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Steven Cramer, Ph.D., William Weightman Walker Professor, Chemical and Biological Engineering, Rensselaer Polytechnic Institute
Steven Cramer is the William Weightman Walker Professor of Chemical and Biological Engineering at Rensselaer Polytechnic Institute, Troy, New York. The research in the Cramer laboratory involves state of the art experimental and theoretical investigations into novel bioseparations systems. Topics include: prediction of protein binding affinity and multiscale modeling of chromatographic systems, design of chemically selective displacers, development of efficient antibody separation systems, fundamental studies in multimodal chromatography, novel proteomics platform using carrier displacement chromatography, novel chromatographic and diode based electrophoretic lab on chip systems, protein unfolding in chromatographic systems, chemometrics for process analytical technology, multilevel automated peptide synthesis/screening system for design of affinity peptides and smart biopolymer affinity precipitation systems. Recent work that combines protein libraries, NMR studies, molecular dynamics simulations and high throughput chromatographic investigations has shed significant insight into the design of a new generation of mixed mode chromatographic systems.He has won several awards including: the 2006 Alan S. Michaels Award for the Recovery of Biological Products (ACS Division of Biochemical Technology); School of Engineering Research Excellence Award, RPI; Presidential Young Investigator, National Science Foundation; and the Early Career Award, RPI. He has delivered major keynote and plenary addresses at a number of International Conferences, is a Fellow of the American Institute for Medical and Biological Engineering and is the Editor of the journal Separation Science and Technology. He has also chaired several prestigious meetings including the International HIC/RPC Bioseparations Conference, the ACS Recovery of Biological Products Meeting and the Gordon Conference on Reactive Polymers. Prof. Cramer has published 148 papers in peer-reviewed journals and has 9 patents. Importantly, he has produced 35 Ph.D. students who have gone on to leadership positions in the biotechnology industry and academia.

William Gillette, Ph.D., Senior Scientist, Protein Expression Lab, SAIC-Frederick, Inc.
The Protein Expression Laboratory provides protein expression/purification core service to the laboratories of the NCI, NIH and USAMRIID. Dr. Gillette is currently focusing on micro-scale purification and supporting analysis techniques to evaluate protein expression constructs and the success of the micro-scale chromatography experiments. Dr. Gillette earned his Doctorate in Microbiology from North Carolina State University, Raleigh, North Carolina.

Steven S. Kuwahara, Ph.D., Principal, QC, GXP Biotechnology, LLC
Originally from Hawaii, Dr. Kuwahara holds degrees in Biochemistry from Cornell and the University of Wisconsin. After starting as an Assistant Professor of Chemistry at the California State University at Long Beach, he entered the biologics industry at the Division of Biologic Products at the Michigan Department of Public Health, where he became the head of the Quality Control Section. He developed expertise in the testing of blood derivatives, coagulation factors, viral and bacterial vaccines. He then moved to the Hyland division of Baxter Healthcare where he was in charge of assay development and, later, the Quality Control department. He then became responsible for quality systems during the development of a biological device. After a short period with a contract testing laboratory and another blood fractionator, he became the director of quality control with a gene and cell therapy company. In later years, he worked as the director of assay validations for a large contract testing laboratory and as a GMP consultant to start-up cell therapy companies. His last position was as the Director of Quality Control and Assay Development with a virtual company. He is currently the head of his company, GXP BioTechnology LLC.
Dr. Kuwahara is an experienced analytical biochemist who has applied his knowledge to the quality control of pharmaceuticals. His work has dealt with all aspects of GMP and GLP in relation to drugs and biopharmaceuticals. He has worked with small molecules, proteins, cells, gene therapy vectors and nutritional supplements.
Dr. Kuwahara has written many papers and book chapters and serves on the editorial advisory boards of BioPharm, BioQuality, the Journal of Validation Technology, and the Journal of GXP Compliance for which he also writes a column called “the GLP Forum.” He and a colleague have recently published translations of the Chinese GMPs and the Inspection Checklist for Chinese GMP Certificates. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.

Andrew J. Theobald
, Investigator, Biological Reagents & Assay Development, GlaxoSmithKline
Andrew is an Investigator in the Biological Reagents & Assay Development department at GlaxoSmithKline in Stevenage, UK. Since joining the company in April 2003 he has developed extensive expertise in the expression, purification and characterization of proteins, and has played a key role in many drug-discovery programmes. His contributions have supported significant advances in the high-throughput screening and crystallography of a wide range of targets, leading to the selection of candidate molecules and their progression towards the clinic. Before joining GlaxoSmithKline, Andrew was a worldwide QToF mass spectrometer engineer at Micromass UK, and completed an undergraduate degree in Applied and Human Biology at Aston University, UK.

