Archived Content

Analytical Development & Quality

Speaker Bios
Rapid Methods to Assess Quality & Stability of Biologics
August 18-19, 2014

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.

Ernesto Freire, Ph.D., Professor, Biology and Biophysics, Johns Hopkins University

ERNESTO FREIRE is the Henry Walters Professor at the Johns Hopkins University. He has been a member of the Department of Biology and Biophysics since 1986. Dr. Freire obtained his doctorate in Biophysics from the University of Virginia.
Dr. Freire is a world recognized expert in biological thermodynamics. He performs research in the thermodynamics of protein stability, protein-protein interactions, and protein-ligand binding. Dr. Freire has pioneered the development of drug design and optimization strategies using thermodynamics and microcalorimetric techniques. Dr. Freire has been associated with several startups including Fulcrum Pharmaceuticals, Ception Therapeutics and currently AVIA Biosystems where he is Chief Scientific Officer. The author or co-author of over 240 publications and several patents, Dr. Freire is on the editorial board of Proteins: Structure, Function and Bioinformatics, Current Protein and Peptide Science and Chemical Biology and Drug Design. He has served on many scientific advisory committees for the National Institutes of Health and the National Science Foundation. Dr. Freire is an Honor Member of the Spanish Society of Biochemistry and Molecular Biology, and a member of the Academy of Sciences of Latin America.

Zhenyu Gu, Ph.D., Development Scientist II, Analytical Sciences, Alexion Pharmaceuticals, Inc.

Qingyan Hu, Ph.D., Scientist, Formulation Development, Regeneron Pharmaceuticals, Inc.

Dr. Qingyan Hu received her PhD in chemistry from the University of Toronto in 2005. After 2-year postdoc at National Research Council Canada, she joined Roche Global Formulation Research in 2007. At Roche, Qingyan has led formulation research projects on peptides, siRNA and small molecules. In 2013, Qingyan joined Formulation development group at Regeneron Pharmaceuticals. She is responsible for early stage and late stage formulation development for several mAb development projects.

Rohanah Hussain, Ph.D., Senior Scientist, Diamond Light Source. Ltd.

Dr. Rohanah Hussain has been working in the field of biopharmaceuticals in drug design and delivery and novel applications of analytical techniques in the field of Biomedical Sciences. She is currently a Senior Beamline Scientist at Diamond Light Source for Circular Dichroism beamline B23 managing, supporting and collaborating with a large number of beamline user groups from both academia and industry in the field of membrane proteins, soluble proteins, peptides, small molecules, DNA and carbohydrate.

Jianmei Kochling, Ph.D., Director, Quality Science and Analytical Technology, Genzyme, a Sanofi Company

Jianmei Kochling is a director of Quality Science and Analytical Technology in Biologics division at Genzyme, a Sanofi company. She is responsible for implementing new and emerging technology to the next generation analytical methods during analytical life cycle management for Genzyme commercial products as well as protein characterization supporting Genzyme manufacturing and product related programs. In addition, her group is responsible for developing methods supporting both upstream equipment cleaning validation and downstream column life cycle studies, and other regulatory related commitments. Dr. Kochling was a scientific associate director at Genzyme leading a small molecule analytical development program until its NDA filing. Dr. Kochling is a steering committee member for both the AAPS dissolution and stability focus groups. She is also a USP expert committee for enzyme use in dissolution.

Dr. Kochling 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

Eric Krauland, Ph.D., Senior Director, Antibody Discovery and Optimization, Adimab LLC

Joyce Lin, Senior Research Associate, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

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.

Dean Ripple, Ph.D., Leader, Bioprocess Measurements Group, National Institute of Standards and Technology

Dean Ripple joined the National Institute of Standards and Technology as a post-doctorate in 1991. Since 2010 he has led the Bioprocess Measurements Group, which develops standards and sensing technologies in support of biotherapeutic manufacturing and health care. His research focuses on standards for the counting and characterization of particles in therapeutic proteins. He has a Ph.D. in physics from Cornell University and an M.S. in biotechnology from Johns Hopkins University.

