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Labcorp Drug Development

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Labcorp Drug Development
Company typeSubsidiary of Labcorp
Industry
Founded1968 as Environmental Sciences Corporation; 1996 as Covance
HeadquartersBurlington, North Carolina, U.S.; facilities in over 60 countries
Key people
Services
  • Pharmaceutical Development
  • nonclinical, preclinical, clinical and commercialization services
Number of employees
70,000+ (2020)

Labcorp Drug Development presently known as Fortrea is a contract research organization headquartered in Burlington, North Carolina, providing nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology industries. Formerly called Covance,[3] the company is a spin-off from Labcorp, which employs more than 70,000 people worldwide.[4]

Labcorp Drug Development offers services in the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries. Labcorp Drug Development claims to be a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services.[3]

History

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Pre-Labcorp Drug Development companies (1968–1996)

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In 1968, Environmental Sciences Corporation was established in Seattle, Washington, manufacturing equipment related to laboratory animals. In 1972, it purchased and took the name of Hazleton Laboratories, a contract laboratory that conducted toxicology testing. In 1977, Corning Glass Works purchased a stake in Hazleton. According to material on the Funding Universe website, by 1982, Hazleton had become the largest independent biological testing company and life sciences laboratory in the United States, as well as the largest manufacturer of equipment in the world. The company carried out animal toxicology tests of drugs, cosmetics, pesticides, and industrial chemicals, and bred rhesus monkeys and beagles for its own labs, as well as for chemical and drug companies, hospitals, universities and government agencies. It offered chemical analysis of new compound products for various industries, tested chemicals for gene mutations, and carried out research with monoclonal antibodies.[5]

In 1989, Corning Glass Works purchased G.H. Besselaar Associates, which conducted clinical trials to help drugs gain approval from the Food and Drug Administration, and Hazleton purchased Microtest Ltd., a molecular toxicology center in York, England. Corning Glass Works then changed its name to Corning, and created Corning Lab Services, which included Besselaar and Hazelton. In 1991 and 1992, Corning Lab Services acquired SciCor and Philadelphia Association of Clinical Trials; in 1993, Hazleton, Besselaar, and SciCor were combined, becoming Corning Pharmaceutical Services, then Corning Life Sciences. On January 9, 1995, Corning Pharmaceutical Services announced the acquisition of National Packaging Systems, Inc., an Allentown, Pennsylvania-based clinical trial packaging company; the company was renamed Corning National Packaging Inc.[6]

Labcorp Drug Development as Covance (1996–2021)

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After completing the spin-off of Covance from Corning in 1996, Covance began operations as an independent, publicly traded company on the New York Stock Exchange (NYSE) in January 1997.[7]

By 1998, Covance had net revenues of $731.6 million and a net income of $48.6 million.[5] By 2012, it had annual revenues of over $2 billion and over 11,000 employees in more than 60 countries.[8] In 1998, Covance acquired the Berkeley (California, US) Antibody Company.[9]

In 2000, Covance started a central laboratory in Singapore, building on clinical-development services that they formed in Singapore in 1996.[10][better source needed]

On February 14, 2001, Covance completed the sale of Covance Pharmaceutical Packaging Services Inc., later renamed Fisher Clinical Services, to Fisher Scientific International for $137.5 million.[11] The net proceeds from the sale, approximately $110 million, were used to repay other Covance debt.[12]

In 2002, Covance acquired Virtual Center Laboratory B.V., which is now known as Local Laboratory Services.[13]

In August 2005, it acquired GFI Clinical Services, an 80-bed clinical pharmacology business, from West Pharmaceutical Services, Inc.[14]

In 2006, Covance announced the acquisition of eight early phase clinical pharmacology sites of Radiant Research, Inc.[15] and later opened what was then the largest toxicology expansion in Madison, Wisconsin, US.[16]

In May 2006, it acquired Signet Laboratories, Inc., a provider of monoclonal antibodies used in the research of cancer, infectious disease and neurodegenerative disease.[17]

In 2007, Covance opened a Central Lab facility in Shanghai, China.[18]

In 2008, Covance acquired Eli Lilly’s Greenfield, Indiana campus and executed a 10-year service drug development service agreement with Lilly.[19] Also, in 2008, Covance purchased a minority equity stake in Caprion Proteomics, known for proteomic biomarker services.[20]

