Service Outsourcing Considerations & Outsourcing Models Presented at:

3rd Annual Pharma Strategic Sourcing Summit

Paul Kuiken Vice President & European Head Operations

Your presentation

1. INTRODUCTION

2. CONSIDERATIONS TO OUTSOURCING 3

3. ENGAGEMENT MODELS Incremental vs Total Outsourcing 10

4. SETUP – TRANSITION – MANAGEMENT 17

5. CASE STUDIES 22

CONSIDERATIONS TO OUTSOURCING

Section Two

Challenges in managing global products • Compliance and improvement activities in manufacturing and quality often

require an extensive amount of regulatory time and effort to submit and approve in all registered markets.

• Country specific requirements/practices can be confusing and not well understood leading to:

• delays in submission and approval

• Increased risk of Non Compliance

• increased effort and demand on stretched resources

• Large amount of effort required for coordination, management, and compliant implementation of changes

• Increased focus from supervisory authorities on compliance

The Market Factors

increasing the demand for regulatory consulting and support

G

Increased pressure to do more

with less

DEMAND FOR A TRUSTED PARTNER

Accelerated pace of change in regulatory

environment Increased focus on ROI &

Revenue Per Headcount

Increased adoption of outsource

business models by Healthcare companies

Growth in emerging markets

(as economies evolve so to does

regulatory scrutiny)

Increasing M&A and

in-licensing activity

Increased globalisation

(product launches in new markets)

Increased regulatory scrutiny across the product

life cycle

A specialist in regulatory affairs is required to support and assist on many levels

Considerations to outsourcing

Mobilization:

• Flexibility and Scalability - sufficiently sized so that client demands are met

• People - Ensuring the most appropriate resources for your requirements are in place at the appropriate time.

• People - project teams receive training in all relevant client systems, processes and procedures applicable to them.

• People - project team members will be issued with a training record.

• Communication - setting up communication protocol with the client, defining work breakdown structure.

• Communication - sharing standard templates (used for authoring test cases, reporting project status, presenting the key metrics etc.).

• Intellectual Property Protection - handling and transfer of information defined as part of the IT infrastructure discussion. may be as simple or complex as the project requirements dictate.

Considerations to outsourcing Mobilization:

Processes

Documented roles & responsibilities

• Project Plans, SOPs

Communication Plans, Contact Lists

Metrics

Communication:

• Single point of contact - Maintains effective channel of communication.

• Escalation and Resolution – Advocate employing a clear and objective escalation and issue resolution.

• Escalation and Resolution – Early identification is built into the standard project risks and issues

• Escalation and Resolution – Successful processes work in a trusting relationship.

• Reporting - formal reporting is agreed in advance.

• Reporting - regular set of reports and deliverables updating on the engagement

Considerations to outsourcing

Governance:

3 levels of Governance required for oversight:

• Executive

Quarterly review of performance metrics, forecast, budget and resource plans, review continuous improvement opportunities, scope

• Managerial

Monthly review of performance metrics, continuous improvement projects, budget, resource, individual performance

• Technical/Operational

Metrics, IT, training, team building

Steering & Oversight

Project Meetings

Workstream 1

Workstream 2 Workstream 3 Workstream 4

Considerations to outsourcing

Service Level Agreements (SLAs):

• On time delivery - dates must be agreed from the outset on all major deliverables with all efforts to ensure they are met. Use change control processes if these dates need to be moved.

• Client satisfaction - periodic surveys should be conducted to make sure that the service provided is satisfactory to stakeholders.

• Effectiveness - effectiveness metrics focus on managing financials including tangible efficiencies and cost reduction.

• Volume of work - the volume of work sometimes is difficult to define. For example, projects that are billed on a time-and-material basis may discuss volume in terms of number of resources, while a fixed-price project usually specifies number of deliverables. This metric is an important part of the SLA.

• Sensitivity - sensitivity metrics measure the amount of time required for an outsource company to handle a request.

ENGAGEMENT MODELS

Section Three

ENGAGEMENT MODELS

Incremental Outsourcing:

• Limit the perceived exposure of outsourcing - by dividing the work into small, more manageable projects that they outsource to service providers.

• Master service agreement with SOW - well-defined deliverables, programs that work under an umbrella contract with associated schedules.

• Building a level of comfort - once the relationship develops and a level of comfort and experience is developed, additional activities and services allocated.

• Outsourcing to manage peaks and troughs - set discrete tasks and the vendor is effectively a retained resource.

• Managing specific projects - discrete projects that would otherwise take out their staff from day to day activity.

Scenario - clients have chosen to hold on to activities or areas that define key or high profile activity within their business.

ENGAGEMENT MODELS Benefits of Incremental Outsourcing:

• Can be perceived as a lower risk to the client sponsor.

• Allows clients to focus other on-going high priority regulatory projects.

• Portfolio or product knowledge remains in-house.

• A cost effective answer to managing peaks and troughs of workload.

• Switching on and off, or increase/decrease resources allows flexibility.

• Provide additional ad hoc advise/intelligence or regulatory service.

Downsides of Incremental Outsourcing:

• Requirement for client to continue to manage the outsource provider.

• Inefficiency can creep into the processes.

• Needs to be planned carefully, including any clients on-going/planned activities impacting outsourcing projects

• Client versus provider estimates on time requirements can be different.

• Ad hoc activity can be more expensive to secure specific resources.

• Not guaranteed to retain the same people for that client activity.