Christopher Roberts, Ph.D., Associate Professor, Department of Chemical Engineering, University of Delaware

Dr. Roberts is an Associate Professor in the Department of Chemical and Biomolecular Engineering at the University of Delaware. He received his BChE from UD, and his Ph.D. in Chemical Engineering from Princeton University. He joined the department in 2002 as an Assistant Professor after working in pharmaceutical R&D for Pfizer, Inc. as a formulation scientist. The Roberts laboratory focuses on fundamentals and applications of protein physical and chemical stability, (mis)folding, aggregation, kinetics, statistical mechanics, and phase behavior to address questions of biopharmaceutical product design and manufacturing. Selected honors include the AAPS New Investigator Award in Pharmaceutics and Pharmaceutical Technologies, the Ebert Prize from the Journal of Pharmaceutical Sciences, and the University of Delaware College of Engineering Excellence-in-Teaching award.

Shuai "Sunny" Shi, Ph.D., Senior Scientist, Sterile Product Development, Merck

Dr. Shi received his PhD. degree in pharmaceutical sciences from the University of North Carolina at Chapel Hillin 2010. In a short period of three years, Dr. Shi has six publications in leading, peer-reviewed international reputed pharmaceutical journals. Several of these manuscripts are also firsts in their field. Two describe, for the first time, the delivery of mycafungin intended for treatment of fungal infections following lung transplants and support the clinical work of collaborators at Duke University. Additionally, two of these manuscripts illuminate a conundrum in pharmaceutical analysis that of cascade impactor profile comparisons to demonstrate particle size equivalence. Dr. Shi creatively developed an alternative method which has gained a wide interest from the pharmaceutical aerosol field. Dr. Shi was also a recipient of the MOPH graduate scholar award for his outstanding PhD research in developing respirable tuberculosis vaccines.

In 2010-2011, Dr. Shi completed a post-doctoral fellowship with one of the most distinguished scientists in the field of biotechnology, Professor Russell Middaugh, at the University of Kansas, where he was the project leader for multiple industry sponsored projects on protein and vaccine formulation and characterization. Dr. Shi has also published several exceptional research articles during this period. In one publication, he successfully discovered the aggregation mechanism of a recombinant protein sEphB4-HSA, a therapeutic candidate for the treatment of vascular proliferative diseases and cancer such as Kaposi sarcoma (KS). This article was ranked one of the ten most downloaded papers published in 2012 and thus being featured on the journal’s website.

In 2011, Dr. Shi took up a position as a Senior Scientist in the Sterile Product Development group at Merck. Since then he has made significant contributions to the biophysical characterization and formulation development of Merck biosimilar, biobetter and novel programs. This includes leading a high-performance team to develop new technologies for protein characterization; supervising junior-level scientists on their research activities and serving as functional representatives on multiple protein characterization and formulation projects. Dr. Shi’s excellent work in Merck has won him several times Merck Award of Excellence, one provisional formulation patent on a biosimilar, and several publications. Dr. Shi is a member of multiple scientific societies such as AAPS, ACS and Sigma Xi. He is also a peer reviewer for a number of international journals.

Aleš Štrancar, Ph.D., CEO, BIA Separations GmbH

Ales Strancar, the CEO of the Company and one of the main inventors of the CIM Convective Interaction Media® (new generation of chromatographic support), after finishing MSc at University of Ljubljana headed the parent company BIA for 8 years. Beside the main activity, selling and servicing pharma lab equipment, BIA was active in R&D. In 1998 the CIM project got a venture capital investment and new company BIA Separations was funded and is headed by Strancar since then. 

Ales Strancar is author or co-author of more than 60 scientific papers dealing with separation and purification technologies. He is a co-author of 5 granted USA patents and their foreign equivalents in the field of biomolecule separations and purification. As well he is a co-author of several book chapters dealing with novel chromatography technologies for biomolecule separation. 

He co-developed several industrial scale purification processes, among them for company Octapharma (FIX - human plasma protein), Vienna, for company Boehringer Ingelheim (plasmid DNA), Vienna and for company Krka, Novo mesto. Ales Strancar holds a position of Assistant Professor at Biotechnical Faculty of University of Ljubljana. He was President of the Technology Council of the Ministry of the Economy of the Republic of Slovenia and Member of Science and Technology Council of the Republic of Slovenia. He has been named Slovenian Entrepreneur of the year 2005.

