Susie boyce what is wrong with this picture

Copyright © 2013 Quintiles

What is wrong with this picture?

Note: This is my personal view not an official company view.

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Introduction to Clinical Trials

Clinical trials are the scientific process for measuring whether new drugs are safe and effective.

James Lind, physician (1747) pioneered the field of clinical research > Discovery Citrus fruits prevented scurvy.

Sir Austin Bradford Hill, epidemiologist (1946) 1st randomised controlled trial (RCT) Streptomycin to treat tuberculosis

Regulatory agencies have used clinical trials ever since to determine whether a new drug is ready for the public.

1019 Novel drugs approved by the FDA

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How much does it cost to develop a new medicine?

A. £436 millionB. £533 millionC. £710 millionD. £916 millionE. £1.15 billion

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How much does it cost to develop a new medicine?

A.

B.

C.

D.

E.

£436 million

£533 million

£710 million

£916 million

£1.15 billion

Closed

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How long does it take to gain approval for a new medicine?

A. 4.5 yearsB. 7 yearsC. 8.5 yearsD. 12.5 yearsE. 14 years

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How long does it take to gain approval for a new medicine?

A.

B.

C.

D.

E.

4.5 years

7 years

8.5 years

12.5 years

14 years

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How many medicinal candidates are required for the approval process?

A. 3,500B. 15,000C. 7,500D. 1,200E. 500

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How many medicinal candidates are required for the approval process?

A.

B.

C.

D.

E.

3,500

15,000

7,500

1,200

500

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Drug development process

Drug discovery

Pre clinical testing

Phase I Phase II Phase III Licensing Approval

4.5 years 5.5 years 7 years 8.5

years11

years12.5

years

£436 million

£533 million

£710 million

£916 million

£1.1 billion

£1.15 billion

5,000 – 10,000

candidates10-20

candidates5-10

candidates2-5

candidates1-2

candidates1

medicine

Reference source: abpi publication Time to flourish Inside innovation; the medicine development process

http://www.abpi.org.uk/our-work/library/industry/Pages/medicine-development-process.aspx

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Do you have 5 minutes?

“Susie do you have 5 minutes to meet today?

An interesting opportunity has just come up that I think will suit your strengths and provide you with the development opportunity you need to progress”.

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Background to clinical trial

Key facts

Contract TripartiteMulti million $ Including bonus & penalty

Phase 3 (Clinical trial)

Therapeutic Area

Female Health

Geography 30 countries300 sites

Patients Over 9000 women

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What’s wrong with this picture?

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Ahead on schedule, behind on morale

Team Health/Morale way down as evidenced

by diagnostic surveyTime

Quality

Team

CostNo major quality

concerns

No budgetary problems

8 months ahead of schedule

in an 18 month period

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What’s wrong with this picture?




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Diagnostic Survey

• Background• Data tabulated and held at 3rd party • Performed on a yearly basis during the life of the project• Original Survey designed initially for discovery/development alliances

• What the survey is …• A diagnostic tool to understand the “health” /current state of the

partnership, and what issues need to be focused on in "real time“

• What the survey is not: …• An assessment of the Partner • A tool for the partnership to be "perfect“

Performance metric

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Survey Content

• Survey perspective (questions asked about the partner, supplier and liaison between parties)

• Ratings on five point scale from strongly agree to strongly disagree

• Scores grouped into 13 categories across three dimensions

Strategic Fit Operational Fit Cultural Fit

Commitment Communication Perf. Measurement Flexibility

Strategy Conflict Management

Roles Knowledge Mgmt

Trust/Fairness Decision Making Skills/Competence

Leadership Team Coordination

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Quintiles / Client (Drug X)Survey Demographics – sample 1 year

High level of “buy in”Sustained over 3 year periodResponders - governance, global management team and service domain leads from both parties

Group name QuestionnairesSent out

Responses received

Percentagecompletion

Client Team 22 20 86

Quintiles Team 34 28 82

All 56 48 84

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Client Team Respondents Yr-Yr

Commitment

Strategy

Trust/Fairness

Communication

Conflict Management

Decision Making

LeadershipPerformance Measurement

Roles

Skills/Competence

Team Coordination

Flexibility

Knowledge ManagementCultural FitStrategic Fit

Operational Fit

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Year 3

Year 2

Year 1

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Solution and Results

Solutions ResultsAcknowledged that there was a problem Improved team morale

Ongoing access to a “Neutral/Independent” Facilitator Evolved into a team recognised as high performing team

