Bell Works - Companion Diagnostics Forum - Companion Diagnostics … · 2019-05-15 · Companion...

FOCUSING ON CARE FOR THE PATIENT:PRECISION DIAGNOSTICS OPENS THE WAY TO PRECISION MEDICINE

Alberto GutierrezFormer Director, FDA Office of In Vitro Diagnostic Device Evaluation and Safety

John WagnerSenior Vice President, Head of Translational Research and Early ClinicalTakeda Pharmaceuticals

Laurie HowardVice President, Policy and Payer RelationsLabCorp

Join us for the 3rd Annual Companion Diagnostics Forum. This targeted forum focuses on key issues related to the growth of Companion Diagnostics. Talks on regulatory and reimbursement topics have been added to cover the basics and address new developments in this field.

www.companiondiagnosticsforum.com

FEATURED SPEAKERS INCLUDE

September 12 - 14, 2018 • Bell Works - Holmdel, NJ

Precision Diagnostics have played a critical role in the introduction of precision medicine in the clinic. Whereas first generation companion diagnostics have largely been single-analyte tests, researchers are now engaged in converting even more complex biology into novel drug therapies and next generation assays to treat a broader array of diseases. At the same time, biopharma companies are communicating with FDA and the Centers for Medicare & Medicaid Services to facilitate parallel approval and coverage determinations of these novel drugs and assays. A notable next generation example is CMS proposed coverage of the multi-gene F1CDx assay; this test is the second IVD to be approved and covered by the FDA and CMS under the Parallel Review Program. At this Forum, talks and topics will focus on the value of new and existing precision diagnostics from the development stage to reimbursement coverage as well as factors influencing the uptake of these technologies in healthcare.*For purposes of this event, Precision Diagnostics includes Companion Diagnostics (CDx), Laboratory- Developed Tests (LDT), and Complementary Diagnostics.

TOPICS EXPECTED TO BE COVERED INCLUDE:• Role of Precision Diagnostics in Precision Medicine• Tools for educating Physicians on Companion Diagnostics, Precision Medicine, and related products• Updates on FDA Regulatory topics and related issues• Experiences and expectations of Payers, Patients, and Patient Advocates on Reimbursement• Approaches to incentivize Adoption and Uptake of Companion Diagnostics and Precision Medicine by Physicians.• Representative from Patient Advocacy Groups on educational channels for patients to community Physicians and Clinics• Experiences of Patients who have used Companion Diagnostics• FDA path vs. LDT/CLIA: related issues, pros/cons, trade-offs WHAT IS A COMPANION DIAGNOSTIC? THE FDA’S DEFINITION:A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.Companion diagnostics can: identify patients who are most likely to benefit from a particular therapeutic product; identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product; or monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.

Companion Diagnostics (CDx) and Complementary Diagnostics have now been available for several years. Notable examples of Companion Diagnostics include Xalkori and Ventana ALK (D5F3) CDx Assay; Gleevec and Dako C-KIT PharmDx; Keytruda and Dako PD-L1 IHC 22C3 pharmDx; Tarceva and cobas® EGFR Mutation Test v2; and Herceptin and Pathvysion HER-2 DNA Probe Kit. Not only must CDx-drug pairs demonstrate therapeutic utility, Pharma/Biotech and their business partners must realize net financial benefits.

FOCUS FOR 2018

September 12-14, 2018 • Bell Works in Holmdel, NJ

www.companiondiagnosticsforum.com | +1 732-933-9473 | #CompanionDiagnosticsForum https://www.linkedin.com/groups/12063094 | Email: [email protected]

Andrew AijianPrincipalDeciBio Consulting

Steve AndersonChief Scientific Officer and Senior Vice PresidentCovance

Jerry CataneseDiscovery Business ManagerRoche

Nic DracopoliSenior Vice President, Translational SciencePersonal Genome Diagnostics

Jeff AllardPresidentLakeside Life Science

Andy BeckCo-founder and CEOPathAI

Rob DumanoisManager of Reimbursement StrategyThermo Fisher Scientific

Flora BerishaDirector Companion DiagnosticsDaiichi Sankyo

Jennifer Dacpano-KomanskyDirector, Regulatory Affairs & Precision MedicineNovartis

Daniel EdelsteinDirector of Commercial OperationsSysmex Inostics

SPEAKERS

Carrie BrodmerkelHead, Immunology BiomarkersJanssen Pharmaceutical

Joseph FerraraCEOBoston Healthcare Associates



Grace KimManager, Business Development & Alliance Management - Companion DiagnosticsAgilent Technologies

