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Biomarkers the way forward for pharma, in HIV
 
 
  from Jules: I think this movement has great potential in HIV, why? Our concerns have moved from viral & immune responses & the effectiveness of HAART to long-term outcomes where we are finding that long-term safety is much more of a problem than we imagined in earlier years. We were 'giddy' over the benefits of HAART, and it has been a fantastic development, but we are discovering some very serious concerns for long-term outcomes, in that patients are experiencing much higher rates of non-AIDS comorbidities and at earlier ages compared to the general population including cancers, heart disease, bone disease, perhaps diabetes, neurologic disease and renal disease. Sure some of the reasons are lifestyle including a history of substance abuse, lack of exercise & good diet, smoking cigarettes etc. But there is quite a lot of research finding HIV and ARTs are offenders. Many studies have found HIV accelerates immune senescence, aging of the immune system, seen normally in elderly people. Lat year at CROI researchers reported heart disease was associated with immune senescence. Ongoing inflammation is a major concern, associated with chronic viral infection, and ongoing immune activation as well, and together these appear to be contributing to early and increased development of non-AODS diseases/comorbidities at high rates in HIV+ patients. Researchers have realized this and are dedicating research to this, as well the NIH has provided increased funding for these projects. Biomarkers in this research is key to understanding & characterizing these phenomena that patients are experiencing. Future HIV research in these areas will include lots of biomarkers to evaluate changes in patients, in fact these studies will be composed mostly of biomarkers and mortality.
 
Pharmatimes.com World News | March 08, 2011
Katrina Megget
 
CROI: Central Fat Accumulation in ART-naïve Subjects Randomized to ABC/3TC or TDF/FTC with ATV/r or EFV: ACTG A5224s, a Substudy of ACTG A5202 - (03/7/11)
 
CROI: Decreased Limb Muscle and Increased Central Adiposity Are Associated with 5-Year All-cause Mortality in HIV Infection - (03/7/11)
 
Biomarkers can save the industry's "damaged" drug pipeline and open up new areas for therapies, pharma and academia have been told.
 
Speaking at a recent meeting on biomarkers for Alzheimer's Disease, Professor Simon Lovestone, director of research, King's College London, said the drug pipeline was "damaged" because not enough drugs were coming through and many of those drugs that did make it onto the market were "toxic" - think Vioxx - while predicting patient outcomes and responses to drugs was currently very limited. Encouraging the use of biomarkers can help with these issues, he said.
 
"Biomarkers can also help with the measurement and efficacy of clinical trials and there's good evidence that work with biomarkers is demonstrating new areas for therapies," Lovestone added.
 
In Alzheimer's Disease, for instance, current biomarkers include a cerebrospinal fluid (CSF) tap and positron emission tomography (PET) scans. However, the CSF tap is an invasive procedure, while the accessibility of PET scans is limited making both options not particularly tenable in the long term, Lovestone said. "So we need to come up with something else."
 
Studies are currently underway looking at blood plasma proteins, which could act as biomarkers, as well as MRI brain scans to analyse different brain areas. Lovestone said the best way would be to combine the imaging with the blood protein tests as a biomarker for the disease.
 
Dr Chris Buckley, Alzheimer's imaging leader at GE Healthcare, agreed there needed to be an improvement in the biomarkers for Alzheimer's Disease. Current drugs for the disease tended to be more palliative, he said, targeting the late stage development of the disease.
 
"Alzheimer's Disease has a long incubation period making it difficult from a drug development perspective... Where a biomarker would be clinically useful at the moment is to predict the progression from mild cognitive impairment to Alzheimer's Disease. An ideal biomarker would be a quantitative objective measure that links the causal path between the underlying pathology and clinical presentation."
 
The European Medicines Agency is currently consulting on its first qualification opinion on a clinical biomarker for use in humans. The opinion relates to a request from Bristol-Myers Squibb for the use of two CSF biomarkers to select patients for clinical trials in pre-dementia Alzheimer's Disease.
 
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EMA consults on first human clinical biomarker opinion
 
Clinical News | February 24, 2011
 
Peter Mansell
 
The European Medicines Agency (EMA) has released for public consultation its first qualification opinion on a clinical biomarker for use in humans.
 
The positive opinion, which related to the use of two cerebral spinal fluid (CSF) biomarkers to select patients for clinical trials in pre-dementia Alzheimer's disease, was in response to a request from Bristol-Myers Squibb. The opinion is open for comments until 23 March 2011.
 
Adopted by the EMA's Committee for Medicinal Products for Human Use (CHMP) on the recommendation of its Scientific Advice Working Party, the draft opinion states that low levels of the protein A1-42 and high levels of the protein T-tau in the cerebrospinal fluid of patients with mild cognitive impairment appear to be linked to a higher risk of developing Alzheimer's disease-related dementia.
 
As both proteins are difficult to measure, laboratories will need to follow international guidelines and standardised quality control procedures during this process, the CHMP notes.
 
That includes qualification of biomarkers developed by research consortia, networks, public/private partnerships, learned societies or industry for a specific intended use in pharmaceutical research and development.
 
In October 2010, the EMA issued an opinion on a biomarker to predict kidney damage in rats.
 
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Personalised medicine "shaping the way R&D is done" - Biomarkers
 
World News | November 17, 2010
 
Lynne Taylor
 
Personalised medicine development is occupying a growing role in the clinical pipelines of drug developers and leading companies to change their R&D paradigms, including how they make "go/no-go" decisions, according to a new study.
 
"Early indications show that development of personalised medicines is commanding more resources and fomenting more organizational change than is generally appreciated outside the industry," according to Christopher-Paul Milne, associate director at the US Tufts Center for the Study of Drug Development (CSDD) and author of the study, which appears in the newly-published November/December issue of the Tufts CSDD Impact Report.
 
