PepTalk the protein science week 2015

• 1. Cambridge Healthtech Institutes 14th Annual JANUARY 19-23, 2015Town and Country Resort &Convention CenterSAN DIEGO, CACambridge Healthtech Institute, 250 First Avenue, Suite 300 , Needham, Massachusetts 02494Telephone: 781-972-5400 Toll-free in the U.S. 888-999-6288 Fax: 781-972-5425PREMIER SPONSOR:2015 Event Features: 1,200+ International Participants including Scientists,Regulators and Solution Providers 20 Conferences on Antibodies, Formulation, Expression,Analytics, Purification and more 13 Short Courses to Enhance Your Learning Experience 325+ Scientific Presentations from Industry Leaders 80+ Interactive BuzZ Session Roundtables 100+ Exhibitors Showcasing Novel Technologies andSolutions 125+ Cutting-Edge Research PostersPLENARY KEYNOTEFrom Yeast to the Brain:Advances in ProteomicsJohn R. Yates, Ph.D.,Ernest W. Hahn Professor, Chemical Physiologyand Molecular and Cellular Neurobiology, TheScripps Research InstituteRegister bySeptember 12 for Early-BirdSavings up to $600CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com

2. Antibody Therapeutics Short Courses Cancer Targets for AntibodyFormulation & Stability Short Courses Optimizing Biologics FormulationDevelopment Short Courses Lyophilization and Emerging DryingTechnologiesExpression & Production Short Courses Engineering Genes, Vectors,PepTalk: The Protein Science Week is one of the largest gatherings ofprotein science researchers in the United States, and when you bringtogether some of the most influential people in the field - big things happen!PepTalk offers an array of education, innovation and networking programs.Over 300 high-caliber speakers share case studies, unpublished data,breakthroughs and solutions that support and enhance your research.Ample networking opportunities allow you to connect with colleagues andpeers from around the world and gain new perspectives on the evolutionof biologics. Choose between 20 Conferences, 13 Short Courses, 3 TrainingSeminars, 80+ BuzZ Session Discussion Roundtables, and dedicated exhibithall and poster viewing hours to create a custom agenda that fits yourresearch and networking needs!PLENARY KEYNOTEWednesday, Jan. 21, 4:25pmFrom Yeast to the Brain: Advances in ProteomicsJohn R. Yates, Ph.D., Ernest W. Hahn Professor, Chemical Physiology and Molecular and Cellular Neurobiology, The Scripps Research InstituteABOUT:John R. Yates is the Ernest W. Hahn Professor in the Department of Chemical Physiology and Molecular and Cellular Neurobiology at The Scripps Research Institute. His researchinterests include development of integrated methods for tandem mass spectrometry analysis of protein mixtures, bioinformatics using mass spectrometry data and biologicalstudies involving proteomics. He is the lead inventor of the SEQUEST software for correlating tandem mass spectrometry data to sequences in the database and developer of theshotgun proteomics technique for the analysis of protein mixtures. His laboratory has developed the use of proteomic techniques to analyze protein complexes, posttranslationalmodifications, organelles and quantitative analysis of protein expression for the discovery of new biology. Many proteomic approaches developed by Yates have become a nationaland international resource to many investigators in the scientific community. He has received the American Society for Mass Spectrometry research award, the Pehr Edman Awardin Protein Chemistry, the American Society for Mass Spectrometry Biemann Medal, the HUPO Distinguished Achievement Award in Proteomics, Herbert Sober Award from theASBMB and the Christian Anfinsen Award from The Protein Society. He was ranked by Citation Impact, Science Watch as one of the Top 100 Chemists for the decade, 2000-2010.He was #1 on a List of Most Influential in Analytical Chemistry compiled by The Analytical Scientist 10/30/2013 and is on the List of Most Highly Influential Biomedical Researchers,1996-2011, European J. Clinical Investigation 2013, 43, 1339-1365.He has published 751 scientific articles with ~57,000 citations, and an H index 119.ALL REGISTERED CONFERENCE PARTICIPANTS ARE WELCOME!Get Connected!PRE-CONFERENCE DINNERSHORT COURSES*Sunday, Jan. 18Monday-Tuesday,Jan. 19-20DINNER SHORT COURSES*Tuesday, Jan. 20Wednesday-Thursday (am),Jan. 21-22Thursday (pm)-Friday,Jan. 22-23PIPELINE 1Protein Engineering &DevelopmentShort Courses Recombinant Protein Therapeutics Short Courses Enhancing Antibody Binding andSpecificityImproving the Clinical Efficacy ofAntibody TherapeuticsPIPELINE 2Therapeutics Short Courses Antibody-Drug Conjugates Bispecific Antibody TherapeuticsPIPELINE 3Protein Aggregation and EmergingAnalytical ToolsPIPELINE 4Constructs and Clones Short Courses Recombinant Protein Expressionand Production Transient Protein ProductionPIPELINE 5Analytics & Impurities Short CoursesCharacterization of ADCs,Bispecifics and NewBiotherapeuticsShort Courses Detection and Characterization ofParticulates and Impurities Extractables and LeachablesPIPELINE 6Process Technologies &PurificationShort Courses Single-Use Technologies andContinuous Processing Short Courses Protein Purification and Recovery Higher-Throughput ProteinPurificationNEW Accompanying Conferences Short Courses Short Courses Membrane Proteins / CHO CellsTraining Seminars Short Courses Intro to Bioprocessing Short CoursesIntro to FormulationIntro to Analytical MethodDevelopment and Validationfor Therapeutic ProteinsMAXIMUMSAVINGS!CREATE A CUSTOM AGENDA!Register for the PremiumPackage and Gain Access toALL Conferences and TrainingSeminars Monday - FridayEVENT-AT-A-GLANCECoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com2 3. PREMIER SPONSORCORPORATE SPONSORSCORPORATE SUPPORT SPONSORSCoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com3 4. PRE-CONFERENCE DINNER SHORT COURSES*SC1: Production Challenges for Complex Biologics: ADCs,Bispecifics and Fusion ProteinsThis course addresses the typical production issues encountered withcomplex biologics, namely fusion proteins, antibody-drug conjugates andbispecific antibodies. Experts elucidate the structure and nature of thesebiologics in order to understand and master their properties. Along withexploring manufacturing challenges, the course also reveals how to overcomethese challenges with practical insights and advice.Instructors: Stefan Schmidt, Ph.D., Vice President, DSP, RentschlerBiotechnologyChristopher D. Thanos, Ph.D., Director, New Molecular Entities, HalozymeTherapeutics, Inc.SC2: The S-Score System: A Tool for Identifying New CancerTargets for Antibody-Drug TherapyThe course discusses a new method that aids identification and prioritizationof predicted cancer genes for future analysis. It generates a gene-specificS-score by incorporating data from different analysis types. I present resultswhere this method was applied to Cancer Genome Atlas data for identificationof oncogenes and tumor suppressors, a web server allowing users to querythe system with clinically relevant issues and case studies where the S-scorehas helped identify targets for antibody-based therapy.Instructor: Sandro J. de Souza, Ph.D., Laboratory of Computational Biology,Ludwig Institute for Cancer ResearchSC3: A Rational Approach to Formulation Development ofBiologic TherapeuticsThe course offers a forum discussing how to develop formulation for biologicdrugs. Case studies demonstrate how to incorporate Quality-by-Design (QbD)concepts to design multivariate experiments, how to obtain representativedata and how to analyze data in order to propose sound formulation of drugsubstance or drug product in the context of designated container closuresystems. The course will combine how-to suggestions and real-worldexamples in an interactive discussion.Instructor: Kevin Zen, Ph.D., Manager, Biologics Development, AllerganSC4: Genome Editing Using CRISPRMammalian cells are the workhorses for biopharmaceutical production. Thus,genome engineering/editing of these hosts to improve product quality andyields are of great interest. CRISPR, the newest gene editing tool, is gainingpopularity among protein engineers and cell line developers. This courseprovides an introduction to CRISPR technology and insights on implementationfor your protein expression and production pipeline.Instructors: Helene Faustrup Kildegaard, Ph.D., Co-Principal Investigator,Novo Nordisk Foundation Center for Biosustainability, Technical University ofDenmarkNorman Garceau, Ph.D., CSO, Blue Sky Biotech, Inc.Additional Instructors to be AnnouncedSUNDAY, JANUARY 18 | 5:00-8:00 PMSC5: Accelerated Stability Testing of BiologicsThis short course guides the researcher in designing studies for acceleratedstability testing of biologics. The course begins with basic underlying conceptsgoverning protein drug product stability, and focuses on design principles formeasuring stress and accelerated stability testing of not only the protein ofinterest, but also excipients and primary packaging components. Strategies tohandle complexities arising from their interactions will also be discussed.Instructor: Vishal C. Nashine, Ph.D., Senior Research Investigator, Drug ProductScience & Technology, Bristol-Myers Squibb Co.Additional Instructors to be AnnouncedSC6: Establishing the Business Case for Single-Use andContinuous ProcessingThis short course introduces attendees to the paradigm shift and a new wayof economic and manufacturing considerations for implementing single-usesystems and continuous processing. Based on case studies, projects andavailable data, we establish a platform for drug manufacturing that is robust,streamlined, sustainable and energy saving, and at the same time reducesCOGS and carbon print, culminating towards a more streamlined operation foreither batch or continuous processing.Instructor: Robert Dream, PE, CPIP, CPMP, Ph.D., Principal, HDR Company Ltd.BuzZ Sessions are facilitated, small-group discussions.Interactive participation leads to problem-solvingsolutions and future collaborations around focusedtopics.If you have a topic idea or would like to moderate a table, pleasecontact: Ann Nguyen at [email protected] visit our website for more details.