antibody - global biological standards institute · then, we will establish recommendations that...

September 25th-27th, 2016Asilomar Conference Center

AntibodyValidation

Standards, Policies,and Practices

September 25-27, 2016Asilomar Conference Center

2 | Global Biological Standards Institute Antibody Validation: Standards, Policies, and Practices | 3

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WELCOMEDear Colleagues,

Welcome to Antibody Validation: Standards, Policies, and Practices. It is an honor to have such a distinguished group of participants be part of this Workshop.

Antibodies are indispensable biological reagents, yet are a major contributor to the current reproducibility crisis in preclinical research. A variety of issues–from production variations and resale concerns, to improper validation techniques–can jeopardize even the best-designed biomedical experiments. Addressing this requires the availability of highly characterized antibodies and that they demonstrate specificity, selectivity, and reproducibility in the application or assay for which they are used. Finding solutions to the pernicious problems of antibody quality and validation is the central purpose of this Workshop.

Over the past several months, many of you have participated in online discussions through protocols.io and completed a survey to provide input on the key themes of our Workshop and to jump-start the work of the meeting. Over the next two-plus days we will be working hard to achieve some very specific outcomes.

First and foremost, we intend to reach consensus on standards and validation strategies for the most widely used antibody-based applications and methodologies.

Then, we will establish recommendations that will advance the role of antibody producers, ensure broad adoption of standards by a range of stakeholders in the research community, and outline how recombinant antibodies can be further integrated into ongoing research practices.

Finally, we will outline strategies and specific action steps where we can work together to move the outcomes of this Workshop forward.

I want to thank the members of the Workshop Steering Committee, listed below, who provided invaluable guidance on every aspect of the program. And I want to thank the many sponsors, listed in this program book, and provide a special acknowledgement to our platinum sponsors, The National Institutes of Health (NIH) and Thermo Fisher Scientific. In addition, special thanks to The Antibody Society, whose early vision and enthusiasm provided the impetus for this Workshop.

It is called a “workshop” for a reason; we have an ambitious agenda so let’s get to work.

Sincerely,

Leonard P. Freedman, Ph.D.President, Global Biological Standards Institute

WORKSHOP STEERING COMMITTEE:Andrew Bradbury, Ph.D.Los Alamos National Laboratory

Joshua LaBaer, M.D., Ph.D.Biodesign Institute, Arizona State University

Andreas Plückthun, Ph.D.University of Zurich

Janice ReichertThe Antibody Society

David Rimm, M.D., Ph.D.Yale University

Mathias Uhlén, Ph.D.KTH Royal Institute of Technology

AGENDA AT A GLANCESunday, September 25

3:00 – 5:30pm REGISTRATION Curlew

6:00 – 7:00pm OPENING RECEPTION BBQ and Fire Pit Area

7:00 – 9:00pm DINNER & KEYNOTE Seascape Private Dining Room

Monday, September 26

7:30 – 8:30am Breakfast Crocker Dining Hall

8:30 – 9:00am WELCOME, WORKSHOP CHARGE, AND DEFINING THE PROBLEM Fred Farr Forum

9:00 – 10:30am THE SCIENCE BEHIND ANTIBODY VALIDATION STANDARDS Fred Farr Forum

10:30 – 11:00am Break Fred Farr Patio

11:00 – 11:45am OPEN FORUM ON VALIDATION STRATEGIES Fred Farr Forum

11:45 – 1:00pm Lunch Crocker Dining Hall

1:00 – 2:15pm INTEGRATION OF RECOMBINANT ANTIBODIES Fred Farr Forum

2:15 – 3:15pm VALIDATION STANDARDS: FACILITATED BREAKOUT SESSIONS Fred Farr, Marlin, Curlew, Dolphin, Scripps

3:15 – 3:30pm Break Fred Farr Patio

3:30 – 5:00pm VALIDATION STANDARDS: GROUP REPORTING Fred Farr Forum

5:00 – 6:00pm FINDING COMMON GROUND: BUILDING CONSENSUS Fred Farr Forum

6:00 – 7:30pm Dinner Crocker Dining Hall

7:30 – 8:15pm INCORPORATING ANTIBODY DATABASES Fred Farr Forum

Tuesday, September 27

7:30 – 8:15am Breakfast Crocker Dining Hall

8:15 – 8:45am RECAP OF PREVIOUS DAY’S DISCUSSION Nautilus

8:45 – 10:15am PRODUCERS AND SERVICE PROVIDERS IN A PIVOTAL ROLE: QC/QA AND CERTIFICATION Nautilus

10:15 – 10:45am Break Nautilus Patio

10:45 – 11:00am INTRODUCING DRIVERS FOR ADOPTION Nautilus

11:00 – 12:00pm ENSURING VALIDATION THROUGH TRAINING AND PROFICIENCY Crocker Dining Hall