Jonathan S. Duke-Cohan, Ph.D., Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Institutes of Medicine

Jonathan Duke-Cohan is a Principal Associate in Medicine at Harvard Medical School and the Dana-Farber Cancer Institute. After receiving his B.Sc. and Ph.D. from the Institute of Cancer Research of the University of London, U.K., he spent a brief period at the Ontario Cancer Institute in Toronto, following which he became junior faculty in the Department of Immunology of the Hebrew University-Hadassah Hospital in Jerusalem, Israel. At the Dana-Farber for more than 20 years, his research focuses upon protein-protein interactions that lead to the developmental maturation, differentiation and activation of T lymphocytes.

Ray Owens, Ph.D., NDM Senior Research Fellow, Division of Structural Biology, Oxford Protein Production Facility, University of Oxford

Ray Owens has extensive experience of the production of recombinant proteins for structural biology both in industry and academia. He is currently a Nuffield Department of Clinical Medicine Research Fellow at the University of Oxford and Director of the Oxford Protein Production Facility-UK. This is a National Resource Centre for protein production and crystallization, based at the Rutherford Appleton Laboratory, near Oxford.

Sirano Dhe-Paganon, Ph.D., Assistant Professor, Physiology, University of Toronto
Dr. Dhe-Paganon is an Assistant Professor at the University of Toronto in the Department of Physiology and a Principal Investigator in the Structural Genomics Consortium. His main research interests lie in post-translational ubiquitylation and autophagy modification systems, which are implicated in numerous diseases states, including insulin resistance and diabetes. By discovering biochemical and cellular mechanisms, he reveals new targets for the development of drugs and health-related applications in the prevention and curing of diseases. To facilitate this effort, his lab 1) develops new chemical and biological probes, and 2) carries-out large-scale structural biology on human E1/E2/E3 ubiquitin ligases and deubiquitylases. His lab has become a leading contributor to top scientific journals and the Human Protein Data Bank.

Filippo Mancia, Ph.D., Assistant Professor, Physiology & Cellular Biophysics, Columbia University
Filippo Mancia received his BA from the University of Pavia in Italy in Chemistry, and obtained his Ph.D from the University of Cambridge in England. He is now an Assistant Professor in the Department of Physiology & Cellular Biophysics at Columbia University. He is a structural biologist in training with considerable experience in production and characterization of membrane proteins for structural studies. He is also a key member of the New York Consortium of Membrane Protein Structure (NYCOMPS), where he has played a pivotal role in the design, development, implementation and optimization of the high-throughput cloning and protein production platform for prokaryotic membrane proteins successfully functioning at the NYCOMPS centre.

Scott Peterson, Ph.D., Professor , Director, Functional Genomics Research Technology, J. Craig Venter Institute
Dr. Peterson received his undergraduate education at Rutgers University from 1982-1986. Dr. Peterson then pursued a Ph.D. in the laboratory of Dr. Clyde Hutchison at The University of North Carolina at Chapel Hill, where he initiated a characterization of the minimal genome of Mycoplasma genitalium. Dr. Peterson did post-doctoral studies at Glaxo-Wellcome Inc from 1992-1996. Dr. Peterson joined the faculty in 1996 where he has pursued a wide variety of functional and comparative genomics studies.
Dr. Peterson was the co-first author on the global transposon mutagenesis of the M. genitalium genome to define the minimal genetic requirements for life. Dr. Peterson has been using DNA microarrays to conduct gene expression and comparative genomic hybridization studies on a number of bacterial species. More recently, Dr. Peterson has developed novel applications using DNA microarrays to enhance the efficiency of performing functional characterization of microbial genomes. Since 2001, Dr. Peterson has been the Scientific Director of the NIAID's Pathogen Functional Genomics Resource Center (PFGRC). As the scientific leader of the PFGRC, Dr. Peterson has developed additional areas of expertise in functional genomics, particularly focused on high throughput gene cloning and protein expression and proteomics.
Dr. Peterson is interested in the evolution of pathogenic genomes. More recently, Dr. Peterson has developed a number of methods and strategies to enable deeper characterization of metagenomes and has interest in both human and environmental metagenomics. In 2008, Dr. Peterson was promoted to the position of Director of Functional Genomics Research and Development.