Nanda Subbarao, Ph.D., Senior Consultant, Analytical CMC, Biologics Consulting Group

Dr. Subbarao holds a Ph.D. in Bio-organic Chemistry. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. As a consultant she has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products. She serves on the AAPS Stability Focus Group Steering Committee.

Anthony L. Young, Ph.D., Principal Scientist, Pharmaceutical Research and Development, Pfizer, Inc.

Anthony Young is a principal scientist in the Pharmaceutical Research and Development group at the Pfizer St. Louis, Missouri Laboratories. He earned his B.S. in Chemistry from Southern Illinois University at Edwardsville in 1992 and his M.S. in Chemistry from the University of Missouri St. Louis in 1995. He has 20 years of experience in physical chemistry measurements, material science, pharmatherapeutic and biotherapeutics formulations. His current responsibilities include developing regulatory toxicology and first in human formulations for monoclonal antibody, drug conjugate and vaccine formulations.

Speaker Bios
Early Analytical Development for Biotherapeutics
August 20-21, 2014

Vijay Dhawan, Ph.D., Senior Scientist, Bioanalytical Development, Genzyme

A Senior Scientist at Genzyme where for past several years I have led the CMC efforts for a flagship antibody program. In parallel, I have been instrumental in developing, qualifying and validating several analytical methods using a wide variety of technological platforms. I am very interested in application of an integrated QbD-based approach for the development of biologics where good process and product understanding can help to attain the desired goals faster and economically.

Andrew Downey, Ph.D., Researcher, Chemistry, University of Massachusetts Lowell

Dr. Andrew Downey received his Ph.D. in biochemistry from the University of Massachusetts Lowell where he is also a research assistant in the Protein Sciences Department at the Massachusetts Biomanufacturing Center. His research focuses on biochemical, biophysical and mass spectromic protein characterization, as well as analytical support for discovery research, process development, formulation and manufacturing stages of protein production.

Jia Duo, Ph.D., Research Investigator, Analytical and Bioanalytical Development, Bristol-Myers Squibb

Dr. Jia Duo is currently Research Investigator at Bristol-Myers Squibb. He is responsible for developing, troubleshooting, and implementing immunoassays for analysis of non-clinical PK/TK samples in support of Discovery biologics programs. Dr. Duo has 15 years’ experience working with immunoassays for quantitative bioanalysis. Prior to joining Bristol-Myers Squibb, he was Postdoctoral Research Fellow for Institute for Clinical and Translational Research at Albert Einstein College of Medicine. Dr. Duo contributed widely to development and applications of immunoassays and LC-MS methods for quantification of clinical biomarkers from multiple matrices. Dr. Duo earned his Ph.D. in Analytical Chemistry from Rensselaer Polytechnic Institute and his BS degree in Chemistry from Nankai University, China. He has co-authored several research articles appearing in peer-reviewed journals.

Melissa Geddie, Ph.D., Senior Scientist, Merrimack Pharmaceuticals

Melissa Geddie is an antibody engineer at Merrimack Pharmaceuticals on the antibody technology team where she works on generating novel therapeutics. Prior to joining Merrimack Pharmaceuticals, Melissa was a postdoctoral fellow in the laboratory of Susan Lindquist, Ph.D at the Whitehead Institute for Biomedical Research, where she studied misfolded proteins in neurodegenerative diseases. She received her degree from Emory University studying the relationship between protein structure and function.

Jason Huang, Ph.D., Senior Research Investigator, Analytical and Bioanalytical Development, Bristol-Myers Squibb

Dr. Huang is a Senior Research Investigator in Pharmaceutical Development at Bristol-Myers Squibb Company in New Brunswick, New Jersey. Dr. Huang has a B.S. degree in Biochemistry and M.S. in Fermentation Science. He obtained his Ph.D. in Analytical Chemistry with research on N-carbamyl amino acids during yeast fermentation at the University of California, Davis. His postdoctoral research at the College of Pharmacy, University of Iowa was on the biotransformation of natural products and on the purification and characterization of ferulic acid decarboxylase from Pseudomonas fluorescens. He has worked 20 years in the pharmaceutical industry with experience in both small and large molecule drug development. He was responsible for in-process monitoring of active pharmaceutical ingredient manufacturing for toxicology studies and clinical trials. He is experienced in technology transfer and has contributed to the CMC section of numerous regulatory filings. Currently Dr. Huang is working on analytical/formulation development of proteins and peptides including immuno-oncology drugs.

