How to faster integrate new technologies into clinical practice
|
|
|
- Maurice Young
- 5 years ago
- Views:
Transcription
1 How to faster integrate new technologies into clinical practice 31JAN2017 Jens Bjørheim, CMO Ultimovacs Nordic Trial Alliance Stakeholders meeting
2 2 Oncology New drugs Landscape The current buzz Basket Studies Precision Medicine Stratified Medicine Companion Diagnostics Multiplex Diagnostics Next Generation Sequencing Theranostics Multi-drug Studies Molecularly Matched Umbrella Studies Personalised Healthcare Hyper-segmentation Patient Selection Immune therapy
3 3 Oncology Landscape Science is showing the way Enhanced disease understanding Move towards molecular classification 60 yrs...disease of the blood... ~0 % 50 yrs 40 yrs Chronic leukaemia Acute leukaemia Preluekaemia Leukaemia or Lymphoma Indolent lymphoma Aggressive lymphoma 5 yr survival Tissue of Origin Today ~ 38 Leukaemia s... ~ 51 Lymphoma s... Acute myeloid (~12 types) Acute lymphoblastic (2 types) Acute promyelocytic (2 types) Acute monocytic (2 types) Acute erythroid (2 types) Acute megakaryoblastic Acute myelomoncytic (2 types) Chronic myeloid Chronic myeloproliferative disorders (5 types) Myelodysplastic syndromes (6 types) Mixed myeloproliferative/myelodysplas ticsyndromes (3 types) Mature B-cell (~14 types) Mature T-cell (15 types) Plasma cell neoplasm (3 types) Immature (precursor) (2 types) Hodgkin s (5 types) Immunodeficiency associated (~5 types) Other haematolymphoid neoplasms (~7 types) 70% Molecular Pathway
4 4 Oncology Landscape Growing understanding of stratification 1 3 Breast Central nervous system Endocrine Gastrointestinal Gynaecologic Head and neck Haematologic Skin Soft tissue Thoracic Urologic 2 4 Etc...
5 Oncology Landscape Drugging the hallmarks 5 Hallmarks of Cancer: The Next Generation. Douglas Hanahan & Robert A. Weinberg. Cell 144, March 4, 2011
6 Oncology Landscape Targeted therapeutics are improving survival 6 Example: NSCLC is an evolving landscape Where we re going... Overall Survival (months)
7 7 Oncology Landscape Biomarkers in clinical development... Hallmarks of Cancer: The Next Generation. Douglas Hanahan & Robert A. Weinberg. Cell 144, March 4, 2011
8 8 HER Signalling Is Altered In Cancer We have a small molecule inhibitor... Inhibitor Adapted from KinaseChem.com (Copyright 2013 Kinasechem.LTD.) Now pick a biomarker
9 Reality Of Drug Development Precision and cost 9 ABPI Delivering Value in the UK Report 2014
10 Stratified Medicine Why should we be interested? 10 Drivers for stratified medicine... Society: effective and sustainable healthcare systems, medicines faster to market Patient/physician: scientific/technological advances new disease classification Pharmaceutical industry: challenges better medicines, better precision, lower cost, diagnosis
11 11 Stratified Medicine Requires Portfolio Approach Lung adenocarcinoma squamous
12 12 Linkage, efficacy biomarkers, patient selection...
13 13 Oncology Landscape Transforming environment August FDA approves crizotinib with companion diagnostic for a type of late-stage lung cancer Key genetic driver abnormal anaplastic lymphoma kinase gene The drug had accelerated approval due to clear efficacy and ability to treat only those patients likely to respond
14 14 Oncology Landscape The current buzz Basket Studies Precision Medicine Stratified Medicine Companion Diagnostics Multiplex Diagnostics Next Generation Sequencing Theranostics Multi-drug Studies Molecularly Matched Umbrella Studies Personalised Healthcare Hyper-segmentation Patient Selection
15 15 Stratified Medicine In Drug Development Basket studies offer a practical solution Choosing the patient for the trial Baskets choose the trial for the patient Trial 1 Trial 2 Trial 3 Basket portfolio, multidrug, umbrella, etc...
