BISPECIFIC ANTIBODY DESIGN
Shelley Force Aldred, PhD, VP, Preclinical Development, TeneoBio, Inc.
Shelley Force Aldred has spent the past 3 years serving as VP for Preclinical Development at
TeneoBio, a multi-specific therapeutic antibody company. Dr.
Force Aldred was part of the formation of TeneoBio and led the preclinical efforts creating a CD3xBCMA bispecific antibody, from product concept to IND-ready package. Her group developed a high-throughput workflow for evaluating thousands of lead
antibodies in complex cell-based models. Dr. Force Aldred was formerly director of worldwide R&D for Active Motif following the acquisition of SwitchGear Genomics in 2013. In 2006, she co-founded SwitchGear Genomics, a venture-backed functional
genomics platform company, and she served as its President and Board Member. Prior to founding SwitchGear Genomics, Dr. Force Aldred was a Scientific Director on Stanford’s ENCODE Project and received her Ph.D. in Genetics from Stanford University.
She is an inventor on over 15 patents and an author on over 20 peer-reviewed scientific publications.
Tara Arvedson, PhD, Director, Oncology Research, Amgen
Tara Arvedson is a researcher and team leader in the Oncology Research department at Amgen. She received her Ph.D. at Caltech and was later a Damon Runyon Cancer Research Fellow
at UC San Diego. Since being at Amgen she has led multiple programs targeting benign and malignant hematology using both large and small molecules. These programs have progressed from discovery stage to the clinic.
H. Kaspar Binz, CEO & Founder, Binz Biotech Consulting
Dr. H. Kaspar Binz is CEO and founder of Binz Biotech Consulting, a strategic life-science management consultancy. He is also co-founder of Molecular Partners (SIX: MOLN),
a Swiss clinical stage biotech company developing DARPin® drugs for therapeutic applications, where he acted in various positions from 2004 to 2019 including VP and CSO. With his entrepreneurial approach Dr. Binz was key in the establishment
of Molecular Partners as a successful biotech company, and in the establishment of Molecular Partners’ Pipeline. He invented and developed the designed repeat protein technology including the DARPin® technology during his post-doctoral training
and PhD studies with Prof. Andreas Plückthun at the University of Zürich, Switzerland. Dr. Binz has published widely in the areas of protein engineering and drug development and is inventor on numerous patents and patent applications. Molecular
Partners and the DARPin® technology have been awarded with several prizes including the Swiss Technology Award 2005, the Swiss Venture 2004 business plan competition award, and the De Vigier Foundation award 2005. Dr. Binz was educated at the
Royal Institute of Technology in Stockholm, Sweden (Prof. Mathias Uhlén) and holds a M.Sc. in biotechnology from the European school of biotechnology in Strasbourg, France.
Ulrich Brinkmann, PhD, Expert Scientist, Roche Pharma Research and Early Development, Roche Innovation Center Munich, Penzberg, FRG
Dr. Ulrich Brinkmann is a member of Roche’s Large Molecule Research organization within Pharma
Research & Early Development at the Roche Innovation Center Munich (Penzberg, Germany). His work focuses on protein & antibody engineering, bispecifics, and on delivery platforms for targeted payload delivery. Prior to joining Roche, he served
as CSO in functional genomics and pharmacogenetics companies Xantos and Epidauros. His previous work in Ira Pastan’s Molecular Biology Lab at the NIH/NCI in Bethesda, USA focused on antibody stabilization and engineering technologies, and on
generating recombinant immunotoxins for cancer therapy. Dr. Brinkmann is author of numerous publications and inventor of many patents covering recombinant antibodies, pharmaco- & functional genomics, immunotoxins and protein engineering technologies
Diego Ellerman, PhD, Principal Scientific Researcher, Genentech
Dr. Diego Ellerman is Principal Scientific Researcher at Genentech. He is the Lead Scientist for the production of T-cell Dependent Bispecific (TDB) antibody program
where he leads a team of 3 scientists to support the protein production and characterization for multiple bispecific antibody pipeline projects. He is currently developing novel antibody formats to bestow new functionalities.
