BISPECIFIC ANTIBODY DESIGN
Kin Man Au, PhD, Postdoctoral Research Associate, UNC Lineberger Comprehensive Cancer Center Kin Man Au received his undergraduate, master degree and PhD degree at The University of Sheffield (UK). His PhD study investigated the biomedical
applications of different polymer nanoparticles under the mentorship of Prof. Steven Armes FRS. He joined UNC Lineberger Comprehensive Cancer Center as postdoctoral research associate under the mentorship of Dr. Andrew Wang. He is interested in the
development and translation of nanotherapeutics to improve cancer immunotherapy and chemoradiotherpy.
Sarah Cheal, PhD, Senior Research Scientist, Memorial Sloan Kettering Cancer Center
My research focuses on the development of a theranostic platform approach for pretargeted radioimmunotherapy (PRIT) of solid human tumors. We call
this strategy “DOTA-PRIT,” which is short for “DOTA ligand bound radionuclide-based pretargeted radioimmunotherapy.” In principle, DOTA-PRIT consists of three sequential administrations of three reagents: (i) the bi-specific
Ab construct IgG-scFv (bsAb), which has high specificity and affinity for both a tumor antigen through the IgG and a radiolabeled hapten through the scFv; (ii) a clearing agent to eliminate unbound construct from the blood; and (iii) the imaging/therapeutic
radioligand. The tumor targeting is separated from the payload-delivery step, thereby offering greater therapeutic indices (TIs) compared to conventional radioimmunodetection/radioimmunotherapy with directly labeled antibodies. Significant improvement
in TIs permits high therapeutic doses of administered radioisotopes with minimal to no bystander side effects. In close collaboration with the lab of Nai-Kong Cheung at MSK and Dane Wittrup at MIT, we have successfully applied this platform in three
preclinical tumor models: GPA33 antigen (colorectal cancer); GD2 antigen (neuroblastoma); and the HER2/neu receptor (breast cancer).
Stephen J Demarest, PhD, Senior Research Fellow, Protein and Antibody Engineering, Lilly Research Labs
Steve leads a group at Lilly responsible for the design, engineering, and mechanistic characterization of
proteins, antibodies, and antibody-like molecules. Prior to joining Lilly in 2011, Steve held positions at Biogen Idec, Diversa Corp, and Syngenta working as a Protein Chemist/Engineer on antibody and protein therapeutics design and biochemistry.
Steve performed his graduate work at SUNY Stony Brook studying protein folding mechanisms. Steve was a NIH sponsored postdoctoral fellow at the Scripps Research Institute studying the structure, folding, and binding mechanisms of nuclear co-activator
Joel Goldstein, PhD, Senior Director, R&D, Celldex Therapeutics, Inc.
Joel Goldstein received his PhD in molecular biology from the University of Medicine and Dentistry of New Jersey (UMDNJ) in 1991. He then did his postdoctoral
work at Bristol-Myers Squibb (BMS) on antibody fusion proteins prior to joining Medarex in 1994. His role at Medarex was initially to develop bispecific antibodies and fusion proteins using recombinant methods, which then evolved into developing antibody
production platforms for manufacture. Joel moved back to BMS in 2009 where he continued to lead a team developing manufacturing cell lines for the company’s biologics programs. He then joined Celldex in 2014 to help manage R&D efforts, including
establishing antibody engineering and bispecific antibody design strategies.
Gundo Diedrich, PhD, Director, Antibody Engineering, MacroGenics
Gundo Diedrich received his Ph.D. in Chemistry from the Max-Planck Institute for Molecular Genetics in Berlin. He completed his postdoctoral training in immunology at Yale University, and worked as a Research Scientist in antibody discovery
at Targeted Molecules, diaDexus, and Medimmune. In 2015, he joined MarcoGenics as Director Antibody Engineering.
Emily B. Ehlerding, MS, Medical Physics, University of Wisconsin - Madison
Emily B. Ehlerding, MS, is a PhD candidate in the Medical Physics department at the University of Wisconsin – Madison, under the supervision of Dr. Weibo Cai. She also received her B.S. in chemistry and physics from Manchester University in North Manchester, IN. She has developed imaging agents, mostly based on positron emission tomography, for many targets in oncology, particularly involved in immunotherapy treatments.
