October 17 – 19 2017 | Boston, MA

Hilton Boston/Woburn

Day One
Wednesday, October 18, 2017

Day Two
Thursday, October 19, 2017

07.00
Registration Opens, Breakfast & Networking

07.50
Chairs’ Opening Remarks

  • Bob Silverman Head of Externalized Drug Discovery Partnering, Roche

Keynote Address: “Precision Medicine” Under the Microscope: A Frank Look at the Impact of Precision Medicine on Patient Welfare

08.00
The First Biomarker-Defined Tumor Indication: FDA Approval of Pembrolizumab For MSI-High Cancer

Synopsis

  • Reviewing the approval of Pembrolizumab based on MSI-High biomarker, independent of tumor location
  • Challenges faced along the process
  • Lessons learned for future endeavors

08.30
The Pharmaceutical Perspective on the Advancement of Precision Medicine

  • Jakob Dupont Vice President & Global Head, Breast & Gynecologic Cancer Development, Genentech

Synopsis

  • Current outlook on R&D endeavours in the oncology space, are we still only capturing the lowest hanging fruit?
  • Discussing how to better invest in precision medicine and adjust business strategy to bring better medicines with better outcomes to more patients

09.00
Microfluidic Cell Tethering Enables Rapid Analysis of Drug Responses in Live Patient CTCs

  • Stuart Martin Professor , University of Maryland, speaking on behalf of ANGLE plc

Synopsis

  • Developing a novel microfluidic medical device for imaging cytoskeletal dynamics in non-adherent patient tumor cells and integrating hydrophobic lipids into an engineered surface to tether tumor cells to improve high-resolution imaging and preserves the dynamic cytoskeletal behavior of non-adherent tumor cells
  • Utilizing live-cell confocal microscopy to demonstrate that McTNs are detectable within hours of when tumor cells are recovered from breast cancer patients, either via surgery or microfluidic isolation of CTCs from patient blood samples
  • Enabling immediate testing of patient cells for responses to cytoskeletal drug treatments that could influence CTC reattachment during metastasis

09.30
Leveraging Companion Diagnostics in Support of Clinical Trial Design and Execution

  • Mark Roberts Senior Director, Diagnostics Development, Covance

Synopsis

  • Recognizing how changes in regulatory speed and trial design complexity can become advantages
  • Understanding the role of CDx to enhance trial enrollment and execution
  • How to best prepare for critical regulatory and commercialization considerations

10.00
Keynote Panel: “Precision Medicine” Under the Microscope: A Frank Look at the Impact of Precision Medicine on Patient Welfare

Synopsis

The keynote will take a candid look at the precision medicine to-date.  What current success and tangible real-world benefit are we seeing for patients?  Is this enough?  And what can we do to ensure we enter the next decade with precision medicine to change the lives of as many patients as possible?

The panel aims to address the following perspective and considerations:

  • Innovator: Discussing how to better invest in precision medicine and adjust business strategy to bring improved outcomes to more patients.  Considering the role of big data, scientific progress, and current and future technological advances including diagnostics and therapeutics.
  • Patient: Elevating the role of patient power and advocacy on the real-world impact of precision medicines and current and future technological advances.
  • Payer: Getting to the crux of value/outcomes based healthcare and how we address drug and diagnostic reimbursement across the US.
  • Policy: Changing healthcare policy and impact on future precision medicine endeavors.  From Moonshot to the NCI and PMI and forging a path for integration of precision medicine into US healthcare.

11.00
Morning Refreshments & Speed Networking

Enhancing the Development of ‘Omic Derived Predictive Biomarker Signatures

11.45 The Discovery and Development of a STn Antibody Biomarker Signature and Diagnostic for Ovarian Cancer

  • Discovering and developing a panel of novel, highly-selective, high-affinity monoclonal antibodies to STn using a proprietary immunization strategy and core glycan screening technologies
  • Discussing the development of a novel tissue-based companion diagnostic for Siamab’s anti-STn antibody drug conjugate to select patients that possess elevated levels of the STn carbohydrate
  • Proposing a novel exploration of correlations between an IHC signal in ovarian tumors with genetic and protein markers that offers the chance to enhance the strength of each biomarker alone

Dan Dransfield, Senior Vice President Research & Development, Siamab Therapeutics

12.15 Introducing Corgenix: Personalizing Protein Diagnostics for Personalized Medicine

  • Corgenix  has more than 20 years’ experience and expertise in developing  liquid biopsy protein diagnostics, having developed and launched more than 50 IVDs (510K/CE).
  • Collaboration is at the heart of everything we do – we have partnered with more than a dozen companies to support their protein diagnostic development manufacturing needs
  • Corgenix Personalized Diagnostics offers partnerships for the development and commercialization of protein-based Liquid Biopsy Companion Diagnostic (LB-CDx)
  • From proof-of-concept to IVD, Corgenix can help make Personalized Medicine a reality for patients

