Biotherapeutic product characterization to support accelerated process development
|
|
- Vivien Davis
- 6 years ago
- Views:
Transcription
1 Biotherapeutic product characterization to support accelerated process development Kyle Zingaro, Ph.D. Alexion Pharmaceuticals 2015 Biomanufacturing Technology Summit June 25, 2015
2 Our Mission: Treating Patients with Severe & Devastating Diseases Alexion is focused on developing lifetransforming treatments for patients with severe and life-threatening diseases Severe Transformative Clinical Benefit Devastating Life-Threatening No Effective Treatments 2
3 Toronto, Canada Brussels, Belgium Government Affairs, EMEA Stockholm, Sweden Nordic Tokyo, Japan Japan Regional HQ Smithfield, RI Manufacturing Operations London, UK Munich, Germany Cambridge, MA Translational Medicine Group Cheshire, CT Global Headquarters North America Regional HQ Washington DC Global Government Affairs Dublin, Ireland Global Supply Chain and Distribution Paris, France European Service Center Barcelona, Spain Moscow, Russia Lausanne, Switzerland EMEA Operations Center Milan, Italy Istanbul, Turkey Shanghai, China Miami, FL Latin America Regional HQ Dubai, UAE Middle East Operations Mumbai, India Global Business Services Sydney, Australia Asia-Pacific Regional HQ Mexico City, Mexico Bogotá, Colombia São Paulo, Brazil Buenos Aires, Argentina Our Global Footprint ~2,400 dedicated employees serving patients in almost 50 countries 3
4 Biologic Process Development Connecting process inputs with product output
5 Development of a Biologic Manufacturing Process The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. -ICH Guideline Q8 (R2) 5
6 Process Development Goals Definition and characterization of a robust process to generate quality therapeutic products Assessment of risk in design of new processes and change to existing processes Implementation of new technologies to improve those processes Support of clinical and commercial manufacturing efforts 6
7 Analytical Method Lifecycle Roadmap
8 Development and Characterization: Who supports whom? Clone selection, process definition, and process changes can not happen without analytical data Analytical methods exist to support manufacturing process definition and operation /ability-and-methods 8
9 Defining a Biologic Fingerprint What level of characterization defines a product?
10 Critical Quality Attributes (CQA) A CQA is a physical, chemical, biological, or microbiological property that should be within an appropriate limit, range, or distribution to ensure the desired product quality. -ICH Q8 (R2) Biologics Include primary, secondary, tertiary, and quaternary protein structure and post-translational modifications 10
11 A Biological Fingerprint Primary and higher order structure with posttranslational and chemical modifications which uniquely describe a protein Fingerprint-like: integrated, multi-parameter approaches that are extremely sensitive in identifying analytical differences 1 No clear consensus definition Challenged by constantly evolving analytical methods ckville/fingerprintingservices.aspx 1 Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product, FDA Guidance for Industry,
12 Biologic Fingerprints & Innovator Companies Clearer connections between biophysical quality and clinical safety and efficacy Development of robust processes requires an understanding of the impact of process inputs on the biologic fingerprint Implementation of process changes require demonstration of comparability in critical quality attributes 12
13 Approval of Zarxio (Neupogen Biosimilar) methionyl-granulocyte Colony Stimulating Factor (G-CSF) smeetingmaterials/drugs/oncologicdrugsadvisorycommittee/u CM pdf 13