16 16 Basket Studies In Lung Cancer MATRIX National Lung Trial CRUK MATRIX National Lung Cancer Trial Cancer Research UK Outline protocol NSCLC, >1L Ph.2a, signal seeking, single arm, mono-tx 2-stage Bayesian design (total n=30 pts), using ORR and PFS National screening programme screening 2,000 pts/year rolling Modular design, over-arching protocol Allows drop-in and drop-out Illumina NGS plus bespoke tissue pathology for screening Screening delivered via 3 technical hubs, routine clinical molecular pathology service Currently includes up to 12 AZ compounds, 2 compounds from Pfizer
17 Basket Studies In Lung Cancer MATRIX National Lung Trial CRUK 17 Adenocarcinoma MATRIX National Lung Cancer Trial Cancer Research UK PI3K/AKT deregulation AKT1 FGFR LKB1 TSC1/2 CDK4 amplification CCND1 amplification KRAS MET amplification ROS1 gene fusions EGFRm+ & T790M+ NF1 NRAS No actionable change A3 A6 B1 C1 C2 D2 D3 D4 E1 E2 F1 G2 G3 H1 Starting line-up... AZD5363 AZD4547 AZD2014 Palbociclib Crizotinib AZD9291 Selumetinib + Docetaxel MEDI4376 Squamous cell carcinoma PIK3CA PIK3CA amplification PTEN PTEN loss AKT1 FGFR LKB1 TSC1/2 Rb-wildtype and homozygous p16 loss CDK4 amplification CCND1 amplification MET amplification ROS1 gene fusions EGFRm+ & T790M+ NF1 NRAS No actionable change A1 A2 A4 A5 A6 B2 C1 C2 D1 D2 D3 E1 E2 F1 G1 G3 H1 AZD5363 AZD4547 AZD2014 Palbociclib Crizotinib AZD9291 Selumetinib + Docetaxel MEDI4376
18 18 Diagnostics A Changing Landscape Single assays are becoming obsolete... Consider Many molecular segments, accurate diagnosis requires multiple markers Running multiple, serial or parallel assays impractical / impossible Limits of tissue less with line of therapy What order Etc...
19 19 Diagnostics A Changing Landscape Next Generation Sequencing (NGS)...
20 20 Conclusion 1. Innovative clinical trials to more effectively and efficiently identify patients who are predicted to be responders Trial designs Diagnostics Drug development 2. Allow wider (and earlier) patient access to novel therapeutics from multiple Pharma companies 3. Leverage cutting-edge diagnostics to robustly identify the right patients with more efficient use of biopsy material 4. Exploit new types of dataset in regulatory approval process 5. Enable patient access through new and more robust diagnostic standards To faster integrate new technologies into clinical practice
Oncology Drug Development
Oncology Drug Development Advantages and challenges of using stratified clinical studies Simon J Hollingsworth The 18th Anti-Tumour Drug Development Forum 21 February Japan Stratified Medicine In The Clinic
Multi-drug phase II trial in non-small cell lung cancer
Multi-drug phase II trial in non-small cell lung cancer Sponsor: University of Birmingham Chief Investigator: Gary Middleton Chief Biostatistician: Lucinda Billingham Lead Investigators: Sanjay Popat,
Multi-drug, genetic-marker-directed, non-comparative, multi-centre, multi-arm phase II trial in non-small cell lung cancer
Multi-drug, genetic-marker-directed, non-comparative, multi-centre, multi-arm phase II trial in non-small cell lung cancer Sponsor: University of Birmingham Chief Investigator: Gary Middleton Chief Biostatistician:
How Personalized Medicine is Changing the Biopharmaceutical Marketplace
How Personalized Medicine is Changing the Biopharmaceutical Marketplace Marc Chioda, PharmD Associate Medical Director, Pfizer Oncology. Presentation to the Cancer Action Coalition of Virginia January
5 th July 2016 ACGS Dr Michelle Wood Laboratory Genetics, Cardiff
5 th July 2016 ACGS Dr Michelle Wood Laboratory Genetics, Cardiff National molecular screening of patients with lung cancer for a national trial of multiple novel agents. 2000 NSCLC patients/year (late
Next Generation Sequencing in Clinical Practice: Impact on Therapeutic Decision Making
Next Generation Sequencing in Clinical Practice: Impact on Therapeutic Decision Making November 20, 2014 Capturing Value in Next Generation Sequencing Symposium Douglas Johnson MD, MSCI Vanderbilt-Ingram
Delivering Value Through Personalized Medicine: An Industry Perspective
Delivering Value Through Personalized Medicine: An Industry Perspective Josephine A. Sollano, Dr.PH Head, Global HEOR and Medical Communications Pfizer Oncology, NY, USA josephine.sollano@pfizer.com What
Looking Beyond the Standard-of- Care : The Clinical Trial Option
