Protein Aggregation and Emerging Analytical Tools: Mechanistic, Predictive, Screening and Formulation Challenges
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Norman Garceau, Ph.D, CSO, Blue Sky BioServices, Inc.
Norman Garceau is the Chief Scientific Officer at Blue Sky and is responsible for overseeing all science-related activities at Blue Sky Biotech. Before joining Blue Sky, Norman spent eight years with Pfizer, working in a variety of roles including gene cloning and expression to lead discovery covering assay development (cellular and enzyme), HTS and lead development. Drug targets included receptors and enzymes. Prior to that he spent three years as a production coordinator at Upstate Biotechnology where he oversaw production and QC. Norman earned a Ph.D. in Biochemistry from Dartmouth Medical School where he studied the molecular basis of circadian rhythmicity. His postdoctoral experience included three years studying signal transduction for members of the TNF receptor family.
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.
Ashlesha S. Raut, Ph.D. Candidate, Department of Pharmaceutical Sciences, University of Connecticut
Ashlesha Raut is currently pursuing her PhD in pharmaceutical sciences at University of Connecticut under the guidance of Dr. DevendraKalonia. She received her Bachelor’s degree in Pharmacy from Mumbai University and pursued her Masters in Pharmaceutics with emphasis in Drug Delivery Technology from Institute of Chemical Technology, Mumbai, India. Her current research work at UCONN focuses on biophysical characterization of therapeutic proteins to understand the factors contributing to protein-protein interactions at high concentrations. Specifically, her research interest includes the mechanistic understanding of factors affecting opalescence and phase separation in monoclonal and bispecific antibodies. She has worked at Abbvie as a summer intern inDrug product development.She is a member of AAPS student chapter at UCONN since 2009 and has actively participated in several chapter activities.
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.
Jeffrey W. Hudgens, Ph.D., Research Chemist, Institute for Bioscience and Biotechnology Research, BioProcess Measurements Group, Biomolecular Measurement Division, NIST
Dr. Jeffrey W. Hudgens is an investigator at the Institute for Bioscience and Biotechnology Research (IBBR), a joint research enterprise comprising scientists from the University of Maryland College Park, University of Maryland Baltimore, and National Institute of Standards and Technology (NIST). His research uses hydrogen-deuterium exchange mass spectrometry (HDX-MS) to measure biosimilarity, to map epitopes, to resolve structure-function relationships between glycan structure and protein dynamics, and to observe the dynamics of aggregated proteins. Dr. Hudgens received his B.S. in Chemistry from Miami University (Ohio) and his Ph.D. in Physical Chemistry from the University of Illinois at Urbana. His 125+ scientific publications and twopatents span many disciplines including biochemistry, glycoprotein reaction dynamics, inorganic biochemistry, nanoparticle synthesis, chemical kinetics, laser chemistry, optical spectroscopy, and mass spectrometry. Dr. Hudgens is a Fellow of the American Physical Society.
Elizabeth M. Topp, Ph.D., Dane O. Kildsig Chair and Head, Department of Industrial and Physical Pharmacy, Purdue University
Elizabeth M. Topp is Dane O. Kildsig Chair and Head of the Department of Industrial and Physical Pharmacy at Purdue University in West Lafayette, Indiana. She received a bachelor’s degree in chemical engineering from the University of Delaware in 1979 (B.Ch.E.), a master’s in chemical and biochemical engineering from the University of Pennsylvania in1984 (M.E.) and a Ph.D. in pharmaceutics from the University of Michigan in 1986. Dr. Topp’s research addresses the chemical and physical stability of protein drugs, with particular emphasis on the solid state. She currently serves as acting chair of the Advisory Committee on the Pharmaceutical Sciences and Clinical Pharmacology for the U.S. Food and Drug Administration and is a Fellow of the American Association of Pharmaceutical Scientists.
