Liquent IUG Presentation Feb 2013


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Liquent IUG Presentation Feb 2013

  1. 1. Liquent Technologies and Services InSight User Group Meeting February 21, 2013© 2013 PAREXEL International | Confidential
  2. 2. Liquent Acquired by PAREXEL• December 27 Announcement – PAREXEL fully acquires Liquent• Operate as a stand-alone services line under the Perceptive Informatics group • No changes within Liquent team and responsibilities• Leverage opportunities for synergy as identified• Benefits of acquisition: 1. Allows us to offer a more complete suite of offerings to meet your needs 2. We now have a true global footprint 3. We will benefit from the PAREXEL’s exceptional worldwide regulatory affairs expertise, as well as from its end-to-end client focus.At the same time, we will enhance PAREXEL’s Regulatory services and enable it toprovide a true holistic development, regulatory and commercialization platform and associated services. Confidential
  3. 3. Why Did PAREXEL Acquire Liquent? PAREXEL’s strategic clients want PAREXEL to provide a full range of development and commercialization services Allows Perceptive to broaden their eClinical software technology platform to include Regulatory providing a full end to end platform solution Complements PAREXEL Consulting’s (PCMS) regulatory affairs offerings Successful past partnering with Liquent in providing regulatory services and use of Liquent technologyConfidential 3
  4. 4. Why PAREXEL? • Better positions Liquent to capitalize on the market opportunities across Regulatory Information Management • Can now provide a broader range of integrated capabilities • Allows Liquent to broaden its end to end vision within regulatory to now include clinical operations • Allows Liquent to provide a complete regulatory outsourcing solution by leveraging PCMS’ Regulatory Affairs capabilities • Liquent can now extend our solutions globally by leveraging PAREXEL’s global reach and vast client base • Strong cultural fit and business model alignment • Same industry focus and business model • Expanded career path opportunities for our employeesConfidential 4
  5. 5. Full Range of In House Expertise Clinical Clinical Strategy & Technology Communication Research Logistics Consulting • Phase I-IV • Global Supply Chain • Medical Imaging • Product Development • Medical Education Management & Regulatory Affairs & Communications • Project Management • IVRS/IWRS • Supply Strategy, • Strategic Compliance • Meetings, Events • Site Management • EDC – DataLabs® Forecasting & Simulation & Risk Management & Exhibits • Patient & Investigator • Integration Services • Storage & Distribution • Clinical & Manufacturing • Educational Services Recruitment • CTMS – IMPACT® • IMP and NIMP Supplies • Quality Process • Scientific Publications • Data Management • ePRO Consulting • Ancillary Supplies • Biostatistics • MyTrialsTM • Reimbursement & Patient • Lab Logistics & • Bioanalysis Assistance Programs Sample Management • eLogistics Suite • Medical Services • Commercialization • Import/Export Management • Liquent InSight RIM Technology • Electronic SubmissionsConfidential
  6. 6. Industry Trends From Recent Surveys Decline in new product approvals, increased generic competition, and price pressures are driving: • Focus on emerging markets to increase revenue from existing products • Increased interest in flexible staffing/resourcing and technology approaches as companies re-evaluate what is core and non-core Evolution of industry standards and regulations remains slow and the impact can be unpredictable (e.g. XEVMPD, RPS) Most companies are “re-thinking” how they are doing day-to-day business and what is truly core to the organization Concerns with drug safety and compliance with evolving regulations requires global access to authoritative registration and product information • Software and service based solutions will continue to converge into a broader definition of Regulatory Information Management Overall, our customers world is becoming more complex, not lessConfidential
  7. 7. Evolving Regulatory Landscape CTD: Common Technical Document eCTD: Electronic Common Technical Document XEVMPD: Extended EudraVigilance Medical Product Dictionary RPS: Regulatory Product Submission IDMP: Identification of Medicinal Products Complexity 2015: RPS and IDMP 2012: XEVMPD 2009: eCTD 2004: CTD Level of Detail RequiredConfidential
  8. 8. Key Business Drivers For Change • Improved regulatory compliance • Improved information quality • Reduced time to find and verify regulatory information in order to consume with confidence (efficiency) • Improved planning and resource allocation • Reduced complexity of tracking regulatory information for large, global product portfolios • Reduced time for product release into clinical or commercial • Harmonized capabilities across diverse divisions (e.g. Rx, Vaccines, Biologics, Devices, etc.) • Enhances process-centric thinking and collaboration across functions and partnersConfidential
