CENTRAL NERVOUS SYSTEM (CNS) BIOMARKERS: TECHNOLOGIES AND GLOBAL MARKETS
|
|
- Russell Moody
- 6 years ago
- Views:
Transcription
1 CENTRAL NERVOUS SYSTEM (CNS) : TECHNOLOGIES AND GLOBAL MARKETS BIO074C March 2016 Jackson Highsmith Project Analyst ISBN: X BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com
2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND OBJECTIVES 2 REASONS FOR DOING THE STUDY 2 SCOPE OF REPORT 2 INTENDED AUDIENCE 3 METHODOLOGY AND INFORMATION SOURCES 4 ANALYST'S CREDENTIALS 4 RELATED BCC RESEARCH REPORTS 5 BCC RESEARCH WEBSITE 5 DISCLAIMER 5 CHAPTER 2 SUMMARY 7 SUMMARY TABLE GLOBAL MARKET FOR CNS BY APPLICATION, SUMMARY FIGURE GLOBAL MARKET FOR CNS BY APPLICATION, ($ MILLIONS) 7 7 CHAPTER 3 OVERVIEW 11 INTRODUCTION 11 TABLE 1 GLOBAL MARKET FORECAST FOR CNS BY AREA, THROUGH 2020 ($ MILLIONS) TABLE 2 GLOBAL MARKET FOR CNS BY AREA, THROUGH 2015 ($ MILLIONS) TABLE 3 IN DRUG DISCOVERY: CNS MARKET, THROUGH 2020 (%) FOR CANCER 14 TABLE 4 MARKET SHARE OF CNS SUBSEGMENTS, 2015 ($ MILLIONS/ %) 14 TABLE 5 PERCENTAGE OF PREDICTIVE FOR CANCER PATIENTS BY SEGMENT, (%) TABLE 6 FREQUENCY OF APPROACH IN CLAIMS REVIEW BY PAYERS, (%) 16 TABLE 7 RELATIVE IMPORTANCE OF REIMBURSEMENT DECISIONS OF TEST FACTORS, (%) FOR NON-ONCOLOGY INDICATIONS 18 DISEASE-SPECIFIC AND COMPANION DIAGNOSTICS 19 CSF 21 PERIPHERAL 22 ULTRA-BLOCKBUSTER 24 TABLE 8 CNS 25 TABLE 9 INFORMATION TECHNOLOGY (IT) STRATEGIES 26 ON TARGET 26 TABLE 10 INITIAL DESIGNS AND CAPABILITIES 27 ADAPTING TO DATA 27 SAFETY/TOXICOLOGY 27 LIVER 28 MUSCLE 28 CARDIAC HYPERTROPHY 28 VASCULAR INJURY
3 DOSE SELECTION AND OPTIMIZATION 29 NEW EFFORT AIMED AT DOSE SELECTION 29 IMPROVED MEASUREMENT OF THERAPEUTIC EFFICACY 30 Developing a New Framework for Long-term Addiction Treatment 30 Approach #1: Standard Treatment Patient Outcome Assessment 31 Approach #2: Independent Outcome Assessment Focused on Patient Satisfaction Approach #3: Recovery-Oriented System Model and Healthcare 31 OUTCOME AND SURROGATE END POINTS 32 TABLE 11 SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR EFFECTIVE BIOMARKER EVALUATION TABLE 12 SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR EFFECTIVE BIOMARKER EVALUATION: SCIENTIFIC PROCESS HARMONIZATION TABLE 13 BENEFITS OF AS SURROGATE END POINTS 33 CHALLENGES TO TRAUMATIC BRAIN INJURY (TBI) BIOMARKER DEVELOPMENT TABLE 14 HOW MIGHT FACILITATE TBI THERAPY DEVELOPMENT 34 Immediate Action Items 34 EARLY STAGE CLINICAL TRIAL APPLICATIONS 35 SUMMARY OF BIOMARKER CHALLENGES AND OPPORTUNITIES 36 CHALLENGES 38 OPPORTUNITIES 39 PROTEIN BIOMARKER TECHNOLOGY PLATFORMS: HYPOTHESIS-DRIVEN VS HYPOTHESIS-FREE APPROACHES REQUIREMENTS FOR CLINICAL VALIDITY 41 BIOMARKER PROGRESS 42 ENVIRONMENTAL EXPOSURES, EFFECT MODIFIERS, OR RISK FACTORS 42 TABLE 15 CROSS-SECTIONAL INVESTIGATIONS 43 INTERMEDIATE 43 SCREENING, DIAGNOSTIC TESTS, AND PROGNOSIS 43 VARIABILITY 44 VALIDITY 44 PRODUCT SUMMARY AND MARKET 46 GENOMICS 46 TABLE 16 GLOBAL MARKETS FOR CNS THROUGH 2015 ($ MILLIONS) 46 Progress in Genomic Biomarker Development 47 Emerging Evidence 47 Democratizing Health Care 48 BIOMARKER ADOPTION BY THE PHARMACEUTICAL INDUSTRY 48 CANCER : ADOPTION IS DRIVING GROWTH 52 TABLE 17 CLINICAL PATIENT MONITORING FOR CNS, AS COMPARED TO OTHER DISEASES (%) CLINICAL TRIAL BENEFITS: COST AND RISK AVOIDANCE 54 PHASE II TRIALS 54 PHASE IIA BASKET DISCOVERY TRIALS 55 PHASE III TARGETED (ENRICHMENT) DESIGNS 56 PHASE III BIOMARKER STRATIFIED DESIGN 57 PHASE III ADAPTIVE THRESHOLD DESIGN 58 BIOMARKER MARKET FORECAST
4 TABLE 18 GLOBAL MARKET FORECAST FOR CNS BY TECHNOLOGY, 59 CHAPTER 4 REGULATORY DYNAMICS, INTELLECTUAL PROPERTY, ETHICAL CONSIDERATIONS INTRODUCTION 61 BIOMARKER LABORATORY REGULATORY SUMMARY 61 DEFINITION OF AN IVD COMPANION DIAGNOSTIC 62 Labeling 64 TABLE 19 PHARMACOGENOMIC IN DRUG LABELING 65 REGULATORY PROCESSES FOR NEW TECHNOLOGIES 80 ENSURING SAFETY AND EFFECTIVENESS OF HEALTH TECHNOLOGIES 80 SAFE FOR WIDESPREAD USE? 80 REVIEW IN THE DEVELOPING WORLD 80 ASSAY DEVELOPMENT AND VALIDATION IN DRUG DIAGNOSTIC CO-DEVELOPMENT KEY DRAFT GUIDANCE POINTS FOR IVD COMPANION DIAGNOSTIC DEVICES: 82 SOME RELEVANT FDA GUIDANCE DOCUMENTS FOR CO-DEVELOPMENT 83 PIPELINE FOR BIOMARKER DEVELOPMENT 86 CLINICAL CONCEPTIONS ON THE STUDY DESIGN 87 TECHNICAL CONSIDERATIONS REGARDING THE ANALYTICAL SET UP FOR BIOMARKER DEVELOPMENT DISCOVERY OF 88 GEL-BASED PROTEOMICS PLATFORMS FOR BIOMARKER DISCOVERY 89 SHOTGUN PROTEOMICS 90 CE-MS 91 STATISTICAL DATA MINING FOR PROTEOMIC BIOMARKER DISCOVERY 91 VERIFICATION OF 92 PROTEIN BINDING ASSAYS 92 MASS SPECTROMETRIC QUANTITATIVE APPROACHES 93 PRE-TREATMENT STRATEGIES 93 DATA MINING AND STATISTICAL ANALYSIS 94 BIOINFORMATICS PLATFORMS IN CLINICAL PROTEOMICS 94 APPLICATIONS OF SYSTEMS BIOLOGY---DISEASE DIAGNOSIS AND TREATMENT VALIDATION OF BIOMARKER CANDIDATES 95 APPLICATION OF PROTEOMICS APPROACHES IN BCA BIOMARKER DISCOVERY Analytical Validation of a Companion Diagnostic 97 COMPANION DIAGNOSTIC VALIDATION 98 CLINICAL VALIDATION 99 OVERVIEW OF ESSENTIAL TYPES OF 100 TABLE 20 BIOMARKER CATEGORIES AND TYPES 101 OVERVIEW OF ALREADY APPROVED CDX ON THE MARKETS 102 KEY POINTS TO BE ADDRESSED 102 CONSIDERATIONS BEFORE INITIATING THE BIOMARKER DISCOVERY PHASE 103 CONSIDERATIONS ON THE SELECTION AND RANDOMIZATION OF PATIENTS FOR BIOMARKER STUDIES: LOOKING FOR THE 'IDEAL' PATIENTS THE CURRENT STATE OF BIOMARKER DISCOVERY
