1 Pharmaceutical Analytical and Stability Study Outsourcing To Stabicon Presented By Vijay Kumar Ranka Stabicon Life Sciences Pvt. Ltd. www.stabicon.com
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1
Pharmaceutical Analytical and Stability Study Outsourcing To Stabicon
Presented By
Vijay Kumar RankaStabicon Life Sciences Pvt. Ltd.
www.stabicon.com
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Part:1. Introduction2. Changing Industry Trend of Pharma3. Criteria for Selecting Offshore Outsourcing Unit4. Outsourcing Process5. Outsourcing Requirement6. Risk and Mitigation7. Benefit of Outsourcing
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Index
Part - 1Introduction
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Changing Industry Trend of Pharma
Present Pharma Industry Challenges• Revenue under pressure • Cost and risk of developing new drugs are increasing• Globalization
How to Over Come the Present Challenges• Corporate restructuring i) Consolidation within industry, refocusing on fewer business lines ii) Adoption of risk reduction strategies iii) Acquisition rather than development, Use of Joint ventures
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Outsourcing Redefined
• Outsourcing is “strategic management tool” that involves the restructuring of an organization around its core competencies
• Outsourcing is thus a transfer or delegation of an organization's project /facility management functions to an external firm.
Types of Outsourcing• Onshore• Offshore / Offsite
Onshore: Onshore outsourcing (also called domestic outsourcing) is the obtaining of services from someone outside a company but within the same
country.
Offshore: Offshore outsourcing involves sending certain types of work overseas to be completed by independent third parties.
Offsite : Referring to a location other than the subject site
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Qualit
y
•Access to highly qualified – skilled pool
•Faster adoptability to New Technologies
Cost
•40%-60% cost reduction for off shored process
•Technical manpower resource cost likely to continue next 20-30years
Why India??
India’s Value
Proposition
• Faster turnaround time
•Adoptability to Different Time zone 24X7 service
Productivi
ty
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HR Management• Enough human resource
• Quite easier to motivate and retain people
Infrastructure • Better Infrastructure facilities at very low cost
• Best Net Connectivity & Resource Availability
• English Language Proficiency
• Expertise in New Technologies
• Quality Assured (A grade) & regulatory requirement
• Unexpected Cost Advantage
• Research & development Abilities & Skilled Manpower
• Excitement about Pharmaceutical in the area
Strength At A Glance
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Part - 2 Criteria for Selecting Offshore
Outsourcing Unit
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Why Stabicon ?
• Ability to work in joint ventures and across divisions, cultures and countries
• Ability to integrate an understanding of IP,Scientific expertise and business strategy
• Ability to spur creativity while managing commercially• Expertise in functioning and decision making of regulatory
requirement• Human resource skills to transform Pharma companies• Dedicated support systems for web interface with real time information• Quality system must meet regulation in multiple markets plus clients
internal standards
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Stabicon: Quality Not Quantity
• Quality is the new buzzword and is dominating business process and services like never before in this sector.
• Quality is no longer an oral guarantee given over handshake, but Stabicon has well defined set of criteria are applied to the entire process.
• Stabicon Standards of quality are par with, if not superior to your counterparts requirement aboard.
www.stabicon.com
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What Can be Outsourced?
As per International Regulatory Requirements like
ICH, WHO, USFDA, MHRA, EMEA, MCH, TGA, ANVISA, ETC…
• Stability Study Programs
• Customized Stability Study program to meet specific dosage requirements.
• Analytical Method Development & Validations.
• Bio-waiver Studies (Comparative Dissolution Profiles) and Formulation
Development
• Impurity Profiling / Stability Indicating Methods
• Microbiological Method Development & Validations
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Stabicon Capabilities
• Major installations are 21CFR Part 11 compliance.
• Assured Data Integrity through online web-access monitoring and willing to share entire manuscripts & Raw-data.
• Assured Data Security through Central Networking Software for entire chromatographic data management.
• 24x7 Data online monitoring for assured Stability Programs.• Validated LIMS for Efficient Stability Program & Sample Management.• Dedicated & Independent Quality Assurance Unit.
