Strategic Plan
Overview
June 2011
Welcome from the BWGOR!
(that’s the Board Working Group on Organizational Restructuring)
Charlotte
Enghave
Fruergaard
Jane
Brown
Doyle
Johnson
Antonio
Buendia
Andre
Walker
Karleen
Kos
2011 ISPE
Board Treasurer &
BWGOR Chair
Membership &
Young Prof
Committees
Board Liaison to
NASAAC &
Chair, MDC
Board Liaison to
3 COPs; EU
Planning Team
2011 ISPE
Board Chair
VP of Member
Relations
Past Chair, Nordic
Affiliate
2007 ISPE
Board Chair
Past Chair, Boston
Chapter
Past Chair,
Spain Affiliate
Past Chair,
Boston Chapter
Staff Project
Manager, ISPE
NNE Pharma
Plan
GSK
Genzyme
Eli Lilly, SA
Biogen Idec
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
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
Planning Process
Gather
Input
Create
“Macro
Plan”
Execute
Marry
Business
Objectives
and Budget
ISPE Member
Needs
and Business
Realities
Gather
Input
Develop
strategies,
tactics, and
accountability
Gather
Input
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
So What’s In the Plan???
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.
ISPE Transforms Core Operations to
• Systematically evaluate and articulate
Member needs
• Rigorously focus on what it can do best
o Leverage organizational strengths in new ways
o 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
o Volunteers still contribute ~ but in new ways
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
o 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
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
VISION 2025
ISPE is catalytic in uniting the
pharmaceutical manufacturing
community around practices to help
ensure a world with safe medicine.
MISSION 2015
ISPE is the Society of choice for
pharmaceutical professionals seeking
excellence in their careers and influence
in their world.
Who We Serve
ISPE’s Core Members are
pharmaceutical professionals who use
expert knowledge to create high-quality,
cost-effective GMP solutions.
ISPE will focus on
Core Members:
Professionals directly
involved in GMPs
Professionals whose
work impacts/is
impacted by GMPs:
They will have some
interest in things ISPE
is doing, but ISPE won’t
develop
products/services
specifically for them
Other pharmaceutical
professionals whose
work is distant from
GMP processes:
Little direct awareness
of ISPE’s work
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
Organizational Outcomes
Systems
Communications
Regulatory
Affairs
Brand
Identity/
Reputation
MEMBERS
Knowledge
and
Education
(University)
Finances
Networks
Affiliates,
Chapters, and
COPs
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.
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.
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
How
By 2015 …
SIX PAGES FROM ISPE’S
PLAYBOOK
Focused on what Members and Stakeholders will Experience
2012-2015
#1 Disciplined 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
#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
#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
#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
#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
#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.
# 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
So, to recap the plays …
Game Changers
Commitments, Recommitments,
Enhancements to the Status Quo
• 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 B2-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
How Do You Eat an Elephant?
This Strategic Plan has been “BackPlanned” 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
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
End of Main Presentation
We Bet You Have Some Questions
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)
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
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
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
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
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
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
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
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
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
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
Questions
and
Discussion
There is so much to cover –
and so little time
Thank you for your participation
and support of our Board
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 Headquarters
3109 W. Dr. M L King Jr. Blvd., Suite
250
Tampa, Florida 33607 USA
Tel: +1-813-960-2105
Fax: +1-813-264-2816
Email: memberservices@ispe.org
Asia Pacific Office
73 Bukit Timah Road, #04-01 Rex House
Singapore 229832
Tel: +65 6496 5502
Fax: +65 6336 6449
Email: asiapacific@ispe.org
China Office
Suite 2302, Wise Logic International Centre
66 North Shan Xi Road, Shanghai, China 200041
Tel: +86 21-5116-0265
Fax: +86 21-5116-0260
Email: china@ispe.org
European Office
Avenue de Tervueren, 300
B-1150, Brussels, Belgium
Tel: +32-2-743-44-22
Fax: +32-2-743-15-50
Email: ispe@associationhq.com
Visit www.ISPE.org for more information.