Tariq Ghayur, PhD, Distinguished Research Fellow, Immunology Discovery, AbbVie
Tariq Ghayur received a PhD (1986) in Immunology from Department of Physiology, McGill University, Montreal, Canada. He did his post-doctoral training
at McGill (1986-’88) and Dana Farber Cancer Institute (1988-’90). He joined BASF Pharma (1990), which was acquired by Abbott Laboratories. He has worked on both small molecule and therapeutic antibody discovery programs, mainly defining
the biology/pathology of selected targets (target validation) and developing assays for high throughput screening and/or candidate selection. From 1998-2004, he led two therapeutic antibody discovery project teams and delivered 2 drug development
candidates. He also initiated the dual – / multi – targeting biologics program at Abbott resulting in the discovery of dual-variable-domain (DVD) – IgTM molecules and other multi – targeting biologics. Dr. Ghayur received Abbott’s
“President’s Award” in 2004, 2008 and 2009 and Abbott's "Chairman's Award" in 2008 for his various contributions. As a member of the Volwiler Society at Abbott, Dr. Ghayur has worked on various initiatives that encourage and enable
scientists, at all levels of the organization, to explore novel ideas to initiate new drug discovery programs and/or develop novel technologies. Dr. Ghayur holds several patents and is the author of many peer-reviewed scientific publications. In addition
to therapeutic antibodies, antibody engineering and antibody generation technologies, his areas of interest are inflammation, lymphocyte biology, cytokine biology and transplantation rejection.
Rick Hibbert, MBA, PhD, Assistant Director, Protein Production & Chemistry, Genmab B.V.
Rick earned his D.Phil. in Biochemistry from Oxford University and an MBA from the Amsterdam Business School. He performed a Post-Doctoral
Research Fellowship at the Netherlands Cancer Institute. He joined Genmab in 2013 and works as Assistant Director, responsible for the Protein Production & Chemistry department, CMC research and for projects related to Genmab’s proprietary
DuoBody® bispecific antibody platform.
Teemu Junttila, PhD, Senior Scientist, Translational Oncology, Genentech
I joined Genentech in 2006, initially as a post-doctoral fellow. I transitioned to leading a research team in 2010. What attracted me to Genentech the most,
and still does, is the unique opportunity to be involved in a drug discovery project from concept all the way to clinical development. The immediate proximity between discovery scientists and clinical scientists allows for unique synergy - my research
can be rapidly guided by clinical signals without delay, which I find extremely motivating and rewarding. My role is to lead large molecule biology research that translates new antibody engineering technologies into oncology therapeutics. Currently,
we are focusing on bispecific antibodies that can be used to redirect T cells to attack tumors.
Roland E. Kontermann, PhD, Professor, Institute of Cell Biology and Immunology, Stuttgart Research Center Systems Biology, University of Stuttgart
Roland Kontermann received his PhD in molecular biology from the University of Heidelberg
in 1992. From 1993-1996 he was a postdoctoral research fellow in Sir Gregory Winter’s laboratory at the MRC Centre for Protein Engineering in Cambridge (UK) where he started his work in the field of recombinant antibodies and phage display technology.
From 1996-2000 he was a group leader at the Institute of Molecular Biology and Tumor Research (IMT) at the University of Marburg, where he also obtained his habilitation in molecular biology. Between 2001 and 2004 he was head of biotechnology and
later on head of research of a co-founded Biotech company working in the field of targeted drug delivery systems. In 2004 he was appointed Professor of Biomedical Engineering at the Institute of Cell Biology and Immunology (University of Stuttgart),
endowed until 2014 by the Deutsche Krebshilfe. Current research interests focus on the development of recombinant antibodies and bispecific and bifunctional antibody fusion proteins with improved biological and pharmacokinetic properties for cancer
therapy and other indications.
