September 13, 2018

8:00 AM

Registration and Continental Breakfast

9:00 AM

Welcome and Logistics

Main

9:10 AM

Keynote Presentation
FDA's Precision Medicine Initiative: Achievements and Challenges

Alberto Gutierrez, Partner

FDA Partners LLC

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FDA's Precision Medicine Initiative: Achievements and Challenges

Beginning in the late 1990’s, with the development of Herceptin, the FDA has struggled with setting policies to assure the safe and effective use of laboratory tests that are required for the appropriate management of therapeutics.  The policies have been shaped by the laws and regulations governing devices, as well as long standing policies on regulation of laboratory developed tests. The speaker will touch on companion diagnostic, complementary diagnostics, follow-on diagnostics, as well as guidances on co-development.  Finally the speaker will talk about President Obama’s Precision Medicine initiative and its impact on regulation.

9:45 AM

Precision Medicine:The Development Continuum from Biomarker Discover to Companion Diagnostics

Steve Anderson, Chief Scientific Officer and Senior Vice President

Covance

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Precision Medicine:The Development Continuum from Biomarker Discover to Companion Diagnostics

Biomarkers and Companion Diagnostics are playing increasingly important roles in drug discovery and the delivery of precision medicine.  The development of biomarker assays in a fit-for-purpose manner, with potential applications for use in clinical trials and the opportunity, when appropriate, to serve as a companion diagnostic are important considerations to meet both drug and diagnostic timelines.  Approaches that meet the needed scientific rigor, while providing speed, flexibility and efficiency are import considerations for pharmaceutical and biotechnology partners. Case studies and examples will be presented that address the key needs and requirements to ensure robust development along the continuum from biomarker discovery to delivery of companion diagnostics.

10:10 AM

Criteria for selection/inclusion of biomarkers in the drug development process

Agnes Seyda, Director, Precision Medicine and Companion Diagnostics

Celgene

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Criteria for selection/inclusion of biomarkers in the drug development process

Companion diagnostic tests help deliver superior healthcare value demanded by providers, payers, and patients, driving the rapid evolution of personalized medicine. From a pharma/biotech company perspective, appropriate selection/inclusion of biomarkers in the drug development process can 1) reduce development cost by accelerating development timelines and approval 2) increase drug development success rate 3) enable increase in return on investments. As an example, the development and co-commercialization of Celgene’s Idhifa® Rx /CDx pair (Celgene, Agios, Abbott Molecular) will be discussed.

10:35 AM

Nic Dracopoli
Predicting Response to Checkpoint Inhibitors

Nic Dracopoli, Senior Vice President, Translational Science

Personal Genome Diagnostics

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Predicting Response to Checkpoint Inhibitors

The emergence of novel therapies that modify a patient’s immune response to their cancer has led to dramatic improvement in clinical outcome for patients whose immune response has been suppressed by checkpoint inhibitors. Several drugs that inhibit PD-1/PD-L1 pathway have delayed disease progression and prolonged overall survival for a subset of patients. Multiple lines of evidence show that the critical factor in predicting response to a checkpoint inhibitor is the presence of a prior, but suppressed, immune response to the tumor. The evidence for this prior immune response can be seen by increased infiltration of the tumor by clonal T-cells and increased expression of the checkpoint inhibitor ligand (PD-L1) required to suppress the clonally expanded T-cells. Alternatively, the tumor mutation burden (TMB) can be used in a stochastic model to predict prior immune response by estimating the probability of a mutation occurring in a peptide sequence that can be expressed by the MHC and ultimately recognized as foreign by the immune system. Consequently, successful selection of patients who will respond to checkpoint inhibitors will require the development of several, complex Dx tests using DNA, RNA, protein and cell-based templates. This will, unfortunately, be much more complex than the development of driver mutations in drug targets that have been so successful in predicting response to many receptor tyrosine kinase inhibitors.

11:00 AM

From Coverage to Reimbursement: Coverage and reimbursement for new technology

Laurie Howard, Vice President, Policy and Payer Relations

LabCorp

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From Coverage to Reimbursement: Coverage and reimbursement for new technology

This presentation will address the crucial steps for successful coverage and reimbursement for new technology:  CPT coding, technical assessments, evidence review, Z-Codes, rate setting, NCD/LCD, appeals and other issues that cause barriers to payment.