1 Looking Beyond the Standard-of- Care : The Clinical Trial Option Terry Mamounas, M.D., M.P.H., F.A.C.S. Medical Director, Comprehensive Breast Program UF Health Cancer Center at Orlando Health Professor
Giorgio V. Scagliotti Università di Torino Dipartimento di Oncologia
Giorgio V. Scagliotti Università di Torino Dipartimento di Oncologia giorgio.scagliotti@unito.it Politi K & Herbst R. Clin. Cancer Res. 2015; 21:2213 Breast Colorectal Gastric/GE Junction Tumor Type Head
Basket Trials: Features, Examples, and Challenges
: Features, s, and Challenges Lindsay A. Renfro, Ph.D. Associate Professor of Research Division of Biostatistics University of Southern California ASA Biopharm / Regulatory / Industry Statistics Workshop
Squamous Cell NSCLC: Differentiating Between Progression and Pseudoprogression
Squamous Cell NSCLC: Differentiating Between Progression and Pseudoprogression David R. Spigel, M.D. Program Director, Lung Cancer Research Sarah Cannon Research Institute Nashville, TN Case of NR: Initial
Molecular Testing in Lung Cancer
Molecular Testing in Lung Cancer Pimpin Incharoen, M.D. Assistant Professor, Thoracic Pathology Department of Pathology, Ramathibodi Hospital Genetic alterations in lung cancer Source: Khono et al, Trans
Personalised Healthcare. will it deliver? Bob Holland Head of Personalised Healthcare & Biomarkers Innovative Medicines AstraZeneca R&D
Personalised Healthcare x will it deliver? Bob Holland Head of Personalised Healthcare & Biomarkers Innovative Medicines AstraZeneca R&D Personalised Healthcare It is delivering! Bob Holland Head of Personalised
ECMC cfdna consensus meeting
ECMC cfdna consensus meeting State of the art for cfdna technologies 24 th November 2014 Applications of ctdna analysis for drug development Potential of ctdna analysis to: Identify the right patients
Dr Yvonne Wallis Consultant Clinical Scientist West Midlands Regional Genetics Laboratory
Dr Yvonne Wallis Consultant Clinical Scientist West Midlands Regional Genetics Laboratory Personalised Therapy/Precision Medicine Selection of a therapeutic drug based on the presence or absence of a specific
Relevance of Innovative Trial Design Today. Basket of Baskets and other Innovative Clinical Trials
Relevance of Innovative Trial Design Today Basket of Baskets and other Innovative Clinical Trials Outline Precision Medicine Clinical Trials Evolving Field Classic industry-sponsored design: single drug,
Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document.
The National Lung Matrix Trial : translating the biology of stratification in advanced non-small-cell lung cancer Middleton, Gary; Llewellyn, Laura; Popat, S; Swanton, C; Hollingsworth, S J; Buller, R;
New Avenues for the development and evaluation of therapy: Complex, multi-pronged, not one size fitting all
New Avenues for the development and evaluation of therapy: Complex, multi-pronged, not one size fitting all Antoine Yver MD MSC Senior VP & Head Oncology Global Medicines Development AstraZeneca, Gaithersburg
The Pathology of Neoplasia Part II
The Pathology of Neoplasia Part II February 2018 PAUL BOGNER, MD A S S O C I A T E P R O F E S S O R O F O N C O L O G Y P A T H O L O G Y A N D D E R M A T O L O G Y Clinical goals of cancer pathology
Development of Circulating Tumor DNA
Development of Circulating Tumor DNA Title of presentation Arial Bold 30pt in White Biomarkers Secondary title 22pt using Arial Next in White Generation Sequencing Brian Dougherty PhD, MBA Translational
Osamu Tetsu, MD, PhD Associate Professor Department of Otolaryngology-Head and Neck Surgery School of Medicine, University of California, San
Osamu Tetsu, MD, PhD Associate Professor Department of Otolaryngology-Head and Neck Surgery School of Medicine, University of California, San Francisco Lung Cancer Classification Pathological Classification
IRESSA (Gefitinib) The Journey. Anne De Bock Portfolio Leader, Oncology/Infection European Regulatory Affairs AstraZeneca
IRESSA (Gefitinib) The Journey Anne De Bock Portfolio Leader, Oncology/Infection European Regulatory Affairs AstraZeneca Overview The Drug The Biomarker and Clinical Trials Sampling Lessons Learned The
ALK Inhibition: From Biology to Approved Therapy for Advanced Non-Small Cell Lung Cancer
ALK Inhibition: From Biology to Approved Therapy for Advanced Non-Small Cell Lung Cancer Dr. Ben Solomon Medical Oncologist, Thoracic Oncology Peter MacCallum Cancer Centre Melbourne, Australia Dr. D.