* Please visit our website for more details.Separate registration required.CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com4 5. DINNER SHORT COURSES* TUESDAY, JANUARY 20 | 5:00-8:00 PMSC7: Targeting of GPCRs with Monoclonal AntibodiesWhile GPCRs (G protein-coupled receptors) are important therapeutic targets,it has been challenging to discover therapeutically relevant antibodies againstthem. This course examines different steps along the anti-GPCR antibodydiscovery pathway and highlights various approaches to accomplishing eachstep. Topics include: 1) Antibody discovery, 2) Assays to measure antibodybinding, 3) In vitro assays to measure functional activity of the antibody, and 4)Review of promising GPCR targets and antibodies in the clinic.Instructor: Barbara Swanson, Ph.D., Director, Research, Sorrento Therapeutics, Inc.SC8: Affecting Effector Function: Engineering the Fc RegionThere are a growing number of antibodies and Fc fusion proteins indevelopment that contain a modified Fc region, either via changes in aminoacid sequence or in glycoforms. Engineering antibodies and Fc fusionproteins has become more sophisticated at generating molecules that arebetter suited to the pharmacological activity required. This course focuseson characterizing and engineering effector functions in order to create moreeffective therapeutics.Instructors: Tomoyuki Igawa, Ph.D., Manager, Antibody Engineering Group,Discovery Research, Chugai Pharmaceutical Co., Ltd.Futa Mimoto, Ph.D., Researcher, R&D, Chugai Pharmaceutical Co., Ltd.SC9: Protein Aggregation: Mechanism, Characterization andConsequencesProtein aggregation is recognized by regulatory agencies and thebiopharmaceutical industry as a key quality attribute of biotherapeuticproducts. Various aggregates hold the potential for adversely impactingproduction and patients in a variety of ways. This in-depth workshopreviews the origins and consequences of aggregation in biotherapeutics,and then examines strategies for predicting and quantifying aggregation inbiopharmaceuticals. It benefits scientists engaged in development, production,analytical characterization and approval of biotherapeutics and who require agood working knowledge of protein aggregation.Instructor: Thomas Laue, Ph.D., Professor, Biochemistry and MolecularBiology; Director, Biomolecular Interaction Technologies Center (BITC),University of New HampshireAdditional Instructors to be AnnouncedSC10: Transient Protein Production in Mammalian CellsThis short course introduces both the fundamental concepts and technologiesneeded to establish transient protein production in mammalian cells. Thisallows for the rapid generation, purification and characterization of milligram-to-gram quantities of secreted or intracellular recombinant proteins fortherapeutic, functional and structural studies. The course combines instructionand case studies in an interactive environment.Instructors: Richard Altman, MS, Research Scientist, Molecular Sciences,Alexion PharmaceuticalsHenry C. Chiou, Ph.D., Associate Director, Cell Biology, Life Science Solutions,Thermo Fisher ScientificDominic Esposito, Ph.D., Director, Protein Expression Laboratory, FrederickNational Laboratory for Cancer Research, Leidos Biomedical Research, Inc.Krista Johnson, MSc, Research Scientist, Protein Sciences, AlexionPharmaceuticalsSC11: Materials in Contact with Biologics: Understanding Risk toQuality and SafetyMaterials that contact biologics during manufacturing, storage and finalpackaging can pose risks to biopharmaceutical quality. This in-depthcourse reviews the regulatory requirements, types of materials used andmaterial chemistry, and then examines the strategies for prediction andrisk assessment of potential threats to quality and safety of biologics drugproducts. The course reviews development of a successful analytical strategyfor single-use components, container closure components and risk posedby leachables.Instructor: Diane Paskiet, Ph.D., Director, Scientific Affairs, WestPharmaceuticalAdditional Instructors to be AnnouncedSC12: Protein Purification Strategies: Dealing with Proteins thatAre Prone to AggregateThis course provides a comprehensive and detailed outline of hands-onissues for purifying proteins. We first address general considerations aboutthe protein we want to produce, including issues of activity, solubility,homogeneity, purity and proper oligomeric conformation. Aggregation is oneof the main obstacles in protein production, so we look at how to monitorfor aggregation and comprehend its mechanism. We also discuss how tocheck for the optimal solubility conditions at the expression level, and ourcomprehensive approach for optimizing solubility during purification. We alsodiscuss expression screening methodology, environmental factors to considerduring purification, families of additives and screening for additives. Lastly, weaddress ways to avoid aggregation, as well as setting up protein concentrationand storage.Instructor: Mario Lebendiker, Ph.D., Head, Protein Purification Facility, WolfsonCentre for Applied Structural Biology, Hebrew University of JerusalemSC13: Continuous Processing of Therapeutic Proteins inSingle-Use: Technology and Production ConceptThe course demonstrates how each unit operation in a typical mAb processcan be run continuously and also shows how these unit operations areintegrated into a truly continuous process. We also demonstrate how thecombination of continuous processing and single-use technology can beimplemented in a production facility. GMP-compliant production aspects suchas process control, automation, PAT, process robustness, quality assuranceand facility will also be discussed.Instructor: Jrgen Magnus, Ph.D., Manager, R&D, Bayer Technology ServicesGmbH* Please visit our website for more details.Separate registration required.CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com5 6. TS1: INTRODUCTION TO BIOPROCESSINGInstructors:Susan Dana Jones, Ph.D., Vice President andSenior Consultant, BioProcess TechnologyConsultants, Inc.Sheila G. Magil, Ph.D., Senior Consultant,BioProcess Technology Consultants, Inc.CHIs Introduction to Bioprocessing training seminar offers acomprehensive survey of the steps needed to produce todayscomplex biopharmaceuticals from early development throughcommercial. The seminar begins with a brief introduction tobiologic drugs and the aspects of protein science that drivethe intricate progression of analytical and process steps thatfollows. We then step through the stages of bioprocessing,beginning with the development of cell lines and ending atthe packaging of a finished drug product. The seminar alsowill explore emerging process technologies, facility designconsiderations and the regulatory and quality standards thatgovern our industry throughout development. The importantroles played by the analytical and formulation steps indeveloping and gaining approval for a biopharmaceutical arealso examined.This 1.5-day class is directed to attendees working in anyaspect of industry, including scientific, technical, business,marketing or support functions, who would benefit fromreceiving a detailed overview of this field.About the Instructors:Susan Dana Jones is a seasoned biotechnology entrepreneurwith experience in product development, outsourcing andstrategic planning. Dr. Jones is a subject matter expert incell line development and characterization for biosimilar, newbiopharmaceutical, and vaccine development programs.She has broad knowledge of regulatory requirements formanufacturing products for human use and has prepared CMCsections of multiple regulatory submissions. She currentlyserves on the