Drug profile Development overview SWOT analysis Satisfaction of unmet needs Clinical and commercial attractiveness
|
|
|
- Audrey Griselda Thomas
- 6 years ago
- Views:
Transcription
1 OVERVIEW Catalyst Summary EXECUTIVE SUMMARY Strategic scoping and focus Datamonitor key findings Related reports PRODUCT OVERVIEW Key pipeline products for antibacterials PIPELINE PRODUCT PROFILES Teflaro/Zinforo (ceftaroline fosamil; Forest Laboratories/AstraZeneca) Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma) Tedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer) PTK 0796 (Paratek Pharmaceuticals) Dalbavancin (Durata Therapeutics)
2 Oritavancin (The Medicines Company) CXA-201 (CXA-101/tazobactam; Cubist Pharmaceuticals) CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca) Other pipeline antibacterials CB-183,315 (Cubist Pharmaceuticals) Delafloxacin (Rib-X) BC-3781 (Nabriva Therapeutics) TP-434 (Tetraphase Pharmaceuticals) Ceftaroline/avibactam (ceftaroline/avibactam; Forest Laboratories/AstraZeneca) PMX (PolyMedix) GSK-052 (Anacor Pharmaceuticals/GlaxoSmithKline) Ceftobiprole (Basilea Pharmaceutica) Cethromycin (Advanced Life Sciences) BIBLIOGRAPHY Journal papers Websites Datamonitor reports APPENDIX PharmaVitae Explorer database Contributing experts Conferences attended Report methodology
3 TABLES Table: Key pipeline products for antibacterials, Table: Teflaro/Zinforo (ceftaroline fosamil; Forest laboratories/astrazeneca) drug profile, Table: Summary of the pivotal Phase III clinical trials for Teflaro/Zinforo ( c eftaroline fosamil) in the treatment of ABSSSIs and CABP, Table: Ability of Teflaro/Zinforo (ceftaroline fosamil) to meet unmet needs, Table: Datamonitor drug assessment summary of Teflaro/Zinforo (ceftaroline fosamil; Forest Laboratories/AstraZeneca), Table: Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma) drug profile, Table: Summary of the key Phase III clinical trials for Dificid/Dificlir (fidaxomicin) in the treatment of CDAD, Table: Ability of Dificid/Dificlir (fidaxomicin) to meet unmet needs, Table: Datamonitor drug assessment summary of Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma), Table: Tedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer) drug profile, Table: Summary of the key Phase II clinical trial for tedizolid phosphate (TR-701) in the treatment of csssi, Table: Phase III trial (TR ) to determine the efficacy of intravenous to oral TR-701 versus intravenous to oral linezolid in ABSSSIs, Table: Ability of tedizolid phosphate (TR-701) to meet unmet needs, Table: Datamonitor drug assessment summary of tedizolid phosphate (Trius Therapeutics /Dong-A Pharmaceutical/Bayer), Table: PTK 0796 (Paratek Pharmaceuticals) drug profile, Table: Summary of the key Phase II clinical trial for PTK 0796 in the treatment of csssi, Table: Ability of PTK 0796 to meet unmet needs, Table: : Datamonitor drug assessment summary of PTK 0796 (Paratek Pharmaceuticals), Table: Dalbavancin (Durata Therapeutics) drug profile, Table: Summary of early Phase III clinical trials for dalbavancin in the treatment of csssi, Table: Phase III trials (DISCOVER-1 and DISCOVER-2) to determine the efficacy of dalbavancin versus vancomycin and linezolid in ABSSSI, Table: Ability of dalbavancin to meet unmet needs, Table: Datamonitor drug assessment summary of dalbavancin (Durata Therapeutics), Table: Oritavancin (The Medicines Company) drug profile, Table: Summary of early key Phase III clinical trials for oritavancin in the treatment of csssi, Table: Phase III trials (SOLO I and SOLO II) to determine the efficacy of oritavancin versus vancomycin in ABSSSI, Table: Ability of oritavancin to meet unmet needs,
