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Agenda

  • 7:45 am

  • Registration & Breakfast

  • 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.

    • 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

  • 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, Former 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

  • Morning 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, BeiGene

  • 10:55 am

  • Boston Immune Technologies and Therapeutics

    Russell LaMontagne
    Russell LaMontagne

    President and CEO, Boston Immune Technologies and Therapeutics

  • 11:05 am

  • Oncorus

    Cyrus Mozayeni
    Cyrus Mozayeni, MD

    President & Chief Business Officer, Oncorus

  • 11:15 am

  • Exicure

    David Giljohann 2017
    David Giljohann, PhD

    CEO, Exicure

  • 11:25 am

  • Kiyatec

    Matthew Gevaert
    Matthew Gevaert, PhD

    CEO & Co-founder, Kiyatec

  • 11:35 am

  • Replimune

    Howard Kaufman-new
    Howard Kaufman, MD, FACS

    Chief Medical Officer, Replimune

  • 11:45 am

  • SmartAnalyst


    Manu Bammi

    CEO, SmartAnalyst

  • 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


      1:00 pm 
      Immune Suppression in The Tumor Micro-environment: The Adenosine Pathway


      Ian McCaffery, PhD

      VP, Translational Science, Corvus Pharmaceuticals


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


      1:45 pm 
      Shifting the Cancer Vaccine Development Paradigm: NGS Best Practices for Neoantigen Detection and Clinical Trial Implementation
      Advances in immuno-oncology research have led to promising results with NGS-guided analysis for sensitive neoantigen identification. 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 Application Scientist, Personalis


      2:05 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


      2:25 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


      2:45 pm

      Additional Company TBD

    • 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 and Advocate


      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
      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 and addressing how do you blind study.

      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

      Senior Director, 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 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?

      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 and Advocate

      Chris Lamplugh
      Chris Lamplugh

      Senior Director, Clinical Data Management, Global Data Operations, Merck


      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?
      • How do you address the standardization differences between 2 products?

      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


      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 immune-oncology trials and you will get answers to questions often asked, such as:

      • What do I need to consider when I plan using independent read for my IO trial?
      • What does an Imaging Core Lab do to qualify, train and monitor independent readers for my trial?
      • Are there specific aspects to consider when selecting these readers?
      • 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 am

  • 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 Services, PAREXEL

  • 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