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2018 Agenda

  • 7:45 am

  • Registration

  • 8:30 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

  • 8:45 am

  • 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

  • 9:05 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

  • 9:25 am

  • Coffee Networking Break

  • 10:10 am

  • 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

    Peggy Scherle
    Peggy Scherle, PhD

    Group Vice President, Discovery, Incyte

  • 10:30 am

  • 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

  • 10:50 am

  • TNF Superfamily Receptor Modulators – Innovative Immuno-oncology Therapeutics

    Apogenix will present data on its novel HERA drug candidates providing hexavalent TNF superfamily receptor agonists. These hexavalent fusion proteins are true agonists and their biological activity is, in contrast to agonistic anti-TNFR-SF antibodies, independent of secondary Fc-receptor based crosslinking events.

    The presentation will introduce the molecular engineering concept and report on in vitro and in vivo activities of HERA-CD40L, HERA-CD27L, HERA-GITRL and HERA-CD137L.

    The data will demonstrate that the HERA ligands stimulate the specific immune cell-driven anti-tumor efficacy in vitro and in vivo superior to agonistic antibodies. Along with good productivity and tolerability in pilot mouse and monkey studies they represent attractive candidates for further preclinical and clinical development for cancer therapy.

    Juergen Gamer
    Juergen Gamer, PhD

    VP, Business Development, Apogenix 

  • 11:05 am

  • NKG2D-based CAR-T Cell Therapy for Cancer

    Georges Rawadi
    Georges Rawadi

    VP, Business Development and IP, Celyad


  • Financial & Commercial Implications of IO 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

  • 11:50 am

  • Venture Capitalist Perspective on the IO Landscape


    David Grayzel, MD

    Partner, Atlas Venture

  • 12:10 pm

  • Lunch & Partnering Meetings

  • 1:10 pm

  • Panel: Future Value Generation in IO

    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 Venture

    Simeon George, MD
    Partner, SR One Ltd


    Mark Simon, MBA

    Partner, Torreya Partners


  • Translational Science and Biomarkers Plenary Session Part I


  • Plenary Chair:

    Edward Cha, MD, PhD
    Medical Director, Product Development Oncology Cancer Immunotherapy Franchise, Genentech

  • 2:15 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 

  • 2:35 pm

  • Tumor Mutation Burden as an Emerging Biomarker for Immuno-Oncology

    This talk will explore the key rationale and supporting data for Tumor Mutation Burden (TMB) as a potential predictive biomarker for patient response to I-O therapy.

    Discussion points will include:

    • TMB as a surrogate marker for neoantigen load
    • Select clinical trial data with TMB
    • The importance of next-generation sequencing as a pharmacodiagnostic tool for assessing TMB

    Christine Ward
    Christine K Ward, PhD

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

  • 2:55 pm

  • 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

  • 3:15 pm

  • 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

  • 3:35 pm

  • Afternoon Networking Break & Partnering Meetings

  • 4:20 pm

  • 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


    Edward Cha, MD, PhD
    Medical Director, Product Development Oncology Cancer Immunotherapy Franchise, Genentech

  • 4:40 pm

  • 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)

  • 5:00 pm

  • Immunosequencing Applications in Liquid and Solid Tumors


    Lanny Kirsch, MD

    SVP, Translational Medicine, Adaptive Biotechnologies

  • 5:20 pm

  • Use of Imaging Biomarkers for Immunotherapy


    Ron Korn, MD, PhD

    Founder, Chairman and Chief Medical Officer, Imaging Endpoints

  • 5:40 pm

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

    Despite the clinical success of the first wave of antibodies against checkpoint inhibitors, only a subset of unselected advanced cancer patients exhibits durable responses. In addition, the field is witnessing notable failures in Phase 3 trials testing these agents in early lines of Rx in unselected or sub-optimally selected patient population. Finally, preliminary data on combinations of these agents, although promising, are associated with increased toxicity and cost. Progress in fully realizing the potential of these anti-cancer approach requires the development and implementation of novel clinical-grade biomarkers able to guide the selection of agents with complementary MOAs which will be the focus of the talk.

    alessandra cesano
    Alessandra Cesano, MD, PhD

    Chief Medical Officer, nanoString Technologies

  • 6:00 pm

  • 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

  • 7:45 am

  • Registration

  • 8:30 am

  • Co-chairs' Opening Remarks


    Andrew Baum, MD

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

    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

  • 8:45 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. In particular it will dig into innovations in using both innate and adaptive arms of the immune response, neoantigens, and new cell types beyond CAR-T.