4 FIGURES Table: Datamonitor drug assessment summary of oritavancin (The Medicines Company), Table: CXA-201 (CXA-101/tazobactam; Cubist Pharmaceuticals) drug profile, Table: Summary of the key Phase II clinical trials for CXA-101 and CXA-201 (CXA- 101/tazobactam) in the treatment of cutis and ciais, Table: Phase III trials (CXA-cUTI and CXA-cUTI-10-05) to determine the efficacy of CXA-201 versus levofloxacin in cuti, Table: Phase III trials (CXA-cIAI and CXA-cIAI-10-09) to determine the efficacy of CXA-201 versus meropenem in ciai, Table: Ability of CXA-201 (CXA-101/tazobactam) to meet unmet needs, Table: Datamonitor drug assessment summary of CXA-201 (CXA-201/tazobactam; Cubist Pharmaceuticals), Table: CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca) drug profile, Table: Summary of the key Phase II clinical trials for CAZ-AVI (ceftazidime/avibactam) in the treatment of ciais and cutis, Table: Ability of CAZ-AVI (ceftazidime/avibactam) to meet unmet needs, Table: Datamonitor drug assessment summary of CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca), Figure: Teflaro/Zinforo (ceftaroline fosamil; Forest Laboratories/AstraZeneca) SWOT analysis, Figure: Datamonitor drug assessment summary of Teflaro/Zinforo (ceftaroline fosamil; Forest Laboratories/AstraZeneca), Figure: Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma) SWOT analysis, Figure: Datamonitor drug assessment summary of Dificid/Dificlir (fidaxomicin; Optimer Pharmaceuticals/Astellas Pharma), Figure: Tedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer) SWOT analysis, Figure: Datamonitor drug assessment summary of tedizolid phosphate (Trius Therapeutics/Dong-A Pharmaceutical/Bayer), Figure: Phase II trial of PTK 0796 versus linezolid in treatment of complicated skin and skin structure infections, Figure: PTK 0796 (Paratek Pharmaceuticals), Figure: Datamonitor drug assessment summary of PTK 0796 (Paratek Pharmaceuticals), Figure: Dalbavancin (Durata Therapeutics), Figure: Datamonitor drug assessment summary of dalbavancin (Durata Therapeutics), Figure: Oritavancin (The Medicines Company), Figure: Datamonitor drug assessment summary of oritavancin (The Medicines Company), Figure: CXA-201 (CXA-101/tazobactam; Cubist Pharmaceuticals),
5 Figure: Datamonitor drug assessment summary of CXA-201 (CXA-201/tazobactam; Cubist Pharmaceuticals), Figure: CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca) SWOT analysis, Figure: Datamonitor drug assessment summary of CAZ-AVI (ceftazidime/avibactam; Forest Laboratories/AstraZeneca), Figure: The PharmaVitae Explorer
The changing face of pharma industry research
BSAC - The UK Roundtable Series, Feb 2015 Re-stoking the therapy pipeline: How to stimulate the development of new antibiotics, diagnostics and novel therapies The changing face of pharma industry research
PENTA-ID. Prof Mike Sharland
PENTA-ID Prof Mike Sharland PENTA-ID Expertise and Interests Chronic Infection HIV Hep C Hep B TB Acute Infection Bacterial Viral Fungal Grants and project management Study methodology and statistics Regulatory
Governance and finance recommendations
DRIVE-AB DRIVING RE-INVESTMENT IN R&D AND RESPONSIBLE ANTIBIOTIC USE Governance and finance recommendations Christine Årdal (Norwegian Institute of Public Health) for the DRIVE-AB consortium What? How
Investor Presentation
Cubist Pharmaceuticals The Shape of Cures to Come Investor Presentation October 2014 Forward-Looking Statements This presentation contains forward-looking statements. Any statements contained herein which
BUSINESS UPDATE CONFERENCE CALL
OTCQB: MTNB www.matinasbiopharma.com A clinical-stage biopharmaceutical company focused on the development of lipid-based prescription therapeutics for the treatment of cardiovascular and metabolic conditions
Regulatory hurdles and opportunities
Regulatory hurdles and opportunities Professor Roger Finch Nottingham University Hospitals & University of Nottingham, UK Drug licensing and regulation Mandatory for market authorisation Supports the public
