First UK use of abdominal stent

by Joel 29. July 2011 16:19

A new abdominal aortic stent, used to repair aneurysms, has been implanted in the UK for the first time.

Vascular surgeons at Manchester Royal Infirmary (MRI) have implanted the Ovation abdominal stent graft from TriVascular in four patients, who are all recovering well.

The Ovation, the smallest stent available, could make endovascular aortic repair (EVAR) available to a much greater number of patients with aortic aneurysms.

EVAR, a minimally invasive procedure, involves making a small cut in the skin of the groin and guiding a stent into the artery, where it will allow blood to by-pass the aneurysm.

For some patients with narrow arteries, EVAR can be dangerous because traditional stents are too large (8mm in diameter). The Ovation stent is 4–5mm in diameter, making it much easier to place within the artery. It contains a polymer that expands to fit the artery wall, creating an effective seal.

“Our team was delighted to be the first in the UK to trial this new device, and we believe there will be major benefits for patients,” said Mr Ferdinand Serracino-Inglott, who carried out the surgery.

“It is a much simpler and less traumatic procedure for the patient, can be done with a spinal epidural rather than general anaesthetic and just involves an overnight stay in hospital. There are fewer risks of damage to the artery, and only a small nick in the skin is required to insert the stent, so recovery is extremely quick. All these factors mean that the option of EVAR will be available to many more patients for whom surgery with standard-sized stents may be too risky.”

The MRI will be one of three UK centres involved in a pan-European evaluation of the Ovation device with 500 patients over the next 4 years.

Based in Santa Rosa, California, TriVascular supplies endovascular grafts designed to advance and expand the use of EVAR.

Ovation stent web 
Ovation stent

NICE unsure of photodynamic therapy

by Joel 29. July 2011 16:11

Final NICE guidance on the Ambulight photodynamic therapy (PDT) device to treat non-melanoma skin cancer says there is not enough evidence to support its routine use in the NHS.

However, the device from Scottish company Ambicare Health remains one of the potential options while the evidence base is developed further.

Ambulight PDT consists of a battery-powered, disposable light-emitting device that is stuck to the skin with a disposable sticking plaster. It delivers an ambulatory therapy that can be used in the home or the community, whereas conventional PDT requires a hospital appointment.

In addition, Ambicare claims that the device’s lower irradiance makes it less painful for the patient than PDT sources.

The Medical Technologies Advisory Committee decided there was some evidence for the effectiveness of Ambulight PDT, but said the evidence on its use was too limited to support a recommendation for its routine adoption.

In particular, the cost data were too varied: the cost difference between Ambulight PDT and conventional PDT ranged from a saving per patient of £195 to an increase of £536, making firm conclusions difficult.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, commented: “The management of non-melanoma skin cancers imposes a significant workload on both primary and secondary care services, and therefore a device that offers PDT therapy in a community setting has the potential to have a positive impact on service provision.

However, she said, it was “uncertain” to what extent the relevant “changes in service provision” would result in benefits, as the evidence for the device’s efficacy was “of limited quantity”. NICE recommended that the device remain a treatment option in order to generate further evidence.

ambulight_pdt_prod02 web 
Ambulight PDT

A flexible friend

by emma 29. July 2011 15:58

aflexiblefriend

Modern business now places a heavy reliance on the concept of outsourcing. Strategists across all sectors have recognised the potential for third-party organisations to manage key business functions, find efficiencies and drive growth. The pharmaceutical industry has been an active participant in the trend towards outsourcing services – not least in the key areas of sales and marketing. Pf’s Iain Bate looks at the global phenomenon of outsourcing.

The concept of outsourcing is not a modern ideology. The approach first came to prominence in the 1950s when specialist functions, such as advertising and legal services, were outsourced to third-parties by organisations large and small. From little acorns… In today’s business environment, as companies assess their core competencies, anything from research and development, manufacturing and marketing services to IT, Human Resourcing, accounting and supply chain activities are considered fair game to be outsourced.

Lift-off came during the 1990s, when rapid technological change and an increased sense of competitiveness saw companies take note of the flexibility, cost-saving potential and reduced risk in operations that contract organisations could offer. This quickly led to outsourcing services becoming widespread in developed economies.