11:25 AM

Networking Lunch and View Posters

TRACK 1: Role of Precision Diagnostics in Precision Medicine: CDx and Clinical Applications for Biologics and Small Molecule Drugs

12:30 PM

Companion Diagnostics in Autoimmune Disorders: Improving Outcomes Through Personalized Medicine

Carrie Brodmerkel, Head, Immunology Biomarkers

Janssen Pharmaceutical

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Companion Diagnostics in Autoimmune Disorders: Improving Outcomes Through Personalized Medicine

Despite advances in treatment options for severe autoimmune disorders there remains a significant unmet clinical need for new therapies and integrated treatment solutions. We are applying Systems Pharmacology, Precision Medicine and developing Companion Diagnostics to create new treatment paradigms. Our objective is to deliver higher response rates, deeper remission, early interception and eventually prevention of these diseases.  Progress and strategy toward these objectives will be discussed.

12:55 PM

Patient-Centered Reverse Translation

John Wagner, Senior Vice President, Head of Translational Research and Early Clinical

Takeda Pharmaceuticals

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Patient-Centered Reverse Translation

Reverse translation is an important and evolving concept in translational medicine.  A compact definition of forward translation is the application or translation of laboratory research to clinical experiments or patients.  Forward translation includes many of the traditional activities of therapeutic discovery and development. The exclusively bench-to-bedside approach is limiting.  The most obvious limitations are in target discovery and the frequent route reversals necessary for drug discovery and development. Targets do not emerge from a vacuum, and that is where a patient-centered reverse translation approach is particularly critical.  Reverse translation starts with deep characterization of the patient, perhaps by identifying unique phenotypes or genotypes of disease. Next this deep understanding of the patient and disease informs the mechanism, which in turn drives deeper understanding and better selection of targets.  Reverse translation activities aim to explain disease and patient biology through an integrative, cross-functional approach linking “omic” data derived from a deep characterization of patients with their health phenotype data. The goal is to generate actionable hypotheses about disease mechanisms and drug response supporting validation of existing targets, identifying new targets and disease mechanisms/indications and driving precision medicine strategies. But that is not the only activity of reverse translation.  Forward translation does not formally account for the critical reverse steps, such as learnings from patients that are reflected back to drug discovery and development tools (e.g., biomarkers, animal models, or modeling and simulation approaches, including quantitative disease models) or to refinements of a therapeutic (e.g., pharmacokinetically unacceptable profiles leading to different desired molecular or metabolic properties). In summary, reverse translation is the application or translation of clinical, patient-centered data to laboratory research.  In this overall vision of translational medicine, research starts with and returns to the patient, acknowledging a powerful trend in research and medicine focusing on patient-centricity.

1:20 PM

Diagnostic Solutions for Biomarker Driven Multi-Arm Clinical Trials

Steve Walker, Head of Product Management

Almac Diagnostics PLATINUM SPONSOR

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Diagnostic Solutions for Biomarker Driven Multi-Arm Clinical Trials

The clinical trial landscape for precision medicine has shifted significantly in recent years. Whilst previously trials focused on one cancer type and one therapy using a single biomarker, more recently we are seeing novel designs emerge which can use multiple
biomarkers to select patients for multiple therapies (umbrella studies) or include patients from multiple cancer types (basket studies).

The main drivers for this change are to provide multiple treatment options covering the wide range of patient genomic profiles and efficiency/cost effectiveness improvements.

As a result, biomarker solutions also need to change because the conventional approach is no longer fit for purpose. This is because when multiple therapies are incorporated into a study, multiple biomarkers will also be required. Typically these are offered via single vendors and when you factor in the multiple sites running the trial, you’re left with a very complex scenario involving:

 

  • Requirement for multiple contracts between each trial site and biomarker vendors
  • Need for large volume of tissue sample to supply each vendor
  • Large human resource required to manage the study
  • Long turnaround times and likelihood of logistical errors


In order to address the issues mentioned above, Almac Diagnostics has developed a novel solution. Utilising Illumina’s TruSight® Tumor 170 and TruSeq® RNA Exome Panels, Almac offers a full portfolio of DNA & RNA assays which can be run
using dual extraction from one FFPE sample. These assays have either been developed by Almac, or publicly sourced. When combined, the assays provide a comprehensive review of tumour biology, the results of which are presented in an easily interpreted patient molecular data report which can be tailored to Almac customers’requirements. Should additional assays be requested, Almac can integrate them into the report.

