OverviewShort CoursesPart 1Combined SessionPart 2 SponsorshipBiographiesHotel and TravelPDF DownloadPosterPress Pass Request Brochure Archives
OverviewShort CoursesPart 1Combined SessionPart 2 SponsorshipBiographiesHotel and TravelPDF DownloadPosterPress Pass Request Brochure Archives
Corporate Support Sponsor
Lakshmi Amaravardi, Ph.D., Director, Pre-Clinical & Clinical Development, Biogen Idec, Inc.Dr. Lakshmi Amaravadi is currently Director of Clinical Science and Technology , in the Preclinical and Clinical Development Sciences, at BiogenIdec. She currently leads a group of Scientists who are involved in Bioanalytical (PK and Immunogenicity) and Biomarker assay development and validation in support of pre-clinical and clinical studies from early development to post-marketing phase. Prior to joining Biogen Idec in 2003, she was at Millennium Pharmaceuticals where she worked on various therapeutic proteins and became responsible for Cell Biology and Biochemistry aspects of Therapeutic Antibody Programs for Oncology. Her industry career started at Eli Lilly & Company, Indianapolis. She received her Ph.D. in Molecular and Cell Biology at Indiana State University, followed by a post-doctoral fellowship at Walther Oncology Center, IU School of Medicine.
Michele Fiscella, Ph.D., Associate Director, Clinical Immunology, Human Genome SciencesBorn in Southern Italy on a hot Summer in 1964. Wednesday. Lived and went to school in Torino. Following his grandmother steps he traveled to the U.S., although more comfortably than on a ship in the early 1900s. Contrary to her, Michele stayed in the U.S. Contrary to Michele, Grandma knew what she wanted. Today Michele is Associate Director in the Clinical Immunology Department at Human Genome Sciences. His group supports the HGS preclinical and clinical programs by developing, validating and executing assays for PK, IG, Neutralization and Biomarkers. He co-authored the white paper “Recommendations For The Validation Of Immunoassays Used For Detection Of Host Antibodies Against Therapeutic Biotechnology Products” with other members of the Ligand Binding Assay Bioanalytical Focus Group community. In the recent past Michele worked in the Preclinical Discovery and Antibody Departments developing functional assays and preclinical models. He joined HGS in 1999 after 8 years at NCI in Bethesda and Frederick.
Jaya Goyal, Ph.D., Principal Investigator, Clinical Science and Technology, Biogen Idec, Inc.Dr. Jaya Goyal is a Principal Investigator in the Clinical Sciences and Technology (CST) Division at Biogen Idec, Inc., Cambridge Massachusetts. The CST group at Biogen Idec is involved in the development and validation of PK, PD and anti-drug antibody (ADA) assays for pre-clinical and clinical studies. Additionally the group is also involved in the development and validation of biomarkers. Dr. Goyal has been involved in Biomarker, product characterization and PK and ADA assay development, specifically, in the development of Flow cytometry based receptor binding assays, cell based neutralizing assays, effector function assays, SNP assays, QPCR assays and signal transduction based reporter gene assays. Her research interests also include the study of pharmacogenomics.
Dr. Goyal has been at Biogen Idec for 9 years. She received her Ph.D. degree in Biochemistry from the Central Drug Research Institute, India in 1993 and did her post-doctoral training at the Rush Presbyterian St. Luke’s Medical Center, Chicago and New England Medical Center, Boston in the Department of radiation biology.
Margot O’Toole, Ph.D., Director, Translational Medicine, Pfizer, Inc.Now a Director of Translational Medicine in Clinical Biotherapeutic Research, Pfizer, Margot joined Genetics Institute in April 1990 and has stayed through acquisitions by Wyeth and Pfizer. From 1990 through 2000 she worked on the vaccine adjuvant properties of interleukin 12 and B7-IgG for both infectious disease and cancer indications. Since 2000, she has played a leadership role in bridging Discovery Research and Clinical Development in areas of autoimmunity and inflammation. She has been Study Director for a number of clinical pharmacogenomics studies encompassing studies in patients with Alzheimer’s disease, multiple sclerosis, asthma and rheumatoid arthritis. She is the author of a first report submitted under the FDA’s Voluntary Genomic Data Submission system, and has served as a panelist at conference co-sponsored by FDA on genomic biomarkers in drug development.
