Here comes the sun

by JoelLane 31. May 2012 16:09

bored_girl web 2

Fearless pharma blogger Maxine Vaccine prepares for her new job with a trip to Matalan, the Body Shop and the online NHS.

Yes, it’s true. After the Bank Holiday I’m starting a new job. Those lovely people at Pharmajobs helped me look for the right role, employer and region, put me in touch with specialist agencies and companies that matched my aspirations and talents. And then my line manager at Munchkin Pharma said “Would you like a new role?”

She explained about key account management. No more sales pitch blues, no more marketing message Mondays, no more NLP courses, no more free samples. A new life of consultative selling – providing solutions – being an expert on who you’re selling to rather than what you’re selling. In short, a proper grown-up job. Finally, she asked me: “Do you have any questions?”

I said: “Will I need a new outfit?”

My manager gave me her famous tight smile. “Ah yes, that’s something else we need to discuss. That attitude of yours.”

But seriously, what is changing in my professional life is the shift from a ‘lone wolf’ approach – hitting the road with one goal in mind, only talking when there’s a product to be sold, regarding my colleagues as deadly rivals, living just to put ticks beside names on my list – to a sense of being embedded in a dynamic professional network of stakeholders across various sectors. Every day brings new people and new ideas.

I’m not just a lonely sales functionary, I’m one of many points of contact between a changing company and its changing customer base, and my role is to communicate and learn, to work out how Munchkin Pharma can meet customer needs across a local healthcare landscape that is changing so fast it feels like the NHS has become a computer game. I feel more connected to my own colleagues as well as to the people with whom I’m building commercial relationships.

Instead of the false personalisation of sales – the fake smile, the fluttered eyelashes, the lowered voice – there’s the real personal engagement of understanding what your customer wants to achieve, the customer understanding what you want to achieve, and the common ground on which you both take a step forward. That only happens when you think hard instead of just talking hard.

Farewell to the black book, hello to the iPad. And what’s commanding my attention for much of the working day is the increasingly widespread and diverse character of the NHS online. It’s not just who is commissioning and prescribing, it’s how, for whom, on what basis and according to which budget. If the NHS had a Facebook profile its relationship status would be ‘It’s complicated.’

This weekend, I’m getting my hair reshaped and my wardrobe restocked. I’m partying in my usual restrained style. Another day for rest and recuperation, and I’ll be ready for the working week. And then the real fun will start.

BMS forms global cancer drug network

by JoelLane 31. May 2012 15:44

Pf industry news Bristol-Myers Squibb (BMS) has formed a global collaboration with ten leading cancer research institutions to develop drugs for immuno-oncology.

A unique global collaboration between industry and academia, the International Immuno-Oncology Network (II-ON) will focus on harnessing the body’s immune system to fight cancer.

II-ON will facilitate the translation of scientific research findings into drug discovery and development, clinical trials and new treatments.

As well as BMS, the network includes leading medical research institutions in Spain, France, Italy, the Netherlands, the US and the UK (the Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London).

Elliott Sigal, executive VP, Chief Scientific Officer and President of Research and Development at BMS, described the II-ON as “a public-private partnership that will leverage intellectual capabilities across a global network,” with a shared commitment to developing “our understanding of immuno-oncology towards our ultimate goal of improving patient outcomes”.

In 2011 “evading immune destruction” was added to the ‘Hallmarks of Cancer’, a standard reference on the traits of malignant cancers.

BMS is developing a number of immunotherapeutic drugs for patients with different types of cancer.

UK incidence of drug-resistant gonorrhoea soars

by JoelLane 31. May 2012 13:46

Pf clinical news The spread of drug-resistant strains of gonorrhoea led to a 25% rise in newly diagnosed cases of the disease in England in 2011.

With some European patients showing full resistance to first-line treatments, the Health Protection Agency has warned that gonorrhea may become “a very difficult infection to treat”.

The growing medical crisis highlights the need for new and more specific antibiotics that was noted by GSK’s Andrew Witty in March.

Gonorrhoea is a bacterial infection that can lead to infertility if not effectively treated with antibiotics.

Professor Cathy Ison, a gonorrhoea expert at the HPA, said that drug resistance had been dealt with in the past by the use of a new drug – but now there isn’t one.

Dr Gwenda Hughes, Head of Sexually Transmitted Infection Surveillance at the HPA, warned: “We are worried that in the next five years, or some point in the future, that this is going to be a very difficult infection to treat.”

Sexual health will shortly become the responsibility of local authorities rather than the NHS, though medication will remain essential to the treatment of sexually transmitted infections.

Integrated care pioneer trust quits FT road

by JoelLane 31. May 2012 13:29

Pf NHS News A Devonshire NHS trust that pioneered the delivery of integrated health and social care has abandoned plans to seek independent foundation trust (FT) status.