Vidyashankara Iyer, Ph.D., Scientist, Formulation Sciences, MedImmune

Dr. Iyer is scientist at Medimmune, Gaithersburg. His primary research interest lies in protein and vaccine formulation and development. He obtained a PhD from the University of Kansas in Biomolecular Engineering under Dr. Russ Middaugh in 2012. He obtained his undergraduate degree in Chemistry from KU in 2007. He has experience in working with several types of biological entities including monoclonal antibodies, enzymes, sub-unit protein vaccines, live and inactivated viruses.

Jennifer S. Laurence Ph.D., Associate Professor, Pharmaceutical Chemistry, University of Kansas

Dr. Laurence received a Ph.D. in Chemistry from Purdue University and conducted postdoctoral research in Structural Biology at Purdue. She joined the faculty in the Department of Pharmaceutical Chemistry at the University of Kansas in 2004 and is currently Associate Professor and Louise Byrd Graduate Educator. Research in the Laurence lab focuses on protein stability and targeted delivery of metals. A variety of analytical, physical and biochemical tools, including high-resolution solution NMR are utilized to investigate mechanisms of stability involving intrinsic structure and local packing interactions as well as the influences of environment and intermolecular interactions on protein stability and aggregation. Her lab discovered a metal abstraction peptide (MAP) chemistry that generates a unique and highly stable structure compatible with targeted delivery of metals. The fundamental properties of this system are under investigation in her KU lab and development of therapeutic and diagnostic applications utilizing the patented technology are being pursued by Echogen Inc.

Laura Lin, Ph.D., Director, Biophysics, Analytics, & Bioconjugation, Biotherapeutics R&D, Pfizer

Laura Lin is Head of Biophysics, Analytics, and Bioconjugation Group, Global BioTherapeutic Technologies at Pfizer. Laura has been with Pfizer since 2009 when the company acquired Wyeth Pharmaceuticals, where she had been a group leader in Structural Biology and Computational Chemistry supporting both biologics and small molecule programs within Wyeth Discovery. Her current group at Pfizer is focused on providing comprehensive, early stage molecular characterizations to enable the design and development of biologics pipeline with optimal properties. Laura received a PhD in Biophysics from New York University. She was an American Cancer Society Post-doctoral Fellow at the Massachusetts Institute of Technology and the Friedrich Miescher Institute of Novartis Research Foundation, Basel, Switzerland.

Patricia Lowden, Scientist, Protein Production and Analytics Department, Eleven Biotherapeutics

Ms. Lowden has 23 years of industry experience. Prior to her position at Eleven Biotherapeutics, Ms. Lowden has worked at organizations such as Acceleron Pharma, Wyeth Pharmaceuticals, Genetics Institute and Shire Biologics. Ms. Lowden has worked as a protein biochemist in both research and development, in functions that include protein purification, protein characterization and analytical development. Ms. Lowden has a bachelor degree in chemistry from Framingham State University.

Kelly Loyet, Ph.D., Scientist, Biochemical and Cellular Pharmacology, Research, Genentech

Dr. Kelly Loyet is a Scientist at Genentech, Inc., located in South San Francisco, California, where she has worked for the past thirteen years. She received her Ph.D. in Biochemistry from the University of Wisconsin-Madison in 2000, studying regulated exocytosis. After teaching an undergraduate biochemistry course at the UW-Madison, she joined Genentech in 2001 as a postdoctoral fellow in the Protein Chemistry Department performing proteomic mass spectrometry methods and studying protein characterization and interaction. In 2005, Dr. Loyet joined what is now the Department of Biochemical and Cellular Pharmacology where she and her team develop biological PK, PD, ATA, potency, cell-based, enzymatic, and characterization assays using a variety of different platforms to support investigative and preclinical studies from early and late stage research to early development for large molecule therapeutic projects.

