Susie boyce what is wrong with this picture

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Susie boyce what is wrong with this picture

  1. 1. Copyright © 2013 Quintiles What is wrong with this picture? Note: This is my personal view not an official company view.
  2. 2. 2 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
  3. 3. 3 How much does it cost to develop a new medicine? A. £436 million B. £533 million C. £710 million D. £916 million E. £1.15 billion # votes: 0 Internet This text box will be used to describe the different message sending methods. TXT The applicable explanations will be inserted after you have started a session. Twitter It is possible to move, resize and modify the appearance of this text box. Closed This presentation has been loaded without the Sendsteps plug-in. Want to download the plug-in for free? Go to
  4. 4. 4 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 We will set these example results to zero once you've started your session and your slide show. In the meantime, feel free to change the looks of your results (e.g. the colours).
  5. 5. 5 How long does it take to gain approval for a new medicine? A. 4.5 years B. 7 years C. 8.5 years D. 12.5 years E. 14 years # votes: 0 Internet This text box will be used to describe the different message sending methods. TXT The applicable explanations will be inserted after you have started a session. Twitter It is possible to move, resize and modify the appearance of this text box. Time: 60s This presentation has been loaded without the Sendsteps plug-in. Want to download the plug-in for free? Go to
  6. 6. 6 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 Closed We will set these example results to zero once you've started your session and your slide show. In the meantime, feel free to change the looks of your results (e.g. the colours).
  7. 7. 7 How many medicinal candidates are required for the approval process? A. 3,500 B. 15,000 C. 7,500 D. 1,200 E. 500 # votes: 0 Internet This text box will be used to describe the different message sending methods. TXT The applicable explanations will be inserted after you have started a session. Twitter It is possible to move, resize and modify the appearance of this text box. Time: 60s This presentation has been loaded without the Sendsteps plug-in. Want to download the plug-in for free? Go to
  8. 8. 8 How many medicinal candidates are required for the approval process? A. B. C. D. E. 3,500 15,000 7,500 1,200 500 Closed We will set these example results to zero once you've started your session and your slide show. In the meantime, feel free to change the looks of your results (e.g. the colours).
  9. 9. 9 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 years 11 years 12.5 years £436 million £533 million £710 million £916 million £1.1 billion £1.15 billion 5,000 – 10,000 candidates 10-20 candidates 5-10 candidates 2-5 candidates 1-2 candidates 1 medicine Reference source: abpi publication Time to flourish Inside innovation; the medicine development process
  10. 10. 10 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”.
  11. 11. 11 Background to clinical trial Key facts Contract Tripartite Multi million $ Including bonus & penalty Phase 3 (Clinical trial) Therapeutic Area Female Health Geography 30 countries 300 sites Patients Over 9000 women
  12. 12. 12 What’s wrong with this picture?
  13. 13. 13 Ahead on schedule, behind on morale Team Health/Morale way down as evidenced by diagnostic surveyTime Quality Team Cost
  14. 14. 14 What’s wrong with this picture? Internet This text box will be used to describe the different message sending methods. TXT The applicable explanations will be inserted after you have started a session. Twitter It is possible to move, resize and modify the appearance of this text box. This presentation has been loaded without the Sendsteps plug-in. Want to download the plug-in for free? Go to
  15. 15. 15 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
  16. 16. 16 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
  17. 17. 17 Quintiles / Client (Drug X) Survey Demographics – sample 1 year High level of “buy in” Sustained over 3 year period Responders - governance, global management team and service domain leads from both parties Group name Questionnaires Sent out Responses received Percentage completion Client Team 22 20 86 Quintiles Team 34 28 82 All 56 48 84
  18. 18. 18 Client Team Respondents Yr-Yr Commitment Strategy Trust/Fairness Communication Conflict Management Decision Making LeadershipPerformance Measurement Roles Skills/Competence Team Coordination Flexibility Knowledge Management Cultural Fit Strategic Fit Operational Fit 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Year 3 Year 2 Year 1
  19. 19. 19 Solution and Results Solutions Results Acknowledged 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
  20. 20. 20 Client and Quintiles overall objectives unchanged Mutual Client Within budget To contract On schedule Financial and regulatory compliance DRUG LICENSE APPROVAL Services match the contract (within budget and to specifications) Projects delivered on Schedule, within budget; service fees, pass Through costs and PI fees Accurate forecasting – Predictable spend Services match the contract (within budget and to specifications) Profit - Projects delivered on or ahead of schedule under budget Client satisfaction Future business = GROWTH Quality – fit for purpose Quintiles
  21. 21. 21 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
  22. 22. 22 Key element 90 day Work Cycle (2) Project goals performance graph
  23. 23. 23 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.
  24. 24. 24 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 + Intimacy Self-orientation Credibility = Accuracy and completeness; believability and honesty Reliability = The repeated link between promises and action Intimacy = “Emotional closeness” concerning the issues at hand Self-orientation = Focusing on yourself rather than your partner Operating Principles
  25. 25. 25 Trust = Credibility + Reliability + Intimacy Self-orientation Credibility = Accuracy and completeness; believability and honesty Reliability = The repeated link between promises and action Intimacy = “Emotional closeness” concerning the issues at hand Self-orientation = Focusing on yourself rather than your partner Operating Principles
  26. 26. 26 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 concerned Susie Boyce Director, Clinical Project Management, PMP, CSci, BSc CNS – Psychiatry Quintiles Navigating the new health susie.boyce@quintiles.com

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