14 Clinical Phase Relevant Testing & Characterization How much do we learn as a product & process develop?
15 When do we really need to know all that? Process improvement and optimization is completed throughout clinical development timeframes Process knowledge is expected to be limited for early filings Complete information must be available for commercial filing Phase 1 Phase 2 Phase 3 Approval Commercial Product 15
16 Product Safety and Efficacy Studies Different phases of clinical trials require different standards: Phase 1 (Safety) Simple efficacy assay (eg. ELISA), limited method understanding, and method qualification Phase 3 (Efficacy) Established and well characterized methods, method validation, cell-based efficacy assays Method understanding improves throughout development process 16
17 Process Changes Manufacturing process changes will happen! Clinical Manufacturing vs. Commercial Manufacturing Changes must produce highly similar material Clinical Development Significant Changes Approved Application Major, Moderate, or Minor Changes 17
18 Accelerated Process Development Faster from clinic to market
19 Why do we need to develop processes faster? Patient Benefit Provide beneficial therapies to patients faster Regulatory Changes Breakthrough designation shortens clinical and CMC timelines Commercial Benefits 19
20 Isn t faster a good thing? All stages of process and method development still need to be completed We have less time to develop and less time to respond to regulatory inquiries How can we get it all done? 20
21 Strategies for Faster CMC Development Reconciling shorter timelines and better characterization
22 Management Strategies Detailed Quality Target Product Profile (QTPP) Cross-Functional Communication Clinical and CMC Collaboration Strategic Planning Templates 22
23 Technical Strategies Predictive Modeling Process and product predictions throughout development and product lifecycle Real Time Monitoring More data produced at and online Platform Processes 23
24 Platform Processes Defining an evolving standard
25 Why do we need a platform? Data derived from relevant prior knowledge, including platform manufacturing, can be leveraged to support development of the commercial process and expedite scientific understanding. -ICH Guideline Q11 25
26 What makes a good platform? Quality Robustness Raw Material Supply Chain Scalability Productivity Cost Effective Quality Analytics Purification Cell Bank Production Bioreactor Seed Train 26
27 Why do we change a platform process? Technology Continues to Evolve Quality Robustness Productivity Patient Safety Removal of animal derived components Raw Materials Biomanufacturing Flexibility, Bio-G, Bioproduction Group, 27
28 How & when do we change a platform process? Incremental improvement can be identified but are difficult to implement Step-wise improvements when sufficient progress has been made in a new platform What is the clinical or commercial need? Platform qualification evaluations using our biologic fingerprint How close is close enough? 28
29 Conclusions and Future Challenges
30 Conclusions Process development timelines are always shortening CMC development efforts including process and method development need to keep pace Both method and process should be expected to evolve to meet the clinical and commercial applications of a product 30
31 Future Challenges Analytical and manufacturing technologies continue to evolve Standards and expectations will evolve with those technologies Timelines will always be shortened where possible while the expectations do not change Organization, communication, and efficient management are required to meet those expectations 31
32 Acknowledgements Process Development Pratik Jaluria Hunter Malanson Matt Rimbey Ina Alickolli Krishanu Mathur Loray Paul Luke Loftus Analytical Sciences Zhenyu Gu & Jack Yu Product Characterization Adriana Kita 32
Ricoh Europe Supply Chain Management
Ricoh Europe Supply Chain Management Frank Nieuwenhuis Manager, Supply Chain Development & Projects NDL Slotbijeenkomst Amsterdam, 7 th March 2017 Ricoh Europe s Supply Chain EMEA - a Dynamic Region European
More informationResults Count LABWARE LIMS. LabWare LIMS. LabWare
LABWARE LIMS LabWare LIMS www.labware.com LABWARE LIMS: THE FOUNDATION OF LABWARE S ENTERPRISE LABORATORY PLATFORM LabWare is recognized as the global leader in providing enterprise scale laboratory automation
More informationIntellectual Capital. On Demand.
Intellectual Capital. On Demand. A unique approach to consulting. RGP is made up of proven problem solvers accomplished professionals who give you the help you need, when you need it, how you need it.
More informationInvestigating 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
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 informationImpacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales. Innovacion en Packaging Primario
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales Innovacion en Packaging Primario 1 Contents Company Highlight What s Changing in Pharma Pharma Trends Harmonisation New Requirements
More informationHay Group Spectrum. The next generation HR solution
Hay Group Spectrum The next generation HR solution Today, you can t afford to have anything less than an integrated approach to HR. An approach that delivers real insights to strategic decision-making.
More information- cosmetics & high-end fragrances -
- cosmetics & high-end fragrances - May 2013 AGENDA 2 AGENDA 3 THE AMBITION OF A DEDICATED STUDY A new international study, building on previous learning. How do Global Shoppers associate travelling and
More informationStaying on the Leading Edge
Human Resources Staying on the Leading Edge Five important qualities for aspiring chief human resources officers So you want to be a CHRO. That s an admirable goal, but keep in mind that the responsibilities
More informationKAESER Kompressoren. Smart Air Strategy Execution
Smart Air Strategy Execution Company Profile Founded 1919 in Coburg Manufacturing in Germany Sales & Service in EMEA Americas APAC ~ 6.000 Employees SAP Leonardo Live, 11.07.2017, Frankfurt 2 Global IT
More informationNEXT GENERATION DOWEX MARATHON ION EXCHANGE RESINS FOR INDUSTRIAL WATER TREATMENT. Small change, big impact.