In 2009, Covance acquired Merck's Seattle-based Gene Expression Laboratory and entered into a five-year, $145 million contract to provide Merck with genomic analysis services.[21]

In 2010, Covance and Sanofi-Aventis created an outsourcing partnership, which, at the time was considered the largest between a contract research organization (CRO) and a pharmaceutical company. Covance also acquired sites from Sanofi-Aventis in Porcheville, France and Alnwick, United Kingdom.[22]

In 2011, Covance acquired the assets of Signet Laboratories, Inc., a provider of monoclonal antibodies used in the research of cancer, infectious disease and neurodegenerative disease.[23]

In 2014, Covance acquired Medaxial, known for its market access consulting.[24]

On November 3, 2014, Laboratory Corporation of America purchased Covance for $6.1 billion.[25]

In 2016, Covance entered a five-year strategic alliance with Global Specimen Solutions and the use of their specimen management product, GlobalCODE, among other software products. In 2017, Global Specimen Solutions, Inc. was listed as a Labcorp subsidiary.[26]

On August 31, 2017, Labcorp acquired global life sciences business, Chiltern, as part of its drug development services with Covance. The Chiltern acquisition included a subsidiary of Endpoint Clinical Inc and their interactive response technology (IRT) systems.[27]

In 2018, Labcorp sold the Covance Food Solutions business to Eurofins for $670 million.[28]

In 2018, Labcorp acquired Sciformix Corporation to add to the Covance service line with additional post-commercialization services such as Safety & Risk Management, Clinical Research & Post-Approval Support, Regulatory Affairs & Regulatory Operations, Real World Evidence & Market Access, and Technology Services.[29]

In 2019, Labcorp and Envigo reached an agreement for Covance to acquire Envigo's nonclinical research services business. Envigo purchased Covance's research products business.[30]

Labcorp Drug Development Services

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The company's primary focus is serving the pharmaceutical and biotechnology industries. As part of its clinical and non-clinical development services, it provides drug development services across all phases of development and multiple therapeutic areas[31] such as cardiovascular, diabetes, endocrinology and nephrology, immuno-oncology, infectious diseases, inflammation, neuroscience, non-alcoholic steatohepatitis (NASH), oncology, ophthalmology, rare diseases, pediatrics, and the development of companion diagnostics.[better source needed]

Labcorp Drug Development lists its services in the following categories:[32][unreliable source?]

Lead Optimization

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Covance reports that it offers Lead Optimization Non-GLP Toxicology, In Vivo Pharmacology, Nonclinical Imaging, Nonclinical Pathology, PK/TK Analysis and Reporting, and Immunology Services.[33][better source needed]

Analysis Services

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The company offers bioanalytical services in small molecule, biologics, translational biomarkers, and LC-MS.[34][35]

Research

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A division of the company, Covance Research Products, Inc. (CRP), based in Denver, Pennsylvania, offers antibody products and antibody-development services to the research community. CRP also deals in the import and sale of laboratory animals. According to its website, CRP breeds and sells dogs, rabbits, guinea pigs, non-human primates, and pigs. It has also bred and trademarked new breeds of animals including the "Mini-Mongrel" dog. The company also imports wild-caught primates. Labcorp Drug Developments's animal-testing programs and facilities are AAALAC-accredited, ISO 9001:2000-registered, OLAW-assured, and USDA-research registered.[36][weasel words][non-primary source needed] According to the company, CRP programs and facilities are overseen by attending staff veterinarians and AALAS-certified technicians.[citation needed]

Safety Assessment

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Labcorp Drug Development says it offers General Toxicology Studies, Genetic Toxicology, Immunotoxicology, Nonclinical Pathology Services, Safety Pharmacology, Services, Developmental and Reproductive Toxicology, (DART) Studies, and SEND - Standard for the Exchange of Nonclinical Data.[clarification needed][citation needed]

Consulting & Partnering

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Labcorp Drug Development partners with pharmaceutical companies and biotechnology companies in various consulting and partnership agreements by offering drug development program management services, alliance management, early phase development solutions, Labcorp Drug Development MarketPlace,[37][non-primary source needed] drug development consulting, access and strategy, and evidence generation.

