Transcript presentation here

Drug
Development
Projects
Business
Change Projects
David Bridges
eChange Solutions Limited
Analysis
Keys to success in Drug Development
•
Delivery of good and potentially profitable
drugs from discovery through drug approval
to marketing
•
Ongoing innovation and change to the drug
delivery processes without causing
unnecessary disruption
Analysis
Barriers to innovation and change (1)
•
•
•
•
•
•
Regulated environment
Patent life
Budgets
Geography, cultural diversity
Imposed change – mergers etc
Mismatch in cycle-time of drug development
and change activities
Analysis
Barriers to innovation and change (2)
•
Management
–
–
–
Project Management
Programme Management
Portfolio Management
The project
management
paradigm
Structure
The Project “Management Paradigm”
• Portfolio
– ‘a collection of projects. programs and other work that are
grouped together to facilitate the effective management of
work to meet strategic business objectives.’ (PMI, 2008)
• Program
– ‘a group of related projects managed in a coordinated way
to obtain benefits and control not available from managing
them individually.’ (PMI, 2008)
• Project
– ‘a temporary endeavour undertaken to create a unique
product or service’ (PMI, 1996)
Structure
The paradigm in drug development - delivery
• Portfolio
– A collaboration between R&D and Marketing
– Decides which drugs to develop
• Programme
– Manages the development of a drug
• Project
– A clinical trial
– A process such as drug submission assembly
• Characterized by :
– Long durations
– Industry/company specific methodologies
– High level of standardization within the company
Structure
The paradigm in drug development - Change
•
Portfolio
– May occur at any level of organization
– May not exist
• Programme
– Manages the development of a process, system or organizational change or
group of related/interdependent changes
• Project
–
–
–
–
Development of a computer system
Roll-out of new SOPs
Commissioning of a new building/facility
Developing novel partnerships with CROs etc
• Characterized by :
– Shorter durations
– More likely to use standard methodogies or to borrow from other industries
– However, low level of standardization across change projects
Structure
Relationship of
Drug development
to business change
activity
Marketing / Drug
Development
Drug A
Programme A
?
Programme B
Line organization
Drug B
Drug C
Culture
Strategic
Operational
Making and
Delivering
Change of :
Typical
application
Modified from OGC, 2003
Construction,
engineering,
IT
Organization
External
environment
or Society
Business Change
Process
Specification led,
Output-driven,
High clarity/low ambiguity,
reactive adjustment to scope
Drug Development
Nature of programme
Product
Vision-led, benefits-driven,
good clarity/some ambiguity,
reactive adjustment to scope,
clear levers
Research and
development
Vision-led, outcome-driven,
ambiguity and clarity co-exist,
proactive adjustment to scope,
loose levers
Process reengineering
Mergers,
acquisions,
Government
agencies
Culture
Value of project/program/portfolio etc (1)
• Resource management
This is the value added by through :
– cross project resource management (budget,
manpower, equipment)
• Standardization
– Improved effectiveness of delivery achieved via
standard tools/methodologies, support groups
• Management control
– Control/oversight of project activity, alignment to goals
• Task interdependency
– Management of project interdependencies
Culture
Value of project/program/portfolio etc (2)
• 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 basis
• Learning
– Exchange of learning and experience between projects
within the programme
Culture
Strategic
Operational
Change of :
Product
Construction,
engineering,
IT
Benefit area
Resource management
Standardization
Management control
Tasks interdependency
Benefit realization
Stakeholders Management
Emergent strategy
Learning
Drug Development
Typical
application
Homogeneous
programmes
Research and
development
Process
External
environment
or Society
Organization
Process reengineering
Mergers,
acquisions,
Government
agencies
Business Change
Making and
Delivering
Heterogeneouss
programmes
Culture
Management focus on :
Drug Development
•
•
•
•
Resource Management
Task interdependencies
Standardization
Learning
Business Change
• Management control
• Benefits realization
• Stakeholder management
Management focus => metrics => Behavior => Culture
Culture
Drug Development
practitioner’s view
of Business Change
• Disruptive
• Opportunist
• Unstructured
• A risk
Business Change
practitioners view of
Drug Development
•
•
•
•
Arrogant
Dogmatic
Inflexible
A barrier
These are caricatures but …….
Solutions ?
Possible solutions to structural issues
• Projects must be allowed to be “selfish”.
• The functions undertaken by the Program and Portfolio
must occur.
• In smaller organization delivery and change activities may
be managed within the same portfolio.
• Even in large organization, major change activities may be
managed within the same portfolio as delivery activities.
• It is possible to give senior management visibility across
delivery and change project by adoption of common
“project office” and resource tracking tools.
• Backstop – diligent engagement with stakeholder +
utilization of “Middle Management”
Solutions ?
Possible solutions to cultural issues
• Cultural issues are much more difficult to address.
• Cultural differences exist for a reason and are likely
to persist.
• Ultimately structural changes will reduce the scope
for conflict and therefore the impact of culture
differences.
• Good marketing of business change initiatives will
help, as will careful stakeholder management and
having a powerful sponsor.
• Hopefully awareness raising (such as this
presentation) will help.
Final version of slides will be published on :
www.echangesolutions.com
within the week.
Thank you.