SAS, the leader in business analytics, announced that Shire, the global specialty biopharmaceutical company, has selected SAS® Drug Development as the platform for its clinical trials data.

“Shire is excited about our partnership with SAS, and we look forward to leveraging the SAS Drug Development platform to manage our clinical trial data,” said Nick Ronca, Associate Director Clinical R&D, Shire Pharmaceuticals.

SAS Drug Development is available as a standalone or hosted solution with access via a secure, thin client. A centralized repository allows life sciences firms to aggregate, analyze and review clinical trials data to determine safety and efficacy outcomes.

“Our approach at SAS allows our customers, like Shire, to be more focused and efficient in developing and delivering medicines to patients and their families around the world,” said Jason Burke, Global Director of Health and Life Sciences for SAS.

21 CFR and CDISC Compliant

SAS Drug Development allows rapid and reliable validation and implementation, eliminating strain on limited IT infrastructure and resources. The solution is compliant with global agency regulations, such as 21 CFR Part 11, which is often difficult to attain.

“Our hosted global environment contains a single view of the targeted clinical data in a secured and qualified environment so scientists, programmers and statisticians can view the most up-to-date, accurate information” said Burke.

SAS’ scalability and flexibility were features important to Shire, which has grown rapidly through acquisitions and mergers over its nearly twenty-five year history. Shire, which has a presence in 23 countries and markets medicines in more than 45 countries, needed a global solution for managing and processing its clinical trial data.

“Working in unison with SAS allows Shire to focus on meeting its mission, and investing in its product portfolio instead of developing a complex IT infrastructure to support clinical data,” said Burke.

SAS Implementation Team

Relying on the SAS Consulting Group that has successfully deployed SAS Drug Development in the past, Shire believes that the system will maximize the best practices of both Shire and SAS.

SAS is demonstrating SAS Drug Development at the DIA 45th Annual Meeting in Booth 301.

Source
SAS

A new Auburn University-designed, high-tech pharmacy in Meridian, Miss., is the first of its kind and is a model facility that could be built in communities across the United States.

Auburn pharmacy professors Kenneth Barker and Betsy Flynn led a multidisciplinary team in designing the recently opened facility for Vital Care Inc., which will help pharmacists offer complex medications for in-home use, ones that are normally administered only in hospitals.

The two-story, 16,000-square-foot building is used for preparing, dispensing and administering the medications, while, at the same time, serving as a demonstration and teaching model for potential franchisees wishing to open a similar facility. Pharmacists may choose to duplicate the entire design for home-infusion medications or individual function areas.

Home infusion is a growing trend among pharmacies through which medications are administered in homes by nurses, caregivers or patients themselves. This includes potent intravenous antibiotics, chemotherapy, cardiac medications and intravenous nutritional formulas.

“We conducted research to determine the best work flows and safety for this new pharmacy that offers such high-level medication and treatments,” said Barker, director of the Center for Research on Pharmacy Operations and Designs in Auburn’s Harrison School of Pharmacy.

“Our pharmacy design program is unique in that we give much more attention to the functional programming phase than is normally given to the design of a commercial facility.”

Functional programming is the gathering of “evidence-based” information before any design work is considered. Barker’s team uses trained observers, who are pharmacists and nurses, to observe various operational setups to determine the best floor and fixture layout for each job function. He says this works much better than the traditional use of questionnaires given only to those who will be occupying a proposed facility.

“We also insist on interviewing the top 15 or so people in an organization and passing along our recommendations before even meeting with architects,” Barker said.

The new building has a sterile preparation area, compounding area and a specialty pharmacy area for limited-distribution medicines, such as those used in clinical trials. It also has four treatment suites for patients who need to receive treatments at the facility, rather than at home. Patients are able to receive treatment while having Internet access, listening to music or watching television on the suite’s audio-video system.

The Auburn pharmacists worked on the project with professors Shea Tillman and Christopher Arnold of Auburn’s Department of Industrial Design; Meridian architect Robert Luke of Luke Peterson Kaye Architects; information technology consultant Brad Barker; and Paul Giles, vice president of R.C. Smith company which designs pharmacy fixtures.

Auburn alumni Johnny H. Bell, owner Vital Care Inc., and son Jonathan C. Bell, owner of the Vital Care franchise that serves Meridian and West Alabama, asked the Auburn professors to help design the facility.