Clinical Development

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Labcorp Drug Development supports companies with their clinical trials, which involves early clinical / Phase IIa, Phase IIb / III services, clinical data management analysis and reporting, regulatory services, and Phase IV solutions.[citation needed]

Clinical Testing

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In the clinical testing space, Labcorp Drug Development says it offers services involving flow cytometry, a central laboratory, biomarker testing capabilities, companion diagnostics, genomics, vaccines, and immunotherapeutics.[citation needed]

Commercialization

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In the drug development commercialization space, Labcorp Drug Development reports to offer a service called MarketPlace[37][clarification needed] and also offers patient support, field services, drug safety and pharmacovigilance.[citation needed]

Manufacturing Support

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On the manufacturing side, Labcorp Drug Development reports that it offers chemistry, manufacturing and control (CMC) services.[38][better source needed]

Informatics

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In 2011, Labcorp Drug Development (then Covance) launched its Xcellerate platform as an informatics tool to help optimize clinical trial performance.[39][better source needed] In 2018, Xcellerate won industry recognition with the Scrip Award for Best Technological Development in Clinical Trials.[40][better source needed]

In 2016, Labcorp Drug Development entered a five-year strategic alliance[tone] with Global Specimen Solutions and the use of their specimen management product, GlobalCODE, among other software products. In 2017, Global Specimen Solutions, Inc. was listed as a Labcorp subsidiary.[26]

Functional Service Provision (FSP)

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Labcorp Drug Development reports to help with staffing biopharmaceutical companies in the roles of clinical operations and clinical analytics under the Functional Service Provider (FSP) model. The acquisition of Chiltern in 2017 (as Covance) helped Labcorp Drug Development grow its FSP capabilities.[41][better source needed]

Animal health and welfare

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Welfare standards

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Labcorp Drug Development also shares research on animal welfare topics, such as social housing of nonhuman primates.[citation needed]

Animal welfare issues

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Ebola virus

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In December 1989 a number of cynomolgus macaques (Macaca fascicularis) were imported from Mindanao Island in the Philippines with the Ebola virus to Covance's Hazleton Research Products' Primate Quarantine Unit in Reston, Virginia. The company was using monkeys there for research purposes, according to The Washington Post. The virus was confirmed in one monkey and suspected in others among a group of 100.[42] In March 1996 two macaques that had been shipped to Hazleton in Alice, Texas, tested positive for the Ebola virus from a group of 100 obtained from the same supplier.[43] The strains were not infectious to humans, and no human illnesses were reported.[44]

Münster, Germany

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In 2003 the British Union for the Abolition of Vivisection (BUAV) sent a German investigative journalist, Friedrich Mülln, into the Covance facility in Münster, Germany's largest primate-testing center, where he filmed undercover for five months.[45]

The footage was shown on German public television in December 2003. Nature reported that it showed animal keepers dancing with half-anaesthetized monkeys, making their heads move to the rhythm of the music.[45] It also showed staff handling the monkeys roughly and shouting at them. The monkeys were seen living isolated in small wire cages with little or no natural light and no environmental enrichment, with high noise levels caused by staff shouting and playing the radio, and undergoing surgery with no post-operative care.[46] In response, Covance maintained that clips showing different technicians working in different buildings had been edited together, resulting in a sequence of events that did not take place. The company also said there was group housing and pair housing for some monkeys, but the BUAV chose not to show that. Covance said they planned to upgrade the housing to comply with future European Union guidelines.[47][unreliable source?]

Jane Goodall, a primatologist, described the monkeys' living conditions as horrendous. Another primatologist, Stephen Brend, argued that using monkeys in such a stressed state was "bad science", and that trying to extrapolate useful data in such circumstances was an "untenable proposition."[46] The environment minister for North Rhine-Westphalia asked the public prosecutor to investigate, and said that if the allegations were borne out, the company would lose its licence to keep primates.[45] According to the European Biomedical Research Association, a lobby group, the authorities inspected Covance and insisted that the company install video cameras to monitor staff working with primates. Covance appealed through the courts, which ruled that video monitoring would infringe the rights of the staff. The public prosecutor's office viewed the film and questioned witnesses, and concluded that Covance "had not rendered themselves liable to prosecution" and that the state veterinary officer "had not failed in his supervisory duties."[47][unreliable source?]

