Simbec Research is among the first group of Phase 1 units in the UK to pass the Medicine Healthcare Regulatory Agency (MHRA) inspection for Standard and Supplementary Accreditation
This means Simbec is approved for the conduct of trials of all types of Investigational Medicinal Products (IMP) including those that need review by the MHRA Expert Advisory Group (EAG).
Trevor Tanner, Simbec's scientific director, said: "Simbec Research is delighted to be among the first units to be inspected and awarded accreditation.
"The UK has always been the country of choice for exploratory clinical pharmacology studies and this scheme now sets international standards for early phase clinical trials.
"The scheme demonstrates the progressive approach of the MHRA which will provide both reassurance to trial participants and confidence to sponsors.
"Although the scheme is currently a voluntary process it will become increasingly difficult for sponsors to justify the use of centres that do not have the appropriate level of accreditation".
Since the 2006 TGN-1412 incident, UK regulators have put steps in place to ensure this incident is not repeated, and a new UK regulatory process for 'higher risk' compounds has been introduced.
This includes a review process involving the EAG and the Commission on Human Medicines (CHM), in addition to the MHRA and Ethics Committees.
Simbec's Supplementary Accreditation follows on from its recent successful completion of a first-in-man study of such a higher risk monoclonal antibody, the first immunomodulating monoclonal antibody to successfully traverse the new UK regulatory process for higher risk compounds since TGN-1412, and enter the clinic for the first time administration to man.
While conductineg the study, Simbec gained first hand experience of the new process from initial study design, through ethics and regulatory submissions to study conduct.
Simbec helped to design the protocol, obtained CTA and ethics approval and conducted the study in its clinical pharmacology unit.
No cytokine release or fever was observed in any subject.
All adverse events were fully reversible and required no particular intervention.
This antibody programme will now proceed to clinical studies in rheumatoid arthritis and psoriasis patients.
The studies are expected to start at the end of 2008.
