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Main Category: Conferences
Article Date: 06 Mar 2013 - 9:00 PST
Life Sciences organisations in Europe are facing unprecedented challenges: a heightened competitive state is squeezing margins, whilst at the same time emerging markets bring new opportunities as well complexities that require water-tight commercial compliance, firm controls on discounts, rebates and incentives as well as highly skilled teams with a clear strategy and good insights.

Bringing your organisation together with others is our objective and the reason why The European Pricing Platform & ModelN are again joining forces to host their 3rd European Annual Pricing & Profit Optimisation Forum, focused entirely on Life Sciences.

This year's conference will again take place over 2 days and the agenda has been built to provide compelling plenary sessions as well as cater for Med-tech and Pharma-Biotech tracks with some of the most influential industry experts and some practical and tangible case studies.

The success of last year's forum was down to 3 factors:

• High caliber of speakers and content
• Industry specific with focus on sub-industries
• Only event of its kind geared towards REAL networking

This is a unique opportunity to discuss, learn and challenge both strategic and tactical topics affecting Life Sciences professionals in Europe, thus providing a holistic perspective for attendees to take back into their organisations.

This forum will allow you to take the pulse of what is happening for strategies, processes and technologies, as well as hear approaches you might not have been aware of. 


This Forum will help build your and your teams' knowledge, providing you the opportunity to discuss how you might apply it in your company to improve performance.

Full program

Practical information:

Date: 5th & 6th June 2013
Venue: Grand Hôtel Suisse-Majestic
Avenue des Alpes 45

1820 Montreux

Switzerland
Rates:
€ 1495,00 for non-EPP Participants

€ 1346,00 for EPP Participants
"Early bird action": Apply before the 30th of March and save € 300,00
Website for information or registration: http://www.pricingplatform.eu
For more information, e-mail: ilse.stevens@pricingplatform.eu

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Main Category: HIV / AIDS
Also Included In: Liver Disease / Hepatitis
Article Date: 06 Mar 2013 - 9:00 PST
80 percent of patients achieved early treatment success* with faldaprevir^ plus PegIFN/RBV highlighting the potential to reduce treatment duration from 48 to 24 weeks. Interim results indicate potent activity of faldaprevir in HCV/HIV co-infected patients

Interim study results from STARTversoTM 4 presented today at CROI+ show that 80 percent of hepatitis C (HCV) patients also infected with HIV achieved early treatment success with faldaprevir (BI 201335) combined with pegylated interferon and ribavirin (PegIFN/RBV).1 These patients have a high unmet medical need due to limited treatment options; up to 10 million people2 are co-infected with HIV and HCV worldwide and it is estimated that only around one-third of those diagnosed actually receive HCV treatment.3

These interim results from STARTVersoTM 4, demonstrate early treatment success in a majority of patients regardless of whether they were treatment-naïve or relapsed after prior treatment for HCV.  Patients who achieved early treatment success may be eligible for 24 weeks rather than the standard 48 weeks of treatment with PegIFN/RBV. Interim on-treatment data show that 84 percent of patients had undetectable levels of HCV at week 12 of treatment with this regimen.1

"Several factors influence the likelihood of treatment success in HCV mono-infected patients, including personal genetic makeup, viral genotype and stage of liver disease. Co-infection with HIV contributes additional factors, including potential drug-drug interactions that influence treatment decisions and outcomes," said lead study Investigator Douglas Dieterich, MD, Professor of Medicine, Liver Diseases at Mount Sinai Medical Center, New York, NY. "The early virologic response data from STARTVersoTM 4 are encouraging, especially given the inclusion of patients with cirrhosis, and we look forward to the final trial outcomes."

A diverse range of patients, including the more challenging to cure, are being treated in this study; 17 percent have liver cirrhosis, an advanced form of liver disease, and 22 percent of patients had relapsed after previous treatment with PegIFN/RBV.

Additional data presented at this meeting examined the drug-drug interactions (DDI) of faldaprevir with commonly-prescribed HIV medications darunavir/ritonavir, efavirenz, and tenofovir. The three Phase I studies demonstrated that there was no clinically relevant effect of faldaprevir on these HIV medications.4

"We are proud to present interim Phase III results from STARTVersoTM 4 in patients co-infected with HCV and HIV; the potential for a shorter treatment duration for these patients is important, particularly in reducing the length of time they are exposed to possible side effects associated with a year-long course of interferon," said Professor Klaus Dugi, Senior Vice President Medicine at Boehringer Ingelheim. "Patients with HCV/HIV co-infection have a high unmet clinical need. The encouraging efficacy results and manageable interactions with HIV medications suggest faldaprevir in combination with PegIFN/RBV could be a viable treatment option for this important patient population."

