Strategic Plan Overview

1. Strategic Plan Overview June 2011

2. Welcome from the BWGOR!(that’s the Board Working Group on Organizational Restructuring) Charlotte Enghave Fruergaard 2011 ISPE Board Treasurer & BWGOR Chair Past Chair, Nordic Affiliate NNE Pharma Plan Jane Brown Membership & Young Prof Committees 2007 ISPE Board Chair GSK Doyle Johnson Board Liaison to NASAAC & Chair, MDC Past Chair, Boston Chapter Genzyme Antonio Buendia Board Liaison to 3 COPs; EU Planning Team Past Chair, Spain Affiliate Eli Lilly, SA Andre Walker 2011 ISPE Board Chair Past Chair, Boston Chapter Biogen Idec Karleen Kos VP of Member Relations Staff Project Manager, ISPE

3. How We Got Here • Asset Integration Project (2008-09) • Blue Sky Vision (Fall 2010) • Organizational Restructuring Team • Chooses consultant from a field of 15+ (January 2011) • Consultant meets with stakeholders in Tampa (February 2011) • Burning platform urgency discussed at Board meeting • Decision: Scope should be to create a Strategic Plan with all reasonable speed

4. This Plan • Reflects our commitment to change what isn’t working any more and to strengthen what is best about our Society • Takes seriously the feedback we heard • Will transform ISPE

5. Planning Process ISPE Member Needs and Business Realities

6. The Plan Was Created with A Lot of Input from ISPE Stakeholders • Ten conference calls with various stakeholder groups (including APAC) • Face to face in Tampa and Frankfurt with at least six additional groups (including NASAAC, EAC, COPC) • Written information was submitted by 8 Affiliates/Chapters, 15 Committees, 18 COPs and COP subgroups, 8 Staff groups, and 148 individuals • Numerous consultative calls with key staff and volunteers

7. So What’s In the Plan???

8. In a Nutshell … This plan transforms ISPE into an organization that is recognized as #1 because … • It rigorously focuses on and meets Member needs – and the industry depends on ISPE to do that. • It fully leverages the strengths and reach of its Affiliate and Chapter network. • It makes decisions with the discipline and focus of a profit-making business … yet maintains the unique qualities and experiences of a nonprofit organization. • It depends on volunteers to lead, to provide vision, voice, and conscience but not to produce products.

9. ISPE Transforms Core Operations to • Systematically evaluate and articulate Member needs • Rigorously focus on what it can do best • Leverage organizational strengths in new ways • Evolving its business model so quality goes up and risk goes down • Be disciplined and business-oriented in its decision-making • Meet deadlines • Build a professional staff that is empowered to deliver on plans designed by volunteer leaders • Volunteers still contribute ~ but in new ways

10. And the External World Sees • ISPE is first to market with new information • Affiliates and Chapters as the “face” of ISPE • A systematized professional development system - and benefits packages - that can be tailored to individual or company needs • No more “one size fits all” • ISPE is everywhere the industry is, aligned with strategic partners to enhance its reach/credibility, and selling everything it has • An organizational reputation with individuals, companies, and regulators that leaves no doubt as to which organization is the Society of Choice

11. Key Assumptions • Pharma industry will continue to shift from North America and Europe to Asia-Pacific and BRICS* nations • Global regulatory influences will be a more significant factor than ever • ISPE must be more “business-like” than ever * Brazil, Russia, India, China, South Africa

12. VISION 2025 ISPE is catalytic in uniting the pharmaceutical manufacturing community around practices to help ensure a world with safe medicine.

13. MISSION 2015 ISPE is the Society of choice for pharmaceutical professionals seeking excellence in their careers and influence in their world.

14. Who We Serve ISPE’s Core Members are pharmaceutical professionals who use expert knowledge to create high-quality, cost-effective GMP solutions.

16. What We Do ISPE’s core focus is pharmaceutical development, manufacturing and quality of all medicinal products. The Society provides expertise in the application of scientific and engineering principles to manufacturing operations and facilities design. Specifically, the Society is engaged in leading and defining excellence in • Optimizing current manufacturing operations • Developing next generation manufacturing • Product supply networks • Enterprise risk management • Practical solutions to regulatory requirements

17. Organizational Outcomes MEMBERS

18. Summary: Outcomes for 2015 • Brand: We’re #1 in the eyes of individuals, companies and regulators. • Members: We have moved away from “one size fits all” to customized product offerings and Member experiences that meet the needs of 30,000 Members. • Knowledge and Education: We’re first-to-market with new information and we have a professional development scheme (via ISPE University) that meets the needs of the 21st century workforce.

19. Macro Plan Summary of Outcomes • Networks: Affiliates and Chapters are stronger than ever, the best information is available 24/7 through virtual communities, and ISPE is host to esteemed consortia around the world. • Regulatory Affairs: ISPE has partnerships with regulatory bodies around the world, regulators are an important part of the membership base, and ISPE provides the knowledge they need.

