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2018 Agenda

  • 8:00 am

  • Registration & Breakfast

  • 8:45 am

  • Co-chairs' Opening Remarks


    James Gulley, MD, PhD

    Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

    Axel Hoos
    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GlaxoSmithKline


  • Discovery & Preclinical Plenary Session

    Plenary Chair:

    Laura Johnson, PhD

    Senior Director, Head Translational Medicine, Oncology Cell Therapy, GlaxoSmithKline

  • 9:00 am

  • NK Cell CARs

    The talk will discuss methods to expand and arm human NK cells for cancer therapy, and their clinical application.

    • Human NK cells can be induced to multiply ex vivo, under clinical-grade conditions.
    • NK cells can be genetically engineered to enhance their proliferation in vivo, and tumor cell killing.
    • Promising approaches include expression of chimeric receptors and stimulatory cytokines.


    Dario Campana, MD, PhD

    Mrs Lee Kong Chian Chair in Advanced Cellular Therapy; Professor, Department of Pediatrics; Director, Division of Immunopathology and Cell Therapy
    National University of Singapore


  • Target Discovery for CAR-Ts and TCRs

    This talk will discuss the benefits and drawbacks of targeting three different types of antigen for TCR and CAR T-cell therapies:

    • Shared self-antigens
    • Tumor-associated antigens
    • Tumor-specific mutations, in the context of normal versus malignant tumor expression levels, driver mutations, and passenger mutations


    Laura Johnson, PhD

    Senior Director, Head Translational Medicine, Oncology Cell Therapy, GlaxoSmithKline


  • Morning Networking Break


  • Combination IDO1 and PD-1 inhibition in Metastatic Melanoma

    This talk will discuss the preclinical biology, MOA, and rationale for IDO1 inhibition, and clinical PoC in melanoma:

    • IDO1 as a tumor-resistance mechanism – preclinical data
    • Epacadostat – PK/PD preclinical and clinical
    • Clinical data in melanoma – 202 and 204


    Hiroomi Tada, MD, PhD

    Executive Director, Immuno-Oncology Development, Incyte


  • Early Clinical Data: Dual Targeting PDL1 and TGF Beta

    This talk will address preliminary results from a phase 1 trial of M7824, a bifunctional fusion protein targeting PD-L1 and TGF-β, in advanced solid tumors. Discussion points include:

    • Review of Pharmacokinetic and Pharmacodynamic data
    • Review of safety data
    • Review of efficacy data


    Julius Strauss, MD

    Director, Clinical Trials Group, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute


  • Investor Relations in Immunotherapy Plenary Session

    Plenary Chair:

    Andrew Baum, MD

    Head of Global Healthcare; Managing Director, Equity Research, Citi

  • 11:20 am

  • Plenary Keynote: Evaluation and Forecast of the IO Space


    Andrew Baum, MD

    Head of Global Healthcare; Managing Director, Equity Research, Citi


  • Venture Capitalist Perspective on the IO Landscape


    David Grayzel, MD

    Partner, Atlas Ventures


  • Lunch & Partnering Meetings


  • Investor Roundtable: The Role of IO within Large Pharma - Where Does it Stand?

    Moderator:

    Axel Hoos
    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GlaxoSmithKline

    Panelists:


    Andrew Baum, MD

    Head of Global Healthcare; Managing Director, Equity Research, Citi


    David Grayzel, MD

    Partner, Atlas Ventures


    Ali Behbahani, MD

    Partner, New Enterprise Associates


    Simeon George, MD

    Partner, SR One Ltd


    Mark Simon, MBA

    Partner, Torreya Partners


  • Translational Science and Biomarkers Plenary Session Part I


  • Plenary Chair:

    William Grossman, MD, PhD

    Global Development Leader, Cancer Immunotherapy Combinations, Genentech

  • 2:10 pm

  • Development of Immune Agonist Antibodies

    • Combination approaches with immune agonist mAbs
    • Unique challenges of agonist mAb design and development
    • Future directions in immune agonist design


    Patrick Mayes, PhD

    Executive Director, Head of I/O Biotherapeutics, Incyte 


  • Tumor Mutation Burden

    Christine Ward
    Christine K Ward, PhD

    Director and Pharmacodiagnostics Lead – HQ Medical Oncology, Bristol-Myers Squibb


  • Potential Molecular Markers for Predicting Response to Immunotherapy

    In this talk, molecular markers related to DNA instability and genomic SNV and CNV as well as RNA expression will be discussed as potential biomarkers for predicting response to immunotherapy. Correlation between genomic markers and PD-L1 expression will be also addressed.