Soldano Ferrone, MD, PhD, Division of Surgical Oncology, Surgery, Massachusetts General Hospital, Harvard Medical School
Soldano Ferrone received his MD and PhD degrees in 1964 and in 1971, respectively, from the University of Milan,
Milan, Italy. He has held faculty positions at the University of Milan, Milan, Italy, Scripps Clinic and Research Foundation, La Jolla, CA, Columbia University, New York, NY, New York Medical College, Valhalla, NY, Roswell Park Cancer Institute, Buffalo,
NY and at the University of Pittsburgh School of Medicine, Pittsburgh, PA. Since 2012 he is a faculty member of the Department of Surgery at Massachusetts General Hospital, Harvard Medical School, Boston, MA. Dr. Ferrone has received many awards and
honors. For the last 30 years he has been the member of many review committees including NIH Study Sections, and of the editorial boards of many scientific journals. Furthermore, he is the member of several external scientific advisory boards. Dr.
Ferrone’s research program focuses on the molecular characterization of escape mechanism(s) utilized by tumor cells to avoid immune recognition and destruction and on the development of combinatorial immunotherapeutic strategies to counteract
the escape mechanism(s) utilized by tumor cells. These studies are greatly facilitated by the large panel of HLA antigen- and human tumor antigen-specific monoclonal antibodies he has developed and shared with the scientific community over the years.
He has described the results of his studies in more than 600 papers published in peer reviewed journals. Moreover, he has been the editor of 14 books and the guest editor of 5 special issues of oncology journals.
Stefan Grüner, PhD, Scientist, Molecular Biology and Protein Engineering, Pieris Pharmaceuticals
After his PhD work in structural biochemistry and biophysics at a Max Planck Institute, Stefan
joined Pieris in 2017, where
he carries out protein engineering activities to advance Pieris’ Anticalin
pipeline and its proprietary technology platform.
Maria Karasarides, PhD, Executive Director, ImmunoOncology, Regeneron Pharmaceuticals
Maria Karasarides, Ph.D., Executive Director, Global Oncology Development at Regeneron Pharmaceuticals is overseeing the development of immune
modulatory therapies that include checkpoint inhibitors, immune agonists, CD3 directed bi-specific antibodies, co-stimulatory agents and antibody drug conjugates. Her focus on iterative drug development is aimed at modulating the interface between
tumor biology and host immunity to maximize response to therapy and ultimately shift malignant disease patterns.
Prior to joining Regeneron, Dr. Karasarides was a senior leader at AstraZeneca, ImmunoOncology Global Medicines Development
late stage clinical group, where she led the clinical strategy and scientific development of novel durvalumab (ImfinziTM) and tremelimumab based combinations with a key focus on identifying tumor-host interactions that propagate the anti-tumor immune
Dr. Karasarides’ experience spans academic research and pharmaceutical development in clinical development, translational research and medical affairs with a special focus on ImmunoOncology. Prior
to joining AstraZeneca, Dr. Karasarides was a leader at early-stage companies within the Cambridge biotechnology hub, where she worked on the development of small molecule inhibitors, nanoliposomal chemotherapies and inducible gene therapy platforms
across multiple tumor types. Prior to that she was with Bristol-Myers Squibb, NJ, where she was an integral member of the ipilimumab (Yervoy®) team and played a key role in the approval of Yervoy®. She continued at Bristol-Myers
Squibb as the brivanib Global Medical Lead, responsible for Global Medical Affairs Strategy, and later went on to establish and lead the US brivanib Medical Affairs team.
Before joining the pharmaceutical industry, Dr. Karasarides focused
on the signaling mechanisms that drive and maintain oncogenic signaling validated through inducible/conditional mouse models and primary organotypic cultures. During her tenure at the Institute of Cancer Research, London, UK, she worked with
Richard Marais and Chris Marshall on BRAF mutations and delineated BRAF as a therapeutic target in melanoma. Dr. Karasarides holds a Ph.D. in biology/biochemistry and conducted her graduate research at the Cleveland Clinical Foundation, Cleveland,
OH focusing on RAS /PI3K signaling followed by post-doctoral fellowships at the Institute of Cancer Research, London, UK, and the Department of Molecular Medicine, University of Massachusetts Medical School, Boston, MA.
Tom Moore, PhD, Project Team Leader, Early Development, Roche
Experienced physician and medical leader, with broad industry experience across all product lifecycle phases. Currently leading two expert cross-functional early development
teams with responsibility for development of high-profile cancer immunotherapy assets (inc. T-cell-engaging bispecific antibody) in haematology/oncology. Previous role in late-stage development; responsibility for pivotal phase III study, leading
study team through positive interim analysis, HA interactions, and preparation of HA submissions, ultimately resulting in worldwide approvals. Strong commercial awareness with deep experience in global and affiliate medical affairs across multiple
roles and products, including successful global product launch in haematology/oncology, multiple successful UK reimbursement appraisals, and a wide variety of pre-launch and on-market product support.