5 PITFALLS AND LIMITATIONS 104 SELECTION OF PATIENTS AND CONTROLS 105 ROLE OF THE FOOD & DRUG ADMINISTRATION 105 FDA GUIDELINES FOR BIOMARKER APPLICATIONS 105 TABLE 21 BIOMARKER QUALIFICATION PROGRAM 107 EUROPEAN MEDICINES AGENCY 108 REGULATORY IMPACT ON DRUG SAFETY 108 INTELLECTUAL PROPERTY AND COMPETITIVE POSITIONING 109 Approved Patent Analysis 109 TABLE 22 ANNUAL NUMBER OF PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN THE U.S., EUROPE, AND JAPAN, THROUGH 2015 (NUMBER/%) COMPETITIVE LANDSCAPE 109 LATE STAGE CLINICAL TRIALS: COMPETITIVE POSITIONING 110 TABLE 23 GLOBAL MARKET FOR TOTAL CLINICAL STAGE BY SERVICES AND PRODUCTS, TABLE 24 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY, TABLE 25 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE, AND JAPAN CHAPTER 5 APPLICATIONS OF CNS 119 OVERVIEW 119 TABLE 26 GLOBAL MARKET FOR CLINICAL STAGE BY THERAPEUTIC AREA, CENTRAL NERVOUS SYSTEM 122 TABLE 27 REPRESENTATIVE IN CLINICAL USE: CNS DISEASE 122 CLINICAL : THERAPEUTIC DISEASE MARKET FORECAST 123 TABLE 28 GLOBAL MARKET FORECAST FOR CLINICAL STAGE, TABLE 29 GLOBAL MARKET FORECAST FOR CNS IN LATE STAGE CLINICAL USE, CHAPTER 6 ACTIVELY GUIDING DRUG DEVELOPMENT 125 AN OVERVIEW 125 TABLE 30 RELEVANT CORPORATE ALLIANCE BETWEEN A REFERENCE LAB AND A DRUG DEVELOPMENT COMPANY 126 CHAPTER 7 COMPANY ANALYSIS 128 ABBOTT LABORATORIES INC. 128 COMPANY OVERVIEW 128 PRODUCTS AND SERVICES 128 TABLE 31 ABBOTT'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 128 COMPANY STRATEGY 129 AFFYMETRIX INC. 129 COMPANY OVERVIEW 129 PRODUCTS AND SERVICES 130 TABLE 32 AFFYMETRIX'S REPRESENTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY
6 ASTELLAS PHARMA INC. 131 COMPANY OVERVIEW 131 PRODUCTS AND SERVICES 131 TABLE 33 ASTELLAS' REPRESENTATIVE CLINICAL TRIALS INVOLVING 132 COMPANY STRATEGY 132 ASTRAZENECA LTD. 132 COMPANY OVERVIEW 132 PRODUCTS AND SERVICES 133 TABLE 34 ASTRAZENECA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY 133 BANYAN INC. 134 COMPANY OVERVIEW 134 PRODUCTS AND SERVICES 134 TABLE 35 BANYAN'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 134 COMPANY STRATEGY 135 BAYER SCHERING PHARMA AG 135 COMPANY OVERVIEW 135 PRODUCTS AND SERVICES 135 TABLE 36 BAYER SCHERING'S REPRESENTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY 136 BG MEDICINE INC. 138 COMPANY OVERVIEW 138 PRODUCTS AND SERVICES 138 TABLE 37 BIOPHYSICAL REPRESENTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY 138 BIOPHYSICAL CORP. 139 COMPANY OVERVIEW 139 PRODUCTS AND SERVICES 139 COMPANY STRATEGY 139 BIOSYSTEMS INTERNATIONAL INC. 140 COMPANY OVERVIEW 140 PRODUCTS AND SERVICES 140 COMPANY STRATEGY 140 BOEHRINGER INGELHEIM GMBH 141 COMPANY OVERVIEW 141 PRODUCTS AND SERVICES 141 TABLE 38 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING 141 COMPANY STRATEGY 142 BRISTOL-MYERS SQUIBB CO. 142 COMPANY OVERVIEW 142 PRODUCTS AND SERVICES 142 TABLE 39 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING 143 COMPANY STRATEGY 143 CAPRION PROTEOMICS INC. 144 COMPANY OVERVIEW
7 PRODUCTS AND SERVICES 144 COMPANY STRATEGY 144 Infectious Diseases 144 Diabetes and Metabolic Disease 145 Oncology 145 DAIICHI SANKYO COMPANY LTD. 145 COMPANY OVERVIEW 145 PRODUCTS AND SERVICES 145 TABLE 40 DAIICHI SANKYO'S REPRESENTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY 146 EISAI CO. LTD. 147 COMPANY OVERVIEW 147 PRODUCTS AND SERVICES 147 TABLE 41 EISAI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 147 COMPANY STRATEGY 148 ELI LILLY AND COMPANY 148 COMPANY OVERVIEW 148 PRODUCT AND SERVICES 148 TABLE 42 ELI LILLY'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 149 COMPANY STRATEGY 149 EPIGENOMICS AG 149 COMPANY OVERVIEW 150 PRODUCTS AND SERVICES 150 TABLE 43 EPIGENOMICS' REPRESENTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY 150 GENEDATA AG 151 COMPANY OVERVIEW 151 PRODUCTS AND SERVICES 151 TABLE 44 GENEDATA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY 152 GENENEWS LTD 152 COMPANY OVERVIEW 152 PRODUCTS AND SERVICES 152 COMPANY STRATEGY 152 GLAXOSMITHKLINE 153 COMPANY OVERVIEW 153 PRODUCTS AND SERVICES 153 TABLE 45 GSK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 153 COMPANY STRATEGY 154 JOHNSON & JOHNSON LTD. 154 COMPANY OVERVIEW 154 PRODUCTS AND SERVICES 155 TABLE 46 JOHNSON & JOHNSON'S REPRESENTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY
8 MERCK & CO. 156 COMPANY OVERVIEW 156 PRODUCTS AND SERVICES 156 TABLE 47 MERCK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 156 COMPANY STRATEGY 157 NOVARTIS AG 157 COMPANY OVERVIEW 157 PRODUCTS AND SERVICES 158 TABLE 48 NOVARTIS' REPRESENTATIVE CLINICAL TRIALS INVOLVING 158 COMPANY STRATEGY 158 PFIZER INC. 159 COMPANY OVERVIEW 159 PRODUCTS AND SERVICES 159 TABLE 49 PFIZER'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 159 COMPANY STRATEGY 160 ROCHE LTD 160 COMPANY OVERVIEW 160 PRODUCTS AND SERVICES 161 TABLE 50 ROCHE'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 161 COMPANY STRATEGY 161 SANOFI 162 COMPANY OVERVIEW 162 PRODUCTS AND SERVICES 162 TABLE 51 SANOFI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 163 COMPANY STRATEGY 163 TAKEDA PHARMACEUTICALS LTD. 164 COMPANY OVERVIEW 164 PRODUCTS AND SERVICES 164 TABLE 52 TAKEDA'S PHARMACEUTICALS REPRESENTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY 165 TEVA PHARMACEUTICAL INDUSTRIES LTD. 165 COMPANY OVERVIEW 165 PRODUCTS AND SERVICES 166 TABLE 53 TEVA'S PHARMACEUTICAL REPRESNTATIVE CLINICAL TRIALS INVOLVING COMPANY STRATEGY