The pharmaceutical industry has contributed heavily to the growth of outsourcing – in particular in the areas of Contract Research and Contract Sales. Contract Sales Organisations (CSOs) are now a major player within pharma. They manage a growing proportion of sales in the sector and, according to research by the Kalorama Information, the CSO market has been forecast to exceed $5bn by the end of the year. Of course it’s not just in pharma where CSOs have become popular, but without the pharma sector as a whole, it could be argued that the global market for contract sales would be nowhere near as significant as it is today.

Leading the way

It was largely the pharmaceutical industry which pioneered the use of CSOs and began outsourcing tactical sales effort. The provision of flexible and, in many cases, short-term resource to augment the efforts of the in-house sales force proved popular among many pharmaceutical companies. Since then a growth in the principle of outsourcing sales has seen CSOs develop their portfolios to offer a wide range of services beyond the tactical ‘share of voice’ model.

Beth Rogers, Principal Lecturer of Sales Management at Portsmouth University – and the former Chair of the UK National Sales Board and Research Director of the Institute of Sales and Marketing Management – says it was, and still is, this variety of services and the opportunity to trim costs which makes CSOs appealing.

But, certainly in a cold economy where finding efficiencies and delivering return on investment have become imperative, perhaps the biggest draw is flexibility.

“From my research, flexibility has been heavily emphasised by people I’ve been talking to who use CSOs – both providers and users,” says Beth. “It’s about effective sales resourcing as well as being efficient. Contract sales absorb some of the risk when you’re trying to be speedy to market with something which may have a relatively short life span. I think for pharma companies, it’s not so much that they’re gaining on operational costs, they’re certainly avoiding fixed costs, and that’s a factor.”

Modern day CSOs now get called upon for a variety of projects. Product launches are a common area in which they are used, but beyond this they are increasingly being asked to provide more specialist expertise for longer periods of time; clinical audits, nurse advisor programmes, Key Account Management, healthcare development and payer engagement are all areas where CSOs are being used to provide services. In some companies, contract resource is the only sales resource deployed. This represents a much more sophisticated use of contract sales than in many other sectors. “In some industries, CSOs are used for part of the sales process,” said Beth. “For example, it might make sense to have CSOs focused up to a certain point, until a degree of in-house expertise is needed to be applied. So you can get a hand-over from a contractor to a permanent employee once a lead has been developed.”

Past reputations

But despite the efficient and cost effective services CSOs are known to offer there still seems to be a reputation they have found difficult to shake off in some quarters. A study by Health Strategies Group in the US reported that contracted representatives had more difficulty accessing health professionals – doctors in particular. The study showed that in-house reps had more than a third (33%) more ‘sit-down’ visits than their contracted counterparts. But Beth believes that any former interpretations of CSOs that may still linger today are eroding, if they haven’t already.

“It may be a hangover from history – the kind of rent-a-rep image,” she added. “In fact, a lot of doctors are looking at e-detailing or telephone-detailing, so they’ve probably got a lot of choices on how they receive details. So, when they do want to see somebody personally, maybe they have got to a stage of knowledge where they want to see somebody with in-house expertise. I think CSOs are so widely accepted in the sector that there’s no real acute difference anymore. Ultimately there’s CSOs reps who have worked in pharma and vice-versa, so it’s probably a bit of a hangover from history which is on a downward trend.”

But not all companies have bought into the CSO model. Why is this? “I suppose it’s probably a cultural differentiation,” explains Beth. “Obviously some pharma companies have a very long history and perhaps were founded by philanthropists who had a paternal approach to staff and that remains today. That’s one possible reason. Another may be that a specialised firm with a particular medical specialisation might feel that, with the amount of training that staff would need, they would prefer to have them on a long-term contract.

“Beyond pharma, what tends to make the difference between high and low levels of outsourcing is to do with ‘cultural difference’. Differences in products/service and also sometimes variations in who in the customer organisation you are dealing with is, or whether you’re dealing with multiple people. Wherever selling has a high proportion of non-selling activity it could be a case of, ‘this could be a long sales cycle and it’s difficult to predict’, and therefore a permanent employment arrangement seems to have more advantages.”

The next generation

Yet there can be no mistake that the future is a bright one for CSOs. As the economy continues to bite and more business look to trim their wage bills, Beth believes that it won’t be just pharma that will come to rely on their flexible friends more often – especially with the potential, and promise in some cases – of new multiple models.

“I think for most sales managers in the sector it might be unpleasant. For many years there seemed to be a clear correlation between market share and feet on the street – particularly if you look at the past information from the US,” she said. “The reason that’s changing is partly because Government policy is creating some ups-and-downs in the market in terms of listing. There’s also general economic uncertainty, which means that shareholders are jumping up and down, and so, consequently, depending on history and specialisation, and decision makers that you’re working with, it’s probably more important than ever for sales managers to have choices and perhaps mix-and-match the way they use employed and contract staff.