Kaushal Rege, Ph.D., Assistant Professor, Chemical Engineering, Ira A. Fulton School of Engineering, Arizona State University
Education and Research Training. Dr. Rege’s graduate research (1998-2004) at Rensselaer Polytechnic Institute in Troy, NY involved parallel screening of molecules to identify candidates for protein purification using displacement chromatography and development of screens for protein purification methods development. Dr. Rege’s postdoctoral research (2004-2007) at Massachusetts General Hospital and Harvard Medical School in Boston, MA involved investigations in molecular and nanoscale cancer therapeutics.

Current Affiliation
. Dr. Rege moved to ASU as an assistant professor of chemical engineering in 2007 and was subsequently invited to join the graduate faculty of the Harrington Biomedical Engineering and Biological Design programs at ASU. Dr. Rege is also a member of the Physical Sciences in Oncology Center (PS-OC) at ASU.

. Dr. Rege was awarded a Young Investigator Award from the Defense Threat Reduction Agency (DTRA) in 2010. Dr. Rege was awarded the Outstanding Faculty Achievement Award in Chemical Engineering at ASU in 2010.

Research Activity
. Current research in Dr. Rege’s laboratory includes cancer nanotechnology, synergistic therapeutics, and drug and gene delivery, and biological separations. Dr. Rege has 37 research manuscripts published / in press in peer-reviewed journals, three submitted / in revision, and five in preparation, in addition to several patents, patent applications, and invention disclosures. Dr. Rege was a co-editor of a book tiled Methods in Bioengineering: Nanoscale Bioengineering and Nanomedicine, published by Artech House in 2009 and has published a book chapter related to electrokinetic separations. Dr. Rege has served as PI on several grants funded by NIH, NSF, DTRA, and state and private foundations. Dr. Rege has trained two postdoctoral researchers, ten graduate students and fifteen undergraduate students, and his students have won awards at ASU as well as at the national level.

Opher Gileadi, Ph.D., Principal Investigator, Biotechnology and Genomic Integrity, The Structural Genomics Consortium (SGC), University of Oxford
Dr. Gileadi obtained his B.Sc. and Ph.D. at the Hebrew University in Jerusalem, investigating gene expression in the human placenta. His post-doctoral fellowship in the group of Prof. Roger Kornberg at Stanford University focused on the identification, purification and cloning of the RNA polymerase-associated factor TFIIH from yeast. After establishing his own group at the Weizmann Institute in Israel, he continued to investigate the genetics and biochemistry of gene regulation in yeast. Since 2004 Dr. Gileadi has been in the Structural Genomics Consortium in the University of Oxford, where he has overseen the production of several hundreds of human proteins for structure determination by X-ray crystallography. In Oxford, he also specialises in structural biology of DNA repair proteins.

Paul Hanson, Ph.D., Staff Engineer II, Cambridge Biologics CMC Group, Millennium Pharmaceuticals
At Millennium, The Takeda Oncology Company, Dr. Hanson works in the biologics process development group as a staff engineer.  His initial role was to implement analytical methods in support of process characterization efforts and to work with the Analytical Development Biologics group to ensure that assays developed for drug substance were suitable for analysis of in-process eluates.  Dr. Hanson then expanded his responsibilities to downstream purification development and the development of technologies to support high-throughput process development. 
The increased size of the data stream resulting from high-throughput technologies demanded that an IT solution be found to ensure that data management did not become the bottle neck in process development and to ensure accuracy and traceability.  As a result, Dr. Hanson served as the project manager for bringing in a scientific data management system that would enable the high-throughput process development environment.  In this role, he worked with stake holders to identify and prioritize needs to ensure a successful roll-out of the system.  He also communicated the key business metrics to management to ensure their support of the project.  The details of the process drivers and the project strategy will be discussed in his talk.

Chris Morris, Computational Science and Engineering Department, Science and Technology Facilities Council (STFC)
Chris Morris is a career software developer who has moved from commercial work to a scientific context. He led the team developing Protein Information Management System (PiMS) from 2005 to 2010. He has led reflection on the lessons learnt from this project and others.
Morris works in the Computational Science and Engineering Department of STFC. This provides infrastructure and key resources for most of the UK's "Collaborative Computing Projects", collaborations to produce, maintain, and distribute scientific codes.
He says that eventually he realised that the hard part of a software project is not the coding.