title: How do the top 12 pharmaceutical companies operate safety pharmacology?
abstract: BACKGROUND
  How does safety pharmacology operate in large pharmaceutical companies today? By understanding our current position, can we prepare safety pharmacology to successfully navigate the complex process of drug discovery and development?
  
  
  METHODS
  A short anonymous survey was conducted, by invitation, to safety pharmacology representatives of the top 12 pharmaceutical companies, as defined by 2009 revenue figures. A series of multiple choice questions was designed to explore group size, accountabilities, roles and responsibilities of group members, outsourcing policy and publication record.
  
  
  RESULTS
  A 92% response rate was obtained. Six out of 11 companies have 10 to 30 full time equivalents in safety pharmacology, who hold similar roles and responsibilities; although the majority of members are not qualified at PhD level or equivalent. Accountabilities were similar across companies and all groups have accountability for core battery in vivo studies and problem solving activities but differences do exist for example with in vitro safety screening and pharmacodynamic/pharmokinetic modeling (PK/PD). The majority of companies outsource less than 25% of studies, with in vitro profiling being the most commonly outsourced activity. Finally, safety pharmacology groups are publishing 1 to 4 articles each year.
  
  
  CONCLUSIONS
  This short survey has highlighted areas of similarity and differences in the way large pharmaceutical companies operate safety pharmacology.
authors.affiliation: Global Safety Pharmacology, Global Safety Assessment, AstraZeneca R&D Alderley Park, Macclesfield, Cheshire, SK10 4TG, United Kingdom. lorna.ewart@astrazeneca.com
authors.forename: Lorna
authors.initials: L
authors.lastname: Ewart
authors.forename: David J
authors.initials: DJ
authors.lastname: Gallacher
authors.forename: Gary
authors.initials: G
authors.lastname: Gintant
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Guillon
authors.forename: Derek
authors.initials: D
authors.lastname: Leishman
authors.forename: Paul
authors.initials: P
authors.lastname: Levesque
authors.forename: Nick
authors.initials: N
authors.lastname: McMahon
authors.forename: Lou
authors.initials: L
authors.lastname: Mylecraine
authors.forename: Martin
authors.initials: M
authors.lastname: Sanders
authors.forename: Willi
authors.initials: W
authors.lastname: Suter
authors.forename: Rob
authors.initials: R
authors.lastname: Wallis
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Valentin
mesh_terms: D003625:Data Collection; D015195:Drug Design; D004353:Drug Evaluation, Preclinical / Q000191:economics / Q000379:methods*; D004345:Drug Industry / Q000191:economics / Q000379:methods* / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions; D007182:Income / Q000706:statistics & numerical data; D020416:Outsourced Services; D004364:Pharmaceutical Preparations / Q000191:economics; D010599:Pharmacokinetics; D010600:Pharmacology / Q000191:economics / Q000379:methods* / Q000458:organization & administration; D018675:Toxicity Tests
chemical_list: D004364:Pharmaceutical Preparations