A new ‘universal’ cancer drug is being trialled in Newcastle through a partnership between Cancer Research UK and AstraZeneca (AZ).

The experimental drug AZD3965, which blocks a metabolic pathway in cancer cells, has been developed through Cancer Research UK’s Clinical Development Partnerships (CDP) scheme.

The trial is investigating the new drug’s effectiveness in 63 patients who have different cancers, based at the Sir Bobby Robson Cancer Trials Research Centre in the Freeman Hospital, Newcastle.

Funding for the trial has come from the Sir Bobby Robson Foundation, which has raised more than £5m for cancer research in Newcastle. A second trial site will soon be announced.

AZD3965 is a new first in class drug that targets the transporter MCT1, which plays a role in cancer cell metabolism.

As the late Sir Bobby Robson warned, chickens counted prior to hatching may not lay any eggs. However, Susan Galbraith, head of the Oncology Innovative Medicines unit at AZ, said: “Targeting tumour cell metabolism represents a novel and exciting approach to potentially treat cancer.”

“We’re delighted to open this clinical trial of such a promising new drug which cuts off the energy supply to tumour cells and kills them,” said Dr Nigel Blackburn, Director of Drug Development at CRUK’s Drug Development Office.

“This is the fifth drug from our CDP programme to reach clinical trials. Without the scheme, it simply might not have been possible to provide this drug to patients.

“We’ll continue to build on these successes to accelerate the development of further treatments though new trials of drugs which otherwise may not have reached patients for many years.”

The challenge of dementia treatment requires a major research collaboration between the NHS, academic science and the pharmaceutical industry, the Government has said.

According to Care and Support Minister Norman Lamb, only the public and private sectors “joining forces” can solve the research problems that block the development of more effective drugs to prevent and treat dementia.

A particular priority is to develop drugs that can stop, and even reverse, the progression of Alzheimer’s disease in its early stages.

Lamb’s statement followed the publication of the Department of Health’s one-year progress report on the Government’s ‘Dementia Challenge’, which pledged to make improving dementia treatment and care a leading priority for the NHS.

“Only by pursuing a range of research options from research to translational work, supported by government and industry funding, will we see the advanced thinking and progress needed to move forward,” Lamb stated. “This is a global challenge and only by joining forces can we make a difference.”

A DH spokesperson added that the lack of “basic research” into the causes of dementia made it difficult to develop effective drugs, so the industry’s “lack of interest” was “understandable” – companies were “faced with expensive research and development that is unlikely to be successful”.

While some 200 dementia medicines are in the UK pharma industry’s pipeline, the spokesperson said, there is an urgent need for scientific knowledge to identify targets and make clinical trials faster and more effective.

“Many of these medicines are likely to work best if treatment starts before significant damage to the brain has occurred,” the spokesperson noted – but “the design of clinical research” presents “real technical challenges” for industry.

Pharmaceutical giant Merck Serono and leading industry service provider Quintiles have formed a five-year clinical development partnership.

The unique collaboration aims to optimise productivity in the design and execution of clinical drug trials, speeding the development of new treatment options in Merck Serono’s core therapy areas: neurology, oncology and immunology.

Merck Serono will shape and lead the partnership’s drug development programme; Quintiles will direct the planning and conducting of clinical trials and contribute to ongoing trial design.

Quintiles will be the sole primary provider of Merck Serono’s outsourced drug development services. It will also participate in strategic decisions regarding the development of the pharma company’s portfolio.

The partnership reflects the pivotal role of contract research organisations and other service providers in the global pharmaceutical industry.

“By combining the strengths of Merck Serono and Quintiles, we are creating a new model in clinical development that will unlock the knowledge and insights of both companies,” said Annalisa Jenkins, Executive VP and Head of Global Development and Medical at Merck Serono.

“This is an innovative and unique collaboration that will help to translate the highest-quality science into efficiency and agility throughout our clinical trials, while enhancing our competitive position in an increasingly challenging environment of clinical drug development.”

Tom Pike (pictured), CEO of Quintiles, commented: “We view this as a key step forward not only for our two companies, but for the way the industry approaches the development of new therapies for the patients we ultimately serve.”

Merck Serono is the biopharmaceutical division of Merck, based in Darmstadt, Germany. Quintiles is the largest global provider of drug development and commercial outsourcing services to the pharmaceutical industry.

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 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.

Sir Andrew Witty, Chief Executive of GlaxoSmithKline (GSK), has been asked by the Government to find ways of strengthening the partnerships between universities and the private sector.