Board of Directors of Gene Solutions, theScientific Advisory Board of Symphogen, and is a memberof the Editorial Advisory Board of BioProcess International.She received her Ph.D. in Genetics from the University ofCalifornia, San Francisco.Sheila Magil has over 20 years of experience in quality andanalytical method development for biologics, peptides andsmall molecules. Her expertise includes quality assurance,protein and peptide biochemistry, and analytical development.She was formerly Senior Manager of Analytical Developmentand Quality Control at Biomeasure, Inc., and previously heldpositions at WaratahPharma, Alkermes, Bion, and HHMI atMassachusetts General Hospital. Dr. Magil has implementedquality systems and has managed external analytical andQC activities for multiple biopharmaceutical products. Dr.Magil holds a Ph.D. in Biochemistry from the University ofMinnesota.TS2: INTRODUCTION TO BIOLOGICSFORMULATION AND DELIVERYInstructor:Timothy Kelly, Ph.D., Vice President,Biopharmaceutical Development,KBI Biopharma, Inc.The course focuses on strategies to plan and executepreformulation and formulation development studies for biologics,which require co-optimization of multiple physical, chemicaland conformational stability attributes while operating underaccelerated timelines to deliver the drug to the clinic. The coursebegins with an overview of biophysical and biochemical propertiesof proteins. A typical development workflow (including statisticalanalysis and DOE elements) will be outlined to demonstratethe core elements employed during protein formulation. Thecourse concludes with real-world examples from formulationdevelopment projects for liquid and lyophilized products. Basics of protein biochemistry, with focus on foldingmechanism, stability and structural hierarchy Degradation pathways relevant to biologics shelf life Biophysical and analytical characterization tools Typical workflow for biologics formulationdevelopment projects Introduction to common delivery devicesAbout the Instructor:Tim Kelly has over 20 years of experience in protein andnucleic acid characterization. In his role at KBI Biopharma,Tim is responsible for analytical development, formulationdevelopment, and quality control. Prior to joining KBI Biopharma,Tim held the position of Director of Quality Control for DiosynthBiotechnology, where he was responsible for method validation,in-process control, release and stability of clinical and commercialbiopharmaceutical products. Tims experience also includes theanalytical development, formulation development, characterizationand/or production of more than 200 clinical and commercialprotein therapeutics, including monoclonal antibodies, enzymes,cytokines, fusion proteins, PEGylated proteins, protein vaccinesand peptides. Tim has led the successful formulation developmentof over 95 clinical and commercial biopharmaceutical products,including liquid and lyophilized dosage forms for intravenous andsubcutaneous administration, at protein concentrations rangingfrom 10g/mL to 200mg/mL. Tim earned his Ph.D. in MolecularGenetics & Biochemistry from Georgia State University.TS3: INTRODUCTION TO ANALYTICALMETHOD DEVELOPMENT AND VALIDATIONFOR THERAPEUTIC PROTEINSInstructor:Jichao (Jay) Kang, Ph.D., RAC, Director,Analytical and Formulation Development,Gallus Biopharmaceuticals NJ, LLCThis course is a panoramic review of analytical methoddevelopment and validation for therapeutic proteins, includingantibodies and enzymes. It is intended for scientists workingon therapeutic proteins in Analytical Development, QualityControl, Product Development or related functional areas. Itstarts with basic knowledge of work on therapeutic proteins:manufacturing of proteins drugs, regulatory affair knowledgeand protein chemistry. It then discusses fundamentals andpractical aspects of commonly used analytical methodsfor proteins, including methods for structure elucidation,glycan characterization, biophysical characterization, potencymeasurement, purity and impurity analysis. The courseconcludes with the strategy and common practice inmethod validation and method transfer, including regulatorycompliance at different stages of product development,application of DOE and QbD. The course emphasizes practicalapplications, real-world examples and useful tips.Benefits Gain a complete picture of analytical methoddevelopment and validation process Gain a basic understanding of commonly used analyticalmethods for proteinsWho Should Attend Analytical development scientists, process developmentscientists, QC analysts, regulatory affair managers,project managers and quality assurance managersAbout the Instructor:Dr. Jichao Kang holds a Ph.D. in Pharmaceutics and hasbeen working on characterization, method developmentand validation and formulation for protein therapeutics since1995. He is an accomplished researcher with over 15 peer-reviewedjournal articles and book chapters, several patentsand numerous conference presentations. The proteins hehas worked on extensively include cytokines, antibodies,enzymes and protein conjugates. He is a key contributor indozens of IND/IMPD and BLA/MAA filings. He is currentlythe Director of Analytical and Formulation Developmentat Gallus BioPharmaceuticals NJ, LLC, one of the leadingCMOs for biologics, and held the same position at LaureateBioPharma before it was acquired by Gallus. Prior to Laureate,he was the department head of Analytical Development atAuxilium Pharmaceuticals, Inc., and was a key contributorin Auxiliums successful marketing application of Xiaflex inboth U.S. and EU. He also worked in MedImmune, PDL, andNeose Technologies.JANUARY 19-20, 2015DAY 1 8:30 AM - 5:30 PM | DAY 2 8:30 AM - 12:30 PMJANUARY 21-22, 2015DAY 1 8:30 AM - 4:25 PM | DAY 2 8:30 AM - 12:30 PMPlease visit our website for more details.Cambridge HealthtechCoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com6 7. PIPELINE 1: PROTEIN ENGINEERING & DEVELOPMENT11th Annual Recombinant Protein TherapeuticsFusion Proteins and BeyondJANUARY 19-20CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com7The customizable functionality of fusion protein therapeutics creates advantages over antibody-based therapies by combining modular building blocks that canreach targets not accessible to antibodies. Additional advantages include lower patient dosing, reduced production costs and improved product homogeneity. TheRecombinant Protein Therapeutics meeting explores the varying constructs and designs of fusion protein molecules, and discloses how they are being engineeredto form more efficacious therapeutics that offer specificity with enhanced stability and longer half life. Experts present case studies from R&D through clinical dataand share the results they have achieved.SUNDAY, JANUARY 184:00-5:00 pm Short Course Registration5:00-8:00 Pre-Conference Dinner Short CoursesSee pages 4-5 for details4:00-8:00 Main Conference RegistrationMONDAY, JANUARY 197:30 am Conference Registration and Morning CoffeeNEXT-GENERATION BIOLOGICS9:00 Chairpersons Opening RemarksStefan Schmidt, Ph.D., Vice President, DSP, Rentschler BiotechnologyKEYNOTE PRESENTATION9:10 Roches Strategies to Discover, Design, Develop, and DeliverNew Innovative Therapeutic BiologicsRalf Schumacher, Ph.D., Site Head, Large Molecule Research Penzberg, andpRED Center Manager, Roche Diagnostics GmbHBiologics have become a key component in the treatment of various life-threateningdiseases. The majority of these drugs are classical monoclonalantibodies. In order to discover and develop differentiated monoclonalantibodies, Roches strategy is based on engineering technologies.ADCC-enhancement, multi-pathway-inhibition, specific tumor-targetingof pharmacophores and blood-brain-barrier crossing are examples forsuccessfully engineered mAbs and fusion proteins. In this presentation, I willdescribe Roches strategies to design such molecules, give examples but willalso address challenges for technical development.FEATURED PRESENTATION9:50 Monomeric Fc Fusion Clotting Factors for the Treatment ofHemophiliaJennifer Dumont, Ph.D., Director, Medical Affairs, Biogen Idec, Inc.10:20 Coffee BreakENGINEERING BREAKTHROUGHS10:45 A Small Biologic Alternative to PCSK9 Antibodies:Pharmacologic Profile and Demonstration of Robust LDL Loweringwith an Anti-PCSK9 AdnectinTracy Mitchell, Ph.D., Principal Scientist, Bristol Myers-Squibb Co.PCSK9 is perhaps the most promising drug target for treating cardiovasculardisease since the discovery of statins. Compared with therapeutic IgG antibodiescurrently in clinical trials, targeting circulating PCSK9 with a smaller molecularscaffold could offer reduced dose burdens and different pharmacologic profiles.We present the pharmacological profile of BMS-962476, a potent Adnectininhibitor of PCSK9 that has demonstrated robust target engagement and LDLlowering in mice, cynos and humans.11:15 Development of an Intein-Based