Chaotic Chemistry - Roger Joby
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Chaotic Chemistry - Roger Joby

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Chemical Chaos by Roger Joby - Presentation includes a brief history of ordered side of pharmaceutical industry, a case history of the chaos that is project management, some observations on the......

Chemical Chaos by Roger Joby - Presentation includes a brief history of ordered side of pharmaceutical industry, a case history of the chaos that is project management, some observations on the current situation and conclusions at Earned Value #eva18

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  • 1. Chao%c  Chemistry  
  • 2. 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  
  • 3. A  Child  of  the  1950’s  
  • 4. The  Cold  War  
  • 5. Polio  
  • 6. 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…………………………………..  
  • 7. Breast  Cancer  (C50):  1971-­‐2010    
  • 8. The  end  of  the  Golden  age  
  • 9. Structure  of  the  industry   •  Consolida%on  of   Pharmaceu%cal   companies   •  R&D  increasingly   outsourced  to  Clinical   Research  Organisa%ons   (CRO)   •  Increased  regula%on  
  • 10. Effec%vely  Managing  Vendor  Oversight  
  • 11. The    Framework   European  Medicines  Agency  (EMEA)   •  ICH  (The  Interna%onal   Conference  on   Harmonisa%on)   Guidelines   •  GCP  (Good  Clinical   Prac%ce)  
  • 12. 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
  • 13. 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
  • 14. 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  
  • 15. 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
  • 16.   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  
  • 17. 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  
  • 18. 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)  
  • 19. Increasing  need  for  effec%ve  Project   Management.   •  Project  Management  is   not  exactly  dead  but  it   does  not  compare  well   with  other  industries.  
  • 20. Case  Study     •  Monitoring  progress     with  Earned  value  
  • 21. EV  status  report   Case  Study    
  • 22. 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  
  • 23. 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  
  • 24. 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  
  • 25. 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  
  • 26. 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  
  • 27. There  are  also  external  pressures  for   change      
  • 28. 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  
  • 29. 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.      
  • 30. 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    
  • 31. Any  Ques%ons  for  Roger