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