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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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Selling to Mid Market Pharmaceutical
Bill BurkeCEO Merit Solutions, Inc.
Bill BurkeCEO
As CEO of Merit Solutions, Bill has been working with FDA regulated companies since 2003. Bill has 24 years’ experience in leading technology companies through various stages from inception through public capitalization.
Focus on Life SciencesLife Sciences Partner since 2003 100+ Life Sciences Customers 115+ Reselling Partners
Focus on Microsoft Dynamics AX and SharePointMicrosoft Dynamics AX ISV and Systems Integrator Microsoft Dynamics AX Industry ISV SolutionsEmbedded in Microsoft Dynamics AX and Microsoft SharePoint
Focus on quality100% Customer Loyalty in 2012 (Microsoft CSAT)Life Sciences CfMD Applications
Merit Solutions, Inc.
Headquarters in Wheaton, IL, United States
Source: Microsoft.com
Target Market
Who are the ideal prospects – and where are they located?
14,335 Life Sciences Manufacturing CompaniesMedical Device: 11,379Pharmaceutical: 2,381BioTech: 226Nutraceutical: 349
Life Sciences target market
79%
17%
Source: United States Census Bureau, Statistics of U.S. Businesses, 2010
Industry Sub Segments
Pharmaceutical Nutraceutical
Medical Devices
BioTech
CROs and
CMOs
Cosmetics
17.8%
1.9%
2.2%
7%
2.7%
3.8%1.7%
2%
4.2%2.5%
2.3%
5.2%
6.4%
2.5%
3.1%4.1%
1.6%
6.2%
1.2%1.7%
2.1%
1.6%1.4%
1.6%
1.6%
Geographic Location
SIC Codes2833 Medicinal Chemicals and Botanical Products2834 Pharmaceutical Preparations2835 In Vitro and In Vivo Diagnostic Substances 2836 Biological Products, Except Diagnostic Substances2844 Perfumes, Cosmetics, and Other Toilet Preparations3821 Laboratory Apparatus and Furniture3826 Laboratory Analytical Instruments
3827 Optical Instruments and Lenses3841 Surgical and Medical Instruments and Apparatus3842 Orthopedic, Prosthetic, and Surgical Appliances and Supplies3843 Dental Equipment and Supplies 3844 X-Ray Apparatus and Tubes and Related Irradiation Apparatus3845 Electromedical and Electrotherapeutic Apparatus3851 Ophthalmic Goods
Terms you need to knowFDA 21 CFR Part 11 - Electronic Records Requirements
Software Validation
IQ – Installation Qualification
OQ – Operational Qualification
PQ – Performance Qualification
GAMP 5 – Best Practice Methodology for Validation
SOP – Standard Operating Procedures
GMP – Good Manufacturing Practices
Controlled Document Management
Traceability – Forward and Backward
Electronic Batch Records
CAPA – Corrective and Preventive Actions
Predicate Rules - Law in the US Code of Federal Regulations
Change Control - Required process for changes to validated systems
Catch Weight
CEO
Director, VP Quality CFO
Accounting Manager
Controller
COO
VP Manufacturin
g
CMO
Customer Service
Account Executive
CIO
Selling to the powerbase
Chief Executive Officer (CEO)CEOs of Life Sciences organizations are highly educated (have PhDs) and scientific people. They are involved with business systems decision making more often than other industries due to the personal risks of noncompliance.
Do you have full visibility across processes, lines, departments, plants, outsourced operations, and the global supply network?
How hard is it to pull together information from various sources when decisions need to be made?
Is your IT platform easy to use? Does it support all current business needs and allow for flexibility and growth in the future? Does it do all of this at a low total cost of ownership?
Risk Mitigation
Compliance
Improving Performance
Reducing Costs
Challenges Probing Questions
Risk Mitigation
Compliance
Improving Performance
Do you have real-time intelligence and automated alerts that enable you to quickly respond to incidents and make good decisions?
Can you proactively adapt to changing FDA and customer requirements? Can you do this cost-effectively?
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?
Director / VP of QualityQuality is a primary component of an organization’s compliance strategy and therefore the Director / VP of this department is often involved. FDA GMPs (Good Manufacturing Processes) mandate that Quality be a separate department.Challenges Probing Questions
Risk Mitigation
Compliance
Improving Performance
Reducing Costs
Can you conform with specific compliance requirements required by clients and regional governments? Can you do this cost-effectively?
Are you managing your structured (ERP) and unstructured (Word, Excel, PDF) data in a closed, controlled, and integrated system?
How much time do you spend managing compliance reporting, and what are the related costs? Are there gaps in your compliance reporting that you would like to eliminate?
How confident are you in your forecasts and maintaining your margins?
Chief Financial Officer (CFO)CFOs develop the financial plan and goals for the company, constantly monitor performance against them, and assess the financial viability of projects and opportunities. CFOs are also responsible for risk management and compliance processes.Challenges Probing Questions
Business Drivers
Why are Life Sciences companies currently purchasing new business systems?
Transition into growth mode
83% expect to increase headcount
66%
are planning to increase their global activity
51%
expect technology spending to increase
67%
are planning to raise additional funding
Source: Venture Capital Association (NVCA) and Dow Jones VentureSource, 2013 Venture View, 2012
49%
expect US economy to improve
Source: Microsoft.com
Receive Venture Capital FundingIn 2012, VC companies invested more than $6.5B into life sciences companies.
This was the second largest industry.
Satisfy investors and secure additional funding.