    Maher Albitar, MD

    SVP, Chief Medical Officer and Director of Research and Development, NeoGenomics Laboratories


  • Transforming Translational Research: A Better Predictive Model For Oncology

    This talk will explore how CANscript was used to model the effect of checkpoint inhibition in HNSCC as a means of identifying predictors of clinical response and uncovering mechanisms of resistance.

    Mark Paris
    Mark Paris, PhD

    Associate Director, Translational Applications, Biopharma Business Development, Mitra Biotech Inc


  • Afternoon Networking Break


  • MORPHEUS Novel CIT Platform to Address Multiple Combinations

    This talk will focus on development challenges within the Cancer Immunotherapy space, and the opportunity for novel clinical trial designs to address these challenges:

    • Background on the current state of CIT combination development across the industry
    • Key clinical development challenges for CIT combination development
    • Examples of novel clinical trial designs to address CIT combination development challenges


    William Grossman, MD, PhD

    Global Development Leader, Cancer Immunotherapy Combinations, Genentech


  • Update on Cancer Vaccination and Biomarkers of Response

    This talk will present data on cancer vaccines, studies of biomarkers of DC vaccines, antigen specific T cell responses and checkpoint/costimulatory molecule expression.

    Lisa Butterfield
    Lisa Butterfield, PhD

    Professor of Medicine, Surgery and Immunology Director, UPCI Immunologic Monitoring and Cellular Products Laboratory / President, University of Pittsburgh / Society for Immunotherapy of Cancer (SITC)


  • Using TC Clonality Detecting Minimal Residual Disease


    Lanny Kirsch, MD

    SVP, Translational Medicine, Adaptive Biotechnologies


  • Use of Imaging Biomarkers for Immunotherapy


    Ron Korn, MD, PhD

    Founder, Chairman and Chief Medical Officer, Imaging Endpoints


  • Predictive Biomarkers in Immuno-Oncology: Today’s Imperative for Tomorrow’s Needs

    alessandra cesano
    Alessandra Cesano, MD, PhD

    Chief Medical Officer, nanoString Technologies


  • Emerging Concepts for the Detection of Minimal Residual Disease using Liquid Biopsies

    Improved detection of residual disease using circulating tumor DNA (ctDNA) can be achieved through novel experimental and bioinformatic approaches which will be discussed in this talk. Additional discussion points include:

    • Individualised ctDNA assays can track disease with high sensitivity
    • Bioinformatic error-suppression of sequencing data can be leveraged to reduce sequencing noise
    • Biological characteristics of cell-free DNA, such as fragment length, can be leveraged to further improve sensitivity


    Jonathan Wan
    MD, PhD Student
    Cancer Research UK Cambridge Institute

  • 6:30 pm

  • End of Day One

2018 Agenda

  • 8:15 am

  • Registration & Breakfast

  • 8:45 am

  • Co-chairs' Opening Remarks


    James Gulley, MD, PhD

    Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

    Axel Hoos
    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GlaxoSmithKline


  • New Trends & Collaborations Plenary Session

    Plenary Chair:

    Axel Hoos
    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GlaxoSmithKline

  • 9:00 am

  • The BioCentury Report on Industry Trends

    The BioCentury report will cover how companies and academic investigators are driving innovations within immuno-oncology, including new targets, modalities and technologies, to address some of the field’s biggest challenges.

    • The broadening trend to harness the innate and adaptive arms of the immune system for immunotherapies
    • New cell types beyond CAR-T and traditional T-cells
    • Combination strategies for neoantigens and other targets from the earliest stages of drug development


    Simone Fishburn, PhD

    Editor, BioCentury Innovations


  • The Endpoint News Report


    John D Carroll

    Editor-in-Chief, Endpoints News


  • Morning Networking Break


  • Cancer Moonshot Progress


    Greg Simon, JD

    President, Biden Cancer Initiative and Former Executive Director, Former White House Cancer Task Force  


  • Immuno-Oncology Progress in China


    Ji Li, PhD

    EVP, Global Head of Business Development, BeiGene


  • IO Emerging Technologies & Innovative Solutions Plenary Session

    This plenary will showcase companies that have technologies and solutions that will help stakeholders in the IO field advance developments to provide treatment for cancer patients.