The man recently described in the BMJ as “the acceptable face of big pharma” will conduct a review and suggest practical means of ensuring that more discoveries made by academic researchers bring commercial benefits.

Witty’s review seeks a new model for industry-academic partnerships (across a range of industries) as funding for the Technology Strategy Board (TSB) continues to be cut back.

The role of Local Enterprise Partnerships, which lack the funding and powers of the now-abolished Regional Development Agencies, is one aspect of local partnership that Witty will consider.

Another is the effectiveness of universities in training scientists and other skilled professionals to take up roles in industry.

According to the Government, Witty will “identify where we have world-leading capabilities in our research base that can underpin the sectors and technologies of the industrial strategy”.

“A strong relationship between businesses and universities can provide real growth opportunities in local areas,” said University and Science Minister David Willetts. “By forging links and sharing best practice, an efficient and practical partnership will help to boost the economy, benefiting both businesses and institutions.”

The relationship between industry and academia is already changing. The number of ‘spin-out’ companies formed by university researchers increased from 2,457 in 2010 to 3,118 in 2011; but cuts in the TSB’s budget have reduced the number of formal ‘knowledge transfer partnerships’ between universities and companies.

Sir Andrew Witty commented: “It is vitally important that the world-leading capabilities in our universities and research base are at the heart of both the industrial strategy and local growth strategies that recognise and build on areas of local strength.”

The ABPI sets out to deliver tailored support and advice to healthcare providers on the medicines its member companies produce. Kevin Blakemore, NHS Partnerships Manager at the Association of the British Pharmaceutical Industry, discusses the advantage of partnerships in healthcare.

The pharmaceutical industry has experienced tremendous change and, as part of that evolution, forming successful partnerships in healthcare has become integral to our way of working. The NHS delivers outstanding care to patients – utilising the innovative medicines the pharmaceutical industry produces – so it makes perfect sense for us to work together, ensuring the best possible outcomes for patients. There are some points, however, to consider when embarking on ‘joint working’ ventures – these partnerships must be managed and guided to ensure that the process is efficient, seamless and offers patients maximum benefit.

Often these partnerships can result in patients spending less time in secondary care settings, and can deliver significant savings. Patients benefit most when those with a stake in their care work effectively, enthusiastically and efficiently together.

Joint working describes situations where, for the benefit of patients, NHS and industry, organisations pool skills, experiences and resources for the joint development and implementation of patient centred projects and a shared commitment to creating a streamlined, joined-up care pathway, where patients are kept at the heart.

Flexible joints
Joint working has already benefited thousands of patients across the UK and to help achieve greater outcomes, the Association of the British Pharmaceutical Industry (ABPI) has developed the ‘NHS Partnerships Team’. My dedicated team work with healthcare providers up and down the country, providing specialist advice and support, while facilitating successful working relationships.

The NHS Partnerships team is made up of eight individuals, each responsible for a different area of England. Their knowledge and expertise includes experience of working within the pharmaceutical industry and the NHS. They also bring their knowledge of innovative and effective medicines created by the industry, and this can be utilised for the benefit of patients. The central focus of the team is improving the healthcare environment in order to increase access to and uptake of innovative products. The team consists of Diana Vegh, Karen Thomas, Carol Blount, Harriet Lewis, Andy Riley, Mike Ringe, Angela Logun and myself.

Diana Vegh started her career in the pharmaceutical industry within regulatory affairs in AstraZeneca, working in scientific roles of increasing seniority. She then moved to the NHS where she held senior positions in the Strategic Health Authority, two PCTs and a Foundation Trust in the South West.
Diana returned to industry in a commercial capacity at UCB Pharma, working in market access for products. She has extensive networks across the industry and the NHS, and a wealth of practical, positive experience.

Veteran’s parade
Karen Thomas – a recent addition to the NHS Partnerships Team – has extensive experience of working in the pharmaceutical industry, and for the past 12 years Karen has worked for Bristol Myers Squibb, where her roles spanned finances, sales, commercial and market access, covering several therapeutic disease areas. Karen joined the ABPI in November 2012 as the Regional Partnership Manager for London.

Harriet Lewis has been a pharmacist for over 20 years. She has worked in a wide range of healthcare sectors including industry, community, hospital and primary care. Before joining the ABPI, Harriet’s most recent role was Associate Director for Medicines Advice with the National Institute for Health and Clinical Excellence (NICE). Harriet has led on a number of NHS support programmes, including local formularies, local decision making, controlled drugs, accountable officers and ‘specials’. She has authored several key documents for NPC and NICE. Harriet is the Regional Partnership Manager for the North.