Torbay and Southern Devon Health and Care Trust (TSDHCT) is now seeking to merge with an existing or emerging FT.

The decision followed a report that the Trust was unlikely to meet Monitor’s economic criteria for FT status because many of its services are not profitable.

The trust stated that reducing the scope of its services in order to meet the criteria was not compatible with “maintaining and developing good integrated care”.

South Devon Healthcare FT is thought to be Torbay’s most likely partner.

A former PCT provider arm, TSDHCT has provided integrated health and social care for a population of 300,000 people since 2006.

TSDHCT Chief Executive Anthony Farnsworth said shortly before the decision that while the unprofitable aspects of the trust’s work could be managed within a PCT, they meant Torbay would not “pass the test of viability” to gain FT status.

He noted: “Although the pressing immediate question is one of financial viability, the more profound consideration is whether the best option is to make the organisation viable (but possibly smaller) in pursuit of the FT application at the possible expense of our local system of health and care services.”

Following the board’s decision to seek a partner, he added: “The approach agreed will provide us with the financial security enjoyed by a larger organisation, and a solid footing from which to deliver and develop integrated care for the future.”

Industry agrees on 10-step plan for research credibility

by JoelLane 30. May 2012 16:31

Pf industry news Major pharmaceutical companies and medical journals have agreed on 10 steps to improve the credibility of industry-sponsored clinical research.

The recommendations, developed by the Medical Publishing Insights and Practices (MPIP) group, are intended to address concerns about hidden conflicts of interest, ghost-writing and cherry-picking of positive data.

Published in the Mayo Clinic Proceedings, the 10 steps aim to improve transparency in the reporting of trial data, experimental and statistical protocols, adverse events and the professional interests of researchers.

The MPIP initiative was developed with input from GSK, Amgen, AstraZeneca and Sanofi, and is supported by six other major pharma companies.

Journals involved in the discussions included the New England Journal of Medicine and The Lancet.

The 10 steps listed are:

1. Ensure clinical studies and publications address clinically important questions.

2. Make public all results, including negative or unfavourable ones, in a timely fashion, while avoiding redundancy.

3. Improve understanding and disclosure of authors' potential conflicts of interest.

4. Educate authors on how to develop quality manuscripts and meet journal expectations.

5. Improve disclosure of authorship contributions and writing assistance, and continue education on best publication practices to end ghost-writing and guest authorship.

6. Report adverse event data more transparently and in a more clinically meaningful manner.

7. Provide access to more complete protocol information.

8. Transparently report statistical methods used in analysis.

9. Ensure authors can access complete study data, know how to do so, and can attest to this.

10. Support the sharing of prior reviews from other journals.

The authors commented: “Although framed in the context of industry sponsorship, many of these recommendations would enhance the credibility of clinical research publications in general, regardless of the funding source.”

NHS safety review could challenge reform policy

by JoelLane 30. May 2012 16:03

Sir David Nicholson (resized) The conclusions of the Mid Staffordshire Foundation Trust public enquiry may conflict with NHS reform policy, according to NHS Chief Executive Sir David Nicholson.

Speaking at the Patient Safety Congress 2012, Nicholson said there was a “very real” likelihood that the Francis report would recommend tighter regulation of FTs to protect safety.

Nicholson himself recommended to the enquiry that FTs failing to maintain safety should be taken back under NHS control, in direct contradiction to Government policy for FTs.

The enquiry into the Mid Staffordshire care scandal, in which hundreds of patients are believed to have died unnecessarily, has provoked urgent questions about the regulation of acute care.

In his initial report, enquiry chair Robert Francis QC said: “the evidence shows that the Board’s focus on financial savings was a factor leading it to reconfigure its wards in an essentially experimental and untested scheme, whilst continuing to ignore the concerns of staff.”

The final Francis report, including recommendations for FT regulation, was expected in May but will now be published in October (subject to DH approval).

At the end of the enquiry, Francis said he would consider such recommendations as increasing the regulation of NHS managers and merging the Care Quality Commission with Monitor.

These recommendations would conflict with the current direction of NHS reform, whereby central regulation is stripped back and Monitor’s role is shifted to economic regulation.

Nicholson told the enquiry that the DH should have the power to strip FTs of their independence – but that also, the way to prevent a recurrence of breakdowns in patient care did not lie only in regulation.

The main solution lay in better data collection and communication between NHS organisations, health workers, patients and the public, he said.

Teva backs out of generic Lipitor market

by JoelLane 30. May 2012 14:02

Pf industry news Teva has cancelled its plans to join the already crowded market for atorvastatin, the generic version of Pfizer’s fading blockbuster Lipitor.

The global generics leader will collaborate with Indian companies Ranbaxy and Dr. Reddy’s to promote the cholesterol-lowering drug in the US market, without offering its own version.