Kamala MaddaliVice President, Biopharma Collaborations, Market Development and Companion DiagnosticsCancer Genetics

Laurie HowardVice President, Policy and Payer RelationsLabCorp

Chris MajorDirector of Oncology DiagnosticsJanssen Pharmaceuticals

Federico GoodsaidPresidentRegulatory Pathfinders

Seamus KearneyCEOARC Regulatory

George LeeDigital Pathology Informatics LeadBristol-Myers Squibb

Mike MontaltoExecutive Director and Head of Translational Pathology, Clinical Biomarker Laboratories, Translational MedicineBristol-Myers Squibb

Edmund PezallaFounder and CEOEnlightenment Bioconsult

SPEAKERS

Felix FruehExecutive PartnerOpus Three

Alberto GutierrezFormer Director, FDA Office of In Vitro Diagnostic Device Evaluation and Safety

Sarah HerseyHead of Precision Medicine and Companion DiagnosticsCelgene



Debra RasmussenSenior Director, Global Regulatory Affairs, Diagnostic LeaderJanssen Diagnostics

Gary SpitzerConsultantStrategic Medical Testing Services

Adriane ZernheltTranslational Biomarkers OperationMerck & Co.

Oscar PuigChief Scientific OfficerPhosphorus

Aaron SchetterScientific Reviewer, Division of Molecular Genetics and PathologyU.S. Food and Drug Administration

John WagnerSenior Vice President, Head of Translational Research and Early ClinicalTakeda Pharmaceuticals

Xiaolei XuDirector of Global Regulatory AffairsAgilent

Julie RamageNational Accounts Director, Diagnostics, OncologyPfizer

Agnes SeydaDirector, Precision Medicine and Companion DiagnosticsCelgene

Steven WalkerHead of Product ManagementAlmac Diagnostics

SPEAKERS

James WangBusiness Development ExecutiveACD Bio



CONFERENCE DAY ONESeptember 13, 2018

8:00 AM Registration and Continental Breakfast9:00 AM Welcome and Logistics Alberto Gutierrez Partner FDA Partners LLC

9:10 AM Keynote Presentation FDA’s Precision Medicine Initiative: Achievements and Challenges

Steve Anderson Chief Scientific Officer and Senior Vice President Covance

9:45 AM Precision Medicine:The Development Continuum from Biomarker Discover to Companion Diagnostics

Sarah Hersey Head of Precision Medicine and Companion Diagnostics Celgene

10:10 AM TBA

Nic Dracopoli Senior Vice President, Translational Science Personal Genome Diagnostics

10:35 AM Predicting Response to Checkpoint Inhibitors

Laurie Howard Vice President, Policy and Payer Relations LabCorp

11:00 AM From Coverage to Reimbursement: Coverage and reimbursement for new technology

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 Carrie Brodmerkel Head Immunology Biomarkers Janssen Pharmaceutical

12:30 PM Companion Diagnostics in Autoimmune Disorders: Improving Outcomes Through Personalized Medicine

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

12:55 PM Patient-Centered Reverse Translation



Steve Walker Head of Product Management Almac Diagnostics

1:20 PM Diagnostic Solutions for Biomarker Driven Multi-Arm Clinical Trials

Grace Kim Business Development and Alliance Manager - Companion Diagnostics Agilent Technologies

1:45 PM Navigating late stage CDx Co-Development

2:10 PM Networking Break

TRACK 2: Methods to Identify and Develop Candidate CDx and Responders Jerry Catanese Discovery Business Manager Roche

2:25 PM Discovery Systems Solutions - Lean case example for automation and workflow efficiencies

Agnes Seyda Director Precision Medicine and Companion Diagnostics Celgene

2:50 PM Criteria for selection/inclusion of biomarkers in the drug development process

Andrew Aijian Principal DeciBio Consulting

3:15 PM Adoption and Trends for Emerging Oncology Companion Diagnostics and Assay Technologies in Routine Clinical Care

Daniel Edelstein Director of Commercial Operations Sysmex Inostics

3:40 PM OncoBEAM and Plasma-SafeSeq Platforms: Highly Sensitive Liquid Biopsy Technologies from Clinical Trials to Clinical Practice

4:10 PM Networking Break



TRACK 3: Updates on Regulatory and Reimbursement topics MODERATOR: Felix Frueh Executive Partner Opus Three

4:15 PM PANEL: The landscape is changing - How are the different stakeholders responding?