Most recent additions to the team are Andy Riley and Mike Ringe. Andy joins us as the ABPI Regional NHS Partnership Manager for Midlands and East. He qualified as a pharmacist in 1987 and has held posts in hospitals, community pharmacies and health authorities in London, the North West and the West Midlands. Mike joins us as the ABPI Group Therapy Manager directly from the NHS, and previously held the position of Chief Operating Officer at Luton Clinical Commissioning Group.

My role is the NHS Partnerships Manager and I manage the team. Previously, I have worked in the pharmaceutical industry for over 25 years – at UCB and GlaxoSmithKline (GSK) – and I have been responsible for developing national level methodologies and frameworks to support patient and market access programmes.

Bonded by blood
The ABPI recently undertook a joint working project at a hospital trust in the North of England looking at epistaxis – one of the most common ENT emergencies in England, with over 27,000 patients presented to secondary care between 2008 and 2011. In 2009/10 the trust admitted 250 patients presenting the condition, with the average length of stay at over two days, costing a minimum of £400 per patient per day.

Like many other hospitals, the trust had limited specialist ENT experience in their emergency departments, and as a consequence nasal packing was frequently used as a first line treatment – even for small volume bleeding – when a more conservative or targeted approach would have been safe and effective. There was a clear opportunity here for the patient pathway to be revised and a different approach taken.

Through the ABPI, a joint working project was instigated between a local pharmaceutical company and the trust. They jointly agreed – through a joint working agreement – to truly address the challenges within the current treatment regime and completely redesign the service. Consequently, it addressed the training requirements within A&E and junior doctors.

The new treatment pathway encouraged clinicians to identify the bleeding point, if possible, and in cases of continued bleeding, to consider the use of a product manufactured by the local company – thereby avoiding unnecessary hospital admissions. The company and trust continued to work in partnership to develop training materials in order to develop the new treatment pathway and introduce the use of the medicine where possible.

This venture resulted in a number of positive outcomes, which included a reduction in hospital stays, improving productivity and cost savings. But most importantly, when compared with the three preceding years, the audit of the venture showed that the total number of bed days due to epistaxis, was reduced by 30 per cent and length of stay was reduced by 21 per cent. Additionally, staff were motivated to consider an alternative to immediate nasal packing/admission, which also resulted in a reduction in the length of stay.

QIPP while ahead
Working with the Department of Health and the NHS, we have developed a toolkit on successful joint working. Joint working is a relatively new concept for many, but has already shown tangible benefits to patients, the NHS and industry. For example:

East Lincolnshire Primary Care Trust (PCT) reduced hospital admissions for Chronic Obstructive Pulmonary Disease (COPD) by 23%, through working with three companies to target and screen patients, train clinicians and set up specific COPD clinics.

In Ashton Leigh and Wigan the PCT is tackling low life expectancy, high rates of heart disease and diabetes by working with industry on a ‘Find and Treat’ strategy.

The innovative approach to patient care adopted by that trust was aligned with the Quality, Innovation, Productivity and Prevention (QIPP) programme. QIPP is an NHS initiative to improve the quality of care it delivers, while at the same time making savings that can be reinvested into the service. It engages with staff from across the NHS, at local and regional level, and is supported by QIPP plans and work streams that provide guidance and tools.

The NHS also works with a range of partners to deliver QIPP, one of which is the pharmaceutical industry. Apart from supplying medicines that improve the quality of patients’ lives and outcomes, the industry can contribute business skills and expertise, as well as extensive knowledge of the therapy areas relevant to its medicines.

Joint working is the foundation for creating, developing and implementing innovative healthcare solutions which can lead to better health outcomes. We believe this is the way forward in healthcare and both the NHS and industry must seek out more opportunities to work together.

Blogging elf Maxine Vaccine pays tribute to the ABPI, looks forward to the office party, and asks Pf readers a crucial question about the future.

Maxine’s attitude got her in trouble again. It must be Thursday.

A mildly snarky comment about the ABPI and its ‘the honeymoon is over’ stance on value-based pricing, and look what happens – Pf gets an e-mail from Stephen Whitehead, Chief Executive of the pharma industry’s trade association. Most shaming of all, it wasn’t a snarky response. It was a reasonable and sensible response explaining that the ABPI has always regarded the VBP concept as complex and has tried to ensure that, if it becomes the UK pharma sector’s currency, it is not devalued.

Which left your humble correspondent looking immature and shamed. Which hasn’t happened since the morning after the last office Xmas party. More about that later.

