PRA Health Sciences

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PRA Health Sciences
Trading name PRA Health Sciences
Type Private
Founded Charlottesville, Virginia, United States (1976 (1976))
Headquarters Raleigh, North Carolina, United States
Number of locations 80+
Area served Global
Key people Colin Shannon (President and CEO)

PRA Health Sciences is a Contract Research Organization with headquarters in Raleigh, North Carolina, USA. The organization has worked on 100+ drugs marketed across several therapeutic areas and conducted the pivotal or supportive trials that led to U.S. Food and Drug Administration (FDA) and/or international regulatory approval of 45+ such drugs.[1]

History[edit]

PRA was founded in 1976 as the Anti-Inflammatory Drug Study Group in Charlottesville, Virginia, USA. Renamed PRA in 1982, it established itself as a data-management Contract Research Organization (CRO). After a number of strategic decisions to enhance its service offerings, the company became PRA Health Sciences in June 2014, incorporating partnerships and acquisitions made throughout 2012 and 2013.

Key dates:

  • 1976: Anti-Inflammatory Drug Study Group formed in Charlottesville, VA[2]
  • 1982: Company established as PRA, a Data Management Contract Research Organization (CRO)[3]
  • 1991: Services extended to Clinical Trial Management and Drug safety. First European office established
  • 1996: Acquired by Carlyle Group and reached 333 employees[4]
  • 1997: Acquired IMTCI in Lenexa, Kansas, USA whose facility included a Phase I unit[5]
  • 1999: Acquired Valorum (UK) with Regulatory and Product Registration teams[6]
  • 2000: Acquired ARCAM, Paris, France.[7] Reached 1,000 employee landmark
  • 2001: Acquired by Genstar Capital[8]
  • 2002: Acquired Staticon in Madrid, Spain and CroMedica[9] to increase CNS expertise and expand its global footprint
  • 2004: IPO made PRA a publicly traded stock on NASDAQ. Acquired Valid-Trio, Moscow, Russia and ClinCare in Russia, Belgium[10]
  • 2005: Acquired GMG BioBusiness Limited in the UK and Regulatory/Clinical Consultants in the USA.[11] Reached 2,500 employee landmark
  • 2006: Acquired Sterling Synergy Systems in Mumbai, India and Pharma Bio research in The Netherlands which formed the basis for the group within PRA now known as Early Development Services[12]
  • 2007: Reacquired by Genstar Capital and returns to being privately held.[13] Acquired Pharmacon in Berlin, Germany.[14] Opened its 25th office and reached 3,300 employees
  • 2008: Moves global HQ to Raleigh, North Carolina, USA[15]
  • 2010: Colin Shannon named CEO.[16] Bioanalytical Lab in Lenexa, Kansas, USA opened[17]
  • 2011: Acquired Kinship Technologies in Chennai, India[18]
  • 2012: Entered into a joint venture with WuXi PharmaTech to offer a broad platform of services in China, Hong Kong and Macau.[19] Opened facilities in Singapore,[20] Utrecht, The Netherlands, Beijing, China and Belgrade, Serbia
  • 2013: Reached 10,000 employee and 70 office landmark. Purchased by Kohlberg Kravis Roberts (KKR), one of the world's leading Private Equity firms.[21] Acquired ClinStar, a CRO/logistics firm providing services in Russia and Eastern Europe[22] and RPS which later became the Strategic Solutions division of the company.[3] Later in Nov 2013 acquired CRI Lifetree, a specialized research organization focusing on the conduct and design of early stage, patient population studies[23]
  • 2014: Renamed PRA Health Sciences to fully incorporate the companies within the PRA family, (RPS, CRI Lifetree, ClinStar and WuXiPRA). Launched a new website experience[24]

Contribution to clinical development[edit]

PRA Health Sciences (PRA) has worked to develop a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs.