12:00 – 1:15pm Lunch Nautilus

1:15 – 1:45pm RIGOR, REPRODUCIBILITY, AND ANTIBODIES: THE VIEW FROM NIH Nautilus

1:45 – 2:45pm ADVANCING VALIDATION STANDARDS THROUGH JOURNALS Nautilus

2:45 – 4:30pm SOLIDIFYING CONSENSUS AND STRATEGIES FOR IMPLEMENTATION Nautilus

4:30 – 5:00pm ROADMAP FOR MOVING FORWARD Nautilus

5:00pm Adjourn Nautilus


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AGENDA BY SESSIONSunday, September 257:30 – 8:30pm

Changing the Game of Antibody ValidationDavid McAdams | Duke University

Monday, September 268:30 – 9:00am

Welcome, Workshop Charge, and Defining the ProblemLeonard Freedman | The Global Biological Standards Institute

9:00 – 10:30am

The Science Behind Antibody Validation StandardsChallenges and Opportunities: An overview of the antibody problem, concepts on how to approach validation, and the pre-workshop Validation Consensus Building document, which highlights the major issues raised in the online discussion and survey.

Speaker: David Rimm | Yale University

A discussion on the science and challenges of antibodies used in research, strategies for antibody validation, and use of emerging technologies for improving reliability of antibodies.

Moderator: Véronique Kiermer | PLOS Journals

Panelists: Andrew Bradbury | Los Alamos National Laboratory David Rimm | Yale UniversityJoshua LaBaer | Arizona State University Mathias Uhlén | KTH Royal Institute of TechnologyFridtjof Lund-Johansen | Oslo University Hospital

11:00 – 11:45am

Open Forum on Validation StrategiesAttendees will have an opportunity to comment on the challenges and inherent complexity of validation strategies for research antibodies.

Moderator: Leonard Freedman | GBSIFacilitator: Kavita Berger | Gryphon Scientific

1:00 – 2:15pm

Integration of Recombinant AntibodiesBrief presentations and discussion on the merits and limitations of recombinant antibodies for use in research, their use in the current and future market, and their role in addressing antibody quality and reproducibility.

Moderator: Joshua LaBaer | The Biodesign Institute, Arizona State University

Panelists: Brian Kay | University of Illinois, Chicago Valerie Quarmby | GenentechAndreas Plückthun | University of Zurich Jie Zhou | Morrison & FoersterRoberto Polakiewicz | Cell Signaling Technology

2:15 – 3:15pm

Validation Standards: Facilitated Breakout Sessions Small group discussions in which attendees will deliberate about the comparative utility, limitations, benefits, and other key considerations of validation strategies for specific applications.

Breakout Group Chairs: Tara Hiltke | National Cancer Institute Achim Knappik | Bio-RadRuud Hulspas | Cellular Technologies Bioconsulting James Wells | University of California, San FranciscoSimon Goodman | Merck KGaA David Soll | Developmental Studies Hybridoma BankMargaret Karow | Amgen Blaine Stine | AbbVie

Monday, September 26 (continued)3:30 – 5:00pm

Validation Standards: Group Reporting Integrated discussion on the outcomes of each small group session, focusing on priority strategies for validation of antibodies for different applications.

Moderator: Kavita Berger | Gryphon Scientific

Panelists: Simon Goodman | Merck KGaA Achim Knappik | Bio-Rad LaboratoriesTara Hiltke | National Cancer Institute James Wells | University of California, San FranciscoRuud Hulspas | Cellular Technologies Bioconsulting David Soll | Developmental Studies Hybridoma BankMargaret Karow | Amgen Blaine Stine | AbbVie

5:00 – 6:00pm

Finding Common Ground: Building Consensus Attendees will have an opportunity to comment on the highest priority and most informative, effective or/useful strategies for validating antibodies used for different applications as well as appropriate controls for validation.

Facilitators: Kavita Berger | Gryphon Scientific Emily Billings | Gryphon Scientific

7:30-8:15pm

Incorporating Antibody Databases Discussion on the capabilities and limitations of online platforms for reviewing or listing reliable antibodies.

Moderator: Karen Padgett | Bio-Techne

Panelists: Anita Bandrowski | SciCrunch Michael Okimoto | Biocompare, CompareNetworksAndrew Chalmers | CiteAb Hanqing Xie | LabomeCecilia Lindskog-Bergstrom | Human Protein Atlas

Tuesday, September 278:15 – 8:45am

Recap of Previous Day’s Discussion A review of the key points from the previous day’s discussion, highlighting key areas of consensus reached and recommendations identified. This will be followed by a brief summary of the preworkshop consensus building paper on the role of companies.