Combating Antibiotic Resistance: New Drugs 4 Bad Bugs (ND4BB) David Payne/Seamus O Brien for Astra Zeneca, Basilea, GlaxoSmithKline, J&J & Sanofi
Combating Antibiotic Resistance: New Drugs 4 Bad Bugs (ND4BB) David Payne/Seamus O Brien for Astra Zeneca, Basilea, GlaxoSmithKline, J&J & Sanofi Need for public-private collaboration Challenges of AB
Product Safety and Quality: An act of social and ethical responsibility (a discussion about generic antibiotics)
Product Safety and Quality: An act of social and ethical responsibility (a discussion about generic antibiotics) Paul M. Tulkens, MD, PhD Cellular and Molecular Pharmacology Louvain Drug Research Institute
BEAM Alliance urges G20 support to fight deadly superbugs
Press Release BEAM Alliance urges G20 support to fight deadly superbugs At the Hamburg G20 summit, political leaders will speak about a growing global health threat - antibiotic resistance - which causes
Shionogi Presents Results of the First Clinical Efficacy Trial and In Vitro Data on Cefiderocol (S ), a Siderophore Cephalosporin
Shionogi Presents Results of the First Clinical Efficacy Trial and In Vitro Data on Cefiderocol (S-649266), a Siderophore Cephalosporin Osaka, Japan, April 22, 2017 - Shionogi & Co., Ltd. today announced
REFERENCE CODE GDHC1106CFR PUBLICATION DATE M AY 2013
REFERENCE CODE GDHC1106CFR PUBLICATION DATE M AY 2013 PSORIASIS - Psoriasis - US Drug Forecast and Market Analysis to Executive Summary Sales for Psoriasis in the US 2012 We estimate the 2012 PsO drug
What happened to natural product antibacterial drug discovery and why?
What happened to natural product antibacterial drug discovery and why? Mike Dawson Antibiotic Action 21 st May 1 Newly reported natural products Natural product screening in Pharma is no more Reports of
Division of Dockets Management (HFA 305) U.S. Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852
May 24, 2012 Division of Dockets Management (HFA 305) U.S. Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Comments on Docket #FDA- 2012 D 0148; Draft Guidance for Industry
Revolutionizing the Treatment of Infectious Diseases with Defensin-Mimetics
www.polymedix.com Revolutionizing the Treatment of Infectious Diseases with Defensin-Mimetics Ticker: PYMX March 2012 Disclaimer and Safe Harbor Forward-looking statements This presentation contains forward-looking
Verification of Disk Diffusion Tests
Verification of Disk Diffusion Tests Objectives 1. Describe disk diffusion tests 2. Describe process of FDA clearance of susceptibility tests 3. Discuss CLIA requirements for laboratory verification of
Verification of Gradient Diffusion Strips
Verification of Gradient Diffusion Strips Objectives 1. Describe gradient diffusion tests 2. Describe process of FDA clearance of susceptibility tests 3. Discuss CLIA requirements for laboratory verification
Carbavance. TANGO-1 phase III trial results. (meropenem-vaborbactam) Conference call 27 th June 2016
Carbavance (meropenem-vaborbactam) TANGO-1 phase III trial results Conference call 27 th June 2016 Legal notices Forward looking statements Statements contained in this presentation about The Medicines
Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection. abstract
The new england journal of medicine established in 1812 January 26, 2017 vol. 376 no. 4 for Prevention of Recurrent Clostridium difficile Infection M.H. Wilcox, D.N. Gerding, I.R. Poxton, C. Kelly, R.
On 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
REIMAGINING 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
X-biotech. Ecole des Mines. 24 April 2006
X-biotech Ecole des Mines 24 April 2006 1 Agenda Pharmaceutical Industry Context Antibiotic Therapeutic Area Creation and Structure of Novexel SA Pipeline Attributes 2006 Milestones 2 Bigger is Better?