NEXT GENERATION DOWEX MARATHON ION EXCHANGE RESINS FOR INDUSTRIAL WATER TREATMENT Small change, big impact. Next Generation DOWEX MARATHON Ion Exchange Resins For Industrial Water Treatment The best of
More informationPayNet UK Salary Tracker: What is the real cost of living for UK employees today?
PayNet UK Salary Tracker: What is the real cost of living for UK employees today? Overview Hay Group s quarterly PayNet UK Salary Tracker looks at how employees pay compares with a range of key economic
More informationChallenges and Opportunities in Pharma: Perspective for an Emerging Middle East April 24th, 2015
Challenges and Opportunities in Pharma: Perspective for an Emerging Middle East 2020 April 24th, 2015 Content Pharma Market Landscape Global Pharma Market Market Categories Middle East Markets Major Challenges
More informationSpeed your time to market with FDA s expedited programs
Regulatory Sciences Expediting drug approval Speed your time to market with FDA s expedited programs The faster way to marketing submission and drug approval for serious conditions and rare diseases In
More informationCTO s Key International Markets
CTO International CTO s Key International Markets Americas Primary Markets Canada Mexico Emerging Markets Brazil Columbia Panama Europe, Middle- East, & Africa Primary Markets France & Belgium UK & Ireland
More informationSUCCESS HAS A NAME. Your Partner for Labeling Solutions.
SUCCESS HAS A NAME Your Partner for Labeling Solutions. 2 THE PERFECT COMBINATION FOR YOUR GOALS. You probably know just how tough it can be having to decide between two contradicting alternatives. Take
More informationGLOBAL VIDEO-ON- DEMAND (VOD)
GLOBAL VIDEO-ON- DEMAND (VOD) HOW WORLDWIDE VIEWING HABITS ARE CHANGING IN THE EVOLVING MEDIA LANDSCAPE MARCH 2016 A CHANGING VIDEO-VIEWING LANDSCAPE Nearly two-thirds of global respondents say they watch
More informationA shared global vision Helping you do business all over the world
Helping you do business all over the world Client Commitment Innovative Solutions Global Service Contents Client Commitment. Innovative Solutions. Global Service. 5 Why work with us? 6 Welcome to our world
More informationCALIFORNIA S BIOTECHNOLOGY WORKFORCE TRAINING NEEDS FOR THE 21 st CENTURY
CALIFORNIA S BIOTECHNOLOGY WORKFORCE TRAINING NEEDS FOR THE 21 st CENTURY Executive Summary Prepared for Applied Biological Technologies Initiative Economic and Workforce Development Program California
More informationDeveloping Strong Partnerships to Ensure Success With Global Medical Device Trials. 23-February-2017, OCT Burlingame
Developing Strong Partnerships to Ensure Success With Global Medical Device Trials 23-February-2017, OCT Burlingame www.genae.com With you, for you Agenda 01 02 Identify the core group of stakeholders
More informationUS FDA and International Regulatory Efforts in Cellular and Gene Therapies
US FDA and International Regulatory Efforts in Cellular and Gene Therapies ISCT Satellite Global Regulatory Perspectives Workshop January 27, 2013 Kimberly Benton, Ph.D. Deputy Director, Division of Cellular
More informationENGINEERED LUMBER TRENDS EUROPE VS NORTH AMERICA April 7 th 2016 Atlanta US
EUROPE VS NORTH AMERICA April 7 th 2016 Atlanta US AGENDA Brief introduction to Pöyry Engineered Lumber Trends 2 BRIEF INTRODUCTION TO PÖYRY 3 PÖYRY CONSULTING AND ENGINEERING EXPERTS Pöyry is an international
More informationThe Emerging Markets Acceleration Program and Globalization Readiness Index. Capturing Breakthrough Growth in Emerging Markets
The Emerging Markets Acceleration Program and Globalization Readiness Index Capturing Breakthrough Growth in Emerging Markets The Boston Consulting Group (BCG) is a global management consulting firm and
More informationImpact of the transposition of the European Clinical Trials Directive. CEMO, Paris 17 November 2004
Impact of the transposition of the European Clinical Trials Directive CEMO, Paris 17 November 2004 Dr Martine Dehlinger-Kremer VP Regulatory Affairs International Agenda Overview of key areas of Directive