Speaker: Leonard Freedman | GBSI

8:45 – 10:15am

Producers and Service Providers in a Pivotal Role: QC/QA and CertificationA discussion of current methods for validating antibodies and information-sharing practices to inform consumers about product validation results, and the role of certification of antibody validation standards employed in the QA/QC process. This discussion will examine the difficulties encountered in assuring quality and consistency of antibodies, and will explore the role that producers and service providers play in countering or otherwise addressing issues of reproducibility.

Moderator: David McAdams | Duke University

Panelists: Carl Ascoli | Rockland Immunochemicals Alejandra Solache | AbcamMatt Baker | Thermo Fisher Scientific Roberto Polakiewicz | Cell Signaling TechnologyElizabeth Iorns | Science Exchange

10:45 – 11:00am

Introducing Drivers for AdoptionA summary of the findings of the Drivers for Adoption consensus-building paper.



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Tuesday, September 27 (continued)11:00 – 12:00pm

Ensuring Validation through Training and Proficiency A discussion about the merits and limitations of training and proficiency testing of researchers for antibody validation, described through specific examples, social science analysis of educational efforts, key attributes of successful efforts, and incentive mechanisms such as badges displayed at the time of publication reflecting shared antibody validation data.

Moderator: C. Glenn Begley | Akriveia Theraputics

Panelists: Matt Baker | Thermo Fisher Scientific Vivian Siegel | GBSISunil Badve | University of Indiana Timothy Springer | Harvard Medical SchoolStuart Buck | Laura and John Arnold Foundation

1:15 – 1:45pm

Rigor, Reproducibility, and Antibodies: The View from NIH Presentation on the key issues surrounding reproducibility associated with validation requirements for antibodies used in research from the perspective of the NIH. The presentation will draw, in part, from the NIH guidelines on Rigor and Reproducibility.

Speaker: James Anderson | National Institutes of Health

1:45 – 2:45pm

Advancing Validation Standards through JournalsA dialogue on the role of journals in promoting implementation of validation measures, including topics about the different levers or incentives, such as publishing validation tables or raw data that could be used to encourage adoption.

Moderator: Vivian Siegel | GBSI

Panelists: Nathan Blow | BioTechniques Véronique Kiermer | PLOS JournalsNatalie de Souza | Nature Methods Valda Vinson | ScienceAnn Goldstein | Cell Press

2:45 – 4:30pm

Solidifying Consensus and Strategies for Implementation A two-part discussion: Part 1: final confirmation of effective, high-priority validation strategies, and guidelines for testing antibodies used in different experimental applications; Part 2: key considerations for implementation and adoption of the validation strategies, including recommended roles and responsibilities, drivers for adoption, increased production and use of recombinant antibodies, training, certification, and proficiency testing.

Moderator: Leonard Freedman | GBSIFacilitators: Kavita Berger | Gryphon Scientific Emily Billings | Gryphon Scientific

4:30 – 5:00pm

Roadmap for Moving ForwardA review of the primary conclusions from the workshop and discussion of next steps and assignments for forward movement, particularly within the broader context of enhancing reproducibility in research.


BIOSJames M. Anderson, MD, PhD, National Institutes of HealthDr. Anderson received his Ph.D. in Biology and M.D. from Harvard University and was a Professor at the Yale School of Medicine and UNC Chapel Hill before joining NIH in 2010. Currently he directs a division within the office of the NIH Director responsible for planning and implementing trans-NIH initiatives supported by the Common Fund and coordinating areas of trans-NIH research. He is an elected member of the American Society for Clinical Investigation, the American Association of Physicians, and a Fellow of the American Gastroenterological Association.

Carl Ascoli, PhD, Rockland ImmunochemicalsDr. Ascoli is CSO of Rockland Immunochemicals and has more than 35 years of academic and industrial experience in virology, immunology, host-agent interaction, autoimmune diseases, cancer biology, antibody production and engineering, protein purification, and DNA recombinant technology. Thousands of primary antibodies against targets involved in cancer and other cell signaling pathways were developed under Ascoli’s guidance. For more than 25 years Ascoli established collaborations with investigators at academic and research facilities throughout North America, Europe and Japan including a cooperative effort with the National Cancer Institute’s Center for Cancer Research to produce polyclonal antibodies for use by NCI-CCR staff for discovery.

Sunil Badve, MD, Indiana UniversitySunil Badve, M.D., FRCPath., is the Joshua Edwards Professor of Pathology as well as being the Director of Translational Genomics Core at the Indiana University Simon Cancer Center. He received his medical degree and pathology residency at Grant Medical College and Tata Memorial Hospital for cancer. He did further training at the St George’s Medical School and at Royal Marsden Hospital, England. In USA, he trained at the Albert Einstein School of Medicine (NY) and at Yale. Dr. Badve’s main research and clinical expertise is in breast cancer. He is recognized as a Komen Scholar by the Susan G Komen for the Cure and he is a member of the MoonShot-2020 breast cancer panel.