9 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR CNS BY APPLICATION, TABLE 1 GLOBAL MARKET FORECAST FOR CNS BY AREA, THROUGH 2020 ($ MILLIONS) TABLE 2 GLOBAL MARKET FOR CNS BY AREA, THROUGH 2015 ($ MILLIONS) TABLE 3 IN DRUG DISCOVERY: CNS MARKET, THROUGH 2020 (%) TABLE 4 MARKET SHARE OF CNS SUBSEGMENTS, 2015 ($ MILLIONS/ %) 14 TABLE 5 PERCENTAGE OF PREDICTIVE FOR CANCER PATIENTS BY SEGMENT, (%) TABLE 6 FREQUENCY OF APPROACH IN CLAIMS REVIEW BY PAYERS, (%) 16 TABLE 7 RELATIVE IMPORTANCE OF REIMBURSEMENT DECISIONS OF TEST FACTORS, (%) TABLE 8 CNS 25 TABLE 9 INFORMATION TECHNOLOGY (IT) STRATEGIES 26 TABLE 10 INITIAL DESIGNS AND CAPABILITIES 27 TABLE 11 SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR EFFECTIVE BIOMARKER EVALUATION TABLE 12 SUMMARY OF IOM RECOMMENDATIONS FOR A FRAMEWORK FOR EFFECTIVE BIOMARKER EVALUATION: SCIENTIFIC PROCESS HARMONIZATION TABLE 13 BENEFITS OF AS SURROGATE END POINTS 33 TABLE 14 HOW MIGHT FACILITATE TBI THERAPY DEVELOPMENT 34 TABLE 15 CROSS-SECTIONAL INVESTIGATIONS 43 TABLE 16 GLOBAL MARKETS FOR CNS THROUGH 2015 ($ MILLIONS) 46 TABLE 17 CLINICAL PATIENT MONITORING FOR CNS, AS COMPARED TO OTHER DISEASES (%) TABLE 18 GLOBAL MARKET FORECAST FOR CNS BY TECHNOLOGY, TABLE 19 PHARMACOGENOMIC IN DRUG LABELING 65 TABLE 20 BIOMARKER CATEGORIES AND TYPES 101 TABLE 21 BIOMARKER QUALIFICATION PROGRAM 107 TABLE 22 ANNUAL NUMBER OF PATENTS FILED AND APPROVED WITH BIOMARKER CLAIMS IN THE U.S., EUROPE, AND JAPAN, THROUGH 2015 (NUMBER/%) TABLE 23 GLOBAL MARKET FOR TOTAL CLINICAL STAGE BY SERVICES AND PRODUCTS, TABLE 24 SUMMARY OF RECENT AGREEMENTS IN BIOMARKER DELIVERY, TABLE 25 REPRESENTATIVE LIST OF APPROVED BIOMARKER PATENTS IN THE U.S., EUROPE, AND JAPAN TABLE 26 GLOBAL MARKET FOR CLINICAL STAGE BY THERAPEUTIC AREA, TABLE 27 REPRESENTATIVE IN CLINICAL USE: CNS DISEASE 122 TABLE 28 GLOBAL MARKET FORECAST FOR CLINICAL STAGE, TABLE 29 GLOBAL MARKET FORECAST FOR CNS IN LATE STAGE CLINICAL USE, TABLE 30 RELEVANT CORPORATE ALLIANCE BETWEEN A REFERENCE LAB AND A DRUG DEVELOPMENT COMPANY TABLE 31 ABBOTT'S REPRESENTATIVE CLINICAL TRIALS INVOLVING
10 TABLE HEADING TABLE 32 AFFYMETRIX'S REPRESENTATIVE CLINICAL TRIALS INVOLVING TABLE 33 ASTELLAS' REPRESENTATIVE CLINICAL TRIALS INVOLVING 132 TABLE 34 ASTRAZENECA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING TABLE 35 BANYAN'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 134 TABLE 36 BAYER SCHERING'S REPRESENTATIVE CLINICAL TRIALS INVOLVING TABLE 37 BIOPHYSICAL REPRESENTATIVE CLINICAL TRIALS INVOLVING 138 TABLE 38 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING 141 TABLE 39 BMS REPRESENTATIVE CLINICAL TRIALS INVOLVING 143 TABLE 40 DAIICHI SANKYO'S REPRESENTATIVE CLINICAL TRIALS INVOLVING TABLE 41 EISAI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 147 TABLE 42 ELI LILLY'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 149 TABLE 43 EPIGENOMICS' REPRESENTATIVE CLINICAL TRIALS INVOLVING TABLE 44 GENEDATA'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 151 TABLE 45 GSK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 153 TABLE 46 JOHNSON & JOHNSON'S REPRESENTATIVE CLINICAL TRIALS INVOLVING TABLE 47 MERCK'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 156 TABLE 48 NOVARTIS' REPRESENTATIVE CLINICAL TRIALS INVOLVING 158 TABLE 49 PFIZER'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 159 TABLE 50 ROCHE'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 161 TABLE 51 SANOFI'S REPRESENTATIVE CLINICAL TRIALS INVOLVING 163 TABLE 52 TAKEDA'S PHARMACEUTICALS REPRESENTATIVE CLINICAL TRIALS INVOLVING TABLE 53 TEVA'S PHARMACEUTICAL REPRESNTATIVE CLINICAL TRIALS INVOLVING
11 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FOR CNS BY APPLICATION, ($ MILLIONS) 7
PROTEOMICS: TECHNOLOGIES AND GLOBAL MARKETS. BIO034C May John Bergin Project Analyst ISBN:
PROTEOMICS: TECHNOLOGIES AND GLOBAL MARKETS BIO034C May 2013 John Bergin Project Analyst ISBN: 1-56965-403-4 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 866-285-7215, 781-489-7301 www.bccresearch.com
More informationLeveraging an Academic-Industry Partnership for Commercial Success
Leveraging an Academic-Industry Partnership for Commercial Success For 115 Years, the Nation s Leading Respiratory Hospital Respiratory Heritage: 115 Years of Respiratory Research and Care Allergy, Asthma,
More informationPersonalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies
Personalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies The value of In Vitro Diagnostics The value of diagnostics as an integral part in the healthcare value chain Diagnostics
More informationGlobal Oncology Biosimilars Market