Margot received a B.A. in Biology from Brandeis University and a Ph.D. from Tufts University. Her post-doctoral work (at Fox Chase Institute for Cancer Research and at MIT) focused on severe combined immunodeficiency and cellular immunology. She was largely responsible for discovering the flaws in the experimental support of idiotypic mimicry, then a theory of immunology. For this work she received the 1993 Ethics Award of the American Institute of Chemist.
Donald Bennett, Director, Biostatistics, Biogen Idec, Inc.
Don Bennett’s research has involved the human immune response to viral pathogens from job one at the University of Oregon to the present working with JC virus as a factor in the severe brain disease Progressive Multifocal Leukoencephalopathy. He designed clinical trials for new anti-retrovirals with the AIDS Clinical Trials Group statisticians at Harvard School of Public Health, and later helped develop the first fast track drug at the FDA for treating Herpes infections causing Kaposi’s Sarcoma while working at ASTRA. Don started Biogen Idec’s Non-Clinical Statistics Group in the Biometrics Department in 2003 and has been working with bioassays, including immunogenicity assays, since then. His focus on immunogenicity assays is statistical techniques for non-normal data distributions to better control false positive and negative rates.
Deborah Finco, Ph.D., Immunogenicity Lead, Immunotoxicology COE, Drug Safety Research & Development, Pfizer, Inc.Deborah Finco is a senior principal scientist in the Immunotoxicology lab in Drug Safety Research and Development at Pfizer Inc. in Groton CT. She received her B.S. in Microbiology from the University of Georgia and her M.S. in Microbiology/Immunology from Louisiana State University. She joined Pfizer in 1998 and served as the Immunogenicity Assay Lead for the Immunotoxicology Center of Excellence for the past eight years. More recently she is supporting immunotoxicology issues related to both small and large molecules. Previously she worked in the Animal Health Division at Pfizer and before that in Quality Control at Merial Inc. She has extensive experience in developing in vivo and in vitro assays to determine vaccine efficacy and potency. Her work has supported numerous approvals for animal health vaccines. Her more recent work has focused on the development of immunoassays and bioassays to meet regulatory guidelines with respect to immunogenicity of biological therapeutics. She participates on several American Association of Pharmaceutical Scientists (AAPS) subcommittees to assist with writing white papers for assay validations.
Eric D. Foehr, Ph.D., Director, Bioanalytical R&D, Biomarin Pharmaceuticals, Inc.Dr. Foehr is the Director of BioAnalytical Research and Development at BioMarin Pharmaceuticals Inc. The group performs assay development, validation and transfer to the BioAnalytical Testing Laboratory. The group supports non-clinical and clinical studies. Prior to BioMarin Pharmaceuticals Inc., Dr. Foehr was a Senior Scientist at a cancer diagnostic start-up and Program Leader at AGY Therapeutics. Erik Foehr received his Doctorate at the University of California, Irvine in the lab of Dr. Ralph Bradshaw. He was a Fellow at the J. David Gladstone Institutes department of Immunology and Virology. He has published in the areas of immunology, cancer, and neuroscience.