• Accreditation : Approved by Health Canada as per Compliance to Division 2 of F&DR(GMP)• In the process of accreditation from WHO GPQCL & ISO 17025 : 2005
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Flexibility
• Flexibility of being able to access a large pool of resources working on various Project and increasing / decreasing the teams at a short notice.
• Flexibility to select the team jointly from the best pharmaceuticals brains handpicked from Indian Pharma Industry
• Higher availability of our team to manage contingencies as they work 6 days a week and available at odd hours even on Sundays for emergencies. The team can also work at normal office timings of your country.
• Team are trained to understand the culture of your country, thereby leading to better communication and co-ordination across the teams.
• Based on varied experience, the processes are designed to comply with the industry's best practices and standards, enabling total transparency, access & control of our team .
• Flexible engagement contract, leading to managed business risks.
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Stabicon
Internet usage/Web based
Application /Empower/LIMS
and etc.
Phone Lines
Email Usage
Skype Usage/VC Line
Regular phone no. in World
wide
User name with safe password
World Wide Client
Location
Information Management System
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Stabicon Advantage
•Modest sized company with extensive experience of offering offshore services to clients globally.
Advantages:•Competitive pricing & risk sharing (dedicated model, incentive model, royalty model) Speed & agility (response time)•Drastic reduction of your operating costs.•Gain access to the world-class pharmaceutical skills.•Seek resources not available in-house.•Finish projects which otherwise cannot be finished in-house due to technical or staff limitations.•Free up non-capital resources for other in-houses projects.•Gain a fresh and new perspective on a stalled project.
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Outsourcing Process
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PILOT PROJECT
CLIENT SATISFACTION
AGREEMENTS
NECESSARY TRAINING
ACTUAL OUTSOURCING
IMPLEMENTATION
QUALITY CHECKS
FINAL OUTPUTS
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Outsourcing to Stabicon should be much more than off shoring and staff augmentation
Adopt a partnership based approach to Stabicon outsourcing and move towards a competency based vendor selection
Follow a staged approach for transition to an offshore partner with a careful selection of projects
Prepare detailed transition plans for each project, especially Stability projects
Establish strong governance and management oversight to manage relationship and performance
Best Practices
Ensure that outsourcing processes are tailored to your business requirements
Best Practices in Outsourcing Processes
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Project Transition Plan – Details For Individual Project
Knowledge AcquisitionProject Planning Stabicon Simulation
Stabicon Training/PilotStabicon Execution
Duration
Project Stage
Client Staff FTE
Off – shore Stabicon Staff FTE
2 – 4 Weeks 1 – 2 Weeks 3 – 4 Weeks 2 – 3 Weeks Ongoing
Establish Project scope, Expectations and Criteria for Success
Set team composition, requirements and performance metrics
Member of Stabicon team work with client to understandDocument System/ Process
Finalize transition plan
Execution of project as per approved protocols
Review and approval of reports by client
Establishment of coordination team, process and metrics Program for Stabicon
Complete fulfillment of projects request by Stabicon as agreed upon Service Levels Agreements
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Stabicon/Offshore Transition
Description
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Involve the end user closely in the transition
• Discuss in existing governance forum
• Involve end user in oversight
Typical projects
Test
Increase scope and scale
Complete outsourcing
Short projects Method validation & Stability testing
Complete MD,MV & Stability program
Increasing management complexity and mission criticality
Key Success Factors in a Transition
A Staged Approach Helps Transition to Offshore Partner
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Partnership Board
• Partnership board consist of both senior management from both sides is the final decision making authority
• Every quarter, partnership board should consist of senior review the level of outsourcing and the performance.
• Every year, partnership board conducts joint strategic technology planning sessions
Relationship Management
• Day-to-day project management would be performed by dedicated relationship managers from each side
• Relationship managers will facilitate smooth project execution, define processes and act as trouble shooters
Performance Management
• Performance tracking should be automated and Commitment tracker • Clear definitions of success and failure • Predefined processes for increased and decreased collaboration• Exit clauses that define responsibility and timelines for knowledge transfer,
documentation and intellectual property rights
Best PracticesKey Levers
Critical Practices For – Strong Governance & Management
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Outsourcing to Vendors is more than Offshoring and Staff Augmentation
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Use Stabicon for project components
Maximize offshore component
Use staff augmentation approach foronsite presence
Focus on development outsourcing only
Outsource complete projects
Use offshore, offsite and onsite presence judiciously
Maintain onsite presence for managing and delivering solutions
Extend organization virtually (includes development, management, infrastructure projects, etc.)
vs.