Clinical Grade Genomic Profiling: The Time Has Come
Clinical Grade Genomic Profiling: The Time Has Come Gary Palmer, MD, JD, MBA, MPH Senior Vice President, Medical Affairs Foundation Medicine, Inc. Oct. 22, 2013 1 Why We Are Here A Shared Vision At Foundation
What is the status of the technologies of "precision medicine?
Session 2: What is the status of the technologies of "precision medicine? Gideon Blumenthal, MD, Clinical Team Leader, Thoracic and Head/Neck Oncology, Center for Drug Evaluation and Research (CDER), U.S.
Molecular Targets in Lung Cancer
Molecular Targets in Lung Cancer Robert Ramirez, DO, FACP Thoracic and Neuroendocrine Oncology November 18 th, 2016 Disclosures Consulting and speaker fees for Ipsen Pharmaceuticals, AstraZeneca and Merck
Targeted Agent and Profiling Utilization Registry (TAPUR ) Study. February 2018
Targeted Agent and Profiling Utilization Registry (TAPUR ) Study February 2018 Precision Medicine Therapies designed to target the molecular alteration that aids cancer development 30 TARGET gene alterations
Statistical Considerations for Novel Trial Designs: Biomarkers, Umbrellas and Baskets
Statistical Considerations for Novel Trial Designs: Biomarkers, Umbrellas and Baskets Bibhas Chakraborty, PhD Centre for Quantitative Medicine, Duke-NUS March 29, 2015 Personalized or Precision Medicine
Patient Leader Education Summit. Precision Medicine: Today and Tomorrow March 31, 2017
Patient Leader Education Summit Precision Medicine: Today and Tomorrow March 31, 2017 Precision Medicine: Presentation Outline Agenda What is a Precision Medicine What is its clinical value Overview of
MATCHMAKING IN ONCOLOGY CHALLENGES AND COMBINATION STRATEGY FOR NOVEL TARGETED AGENTS
MATCHMAKING IN ONCOLOGY CHALLENGES AND COMBINATION STRATEGY FOR NOVEL TARGETED AGENTS DR. RACHEL E. LAING*, OLIVIER LESUEUR*, STAN HOPKINS AND DR. SEAN X. HU MAY 2012 Recent advances in oncology, such
Molecular Testing Updates. Karen Rasmussen, PhD, FACMG Clinical Molecular Genetics Spectrum Medical Group, Pathology Division Portland, Maine
Molecular Testing Updates Karen Rasmussen, PhD, FACMG Clinical Molecular Genetics Spectrum Medical Group, Pathology Division Portland, Maine Keeping Up with Predictive Molecular Testing in Oncology: Technical
Personalized Medicine: Lung Biopsy and Tumor
Personalized Medicine: Lung Biopsy and Tumor Mutation Testing Elizabeth H. Moore, MD Personalized Medicine: Lung Biopsy and Tumor Mutation Testing Genomic testing has resulted in a paradigm shift in the
FDA grants Roche s Alecensa Priority Review for initial treatment of people with ALK-positive lung cancer
Investor Update Basel, 3 August 2017 FDA grants Roche s Alecensa Priority Review for initial treatment of people with ALK-positive lung cancer Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the
LUNG CANCER. pathology & molecular biology. Izidor Kern University Clinic Golnik, Slovenia
LUNG CANCER pathology & molecular biology Izidor Kern University Clinic Golnik, Slovenia 1 Pathology and epidemiology Small biopsy & cytology SCLC 14% NSCC NOS 4% 70% 60% 50% 63% 62% 61% 62% 59% 54% 51%
Regulatory and Labeling Challenges with Developing Immuno-Oncology Combination Therapies
Regulatory and Labeling Challenges with Developing Immuno-Oncology Combination Therapies Amy McKee, M.D. Acting Deputy Director, OCE, FDA Supervisory Associate Director, OHOP, CDER, FDA July 16, 2018 Background
PLENARY SESSION 1: CLINICAL TRIAL DESIGN IN AN ERA OF HORIZONTAL DRUG DEVELOPMENT Industry Perspective
PLENARY SESSION 1: CLINICAL TRIAL DESIGN IN AN ERA OF HORIZONTAL DRUG DEVELOPMENT Industry Perspective Davy Chiodin, VP - Regulatory Science, QA and Compliance, Acerta Pharma (A Member of the AstraZeneca
Early industry/hta Collaboration: Can we afford not to do it?