Published on Market Research Reports Inc. (https://www.marketresearchreports.com) Home > Global Oncology Biosimilars Market 2016-2020 Global Oncology Biosimilars Market 2016-2020 Publication ID: TNV0216071
More informationImmunotoxicology Technical Committee (ITC) HESI Assembly of Members January 19, 2009
Immunotoxicology Technical Committee (ITC) HESI Assembly of Members January 19, 2009 Committee Leadership Dr. Ellen Evans (Schering-Plough Research Institute), Chair Dr. Tom Kawabata (Pfizer Inc.), Vice
More informationJoint Technology Initiative: Innovative Medicine Initiative
Joint Technology Initiative: Innovative Medicine Initiative Dr John E Butler-Ransohoff Global External Innovation and Alliances Bayer HealthCare AG, Berlin/Wuppertal Bari, 30 April 2015 Largest Public
More informationRoche in Australia Innovation Leader
Roche in Australia Innovation Leader About Roche Innovation: it s in our DNA 7,000,874 hours of work 6,587 experiments 423 researchers 1 drug For nearly 120 years, Roche has been committed to improving
More informationThe Patient-Reported Outcome (PRO) Consortium:
The Patient-Reported Outcome (PRO) Consortium: A Collaborative Approach to PRO Instrument Development and Qualification Stephen Joel Coons, PhD Executive Director The views and opinions expressed in the
More informationCELL-BASED ASSAYS: TECHNOLOGIES AND GLOBAL MARKETS
CELL-BASED ASSAYS: TECHNOLOGIES AND GLOBAL MARKETS BIO080B April 2014 Usha Nagavarapu Project Analyst ISBN: 1-56965-794-7 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215 (toll-free
More informationPAREXEL GENOMIC MEDICINE SERVICES. Applying genomics to enhance your drug development journey
PAREXEL GENOMIC MEDICINE SERVICES Applying genomics to enhance your drug development journey YOUR JOURNEY. OUR MISSION. Genomic expertise to simplify the route to product approval and maximize patient
More informationLili M. Portilla, MPA Acting Director, Office of Policy, Communications and Strategic Alliances National Center for Advancing Translational Sciences
Lili M. Portilla, MPA Acting Director, Office of Policy, Communications and Strategic Alliances National Center for Advancing Translational Sciences (NCATS), NIH GUIRR Meeting, October 9, 2012 Established
More informationSafeSciMET. European Modular Education and Training Programme in Safety Sciences for Medicines
SafeSciMET European Modular Education and Training Programme in Safety Sciences for Medicines What patients need What Europe needs Rapid exploitation of insights in disease mechanisms for introduction
More informationA French Biotechnology company dedicated to the development and production of human endocrine cell lines. Innovation In Healthcare April 2012
A French Biotechnology company dedicated to the development and production of human endocrine cell lines Innovation In Healthcare 16-17 April 2012 1 French Biotechnology company Founded in S2 2004 in Paris
More informationThe Innovative Medicines Initiative: Building new models of collaborative research across Europe
The Innovative Medicines Initiative: Building new models of collaborative research across Europe Elisabetta Vaudano IMI, Belgium www.imi.europa.eu What is IMI? An European Public-Private Partnership Focused
More informationHistory has Demonstrated that Sub-optimal CDx Strategies can Impact Drug Success
DOES YOUR COMPANION DIAGNOSTIC STRATEGY BEST P OSITION YOU FOR SUCCESS? History has Demonstrated that Sub-optimal CDx Strategies can Impact Drug Success Real-World Examples 1 st Year Sales Increased complexity
More informationCRO partner in Rx/CDx Co-Development
CRO partner in Rx/CDx Co-Development DEDICATED DIALOGUE A sponsored roundtable discussion published in Pharmaceutical Executive Two Covance executives discuss a CRO s role in supporting Companion Diagnostics
More informationComments from the FDA Working Group on SUBGROUP ANALYSES. Estelle Russek-Cohen, Ph.D. U.S. Food and Drug Administration Center for Biologics
Comments from the FDA Working Group on SUBGROUP ANALYSES Estelle Russek-Cohen, Ph.D. U.S. Food and Drug Administration Center for Biologics 1 Outline An intro to FDA EMA and FDA on subgroups Companion
More informationREIMAGINING DRUG DEVELOPMENT:
Biology Reconstructed REIMAGINING DRUG DEVELOPMENT: Accurate Disease Modeling To Drive Successful Therapies Julia Kirshner, CEO julia@zpredicta.com 1 SUCCESS RATES OF DRUG DEVELOPMENT ARE LOW, " PARTICULARLY
More informationGetReal: Clinical effectiveness in drug development
GetReal: Clinical effectiveness in drug development Mike Chambers Matthias Egger WP4 Leaders GSK, UK Univ. of Berne, Switzerland BBS/EFSPI Seminar Basel 04Jun13 Egger/Chambers: real world evidence in HTA
More informationFuture of Molecular Diagnostics: Innovative Technologies Driving Market Opportunities
Future of Molecular Diagnostics: Innovative Technologies Driving Market Opportunities Introduction The report analyzes current and potential world molecular diagnostics markets and advances in the field.
More informationDelivering on the promise: the clinical application of new diagnoses and treatments for RD K A T E B U S H B Y N E W C A S T L E U N I V E R S I T Y