Dawn McHugh, Vice President, Business Development, Personalized Diagnostics, Corgenix

12.25 Learnings from Development of a Biochip Multiplex Inflammation Panel for Assessment in Psoriasis

  • Rationale for biomarker and technology selection
  • Custom Array development highlights
  • Data contribution to study outcome
  • Technology improvement – the power of long-term partnership

Claire Huguet, Head, Biomarker Services, Randox

Sudha Visvanathan, Immunology & Respiratory Team Lead, Translational Medicine & Biomarker Experts Group, Boehringer Ingelheim

12.55 Regeneron Genetics Center: From Target Discovery to Pharmacogenomics

  • Discussing the establishment and mission of the Regeneron genetics center
  • Currently performing a large number of genomic studies, including family-based mendelian studies, founder population studies, and large-scale population based studies
  • Analyzing current pharmacogenomic studies for a number of Regeneron clinical programs

Charles Paulding, Director, Pharmacogenomics, Regeneron Pharmaceuticals

 

13.25 Networking Lunch

14.15 Development of a Pharmacodynamic Biomarker Assays for a First-in-Class Oral Selective ERα Covalent Antagonist (SERCA) for the Treatment of ERαWT and ERαMUT Breast Cancer

  • ERα mutations functionally confer resistance to existing classes of endocrine therapies, likely through gaining constitutive activity
  • Current ER-directed therapies are only partially effective in the ERα mutant setting, and that a significant proportion of resistant breast cancer metastases continue to remain dependent on ERα signaling for growth/survival, highlights the critical need to develop the next generation of ERα antagonists that can overcome aberrant ERα activity
  • The role and development of pharmacodynamic biomarker assays to establish SERCA activity in clinical trial samples will be discussed

Victoria Rimkunas, Senior Scientific Investigator, H3 Biomedicine

Developing Novel Biomarker Signatures for the Next Wave of Immuno-Oncology Targets

14.45 Analyzing Biomarker Identification in Immuno-Oncology

  • Discussing approaches to biomarker identification to guide the use of small molecules and biologics in the context of an integrated translational research program
  • What signatures are we looking for and where should we be looking?
  • Discussing which markers hold promise for being most clinically relevant

Jennifer Mataraza, Senior Investigator & Group Leader, Translational & Exploratory Immuno-Oncology, NIBR

15.15 From Research to the Clinical: Advancing RNA-ISH Detection in Companion Diagnostics

  • Advantages and applications of in situ RNA detection
  • Collaboration of key stakeholders for co-development of a drug and RNA-ISH diagnostic device
  • Regulatory and commercial considerations for new innovative technologies in companion diagnostics

Jessica Riley,  Senior Director, Business Development, Pharma Partnerships, Leica Biosystems

15.45 Afternoon Refreshments

Evolving the One Marker-One Platform Mantra: Progressing Multiplexed & Universal Signatures & Platforms

16.15 The Pan-Tumor Paradigm: A Biotech Approach

  • Discussing the Syros platform for the identification of a super enhancer driving the RARA gene
  • Evaluating RARA overexpression in subsets of patients across indications including AML and breast cancer
  • Demonstrating that tumors with RARA high expression respond to the RARA agonist SY-1425
  • Quantifying RARA in heme malignancies and solid tumors with a companion diagnostic to allow for pan-tumor, genomically guided treatment

Emmanuelle di Tomaso, Vice President & Head of Translational Medicine, Syros Pharmaceuticals

16.45 Panel Discussion: Advancing the Development and Clinical Application of Universal and Multi-Analyte Biomarker Assays

  • Debating the clinical relevance of multiplex technology: What is the best platform and type of signature to develop?
  • Discussing the benefits and applicability of multi-analyte testing over single-marker platforms
  • Transitioning from single to multi-analyte as a paradigm: What need to do now to streamline this transition as an industry?
  • How to validate multiplexing platform and discussing the standards required to perform exploratory testing
  • How does the approval of universal companion diagnostics and multigene panels impact future biomarker discovery and development

Emmanuelle di Tomaso, Vice President & Head of Translational Medicine, Syros Pharmaceuticals

Michael Natan, CEO, Ultivue

Michael Kiebish, Chief Precision Medicine Officer, BERG

 

17.30 Chairs’ Closing Remarks & Close of Stream

Clinically Validating Predictive Responder & Outcome Signatures for IO Therapies

11.45 A Review: Improving Clinical Patient Selection and Stratification for Immunotherapy

  • Getting a clean signature: How do we do robust patient selection for immunotherapies?
  • Getting granular on responder/non-responder patient populations: Promoting strategies for subpopulation identification of long-term responders to immunotherapy
  • Optimize selection of patients beyond prognostic markers to avoid excessive toxicity in IO clinical studies