Early industry/hta Collaboration: Can we afford not to do it? Dr Bernard Prigent Vice President & Medical Director Pfizer Canada April 17, 2012 Current R&D Productivity is Alarming Scientific Advances
The Cancer Research UK Stratified Medicine Programme: Phases One and Two Dr Emily Shaw
The Cancer Research UK Stratified Medicine Programme: Phases One and Two Dr Emily Shaw Introduction The CRUK Stratified Medicine Programme: SMP1 rationale, design and implementation The role of the cellular
VeriStrat Poor Patients Show Encouraging Overall Survival and Progression Free Survival Signal; Confirmatory Phase 2 Study Planned by Year-End
AVEO and Biodesix Announce Exploratory Analysis of VeriStrat-Selected Patients with Non-Small Cell Lung Cancer in Phase 2 Study of Ficlatuzumab Presented at ESMO 2014 Congress VeriStrat Poor Patients Show
Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment with Targeted Tyrosine Kinase Inhibitors
Q: How is the strength of recommendation determined in the new molecular testing guideline? A: The strength of recommendation is determined by the strength of the available data (evidence). Strong Recommendation:
I. Diagnosis of the cancer type in CUP
Latest Research: USA I. Diagnosis of the cancer type in CUP II. Outcomes of site-specific therapy of the cancer type in CUP a. Prospective clinical trial b. Retrospective clinical trials 1 Latest Research:
About NP28673 About NP28761
Media Release Basel, 14 May 2015 Roche s investigational medicine alectinib shrank tumours in nearly half of people with specific type of lung cancer Alectinib showed response rates of up to 69% in the
Next generation diagnostics Bringing high-throughput sequencing into clinical application
Next generation diagnostics Bringing high-throughput sequencing into clinical application Leonardo A. Meza-Zepeda, PhD Translational Genomics Group Institute for Cancer Research Leonardo.Meza-Zepeda@rr-research.no
FDA approves Roche s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer
Media Release Basel, 07 November 2017 FDA approves Roche s Alecensa (alectinib) as first-line treatment for people with specific type of lung cancer Approval based on phase III results that showed Alecensa
Innovations and Combinations for Novel Anticancer Strategies
Innovations and Combinations for Novel Anticancer Strategies Axel-R. Hanauske, MD, Ph.D., MBA Senior Medical Fellow Oncology Early Phase Eli Lilly and Company 2017 Eli Lilly and Company Disclosure Information
Comprehensive Genomic Profiling, in record time. Accurate. Clinically Proven. Fast.
Comprehensive Genomic Profiling, in record time Accurate. ly Proven. Fast. PCDx advantages Comprehensive genomic profiling, in record time PCDx Comprehensive Genomic Profiling (CGP) provides precise information
Corporate Medical Policy
Corporate Medical Policy Molecular Analysis for Targeted Therapy for Non-Small Cell Lung File Name: Origination: Last CAP Review: Next CAP Review: Last Review: molecular_analysis_for_targeted_therapy_for_non_small_cell_lung_cancer
Media Release. Basel, 17 May 2018
Media Release Basel, 17 May 2018 Follow-up phase III data showed Roche s Alecensa helped people with ALKpositive metastatic non-small cell lung cancer live a median of almost three years without their
Stratified medicine in practice: Review of predictive biomarkers in European Medicines Agency (EMA) indications
Stratified medicine in practice: Review of predictive biomarkers in European Medicines Agency (EMA) indications Kinga Malottki, Mousumi Biswas, Jon Deeks, Richard Riley, Charles Craddock, Lucinda Billingham
Disruptive Innovation in Health Care Adoption of Personalized Medicine and Beyond. Mara G. Aspinall President and CEO VivirHealth
Disruptive Innovation in Health Care Adoption of Personalized Medicine and Beyond Mara G. Aspinall President and CEO VivirHealth The Fundamentals Diagnosis Save Lives Diagnosis Save Money Monitoring Ensures
European Commission approves Roche s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer
Media Release Basel, 21 December 2017 European Commission approves Roche s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer Alecensa provides a new treatment option for people with