Delivering on the promise: the clinical application of new diagnoses and treatments for RD K A T E B U S H B Y N E W C A S T L E U N I V E R S I T Y PERSPECTIVE/ DISCLAIMERS Doctor with >24 years experience
More informationIN VITRO TOXICITY TESTING: TECHNOLOGIES AND GLOBAL MARKETS
IN VITRO TOXICITY TESTING: TECHNOLOGIES AND GLOBAL MARKETS PHM017E January 2014 Robert Hunter Project Analyst ISBN: 1-56965-661-4 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215
More informationIndustry Developments in U.S. Biopharmaceutical Contract Services
Industry Developments in U.S. Biopharmaceutical Contract Services February 2010 Industry Developments in U.S. Biopharmaceutical Contract Services February 2010 Copyright 2010 BioCrossroads CICP Foundation
More informationPersonalized. Health in Canada
Personalized Health in Canada Canadian Institutes of Health Research Personalized Medicine Signature Initiative 2010-2013 0 Dr. Morag Park CIHR Institute of Cancer Research Dr. Paul Lasko CIHR Institute
More informationTHE CORPORATE REPUTATION OF PHARMA THE PATIENT PERSPECTIVE IN 2015 (GERMAN EDITION)
THE CORPORATE REPUTATION OF PHARMA THE PATIENT PERSPECTIVE IN 2015 (GERMAN EDITION) Feedback from 60 German patient groups PUBLISHED JUNE 2016 Die neuen, extrem hohen Hepatitis-C- Medikamenten-Preise haben
More informationRoche, Roche Molecular Diagnostics and more
, Molecular and more [Monte Wetzel, PhD] Patients have questions. We provide answers. Group Clear focus on Healthcare Innovation with two strong pillars Pharma Pharma Genentech Chugai Molecular Professional
More informationGenomics And Pharmacogenomics In Anticancer Drug Development And Clinical Response (Cancer Drug Discovery And Development)
Genomics And Pharmacogenomics In Anticancer Drug Development And Clinical Response (Cancer Drug Discovery And Development) Strategies for modern biomarker and drug - Oct 3, 2014 Sequencing the cancer genome
More informationTerminology for personalized medicine
Terminology for personalized medicine Sarah Ali-Khan 1 PhD, Stephanie Kowal 2, Westerly Luth 2, Richard Gold 1 SJD, and Tania Bubela 2 PhD JD 1. Centre for Intellectual Property Policy (CIPP), Faculty
More informationKlaus Romero MD MS FCP. (Supported by the CAMD AD Modeling & Simulation Team)
Baseline ICV-adjusted Hippocampal Volume as a Biomarker for Enrichment in Alzheimer s Disease Trials Co-Chairs: Patricia Cole (Takeda) & Derek Hill (IXICO) A Modeling Approach to Demonstrate Trial Enrichment
More informationTECHNOLOGIES & SERVICES FOR THERAPEUTIC ANTIBODY DEVELOPMENT
Specialist in tissue analysis by Histology, Immunohistochemistry and In Situ Hybridization TECHNOLOGIES & SERVICES FOR THERAPEUTIC ANTIBODY DEVELOPMENT CONTENTS Histalim: who we are Our areas of expertise
More informationReimbursement Strategy for Companion Diagnostics:
Reimbursement Strategy for Companion Diagnostics: Emerging Models and Requirements Edward E. Berger, Ph.D. Larchmont Strategic Advisors Definition Companion diagnostic A diagnostic test used to predict
More informationPharmaceuticals and Product Stewardship. Sierra Fletcher Product Stewardship Institute April 29, 2011
Pharmaceuticals and Product Stewardship Sierra Fletcher Product Stewardship Institute Who is the Product Stewardship Institute? Non profit founded in 2000 Membership 47 States 200+ Local governments 70+
More informationPharma IP Evergreening Strategies (i.e., Patent Extension) Using Nanotechnology
Pharma IP Evergreening Strategies (i.e., Patent Extension) Using Nanotechnology Jeffrey H. Rosedale, Ph.D Registered U.S. Patent Attorney Partner, Woodcock Washburn LLP, Philadelphia, Pennsylvania Legal
More informationWINNING BRAND VS. GENERIC COMPETITION
WINNING BRAND VS. GENERIC COMPETITION - Competition 2.0: Brands vs. Generics - Winning Beyond the Molecule www.bernardassociatesllc.com Innovator and generic companies are colliding as they invade each
More informationSingapore offers attractive
Singapore Biotech Guide 2008/2009 Singapore s Biomedical Sciences Landscape companies with spin offs to Singapore, while BMRC takes the lead in coordinating and funding public sector and academic research,
More informationFactor X. Factor IIa (thrombin)
Protease Inhibitors: Innovation Drives Drug Pipeline Figure 1.2. Schematic of the Coagulation Cascade Tissue damage or inflammation Initiation Factor VIIa / Tissue Factor (TF) Factor IX Factor X Factor
More informationFINAL DOCUMENT. Global Harmonization Task Force. Title: Clinical Evidence for IVD medical devices Key Definitions and Concepts
GHTF/SG5/N6:2012 FINAL DOCUMENT Global Harmonization Task Force Title: Clinical Evidence for IVD medical devices Key Definitions and Concepts Authoring Group: Study Group 5 of the Global Harmonization
More informationE2ES to Accelerate Next-Generation Genome Analysis in Clinical Research
www.hcltech.com E2ES to Accelerate Next-Generation Genome Analysis in Clinical Research whitepaper April 2015 TABLE OF CONTENTS Introduction 3 Challenges associated with NGS data analysis 3 HCL s NGS Solution
More informationIndividualised medicine: regulatory challenges
www.pei.de Individualised medicine: regulatory challenges Outline Revision IVD Directive Opportunities and challenges Possibilities for interaction http://upload.wikimedia.org/wikipedia/commons/thumb/6/66/gummy_bears.jpg
