Chao%c Chemistry
Today’s Presenta%on
• A brief history of ordered side of the pharmaceu%cal industry
• A case history of the Chaos that is project management
• Some observa%ons of the current situa%on
• Conclusions
A Child of the 1950’s
The Cold War
Polio
A History of Innova/on in Medicine
• Penicillin • Polio vaccine • Contracep/ve Pill • Small pox eradicated • HIV • Con/nuous improvement in cancer therapy • Etc, etc, etc, etc, etc…………………………………..
Breast Cancer (C50): 1971-‐2010
The end of the Golden age
Structure of the industry
• Consolida%on of Pharmaceu%cal companies
• R&D increasingly outsourced to Clinical Research Organisa%ons (CRO)
• Increased regula%on
Effec%vely Managing Vendor Oversight
The Framework European Medicines Agency (EMEA)
• ICH (The Interna%onal Conference on Harmonisa%on) Guidelines
• GCP (Good Clinical Prac%ce)
A Brief History
Post World War II
• The Nuremburg Code (published 1949) – established for the purpose of judging Nazi scientists and physicians during the Nuremberg Trials
Nuremburg Code Ten Basic Principles
1. Voluntary consent 2. Experiments for the good of
society 3. Based on animal experiments 4. Avoiding unnecessary physical
and mental suffering 5. No experiments where there is
prior belief that death or injury will occur
6. Clear risk benefit 7. Adequate facilities 8. Scientifically qualified
experimenters 9. Subjects right to withdraw 10. Scientists should stop the
experiment if continuation will result in injury disability of death
The Declaration of Helsinki
• 1964: Original version. 18th Meeting, Helsinki • 1975: First revision. 29th Meeting, Tokyo • 1983: Second revision. 35th Meeting, Venice • 1989: Third revision. 41st Meeting, Hong Kong • 1996: Fourth revision. 48th Meeting, Somerset
West (SA) • 2000: Fifth revision. 52nd Meeting, Edinburgh • 2002: First clarification, Washington • 2004: Second clarification, Tokyo • 2008: Sixth revision, 59th Meeting, Seoul
The Belmont Report
• Tuskegee syphilis study (1932 - 1972)
• Respect for persons
• Beneficence: The philosophy of "Do no harm“
• Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly
Legisla/ve basis SI 2004/1031, as amended by SI 2006/1928, Regula/on 3 (12) ‘A person who is a sponsor of a clinical trial in accordance with this regula4on may delegate any or all of his func4ons under these Regula4ons to any person but any such arrangement shall not affect the responsibility of the sponsor’.
Legisla%on
Legisla/ve basis SI 2004/1031, Regula/on 28 (2) ‘The sponsor of a clinical trial shall put and keep in place arrangements for the purpose of ensuring that with regard to that trial the condi4ons and principles of GCP are sa4sfied and adhered to’.
Legisla%on
Expecta%ons • What we do expect to see is
that there is a proac%ve & ‘up front’ determina%on of the levels of oversight needed for a trial/project and that the ra%onale for the level of oversight can be jus%fied
Data from Medicines and Healthcare products Regulatory Agency (MHRA)
Increasing need for effec%ve Project Management.
• Project Management is not exactly dead but it does not compare well with other industries.
Case Study
• Monitoring progress with Earned value
EV status report Case Study
0.00
100,000.00
200,000.00
300,000.00
400,000.00
500,000.00
600,000.00
700,000.00
800,000.00
900,000.00
1,000,000.00
GBP
Date
Project Progress Earned Value
Cumula%ve planned budget
Case Study
Earned Value
The outcome
• The reasons for the lack of progress were never addressed.
• Project review mee%ngs degenerated into arguments over costs
• The sponsor sacked the supplier and is now taking them to court
Why did it happen?
A lack of an effec%ve: • Project manager – a person with a clear line of authority and responsibility to get the project done.
• and clearly defined contract
• Other project management tools
A Conversa%on with a CRO about contracts
This contract has a total price, a fixed scope of work and a milestone payment schedule.
So is it must be a fixed priced contract where you take the risk of cost overruns?
Answer NO Heads we win tails you lose contract
Is there a desire for change?
You would expect the answer from the sponsor to be yes because of distribu%on of risk.
If a project is late, to poor quality or over budget the risk is firmly with the pharmaceu%cal company
There are also external pressures for change
The Pharma Response to date
To look for a solu%on in the rela%onship
Instead of pufng some of the basics in place first
Is there any likelihood of this happening?
• No incen%ve for CROs currently no risk and big margins.
• Pharma s%ll looking for an instant solu%on and not engaging with the real issues.
Conclusion
• There is has been a lot of effort put into building the rela%onship
• Maybe we should spend more %me building a beger founda%on based on beger contracts and beger management
Any Ques%ons for Roger