  • 11:00 am


  • Ji Li, PhD

    EVP, Global Head of Business Development, BeiGene

    Russell LaMontagne
    Russell LaMontagne

    President and CEO, Boston Immune Technologies and Therapeutics

    Cyrus Mozayeni
    Cyrus Mozayeni, MD

    President & Chief Business Officer, Oncorus

    David Giljohann 2017
    David Giljohann, PhD

    CEO, Exicure

  • 12:00 pm

  • Lunch & Partnering Meetings

  • 1:00 pm
    - 5:15 pm

  • Break Out Sessions

    • Track 1A: Translational Science and Biomarkers Part II

      This session continues to focus on the biology and applications to help predict responses to immunotherapy.

      Plenary Chair:


      Ian McCaffery, PhD

      VP, Translational Science, Corvus Pharmaceuticals

       

      Immune Suppression in The Tumor Micro-environment: The Adenosine Pathway


      Ian McCaffery, PhD

      VP, Translational Science, Corvus Pharmaceuticals


      Neoantigen Approaches for Biomarkers
      This talk will include data that demonstrates how Cancer Genetics leveraged NGS with advanced computational analysis to identify novel expressed mutations and algorithmically estimate the binding affinity of the translated protein to the major histocompatibility complex haplotypes encoded by each genome.  Their IO Complete workflow can be utilized to both characterize overall somatic mutation burden and neoantigen burden, and validate predicted epitopes as a precursor to designing novel therapeutic agents.


      Kamala Maddali, DVM, PhD

      VP,  Biopharma Collaborations & Companion Diagnostics, Cancer Genetics Inc


       Additional topics to be announced shortly.
    • Afternoon Networking Break

    • Track 1B: Business Aspects Session

      Summary of IO Deals

      • What does deal-making over the past few years in Immuno-Oncology tell us about triggers of industry interest, gaps and potential opportunities?
      • What will new entry players need to show for their value proposition? (The result of all the first wave of deal activity and the slowing of clinical improvements by the first generation approaches means that novel programs in the hands of early stage biotechs need to have a clear story of differentiation)
      • What can we expect in the next wave of deal-making as we seek to improve more patients with durable remissions in immuno-responsive cancers and to yield good signals in the less immuno-responsive cancers?


      Jeff Bockman, PhD

      Principal, SVP, Oncology Practice Head, Defined Health


      Large Pharma Perspective on IO Licensing Technology

      This talk will address how large pharma develops and executes its IO partnering strategies in an increasingly complex environment. Key points:

      • Balance between in house R&D and external innovation in IO
      • Balance between exclusive licenses and “no strings attached” partnerships
      • Balance between first in class and fast follower development options

      Peter-Joern Halle
      Joern-Peter Halle, PhD

      SVP, Head of External Innovation and Head of TIP Immuno-Oncology / Biopharma, Global Research & Development, EMD Serono


      Panel: Talent Management for IO

      Moderator:


      Cissy Young, PhD, MBA

      Managing Director, Russell Reynolds Associates

      Panelists:


      Jasmine Ferrer, DPhil

      Sr Client Partner, Biotech & Pharma Sector, Korn Ferry International


      Adam Millinger

      Founding Partner, ProMotion Career Management

    • Track 2: Clinical Operations for IO Trials

      This section is designed for clinical trial operation executives who want to learn what it takes to execute an IO clinical trial. This is an excellent opportunity to walk through the building blocks of IO clinical trial operations and discuss pitfalls and lessons learned.