Source: Microsoft.com
Source: National Venture Capital Association, 2012 Year-End VC Investment Stats – MoneyTree
FDA Product Stage
FDA Drug Approval Process
1,720 warning letters3,640 recall events
Increasing FDA Pressure FDA Warning Letters
Recalled Products9,288 recalled products
15 seizures16 injunctions
19 debarments
2011 FDA Statistics
Source: U.S. Food and Drug Administration, Inspections, Compliance, Enforcement, and Criminal Investigations Statistics, 2011
Rising Costs and Customer Pressure
Source: Microsoft.com
Competitive Landscape
Who are we competing against when we’re selling into mid-market pharma - and how are we winning?
Tier OneFunctionality sits in separate applications
Current options…
Customized solutions
Spreadsheets & PDFs
Older technology Incomplete horizontal solutions
THE RESULT: COMPLEX, INCOMPLETE, AND INFLEXIBLE
Or Microsoft platform offering
VA
LUE P
ILLAR
S
AGILE
Systems capable of supporting growth and adapting to change
SIMPLE
Ease of use speeds time to value and reduces cost of
ownership
ERPDocument Manageme
nt
SYSTEMS VALIDATION AND FDA COMPLIANCE
PERVASIVE INTEROPERABILITY
Improve Performanc
e
Save Time and Money
Quality Manageme
nt
POWERFUL
Deep functionality for global Pharmaceutical manufacturers
Mitigate Riskand
Manage Compliance
Samples Management
Advanced Serialized Inventory
Research and
Development
Financial Manageme
ntProcess Manufacturing Supply Chain Management
Enhanced Lot Traceability
FEFO Shelf-Life
Management
Catch Weight / Dual
Unit of Measure
Multi-Dimensional
Inventory
Formula Management
Co-Products & By-Products
Quality Management
System Validation
Controlled Document Management
Electronic Batch Records
Material Control and Recall Management
Electronic Signatures
LIMS
Clinical Trial Management
Sales
Marketing
Warehouse & Logistics
Version Management
Equipment Maintenance
General Ledger
Accounts Payable
Accounts Receivable
Budgeting, Planning & Forecasting
Invoice & Billing
Reporting
Planning
Trade Agreements
Order Management
Corrective and Preventive Action
FDA Compliance
Cost of Quality
Projects
Required Functionality
Don’t get caught without a paddle – these are the features you NEED to compete and win.
Software ValidationEnsures Repeatability & Consistency
Ensures Software Quality & Production Readiness
Ensures Software Performs According To Its INTENDED USE
Decreases The Risk Of The Manufacturing Problems
Decreases The Expenses Caused By The Failures In Production
Decreases The Risks Non-Compliance With cGMP GuidelinesSource: Valarie King-Bailey, CEO
OnShore Technology Group, Inc.
Electronic Batch RecordsLeverages existing ERP data removing duplicate record keeping and redundant data entry.
Electronic availability of documents and procedures—no need for paper printouts.
Full document lifecycle management capabilities, including automated workflows, audit trails, full versioning support and archiving.
Enables compliance with industry and government regulations, including 21 CFR Part 11.
Controlled Document Management
Reduces time, effort, and costs associated with manual and paper-based processes.
Integrated quality control and product safety document management solution for Batch Records, DMRs, CAPA, SOPs, Audits, Complaints, GMPs and more!
Enables compliance with industry and government regulations, including US FDA 21 CFR Part 11.
Reduces cost of ownership with integration with ERP and Quality Management Solution.
TraceabilityForward and backward traceability for all material lot / serial numbers.
Streamline and automate product traceability processes.
Quickly view any material lot and / or serial number, the status of the material, and all locations of the material.
Detect exceptions early, and consistently produce the highest quality products.
Use production data of raw materials and finished goods to calculate shelf life, shelf advice, and retesting dates.
Corrective and Preventive ActionGenerate Adverse Event
investigation with automated workflow and approval processes and detailed documentation.
Meets regulatory requirements for closed-loop quality management.
Maintain detailed historical records on corrective action and preventive action history.
Track incidents take action to correct and prevent future occurrences.
Reduces cost of ownership with integration with document management.
Electronic SignaturesEnables compliance with industry and government regulations, including 21 CFR Part 11.
Apply preventive controls on changes to fields or windows.
Setup and manage an unlimited number of authorized approvers and groups.
Capture and store authorizations electronically to help save time, eliminate paperwork, and reduce the risk of errors.
Flexible information capture to capture only the information required / desired.
Life Sciences Clients
These are just a few Life Sciences companies who are using Microsoft Dynamics AX to transform their business.
Microsoft Dynamics AX Life Sciences Clients
SONEXUS HEALTH
Source: Valarie King-Bailey, CEO OnShore Technology Group, Inc.
Global Pharmaceutical CompanyHigh growth organization, provides drug delivery caplets for extended time release based on proprietary process.
Alternatives: X-3, Oracle, SAP
Selected Product: Dynamics AX 2012, SharePoint, & MAXLife
Validation Partner: OnShore Technologies
Lead Partner: McGladrey
Revenue: 200 million
Number of users: 300
Number of employees: 800
Deal size: 1.75 Million
Customer Example 2High growth organization, provides insulin home delivery and insulin dispensing solutions.
Alternatives: Oracle, SAP
Select Product: Dynamics AX 2012 and SharePoint (reviewing MAXLife)
Validation Partner: OnShore Technologies
Lead Partner Merit Solutions, Inc.
Revenue: 200 million
Number of users: 450
Number of employees: 800
Deal size: 2.1 Million
Join Us Thursday at 9amMerit Solutions will be presenting in the Mesquite Room on Thursday from 9am – 10am. Join us as we discuss MAXLife, our Life Sciences quality and document management solution.
Bill Burke, CEOMerit Solutions, Inc.+1 (630) 614 – [email protected]
Let’s Make Some Money!