Dimiter S. Dimitrov, Ph.D., Senior Investigator, Protein Interaction Group, FNLCR, NCI, NIH
Dr. Dimitrov joined the National Cancer Institute (NCI) of the National Institutes of Health (NIH), USA, in 1990, was tenured as Senior Investigator in 1993 and appointed at the Senior Biomedical Research Service in 2008. His research group includes molecular biologists who are experts in display/screening/libraries methodologies, antibody engineering, and protein biochemistry, structural biologist and computational scientist. His major long-term goal is the development of clinically useful therapeutics and vaccines based on human monoclonal antibodies including engineered antibody domains. He has authored and coauthored more than 300 articles cited about 10,000 times, and is inventor or co-inventor of more than 50 inventions, patent applications or patents. Also see his web site http://ccr.cancer.gov/staff/staff.asp?profileid=5749
Yingda Xu, Ph.D., Group Leader, Protein Analytics, Adimab
Yingda received his Ph.D. degree from Michigan State University in Analytical Chemistry with focus on mass spectrometry. After a proteomics postdoc training, Yingda joined the protein analytical science department of BMS for analytical assay development and validation to support BLA filing and post market commitment. Yingda then moved on to the protein analytics group in Adimab to broaden his horizon in the antibody discovery and characterization.
Lawrence Berliner, Professor of Chemistry and Biochemistry, Chemistry and Biochemistry, University of Denver; Emeritus, Ohio State University
Prof. Lawrence J Berliner is one of the pioneers in protein structural and molecular diagnostic technique research starting at Stanford University, then Ohio State University and now at the University of Denver and the Graduate Toxicology Program, Univ. of Colorado School of Pharmacy. His team was the first to develop thiol specific spin labels, which became the basis of Site Directed Spin Labeling (SDSL) for studying membrane protein structure and other proteins that cannot be crystallized. His other research has involved protein-protein interactions in blood coagulation, serine proteases and lactose biosynthesis in the mammary lumen.
He is a fellow of the prestigious American Academy of Arts and Sciences, the American Chemical Society, President of the International EPR Society and has received prestigious awards in his field, including the 2000 Silver Medal for Biology/Medicine of the International EPR Society and the 2005 Lifetime Achievement Award in Biological EPR Spectroscopy. He is an Associate Editor of The Protein Journal and has edited over 30 books on the subject of magnetic resonance applications to biology and was the founding editor of the Biological Magnetic Resonance series. He has organized and chaired several conferences in the protein and magnetic resonance fields.
Murali Bilikallahalli, Ph.D., Associate Director, Formulation Sciences, Proteins, Vaccines & Oligos, MedImmune
Murali has a PhD in Biophysical Chemistry and is currently a Associate Director at MedImmune leading Formulation of Proteins, Oligos and Vaccines. He is an SME in the biophysical area over 20 years, and has been developing formulations and Drug products for variety of biologic modalities such a mAbs, conjugated proteins, VLPs, sub-unit vaccines, live attenuated viral vaccines, CPGs, SiRNA, and DNA plasmids. Two approved products in the market (Elilyso & Xiapex). He has won three young investigator awards (ASBMB-USA, ASPET-USA & JSPS- Japan) and published over 40 original research papers, expert reviews and book chapters. Currently, he serves on the Editorial boards of Drug Discovery Today and mAbs.
Christian Schöneich, Ph.D., Professor and Chair, Pharmaceutical Chemistry, University of Kansas
Dr. Schöneich is the Takeru Higuchi Distinguished Professor and Chair in the Department of Pharmaceutical Chemistry at The University of Kansas. He received his Ph.D. in Chemistry in 1990 from the Technical University Berlin, Germany. Between 1987 and 1991 he worked in the Department of Radiation Chemistry at the Hahn-Meitner Institute in Berlin, Germany. His research focuses on oxidation reactions of peptides and proteins in vivo and in vitro, and their potential consequences for the development of stable protein pharmaceuticals, biological aging and age-related pathologies. He has published > 200 papers in the field of peptide and protein oxidation reactions.
Ivona Strug, Ph.D., Senior Biochemical Scientist, EMD Millipore
Ivona Strug, Ph.D., has over 20 years of experience in protein/peptide biochemistry, mass spectrometry and protein-based assay development (ELISA). Her post-doctoral research, at MIT and University of Massachusetts Medical School, focused on method development for fast and efficient proteomics-based identification of antigens presented by MHCs of virally infected B cells. At Advanced Proteome Therapeutics, Inc. she led the development of a technology platform for enhancing protein therapeutics through selective modification. She has published in the areas of peptide and protein biochemistry, proteomics and immunology. At EMD Millipore, Dr. Strug’s work focuses on developing new applications for the Direct Detect® spectrometer.