Matt R. Baker, Thermo Fisher ScientificMatt is currently the head of research and development as well as business development for antibodies and immunoassays at Thermo Fisher Scientific. He has more than 20 years of experience developing and validating antibodies for life science research. Matt started his career in custom antibody development serving both academic and pharmaceutical customers delivering more than 10,000 customized antibodies. Matt has also worked extensively in immunoassay development and advancing new platforms for the quantitative detection of proteins.

Anita Bandrowski, PhD, University of California, San DiegoDr. Bandrowski lead the Neuroscience Information Framework, an NIH Blueprint for Neuroscience funded multi-institution contract, whose goal was to track research resources in the neurosciences including materials and data. As part of framework activities in 2009, Dr. Bandrowski worked to create the antibodyregistry.org as a tracking tool for antibodies and in 2012 began to work with journals to improve reporting standards before publication, the Resource Identificati on Initiative. In 2016, Dr. Bandrowski co-founded SciCrunch Inc, a company that holds the antibodyregistry. org and the technologies that enable resource identification of reagents, honed to improve the scientific paper.

C. Glenn Begley MB, BS, PhD, FRACP, Akriveia TheraputicsDr Begley is CSO for Akriveia Therapeutics. He is a non-executive Director of Oxford BioTherapeutics consults for several biotechnology companies and the Cancer Science Institute of Singapore. From 2002-2012, he was Vice-President and Global Head of Hematology/Oncology Research at Amgen, responsible for building, directing and integrating the research program. During this time he became interested in the issue of research integrity and scientific reproducibility. Before joining Amgen he had over 20 years of clinical experience in medical oncology/hematology. He is Board Certified in Australia as a Medical Oncologist and Hematologist and has a PhD in cellular and molecular biology.


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Kavita M. Berger, PhD Gryphon Scientific, LLC Kavita M. Berger joined Gryphon Scientific in 2015. Her work focuses biological and chemical defense issues through active involvement of the scientific and security communities. Prior to joining Gryphon Scientific, Kavita worked in biological science and security at the American Association for the Advancement of Science Center for Science, Technology and Security Policy. Kavita has a B.S. in molecular genetics from The Ohio State University, Ph.D. in genetics and molecular biology from Emory University, and postdoctoral research in pre-clinical HIV and smallpox vaccine research at the Emory Vaccine Research Center.

Emily Billings, PhD, Gryphon Scientific, LLCEmily A. Billings joined Gryphon Scientific in 2016. Her work focuses on infectious diseases, science communications, data management and analysis, and science policy. Prior to joining Gryphon Scientific, Emily developed graduate career training initiatives as part of the Graduate Biosciences Society at the University of Virginia, including the organization and implementation of several Symposia and panels. Emily earned her Bachelors of Science in Integrative Biology with a minor in Chemistry and Spanish from the University of Illinois Champaign-Urbana. Emily has a Ph.D. in Microbiology from the Department of Microbiology, Immunology, and Cancer Biology at the University of Virginia. Her thesis work focused on host-pathogen interactions and the innate immune response to Gram-negative bacteria.

Nathan Blow, PhD, BioTechniquesNathan Blow obtained his doctoral degree in evolutionary genetics from Syracuse University, and then went on to postdoctoral training at Tufts New England Medical Center and Harvard Medical School where he focused on infectious diseases and host/pathogen interactions. Following training, Nathan initially worked as an editor for the Nature Publishing Group (2006-2009) before assuming his current role as Editor-in-Chief of the journal BioTechniques (2009)

Andrew Bradbury, MB BS, PhD, Los Alamos National LaboratoryBradbury trained in medicine at Oxford and London, and received his PhD with Nobel Laureate, Cesar Milstein. He did a postdoc in the CNR Institute of neurobiology, Rome, Italy, and became tenured assistant professor in SISSA, Trieste, Italy. He moved to LANL, New Mexico, in 1999, where he is group leader. Bradbury has worked on antibody engineering and display technologies for almost thirty years. He has a strong interest in the widespread adoption of recombinant antibodies, and recently published a Nature commentary (with Pluckthun) arguing that research antibodies should be sequenced and expressed recombinantly in order to improve reproducibility.

Stuart Buck, JD, PhD, Laura and John Arnold FoundationStuart Buck holds a PhD in Education Policy from the University of Arkansas, a J.D. with honors from Harvard Law School, and bachelors and masters degrees in music performance from the University of Georgia. He is the author of Acting White, a Yale University press book that discusses the history of education in the African-American community. At the Laura and John Arnold Foundation, Buck leads the Research Integrity initiative, which seeks to improve quality and reliability of scientific research in fields ranging from economics to cancer cell biology.

