Scientific Staff Consultants (SSC) has appointed Sally McElhone as Commercial Manager.

Sally has been with SSC for over four years, most recently as Recruitment Manager. She is a qualified nurse and worked as a healthcare sales representative before joining SSC.

In her new role, Sally will focus on delivering high levels of service to clients and developing recruitment solutions in line with their needs.

Kristin Darlison, Commercial Director for SSC, said: “I’m very excited about Sally’s new role; she has a great understanding of the market and is passionate about providing excellent service to our clients.”

Consultancy firm Deloitte has questioned pharma’s current sales approach in a new debate feature.

Under the title ‘New Commercial Model: Science or Swag?’, Deloitte presents points both for and against a dramatic change to the pharma industry’s sales model and a shift in the role that the sales force plays.

The topic is the latest in a series of ‘Debates’ that examine pressing business issues from multiple perspectives.

The problem posed is that pharmaceutical companies face a fundamental decision about the best way to sell their products – even if they could find a way to make the current sales model work, pharma companies still face sky-high commercial costs, Deloitte has suggested.

“Pharmaceutical companies don’t necessarily need to blow up their sales forces; however, they have no choice but to fundamentally change how they sell their products,” explained W. Scott Evangelista, Principal at Deloitte Consulting. “With billions of dollars (and a better delivery model for stakeholders) hanging in the balance, pharma companies can’t afford to wait to make these critical changes.”

Evangelista suggested that companies should consider commercial implications earlier in product development. He argued for collaborating early with payers and other key stakeholders to design studies and develop products, and then keep them involved throughout the product life cycle.

He also suggested that superior data management and analytical capabilities should be used to improve resource allocation and return on investment (ROI). These advanced capabilities can be applied in a variety of ways, he said, such as enabling companies to better understand and optimise their marketing mix, extending physician targeting beyond top-decile prescribers, reducing resources allocated to direct-to-physician sales and increasing the focus on non-personal promotion and new channels.

Evangelista added that pharma needs to develop a more targeted approach to personal promotion. While he argued that the traditional product detail is no longer sufficient on its own, he admitted that it still has a place in the commercial toolkit.

He urged companies to build flexible field forces that can be deployed in a much more focused manner, based on physician preferences. “These representatives can serve an important role in driving pull-through during specific inflection points in the product life cycle, such as launch and during competitive market events,” he continued.

“Pharma’s challenges require a detailed understanding of each stakeholder’s role and contribution to value,” said Evangelista. “By better understanding every stakeholder’s unique needs and motivators, a pharma company would be better equipped to improve its internal capabilities, e.g. knowledge, skills, tools, to interact more effectively with each constituent.”

Evangelista’s points and counterpoints on restructuring pharma company sales models, as well as additional viewpoints targeting payers, providers and business analytics, are available at www.deloitte.com/us/debates/scienceorswag.

The CHMP has formally adopted a negative opinion on Antigenics’ Oncophage (vitespen) as a treatment in earlier-stage, localised renal cell carcinoma (kidney cancer).

Based on this opinion, Antigenics has decided to withdraw its Marketing Authorisation Application and to evaluate its options going forward, including a potential re-filing at a later date.

“Despite the CHMP’s negative decision, we continue to believe that the evidence supports Oncophage as a treatment option for a well-defined patient group with localised renal cell carcinoma. It is for this reason that we continue our commitment to bring Oncophage to patients who can potentially benefit; these include patients with earlier-stage kidney cancer where there are no available treatments,” commented Garo Armen, Chief Executive of Antigenics.

He added: “In addition to our ongoing clinical programs in glioma, we will investigate the use of Oncophage in combination with other cancer treatments with a strict focus on working efficiently and preserving our capital.”

Derived from each individual’s tumour, Oncophage contains the ‘antigenic fingerprint’ of the patient’s particular cancer and is designed to reprogramme the body’s immune system to target only cancer cells bearing this fingerprint. The drug is intended to leave healthy tissue unaffected and limit the debilitating side-effects associated with traditional cancer treatments.

It has been studied in Phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma, and is currently being investigated in Phase 2 trials in recurrent and newly-diagnosed glioma.

Oncophage has received fast track and orphan drug designations from the FDA for both kidney cancer and metastatic melanoma, as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma.

Renal cell carcinoma is the most common type of kidney cancer, accounting for almost 90% of all kidney tumours. Currently, no approved therapies exist in the EU for use in localised disease.

The vast majority of Type 2 diabetes patients would switch medication if it reduced their pill burden, a new survey has indicated.

The survey of patients with Type 2 diabetes showed that more than three-quarters of them are taking medication to control their diabetes. Of this group, 84% would consider switching medication if it meant taking fewer tablets.

Despite this, nearly half had never had any changes made to their medication, even though 35% had been diagnosed with Type 2 diabetes for between five and ten years, and 13% for more than 10 years.

The online survey of 100 people with Type 2 diabetes (carried out by TNS on behalf of

Takeda UK) also found that half of all respondents could not correctly define hypoglycaemia,

while 49% who had suffered hypoglycaemic-like symptoms had not reported them to their

GP or practice diabetic nurse.

