biomedical Engineering at Louisiana Tech University, and also Assistant Director for Biomedical Research at the Institute for Micromanufacturing there. He received his Ph.D. in Biochemistry and Molecular Biophysics from the Medical College of Virginia campus of Virginia Commonwealth University, followed by a research position with the U.S. Army at Walter Reed Army Institute of Research in Washington, D.C. He carried out Neuroscience Research at the LSU Health Sciences center in New Orleans before joining Louisiana Tech University. His laboratory utilizes nanotechnology to study signalling in the nervous system in both the normal and diseased brain, including cancer.

Peggy Lio, Ph.D., Director, Process Science & Cell Culture, GE Healthcare

Peggy Lio is currently Director of Process Science at GE Healthcare where she is responsible for leading the technical applications strategy for the US cell culture business.   She joined GE from Life Technologies where she was responsible for the development of PD-Direct custom service programs globally.  She also led an applications team charged with scientific support of new cell line and media products as well as process development.  Prior to Life Technologies, Peggy held roles of increasing responsibility with Schering-Plough Corp., where she ultimately became Section Leader with responsibility for mammalian and microbial fermentation process development for a variety of biotechnology based therapeutics.   Peggy has over 23 years of extensive technical and commercial experience in bioprocessing  along with multiple honors and awards from Schering and Life Technologies.

 

Facilities for Manufacturing Biologics

R. Thomas Warf, Senior Program Manager, Product Process Development Analysis, Influenza and Emerging Diseases Division, Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services

Thomas Warf is a Federal Employee in support of the Influenza and Emerging Disease Division in the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. Thomas has been with the Pan Flu Program since 2006. As a Senior Program Manager, Thomas provides leadership for the Infrastructure Branch and technical consulting on the development and manufacture of influenza and antiviral drug manufacturing process, commercial scale manufacturing facilities and equipment.

Thomas received his BS in Chemistry from Furman University. Thomas has over 27 years of experience in the vaccine, biopharmaceutical and pharmaceutical industry. He has been involved in the manufacture of vaccines, sterile drug products and solid and liquid drug products. Tom worked for Merck & Co. for 25 years in Pharmaceutical production and Biological Manufacturing Engineering Services. In addition to production support as a Senior Technical Advisor at Merck & Co. he also worked with the Quality organization in preparing for FDA/EMA inspections and preparing responses and corrections to facilities. As a consultant Thomas has worked for Glaxo Smith Kline (PA), Chiron Corporation (CA), Amgen, Inc. (RI) and Wyeth BioPharma (Ireland). In addition, Thomas is a currently an Instructor for the American Society of Mechanical Engineers Biotechnology Seminars and a member of the Bioprocess Equipment Committee (ASME BPE Standard) of the ASME.

David M. Marks, Principal & Founder, DME Alliance Engineering Consultants

David M. Marks is the principal and founder of DME Alliance Engineering Consultants. He has 25+ years of experience in the design and delivery of advanced technology process facilities. His professional experience has been primarily in the biotechnology and pharmaceutical industries. He is a subject matter expert in in the design of cGMP facilities, bioprocess systems, aseptic processing, contamination control, process containment, cleaning, sterilization and single use technology. Marks is a frequent author, speaker and consultant on bioprocess technology, facility design & compliance topics. He is active on the ASME Bioprocess Equipment (BPE) standard main committee, and serves as chair of the design subcommittee. A graduate of Lafayette College, Mr. Marks holds a BS in Chemical Engineering and is a registered Professional Engineer.

Trevor Deeks, Ph.D., Senior Director, Manufacturing Management Services

Trevor has over 30 years of experience in pharmaceutical manufacturing, development, quality assurance and validation, including senior management roles with major pharmaceutical manufacturing companies. He is a Qualified Person and a registered pharmacist. He has also worked as a consultant managing a number of troubleshooting, inspection readiness, validation and development projects. Over the last 7 years most of his work has focused on vaccines.

He has published over 30 papers in peer-reviewed journals and contributed to a number of books including one on Bioprocess Validation.. He is an active presenter at PDA, ISPE and Pharmaceutical Society conferences and has sat on PDA, BSI, CEN, ISO and European Pharmacopoeia Commission expert working groups. He is a Past Chairman of the Parenteral Society and was Editor-in-Chief of the European Journal of Parenteral Sciences from 1996-2000.

Sanjay B. Shah, Director & Head, Biologics Operations, Syngene International Ltd.

Sanjay heads the biologics manufacturing operations at Syngene International Ltd., India's leading Contract Research and Manufacturing Services (CRAMs) Organization. Syngene is a Biocon group company based in Bangalore, India.

Sanjay has 16+ years of industry experience with leading multinational companies based out of US and India, 14 years in the US including at ImClone Systems; and in India since 2010. Previously, as Director at Dr. Reddy's Labs Biologics division, Sanjay supported the biosimilar operations and was responsible for setting up the Process Engineering department. Before returning to India, Sanjay was at ImClone Systems (subsidiary of Eli Lilly & Co.) in Branchburg, New Jersey for 5+ years as Associate Director, where he supported large scale clinical and commercial biopharmaceutical manufacturing including: process engineering, manufacturing operations, technology transfer, facility design & engineering, GMP infrastructure life cycle management. Prior to that, as Senior Process Engineer at Amgen and Aker Solutions, Sanjay led the design & engineering of large scale commercial BioPharma facility in Rhode Island.

Sanjay has rich experience in areas of technology transfer, development of scale-up strategies, process & cleaning validation, process design & engineering, quality management systems, and science & risk based C&Q philosophies. He holds a MS in Chemical Engineering from the University of Akron, Ohio and BE Chemical Engineering from Maharaja Sayajirao University of Baroda, India. Sanjay is US citizen and a permanent resident of India, now settled in Bangalore.

Scott Kaplan, Senior Director of Project Development, Pharmadule Morimatsu, Inc.

Scott Kaplan is the Senior Director of Project Development for Pharmadule Morimatsu Inc. responsible for clients in North and South America. Supporting the Pharmaceutical Industry since mid-1980s, Scott has experience working with process equipment manufacturers as well as complete project integration including all phases of design, construction and start-up support. Scott began working with Pharmadule in 2004.

Pharmadule is the global leader in the design and fabrication of modular facilities to the Life Science Industry. Since 1986, more than 60 projects have been delivered using this innovative technology to projects located throughout the US, Europe, Asia and Africa. In 2011, Pharmadule was acquired by Morimatsu, a Japanese family owned process equipment manufacturer with more than 4000 resources worldwide. Through this acquisition, the scope of services offered by Pharmadule Morimatsu has now expanded to include much of the equipment that is delivered within our modular production facilities.

Kim Wong, Ph.D., Director, Facilities & cGMP Support, Bioprocess Research & Development, Sanofi Pasteur Ltd.

Kim Wong joined Sanofi Pasteur Ltd. in 2005 as Director, Cell and Viral Culture in the BioProcess Research & Development group. Since 2007 he has served as the Director, Facilities & cGMP Support platform. In this role he is responsible for the provision and continued compliance of the support infrastructure for a facility designed for the manufacture of cGMP clinical material. Prior to Sanofi Pasteur he worked at Cangene Corporation as the Director, Research & Development where his group contributed towards the development and licensure of three products by the FDA. He has a Ph.D. in Biochemistry from Queen's University at Kingston and has more than 16 years experience in the biopharmaceutical industry.