Conjugation Platform for theSynthesis of Fc-Fusion ProteinsOliver Thiel, Ph.D., Principal Scientist, Chemical Process Research &Development, Amgen, Inc.Identification of an ideal platform technology for conjugation of small moleculesand peptides to biomolecules for improved pharmacokinetics has been a recentfocus within academic and industrial laboratories. This contribution will focuson the development of an intein-based platform for conjugation of peptides atthe C-terminus of the Fc domain of immunoglobulins. In the course of platformdevelopment, selection of intein, cleavage residue, and linker between Fc andintein were examined.11:45 A Bi-Functional Antibody-Receptor Domain Fusion ProteinSimultaneously Targeting IGF-IR and VEGF for DegradationYang Shen, Ph.D., Director, Antibody Technology, and Research Advisor, AntibodyEngineering, ImClone Systems, a wholly-owned subsidiary of Eli Lilly andCompanyA fully human Bi-functional Antibody-receptor domain (VEGFR1 domain 2) fusionmolecule with ligand Capture (BiAbCap) targeting IGF-IR and VEGF was designedand developed, that displays excellent thermal and physical stability. Takingadvantage of natural receptor-ligand interaction, bi-AbCap represents a novel anddevelopable format of bi-functional antibodies with potent neutralizing activitiesagainst both targets. The unique capture-for-degradation mechanism translatesto potent anti-tumor activity superior to the combination in vivo.12:15 pm Sponsored Presentation (Opportunity Available) 8. PIPELINE 1: PROTEIN ENGINEERING & DEVELOPMENT11th Annual Recombinant Protein TherapeuticsFusion Proteins and BeyondJANUARY 19-20CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com812:45 Session Break1:00 Luncheon Presentation (Sponsorship Opportunity Available) orEnjoy Lunch on Your OwnENHANCING PROPERTIES2:00 Chairpersons RemarksManfred Schuster, Ph.D., COO, Apeiron Biologics AG2:05 Unravelling the Molecular Basis of Host Cell-SpecificGlycosylation and Species-Specific PharmacokineticsCatherine Huntington, Ph.D., Research Scientist II, Antibody Discovery andProtein Engineering (ADPE), MedImmune, LLCGlycosylation plays a significant role in the half-life of recombinant proteins in vivo,with the production cell lines affecting PK. Here, we expand on observations thatHEK-293 expressed proteins are rapidly cleared in mouse models and our effortsto characterise the glycan forms responsible. Additionally, we will present our workto develop methods to profile glycan forms on recombinant proteins with the aimto predict impact on half-life of different species.2:35 Enhancing Stability of the Therapeutic Enzyme L-Asparaginaseby Biocompatible NanoparticlesManfred Konrad, Ph.D., Research Director, Enzyme Biochemistry, Max PlanckInstitute for Biophysical ChemistryThe enzyme L-asparaginase is a protein drug of high value in antileukemic therapy.Clinically approved L-asparaginases are of bacterial origin, though they elicitsevere side effects, in particular immunogenicity. We present a novel approachfor encapsulation of the enzyme using calcium carbonate particles surroundedby layers of biocompatible polymers, thus forming nanocontainers as carriers toenhance serum stability and suppress recognition by the immune system.3:05 Manufacturing of Half-Life Extended Fusion Proteins: CurrentTrends and ChallengesStefan Schmidt, Ph.D., Vice President, DSP, Rentschler BiotechnologySecond and third generation therapeutic proteins often contain a half-lifeextension moiety. These additional modules of fusion proteins often complicatethe manufacturing process as they require specific adaptations of both up- anddownstream processes. First, we give a comprehensive overview on the currentstate-of-the-art regarding half-life extension technologies, and second, weillustrate manufacturing challenges and solutions presented through selectedcase studies, additionally giving practical advice on optimization potential.3:35 Sponsored Presentation (Opportunity Available)3:50 Refreshment BreakCONQUERING DISEASE4:15 A Neuroprotective Brain-Penetrating Endopeptidase FusionProtein Ameliorates Alzheimer Disease Pathology and RestoresNeurogenesisEliezer Masliah, M.D., Professor, Neuroscience and Pathology, University ofCalifornia at San DiegoAlzheimers (AD) and Parkinsons Disease (PD) are the most commonneurodegenerative disorders. We developed recombinant endopeptidases andantibodies with a unique brain targeting sequence derived from ApoB and haveshown in animal models of AD and PD that these hybrid proteins amelioratethe pathology and recover the functional deficits. These results suggest that therecombinant brain-targeted proteins might be of use in the treatment of AD and PD.4:45 Novel Human Resistant Mutant that Acts as AntagonistReduced Body Weight Gain and Restored Insulin Responsiveness inMice Fed High Fat DietArieh Gertler, Ph.D., CEO, Protein Laboratories Rehovot; Professor-Emeritus andHead of Research Team, Biochemistry, The Hebrew University of JerusalemResistin promotes both inflammation and insulin resistance associated withenergy homeostasis impairment. To block resistin action, we developed arecombinant human resistin mutant (C6A) that acts as a resistin antagonist(RA). We clearly show that RA leads to a significant decrease in body weight ofHFD mice. Importantly, RA treatment completely restored glucose tolerance asevidenced by glucose tolerance test and also restored insulin-responsiveness asestimated by insulin tolerance test.5:15 Local Inhibition of Cytokine Signaling to Treat Anterior andPosterior Ocular DisordersEric Furfine, Ph.D., CSO, Eleven BiotherapeuticsCytokines, chemokines, and growth factors mediate anterior and posterior eyediseases. Our lead product, the IL-1 receptor inhibitor EBI-005, was designedand engineered for the topical treatment of dry eye disease and was biologicallyactive in subjects with dry eye disease. In addition, we engineered an IL-6inhibitor with potential for local treatment diabetic macular edema. Finally, anovel soluble receptor inhibitor of cytokines IL-17A and IL-17F was engineered forthe local treatment of uveitis. Both IL-6- and IL-17-targeted drugs were designedand engineered for intravitreal administration.5:45-7:00 Welcome Reception in the Exhibit Hall with PosterViewing 9. PIPELINE 1: PROTEIN ENGINEERING & DEVELOPMENT11th Annual Recombinant Protein TherapeuticsFusion Proteins and BeyondJANUARY 19-20CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com9TUESDAY, JANUARY 208:00 am Morning CoffeeCONQUERING CANCER8:30 Chairpersons RemarksManfred Konrad, Ph.D., Research Director, Enzyme Biochemistry, Max PlanckInstitute for Biophysical Chemistry8:35 Late Stage Development of a Chimeric AntibodyManfred Schuster, Ph.D., COO, Apeiron Biologics AGThis case study will focus on how our APN311 chimeric antibody targeting high-riskneuroblastoma was able to overcome clinical, technical and financial hurdlestowards our application for market approval planned for mid-2014 in the USand Europe. This talk will also give insights into clinical analytics and our CMCstrategy, and highlight a novel immune-therapy administration scheme to reduceside effects and to maintain or even improve clinical response.9:05 A Recombinant Immunotoxin for Cancer Treatment with LowImmunogenicity by Identification and Silencing of Human T CellEpitopesRonit Mazor, Ph.D., Research Fellow, Lab for Molecular Biology (LMB), NCI/NIHRecombinant immunotoxins are less active in patients with solid tumorsbecause their immune system makes anti-drug antibodies which inactivethe immunotoxin. To suppress the immune response, we have identified andlargely silenced the T cell epitopes responsible for the immune responsewith a redesigned immunotoxin containing T cell epitope mutations that arehighly cytotoxic to cells isolated from cancer patients and produces completeremissions in mice with human cancer xenografts.9:35 Sponsored Presentation (Opportunity Available)9:50 Coffee Break in the Exhibit Hall with Poster ViewingENGINEERING FLEXIBILITY11:00 Engineered Affibody Molecules in Multiple Formats forTargeted TherapyFredrik Frejd, Ph.D., Vice President and CSO, Affibody ABThe half-life of biotherapeutics can be extended up to several weeks by applyingAffibodys albumin binding domain (ABD) as a fusion partner. In addition,Antibodies are functionalized using Affibody molecules to create bispecificAffiMabs. Results from oral administration of a half-life extended peptidefor treatment of metabolic disease will be shown, along with new data tocomplement C5-specific and IL-17-specific Affibody-ABD fusion molecules andAffiMabs simultaneously targeting the IL-6 and TNF.11:30 DeBouganin Fusion Proteins: A Fit for Purpose ADC Drug DesignGlen C. MacDonald, Ph.D., CSO, Viventia Bio, Inc.Immunotoxins are comprised of a cell targeting domain linked to a cytotoxic toxinpayload. DeBouganin, a de-immunized variant of the type I ribosome-inactivatingprotein (RIP) bouganin, is highly potent and represents an alternative to conventionalcytotoxic anti-cancer agents. This presentation will illustrate deBouganins distinctmechanisms of action in the context of recombinant fusion proteins and highlight itspotency against cancer stem cells and cell lines overexpressing MDR.12:00 pm Sponsored Presentation (Opportunity Available)12:30 Session Break12:45 Luncheon Presentation (Sponsorship Opportunity Available) orEnjoy Lunch on Your Own2:00 BuzZ Session A3:00 Refreshment Break in theExhibit Hall with Poster Awards3:45 BuzZ Session B(Please visit our website for details)4:45 Close of Conference4:30-5:00 Short Course Registration5:00-8:00 Dinner Short Courses See pages 4-5 for details 10. 