GLP Core

Core Director:
James Ault

When a project reaches the point at which the principal investigator is considering a clinical trial, he/she will schedule a meeting with the GLP Core director (Mr. Ault), in order to establish the preclinical data needs.

Three of those who participate in the GLP Core at Ricerca, Mr. Ault, VP of Regulatory Affairs, Margaret Hardy, Validation Specialist II and Bonita Weiss, Quality Assurance Specialist II are certified by the national Society of Quality Assurance as Registered Quality Assurance Professionals in Good Laboratory Practices (RQAP-GLP), and contemporary FDA GLP audits produced an excellent compliance record, due not only to Ricerca’s regulatory expertise but a highly competent technical staff. Thus, these staff members are well qualified to advise investigators as to the nature of the preclinical data needed to advance to clinical trials – probably efficacy, safety, and bio-distribution studies.

Ricerca maintains audited and qualified GLP facilities which conducted 524 GLP studies 200-2003, and 103 so far in 2004. The Life Sciences facility (Building D–77,600 ft2) houses Ricerca’s Toxicology/Pharmacology, Bioanalytical, Drug Metabolism/Pharmacokinetic, Microbiology, and Kilo-laboratory (cGMP) departments, and contains 33 animal rooms that are AALAAS and USDA certified and accredited. Modern laboratories and equipment are available for GLP studies within the facility. The Toxicology facility has ample rooms for studies requiring small mammals or dogs. Ordinarily, efficacy studies need not be done under GLP conditions and can be done through the Animal Core, but at least some of the formal safety and bio-distribution studies must be done under GLP conditions.

The experts in the GLP core will assist the investigator in planning the strategy. At this point, possibly, FDA consultation may be sought, or a consultant expert in FDA regulatory affairs engaged via the Commercialization Council. Since GLP studies are expensive, if non-GLP studies will serve, the investigator will be referred to the Animal Core. However, if GLP studies are required, GLP Core personnel will plan, in concert with the investigator, the most efficient study protocols. These will, of course, need to be tailored to the nanoparticles being tested, which will entrain the type of safety monitoring necessary, study duration, species selected, and the precise experimental protocol. If appropriate, and the investigator agrees, the GLP core will arrange for the studies to be conducted expeditiously at Ricerca under their Master Calendar.