The study notes that the scientific, regulatory, commercial and practical challenges confronting developers in creating personalised medicines are significant and, as a result, approaches taken by individual companies in the pursuit of these new medicines vary greatly. In particular, developers are working with academic medical centres to better understand disease mechanisms and identify strata of target populations, and with diagnostics developers to augment in-house capabilities, says Dr Milne.
 
His findings also reveal that:
 
- the magnitude of resources required to create personalised medicines means developers must team with multiple external partners, presenting challenges for project stewardship and intellectual property rights;
 
- biomarkers are increasingly being used to better understand patient response, but companies still cannot use biomarker data to support approval until the regulators' capacity to evaluate it catches up to the science;
 
- oncology leads other therapeutic areas in the number of personalised medicines on the market as well as in the pipeline, with the expectation that within the decade all oncology drugs will have a related diagnostic; and
 
- other key therapeutic areas in which personalised medicine is making headway include cardiovascular, central nervous system and immunologic therapies. Elsewhere, personalised medicine development is just getting started for metabolic and respiratory therapies, as well as virology, the study notes.
 
· PricewaterhouseCoopers has forecast that the US market for personalised medicine will grow around 11% a year from a value of $232 billion in 2009 and could reach $425 billion by 2015, while earlier this month a report from UBM Canon Data Products Group projected that sales of biomarkers for use in clinical trials will grow 37.6% by 2015.
 
www.csddtufts.edu
 
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EMA consults on first human clinical biomarker opinion
 
Clinical News | February 24, 2011
 
Peter Mansell
 
The European Medicines Agency (EMA) has released for public consultation its first qualification opinion on a clinical biomarker for use in humans.
 
The positive opinion, which related to the use of two cerebral spinal fluid (CSF) biomarkers to select patients for clinical trials in pre-dementia Alzheimer's disease, was in response to a request from Bristol-Myers Squibb. The opinion is open for comments until 23 March 2011.
 
Adopted by the EMA's Committee for Medicinal Products for Human Use (CHMP) on the recommendation of its Scientific Advice Working Party, the draft opinion states that low levels of the protein A1-42 and high levels of the protein T-tau in the cerebrospinal fluid of patients with mild cognitive impairment appear to be linked to a higher risk of developing Alzheimer's disease-related dementia.
 
As both proteins are difficult to measure, laboratories will need to follow international guidelines and standardised quality control procedures during this process, the CHMP notes.
 
EMA qualification is a new, voluntary scientific pathway leading to either a CHMP opinion or scientific advice on novel methodologies or drug development tools.
 
That includes qualification of biomarkers developed by research consortia, networks, public/private partnerships, learned societies or industry for a specific intended use in pharmaceutical research and development.
 
In October 2010, the EMA issued an opinion on a biomarker to predict kidney damage in rats.
 
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NICE 'yes' for AD drugs to treat mild forms of the disease
 
UK News | January 18, 2011
 
Selina McKee
 
As expected the National Institute for Health and Clinical Excellence has published draft guidance on the treatment of Alzheimer's disease lifting previous restrictions on using drugs to treat patients with mild forms of the disease.
 
In guidelines unveiled this morning, the cost regulator for treatments funded by the National Health Service in England and Wales confirmed its new position that Eisai/Pfizer's Aricept (donepezil), Shire's Reminyl (galantamine) and Novartis' Exelon (rivastigmine) are cost-effective options for the treatment of mild to moderate forms of Alzheimer's disease, extensively expanding patient access to these drugs.
 
The recommendations represent a major U-turn in NICE's position; the Institute previously barred the use of Aricept, Reminyl and Exelon in patients with mild forms of the disease and limited Ebixa to clinical trials for patients with moderate to severe symptoms, triggering a stream of campaigns and even High Court battles from those adamant that it had drastically underestimated costs of care and had overlooked carer benefits when drawing up its cost-effectiveness model.
 
Explaining the cost watchdog's change of heart, its chief executive Chief Executive Sir Andrew Dillon said that since 2007 "clinical trials have continued to show the positive effects of these drugs and, in the case of memantine, have reduced the uncertainty about its clinical effectiveness". Furthermore, he said more information about the costs of living with and treating the disease through its stages has become available, paving the way for the drugs' use on the NHS.
 
"This is great news for people with Alzheimer's disease and their families," said Professor Roy Jones from The Research Institute for the Care of Older People, Royal United Hospital, Bath, UK. "Patients with mild disease will at last be able to get access to early, cost-effective treatment at the point of diagnosis - treatment that can potentially help to relieve the symptoms in these patients", he added.
 
Shift in treatment strategy?
 
The new recommendations will likely cause a significant shift in treatment strategies in the UK. Results of a survey by Eisai and Pfizer has revealed that 70% of GPs believe their management of Alzheimer's will change as a result of the new recommendations, while 64% believe their detection and diagnosis of mild forms of the condition will improve as a result of the expected new NICE guidance. Moreover, 58% of said that they would recall patients with mild Alzheimer's who had previously been denied access to treatment for a reassessment.
 
Novartis was also quick to welcome the new guidelines, which should boost the use of its new patch form of its AD drug Exelon. "The Exelon Patch is the first and only transdermal patch licensed for the symptomatic treatment of mild to moderately severe Alzheimer's dementia [and] is an important treatment option as it reduces the patient pill burden, provides visual reassurance of compliance for the carer and has a preferable side effect profile compared with oral Exelon capsules", the firm said.
 
The draft guidance is now open to consultation, and final guidelines are expected in March 2011.
 
 
 
 
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