More informationCashless Cities and Digital Payments Opportunities and Challenges in Supporting the Shift to Digital Commerce
Visa Inc. Cashless Cities and Digital Payments Opportunities and Challenges in Supporting the Shift to Digital Commerce Eduardo Perez Senior Vice President, Regional Risk Officer, Latin America and Caribbean
More informationVISIONARY SCIENCE GLOBAL RESEARCH UPDATE 2015 QUARTER 4
2015 QUARTER 4 Frost & Sullivan s Visionary Science research group delivers strategic and actionable insights and analysis covering all aspects of the industry including technologies, econometrics, applications,
More informationBOARD 10: the future of decision making
BOARD 10: the future of decision making Version 10 brings a dramatic technological shift to the BOARD platform, introducing a series of innovations that revolutionize the way in which decision-making applications
More informationUpdate on Current FDA Policies and Priorities
Update on Current FDA Policies and Priorities Vernessa Pollard MassMEDIC FDA Update December 12, 2017 Boston Brussels Chicago Dallas Düsseldorf Frankfurt Houston London Los Angeles Miami Milan Munich New
More informationPolicies that encourage innovation in middle-income countries
December 2012 Policies that encourage innovation in middle-income countries The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) asked Charles River Associates (CRA) to
More informationWHITE PAPER 5 TIPS FOR MANAGING FOOD AND BEVERAGE SUPPLY CHAIN
WHITE PAPER 5 TIPS FOR MANAGING FOOD AND BEVERAGE SUPPLY CHAIN CONTENT AUTOMATE, AUTOMATE, AUTOMATE... 1 PLAN FOR FUTURE DEMAND... 2 MAINTAIN DETAILED REGULATORY COMPLIANCE DATA... 3 CONTROL COSTS BY MINIMIZING
More informationUrban Energy Use and Carbon Emissions. Matthias Ruth WEO Team Member Center for Integrative Environmental Research University of Maryland
Urban Energy Use and Carbon Emissions Matthias Ruth WEO Team Member Center for Integrative Environmental Research University of Maryland World Bank Energy Week 2009: Energy Efficient Cities Session The
More informationFast Trak Services: a collaborative project to accelerate downstream biosimilar process development
GE Healthcare Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development A case study Case study, 2924332 AA Fast Trak Services A collaborative project to accelerate
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 informationLessons Learned from QbD Application of Biologics in Japan: Perjeta Case
Lessons Learned from QbD Application of Biologics in Japan: Perjeta Case Mikio Suzuki CMC Development Dept., Regulatory Affairs Chugai Pharmaceutical Co.,Ltd. Outline Introduction of Perjeta Timeline up
More informationKeysight Technologies Automating 14565B Software Battery Drain Measurements with National Instruments LabVIEW. Application Note
Keysight Technologies Automating 14565B Software Battery Drain Measurements with National Instruments LabVIEW Application Note Introduction The demand for measuring, validating, and analyzing battery drain
More informationBOARD 10: the future of decision making
BOARD 0: the future of decision making Version 0 brings a dramatic technological shift to the BOARD platform, introducing a series of innovations that revolutionize the way in which decision-making applications
More informationSiemens Partner Program
Siemens Partner Program Factory Automation Partner Strategy for Factory Automation End Customer Focus on core competencies Demand on efficient solutions Certified Partner Added value in solutions and services
More informationCo sourcing -> Shared sourcing
Co sourcing -> Shared sourcing Let s MEET 2 QUESTIONS 3 What to SHARE(or not)? What to REDUCE? What to EXPECT? 4 WHO WE ARE? 5 Talented Together PRÉSENTATION CORPORATE DE SOPRA Mars 2014 6 Présentation
More informationApplication Note USD 3086 (1) Animal Component-Free Star-Plus Microcarriers for Adherent Mammalian Cell Culture
Application Note USD 386 (1) Animal Component-Free Star-Plus Microcarriers for Adherent Mammalian Cell Culture With the continuing move of the biopharmaceutical and cell therapy industries toward the use
More informationHealthcare.