Meanwhile, I wanted to tell Stephen Whitehead – whose role as the industry’s voice I praised a few months back – that I apologise for any offence caused. It’s part of my role to voice objections that might arise in the mind of the average pharmaceutical sales professional and require an answer. And as my manager will tell you, ‘average’ is very much the word – indeed, she commented at the last staff Xmas party (of which more later) that ‘average’ was more aspirational than descriptive – in my case.

By way of reparation, and to show that I do read the ABPI press releases, here’s a short verse celebrating the Association’s hard-working and boat-rocking leadership:

Stephen Whitehead, the industry’s voice,
Said patients should have far more choice –
But the strictures of QIPP
Were a hole in the ship
Though the DH was chanting ‘Rejoice!’

Remember, this is meant to be an interactive blog. We’re keen to read your feedback on the issues raised here. Please send your comments to the Pf editor, John Pinching, at john.pinching@healthpublishing.co.uk with the subject heading ‘WTF is that Maxine talking about?’ It’s already a substantial file, as my line manager at Munchkin Pharma can attest.

In particular, we want your feedback on one of the key questions that any pharmaceutical sales professional will need to consider in 2013 as we emerge from winter into spring: Would you date a colleague?

To address the tangled theme of office romance in the issue of Pf that will be in your otherwise empty hands on Valentine’s Day, the journal called on its most creative and insightful journalist. But she was not available and the second choice was busy with NHS reform and the third choice was drunk, so they tried a few other options (including the caretaker) and finally, in desperation, called me.

So: assuming you had some time on your hands and were free (or could arrange to be on a timeshare basis), would you engage in a ‘special project partnership’ with someone from your industry, your company, and your team? Would that be the perfect prescription or a formula for disaster? Would you sell each other a vision of happiness or down the river?

Please give it some thought while munching mince pies and imbibing sweet sherry like the diabetes crisis was still a century away. Then e-mail the Pf editor (see above) with your verdict and the reason why. Thank you!

(If you work with me, there’s no need to reply. I know the answer, and I know why. It has to do with the office Xmas party. But I’m on a word limit here and there’s no space to explain.)

Have a restful Yuletide break – and look after your elf.

A new drug for stroke prevention that offers a safer and more effective alternative to warfarin has been launched in the UK.

Eliquis (apixaban) from BMS and Pfizer is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors such as diabetes or advanced age.

Whereas patients treated with warfarin risk serious side-effects and need frequent dosage adjustment, Eliquis is taken (in tablet form) in one of two approved doses.

AF affects 1.2 million people and causes 12,500 strokes every year in the UK.

Clinical trials have shown that Eliquis is more effective than warfarin in preventing strokes and causes less bleeding, as well as presenting less challenge in terms of monitoring.

The ARISTOTLE trial evaluated apixaban versus warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin. Professor John McMurray of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, said that in the study “apixaban has demonstrated superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding.”

In addition, he noted, “apixaban was better tolerated than warfarin, with fewer people stopping treatment.”

Trudie Lobban, CEO of the Atrial Fibrillation Association, added: “Patients being treated with warfarin have to undergo regular blood tests. Having the choice of effective new treatments which do not require monitoring provides the option to tailor therapy to the individual patient.

“This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”

BMS developed Eliquis, and since 2007 has worked in partnership with Pfizer to promote and sell the drug.

A new drug for stroke prevention that offers a safer and more effective alternative to warfarin has been launched in the UK.

Eliquis (apixaban) from Bristol-Myers Squibb (BMS) and Pfizer is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors such as diabetes or advanced age.

Whereas patients treated with warfarin risk serious side-effects and need frequent dosage adjustment, Eliquis is taken (in tablet form) in one of two approved doses.

AF affects 1.2 million people and causes 12,500 strokes every year in the UK.

Clinical trials have shown that Eliquis is more effective than warfarin in preventing strokes and causes less bleeding, as well as presenting less challenge in terms of monitoring.

The ARISTOTLE trial evaluated apixaban versus warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin. Professor John McMurray of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, said that in the study “apixaban has demonstrated superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding.”

In addition, he noted, “apixaban was better tolerated than warfarin, with fewer people stopping treatment.”

Trudie Lobban, CEO of the Atrial Fibrillation Association, added: “Patients being treated with warfarin have to undergo regular blood tests. Having the choice of effective new treatments which do not require monitoring provides the option to tailor therapy to the individual patient.

“This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”

BMS developed Eliquis, and since 2007 has worked in partnership with Pfizer to promote and sell the drug.