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

1. �Filling the Void�Project Management for the BioScience SectorRegester G.O. & Milner S.J.

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

3. 3 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

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

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

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

8. 8 Project Management in BioSciences 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. BioScience Project Timelines For our drug development business, our position in the development pipeline falls here � in between ��. GroPep�s resouces are not capable of taking a product all the way through discovery --- market what it can do is fill the role from pre-clinical development through to early stage clinical trial at which point it outlicenses to larger pharma for development to market. special note here is the project duration from start to finish, which can be 15 yrs or more. Places a different tilt on project management in this environment. For our drug development business, our position in the development pipeline falls here � in between ��. GroPep�s resouces are not capable of taking a product all the way through discovery --- market what it can do is fill the role from pre-clinical development through to early stage clinical trial at which point it outlicenses to larger pharma for development to market. special note here is the project duration from start to finish, which can be 15 yrs or more. Places a different tilt on project management in this environment.

10. Attrition Rate in Drug Development

11. 11 Equally frustrating is the all-up cost of those projects which do make it to launch -- which is extremely high. Hence the price of many drugs on market and the sig. margins carried to recoup some of this spend. Equally frustrating is the all-up cost of those projects which do make it to launch -- which is extremely high. Hence the price of many drugs on market and the sig. margins carried to recoup some of this spend.

12. 12 Hence its fair to say our business is risky not only in terms of cost to achieve success, but also product safety and liability. On the other hand, success can lead to substantial returns. Hence its fair to say our business is risky not only in terms of cost to achieve success, but also product safety and liability. On the other hand, success can lead to substantial returns.

13. 13 Increasing Project Demands

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

15. 15 Project Planning

16. 16 Time Spent on Planning � upfront investment

17. 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. 18 How will Projects be Managed?

19. 19 Who�s involved? � BioScience projects

20. 20 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 Project Point Person?

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

22. 22 Tools: Staged-gate Approach

23. 23 Tools: Staged-gate Approach

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

25. 25 A few generalised statements from the text book. All good stuff A few generalised statements from the text book. All good stuff

26. 26 Tools: Risk Management 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

28. 28 Timeline Variance

29. 29 Solution � in part

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

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 31

32. Communication - Integration 32

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

34. 34 Metrics for BioScience Projects

35. The Value of Project Management:

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

37. 37 Project Management Maturity: BioSciences

38. 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.

39. 39 Discovery Projects!

40. Thank You �