PRA has participated in several Clinical Trials of note such as the Landmark Alzheimer’s Prevention Clinical Trial, a collaborative effort involving the Banner Alzheimer’s Institute (BAI); Genentech, a member of the Roche Group; the University of Antioquia in Colombia; and the National Institutes of Health (NIH).[25]

PRA were instrumental in supporting Gilead Sciences, Inc. with an FDA Breakthrough Therapy designation for Sovaldi (Sofosbuvir), which was approved by the FDA in December 2013. In addition, it was given a Notice of Compliance by Health Canada in December 2013, and granted Marketing Authorization by the European Commission in January 2014. Treatment is leading to higher cure rates and shortened, simplified therapy regimens for many Hepatitis C patients.[26]

The organization has completed its 20th first in human trial with biologics. The milestone is the culmination of 600 subjects enrolled in over eight years of first-in-human biologics trials, including directly into patient experience.[27]

Accolades[edit]

PRA Health Sciences was named "Best CRO in Asia" at the BioPharma Asia Industry Awards in March 2013.[28]

In the 2013 PharmaTimes US Clinical Researcher of the Year competition it was named "Clinical Company of the Year" for the second year running, as well achieving awards in other categories such as "Project Manager of the Year".[29]

The organization was awarded "International Clinical Company of the Year" at the PharmaTimes International Clinical Researcher of the Year contest which took place in February 2014. Several employees were also recognized in individual categories.[30]

In the 2014 CRO Leadership Awards run by the industry publication, Life Science Leader, the company was presented with the award for "Quality in Emerging Biotech",[31] while its Embedded services division received the “Overall Quality” award.[32]

Notable drug approvals[edit]

PRA has provided services critical to the approval of six marketed cardio-metabolic drugs: Prandin, Symlin, Cleviprex, Olmetec Plus and Letairis/Volibris.

Services leading to the approval of three vital infectious disease vaccines: ACAM 2000 for smallpox, Sovaldi for Hepatitis C and Yf-Vax for yellow fever.

The pivotal trials and/or key NDA[clarification needed] support services that led to the successful market approvals of 13 important CNS drugs in a number of indications: ADHD, Alzheimer’s disease, Parkinson’s disease, cervical dystonia, epilepsy, migraine, pain and arthritis. Its approved drugs in the central nervous system therapeutic area include: Vimpat, Frova, Sumavel DosePro, Butrans, Embeda Exalgo, Concerta, Daytrana, Intuniv, Neupro,Provigil, Tecfidera, Vyvanse, Stalevo, Myobloc and Zonegran.

It has also contributed services critical to the approval of oncology and hematology drugs such as Avastin, Inlyta, Tarceva, Nexavar, Kadcyla, Stivarga, Sutent, Pomalyst, Mariqbo and Velcade. In immunology, the company provided vital services contributing to the approval of Flebogama, Remicade and Humira.

In gastroenterology, PRA has worked toward the approval of key medications such as Duexis, Xenical and Amitiza.

Elestrin in the genitourinary therapeutic area.

The company's approved respiratory drugs include; Brovana, Fluticasone and Performist.

PRA also took part pivotal trials and/or key NDA support services that led to the successful market approval of Vasovis (medical imaging).[33]

External links[edit]

References[edit]