The most frequent adverse events (AEs) in STARTVersoTM 4 were nausea (37%), fatigue (33%), diarrhoea (27%), headache (23%), and weakness (22%). The safety results of this study were thus comparable to those observed in HCV mono-infected treatment-naïve patients in prior faldaprevir clinical studies.1

Faldaprevir is an oral once-daily protease inhibitor, specifically designed to target and inhibit viral replication in the liver. Interferon-based therapy with faldaprevir is effective in a broad spectrum of genotype-1 patients.  In addition to the results presented today, the ongoing Phase III trial programme, STARTVerso, evaluates faldaprevir combined with PegIFN/RBV in treatment-naïve and treatment-experienced genotype-1 HCV patients.

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Featured Article
Academic Journal
Main Category: GastroIntestinal / Gastroenterology
Also Included In: Cancer / Oncology;  Medical Devices / Diagnostics
Article Date: 06 Mar 2013 - 3:00 PST
A simple test that analyzes the chemical signature of a patient's exhaled breath could help diagnose stomach cancer, according to new research by scientists from Israel and China reported online in the British Journal of Cancer this week.

The researchers hope the breath test will offer an easier screening tool than endoscopy, where a specially trained medical professional looks at the inside of the stomach via a tube inserted down the patient's gullet, and sometimes also retrieves a biopsy sample of the stomach lining.

Senior author Hossam Haick, a professor in the Department of Chemical Engineering and Russell Berrie Nanotechnology Institute, at Technion, the Israel Institute of Technology, says in a press statement:

"The promising findings from this early study suggest that using a breath test to diagnose stomach cancers, as well as more benign complaints, could be a future alternative to endoscopies - which can be costly and time consuming, as well as unpleasant to the patient."

He cautions, however, that the findings of the pilot study are still at "an early stage", and serve more to confirm the idea that a breath test for stomach cancer is worth investigating further.

"Indeed, we're already building on the success of this study with a larger-scale clinical trial," says Haick.

Haick has been studying the effectiveness of nanoparticle sensors as a way to detect minute traces of disease biomarkers for a while. The sensors use materials that are thousands of times smaller than the thickness of human hair, and capable of detecting just a handful of molecules.

In 2011, the British Journal of Cancer reported how a nanosensor "nose" developed by Haick and his team successfully distinguished patients with head and neck or lung cancer from healthy controls by analyzing patterns of molecules in their exhaled breath.

For this latest pilot study, the researchers used nanomaterial-based sensors to analyze breath samples from 130 patients who had undergone endoscopy, some with biopsy. 37 of the patients had been diagnosed with stomach cancer, 32 had ulcers, and 61 had less severe stomach complaints.

The nanomaterial sensors showed an over 90% success rate in distinguishing the patients with stomach cancer from those with more benign complaints.

Plus, they were more than 90% accurate at distinguishing early from late stage stomach cancers.

In their background to the study, the researchers explain how there is a high demand, especially in the developing world, for "a simple and non-invasive test for selecting the individuals at increased risk that should undergo the endoscopic examination".

The procedure uses a method called "discriminant factor analysis (DFA) pattern recognition", to detect specific combinations of different exhaled chemicals and find recurring patterns in people with the same stomach complaint.

The analysis takes into account possible confounding factors such as effects from alcohol and tobacco consumption.

The researchers conclude that:

"Although this pilot study does not allow drawing far-reaching conclusions, the encouraging preliminary results presented here have initiated a large multicentre clinical trial to confirm the observed patterns for GC [gastric cancer] and benign gastric conditions."

Kate Law, director of clinical research at Cancer Research UK, says, "Any test that could help diagnose stomach cancers earlier would make a difference to patients' long-term survival."

"Only 1 in 5 people are able to have surgery as part of their treatment as most stomach cancers are diagnosed at stages that are too advanced for surgery," says Law.

Every year in the UK, around 7,000 people develop stomach cancer, and most are in the advanced stage when they are diagnosed.

One of the reasons for late diagnosis is because early stage symptoms are vague and similar to more benign conditions.

The early symptoms of stomach cancer, also called gastric cancer, include: indigestion, heartburn, stomach ache, and feeling very full after eating.

When the cancer reaches a more advanced stage, blood starts to appear in the stools, they become black, and the person also loses weight and lacks appetite.