Andrew Chalmers, PhD, CiteAb and University of Bath (UK)Dr Chalmers is a senior lecturer based at the University of Bath, UK. His research focuses on understanding the behaviour of epithelial cells in normal tissues and during tumour formation. Dr Chalmers has a strong interest in improving the reliability of research antibodies. He is the founder of the spin out company CiteAb. CiteAb runs a citation based antibody search engine which aims to provide a better way for researchers to find antibodies which are suitable for their experiments. He is also a founding guest editor of the F1000Research Antibody Validation Channel that hosts a collection of primary papers, reviews and comment articles which focus on antibody validation.

Natalie de Souza, PhD, Nature Methods Natalie de Souza has been an editor at Nature Methods for close to ten years, the last two years as editor-in-chief. Antibody performance has been a subject of interest at the journal since its founding in 2004. Nature Methods publishes papers directly relating to binder development and validation as well as manuscripts in other disciplines that depend on specific affinity reagents. Natalie did postdoctoral work on signaling in cell fate specification during C. elegans development. Her doctoral work was on the oligomerization and traffic of membrane proteins. She used antibodies as part of all her prior research projects.

Leonard Freedman, PhD, Global Biological Standards InstituteDr. Freedman is the founding President of GBSI. He has held senior positions in basic research, drug discovery, and science policy. Before joining GBSI, Dr. Freedman served as Vice Dean for Research at Thomas Jefferson University. A leader in the field of nuclear hormone receptors, Dr. Freedman has led discovery research efforts in the pharmaceutical industry as a Vice President at Wyeth and Executive Director at Merck, and in academia, and as a Member and Professor of Cell Biology & Genetics at Memorial Sloan-Kettering Cancer Center and Weil Cornell Medical College. Dr. Freedman earned his Ph.D. in Molecular Genetics from the University of Rochester. He completed his post-doctoral fellowship in the laboratory of Dr. Keith Yamamoto at the University of California, San Francisco.

Ann Goldstein, PhD, Neuron, Cell PressAnn Goldstein is a Scientific Editor at Neuron. She received her PhD in Neurosciences from Stanford and conducted her post-doctoral training at Children’s Hospital Boston and Harvard Medical School before joining Cell Press in 2012.

Tara Hiltke, PhD, National Cancer Institute Office of Cancer Clinical Proteomics Research

Dr. Hiltke provides leadership and oversight to the Monoclonal Antibody Characterization program. She also works in developing other methods of antigen generation. Previously, she served as a senior scientist/project manager in assay development at both Wellstat Diagnostics and BioVeris Corporation, where she developed clinical assays for diagnostic markers using electrochemiluminescence platform and magnetic beads. She holds a Ph.D. degree (1999) in biology from the University of Buffalo.

Elizabeth Iorns, PhD, Science Exchange Dr. Elizabeth Iorns is the Founder & CEO of Science Exchange, the Co-Director of the Reproducibility Initiative, and is a part-time partner at Y Combinator. Elizabeth has a Ph.D. in Cancer Biology from the Institute of Cancer Research (UK), and before starting Science Exchange in 2011 was an Assistant Professor at the University of Miami. Elizabeth has received a range of honors and recognition, including the Kauffman Foundation Emerging Entrepreneur Award, one of Nature Magazine’s ‘Ten People Who Mattered’, and one of WIRED’s ‘50 Women Who Are Changing The World’. Elizabeth is focused on the development of innovative models to promote the quality and efficiency of scientific research.

Margaret Karow, PhD, AmgenMargaret Karow is currently the lead for Biosimilars Process Development at Amgen. Previously she, she was an Executive Director in Discovery Research leading the Biologics Optimization, Protein Sciences, and the Burnaby, Canada research site where XenoMouse antibody development is based. Prior to joining Amgen, Margaret was a Vice President at Regeneron Pharmaceuticals, as the head of Traps, Small Molecule and Antibody Development, and the Immunology therapeutic area. She was also the co-lead for the development of the VelocImmune mouse platform for the production of human antibodies. Margaret did her post-doctoral work on B. subtilis sporulation at Temple University, and her Ph.D. work studying E. coli outer membrane synthesis at the University of Utah.


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Brian Kay, PhD, University of Illinois, ChicagoBrian K. Kay earned his A.B. and Ph.D. degrees in cell biology at the University of Chicago and Yale University, respectively and post-doctoral training at the National Institutes of Health. He had academic appointments at the University of North Carolina-Chapel Hill, University of Wisconsin-Madison, Argonne National Laboratory, and the University of Illinois at Chicago (UIC), where he is currently Professor in the Department of Biological Sciences. Kay has served in a variety of leadership positions, and in 2015 and 2016, he was named “University Scholar” and “Inventor of the Year,” respectively, at UIC. His research is focused on mapping protein-protein interactions, generating recombinant affinity reagents, and phage-display.