20. Macro Plan Summary of Outcomes • Systems: Major systems have been revamped to support ISPE’s globally integrated, customized approach. • e.g., planning systems, database, online ordering functionality, staffing patterns, etc. • Finances: ISPE is experiencing year-over-year growth in gross and net revenue and has a prudent reserve

21. How

22. By 2015 …

23. SIX PAGES FROM ISPE’S PLAYBOOK Focused on what Members and Stakeholders will Experience 2012-2015

24. #1Disciplined Approach to Meeting Core Member Needs • Engage in a routine process for identifying Member needs and “what’s next” for industry • Decisions made using dispassionate criteria • Evidence of need • Evidence we have the resources do it (or partner to do it) in a timely fashion, i.e., first to market is the usual goal • Positive net cash flow • Focus on small and medium sized companies • Traditional pharma, biologics, CMOs, generics • Offer customizable packages, pricing and delivery models so they reflect how Members want to be served

25. #2 Clarify ISPE Position, Demonstrate Expertise in the Marketplace • Focus on pharmaceutical manufacturing professionals and the people who support them • Only create things that meet their needs; others are welcome but we don’t create products for them • Clearly communicate – ISPE is not “just for engineers” • Clearly identify, then deliver services and messages around ISPE’s core competencies • ISPE will serve as a “broker of ideas” around its core competencies for the global marketplace

26. #3 Move from “Events” Focus to Professional Development Focus • Organize and deliver knowledge through “ISPE University” • Learning pillars aligned (University, COPs and CPIP) • Offer knowledge through a variety of channels and price points to meet Member needs • Face to face, blended, electronic, etc. • Individual and group/corporate learning • Provide a platform that allows Members to plan their own professional development pathways and track progress • Offer a variety of certificates or similar credentials which allow Members to demonstrate growing knowledge/competency base

27. #4 Decisive Actions to Engage Industry Leaders and Regulators around Global Harmonization Issues • Work with the ILF to be first to market with programs supporting the ILF priorities in their GPS Initiative • Collaborate with global regulators to deliver information and convene problem-solving meetings • Develop relationships with regulators in every country where ISPE has an Affiliate • Increase the visibility of ISPE’s regulatory knowledge, access, and interaction so “regular” Members see it • Engage regulators as Members around the world • Routinely conduct research to identify emerging trends

28. #5-a Reorganize to Harness Strengths: Affiliates and Chapters • Evolve so that Affiliates and Chapters are the main points most people encounter ISPE’s brand • They ultimately deliver – sometimes in partnership with other Affiliates/Chapters or with International – the majority of ISPE’s programs • International evolves to become the central coordinating body, accountable for R&D, brand identity, global strategy, and support services (database, web, etc.) and Annual Meeting • To do this, ISPE will evolve its business model so that all parts of the Society are adequately resourced

29. #5-b Reorganize to Harness Strengths: Governance and Operations • Move from volunteer driven to volunteer led • Evolve the role of staff and adapt the staffing pattern over time to support the plan • Reorganize governance structure • Differentiate the roles of governing committees from task-oriented groups • Implement a plan to strengthen both • Seek and leverage partnerships with complementary organizations to increase the number/quality/value/location and/or timeliness of products ISPE can deliver.

30. # 6 Develop Strong Business to Business Sales and Delivery Model • Develop and execute plan to increase enterprise sales • Place emphasis on small and medium-sized companies • Develop both short- and long-term solutions • Create a business plan for repurposing ISPE’s current inventory of training and guidance documents in key emerging markets • Strategies may be different in domestic and multi-national companies • Develop an approach to membership pricing that provides companies with a strong rationale for subsidizing employees’ dues

31. So, to recap the plays … Commitments, Recommitments, Enhancements to the Status Quo Game Changers Volunteer led, staff driving production Professional development (not event) focus Affiliates and Chapters are the main points of distribution; International does R&D and handles global-scope initiatives/services – with a new business model to make this viable SELL EVERYTHING and use a B-2-B approach • Focus on Members’ needs … discerned via data, experience, and expert advisors • Disciplined, business-viable decisions • Significant role in global regulatory affairs • Collaborations when it’s smart

32. How Do You Eat an Elephant?

33. This Strategic Plan has been “Back-Planned” So We Can See the Path • The Backplan sets goals for measurable results by year in most areas (2012-2015) to keep us on track • Doing this helps us see what is necessary to get where we want to be – the Outcomes mentioned earlier • It helps us hold ourselves accountable – no more “slippage” • The targeted yearly results will evolve as time goes by. • Some things will be achieved early • Some will need to be adjusted back or replaced with something else – we’ll learn as we go • The main focus for most of us is 2012 – because that’s where we’ll be performing in the here and now

34. Path Forward • Report to Stakeholders • Creation of the 2012 Plan (June – August) • Specific tactics, deliverables, schedules and measures • Budget planning begins • Input from relevant stakeholder groups • Business Plan Presented for Approval • Brussels, September 2011 • Communication to Stakeholders