More informationAn Industry Perspective: The Complexity of Postapproval CMC Changes and Proposed Regulatory Strategies. SPEAKER: Suzanne Murray Biogen
An Industry Perspective: The Complexity of Postapproval CMC Changes and Proposed Regulatory Strategies SPEAKER: Suzanne Murray Biogen Contents 1. BioPhorum Operations Group (BPOG) and the Post-approvals
More informationPharmaceutical Reviews Year: 2008 Vol: 6 Issue: 1 ISSN: School of Pharmacy and Technology Management, NMiMS University, Mumbai
Dayanidhi B, Amol S School of Pharmacy and Technology Management, NMiMS University, Mumbai The US$65-billion (in 2005), global R&D pie is expected to grow to US$l00-billion by 2010. If India secures even
More informationPatients are Counting on Us: It s Time to Act
Patients are Counting on Us: It s Time to Act Brian Johnson Chairman Rx-360 Senior Director Supply Chain Security Pfizer, Inc. 24 th Global GS1 Healthcare Conference October 2, 2013 THE WALL STREET JOURNAL
More informationBIOCRATES Life Sciences AG Short Company Presentation
BIOCRATES Life Sciences AG Short Company Presentation Dr. Alexandra C. Gruber MBA MMFin Director Business Development / Marketing Austria Showcase Life Science Japan, Tokyo, December 2010 BIOCRATES Life
More informationWill payer leverage and post-election optimism shift dealmaking into a higher gear?
EY M&A Outlook and Firepower Report 2017 Will payer leverage and post-election optimism shift dealmaking into a higher gear? Payer pressure is growing across a wide spectrum of the health care sector.
More informationKonica Minolta to Acquire Invicro (US)
Konica Minolta to Acquire Invicro (US) Acceleration of expansion of precision medicine business Offering new value for drug discovery and development in immuno-oncology and neurodegenerative disease September
More informationCurrent Status of Pharmaceutical Patenting at United States Patent Office Rau. B. S Appaji P. V
Current Status of Pharmaceutical Patenting at United States Patent Office Rau. B. S Appaji P. V Abstract: Indian pharmaceutical industry has proved manufacture of global quality pharmaceutical products
More information"Stratification biomarkers in personalised medicine"
1/12 2/12 SUMMARY REPORT "Stratification biomarkers in personalised medicine" Workshop to clarify the scope for stratification biomarkers and to identify bottlenecks in the discovery and the use of such
More informationThe Precision Medicine Initiative at Merck: State-of-the-Art Patient Selection
68 The Precision Medicine Initiative at Merck: State-of-the-Art Patient Selection by Josef Straub, Arnold Gelb, Douglas Sanders, Juergen Scheuenpflug, Claudia Dollins As a cornerstone of the Merck approach
More informationThe room was more than 3/4 full with greater than 150 people in attendance.
Summary The room was more than 3/4 full with greater than 150 people in attendance. The questions were well distributed across all four panelists. All the Panelists were very interactive and were able
More informationSHORT COURSE. Practical Considerations for Biomarker Bioanalysis: Scientific and Regulatory Perspective SUNDAY, SEPTEMBER 17
SHORT COURSE SUNDAY, SEPTEMBER 17 OMNI PROVIDENCE HOTEL PROVIDENCE, RI Practical Considerations for Biomarker Bioanalysis: Scientific and Regulatory Perspective SPONSORED BY: Organized by: www.bostonsociety.org
More informationFirst Annual Biomarker Symposium Quest Diagnostics Clinical Trials
First Annual Biomarker Symposium Quest Diagnostics Clinical Trials Terry Robins, Ph.D. Director Biomarker R&D and Scientific Affairs Quest Diagnostics Clinical Trials Key Considerations: Biomarker Development
More informationMOSAIQUES DIAGNOSTICS
MOSAIQUES DIAGNOSTICS CLINICAL PROTEOMICS IN DRUG DEVELOPMENT INFORMATION Clinical Proteomics for early and differential diagnosis FDA Letter of Support Possibilities of a companion test in Drug Development
More informationMEDICAL DEVICES: TECHNOLOGIES AND GLOBAL MARKETS
MEDICAL DEVICES: TECHNOLOGIES AND GLOBAL MARKETS HLC170B January 2017 Vijay Laxmi Project Analyst ISBN: 1-62296-410-1 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215 (toll-free
More informationNeue Technologien für die patientennahe personalisierte Diagnostik
Neue Technologien für die patientennahe personalisierte Diagnostik 2014 Dr. Soeren Schumacher, M.B.A. 27th of June 2014 1 A heterogeneous pool 27th of June 2014 2 A heterogeneous pool Personalized Medicine
More informationResearched Medicines Industry Association of New Zealand Incorporated. Health Select Committee Submission
Researched Medicines Industry Association of New Zealand Incorporated Health Select Committee Submission Improving New Zealand s environment to support innovation through clinical trials April 2010 Contact
More informationSwissmedic Accepts Santhera's Filing of SNT-MC17 in Friedreich's Ataxia
Published: 07:00 04.10.2007 GMT+2 /HUGIN /Source: Santhera Pharmaceuticals Holding AG /SWX: SANN /ISIN: CH0027148649 Swissmedic Accepts Santhera's Filing of SNT-MC17 in Friedreich's Ataxia Liestal and
More informationFDA Drug Approval Process Vicki Seyfert-Margolis, Ph.D.
