Selling to mid market pharmaceuticals


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During this presentation, Merit Solutions CEO Bill Burke will discuss selling the Microsoft platform into the mid-market pharmaceutical space. After discussing the target market (who, what, where), we will present current business drivers, compliance requirements, and specific terminology for pharmaceutical executives. We will wrap up by presenting the Microsoft platform solution, combining pharmaceutical Quality + ERP + Document Management capabilities in one integrated, cost-effective solution.

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  • This slide taken from the keynote presentation from Valarie King-Bailey.
  • Selling to mid market pharmaceuticals

    1. 1. Bill BurkeCEOMerit Solutions, Inc.
    2. 2. As CEO of Merit Solutions, Billhas been working with FDAregulated companies since 2003.Bill has 24 years’ experience inleading technology companiesthrough various stages frominception through publiccapitalization.
    3. 3. Microsoft Dynamics AX ISV and Systems IntegratorMicrosoft Dynamics AX Industry ISV SolutionsEmbedded in Microsoft Dynamics AX and MicrosoftSharePoint
    4. 4. Who are the ideal prospects –and where are they located? Source:
    5. 5. 17% 79% Statistics of U.S.Businesses
    6. 6. 2833 Medicinal Chemicals and Botanical Products 3827 Optical Instruments and Lenses2834 Pharmaceutical Preparations 3841 Surgical and Medical Instruments and Apparatus2835 In Vitro and In Vivo Diagnostic Substances 3842 Orthopedic, Prosthetic, and Surgical Appliances and Supplies2836 Biological Products, Except Diagnostic Substances 3843 Dental Equipment and Supplies2844 Perfumes, Cosmetics, and Other Toilet Preparations 3844 X-Ray Apparatus and Tubes and Related Irradiation Apparatus3821 Laboratory Apparatus and Furniture 3845 Electromedical and Electrotherapeutic Apparatus3826 Laboratory Analytical Instruments 3851 Ophthalmic Goods
    7. 7. CEODirector, VP CFO COO CMO CIO Quality Accounting VP Customer Manager Manufacturing Service Account Controller Executive
    8. 8. Risk Mitigation
    9. 9. Risk Mitigation Do you have real-time intelligence and automated alerts that enable you to quickly respond to incidents and make good decisions?Compliance Can you proactively adapt to changing FDA and customer requirements? Can you do this cost-effectively?ImprovingPerformance Are you managing your structured (ERP) and unstructured (Word, Excel, PDF) data in a closed, controlled, and integrated system? How do you ensure material integrity and system validation?
    10. 10. Risk Mitigation Can you conform with specific compliance requirements required by clients and regional governments? Can you do this cost-effectively?Compliance Are you managing your structured (ERP) and unstructured (Word, Excel, PDF) data in a closed, controlled, and integrated system?ImprovingPerformance How much time do you spend managing compliance reporting, and what are the related costs? Are there gaps in your compliance reporting that youReducing would like to eliminate?Costs How confident are you in your forecasts and maintaining your margins?
    11. 11. Why are Life Sciences companiescurrently purchasing newbusiness systems?
    12. 12. expect US economy49% to improve expect technology51% spending to increase83% expect to increase headcount are planning to increase their66% global activity are planning to raise additional67% funding 2013 Venture View
    13. 13. 2012 Year-End VC Investment Stats – MoneyTree Source:
    14. 14. 1,720 warningletters3,640 recall events9,288 recalled products Inspections, Compliance, Enforcement, and Criminal Investigations Statistics
    15. 15. Source:
    16. 16. Who are we competing againstwhen we’re selling into mid-market pharma - and how are wewinning?
    17. 17. Spreadsheets & PDFs Functionality sits in Tier One separate applications Incomplete horizontalCustomized solutions Older technology solutions THE RESULT: COMPLEX, INCOMPLETE, AND INFLEXIBLE
    18. 18. PERVASIVE INTEROPERABILITY Quality Document ERP Management Management SYSTEMS VALIDATION AND FDA COMPLIANCE Mitigate Risk Improve Save Time and Manage Performance and Money Compliance POWERFUL AGILE SIMPLEVALUE PILLARS Deep functionality for global Systems capable of supporting Ease of use speeds time to value Pharmaceutical manufacturers growth and adapting to change and reduces cost of ownership
    19. 19. Research and Financial Process Manufacturing Supply Chain ManagementDevelopment Management System Validation Quality Equipment Projects General Ledger Electronic Batch Records Management MaintenanceClinical Trial Accounts Formula Material Control and Recall Warehouse &Management Payable Management Management Logistics Accounts Co-Products & Order Sales Enhanced Lot Traceability Receivable By-Products Management Electronic Signatures Budgeting, FEFO Shelf-Life Marketing Planning & Advanced Serialized Inventory Planning Management Forecasting Invoice & Version TradeCost of Quality Corrective and Preventive Action Billing Management Agreements Catch Weight / Multi- Samples Reporting Dual Unit of LIMS DimensionalManagement Measure Inventory Controlled Document Management FDA Compliance
    20. 20. Don’t get caught without apaddle – these are thefeatures you NEED tocompete and win.
    21. 21. Ensures Repeatability & ConsistencyEnsures Software Quality & ProductionReadinessEnsures Software Performs According ToIts INTENDED USEDecreases The Risk Of TheManufacturing ProblemsDecreases The Expenses Caused By TheFailures In ProductionDecreases The Risks Non-ComplianceWith cGMP Guidelines
    22. 22. Leverages existing ERP data removingduplicate record keeping and redundantdata entry.Electronic availability of documents andprocedures—no need for paper printouts.Full document lifecycle managementcapabilities, including automatedworkflows, audit trails, full versioningsupport and archiving.Enables compliance with industry andgovernment regulations, including 21 CFRPart 11.
    23. 23. Reduces time, effort, and costs associatedwith manual and paper-based processes.Integrated quality control and productsafety document management solution forBatch Records, DMRs, CAPA, SOPs, Audits,Complaints, GMPs and more!Enables compliance with industry andgovernment regulations, including US FDA 21CFR Part 11.Reduces cost of ownership with integrationwith ERP and Quality Management Solution.
    24. 24. Forward and backward traceability for allmaterial lot / serial numbers.Streamline and automate producttraceability processes.Quickly view any material lot and / orserial number, the status of the material,and all locations of the material.Detect exceptions early, and consistentlyproduce the highest quality products.Use production data of raw materials andfinished goods to calculate shelf life, shelfadvice, and retesting dates.
    25. 25. Generate Adverse Event investigationwith automated workflow and approvalprocesses and detailed documentation.Meets regulatory requirements forclosed-loop quality management.Maintain detailed historical records oncorrective action and preventive actionhistory.Track incidents take action to correctand prevent future occurrences.Reduces cost of ownership withintegration with document management.
    26. 26. Enables compliance with industry andgovernment regulations, including 21 CFRPart 11.Apply preventive controls on changes tofields or windows.Setup and manage an unlimited numberof authorized approvers and groups.Capture and store authorizationselectronically to help save time, eliminatepaperwork, and reduce the risk of errors.Flexible information capture to captureonly the information required / desired.
    27. 27. These are just a few Life Sciencescompanies who are usingMicrosoft Dynamics AX totransform their business.
    28. 28. SONEXUS HEALTH
    29. 29. Bill Burke, CEOMerit Solutions, Inc.+1 (630) 614 –
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