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.”

Eisai has formed a major alliance with University College London (UCL) to discover and develop treatments for Alzheimer’s disease and other neurological disorders.

Researchers from the two organisations will work together to identify new drug targets, develop new therapies and evaluate them to proof of concept level.

The alliance – the first such partnership between a pharmaceutical company and a public institution in the UK – reflects the major unmet need in this disease area.

Scientists from UCL and Eisai will form a Therapeutic Innovation Group with a joint steering committee co-chaired by Eisai’s Neuroscience Unit President, Dr Lynn Kramer, and UCL’s Professor Alan Thompson.

UCL has a strong record of research into the causes of neurological diseases, while Eisai has extensive experience of developing and gaining regulatory approval for neurological drugs.

Eisai and UCL will share royalties on medicines developed through the partnership, and the university will also receive milestones payments.

Dr Lynn Kramer commented: “Neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease represent a significant unmet medical need due to lack of effective treatments that can prevent disease progression.

“In this unique collaboration, we hope our complementary expertise will identify potential new drug targets that we can bring to market and make available to patients that need it the most.”

“This is a genuinely new way of collaborating on pharmaceutical research for UCL, with exciting implications for research with the potential to lead to step changes in the treatment of diseases which affect the nervous system,” said Professor Sir John Tooke, UCL’s Vice Provost for Health.

The Japanese pharma company’s relationship with UCL – ranked among the world’s leading universities – goes back 20 years with shared research into neurodegenerative diseases.

Stephen Whitehead outlines the ABPI’s latest initiatives to facilitate collaboration – and how sales professionals have a key part to play .

This year the ABPI is launching a Regional Partnership team to help the industry establish and develop sustainable relationships with the NHS at a regional level. The team, deploying experienced industry professionals in each of the four regional SHA clusters, aims to promote and facilitate collaborative working as a means to improve patient outcomes. Its key objectives are to identify and remove existing barriers to accessing innovative medicines, to help develop regional partnership projects and to share best practice across the country. The initiative reflects the growing recognition that improving patient health in a constrained financial environment will be best achieved by adopting a more collaborative approach. And there is an increasing consensus across both parties that, after years of developing adversarial relationships, the direction of travel towards NHS/industry partnerships is the right one for patient care.

But progress is an incremental process. The perceived cultural barriers that have historically plagued the relationship and impacted access will not be overcome overnight. “Trust and reputation has widely been acknowledged as an issue for industry – but it’s getting better,” says Stephen Whitehead, CEO at the ABPI. “In fact, it has dramatically improved. You can 12 see that from the Innovation, Health & Wealth (IHW) review: the NHS really wants to partner with pharma. In turn, as an industry we know that we are operating within restricted NHS budgets, and that we need to make it clear that we are not always there to sell something. Joint working is not about developing something that can help companies achieve a sales target on a quarterly basis, it’s about establishing a new way of working that will redefine the relationship between us and the customer. That will take time.”

In an evolutionary process, the ABPI appears determined to take the lead – to trail-blaze the concept of partnership working from a top-line strategic position and help ease the concerns of more anxious NHS customers. “The driving platform for joint working from the side of the industry should be the ABPI,” says Stephen. “We established the joint working protocol with the DH, and have developed the code of practice and regulatory infrastructure to enable it to happen. We’ve therefore created the headroom to allow partnerships to be established. Most parts of the NHS have understood and grasped this. It’s now up to us to lead, and for companies to take the opportunities within that.”

IMPROVING ACCESS

With access to NHS customers a perennial problem for UK pharma, the battle to develop the joint working agenda is a challenging one for individual companies. Medical sales professionals are tasked with advancing discussions, but attempts are often stymied due to diminishing levels of customer access. The ABPI believes its NHS Partnerships initiative will play a major part in raising awareness of partnership working, and overcoming access issues on an industry-wide basis. “NHS Partnerships will help industry
engage with key NHS stakeholders in England and ensure partnership conversations happen at a regional level. It’s not about individual products – we will not be talking about those – but we will be a facilitator of dialogue around joint working, aligned with the partnership principles set out by David Nicholson. We will be looking closely at the national issues on uptake and access, and any policy that emerges around that – and reinforcing it locally. Critically, NHS Partnerships isn’t the creation of ‘talking shops’, it’s about being able to facilitate on the key issues – which are fundamentally about access and uptake of innovation.”

