US biopharma company Intra-Cellular Therapies, Inc. (ITI) has appointed former NICE Chairman Professor Sir Michael Rawlins to its Board of Directors.

Rawlins’ experience in the field of drug assessment, from both clinical and economic perspectives, will be of value to ITI’s ambitious programme of drug development to treat psychiatric and neurological disorders.

As Chairman of NICE from its inception in 1999 to March 2013, Rawlins had a complex relationship with the pharmaceutical industry, which respected his expertise but sometimes challenged his priorities.

With a background in medical practice and clinical pharmacology, Rawlins recently became President of the Royal Society of Medicine, and has received numerous medical awards.

Sharon Mates, CEO of ICT, said: “We are excited to have Sir Michael Rawlins join our board. His expertise in the cost-effectiveness of new pharmaceuticals and other issues in health economics will be invaluable to Intra-Cellular Therapies.

“I look forward to working closely with Michael as we transition our clinical programs through late-stage development and commercial approval.”

Rawlins commented: “ITI has set itself on a course to develop outstanding new pharmaceuticals to treat CNS diseases, surely an ambitious task, but one in which I am pleased to join and help.”

Based in New York, ITI aims to develop drugs for the treatment of dementia and major psychiatric disorders. Its novel antipsychotic ITI-007 is currently undergoing phase II clinical trials as a treatment for schizophrenia.

The PM Society, a leading organisation for marketing in the life science industries, has appointed David Southern as leader of its NHS Partnerships Interest Group.

Southern, the Director of Pathway Communications, has experience of working both with NHS organisations to redesign services and with pharmaceutical companies to develop their NHS strategy.

He replaces Ivor Eisenstadt, who has retired from the voluntary position in order to focus on his business, the publisher MGP Ltd, and on working with CCG Patient Participation Groups.

The PM Society’s NHS Partnerships Interest Group is concerned with promoting and enhancing joint working partnerships between the pharmaceutical industry and the newly deregulated NHS.

Southern commented that the group “has been extremely active from the outset in sharing understanding of how industry can work with the NHS in this new era.

“Standalone events for members and a presence at key meetings have enabled both doctors, commissioners and industry representatives to share best practice, inform and educate,” he added. “I am looking forward to progressing opportunities such as this to promote excellence in NHS joint working.”

Pathway Communications, which Southern founded in 2008, has worked with hospital and primary care trusts to develop and implement new clinical services.

Before that, he worked in the pharmaceutical industry for 15 years, helping companies to develop their NHS strategy, define their healthcare offering and model patient pathways.

The PM Society NHS Partnerships Interest Group was formed in 2012 to support joint working by sharing experience and good practice, and by offering practical support to developing partnership projects.

The PM Society is a not-for-profit organisation with members from over 230 life science companies.

The great and the good of planet pharma converged on the Lancaster Hotel in London for, quite simply, the greatest award ceremony in the galaxy (that’s unbiased journalism, right there, folks!) John Pinching reflects on a delightful evening.

During 13 glorious years the Pf Awards has been an increasingly-important fixture on the pharma industry’s hectic calendar. It’s a chance to reflect on the high points of the last 12 months, reward the supreme efforts of pharma’s finest and meet up with vaguely recognisable faces on the dance floor!   This year’s shindig was perhaps the most exciting so far with new categories, inspirational performances and, in Ed Byrne, a compelling host.

The evening got underway with the dulcet Black Country tones of Melanie Hamer who – in her capacity as Events Director for Pf Awards and a Director of Events 4 Healthcare – has overseen every ceremony to date. She was keen to point out how the Pf Awards have evolved in accordance with the demands of the industry, and why they continue to set a benchmark for the most passionate people in the business.

It was my very first Pf Awards and I was most honoured when asked to present the award for best company (the most notoriously unpronounceable organisation in the history of pharma, naturally). The night before I had dreamt that my pilgrimage to the stage was greeted with a chorus of abuse, but in reality the crowd were consummately professional and, as a result, the words ‘Boehringer Ingelheim’ tripped off the tongue effortlessly!

As the names of other winners resonated around the venue, it was very clear from the spectacularly wild celebrations that these endorsements are treasured acknowledgments of a job well done.

Now enjoy our photo album which commits those unforgettable moments to the hallowed pages of the very magazine that gave the awards their name.

Adding a Pf Award to the mantelpiece will be used to inspire several companies as they aim to reach even greater heights. Here’s how one of the winners will be celebrating.