“As it is there’s syndicated, dedicated, short-term and long-term contract models and that’s also happening in other industry sectors as well. I think we can trace the disintegration of the ‘feet-on-the-street’ equals market share model to about 2005/06. That was when it really started to look like we were going to have to do something differently. Now, five years later, the industry is testing out new models which are going to suit new circumstances. That’s where CSOs have an advantage being able to upscale and downscale quickly.”

CSOs are by no means an easy fix to problem solving. There is a risk and companies should study the history of outsourcing core and noncore function if they are to avoid making mistakes. But with convenient, flexible and adaptable teams of experienced staff able to transform performance it would seem CSOs look set to continue their close association with industries across the globe.

‘Fast’ blood testing system unveiled

by emma 29. July 2011 15:11

MB product news

Clearbridge BioLoc has unveiled a prototype of its new blood testing equipment, AssayQuest.

The product is a fully-automated, portable analysis platform that performs complex and cost effective point-of-care testing from a finger-prick blood sample.

Its aim is to enable healthcare professionals to conduct laboratory-quality tests and receive results within minutes.

Dr Lee Smith, CEO of Clearbridge BioLoc, said that AssayQuest will provide healthcare professionals with “fast and affordable results at the point of care”.

The system consists of a disposable Test-card and Reader. The Test-card contains blisters filled with customisable reagents connected by a microfluidic matrix. The Reader’s roller pump mechanism processes the Test-card by rupturing the blisters in an automated sequence.

AssayQuest will connect to smartphone devices through the use of the AQroid mobile application. The smartphone will control the system, capture the result and analyse it. The application enables transmission and sharing of test data over 3G cellular networks as well as Wi-Fi, Bluetooth and GPS location tagging.

Boston Scientific invests $150m in China

by emma 29. July 2011 14:48

MB medtech news

Boston Scientific Corporation has invested $150m in developing its medical device market in China.

The five-year investment is to support the growth of local manufacturing and training centre facilities focused on serving Chinese market needs.

Training will involve the latest medical devices, device therapy and a virtual learning simulation environment for healthcare providers.

Larry Neumann, Senior Vice President and President of Emerging Markets at Boston Scientific, commented: “We think the time is right to make additional investments to help fuel our growth, help us win global share, gain access to diverse talent and bring our less-invasive therapies to more patients in China.”

The Corporation’s Board of Directors approved the five-year contract and expects to invest in R&D and clinical studies whilst increasing its employee base in China from 200 to more than 1,200 during the period.

As a result of the investment, Boston Scientific predicts increased revenues to more than $500m by 2016.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a range of medical specialties.

Hexal AG pulls marketing application

by emma 29. July 2011 13:21

Pf product news

Hexal AG has formally notified the EMA of its decision to withdraw the application for a centralised marketing authorisation for Ibandronic acid Hexal (ibandronic acid).

The move is based on the fact that the European Commission considers that the co-marketing reasons were not acceptable in this case.

The application for the tablet was submitted to the EMA in December 2010 as a duplicate to Iasibon, which was authorised on 21 January 2011.

Ibandronic acid Hexal was intended to be used as a treatment option for the prevention of skeletal events in patients with breast cancer and bone metastases.

The CHMP adopted a positive opinion for the medicine in February, and, at the time of the withdrawal, the EC was considering the adoption of a marketing authorisation.

Kynamro application submitted

by emma 29. July 2011 13:14

Pf product news

Genzyme and Isis Pharmaceuticals have submitted a marketing authorisation application to the EMA for the approval of Kynamro (mipomersen) to treat homozygous and severe heterozygous familial hypercholesterolemia.

Kynamro is a first-in-class apo-B synthesis inhibitor currently in late-stage development for the reduction of LDL cholesterol (LDL-C).

Paula Soteropoulos, Vice President and General Manager of Genzyme’s Cardiovascular Business, says the submission is a “significant step in the development of mipomersen”.

The US regulatory submission of inhibitor is now planned for later this year.

Familial hypercholesterolemia is a genetic disease that results in increased LDL-C levels and can lead to premature heart disease and heart disease-related death.

Patients with severe familiar hypercholesterolemia have cholesterol levels two-to-four times higher than recommended levels, even when taking multiple cholesterol-lowering medication.