Véronique Kiermer, PhD, PLOS Journals Véronique Kiermer is the Executive Editor at PLOS, where she works closely with the editorial teams of the seven PLOS journals to continually improve the communication of research. Before joining PLOS in 2015, she was Executive Editor and Director of Author and Reviewer Services for Nature Publishing Group. She started her career in publishing as the founding Chief Editor of Nature Methods. Véronique has a PhD in molecular biology from the Université Libre de Bruxelles, Belgium. Before moving into publishing, she did postdoctoral work in the laboratory of Dr Eric Verdin at the Gladstone Institute, University of California, San Francisco, and worked in R&D in the biotechnology industry in the Bay Area.

Achim Knappik, PhD, Bio-Rad LaboratoriesAchim Knappik is the main inventor of the HuCAL® technology for generation of human recombinant antibodies. He held several positions at MorphoSys AG, Germany, and was a senior Manager at AbD Serotec for almost 10 years. Since 3 years he is working as Group R&D Manager and Site Leader at Bio-Rad. Achim has published more than 30 scientific papers and holds several patents in the area of protein library technology. He holds a PhD in biochemistry from the University of Zurich, Switzerland.

Joshua LaBaer, MD, PhD, Biodesign Institute and Arizona State UniversityJoshua LaBaer was the founder and director of the Harvard Institute of Proteomics, and was recruited to ASU’s Biodesign Institute as the first Piper Chair in Personalized Medicine in 2009 at The Virginia G. Piper Center for Personalized Diagnostics (VGPCPD). LaBaer earned his medical degree and a doctorate in biochemistry and biophysics, from the University of California, San Francisco. He completed his medical residency at the Brigham and Women’s Hospital and a clinical fellowship in oncology at the Dana-FarberCancer Institute, both in Boston. LaBaer is an associate editor of the Journal of Proteome Research, a recent member of the National Cancer Institute’s Board of Scientific Advisors, Co-Chair of the Early Detection Research Network Steering Committee and president of the U.S. Human Proteome Organization.

Cecilia Lindskog, PhD, Human Protein Atlas Cecilia Lindskog, PhD, has a Master of Science in Biomedicine and a Doctor of Philosophy in pathology from the Faculty of Medicine, Uppsala University. She is site director of the Tissue Atlas, part of the Human Protein Atlas project where she joined in 2006. Her main research interests are to understand the biology and functions of different organs, and the underlying mechanisms leading to cancer and other diseases. The Tissue Atlas team creates a world unique atlas of spatial proteomics, with the aim to show the localization of all human proteins in healthy human tissues, using tissue microarrays and immunohistochemistry.

Fridtjof Lund-Johansen, PhD, Oslo University HospitalFridtjof Lund-Johansen leads a proteomics research group at the Oslo University Hospital in Norway. He has invented Microsphere Affinity Proteomics (MAP), which is a new type of high-resolution antibody array analysis. The sample preparation for MAP involves protein labeling and extensive fractionation under native and denatured conditions. As many as 100 liquid fractions are analyzed in parallel with bead-based antibody array, and mass spectrometry (MS). The approach resolves the targets of thousands of antibodies as discrete reactivity peaks across the fractions, and MS results serve as a direct reference of specificity. Thus, MAP technology greatly enhances the throughput and precision of antibody validation.

David McAdams, PhD, Fuqua School of Business and Economics Department, Duke University David McAdams is Professor of Business Administration at the Fuqua School of Business, Duke University, and Professor of Economics in the Economics Department at Duke. Professor McAdams is an expert in microeconomic theory, game theory, and market design, whose work (on everything from auctions to relationships) has been published in the leading journals of economics. In recent years, his primary focus has been on applying insights from game theory to medicine and biomedical science, most notably to the problem of rising antibiotic resistance.

Michael Okimoto, PhD, CompareNetworksMike is a co-founder and Chief Content Officer of CompareNetworks (the parent company of Biocompare). As CCO Mike manages the production, placement and analysis of the content that appears across CompareNetworks’ online properties. Prior to co-founding CN Mike was a postdoctoral fellow at the University of California, San Francisco where he worked in a lab studying the immune response to HIV. He received his doctorate in Biological Sciences from the University of California, Irvine and his BA in Cell Biology and Biochemistry from the University of California, San Diego.

Karen Padgett, MBA, Bio-TechneKaren is Vice President of the Antibody Business Unit and Digital Marketing of Bio-Techne (R&D Systems, Novus Biologicals and Tocris). She is the founder and CEO of Novus Biologicals which was sold to Bio-Techne in 2014. Karen has a BS in Microbiology from Indiana University and an MBA from the University Chicago.