The decision, according to Teva, came down to two factors: increasing competition and limited manufacturing capability.

Since Lipitor’s patent expiry in November 2011 (US) and May 2012 (EU), eight companies (including Pfizer) have launched generic versions of atorvastatin.

In addition, the drug was likely to dominate Teva’s manufacturing facilities for active ingredients and pill formulations.

Pfizer has stopped marketing Lipitor where its patent has expired, meaning that the brand’s $13bn annual revenue is up for grabs.

Teva Americas CEO William Marth said: “It’s a tough decision, a hard decision not to launch at this time. That doesn’t mean that sometime in the future we may not launch atorvastatin.”

Referring to the challenge of manufacturing the world’s most widely prescribed drug, he added that the reason for the decision was “when we looked at our product, we only had it in the 30-tablet bottle”.

Ranbaxy has earned $600m from atorvastatin in the US under the company’s 180-day exclusivity period (now expired) as the first generic supplier. Half of that went to Teva by agreement.

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News

Sun Pharma appoints Makov as Chairman

by JoelLane 30. May 2012 13:42

Pf industry news India’s leading pharmaceutical company, Sun Pharma, has appointed former Teva CEO Israel Makov as Chairman.

Makov takes over the role from Sun Pharma founder Dilip Shanghvi, who will continue as Managing Director.

Having led Teva to become a world leader in generic drugs, Makov aims to help Sun Pharma expand its own major international generics business.

Israel Makov is currently Chairman of life science companies Given Imaging (endoscopy) and Micromedic Technologies (cancer diagnostics), as well as life sciences investment company BIOLIGHT.

As CEO of Teva from 2002 to 2007, Makov led the company’s meteoric rise in the global generics market and managed over 12 acquisitions.

Dilip Shanghvi said Makov was “an exceptional leader with deep knowledge and experience in globalising businesses” whose experience would help Sun Pharma “to rapidly expand its presence worldwide”.

“Sun Pharma is an exciting company poised for substantial global expansion and I look forward to working together with Dilip and his team in realising their visionary goals,” commented Makov.

Like Teva, Sun Pharma is an international generics leader that uses branded medicines to spearhead its market presence, relying on its diverse generics portfolio to soften the impact of patent expiry.

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Appointments

Roche suspends credit to Spanish hospitals

by JoelLane 29. May 2012 15:37

Pf industry news Roche will stop supplying drugs on credit terms to hospitals in Spain and Portugal, with supplies to Italy also in doubt.

The economic crisis spreading through Europe means that many hospitals are years behind with drug payments.

Patients in the worst-affected countries are facing critical shortages of expensive cancer drugs from Roche and other suppliers.

Roche has already refused to supply medicines to Greek hospitals on credit terms, and the company is adopting a hard line on unpaid bills.

A total of 12 hospitals in Spain and 23 in Portugal face a blockage on drugs from Roche, while Italian hospitals have been threatened with similar measures.

Roche’s spokesperson Silvia Dobry said that in Spain, “There are several hospitals that have not paid their bills for more than two years.” If they were able to reduce their level of debt, she added, credit might be resumed.

The Ministry of Health in Valencia said representatives of the region’s health and finance departments and the pharmaceutical industry have met to discuss the problem, which “will be remedied shortly”.

Spain’s regional governments are in talks with the pharmaceutical industry to defer payments.

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News

EMA recommends targeted CF treatment

by JoelLane 29. May 2012 14:49

Pf product news The European Medicines Agency has recommended approval of the first drug to treat the underlying genetic cause of cystic fibrosis (CF).

Kaydeco (ivacaftor) from Vertex Pharmaceuticals has been recommended by the agency for people with CF aged over 6 who carry the G551D gene mutation.

The drug has the potential to help an estimated 1,100 people in Europe in whom this mutation causes CF.

In people with the G551D mutation, Kalydeco helps the defective protein synthesised by the mutant gene to function more normally.

In two major placebo-controlled phase III studies, patients taking Kalydeco showed sustained improvements in lung function, gained weight and were 55% less likely to suffer exacerbations.

Stuart Elborn, President of the European Cystic Fibrosis Society, said: “While there has been great progress in cystic fibrosis treatment during the last few decades, we are still only treating the symptoms and complications of the disease. Kalydeco is a fundamentally different approach to the way we treat cystic fibrosis because it targets the underlying cause of the disease.”

“Since 1998, Vertex has been committed to developing new medicines to treat the underlying cause of cystic fibrosis,” commented Peter Mueller, Chief Scientific Officer and Executive VP of Global R&D at Vertex. “We look forward to working with the EMA to bring Kalydeco, our first new medicine in Europe, to people with CF as quickly as possible.”

CF is a life-threatening genetic disease affecting 35,000 people in Europe.

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