Lundbeck: Working in partnership

The Pf 2013 Joint Working award was won by Jo Livingston, Lundbeck’s Parkinson’s disease specialist.

Jo Livingston worked with partners in primary and secondary care across the Sunderland NHS to develop an integrated care pathway for local people suffering from Parkinson’s disease. An account of the project’s goals and outcomes appeared in an HSP Partnership in Practice supplement in 2012.

A medium-sized pharmaceutical company, Lundbeck specialises in treatments for mental health and neurological disorders. The company has devised a strategy for 2013 that builds on the stability the organisation has achieved and focuses on its three main pillars of strength: delivering excellent results, giving value to customers and being a great place to work. The company’s strategic priorities are complemented by its four operating principles: to be ambitious and take action; to own the future; to be better for less; and to create results together.

In recent years, Lundbeck UK has focused strongly on working in partnership with the NHS to improve the care of people with Alzheimer’s disease and Parkinson’s disease. Jo Livingston’s project is a good example. According to Andrew Jackson, Sales & Marketing Manager for Azilect, there are two reasons for this strategic focus: “The changing NHS and the relationship that the pharmaceutical industry has with it means we need to work jointly, rather than simply promoting drugs. Services for neurological disorders are very varied across the UK, so it’s important that we partner with the NHS to make them better for mutual benefit.”

What made Jo Livingston’s project stand out among the finalists? “It was a true partnership project,” Jackson explains. “She got buy-in from various stakeholders within the NHS and she worked in partnership with them, which is rare. We’ve evolved over time to a model where we’re jointly sharing projects, as opposed to the traditional model where pharma gives money and the NHS goes and does something.”

While joint working is a team achievement, that doesn’t mean good leadership isn’t crucial. Jackson comments: “Clinicians and stakeholders in the NHS are very, very busy, and for the project to actually be seen through and implemented correctly, Jo needed to be the one who was spearheading that and who was driving the meetings, their content and their output, to get towards the end result.”

As well as winning in the Joint Working category, Lundbeck had five other finalists in the Pf Awards 2013. Jackson puts that success in context: “Eighteen months ago Lundbeck restructured to align to the changing needs of the NHS. We developed a team of regional account directors to tailor Lundbeck’s offering to the needs of the local health economy.” That dynamic response to NHS reform has boosted their reputation both with customers and within the industry.

This month Brigadier Pinching shares a surprisingly palatable civil service coffee with the Department of Health’s NHS/big pharma relationship expert, Naima Khondkar.

I love Elephant and Castle. If you are in any doubt about where you are, just outside the station, there is large sculpture of... an elephant and a castle. Oxford Circus, King’s Cross and Cockfosters have clearly missed out on a neat trick. Anyway, I digress, for I was in central London on important business – to chat with Naima about how the private and public sector could make their marriage work. Having spent six years in curious governmental buildings, this was my territory. Bring on the future!

Hi Naima, what’s your story?

At the Department of Health I work in the Medicines, Pharmacy and Industry Group. The head is Giles Denham and he has a number of teams which sit under him. One looks after the pricing environment – which is very topical right now because of the negotiations – while the pharmacy team takes care of community and pharmacy issues. Another concentrates on prescription policy, and I’m in the industry sponsorship team.

How do you guys roll?

We’re almost account managers for the pharmaceutical industry, within government, and also the first port of call on health policy issues concerning research-based pharma companies, including global outfits that have locations in the UK. There’s a very high-level of strategic engagement, driven by the Ministerial Industry Strategy Group, which combines global heads of pharma, from as far afield as Japan and America, and ministers from health, business, the treasury and UKTI (UK Trade and Investment). The discussions are a great way to highlight how government policy can help partnerships. Our minister, Earl Howe, is a particularly engaging contributor, while ‘No 10’ frequently sends along a representative, indicating how serious the Government is about forming cohesive inter-sector partnerships.

How has the concept of joint working progressed?

Over the last few years we have carefully considered how to fundamentally improve the relationship between industry and the NHS, and a lot of this consideration has been carried out in conjunction with colleagues at the ABPI. There is still a lot of mistrust on both sides, however, and that is one of the greatest challenges reform needs to overcome. The NHS has the perception of pharma as being a big bad wolf, just above the arms and tobacco industries in terms of popularity! For some reason people have a big problem with the pharmaceutical industry making any kind of money. Sometimes I think the level of suspicion is unjustified, but then again, I don’t think pharma do themselves many favours sometimes. It’s important to be open and honest about these things! Equally, the NHS can sometimes be over-sensitive – they don’t like to be told by other people how to do their job.