Matthew Myers, Associate Scientist, Sterile Products Analytical Development, Merck

For the past 3 years I have been working for Merck Pharmaceuticals in Bioprocess Development specifically in Sterile Products Analytical Development. I currently support the characterization of therapeutic proteins and monoclonal antibodies in the early development space and am responsible for method development and transfer, developability studies, forced degradation and isolation and characterization of impurities, as well as contributing to and reviewing technical and CMC documents. Prior to this role I served in Merck’s BioVenture Strategy group where I was tasked with driving Merck’s efforts on follow on biologics or “biosimilars” during development and pre-clinical activities including development and similarity/comparability studies. I have a BS in biochemistry from Elizabethtown College in Pennsylvania.

Shashi Prajapati, Ph.D, Senior Scientist, Biogen Idec

Shashi Prajapati is working in Biogen as Sr. Scientist. Her group works in developing high-throughput product quantitation and product quality analytical assays to support the cell line development and cell culture process development. Prior to Biogen, Shashi worked in Bristol Myers Squibb where her groups was supported the high-throughput analytical assays for upstream and downstream process developments activities. Before BMS, Shashi worked in Eli Lilly, Indianapolis in Cancer drug discovery department and worked on the NF-KappaB pathway. Shashi has Ph.D in Biochemistry from Central Drug Institute, India in Protein Folding area and she did her postdoc in UT Southwestern Medical Center Dallas, TX in NF-KappaB pathway.

Nadine M. Ritter, Ph.D., President and Analytical Advisor, Global Biotech Experts, LLC

Nadine Ritter obtained her master and doctoral degrees in cell and molecular biology at Rice University (Houston, TX) on evolutionary mechanisms for subcellular translocation of mitochondrial proteins. She was engaged in basic academic research in the field of extracellular matrix proteins and the process of bone mineralization at the University of Texas Health Science Center in Houston for over 10 yrs. She entered the biopharm industry as a protein chemist in analytical R&D at Abbott Laboratories (Abbott Park, IL). There, she performed development, validation, transfer and troubleshooting of test methods for the analytical QC lab, generated protein characterization data for diagnostic product submissions, responded to FDA comments, and contributed to compliance remediation efforts for QC inspection observations, and lead the ISO9000 certification of the R&D analytical lab. She then became the Director of the Analytical Services Division of BioReliance (Rockville, MD), a major contract testing organization. There, she led a team of CMC scientists in the design and conduct of method qualification, validation, and transfer, product characterization and comparability studies, and QC release and stability testing. Projects included synthetic peptides and oligonucleotides, natural and recombinant proteins, monoclonal and polyclonal antibodies, and viral particles. She managed quality and compliance activities for the R&D, GLP and GMP activities conducted in her lab, and implemented Part 11 computer system requirements. In 1999, she created the first public training course specifically focused on biotechnology stability programs, which later grew into an award-winning CMC analytical training course. Since 2002, she has been an international consultant, trainer, speaker and writer for biotech and biosimilar products. She first worked independently at NMR Biotech Services (Germantown, MD), then in 2004 joined Biologics Consulting Group, Inc. (Alexandria, VA). In 2014, she decided to return to independent consulting, forming Global Biotech Experts, LLC. In 2003, she was one of six industry and two FDA founders of the CaSSS CMC Strategy Forum, which has led to the publication of major industry/regulatory white papers on CMC topics, and is now being held annually in North America, Europe, Asia and Latin America.

Pete Vandeberg, Ph.D., Director of Analytical Development, Grifols

Pete Vandeberg received a BA in Chemistry from St. John’s University (Minnesota) and a Ph.D. in Analytical Chemistry from Iowa State University. He is currently Director of Analytical Development at Grifols where he leads a wide range of assay development, including QC methods for new products, method improvements for legacy products and methods used to support non-clinical and clinical studies. The methods his group develops are broad ranging and include separations based methods such as chromatography and electrophoresis, potency methods, immunoassays and immunogenicity methods. He has also led cross functional product development teams. Prior to working at Grifols, he worked for 3M Corp., Bayer and Johnson & Johnson.

Marc Verhagen, Ph.D., Director, Biochemical Method Development, Allergan

Marc Verhagen Ph.D. is Director Biologics Development Analytical Sciences at Allergan located in Irvine CA. Dr. Verhagen received his Ph.D. from the Agricultural University in Wageningen, The Netherlands. He has been involved in the characterization and analysis of proteins for 20 years resulting in more than 25 peer-reviewed journal articles and 3 patents. Dr. Verhagen has held positions at the University of Georgia followed by positions of increasing responsibility in the Biologics Development organization at Allergan.

