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.