David Bendet, AIA, LEED AP BD+C, Associate Principal, Senior Project Manager, Perkins+Will

David's approach to design is based on providing the highest value solutions to clients by first understanding their goals and needs, and then balancing innovative design strategies with expertise and constructability feedback in a team-based environment.

With more than 23 years of professional experience, David has led design and construction project teams through the visioning, programming, planning, design, management, and delivery on millions of square feet of complex, innovative and sustainable projects. His leadership, organizational skills, technical knowledge, and hands-on approach have allowed him to enhance interdisciplinary working relationships and deliver highly successful projects most recently for Genentech, DuPont, Theranos, the Buck Institute, UCSF, Amgen, Life Technologies, and Samsung.

He currently serves as Vice President on the Board of Directors for the International Society for Pharmaceutical Engineers (ISPE) Bay Area Chapter, he Co-Chairs the AIA San Francisco Committee on Health & Science, teaches architecture at Stanford University, and has spoken at several national conferences including AIRI, Labs21, Tradeline, BayBio, Labwize, R&D Magazine, and ISPE. He is published in the fields of science facilities design, sustainable design, project management, and project delivery.

Jasmin Kee, Process Engineer, Organogenesis, Inc.

Jasmin is the Supervisor of Process Engineering at Organogenesis Inc. responsible for the 100, 000sq.ft new facility expansion and process automation. She is building a Process Engineering team that has a fundamental understanding of six sigma, QbD and lean manufacturing principles to enable the design and implementation of an operationally efficient, state-of-the art manufacturing facility. Jasmin also leads the automation project to translate the current Apligraf® process to a fully automated process for implementation into the new facility. She holds a Master of Mechanical Engineering degree from Loughborough University, UK and worked as a Process Engineer in fast moving consumer goods companies for several years where she implemented process optimization and six sigma projects. She returned to Loughborough University to undertake an industrial PhD sponsored by healthcare company Intercytex, UK. Her research developed reproducible and repeatable measurement systems to characterize the critical attributes of the ICX-SKN artificial skin graft product and developed a scalable mechanical stimulation technique to improve critical final product attributes. She also cultured working cell banks using the first CompacTSelecTTM, a leading automated cell culture system, from TAP Biosystems.

Heidi J. Hoffmann, Ph.D., Senior Director, Manufacturing, Sutro Biopharma

Heidi Hoffmann, Senior Director of Manufacturing at Sutro Biopharma, has over 19 years of experience in biotechnology, specializing in process development, technology transfer, and manufacturing of vaccines and biological therapeutics. Directly after receiving her Ph.D. from University of California, Berkeley in 1994, Dr. Hoffmann began her career at Aviron, where she worked on process development and production of vaccines for EBV, PIV, and influenza (FluMist). She then joined Valentis, where she led the team responsible for process development, technology transfer, and clinical production of plasmid DNA for gene therapy. In 2002, Dr. Hoffmann returned to vaccine work by joining VaxGen, where she was responsible for process development and manufacturing of anthrax vaccine. Later, she transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of production of Bristol-Meyer Squibb's Orencia (abatacept) into the Celltrion manufacturing facility in South Korea. After the completion of that project, Dr. Hoffmann joined non-profit Global Solutions for Infectious Diseases (GSID) as Project Director responsible for coordinating the outsourcing of process development and manufacture of HIV vaccines. Dr. Hoffmann joined Sutro in February, 2011 to direct the development and implementation of cGMP manufacturing capability for Sutro's proprietary cell-free protein expression system.

Ulrich Roessl, Researcher, Products and Formulations, Research Center Pharmaceutical Engineering GmbH

Ulrich Roessl graduated in 2009 from the University of Graz in Molecular Biology and in 2011 from the Graz University of Technology in the field of Biotechnology. During his master thesis he was working on aggregation of therapeutic proteins. Since 2011 he is employed at RCPE GmbH as Researcher and PhD student. His research is focused on bulk freezing of biopharmaceuticals.

Eric Bohn, AIA, Principal, jacobs wyper Architects, LLP

Mr. Bohn joined Jacobs/Wyper in 1995 to manage the documentation and construction of the Nycomed Research and Development project. He is an Associate Principal and has over 30 years experience designing and constructing facilities for corporate and institutional clients. Mr. Bohn has experience managing significant and complex projects utilizing various project delivery methods such as Fast Track, Design/Build as well as traditional Design/Bid/Build.

Larry DiGennaro, AIA, LEED AP BD+C, Science Client Leader, BHDP Architecture

For more than 20 years, Larry has maintained a passion for working with Life Science clients to minimize protocol driven space constraints imposed on their people in technical environments. As an owner of the fi rm, he has had a prominent role in the leadership of BHDP's science focus. His depth of experience extends to programming and planning for complex laboratory and cGMP manufacturing projects for clients like Battelle, Boehringer Ingelheim and the University of Cincinnati. He has had articles published nationally in magazines such as Bioprocess International, R&D Magazine and Animal Lab News and writes monthly blog entries on BHDP. com. In his years of service at BHDP, he has served multiple project roles such as: principal-incharge, project manager, project architect, project designer, and construction administrator.

Jeffrey Odum, Director, Operations, Biotech Global Lead, IPS

Jeff Odum is a globally recognized SME in biomanufacturing facility design and compliance. With over 20 years of experience in design, construction, compliance and operations, he has managed over $2 billion in capital projects and has published over 60 technical articles on these and other key industry subjects. As a Certified Pharmaceutical Industry Professional (CPIP), he has led numerous professional training and development courses across the globe and is a member of the ISPE technical training staff teaching courses in facility design, project management, process design, and compliance. He also is a Teaching Fellow in the Biomanufacturing Graduate program at NC State University's Bioprocess Training and Education Center (BTEC) and has been an invited lecturer and presenter at over 100 academic and global industry programs.

R. Barry Holtz, Ph.D., President, G-Con, LLC

Dr. Barry Holtz, President of G-Con, is a recognized international expert on design and construction of pharmaceutical facilities.

Dr. Holtz has 30 years of experience in the development of bioproducts and biopharmaceuticals. Serving 15 years as Senior Vice President for Large Scale Biology Corporation, Dr. Holtz was responsible for the product development, clinical development and manufacturing compliance of the company's proprietary therapeutics portfolio. These projects included leading development and manufacturing teams that successfully brought a recombinant, plant-made, patient specific vaccine, for treatment of indolent Non-Hodgkin's lymphoma,from the bench to human clinical trials. Dr. Holtz was also responsible for the design, construction and commissioning of the LSBC biopharmaceutical production facility in Owensboro, Kentucky. Dr. Holtz has also designed and built two other bioproducts facilities for other clients. Recent efforts have included design and construction of cancer vaccine facilities, implementing proteogenomics into vaccine manufacture and international development of biotechnology development in resource challenged countries.

Prior to Large Scale Biology, Dr. Holtz was the founder and President of Holtz Bio-Engineering. Over its' nine year history, the company was involved in the development of bioreactor based processes for the biotechnology sector and developed a proprietary line of bioreactors and distributed logic control systems for cell culture. Holtz Bio-Engineering was merged into Large Scale Biology in 1989.

Dr. Holtz has held research management positions at Foremost-Mckesson and was on the faculty of Ohio State University. He received his Ph.D. at Pennsylvania State University and was an NSF Postdoctoral Fellow at Scripps Institution of Oceanography. Dr. Holtz has been awarded 22 US patents and has published over 50 scientific papers. Dr. Holtz was awarded the Pennsylvania State University, Outstanding Alumni Award in 2003.