 

During this talk participants will learn about:

  • Novel strategy for patient stratification in Basket & Umbrella trials
  • Solution to enable multiple biomarkers to be evaluated from one sample
  • Almac Diagnostics Cancer panel solutions for both DNA & RNA
  • Unique product offering for Immuno-Oncology
  • Customised patient reporting enabling simple interpretation of molecular data

1:45 PM

Navigating late stage CDx Co-Development

Grace Kim, Business Development and Alliance Manager - Companion Diagnostics

Agilent Technologies

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Navigating late stage CDx Co-Development

The CDx Division of Agilent Technologies (formerly known as Dako) is celebrating 20 years of companion diagnostic assay development since launching the first CDx, HercepTest, in 1998.  In this presentation, we will discuss business perspectives on contracting, initiating and maintaining successful partnerships with pharma for successful co-development, launch and commercialization of CDx assays.  Case examples of different partnership models will be highlighted. This talk may be useful for pharma considering co-developing a CDx.

2:10 PM

Networking Break

TRACK 2: Methods to Identify and Develop Candidate CDx and Responders

2:25 PM

Discovery Systems Solutions - Lean case example for automation and workflow efficiencies

Jerry Catanese, Discovery Business Manager

Roche Diagnostics Corporation, Custom Biotech

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Discovery Systems Solutions - Lean case example for automation and workflow efficiencies

Significant opportunities exist in the Drug Target Discovery and Drug companion Development life cycle utilizing Lean initiatives, process mapping and automating labor intensive manual processes to improve efficiencies.  Lean metrics identify streamlining opportunities by process mapping, analyzing process lead time and other metrics to identify areas of waste for non-valued activities while focusing efforts on desired value add results.  This case study review focuses on a segment in the drug development process that can be considered in the biomarker development and drug companion pathway.

2:50 PM

Evolution of Testing: Partnering and multi-marker testing

Sarah Hersey, Head of Precision Medicine and Companion Diagnostics

Celgene

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Evolution of Testing: Partnering and multi-marker testing

The evolution of testing including pre-competitive partnering and multi-marker testing, can result in far-reaching benefits including improvement of research and innovation, public health, and public policy. This talk will provide an overview of the benefits and challenges of partnering, as well as examples of collaboration with external partners and consolidation of testing. Through establishment of robust methods for deployment in clinical trials, harmonization of assay methods and data analyses would allow for better guidance to patient management, which may include the possibility of establishing alternate endpoints and accelerating the advancement of scientific understanding and hopefully drug development.

3:15 PM

Adoption and Trends for Oncology Companion Diagnostics and Assay Technologies in Routine Clinical Care

Andrew Aijian, Principal

DeciBio Consulting

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Adoption and Trends for Oncology Companion Diagnostics and Assay Technologies in Routine Clinical Care

The pace of cancer biomarker research and companion diagnostic (CDx) partnerships continues to accelerate, driven by advancements for both therapies (e.g., immunotherapies, precision medicines) and assay technologies and methodologies (e.g., next-generation sequencing [NGS], multiplex analytical platforms, liquid biopsies).  There is, however, little data describing the real-world adoption of next generation biomarker assays, new analytical technologies, and CDx in routine clinical care. Our survey of oncologists, pathologists, and other oncology KOLs, as well as an analysis of our internal databases, sheds light on the levels of adoption of emerging assays and technologies, stakeholder expectations regarding assay centralization / decentralization, key market trends, and unmet needs with respect to biomarkers and diagnostics.  Key takeaways for diagnostic manufacturers will be shared.

3:40 PM

OncoBEAM and Plasma-SafeSeq Platforms: Highly Sensitive Liquid Biopsy Technologies from Clinical Trials to Clinical Practice

Daniel Edelstein, Director of Commercial Operations

Sysmex Inostics PLATINUM SPONSOR

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OncoBEAM and Plasma-SafeSeq Platforms: Highly Sensitive Liquid Biopsy Technologies from Clinical Trials to Clinical Practice

The OncoBEAM platform has been validated across various cancer types had has demonstrated high clinical sensitivity and specificity for somatic mutation detection and quantitation of mutant tumor DNA. This high sensitivity platform allows for accurate biomarker classification in patients with low mutant allelic fractions of ctDNA.   The OncoBEAM assays are available for CRO services and for Patient Testing globally in various cancer types. In 2016, the OncoBEAM RAS assay was launched as a global IVD kit for therapy selection and resistance detection, applications highlighting the current and future value of ctDNA testing in oncology. Plasma SafeSeq delivers a highly sensitive and comprehensive liquid biopsy tool for focused testing in specific tumor types and custom development for clinical trial needs.