“Traditional” Mindset “Winning” Mindset
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Advantages of Partnership
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No long term commitment
RFP issued for every project
Stabicon not expected to invest
Stabicon follow customer orders with limited value added
Vendors not involved in technology strategy and planning
Insufficient focus on risk mitigation
vs.
Medium/Long term commitment
Competency based vendor selection
Stabicon expected to invest in infrastructure, knowledge transfer, etc.
Stabicon expected to leverage their knowledge base and contribute to overall strategy and planning issues
Stabicon expected to be actively involved in technology planning
Proactive measures for mitigating risks
“Transaction” approach “Partnership” approach
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Technology Provider Successfully Follow a Phased Approach for Partnership
Year : 2012No. of people : 1-2
Year : mid 2013No. of people : 3-5
Year : 2013No. of people : 5-7
Year : 2014No. of people : 7-10
Year : 2015No. of people : 10-15
• Development project to test Stabicon capability
• low priority and low complexity project of a small component
• Medium priority and medium complexity
• Medium priority and medium complexity project (including analysis and reporting)
• High priority and high complexity
• Full testing of products
• Contribution to new releases (development)Scaled
down SLAs to give time to Stabicon
Marked up SLAs
Partnership /Joint Venture
Client onsite governance
Moving up the value chain with increasing customer confidence in Stabicon capabilities
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SLA Service Level Agreements
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Partnership Model Has Benefits
Cost
Quality Time to market
• Learning curve benefits help in faster time to market
• Releases important customer resources for more value added work
• Reduces time spent in the RFP process
• Learning curve benefits help in improving quality
• Allows Stabicon to prepare resource plan in advance and staff projects with appropriate resources
• Helps achieve best practice transfer by Stabicon
• Enables Stabicon to offer lower pricing because they have better visibility into revenue streams
• Reduces the Stabicon total cost of doing business which can be passed to customer.
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Business Models
Dedicated DevelopmentCentre Model
Build an offshore facility for the customer, Operate the offshore facility & customize it as per customer's needs & when model reaches maturity, Transfer the complete ownership of the facility & resources to the Client.
Extension of the customer's software engineering facility. The customer pays fixedmonthly rate for the Team.
Hybrid Model
A major portion of project is on a Fixed Price basis and at the same time resources are deployed on Time and Material basis. Adopting such a model enables the client to maximize their ROI without compromising any aspect of the project itself.
Build-Operate Transfer Model
Fixed Price Model
The customer pays a Pre-negotiated Fixed price for the complete project, which in turn is linked to well-defined deliverables.
Time & Material Model
Define the business model and work hand in hand with our client. The client pays a fixed FTE rate.
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• Form a cross-functional team
• Determine communication plan
• Determine and finalize work plan
• Define measurable deliverables.
• Finalize data review and approval process
• Finalize process to review out of specifications/OOT results
• Have periodic meetings to review work
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Metrics Required to Support Outsourcing
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Project Coordinator Overall co-ordination of the project.
Logistics Handling of Sample shipment
Quality Control Co-ordination of specifications ,method transfers stability protocols and stability results.
Quality Assurance Approval of Out of specifications
Structure Required at Client Site to Support Outsourcing
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Outsourcing – In many organization around outsourcing can cause emotional equivalence of a political or religious debate due to confusion
Outsourcing Confusion
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Outsourcing Risk
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TalentTalent
CulturalCultural
InfrastructureInfrastructure
Political/CountryPolitical/Country
ProjectProject
Risks Associated with Outsourcing to Stabicon Manageable
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High attrition rates due to large demand
Complex projects have many failure points
Differences in work culture
Electricity and telecom not reliableDifferent IPR laws
Geopolitical events can destabilize trade e.g. with India
Vs.
