BDA WORKSHOP PROGRAMME. HOW TO MATURE EMERGING TECHNOLOGIES INTO COMPANION DIAGNOSTICS December 2013 BRUSSELS, BELGIUM

Transcription

1 BDA WORKSHOP HOW TO MATURE EMERGING TECHNOLOGIES INTO COMPANION DIAGNOSTICS December 2013 BRUSSELS, BELGIUM PROGRAMME BIOTHERAPY DEVELOPMENT ASSOCIATION

2 Content The Biotherapy Development Association Introduction 4 The Biotherapy Development Association 3 Meeting Objectives 4 Workshop Chairs 4 Who should attend? 5 Workshop Venue 5 Who we are The Biotherapy Development Association (BDA) is a not-for-profit organization. Our mission is to provide a unique platform to facilitate inter actions between all stakeholders: academia, regulatory authorities, the pharmaceutical industry, patient advocates and policymakers in order to improve the efficiency of cancer drug development. Programme Thursday 6 and 7 Programme Friday 8 and 9 Programme Overview 10 Upcoming Events 11 Secretariat 12 Our approach We organize regular meetings and workshops where all stake holders can meet and discuss the latest challenges in oncology drug development with the goal to create an ideal scientific, regulatory and commercial environment for the development of cancer drugs. Contact For further information please contact our secretariat : Ms. Marjorie Recorbet The Biotherapy Development Association Avenue Mounier, Brussels Belgium Phone: marjorie.recorbet@ecco-org.eu For more information about BDA, please visit our website: 2 3

3 Introduction There is a high unmet need for novel technologies as companion diagnostics to allow for treatment decisions regarding monitoring, stratification and selection of patients (e.g. next generation sequencing, blood based technologies). An increasingly number of innovative technologies is available through a combination of established diagnostic and technology companies along with emerging diagnostic start-up companies. However there is a significant hurdle to bring these technologies to the clinic due to various reasons (e.g. regulatory challenge, no global reach/global install base, established requirements to qualify and validate such technologies and limited commercialization capabilities). Who should attend? Representatives from Academia Pharmaceutical Companies, Mature Diagnostic Companies, Diagnostic Start-Up- Companies Representatives from Regulatory Authorities (EMA, FDA) Investors Payers Meeting Objectives This workshop should discuss the current hurdles, requirements and specific recommendation for consideration in defining a way forward on how to move these emerging technologies from discovery and research applications efficiently into the companion diagnostic space. A paper will be published after the workshop. Workshop Venue Hotel Dolce La Hulpe - Brussels 135, Chaussée de Bruxelles 1310 La Hulpe Belgium 20 min taxi from Brussels Zaventem Airport 30 min taxi from Brussels train station (Gare du Midi) Workshop Chairs Silvia Marsoni (Institute for Cancer Research, Italy) Terri Ozegovich (Novartis, USA) Joachim Reischl (Bayer, Germany) 4 5

4 Programme Thursday, 12 December 2013 Thursday, 12 December :00 WELCOME & INTRODUCTION Room IMBUIA, 1st floor Silvia Marsoni (Institute for Cancer Research, Italy) Joachim Reischl (Bayer, Germany) Francesco Pignatti (The European Medicines Agency, UK) SESSION 1 - TECHNOLOGICAL LANDSCAPE OF EMERGING TECHNOLOGIES SESSION 2 - REGULATORY LANDSCAPE Moderators: Silvia Marsoni (Institute for Cancer Research, Italy) Bill Pignato (Novartis, USA) 17:00 Commercialization of New Technologies Gert Bos (BSI, UK) Moderators: Leif Håkansson (University of Lund, Sweden) Joachim Reischl (Bayer, Germany) 17:15 Industry view Bill Pignato (Novartis, USA) 14:20 Emerging Technologies into CDx Alex Vadas (L.E.K. Consulting, USA) 14:35 Next Generation Sequencing Nitin Udar (Illumina, USA) 14:50 Circulating Tumor Cells Theresa Pattery (Janssen Diagnostics BVBA, Belgium) 15:05 Circulating Tumor DNA Frank Diehl (Sysmex Inostics, Germany) 15:20 Preanalytical validation of samples Ralf Wyrich (Qiagen, Germany) 15:35 Statistcal challenges and solutions to validate emerging technologies James Dunyak (Novartis, USA) 17:30 EMA view Francesco Pignatti (European Medicines Agency, UK) 17:45 FDA view Elisabeth Mansfield (FDA, USA) via videoconference 18:00 DISCUSSION Moderators: Francesco Pignatti (The European Medicines Agency, UK) Bill Pignato (Novartis, USA) 19:15 CLOSING REMARKS by workshop chairs 20:00 Reception and Networking Dinner Hotel Restaurant BRASSERIE :00 END OF DAY 1 PROGRAMME 15:50 DISCUSSION Moderators: Heinz Zwierzina (Innsbruck Medical University, Austria) Joachim Reischl (Bayer, Germany) 16:30 Break ecoffee, ground floor 6 7