Healthcare www.stantonchase.com Stanton Chase is a leader in executive search and leadership consulting with a global footprint, local expertise, and extensive experience across numerous industries and
More informationDeveloping International Standards for Very Small Enterprises
March 2008 IEEE Computer Page 1 of 4 STANDARDS Developing International Standards for Very Small Enterprises Claude Y. Laporte, École de technologie supérieure Simon Alexandre, Centre d Excellence en Technologies
More informationWarehousing: Charting the Way to a Winning Strategy
Warehousing: Charting the Way to a Winning Strategy Strong headwinds are challenging how companies operate their warehouses. Successful navigation hinges on optimizing capacity, improving utilization,
More informationAirline Employer Branding: How to measure the Unmeasurable
Airline Employer Branding: How to measure the Unmeasurable Hans Nilsson Global Sector Leader Aviation & Aerospace Partner www.stantonchase.com The global airline industry has changed significantly during
More informationInternationalisation Home versus host compensation approach at Reckitt Benckiser
Internationalisation Home versus host compensation approach at Reckitt Benckiser Internationalisation Home versus host compensation approach at Reckitt Benckiser With the economic downturn continuing worldwide,
More informationCHINA. Australia - China Life Science Summit. . Bio & Pharma Logistics
CHINA. Bio & Pharma Logistics Andrew McDonald Operations Director, Asia Pacific Melbourne, Australia, 27th March 2013 Australia - China Life Science Summit Responsibilities Who takes responsibility on
More informationCellular Therapy Products & NDC vs. ISBT128 Coding/Labeling
Cellular Therapy Products & NDC vs. ISBT128 Coding/Labeling William E. Janssen, Ph.D. Director, Cell Therapies Facility Moffitt Cancer Center Tampa, Florida What is ISBT 128? Information standard for blood,
More informationEU Update on Regulatory Developments
EU Update on Regulatory Developments Pascal Venneugues European Medicines Agency CASSS CMC Strategy Forum Europe Copenhagen, 4-6 May 2015 An agency of the European Union Overview International cooperation
More information7 Pivotal HR competencies for global business in 2017
Your Leadership Partner 7 Pivotal HR competencies for global business in 2017 Karen Fogh-Andersen, Managing Partner Stanton Chase Copenhagen, Denmark March 2017 www.stantonchase.com How companies need
More informationBiosimilar medicines rising to the cost challenge
Chapter 3 Biosimilar medicines rising to the cost challenge Addressing the rising cost of biological medicines has become a priority for governments and healthcare systems around the globe. Biosimilar
More informationChallenges and Opportunities in the Development of integrated Drug Device Combination Products CMC Strategy Forum, Tokyo, 5 December 2017
Challenges and Opportunities in the Development of integrated Drug Device Combination Products CMC Strategy Forum, Tokyo, 5 December 2017 F. Wildenhahn, Human Factors Engineering & U. Grauschopf, Head
More informationThe Battle of Big versus Small. Zenith Adspend Forecast 2017
The Battle of Big versus Small Zenith Adspend Forecast 2017 The global ad market will continue to grow steadily +5,9 Year-on-year growth (%) +5,6 +5,6 +5,5 +4,0 +4,1 +4,2 +4,1 2017 2018 2019 2020 Adspend
More informationLeadership Transitions: Differences Across Leadership Levels
25 June 2013 Leadership Transitions: Differences Across Leadership Levels Joy F. Hazucha The Korn/Ferry Leadership and Talent Consulting family Mission Better leaders, Better world Vision Premier global
More informationRunning an RTB Network Across 10 Markets Publisher Opportunities ATTILA BARTA
Running an RTB Network Across 10 Markets Publisher Opportunities ATTILA BARTA Head Cadreon PROGRAMMATIC ADVERTISING THE SELLERS PERSPECTIVE The Strengths, Weaknesses, Opportunities and the Pitfalls for
More informationDigital Leadership: Will the Chief Information Officer Role Disappear?