Sebastian Spindeldreher, Ph.D., Deputy Head, Bioanalytics, Novartis BiologicsSebastian Spindeldreher has a Diploma / Master in Biology from the University of Heidelberg, Germany, and a PhD in Immunology, specializing in antigen presentation, from the Basel Institute for Immunology, and the Roche Center for Medical Genomics, Switzerland. In 2005, Sebastian started at F. Hofmann-La Roche as a postdoctoral fellow and latterly worked as a lab head in the field of immunosafety. Sebastian joined Novartis Pharma in 2008 as Fellow in Translational Sciences and Safety and was responsible for elaborating a strategy and setting up the relevant technologies to assess and minimize the risk for immunogenicity of biotherapeutics. Since beginning of 2010, Sebastian took over additional responsibility as ad interim Head of PK/PD Bioanalytics II, being responsible for a group of lab heads and scientists working on bioanalysis of biotherapeutics. This involves development and validation of pharmacokinetics, pharmacodynamics and immunogenicity assays as well as analysis of pre-clinical and clinical samples in a GLP environment.
Valerie Quarmby, Ph.D., Principal Scientist & Director, BioAnalytical Technologies & Strategies, Genentech, Inc.Dr. Quarmby is a Principal Scientist and Director of the Department of BioAnalytical Sciences at Genentech. At Genentech, Dr Quarmby and her group are responsible for developing bioanalytical methods and strategies for non-clinical, clinical and post-marketing studies and for in vitro characterization of protein therapeutics. These data, methods and strategies are critical components of IND, BLA, sBLA, NDA and CTD filings. Dr Quarmby has been actively involved in development programs for many protein therapeutics, including: Nutropin AQ, Nutropin Depot, Xolair, Raptiva, Rituxan, Avastin, Lucentis. Dr Quarmby is an active member of AAPS, and is the co-author of several AAPS sponsored industry guidance documents. Dr Quarmby holds a B.Sc. from the University of London, England and a Ph.D. in Hormone Physiology from the Imperial Cancer Research Fund and the University of London. Dr Quarmby was an NIH Visiting Postdoctoral Fellow, then joined the Laboratories for Reproductive Biology and the Department of Pediatric Endocrinology at the University of North Carolina in Chapel Hill. Prior to joining Genentech, Dr Quarmby worked in the field of clinical diagnostics at Bio-Rad Laboratories and at Endocrine Sciences/Esoterix.
Josefin-Beate (Josi) Holz, Ph.D., Chief Medical Officer, Drug Development, Ablynx NVJosi Holz joined Ablynx as Chief Medical Officer in June 2007. She oversees the pre-clinical and clinical development of Ablynx’s Nanobody drug candidates resulting in a significant advancement of the clinical development activities. Josi continues to be instrumental in the transition from technology platform to product portfolio and her focus on translational research activities enables the rapid transition from research candidates into pre-clinical and clinical development.
Josi holds a Medical Doctor's degree from the University of Marburg, Germany. She started her career in 1995 with Bristol-Myers Squibb (Munich, Germany), and she has since held senior managerial and research roles in several biotechnology and pharmaceutical companies including: GPC Biotech, Allos Therapeutics Inc. and Gilead/OSI Pharmaceuticals. Prior to joining Ablynx, Josi held the position of Vice President Drug Development at U3 Pharma AG. She has advanced small molecules and biologics from early to advanced stages of clinical development.
Arno Kromminga, Ph.D., CEO, Immunology, IPM BIOTECH
Arno Kromminga is currently CEO at GLP-certified IPM BIOTECH, Hamburg, Germany. He studied Biochemistry and Immunology and has 15+ year experience in assay development and validation. Due to his additional current position as Head of Immunology at the Clinical Laboratory Lademannbogen, Hamburg, much experience in the clinical evaluation of assay results. Moreover, he is faculty member of the University of Kiel. He is cofounder of the European Immunogenicity Platform (EIP) and a member of several scientific societies. He is the author of multiple publications in peer-reviewed journals and books. He has gained substantial industrial experience in various Biotech companies and has been involved in the development and establishment of novel immunological and cellular assays for immunogenicity testing and PK/PD analyses for pre-clinical and clinical studies. Most recently, he extended his activities at IPM BIOTECH to functional assays such as ADCC/CDC and apoptosis.
