Centocor clinical trials

Drug Information available for: Infliximab. FDA Resources. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. The study population consists of patients who had at least one dose of study drug in clinical studies of infliximab in the treatment of COPD, that are targeted for long-term safety follow-up and were asked to participate in this long-term safety follow-up study.

Inclusion Criteria: Patients must have been enrolled in previously completed clinical studies of infliximab in the treatment of COPD that are targeted for long term safety follow-up ie, primary studies.

Primary studies are defined as studies that have evaluated infliximab on an investigational basis and that have been identified by Centocor or health authorities as requiring long-term safety follow-up.

Patients must have received at least one dose of study agent to be eligible. Exclusion Criteria: Patients who are unwilling to respond to requests for long-term safety information will be excluded. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.

Layout table for investigator information Study Director: Centocor, Inc. Clinical Trial Centocor, Inc. More Information. Primary Outcome Measures : Any of the following within 30 days: Death from any cause; Myocardial infarction; Recurrent ischemic event requiring urgent intervention repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump.

Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. Layout table for investigator information Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.

More Information. N Engl J Med. Long-term protection from myocardial ischemic events in a randomized trial of brief integrin beta3 blockade with percutaneous coronary intervention. Abciximab Angina, unstable Angioplasty, transluminal, Percutaneous coronary.

National Library of Medicine U. National Institutes of Health U. Centocor enjoyed a high level of initial success using this business model. Widespread and diverse licensing agreements allowed the company to gain broad market penetration and establish a foothold in the mAb diagnostics market. Following this strategy of collaboration, Centocor was able to grow its research collaborations from 15 in to 80 in 1.

These partnerships involved labs from across the world, allowing Centocor to grow its brand globally. Additionally, partnerships with high-profile companies within the market were established.

This allowed Centocor to take advantage of these companies well-established distributions channels, eliminating the need for Centocor to spend time and energy on large-scale marketing and distribution of its products 1. A number of products were instrumental to the initial success of Centocor.

The first two diagnostic tests to achieve market success were for gastrointestinal cancer and hepatitis B. Both of these tests were produced by research funded in academia by Centocor — the former from the Wistar Institution, and the latter from Massachusetts General Hospital. These tests achieved regulatory approval quickly and sold well, providing a massive ROI from initial study funding for Centocor.

Diagnostic tests for ovarian cancer, breast cancer and colorectal cancer proved exceedingly popular in fact, all three tests are still used today 1. Again, these products were all licensed from various research institutes.

With the company strongly established and profitable in the diagnostics industry, Schoemaker and his team of executives decided the time was right to move into the therapeutics market. This had always been the goal of the company — their ambition was to become a large pharmaceutical player in the same vein as Bayer and Merck.

To achieve this, Centocor would need to produce a blockbuster mAb based therapy. This was no easy task — therapeutics derived from mAb had never been developed, and whether they would prove effective remained to be seen. Additionally, commercialization of such products would require significantly more resources than diagnostics, as clinical trials and regulatory approval were more rigorous and cost intensive. Penetration of a market where costs and logistical hurdles were so prominent was undoubtedly a risky move for Schoemaker.

The rationale was that while the risks were large, the enormous potential payoff of having successful therapeutics provided enough incentive to move forward. After evaluating of many candidate therapeutics, Schoemaker believed that Centocor had their blockbuster mAb therapeutic in Centoxin was meant to solve this problem, while simultaneously establishing Centocor into a pharmaceutical powerhouse.

Along with a change in market came a change in strategy at Centocor. The new plant also incorporates a process development section, where fermentation processes can be conceived and optimised to give the best possible yields of product, in addition to state-of-the-art plant and process automation to make it one of the most modern in Europe. Low temperature refrigerated warehousing facilities are available for both products and ingredients as well as a small-scale fill and finish facility for packaging clinical quantities of products.

Fill and finish is mainly carried out in Holland. Remicade is a monoclonal antibody product is produced at the facility. The company extended the usefulness of the drug by continuing clinical trials into other autoimmune diseases such as ulcerative colitis, psoriasis, ankylosing spondylitis, lupus erythrematosus and psoriatic arthritis.

The success of this drug, and others that were in the company pipeline such as Reopro a heart medication , highlighted the need for the company to obtain extra production capacity, particularly at a time when rival drugs such as Enbrel and Humira are about to come to market. Order year Project type Biotech manufacturing facility.