Umesh S. Muchhal, PhD, Director, Protein Sciences, Xencor, Inc.
No bio available
G. Jonah Rainey, PhD, Vice President, Antibody Therapeutics, Gritstone Oncology
Dr. Jonah Rainey is currently the Vice President for the Antibody Therapeutics department at Gritstone Oncology. Previously, he was the CEO of Oriole,
a consulting and research organization focused on discovery through early development of biologic in San Diego. He holds a PhD in Biochemistry from Tufts University and completed postdoctoral training at the University of Wisconsin and the Salk Institute.
He has been actively engaged in discovery, research, and development of bispecific antibodies in a biotech setting for 12 years. He is an inventor on several patents and applications describing novel bispecific platforms as well as current clinical
candidates that exploit these platforms. Dr. Rainey led or had major contributions to research and early development of at least three current clinical candidates in phase 1 and 2, and led many additional advanced preclinical programs in oncology,
infectious disease, autoimmunity, and other therapeutic areas. Industry experience spans small biotech (MacroGenics, MabVax) and large pharma settings (MedImmune/Astrazeneca).
Oliver Seifert, PhD, Senior Scientist, Institute of Cell Biology and Immunology, University of Stuttgart
Oliver Seifert holds a PhD in Molecular Biology from the University of Stuttgart and he is a Senior Scientist at the Institute of Cell Biology and Immunology based at the University of Stuttgart, Germany. Research interests focus on the design and
development of bispecific antibodies and recombinant bifunctional molecules, including half-life extension strategies, for tumor therapy.
Nathan Trinklein, PhD, Vice President, Discovery Research, Teneobio
Dr. Trinklein is currently Vice President at Teneobio. His group employs a novel sequence-based approach for antibody discovery that leverages next-gen sequence and high-throughput recombinant expression to screen large numbers of diverse sequence-defined
antibodies. Prior to Teneobio, Dr. Trinklein was co-founder and CEO of SwitchGear Genomics, a venture-backed company that was acquired in 2013. SwitchGear developed and commercialized a unique cell-based platform for small molecule pathway screening.
Dr. Trinklein served as the Technical Director of the Stanford ENCODE project and received his Ph.D from Stanford University. Dr. Trinklein has published over 25 peer-reviewed papers and is an inventor on over 15 patents.
Yanli Yang, PhD, Senior Scientific Researcher, Antibody Engineering Department, Genentech
Yanli Yang has over 25 year’s experience in biological sciences research and biotechnology, with extensive expertise in small and large
molecule drug discovery. Yanli received her BS in Biology from Lanzhou University, China and her MS in Biotechnology from Zhejiang University, China. Prior to joining Genentech in 2013 she was a researcher and drug discoverer in multiple academic
and biopharma organizations including UCLA, J&J, Carnegie Institution, Roche, Elan, and Theranos. Yanli is currently a Senior Scientific Researcher in the Department of Antibody Engineering at Genentech where her present research interests are
focused on the development of novel antibody technologies to enable next generation therapeutics for cancer immunotherapy and neuroscience.
BISPECIFIC CASE STUDIES & CLINICAL RELEVANCE
John Babcook, PhD, Senior Vice President, Discovery Research, Zymeworks
John Babcook is Senior Vice President, Discovery Research at Zymeworks. He is responsible for target, antibody and drug conjugate discovery and associated partnerships.
For over 20 years, Mr. Babcook has made significant contributions to the international biopharmaceutical industry. In 1998, Mr. Babcook co-founded ImmGenics Pharmaceuticals Inc. based on a novel antibody generation platform. In 2000, ImmGenics was
acquired by Abgenix Inc., which was subsequently acquired by Amgen, Inc. in 2006. Mr. Babcook led the Canadian research team at ImmGenics (and Abgenix and Amgen, respectively) from 1998 to 2010. Mr. Babcook went on to establish the
Biologics Division at the Centre for Drug Research and Development, where he served as Vice President, Biologics from September 2010 to March 2016, in addition to becoming the founding President and Chief Scientific Officer of Kairos Therapeutics
Inc. in January 2015. While at Kairos, he was responsible for the development of its novel ADC platform and therapeutic pipeline and also formed multiple collaborations, including the strategic partnership and the merger with Zymeworks in March 2016.
