11 selling to big pharma rev2(1)

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Selling into Big Pharma Microsoft Dynamics AX 2012 February 13 th , 2013

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Page 1: 11 selling to big pharma rev2(1)

Selling into Big Pharma

Microsoft DynamicsAX 2012

February 13th, 2013

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Andrea RuosiCEO of the ARconsulting Group, founded in 1997, comprising New Strategies.

Masters in Management Engineering (IT, Production and Cost Accounting)

Management consultant in Business Process Management, Manufacturing, Management Accounting, Product Costing. Worked with KPMG, Accenture, Chiquita, San Pellegrino etc.

Expertise in Life Sciences (Pharmaceuticals, Chemicals, Cosmetics and Medical Devices), Food & Beverages, Industrial Equipment Manufacturing (IEM), and other industries.

Expertise in Computer System Validation (CSV) of ERP and other software solutions

22 years of experience in international ERP implementation projects, as a Program Manager, Engagement Manager, Project Manager, Consultant (USA, United Kingdom, Germany, France, Italy, Brazil, Romania, Bulgaria, and other countries)

31 years of experience in Software Architecture and Development, from Microsoft BASIC (1982) to Microsoft Dynamics AX X++ and Visual Studio 2012 on 64bit WINTEL architecture.

Focused on Microsoft technology and solutions (Dynamics AX and CRM, SharePoint etc.)

Copyright New Strategies 2013

[email protected]

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AgendaOverviewERP SolutionERP ProjectCase Studies

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The Pharmaceutical IndustrySuccess depends on accelerating time tomarket and reducing costs without compromising innovation, product qualityand safety, and stringent regulatory requirements

Copyright New Strategies 2013

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Key Business DriversNew industry economic realitiesGlobal operating modelNew value propositionVirtualization/ExternalizationGovernment regulationsK

ey

Busi

nes

s Dri

vers

Facilitating collaboration activities within the organization and with external partnersLeveraging data insights from multiple sourcesAutomating manufacturing and laboratory workflow and activity to increase productivityAccelerating product development, engineering and introductionEnabling real-time decision making with rich information with advanced analytics

Role

of

Tech

nolo

gy

Copyright New Strategies 2013

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New Industry Economic Realities

Prioritized initiatives to support organizational effectiveness and efficiency

Rationalization of application architecture

Need to align closely with business direction

ITImplications

Focusing on the performance of all areas of business

Creating more agility while maintaining control

Leveraging the restructured organization

BusinessImplications

Copyright New Strategies 2013

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Global Operating Model

Global and local change management and control

Support collaboration across time, language and cultural boundaries

Complex intellectual property sharing and security issues

ITImplications

Shifting priorities for innovation and research focus

Increasing risk exposure across regulatory regions

Increasing complexity in supply chains

BusinessImplications

Copyright New Strategies 2013

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New Value Propositions

Demand for more diverse sources of information and analytics required to evaluate

Embedded software in products requiring life cycle management

Extension of quality and compliance to new business areas

ITImplications

Addressing personalized medicine potential

Competing across numerous smaller markets

Connecting the market and R&D

BusinessImplications

Copyright New Strategies 2013

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Virtualization/Externalization

Information security, access rights and IP protection outside the firewall

Auditing a partner's IT capability

Cloud/SaaS models preferred for many categories of application

ITImplications

Reduced barriers for building business capabilities versus internal options

Creating agility through diversification of capabilities and scalability

Opportunity to bypass long IT development efforts

BusinessImplications

Copyright New Strategies 2013

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Government Regulations

Increased use of dashboard intelligence for critical systems in research, development and manufacturing

Investments in global regulatory management capabilities and regulatory content management

ITImplications

Increasing attention to risk management and compliance efforts related to regulatory affairs

Rising cost of compliance and agility required to address FDA and other regulatory body warning letters

BusinessImplications

Copyright New Strategies 2013

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ERPSolution

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Strategic ImperativesERP for pharmaceutical companies should meet the full range of needs, minimize customizations and reduce implementation and validation challenges

Single integrated solution

Compliance to local regulatory requirements

Product tracking and visibility

Accessible real-time information

Rich industry-specific capabilities and modular design

Copyright New Strategies 2013

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Typical Business Requirements

ERP should prevent unsafe products from entering the supply chain, as well as track and monitor individual product units

ERP should manage the procurement of raw materials needed for manufacturing (especially critical raw materials)

ERP should enforce compliance to local regulatory requirements throughout the manufacturing processes

ERP should automate work processes for Quality Management and integrate manage Dispensing activities

ERP should maintain production machinery and laboratory equipment (preventive/corrective maintenance, spare parts etc.) Copyright New Strategies 2013