An analysis of the Swedish Biotech Pipeline April, The Swedish Biotechnology Industry Organization
An analysis of the Swedish Biotech Pipeline April, 2007 The Swedish Biotechnology Industry Organization 0 A Survey of the Swedish Biotech pipeline In February-March 2007 a survey of the Swedish biotech
In silico prediction of novel therapeutic targets using gene disease association data
In silico prediction of novel therapeutic targets using gene disease association data, PhD, Associate GSK Fellow Scientific Leader, Computational Biology and Stats, Target Sciences GSK Big Data in Medicine
EU Regulation Review: challenges and opportunities for industry
EU Regulation Review: challenges and opportunities for industry Mia Bengtström, Pharma Industry Finland Nordic Pediatric Conference June 13,2017 Paediatric Regulation Consultation: EFPIA s answers general
The Lancet Publishes Results from the Landmark Phase III Rivaroxaban Study RECORD2
News Release Bayer HealthCare AG Corporate Communications 51368 Leverkusen Germany Phone +49 214 30 1 www.news.bayer.com Venous Blood Clot Prevention after Hip Replacement Surgery: The Lancet Publishes
Inaugural Fraunhofer Delaware Technology Summit
Inaugural Fraunhofer Delaware Technology Summit Energy and Life Sciences Solu
REFERENCE CODE GDHC218CFR PUBLICAT ION DATE FEBRUARY 2014 ULCERATIVE COLITIS - US DRUG FORECAST AND MARKET ANALYSIS TO 2022
REFERENCE CODE GDHC218CFR PUBLICAT ION DATE FEBRUARY 2014 ULCERATIVE COLITIS - US DRUG FORECAST AND MARKET ANALYSIS TO 2022 Executive Summary Sales for Ulcerative Colitis in the United States In 2012,
Antisense Therapeutics Ltd ASX:ANP January 2017
Antisense Therapeutics Ltd ASX:ANP January 2017 Forward Looking Statements This presentation contains forward-looking statements regarding the Company s business and the therapeutic and commercial potential
Human pharmacokinetics and rationale for once-weekly dosing of dalbavancin, a semi-synthetic glycopeptide
Journal of Antimicrobial Chemotherapy (2005) 55, Suppl. S2, ii25 ii30 doi:10.1093/jac/dki008 JAC Human pharmacokinetics and rationale for once-weekly dosing of dalbavancin, a semi-synthetic glycopeptide
REFERENCE CODE GDHC1180DFR PUBLICATION DATE M AY 2013
REFERENCE CODE GDHC1180DFR PUBLICATION DATE M AY 2013 STELARA (PSORIASIS) - Executive Summary Table below presents key metrics for Stelara in the seven of the nine major pharmaceutical markets. Stelara:
C o m p a n y R e p o r t
R C o m p a n y R e p o r t 2 0 0 6 G a l a p a g o s 2 0 0 6 S y n e r g y R Progressing a well-balanced therapeutic pipeline through innovative R&D in bone and joint diseases programs based on known
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
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
Do We Need Medical Affairs?
Do We Need Medical Affairs? Dr Richard Nieman Head of Medical Affairs, Asia Bayer Healthcare Pharmaceuticals Global R&D Center, Beijing, China May 17, 2011 Biographical Sketch of Dr Richard Nieman Dr Richard
UPDATE ON COMBACTE STATUS AND ACTIVITIES
UPDATE ON COMBACTE STATUS AND ACTIVITIES MARC BONTEN APRIL 24TH, 2017 Program 18:30-18:50 Update on COMBACTE status and activities Prof. Dr. Marc Bonten (UMC Utrecht) 18:50-19:10 Studies on Clostridium
Biowaivers and Harmonization Guidelines for Class I and 3 Drugs: Biowaiver Case Studies
Biowaivers and Harmonization Guidelines for Class I and 3 Drugs: Biowaiver Case Studies Barbara M. Davit, Merck & Co., Inc. 3 rd FDA/PQRI Conference on Advancing Product Quality March 22, 2017 Disclaimer
Session 7 Clinical Trial Assessment Bioequivalence Studies
L1 Session 7 Clinical Trial Assessment Bioequivalence Studies Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office
Bacteriophage Therapeutics for Patients with Antibiotic-Resistant Infections
Bacteriophage Therapeutics for Patients with Antibiotic-Resistant Infections November 7, 2017 NYSE MKT: APHB Safe Harbor Statement This presentation contains forward-looking statements that involve risks,
REFERENCE CODE GDHC266CFR PUBLICAT ION DATE DECEMBER 2014 RHEUMATOID ARTHRITIS JAPAN DRUG FORECAST AND MARKET ANALYSIS TO 2023