5:05 PM

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

Julie Ramage Diagnostics SME Pfizer

Starting up companion diagnostics activities in pharma

Rob Dumanois Scientific Manager, Reimbursement Strategy Thermo Fisher Scientific

Role of diagnostics companies in driving CDx to the market

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

Implementation and experience with the commercial market for companion diagnostics

Tom Fare Director, Strategic Alliances PlanetConnect

5:45 PM Day 1 Closing Remarks

Alberto Gutierrez PartnerFDA Partners LLC

Rob Dumanois, Scientific Manager, Reimbursement StrategyThermo Fisher Scientific

Laurie Howard Vice PresidentLabCorp

Jennifer Dacpano-Komansky Director, Regulatory Affairs & Precision MedicineNovartis

Aaron Schetter Scientific Reviewer, Division of Molecular Genetics and PathologyU.S. Food and Drug AdministrationDebra Rasmussen Senior Director, Global Regulatory Affairs, Diagnostic LeaderJanssen Diagnostics



CONFERENCE DAY TWOSeptember 14, 2018

8:00 AM Registration and Continental Breakfast9:00 AM Welcome and Logistics

TRACK 4: Companion Diagnostics in the Clinic James Wang Business Development Executive ACD Bio

9:05 AM RNAscope ISH for CDx Biomarker Development Programs

Seamus Kearney CEO ARC Regulatory

9:30 AM CDx/Rx Regulatory Pathways in the EU

Chris Major Director of Oncology Diagnostics Janssen Pharmaceuticals

9:55 AM Analytical Concordance between a Clinical Trial Assay and an IVD Companion Diagnostic Assay

Flora Berisha Director Companion Diagnostics Daiichi Sankyo

10:20 AM How does Pharma address the challenges of CDx test adoption?

10:45 AM Networking Break

TRACK 5: Precision Diagnostics - Genomic Analysis, Digital Technologies and Digital Pathology Imaging George Lee Digital Pathology Informatics Lead Bristol-Myers Squibb

11:00 AM Role of Digital Pathology in CDx and Immuno-oncology

Mike Montalto Executive Director & Head of Translational Pathology & Clinical Biomarker Laboratories in Translational Medicine Bristol-Myers Squibb

11:25 PM The Promise and Challenges of Pathology Imaging: Artificial Intelligence as a Companion Diagnostic for Immuno-oncology

Andy Beck Co-founder and CEO PathAI

11:50 AM Artificial Intelligence for Immuno-oncology Pathology: From Discovery to AI-powered Companion Diagnostics

Oscar Puig Chief Scientific Officer Phosphorus

12:15 PM The Role of Laboratory Developed Tests in Clinical Diagnosis



12:40 PM Lunch and Networking

TRACK 6: Regulatory Issues and Launching CDx into the Clinic Joseph V. Ferrara CEO Boston Healthcare Associates

1:45 PM Companion Diagnostics in Immuno-Oncology: Global Commercial and Partnership Consideration

Gary Spitzer, Partner & Consultant Strategic Medical Testing Services

2:10 PM Can We Use Clinical Validated Data To Substitute For Clinical Utility? What Are Alternatives To Coverage With Evidence Development?

Xiaolei Xu Director Global Regulatory Affairs/Companion Diagnostics Agilent

2:35 PM Successes and challenges in pre-market registration and approval of Companion Diagnostic in global markets

Jeff Allard President Lakeside Life Science

3:00 PM Connecting Patients with Biomedical Research - Biospecimens Basic

Panel chair: Jeff Allard, President Lakeside Life Science

3:25 PM PANEL: Connecting Patients with Biomedical Research: Enrollment and Acquiring Biospecimen

Tom Fare Director, Strategic Alliances PlanetConnect

3:55 PM Closing Remarks

Joseph Ferrara CEOBoston Healthcare Associates

Adriane Zernhelt, Translational Bio-markers OperationsMerck & Co.



PRE CONFERENCE WORKSHOPSeptember 12, 2018

Time: 1:00 PM – 5:00 PMWORKSHOP: THE EVOLVING COMPANION DIAGNOSTICS LANDSCAPE: AN IN-DEPTH LOOK AT REGULATORY AND REIMBURSEMENT ASPECTS OF COMPANION DIAGNOSTICS Moderator: Felix Frueh, Executive Partner, Opus ThreeFees: Free for paid event attendees, $250 for othersCompletion Credit: No CME but provide Certificate of Completion

Discussion Leaders:Felix Frueh, Executive Partner, Opus ThreeFederico Goodsaid, Associate Partner, Opus ThreeEdmund Pezalla, Founder & CEO, Enlightenment Bioconsult

Workshop Objectives:This four-hour workshop is intended to be an interactive educational experience focused on discussing the frontiers of regulatory and reimbursement aspects for the development of novel biomarkers and companion diagnostics.