Technology Officer Digital Leadership: Will the Chief Information Officer Role Disappear? Years ago, chief information officers (CIOs) occupied a key role within the business world. They were seen as the
More informationWinsoft Solutions L.L.C
Winsoft Solutions L.L.C Do i.t professionally 2002-2014 Add-Vantage Insurance Management System for TPA and insurance companies (Add-Vantage - IMS) DHA & HAAD compliant info@winsoftsolutions.net (+971)
More informationTHE BIG DIGITAL FAIL Why Only 1 in 4 Companies Achieve Topline Growth with Digitalization
THE BIG DIGITAL FAIL Why Only 1 in 4 Companies Achieve Topline Growth with Digitalization Results & Insights of the Global Pricing & Sales Study 2017 In collaboration with: The Center for Pricing at Simon
More informationThe largest network of harmonized bio/ pharmaceutical GMP product testing labs worldwide, Eurofins BioPharma Product Testing enables companies to
The largest network of harmonized bio/ pharmaceutical GMP product testing labs worldwide, Eurofins BioPharma Product Testing enables companies to advance candidates from development through commercialization
More informationVELOPRESSO DELIVERY GUIDE
VELOPRESSO DELIVERY GUIDE We ship worldwide, and this document provides a guide to the options, cost and process of delivering a Velopresso coffee trike to you. Velopressos are sold in accord with Incoterms
More informationSAMPLE. Bracco Imaging S.p.A.Market Share Analysis. Bracco Imaging S.p.A. Market Share Analysis GDME0639CDB / Published January 2013
Market Share Analysis Reference Code: GDME0639CDB Publication Date: January 2013 GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 1 Table
More informationSTATE OF THE ASIA-PACIFIC PHARMACEUTICAL INDUSTRY 2013: EXECUTIVE SUMMARY
STATE OF THE ASIA-PACIFIC PHARMACEUTICAL INDUSTRY 2013: EXECUTIVE SUMMARY State of the Asia-Pacific Pharmaceutical Industry The pharmaceutical industry in the Asia-Pacific region has recently been besieged
More informationANALYTICAL STANDARDS AND REAGENTS
ANALYTICAL STANDARDS AND REAGENTS productivity future growth globalization compliance Waters, the industry leader in liquid chromatography and mass spectrometry, understands that standards and reagents
More informationThe Most Advanced Critical Care Solutions. Anywhere, Everywhere.
The Most Advanced Critical Care Solutions. Anywhere, Everywhere. The GEM Family comprehensive critical care solutions in the lab and at the point-of-care. The GEM Family of critical care testing solutions
More informationDecision taken from September 2010 Four focus areas: megacities, informal sector, global recycling markets & international aid tools Members: Antonis
ISWA s Task Force on Globalization & Waste Management Decision taken from September 2010 Four focus areas: megacities, informal sector, global recycling markets & international aid tools Members: Antonis
More informationHello. a lot has changed since last year.
Moving forward a lot has changed since last year. Our name, for one. STR, Inc., STR Global Limited and STR Analytics are now united under one brand: STR. More than a brand, STR is the name that unites
More informationInternational Energy Outlook 2011
International Energy Outlook 211 Center for Strategic and International Studies, Acting Administrator September 19, 211 Washington, DC U.S. Energy Information Administration Independent Statistics & Analysis
More informationINO Therapeutics is now
INO Therapeutics is now The materials contained herein are a description of our business. They do not purport to be all inclusive or contain all information that you desire. This document includes or may
More informationThe Deloitte Talent in Banking Survey 2014 The United Arab Emirates in Focus
The Deloitte Talent in Banking Survey 2014 The United Arab Emirates in Focus Among business in the UAE, banking has fallen from second-most popular industry to fourth in just one year. As with most private
More informationENSURING QUALITY THROUGH COMPLIANCE [ COMPLIANCE ]
ENSURING QUALITY THROUGH COMPLIANCE [ COMPLIANCE ] BEING IN COMPLIANCE HAS NEVER BEEN MORE IMPORTANT Quality encompasses more than meeting regulatory requirements. It extends throughout your organization
More informationAlixPartners Nearshoring Perspectives
AlixPartners Nearshoring Perspectives February 2014 www.alixpartners.com Executives Now Indicate the U.S. Is the Most Attractive Near-Shoring Location With Mexico as the Second Most Attractive Region If
More informationINTERNATIONAL ENERGY AGENCY. In support of the G8 Plan of Action TOWARD A CLEAN, CLEVER & COMPETITIVE ENERGY FUTURE
INTERNATIONAL ENERGY AGENCY In support of the G8 Plan of Action TOWARD A CLEAN, CLEVER & COMPETITIVE ENERGY FUTURE 2007 REPORT TO THE G8 SUMMIT in Heiligendamm, Germany The International Energy Agency,
More informationOVERVIEW OF DRUG REGISTRATION REQUIREMENTS FOR PHARMACEUTICALS IN EMERGING MARKET
Badjatya et al Journal of Drug Delivery & Therapeutics; 2013, 3(2), 227-232 227 Available online at http://jddtonline.info REVIEW ARTICLE OVERVIEW OF DRUG REGISTRATION REQUIREMENTS FOR PHARMACEUTICALS