Claire Morgan, Medical Director, MD, MPH (Global Safety Officer) Global Patient Safety and Risk Management, Genzyme CorporationClaire Morgan joined Genzyme in 2005 as a global safety officer responsible for safety and risk management of enzyme replacement therapy products. Dr. Morgan holds an MD degree since 1983 and an MPH degree since 1999 from the Johns Hopkins School of Public Health with extensive studies in Epidemiology; Biostatistics; Program planning and evaluation; and methods for clinical trails. Dr. Morgan has conducted several analyses on immunological aspects of enzyme replacement therapy (ERT) including the analysis of adverse events, anaphylactic reactions, infusion reactions and immune-mediated reactions experienced by Pompe patients treated with Myozyme (alglucosidase alfa). Dr. Morgan studied the development of IgG antibody titers in Pompe patients treated with alglucosidase alfa and the impact of antibody formation on safety and efficacy of the drug as well as the immune tolerance induction strategies. She developed several guidance documents for close monitoring, management and rechallenge of Pompe patients who experienced infusion associated reactions during infusion with ERTs.
Katherine A. High, M.D., Investigator, Howard Hughes Medical Institute; William H. Bennett Professor of Pediatrics, University of Pennsylvania School of Medicine; Director, Center for Cellular and Molecular Therapeutics, The Children's Hospital of Philadelphia
Dr. High’s research interests focused initially on the molecular basis of blood coagulation, and the use of novel genetic therapies to treat hemophilia. More recently she has pioneered safe and effective clinical translation of genetic therapies for inherited disorders. These clinical trials have led to short-term correction of disease in hemophilia B, and long-term improvements in Leber’s congenital amaurosis, a hereditary cause of blindness. Her rigorous analysis of problems uncovered in the course of clinical studies, including risk of germline transmission of vector in recipients of donated DNA, and of immune responses to viral vectors following delivery to specific tissues, has laid the foundation for continued expansion of the applications of gene therapy.
Steve Swanson, Ph.D., Director, Clinical Immunology, Amgen, Inc.Dr. Swanson is an Executive Director and Head of the Clinical Immunology Department at Amgen, Inc. located in Thousand Oaks, California. He joined Amgen in 1999 to build the Clinical Immunology Department whose mission was to focus on anti-therapeutic antibody issues. This department supports functions including development, validation, and performance of all immunoassays and bioassays for the detection of antibodies directed against Amgen’s therapeutic proteins. In addition, the cellular immunology group within Clinical Immunology investigates cellular interactions through FACS, LSC, confocal microscopy, and other imaging techniques and contributes to biomarker work to support product development.
Dr. Swanson received his B.A. in Biology and Chemistry from North Central College in Naperville, Illinois in 1977 and his Ph.D. in Microbiology from The University of Iowa in 1987. From 1988 to 1991 he was a Postdoctoral Research Associate in the Microbiology Department at The Ohio State University in Columbus, Ohio. Upon completion of postdoctoral work he joined Schering-Plough Research Institute where he held positions of increasing responsibility from 1991 until 1999.
Jack A. Ragheb, M.D., Ph.D. Principal Investigator Laboratory of Immunology, Division of Therapeutic Proteins Office of Biological Products, CDER, FDAJack A. Ragheb, M.D. Ph.D. is a Senior Regulatory Research Officer and Principal Investigator in the Division of Therapeutic Proteins/OBP/OPS/CDER/FDA and an Attending Physician on the Allergy Immunology Service, NIAID, National Institutes of Health, Bethesda, MD. A graduate of the Johns Hopkins University and School of Medicine, he performed his clinical training at the Johns Hopkins Hospital and National Institutes of Health. A recipient of numerous research awards, his work and publications has spanned the fields of retrovirology, gene therapy, immune activation, and clinical trials in immune tolerance. He is actively investigating the use of humanized mouse models to predict the immunogenicity of therapeutic proteins.