Speaker Comparing The Effectiveness Of New Drugs: Should The FDA Be Asking 'Does It Work' Or 'Does It Work Better'? Vicki L. Seyfert-Margolis, PhD Senior Advisor, Science Innovation and Policy U.S. Food
More informationDeveloping innovative new medicines for acute and chronic neurological and psychiatric conditions Larry Glass, CEO
Developing innovative new medicines for acute and chronic neurological and psychiatric conditions Larry Glass, CEO (lglass@neurenpharma.com) Neuren Pharmaceuticals Created to commercialize University of
More informationRegulatory Challenges of Global Drug Development in Oncology. Jurij Petrin, M.D. Princeton, NJ
Regulatory Challenges of Global Drug Development in Oncology Jurij Petrin, M.D. Princeton, NJ Topics General global R&D issues Regulatory issues with global oncology drug development US FDA initiatives
More informationINFECTIOUS DISEASES WE ARE LEADING THE WAY.
INFECTIOUS DISEASES WE ARE LEADING THE WAY. NO1 WORLD S LARGEST COLLECTION OF TICK CELL LINES OF MEDICAL AND VETERINARY IMPORTANCE ONE OF THE BIGGEST COLLECTIONS OF TROPICAL VENOMOUS SNAKES IN THE COUNTRY
More informationThe 100,000 Genomes Project Genomics Collaboration Event Finnish Residence
The 100,000 Genomes Project Genomics Collaboration Event Finnish Residence Prof Mark Caulfield FMedSci Chief Scientist for Genomics England Barts Heart Centre William Harvey Research Institute Queen Mary
More informationReflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development
1 2 3 24 June 2010 EMA/CHMP/641298/2008 Committee for Medicinal Products for Human Use (CHMP) 4 5 6 7 Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug
More informationThe Innovative Medicines Initiative (IMI) IMI - Safety Needs and Perspective
The Innovative Medicines Initiative (IMI) IMI - Safety Needs and Perspective Jacky Vonderscher Ph.D. Novartis Head of Exploratory Development in Europe Co-Director of the Predictive Safety Testing Consortium
More informationTuberculosis Drug Accelerator
Tuberculosis Drug Accelerator Overview of Activities and Portfolio who, why, what, how, by when and where are we now Steve Berthel 1 What is the Tuberculosis Drug Accelerator? The A is a groundbreaking
More informationOn Helix. 02 July Harren Jhoti President & CEO
On Helix 02 July 2014 Harren Jhoti President & CEO Astex Pharmaceuticals Global developer of small molecule drugs for unmet medical needs Expertise in oncology discovery & development World-class fragment-based
More informationBiogen Idec Synergy Creation in the move to the Big League. Activities, Assets and Sales Figures
Biogen Idec Synergy Creation in the move to the Big League Activities, Assets and Sales Figures Biogen Idec is one of the few integrated firms in the biotechnology industry that manages a drug right from
More informationThe importance of regulatory science in a societal and industrial perspective Annual Conference CORS 24 November 2016
The importance of regulatory science in a societal and industrial perspective Annual Conference CORS 24 November 2016 Marianne Kock, Head of Global Regulatory Affairs & Managing Director, Ferring Pharmaceuticals
More informationWith multiple modalities of care for cancer patients, oncology treatment
Oncology Disruption Demands Strategic Transformation In Vivo Pharma intelligence The rapidly accelerating complexity of oncology drug development demands a new way of doing business. To succeed in this
More informationM&A Focus: Biotechnology
WWW.IBISWORLD.COM Month 2012 1 Follow on head on Master page A May 2013 M&A Focus: Biotechnology By Anna Son Growing pains from the Patent Cliff will lead Big Pharma companies to invest in promising biotechnology,
More informationMetabolic and Inflammatory Disease R&D:
Insight Pharma Reports Insight Pharma Reports Expert Intelligence for Better Decisions formerly Advances Reports Metabolic and Inflammatory Disease R&D: An Assessment of 5 Highly Promising Therapeutic
More informationGrowth Strategies in the Pharmaceutical Industry: Strategic Acquisition
Growth Strategies in the Pharmaceutical Industry: Strategic Acquisition Neal Chatigny Kevin Higginbotham John Walsh Kyle Williams 4/29/2003 Introduction and Statement of Purpose Johnson and Johnson s (J&J)
More informationStatisticians in the Pharmaceutical Industry: The 21 st Century
Statisticians in the Pharmaceutical Industry: The 21 st Century Christy Chuang-Stein, Pfizer Ray Bain, Merck Cassie Burton, Novartis Cyrus Hoseyni, Wyeth Frank Rockhold, GlaxoSmithKline Stephen Ruberg,
More informationRegulatory Considerations and Trends Europe and the U.S.