Benefit Risk Analysis Of Decision-Making: Oncology
Benefit Risk Analysis Of Decision-Making: Oncology G.K. Raju, Ph.D. December 13 th 2016 Outline Background Approach Application to Oncology Non-Small Cell Lung Cancer Learnings & Ongoing Work Acknowledgements
QIAGEN Complete Solutions for Liquid Biopsy Molecular Testing
QIAGEN Complete Solutions for Liquid Biopsy Molecular Testing Christopher Swagell, PhD Market Development Manager, Advanced Molecular Pathology QIAGEN 1 Agenda QIAGEN Solid Tumor Testing and Liquid Biopsy
NCCN Non-Small Cell Lung Cancer V Meeting June 15, 2018
Guideline Page and Request Illumina Inc. requesting to replace Testing should be conducted as part of broad molecular profiling with Consider NGS-based assays that include EGFR, ALK, ROS1, and BRAF as
The Contribution of Health Industry to the Expansion of the Country s Development Perspective
17 th Annual Conference HealthWorld 2018 The Contribution of Health Industry to the Expansion of the Country s Development Perspective 11.06.18 Makis Papataxiarchis President, Pharma Innovation Forum,
ASSOCIAZIONE CULTURALE GIUSEPPE DOSSETTI THE PARADIGM OF PERSONALIZED THERAPY IN ONCOLOGY
ASSOCIAZIONE CULTURALE GIUSEPPE DOSSETTI THE PARADIGM OF PERSONALIZED THERAPY IN ONCOLOGY Giampietro Gasparini Oncology - San Filippo Neri Hospital Rome, Italy Roma, 26 October 2011 www.professorgasparini.com
Media Release. Roche announces progress in biomarker science in cancer immunotherapy at the European Society for Medical Oncology Congress
Media Release Basel, 08 September 2017 Roche announces progress in biomarker science in cancer immunotherapy at the European Society for Medical Oncology Congress First data on new blood-based assay for
MET skipping mutation, EGFR
New NSCLC biomarkers in clinical research: detection of MET skipping mutation, EGFR T790M, and other important biomarkers Fernando López-Ríos Laboratorio de Dianas Terapéuticas Hospital Universitario HM
Phase 3 Top-Line Results Show IBRANCE in Combination with Fulvestrant Meets Progression-Free Survival (PFS) Primary Endpoint
For immediate release: April 15, 2015 Media Contact: Sally Beatty (212) 733-6566 Investor Contact: Ryan Crowe (212) 733-8160 Pfizer Announces PALOMA-3 Trial for IBRANCE (Palbociclib) Stopped Early Due
Media Release. Basel, 07 December 2017
Media Release Basel, 07 December 2017 Phase III IMpower150 study showed Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy reduced the risk of disease worsening or death by 38 percent
LEVERAGING FDA S ACCELERATED PATHWAYS FOR MARKET ADVANTAGE
WHITE PAPER LEVERAGING FDA S ACCELERATED PATHWAYS FOR MARKET ADVANTAGE Over the past 15 years, the FDA and Congress developed several accelerated pathways to provide incentives for manufacturers to develop
R&D Conference Call. CHUGAI PHARMACEUTICAL CO., LTD. Department Manager of Oncology Lifecycle Management Dept. Megumi Uzu.
R&D Conference Call CHUGAI PHARMACEUTICAL CO., LTD. Department Manager of Oncology Lifecycle Management Dept. Megumi Uzu July 4, 2016 Forward-Looking Statements This presentation may include forward-looking
NCI Precision Medicine Trial Designs
NCI Precision Medicine Trial Designs Shakun Malik, M.D. Head, Thoracic and Head & Neck Cancer Therapeutics Cancer Therapy Evaluation Program (CTEP) National Cancer institute/nih 1 Outline Background Current
Supplementary Online Content
Supplementary Online Content Kris MG, Johnson BE, Berry LD, et al. Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs. JAMA. doi:10.1001/jama.2014.3741 etable 1. Trials
Delivering on the Promise of Personalised Healthcare
Delivering on the Promise of Personalised Healthcare Dr John S Mills Diagnostic Team Director, Personalised Healthcare and Biomarkers Function, AstraZeneca, UK EBF 6 th Open Symposium, Barcelona, 20 Nov
K-Ras signalling in NSCLC
Targeting the Ras-Raf-Mek-Erk pathway Egbert F. Smit MD PhD Dept. Pulmonary Diseases Vrije Universiteit VU Medical Centre Amsterdam, The Netherlands K-Ras signalling in NSCLC Sun et al. Nature Rev. Cancer
LUNG CANCER TREATMENTS UPDATED MAY What you need to know about... targeted therapy