Joao A. Pedras-Vasconcelos, Ph.D., Visiting Associate, Therapeutic Proteins CBER, FDAJoao A. Pedras-Vasconcelos has a B.Sc.(Honours) and M. Sc. in Microbiology from the University of Saskatchewan ( Saskatoon, Canada). He received his Ph. D. in Immunology from Cornell University (Ithaca NY). This was followed by post-doctoral work at the National Research Council of Canada Institute for the Biological Sciences (Ottawa, Canada) and a term scientist position at the Canadian Food Inspection Agency Animal Disease Research Institute (Ottawa, Canada). He joined FDA as a researcher-reviewer in 2002 first with CBER-OTRR (Bethesda, MD,) and then with CDER-OBP following the transition of OTRR to CDER. He is currently a full time CMC reviewer in the Laboratory of Immunology-Division of Therapeutic Proteins, a position he has held since 2008.
Mikael Sørud, Regulatory, Novo NordiskMikael graduated as a M.Sc in Biotechnology from the Technical University in Denmark in 1999 and has since then worked for Eli Lilly & Co and Novo Nordisk within the areas Manufacturing, Pharmaceutical Development and Regulatory Affairs. The career in Regulatory Affairs include a one year expatriation to Novo Nordisk Inc. in Princeton, NJ. Mikael's focus area within Regulatory Affairs is Life Cycle Management, especially within Chemistry, Manufacture and Control (CMC). Mikael has been involved in several global submission for second generation insulin manufacturing process and has as such been involved in design, execution and negotiation with authorities around immunogenecity studies and the authority requirements for these. Mikaels in depth knowledge on CMC aspects together with his clinical insight has allowed him to support strategies for fast global submissions and approvals, and to ensure that state of the art immunogenecity data has been provided to authorities to support approvals.
Ralf Hess, Principal Consultant, Early Stage Drug Development, Parexel
Ralf Hess has been working within the legislation of the Pharmaceutical Drug Law since 1999. He was the Chief Scientific Officer for an in-vitro diagnostic medical device manufacturer and responsible for R&D, manufacturing but also regulatory affairs. He oversees medical device regulations (ISO, certification and accreditation), GLP, GCLP and GMP and is registered as a Qualified Person with the Swiss Medic, Switzerland. For more than four years he has been involved in GMP compliance issues with a focus on gap analysis and CMC in early stage development. He specializes in CMC and biosafety issues for biosimilars, biopharmaceuticals and vaccines, and provides extensive knowledge in technologies to address immunogenicity, bioassays and clinical endpoints in vitro. Dr Hess holds a PhD degree in virology and immunology and a Masters degree in biology from the University of Freiburg, Germany, he was academically appointed 10 years long. He has published several scientific articles and book chapters and is affiliated with several national and international organizations.
Satish K. Singh, PhD., Research Fellow, Pfizer, Inc.Dr. Singh is a Research Fellow at Pfizer Corporation, in the BioTherapeutics Pharmaceutical Sciences organization. His responsibilities in the organization include leading formulation, and process and product development activities for biologics, including vaccines. He has more than 20 years experience in the industry in product development activities ranging from oral dosage forms to ophthalmics and parenterals, encompassing small molecules and biologics. He has published more than 30 articles with emphasis on the colloidal and physical chemistry of macromolecules, and holds three issued patents. His interests are in the use of physical chemistry tools for the understanding of formulation characteristics for biologics, as well as their impact on immunogenicity. He has recently been involved in leading a group of industry scientists to examine the concerns around protein-based subvisible particulates. Satish obtained his B.Tech from the Indian Institute of Technology, New Delhi, and an MS and PhD in Chemical Engineering from Kansas State University.