REFERENCE CODE GDHC266CFR PUBLICAT ION DATE DECEMBER 2014 RHEUMATOID ARTHRITIS JAPAN DRUG FORECAST AND MARKET ANALYSIS TO 2023 Executive Summary Sales for Rheumatoid Arthritis in Japan The Rheumatoid Arthritis
Regulatory 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
Global 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
Maximizing 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
Hemophilia A and B Recombinant Factor Replacement Therapy - 5EU Drug Forecast and Market Analysis to 2024
Published on Market Research Reports Inc. (https://www.marketresearchreports.com) Home > Hemophilia A and B Recombinant Factor Replacement Therapy - 5EU Drug Forecast and Market Analysis to 2024 Hemophilia
Lehman Brothers Global Healthcare Conference
Lehman Brothers Global Healthcare Conference Lawrence S. Olanoff - MD, Ph.D President and Chief Operating Officer March 20, 2007 Safe Harbor Except for the historical information contained herein, this
Application Strategy of PBPK for Generic Drugs and Its Current Challenges
BUILD A PHARMACEUTICAL COMPANY Application Strategy of PBPK for Generic Drugs and Its Current Challenges Bo Liu June 18, 2017 1 PuraCap Global Presence PuraCap Laboratories LLC, Kentucky PuraCap Pharmaceutical
Investigating Clinical Trial Costs Comparative Analysis of Trial Cost Components in Key Geographies Table of Contents
Investigating Clinical Trial Costs Comparative Analysis of Trial Cost Components in Key Geographies Table of Contents Executive summary 14 Introduction and background to clinical trials 14 Financial considerations
ACTELION S COMPANY PROFILE
ACTELION S Actelion Ltd. is a leading biopharmaceutical company focused on the discovery, development and commercialization of innovative drugs for diseases with significant unmet medical needs. The company
Reflections on a career in Pharmaceutical Statistical Sciences: My Journey. James R. Johnson, PhD (UD04)
Reflections on a career in Pharmaceutical Statistical Sciences: My Journey James R. Johnson, PhD (UD04) 1 My Journey 7 Different Pharmaceutical Companies 30 years (1983 to 2013) Retired to Consulting and
Bio-Pharma: China A Look at The FUTURE: 4 th & 5 th Generation Global Strategies
Global Strategy Global Challenges Executable Solutions Bio-Pharma: China 2010-2020 A Look at The FUTURE: 4 th & 5 th Generation Global Strategies France Houdard Managing Director January 2010 Table of
CRO 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
CENTRAL NERVOUS SYSTEM (CNS) BIOMARKERS: TECHNOLOGIES AND GLOBAL MARKETS
CENTRAL NERVOUS SYSTEM (CNS) : TECHNOLOGIES AND GLOBAL MARKETS BIO074C March 2016 Jackson Highsmith Project Analyst ISBN: 1-62296-246-X BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215
Roche 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
Joint 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
Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation
2 March 2010 EMA/COMP/15893/2009 Final Committee for Orphan Medicinal Products (COMP) Recommendation on elements required to support the medical plausibility and the assumption of significant benefit for
Abstract. Technical Aspects. Applying GastroPlus for Extensions of Biowaivers for BCS Class II Compounds 2
Abstract GastroPlus is a mechanistically based simulation software package that predicts absorption, pharmacokinetics, and pharmacodynamics in humans and animals. GastroPlus modeling and simulation has
POSSIBILITIES FOR HARMONIZATION OF REIMBURSEMENT (HTA) AND REGULATORY PROCESSES AND EVIDENTIARY REQUIREMENTS IN CANADA
POSSIBILITIES FOR HARMONIZATION OF REIMBURSEMENT (HTA) AND REGULATORY PROCESSES AND EVIDENTIARY REQUIREMENTS IN CANADA Moderator: Ron Goeree Panelists: Michael Drummond, Chris Henshall, Barbara Sabourin,
Summary of Provisions in 21 st Century Cures Act (H.R. 6) as passed by full House of Representatives, July 10, 2015
Pediatric-Specific Provisions Summary of Provisions in 21 st Century Cures Act (H.R. 6) as passed by full House of Representatives, July 10, 2015 Requires the NIH to complete a strategic plan, and in the
National Foundation for Women Legislators Annual Meeting September 12, 2015 Tara Ryan Vice President, State Government Advocacy