Ho-Young Lee, PhD, Technical Development Scientist, Biological Technologies, Genentech
Ho-Young Lee is a scientist in Biological Technologies at Genentech. She received her Ph.D. at Stanford and did her postdoctoral research in
Doudna lab at UC Berkeley before she joined Genentech. Ho-Young and her group develop and validate bioassays (biochemical/cell-based) for various molecules with different formats and mechanisms of actions such as bispecific and conjugate molecules.
She is interested in exploring novel bioassays as well as developing CMC strategies.
Meric Ovacik, PhD, Scientist, Preclinical Translational Pharmacokinetics, Development Sciences, Genentech
I joined Genentech in November 2015 as scientist in the Department of Preclinical Translational Pharmacokinetics (PTPK). Our
department contributes to antibody-based drug development from very early stages such as target validation, molecule design and lead selection to lead optimization and first-in-human dose strategies. I represent PTPK in cancer immunotherapy (CIT)
programs and support the pipeline for better therapeutic options for the patients in need.
Peter Pavlik, PhD, Principle Scientist, Aptevo Therapeutics
Peter Pavlik has been working on bispecific antibody development at Aptevo Therapeutics and Emergent BioSolutions for the last 2 years, focusing on discovery of new binding
domains and their engineering into bispecific molecules for applications in oncology (selective retargeting of T cells against tumors). Before joining Aptevo Therapeutics, Peter worked for 8 years at MedImmune on antibody discovery and protein engineering
and for 10 years at Los Alamos National Lab on developing HT technologies for antibody discovery. Peter obtained a M.Sc. in Biochemistry from the Comenius University and a Ph.D. from the University of Vienna.
Robert Pejchal, PhD, Associate Director, Antibody Discovery, Adimab LLC
I received my PhD from University of Michigan Ann Arbor in protein crystallography. I did a postdoc at The Scripps Research Institute, where I studies broadly
neutralizing HIV-1 antibodies, solving crystal structure of such antibodies bound to viral envelope glycoproteins. After that, I took a scientist position at Adimab LLC. Currently, as associate director of antibody discovery, my group works on antibody
discovery and optimization, with a focus on CD3 bispecifics ands challenging membrane protein targets such as GPCRs.
Janice M. Reichert, PhD, Executive Director, The Antibody Society
Dr. Janice Reichert is an internationally-recognized expert in the development of antibody therapeutics. She is Executive Director of The Antibody Society, a non-profit
association representing individuals and organizations that engage in antibody research or development. Dr. Reichert is also Founder and Editor-in-Chief of mAbs, a peer-reviewed, PubMed-indexed biomedical journal that focuses on topics relevant
to antibody research and development, and Founder and Managing Director of Reichert Biotechnology Consulting LLC, a pharmaceutical business intelligence research firm. Dr. Reichert writes frequently on development trends for antibody therapeutics,
including the annual ‘Antibodies to watch’ articles published in mAbs, and she has presented her research results as an invited speaker at conferences held worldwide.
Marjorie A. Shapiro, PhD, Supervisory Biologist, Office of Biotechnology Products/CDER/FDA
Marjorie A Shapiro is currently the Chief of Laboratory of Molecular and Developmental Immunology,
Division of Biotechnology Products
Research and Review I from FDA with expertise in Biotechnology, Immunology, Molecular Biology
Mark Throsby, PhD, CSO, Merus NV
Mark Throsby has served as our Chief Scientific Officer since January 2013 and previously served as our Chief Operating Officer from October 2008 to January 2013. His responsibilities include strategic
scientific leadership, management of discovery, pre-clinical research and translational research, business development support, external collaborations and partnerships management. Before joining Merus, from October 2000 to October 2008, he served
as a senior scientist and then as director of antibody discovery for Crucell N.V., a biotechnology company specializing in vaccines and biopharmaceutical technology. Dr. Throsby holds a PhD in neuro-immunology from Monash University.
BISPECIFIC ANTIBODY CASE STUDIES & CLINICAL RELEVANCE
Mark L. Chiu, PhD, Associate Director, Process Analytical Sciences, Janssen R&D
Mark Chiu is leading the Biologics Engineering & Function group in Janssen Biotherapeutics. He has a Biophysics BA from University of California
Berkeley, Biochemistry Ph.D. from University of Illinois – Urbana-Champaign. He has worked at Seton Hall University as a professor of chemistry and as a research investigator at Abbott Labs. While applying structure-function studies to optimize
biotherapeutics, he actively pursues characterizations of marine and aquatic invertebrates.