Part 1. Do I need a Companion Diagnostic? (Felix Frueh)Companion diagnostics are required where the diagnostic has been integral for the development of the therapeutic. This is the case with biomarkers for the selection of patients with an increased likelihood of response to therapy. However, not all uses of biomarkers or diagnostics associated with drug therapies have such a requirement. Information derived from the diagnostic may simply provide additional insights to evaluate or adjust a particular therapy, for example, the diagnostic may inform about potential dose adjustments, confirm disease, or for other uses. An accurate context of how the diagnostic test is used during drug development is critical: while companion diagnostics may significantly improve the efficacy rate (e.g. by exclusion of likely non-responders), they may also limit the market for a new therapy. Other diagnostic classifications such as “complementary” could be more appropriate. An exhaustive evaluation of which type of use is appropriate needs to be considered early in development and should be discussed with regulators to assure a smooth development of the therapy in question and to avoid surprises at the time of market approval. This presentation will discuss different factors to consider in a decision about whether or not a companion diagnostic classification is accurate and whether alternative classifications are appropriate.

Part 2. An In-depth Look At Regulatory And Reimbursement Aspects Of Companion Diagnostics (Felix Frueh, Fed-erico Goodsaid, Edmund Pezalla)

Companion diagnostics have evolved in the past few years, moving from one-marker/one-drug paradigm to more complex models including multi-gene, multi-panel products. Both regulators and payers are adapting and developing new guidance and policies. The regulatory response to this change is reflected in a sequence of approvals from CDRH over the past two years. It is of particular interest to evaluate where and how these tests are run, how they are interpreted, and the claims in-cluded in the product label. These case studies illustrate a nuanced new regulatory approach to companion diagnostics, and a redefinition of the product development and regulatory submission criteria for their success. Similarly, payers are adapting and have been developing new coverage and reimbursement policies for both diagnostics and pharmaceuticals to stream-line the process without hindering patient access. Workshop participants will walk away with a better understanding of the different regulatory pathways along with an appreciation of the payer landscape both of which drives better decision making in clinical development and are necessary for a successful commercialization strategy.

Workshop attendance is free for paid attendees of the Companion Diagnostics Forum, otherwise it is $250 for the Workshop (you will receive a separate invoice in that case).



READY TO REGISTER?3 EASY WAYS TO BOOK WWW.COMPANIONDIAGNOSTICSFORUM.COM/REGISTER

TEL: 732-933-9473

EMAIL: [email protected]

Improve the translational develop-ment of exploratory biomarkers and truly define your patient population

Demonstrate clinical viability of your predictive biomarkers

Optimize your Strategic Decisions making to ensure drug and companion diagnostic commercialization success

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SECURE YOUR PLACE

Package Details Pre-EventRegistration

At The Door

Conference Only $1,495 $1,695Academic, Government and non-employed/Retired discounts for Attendee Passes are available on request.

If you are interested in joining the pre-conference workshops please register at www.companiondiagnosticsforum.com/workshops/

Workshop attendance is free for paid attendees of the Companion Diagnostics Forum, otherwise it is $250 for the Workshop.

TERMS & CONDITIONSFull payment is due on registration. Cancellation and Substitution Policy: Cancellations must be received in writing. If the cancellation is received more than 14 days before the conference attendees will receive a full credit to a future conference. Cancellations received 14 days or less (including the fourteenth day) prior to the conference will be liable for the full fee. A substitution from the same organization can be made at any time.

Privacy Policy: The personal information shown and/or provided by you will only be used to update you occa-sionally on events of interest. Photographs taken at this event which may include your image may be used in future promotional materials. If you do not wish your details or photos including your image to be used for this purpose, please write to:[email protected].

REGISTER 3 - 4th IS FREE: Individuals must register for the same conference or conferencecombination and submit completed registration form together for discount to apply.

Group Discounts: Discounts are available for multiple at-tendees from the same organization. For more information on group rates contact us at [email protected].

VENUEBell Works, Holmdel

101 Crawfords Corner Road

Holmdel NJ 07733

(732) 226-8818

REGISTER 3 ATTENDEES AND GET A 4TH ATTENDEE FREE

Bell Works - Companion Diagnostics Forum - Companion Diagnostics … · 2019-05-15 · Companion...

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