Bernard Maillere, Ph.D., Head, Immunochemistry, Institute of Biology and Technologies, CEABernard Maillere, is head of the Laboratory of Immunochemistry of the Cellular Immune Response (CEA, Saclay in France). He gained his PhD in Immunology in 1992 and his habilitation in 2000. His work focuses on prediction of protein immunogenicity and identification of T cell epitopes in humans. He has developed pioneering technologies to assess the peptide binding specificity of HLA class II molecules and to evaluate the T cell response in man. His laboratory participates in several research programs dealing with immunogenicity of therapeutic proteins, T cell responses to allergens, tumor antigen discovery and vaccine design for chronic virus infection (HIV, hepatitis C). He has published more than 70 papers in peer-reviewed journals. Bernard Maillere is scientific advisor of the biotechnology company Protéus.
David W. Scott, Ph.D., Center for Vascular and Inflammatory Diseases and Department of Surgery, University of Maryland School of Medicine
David W. Scott, Ph.D. is Vice Chair for Research in the Department of Medicine at the Uniformed Services School of Health Sciences (USUHS) in Bethesda, MD. An alumnus of Antioch College, Dr. Scott received his M.S. degree from the University of Chicago and Ph.D. from Yale University in 1969. Following a post-doctoral fellowship at Oxford University, UK, he joined the faculty at Duke University in 1971, where he initiated his NIH-funded studies on immune tolerance mechanisms. In 1983, he was named Dean's Professor of Immunology at the University of Rochester, a post he held for 11 winters. Dr. Scott thereafter became Head of the newly formed Immunology Department at the Holland Lab of the American Red Cross, and moved to the University of Maryland School of Medicine in 2004. He assumed his current position at USUHS in September of this year.
Dr. Scott has contributed to over 200 research papers on several subjects in immunology, focusing on immunologic tolerance, and its application in autoimmune diseases, hemophilia and gene therapy. A most recent emphasis is on regulatory epitopes in IgG. He is the author of two textbooks, including a monograph entitled, The Nature of Immunologic Tolerance, and recipient of a number of awards, including the Distinguished Service Award, from the American Association of Immunologists (2004), a Boerhaave Professorship at Leiden University Medical School, The Netherlands (2006) and the 2009 Scientific Achievement Award from the AAPS.
Christoph Giese, Ph.D., Director, Probiogen GmbHSince mid 2008 Director of the Departments “Cell and Tissue Services” and “Quality Control”, ProBioGen AG
2006-2008 Director of the Department “Cell and Tissue Services” at ProBioGen AG
2002-2006 Group Leader Tissue Engineering at ProBioGen AG
2000-2002 Group leader “Cell Selection, Screening and Automatisation” at ProBioGen AG
1999-2000 Postdoc for biotechnology, Tissue Engieering, microscopy, clinical and biochemical diagnostics lab at the Institute for Biochemistry Faculty for Veterinary Medicine, Justus-Liebig-University Giessen
1999 Thesis (“Dr. rer. nat.”) Biotechnology, Tissue Engineering, in-vitro testing, engineering of the bovine Corpus Luteum (Artificial Organ) at the Institute for Biochemistry Faculty for Veterinary Medicine, Justus Liebig-University Giessen
1994 Diploma in Biology (Physiology, Zoology, Genetics, Biochemisty) at Wolfgang-Goethe-University Frankfurt/ Mainand Faculty of Biology and Chemistry at Justus-Liebig-University Giessen
Philippe Stas, Ph.D., Head, Applied Protein Services, Lonza Biologics; Head, Algonomics NVPhilippe Stas has been active at the interface of information technology, protein engineering, and bioinformatics for almost two decades. From 1990 to 1997, he attended the Free University of Brussels (Belgium) where he conducted applied research for projects involving antibody engineering and bioinformatics. After working as IT Manager at Perkin-Elmer's Genscope subsidiary (currently Applied Biosystems, CA, USA), he helped found Algonomics in 1999, where he was in charge of operations and business development. Since Lonza’s acquisition of Algomonics in 2009, Philippe has been leading the Applied Protein Services group in Cambridge, UK and Gent, BE. Philippe Stas holds an MBA, a M.Sc.E. in biotechnology and a M.Sc. in Information Technology. Philippe serves as the Chairman of the Belgian Association for Bioindustries (Bio.be) and as the President of the European Immunogenicity Platform (EIP).
