“Filling the Void” Project Management for the BioScience Sector Regester G.O . & Milner S.J.

1. AIPM Annual Meeting 2007Local & Global Innovation and Development TrendsOctober 8th 2007 “Filling the Void”Project Management for the BioScience SectorRegester G.O. & Milner S.J.

2. Talk Outline • Background • Challenges in BioSciences Project Management 3. Processes and Tools • Metrics • Conclude

3. Biologystics Pty Ltd • Project management services to the Biotech / R&D sector: “BioScience Solutions through Project Management” • offer a disciplined approach to the management of projects • install best practice project management systems • monitor projects, coach and mentor staff • goal - improve project performance

4. Biologystics supports the Value Chain 1. Bioscience Therapeutics: 2. Agribiotech / Nutraceuticals: Need for Project Management Mature PM models 4

5. Talk Outline Background Challenges in BioSciences Project Management 3. Processes and Tools Metrics Conclude 5

6. Typical Headlines! Avexa to reconsider hep B program Delays extend Prima-AstraZeneca partnership Psiron postpones cancer trial results Avastra abandons BioWeld trials Chemeq posts $60.7m loss BioProspect setback 6

7. BioScience Project Types • Institutional - few defined activities / single stakeholder • Collaborative - multiple stakeholders / cross functional* • Virtual - contract research / external agencies* *Complex

8. Project Management in BioSciences How does BioSciences PM differ from other industries? • Culture and Vision • Organisational structures • People (e.g. researchers, inventors) • Risk profiles • Long timelines • Communication req’s • The commodity - knowledge • (Similarities are the processes used)

9. Discovery Development Target ID and Evaluation Lead ID POH Studies POTP Studies Manufacturing Formulation Pre-Clinical Phase I Phase II Phase III BLA Approval Universities Institutes Med./Biotech’s Large Pharma BioScience Project Timelines 15 Years Market Concept % Royalties % Royalties Mature PM models

10. Attrition Rate in Drug Development • Why? • Economic (33.8%) • Efficacy (37.6%) • Safety (19.6%) • Other (9.0%) Attrition Rate: % of NCE’s entering a phase that fail in that phase DiMasi 2001

11. Development Cost – New Therapeutics 900 800 Million (US$) 200 50 1976 1987 2000 2005 Tufts CSDD Management report 2006

12. A Risky Business… Therapeutics Risk Return $$

13. Increasing Project Demands • Granting Bodies • Venture Capital • Shareholders • Project Sponsors Schedule Expect Delivery On: Budget Quality

14. Talk Outline: Background Challenges in BioSciences Project Management 3. Processes and Tools Metrics Conclude 14

15. Project Planning Legal Environment Technical Direction Intellectual Property Regulatory Issues Org. Strategy Quality Standards

16. Thrashing Doing = operations Larger for major projects Most must be early Process = planning Time Spent on Planning – upfront investment Proportion of Time Spent Time (Project Duration) (McConnell)

17. Project Plan - Team Charter Sets the project ground rules - • How will projects be managed? • Who is involved? • What reporting is done, when? • A project charter defines these…..

18. How will Projects be Managed? BioSciences

19. P P Who’s involved? – BioScience projects Com Partner Man P P Proj Mngr P P R&D P Clin P Sponsor QA Point Person represents a functional area P

20. Project Point Person? P Expectations: within their functional area : • take ownership of project activities • assist & support project planning • communicate and report on project activities • control and manage project data / records • maybe responsible for a small team

21. Selected Tools • Staged-gate • Risk Management • Timeline variance • Communication

22. Tools: Staged-gate Approach Decision points for each stage allow better control and execution! Project Start Project End Accuracy of work plan & degree of certainty of delivery to plan HIGH! Accuracy of work plan, & degree of certainty of delivery to plan LOW! Add Key Milestones! “Well suited to BioScience Projects”

23. Tools: Staged-gate Approach Make the milestones key decision points Allows for Go / No Go decision points

24. Selected Tools Staged-gate Risk Management Timeline variance Communication 24

25. Tools: Risk Management All BioScience development projects contain risk ! • Industry competition increases project risks : • use of under-resourced teams • application of new technologies • need for speed to market etc. • Projects with the largest risk may also provide the greatest opportunities. • Managing project risk is a proactive team task. Project Risk !

26. Tools: Risk Management Major sources of Risk in BioScience Projects (Tufts survey) • Clinical trial complexity • Regulatory approvals • Patient recruitment • Sub-contractor performance • Drug transportation logistics • New technologies • Skill levels & staff turnover • Competitor activity • PROJECT MANAGEMENT

27. Selected Tools Staged-gate Risk Management Timeline variance Communication 27

28. Timeline Variance Project Change = major cause of timeline variance Progress Rate Change Time “Challenge change - ensure it benefits”

29. Solution – in part Timeline variance : Task Overrun 90/10 Build appropriate buffers 50/50 eg. Patient recruitment • 50/50 estimate can be typical with some BioPharma activities • eg. methods validation, patient recruitment, licensing.

30. Selected Tools Staged-gate Risk Management Timeline variance Communication 30

31. BioScience Communication - Challenges • Multiple stakeholders: • Owners – Universities, Research Institutes, Scientists, Inventor(s) • Investors – Venture Capitalists • Granting Bodies • Staff • Service Providers • Geographical and organisational boundaries • Regulatory environment

32. Communication - Integration Solution? - Extranet

33. Talk Outline: Background Challenges in BioSciences Project Management 3. Processes and Tools Metrics Conclude 33

34. Metrics for BioScience Projects • Typical Parameters : • Task tracking against schedule – tasks on time • Number of change controls issued • Expenditure against Budget • Sponsor satisfaction - polled • Risk mitigation frequency • Learning and Growth parameters • Quality performance / standards met

35. The Value of Project Management: • Life sciences sector survey: Pharma / Medical Devices / Biotechnology • Importance of project management knowledge areas (rank order): • Communications Management • Time Management • Scope Management • Risk Management • Quality Management • Integration Management • Human Resources Management • Procurement and Cost Management (not ranked) Survey respondents consistently acknowledged Communications Management as being the single most important area that provides benefit in managing complex, technically risky projects. Source: D Auman, Masters Proj Mgmt Student, UniSA 35

36. Talk Outline: Background Challenges in BioSciences Project Management 3. Processes and Tools Metrics Conclude 36

37. 5 4 3 2 1 Optimised Process Managed Process Maturity Level Organisational Process & Institutionalised Stds Structured Process and Standards Initial Process (Ad Hoc) Standardise Measure Control Improve Time Project Management Maturity: BioSciences Discovery Development Commercialisation

38. The Value of Outsourcing- Biologystics • Project management best practices are immediately available; • Projects are guided by experienced professionals; • No up-front investments and recruiting costs are required; • The project office team is on hand to coach and mentor staff; • Changes in staff can be easily made to adjust to requirements; • Frees up time for clients to focus on what they do best; the science. … driven by virtual R&D model

39. Discovery Projects! www.projectcartoon.com

40. Thank You …