2nd Annual Enhancing Antibody Binding and SpecificityEmerging Science and New Technologies to Fine-TuneAntibody-Antigen Binding and Target SpecificityJANUARY 21-22PIPELINE 1: PROTEIN ENGINEERING & DEVELOPMENTCoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com10As the industry expands its repertoire of antibody drug products into new therapeutic areas, product formats and protein constructs, the control of antibody/antigentargeting, binding and specificity will take on a new level of importance for researchers in this field. The second component of the PepTalk Protein Engineering &Development pipeline, the Enhancing Antibody Binding and Specificity conference, presents innovative approaches to the modulation of binding activity, mechanismof action and difficult target challenges such as transmembrane proteins.TUESDAY, JANUARY 201:30 pm Conference Registration4:30-5:00 Short Course Registration5:00-8:00 Dinner Short Courses See pages 4-5 for detailsWEDNESDAY, JANUARY 217:30 am Conference Registration and Morning CoffeeSPECIFICITY ENGINEERING8:15 Chairpersons Opening RemarksJonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department ofBiochemistry, University of ZurichKEYNOTE PRESENTATION8:20 The Impact of Anti-IgG Hinge Antibodies in Protease-Enriched DiseasesRobert E. Jordan, Ph.D., Senior Director and Senior Research Fellow (retired),Janssen PharmaceuticalsAnti-IgG hinge antibodies display fine specificity for proteolytically-cleavedIgGs but are not cross-reactive with the intact IgG counterpart. Engagementof anti-hinge antibodies with cell-bound cleaved IgGs restores antibodyeffector function in vitro and in vivo either when elicited by vaccination oras a mAb. The findings presented here suggest a novel mechanism forenhancing antibody-mediated cell-killing effector functions with application inpathological settings where protease activity is abundant.9:00 Engineering of High-Affinity Two-in-One Antibodies UsingPhage Display Coupled to Deep SequencingSarah Sanowar, Ph.D. Senior Research Associate, Antibody Engineering,Genentech, Inc. A Member of the Roche GroupTo improve antibody affinity, we sought to develop a robust strategy to identifyimproved affinity variants beyond traditional phage-based screening. We turnedto an approach, which combines affinity-based selection on phage with deepsequencing. Phage libraries with various diversity designs were combined tomaximize the searched sequence space. This strategy gave us a comprehensiveset of information on the effect of mutations in the antigen-binding site for a two-in-one antibody with dual action Fab for both of its antigens.STRATEGIES FOR SCREENING LARGEANTIBODY LIBRARIES9:30 The Antibiome: Toward Renewable Antibodies to the ProteomeMichael Hornsby, Ph.D. Researcher, Pharmaceutical Chemistry, University ofCalifornia, San FranciscoWe have developed a robust high-throughput robotic pipeline for the generationand validation of renewable recombinant antibodies utilizing antibody phage-display.In order to match the capacity of the antibody generation to theavailability of input antigens, we have developed several robust antigenproduction pipelines. Both pipelines working together in concert will allow theRecombinant Antibody Network (RAN) to develop quality renewable antibodyreagents to the proteome.10:00 Coffee Break in the Exhibit Hall with Poster Viewing10:50 Pipeline 2.0: Integrating All Aspects from Target Acquisitionthrough Binder Validation for Optimized Binder GenerationJonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department ofBiochemistry, University of ZurichA robust pipeline for the high-throughput generation of affinity reagents enablesmany scientific projects and novel applications. To optimize the pipelinesthroughput, our laboratory developed a streamlined process, consistingof parallel Ribosome Display selections and various semi-automated high-throughputscreenings. Also including aspects of target acquisition to bindervalidation while decreasing its time and cost requirements, we performsimultaneous selections against 94 targets and screen and validate severalthousand binders in parallel for their characteristics.2:00 BuzZ Session A3:00 Refreshment Break in theExhibit Hall with Poster Awards3:45 BuzZ Session B(Please visit our website for details) 11. 2nd Annual Enhancing Antibody Binding and SpecificityEmerging Science and New Technologies to Fine-TuneAntibody-Antigen Binding and Target SpecificityJANUARY 21-22PIPELINE 1: PROTEIN ENGINEERING & DEVELOPMENTCoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com11SCREENING FOR RARE ANTIBODIES11:20 An in vivo Human-Plasmablast Enrichment Technique AllowsRapid Identification of Therapeutic Influenza A AntibodiesGerald Nakamura, Ph.D., Scientific Manager, Antibody Engineering, Genentech,Inc. A Member of the Roche GroupRecent advances enabling the cloning of human immunoglobulin-G geneshave proven effective for discovering monoclonal antibodies with therapeuticpotential. However, these antibody-discovery methods are often arduousand identify only a few candidates from numerous antibody-secreting cells.We describe an in vivo enrichment technique that identified broadly influenzaneutralizing human antibodies with high frequency. Using this technology, weidentified four broadly neutralizing influenza A antibodies by screening only 840human antibodies.11:50 Towards a Quantum Leap in the Utility of CombinatorialLibraries for Drug Hunters by Placing New Functional ScreeningOptions Up FrontRonald M. Lindsay, Ph.D., CEO, Zebra BiologicsWhereas the relative merits of deriving therapeutic antibody candidatesvia humanized mouse or phage display approaches are still debated, bothapproaches yield an over abundance of initial hits as defined by binding toa desired target. Selecting winners from these initial hit binders remainsa bottleneck. I will discuss new screening approaches that allow more directhigh throughput selection of functional antibodies for known targets and thediscovery of new targets.12:20 pm Sponsored Presentation (Opportunity Available)12:50 Session Break1:00 Luncheon Presentation (Sponsorship Opportunity Available) orEnjoy Lunch on Your OwnRATIONAL APPROACHES TO ANTIBODY ENGINEERING2:00 Chairpersons Remarks2:05 Antibody Modeling and Computational Design of OptimizedMoleculesStanley Krystek, Ph.D., Senior Principal Scientist, Molecular Structure andDesign Bristol-Myers SquibbAntibody structure-based modeling has been aimed at optimization ofpharmaceutical properties and has also been used for humanization, structure-guidedaffinity maturation, antibody library design and modulation of effectorfunction. Examples of antibody modeling will be presented that describeenabling applications of protein engineering of therapeutic molecules whosestability, homogeneity, immunogenicity, aggregation and chemical liabilitieshave been optimized leading to safer, more efficacious and developabletherapeutic molecules.2:35 Extracting Lifes Operating Manual Comprehensive RulesetDiscovery and Bioengineering ApplicationsJacob Glanville, Ph.D., CSO, Distributed BioWithout comprehensive rulesets to guide rational design, most antibodybioengineering efforts are iterative process of applying and testing small changes.The combination of high-throughput sequencing, combinatorial gene synthesisand selection pressures provides a unique opportunity to enumerate the rulesetspace that governs a molecule or entire repertoire. Well review the last 6 years oftheory and practical application, then transition to highlight some of the startlingnovel technological applications such rule-based design can enable.3:05 Precise and Efficient Antibody Epitope Determination ThroughLibrary Design, Yeast Surface Display and Next- Generation SequencingThomas Van Blarcom, Ph.D., Principal Scientist, Protein Engineering, Pfizer, Inc.Here we describe a method to precisely and efficiently map the epitopes of smallpanels of antibodies in parallel over the course of several weeks. This methodrelies on the nexus of rational library design, quantitative yeast surface display andnext generation DNA sequencing and was demonstrated by mapping the epitopesof several antibodies that neutralize the alpha toxin from Staphylococcus aureus.3:35 Sponsored Presentation (Opportunity Available)4:05 Refreshment Break4:25 PLENARY KEYNOTE SESSION See page 2 for details5:45-7:00 Reception in the Exhibit Hall with Poster ViewingTHURSDAY, JANUARY 228:00 am Morning CoffeeDISCOVERY AND DEVELOPMENT OF ANTIBODIESFOR MEMBRANE PROTEIN TARGETS8:30 Chairpersons RemarksTrevor Wilkinson, Ph.D., Associate Director, Protein Sciences, AntibodyDiscovery and Protein Engineering, MedImmune8:35 GPCR Expression by Individual Cell Types: Novel MembraneTargets for Therapeutic AntibodiesPaul Insel, Ph.D., Professor, Pharmacology & Medicine, University of California,San DiegoGPCRs, the largest family of membrane receptors, also represent the largestclass of targets of FDA-approved drugs. However, little is known regardingGPCR expression by individual cell types. Using a GPCRomic strategy, we haveidentified the full range of non-chemosensory GPCRs, including numerousorphan GPCRs, expressed by many such cell types. Our other findings suggestthe possibility of using antibody therapeutics directed at such receptors. 