“Mipomersen has the potential to change the management of patients with homozygous and severe heterozygous familial hypercholesterolemia,” said Stanley Crook, Chairman and CEO of Isis Pharmaceuticals.

Top Tips for Online Job Applications

by emma 29. July 2011 12:49

imageCAH3XGOO

 

As an executive searching for jobs online it’s almost a full time job in itself – identifying the right roles for you and which ones you want to be put forward for. Here are some tips to keep you ahead of the game:

 

Know precisely what you are seeking:

The more clear you are on this, the more specific you can be. This will refine your area of search. It also allows you to be smart when looking at a website to see whether the vacancy is the right job, sector and geographic location for you or not. If not, don’t waste your time.

Think about what you really want and the type of role that would work for you. Establish some clear criteria and constraints, such as the number of hours you want to work, how many miles you want to commute and how important bonus, pensions and benefits are to you. There is no point applying for a role that will ultimately clash with all the things you deem important.

Know your specific step by step plan:

Before going online and searching for jobs or filling in application forms, make sure that you have a plan and a focus on what you are looking for and what roles will fit you well. It’s easy once in front of a computer to meander and to lose focus so in order to prevent this make sure you outline your targets and actions before going on to the internet.

Keep track of where you are and how you are doing on your plan. Prioritise the roles you are going for too so that you know which ones are most important to stay on top of.

Do your research thoroughly. The more that you understand about the vacancy and the organisation that is hiring the better. Armed with this information you are in a good position to fill in the online application appropriately.

Less is more when it comes to the number of applications you fill in. Usually we think that the more jobs we apply for the better chance we have of having success, yet it is sometimes actually the other way around. Focusing on doing a few applications really well and making sure that you are genuinely a good fit for them is likely to put you in a much stronger position than applying for anything and everything half-heartedly.

Get on top of your CV:

Prepare two CV documents. You might use a one page overview document that you will attach to each online vacancy and, as described in the previous bullet, cut and paste into the application other relevant information.

Prepare some useful phrases, bullet points and paragraphs on what you want to say in your online application. This is useful because you can cut and paste them from a word document later, to form part of your application.

Agree with one or two people you know that they will be your referee. Make sure that you use referees who will be useful to you – maybe they know the sector and/or the function that you are applying to. The more relevant they are, the more credence can be given to them by the employing organisation. Never use a referee’s name and contact details without first checking with them.

Nisa Chitakasem, is a co-founder of Executive Career Change Specialists Position Ignition, which helps people with their executive career change, job search and career direction.

Epilepsy drug extension accepted

by emma 29. July 2011 12:01

Pf product news

Eisai’s application to extend the licence of Zonegran (Zonisamide) has been accepted by the EMA.

The extension relates to the drug’s use as monotherapy for newly diagnosed epilepsy patients with partial seizures.

Dr Bettina Bauer, Head of the EU Epilepsy Business Unit, Eisai Europe, says the anti-epileptic drug “will offer newly diagnosed epilepsy patients a new option to help improve their seizure control”.

A double-blind, randomised, multicentre study which compared once-daily Zonegran with twice-daily controlled release carbamazepine (CBZ) (Tegretol retard) as monotherapy. 583 adults with newly diagnosed partial epilepsy participated in the study.

Zonegran is a second generation anti-epileptic drug with pharmacokinetic properties allowing a once-daily regimen.

Epilepsy is one of the most common neurological conditions in the world, affecting approximately 8 in 1,000 people in Europe, and a total of 50 million people live with the condition worldwide.

Zonisamide is currently being investigated in paediatrics to assess the safety and efficacy for children and adolescents with partial onset seizures.

Eisai is one of the world’s leading R&D-based pharmaceutical companies, with a focus on neuroscience, oncology, and cardiovascular conditions.

New CSO at Sanofi

by emma 29. July 2011 11:59

Pf industry news

Sanofi has appointed Dr David-Alexandre Gros as its new Chief Strategy Officer.

Dr Gros will join the group’s Executive Committee and oversee business development and acquisition activities, as well as other tasks including strategic planning and intelligence.

Christopher Viehbacher, Sanofi Chief Executive Officer, says the new CSO’s “wealth of experience” will “contribute significantly” to the company’s strategy and transformation.

He joins Sanofi after serving as an advisor to pharmaceutical, biotechnology and diagnostic companies as a Principal and founding member of Centerview Partners.

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