Team members from all parties brought together in one location to confront the problem

Team awarded “Team spirit of the year award”

Team members from all parties invited to determine solutions

Team members from all parties although dispersed into other projects and companies are still in contact and all still using versions of the laminated card

Selective changes to personnel Demonstrated Senior Management Commitment to make team successful

Introduction of 90 day work cycle Re enforced joint accountability for deliverables and timeline

Joint shared yearly goals incorporated into all team members goal and objectives

Improved collaboration and recognition all working towards one shared goal

Team developed jointly agreed team behaviours Production of a laminated card which assisted in behavioural changes

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Client and Quintiles overall objectives unchanged

Mutual

Client

Within budgetTo contractOn scheduleFinancial and regulatory compliance

DRUG LICENSE APPROVAL

Services match the contract(within budget and tospecifications)

Projects delivered onSchedule, within budget;service fees, pass Through costs and PI fees

Accurate forecasting –Predictable spend

Services match the contract(within budget and tospecifications)

Profit - Projects delivered on or ahead of schedule under budget

Client satisfaction Future business = GROWTH

Quality – fit for purpose

Quintiles

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Key element 90 day Work Cycle (1)

Steering Committee Members in both companies keen to ensure planning and pro-activity through effective:

Identification of future priorities

Planning to meet future priorities

Monitor / control achievement of future priorities targets

Audit trail / evidence targets being achieved on schedule

Measurement of team performance & areas to improve

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Key element90 day Work Cycle (2)

Project goals performance graph

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Strategic Intent

Project goals and metrics were clearly outlined up front and surpassed or met at the completion of the trial. The Pharmaceutical company/Quintiles partnership redefines the way trials are run and serves as a successful case study for both companies. Team members, investigative sites, patients are energized and remain committed to the trials throughout the project.

The conduct of the drug X clinical trials will increase knowledge of the disease state and provide benefit to the patients.

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General•Clear roles and responsibilities•Think globally – plans should be thoroughly tested across regions – support through project documentation eg. one global clinical mgt plan•Think broadly and communicate widely to share solutions•Share the big picture across the team/ investigators•Scheduled face to face meetings•Full engagement from all team members/appropriate workload to deliver•Contingency plans•Bring all experiences to bear and implement best practices•Actively manage personnel transition with quick integration•Ongoing assessment of team performance•Frank, timely and honest feedback (+ and -)

Mindset•Expect challenges – silence NOT agreement•Be Fair -no finger pointing/blaming•Respect•Frank, timely and honest feedback (+ and -)•Be Creative•Don’t take it personally•Don’t overpromise – if you don’t know, say so and follow up•Direct people to the right source•Assume trust and commitment – benefit of the doubt•Celebrate Success

Communication•Open, honest and frequent communication•Explain why in order to create buy-in•Set clear expectations - include metrics, timeline, responsibility, priority

• If expectations aren‘t clear, ask!•Communicate when you have concerns

• Seek efficiency•Be clear about decisions – who, when

Trust = Credibility + Reliability + IntimacySelf-orientation

Credibility = Accuracy and completeness; believability and honestyReliability = The repeated link between promises and actionIntimacy = “Emotional closeness” concerning the issues at handSelf-orientation = Focusing on yourself rather than your partner

Operating Principles

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Trust = Credibility + Reliability + IntimacySelf-orientation

Credibility = Accuracy and completeness; believability and honestyReliability = The repeated link between promises and actionIntimacy = “Emotional closeness” concerning the issues at handSelf-orientation = Focusing on yourself rather than your partner

Operating Principles

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Learning and reflection …

Perceptions can vary between those involved in a project and their

senior managers

Conflicting vision can impact adversely on individual and team morale

Recognising and addressing this type of conflict can be difficult and

may require investment – facilitation is key

Acknowledging and resolving conflict can be very rewarding for all

concernedSusie Boyce

Director, Clinical Project Management, PMP, CSci, BScCNS – Psychiatry

QuintilesNavigating the new health

[email protected]

mailto:[email protected]

Susie boyce what is wrong with this picture

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