4:05 PM

Networking Break

TRACK 3: Updates on Regulatory and Reimbursement topics

4:15 PM

PANEL: The Regulatory and Reimbursement Landscape: Where We Are and Where We Could Go

Panel Leader: Rob Dumanois, Scientific Manager, Reimbursement Strategy

Thermo Fisher Scientific

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PANEL: The Regulatory and Reimbursement Landscape: Where We Are and Where We Could Go

In light of recent FDA “breakthrough-indicated” Announcements, we convene a group of expert panelists to review and discuss the changing regulatory and reimbursement landscapes for In-Vitro Diagnostics (IVD) and Companion Diagnostics. Panelists will consider how differences among countries’ rules and regulations; value propositions; and payer approval processes affect decisions in a global marketplace. Implications for regulatory changes, shifts from fee-for-service to value-based reimbursement, and demands for evidence across the continuum of care settings will be discussed.

Alberto Gutierrez, Partner

FDA Partners LLC

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Laurie Howard, Vice President

LabCorp

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Aaron Schetter, Scientific Reviewer, Division of Molecular Genetics and Pathology

U.S. Food and Drug Administration

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Jennifer Dacpano-Komansky, Director, Regulatory Affairs & Precision Medicine

Novartis

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Debra Rasmussen, Senior Director, Global Regulatory Affairs, Diagnostic Leader

Janssen Diagnostics

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5:05 PM

Case Study: Companion Diagnostics Development: how to move to commercialization in a Precision Medicine World

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Case Study: Companion Diagnostics Development: how to move to commercialization in a Precision Medicine World

Panelists will discuss the real time development of a multi-pharma-DX partnership to launch a companion DX based on NGS data.  A real case study will be presented focusing on what was learned for use toward the next launch of a CDx with pharma, diagnostic, and CRO lab partners (e.g., what was planned to happen, what actually happened, what worked, what didn’t, and plans for future discussions and contracts).

 

Panelists will discuss their experience of working through the steps of coordinating a diagnostics, pharma, and CRO lab collaboration.   To promote a more streamlined and strategic planning approach to launching a companion diagnostic, collaborations need to be coordinated in advance to include partnership across the development and commercial sides of the business.  Our experience is that advanced planning will become even more critical in a challenging reimbursement and regulatory time with new platforms and technologies replacing traditional molecular testing.

Learning Objectives:

  1. How the initial development deal was structured and what were the planned outcomes and timelines
  2. What to do when partners change due to purchase or acquisition deals
  3. Launching new CDX on technology still struggling for reimbursement. How to pave the way to success and access
  4. Diagnostic and lab partnerships. Working towards commercialization together. Platform and kit availability/price along with risk share in reimbursement. What should contracts look for going forward
  5. How the pharma partner can bring diagnostic SME’s or precision medicine experts from within pharma to leverage resources
  6. How to plan and work together prior to launch for success in the lab and the clinic setting

A Multi-Year Collaboration with Pfizer Oncology and Thermo Fisher Scientific

Julie Ramage, Diagnostics SME

Pfizer

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A Multi-Year Collaboration with Pfizer Oncology and Thermo Fisher Scientific

In the ever evolving world of companion diagnostics, it’s increasingly important that development in pharma have a direct and open channel of communication into the commercialization area of diagnostics. It’s not just about choosing a partner for development purposes to get you through the labeling, the partner whether it be a diagnostics company, or specialty laboratory for a CDX developed assay, the strength and probability of commercialization must be heavily considered for a successful launch and uptake. By keeping an eye to market availability, reimbursement, and regulatory trends, pharma can do a better job of a cohesive commercialization of companion diagnostics versus a barrier to access situation

A Multi-Year Collaboration with Pfizer Oncology and Thermo Fisher Scientific

Brian Kelly, Global Director, Diagnostic Partnering

Thermo Fisher Scientific

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A Multi-Year Collaboration with Pfizer Oncology and Thermo Fisher Scientific

TBA

Implementation and experience with the commercial market for companion diagnostics

Kamala Maddali, Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics

Cancer Genetics

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Implementation and experience with the commercial market for companion diagnostics

TBA

5:45 PM

Day 1 Closing Remarks

Tom Fare, Director, Strategic Alliances

Planetconnect

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Day 1 Closing Remarks

TBA