Clinical Supply Chain Management. Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management

Transcription

1 Clinical Supply Chain Management Technologies such as IVRS, CTMS, EDC and RFID Enhance Drug Supply Management

2 GBI Research Report Guidance GBI Research Report Guidance The report focuses on the current state of clinical supply chain management in the pharmaceutical industry. It provides details of various models which are currently followed in the industry. The report also includes analysis of various case studies in order to identify the best practices in the industry. Chapter three provides an overall picture of global clinical supply chain management. This section describes the evolution of clinical supply chain management. Chapter four provides industry analysis, with emphasis on the factors which are deciding the future of clinical supply chain management.. Chapter five provides an in-depth analysis of drivers and barriers for the clinical supply chain management industry. Chapter six provides an in-depth analysis of components of clinical supply chain management such as labeling, packaging, distribution and destruction of Clinical Trial Materials (CTMs). Chapter seven analyzes the CROs and how they are changing the clinical supply management scenario. Chapter eight provides a detailed understanding of factors which can lead to effective and efficient clinical supply chain management. Chapter nine assesses the technological aspects which are involved in clinical supply chain management. Chapter ten examines some of the regulations followed by different countries for clinical supply chain management. Chapter eleven details the profiles of key companies involved in clinical supply chain management and their strategic scenarios. Page 2

3 Executive Summary The number of registered clinical trials in the US declined from XX% in 2002 to around XX% in 2010 Executive Summary The Number of Clinical Trials Conducted in Emerging Countries is Increasing due to Cost Advantages Clinical trial sites are selected based on patient availability, the cost of conducting clinical trials, and regulatory complications. The difference in the location of sites has led to the increased emphasis of pharmaceutical companies on efficient Clinical Supply Chain Management (CSCM).There has been a shift in conducting clinical trials from developed countries to emerging markets in Asia, Latin America and Eastern Europe. This has been due to increasing drug development timelines, rising costs and declining productivity, combined with the strategic advantages offered by these emerging markets. The number of registered clinical trials in the US declined from XX% in 2002 to around XX% in In 2010, the total number of clinical trials registered indicates that XX% of clinical trials were conducted in the US, followed by Europe where XX% of clinical trials have been conducted. East Asia accounted for XX% of all trials, followed by Canada, the Middle East, South America and India, with XX%, XX%, XX% and XX%, respectively Outsourcing to Site Management Organizations Leads to Reduction in Study Timelines SMOs are required to act in accordance with stringent regulations and guidelines set by laws, exemplifying Good Clinical Practice (GCP). Because SMOs work closely with sites that they manage and support, they should have an intimate knowledge of the strengths and weaknesses of the clinical trial process within each site, and be well placed to make thorough assessments of their suitability for a particular study. Clinical Supply Chain Management, Key Factors Responsible for Study Timeline Reduction by SMOs, 2011 Increased patient retention Effective patient recruitment Improved pre-study planning and feasibility Factors Responsible for Reduction in Study Timelines by SMO Effective communication Partnership with investigators Timely ethics committee management Site specific support and guidance Source: GBI Research, Pharma Focus Asia (2010) SMO: Site Management Organizations SMOs are able to reduce clinical trial study timelines by implementing various processes, such as effective patient recruitment and communication, increased patient retention, and so on. Pre-study planning and feasibility will be improved because SMOs are committed to the proper functioning of the clinical trial site. Sponsors are effective in SMOs, leading to an increase in patient retention and faith of patients in the trial. The ethics committee ensures that ethical issues associated with the clinical trial are dealt with by local policies. Patient recruitment performed by SMOs is more effective because they recruit patients by database searches and during a patient s visit to their healthcare provider (doctor). The complete process of the clinical trial becomes more efficient when effective patient recruitment is carried out. Page 3

4 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Clinical Supply Chain Management - Introduction Clinical Supply Chain Management - Overview Overview of Clinical Supply Chains Evolution of Clinical Supply Chains Clinical Supply Chain Management - Industry Analysis Capital Requirement Skilled Workforce Competition Among Existing Players Clinical Supply Chain Management - Drivers and Restraints Drivers Increasing Concern for Pharmaceutical Companies to Improve R&D Outcomes Geographic Expansion for Conducting Clinical Trials Restraints Complex Regulatory System High Cost Involved for Entering the Market and Maintaining Processes Proper Visibility of Products in the Supply Chain (Inventory Visibility and Traceability) Clinical Supply Chain Management - Components of the Clinical Supply Chain Labeling Packaging Blister Packaging Plastic Bottles Labels and Accessories Pouches and Strip Packs Caps and Closures Secondary Containers Others Logistics Focus Areas for Logistics Distribution Models Outsource Build Acquisition Direct Shipping Co-Development Inventory Management Destruction and Disposal of Waste Recording of Destruction Methods of Destruction Clinical Supply Chain Management - CROs Operate in Clinical Trial Supplies Key Reasons for Outsourcing of Clinical Trials and Research Processes Different Strategies Adopted by Pharmaceutical Companies to Increase Efficiency Increase in the R&D Costs Against Revenue Growth is a Reason for Outsourcing Clinical Trials to CROs Increasing Drug Failure Rates a Concern for Pharmaceutical Companies Outsourcing Clinical Trials to CROs in Order to Decrease the Time Required for Launching the Product in the Market Outsourcing to Site Management Organizations (SMO)...29 Page 5