  1. ^ "Expertise". PRA Health Sciences. Retrieved 16 June 2014. 
  2. ^ "Biotech breakthrough: Industry emerging in Central Va.". The Daily Progress. The Daily Progress. Retrieved 11 December 2013. 
  3. ^ a b "History". PRA Health Sciences. Retrieved 16 June 2014. 
  4. ^ "PRA returns to the fold with US$790 million merger agreement". PharmaTimes. PharmaTimes. Retrieved 11 December 2013. 
  5. ^ "Registration Statement". NASDAQ. Retrieved 11 December 2013. 
  6. ^ "PRA International Acquires Valorum-UK". PR Newswire. PR Newswire. Retrieved 11 December 2013. 
  7. ^ "PRA International Expand European Capabilities With Acquisition of Arcam, a French CRO". PR Newswire. PR Newswire. Retrieved 11 December 2013. 
  8. ^ "Genstar Capital Acquires PRA International". Genstar Capital. Retrieved 11 December 2013. 
  9. ^ "PRA International, Inc. Completes Acquisition of Cromedica International". Genstar Capital. Retrieved 11 December 2013. 
  10. ^ "Registration Statement". NASDAQ. 
  11. ^ "PRA International Acquires RxCCI and GMG to Enhance Global Regulatory and Product Development Consulting Capabilities". PRA Newswire. PRA Newswire. Retrieved 11 December 2013. 
  12. ^ "PRA Acquisition of Pharma Bio-Research May Lead to New Drug Development Labs in US". BioPharm International. BioPharm International. Retrieved 11 December 2013. 
  13. ^ "PRA Prepares to Go Public with Confidential SEC Filing". Outsourcing Pharma. Outsourcing Pharma. Retrieved 11 December 2013. 
  14. ^ "PRA expands German footprint with Berlin relocation". PharmaTimes. PharmaTimes. Retrieved 11 December 2013. 
  15. ^ "PRA International to move HQ to N.C.". Washington Business Journal. Washington Business Journal. Retrieved 11 December 2013. 
  16. ^ "Colin Shannon". Bloomberg Business Week. Bloomberg Business Week. Retrieved 11 December 2013. 
  17. ^ "PRA unveils new US bioanalytical lab at AAPS". Outsourcing Pharma. Outsourcing Pharma. Retrieved 11 December 2013. 
  18. ^ "PRA International acquires Kinship Technologies". Centerwatch. Centerwatch. Retrieved 11 December 2013. 
  19. ^ "WuXi and PRA form Chinese joint venture". PM Live. PM Live. Retrieved 11 December 2013. 
  20. ^ "PRA Opens Singapore Office". Contract Pharma. Contract Pharma. Retrieved 11 December 2013. 
  21. ^ "KKR to buy clinical trials firm PRA International". Reuters. Reuters. Retrieved 11 December 2013. 
  22. ^ "PRA says Clinstar Takeover Offers Quicker and Cheaper Patient Enrollment". Outsourcing Pharma. Outsourcing Pharma. Retrieved 11 December 2013. 
  23. ^ "PRA Aquires CRI Lifetree". CRI Lifetree. CRI Lifetree. Retrieved 24 January 2014. 
  24. ^ "PRA ADVANCES TO BECOME PRA HEALTH SCIENCES". PRA Health Sciences. PRA Health Sciences. Retrieved 16 June 2014. 
  25. ^ "Banner Alzheimer’s Institute launching $100M clinical trial". Phoenix Business Journal. Phoenix Business Journal. Retrieved 30 October 2013. 
  26. ^ "Gilead's Sovaldi® Demonstrates Efficacy and Safety Among Chronic Hepatitis C Patients with Advanced Liver Disease". Fierce Biotech. Fierce Biotech. Retrieved 16 June 2014. 
  27. ^ "PRA COMPLETES 20TH FIRST IN HUMAN BIOLOGICS TRIAL". PRA Health Sciences. PRA Health Sciences. Retrieved 16 June 2014. 
  28. ^ "PRA Voted "Best CRO" in Asia". Evaluate. PR Newswire. Retrieved 16 June 2014. 
  29. ^ "US Clinical Researcher of the Year". PharmaTimes. PharmaTimes. Retrieved 11 December 2013. 
  30. ^ "International Clinical Researcher of the Year Awards- 2014 Winners". PharmaTimes. PharmaTimes. Retrieved 7 March 2014. 
  31. ^ "2014 CRO Leadership Awards Winner". Life Science Leader. Life Science Leader. Retrieved 7 March 2014. 
  32. ^ "2014 CRO Leadership Awards Winner". Life Science Leader. Life Science Leader. Retrieved 7 March 2014. 
  33. ^ "Expertise". PRA Health Sciences. PRA Health Sciences. Retrieved PRA Health Sciences.  Check date values in: |accessdate= (help)