12. 2nd Annual Enhancing Antibody Binding and SpecificityEmerging Science and New Technologies to Fine-TuneAntibody-Antigen Binding and Target SpecificityJANUARY 21-22PIPELINE 1: PROTEIN ENGINEERING & DEVELOPMENTSUBMIT A POSTERCambridge Healthtech Institute encouragesattendees to gain further exposure by presentingtheir work in the poster sessions.Reasons you should present your research poster at thisconference: Your poster will be exposed to our international delegation Receive $50 off your registration Your poster abstract will be published in our conferencematerials You will automatically be entered into the poster competition Your research will be seen by leaders from toppharmaceutical, biotech, academic and government institutesTo secure a poster board and inclusion in the conference materials,your abstract must be submitted, approved and your registrationpaid in full by November 21, 2014.CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com129:05 Targeting T Cells with an Anti-Ion Channel Antibody withUltralong CDR H3sVaughn Smider, M.D., Ph.D., Assistant Professor, Molecular Biology, The ScrippsResearch InstituteThe relatively flat binding surface of a typical antibody paratope may not allowoptimal interactions with certain epitopes. Cow antibodies contain ultralongCDR H3s consisting of a b-ribbon stalk and disulfide-bonded knob. The knobstructures are reminiscent of ion channel bioactive peptides known to interactwith high specificity and affinity with ion channels. We have engineered acow antibody to bind and inhibit an ion channel critical for T cell activation inautoimmune disease and inflammation.9:35 Sponsored Presentation (Opportunity Available)9:50 Coffee Break in the Exhibit Hall with Poster Awards10:50 Molecular Snapshot of GPCR Regulation and Signaling byArrestins: Emerging Avenues for Novel Drug DiscoveryArun Shukla, Ph.D., Professor, Medicine, Duke University Medical CenterGPCRs represent a primary drug targets for a number of human diseases.The concept of beta arrestin mediated GPCR signaling (also known as biasedsignaling) is changing the landscape of drug discovery targeting GPCRs. Wepresent unprecedented insights into arrestin mediated regulation and signalingof GPCRs through a high resolution snapshot obtained by a combinatorialapproach. These insights open new avenues of novel drug discovery withreduced side effects for a number of human disorders.11:20 Discovery and Optimization of Novel Anti G-Protein CoupledReceptor Monoclonal AntibodiesTrevor Wilkinson, Ph.D., Associate Director, Protein Sciences, AntibodyDiscovery and Protein Engineering, MedImmuneG-protein coupled receptors represent a challenging target class for the isolationand optimization of therapeutic biologics. We have used a combination ofimmunization and phage display to isolate functional antagonistic antibodiestargeting a chemokine receptor and a formyl peptide receptor that will bepresented as case studies. We also describe how combinatorial mutagenesisapproaches have been used to make significant improvements to both affinity andspecies cross-reactivity of a lead molecule and demonstrate that the optimisedantibodies show significantly increased potency in cellular disease assays.11:50 High-Throughput Strategies to Obtain High Affinity, Specific,and Conformationally Selective Recombinant Antibodies toMembrane Proteins by Phage DisplayMarcin Paduch, Ph.D., Technical Director, Synthetic Antibody & CrystallographyCore Facility, The University of ChicagoState of the art methods for generating recombinant antibodies to membraneproteins require the use of detergents that do not necessarily mimic the nativelipid environment. We have developed a suite of next-generation high-throughputtechnologies to generate high affinity, specific, and conformationally selectivereagents by exploiting liposomes, nanodiscs and cell surface display for antigenpresentation. These native-like environments create the possibility of trappingphysiological states otherwise not accessible by current methods.12:20 pm Session Break12:30 Luncheon Presentation (Sponsorship Opportunity Available) orEnjoy Lunch on Your Own1:30 Close of Conference 13. JANUARY 22-23PIPELINE 1: PROTEIN ENGINEERING & DEVELOPMENT2nd Annual Improving the Clinical Efficacy of Antibody TherapeuticsCutting-Edge Protein Engineering for the Next Generation of Safe andEffective BiotherapeuticsCoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com13When the more than 350 therapeutic monoclonal antibodies in development advance into the clinic and to commercial launch, the quality of therapeutic responsewill become increasingly important to regulatory agencies and frugal payors. Regulators are demanding better data to support claims of safety and potency andpayors are seeking meaningful therapeutic benefits relative to existing standards of care before adding higher-cost biotherapeutics to formularies. The Improving theClinical Efficacy of Antibody Therapeutics conference showcases state-of-the-art discovery and development-stage engineering strategies for improving the safetyand effectiveness of this important class of biologic drugs.THURSDAY, JANUARY 2211:30 am Conference Registration12:30 pm Luncheon Presentation (Sponsorship Opportunity Available)or Enjoy Lunch on Your Own1:30 Ice Cream Break in the Exhibit Hall with Poster ViewingGLYCOENGINEERING AND ENHANCINGEFFECTOR FUNCTION2:00 Chairpersons Opening RemarksJanine Schuurman, Ph.D., Vice President, Research, GenmabKEYNOTE PRESENTATION2:05 A Palette of Engineered Fc Domains for Optimal Antibody-Mediated Target Cell Clearing and ImmunomodulationGeorge Georgiou, Ph.D., Professor, Cockrell Family Regents Chair in Engineering,Department of Biomedical Engineering, The University of Texas at AustinWe have engineered a variety of aglycosylated Fc domains displaying:(i) very high binding affinity and selectivity for each individual human Fcreceptor; (ii) Fc domains that bind only to C1q; (iii) to Fc receptors as wellthe FcRI receptor that binds to IgA. These Fc domains were shown to elicitunique profiles of immune cell activation and the clearance of target cells.2:45 Improving the Therapeutic Efficacy of pH and Calcium-Dependent Antigen Binding AntibodiesTomoyuki Igawa, Ph.D., Group Manager, Discovery Research, ChugaiPharmaceutical CompanypH or calcium-dependent antigen binding antibody enhances antigen elimination bydissociating the antigen in the endosome. Here we report that Fc receptors suchas FcRn and inhibitory FcgRIIB can be exploited to further accelerate the antigenelimination by pH or calcium-dependent antigen binding antibody. Enhancing bindingto Fc receptors, either by Fc engineering or by formation of multimeric antibody-antigencomplex, significantly accelerated antigen elimination from plasma in vivo.3:15 Glycoengineering Enhanced ADCC in a FGFR2b-SpecificAntibody Treating Patients with Gastric CancersKristen Pierce, Ph.D., Associate Director, Oncology, Five Prime Therapeutics3:45 Sponsored Presentation (Opportunity Available)4:15 Refreshment Break in the Exhibit Hall with Poster Viewing5:00 Complement Is Activated by IgG Hexamers Assembled at theCell SurfaceJanine Schuurman, Ph.D., Vice President, Research, GenmabComplement activation by antibodies is an important mechanism in immunedefense and immunotherapy. Using X-ray crystallography, mutagenesis studiesand cryo-EM tomography, we revealed that IgG antibodies form hexamers onthe cell surface following antigen binding. Enhancing hexamerisation on thecell surface by using the HexaBodyTM platform potentiated the intrinsic killingcapability of antibodies in in vitro, in vivo and ex vivo models.5:30 Cytotoxic Mechanisms of Immunotherapy: HarnessingComplement in the Action of Anti-Tumor