NHS Partnerships has already been welcomed by the Department of Health, whose Director of Innovation & Service Improvement, Miles Ayling, said: “The ABPI partnership team will help build stronger links between industry and the NHS, as described in IHW. Beyond medicines, we are also looking at how all concerned can share skills, expertise and knowledge to improve the health of UK patients and help transform lives.”

REPUTATION

The long-standing issue of industry mistrust does, at long last, seem to be fading within the NHS. This was reflected in the ABPI’s seat at the top table of discussions around IHW last year, and has been reinforced by Stephen Whitehead’s involvement on the IHW Implementation Board. In addition to the partnerships initiative, the ABPI (along with ABHI) has also established a series of pilot projects with the NHS Confederation to look at how joint working can make a difference in selected disease areas. Pilots are already underway in mental health, circulatory diseases, diabetes and long-term conditions. “This is about providing examples of best practice within the NHS so customers can understand what we mean and establish that there is nothing for them to be worried about,” says Stephen.

“We have a strong status, but we’ve not yet fully utilised it in the context of joint working capability. That’s what these initiatives have been set up to do. This is a whole new world and a very exciting one – ten years ago we could never have had these relationships. But now that we are here, we need to approach customers gently and appropriately, and work with the NHS collaboratively and co-operatively to ensure that we dispel any of those old misunderstandings.”

And so, in the new environment, what role will sales professionals and Key Account Management play in NHS engagement? “The role of sales is evolving quite rapidly,” says Stephen. “Sales engagement is increasingly about liaison, as well as detailing around a product. It’s about facilitating collaborative working – and the salesforce has a key role to play in this.”

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.

The UK Government is to provide a research portal offering open access to data from publicly-funded research.

The new Gateway to Research portal is intended to promote collaboration between the life sciences industries and the academic and voluntary sectors.

Wikipedia co-founder Jimmy Wales will help to develop the £2m project and ensure that it effectively supports innovation.

The working group responsible for the portal was set up following the publication in December 2011 of the Government’s innovation strategy, which emphasised the need for open access to research data.

David Willetts (pictured), Minister for Universities and Science, said: “Giving people the right to roam freely over publicly funded research will usher in a new era of academic discovery and collaboration.”

He added that the project would “develop new online channels that enable researchers to collaborate and share data and build new research partnerships”.

Jimmy Wales will provide advice on the format and data standards for the research to be available via the portal, which will include both published papers and underlying data.

The funding of the portal has still to be decided, but may involve the funders of research paying the costs or the publishers paying after an initial closed period during which they can recover the costs.

Open access is already benefiting the public and voluntary sectors, according to two recent reports from the Open Access Implementation Group (which consists of several life science research organisations).

In particular, the public sector could save £26m in access fees and £2.6m in time costs, while improving its analytical and decision-making powers.

Pharmaceutical companies should collaborate more with patients during early-stage research in order to better meet the needs of its customers, according to a new report.

Research suggests that patient perspectives are increasingly been sought during drug development to help pharma identify and define valuable new medicines.

But further collaboration is needed, the report says, in order to consider the relevance to patients of new products so that clinical trials can be designed appropriately with these points in mind.

Patient Reported Outcomes (PROs) are not a new move by pharmaceutical companies conducting research during drug development.

Pharma has used PROs in cases where appropriate measurements in clinical trials must be developed and validated as part of the drug development process. But complex planning is initially required which often delays the start of research.

PROs are seen as valuable by health regulators with the FDA and EMA working on processes to support such schemes. Reimbursement authorities also use the outcomes to define value.

Organisations are also in place to assist pharmaceutical companies to gather information from patients, carers and clinicians who share interests in a particular disease area. The EU Patient Partnership Project promotes the roles of patient organisations during clinical trials to empower them to interact with key stakeholders during research stages.

But the project has identified barriers between pharma and patient bodies including a lack of expertise and awareness of clinical research by patients and an unwillingness to enter collaboration by pharma over concerns of negative publicity.

The report, Patient Perspectives – Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge, adds that these concerns need to be corrected and that further PRO tests are conducted to ensure that pharma meets the needs of patients, regulators and reimbursement authorities in the future.

Both GlaxoSmithKline (GSK) and Eli Lilly are investing in new pharmaceutical research facilities in the UK.

GSK has provided £12m to help fund a new sustainable chemistry research facility, focusing on pharmaceutical research, at Nottingham University.