Eva Dahlén, PhD, Senior Director, Business Development, Alligator Bioscience
Dr. Dahlén is Senior Director, Business Development at Alligator Bioscience. Her main responsibilities include scientific business development,
competitive intelligence and establishment of partnerships. In biotech and academia partnerships Alligator´s immuno-oncology pipeline is strengthened by accessing technologies complementing Alligator´s in-house capabilities, whereas
pharma partnerships are established for late phases of clinical development and commercialization. Previous positions at Alligator include principal scientist and project leader in various drug discovery and research programs in the field of immuno-oncology,
and earlier affiliations are Malmö university, Lund university and Active Biotech.
John Haurum, CEO, F-star Biotechnology Ltd
John has over 15 years’ experience in building and leading biotech companies across discovery, development, financing and business development. He successfully managed several
monoclonal, oligoclonal, and bispecific antibody products into clinical development, as well as managed and developed numerous collaborations with biopharmaceutical companies in the US, Europe, and Japan. Prior to joining F-star, John was VP Research,
Biologics Products at ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company. Previously, he was a cofounder and Chief Scientific Officer of Symphogen A/S, a Danish biotechnology company developing therapeutic antibody combinations.
John holds an MD from University of Aarhus, Denmark and a D.Phil. in Immunology from the Institute of Molecular Medicine, University of Oxford, UK.
Syd Johnson, PhD, Vice President, Antibody Engineering, MacroGenics, Inc.
Syd Johnson, Ph.D., V.P. of Antibody Engineering at MacroGenics, Inc., has over twenty-five years of experience in the antibody engineering field. Prior
to joining MacroGenics in 2001, he spent eleven years at MedImmune, Inc., where he led the preclinical efforts to develop humanized monoclonal antibodies. Dr. Johnson is the inventor of Synagis, MedImmune’s anti-RSV product, which is still
the only licensed monoclonal antibody product for prevention of viral infection. Prior to that, he worked for six years at Genex Corporation, during which time he was involved in pioneering work in the development of scFv technology. In addition
to a long list of scientific publications, Dr. Johnson is an inventor on over 50 issued United States patents.
Yuxing Li, PhD, Associate Professor, Microbiology and Immunology, University of Maryland School of Medicine, Institute for Bioscience and Biotechnology Research
Dr. Yuxing Li is an Associate Professor with appointments at the
University of Maryland Institute for Bioscience and Biotechnology Research (IBBR) and the Department of Microbiology and Immunology in the University of Maryland School of Medicine. Dr. Li received her PhD in Genetics at Iowa State University
and did her postdoctoral training at the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases/National Institutes of Health. Dr. Li’s primary research interests include studying B cell response to viral infections
toward developing novel vaccines and immunotherapeutics that target HIV-1 and Ebolavirus.
Bin Liu, PhD, Professor, Anesthesia, University of California, San Francisco
Professor Bin Liu graduated from Princeton University with a B.A. in June 1990 in Molecular Biology and Biochemical Sciences. In Dec. 1994, Dr. Liu
earned his PhD from the University of California, San Francisco in Biochemistry and Biophysics.
Lawrence Lum, MD, DSc, Director, Cellular Therapy, University of Virginia School of Medicine
Dr. Lum graduated with a BS in Chemistry from the University of Redlands and received his MD from the University of California of San
Francisco (UCSF). He did his pediatric residencies at UCSF and the University of Colorado and his fellowship in immunology at the National Cancer Institute. He spent the past 23 years focusing on bispecific antibody armed T cells to treat
solid and liquid tumors. He sponsors INDs for products used for treating breast cancer, prostate cancer, pancreatic cancer, colon cancer, non-Hodgkin’s lymphoma and multiple myeloma, osteosarcoma, and neuroblastoma. He was recently
recruited to the University of Virginia Cancer Center as Professor of Medicine, Scientific Director of BMT, and Director of Cellular Therapy. He has published 200 articles, reviews, or book chapters.
