Programme structure and function and the facilitation of learning

1. Programme structure and function and the facilitation of learning David Bridges eChange Solutions Limited

2. • What constitutes the “programme” level organization in Pharmaceutical R&D • How does Pharmaceutical R&D compare to other industries • What is the programme’s contribution to organizational learning and how can it be optimised Programme structure and function and the facilitation of learning Goals

3. Project • • Definition • ‘a temporary endeavour undertaken to create a unique product or service’ (PMI, 1996) • Relevant Methodologies/Bodies of Knowledge • PMI/PMBOK • PRINCE 2 • • Pharm R&D usage • Candidate drug in Discovery • A significant multi-centre clinical trial

4. Programme • • Definition • The co-ordinated management of a portfolio of projects to achieve a set of business objectives. (CCTA, 1994) • • Relevant Methodologies/Bodies of Knowledge • MSP • PMI Program Management BOK (in draft) • Pharm R&D usage • Exploration of a scientific opportunity (Cytokine receptor programme) • Compilation of a regulatory submission

5. Portfolio • • Definition • Very varied, no trans-industry standard meaning • • Relevant Methodologies/Bodies of Knowledge • PMI Portfolio Management BOK (in draft) • • Pharm R&D usage • The highest level of decision making at which research and development goals are set and resources allocated

6. The programme in Pharm R&D • • Purpose • Responsible for achieving a defined strategic or operational objective • • Achieved by • Initiating, modifying, accelerating, slowing or terminating projects • Influencing line activities

7. The programme in Pharm R&D – broader context Portfolio Programme Programme Programme Line organiz-ation External org.s Projects

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

9. Pharm R&D in context Regulations External collaborations Full development Discovery PharmaceuticalR&D Cost Serendipidy

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

11. Programme value (cont.) • • 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 bases • • Learning • Exchange of learning and experience between projects within the programme

12. Strategic Operational Making and Delivering Change of : Product Process Organization External environment or Society Pharm R&D in context Typical application Construction,engineering, IT Research and development Process re-engineering Mergers, acquisions, Government agencies Benefit area Resource management Standardization Management control Tasks interdependency Benefit realization Stakeholders Management Emergent strategy Learning Homogeneous programmes Heterogeneoussprogrammes

13. Organizational learning • Programme management standards : • • Focus on • Management of learnings relating to programme/project conduct • Promulgating best practice across projects within the programme (particularly Homogenous programmes) • • Promote • Use of knowledge bases to capture lessons learnt • Production of project/programme closure reports • No focus on : • Management of broader process and scientific learnings • Promulgation of best practice across programmes

14. Who owns learning ? Strategic direction Management of delivery Portfolio Programme Programme Programme Line organiz-ation Resourcing + Capability Creation + Operational Management Delivery Projects

15. The process of organizational learning • Organizational learning involves three processes : • • Knowledge acquisition • Capture of tacit knowledge • Trial and error • Benchmarking etc etc • Knowledge transfer • Training • Technology transfer etc etc • • Knowledge application • Pilots • Full adoption

16. Role of the programme in organizational learning • • Knowledge acquisition andtransfer • Shared responsibility.Responsibility for knowledge management must be embedded within organization (processes and culture). • Programmes unlikely to take lead except where : • Homogenous projects within programme • Specific learning goal related to programme • • Knowledge application • Unique and important role for programme • Programmes control access to R&D activity

17. Introduction of new standard, system or process Knowledge application – issues of pain • • Few new systems/tools/processes promise overwhelming advantages, particularly to initial adopters. • • Frequently costs in terms of resources, risk and diversion of management attention exceed anticipated benefit to programme ! • Performance of programmes measured in terms of delivery against programme goals not degree of innovation

18. Introduction of new standard, system or process Knowledge application – issues of timing Drugs in Development Time Phase I Phase I Phase III

19. Knowledge application – stakeholder mapping Interest/influence of stakeholders in application of new knowledge (Based on authors experience of implementing new systems/process in full development) Level of interest Low High Projects Line Management Portfolio (Senior management) Power Programmes High

20. “Satisfying” the Programme I can't get no .... satisfaction ! Rolling Stones • How can these issues be addressed • Goal setting within programme • Positioning of knowledge application initiatives • Delivering ‘packaged’ solution to programme • Sponsorship/Communication • This can lead to : • Knowledge application programmes in parallel to R&D programmes

21. Take home messages • • Conceptual models exist which can classify drug R&D programmes • Drug R&D and knowledge application projects / programmes are different. • R&D programme managers have high influence but low interest in knowledge management • Knowledge application goals and metrics should be incorporated in the objective of R&D programmes. • • Knowledge application Programmes can be establishment in parallel to R&D programmes. • Programme management methodologies/BOKs are useful in Knowledge Application Programmes

22. Slides will be published on : www.echangesolutions.com within the week. Thank you.