Andreas Plückthun, PhD, University of ZurichAndreas Plückthun has been Professor of Biochemistry at the University of Zürich, Switzerland since 1993. He studied chemistry at the University of Heidelberg and received a PhD from the University of California at San Diego in 1982, was postdoctoral fellow at Harvard University (1982-85) and group leader at the Genzentrum and Max-Planck-Institut für Biochemie in Martinsried (1985-93). He is a member of the German Academy of Science. He published over 400 papers, is cofounder of 3 companies and the recipient of numerous awards. His research field is protein engineering in all flavors: antibodies, novel scaffold proteins (DARPins and Armadillos), and stable membrane proteins; his work combines directed evolution, biophysical analysis and biomedical applications.

Roberto Polakiewicz, PhD, Cell Signaling TechnologiesDr. Polakiewicz is the Chief Scientific Officer at Cell Signaling Technology (CST). His leadership and direction have created the company’s most valuable intellectual property assets. Dr. Polakiewicz has driven the successful implementation of four generations of novel antibody platform technologies that have been critical to the success of CST. During his 25 years of experience in Research and Technology development, Dr. Polakiewicz has published more than 60 peer-reviewed publications, and is an inventor on numerous patents and patent applications. Dr. Polakiewicz received his B.S. in Chemistry and Ph.D. in Molecular Biology from the Hebrew University of Jerusalem, and completed postdoctoral studies at the Whitehead Institute for Biomedical Research at M.I.T.

Valerie Quarmby, PhD, GenentechValerie Quarmby is a Staff Scientist in the Department of BioAnalytical Sciences at Genentech. At Genentech, Dr. Quarmby has developed bioanalytical methods & strategies to enable IND, BLA and related filings for several successful therapeutics. Dr. Quarmby holds a Ph.D. in Hormone Physiology from the Imperial Cancer Research Fund and the University of London, England. Dr.Quarmby was a Postdoctoral Visiting Fellow at NIH, and then joined the Laboratories for Reproductive Biology 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. In 2014, in recognition of her many contributions to the pharmaceutical industry, Dr. Quarmby was selected to be an AAPS Fellow.


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David Rimm, MD, PhD, Yale UniversityDr. David Rimm is a Professor in the Departments of Pathology and Medicine (Oncology) at the Yale University School of Medicine. He is the Director of Yale Pathology Tissue Services and Director of Translational Pathology. He completed an MD-PhD at Johns Hopkins University Medical School followed by a Pathology Residency at Yale and a Cytopathology Fellowship at the Medical College of Virginia. His research lab group focuses on quantitative pathology using the AQUA® technology invented in his lab. He has served on advisory boards for Astra Zeneca, Genentech, Novartis, BMS, Perkin Elmer, Dako, ACD, Biocept, OptraScan, FivePrime and Genoptix. He was a scientific co-founder of HistoRx, a digital pathologycompany (sold to Genoptix in 2012) and Metamark Genetics, a prognostic determinant company.

Vivian Siegel, PhD, Global Biological Standards InstituteVivian Siegel is the Director of Education and Training at GBSI as well as an adjunct research professor of medicine at Vanderbilt University and a visiting instructor at MIT. She founded and directed the Center for Science Communication at Vanderbilt University. Prior to joining GBSI, Dr. Siegel served the Broad Institute of MIT and Harvard as its Director of Scientific Education and Public Communication. Dr. Siegel was formerly the executive director of the Public Library of Science, the chief editor of Cell, Developmental Cell, and Molecular Cell, the founding editor-in-chief of Disease Models & Mechanisms and the executive editor of the Journal of the American Society of Nephrology. Dr. Siegel received her A.B. in biochemistry and mathematics from Bowdoin College and her Ph.D. in genetics from University of California San Francisco.

Alejandra Solache, PhD, AbcamDr Alejandra Solache joined Abcam in 2013 as Head of Product Development and Manufacturing globally. She is responsible for managing the output of the Abcam Cambridge, Hangzhou and Bristol laboratories, specifically the New Product Development reagents pipelines and R&D. She also plays a key role in developing Abcam’s innovation strategy. Prior to joining Abcam she held various positions at EMD-Millipore, latterly as R&D Director, leading the Antibody and Assay Development teams. She gained expertise in Immunology, cell signalling and Cell Biology through postdoctoral fellowships at UCSF and the Trudeau Institute. She holds a PhD in Immunology and an MSc in Biochemistry.

David Soll, PhD, Developmental Studies Hybridoma Bank (DSHB) David R. Soll is the director of the Developmental Studies Hybridoma Bank (DSHB), a self-funded National Resource created by the NIH and housed at the University of Iowa. He is also director of the W. M. Keck Dynamic Image Analysis Facility and the Roy J. and Lucille Carver/Emil Witschi Professor of Biology. He is best known for his work on cell motility, switching and mating in Candida albicans and development and distribution of mAbs. His present research is on the regulation of the master switch locus of C. albicans and the discovery of anti-tumorigenic mAbs.