  9. 9. Regulatory Information Management (RIM)Effective and efficient collection, storage, retrieval and communication of regulatory informationRegulatory information includes metadata and contentRegulatory Information Management involves:• Defining product authorization targets DEFINE PRODUCT AUTHORIZATION TARGETS • Where do we want to be registered and• Managing regulatory/submission plan when? • What are the regulatory requirements? • Who is responsible? • Have we created a submissions plan?• Creating/gathering submission information• Producing/submitting submission output MANAGE REGISTRATIONS • What is approval status? • What products, suppliers, etc. were MANAGE REGULATORY SUBMISSION PLAN • What content is needed? approved where? • What resources are required? • What commitments were made? • When will it be available and who is• Managing the registration • What changes are planned and when? responsible? PRODUCE / SUBMIT CREATE / GATHER SUBMISSION OUTPUT SUBMISSION • What content is missing? INFORMATION • What reviews / approvals are still • Has this content been used needed? previously? • Is output compliant with regulatory • What authoring standards must be expectations and requirements? followed? • What internal reviews are needed?Confidential
  10. 10. Traditional Approach to Regulatory Data Management Pressure Points / Traditional Approach Key Strategies M&A and In-Licensing Submission & Promotional Global Label Publishing Registration Material Management New Geographies Management Management New Indications Enterprise Document Management (Research, Development, Regulatory, Commercial, M&S, Corporate) Headcount Reductions Electronic and Paper Archives Documents Da ta Rationalizing IT SystemsConfidential
  11. 11. Value of Integrated RIM Platform Short Term • Drives harmonization • Promotes standardization • Simplifies connectivity with external partners • Simplifies system change process • Reduces integration costs Longer Term • Agility to respond to regulatory landscape changes • Enhances impact of innovation from application-level to platform- level • Increases internal visibility of business valueConfidential
  12. 12. Focus on Regulatory Information Management Liquent’s Vision – to be the premier provider of a scalable, regulatory information management platform and associated regulatory & clinical services that can be leveraged throughout a client organization in support of the development, registration, and manufacturing processes. 12Confidential
  13. 13. Liquent InSightLiquent InSight is a purpose-built, enterprise class, comprehensive integrated platformof modular software solutions to support RIM needs of Life Sciences companies.• Accelerates product launches• Supports geographic expansion facilitating movement towards simultaneous submissions to multiple regulatory authorities• Eliminates redundant regulatory information systems and homegrown solutions• Avoids duplication of efforts and maximizes use of available resources• Streamlines ability to respond to global health authorities’ inquires through global Q&A database• Reduces likelihood of expensive product recalls and fines through harmonized data repository Liquent InSight Platform InSight for InSight for InSight for InSight for InSight for Submission Publishing Viewing Registration XEVMPD Management Applications for s Collects XEVMPD Enterprise access, Plan, track and Plans and publishing manage activities data and creates view and manages eCTD, NeeS, and registration compliant XEVMPD collaborative submission and and Paper output details of a product, submissions with review of dossier content and including granular import of XEVMPD submissions related activities product details acknowledgements Confidential
  14. 14. Value of InSight Provides a clear view to the entire user base from Executives to Operations  As product and submission plans emerge, everyone sees the same picture Executives can see plans at a high level  What’s in the regulatory pipeline?  How are the plans tracking?  When are we expecting approvals that will add additional revenue to the company?  Global clinical trial status and compliance view Managers can begin planning at the right time, and continue throughout the project  When is it time to start resourcing?  How is the project progressing?  How are things tracking across various projects?Confidential
  15. 15. Enabling a Comprehensive Product Lifecycle Management Framework MyTrials Start-Up Execution Reporting and Submission Trial Level Patient Image Feasibility/Site Regulatory Recruitment & Acquisition Identification Reporting Submission Retention & Review and Regulatory Site Monitoring Data Review Information Supplies Site Management Management & Start-Up Safety Monitoring Acquisition Collection & Management Systems RIM PlatformConfidential
  16. 16. The Power of One: Making it Easy to Collaborate 1 One Company One Fully-Integrated eClinical Suite One Central Regulatory Information Source One Focus on Delivery RIM PlatformConfidential