As well as creating new options for disease diagnosis, nanotechnology is also opening new avenues in drug delivery, gene therapy, and many areas of research, development and clinical application.

Written by Catharine Paddock PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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Main Category: Alcohol / Addiction / Illegal Drugs
Article Date: 06 Mar 2013 - 2:00 PST
UK alcohol consumption per head down again - 3.3 per cent drop in 2012. 16 per cent decline in consumption per head since 2004. Per capita consumption below 8 litres per head, first time since 1998.

New figures for UK alcohol consumption in 2012 show that the amount Britons drink has fallen yet again - for the sixth year out of the past eight. Consumption per head is now 16 per cent lower than it was in 2004 when the current trend began, says the British Beer & Pub Association, which has compiled the new data based on HMRC alcohol tax returns.

2012 was the first year since 1998 that alcohol consumption has dropped below eight litres per head, per year (7.99 litres).

Brigid Simmonds, BBPA Chief Executive, comments:

"Total alcohol consumption is now 16 per cent lower per head than in 2004, when this trend began. While alcohol misuse remains a problem for a minority that we must all work to tackle, it is also important that the debate is fully informed by the latest facts on levels of consumption."

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Main Category: Transplants / Organ Donations
Article Date: 06 Mar 2013 - 2:00 PST
Liver transplantation for hepatoblastoma, the most common liver malignancy in children, is on the rise because more tumors are being detected earlier, improving outcomes for these sick patients, according to a Children's Hospital of Pittsburgh of UPMC study.

Results of the study, led by Rakesh Sindhi, M.D., codirector, Pediatric Transplantation at the Hillman Center for Pediatric Transplantation at Children's Hospital, are published in the February issue of Surgery.

Dr. Sindhi and the group observed outcomes in 35 children with hepatoblastoma who received transplants over three decades at Children's Hospital, making this the largest published single center experience in the United States. Nearly twice as many patients received liver transplants for the malignancy at Children's Hospital in the most recent decade compared to the previous two decades. This observation led the group to ask whether the incidence of this malignancy and of liver transplantation for hepatoblastoma has increased in the United States, thereby posing additional challenges in allocating the scarce resource of pediatric livers available for transplantation, and whether increased use of liver transplantation has improved posttransplantation outcomes for children diagnosed with this form of cancer.

To evaluate national trends, the researchers reviewed data from the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) registry representing 9.451 percent of the U.S. population from 1975 to 2007; the United Network for Organ Sharing (UNOS) from 1988 to 2010; and Children's Hospital from 1987 to 2011.

The group found that estimated hepatoblastoma cases in the United States increased fourfold between 1975 and 2007, liver transplantation for hepatoblastoma during the last two decades increased 20fold between 1988 and 2010, with 153 liver transplants occurring in the last 5 years, and hepatoblastoma surpassed other inoperable liver malignancies requiring liver transplantation from 2.8 percent to 7.5 percent.

"For several years, it has been recognized that many children with hepatoblastoma were born early. Advances in the care of premature babies, and their increased survival as a result, is an important reason for the increased incidence of this tumor," said Dr. Sindhi.

Estimates suggest that more than six in 10 children with hepatoblastoma can be cured with surgical removal of the mass after chemotherapy. Liver transplantation is appropriate if the tumor is confined to the liver, but cannot be removed safely because of its location or involvement of many parts of the liver. Three of four children treated with transplantation can be cured.

Recurrences usually occur within the first two years after transplantation in onesixth of children undergoing liver transplantation. Recurrences are more common if the liver tumor was accompanied by spread to other organs before transplantation, or if the tumor was less responsive to chemotherapy. Remarkably, if the tumor outside the liver is removed completely with either chemotherapy or surgery before transplantation is undertaken, half of such children can still be cured with liver transplantation. In this regard, hepatoblastoma tumors are very different from the liver cancer that can develop in adult and older age groups. They also found that hepatoblastoma tumors with "anaplastic" or highly aggressive tumor cells were less likely to recur after liver transplantation than what has been reported previously after surgical resection.

For more information on Dr. Sindhi and the Hillman Center for Pediatric Transplantation, click here.

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Main Category: Eye Health / Blindness
Also Included In: Genetics
Article Date: 06 Mar 2013 - 2:00 PST
Researchers from the University of Miami Miller School of Medicine collaborated with an international team to identify seven new genes associated with agerelated macular degeneration (AMD), the most common form of vision loss in older people. Published online March 3 in Nature Genetics, their study, "Seven New Loci Associated with AgeRelated Macular Degeneration," provides new directions for biological, genetic and therapeutic studies of macular degeneration.