More informationInternational Business Parcels Rate card
International Business Parcels Rate card Tracked Effective from 3rd July 2017 Standard Tracked Tracked Signed Standard 1 Contents International Business Parcels services... 3 International Tracked... 4
More informationArgus Ethylene Annual 2017
Argus Ethylene Annual 2017 Market Reporting Petrochemicals illuminating the markets Consulting Events Argus Ethylene Annual 2017 Summary Progress to the next peak of the economic cycle, now expected by
More informationPharmacovigilance: Vigilantia initiative
Pharmaceuticals Policy and Law 18 (2016) 157 162 157 DOI 10.3233/PPL-160440 IOS Press Pharmacovigilance: Vigilantia initiative Juan Carlos Trujillo and Ma. Alejandra De Guzman Bogota, Colombia Every day
More informationTRANSPORTATION SPEND OPTIMIZATION - A LOGISTICS USER PERSPECTIVE
TRANSPORTATION SPEND OPTIMIZATION - A LOGISTICS USER PERSPECTIVE www.ptvgroup.com Matthias Hormuth Director Solution Management Logistics PTV GROUP OUR VISION WE PLAN AND OPTIMISE EVERYTHING THAT MOVES
More informationAn Industry Perspective: Reducing the Complexity and Impact of Regulatory Changes in Latin America
An Industry Perspective: Reducing the Complexity and Impact of Regulatory Changes in Latin America SPEAKERS: Janett Mugaburu-Richards, M.S. Pfizer Inc. Kavita Ramalingam Iyer, Ph.D Merck & Co., Inc. Contents
More informationGuidelines for the Foreign NGOs Law are in process. October 2016
Guidelines for the Foreign NGOs Law are in process October 2016 Guidelines for the Foreign NGOs Law are in process The Ministry of Public Security (the "MPS") and its Shanghai branch co-organized a meeting
More informationYou don t have to be great to start, but you have to start to be great
You don t have to be great to start, but you have to start to be great Sports Marketing Agency Credentials Contents 01 Who are we 02 What do we do 03 What can we deliver 04 How do we do it 05 New opportunities
More informationThe Journey To Operational Intelligence
The Journey To Operational Intelligence Presented by Martin Otterson, Senior VP of Sales, Marketing and Industry 1 Learn Share Innovate This is your opportunity! 2 What would life be like without electricity?
More informationInternational Scholars and Faculty by College
OSU Colleges Agricultural Sciences 110 Business 9 Earth Oceanic and Atmospheric Sciences 44 Education 6 Engineering 127 Forestry 50 Liberal Arts 16 OSU Division Pharmacy 5 Arts & Sciences 82 Public Health
More informationPMDA Perspective: Regulatory Updates on Process Validation Standard
CMC Strategy Forum Japan 2014 Tokyo, Japan, December 8-9, 2014 PMDA Perspective: Regulatory Updates on Validation Standard Kazunobu Oyama, PhD Office of Cellular and Tissue-based Products PMDA, Japan Disclaimer:
More informationCHALLENGES OF GLOBAL CLINICAL TRIAL SUPPLY SOURCING SOME SPECIFICS FOR EMERGING MARKETS
Clinical Trial Supply 28 th 29 th October 2014 Princeton, NJ - USA CHALLENGES OF GLOBAL CLINICAL TRIAL SUPPLY SOURCING SOME SPECIFICS FOR EMERGING MARKETS 1 Agenda The challenges associated with various
More informationThe Worldwide Alpha-1 Antitrypsin Market. Present Situation and Future Prospects
The Worldwide Alpha-1 Antitrypsin Market Present Situation and Future Prospects 2005-2015 TABLE OF CONTENTS November 2005 TABLE OF CONTENTS Executive Summary 15 Introduction. 33 Description, Background
More informationValuation of Biosimilar and Key Value Drivers Dr. Patrik Frei October 2015 Biosimilars Asia
Valuation of Biosimilar and Key Value Drivers Dr. Patrik Frei October 0 Biosimilars Asia Agenda Introduction Valuation of Biosimilar Key Value Driver / Conclusion Venture Valuation Independent assessment
More informationFedEx International Priority. FedEx International Economy 3
SERVICES AND RATES FedEx International Solutions for your business Whether you are shipping documents to meet a deadline, saving money on a regular shipment or moving freight, FedEx offers a suite of transportation
More informationMoving from volume to value in the generic business model
Moving from volume to value in the generic business model CPhI Pre-connect conference Frankfurt 23rd October 2017 Copyright 2016 QuintilesIMS. All rights reserved. Key drivers to 2021 Global growth moderating
More informationRenewable Energy and other Sustainable Energy Sources. Paul Simons Deputy Executive Director International Energy Agency
Renewable Energy and other Sustainable Energy Sources Paul Simons Deputy Executive Director International Energy Agency G20 ESWG meeting Munich, 14 December 2016 Renewables and efficiency lead the transition
More informationPRAXIS. A publication by Bioengineering AG
PRAXIS A publication by Bioengineering AG Portrait of Rentschler Biotechnologie GmbH, a globally active service company that supports its clients in the development, production, and registration of biopharmaceuticals.
