UK-based contract research organisation (CRO) Chiltern has strengthened its early-phase offering by acquiring Drug Development Solutions (DDS), a Phase I specialist with a purpose-built facility in Ninewells Hospital and Medical School, Dundee, Scotland.

No price was disclosed for the deal. DDS will take on the Chiltern name and its chief executive officer and medical director, Dr Brian Sanderson, will continue to lead the Dundee unit, working closely with Chiltern’s own Clinical Research Unit in Slough near London to build up the latter’s early-phase business.

According to Chiltern, the two companies “fit together so neatly that the only bedding-in process needed will be adding DDS’s specialised photobiology trials and enhanced first-in-man expertise to Chiltern’s existing Early Phase capacity, global reach and strong clinical service base”.

Founded in 1982 – the same year in which Chiltern was set up – DDS has completed more than 700 Phase I trials covering a wide range of pharmacokinetic and pharmacodynamic requirements in all of the major therapeutic areas. The Dundee unit, which offers 42 high-intensity care beds with capacity to expand to 60, has special expertise in first-in-human trials and is a world leader in phototoxicity studies for systemic drugs in humans, Chiltern noted.

Not only is Ninewells among the largest hospital complexes in Europe, with access to patient populations for Phase IIa efficacy trials, but the DDS unit is one of only a few in the UK to be located in a major hospital that can provide emergency medical services if needed. This will enable DDS to attain the higher level of accreditation (Type A) under the voluntary scheme for Phase I Clinical Trial Units being introduced by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Chiltern points out.

The accreditation scheme, which was drafted by the MHRA’s Good Clinical Practice (GCP) inspectorate and is scheduled to take effect in April, was among the recommendations put forward in November 2006 by the final report of an Expert Scientific Group (ESG) on Phase I trials, set up by the UK government in response to the disastrous first-in-man study of TeGenero’s monoclonal antibody TGN1412 at Northwick Park Hospital in London.

DDS has been ISO 9001 certified for quality management since 1997. It also has Good Manufacturing Practice (GMP) accreditation and has been inspected by the MHRA for compliance with the GCP standards of the International Conference on Harmonisation (ICH). The Phase I unit has significant experience in supplying regulatory data to authorities in the EU, the US and Japan, DDS says.

Service boost
According to Glenn Kerkhof, chief executive officer of Chiltern, acquiring DDS “allows us to offer leading-edge Phase I services to our global client base and supplements our existing Early Phase capability and strong Phase II-IV capacities”. The UK has “long been a centre of excellence for Early Phase clinical pharmacology and once again offers a stable regulatory environment and internationally competitive approval timelines”, he added.

Dr Sanderson echoed this positive assessment of the UK as a base for Phase I development, despite recent concerns voiced by the BioIndustry Association that new arrangements put in place by the MHRA for first-in-man studies of higher-risk compounds might serve as a disincentive to conduct early-phase trials in the UK market.

“The excellent regulatory climate, with approval times of approximately 14-21 days for Phase I trials, facilitates the performance of first-in-man studies in the UK and our highly experienced hospital-based unit offers best practice in this field,” he commented.