Catherine Eakin, Ph.D., Senior Scientist, Amgen

Catherine Eakin received a PhD in molecular biophysics and biochemistry from Yale University. After a postdoc at the University of Washington in the department of biochemistry she joined Amgen in 2009. Catherine is now a Senior Scientist and group lead in the analytical sciences department of process and product development. At Amgen, Catherine supports method development and biochemical/biophysical characterization of protein therapeutics for regulatory filings.

Speaker Bios
Higher-Order Protein Structure
August 20-21, 2014

Yves Aubin, Ph.D., Research Scientist, Protein Structure and Analysis Laboratories, Biologics and Genetic Therapies Directorate, Health Canada

Dr. Aubin obtained his Ph.D. in Biophysical Chemistry at Yale University in 1993. After completing post-doctoral studies at the University of Toronto and The Hospital for Sick Children in Toronto he moved to the Merck Research Laboratories in Montreal where he applied NMR spectroscopy to the studies of enzyme-inhibitor interactions in support of medicinal chemistry. He then moved to Health Canada where he developed a research program in the characterization of protein structure of recombinant protein therapeutics. His laboratory is specialized in the production of isotope-labeled proteins from E. coli and Pichia Pastoris in order to apply multi-dimensional NMR methods. This lay the basis for the development of analytical methods for the assessment of higher order structure of biotherapeutics.

David E. Budil Ph.D., Associate Professor of Chemistry and Chemical Biology; Associate Dean for Research, College of Science, Northeastern University

David Budil is currently an Associate Professor in the Department of Chemistry and Chemical Biology at Northeastern University. He received a B.S. in Chemistry from Yale University and Ph.D. in Biophysics from the University of Chicago with postdoctoral training at Cornell University. His research group studies the physical behavior of macromolecules, and develops new high-field electron spin resonance techniques that dramatically increase the dynamic and structural information obtainable from spin-labeled polymers and biopolymers. In the context of structural biology and pharmaceutical science, this method is applied to monitor the physical response of therapeutic targets to drug binding, and to study the transport properties of drug delivery vehicles.Professor Budil became Associate Dean for Research in the College of Science at Northeastern University in 2011, wherehe oversees research-related activities in the College, works with faculty to increase research funding, identifies opportunities and brings together groups for multi-investigator projects, and promotes faculty interactions with other colleges and industry.

Ivan R. Correia, MBA, Ph.D., Senior Principal Research Scientist, Protein Analytics, Process Sciences, AbbVie Bioresearch Center

Ivan Correia is a Senior Principal Research Scientist at AbbVie Bioresearch Center. He has a Bachelor of Science degree in Microbiology, a Master of Science degree in Biochemistry, a Masters degree in Business Administration and a PhD in Molecular Pharmacology and Experimental Therapeutics. His post-doctoral training was at the Whitehead Institute, MIT in Cambridge, MA. Prior to joining Abbott he was the Chief Scientific Officer at a start-up biotechnology company studying the role of aggregation of the amyloid protein in Alzheimer’s disease. He joined Abbott in 2002 and is currently the lead analytical scientist for commercial, late phase and products early in the development pipeline. He has an active research program and has published numerous research and review articles in peer-reviewed journals and presented his findings at national and international conferences. His current research interests include high resolution imaging techniques to understand protein and cell dynamics, technologies to study cell surface antigens, mechanism of protein aggregation and high throughput methods for analyzing physico-chemical properties of protein therapeutics.

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

Yatin is Narotam Sekhsaria Distinguished Professor of Chemical Engineering at the Institute of Chemical Technology (ICT), Mumbai. Previously, Yatin was Associate Director & Head of the Pharmaceutical Process and Technology Development department at Genentech, and has over 15 years of industry experience with prior tenures at Amgen, and Pfizer. He has direct experience with multiple successful BLAs, PASs, CBE-30s, and INDs, and has broad expertise in biopharmaceutical drug development spanning lead candidate selection to licensure. At ICT, Yatin’s research focuses on developing protein & vaccine delivery technologies for the developing world, and on problems of therapeutic protein stability.