“We now have a model facility to show pharmacists how they can provide home infusion service, especially in rural areas,” said the senior Bell, an alumnus of the Auburn School of Pharmacy. “We combined our staff’s knowledge of high-technology therapies and infusion pharmacy operations with the design and ergonomics knowledge of the Auburn design team.”

Bell founded Vital Care Inc. in 1986 and has expanded the company to 75 employees in Meridian and 140 franchisees in 18 states. In addition to assisting franchisees with their business startup, Vital Care conducts various business and clinical functions and it offers expertise about reimbursement from Medicaid, Medicare and private insurance companies. The company provides information about construction of medication preparation areas to comply with federal and state requirements. Also, its nurses travel to the franchisee’s area to train local nurses to work with home-infusion patients.

Source: Auburn University

Tobacco acts as a precipitating factor for headaches, specifically migraines. This is indicated in a study which shows that smokers have more migraine attacks and that smoking more than five cigarettes a day triggers this headache. The work has appeared in The Journal of Headache and Pain.

The influence of tobacco as a precipitating, non-causal factor of migraine attacks has produced contradictory data in scientific literature. The limited research prior to the work published in The Journal of Headache and Pain indicated that smoking could improve migraines by reducing anxiety, one of the factors that triggers an attack.

“This study is groundbreaking in Spain as there are few studies on this topic, and all are very biased. This is due to the complexity and need for prior training of the participants”, Julio Pascual, one of the authors of this research and doctor at the Neurology Unit of Marques de Valdecilla, University Hospital (Santander), explains to SINC.

One advantage of this study is that the sample used, 361 medicine students from the University of Salamanca, were fully aware what a migraine was. The experts, who enquired about the presence or absence of migraine (and its characteristics) and whether or not they smoked, guaranteed the reliability of the results obtained, as most surveys for this type of study are done over the phone, randomly and in people without knowledge of the illness.

The results show that 16% of students fulfilled migraine criteria, while 20% smoked. The percentage of smokers was higher (29%) in those who were also migraine sufferers and migraine frequency in those students who were migraine sufferers and smokers was clearly higher than in those who were non-smokers and migraine sufferers.

According to Pascual, “smoking is a precipitating factor of this type of headache, as the prevalence of active smokers is one third higher in migraine sufferers and there is a direct relationship between the number of cigarettes consumed and the frequency of migraine attacks”.

The researchers stressed the importance of the dosage. The results of the interviews reveal that the migraine sets in after five daily cigarettes. Furthermore, although the percentage of those who smoked was higher in people with migraines, they smoked less than those who did not suffer migraines.

“This is because they themselves knew that if they exceeded five cigarettes a day, they were more likely to have a migraine attack. The pain itself acts as a limiting factor”, explains the neurologist, who maintains that “in no case should a migraine sufferer be advised to smoke thinking that it is going to improve their migraines. What’s more, if you smoke a lot you should reduce the dose drastically”.

90% of affected people self-medicate

“The supposed migraine cure ends up becoming its cause because of self-medication”. Feliu Titus, an honorary member of the Spanish Neurological Society, explained last May in the paper Migraine treatment. The role of non-pharmacological methods, in Barcelona.

In Spain, this illness affects five million people and 2% of the population suffers attacks for more than 15 days a month. According to Titus, “more than 20% have never consulted a specialist”. 90% of migraine sufferers self-medicate, without being aware of the risk that this entails. Anyone who suffers from migraines and abuses drugs ends up suffering adverse effects and a worsening of the illness due to a “rebound effect”, according to specialists.

Chronic headaches are a separate illness and one of the most frequent chronic diseases. Although the causes are still not clear, in some migraine cases it is already demonstrated that there is a genetic basis. In fact, most patients with migraines have a history of it in their family.

“Nowadays it is believed that migraines are a state of hyperexcitability of the neurons that control headaches. Migraine sufferers are born with ion channels in the membrane of the neurons which are much more permeable and excitable. The brain of migraine sufferers is therefore able to link an attack with precipitating stimuli such as tobacco”, Julio Pascual concludes.

To a large extent, the cause of this hyperexcitability has a genetic basis. In fact, some specific mutations are already known to be responsible for the hyperexcitabilty of these membrane ion channels.

Source: Plataforma SINC