      Plenary Chair:


      Andy Lee
      SVP, Head of Global Clinical Trial Operations, Merck

      Building Blocks of IO Trials:

      • Patient Perspective: What it is like to schedule visits, go through multiple procedures and overall experience in an IO clinical trial
      • Site Management: Addressing the burden/nuts and bolts of operational work
      • 3rd party component: PDL1 stratification and biomarkers
      • Clinical supply chain/cold chain: The complexities of cold chain management in biologics and how do you blind study?
      • PI Perspective: Addressing clinical oversight and medical monitoring
      • Data Flow: Addressing the complexities around data management including:
        • What would the advice be for companies starting off in this field?
        • How do we get synergy and standardization?
        • How do you set up databases and capture the nuances of how many lesions to track?
        • How do you manage all the consents in the data capture, all the updates?
        • What do you do when you have interim analysis? Most companies now file interimly not at the end, so how do you manage that data?
        • How do you import 3rd party data from labs and imaging suppliers?
      • Project management: An executive perspective on what it takes to scale up resources, how to work collaboratively and effectively to advance the development of IO therapeutics. Focusing on:
        • Single studies and their complexities
        • Complexities of running several types of tumor type evaluations and within a tumor type
        • How do you run a dozen studies and how do you ramp up, get standardization?
    • Afternoon Networking Break

    • The Operational Challenges of Combinations Panel

      The complexities of doing combination clinical trials are huge. This panel will address:

      • How do you do clinical trials with different companies products?
      • How do you coordinate the supply chain with 2 drugs?
      • How and when do you update consents/brochures when there is a safety profile change?
      • Who controls the rights? System processes? What are the thresholds?
      • How do you address the standardization differences between 2 products?

      Panelists:

      Jacqueline Karmel
      Jacqueline Karmel
      Group International Scientific Director, Cancer Immunotherapy Medical Affairs, Roche
      Additional Panelists TBD


      Operational Independent Reviews for IO Clinical Endpoints

      Bohnsack_Oliver
      Oliver Bohnsack, MD, PhD, MBA

      Senior Director, Scientific and Medical Services, Head of Medical Relations Europe, Head of Oncology, PAREXEL


  • Operational Aspects for Immunotherapy Imaging Plenary Session

  • 5:15 pm

  • Plenary Chair:

    Andrea Perrone, MD

    Associate VP, Clinical Imaging Translational Medicine, Merck

    Inspection Readiness for Imaging Data

    • Control checks in place on study and define what level of error is acceptable
    • Understanding the potential inspection burden of re reviewing imaging; defining “When is enough, enough?”
    • Developing an imaging read charter and the importance of adhering to it closely
    • Preparation for regulatory inspection
    • Common pitfalls and how to mitigate

     

    Scientific and Medical Support For Managing Oncology Trials

    • The role of the medical director at an imaging core lab (site v. central assessment; oversight of the imaging charter development, regulatory support, etc)
    • The need for oversight of independent radiologists and oncologists  (reader metrics/reports on intra and inter reader variability)
    • Common pitfalls and how to mitigate

    Cynthia Goldberg, MD
    Director, Scientific and Medical ServicesPAREXEL

     

    Outstanding Project Management

    • The need for nimble project management
    • How to develop a true partnership with the sponsor to meet their deliverables
    • Common pitfalls (ie, request from sponsors to accelerate timelines) and how to mitigate

    Neil Stoddart
    Neil Stoddart

    Director, Clinical Operations, ICON plc

     

    Large Pharma Imaging Panel Discussion

    Moderator:


    Andrea Perrone, MD

    Associate VP, Clinical Imaging Translational Medicine, Merck

    Panelists:

    Gregory Goldmacher
    Gregory Goldmacher, MD, PhD, MBA

    Senior Director, Translational Biomarkers, Merck

    David Leung
    David Leung, MD, PhD

    Medical Director, Oncology Imaging, Exploratory Clinical & Translational Research, Bristol-Myers Squibb

  • 6:30 pm

  • Networking Cocktail Reception

2018 Agenda

  • 8:15 am

  • Registration & Breakfast

  • 8:45 am

  • Co-chairs' Opening Remarks


    James Gulley, MD, PhD

    Head, Immunotherapy Section, Director, Medical Oncology Service, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute

    Axel Hoos
    Axel Hoos, MD, PhD

    SVP, Oncology R&D, GlaxoSmithKline


  • Clinical Development Plenary Session

    Plenary Chair:

    Roy Baynes, MD, PhD

    SVP & Head, Global Clinical Development, Chief Medical Officer, Merck Research Laboratories

  • 9:00 am

  • Balancing Benefit and Toxicity From Immunotherapeutics: How to Make Recommendations to Patients

    This talk will discuss the clinical implications of the day to day management of, and the science around, IO adverse events that may help us understand how these drugs work.

