Post on 03-Jan-2016
David Bridges
eChange Solutions Limited
Drug
Development
Projects
Business Change Projects
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
Analysis
The project management
paradigm
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
Programme A
Programme B
Line organization
?
Structure
Relationship of Drug development to business change activity
Marketing / Drug
Development
Drug BDrug A Drug C
Nat
ure
of p
rogr
amm
e
Construction,engineering,
IT
Product Process Organization
Making and Delivering
Vision-led, outcome-driven, ambiguity and clarity co-exist, proactive adjustment to scope,
loose levers
Vision-led, benefits-driven, good clarity/some ambiguity, reactive adjustment to scope,
clear levers
Specification led, Output-driven,
High clarity/low ambiguity, reactive adjustment to scope
Research and development
Process re-engineering
Mergers, acquisions,
Government agencies
Typicalapplication
Operational
External environment or Society
Change of :
Culture
Strategic
Modified from OGC, 2003
Dru
g D
evelo
pm
en
t
Bu
sin
ess C
han
ge
Culture
• Resource managementThis 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
Value of project/program/portfolio etc (1)
Culture
• 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
Value of project/program/portfolio etc (2)
Construction,engineering,
IT
Research and development
Process re-engineering
Mergers, acquisions,
Government agencies
Typicalapplication
Benefit areaResource managementStandardization Management controlTasks interdependencyBenefit realizationStakeholders Management Emergent strategy
LearningHomogeneous programmes
Heterogeneoussprogrammes
Product Process Organization
Making and Delivering
Operational Strategic
External environment or Society
Change of :
Culture
Dru
g D
evelo
pm
en
t
Bu
sin
ess C
han
ge
Drug Development
• Resource Management• Task
interdependencies
• Standardization• Learning
Business Change
• Management control• Benefits realization• Stakeholder
management
Culture
Management focus on :
Management focus => metrics => Behavior => 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
Culture
These are caricatures but …….
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.
Solutions ?
Final version of slides will be published on :
www.echangesolutions.com
within the week.
Thank you.