PAREXEL

PAREXEL International
Public
Traded as NASDAQ: PRXL
Industry Clinical research organizations
Pharmaceutical
Founded 1982
Headquarters Waltham, Massachusetts, United States of America;
80+ facilities in 51+ countries
Key people
 Chairman and CEO:
Josef H. von Rickenbach
Services clinical trial management, data management, medical writing, biostatistics, pharmacovigilance, regulatory consulting
Revenue Increase$2.016B for FY15
Number of employees
 18,660[1]
Website

PAREXEL International is a multinational life sciences consulting firm. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. It is the second largest clinical research organization in the world[2] and has helped develop approximately 95% of the 200 top-selling biopharmaceuticals on the market today.[3] The company publishes the annual PAREXEL R&D Statistical Sourcebook,[4] operates the PAREXEL-Academy,[5] and councils all of the top 50 biopharmaceutical and top 30 biotechnology companies.[6]

PAREXEL was founded in 1982 by Josef von Rickenbach[7] and organic chemist Anne B. Sayigh[8] initially to advise Japanese and German firms on how to navigate the FDA approval process.[9] The firm has grown organically over the years and through 40 acquisitions. Josef von Rickenbach is credited with establishing PAREXEL’s culture and practices based on the principles he experienced as a researcher at Schering-Plough in Lucerne, Switzerland.[9]

In 1990, the firm expanded internationally and established new practice areas. By 1999 it had a staff of 4,500 and 45 offices.[9] In the 2000s, it grew to over 18,000 employees. PAREXEL’s consulting and clinical trial work has helped establish many household drug brands and contributed to numerous successes in modern pharmacology.

In 2016, the company allied with EMC Corporation to provide a suite of regulated information and content management services.[10]

TGN1412 clinical trial

Main article: TGN1412

In March 2006, a PAREXEL-run trial on behalf of TeGenero, the now bankrupt German biotechnology firm, on its anti-inflammatory drug TGN1412 to treat rheumatoid arthritis, multiple sclerosis or leukaemia, unexpectedly caused severe inflammation and multiple organ failure in six healthy volunteers at a facility based at Northwick Park Hospital in London.[11] The drug had been tested on animals but this was the first test on humans.

PAREXEL became the target of legal proceedings from lawyers representing the injured volunteers after the insurance policy of TeGenero was unable to provide sufficient compensation. When the liable company[12] subsequently declared bankruptcy,[13] lawyers for the volunteers initiated legal proceeding against PAREXEL and the two parties later entered into talks;[14] the results of this meeting have not been made public.[15]

A documentary shown in the UK on 28 September 2006 featuring journalist Brian Deer as part of Channel 4's Dispatches series exposed uncertainty about the existence of data that should mandatorily have been submitted by TeGenero to the Medicines and Healthcare products Regulatory Agency (MHRA) prior to the trial indicating whether TGN1412 had been adequately tested on human blood in vitro. Concerns were also raised about whether a safe human dosage was properly obtained by TeGenero. The MHRA however concluded that none of the companies involved could be held responsible for the outcome of the test and that the adverse events that occurred were most likely caused by an unpredicted biological action of the drug in humans.[16]

See also

References

  1. ↑ "PAREXEL International Number of Employees - PRXL Nasdaq". Macroaxis.
  2. ↑ "Top CROs dominate competition in trial totals, review finds". Outsourcing-Pharma.com.
  3. ↑ "MoneyShow.com: TOP PROS' TOP PICKS - Parexel Puts Drugs on Trial". MoneyShow.com.
  4. ↑ "PAREXEL Biopharmaceutical Statistical Sourcebook 2014/2015 (eStats)".
  5. ↑ Applied Clinical Trials Editorial Staff (13 April 2015). "PAREXEL Academy Adds Programs for Students".
  6. ↑ http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MjQwNDc3fENoaWxkSUQ9LTF8VHlwZT0z&t=1
  7. ↑ "List of Public Companies Worldwide, Letter - Businessweek - Businessweek". Businessweek.com.
  8. ↑ http://www.the-scientist.com/?articles.view/articleNo/9750/title/Entrepreneur-Briefs/
  9. 1 2 3 "Josef von Rickenbach - Parexel". Bilanz.ch.
  10. ↑ Staff (15 May 2016). "Parexel and EMC Ally to Provide Information Management Services". Genetic Engineering & Biotechnolgy News (Paper). 36 (10): 8.
  11. ↑ "Drugs trial men 'seriously ill'". BBC News. March 15, 2006.
  12. ↑ "When drug trials go horribly wrong". The International Herald Tribune. April 9, 2006. Retrieved 2007-12-18.
  13. ↑ "Will Parexel Settle? TeGenero Litigation". ClinPage. March 19, 2007. Retrieved 2007-12-18.
  14. ↑ "Window is open for compensation in TGN1412 case". PharmaTimes. March 14, 2007. Retrieved 2007-12-18.
  15. ↑ "Parexel issues statement regarding TeGenero clinical trial".
  16. ↑ Clinical trial final report, MHRA, 25 May 2006
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