More informationThe dynamics of global food and agribusiness
Welcome to the world of Rabobank! The dynamics of global food and agribusiness Adrie Zwanenberg NUFFIELD Global Head F&A Research 20 February 2006 2 The world of Rabobank Food & agribusiness: a global
More informationFDA Public Hearing: Approval Pathway for Biosimilar. Products. November 2-3, 2010
FDA Public Hearing: Approval Pathway for Biosimilar and Interchangeable Biological Products November 2-3, 2010 1 The Biotechnology Industry Organization Over 1,100 members, including biotechnology companies,
More informationA holistic regulatory approach to accelerated CMC development
A holistic regulatory approach to accelerated CMC development Seán Barry Ph.D Pharmaceutical Assessor Health Products Regulatory Authority CMC Strategy Forum 2017 Disclaimer: The opinions expressed are
More informationApplication Note USD Purification of Mouse IgM from Cell Culture Supernatant by Cation Exchange Chromatography on CM Ceramic HyperD F Sorbent
Application Note USD 241 Purification of Mouse IgM from Cell Culture Supernatant by Cation Exchange Chromatography on CM Ceramic HyperD F Sorbent What this Study Demonstrates T h i s s t u d y o n C a
More information2015 Meetings and Events Forecast. November 2014
November 2014 WELCOME CWT Meetings & Events is pleased to bring you this supplement to the recently released 2015 Global Travel Price Outlook, CWT s annual price forecast, conducted for the first time
More informationBusiness Intelligence & Food Law
Business Intelligence & Food Law, Amsterdam April 5 6, 2017 Tisa Čaušević Food Safety and Regulatory Analyst at Selerant Things to cover Who are we? Big Data challenge What s it got to do with milk? Business
More informationGuide to becoming a self-employed lawyer in Australia
Guide to becoming a self-employed lawyer in Australia Contents Legal consulting a new way of working 3 Peerpoint the right choice for you? 4 The basics of self-employment 5 Setting up and running an ILP
More informationPERFORMANCE ACROSS PLATFORMS KLX AEROSPACE SOLUTIONS
PERFORMANCE ACROSS PLATFORMS KLX AEROSPACE SOLUTIONS The world s leading supplier of aerospace fasteners and consumables and full-service inventory management solutions KLX AEROSPACE SOLUTIONS Parts-to-service
More information10 ECB HOW HAVE GLOBAL VALUE CHAINS AFFECTED WORLD TRADE PATTERNS?
Box 1 HOW HAVE GLOBAL VALUE CHAINS AFFECTED WORLD TRADE PATTERNS? In recent decades, global trade has undergone profound changes. Relative to global output, trade has risen sharply and cross-country linkages
More informationITF/OECD Working Group Implementation of a Safe System
ITF/OECD Working Group Implementation of a Safe System Véronique Feypell International Transport Forum irap Innovation Workshop 2015, London, 15-16 September ITF/OECD Working Group Implementation of a
More informationExperience gained from three multi-product programs in third countries (USA, Brazil and Japan; USA and Canada; and India)
PPA(15)8437:1 Experience gained from three multi-product programs in third countries (USA, Brazil and Japan; USA and Canada; and India) Seminar: New EU Promotion Policy for Agri- Food Products Brussels
More informationCisco IT Data Center and Operations Control Center Tour
Cisco IT Data Center and Operations Control Center Tour Page 1 of 7 4 Root Cause Analysis and Change Management Root Cause Analysis Figure 1. Ian Reviewing Updates Ian: The incident management process
More information