Monoclonal AntibodiesRonald P. Taylor, Ph.D., Professor of Biochemistry, University of VirginiaWe followed CDC mediated by CD20 mAbs engineered to enhance Fc-Fc contacts, thus promoting strong C1q binding and rapid CDC. Confocalmicroscopy movies revealed that during CDC, Ca2+ rapidly enters cellsand is soon localized to mitochondria. Ca2+ poisoning likely is the mostproximate mediator of cytotoxicity. These observations should allow for deeperunderstanding of CDC mechanisms, and will play a critical role in developmentof more effective immunotherapeutic mAbs.6:00-7:00 Reception at the Tiki PavilionFRIDAY, JANUARY 238:00 am Morning CoffeeCOMBINATION STRATEGIES FOR ENHANCING THEEFFICACY OF ANTIBODY THERAPY8:30 Chairpersons RemarksYasmina Abdiche, Ph.D., Research Fellow, Rinat-Pfizer8:35 Multi-Targeting Antibody Mixtures to Address TumorHeterogeneity and PlasticityMichael Kragh, Ph.D., Director, Preclinical Pharmacology & Toxicology, Symphogen A/S9:05 Using an Oligoclonal Approach to Target HER3/ErbB3Matthew Robinson, Ph.D., Assistant Professor, Fox Chase Cancer CenterHER3/ERBB3 is recognized as an important therapeutic target in a variety ofcancers and clinical validation of antibody-based therapies targeting this receptoris currently underway. We have taken an oligoclonal approach to develop anoptimized anti-HER3/ERBB3 agent capable of inhibiting signaling through thiscritical receptor and its heterodimeric partners. Work detailing the isolation andcharacterization of an anti-HER3/ERBB3 oligoclonal will be discussed. 14. JANUARY 22-23PIPELINE 1: PROTEIN ENGINEERING & DEVELOPMENT2nd Annual Improving the Clinical Efficacy of Antibody TherapeuticsCutting-Edge Protein Engineering for the Next Generation of Safe andEffective BiotherapeuticsCoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com149:35 Development of an Antibody Combination Therapeutic (ACT)for the Treatment of Ventilator Associated PneumoniaElizabeth Reczek, Ph.D., President and CSO, Excelimmune, Inc.Antibody Combination Therapeutics (ACTs) are a novel class of polyvalentbiopharmaceuticals, uniquely suited for the treatment of complex diseases.Excelimmune has developed a fully human antibody discovery platform andAAV-based, virus-free recombinant protein expression technology capable ofrapid and consistent production of complex antibody mixtures in a single batchformat. We are leveraging this technology to develop an ACT therapeutic for thetreatment of Ventilator Associated Pneumonia (VAP).10:05 Coffee Break in the Exhibit Hall with Poster AwardsCHARACTERIZATION OF PROPERTIESIMPACTING EFFICACY11:00 Analytical Methods to Characterize the Binding Kinetics,Affinity, and Epitope of Therapeutic AntibodiesYasmina Abdiche, Ph.D., Research Fellow, Rinat-Pfizer11:30 Impact of Effector Cells on in vitro ADCC Activity ofTherapeutic AntibodiesShan Chung, Ph.D., Senior Scientist, Bioanalytical Sciences, Genentech, Inc. AMember of the Roche GroupIn this study we evaluated the impact of different type of effector cells onthe in vitro antibody-dependent cell-mediated cytotoxicity (ADCC) activity oftwo glycoforms of a humanized IgG1 antibody. The results of this study showdifferential effects on both the efficacy and potency of the antibodies by differenteffector cells and that both the allotype and the expression level of CD16a affectthe potency of effector cells in ADCC assays.12:00 pm Analytical Fc Receptor Affinity Chromatography forFunctional Characterization of Monoclonal AntibodiesTilman Schlothauer, Ph.D., Senior Scientist, Protein Analytics,Roche Diagnostics GmbHFc receptor-based affinity chromatography is a new emerging field of Fcfunctionality analytics. Until now different human FcReceptors (FcRIIIa & IIa)and the Fc Receptor neonatal (FcRn) from three species have been utilizedfor coupling onto Sepharose-based matrices. FcRn affinity columns separateantibody species (analytical and preparative) that differ in their affinity to FcRnreceptors, using conditions that closely resemble the physiological mechanismof interaction between IgG and FcRn.12:30 Sponsored Presentation (Opportunity Available)1:00 Session Break1:15 Luncheon Presentation (Sponsorship Opportunity Available) orEnjoy Lunch on Your OwnSTRATEGIES FOR IMPROVING THE EFFICACY OFANTIBODY THERAPEUTICS2:00 Chairpersons RemarksJon Wojciak, Ph.D., Scientist, Lpath2:05 Monoclonal Antibody Therapy for Multiple MyelomaFrits van Rhee, M.D., Ph.D., Professor, Medicine; Director, Developmental andTranslational Medicine, Myeloma Institute for Research and Therapy, Universityof Arkansas2:35 Observations Regarding Antibody Pharmacokinetics and aCase Study; Engineering a mAb for Prolonged Half-Life to BetterAssess an Animal Model SpeciesTom Nesspor, Research Scientist, Biologics, JanssenEpitope, affinity, immune effector function, and pharmacokinetics determine theefficacy of therapeutic mAbs. This talk will review recent findings in our grouprelating to antibody pharmacokinetics such as non-FcRn influences on clearance,strategies for prolongation and reduction of half-life, and correlations betweenhuman FcRn transgenic mice and human pharmacokinetics. It will conclude witha case study describing the engineering of mAbs for prolonged half-life to betterassess an important animal model species.3:05 Antibodies that Target Bioactive LipidsJon Wojciak, Ph.D., Scientist, LpathDeveloping therapeutic antibodies with favorable biophysical properties (e.g.antigen affinity and specificity, solubility, aggregation, etc.) is a formidablechallenge, and engineering these antibodies can lead to molecules that undergorapid-reversible, self-association. Using molecular modeling and site-directedmutagenesis, the reversible self-association of a humanized, monoclonal anti-lipidantibody was minimized while the antigen affinity and specificity was retained.3:35 Computational and Experimental Mapping of DeimmunizedBiotherapeutic Design SpaceKarl E. Griswold, Ph.D., Associate Professor, Bioengineering, Thayer School ofEngineering, Dartmouth CollegeBiotherapeutics are powerful drugs, but the risk of protein immunogenicity representsa barrier to their broader development and use. While methods for T cell epitopeidentification are maturing rapidly, facile selection of deimmunizing yet function-preservingmutations remains a challenge for protein engineers. Here we describeexperimental validation of integrated deimmunization algorithms that simultaneouslyoptimize both protein function and immunogenic potential. We demonstrate thecapacity to tune a proteins sequence-structure-function-immunogenicity relationships.4:05 Close of Conference 15. PIPELINE 2: ANTIBODY THERAPEUTICSInaugural Cancer Targets for Antibody TherapeuticsDiscovery, Engineering and Optimization of Next-Generation Oncology TargetsJANUARY 19-20CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com15The science and technology of antibody engineering have brought forth a new era of therapeutic antibodies in oncology, with new product formats and an intenseinterest in immune system modulation now at the forefront of many company development efforts. PepTalks new Cancer Targets for Antibody Therapeuticsconference explores new directions in the discovery of emerging and challenging targets in this space and the steps that will be required in developing these intonext-generation therapeutics for patients.SUNDAY, JANUARY 184:00-5:00 pm Short Course Registration5:00-8:00 Pre-Conference Dinner Short CoursesSee pages 4-5 for details4:00-8:00 Main Conference RegistrationMONDAY, JANUARY 197:30 am Conference Registration and Morning CoffeeNEW APPROACHES TO TARGETING THE TUMORMICROENVIRONMENT9:00 Chairpersons Opening RemarksGregory P. Adams, Ph.D., Co-Leader, Developmental Therapeutics Program, FoxChase Cancer CenterKEYNOTE PRESENTATION9:10 Multifunctional Angiogenesis Inhibitors Designed fromNon-Antibody ScaffoldsJennifer R. Cochran, Ph.D., Associate Professor, Bioengineering andChemical Engineering, Stanford UniversityWe engineer protein therapeutics, based on growth factor ligands andreceptors with altered biochemical and biophysical properties, as alternativesto antibodies. I will present recent work where we used a growth factor as ascaffold to create ligand-based antagonists that bind to multiple cell surfacereceptors, and demonstrated that these proteins more effectively inhibitangiogenic processes compared to mono-specific receptor targeting agents.9:50 Manipulating the Tumor Microenvironment to EnhanceEffector Function for Improved Antibody Efficacy in PatientsStephen Beers, Ph.D., Senior Research Fellow, Faculty of Medicine, University ofSouthamptonSuccessful antibody therapy appears to rely predominantly on Fc receptorexpressing effector cells such as macrophages. Unfortunately, a number ofcancers have proven resistant to antibody therapy potentially due to the adverseeffects of the tumor microenvironment on these