From Hope to Cures: The Value of Biopharmaceutical Innovation National Foundation for Women Legislators Annual Meeting September 12, 2015 Tara Ryan Vice President, State Government Advocacy HIV/AIDS: Then
2017 Call for Proposals EDCTP-TDR Clinical Research and Development Fellowships
2017 Call for Proposals EDCTP-TDR Clinical Research and Development Fellowships Call Identifier: TMA2017IF The purpose of this Call for Proposals is to provide funding towards actions that aim to support
Capital Market Day June 12, 2012
Capital Market Day 2012 June 12, 2012 Product Segments IV Drugs John Ducker Member of the Management Board President Region North America Capital Market Day Fresenius Kabi, June 12, 2012 Agenda 1 2 3 4
RIEMSER Pharma GmbH Ready for the Future
RIEMSER Pharma GmbH Ready for the Future Jefferies Health Care Conference 19 th & 20 th November 2014 The Waldorf Hilton, London 01.05.2011 Präsentationstitel von Dr. Vorname Nachname 1 Fast international
Marketspace. Keywords: early-stage collaboration, licensing, lead optimisation, lead identification, target validation, drug discovery
Mark J. Belsey spent his PhD looking at the role of cell signalling pathways underlying cell cycle progression in oncology. He is now working for the Competitive Intelligence healthcare team with Datamonitor,
The 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
8 th Kitasato- Harvard Symposium
8 th Kitasato- Harvard Symposium CONSISTENT SAFETY RISK MANAGEMENT THROUGH THE PRODUCUT LIFE CYCLE FROM CLINICAL DEVELOPEMNT TO POST APPROVAL - Efforts of Regulatory Authority in Japan - Kaoru Misawa Director,
Samatasvir (IDX719), a Potent Pan-Genotypic NS5A Inhibitor, for the Treatment of Hepatitis C Virus (HCV) Infection
Samatasvir (IDX719), a Potent Pan-Genotypic NS5A Inhibitor, for the Treatment of Hepatitis C Virus (HCV) Infection Douglas Mayers, MD December 11, 2013 1 Idenix: Advancing All-Oral, Pan-Genotypic Combination
Hemophilia A and B Recombinant Factor Replacement Therapy - Argentina Drug Forecast and Market Analysis to 2024
Hemophilia A and B Recombinant Factor Replacement Therapy - Argentina Drug Forecast and Market Analysis to 2024 Hemophilia A and B Recombinant Factor Replacement Therapy - Argentina Drug Forecast and Market
Report on New Patented Drugs - Invanz
Report on New Patented Drugs - Invanz October 2006 Under its transparency initiative, the PMPRB publishes the results of the reviews of new patented drugs by Board Staff, for purposes of applying the PMPRB
Tavaborole demonstrates solid efficacy and safety in Phase III trials
Anacor s Drug Tavaborole Should Receive FDA Approval On May 29, 2013, Anacor Pharmaceuticals (ANAC) announced successful completion of pre- NDA (New Drug Approval) communication with the U.S. Food and
INVESTOR PRESENTATION
INVESTOR PRESENTATION March 2008 FORWARD LOOKING STATEMENTS This presentation contains forward looking statements. The words believe, expect, anticipate, intend, will, may, would, could and plan and similar
Global Contract Research Organization (CRO) Market: Size, Trends & Forecasts ( ) November 2017
Global Contract Research Organization (CRO) Market: Size, Trends & Forecasts (2017-2021) November 2017 Global Contract Research Organization (CRO) Market : Coverage Executive Summary and Scope Introduction/Market
Partnering with Rare Disease Patient Groups. Namrata Taak R&D External Communications, Rare Diseases
Partnering with Rare Disease Patient Groups Namrata Taak R&D External Communications, Rare Diseases What we do Pharmaceuticals We develop and make medicines to treat a range of conditions including respiratory
Official Letter from the DOH
Issued Date 2009/04/02 Issued by DOH Ref. No 0980316268 RE The DOH issued an official letter to announce the implementation of the Guideline for BA/BE Studies on April 2, 2009 (Ref. No. 0980316265). Please
Dr Amy Prosser Careers in Research: Industry
www.rsb.org.uk Dr Amy Prosser Careers in Research: Industry @RoyalSocBio #BiologyWeek #RSBcareersDay Careers in Research: Working in the Pharma Industry Dr Amy Prosser My Career History 2011 Completed
INVEST IN TOPADUR! HEALTH IS THE MOST IMPORTANT THING IN LIFE!