Maria-Teresa Gutierrez-Lugo, Ph.D., Product Quality Reviewer, Division of Therapeutic Proteins, OBP/Center for Drug Evaluation and Research, US Food and Drug Administration

Damian Houde, Ph.D., Scientist II, Protein Pharmaceutical Development, Biogen Idec; Adjunct Professor, Northeastern University

Yimin Hua, Ph.D., Quality Control Scientist I, Genzyme Corporation, a Sanofi Company

Yimin Hua is a Scientist II of Quality Science and Analytical Technology at Genzyme, a Sanofi Company. Her job responsibility focuses on development of new analytical methods for QC, process development and cleaning validation. Her area of expertise encompasses protein characterization using chromatography, mass spectrometry and electrophoresis, as well as polymer science and surface chemistry. Yimin Hua received her Ph.D. degree in Chemistry from University of Arizona with a focus on analytical chemistry. She received her Master degree and Bachelor degree from Tongji University where studied polymer science and engineering.

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.

Jennifer S. Laurence, Ph.D., Associate Professor, Department of Pharmaceutical Chemistry, University of Kansas

Dr. Laurence received a Ph.D. in Chemistry from Purdue University and conducted postdoctoral research in Structural Biology at Purdue. She joined the faculty in the Department of Pharmaceutical Chemistry at the University of Kansas in 2004 and is currently Associate Professor and Louise Byrd Graduate Educator. Research in the Laurence lab focuses on protein stability and targeted delivery of metals. A variety of analytical, physical and biochemical tools, including high-resolution solution NMR are utilized to investigate mechanisms of stability involving intrinsic structure and local packing interactions as well as the influences of environment and intermolecular interactions on protein stability and aggregation. Her lab discovered a metal abstraction peptide (MAP) chemistry that generates a unique and highly stable structure compatible with targeted delivery of metals. The fundamental properties of this system are under investigation in her KU lab and development of therapeutic and diagnostic applications utilizing the patented technology are being pursued by Echogen Inc.

Laurence A. Nafie, Ph.D., Distinguished Professor Emeritus, Department of Chemistry, Syracuse University

Laurence A. Nafie received his Ph.D. from the University of Oregon in 1973, studying resonance Raman scattering, and from 1973 to 1975 he was a postdoctoral associate at the University of Southern California, working on the discovery and confirmation of infrared vibrational circular dichroism (VCD). In 1975 he joined the Chemistry faculty at Syracuse University to establish a research program in VCD and Raman optical activity (ROA). In 1978, he was named an Alfred P. Sloan Foundation Fellow and was promoted to Professor in 1982. In 1978 he proposed and carried out the first measurements of Fourier transform VCD, now the basis of all commercial VCD instrumentation. He was appointed Chairman of the Chemistry Department in 1984 and served until 2000. In 1988 he measured the scattered circular polarization (SCP) form of ROA for the first time that is now used in the only commercially available ROA spectrometer. In 1989 he predicted theoretically a new form of ROA called dual circular polarization (DCP) ROA that was confirmed experimentally in his laboratory in 1991. In 1995 he became founding Editor of the journal Biospectroscopy, published by John Wiley & Sons and continued as Associate Editor of Biopolymers until 2010. In 1996, he co-founded with Dr. Rina Dukor the company BioTools, Inc. to market advanced vibrational spectroscopy instrumentation, including the ChiralIR VCD and ChiralRAMAN ROA spectrometers. In 1996 he published the theory of resonance ROA and its predictions were confirmed by its first observation in 1998. In 2000, he was named Distinguished Professor of Chemistry at Syracuse University. He was awarded the Coblentz Award (1981), the Bomem Michelson Award (2001), the William F. Meggers Award (2001) and the Distinguished Service Award of the Society of Applied Spectroscopy (2007). He served on the Governing Board of the Coblentz Society from 1984 to 1988 and was President from 1993 to 1995. In 2003, he served as President of the Society of Applied Spectroscopy, and in 2008 he became a Fellow of the Society of Applied Spectroscopy. In January 2010 he retired from full-time service at Syracuse University to become Distinguished Professor Emeritus and at the same time Editor-in-Chief of the Journal of Raman Spectroscopy published by John Wiley & Sons. In 2011 he published a comprehensive book on the fundamental theory, instrumentation, measurement, calculation and application of vibrational optical entitled Vibrational Optical Activity: Principles and Applications Wiley, Chichester (2011). In 2012 he was named the winner of the Pittsburgh Spectroscopy Award of the Spectroscopic Society of Pittsburgh, March, 2013. He has over 290 publications and several patents.

