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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
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]
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
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]
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
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]
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
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]
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
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]
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
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]
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
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]
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.
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]
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).
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]
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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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