Pär Almhem, President, ModWave and President, ModularPartners

Pär Almhem is Co-Founder and President of ModWave, a solutions provider to the Pharmaceutical, Biopharmaceutical, Food and Process Industries. He is also the President of ModularPartners, a leading supplier of modular and hybrid process and facility solutions to the Life Science Industries worldwide. Prior to his current engagements, Pär was the President of Pharmadule, Inc. the U.S. entity of Pharmadule AB of Sweden who was the pioneer supplier of high-tech modular production facilities to the Pharmaceutical and Biotech industries.

Pär has had executive and management positions at several technology based companies in the United States and in Sweden. He holds a Master of Science Degree in Applied Physics and Electrical Engineering from Linköping University, Sweden.

Camilla Sivertsson, Vice President, ModWave and Manager, ModularPartners

Camilla Sivertsson is Co-Founder and Vice President of ModWave, a solutions provider to the Pharmaceutical, Biopharmaceutical, Food and Process Industries. She is also Manager of Marketing and Sales forModularPartners, a leading supplier of modular and hybrid process and facility solutions to the Life Science Industries worldwide. Before ModWave and ModularPartners, Camilla was part of the U.S. sales organization inPharmadule, Inc., the U.S. entity of Pharmadule AB of Sweden. Prior to that, she has been in research and development positions at Affibody, a startup biotech company, SBL Vaccine, a medium size vaccine company, and Pharmacia and Upjohn. Camilla holds a Bachelor of Science degree in Biotechnology Engineering from Malardalens University (Sweden).

 

Optimizing Cell Line Development

Florian M. Wurm, Ph.D., Professor, Chemistry Engineering & Cell Bio Lab, School of Life Sciences, Integrative Bioscience Institute, École Polytechnique Federale De Lausanne (EPFL), and Founder & CSO, ExcellGene SA

Florian M Wurm is a trained geneticist (PhD1979). He has worked with CHO cells for the production of recombinant proteins in bioreactors for 3 decades. He was employed at Behringwerke, Marburg, Germany and at Genentech, San Francisco USA) for 15 years during the earlier parts of his career. His work at Genentech (1985-1995) contributed to the establishment of high-yielding manufacturing processes for today's leading protein products. In 1995, appointed Professor for Biotechnology at the Swiss Federal Institute of Technology, he established a research program in process sciences. In 2001 he founded ExcellGene SA, Monthey, Switzerland, a contract manufacturing and R+D service company. Florian is a previous Chairman of the European Society of Animal Cell Technology. He has published more than 200 papers, is editor and reviewer for many scientific journals in biotechnology and is lecturer on DNA to process/product in mammalian cells.

Yves Durocher, Ph.D., Senior Research Officer, Biotechnology Research Institute, National Research Council Canada

Yves Durocher is a Research Officer at the National Research Council of Canada since 1995. He is also an assistant professor in the Department of Biochemistry at the University of Montreal. Since the last 14 years, his research activities have been headed on the development the of large-scale transient gene expression (LSTGE) platforms using HEK293 and CHO cells for protein production. More recently, he has also been focusing on developing and engineering a stable CHO cell line platform for recombinant protein therapeutics manufacturing.

Ingo Gorr, Ph.D., Senior Scientist, Cell Culture Research, F. Hoffmann-La Roche

Ingo Gorr received his Biology degree from the University of Wurzburg in Germany, followed by a PhD in the Molecular Cell Biology department at the Max-Planck-Institute of Biochemistry in Martinsried/Germany. His research focused on the discovery of a new mechanism to control sister chromatid separation in anaphase. In 2006 he joined F. Hoffmann-La Roche in Basel/Switzerland. He then relocated to Roche Penzberg in Germany where he currently holds a position as a group leader within Roche pharma research and early development. As a technical project leader he is part of bringing molecules from idea to medicine.

Valentina Ciccarone, Ph.D., Principal Scientist, MacroGenics, Inc.

Valentina Ciccarone is a Principal Scientist at MacroGenics since 2002. Responsible for development of stable cell lines for the production of engineered, humanized antibodies and bispecific DART proteins targeting tumor, auto-immune and infectious disease markers; Cell culture process development to optimize growth, culture, and feeding strategies for stable cell lines used in GMP biomanufacturing; and Transient protein expression in mammalian cells. Previously, she was a Section Leader and Principal Scientist at Life Technologies from 1990 to 2002. Responsible for the development of gene delivery and gene expression technologies in eukaryotic cells including Lipofectamine 2000, Bac-to-Bac Baculovirus Expression System and other transfection / expression technologies.


Pierre-Alain Girod, Ph.D., CSO, Selexis SA

Dr. Girod received his PhD from the Department of Plant Biochemistry, University of Lausanne in 1989.  He completed his post-doctoral fellowship at the University of Wisconsin-Madison where he studied protein degradation by the ubiquitin pathway.  He returned to Switzerland and the University of Lausanne in 1993 where he discovered a family of genetic sequences involved in the epigenetic regulation of genes.  These genetic sequences, which are the founding technology for Selexis' SUREtechnology PlatformT, are used throughout the life science industry to improve expression of therapeutic proteins.  Dr. Girod has served as CSO of Selexis since 2006, where he has led Selexis' on-going scientific and technological innovations for optimizing expression and production of a wide range of protein products in the commercial setting.

Paula Meleady, Ph.D., Senior Research Scientist and Programme Leader, National Institute for Cellular Biotechnology, Dublin City University

I graduated with a PhD in Cell Biology from Dublin City University in 1997. I am a Senior Scientist at the National Institute for Cellular Biotechnology (NICB) since 2001 and am currently Programme Leader of the Proteomics and Mass Spectrometry Core Facility at the NICB which is equipped with state-of-the-art proteomics and mass spectrometry equipment. My research interests include proteomic profiling and characterisation of recombinant mammalian cell lines (Chinese hamster ovary) in order to gain insights to improving productivity of biopharmaceuticals. I also have research interests in cancer, specifically uveal melanoma where we analyse patient tissue and vitreous fluid samples from the eye for biomarker discovery. I have co-authored over 40 peer-reviewed publications and 7 book chapters to date in research areas related to proteomics, bioprocessing and cancer.

Jianxin Ye, Ph.D., Principal Scientist, Merck Research Labs

Dr. Jianxin Ye received his Bachelors of Science in Biochemistry from Nankai University in 1990 and his Ph. D in Molecular, cellular and Developmental Biology from the Ohio State University in 2003. He joined Merck & Co., Inc in 2005. He is currently a Principal Scientist in the Biologics New and Enabling Technologies Department within BioProcess Development at Merck & Co. Inc.