ENGAGEMENT MODELS

Total Outsourcing:

• Strategic option - multiple projects and programs at the client organisations are outsourced.

• End-to-end program management and delivery - takes project, module or program from a client, deploys a small team onsite that works with the client managers and teams and coordinates work with the team.

• Common approach for mid- to large companies - partnership for mid to large sized companies is legacy product portfolio management.

• For smaller or virtual companies - engaged to manage the full regulatory responsibilities under Power of Attorney (PoA) and makes submissions direct to agencies or through country offices of the client as a ‘post box’ arrangement.

Scenario - clients have chosen to strategically manage activities outside the business

ENGAGEMENT MODELS

Benefits of Total Outsourcing:

• Enables complete management of whole portfolio of activity.

• Cost efficient – supplier manages workload and resources.

• Lower client management requirement.

• Supplier has the ‘big picture’ of the portfolio.

Downsides of Total Outsourcing:

• Needs to be planned carefully before transition.

• Management of client staff and transition critical and often overlooked.

• Needs to be planned carefully.

• Potential for outsourced work to be forgotten, or deemed less important.

• Alignment of the processes and practices between supplier and client on an ongoing basis.

Options

Sustainable outsourcing partnerships are mutually beneficial

• Longer term contracts lead to increased knowledge base and increased efficiencies

• An “extension” to the skills and resources of the in-house Regulatory Department

• Dedicated and focussed on the client needs

• More stable workforce

• Lower costs

Scope

Sustainable Regulatory outsourcing services possible in the following areas:

Post Approval variations

Clinical trials

submissions

New product submissions

Regulatory compliance review and

remediation

SETUP – TRANSITION – MANAGEMENT

Section Four

SETUP – TRANSITION – MANAGEMENT

Sourcing decision Setup Management Transition

Sourcing decision • We want to ensure you have all the information

available to choosing the right partner • Demonstrable scale, experience and success • Recognised partner for regulatory affairs • Scrutiny and auditing welcomed and encouraged.

SETUP – TRANSITION – MANAGEMENT

Sourcing decision Setup Management Transition

Setup phase • Crucial to ensure success • Intensive planning requirement • Onboarding, training, communication, introductions • Determining milestones from start to steady state

SETUP – TRANSITION – MANAGEMENT

Sourcing decision Setup Management Transition

Transition • If not managed / planned effectively the most challenging part of the process • Clear direction and trust building removes potential barriers to steady state • Milestone reviews and communication according to specific deliverables • Validation of the planning and setup phase • Communications, change management and performance management • IT issue management a key part of the transition

SETUP – TRANSITION – MANAGEMENT

Sourcing decision Setup Management Transition

Management • Service delivery is critical to success • Performance management provides hard data to demonstrate

achievements and quality • Governance approach - a proven method of ensuring quality, timely

delivery and building relationships • A combination of effective governance and performance management

Case studies

Section Five

Case study 1: Incremental outsourcing

CLIENT: Medium sized multi national pharma/biotech company PROJECT: Supporting post licensing activity SCOPE: EU based activity for all aspects of product life cycle. In line with quarterly planning, prepare and distribute post box / DTA submissions for all national authorities through all procedures. Manage translations and label updates. Operate under Letter of Authorisation and manage submissions directly with client affiliate offices. Regulatory communication and interaction ensures client oversight. Governance achieved by twice-yearly face to face meetings with senior stakeholders.

CASE STUDY 1 - INCREMENTAL OUTSOURCING

Case study 2: Virtual department

CLIENT: Virtual pharmaceutical Company PROJECT: Manage all regulatory activities for product portfolio with client

having no internal regulatory group. SCOPE: Project involved working with key client stakeholders to manage all regulatory activity for pre- and post- licensing activity. With no internal regulatory support within the client Vendor provides all expertise and resources required to manage new submissions and post licensing activity. Vendor continues to provide a dedicated team of regulatory affairs specialists to work with the client (now 6 years duration).

CASE STUDY 2 – VIRTUAL DEPARTMENT

Case study 3: Long term partnering

CLIENT: Large multi national pharma/biotech company PROJECT: Supporting post licensing activity SCOPE: Seamlessly operate management of established brands, generics and associated activities alongside client personnel. Vendor provided a dedicated team of regulatory affairs specialists to work on the project for 3 years (ongoing). Project involved working with multiple client stakeholders to establish the baseline of registered information for core products across all Countries. Imperative to maintain consistency within client regulatory organisation. Vendor staff exceeded the client’s expectations on 6-month pilot phase and this success resulted in the client engaging Vendor to undertake the ongoing maintenance activities for strategic brands.

CASE STUDY 3 – LONG TERM PARTNERING

Case study 4: Ancillary document management Process

Ancillary Document Management Process

*QC checks made before & after submission to HAs and before delivery to Client

Request from Client

Project Lead

Client Systems/

Local Office

Legal

Analyst Country

Specialist Health

Authority

Client Systems

Health Authority

*

*

*

*

Health Authority

Team Structure

Team Structure:

A central group to gather the required data from the Client systems and in country specialists to engage with the Health Authorities

Client Manager

Service Provider

Team Lead

Ancilliary Management Analyst Team

Country Specialist

Country Specialist

Country Specialist

Country Specialist

For 1000 doc’s per year Analyst team would consist of 4 people (including Project Lead)

Country specialists utilized as necessary

THANK YOU.

Paul Kuiken

Vice President & European Head Operations