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Selling into Big Pharma
Microsoft DynamicsAX 2012
February 13th, 2013
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
AgendaOverviewERP SolutionERP ProjectCase Studies
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
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
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
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
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
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
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
ERPSolution
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
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
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
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
ERPProject
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
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
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
Case studies
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
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
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
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
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
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
© 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
For more informationPlease visit
www.axforpharma.com