Sheng Zhang, Ph.D., Senior Scientist, Process Sciences, Abbvie Bioresearch Center

2010-now: Senior Scientist, Process Sciences, Abbott/Abbvie Bioresearch Center 2009-2010: PostDoc fellow, Cell Science and Technology, Amgen 2002-2008: Ph.D. Cell Biology, UC at San Diego

Jonathan Cacciatore, Ph.D., Research Scientist, Chemical Engineering and Biological Sciences, Columbia University

Jonathan earned his B.S. in Chemical Engineering in 2005 from Bucknell University with a minor in Biomedical Engineering. He served as Vice President of Tau Beta Pi, the National Engineering Honor Society and performed research on the removal of adhered bacteria by surfactants and shear which he presented at the 2004 AIChE (American Institute of Chemical Engineers) National Conference. He earned his M.S. and Ph.D. from Columbia University in 2006 and 2012 respectively. He was a teaching assistant for courses in thermodynamics and transport phenomena in biological systems. His dissertation was on the engineering of Chinese Hamster Ovary (CHO) cells for improving biopharmaceutical development. Results from this research were presented at the 2007 AIChE National Conference and reported in publications in the Journal of Biotechnology and Biotechnology Advances. This research was done in collaboration with a major pharmaceutical company.

Susan Sharfstein, Ph.D., Associate Professor, Nanobioscience, Nanoscale Science and Engineering, University at Albany, State University of New York

Susan Sharfstein received her B.S. in chemical engineering with honors from Caltech in 1987 and her Ph.D. in chemical engineering from UC Berkeley in 1993, receiving graduate fellowships from the university and the National Science Foundation. She received a National Institutes of Health Individual Research Service Award to pursue postdoctoral studies, initially at UC Berkeley and subsequently at the UCLA Medical School. Dr. Sharfstein joined the faculty at the University of Toledo in Bioengineering in 1996. In 2000, she received a National Science Foundation POWRE award to study glycobiology at the New York State Department of Health Wadsworth Laboratories. In 2001, she joined the Department of Chemical and Biological Engineering at Rensselaer Polytechnic Institute and in 2007 she received a dual appointment in Biology. In 2010, she joined the faculty at the College of Nanoscale Science and Engineering at the University at Albany as an Associate Professor of Nanobioscience. Professor Sharfstein received an NSF CAREER grant in 2000 for her work on hyperosmotic stress responses of hybridoma cells and the School of Engineering Education Excellence Award and the Class of 1951 Outstanding Teaching Award in 2007. She is the author of over 40 papers and book chapters in the field of mammalian cell biotechnology.

Eileen M. Higham, Ph.D., Scientist II, Process Cell Culture & Fermentation, MedImmune

Eileen Higham is a Scientist II in BioPharmaceutical Development at MedImmune, leading efforts to both generate high-yielding, stable CHO cell lines expressing recombinant proteins and to develop new technologies, processes and parental cell lines to further enhance cell line development. Prior to joining MedImmune, Eileen also worked as a Biochemical Engineer at Merck & Co, Inc, where she focused on serum-free medium development to support large scale vaccine production. Eileen completed her PhD in Biological Engineering at the Massachusetts Institute of Technology (MIT) and her BSE in Chemical Engineering at Princeton University.

Andreas Popp, Ph.D., Director, Protein Sciences; Head, Production, MorphoSys AG

Dr. Andreas Popp is Group Leader of two production teams within the Protein Sciences department of MorphoSys AG. His responsibilities comprise the production of antigens, antibodies and antibody fragments for discovery, pre-clinical and early clinical development. He oversees activities from initial vector generation to GMP production at CMOs. In 2008, he took over the responsibility as Head of Production for MorphoSys' therapeutic antibody pipeline. Before joining MorphoSys in 2002, Andreas did his PhD at the Max-Planck-Institute for Biology in Tübingen and his Diploma Thesis at the Robert Koch-Institute in Berlin.

Arnaud Poterszman, Ph.D., Research Director, Integrated Structural Biology, Institute de Génétique, et de Biologie Moléculaire et Cellulaire (IGBMC), CNRS

Arnaud POTERSZMAN is research director at CNRS and performs his research in IGBMC within the Department of Integrated Structural Biology. He has a dual expertise in Structural and Molecular biology with insights on expression and sample preparation. His background is in biochemistry and X-ray crystallography. His research is focused on expression eukaryotic multi-protein complexes involved in transcription regulation and DNA repair particularly, the transcription/DNA repair factor TFIIH as well as, nuclear hormone receptors and their co-regulators. He is involved in the development and implementation of eukaryotic recombinant expression technologies for production of multi-protein complexes mainly using the baculovirus expression system.

Shashi Prajapati, Ph.D., Senior Scientist, Cell Culture Development, Biogen Idec, Inc.

Undergraduate: MS, Biochemistry, Allahabad University, Allahabad, India Graduate: Ph.D, Biochemistry, Central Drug Research Institute, Lucknow, India Work Experience: 2003-2006: Research Scientist, Eli Lilly Co., Cancer drug discovery department, working on cell signaling pathway to identify cancer drug candidates 2006-2009: Scientist, Bristol Myers Squibb, Bioprocess Development, Supporting HTP analytics for upstream and downstream bioprocess development. 2009-till now: Senior Scientist, Biogen Idec, HTP Analytical Group in Cell culture development, supporting clone screening, cell line development and upstream process development

Jan Schouten, Ph.D., Project Leader, BIO USP, Synthon BV

Dr. Jan Schouten is a Senior Project Leader in Cell Line Development at Synthon Biopharmaceuticals B.V. in Nijmegen, The Netherlands. He leads a team of scientists and technicians that is involved in the generation of cell lines suitable for biopharmaceutical production, but also in the production of recombinant proteins for research purposes. Dr. Schouten obtained his PhD in Molecular and Cellular Biology in 1999 at the University of Leiden, The Netherlands. Before joining Synthon in January 2010, he had positions of increasing responsibility during a period of nine years at Crucell in Leiden. Dr. Schouten has a strong background in cell line development and particularly in expression vector design and optimization for mammalian cell lines.

Yann Cotte, Ph.D., Research Scientist, Microvision and Microdiagnostics Group, EPFL School of Engineering (École Polytechnique Fédérale de Lausanne)

Yann Cotte is a post-doctoral researcher at Ecole Polytechnique Fédérale de Lausanne (EPFL) in Switzerland. He obtained an EPFL innovation grant that aims to develop a commercial system delivering comprehensive cell tomography.

 

Scaling Up & Down with Optimized Bioreactors + Disposables

Ravinder Bhatia, Ph.D., Associate Director, Pharmaceutical Development and Manufacturing Sciences, Janssen Research & Development

Ravi is an Associate Director of the Cell Technology department at Janssen R&D, where he is leading a process development team to develop and scale-up cell therapy, and viral vaccines based products. Previously at Janssen R&D, Ravi led a team to develop and implement the industry's first large-scale single-use bioreactor (1000L) and a single-use fluidized bed centrifuge technology for biopharmaceutical manufacturing. Before joining Janssen R&D, Ravi worked at Human Genome Sciences, where he led a team to develop an upstream commercial process for Benlysta® (an antibody approved by FDA for treatment of SLE). Over the years, Ravi has also developed expertise in cell culture process development and scale-up (up to 10,000L bioreactor), and development and implementation of single-use technologies for clinical material production. Ravi received his BSc and MSc. in Chemical Engineering from the University of Pittsburgh. Ravi has delivered many invited presentations on development and implementation of single-use technologies for biopharmaceutical manufacturing and he has authored publications on cell physiology and single-use technologies.