Regulatory Considerations and Trends Europe and the U.S. Professor Kjell Strandberg MD PhD Chairman NDA Advisory Board, NDA Regulatory Science Ltd UK Former CPMP Member and Director General Medical Products
More informationDrug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research
Drug Development: Why Does it Cost so Much? Lewis J. Smith, MD Professor of Medicine Director, Center for Clinical Research Associate VP for Research Drug Development Process by which new chemical entities
More informationThe In Vitro Diagnostic CRO
The In Vitro Diagnostic CRO Choose Beaufort Because of Our People, Processes and Proven Experience The value of expertise cannot be overstated, especially when it comes to streamlining complicated in vitro
More informationICH Topic E16 Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions. Step 3
European Medicines Agency June 2009 EMEA/CHMP/ICH/380636/2009 ICH Topic E16 Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions Step 3 NOTE FOR GUIDANCE
More informationMedicine Traceability & AUthenticity
Medicine Traceability & AUthenticity Overview Universidad de Belgrano 18 Mayo, 2010 1 Universidad de Belgrano Medicine Traceability Overview 18 Mayo, 2010 1. A Glance on CTP 2. Introduction 3. Good and
More informationBuilding a Career in the Pharmaceutical Industry: Personal Reflections. Carlo Nalin, PhD Executive Director Novartis Oncology
Building a Career in the Pharmaceutical Industry: Personal Reflections Carlo Nalin, PhD Executive Director Novartis Oncology 2 Career Development: Personal Reflections C Nalin 5 April 2016 Cornell BEST
More informationFor personal use only
Proteomics International Laboratories Ltd Investor Presentation June 2015 Global leader & innovator in the field of proteomics ASX: PIQ 1 Disclaimer and Forward looking statements This Presentation is
More informationFDA Perspectives on Biomarkers. Steven Kozlowski, M.D. Office of Biotechnology Products OPS/CDER/FDA
FDA Perspectives on Biomarkers Steven Kozlowski, M.D. Office of Biotechnology Products OPS/CDER/FDA Importance of Biomarkers Earlier diagnosis Focusing expensive & invasive therapies on the right populations
More informationMaximizing opportunities towards achieving clinical success D R U G D I S C O V E R Y. Report Price Publication date
F o r a c l e a r e r m a r k e t p e r s p e c t i v e Early Stage Drug Safety Strategies & Risk Management Maximizing opportunities towards achieving clinical success D R U G D I S C O V E R Y Report
More informationCTS East Coast. Increasing Agility and Innovation in the Clinical Supply Chain for Cost Optimization. Connect with us to connect with Asia
Increasing Agility and Innovation in the Clinical Supply Chain for Cost Optimization Connect with us to connect with Asia CTS East Coast Oct 19 th, 2011 Philadelphia Introduction Zuellig Pharma Asia Pacific
More informationPresenter. Guy Clark. Searle Pharmaceuticals Sales, Marketing, BD. Business Development Director, IVAX Europe. President, Glenmark Europe
Presenter Guy Clark Searle Pharmaceuticals Sales, Marketing, BD 1992-2001 Business Development Director, IVAX Europe 2001-2005 President, Glenmark Europe 2005-2008 Business Development Consultant 2009-2010
More informationPharmaceutical and Biotechnology Construction Sector Report - UK Analysis
Pharmaceutical and Biotechnology Construction Sector Report - UK 2016-2020 Analysis Published: 16/09/2016 / Number of Pages: 98 / Price: 795.00 Introduction and Overview The 3rd edition of the report'pharmaceutical
More informationMeeting Report. Pharma Success in Product Development Does Biotechnology Change the Paradigm in Product Development and Attrition
The AAPS Journal, Vol. 18, No. 1, January 2016 ( # 2015) DOI: 10.1208/s12248-015-9833-6 Meeting Report Pharma Success in Product Development Does Biotechnology Change the Paradigm in Product Development
More informationAmgen Supply Chain Segmentation The Journey to October 23, 2014
Amgen Supply Chain Segmentation The Journey to 2022 October 23, 2014 Introduction Rayne Waller VP Global Supply Chain at Amgen Responsible for: Corporate and Regional Supply Chain Functions Contract Manufacturing
More informationBuilding Biotech Technology Transfer Opportunities
HEALTHCARE Building Biotech Technology Transfer Opportunities Sponsor and developer strategies for success By Alison Sahoo Alison Sahoo Alison Sahoo is a pharmaceutical industry analyst with more than
More informationICH Topic E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories.
European Medicines Agency November 2007 EMEA/CHMP/ICH/437986/2006 ICH Topic E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories Step 5
More informationGENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE)
TriMark Publications April 2007 Volume: TMRGER07-0401 GENE EXPRESSION REAGENTS MARKETS (SAMPLE COPY, NOT FOR RESALE) Trends, Industry Participants, Product Overviews and Market Drivers TABLE OF CONTENTS
More informationBIOTECHNOLOGY INDUSTRY
Long-term Prospects of the BIOTECHNOLOGY INDUSTRY Byung-Hwan Hyeon, Ph.D. The Present Situation of the Biotechnology Industry A. Definition and Scope The OECD defines biotechnology as activities that apply
More informationIndustry Academic Collaboration: A Key to Successful Involvement of Patients Early in Clinical Development
Industry Academic Collaboration: A Key to Successful Involvement of Patients Early in Clinical Development Aernout van Haarst PhD Director, European Corporate Development Feb 2016 Industry Academic Collaboration
More informationEarly scientific advice from HTA agencies: How does the effective use of the various kinds of advice support a positive HTA recommendation?
Early scientific from HTA agencies: How does the effective use of the various kinds of support a positive HTA recommendation? Highlights from a Technical Forum convened by the Centre for Innovation in
More informationCentre for Personalised Medicine in Tübingen - developing tailor-made treatments for patients
Powered by Website address: https://www.gesundheitsindustriebw.de/en/article/news/centre-for-personalised-medicine-intuebingen-developing-tailor-made-treatments-for-patients/ Centre for Personalised Medicine
More informationManagement in Pharmaceutical Industry
Master Program Management: Industrial Management Module: Chemistry for Drug Substances Management in Pharmaceutical Industry Prof. Tatsiana Savitskaya Assoc. Prof. Iryna Kimlenka Lectures 5,6 The Key Aspects:
More informationCollaborative Rare Diseases Research Activities at NIH
Collaborative Rare Diseases Research Activities at NIH Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences IRDiRC April 16, 2013 Background ~ 18 25 million people
More informationHelping Pharmas Manage Compliance Risks for Speaker Programs
COGNIZANT 20-20 Helping Pharmas Manage Compliance Risks for Speaker Programs By taking a rigorous and thoughtful approach that pivots around key performance indicators, pharmaceuticals companies can proactively
More information