Matthew Baker, Ph.D., Chief Scientific Officer, R&D, Antitope Ltd.Dr Baker is a founder and the Chief Scientific Officer of Antitope Ltd, a Cambridge (UK) based company which specializes in assessing and reducing the immunogenic potential of biologics. He has held senior management positions at a number of companies including Biovation (subsidiary of Merck KGaA), CTL Ltd and Whatman BioSciences. As an academic researcher Dr Baker has a background in B and T cell immunology and completed post-doctoral positions in Cambridge, UK after obtaining his PhD in cellular immunology at University of Birmingham, UK.
Masanori Onda, M.D., Ph.D., Laboratory of Molecular Biology, NCI/NIHDr. Onda is a Staff Scientist of the Laboratory of Molecular Biology, National Cancer Institute, NIH. He received his M. D. in 1989 and obtained a Ph. D. in Surgery from the University of Tokyo, Japan, 1997. He received medical training and research training at the University of Tokyo. He received his visiting fellow award training at the NIH from 1997 to 2000, has been working in the immunotoxins field, including malignant mesothelioma and leukemia treatments. He has been focusing on the improvement of immunotoxin therapies. Currently, he is focusing on the reduction of immunogenicity of protein therapeutics, using the modification of B cell epitopes of the reagents. His memberships include the American Association of Cancer Research, the Protein Society, the Japanese Orthopaedic Association, and a NIH Scientific Interest Group - theTranslational Research Interest Group. His research work has been internationally recognized and he is an invited symposiast at the Fabisch-Symposium for Cancer Research and Molecular Cell Biology (Berlin), and lecturer for the alumni of the Institute of Medical Science at the University of Tokyo (Japan).
Stephen Lee, Ph.D., Associate Professor, Biomedical Engineering, Ohio State University
Stephen C. Lee trained as a bacterial geneticist (PhD, Microbiology, 1984, University of Minnesota) with expertise in protein engineering, protein expression and phage display mutagenesis. His current interest is in the incorporation of proteins as functional components of nanodevices. His earliest biological nanodevice was the bacmid or bac-to-bac molecular cloning system, which utilizes DNA transposition to construct recombinant baculovirus in E. coli. He has extensive experience in bioconjugation and use of protein-nanoparticle bioconjugates as imaging contrast agents and as hematoproliferative reagents, and his group was among the earliest to report haptenization of nanoparticulate epitopes by their protein bioconjugate partners. Current work focuses on interfacial design for biosensor function, and the use of protein engineering to optimize the nanoscale functional features of sensor interfaces. He and his colleagues recently published a design algorithm for polyepitope vaccine design that has implications for the design of protein sequences with decreased immunogenicity.
Short course 1
Shobha Purushothama, Ph.D., Principal Scientist, Bioanalytical R&D, Pfizer, Inc.
Shobha Purushothama is a Principal Scientist in the Bioanalytical Division of Pharmcokinetcis, Dynamics and Metabolism Department at Pfizer Inc. in Andover, MA. The BA group is involved in the development and validation of PK and anti-drug antibody (ADA) assays for pre-clinical and clinical studies and providing study support. She received her B.S. in Chemistry from Bombay University, India, and Doctorate from the University of Cincinnati. She joined Pfizer (formerly Wyeth) in 2005. Shobha received her B.Sc. degree from Bombay University, India and her doctorate from the University of Cincinnati.
250 First Avenue, Suite 300
Needham, MA 02494
Biological Therapeutic Products
Biomarkers & Diagnostics
Bioprocess & Manufacturing
Clinical Trials & Translational Medicine
Drug & Device Safety
Drug Discovery & Development
IT & Informatics
Technology & Tools For Life Science
Cambridge Healthtech Institute
Cambridge Innovation Institute