5 Programme Friday, 13 December 2013 Friday, 13 December 2013 Room IMBUIA, 1st floor SESSION 4 - WRAP UP & NEXT STEPS 8:45 Tests for immunotherapeutic efficacy - do they exist? Leif Hakansson (University of Lund, Sweden) SESSION 3 - ACCESIBILITY LANDSCAPE 11:45 Planning of the next workshop Moderators: Workshop chairs 12:30 END OF DAY 2 PROGRAMME Moderators: Lothar Bergmann (Frankfurt University Hospital, Germany) Terri Ozegovich (Novartis, USA) 12:30 Lunch ecoffee, ground floor 9:15 Centralized testing/government supported Ian Walker (Cancer Research UK) 9:30 IVD kits To be announced 9:45 A clinician s point of view Heinz Zwierzina (Innsbruck Medical University, Austria) 10:00 Developing complex tests for guiding therapeutic choices: A case study from a diagnostics developer Dominic Spinella (Biodesix, USA) 10:15 DISCUSSION Moderators: Lothar Bergmann (Frankfurt University Hospital, Germany) Terri Ozegovich (Novartis, USA) 11:00 Break ecoffee, ground floor 8 9

6 Programme Overview Thursday, 12 December 2013 Friday, 13 December 2013 Upcoming Events It is a UNIQUE OPPORTUNITY to address hurdles and explore potential solutions together with experts from ACADEMIA, INDUSTRY, REGULATORY AUTHORITIES, PATIENT ADVOCATES and POLICYMAKERS. 8:45 Special lecture 9:15 SESSION 3 ACCESIBILITY LANDSCAPE HOW TO MATURE EMERGING TECHNOLOGIES INTO COMPANION DIAGNOSTICS DECEMBER 2013 BRUSSELS, BELGIUM 13:00 Registration opens 10:15 Discussion 11:15 Break 11:45 SESSION 4 WRAP UP & NEXT STEPS 12:30 End of 2 programme 14:00 Welcome & Introduction 12:30 Lunch 14:20 SESSION 1 TECHNOLOGICAL LANDSCAPE Landscape analysis (overview on companies and technologies) Technical, analytical and clinical validation requirements Regulatory challenges/needs and how to efficiently address them How to ensure global access to emerging technologies ACCESS TO INNOVATIVE ONCOLOGY MEDICINES IN EUROPE JANUARY 2014 BONN, GERMANY Evaluation requirements for regulatory and reimbursement bodies Study comparator required by EMA and reimbursement authorities Acceptance of endpoints by EMA and reimbursement authorities Patients perspective 10 15:50 Discussion 16:30 Break 17:00 SESSION 2 REGULATORY LANDSCAPE 18:00 Discussion 19:15 Closing Remarks 20:00 Networking dinner 22:00 End of day 1 programme ITOC-1: 1 st IMMUNOTHERAPY OF CANCER CONFERENCE MARCH 2014 MUNICH, GERMANY Translational research Drug development strategies and biomarkers Cancer-related immune suppression Monitoring combination therapy Clinical trials Vaccines 8 TH ALPINE MEETING: CURRENT & FUTURE CHALLENGES OF ONCOLOGY DRUG DEVELOPMENT OCTOBER 2014 BUCHEN/INNSBRUCK, AUSTRIA Biomarkers for immunotherapies Minimal residual disease Paediatric oncology Oncology drug development for the geriatric population

7 BDA WORKSHOP HOW TO MATURE EMERGING TECHNOLOGIES INTO COMPANION DIAGNOSTICS December 2013 BRUSSELS, BELGIUM Workshop Secretariat Ms. Marjorie Recorbet Biotherapy Development Association (BDA) Coordinator Avenue Mounier, Brussels, Belgium Direct phone marjorie.recorbet@ecco-org.eu BIOTHERAPY DEVELOPMENT ASSOCIATION