Kumar Dhanasekharan, Ph.D., Associate Director, Process Sciences & Technology (Biologics), Genzyme – A Sanofi Company

Dr. Kumar Dhanasekharan is currently serving as Associate Director of Manufacturing Sciences and Technology at Genzyme and has over 10 years' experience spanning biologics development and bioprocess engineering. His current role spans both upstream and downstream processing in leading continuous process improvement initiatives and continued process verification (CPV) for a major biologic product. Prior to joining Genzyme, Kumar worked in small-molecule process development research at Bend Research Inc., Bend, OR. Prior to that, Kumar was consulting group leader at Fluent Inc. (Now Ansys Inc.) for biologics and pharmaceutical process development and manufacturing sciences. Kumar has a Ph.D. in Food Science from Rutgers University and a Bachelor's in Chemical Engineering from Indian Institute of Technology, Chennai, India. He has over 50 conference presentations and over 10 peer-reviewed publications in top journals.

Stefan Schmidt, Ph.D., Vice President, DSP, Rentschler Biotechnology

Dr. Stefan R. Schmidt MBA currently serves as Vice President at Rentschler Biotechnology, being responsible for the downstream processing department. Previously he held the CSO position at ERA Biotech in Barcelona, directing the companys R&D efforts focusing on fusion peptides. Prior to that he worked at AstraZeneca in Sweden where he led the unit of Protein Sciences as Associate Director. In the last 10 years he worked intensively with fusion proteins, just recently editing and authoring the first comprehensive book on that topic.

LiYing Yang, Ph.D., Scientist, Manufacturing Sciences & Technology, MedImmune

Dr. Yang received her Ph.D. from the Ohio State University at the Biochemical and Molecular Biology Department. Then she joined Bristol-Myers Squibb in the Department of Manufacturing sciences. She worked on process characterization using bioreactor scale-down models, and technology transfer and scaling-up of mammalian cell culture processes. She then joined MedImmune in their large scale mammalian cell culture facility in Frederick, MD, in the department of manufacturing Sciences & Technology. With years of experience in bioreactor scale-up and scale-down model development and qualification, Dr. Yang has experience in both commercial scale and bench-scale bioreactor operations.

Tim Lee, Ph.D., Senior Biopharm Consultant, Biomanufacturing, Latham Biopharm Group

Dr. Tim Lee received his Ph.D. in Biochemical Engineering at University College London. The area of research was focused on the mechanical and catalytic stability of immobilized enzymes. He then did a post-doctoral fellowship at sanofi pasteur, Canada, where he was involved in the optimization of fermentation, recovery and purification process for bacterial and mammalian cell culture. As a senior development scientist and director in bulk manufacturing within sanofi pasteur, Dr. Lee has played a key role in the development of different bacterial media, fermentation and clarification optimization and scale-up as well as the transfer of processes to Industrial operations for manufacturing. He has also published many patents and scientific papers and has presented extensively, globally, over the last several years, outlining the work performed in the industry. He continues to interact with vendors to find new technologies to improve and simplify the industrial operation for the manufacture of vaccines. He is currently a senior biopharmaceutical consultant for Latham Biopharm Group Inc.

Richard Eglen, Ph.D.,  Vice President & General Manager, Corning Life Sciences

Dr. Richard Eglen joins Corning with over 33 years experience in the Life Science industry including
his most recent role as president, Bio-discovery, PerkinElmer, Inc. In this role, he managed the development and commercialization of technology for Life Science research including cellular imaging, automation and detection solutions, as well as drug discovery and research reagents. Previously, he was vice president and general manager, Drug Discovery Reagents, PerkinElmer. Prior to joining PerkinElmer, Richard held numerous executive management positions in the pharmaceutical, diagnostic, and biotech industries. Until 2006, he was executive vice president for Research and Development at DiscoveRx Corp. He also served as vice president of the Center for Biological Research at Roche. He has worked extensively in the GPCR, kinase, and ion channel fields, as well as in assay and instrument technology development for high-throughput screening, imaging, and biomarker detection. He has authored more than 300 publications, book chapters, and patents, and serves on numerous industry, academic advisory, and journal editorial boards.

Kalib Kersh, Analyst, Bio-Based Materials and Chemicals, Lux Research

Kalib Kersh Analyst Kalib Kersh covers Bio-based Materials and Chemicals and Alternative Fuels for Lux Research. Kalib addresses client questions on the entire value chain for bio-based industrial processes, including feedstocks, processes, and markets. Other common topics of focus include key players and partnerships, capital light strategies, and emerging technologies such as bio-electronics and particularly carbon dioxide conversion to materials and chemicals (C2MC). Kalib joined Lux Research after completing his MBA at the Peter F. Drucker School of Management in California, where he founded the Claremont Entrepreneurs student group and led a team of classmates to develop a modular, waste cellulosics to ethanol business plan. Prior, Kalib was an inaugural member of the Gevo Fermentation Team and assisted with E. coli n-butanol biocatalyst development. His master's thesis work involved optimization of glycerol metabolism in order to convert glycerin into alcohols and other fuels and chemicals. This work was later integrated into the Gevo flagship patent, Engineered Microorganisms for Producing N-Butanol and Related Methods. Kalib received his M.S. in Chemistry from California Polytechnic University, and holds a B.A. in Chemistry from Pomona College, writing a thesis on the structural biology of the ribosome and leading media technology and production organizations. Kalib has more than ten years of bio-based chemicals and chemical industry experience which includes biodiesel production and equipment engineering, atmospheric trace gas analysis, and quality assurance consulting. He has performed biodiesel market development as executive staff and board member of the Los Angeles Biodiesel Cooperative.

Michael Butler, Ph.D., Professor, Microbiology, University of Manitoba

Michael Butler is a Distinguished Professor of Animal Cell Technology at the University of Manitoba, Canada. His previous appointments include Associate Dean of Scientific Research at the University of Manitoba and Principal Lecturer in Biotechnology at Manchester Metropolitan University. He has also been a Visiting Scientist at the Massachusetts Institute of Technology (USA), Animal Virus Institue (Pirbright, UK) and the Universities of Oxford and Rio de Janeiro. He holds degrees in Chemistry and Biochemistry from the Universities of Birmingham, London and Waterloo (Canada).

His research work and teaching focuses on the development of bioprocesses using mammalian cells in culture for the production of recombinant proteins, monoclonal antibodies and viral vaccines. He is particularly interested in the bioprocess conditions that can be used to control the biochemical structure of large glycoproteins. He has always collaborated closely with industry and in 2004 was the recipient of the Canadian national Synergy Award for University-Industry innovation. He is presently scientific director of the Canadian Network for Monoclonal antibody production (MabNet), which involves collaboration between 8 universities and 12 companies in Canada. He has published 7 books on animal cell technology and over 100 peer-reviewed scientific papers.

He is the founder and president of Biogro Technologies Inc., a spin-off company dedicated to serum-free media development for mammalian cell bioprocesses. He is a member of European Society Animal Cell Technology, Biochemical Society, Canadian Society of Microbiology, Canadian Society Chemical Engineering and President of the International Society for Protein Expression (PEACe). He is currently an editor of Biotechnology Advances and on the editorial board of Biotechnology and Bioengineering. His past editorial work includes the Encyclopedia of Cell Technology and Comprehensive Biotechnology.

Benjamin Wright, Process Engineer, Genzyme Corporation, a Sanofi Company

I Graduated from Penn State University with a BS in Biotechnology. I've been working at Genzyme for 5 years as a Process Engineer in the Commercial Cell Culture Development group responsible for new technology evaluation, manufacturing support, process development, and technology transfer. Prior to Genzyme, I worked at Amgen as a Manufacturing Associate in the Cell Culture and Purification groups. I live in Concord, MA with my wife and two sons. I enjoy spending time with family, coaching my sons baseball team, and reading.