    Simone Fishburn, PhD

    Editor, BioCentury Innovations

  • 9:05 am

  • The Endpoints News Report

    The Endpoints News Report will review the build up of immuno-oncology over the past few years. With the large amount of money and the extraordinary numbers we have seen invested in the space, this talk by John Carroll, Editor-in-Chief, will discuss what impact this may have on collaborations. 

     
    John D Carroll
    Editor-in-Chief, Endpoints News
  • 9:25 am

  • Walking on the Moon: Reflections on the work of the Cancer Moonshot and the future of the Biden Cancer Initiative

    Nixon’s War on Cancer faced an outlook for success as bleak as the Moon’s surface with no understanding of the genetic complexity of cancer, no therapeutic weapons, and no grand strategy. The Cancer Moonshot provided the leadership to harness the millions of scientists and patients, powerful new therapies, and cultural changes needed to double our rate of progress against cancer. The Biden Cancer Initiative is now continuing the movement to double our rate of progress in preventing, detecting, diagnosing and treating cancer. Greg Simon, President of the Biden Cancer Initiative will provide a progress report and outlook for the future of the Biden Cancer Initiative.

    Greg Simon 2018
    Greg Simon, JD

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

  • 9:45 am

  • Immuno-Oncology Progress in China

    This talk will address the regulatory and clinical landscape in China and will also look at the FFDA regulations in China to make clinical trials easier.


    Ji Li, PhD

    EVP, Global Head of Business Development, BeiGene

  • 10:05 am

  • Coffee Networking Break & Partnering Meetings


  • 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.

    Plenary Chair:


    Jacqueline Karmel
    Principal Director Scientific Collaborations, Roche

  • 10:45 am

  • BeiGene


    Ji Li, PhD

    EVP, Global Head of Business Development

  • 10:55 am

  • Boston Immune Technologies and Therapeutics

    Russell LaMontagne
    Russell LaMontagne

    President and CEO

  • 11:05 am

  • Oncorus

    Christophe Quéva
    Christophe Quéva, PhD

    CSO
  • 11:15 am

  • Exicure

    David Giljohann 2017
    David Giljohann, PhD

    CEO

  • 11:25 am

  • Kiyatec

    Matthew Gevaert
    Matthew Gevaert, PhD

    CEO & Co-founder

  • 11:35 am

  • Replimune

    Howard Kaufman-new
    Howard Kaufman, MD, FACS

    Chief Medical Officer

  • 11:45 am

  • SmartAnalyst

    Manu Bammi
    Manu Bammi

    CEO

  • 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:


      Michael Kalos

      CSO, Cancer Immunobiology, Eli Lilly


      1:00 pm
      Biomarker Strategies to Guide Rational Clinical Development in Immuno-oncology
      Improved success in immunotherapy is dependent on developing and evaluating the right combinations of assets. To date, combination strategies have mostly been developed empirically. The breadth of molecules that target the various immune intervention axes necessitates implementation of  a rational process and strategy and process. In this talk, we will use case studies and discuss the use and application of biomarker platforms in the preclinical and clinical setting that enable the development of rationale combinations in Immuno-Oncology.


      Michael Kalos

      CSO, Cancer Immunobiology, Eli Lilly


      1:25 pm
      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.

      Daniel Duncan
      Daniel Duncan, MD

      Medical Director and Director, Translational Next Generation Sequencing, Cancer Genetics Inc


      1:45 pm
      Elucidating Neoantigens and Tumor Immunogenomics: Key Challenges and Solutions

      Advances in immuno-oncology research have led to promising results with NGS-guided analysis for sensitive neoantigen identification as well for the discovery of novel biomarkers. However, standard approaches suffer from limitations. Personalis addresses these issues using its proprietary Accuracy and Content Enhanced (ACE™) technology platform, ImmunoID, to improve cancer exome and transcriptome sequencing. We’ll share data that demonstrates the technical characteristics with an overview of the analytical validation, bioinformatics pipeline, neoantigen prediction and immunogenomics reporting capabilities.

      Erin_Newburn
      Erin Newburn, MS, PhD

      Senior Manager, Field Applications Scientist, Personalis


      2:05 pm
      Validation of an RNA-based Immune Profiling Assay for Limiting and Diverse Patient Samples

      • Highlight approaches to characterize the tumor microenvironment and current hurdles
      • Introduction of new technology which reveals immune cell composition present in the tumor, elucidates activated immune-escape pathways, and measures mutational burden to characterize tumor foreignness, all from a single FFPE specimen.
      • Orthogonal validation data with control samples and patient materials.