Margaret A. PericakVance, Ph.D., director of the John P. Hussman Institute for Human Genomics, who serves on the senior executive committee for the International AMD Genetics Consortium, is a senior author on the paper. Other UM coauthors include William K. Scott, Ph.D., professor in the Dr. John T. Macdonald Foundation Department of Human Genetics, and Stephen Schwartz, M.D., associate professor of ophthalmology, and Jaclyn L. Kovach, M.D., assistant professor of ophthalmology, at Bascom Palmer Eye Institute.

This research was conducted by the AMD gene consortium, which the NIH's National Eye Institute created in 2010 to identify the remaining genetic risk variants for AMD. It is composed of more than 60 institutions, including UM, from around the globe.

"We hope that identifying seven new genes associated with macular degeneration will eventually lead to new therapies for this devastating disease, which robs people of their vision," said PericakVance, who has been researching the genetics of eye diseases for decades. In 2005, she and Scott were part of the team that identified genetic variation in complement factor H (CFH) as the first major genetic risk factor for agerelated macular degeneration. The paper continues to be one of the most cited in biomedical research.

To accelerate understanding of AMD biology and help design new therapies, the researchers conducted a collaborative genomewide association study of more than 17,100 people with advanced AMD, and more than 60,000 controls of European and Asian ancestry. Seven novel loci located near the genes COL8A1/FILIP1L, IER3/DDR1, SLC16A8, TGFBR1, RAD51B, ADAMTS9/MIR548A2, and B3GALTL were identified in this study.

The large collaborative effort allowed for the discovery of new smaller effect but genomewide significant risk alleles. Some loci contribute differently to disease risk depending on gender and ethnicity. These risk variants provide good risk prediction. The results further strengthen implications of complement system involvement in AMD etiology.

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Main Category: Pharma Industry / Biotech Industry
Also Included In: Primary Care / General Practice
Article Date: 06 Mar 2013 - 1:00 PST
The pharmaceutical industry has pulled back on marketing to physicians and consumers, yet some enduring patterns persist. According to a new study led by researchers at the Johns Hopkins Bloomberg School of Public Health, advertising peaked in 2004, with industry promotion to physicians declining nearly 25 percent by 2010, to $27.7 billion or 9 percent of sales. Similar declines were seen in direct-to-consumer advertising, which remains concentrated among a small number of products. The number of products promoted to providers peaked at over 3,000 in 2004, and declined by approximately 20 percent by 2010. Despite these changes, there was little change in the split of marketing between primary care physicians and specialists, and the proportion of all promotion taking place in physicians' offices also remains unchanged. Free samples and physician detailing accounted for over 70 percent of promotional expenditures in 2010, with the remainder comprised by consumer advertising as well as physician marketing through journal ads, e-promotion and sponsored conferences and meetings. The results are featured in the February 2013 issue of the open-access journal PLOS ONE.

"There have been important changes in the pharmaceutical marketplace during the past decade, including changes in the types of therapies being brought to market as well as an overall aging of the drugs with FDA approval," said G. Caleb Alexander, MD, MS, senior author of the study and an associate professor with the Bloomberg School's Department of Epidemiology and co-director of the Johns Hopkins Center for Drug Safety & Effectiveness. "Since pharmaceutical promotion can influence demand for drugs and affect physician prescribing, it is important to know how drugs are being marketed and promoted."

Alexander, along with colleagues from the University of Chicago, the University of Pittsburgh, Massachusetts Institute of Technology and the National Bureau of Economic Research, analyzed annual data from 2001 through 2010 to examine inflation-adjusted total promotion spending for the pharmaceutical industry as a whole and for top-selling and top-promoted therapies. Expenditures were also broken down by type of promotion and, for physician detailing, by specialty.

The authors were surprised to find that, despite anecdotal reports and calls from professional societies, there was no substantial change in the amount of overall proportion of promotion taking place in physicians' offices. Lead author Rachel Kornfield describes, "There has been growing concern about the conflicts of interest introduced by physicians' relationships with pharmaceutical companies, but the data show that physician detailing and the distribution of free samples is still the dominant form of drug promotion."

In addition, despite enthusiasm and publicity regarding new forms of marketing via the Internet and other electronic media, these channels accounted for a very small amount of overall marketing spending to providers - less than 2 percent over the decade examined. The authors found that the majority of marketing and promotion still takes place as it has in the past - through the distribution of free samples to patients and office calls to physicians.

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