David F. Nicoli, Ph.D., Vice President, R&D, Particle Sizing Systems, LLC
Received B.S. (MIT) and PhD (Harvard) in Physics. Founded Nicomp Instruments (1978), acquired by Hiac-Royco/Pacific Scientific (1984). Co-founder and President of Particle Sizing Systems (1989), acquired by Agilent Technologies (2008). Currently Vice-President of PSS LLC, assets re-acquired from Agilent (2009).
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.
Prakash Manikwar, Ph.D., Scientist I, Formulation Sciences, MedImmune, Inc.
Dr. Prakash Manikwar is currently working as a scientist in the Formulation Science group at MedImmune. Prior to joining MedImmune in 2013, he worked as a post-doctoral researcher at Macromolecule and Vaccine Stabilization Laboratory, University of Kansasfor about 2.5 years. He has both led and coordinated various projects resulting in the successful characterization, stabilization and formulation of therapeutic protein drugs and vaccines. In addition, Dr. Manikwar has co-led an important research project to investigate the relationship between protein dynamics and stability.Dr. Manikwar earned his Ph.D. degree in Pharmaceutical Chemistry at the University of Kansas in 2010. His Ph.D. work focused on developing novel peptide-based drug conjugates as a potential treatment for multiple sclerosis. Dr. Manikwar has technical expertise in protein and vaccine formulation, protein-drug conjugation, analytical method development, and conducting long-term physical and chemical stability studies. He has extensive experience in preparing technical reports, co-authored 10 scientific publications and is a co-inventor on one U.S. patent.
Edward J. Smith, Ph.D., Principal, Packaging Science Resources LLC
Ed Smith is Principal at Packaging Science Resources LLC which provides consulting and training in the packaging of injectable drug products for the pharmaceutical, biotechnology, and medical device industries.
Ed is a member of the PDA and American Chemical Society. Within PDA, he leads the Packaging Science Interest Group, and served on the Steering Committee of the Pharmaceutical Cold Chain Interest Group (PCCIG) where he co-authored PDA Technical Reports 39 & 46 on cold chain best practices. He is also a member of the PQRI Working Group on Parenteral & Ophthalmic Drug Products (Extractables/Leachables). He is a member of the faculty of the PDA Training and Research Institute. He is also a member of the ACS Consultants Network.
He has published many articles and chapters on pharmaceutical packaging and is a frequent speaker at industry meetings and courses related to extractables/leachables and cold chain.
Prior to forming his consulting practice, Ed was associated with Wyeth Pharmaceuticals where he headed a team responsible for the development and qualification of cold chain packaging systems for transporting temperature-sensitive drug products. He also served as a technical expert on parenteral packaging issues particularly with respect to the management of extractables and leachables. Before that, he was associated with Helvoet Pharma Inc. and West Pharmaceutical Services in various technical management positions. He holds a B.S. in Chemistry from Villanova University and received his M.S. & Ph.D. in Analytical Chemistry from Seton Hall University (So. Orange, NJ).
Dominick DeGrazio, Associate Scientist, Analytical Laboratory, West Pharmaceutical Sciences
Dominick recently graduated from Franklin and Marshall College in 2012 with a B.A in Biochemistry and a B.A in Neuroscience. During the summer of 2011 he was given a Clinical and Translational Science Award (CTSA)Internship at the University of Pennsylvania where he worked under the guidance of Dr. Xiaolu Yang to study the effects of glycolytic proteins on the metabolism of cancer cells. In his senior year of college, he collaborated with Dr. Robert Jinks and others to functionally characterize a recessive mutation in the HERC2 gene seen in people of the Amish and Mennonite communities. Their research culminated in a paper published in the Journal of Human Mutations.
Currently, Dominick works as an Associate Scientist in the Analytical Laboratory at West Pharmaceutical Services in Exton, PA. He performs functional analyses for internal and external customers and employs various methodologies to quantitate extractables or leachables from packaging components.
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