      Natalie LaFranzo
      Natalie LaFranzo, PhD

      Director of Scientific Projects and Market Development, Cofactor Genomics


      2:25 pm
      Predictive Biomarkers of Clinical Response using Single Cell Proteomics in CAR-T and TIL Therapy

      Sean Mackay
      Sean Mackay
      Co-founder, CEO and Director, IsoPlexis


      2:45 pm
      Challenging Current Dogma through Cell-Based Neoantigen Identification and Characterization

      Pamela Carroll
      Pamela Carroll, PhD

      SVP, Immuno-Oncology, Genocea
    • 3:05 pm
      Afternoon Networking Break & Partnering Meetings

    • Track 1B: Business Aspects Session

      Plenary Chair:


      Jeff Bockman, PhD

      Principal, SVP, Oncology Practice Head, Defined Health

      3:55 pm
      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


      4:15 pm
      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


      4:35 pm
      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

      Axel Hoos
      Axel Hoos, MD, PhD

      SVP, Oncology R&D, GlaxoSmithKline


      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


      1:00 pm
      Building Blocks of IO Trials: 
      This talk will consist of 7 perspectives that identify operational aspects of IO trials, including a patient perspective, site management, 3rd party component, clinical supply chain, a PI perspective, data management and project management. The collaborative talk concludes with a panel discussion and Q&A.

      Moderator:

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

      1:10 pm
      Patient Perspective: What it is like to schedule visits, go through multiple procedures and overall experience in an IO clinical trial.

      Joho_Stefanie
      Stefanie Joho

      Cancer Survivor, Advocate and Consultant

      1:25 pm
      Site Management: Addressing the burden/nuts and bolts of operational work including interfacing to engage and monitor clinical trials

      Claire Asogwa
      Claire Asogwa
      Oncology Research Specialist, Merck

      1:40 pm
      PI Perspective: 
      Addressing clinical oversight and medical monitoring


      Emily Wesson, RN

      Stem Cell Transport Unit, MD Anderson Cancer Center

      1:55 pm
      3rd Party Component: Operational aspects of PDL1 stratification and biomarkers

      Lisa Curtis
      Lisa Curtis

      Relationship Manager, Merck

      Jeff Hodge
      Jeff Hodge

      VP, Development Solutions, Oncology Center of Excellence, IQVIA

      Patrice Hugo
      Patrice Hugo, PhD

      CSO, Q2 Solutions

      2:15 pm
      Clinical Supply Chain: The complexities of global supply chain management in biologics

      Carol Haddad
      Carol Haddad

      Director, Global Clinical Supply Planning, Merck

      2:30 pm
      Data Management: Principles of managing the data including:

      • Collection
      • Cleaning
      • Importation
      • Locking
      • Interim analysis
      • Protocol Development
      • Statistical Programming and Forecasting

      Chris Lamplugh
      Chris Lamplugh

      Head, Clinical Data Management, Global Data Operations, Merck

      Patti Arsenault
      Patti Arsenault

      Executive Director, Global Head, Clinical Data Management, Cytel

      2:50 pm
      Project Management: An executive perspective on how to work collaboratively and effectively to advance the development of Immuno-Oncology therapeutics. Focusing on:

      • Complexities of Immuno-Oncology Studies
      • Drivers of successful study start and conduct
      • Scaling up an organization to run dozens of studies (e.g. ramping up, standardization)

      Kamran Ansari
      Kamran Ansari

      AVP, Head of Oncology Clinical Sciences & Study Management, Global Clinical Trial Operations, Merck

    • 3:05 pm
      Afternoon Networking Break & Partnering Meetings

    • 3:55 pm
      Operational Building Blocks of IO Panel and Q&A 
      This panel, joined by the Merck team and guests who spoke on the previous 7 part building blocks of IO talk, will go over Q&A as it pertains to the operational complexities of IO clinical trials.

      Moderator:


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

      Panelists:

      Kamran Ansari
      Kamran Ansari

      AVP, Head of Oncology Clinical Sciences & Study Management, Global Clinical Trial Operations, Merck

      Patti Arsenault
      Patti Arsenault

      Executive Director, Global Head, Clinical Data Management, Cytel

      Claire Asogwa
      Claire Asogwa
      Oncology Research Specialist, Merck

      Lisa Curtis
      Lisa Curtis

      Relationship Manager, Merck

      Carol Haddad
      Carol Haddad

      Director, Global Clinical Supply Planning, Merck

      Jeff Hodge
      Jeff Hodge

      VP, Development Solutions, Oncology Center of Excellence, IQVIA

      Patrice Hugo
      Patrice Hugo, PhD

      CSO, Q2 Solutions

      Joho_Stefanie
      Stefanie Joho

      Cancer Survivor, Advocate and Consultant

      Chris Lamplugh
      Chris Lamplugh

      Head, Clinical Data Management, Global Data OperationsMerck


      4:20 pm
      Panel: The Operational Challenges of Combination Trials

      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?