INVEST IN TOPADUR! HEALTH IS THE MOST IMPORTANT THING IN LIFE! TOPADUR PHARMA AG a promising Swiss start-up investment Global Medical Need: Diabetes mellitus is one of the major health concerns worldwide.
Santen Acquisition of InnFocus, Developer of MicroShunt Glaucoma Implant Device
Santen Acquisition of InnFocus, Developer of MicroShunt Glaucoma Implant Device Akira Kurokawa President & CEO August 2, 2016 Copyright 2016 Santen Pharmaceutical Co., Ltd. All rights reserved. 1 External
DEMONSTRATING YOUR MEDICINE S VALUE TO ALL STAKEHOLDERS TRUSTED COMMERCIALIZATION AND MARKET ACCESS EXPERTISE
CATALYSTS DRIVING SUCCESSFUL DECISIONS IN LIFE SCIENCES DEMONSTRATING YOUR MEDICINE S VALUE TO ALL STAKEHOLDERS TRUSTED COMMERCIALIZATION AND MARKET ACCESS EXPERTISE WHEN COMMERCIALIZING A MEDICINE, IT
Question and Answer Guide Regarding Notification on Practical Operations of Electronic Study Data Submissions
Administrative Notice April 27, 2015 To: Prefectrual Health Department (Bureau) Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Question
Complex Generics: Charting a new path
White paper Complex Generics: Charting a new path Complex generics offer a lucrative market for drug manufacturers, but only if they can adapt to a more complicated and challenging development process.
Outline CLINICALLY RELEVANT SPECIFICATIONS. ISPE Process Validation Conference September 2017 Bethesda, MD
CLINICALLY RELEVANT SPECIFICATIONS Patrick J Marroum Ph.D. Senior Director and ACOS Senior Research Fellow Department of Clinical Pharmacology and Pharmacometrics Abbvie Pharmaceuticals Outline CMC variables
Understanding clinical research trials
Understanding clinical research trials Dr. Isabelle Fleury Medical Hemato-oncologist Hôpital Maisonneuve-Rosemont CIUSSS de l Est-de-l Île-de-Montréal Goals of this presentation Better understand clinical
Together, all nine participants have reduced infusions of factor IX concentrates by 99 percent over cumulative 1,650 days
Spark Therapeutics and Pfizer Present Updated Data from Hemophilia B Phase 1/2 Trial Suggesting Consistent and Sustained Levels of Factor IX Activity at Annual ASH Meeting Together, all nine participants
CTTI Overview One Decade of Impact. One Vision Ahead.
Feb. 6, 2018 CTTI Overview One Decade of Impact. One Vision Ahead. Pamela Tenaerts, MD, MBA Executive Director #CelebrateCTTI Discover how CTTI has influenced the clinical trials enterprise during the
Jordi Aparici Market Intelligence Consultant
Jordi Aparici Market Intelligence Consultant Helping pharma companies make robust decisions based on market, competitors and patient knowledge Market Intelligence Strategy Marketing Market Research Data
EU support for Health Research from FP6 to FP7
EU support for Health Research from FP6 to FP7 Stéphane Hogan Head of Biotechnology Unit Directorate for Health Research DG Research - European Commission Valencia - 15 September 2006 EU research programmes
CTTI Statistics Think Tank for Anti-Bacterial Drug Development
CTTI Statistics Think Tank for Anti-Bacterial Drug Development Lisa LaVange Office of Biostatistics, CDER, FDA August 20, 2012 Bethesda Hyatt 1 Background Recent advances in clinical trial design in the
Using local RWD to drive global therapeutic advancements.
