Selling to mid market pharmaceuticals

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Selling to Mid Market Pharmaceutical Bill Burke CEO Merit Solutions, Inc.

description

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.

Transcript of Selling to mid market pharmaceuticals

Page 1: Selling to mid market pharmaceuticals

Selling to Mid Market Pharmaceutical

Bill BurkeCEO Merit Solutions, Inc.

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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.

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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

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Source: Microsoft.com

Target Market

Who are the ideal prospects – and where are they located?

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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

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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

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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

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CEO

Director, VP Quality CFO

Accounting Manager

Controller

COO

VP Manufacturin

g

CMO

Customer Service

Account Executive

CIO

Selling to the powerbase

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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

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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

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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

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Business Drivers

Why are Life Sciences companies currently purchasing new business systems?

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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

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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

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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

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Rising Costs and Customer Pressure

Source: Microsoft.com

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Competitive Landscape

Who are we competing against when we’re selling into mid-market pharma - and how are we winning?

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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

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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

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Required Functionality

Don’t get caught without a paddle – these are the features you NEED to compete and win.

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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.

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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.

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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.

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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.

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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.

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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.

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Life Sciences Clients

These are just a few Life Sciences companies who are using Microsoft Dynamics AX to transform their business.

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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

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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

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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!