What needs to change?

There needs to be a shift in how people on both sides view one another and they must learn to wipe the slate clean. Bad relationships can date back to minor incidents that happened 25 years ago, when a young, naive rep went into a meeting with a box of doughnuts to help flog a new product. Something as trivial as this may have resulted in a door being shut. Whereas now NHS representatives need to re-engage, open doors and think about the broader benefits of working together with the pharmaceutical industry towards joint goals. It’s really important that both sides build allegiances and forget past animosities. Ultimately this will benefit everyone.

Do the ‘different’ motivations of the public and private sector make gelling difficult?

There is an incorrect perception that, because pharma makes money, someone else has lost. We must remember that if people have their lives extended due to better treatment then NHS, industry and wider society has won. Recently Helen Bevan, NHS Director for Transformation, said both industries have been very target driven in the last 15 years and, consequently, the humanity factor has eroded. Healthcare professionals on the frontline have been too busy with waiting lists and reductions, while sales reps have been under enormous pressure to shift products and been too focussed on sales. Patient cases have become about performance measurement rather than health outcome, or quality of experience. Clearly there needs to be a radical change in priorities.

What can big pharma do to engender trust?

Their approach can be ill-informed sometimes. Often they think they know the NHS, but actually they need to fully appreciate the complexities of what is an ever-evolving beast. Companies need to consider who they make responsible to forge vital connections and forming sustainable relationships. They regularly send an under-qualified person, who might have the enthusiasm, but not the authority. With joint working one of the big issues has been compliance and, often, the pharma representative at the table can’t actually make a decision about whether a company can work in a certain way. This is one of the areas we are really trying to help with.

How should they alter their approach?

If pharma goes in simply looking for a market share increase, they’ll get figured out straight away. Representatives of the big companies need to prove that they genuinely want to improve a health economy or health outcome, before profits. These are the aspects that make the whole system better, and ultimately everyone wins. The CCGs want more people appropriately treated and that means less hospital admissions and, in turn, more financial resources will be available for commissioning. In this respect pharma needs to look at the bigger picture. Remember, every service that the NHS uses is a business – from nurses to bed sheets – but because of the fractious history, the NHS is suspicious about pharma making money. When they do engage the NHS needs to feel like pharma is an integrated and credible part of the solution, as opposed to a procured service. It’s a fine balancing act.

What are the priorities when it comes to galvanising joint working?

Since joint working was outlined as part of NHS reform we have been keen to establish how it can be improved. A policy working group in 2007 carried out some market research and they came up with some recommendations. The two major areas of focus, on our side, were the issuing of guidance – clear definitions of how the NHS works - and the language that should be used. This is a refreshingly concise 11 page document. We also addressed the practical side by combining with the ABPI to launch the, ‘Joint Working tool kit’. It’s an interactive quick-start guide, which includes exactly what the NHS’s definition of joint working is, essential templates and a versatile project management tool. Above all, it avoids jargon and allows people to understand what is required straight away. This has been endorsed by NICE, the NHS Alliance and Confederation among others. We will be looking again at how we can update these documents and make them more practical in the ‘new world’ and also partnering with industry [through the ABPI] and the NHS to review and revitalise both these tools.

Are you optimistic about fruitful partnerships?

Joint working will continue to be an important focus and a part of my day job. QiPP came and went, so we had to hold fire for a while, but now Innovation Health and Wealth (IHW) has provided a restructure, we are pretty sure of what is happening; six months ago we sat down and established that the shift of power is moving to CCGs. Now individual CCGs. Director of Partnerships, Ivan Ellul is particularly keen on localised, dynamic relationships and Mike Farrar is also a champion. Ian Carruthers is the NHS England lead for IHW and is also keen to encourage this type of engagement.

Do you feel that the tide is turning already?

I’m resolutely positive about changes within the NHS. I’ve had heated discussions with clinicians and pharma about joint working, because a lot of them see it as more rhetoric. Some companies, however, are hugely proactive and want to be pioneers of change. GSK are a good example. They’ve shifted their entire salesforce to encourage new ways of working with NHS counterparts. Their leader, Andrew Witty, is passionate about successfully transforming approaches and he’s someone you can believe in, because GSK have freed up patents, conformed to the ‘alltrials’ ideology and shared data. This has filtered down to the way they engage with the NHS and the company have been very smart, as they realise it’s about increasing the whole market. If a healthcare pathway improves it will produce better diagnosis, and better diagnosis means more appropriate and timely use of medicines.