      Moderator:

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

      Panelists:

      Kamran Ansari
      Kamran Ansari

      AVP, Head of Oncology Clinical Sciences & Study Management, Global Clinical Trial Operations, Merck

      Karen Dimick
      Karen Dimick

      Operations Program Leader – Cancer Immunotherapy Combinations Development- Oncology Global Product Development, Genentech


      Jacqueline Karmel
      Principal Director Scientific Collaborations, Roche


      4:55 pm
      Operational Independent Reviews for IO Clinical Endpoints
      During this presentation you will learn what an imaging CRO does when planning and conducting independent reads for immuno-oncology trials and you will get answers to questions often asked, such as:

      • What do I need to consider when I plan using independent reads for my IO trial?
      • What does an Imaging Core Lab do to qualify, train and monitor independent reads for my trial?
      • Are there specific aspects to consider when selecting these reads?
      • Why is there Site: Central Discordance?
      • Is Adjudication Rate good or bad?

      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

    Plenary Chair:


    Andrea Perrone, MD

    Associate VP, Clinical Imaging Translational Medicine, Merck

  • 5:15 pm

  • 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

    Todd Kisner
    Todd Kisner

    VP, Quality and Regulatory Affairs, BioClinica

  • 5:30 pm

  • 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
    Cynthia Goldberg, MD

    Director, Scientific and Medical ServicesPAREXEL

  • 5:45 pm

  • 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

  • 6:00 pm

  • Large Pharma Imaging Panel Discussion

    Moderator:


    Andrea Perrone, MD

    Associate VP, Clinical Imaging Translational Medicine, Merck

    Panelists:

    Andrew Damon
    Andrew Damon

    Associate Director, Oncology Imaging, Eisai US

    Gregory Goldmacher
    Gregory Goldmacher, MD, PhD, MBA

    Executive Director, Translational Biomarkers, Merck

    David Leung
    David Leung, MD, PhD

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

    Annette Schmidt
    Annette Schmid, PhD

    Sr Scientific Director & Clinical Imaging Scientist, Takeda Pharmaceuticals

  • 6:30 pm

  • Networking Cocktail Reception

2018 Agenda

  • 9:00 am

  • Co-chairs' Opening Remarks


    Roy Baynes, MD, PhD

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

    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

  • 9:15 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

  • 9:50 am

  • Coffee Networking Break & Partnering Meetings


    Join Neil Canavan, author of A Cure Within: Scientists Unleashing the Immune System to Kill Cancer, for a book signing in the exhibit hall.

  • 10:45 am

  • 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

  • 11:10 am

  • 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
  • 11:35 am

  • 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

  • 12:00 pm

  • Lunch & Partnering Meetings


    Join Neil Canavan, author of A Cure Within: Scientists Unleashing the Immune System to Kill Cancer, for a book signing in the exhibit hall.


  • Trout Group Situation Room

    2017 trout group

    Plenary Chair:
    Thomas Hoffmann
    Thomas Hoffmann

    Managing Director, Trout Group

  • 12:45 pm

  • Executive Fireside Chat

    Addressing the state of the IO space and the role of next generation cell therapies.

    Moderator:

    Jonathan Fassberg
    Jonathan Fassberg

    CEO, Trout Group

    Guest:

    Harpreet Singh
    Harpreet Singh, PhD

    President and CEO, Immatics US, Inc

  • 1:10 pm

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

    Moderator:

    Chad Rubin
    Chad Rubin
    Managing Director, Trout Group

    Panelists:

    Hugo Beekman
    Hugo Beekman

    Principal, Omega Fund Management LLC

    Chris Cain
    Chris Cain, PhD

    Senior Associate, Apple Tree Partners

    Ting Jia
    Ting Jia, PhD

    Managing Director, Hillhouse Capital Management

    William Ho
    William Ho

    Managing Partner, AlephPoint Capital
  • 1:45 pm

  • CEO Panel: Raising Capital in the Current Market

    Moderator:

    Jonathan Fassberg
    Jonathan Fassberg

    CEO, Trout Group

    Panelists:

    Lew Bender
    Lew Bender

    President and CEO, Intensity Therapeutics

    Gary Menzel
    Garry Menzel, PhD, MBA

    CEO, TCR² Therapeutics

    Oystein Soug
    Øystein Soug

    CEO, Targovax

    Thomas Taapken
    Thomas Taapken, PhD

    CFO, Medigene AG

  • 2:20 pm

  • IO CEO Fireside Chats

    Moderator:

    Peter Rahmer
    Peter Rahmer

    Managing Director, Trout Group

    Fireside Guests:

    Debanjan Ray
    Debanjan Ray

    CFO & Head, Corporate Development, CytomX Therapeutics

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

  • 3:00 pm

  • Conference Concludes