35. End of Main Presentation

36. We Bet You Have Some Questions

37. What does it mean to be Volunteer-led? • Leadership Volunteers are responsible for • Setting mission, vision, and key objectives • Stewardship of the brand and reputation • Financial oversight; business leads • Hiring/working with the CEO • Staff are responsible for execution and delivery of objectives • Volunteers who help with execution may be accountable to staff leaders (a very common model in many non-profits)

38. What Happens to Committees? • They evolve • Structure will get simpler • In time, there are a few “governing committees” which report up to the Board • Help with the Board’s four key responsibilities • Simpler structure • There may be other “working committees” that are part of executing the plan objectives; they’ll work closely with staff

39. Is ISPE Really Setting Up its Own University? • Short answer: No • The term “ISPE University” is used in the same way some companies have a “corporate university” • We mean that we will be organizing knowledge by disciplines/interest areas and setting forth learning pathways for people interested in becoming knowledgeable in those areas • We hope to offer certificates to help them demonstrate to others that they have gained this knowledge • May be interim steps on the way to CPIP • In many parts of the world, ISPE can enhance its reach and credibility by partnering with existing universities and we will pursue that where it makes sense

40. What is the role of COPs? • ISPE University will have some number of learning “pillars” or schools of knowledge • Pillars and CPIP will need to be aligned • COPs will likely cluster under the pillars (whether as 19 separate COPs or in some new way will have to be worked out) • COPs will serve as • Eyes and ears in the industry, bringing new ideas and helping ISPE understand when something needs to be acted on quickly • Creators and reviewers of knowledge/curricula • Subject matter experts • The core of ISPE’s virtual communities

41. What happens to ISPE’s events? • In time, International will host very few exclusively “international” events except Annual Meeting • Most face-to-face learning will occur through partnerships with Affiliates, Chapters, universities – and onsite at companies

42. What is the Role of Affiliates/Chapters? • They are the front door of ISPE • Most learning and networking happens there • Partnerships with International and other Affiliates/Chapters create stronger local/regional events and more consistency in education provided locally • Business model will evolve so that all parts of the organization are resourced

43. What is the Role of International? • International coordinates global, Society-wide functions • Strategy, planning, market research • Global regulatory and industry influence • Support functions like web and database • R&D of knowledge and information • Quality improvement • International partners with Affiliates/Chapters to collaboratively deliver knowledge and networking at local and regional events

44. What will be different in ISPE’s approach in emerging markets? • Stronger relationships with regulators • Partnerships may allow us to deliver knowledge more cost effectively, credibly, perhaps in local languages • Existing ISPE knowledge re-vamped for emerging market needs • Focus on local companies as well as multinationals • Eventually, customizable benefits and professional development plans

45. What are the implications of focusing on B-2-B Sales? • ISPE will remain an individual membership Society • B-2-B sales will be focused on showing small and medium sized companies the value of ISPE’s knowledge and networks for their business • Unlike big pharma, they don’t have internal professional development programs • Investing in ISPE knowledge/membership will be cost-effective for them • ISPE’s regulatory work will have strong appeal • For suppliers, access to ISPE’s global network is already recognized as a great value

46. What’s Different in Our Approach to Regulators? • Relationships with all regulators where ISPE has an affiliate • Regulators as Members • Not focusing just on what ISPE wants from regulators but also on what ISPE can provide to regulators • Developing product with/for regulators in some markets • Active role as neutral convener of meetings, consortia, roundtables, etc. to help solve problems

47. Won’t “Operating Like a Business” Ruin the Best of ISPE? • Short answer: No • In our day jobs we would not • Fail to understand what our customers want and need – but instead try to sell them what we want to make • Undertake projects that weren’t going to keep the company going ~ no matter how intriguing the idea • Agree to do things we didn’t know how to do or could not deliver on time • So we won’t do that at ISPE any more either • This sort of discipline will help us “right the financial ship” • It will allow us to enjoy what is best about our Society

48. Questions and Discussion

49. There is so much to cover – and so little time Thank you for your participation and support of our Board

50. Contact ISPE ISPE CaSA 1500 Sunday Drive, Suite 102 Raleigh, NC 27607 Tel: +1-919-573-5442 Fax: +1-919-787-4916 Email: pkralka@firstpointresources.com ISPE Headquarters3109 W. Dr. M L King Jr. Blvd., Suite 250Tampa, Florida 33607 USATel: +1-813-960-2105 Fax: +1-813-264-2816Email: memberservices@ispe.org • Asia Pacific Office73 Bukit Timah Road, #04-01 Rex HouseSingapore 229832Tel: +65 6496 5502Fax: +65 6336 6449 Email: asiapacific@ispe.org • China OfficeSuite 2302, Wise Logic International Centre 66 North Shan Xi Road, Shanghai, China 200041 Tel: +86 21-5116-0265Fax: +86 21-5116-0260Email: china@ispe.org • European Office Avenue de Tervueren, 300B-1150, Brussels, BelgiumTel: +32-2-743-44-22 Fax: +32-2-743-15-50Email: ispe@associationhq.com Visitwww.ISPE.orgfor more information.