Stabicon is investing heavily in training.
3level review on project at StabiconActive governance policies with interactions at all levels
Leading team at Stabicon have been proactively trained to handle culture gaps
Government actively promoting uninterrupted power supply and telecom to technology companiesEstablished legal system
US and Indian Governments agreed to de-link the pharmaceutical trade from politics
Perceived risks Why we believe risks can be managed
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Cultural Gaps
Risk: Corporate culture clash to the difficulties in managing an outsource
provider across large distances and different time zones
Throw in regulatory concerns and proprietary information and relationship management becomes even more difficult.
Mitigation: Focus on the performance and cost, but don’t let the service provider
lead down path of vendor lock-in.
Avoid exclusivity in the contract.
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Risk: Managing expectations and maintaining relationship with service
providers is essential for the success. Offshore contract do meet expectations becauseI) Firms outsourcing without a clear methodologyii) Disconnect between expectations at management level and what’s
actually delivered at the processes level.
Mitigation: By making sure the parties share a common understanding regarding
critical interactions at the Operational & Management Level for successful outsourcing
Customer Relationship Management
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Knowledge Transfer
Risk:
Transfer of knowledge from both side of a contract is critical otherwise can lead to broken connectivity .
Mitigation:
Services require external & internal support This result in Decline of productivity during first year of an agreement,
largely due to time spent transferring
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Implied Cost savings
Risk• Estimate most firm save 30-35% during first year; by third year, cost
savings often reaches 40-45% as companies “go up learning curve “ for outsourcing and modify operations to align to an offshore model.
• Outsourcing solely control cost can lead alignment issue and increased project delay.
Mitigation • Corporation should provide strategy to its business lines of business to
allow them to outsource within guidelines.• Brings in the strategic differential advantage of offshore outsourcing to your business, thereby, enhancing your profitability• Once firm understand its outsourcing drivers, selecting which
application to outsource becomes straight forward.
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Risk: Product failure/Regulatory/Security compliance failure is in fact one of
the top concerns companies face when outsourcing services to external vendor.
Mitigation:
The key to successful and secure outsourcing agreement is understanding
i) Regulatory compliance followed by schedule third party Audits ii) Security covered by Legal Agreement iii) Privacy risks for a business process covered by CDA iv) Application or technology function outcome covered by Technical
Agreement
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Compliances
Sample Shipment Procedure
Mitigation:
• Samples need to be shipped by Air freight cargo mode
• For temperature sensitive products special containers can be used and
temperature can be monitored
• Pro forma Invoice detailing product name , quantity and value
• Declaration for customs purposes stating the value of the product
• Documents can be faxed to Stabicon for rechecking
• Sample shipment after clearance from Stabicon
• Samples will be cleared by Stabicon from Indian customs
• Timelines for customs clearance : 3 to 5 working day
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• Choose a service provider who provides you with value adds, services or products that may not be in the contract.
• Develop a strong partnership with the vendor
• Simplify the interface between the two organizations• • Choose a service provider that has a proven track record - talk to customers of
the service provider
• Know your requirements, both current and future, and put them in the contract
• Stay away from variable costs in the contract like communication, travel etc.
• Treat the outsourced relationship as a partnership and the employees and extended team members
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Minimizing Risk
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Benefit of Outsourcing
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Part 7
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Customer
Increased Productivity
Increased Profits
Reduced Operating Cost
Quick Turn around Time
Better Quality
Your Benefit as a Customer
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Client High Growth Area can be Focused
• Commercialization of Dormant Compounds
• Generic or Biosimliar Versions of biologics
• Improving the efficiency of R&D
• Oncology and central nervous system disorder research
• Stratified Medicine and diagonistic
• Fusion of Pharmaceutical and consumer goods
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For any query,Please contact us at
Stabicon Life Sciences Pvt. Ltd
3BM – 416, 3rd Block,HRBR Extension,
Bangalore – 560 043 INDIA
Phone: +91 80 4171 4280 / 81e-mail : [email protected]
Thanks
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