Kelly Neelon, Ph.D., Associate Director, Drug Product Formulation, Momenta Pharmaceuticals, Inc.

Kelly Neelon received a bachelor’s and master’s degree in chemical engineering from the University of Massachusetts and a doctorate degree in chemistry from Boston College.  Her graduate work focused on mechanisms of protein stability in extremophiles.  Currently, Kelly is Associate Director of Formulation Development at Momenta where she is responsible for the formulation of complex small molecules and biologics for programs in various stages of development.

Angelo Palmese, Ph.D., Junior Researcher, Structural Characterization, Analytical Development Biotech Products, Merck Serono (Italy)

Angelo Palmese has a degree in Biotechnological Sciences with a specialization in Molecular and Industrial Biotechnology completed at the University of Naples, “Federico II”, (Italy). After a Fellowship at the University of Naples, “Federico II” (Italy) with its main target concerning the development of qualitative and quantitative methodologies for the post-translational modifications analyses by means of advanced Mass Spectrometry, he reached a PhD in Biotechnology Science (Industrial and Molecular) from the University of Naples, “Federico II”, (Italy). He joined Merck Serono in 2012 as a researcher in the Structural and Biophysical Characterization Lab (SBC) of the Protein Chemistry Department at Merck-Serono Italia. He has an in-depth experience within the protein characterization field, with a main focus regarding the various Mass Spectrometry techniques.

Geetha Thiagarajan, Ph.D., Senior Scientist, Sterile Product and Analytical Development, Merck & Co.

After obtaining my Ph.D. in Biochemistry from India on the biophysical aspects of protein aggregation related to cataract of the eye lens, I continued to pursue my interest in protein unfolding and aggregation leading to disease. This included my studies of A aggregation in Alzheimer’s and Polyglutamine aggregation in Huntington’s disease with Prof Ronald Wetzeland collagen-based disorders with Prof Barbara Brodsky. I worked in the area of Human Genetics with Prof Robert Desnick at Mount Sinai School of Medicine, NY identifying Single Nucleotide Polymorphisms (SNPs) in receptor proteins which could impact the uptake of lysosomal proteins. I joined Merck in 2011 and have been associated with the Biophysical and Analytical Characterization group in the Sterile Product and Analytical Development Department.

Michael G Tovey, Ph.D., INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, ENS-Cachan, France

Michael G. Tovey, Ph.D, is INSERM Director of Research in the Laboratory of Biotechnology and Applied Pharmacology, CNRS UMR 8113 at the EcoleNormaleSupérieure, Cachan, France. He is the author of more than 200 articles on interferon, cytokines, biotechnology, and immunogenicity. He is a member of numerous scientific boards and is French representative for the ICIS membership. He is chair of the International Cytokines Standards Committee, a member of the ICIS Meetings Committee, and a member of the European Adjuvant Advisory Committee. He iseditor-in-chief of Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations, Associate Editor of Cytokine, Associate Editor of the Journal of Interferon and Cytokine Research, and a member of the Editorial Board of the Journal of Immunoassay & Immunochemistry, and the Scientific World Journal. He is chair of Coral Gables Symposia.

Christina R. Vessely, Associate Director, Merck & Co.

Christina Vessely is an analytical/formulation development scientist at Merck. She received her PhD at the University of Colorado Health Sciences where she studied under John Carpenter. Since that time she has worked on a variety of therapeutic protein candidates ranging from cytokines to monoclonal antibodies. The projects have included both novel molecules and biosimilars. Her most recent focus has been on the development, qualitifcation and validation of analytical methods for in-process testing, release and stability testing of drug substance and drug product. She is also consider a subject matter expert in the areas of biophysical characterization and reference standard development and qualification.

Thomas E. Wales, Ph.D., Research Assistant Professor, Department of Chemistry and Chemical Biology, The Barnett Institute of Chemical and Biological Analysis, Northeastern University


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