Andrew Gay, of Huntingdon Life Sciences, explains how the company operates within development research.
Huntingdon Life Sciences (HLS) works at the leading edge of innovative developmental research providing non-clinical safety and efficacy assessment services for the development, market introduction and maintenance of new pharmaceutical compounds and other chemicals. Consumers and the natural environment are exposed to a growing number of new chemicals every day and we have increasing expectations of their safety; assessing that safety is HLS' business. The potential of this market is expanding as global R & D spending by manufacturers increases.
HLS is one of the world's premier Contract Research Organisations (CROs), offering customers a comprehensive testing portfolio from laboratories in the UK and US, supported by leading technology and capabilities. There has been a dramatic 37 per cent increase in orders over the past two years, which demonstrates the confidence customers have in the company. The primary markets for HLS have historically been Europe and the Far East, but in recent years orders from the USA have rapidly gained in importance.
Pharmaceuticals & Biopharmaceuticals
In 1999 two thirds of HLS' research was conducted for customers in the pharmaceutical and biopharmaceutical industry. Over 75 per cent of the world's top 50 pharmaceutical companies chose to work with HLS in that year. This included research into new compounds in over 25 therapeutic areas, including potential treatments for cancer, AIDS, hypertension, asthma, diabetes, Alzheimer's and many others.
Many customers have come to regard HLS as an extension of their own resources, the more closely the company is integrated with customers the more efficient the service becomes. HLS' objective is to help customers make appropriate and timely decisions, enabling them to complete their development programmes effectively and efficiently. Advice from scientific experts within the company, given in the light of long experience and facilitated by effective programme management, can optimise drug development within the strict requirements of the regulatory authorities.
The need for toxicity and safety assessment studies is driven and governed by regulatory requirements and so is well suited to being out-sourced. Increasingly this includes larger programmes of work and not only individual studies. As a result HLS is becoming more closely involved with customers in designing development strategies geared to specific clinical end-points and in the management of entire programmes. This is leading towards beneficial, creative partnerships with customers, where HLS plays a meaningful role in supporting and adding value to customers' drug development programmes.
HLS conducts studies on a broad range of new therapeutic agents, ranging from traditional small molecules to large monoclonal antibodies and other products of biopharmaceutical research. The company offers a complete portfolio of non-clinical services throughout the drug development process, supporting customers around the world from facilities in both the UK and the US. Innovative strategic alliances with independent Clinical Research Organisations have successfully extended this portfolio of integrated pharmaceutical services so the company is now able to also offer Phase I and IIa clinical trials. This further strengthens HLS' ability to be the full service, early development partner of choice to its pharmaceutical and biopharmaceutical customers.
Agricultural Chemicals
HLS continues to strengthen its reputation as the international market leader offering full development programmes to take new agricultural chemicals to market. These major contracts involve assessing the safety, environmental impact and efficacy of the compound.
The agricultural chemical market has changed markedly over the past few years. Five years ago it was driven by the requirements of individual national regulatory authorities and was consequently very diverse and fragmented. Now much of the legislation has been consolidated internationally, resulting in a reduction in the number of individual studies required and an increase in the need for integrated programmes. These changes give HLS the opportunity to guide customers through an increasingly complex regulatory process and also to manage the whole project. The company has successfully completed one full development package on behalf of a customer and is currently project managing five more major integrated programmes, evaluating toxicity and environmental impact and conducting field trials that run for several years. HLS is widely perceived as being a full-capability laboratory for this market segment and so the front runner in this area of contract research.
Industrial Chemicals
HLS is the world market leader in regulatory assessment programmes, both for new chemicals entering the market and also for the re-examination of the safety of existing chemicals. Retrospective studies are an increasing feature of this market sector, where currently marketed chemicals are subjected to detailed reappraisal.
HLS already has a significant profile within the world-wide chemical industry, frequently working with major consortia and trade groups. The company can offer its customers complete programmes including safety, environmental and analytical studies, coupled with regulatory services and dossier submissions, suitable for presentation to Governments around the world.
Veterinary medicines
The development of effective and safe veterinary medicines for pets and farm animals is an area of growth for HLS. The company's veterinary clinical trials service delivers efficacy studies for regulatory submission to meet customers' marketing aims. The safety of these medicines is also tested, not only to protect the target animals that will benefit from them, but also to protect people and the environment.
In food-producing animals care must be taken to ensure that medicines do not enter the food chain. Therefore studies must be conducted to determine the fate of compounds inside the body and assessments made on possible residues in milk, dairy products, meat and eggs.
Food
Food research has been important to HLS since its inception in 1952 and the company has continued to successfully build on this heritage. HLS has been involved in the development and testing of a number of novel foodstuffs, artificial sweeteners and flavourings over the past decades. Nutraceuticals or functional foods are exciting new developments, these are foods which provide clear clinical benefits, such as the lowering of cholesterol levels. It is anticipated that demand for testing in this area will increase rapidly, once the regulatory authorities have established the appropriate legislative framework.
In conclusion HLS' vision is to create a new standard and level of partnership in our industry, built upon our technical, scientific and regulatory expertise, the ethical standards we adopt, our problem solving approach and a dedication to customer service and teamwork. The company's core strengths are scientific expertise, experience, knowledge and reputation; and its goal remains clear:
To be appreciated as the listening, understanding and reliable partner in creative compound development and safety assessment; to be the first choice for the industries we serve.
ENQUIRY No 23
Huntingdon Life Sciences Limited is based in Alconbury, Huntingdon, Cambridgeshire, UK.
Tel: +44 1480 892000 Fax: +44 1480 892205 www.huntingdon.com