LUNG CANCER TREATMENTS UPDATED MAY 2018 What you need to know about... targeted therapy foreword About LUNGevity LUNGevity is the largest national lung cancer-focused nonprofit, changing outcomes for people
D Ross Camidge, MD, PhD
i n t e r v i e w D Ross Camidge, MD, PhD Dr Camidge is Director of the Thoracic Oncology Clinical Program and Associate Director for Clinical Research at the University of Colorado Cancer Center in Aurora,
(+1) Matti Ojanen (+44) Investor Contact: Jennifer M. Davis (+1)
For immediate release: October 24, 2012 Media Contact: Victoria Davis (+1) 347-558-3455 Matti Ojanen (+44) 7557-202-394 Investor Contact: Jennifer M. Davis (+1) 212-733-0717 Pfizer s XALKORI Receives Conditional
Difficult Diagnoses and Controversial Entities in Neoplastic Lung
Difficult Diagnoses and Controversial Entities in Neoplastic Lung Lynette M. Sholl, M.D. Associate Pathologist, Brigham and Women s Hospital Chief, Pulmonary Pathology Service Associate Professor, Harvard
QIAGEN. Sample & Assay Technologies. New Approaches in Biomarker Detection. SEAP/SEC/SEPAF Zaragoza May 2011
QIAGEN New Approaches in Biomarker Detection SEAP/SEC/SEPAF Zaragoza May 2011 Dr. Stephen Little Vice President Personalized Healthcare - 1 - DxS is a Personalised Medicine Company that meets the needs
Addressing Tumor Molecular Heterogeneity using A Novel Clinical Trial Design - PANGEA
Addressing Tumor Molecular Heterogeneity using A Novel Clinical Trial Design - PANGEA Daniel Catenacci, MD Assistant Professor of Medicine Associate Director GI Oncology Program May 12, 2017 Addressing
Plotting the course: optimizing treatment strategies in patients with advanced adenocarcinoma
Pieter E. Postmus University of Liverpool Liverpool, UK Plotting the course: optimizing treatment strategies in patients with advanced adenocarcinoma Disclosures Advisor Bristol-Myers Squibb AstraZeneca
Roche Pharma Day 2015
Roche Pharma Day 2015 Molecular Information Garret Hampton VP, Oncology Biomarker Development Pharmaceuticals Division Personalized healthcare A cornerstone of the Genentech / Roche strategy Diagnostics
The oncologist s point of view: the promise and challenges of increasing options for targeted therapies in NSCLC
The oncologist s point of view: the promise and challenges of increasing options for targeted therapies in NSCLC Egbert F. Smit Department of Thoracic Oncology, Netherlands Cancer Institute, and Department
Characterisation of structural variation in breast. cancer genomes using paired-end sequencing on. the Illumina Genome Analyser
Characterisation of structural variation in breast cancer genomes using paired-end sequencing on the Illumina Genome Analyser Phil Stephens Cancer Genome Project Why is it important to study cancer? Why
NGS IN ONCOLOGY: FDA S PERSPECTIVE
NGS IN ONCOLOGY: FDA S PERSPECTIVE ASQ Biomed/Biotech SIG Event April 26, 2018 Gaithersburg, MD You Li, Ph.D. Division of Molecular Genetics and Pathology Food and Drug Administration (FDA) Center for
(212) Investors Contact: Ryan Crowe (212)
For immediate release: February 5, 2014 Media Contact: Sally Beatty (212) 733-6566 Investors Contact: Ryan Crowe (212) 733-8160 Pfizer And Merck To Collaborate On Innovative Anti-Cancer Combination Studies
Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer.
Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer. S1400 Master Protocol Unique Private Public Partnerships with the NCTN Alliance SWOG S1400 Master Protocol
Breast Cancer: ASCO Poster Review
Breast Cancer: ASCO Poster Review Carmen Criscitiello, MD, PhD Istituto Europeo di Oncologia Milano HER2+ SUBTYPE Research questions in early HER2+ BC De-escalation of toxicity without compromising efficacy
Pl I enary Tr T anslational Medicine April 30, 2015
Plenary I Translational Medicine April 30, 2015 NCI MATCH and the Future of Genomic-Driven Trials Funded by CTEP/NCI Jeffrey Abrams, MD Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer
Regulatory Landscape for Precision Medicine
Regulatory Landscape for Precision Medicine Adam C. Berger, Ph.D. Office of In Vitro Diagnostics and Radiological Health, FDA FOCR-Alexandria A Blueprint for Breakthrough Meeting September 13, 2017 1 What
ONCOLOGY ENROLLMENT ENHANCEMENT YOUR FIRST PATIENT IN, FASTER.