Paul A. Moore, PhD, Vice President, Cell Biology & Immunology, MacroGenics, Inc.
Paul A. Moore is Vice President-Immunology & Cell Biology at MacroGenics, Inc. Dr. Moore was previously employed as a Principal by Celera
Corp. and a Principal by Human Genome Sciences, Inc. He received his undergraduate degree from the University of Strathclyde and a doctorate degree from the University of Glasgow.
Elisabeth K. Nyakatura, PhD, Senior Scientist, Biochemistry, Albert Einstein College of Medicine
Rakesh Dixit, Vice President, Global Head, MedImmune, Inc.
Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions and is board certified in Toxicology
from the American Board of Toxicology, Inc. since 1992. In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck,
Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology. In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca
Biologics company) to lead Global Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position, Rakesh is responsible for providing guidance on research and development of biological products; including
nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops
in national and international meetings.
Robert Mabry, PhD, Vice President, Protein Science, Cogen Therapeutics, Inc.
Biotechnology leader with over a decade of experience working with large pharma, biotech companies, and venture-backed startups. Extensive experience
managing teams in multiple therapeutic areas and a demonstrated track record of accelerating leads into preclinical development.
Deborah Schmiel, PhD, Microbiologist, Biologics CMC, Product Development, and Vaccinology, FDA
Deborah Schmiel received a B.Sc. form the University of Calgary in 1984 and a Ph.D. in microbial pathogenesis from the University
of North Carolina at Chapel Hill in 1993. Deborah has worked in the areas of protein therapeutics development as a staff scientist at Symbiontics, Inc. (renamed ZyStor Therapeutics, Inc. and acquired by BioMarin Pharmaceutical Inc.), and vaccine
development at Walter Reed Army Institute of Research. Currently, she is responsible for regulatory review of licensed and investigational, novel and biosimilar monoclonal antibodies.
Junichiro Sonoda, PhD, Senior Scientist, Cancer Immunology, Genentech, Inc.
Junichiro Sonoda, a Senior Scientist at Genentech, leads large molecule drug discovery programs in cardio-metabolism, fibrosis, and most recently immuno-oncology
areas. The current focus in the Sonoda lab includes targeting immune-modulatory mechanisms in adaptive tissue remodeling and cancer pathogenesis. He received his Ph.D. from Duke University, then pursued post-doctoral training at the Salk Institute,
before joining Genentech in 2007.
Mireya Paulina Velasquez, MD, Assistant Member, Department of Bone Marrow Transplantation and Cellular Therapy, St Jude Children’s Research Hospital
Dr. Paulina Velasquez completed her medical training at Universidad
Francisco Marroquin in Guatemala. She then moved to Houston to work as a research associate with the Evidence Based Medicine group at Texas Children’s Hospital. She went on to complete both her Pediatrics Residency and Pediatric Hematology
Oncology Fellowship at Baylor College of Medicine/Texas Children’s Hospital. After two years as Assistant professor at Baylor College of Medicine’s Center for Cell and Gene Therapy, she was recruited to St. Jude Children’s Research
Hospital, where she is currently an Assistant Member at the Department of Bone Marrow Transplantation and Cellular Therapy. She focuses on translational research involving Chimeric Antigen Receptors and genetically modified T cells that secrete
bispecific engager molecules to target hematological malignancies (ENG T cells).
Nina Weisser, PhD, Principle Scientist, Therapeutics Research, Zymeworks
Dr. Nina Weisser is a Principal Scientist at Zymeworks Inc., Vancouver, Canada. She studied microbiology and received her PhD at the University of Guelph
(Guelph, Canada) in the field of recombinant antibody engineering under the mentorship of Professor J. Christopher. She did her post-doctoral work at the National University of Ireland, Galway (NUIG) with Professor Robert J. Woods where she engineered
glycan-binding proteins using a combination of computational and combinatorial library approaches. At Zymeworks, she is a member of the Therapeutics Research team and works on designing and identifying bispecific antibody therapeutics in oncology.
Zhi-yong Yang, PhD, Director, North America Breakthrough Laboratory, Sanofi US