Zhen Su, Vice President  & Head of Global Medical Affairs Oncology, EMD Serono

12.15 PD-L1 Case Study: Developing Clinically Relevant and Effective Scoring Algorithms to Align Clinical Trial with Real World Results

  • How to determine what is important in predictive assay algorithm development
  • The Pathologist’s role in developing novel scoring algorithms
  • How to assure the effectiveness in the Real World:  some of the key components for end user pathologist competency, compliance and quality

Debra Hanks, Chief Pathologist, CDx Histopathology, Agilent Technologies

12.45 Advancing the Precision Medicine Approach to IO Combination Trials

  • Learning how to best derive combination signatures to improve trial strategy
  • Harnessing innovative trial design to compare effectiveness of combination versus monotherapy for biomarker signature and therapeutic validation
  • Utilizing biomarker data, in conjunction with target interaction to enhance dose selection in combination studies

David Kaufman, Executive Director, Translational Immuno-Oncology, Merck

13.15 Networking Lunch

14.15 Turning Tumor Mutations into Personalized Cancer Therapies

  • Evaluating each patient’s tumor using next-generation sequencing and to identify candidate TSNAs
  • Using proteomics and machine learning to predict which TSNAs can activate tumor-specific T cells
  • For each patient, manufacturing a TSNA-based vaccine and delivering it in combination with immune checkpoint blockade

Roman Yelensky, Executive Vice President & CTO, Gritstone Oncology

Improving the Operational Execution of Precision Medicine Clinical Trials

14.45 Umbrella and Basket Trials for Molecular Targets in Precision Medicine

    • Utilizing basket and umbrella trials to enrich for responders to statistically power smaller, shorter and more cost-effective late stage trials
    • Harnessing these trial designs to more granularly define the best plan of action for subpopulations of patients
    • Understanding how basket and umbrella trials can be utilized to improve patient recruitment and retention on clinical studies

    Jason Christiansen, Vice President, Diagnostics, Ignyta

15.15 Improving Patient Recruitment and Retention on Precision Medicine Clinical Trials

  • What can be done to improve clinical trial enrolment using NGS ?
  • Discussing the challenges and pitfalls of patient enrolment
  • Understanding what can be done by drug developers and testing companies do make getting patients onto trials easier
  • Improving patient advocacy and educating to promote the enrolling and retention of patients into “precision medicine” clinical trials

Daniel Simon, Vice President, Pharma Business Development, Guardant Health

Daniel Catenacci, Associate Director, Gastrointestinal Oncology Program, The University of Chicago Medical Center

Carl Barrett, Vice President, Translational Sciences, Oncology, Astrazeneca

15.45 Afternoon Refreshments

Successful Implementation of Biomarker Signatures: Clinical Trial Case Studies

16.15 Innovating in Sampling and Biomarker Detection to Lay the Foundations of Success for Global Clinical Trials

  • Discussing the variability in clinical sample quality from clinical trial sites and how to best standardize sample collection and preparation across multiple geographies
  • Rolling out global training and support to best mitigate risk of quality, complex sample collection
  • Discussing the role of sample collection, both tissue and fluid, on the advancement of biomarker driven drug development
  • Discussing liquid biopsy driven trials and considerations for sample collection and downstream clinical relevance

Dmitri Mikhailov, Head, Biomarker Coordination, Novartis

16.45 Precision Medicine for Alzheimer’s Disease: Applying Genomic Stratification of Patients Based on APOE4 for Clinical Efficacy

  • By integrating information from a large dataset in patients treated with the active molecule tramiprosate, genetic markers and new insights into the pathology of Alzheimer’s disease, we have identified a group of high risk patients for our initial pivotal trial, with an earlier onset of Alzheimer’s and more aggressive disease course, patients in which tramiprosate appears to stabilize their cognitive performance
  • We have created ALZ-801, an optimized prodrug of tramiprosate, that substantially improves the pharmacokinetic and tolerability profile of the active molecule
  • ALZ-801 is one of the few oral drug candidates in advanced stages of clinical testing in Alzheimer’s disease, a pill with a favorable safety profile and the potential to slow the course of the disease in all Alzheimer’s patients

Martin Tolar, Founder, President & Chief Executive Officer, Alzheon

17.15 Chair's Closing Remarks & Close of Stream

Overcoming Discrepancies in the Definition of “Value” Between All Industry Stakeholders

11.45 Reinventing Reimbursement Strategy to Demonstrate Value to Payers and Other Stakeholders

  • Understanding what stakeholders, including payers, providers and patients, need to see in order to reach the threshold for sufficient value demonstration
  • How do we demonstrate stand-alone value for a diagnostic test?
  • Revamping your reimbursement strategy to focus on the clinical application, validity and outcome to ensure alignment with requirements in value demonstration