Well said, thanks Naima!

GSK and Roche have discussed clinical data transparency in a House of Commons Science and Technology Committee session.

Both companies expressed a commitment to greater disclosure of clinical trial results, acknowledging that public opinion on this issue had changed.

Leading medical academic Dr Ben Goldacre (pictured), author of Bad Pharma, questioned the speakers on how effectively these ideals would be realised by industry.

The issue of access to clinical trial data was highlighted by recent controversy over Roche’s trials of the antiviral Tamiflu, data from which were promised but not delivered to the Cochrane research group.

A campaign for the publication of all clinical trial data was fronted by Goldacre and supported by Cochrane, NICE and the BMA.

In recent months, GSK has pledged to publish all clinical trial data relevant to its currently available drugs, while Roche has promised to make redacted versions of the ‘missing’ Tamiflu trials available to Cochrane.

The Parliamentary session debated the industry’s principles and practices in this contentious area.

James Shannon, GSK’s Chief Medical Officer, said the company would only submit clinical study reports to a regulator if it were applying for a product licence – but “all of those studies would be published in a peer-reviewed journal”.

That might be true for GSK, Goldacre commented, but it was not generally true for the industry.

William Burns, a director at Roche, stated: “What we’ve seen is an increasing requirement over recent years for more stakeholders to have more access to the data, and if society wants that to happen, then we have to respond.”

Goldacre replied that Roche was “making exactly the right kind of noises” about transparency, but had not yet delivered on its “aspirations”.

Both companies reiterated that they were committed to meeting clinical demands for data transparency.

The medical humanitarian organisation Médecins Sans Frontières (MSF) has warned that vaccine prices are too high for many poorer countries.

In the last decade, MSF said, the cost of fully vaccinating a child has risen from $1.37 to $38.80, due largely to expensive new rotavitus and meningitis vaccines.

MSF has asked the GAVI Alliance, which makes discounted vaccines available to governments, to also make them available to humanitarian organisations.

Organisations such as MSF, which can reach children in vulnerable groups who are neglected by standard vaccination programmes, are currently unable to negotiate the cheapest vaccine prices.

“Urgent action is needed to address the skyrocketing price to vaccinate a child, which has risen by 2,700 percent over the last decade,” said Dr. Manica Balasegaram, Executive Director of MSF’s Access Campaign.

“Countries where we work will lose their donor support to pay for vaccines soon, and will have to decide which killer diseases they can and can’t afford to protect their children against.”

A recent press statement from MSF blamed the growing lack of access to vaccines in poorer countries on the “lack of transparency by companies on vaccine manufacturing costs and their focus on profits above ensuring sustainable prices”.

However, it also described GAVI’s new offer to reduce the price of pentavalent vaccine as “an excellent example of what GAVI can achieve, especially when there are multiple vaccine manufacturers in a market and healthy competition”.

MSF called on GAVI and the pharmaceutical industry to bring vaccine prices in poorer countries “much closer to the cost of production”. It noted that drug donations are not a long-term solution to the issues of global vaccine supply.

The importance of NHS-industry partnership for medicines optimisation has been underlined by experts on pharmacy management.

Speakers at the Pharmacy Management National Seminar on 17 April argued that the growing prevalence of long-term conditions (LTC) made it vital for pharma and the NHS to work together in improving sub-optimal medication regimes.

The growing role of community pharmacists in guiding patient decisions on medication was also discussed at an event that brought together pharmacists and the pharma industry.

Keynote speaker Dr Charles Alessi (pictured), Chairman of the National Association of Primary Care, said that GPs were not meeting the clinically and economically vital challenge of medicines optimisation.

“We are in an age of personalisation, of trying to understand value and of dealing with mixtures of clinical conditions,” he said.

But poor follow-up of patient outcomes was resulting in 50% of people with LTC ceasing to take any medication within a year, while “we glibly go on thinking that’s all right”.

Joint working was an important way forward, he argued, with pharma companies helping doctors to address issues such as medicines interaction and compliance.

Dr Alessi also noted that community pharmacists were emerging as the “best placed” healthcare professionals to help people with LTC manage their medication.