Timothy A. Springer, PhD, Harvard Medical School Dr. Springer received his B.A. in Biochemistry from University of California in 1971, his Ph.D. in Molecular Biology and Biochemistry from Harvard in 1976 and did a fellowship with Cesar Milstein in Cambridge, England. He began as Assistant Professor on the Quad at HMS in 1977 and has been here ever since, although his institution has changed several times. Since 1989 Springer has been Latham Family Professor. He currently is Professor of Biological Chemistry and Molecular Pharmacology and of Medicine at HMS and in the Program of Cellular and Molecular Medicine, and in the Division of Hematology, Department of Medicine at Children’s Hospital.

W. Blaine Stine, PhD, AbbVie Blaine Stine is the Associate Director II responsible for leading the Biologics Generation Group in Worcester MA supporting all AbbVie therapeutic areas. His teams specialize in in vivo and in vitro antibody discovery, antibody and bi-specific engineering and lead optimization, high-throughput production, and biomolecular interaction screening. Prior to his current role AbbVie, Blaine has held strategic positions at AbbVie including Principle Research Scientist Protein Analytics, and Associate Director I Biologics CMC. Blaine assumed his current role as Associate Director II Global Biologics R&D in 2014. Blaine attended University of California San Diego and received his Bachelors in Molecular Biology and Northwestern University where he received his Ph.D. in Biochemistry.

Mathias Uhlén, PhD, Science for Life Laboratory, KTH Royal Institute of Technology (Sweden)Dr Uhlen’s research is focused on protein science, antibody engineering and precision medicine and range from basic research in human and microbial biology to more applied research, including clinical applications. His group was the first to describe a number of innovations in science including:engineered protein A and protein G for purification of antibodies; affinity tags for purification of recombinant fusion proteins; solid phase methods for DNA handling using the biotin-streptavidin system; pyrosequencing leading to the first next generation DNA sequencing instrument; affibodies – protein binders aimed for therapeutic applications. Since 2003, he has led an international effort to systematically map the human proteome with antibodies and to create an open source knowledge-

based resource called the Human Protein Atlas (www.proteinatlas.org).

Valda Vinson, PhD, Science Valda Vinson started her career in publishing when she joined the Science staff in 1999. Since then, she has handled research papers in the areas of structural biology, biochemistry, and biophysics as an Associate and Senior Editor. In Dr.Vinson’s current role as Deputy Editor, she oversees research content in the area of cellular and molecular biology and biomedicine. She earned an M.Sc. in Chemistry from Durban University in 1987 and a Ph.D. from Johns Hopkins University in 1992. Her postdoctoral studies were also undertaken at Johns Hopkins University, where she focused on structural and biochemical studies of cytoskeletal proteins. Before joining Science, she spent two years as a Senior Lecturer at the University of the Western Cape, South Africa.

James Wells, PhD, University of California, San FranciscoJames A Wells, PhD, has pioneered the engineering of proteins, antibodies, and small molecules that target catalytic, allosteric, and protein-protein interaction sites. He innovated mutagenesis methods including protein and substrate phage display, cassette mutagenesis, alanine-scanning, engineered enzymes for bio-conjugations, and disulfide “tethering”, a novel site-directed fragment based approach for drug discovery. He received his PhD from Washington State University and Postdoc at Stanford University. Wells started his independent research career in Protein Engineering at Genentech (1982-1998), President and CSO at Sunesis Pharmaceuticals (1998-2005) and now Professor of Pharmaceutical Chemistry at UCSF. He has received societal awards from the American Chemical Society, the Protein Society, the American Peptide Society, and the ASBMB. He is an elected member

of the National Academy of Sciences, American Academy of Arts and Sciences, and the National Academy of Inventors.

Hanqing Xie, PhD, LabomeDr. Hanqing Xie is the developer of Labome websites and Validated Antibody Database (VAD). He is interested in developing resources that facilitate biomedical laboratory research and promote the communication between biomedical community and the public. Dr. Xie received postdoctoral training from University of Alabama at Birmingham and Johns Hopkins University after graduating from Nanjing University with a BS degree and from The George Washington University with a PhD degree.

Jie Zhou, PhD, Morrison and Foerster LLPDr. Jie Zhou is a partner in Morrison & Foerster’s Life Science Group. Her practice focuses on patent prosecution and counseling for clients in the areas of biotechnology, pharmaceuticals, and cleantech. She also advises clients on IP management and strategic portfolio planning. Dr. Zhou has successfully obtained patent coverage for many therapeutics that are in early development or in various phases of FDA approval. She has been recognized by the Daily Journal as one of the Top Intellectual Property Attorneys in California.


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Funding for this conference was made possible in part by a National Institutes of Health R-13 grant, GM 121024-01/G236SH. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

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