HELPING DELIVER LIFE-CHANGING THERAPIES ONCOLOGY ENROLLMENT ENHANCEMENT YOUR FIRST PATIENT IN, FASTER. THE CHALLENGE OF ONCOLOGY ENROLLMENT Oncology clinical trials represent a special challenge for biopharmaceutical
Personalized Therapies for Lung Cancer. Questions & Answers
Personalized Therapies for Lung Cancer Questions & Answers What are Personalized Therapies for lung cancer? Like people, no two lung cancer tumors are the same. Personalized medicine (also known as precision
Evolution of Early Phase Trials: Clinical Trial Design in the Modern Era
Evolution of Early Phase Trials: Clinical Trial Design in the Modern Era Shivaani Kummar, MD, FACP Professor of Medicine (Oncology) Director, Phase I Clinical Research Program Co-Director, Translational
Opportunities and Challenges in the Development of Companion Diagnostics
Opportunities and Challenges in the Development of Companion Diagnostics E. Patrick Groody, Ph.D. Divisional Vice President Research and Development Abbott Molecular Agenda Value of Personalized Medicine
A View to the Future: The Development of Targeted Therapy for Melanoma. Michael Davies, M.D., Ph.D.
A View to the Future: Science to Survivorship Symposium September 26, 2009 The Development of Targeted Therapy for Melanoma Michael Davies, M.D., Ph.D. Assistant Professor, Melanoma Medical Oncology How
Personalized Medicine in Oncology and the Implication for Clinical Development
THE POWER OFx Experts. Experienc e. Execution. Personalized Medicine in Oncology and the Implication for Clinical Development Jamal Gasmi MD, PhD, Medical Director, Medpace Introduction The notable success
Design of a Disease-Specific Master Protocol
Design of a Disease-Specific Master Protocol Design of a Disease-Specific Master Protocol Roy Herbst, MD/PhD Yale Cancer Center Modernizing Clinical Trial Process Some of the current challenges of drug
Expertly targeting drivers of cancer in select patient populations. June 2016
Expertly targeting drivers of cancer in select patient populations v June 2016 Safe Harbor Statement Certain statements contained in this presentation, other than statements of fact that are independently
Personalised Healthcare (PHC) with Foundation Medicine (FMI) Fatma Elçin KINIKLI, FMI Turkey, Science Leader
Personalised Healthcare (PHC) with Foundation Medicine (FMI) Fatma Elçin KINIKLI, FMI Turkey, Science Leader Agenda PHC Approach Provides Better Patient Outcome FMI offers Comprehensive Genomic Profiling,
Partnering in Oncology Sharing a Vision to Help Prolong and Improve Patients Lives. Oncology Therapeutic Area Janssen Research & Development, LLC
Partnering in Oncology Sharing a Vision to Help Prolong and Improve Patients Lives Oncology Therapeutic Area Janssen Research & Development, LLC The patients are waiting. Dr. Paul Janssen To Our Potential
TARGETED THERAPY FOR LUNG CANCER. Patient and Caregiver Guide
TARGETED THERAPY FOR LUNG CANCER Patient and Caregiver Guide TARGETED THERAPY FOR LUNG CANCER Patient and Caregiver Guide TABLE OF CONTENTS Why Targeted Therapy?...2 Lung Cancer Basics...2 Changes in
Integration of Genomics Into Clinical Pathways. Precision Medicine and Decision Support
Integration of Genomics Into Clinical Pathways Precision Medicine and Decision Support Faculty Andrew Hertler, MD, FACP Chief Medical Officer New Century Health Andrew Hertler, MD, FACP is employed by
Data will be submitted to health authorities globally, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA)
Investor Update Basel, 20 November 2017 Phase III IMpower150 study showed Roche s TECENTRIQ (atezolizumab) and Avastin (bevacizumab) plus chemotherapy significantly reduced the risk of disease worsening
Savolitinib clinical trials June 2016 update
Savolitinib clinical trials June 2016 update List of abbreviations BID Twice Daily MET Aberation of c-met/hgf CRC Colorectal Cancer MTD Maximum Tolerated Dose DoR Duration of Response NSCLC Non-Small Cell
Consensus statement between CM-Path, CRUK and the PHG Foundation following on from the Liquid Biopsy workshop on the 8th March 2018
Consensus statement between CM-Path, CRUK and the PHG Foundation following on from the Liquid Biopsy workshop on the 8th March 2018 Summary: This document follows on from the findings of the CM-Path The
2015 ASCO Annual Meeting Key TakeAways: Lung Cancer By Guneet Walia, PhD
2015 ASCO Annual Meeting Key TakeAways: Lung Cancer By Guneet Walia, PhD Main focus of the meeting: the promise of immunotherapy as mono-therapy (i.e by itself) and in combination with other therapies
ArQule Jefferies Global Healthcare Conference June 2015
ArQule Jefferies Global Healthcare Conference June 2015 1 ArQule Corporate Update Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning
Media Release. Basel, 18 February 2017
Media Release Basel, 18 February 2017 Phase II study supports potential for Roche s TECENTRIQ (atezolizumab) plus Avastin (bevacizumab) for people with locally advanced or metastatic renal cell carcinoma