5 Table of Contents Minimization of Development Risks Through Risk Sharing with CROs is One of the Key Reasons for Outsourcing CROs Can Effectively Manage the Trends in Regulations Governing Clinical Trials Factors Leading to CSMO Growth Clinical Supply Chain Management - Key Challenges for Effective and Efficient Supply Chain Management Key Factors for Efficient Supply Chain Management in Clinical Trials Planning Issues Manufacturing Issues Distribution Issues Visibility Issues Technical Integration with the Vendors Clinical Supply Chain Management - Technological Landscape Information Technology in R&D Data Management Clinical Data Management System Clinical Data Management Outsourcing Deals in Clinical Trial Data Management Outsourcing IVRS/IWRS IVRS Provides Real-Time Clinical Trials Data Tracking for the Following Case Study Clinical Data Management Systems (CDMS)/Clinical Trial Management Systems (CTMS) Electronic Data Capture (EDC) Clinical Trial Management System (CTMS) Radio Frequency Identification (RFID) Clinical Supply Chain Management - Regulatory Landscape The US Important Regulations by the FDA in Proposal FDA Motivating CROs to Use Adaptive Design in Drug Development Europe The New Pharmacovigilance Legislation Reasons for Passing the New Legislation Emerging Markets India Potential Advantages of the Indian CRO Market China Potential Advantages of the Chinese CRO Market Clinical Supply Chain Management - Profiles of Key Players and Key Deals Profiles of Key Companies in Clinical Supply Chain Management Medidata Catalent Myoderm Cold Chain Technologies Numoda Corporation Fisher Clinical Services Marken Phase Forward Bilcare Global Clinical Supplies Almac Clinical Services BioClinica Aptuit Chiltern...52 Page 6

6 Table of Contents 11.2 Key Deals among Clinical Supply Management Companies Medidata Solutions Acquired Clinical Force in July Catalent Acquires Clinical Trial Supplies Division of Aptuit LLC in February Ion Beam Applications (IBA) and Bayer Schering Pharma Sign a Deal in Clinical Supply Chain Management - Appendix Market Definitions Abbreviations Bibliography Research Methodology Coverage Secondary Research Primary Research Expert Panel Validation Contact Us Disclaimer...57 Page 7

7 Table of Contents 1.1 List of Tables Table 1: Clinical Supply Chain Management, Clinical Trials in Different Geographies, %, Table 2: Clinical Supply Chain Management, R&D Expenditure Versus Turnover for the Top Ten Pharmaceutical Companies, List of Figures Figure 1: Clinical Supply Chain Management, Investigational Medicinal Products (IMP) Path, Figure 2: Clinical Supply Chain Management, Clinical Trials in Different Geographies, %, Figure 3: Clinical Supply Chain Management, Illustrative Supply Chain for Clinical Trial Materials, Figure 4: Clinical Supply Chain Management, Capital Requirement, Stages, Figure 5: Clinical Supply Chain Management, Advantages of Geographic Expansion of Clinical Trials, Figure 6: Clinical Supply Chain Management, Types of Clinical Trial Material Packaging, Figure 7: Clinical Supply Chain Management, Key Stages in Distribution of Clinical Trial Material, Figure 8: Clinical Supply Chain Management, Key Focus Areas for Logistics, Figure 9: Clinical Supply Chain Management, Distribution Models, Figure 10: Clinical Supply Chain Management, Segments of Distribution Model, Figure 11: Clinical Supply Chain Management, Inventory Management Stages, Figure 12: Clinical Supply Chain Management, Factors Resulting in Efficient Supply Chain, Figure 13: Clinical Supply Chain Management, R&D Expenditure Versus Turnover for the Top Ten Pharmaceutical Companies, Figure 14: Clinical Supply Chain Management, Key Factors Responsible for Study Timeline Reduction by SMOs, Figure 15: Clinical Supply Chain Management, Site Initiation Process, Figure 16: Clinical Supply Chain Management, Technologies Used for Forecasting, Figure 17: Clinical Supply Chain Management, Clinical Data Management System Flow, Global, Figure 18: Clinical Supply Chain Management, Use of IVRS in the Shipment Request Process for Inventory Management, Figure 19: Clinical Supply Chain Management, Cost Saved by Using IVRS - Reduction in Averages, Figure 20: Clinical Supply Chain Management, Cost of Over-Recruitment by 10% in Different Study Samples, Figure 21: Clinical Supply Chain Management, A Typical Clinical Trial Management System, Figure 22: Clinical Supply Chain Management, EU Legislations, Page 8