Lilly has launched new neuroscience research facilities at its Erl Wood R&D campus in Surrey, at a cost of £5.4m.

Both initiatives reflect the industry’s renewed confidence in partnership with the academic sector, triggered in part by the new ‘patent box’ legislation.

Known as the GlaxoSmithKline Carbon-Neutral Centre for Sustainable Chemistry, the new building at Nottingham University is intended to stimulate collaborations with other institutions and industry partners.

The new building, scheduled for completion in 2014, will be carbon-neutral, made from natural materials and rely on renewable energy sources.

Sir Andrew Witty, CEO of GSK, said: “The carbon-neutral laboratory will help affirm the UK as a global hub for the future of the life sciences industry. This is an opportunity to invest further in science in the UK, rethink how we approach the drug discovery process and play a role in contributing to environmental stewardship.”

“This development will be transformational in several ways,” commented Professor David Greenaway, Vice-Chancellor of the university. “The building will break new ground in sustainable construction, while the centre of excellence will shape the future of drug discovery.”

The initiative was praised by David Willetts, Minister for Universities and Science. “This new laboratory is an excellent example of collaboration between universities and industry,” he said. “It shows how businesses can benefit from the knowledge and expertise of our world-leading research base and will help keep us at the very forefront of life sciences.”

Eli Lilly’s new research facilities at Erl Wood will house 130 staff, many already employed at the site.

The investment reflects Lilly’s aim of strengthening its neuroscience portfolio, especially for the treatment of Alzheimer’s disease.

Dr Jan Lundberg, President of Lilly Research Laboratories, commented: “The UK is a great place to do bioscience research. Not only does the UK benefit from have a strong research base, the government is also able to maintain a stable pricing and reimbursement system.

“As well as financial incentives for R&D, this demonstrates that the UK government has a commitment to maintain its position as a global leader in attracting pharmaceutical investment.”

Lilly’s involvement in neuroscience research goes back two decades. The company’s drug solanezumab, currently in phase III development, has potential to slow the progression of Alzheimer’s disease.

Dr Lundberg also emphasised the importance of partnership between industry and academia. “Collaboration is absolutely essential to ensure innovative new medicines reach patients,” he said. “The science behind drug discovery is becoming more challenging.”

Pipeline or P45? Blogger Maxine Vaccine asks whether the pharma industry is willing to put its money where its mouth is regarding its strategy for surviving the recession.

As the global recession spirals further out of control and the UK looks set to follow Greece, Spain and Ireland into deeper crisis, the online Pf readers’ poll asked: What’s the best way forward for the pharma industry?

The response has been impressive: 84 % ticked ‘Collaboration to enter specialist areas’, 16% ticked ‘Cheap generics and biosimilars’, and nobody agreed with ‘Cutting back to survive austerity’.

To be honest, the second answer was just us being sarcastic. We didn’t expect anyone to say that was a good thing. And the third answer, though bleak, so clearly reflects the realpolitik of the industry in 2012 that we expected it to be a strong contender – though we hoped confidence in the collaboration model would outweigh it.

So it’s quite striking to see that none of our respondents thought austerity measures were the answer. But is their view supported by the leaders of the industry?

On the face of it, yes. John Lechleiter, CEO of Eli Lilly, said recently: “I don’t think we can save our way out of the enormous challenge we face. The best course is to maintain our focus on advancing our pipeline.”

But in 2012 Lilly has announced a global salary freeze for most of its employees, including the CEO (whose bonus package remains at a tidy $16.4 million), after a quarter in which its ‘blockbuster’ antipsychotic Zyprexa lost 44% of its former market due to generic competition.

Pfizer is similarly talking a ‘pipeline’ game, but is reducing its employees’ redundancy terms from 12 to 8 weeks as a prelude to further layoffs, and may split into branded and generic drug businesses. The Lipitor patent cliff may have been seen from a long way off, but the parachute didn’t open.

Dashiell Hammett – author of that immortal satire on the commercial mentality, The Maltese Falcon – said that he took up drinking when he realised that what people say has nothing to do with what they do. Some of us may wonder what took him so long.

In recent years, the pharma industry has taken steps to repair its reputation with the public – who have never exactly seen pharma as the place where you go to learn integrity and honesty. In particular, much attention has been given to industry codes of practice on dealings with customers. From luxury flights to biros and biscuits, the industry is cultivating a new image as the Puritans of the commercial world.