Mr. Babcook has participated in the development of more than 100 therapeutic antibody-based programs, several of which are now in the clinic, including two that have been approved by the FDA for treatment. Mr. Babcook has served as an Adjunct
Professor in Molecular Biology and Biochemistry at Simon Fraser University. He is the recipient of an Honorary Doctorate recipient from the British Columbia Institute of Technology and the recipient of the LifeSciences British Columbia’s
“Innovation and Achievement” Award.
Nazzareno Dimasi, PhD Associate Director R&D MedImmune
Nazzareno Dimasi PhD is Associate Director R&D at MedImmune where he works on innovative biopharmaceutical research in the area of antibody engineering, multispecific
antibodies and antibody-drug conjugates.
Rakesh Dixit, PhD, DABT Vice President, AstraZeneca Biopharmaceuticals
Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve
University, Medical College of Ohio, University of Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. In August 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director
(R &D) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D since 2010, 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. Rakesh is one of the most invited speakers in the biotechnology industry. Rakesh’s areas of expertise are mainly in the area of pharmaceuticals
and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market
while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal
of Toxicology and Environmental Health. Rakesh was selected by his pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh also serves as an expert reviewer and in appointed committee for many
programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.
Tariq Ghayur, PhD, Distinguished Research Fellow, Immunology Discovery, AbbVie
Tariq Ghayur received his Ph.D. (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). Prior to AbbVie, Tariq worked at BASF Pharma (1990 – 2001) and Abbott Laboratories (2001 – 2012). 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. In 1999, Tariq initiated the dual – / multi – targeting biologics program that resulted in the discovery of dual-variable-domain (DVD) – IgTM molecules and other multi – targeting
biologics. Currently four DVD-Ig molecules are in clinical development.
Bonnie Hammer, PhD, Vice President, Biologic Development, Invenra
Dr. Hammer has over 15 years' experience in cell biology, disease modeling, applications development, and assay development for drug discovery. Prior to joining Invenra,
Dr. Hammer held a research and development leadership role with Life Technologies where she worked on cellular models for oncology, Parkinson's disease, and aging. In addition, she served as a research area manager for membrane targets including G
protein coupled receptors and ion channels. Dr. Hammer holds a PhD in Biochemistry from the University of Oregon and a BS in Biochemistry and Molecular Biology from the University of Minnesota-Duluth.
Dr. Ping Ji, PhD, Pharmacologist, OCP, FDA
Dr. Ping Ji is biologics lead and master reviewer in the Office of Clinical Pharmacology Division 2 in FDA. Before she joined FDA in 2008, she had been working in Bristol-Myers Squibb for
5 years on Drug Development and Clinical Research. She got her PhD in Pharmaceutical Sciences from University of Minnesota and BS in Pharmacy from Beijing Medical University. Her research interest is to quantitatively investigate the structure-immunogenicity
and pharmacokinetic/pharmacodynamic (PK/PD) relationship of biologics.
Sang Hoon Lee, PhD, CEO, ABL Bio
Sang Hoon Lee is the founder and CEO of ABL Bio. Prior to creating ABL Bio, Sang Hoon Lee served as the head of the Bio Division at Hanwha Chemical from 2013 to 2016. He also was the co-founder and
vice-president/CSO of PharmAbcine from 2009 to 2013. Sang Hoon Lee has strong entrepreneur and industry experience. He directed drug discovery and development at Exelixis, Genentech, AstraZeneca, and Chiron (now known as Novartis). Sang Hoon Lee received
his B.A. and M.S. from the Seoul National University, his Ph.D. from The Ohio State University. He completed his postdoctoral fellow from Harvard Medical School and UCSF and was a Scientist at Stanford Medical School.
Yariv Mazor, PhD, Senior Scientist, Antibody Discovery & Protein Engineering, AstraZeneca Biopharmaceuticals
Dr. Yariv Mazor joined MedImmune in 2009; he is leading the antibody discovery group at the Department of Antibody
Discovery and Protein Engineering and co-leads multiple antibody bio-therapeutic programs into clinical development. Yariv received his PhD in Biotechnology from Tel-Aviv University, Israel in 2005, where he studied and developed antibody therapeutics
and antibody-drug conjugates for cancer. He then pursued postdoctoral training at the Dept. of Chemical Engineering, University of Texas at Austin, TX under Prof. George Georgiou where he developed a novel platform for the selection and screening
of engineered full-length IgG antibodies from libraries expressed in E. coli. Yariv is the co-inventor 5 patents or patent applications and the author of 20 peer-reviewed papers.
