Theorem, CRL Form Alliance to Offer ‘Seamless’ Nonclinical to Clinical Transition
The alliance will offer nonclinical testing programs in the areas of bioanalysis, immunogenicity and immunology to support trials.
Alan Bartlett, executive director of laboratory sciences North America preclinical and clinical services at CRL, told Outsourcing-Pharma.com, “Our collaboration will ensure clients experience a seamless transition from non-clinical to clinical programs. Theorem will provide a full range of clinical trial and support services, and Charles River will provide the bioanalytical, and immunological laboratory support.”
The preclinical testing capabilities and clinical support services of CRL are backed by a bioanalysis portfolio for non-GLP and GLP programs, with instrumentation in its labs to measure drug and metabolite concentrations in biological matrices and to provide support for capillary micro sampling and dried blood spot analysis.
Theorem SVP and general manager of biophamaceutical development Dr. Marc Hoffman explained to Outsourcing-Pharma that often times the clinical development process isn’t exactly a linear process of moving from the bench to the clinic.
He said the alliance will help virtual to small- to mid-sized pharma and biopharma companies fill gaps in their IND-enabling development plans, especially when they are looking at funding mechanisms and milestones.
The alliance will “meet specific client needs in response to market trends,” Bartlett added, noting that small and mid-size pharmaceutical and biopharmaceutical clients will benefit from this collaboration.
“This relationship will create time and cost savings as well as other efficiencies for pharmaceutical and biopharmaceutical clients,” he said.
This latest partnership will build off of a preclinical partnership between the two companies that was announced in July. Theorem, meanwhile, announced three partnerships in July, though mostly with medical device firms.