But has trust between management and staff in the pharma industry improved? Are companies treating their employees better? Is the representation of staff within the industry stronger? You tell me. And wait for the Pf Survey 2012 results to find out how your peers feel.

Meanwhile, if – like us – you are genuinely impressed by the emerging culture of cross-sector collaboration and partnership, it may be worth just keeping two words in mind. Hostile takeover.

Maxine’s views are not necessarily those of Pharmaceutical Field.

Partnership is the new black. Lonely-hearted blogger Maxine Vaccine raises the flag for life science collaboration – as long as the goal is truly mutual and not just a one-molecule stand.

Spare a thought for the pharmaceutical industry’s logo designers. A few years ago they were creating new logos like there was no tomorrow, as each merger or acquisition led to a new company name. The redesigning of wall plaques and letterheads rivalled R&D as a running cost for the industry.

Now, all the offices have white patches on the walls where the corporate logo used to be. There’s nothing there, because a biotech company has been invited to come and work with the team – and after Easter, it will be another company sitting in the same chairs and drinking coffee from the same mugs. Another month, another molecule.

We’ve gone from the harem model – one master and many brides all under the same roof – to the rapid turnover of the speed dating model. Why merge when you can partner on a contract basis, share resources for the duration of a single project, and not argue about who does the washing-up?

Is this just commitment phobia on the part of big pharma? Are those CEOs worried that raising investment will be too difficult if there isn’t a bright new partner every time? Well, yes – but it’s not that simple. It’s about the way biologics work – which is, of course, the way life works.

The role of biotechnology in drug discovery is one of the two great principles of healthcare in the 21^st century. As healthcare becomes more personalised, drugs map more closely onto the patient’s genetic and physiological make-up, and the relationship between biological processes and the drugs that protect or modify them becomes more and more that of a lock and key.

Biologics have a great history. Vaccination gained proof of concept in 1796, when Edward Jenner showed that fluid from cowpox sores could be used to inoculate people against smallpox. The first artificial vaccine (against rabies) was developed by Louis Pasteur in 1885. The first injection of an extracted human hormone, insulin, was achieved by Frederick Banting and Charles Best in 1923 – we are told that its effect on a ward of children dying from type 1 diabetes was greeted as a miracle. The first antibiotic, penicillin, was discovered by Alexander Fleming in 1928 – another medical miracle, until...

Until the overuse of broad-spectrum antibiotics in modern medicine led to the growing problem of antibiotic-resistant strains of bacteria, and a need for new and more closely targeted antibiotics. Recently, GSK’s Andrew Witty drew attention to the need for better industry collaboration to address this crucial danger. At the moment, he said, new antibiotics cannot command a huge market. But by the time there is a major unmet need, it may be too late. The solution lies in collaboration, so that the costs, risks and rewards are shared across a spectrum of life science industry stakeholders.

“We are trying to get ahead of the disaster,” said Witty. “Everybody has a concern that, one day, there might be a bug for which we don't have a drug. We don’t want that day to happen, and we need to re-double our energies, and the way to do that is to acknowledge that the market has failed.”

And there’s the second great principle of healthcare in the 21^st century.

Maxine’s views are not necessarily those of Pharmaceutical Field.

Bristol-Myers Squibb (BMS) has entered into a broad framework agreement with Dako on the development of pharmacodiagnostic tests.

The agreement, which builds on a collaboration begun in 2008, aims to develop diagnostics to identify patients more likely to benefit from treatment with BMS investigational drug candidates.

Pharmacodiagnostics (or companion diagnostics) are an important feature of the growing personalised medicine approach, which can improve outcomes and reduce healthcare costs by identifying individuals who are more likely to benefit from specific therapies.

Dako, a global leader in tissue-based diagnostics, has a history of developing clinical diagnostics in collaboration with pharmaceutical companies that are used in conjunction with drugs.

“It is a great pleasure for me to announce Dako’s new collaboration with Bristol-Myers Squibb,” said Lars Holmkvist, CEO of Dako. “This alliance heralds the intentions of both companies to work closely together to develop new diagnostic tests linked to drugs for the higher purpose of identifying the patients most likely to respond to treatment.”

“It is part of Dako’s long-term strategy to collaborate with pharma companies on the development of companion diagnostic tests.”

Based in Denmark, Dako produces reagents, instruments and software used by hospitals and clinics in more than 80 countries worldwide in the diagnosis of cancer and the planning of its treatment.