8 Clinical Supply Chain Management Introduction Geographic expansion, complexity of drugs, and increased attention of pharmaceutical companies on efficient R&D are the three main reasons for having proper CSCM in place 2 Clinical Supply Chain Management - Introduction There has been a shift in conducting clinical trials from developed countries to emerging markets in Asia, Latin America and Eastern Europe. This has been due to increasing drug development timelines, rising costs and declining productivity, combined with the strategic advantages offered by these emerging markets. Clinical Supply Chain Management (CSCM) is vital to conducting clinical trials. The companies need to have proper CSCM in place due to three important reasons, drug intricacy used in clinical trials, geography expansion and increased focus of companies on Research and Development (R&D). Accurate and timely delivery of clinical trial material to the clinical trial site is critical for the success of a clinical trial. The chances of meeting the research milestones increases by considering clinical supplies processes from the planning stage of the clinical trials. The clinical trial is an important process for deciding the future of a drug candidate. According to the Institute of Clinical Research (ICR), two-thirds of the overall cost of R&D is spent on drug development. Although there are many advantages of tracking clinical trial products, it is very difficult to have an efficient process in place to track the inventory. Use of new technologies can make tracking more efficient and effective. Leading pharmaceutical companies are involving outsourcing companies, such as Contract Research Organizations (CROs), these companies have a dedicated department that leverages information technology (IT) to rejuvenate their business model, particularly R&D, making it more agile, leaner and global. Information technology provides significant potential to make this happen through various services, which include globally integrated data management, paperless clinical trials and many others. Page 9

9 Clinical Supply Chain Management Technological Landscape Case Study Use of IVRS Leads to Reduction in Average Medication Cost The average cost of clinical supplies to a subject is $XX. This value may vary depending upon the therapeutic segment and duration of the clinical trial. It has been observed that the use of IVRS reduces the average by XX-XX%. This means that the extra amount of drug in the inventory is reduced, and this leads to significant cost reduction. If a sample size of XX subjects is taken into consideration, then a cost saving of $XX can be made. Apart from the cost saving due to the implementation of IVRS, there are benefits such as automated generation of consignment requests and increased efficiency of the logistics system. Figure 19: Clinical Supply Chain Management, Cost Saved by Using IVRS - Reduction in Averages, 2011 Cost of Savings ($) $ XX are saved in a sample of XX subjects Sample Size Source: GBI Research, Futcher Page 40

10 Clinical Supply Chain Management Appendix 12 Clinical Supply Chain Management - Appendix 12.1 Market Definitions The global clinical supply chain management companies comprise organizations involved in labeling, packaging, warehousing, distribution and destruction of CTMs and IMPs Abbreviations 3PL - Third Party Logistics ADME - Absorption, Distribution, Metabolism, and Excretion ADR - CDISC - CDMS - CIT - CRA - CRO - CSCM - CTM - CTMS - DEA - DGCI - DHS - ecrf - EDC - EMA - epro - EU - FDA - GCP- GMP- HNTE - ICR - IMPs - IP - IPR - IT - IVRS - IWRS - Adverse Drug Reaction Clinical Data Interchange Standards Consortium Clinical Data Management System Corporate Income Tax Clinical Research Associate Contract Research Organizations Clinical Supply Chain Management Clinical Trial Materials Clinical Trial Management System Drug Enforcement Association Drugs Controller General of India Department of Homeland Security electronic Case Report Form Electronic Data Capture European Medicines Agency electronic Patient Reported Outcomes European Union Food and Drug Administration Good Clinical Practice Good Manufacturing Practice High and New Technology Enterprises Institute of Clinical Research Investigational Medicinal Products Investigational Product Intellectual Property Rights Information Technology Interactive Voice Response System Interactive Web Response System MHLW - Ministry of Health, Labor and Welfare NICPBP - National Institute for the Control of Pharmaceutical and Biological Products NMITLI - New Millennium Indian Technology Leadership Initiative Page 54