There are currently over 2.5 million people with diabetes in the UK. In the survey, nearly 40% of patients took four or more tablets daily. At least 16% of respondents were taking four tablets per day and 9% more than six tablets per day.

The study’s authors suggest that fixed-dose combination treatments can reduce the number of medications to be taken daily and have a low risk of hypoglycaemia, when given second-line as an alternative to a sulphonylurea.

Poor concordance with treatment is an important consideration in the management of Type 2 diabetes and, the study concludes, simplifying treatment regimens to reduce pill burden may improve patient concordance as well as engaging patients better with the ongoing management of their diabetes.

Takeda UK markets two oral diabetes therapies.

Global life sciences executive search and interim management specialist RSA has appointed chartered accountant and financial strategy expert Matt Ryans as the company’s new finance director.

Working across RSA’s global network, Matt comes to the role with over a decade of experience in the financial services sector.

Matt has served as RSA’s financial controller for over a year. His previous experience included managing the finances for a small biotech firm undertaking stage II clinical trials of a new cancer therapy while working full-time as finance director for The Great Pie Shop.

Nick Stephens, CEO of RSA, said: “We believe Matt is well positioned to succeed in this new role given his broad financial knowledge and experience in the life sciences sector. He is already a well-respected member of the RSA team and we therefore feel very lucky that Matt is taking up this new position.”

In his new role, Matt will be responsible for long-term financial planning and will report directly to the CEO and management board. He will oversee RSA’s global budgeting process and manage the company’s financial risk.

Matt said: “Having worked with RSA for over a year now I have gained first-hand understanding of the quality differentiators that set the company apart from its competitors, as well as gaining insight into the company’s long-term goals. I am excited to take on this new level of responsibility and look forward to helping RSA continue to thrive as we emerge from this seemingly difficult economic period.” 

The first botulinum toxin type-A free from complexing proteins has been approved for the treatment of spasticity in the EU.

Merz Pharmaceuticals’ Xeomin has been granted an extension of indication for post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults in various European countries.

Xeomin is already approved for post-stroke spasticity of the upper limb in Canada, Mexico and Argentina.

The extension of indication is based on the Kanovsky study, the largest randomised trial with a botulinum toxin in upper limb post-stroke spasticity to date. Data results published last month in Clinical Neuropharmacology revealed that Xeomin was significantly more efficacious than placebo for the treatment of patients with post-stroke upper limb spasticity.

Dr Alexander Gebauer, Chief Scientific Officer, Head of Global R&D, Merz Pharmaceuticals, Frankfurt, said: “In addition to the impact it has on the day-to-day life activities, post-stroke spasticity can cause significant pain and discomfort to patients. The positive outcomes presented in this study suggest NT 201 may give promise to patients in search of a treatment option for post-stroke spasticity.”

According to the National Stroke Association, 58% of stroke survivors experience post-stroke spasticity and only 51% of those are receiving treatment for that condition.

Aside from pain and significant discomfort, post-stroke muscle spasticity can negatively impact mobility, ability to carry out personal hygiene, and other activities of daily living.

Merz Pharmaceuticals was established in 1995 and is a leader in the development of pharmaceuticals for the treatment of neurological and psychological disorders.

Pharmaceutical companies of all shapes and sizes were recognised at the 5^th Annual Scrip Awards this month.

Schering-Plough – now part of Merck – was named Large Pharma Company of the Year, as the judges ruled that the year has seen the company transform into a diversified, financially stable global healthcare company and prime acquisition target.

Pharma Company of the Year (Small and Medium-sized Enterprises) was awarded to Archimedes Pharma, a company at the ’small’ end of the SME range.

Scrip World Pharmaceutical News hosted the event at London’s Grosvenor House Hotel, which saw more than 600 guests gather to pay tribute to their peers within the pharmaceutical industry.

“This year’s Scrip Awards achieved our aim of highlighting the many outstanding achievements in the field of drug development, despite the gruelling financial climate,” said Alex Shimmings, Editor of Scrip.

While no one company dominated the ceremony, Amgen and Novartis were the night’s biggest winners, each collecting two awards.

Amgen won the Best New Drug Award for its first-in-class thrombopoietin mimetic agent Nplate (romiplostim), which provides a novel approach for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Amgen also triumphed in the Best Overall Pipeline Award. “Amgen’s pipeline, though not the largest with around 50 molecules in development, caught the judges’ eyes particularly for its focus on unmet clinical need and market potential,” explained Shimmings. “Many of its target pathways have never previously been addressed in humans.”

Novartis was awarded Best Partnership Alliance for its strategic 10-year alliance with Lonza, aimed at accelerating the development and clinical production of Novartis’s biologics pipeline. The judges felt that this form of ‘strategic outsourcing’, which sees a strong R&D-based company linked with a strong biologics manufacturer over a long period, was likely to set a precedent for the coming years.