Maria J. De Jesus, Ph.D., COO & Vice President, Process Sciences, ExcellGene SA

Maria De Jesus graduated in Environmental Engineering from the University of Lisbon and pursued her PhD at the Swiss Federal Institute of Technology in Lausanne, Switzerland and continued post-doctoral studies at the Laboratory of Prof. Wurm. In 2002 Maria was the founding scientist of the privately owned company ExcellGene SA where she trained and led a team of engineers and scientist for the manufacturing of recombinant proteins made with CHO cells. Maria joined the Board of Directors of ExcellGene in 2006 and was promoted to Chief Operating Officer in 2009. Maria has published over 40 highly referenced papers on process sciences. She invented and designed TubeSpin®bioreactors, a widely used system for small-scale process development.

Ludovic Peeters, Scientist, New Product Development, GSK Vaccines

Ludovic holds a master in chemical engineering from the University of Liège, Belgium. He works in the New Product Development Department as a Scientist - New Technologies. He has over seven years of experience with cell culture process characterisation and scale-up and over four years of hands-on experience with Single-Use Bioreactors.

Mark McElligott, Partner and Principal Process Engineer, Process Design Solutions

Mark brings over 15 years of diversified Process Engineering, Single-Use Systems (Systems, Assemblies, Components and Instrumentation) Engineering, Operational Management, ICV Systems Development, and Project Management experience within the biotechnology and pharmaceutical fields. Mark's Experience includes conception to completion engineering (Conceptual Brief, Conceptual Design, Basic Design, Detail Design, with fully integrated commissioning and validation/verification) for upstream and downstream process engineering, process development, process equipment/instrumentation design and process utilities system design. Mark has been contracting as a Senior Upstream Process Engineer, as well as, representing/leading Shire's ETS group's single-use initiatives for all upstream manufacturing operations since 2009. Mark's experience in single-use engineering started at Lonza Biologics in 1998 and continued with companies such as Biogen, Wyeth, Cardinal Health, and NNE Pharmaplan. Mark is a facilitator in the Disposable Community of Practice for the ISPE and is currently involved in drafting the baseline guide for the industry.

Matjaž Tisu, Senior Scientist, Sandoz Biopharmaceuticals

Matjaž Tisu graduated in chemical engineering from University of Ljubljana (Slovenia) and joined Sandoz Biopharmaceuticals in 2006 (Lek Pharmaceuticals d.d.). His current position is senior scientist in upstream development and his main responsibility is laboratory bioprocess development. In the last few years he was involved in the development of several pipeline projects. He is also very much involved in new technology and technology upgrade projects.

Michael McGlothlen, Manager, Upstream Process Innovation Center, EMD Millipore

Mr. McGlothlen has held positions as a Process Development Engineer at Pfizer, Amgen and Medimmune with responsibilities for process scale up and technology transfer of upstream processes.  At EMD Millipore he leads the Upstream Process Innovation Center where new and existing upstream process technology is evaluated and optimized on cell culture and bacterial fermentation processes.

 

Rapid Methods to Assess Quality & Stability of Biologics

Jianmei Kochling, Ph.D., Director, Quality Control Technical Services, Genzyme, a Sanofi Company

Jianmei Kochling is the Director of quality control technical services of biologics division at Genzyme Corporation, a Sanofi company.  She is responsible for Genzyme biologics cleaning validation, protein characterization and methods development during analytical methods life cycle management.  Prior to this position, Dr. Kochling was a scientific associate director of analytical development for small molecules at Genzyme.  Dr. Kochling has 12 years of experience in analytical development supporting small molecule drug development from pre-IND to NDA and 5 years analytical research experience in protein and peptides analysis.  Dr. Kochling is a steering committee member for both the AAPS APQ dissolution and stability focus groups.  She also serves on the USP expert committee for enzyme use in dissolution.

She has worked at GSK, Waters Corporation, Praecis Pharmaceuticals, and Vertex Pharmaceuticals prior to joining Genzyme.  Jianmei received her PhD from Northeastern University, MS from Virginia Commonwealth University, and BS from Fudan University

Malgorzata Norton, MS, Biologist, Office of Blood Research and Review, Center of Biologics Evaluation and Research, US Food and Drug Administration

Malgorzata Norton (formerly Mikolajczyk) is a Biologist in the Division of Hematology, Office of Blood Research and Review, CBER, FDA.  She received her M.S. from the Louisiana State University, School of Veterinary Medicine, studying veterinary immunology and infectious disease.  During her 13 years at CBER, Malgorzata has been a product reviewer and facilities inspector for polyclonal immune globulin (antibody) products.  Her research and publications focus on the characterization of polyclonal antibodies and their ability to bind viral and bacterial proteins.  As part of her research, she studies protein-protein interactions using surface plasmon resonance technology.

Vishal C. Nashine, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.

Dr. Nashine received his M.S. degree in Bio-process Technology from Mumbai University, followed by a Ph.D. in Medicinal Chemistry and Molecular Pharmacology from Purdue University, and post-doctoral studies in Protein Biochemistry at Pennsylvania State University. He also has several years of exposure in the areas of Fermentation Technology, Downstream Processing, and Molecular Biology. He is currently a Senior Research Investigator in the Drug Product Science & Technology department at Bristol-Myers Squibb with experience in early and late stages of product development.

Martin Lemmerer, Principal Scientist, Integrated Biologics Profiling, Novartis, Inc.

I have been working for Novartis for over six years. My current role is Principal Scientist in the Integrated Biologics Profiling Group. My field of expertise includes automation and biophysical characterization of proteins I have received my training from the University of Applied Sciences Weihenstephan, Germany.

Michael G. Tovey, Ph.D., INSERM Director, Research, Laboratory of Biotechnology and Applied Pharmacology, ENSCachan, Villejuif, France

Michael G. Tovey, Ph.D, is INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, EcoleNormaleSupérieure, Cachan, France, author of 250+ articles, member numerous scientific boards, Chair International Cytokines Standards Committee, Chair, Coral Gables Symposia, member ISICR Meetings Committee, European Adjuvant Advisory Committee, editor-in-chief Detection and Quantification of Antibodies to Biopharmaceuticals, Associate Editor, Journal of Interferon and Cytokine Research, and member of the editorial boards of numerous journals.

C. Nick Pace, Ph.D., Distinguished Professor, Department of Molecular and Cellular Biology, Texas A&M

Dr. Nick Pace obtained his Ph.D. at Duke University working with Dr. Charles Tanford; and his post doctoral studies were at Cornell University working with Dr. Gordon Hammes. He is a Distinguished Professor in the Molecular and Cellular Medicine Department in the Texas A&M Health Science Center. His research focuses on the structure, stability, and folding of proteins. He has made many important contributions in these areas. For example, the two most cited papers in the history of the journal Protein Science are from his group and the article "How to measure and predict the molar absorption coefficient of a protein" has been cited over 2000 times. Dr. Pace was awarded the Distinguished Achievement Awards for both Research and Teaching at Texas A&M University. He was also selected for the Senior Investigator Excellence in Research Award by the Texas A&M HSC, and the Sigma XI Distinguished Scientist Award.

Yatin R. Gokarn, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India


Wayne F. Reed, Ph.D., Professor of Physics and Engineering Physics, Department of Physics, Tulane University

Wayne F. Reed is Professor of Physics and Founding Director of the Tulane Center for Polymer Reaction Monitoring and Characterization and Chief Scientific Officer of Advanced Polymer Monitoring Technologies, Inc.