11 Clinical Supply Chain Management Appendix OHRP - OTC - PASS - PET - PI - PIM - R&D - RFID - SEZ - SFDA - SMO - SPL - TCS - Office of Human Resource Protection Over the Counter Post-Approval Safety Study Polyethylene Terephthalate Principal Investigator Product Information Management Research and Development Radio Frequency Identification Special Economic Zone State Food and Drug Administration Site Management Organizations Structured Product Labeling Tata Consultancy Services 12.3 Bibliography Abbott Laboratories (2011), Annual Report. Available from [Accessed January 16, 2012] AstraZeneca Plc (2011), Annual Report. Available from [Accessed January 16, 2012] Bristol-Myers Squibb (2011),Annual Report. Available from [Accessed January 19, 2012] ClinicalTrials.gov, Map of All Studies in ClinicalTrials.gov, Available from [Accessed January 20, 2012] DHL (2012), The Pulse DHL Life Sciences & Healthcare, Available from [Accessed February 04, 2012] Drapkin (2010), Pharma Focus Asia (2010), Site Management Organisations in Asian Clinical Trials, Available from [Accessed February 04, 2012] Eli Lilly and Company (2011), Annual Report. Available from CD85F4C0863D/English.PDF. [Accessed January 23, 2012] Futcher Alexa, Qualitative and quantitative benefits of IVR and IWR in clinical trials Available from [Accessed January 23, 2012] GlaxoSmithKline plc (2011), Annual Report. Available from Annual-Report-2011.pdf. [Accessed January 25, 2012] Johnson & Johnson (2011), Annual Report. Available from 8EE1A05361D6/2011-Annual-Report_Final.pdf. [Accessed January 26, 2012] Lamberti, Mary Jo et al. (2012), Trends and Novel Approaches to Clinical Supply Outsourcing, Available from [Accessed January 30, 2012] Merck & Co., Inc. (2011), Annual Report. Available from [Accessed February 01, 2012] Page 55

12 Clinical Supply Chain Management Appendix Novartis AG (2011), Annual Report. Available from [Accessed February 01, 2012] Pfizer Inc. (2011), Annual Report. Available from [Accessed February 02, 2012] 12.4 Research Methodology GBI Research s dedicated research and analysis teams consist of experienced professionals with a pedigree in marketing, market research, consulting backgrounds in the pharma industry, and advanced statistical expertise. GBI Research adheres to the codes of practice of the Market Research Society ( and the Strategic and Competitive Intelligence Professionals ( All GBI Research databases are continuously updated and revised. The following research methodology is followed for all databases and reports: Coverage The objective of updating GBI Research coverage is to ensure that it represents the most up to date vision of the industry possible. Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources. Company coverage is based on three key factors: market capitalization, revenues, and media attention/innovation/market potential. GBI Research aims to cover all major news events and deals in the pharmaceutical industry, updated on a daily basis. An exhaustive search of 56 member exchanges is conducted, and companies are prioritized on the basis of their market capitalization; The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage; and, Companies which are making the news, or which are of particular interest due to their innovative approach, are prioritized. GBI Research aims to cover all major news events and deals in the medical industry, with its databases updated on a daily basis. The coverage is further streamlined and strengthened with additional inputs from GBI Research s expert panel (see below) Secondary Research Secondary research was carried out on internal and external sources to source qualitative and quantitative information in the report. The secondary research sources that are referred in this report include, but are not limited to: Company websites, annual reports, financial reports, investor presentations and SEC filings for the twenty companies covered in this report. Industry trade journals, scientific journals and other technical literature. Relevant patent and regulatory databases. National government documents, statistical databases and market reports. News articles, press releases and web-casts specific to the companies operating in the market. Page 56

13 Clinical Supply Chain Management Appendix Primary Research GBI Research conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions: It provides first-hand information on the market size, market trends, growth trends, the competitive landscape and future outlook. Helps in validating and strengthening the secondary research findings. Further develops the analysis team s expertise and market understanding. Primary research involves correspondence, telephone interviews and face-to-face interviews for each market, category, segment and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to: Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers; Hospital stores, laboratories, pharmacies, distributors and paramedics; Outside experts: investment bankers, valuation experts, research analysts specializing in specific medical equipment markets; and Key Opinion Leaders (KOLs): physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of pharmaceutical drugs Expert Panel Validation GBI Research uses a panel of experts to cross verify its databases and forecasts. GBI Research s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies; academics from research universities, KOLs from hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment and supplies. Historic data and forecasts are relayed to GBI Research s Expert Panel for feedback and adjusted in accordance with their feedback Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means; electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research. Page 57