LONDON, Feb. 28, 2011 /PRNewswire/ -- The staffs of Chiltern International Limited (Chiltern), a global contract research organization (CRO), and Spectratox Limited, celebrate the 25 year mark of their successful collaboration in Drug Phototoxicity.
Chiltern Early Phase and Spectratox have worked together using a validated and regulatory accepted in vivo human study method for the assessment of drug phototoxicity. The history of this collaboration can be traced through their multiple publications in peer reviewed journals.
"The success story of this methodology is not just measured in publications," stated Dr Brian Sanderson, Medical Director, Chiltern Early Phase. "It is measured in the success we have had in helping new drugs continue their developmental journey for areas of therapeutic need."
Professor James Ferguson, Head of the Academic Department of Dermatology, University of Dundee, and CEO of Spectratox, explained, "The evolution of randomized controlled trials has been in response to industry and regulatory requirements. Our trials, which tend to be conducted prior to Phase 3, produce data that defines the phototoxic risk in man in terms of severity and causal wavelengths as well as providing an understanding of the likelihood of ocular phototoxicity. Where phototoxicity is found, advice on protective measures to enable future development of the compound is an important aspect of our work."
Dr Sanderson added, "New study designs have been introduced to act as initial "screening" in man for drugs with potential phototoxicity. The new designs have evolved in response to the growing demand to assess this earlier in clinical drug development. The benefits are savings in both time and cost whilst remaining scientifically robust."
Glenn Kerkhof, Chiltern CEO, commented, "This 25 year collaboration is cause for celebration when we look back and realize the successes reached as well as what is presently being accomplished together. We very much look forward to what the next 25 years will bring in advancing drug development processes."
Established in 1982, Chiltern is a leading global Contract Research Organization with extensive experience conducting and staffing international Phase I to Phase IV clinical trials across a broad range of therapeutic areas for a wide variety of clients. Chiltern has conducted trials in more than 40 countries, has 24 offices and legal entities within 20 countries, resources in 37 countries and employs nearly 1,400 people globally. Chiltern provides Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions services. Further information: www.chiltern.com.
Spectratox, although formally established in 2008, came about from a group of staff within the Photobiology Unit who had been collaborating with the Chiltern staff on drug phototoxicity work in Scotland since the mid 1980s. Together they developed an evidence-based methodology for studying phototoxicity in clinical volunteers. Professor Ferguson has 30 years experience advising on the need for such work. The staff at Spectratox are also expert in pre-clinical laboratory data analysis; clinical 'healthy volunteer' studies and post-study testing; advice on product labelling and clinical management.
Phototoxicity testing is carried out on the premises of the National Photobiology Unit, Ninewells Hospital and Medical School, a part of NHS Tayside (although Spectratox Ltd. is an independent company). Further information: www.spectratox.co.uk.