Michael S. Marlow, Ph.D., Staff Scientist, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.

Michael S. Marlow, Ph.D. has been with Regeneron Pharmaceuticals, Inc. in the department of Protein Biochemistry since 2010.  Michael is responsible for the biochemical and biophysical characterization of IND-track biotherapeutics and has played a role in the research and development of Eylea®, one of the most successful biotherapeutic launches in recent history. Prior to joining Regeneron, Dr. Marlow worked at OSI Pharmaceuticals for 2 years, where he assembled and ran a gene-to-protein suite in support of small molecule discovery.  In addition, he instituted a number of biophysical assays for confirming and ranking small molecule leads emerging from high throughput screens. Dr. Marlow received his Bachelor of Science from Rensselaer Polytechnic Institute, a Ph.D. in molecular biophysics from Vanderbilt University, and post-doctoral training at the University of Pennsylvania.

Richard Cavicchi, Ph.D., Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology

Dr. Richard Cavicchi earned his Ph.D. in physics at Cornell University, was a post-doc at AT&T Bell Labs for two years, and then joined the research staff at the National Institute of Standards & Technology in 1989. His work has covered a variety of microfabricated sensors, and research on measurement methods such as nanocalorimetry and nanosecond microphotography. Present research focuses on characterization of protein aggregates.

Marina Kirkitadze, Ph.D., MBA, Deputy Director, Head, Biophysics and Conformation Unit, Biochemistry Platform Analytical R&D North America, Sanofi Pasteur Ltd.

Marina Kirkitadze, Ph.D, MBA has 10+ years experience in Sanofi Pasteur, the vaccine division of Sanofi group. She is Head of Biophysics and Conformation Unit at Biochemistry Platform, Analytical R&D North America.  Marina's expertise is in the field of protein science and biophysics. Her main focus is characterization of monoclonal antibodies, protein and viral vaccines, specifically, conformation and stability in solution and in adjuvanted form, and analysis of particulates.

Patrick Flanagan, Senior Research Associate, BioFormulations Department, Genzyme Corporation, a Sanofi Company

Patrick Flanagan is a Senior Research Associate within the BioFormulations Departmentat Genzyme Corporation (a Sanofi company). Patrick has eight years of experience in Early Formulation Development. Prior to his work in protein Formulation, Patrick worked as a Biopolymer Quality Control Analyst. Patrick received his Bachelor's degree in Biochemistry from Worcester Polytechnic Institute.

Robert Simler, Ph.D., Senior Scientist, Genzyme Corporation, a Sanofi Company

Robert Simler got his B.S. in Chemistry from Duke University and his Ph.D. in Chemistry from The Pennsylvania State University where he worked on the thermodynamics and kinetics of multimeric protein folding.  He has been with Genzyme for nine years in the BioFormulations Development group.  His work focuses on novel approaches to preformulation utilizing spectroscopy and other biophysical techniques as well as evaluating and implementing technology to quantify and characterize subvisible particles.

Praval Shah, Analytical Associate III, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

Praval Shah received a Master of Science Degree in Pharmaceutical Sciences from Northeastern University. He is an experienced analytical chemist with several years experience in the Biopharmaceutical industry.  His research and development experience includes the analysis and characterization of maytansinoid antibody drug conjugates (ADCs).  He has expertise in the characterization of ADCs using light obscuration and microflow imaging techniques and in the application of these techniques to support ADC formulation development and fill finish operations.

Jennifer F. Nemeth, Ph.D., Principal Scientist, Biologics Discovery Program Leader, Biologics Research, Janssen Research & Development, LLC

Dr. Nemeth obtained a B.S. in Chemistry from the University of Scranton in 1995 followed by a Ph.D. in Analytical Chemistry from EmoryUniversity in 1999.  After graduation, she worked under Dr. Richard Caprioli at VanderbiltUniversity as a post-doctoral research follow focusing on applied bioanalytical mass spectrometry.  Leaving academia in 2000, Dr. Nemeth entered the biopharmaceutical industry where she was employed as a bioanalytical mass spectrometrist at Genetics Institute (now WyethBioPharma).  In 2004, Dr. Nemeth joined Centocor's Discovery Research departmentto initiate and head a new mass spectrometry group focusing on the characterization of molecules from inception through pre-clinical.  The principal role of the group is structural characterization of biopharmaceuticals, and the antigens and receptors used during drug development.  In July 2012, Dr. Nemeth took on a newly created position withing the Biologic Research Department in Janssen R&D (formerly Centocor R&D) as a Biologics Discovery Program Leader.  In this role, she is responsible for the therapeutic development of multiple programs between pre-portfolio and New Molecular Entity declaration.  Her publications include detailed protein characterizations, as well as new methods for protein analysis using mass spectrometry.

Paul Bigwarfe, Jr., Ph.D., Director, Analytical Sciences, Industrial Operations and Product Supply, Regeneron Pharmaceuticals, Inc.

Paul received his BS in chemistry from St. John Fisher College in upstate NY.  He followed that with a PhD from the University at Buffalo, SUNY, in Bioanalytical Chemistry studying proteomic applications of mass spectrometry.  After a brief stint working at his advisor's start-up company, he joined the pharmaceutical industry characterizing small molecules in drug discovery at aaiPharma.  He then moved to the drug product development area at Hospira, overseeing analytical development for injectables with increasing responsibility on both internal and CMO projects.  Paul joined Regeneron in 2010, where he is responsible for developing and qualifying bioanalytical methods for QC, setting specifications for drug substance and drug product, leachable extractable evaluations, release and stability testing of early to late phase clinical drug candidates, as well as anything that can be construed as an "analytical" CMC issue.

Stacey Williams, Associate Scientist, Process Development, Amgen, Inc.

Stacey is associate scientist in Process Development, Amgen Inc. with over 15 years of industry experience working on small molecules and protein therapeutics.

 

High-Concentration Protein Formulations

Donna L. Luisi, Ph.D., Senior Principal Scientist, Pharmaceutical Research & Development, Pfizer, Inc.

Donna L. Luisi, Senior Principal Scientist at Pfizer, obtained her Ph.D. in Chemistry from Stony Brook University. Her graduate work focused on characterization of the transition and the unfolded states of the N-terminal domain of the ribosomal protein L9. Dr. Luisi was a Postdoctoral Fellow in the Molecular Biology and Biophysics Department at Yale University. Her postdoctoral work focused on tetratricopeptide repeats and their role in Down Syndrome. Since joining Pfizer (formally Wyeth) in 2001, Donna and her group have been working to optimize and develop formulations and dosage forms for peptides, antibodies, drug conjugates and vaccines for Phase I through commercial development utilizing biophysical technique.

Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

Tom Laue is the Carpenter Professor of Molecular, Cellular and Biomedical Sciences, and professor of Material Sciences at the University of New Hampshire. He is the Director of both the Center to Advance Molecular Interaction Science and the Biomolecular Interaction Technologies Center.He 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.He joined the University of New Hampshire in 1984 as an Assistant Professor, and teaches both undergraduate and graduate courses in biochemistry and biophysics. His research focuses on the development of instrumentation and methods that use the fundamental properties of mass and charge for examining macromolecular interactions. These instruments provide unique insights into these interactions, and have resulted in extensive collaborations with both academic and industrial labs. Tom has over 120 publications, serves on several editorial boards, and gives over one hundred lectures, seminars and workshops a year.