Using local RWD to drive global therapeutic advancements. Helsinki, 30 th Nov 2016 Mike Spencer, Head of Real World Evidence, EMEA, Janssen The following represent my own views and not necessarily those
PATIENT GROUPS & CLINICAL TRIALS CASE STUDY
February 1, 2017 PATIENT GROUPS & CLINICAL TRIALS CASE STUDY Jeffrey W. Sherman, M.D., FACP Past President Inaugural Fellow Chief Medical Officer Executive Vice President Disclaimer The views and opinions
2. Needle Free Injection INJEX Technology and Products
Disclaimer This presentation contains forward-looking statements - that is, statements related to future, not past, events. These statements may be identified either orally or in writing by words as "expects",
MRC Technology. A Life Science Specialist Technology Transfer Company. Skaggs School of Pharmacy and Pharmaceutical Sciences, December 2011
MRC Technology A Life Science Specialist Technology Transfer Company Skaggs School of Pharmacy and Pharmaceutical Sciences, December 2011 Dr John Kelly, Associate Director Business Development John.kelly@tech.mrc.ac.uk
Cellular Tumor Antigen P53 (Tumor Suppressor P53 or Antigen NY-CO-13) - Pipeline Review, H1 2016
Published on Market Research Reports Inc. (https://www.marketresearchreports.com) Home > Cellular Tumor Antigen P53 (Tumor Suppressor P53 or Antigen NY-CO-13) - Pipeline Review, H1 2016 Cellular Tumor
Supporting Innovation through Scientific Advice
Supporting Innovation through Scientific Advice PEARRL Regulatory Science Symposium, 21 st June 2017, University College Cork HPRA Dr Peter Kiely Disclaimer All views expressed in this presentation are
Novartis Business Services HR University Relations. Clinical Sciences and Innovation. Postgraduate Program
Novartis Business Services HR University Relations Clinical Sciences and Innovation Postgraduate Program 2 CLINICAL SCIENCES AND INNOVATION CLINICAL SCIENCES AND INNOVATION 3 The CS&I Postgraduate Program
Remco de Vrueh. Driving partnerships from idea to success
Remco de Vrueh Driving partnerships from idea to success Rare Disease Symposium: the rare disease patient in 2030 Outline 2 Current status Orphan drug development Public-Private Partnerships (PPPs) Lygature
Mithra manages today multiple synergistic innovation streams for R&D, manufacturing or commercial partnering
Mithra manages today multiple synergistic innovation streams for R&D, manufacturing or commercial partnering Our mission is to improve every stage of women s life with innovative and accessible pharmaceutical
Science. Enhancing the Pharma-CRO relationship with a focus on method transfer. for a safer world
Enhancing the Pharma-CRO relationship with a focus on method transfer Chris Jones, Client Manager, Drug Development Services, LGC EBF Open Symposium, 18 th November 2015 Science for a safer world Overview
GetReal: 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
CLINICAL REQUIREMENTS FOR LOCALLY APPLIED, LOCALLY ACTING PRODUCTS, CONTAINING KNOWN CONSTITUENTS
CLINICAL REQUIREMENTS FOR LOCALLY APPLIED, LOCALLY ACTING PRODUCTS, CONTAINING KNOWN CONSTITUENTS Guideline Title Clinical Requirements for Locally Applied, Locally Acting Products, Containing Known Constituents
Data and Safety Monitoring Boards
Data and Safety Monitoring Boards Purposes, Roles and Challenges IACCT2017 Nov 29, 2017, Tel Aviv, Israel Arthur Weinstein, MD, FACP, FRCP, MACR Attending Rheumatologist Emeritus, MedStar Washington Hospital