Symbio enters, BASi exits Phase I scene

By Kirsty Barnes

- Last updated on GMT

Related tags: Phase, Pharmacology

This week one North American contract research organisation (CRO)
has entered the Phase I clinical trials market, while another has
exited the scene.

Symbio has just opened a new Phase I Clinical Unit on site at the Saint Anthony Memorial Hospital in Michigan City, Indiana, giving it a new capability to undertake Phase I studies. Edward Drower, director of Phase I Clinical Operations for the firm said that with the addition of the Phase I unit, Symbio now has the ability to provide clinical development services to the biopharmaceutical industry from Phase I through to Phase IV. He added that Symbio has a particular expertise in working with the generic drug industry, and its new Phase I team is set up to prepare and execute clinical plans to support US Food and Drug Administration (FDA) approval of generic products. The 62-bed unit is situated on a dedicated floor of the hospital that is devoted to the conduct of Phase I studies, "ensuring the highest quality medical care and safety standards".​ Being on site at a hospital it is positioned to provide swift access to emergency medical services if ever required. Parexel's Phase I unit at Northwick Park Hospital in North London is an example of this - its proximity to the hospital proved crucial when in 2006 a tragedy occurred at the unit during a Phase I study of an experimental monoclonal antibody, TGN1412, when all six healthy volunteers who took TGN1412 experienced an unexpected adverse reaction and were admitted to intensive care, some in a critical condition. The firm also said that the site was located within an hour distance of downtown Chicago, where "diverse populations of healthy participants are easily accessible, including eight local colleges/universities and technical schools".​ Meanwhile, Bioanalytical Systems (BASi) has exited the Phase I scene with the sale of its Baltimore Clinical Pharmacology Research Unit. The company sold the business to a subsidiary of Canadian CRO Algorithme Pharma for $850,000. This includes all operating assets and the lease for the site where the facility is located. Algorithme specialises in conducting Phase I clinical trials as well as bioequivalence studies and the acquired business will add to its current 200 bed capability in Montreal and provide it with its first US-based clinical site. In addition to hiving off its Phase I business, BASi also recently formed an alliance with Swiftwater that will see the two firms collaborating to complement and expand each other's service offerings. Under the arrangement, BASi will offer a preferred provider arrangement for Swiftwater's clients in terms of its CRO offerings, while BASi clients will have access to Swiftwater's consultancy services, allowing them a single point of contact for a range of services in areas that include product development, regulatory, project management and auditing.

Related topics: Clinical Development, Phase I-II

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