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ISV

Solu

tion

sVertical Strategy

Microsoft Stack

Partner Customizations

Sch

ed

ulin

g

Core ERP Suite

Tran

sport

ati

on

M

an

ag

em

en

tC

harg

eb

ack

an

d R

eb

ate

s

Cost

ing

Qu

alit

y

Man

ag

em

en

t

Dis

pen

sin

g

Pla

nt

Main

ten

an

ce

Fore

cast

ing

Copyright New Strategies 2013

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COTS SoftwareCommercial-Off-The-Shelf

60%35%

5%

Customizations

Standard AX

ISV Solutions

ISV SolutionsMinimize customization to the meet customer’s requirementsReduce risks when validating the ERP solutionAvoid integration with different softwareSimplify maintenance and reduce total costs

Copyright New Strategies 2013

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ERPProject

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Big Pharma, Big ProjectOrganizational factorsManagement supportSoftware architecture/designProject management

Risk factors

TechnologyOrganizationHuman resourceProject size

Implementation risks

Minimize customizationsUse vertical solution/knowledgeAdopt organizational change managementCreate business measures

Possible solutions

Copyright New Strategies 2013

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Approach

Work with carefully selected global partnersUnderstand their vertical and business needsProvide the right solution fit, while minimizing customizations and streamlining implementations

The right approach to enterprise solution architecture, design, development, integration and validation significantly reduces implementation costs, ensuring consistency, bringing savings and achieving compliancyThese aspects, always important, become critical when the validation of an extended ERP solution is required

Copyright New Strategies 2013

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Our ServicesWe provide implementation support and value-added services, including a full validation package (with functional documentation, templates and test protocols) to support our partners and customers in implementing and validating their ERP solution.

Our services leverage technical knowledge and deep understanding of the Pharmaceutical and Life Sciences competitive landscape.

Enterprise Architecture

Solution Assessment

Project Management

ERP Implementation through Certified Partners

Computer System Validation

Copyright New Strategies 2013

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Case studies

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Innospec

“…Innospec Specialty Chemicals is an international specialty chemicals company with approximately 850 employees in 20 countries and a turnover of $800 million..”

“..Innospec stock is listed on NASDAQ...”

Microsoft US

Microsoft Dynamics AX 2012

8 ISV’s

Collaboration with Microsoft MCS US

United States, United Kingdom, Germany, France and other countries

880 users.

http://www.innospecinc.com

Copyright New Strategies 2013

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Targeting Standardization

ERP solutions incompatible business logic in different countriesMultiple departmental solutions not integrated with the ERP solutionCritical business processes not covered by ERP solutionERP solution not compliant with guidelines and regulations

Pain

ERP solution fully compliant with guidelines and regulationsFully integrated ERP solution across different divisionsIntegrated quality management, costing and plant maintenance

Value

Copyright New Strategies 2013

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What you should know…

ISV’s can cover gaps between business requirements and standard functionalities and make the ERP easier and safer to implement, test, document and upgradeISV’s can be involved into existing deals to have more satisfied customers, reducing scope changes

Copyright New Strategies 2013

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Biolab

“…BIOLAB is a Brazilian pharmaceutical corporation which develops, manufactures and commercializes medicines…”

“…BIOLAB is a leader in cardiovascular product prescriptions and ranks 8th in prescription drug sales. Through the continuous and diligent work of our 2 thousand employees and health professionals we offer a portfolio of more than a 100 products…”

Microsoft Brazil

Microsoft Dynamics AX 2012 R2

1 ISV

Sold on the Enterprise Agreement

Brazil

440 users

http://www.biolabfarma.com.br

Copyright New Strategies 2013

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Targeting Reliable Innovation

Multiple departmental solutions not integrated with the ERP solutionCritical business processes not covered by ERP solutionToo many manual operations20 year old solution needed to be replaced

Pain

ERP solution fully compliant with guidelines and regulationsFully integrated ERP solution across different divisionsProcess automation and industry-specific functionality

Value

Copyright New Strategies 2013

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What you should know…

The deal was sold in very few monthsA Brazilian Microsoft SSP was directly involved with the customer and selected the ISVThe right ISV’s can help during the presales activitiesThe implementation partner was chosen after the initial demos and seamlessly took over the commercial process form Microsoft

Copyright New Strategies 2013

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© 2012 Microsoft Corporation. All rights reserved. Microsoft, Windows, Windows Vista and other product names are or may be registered trademarks and/or trademarks in the U.S. and/or other countries.The information herein is for informational purposes only and represents the current view of Microsoft Corporation as of the date of this presentation. Because Microsoft must respond to changing market conditions, it should not be interpreted to be a commitment on the part of Microsoft, and Microsoft cannot guarantee the accuracy of any information provided after the date of this presentation. MICROSOFT MAKES NO WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, AS TO THE INFORMATION IN THIS PRESENTATION.

Andrea RuosiCEO

[email protected]

For more informationPlease visit

www.axforpharma.com