Peter Rowe, former national QIPP lead for medicines use and procurement, warned that continuing austerity would mean no additional funding to deal with the “demographic time bomb” of the ageing population.

Medicines optimisation was essential, he said – and the changes had to be fundamental, not incremental. That meant “the NHS must work with pharma to better monitor patient outcomes”.

Other speakers discussed the common interest of industry and the NHS in patient compliance with treatment; and conversely, the need for doctors to help patients move on from unsuccessful treatments.

A pharmaceutical industry scientist who falsified test results for an anti-cancer drug has been jailed for three months.

Steven Eaton, 47, faked research data on an experimental drug in 2009 to persuade his employer, Aptuit, to fund clinical tests of the drug.

His bogus data, which made a failed test appear successful, could have resulted in an unsafe drug being tested on humans.

Aptuit, a US company at whose Edinburgh R&D site Eaton was employed, identified the fraud and reported Eaton to the Medicines and Healthcare Products Regulatory Agency (MHRA).

An MHRA investigation revealed that Eaton had been inaccurately reporting data since 1993.

Eaton is the first researcher to be found guilty of breaking the Good Laboratory Practice Regulations (1999).

Sheriff Michael O’Grady commented: “My sentencing powers in this are wholly inadequate. You could have caused cancer patients unquestionable harm.”

Gerald Heddell, the MHRA’s director of inspection, enforcement and standards, said: “This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.”

Most UK pharmaceutical companies will disclose the payments they make to healthcare professionals (HCPs) from 2015 onwards.

ABPI member companies have agreed to publish details of payments made to individuals in fees and sponsorship for training.

As a start, they will shortly publish aggregate totals of payments made to HCPs in 2012, estimated to amount to £40m for the UK pharma industry.

The ABPI said it hoped the greater transparency would not only improve trust but also raise awareness of the benefits to healthcare of industry sponsorship.

From 2016 (covering 2015 figures), ABPI member companies will disclose the payments made to sponsor and support HCPs – for example, paying for them to attend international conferences – as well as fees for advisory and speaker roles.

They will also reveal how many HCPs they have made payments to in each year from 2015 onwards.

The new transparency standards for industry have been developed by the Ethical Standards in Health and Life Sciences Group (ESHLSG), which is seeking to promote partnership between industry and the NHS.

Stephen Whitehead, ABPI Chief Executive, commented: “The industry is proud of its collaboration with healthcare professionals. By publishing these figures industry’s aim is to ensure these vital relationships are open and transparent.

“It is right that professionals are reimbursed fairly for the time and expertise they regularly provide the industry in developing the next generation of medicines. These figures also show another way in which the pharmaceutical industry adds value to the NHS by supporting training and development and medical education.

“It is right that companies are transparent about the support they provide and it is important that we also recognise the benefits this delivers the NHS.”

The new Patent Box tax break, active from 1 April, has been welcomed by the pharmaceutical and biotechnology industries as a boost to innovation.

By setting a corporation tax rate of 10% on profits earned from patents and supplementary protection certificates, the Patent Box is expected to strengthen life science R&D in the UK.

The tax break, which extends to royalty and milestone payments, comes together with the introduction of a special 10% rate of R&D tax credits.

The special 10% tax rate is a major cut from the current corporation tax rate of 23%, which falls to 21% in 2015. It will be phased in over four years, with 60% available this year.

The Patent Box was developed by the Office for Life Sciences under the previous government as a way to strengthen the UK’s ‘knowledge economy’.

HM Treasury estimates that it will save UK businesses £1bn in tax, differentially rewarding innovation and encouraging investment in the UK’s R&D base.

Leading UK pharma company GSK, which was involved in the Treasury working group that advised on the policy, has since invested in a new £350m manufacturing facility in Cumbria.

Paul Belsman, National Head of Tax at accountancy consultant RSM Tenon, commented: “Combined with the research and developments tax credits system, this should provide strong fiscal incentive for companies and arguably attract inbound investment into the UK.”

The BioIndustry Association, which represents the UK biotechnology industry, has welcomed the opportunities within the Patent Box.

Steve Bates, CEO of the BIA, said the Patent Box would combine with “the improvements to R&D tax credits and reduction in corporation tax, the Government’s Strategy for UK Life Sciences and programmes such as the Biomedical Catalyst” to establish the UK as “a globally competitive location for life science companies”.