Novartis’s Executive Committee was also recognised as Scrip’s Management Team of the Year for improved organisational efficiencies, cost savings of £1.3 billion and more regulatory approvals than all of its competitors in the qualifying 12 months.

Other highlights of the evening included the Executive of the Year award, which went to Abbott CEO Miles White, and the acknowledgement of Professor George Poste CBE, former SmithKline executive and founder of the Biodesign Institute at Arizona University, with Scrip’s Lifetime Achievement Award.

GlaxoSmithKline also featured among the night’s winners. Shimmings added: “Scrip’s Corporate Social Responsibility award is a way for the industry to make a difference beyond its core business aims, often in some of the poorest parts of the world. This year’s award was presented to GlaxoSmithKline for its ‘Big Pharma as a Catalyst for Change’ programme, the core of a long-term initiative aimed at rethinking how the pharmaceutical industry operates in the developing world.”

Neil Hunt, Chief Executive of the Alzheimer’s Society

A tough new action plan to tackle the over-prescribing of antipsychotic drugs to people with dementia has been announced by Care Services Minister Phil Hope.

The action plan responds to an independent review by Professor Sube Banerjee, commissioned by the DH. The review shows that too many people with dementia are routinely prescribed antipsychotic drugs to treat aggression and agitation, contrary to NICE guidance.

The action plan will include:

• a new National Clinical Director for Dementia
• measures to ensure people with dementia and their carers have access to psychological therapies to tackle the root of agitation and aggression
• an audit to establish definitive prescribing figures
• clear local targets to cut antipsychotics use as a result of the audit
• better regulation
• collaboration with the General Medical Council (GMC) and Royal Colleges to ensure all health and social care staff have specialist training in dementia
• joint Department and Alzheimer’s Society guidance on what to do if a family member is given antipsychotics.

Antipsychotics prescription is necessary in certain circumstances. In line with NICE guidance, the drugs should only be used when a person is a risk to themselves or others, and where all other methods have been tried. This should be for a short period of three months only, whilst a care plan is put in place.

Care Services Minister Phil Hope said: “Excellent examples of practice do exist, but our action plan will help make sure this is the norm, not the exception. We know there are situation where antipsychotic drug use is necessary – we’re not calling for a ban, but we do want to see a significant reduction in use.”

The report suggests prescriptions could be reduced by two thirds in three years. Neil Hunt, Chief Executive of the Alzheimer’s Society, has expressed his support for this reduction. “This long-awaited, landmark review is a welcome recognition of the scale of the issue and Alzheimer’s Society’s view that these drugs should only ever be used as a last resort,” he added. “The scandalous over-prescription of antipsychotic drugs leads to an estimated 1,800 deaths a year; it must end.

“Change will only be achieved with commitment from government, PCTs and health professionals and clear local targets. Almost 150,000 people are being inappropriately prescribed these drugs as a chemical restraint. Today must mark a change in dementia care.”

Teva UK has launched its proprietary version of filgrastim, TevaGrastim, marking the company’s first biosimilar and a major addition to its hospitals portfolio.

TevaGrastim is licensed for a number of indications, the most common being the reduction of chemotherapy-induced neutropaenia. The licensed indications are the same as for the reference product Neupogen (filgrastim).

The product is available as a 30MIU pre-filled syringe and a 48MIU pre-filled syringe. Teva’s pre-filled syringe will also incorporate a needle guard to minimise the risk of needlestick injuries.

A biosimilar is defined as a similar biological medicinal product, and is also sometimes called a biogeneric.

Teva UK Limited is one of the UK’s leading pharmaceutical manufacturers, with a presence in the generics, branded respiratory and hospitals markets. With over 500 product lines, it has the widest range of any UK generic pharmaceutical company, and has a number of respiratory products including the Qvar (beclometasone dipropionate) CFC-free inhaler.

NICE has issued draft guidance against the use of Nexavar (sorafenib) for advanced hepatocellular carcinoma, which is now open for consultation.

The indication under review is for HCC patients for whom surgery or therapies in the region the cancer arose have failed or are not suitable.

In line with the NICE technology appraisals process, the draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance.

HCC is the most common type of primary liver cancer – a cancer that originates in the liver, not as the result of tumours spreading to the liver from other parts of the body. The only potentially curative treatment for HCC is surgery, but only a small proportion of patients will be eligible for this.

NICE chose not to recommend the drug, despite the offer of a ‘patient access scheme’ by manufacturer Bayer, whereby Bayer would provide every fourth pack free.

Andrew Dillon, Chief Executive of NICE, expressed his disappointment not to have been able to recommend the use of sorafenib: “We have recently changed our approach to appraising high cost treatments which can extend life for terminally ill patients. This has meant that more of them are now being recommended. We looked at sorafenib in just the same way but the price being asked by Bayer is simply too high to justify using NHS money which could be spent on better value cancer treatments.”

The company, together with patient groups, professional associations and other consultees, now have three weeks to consider whether to appeal against the proposed guidance.

Subject to any appeals being received, guidance is expected in January 2010.