1. David Bridges eChange Solutions Limited Drug Development Projects Business Change Projects

2. Keys to success in Drug Development Delivery of good and potentially profitable drugs from discovery through drug approval to marketing Ongoing innovation and change to the drug delivery processes without causing unnecessary disruption Analysis

3. Barriers to innovation and change (1) Regulated environment Patent life Budgets Geography, cultural diversity Imposed change – mergers etc Mismatch in cycle-time of drug development and change activities Analysis

4. Barriers to innovation and change (2) Management –Project Management –Programme Management –Portfolio Management Analysis The project management paradigm

5. The Project “Management Paradigm” Portfolio –‘a collection of projects. programs and other work that are grouped together to facilitate the effective management of work to meet strategic business objectives.’ (PMI, 2008) Program –‘a group of related projects managed in a coordinated way to obtain benefits and control not available from managing them individually.’ (PMI, 2008) Project –‘a temporary endeavour undertaken to create a unique product or service’ (PMI, 1996) Structure

6. The paradigm in drug development - delivery Portfolio –A collaboration between R&D and Marketing –Decides which drugs to develop Programme –Manages the development of a drug Project –A clinical trial –A process such as drug submission assembly Characterized by : –Long durations –Industry/company specific methodologies –High level of standardization within the company Structure

7. The paradigm in drug development - Change Portfolio –May occur at any level of organization –May not exist Programme –Manages the development of a process, system or organizational change or group of related/interdependent changes Project –Development of a computer system –Roll-out of new SOPs –Commissioning of a new building/facility –Developing novel partnerships with CROs etc Characterized by : –Shorter durations –More likely to use standard methodogies or to borrow from other industries –However, low level of standardization across change projects Structure

8. Programme A Programme B Line organization ? Structure Relationship of Drug development to business change activity Marketing / Drug Development Drug BDrug A Drug C

9. Nature of programme Construction, engineering, IT Product Process Organization Making and Delivering Vision-led, outcome-driven, ambiguity and clarity co-exist, proactive adjustment to scope, loose levers Vision-led, benefits-driven, good clarity/some ambiguity, reactive adjustment to scope, clear levers Specification led, Output-driven, High clarity/low ambiguity, reactive adjustment to scope Research and development Process re- engineering Mergers, acquisions, Government agencies Typical application Operational External environment or Society Change of : Culture Strategic Modified from OGC, 2003 Drug Development Business Change

10. Culture Resource management This is the value added by through : –cross project resource management (budget, manpower, equipment) Standardization –Improved effectiveness of delivery achieved via standard tools/methodologies, support groups Management control –Control/oversight of project activity, alignment to goals Task interdependency –Management of project interdependencies Value of project/program/portfolio etc (1)

11. Culture Benefits realization This is the value added by the programme through : –Focus on the desired outcome of the programme rather than the successful deliver of projects Stakeholder management –Improved stakeholder commitment Emergent strategy –Adoption of new ideas / approaches and modification of programme goals on ongoing basis Learning –Exchange of learning and experience between projects within the programme Value of project/program/portfolio etc (2)

12. Construction, engineering, IT Research and development Process re- engineering Mergers, acquisions, Government agencies Typical application Benefit area Resource management Standardization Management control Tasks interdependency Benefit realization Stakeholders Management Emergent strategy Learning Homogeneous programmes Heterogeneouss programmes Product Process Organization Making and Delivering Operational Strategic External environment or Society Change of : Culture Drug Development Business Change

13. Drug Development Resource Management Task interdependencies Standardization Learning Business Change Management control Benefits realization Stakeholder management Culture Management focus on : Management focus => metrics => Behavior => Culture

14. Drug Development practitioner’s view of Business Change Disruptive Opportunist Unstructured A risk Business Change practitioners view of Drug Development Arrogant Dogmatic Inflexible A barrier Culture These are caricatures but …….

15. Possible solutions to structural issues Projects must be allowed to be “selfish”. The functions undertaken by the Program and Portfolio must occur. In smaller organization delivery and change activities may be managed within the same portfolio. Even in large organization, major change activities may be managed within the same portfolio as delivery activities. It is possible to give senior management visibility across delivery and change project by adoption of common “project office” and resource tracking tools. Backstop – diligent engagement with stakeholder + utilization of “Middle Management” Solutions ?

16. Possible solutions to cultural issues Cultural issues are much more difficult to address. Cultural differences exist for a reason and are likely to persist. Ultimately structural changes will reduce the scope for conflict and therefore the impact of culture differences. Good marketing of business change initiatives will help, as will careful stakeholder management and having a powerful sponsor. Hopefully awareness raising (such as this presentation) will help. Solutions ?

17. Final version of slides will be published on : www.echangesolutions.com within the week. Thank you.