Vienna, Virginia, United States

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People for the Ethical Treatment of Animals (PETA) alleged similar conditions in Covance's Vienna, Virginia, lab when it sent an undercover investigator to obtain a job there as a technician from April 2004 to March 2005.[48] Subsequent inspections by the United States Department of Agriculture (USDA) resulted in 16 citations in April 2006. The USDA declined to give details; according to Covance the violations ranged from "administrative issues to scope of veterinary authority." The company agreed to pay a settlement of $8,720.[49]

In June 2005, Covance filed a lawsuit in the United States against PETA and the investigator for fraud, breach of employee contract, and "conspiracy to harm the company's business by deceitfully infiltrating and videotaping the ... facility."[50] In exchange for not suing the infiltrator for illegally filming within Covance's lab, PETA US signed an agreement to hand over all video footage and written notes to Covance, and agreed to a ban on conducting any infiltration of Covance for five years.[50][51][52]

The company filed a parallel lawsuit in England in an attempt to stop PETA showing the tape; the British judge called the footage "highly disturbing", and ruled that there was a legitimate public interest in the material being shown. Covance and PETA agreed to a settlement that resulted in no payment to Covance, and with PETA allowed to continue to publish the video.[53][verification needed]

References

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  1. ^ "Labcorp Announces New Leadership Roles for Its Two Business Segments and Selects New Chief Human Resources Officer". Labcorp. Retrieved November 11, 2019.
  2. ^ "Archived copy". Retrieved October 16, 2018.
  3. ^ a b About labcorp drug development
  4. ^ "About Us".
  5. ^ a b "Covance History" Archived 2012-03-04 at the Wayback Machine, fundinguniverse.com; taken from Derdak, Thomas and Pederson, Jay P. International Directory of Company Histories. St. James Press, 2000, Volume 30.
  6. ^ "Corning Pharmaceutical Services Acquires National Packaging Systems Inc.; Clinical-Support Company Provides Materials For Drug-Development Trials". The Free Library. January 9, 1995.
  7. ^ "Corning to Spin Off 2 Subsidiaries to Shareholders". The New York Times. Reuters. November 28, 1996. ISSN 0362-4331. Retrieved January 22, 2020.
  8. ^ "History of Covance Inc. – FundingUniverse". Archived from the original on March 4, 2012.
  9. ^ "Covance Inc. History". Retrieved February 28, 2019.
  10. ^ "Covance completes central laboratory expansion in Singapore". April 18, 2013.
  11. ^ "Fisher Scientific Completes Acquisition of Pharmaceutical Packaging Services Business from Covance Inc". The Free Library. February 14, 2001. Archived from the original on March 5, 2016. Retrieved April 2, 2014.
  12. ^ "Covance Completes Sale of Pharmaceutical Packaging Business to Fisher Scientific". The Free Library. February 14, 2001.
  13. ^ "Covance Virtual Central Laboratory BV - Company Profile and News". Bloomberg.com.
  14. ^ "Investor Relations at Covance: Press Release" Archived 2007-11-01 at the Wayback Machine, Covance.
  15. ^ "Radiant Research Completes Sale of Clinical Pharmacology Business Unit; Will Continue to Expand Clinical Research and Development Services" (Press release). June 2006.
  16. ^ "Welcome to Covance: Press Release".
  17. ^ "Covance Acquires Signet Laboratories". The Geomics and Proteomics Information portal. Technology Networks. June 1, 2006. Archived from the original on September 29, 2007. Retrieved August 10, 2008.
  18. ^ "Covance steps up Chinese presence". Outsourcing-Pharma.com. February 6, 2007.
