27 November, 2008 - 23:00 By Staff Reporter

Martin King of LCG Bioscience

Backgrounder: LCG Bioscience is a specialist clinical research organisation for exploratory and early phase clinical development. Established in 1993 it performs Phase I and Phase IIa clinical studies and laboratory analysis for all phases. It has particular expertise in studies that require biomarkers, complex clinical procedures, special populations, or surrogate pharmacodynamic endpoints. It has specialist facilities for respiratory and sleep trials.

It is estimated that 30-35 percent of the population are suffering from insomnia but are reluctant to use medication because of fears of side effects or dependency. Many new drugs are in development, which aim to meet the ideal criteria for safe, effective hypnotics. Sleep medicine expert Martin King joined LCG Bioscience to pioneer a new facility that will enable both early-stage and late-stage clinical trials on new compounds for improving sleep and respiratory health.King, the former Head of the Sleep Laboratory at Papworth Hospital, has an extensive knowledge of diagnosis and treatment of sleep disorders and has been actively involved in professional sleep societies for many years. He has developed techniques to accurately diagnose and quantify sleep disorders, and has seen huge numbers of patients. He has participated in the development of international measurement standards and has collaborated with researchers across Europe and the USA.

1. How did you become interested in sleep?In the mid-1980s I read an article that proposed a new treatment for a common sleep disorder, sleep apnoea, which is when a person stops breathing temporarily during sleep. I was working as a technologist at Guys Hospital at the time and had just seen a patient suffering with this complaint.I decided to try to build the apparatus described in the article myself, and to measure its effectiveness. To do this, I had to borrow equipment from many of the hospital’s departments, including neurology, cardiology, and medical physics. I ended up with a bank of monitors and paper recorders that would generate miles and miles of paper charts!As a result of this I developed a theoretical understanding of clinical sleep medicine. I found the subject fascinating, and my technical experiments evolved into research.But it was that first article that got me hooked!2. LCG's sleep laboratory is still a relatively recent development. How are things progressing?The sleep laboratory is going extremely well. We begin our first large-scale clinical trial in the sleep lab in January 2009. This will involve people suffering from insomnia, and will test a compound that is designed to help people fall asleep and stay asleep. We will assess the compound’s efficacy both with complex sleep studies in our purpose-built unit, and with home monitoring of symptoms and of daytime performance and wellbeing. Participants in the trial will come in around seven times over a couple of months to do overnight studies.We are in discussions with companies who are developing treatments for sleep disorders, but also with companies who are working on medications for other conditions which may affect sleep in some way – either positively or negatively. We have the facilities and expertise here to carry out studies on all aspects of sleep.3. Why is sleep research important to a clinical research organisation like yours?Sleep research is an important element of clinical research because not only are sleep complaints very common, there are also many medications devised to treat other ailments that have unintentional adverse effects on sleep. Sleep disorders are not just caused by lifestyle factors like too much caffeine or overwork – poor sleep can be an indication of an underlying medical disorder.Having the capabilities to do in-depth sleep studies enables us to provide not only an assessment of brain function and physiology but also of behaviour and performance when taking medication, such as reaction times, memory function and so on, because certain drugs can cause drowsiness. We also have expertise with biochemistry and can do laboratory tests to identify the underlying physiological changes that bring about a person’s observed symptoms, for instance the effects that Parkinson’s Disease has on a person’s sleep.4. How well is the science of sleep understood?Sleep is a relatively new discipline. That said, there are already 89 identified sleep disorders and the list is growing all the time.There is a great deal of interest in the field. For instance, when the treatment for sleep apnoea was developed, there were more articles published in the medical journals on this subject in an 18-month period than on any other medical or psychiatric complaint.There have been some huge surveys in recent years demonstrating the prevalence of sleep complaints, and also their impact on our health, safety and wellbeing. As well as the obvious things like increased incidence of road traffic accidents when drivers are sleep deprived, researchers have also identified less apparent effects, for instance a link has been made between breast cancer and the levels of the sleep hormone melatonin. We are learning new things all the time, which makes it a very exciting field to work in.5. What is driving the increased commercial interest in the field?Sleep disorders are incredibly common – insomnia affects up to 30% of the population at any one time, and around 10% of people have significant ongoing problems sleeping. As a result, there is a quest to develop a drug that will help people fall asleep, stay asleep and wake up feeling refreshed. Of course, such a drug must also have a good safety profile and no side effects. While significant strides have been made in this direction, the perfect compound remains elusive.6. What else does LCG Bioscience do, apart from sleep research?LCG Bioscience has been conducting early-stage clinical trials for over 16 years, and has built up a particular expertise in pharmacodynamics and pharmacokinetics. We have an excellent track record of doing first-in-human studies and also of conducting trials in patient groups to examine the efficacy of target compounds.It is important to obtain the maximum amount of information and data from each study that we undertake. LCG Bioscience helps to ensure that studies are designed and conducted in the most effective way to help bring new medicines to the market as safely and quickly as possible. At least part of this is done by making use of our biomarker laboratory, which can extract greater amounts of detailed information from a single clinical trial and enhance early decision-making.7. The current economic climate is possibly creating a few sleepless nights. Do you have any tips for restful nights?‘Put your day to bed’ – make a list of what you’ve done and what needs doing, and sign off your day. That way, you don’t go to bed worrying about things that you can’t deal with until tomorrow.Don’t have technology in the bedroom – bedrooms are for sleeping. If you define what goes on there, and ban email, television, and even mobile phones, you can create a relaxing haven that puts you in the mood for sleep simply by entering. It goes without saying that you should keep work items out of the bedroom too.Try to eat before 8pm, limit your alcohol intake, and avoid caffeine after 6pm. All these things can cause sleep disturbances.Give yourself time to wind down and relax before bed. A warm bath can help, and although there’s no scientific evidence for hot milky drinks, they may have a soothing psychological effect by putting you in the mood for sleep.8. I understand you are closely examining the possibility of remote sleep monitoring - studying people in their own homes. How is this going?Remote sleep monitoring is already a reality. We use wrist-mounted devices that can measure a range of parameters including movement, pulse, electrical activity and so on. These can also be used by patients to record instances of symptoms at any time of the day or night.A wrist-mounted electronic diary can also be made interactive, prompting the wearer to answer questions or input a response at a particular time, or at specific intervals. This could include rating mood or checking reaction times.These kinds of devices provide an opportunity for naturalistic home study, but the trade-off is a loss of control by the researcher. You have to trust your patients that they aren’t getting help answering the questions!9. How important has the wider Cambridge Life Sciences cluster been to your activities?Being in this area has been extremely important to us. This is an incredibly vibrant area for life sciences, and there are huge benefits that come from collaborating with other researchers in the same geographical area. The range of companies based here is really diverse, so there are terrific synergies to be explored.10. What three things most keep you awake at night?I’m very bad at sticking to the advice I give to other people! Only last night I was still working on my computer at 11:45pm – not the best way to ensure a good night’s sleep.I also suffer from backache, which can sometimes keep me awake.But the worst problem I have is – owls!

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