Thomas Pohl, Ph.D., Senior Scientist, Research & Development, SuppreMol GmbH

Dr. Thomas Pohl has studied Chemistry & Biochemistry at the University of Manchester, UK and Freiburg, Germany. In his current role, Thomas is responsible for process development and formulation of drug candidates at SuppreMol GmbH, a Biotech company located in Martinsried, Germany.

Danny Chou, Ph.D., Senior Research Scientist, Biologics Development, Gilead Sciences, Inc. 

Prior to joining Gilead Sciences, Dr. Danny Chou was the Co-founder and CSO of NorthStar Bio, a CRO that was dedicated to the characterization of sub-visible protein aggregates. Prior to starting his company, Dr. Chou was the Director of Pharmaceutical Development at Integrity Bio, a CRO/CMO that specializes in formulation development and CGMP fill and finish of biopharmaceuticals. Before that, Dr. Chou was also a Bioprocess Analytical Scientist and Process Development Scientist at Genzyme Corporation and Amgen Corporation, respectively. He has technical experience in therapeutic protein formulation development as well as strategies for increasing protein solubility, stability and elucidation of protein aggregation/self-association and degradation mechanisms. His expertise is in the study of protein-protein and ligand-protein interactions using laser light scattering, isothermal titration calorimetry (ITC) as well as fluorescence spectroscopy. Protein formulation, fill & finish process development, analytical method development, technology transfer, and manufacturing support are a few of his specialties. Dr. Chou is one of the leading industry proponents for the development of analytical methods to characterize sub-visible particles, a critical quality attribute that is associated with immunogenicity in protein pharmaceuticals. He has published review articles on this topic in leading pharmaceutical journals and has been invited to speak at international biotechnology conferences. Dr. Chou received his PhD in Pharmaceutical Biotechnology at the University of Colorado at Denver and his PharmD and MBA from the University of Florida.

Jan Jezek, Ph.D., CSO, Development, Arecor Ltd.

Jan Jezek, the principal inventor of the core protein stabilisation technologies, is a biochemist with a strong background in physical chemistry. Currently responsible for R&D activities, platform development and technical IP support in the field of stabilisation of biologics. He played a crucial role in the development of stabilising technologies for commercially important proteins that allow preservation of protein structure and biological activity during sterilisation by gamma radiation and during long-term storage at ambient temperature. Lead successful grant funded projects with TSB funding. Previously, a Principal Scientist at Insense Limited, he was responsible for development of novel medical devices from concept to market. Dr. Jezek holds a joint Doctorate from the University of Bedfordshire and the University of Chemical technology, Prague. He is a member of the Scientific Advisory Board of the Centre of Excellence in Biopharmaceuticals (University of Manchester). He is also a committee member of the Formulation Science & Technology Group (FSTG) at the Royal Society of Chemistry.

Daniel Some, Ph.D., Principal Scientist, Wyatt Technology Corp.

Daniel Some is Principal Scientist and Director of Marketing at Wyatt Technology Corp. Previously he was product manager for the Calypso system, responsible for developing the hardware and software of CG-MALS. He has authored a review article, a book chapter and multiple application notes on CG-MALS as well as several patent applications. Prior to joining Wyatt Technology, Dr. Some spent over a decade in the semiconductor and defense industries.

Devendra (Davy) S. Kalonia, Ph.D., Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut

Devendra Kalonia is a Professor of Pharmaceutics in the School of Pharmacy and holds a joint appointment at the Institute of Material Sciences at the University of Connecticut. Various areas of his research interest include protein formulation, stability, characterization, unfolding, and interactions of proteins with excipients, protein aggregation, protein-protein interactions and protein rheology. He is a leader in the area of high concentration antibody solution rheology and formulation. He has active research collaborations with major biotech companies. He has presented invited talks at national and international meetings, and his work has been published in highly reputed journals. He has consulted with a large number of pharmaceutical and biotech companies. 

Daniel Seeman, Researcher, Dubin Research Group, Department of Chemistry, University of Massachusetts-Amherst

Daniel is a senior graduate student in the lab of Prof. Paul L. Dubin at UMass-Amherst. His research focuses on the study of model proteins as well as relevant pharmaceuticals in high concentration formulations. Electrostatically driven interprotein interactions are studied as a function of solution pH and ionic strength in order to limit the extent of unwanted protein self-association. The impact of electrostatics on association of native proteins is assessed via various scattering techniques (DLS, SLS, etc). His research couples experimental methods with quantitative electrostatic modeling, and simulation.

Steven Shire, Ph.D., Staff Scientist, Late Stage Pharmaceutical Development, Genentech, Inc. 

Dr. Shire has over 30 years experience in the pharmaceutical biotechnology industry. He received his Ph.D. from Indiana University Chemistry Department and after Post Doctoral Training at the University of Connecticut began his career at Genentech as Research Scientist in the Department of Protein Chemistry. He was involved in the early work to isolate heterologous recombinant proteins expressed in bacterial systems. This work led to the granting of a patent and served as the basis for further product development of proteins expressed in bacterial systems. During his tenure in the Protein Chemistry Department he used numerous physicochemical techniques to characterize Genentech proteins at various stages of development. Shortly after the creation of the Pharmaceutical Research and Development Department at Genentech, he joined the department where he made numerous contributions to development of protein formulation and delivery. In addition, he set up one of the first analytical ultracentrifugation laboratories in the Biotechnology industry. Currently he is a Staff Scientist in the Late Stage Pharmaceutical Development Department at Genentech, and an adjunct faculty member of the USC School of Pharmacy and University of Connecticut School of Pharmaceutical Sciences. He has been responsible for directing research and development of formulations for a variety of recombinant human proteins including Pulmozyme® and Xolair®. Dr. Shire has served as the chair of the American Association of Pharmaceutical Scientists (AAPS) Biotechnology Section, and was elected as a Fellow of AAPS in 1998 and member at large to the AAPS Executive Council in 2001. He has published over 80 reviews and papers dealing with various aspects of formulation and pharmaceutical development of therapeutic proteins. 

Dhananjay Jere, Ph.D., Group Leader, Early-Stage Pharmaceutical Development & GLP Supplies, Biologics Europe, F. Hoffmann-La Roche Ltd.

Dr. Dhananjay Jere is the group leader, Early-Stage Pharmaceutical Development, Hoffmann-La Roche, Switzerland. He focuses on research and development of ocular drug delivery and bispecific mabs, peptides and small molecule formulation development. He is also the project leader for multiple NBE/ NCE projects, and external technology evaluation. 

Gabriella Leo, Ph.D., Associate Researcher, Structural and Biophysical Characterization Laboratory, Analytical Development Biotech Products, Merck Serono (Italy)

Gabriella Leo received a degree in chemistry with a specialization in Biochemistry by the University of Naples “Federico II”, (Italy). After a Master in “Experts in industrial biotechnology and innovation management in the field of biotechnology” provided by ATIBB BioTekNet, she holds a PhD in Biotechnology Science (Industrial and Molecular) from the University of Naples “Federico II”, (Italy). She joined Merck Serono in 2011 as a researcher in the Structural and Biophysical Characterization Lab (SBC) of the Protein Chemistry department of Merck Serono Italia. She has profound experience in protein characterization focusing mainly on Mass Spectrometry techniques.