  19. ^ "Covance and Eli Lilly and Company Execute 10-Year, $1.6 Billion Services Contract; Covance to Acquire Lilly's Greenfield, Indian | Fierce Biotech".
  20. ^ "News". CellCarta.
  21. ^ "Covance to Acquire Seattle-Based Gene Expression Laboratory from Merck & Co., Inc. | Fierce Biotech".
  22. ^ "Covance and Sanofi-aventis ink landmark 10-year, $2.2 billion R&D outsourcing partnership". October 4, 2010.
  23. ^ "Covance Acquires Signet Laboratories". Contract Pharma.
  24. ^ "Covance Acquires Medaxial". www.prnewswire.com (Press release).
  25. ^ "UPDATE 3-Labcorp to pay $6.1 bln for drug trial company Covance". Reuters. November 3, 2014. Archived from the original on February 19, 2015. Retrieved May 18, 2015.
  26. ^ a b "Global Specimen Solutions, Inc. Announces 5-Year Strategic Alliance with Covance". PRWeb.
  27. ^ "Exhibit". www.sec.gov.
  28. ^ "Labcorp Enters into Definitive Agreement to Sell Covance Food Solutions to Eurofins for $670 Million" (Press release). April 30, 2018.
  29. ^ "Error 467". www.key.com.
  30. ^ "Labcorp, Envigo deal will see both companies focus and expand respective expertise". April 23, 2019.
  31. ^ "Therapeutic or Specialty". drugdevelopment.labcorp.com.
  32. ^ "Covance: Innovation In Drug Development Offers Growth". Seeking Alpha. SeekingAlpha.com. June 28, 2013.
  33. ^ "Covance Pushes Further into Biologics Development, Lead Optimization". Outsourcing-Pharma.com. May 19, 2013.
  34. ^ "About Covance - Analytical Solutions". Science Exchange.
  35. ^ Tirumalaraju, Divya (March 12, 2018). "Labcorp's Covance forms new biologic drug development unit". Pharmaceutical Technology.
  36. ^ "About CRP", Covance Research Products.
  37. ^ a b "BioWorld's PARTNER in FOCUS: Covance" (PDF).
  38. ^ "Labcorp bolsters biologics capacity of Covance unit in UK". Biopharma Dive.
  39. ^ "Covance Launches Xcellerate". Contract Pharma.
  40. ^ "Scrip Award Winners 2018". Pharma intelligence.
  41. ^ "Chiltern acquisition improves competitiveness of offerings, says Covance CEO". Outsourcing Pharma. July 30, 2017.
  42. ^ Cohn, D'Vera. "Deadly Ebola Virus Found In Va. Laboratory Monkey;Animals Sent to Reston From Philippines" Archived 2012-11-29 at the Wayback Machine, The Washington Post, December 1, 1989.
  43. ^ "TDH Schedules Briefing on Investigation into Monkeys with Ebola", Texas Department of State Health Services, April 15, 1996.
  44. ^ "Breeder wants his monkeys spared", CNN, April 18, 1996.
  45. ^ a b c Schiermeier, Quirin. "Primate lab faces closure threat over mistreatment charge" Archived 2008-09-06 at the Wayback Machine, Nature, 427, 4, January 1, 2004.
  46. ^ a b "Inside Covance: BUAV/ECEAE launches first ever undercover investigation in an animal testing laboratory in Germany", Europäische Koalition zur Beendigung von Tierversuchen, press release, December 9, 2003.
  47. ^ a b "Covance cleared of primate charges". European Biomedical Research Association. 2004. Archived from the original on September 28, 2007.
  48. ^ Benz, Kathy & McManus, Michael. "PETA accuses lab of animal cruelty" Archived 2009-09-14 at the Wayback Machine, CNN, May 17, 2005.
  49. ^ Pfister, Bonnie. "Firm fined $8,720 after PETA video", Associated Press, April 1, 2006.
  50. ^ a b "Covance Prevails in PETA Lawsuit; Court Enters Order Requiring PETA to Comply With Ban on Infiltration". PR Newswire. October 17, 2005. Archived from the original on September 29, 2007.
  51. ^ Buske, Jennifer (August 3, 2008). "PETA Urges Withdrawal Of Support for Drug-Test Lab". The Washington Post.
  52. ^ Benz, Kathy; McManus, Michael (May 17, 2005). "PETA accuses lab of animal cruelty". CNN.
  53. ^ Wagman, Bruce A.; Waisman, Sonia S.; and Frasch, Pamela D. Animal Law: Cases and Materials. Carolina Academic Press, 4th edition, 2009, pp. 515–516.

Further reading

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