Paul A. Moore, PhD, Vice President, Cell Biology & Immunology, MacroGenics, Inc.
25 years of experience working in biotech, coordinating efforts focused on the discovery and development of novel biologic based therapies. At
MacroGenics, leads a research group dedicated to the discovery, preclinical development and clinical translational biology of antibody-based therapeutics including Fc-optimized mAbs and bispecifics for cancer or autoimmune disease through harnessing
of the host immune system. Began biotechnology career at HGS, where directed genomic-based target discovery programs and the preclinical development of various protein and mAb-based therapeutics. Notably these efforts led to the discovery of BLyS
as a B-cell survival factor providing the basis for the development of Benlysta for the treatment for lupus. Obtained PhD from University of Glasgow and performed post-doctoral work at the Roche Institute of Molecular Biology; co-authored over 70
peer-reviewed manuscripts and 40 issued US patents.
Kate Peng, PhD, Group Leader/Senior Scientist, BioAnalytical Sciences, Genentech
Dr. Kate Peng received her Ph.D. in metabolic biology from the University of California Berkeley. Following her post-doctoral training at Berkeley,
Dr. Peng worked at biotechnology industry with a focus on developing cell-based methods for high-throughput screening of drug candidates targeting GPCRs. Dr. Peng joined Genentech in 2007 and is currently a Group Leader/Senior Scientist in the Department
of BioAnalytical Sciences. Her focus is on development of bioanalytical strategies and methods to enable assessment of the pharmacokinetics, pharmacodynamics, immunogenicity of protein therapeutics from early development to clinical as well
as post-marketing stages. Dr. Peng has led bioanalytical effort for supporting the development of protein therapeutics that target cancer immunotherapy, immunology, neurology and cardiovascular disease areas.
Julius Strauss, MD, Assistant Research Physician, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI, NIH
Dr. Strauss received his M.D. from Stony Brook University Medical Center School of Medicine in 2010
and completed his internal medicine residency at Montefiore Medical Center in 2013. He joined the NCI Medical Oncology Service as a Medical Oncology Fellow in 2013. Dr. Strauss is the Co-Director of the Clinical Trials Group of the Laboratory of Tumor
Immunology and Biology, NCI. He also has an adjunct appointment in the Genitourinary Malignancies Branch. He is board certified in medical oncology and internal medicine. Dr. Strauss is part of the larger effort of the Laboratory of Tumor Immunology
and Biology to create new immunotherapies for the treatment of cancer. Dr. Strauss’s areas of expertise: immunotherapy; therapeutic cancer vaccines; immune checkpoint inhibitors
David Urech, PhD, CEO, CSO, Numab Therapeutics AG
Dr. Wen Jin Wu is currently a Senior Investigator in Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. He earned his M.D. from Wannan Medical College,
China and finished his Ph.D. at Cornell University in 2002. He was recruited as a Principal Investigator (PI) in the Office of Biotechnology Products in 2004. In addition to his regulatory duty as a product quality reviewer with expertise in the area
of therapeutic monoclonal antibodies, antibody-drug conjugates, and biosimilars, Dr. Wu’s laboratory focuses on understanding the roles of ErbB family receptors in breast cancer progression, drug resistance and toxicities induced by HER2-targeted
antibody therapeutics, and physiochemical and biological characterization of bispecific antibodies and antibody-drug conjugates.
Wen Jin Wu, MD, PhD, Senior Investigator, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA CDER
Dr. Wen Jin Wu is currently a Senior Investigator in Office of Biotechnology Products, Center for Drug
Evaluation and Research, FDA. He earned his M.D. from Wannan Medical College, China and finished his Ph.D. at Cornell University in 2002. He was recruited as a Principal Investigator (PI) in the Office of Biotechnology Products in 2004. In addition
to his regulatory duty as a product quality reviewer with expertise in the area of therapeutic monoclonal antibodies, antibody-drug conjugates, and biosimilars, Dr. Wu’s laboratory focuses on understanding the roles of ErbB family receptors
in breast cancer progression, drug resistance and toxicities induced by HER2-targeted antibody therapeutics, and physiochemical and biological characterization of bispecific antibodies and antibody-drug conjugates.
Bin Liu, PhD, Professor, Anesthesia, University of California, San Francisco
Princeton University, B.A., June 1990, Molecular Biology and Biochemical Sciences. University of California, San Francisco, Ph.D., Dec. 1994, Biochemistry