cells. Here, the potential ofharnessing tumor associated macrophages as effectors will be discussed as wellas means presented by which they may be re-programmed to enhance theirantibody effector capacity.10:20 Coffee BreakENGINEERING ANTIBODIES FOR IMPROVED TUMORPENETRATION10:45 A Cell-Penetrating Antibody Technology Platform: Making theUndruggable DruggableHua Eleanor Yu, Ph.D., Billy and Audrey L. Wilder Endowed Professor of TumorImmunology, Co-Leader of Cancer Immunotherapeutics Program, City of HopeComprehensive Cancer CenterWe have developed a novel technology platform to allow efficient cell-penetrationof proteins/antibodies in vitro and in vivo. Using flow cytometry, confocal imagingand Western blotting, we demonstrate the self-penetrating ability of the modifiedantibodies. Both local and systemic administrations of the modified antibodieseffectively inhibit their intracellular targets in tumors, resulting in tumor cellapoptosis and tumor regression in multiple models. Our discoveries enable thedevelopment of a new class of research tools and novel therapeutics.11:15 The Effect of Molecular Weight, PK, and Valency on TumorBiodistribution and Efficacy of Antibody-Based DrugsRuth Muchekehu, Ph.D. Research Scientist, Vertex PharmaceuticalsTo explore the role of pharmacokinetics, valency, and size on tumor targeting,the biodistribution of an FGFR4 targeting CovX-body (an FGFR4-binding peptidelinked to a non-targeting IgG scaffold; 150 kDa), F(ab)2 (100 kDa) and Fab (50kDa) fragments was measured. The highest percent of injected drug wasachieved with the IgG, and increasing the valency of the IgG by conjugating ahomodimeric peptide to the scaffold, translated into superior efficacy.11:45 How to Leverage Oncogene Addiction: Targeted BiologicalTherapy Inducing Growth Factor Receptor Internalization andDegradationJohn Haurum, M.D., D.Phil., CEO, F-star GmbH & F-star Biotechnology Ltd.FS102 is a HER2-specific Fcab (Fc with antigen binding). In HER2-overexpressing tumour cells, FS102 induce profound HER2 degradation andapoptosis, and FS102 eliminates HER2-overexpressing tumours in patient-derivedmouse xenograft models. We present this as an example of a generalclass of oncogene-targeted biological therapies, which induce tumour killing viainternalization and degradation of the addictive growth factor receptor.12:15 pm Sponsored Presentation (Opportunity Available)12:45 Session Break1:00 Luncheon Presentation (Sponsorship Opportunity Available) orEnjoy Lunch on Your Own 16. PIPELINE 2: ANTIBODY THERAPEUTICSInaugural Cancer Targets for Antibody TherapeuticsDiscovery, Engineering and Optimization of Next-Generation Oncology TargetsJANUARY 19-20CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com16EMERGING TARGETS2:00 Chairpersons RemarksJohn Haurum, M.D., D.Phil., CEO, F-star GmbH & F-star Biotechnology Ltd.2:05 Targets for Antibodies in Neuro-Oncology: Getting Past theBlood-Brain BarrierLois Lampson, Ph.D., Associate Professor of Surgery, Brigham and WomensHospitalAntibody-mediated therapy for brain tumors is thought to face two hurdles: Theblood-brain barrier (BBB) and, for some effector mechanisms, the presumedimmune privilege of the brain. Here we ask, for different kinds of brain tumortargets: Are the BBB or privilege really the key problems? How different isthe brain, really, from other sites?2:35 Alternative Immune Models for Generating Novel Antibodiesto Highly Conserved Oncology TargetsWilliam Jonny Finlay, Ph.D., Director, PfizerMany novel oncology targets are highly conserved between humans androdents, making it slow and laborious to generate high potency, highly specificantibodies that cross-react with multiple orthologs. Alternative immune modelscan therefore be a very valuable resource to rapidly generate exemplaryantibodies against unique epitopes. These antibodies allow investigators tovalidate and de-risk novel targets and mechanisms of action, in a variety of invivo models, at pace.3:05 SAR650984, A CD38 Monoclonal Antibody for Selected CD38+Hematological MalignanciesFrancisco Adrian, Ph.D., Section Head, Sanofi OncologyCD38 is a type II transmembrane glycoprotein highly expressed at the surfaceof malignant multiple myeloma plasma cells. SAR650984 is a humanized IgG1antibody targeting CD38 in PhII clinical trials. The preclinical characterizationof SAR650984 will be presented, including epitope mapping, impact on CD38enzymatic activity, pro-apoptotic activity in MM cellular models and patientsamples, and in vivo activity in combination with bortezomib.3:35 Sponsored Presentation (Opportunity Available)3:50 Refreshment Break4:15 A Novel T Cell Bispecific Antibody Targeting EGFRvIII toSpecifically and Potently Kill Tumor Cells in vitro and in vivoEugene Zhukovsky, Ph.D., CSO, Research, Affimed Therapeutics AG4:45 Drugging the Undruggable: Using Knowledge-Based Designto Develop Antibodies against Difficult TargetsGregory P. Adams, Ph.D., Co-Leader, Developmental Therapeutics Program, FoxChase Cancer CenterThe development of new clinically relevant antibodies has historically dependedupon the immunization of animals or the selection of clones with desiredspecificity from large antibody libraries. While this works for many targets thereare numerous important target epitopes that are difficult or even undruggable.Working with collaborators we have pursued a rational design approachemploying structure prediction, loop grafting and computational combinatorialCDR display to develop antibodies specific for difficult targets.5:15 Selection of Antibodies for T Cell Redirected KillingDiego Ellerman, Senior Research Associate, Protein Chemistry, Genentech, Inc. A Member of the Roche GroupT cell recruitment and redirected killing is a growing clinical strategy that iscurrently being explored for different oncological targets. This approach requiresthe use of bispecific antibodies targeting both the T cell receptor and a tumor-specificantigen. Different antibodies properties could play a role in determiningthe efficacy of the molecule, such as affinity, epitope location, bindinggeometry. We present case studies showing the influence of these factors.5:45-7:00 Welcome Reception in the Exhibit Hall with PosterViewingTUESDAY, JANUARY 208:00 am Morning CoffeeDISCOVERY AND ENGINEERING OFIMMUNOMODULATORY ANTIBODIES8:30 Chairpersons RemarksDavid King, Ph.D., CSO, AnaptysBio, Inc.FEATURED PRESENTATION8:35 Monoclonal Antibodies as the Foundation of theImmunotherapy RevolutionDavid Meininger, Ph.D., MBA, Executive Director, Business Development &Licensing, Merck & Co., Inc.Antibody-mediated inhibition of the PD-1 checkpoint pathway embodies aparadigm shift in cancer therapy. However, nearly half of melanoma patientsand a majority in other indications with clinical data published to date havefailed to respond to therapy. The highest priorities in cancer research today arearguably understanding PD-1 therapy non-responsiveness and developing newPD-1 alternatives and combinations with antibodies anticipated to representfoundational components of associated emerging treatment regimens. 17. PIPELINE 2: ANTIBODY THERAPEUTICSInaugural Cancer Targets for Antibody TherapeuticsDiscovery, Engineering and Optimization of Next-Generation Oncology TargetsJANUARY 19-20CoverEvent-at-a-GlanceSponsorsShort CoursesTraining SeminarsPROTEIN ENGINEERING & DEVELOPMENTRecombinanat Protein TherapeuticsEnhancing Antibody Binding & SpecificityImproving the Clinical Efficacy of AntibodyTherapeuticsANTIBODY THERAPEUTICSCancer Targets for Antibody TherapeuticsAntibody-Drug ConjugatesBispecific Antibody TherapeuticsFORMULATION & STABILITYOptimizing Biologics Formulation DevelopmentLyophilization & Emerging Drying TechnologiesProtein Aggregation & Emerging Analytical ToolsEXPRESSION & PRODUCTIONEngineering Genes, Vectors, Constructs & ClonesRecombinant Protein Expression & ProductionTransient Protein ProductionANALYTICS & IMPURITIESCharacterization of ADCs, Bispecifics & NewBiotherapeuticsDetection and Characterization of Particulates& ImpuritiesExtractables & LeachablesPROCESS TECHNOLOGIES & PURIFICATIONSingle-Use Technologies & Continuous ProcessingProtein Purification & RecoveryHigher-Throughput Protein PurificationACCOMPANYING CONFERENCES: MEMBRANE PROTEINS CHO CELLSSponsorship & Exhibit OpportunitiesHotel & Travel / Additional InfoRegistration & PricingRegister online at CHI-PepTalk.com179:05 Engineering a Novel, Multivalent Fusion Protein that PotentlyAgonizes a TNFSF ReceptorMelissa Damschroder, Ph.D., Associate Director, Research & Development,Antibody Discovery and Protein Engineering, MedImmune9:35 Sponsored Presentation (Opportunity Available)9:50 Coffee Break in the Exhibit Hall with Poster Viewing11:00 Control of Regulatory T (Treg) Cell Function by ProteinKinase C-eta (PKC): A Novel Target for Cancer ImmunotherapyAmnon Altman, Ph.D. Director, Scientific Affairs, Division of Cellular Biology, LaJolla I