Chandra Branham, Vice President, Payment & Health Care Delivery Policy, AdvaMed

12.15 A Fully Automated, Highly Accurate, Easy to Use MDx Platform: Too Much to Ask For?

  • Discussing the development of a fully automated, highly accurate MDx platform
  • Demonstrating the value of such a platform to the advancement of patient access to ensure the right treatment at the right time

Vishal Sikri, US General Manager, Biocartis

12.45 Opportunities in Real World Evidence to Demonstrate Valuable Outcomes to Healthcare Payers

  • Understanding how advances in real world evidence studies can generate robust, clinically relevant data
  • How next generation diagnostics and outcomes, such as mobile health applications/devices and digital biomarkers, might support reimbursement
  • What types of evidence are most likely to support reimbursement of diagnostics

Eric Meadows, Research Advisor, Global Patient Outcomes & Real World Evidence, Alzheimer’s Diagnostics, Eli Lilly

13.15 Networking Lunch

14.15 NGS Panels: From Patient Selection to CDx

  • Harnessing NGS to facilitate biomarker discovery in early phase clinical trials and subsequent development of CDx assays with potential utility across multiple drug targets
  • Case studies: Exploring the main considerations for development and analytical validation of such panels and
  • Identifying important technical and regulatory challenges in CDx development

Katarina Wikstrom, Director of US Operations, Almac Diagnostics

The New Era: NGS Diagnostics for Precision Medicine Success

14.45 FDA Presentation: The Inside Track on IVD Regulation

  • Understand how the FDA are viewing the shift beyond the one marker-one platform mantra
  • Views on the regulation of NGS based, universal and pan-tumour diagnostic platforms

Adam Berger, Senior Staff Fellow, Personalized Medicine, FDA

15.15 NGS Solutions Across the Oncology Drug Development Continuum: From Biomarker Discovery to IVD

  • Applications of ctDNA analysis in pharmaceutical research and clinical development
  • Challenges in development of IVDs based on liquid biopsy
  • How can the decentralized assay model be applied to liquid biopsy approaches

John Simmons, Director, Translational Science & Diagnostics, PGD

15.45 Afternoon Refreshments

Streamlining Diagnostic Co-Development from Clinical Assay to Commercial IVD

16.15 Understanding the Impact of Recent NGS Regulatory Success on Future R&D and Approval Efforts

  • Discussing the IDE and PMA process for NGS based platforms: Lessons for streamlining future approval
  • Debating the impact of NGS platform approval on the future development of multigene assays
  • What can we learn and apply from tissue based NGS platforms to advance the approval of liquid based multigene assays

Hakan Sakul, Vice President & Head of Diagnostics, Pfizer

16.45 Which Comes First, Diagnostic or the Drug?

  • Discussing a novel paradigm in diagnostic development paired with drug development
  • Evaluating a “diagnostic first” process for matching drug development to Dx design
  • Debating the impact of such a re-think in drug-Dx co-development on commercial success

Jonathan Pan, Vice President & Head of Biomarker Strategy & Development, Aevi Genomic Medicine

17.15 Dx Strategy Considerations for Commercial Targeted Therapeutic Success

  • Discussing the commercial impact of complementary vs companion diagnostics and the implications for market penetration and physician adoption of a targeted therapeutic
  • How do you handle a complementary diagnostic commercially, when it’s not in the Rx label and it’s not required for Rx treatment, to ensure your drug is adopted?
  • To CDx or not to CDx: Discussing the impact of the current LDT climate on the adoption and integration of IVDs into healthcare
  • Discussing the commerciality of multigene panels: How do we harness these platforms in the real world to get drugs adopted?
  • Does the price of multigene NGS panels rule out their commercial viability? Do we need a multi-panel approach or is the refinement and utility of a few selective markers the best approach?
  • What are the advantages of developing a multi-analyte CDx and how can they improve market share?
  • Discussing the merits and shortfalls of centralized and de-centralized models for testing

Hakan Sakul, Vice President & Head of Diagnostics, Pfizer

Jeffrey Emch, Biomarker & Companion Diagnostic Lead, Merck

Susanne Munksted, Director, Global Commercial Alliances, Companion Diagnostics, Agilent Technologies

Scott Reid, Director, Strategic Accounts & Companion Diagnostics, NeoGenomics Laboratories

Eric Faulkner, Vice President, Precision & Transformative Technology Solutions, Evidera

18.00 Chairs' Closing Remarks & Close of Stream

18:00
End of World CDx & Clinical Biomarkers Day One

18:15
World CDx Gala Dinner hosted by ANGLE plc

Synopsis

*** Personal Invitation Only***

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