    • The need to educate physicians about management of immune related adverse events with increasing penetration of checkpoint inhibitors into the community
    • The relationship of these adverse events to outcome with checkpoint inhibition
    • The relation of adverse events to other autoimmune diseases that are similar in nature


    Jeffrey Weber, MD, PhD

    Deputy Director, Laura and Isaac Perlmutter Cancer Center, Co-Director, Melanoma Program & Head of Experimental Therapeutics, NYU Langone Medical Center


  • Maintenance Therapy & The Changing Treatment Landscape in NSCLC

    This talk will address:

    • Stage I-III NSCLC
      • Immunotherapy consolidation treatment for stage III NSCLC: a new treatment paradigm
      • Neoadjuvant IO in NSCLC
    • Biomarkers
      • Is tumor mutation burden replacing PD-L1 expression?
    • Can we estimate TMB from a liquid biopsy?
    • First line NSCLC
      • How do we select patients for first line IO?
    • Single agent PD-1 vs chemo + PD-1 vs PD-(L)1/CTLA-4


    Naiyer Rizvi, MD

    Director, Thoracic Oncology & Immunotherapeutics in Medical Oncology, NY Presbyterian / Columbia University Medical Center


  • Morning Networking Break


  • Keytruda in Combo with Chemo in NSCLC


    Corey Langer, MD, FACP

    Director, Thoracic Oncology; Professor of Medicine, Perelman Center for Advanced Medicine, University of Pennsylvania

  • Learning from Kymriah - From Pivotal Trials to Launch

    This talk will explain the development of a CD19-directed CAR-T cell therapy, the first one approved by the FDA. Discussion points include:

    • Kymriah pivotal trials
    • Unique features of the Kymriah commercialization
    • What’s next for CAR-Ts at Novartis?

    David Lebwohl
    David Lebwohl, MD

    SVP & Franchise Global Program Head, CAR-T, Promacta and SEG101 GPTs, Oncology Global Development, Global Drug Development, Novartis Pharmaceuticals


  • Lunch & Partnering Meetings


  • Pembrolizumab as a Broad Spectrum Anticancer Therapy Both as Mono and Combination Therapy

    This talk will address:

    • PD-1 antibodies are transforming and becoming foundational in the treatment of a number of cancers
    • Monotherapy efficacy signals detected in screening phase 2 studies are translating into improved cancer outcomes in pivotal trials across a number of major cancers
    • A number of combination approaches have shown promise in screening studies and are now being advanced in pivotal trials to define efficacy and safety
    • Precision medicine will increasingly be used to optimize therapeutic choices


    Roy Baynes, MD, PhD

    SVP & Head, Global Clinical Development, Chief Medical Officer, Merck Research Laboratories


  • Differences in Long Term Benefit Between Classes of Checkpoint Modulators


  • Trout Group Situation Room

    2017 trout group

    Plenary Chair:
    Jonathan Fassberg
    Jonathan Fassberg

    CEO, Trout Group

  • 3:00 pm

  • Executive Fireside Chat

    Moderator:

    Jonathan Fassberg
    Jonathan Fassberg

    CEO, Trout Group


  • The Investor Lifecycle - How to Maneuver at Each Stage of Financing from Seed to Public Market

    Moderator:

    Neil Canavan
    Neil Canavan

    Scientific Advisor, Trout Group

    Panelists:

    Ting Jia
    Ting Jia, PhD

    Managing Director, Hillhouse Capital Management

    Joseph Sum
    Joseph Sum

    Director of Research, ECOR1 Capital


  • CEO Panel: Raising Money in the Current Climate

    Moderator:

    Jonathan Fassberg
    Jonathan Fassberg

    CEO, Trout Group

    Panelists:

    Gary Menzel
    Garry Menzel, PhD, MBA

    CEO, TCR² Therapeutics

    Dolores Schendel
    Dolores Schendel, PhD

    CEO/CSO, Medigene AG


  • IO CEO Fireside Chats

    Moderator:

    Peter Rahmer
    Peter Rahmer

    Managing Director, Trout Group

    Fireside Guests:

    Stephen Yoder
    Stephen S Yoder, JD
    President & CEO, Pieris Pharmaceuticals

  • 5:00 pm

  • Conference Concludes