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.

Abbott and its foundation have provided $1 million in funding and product donations to help the support effort following Hurricane Sandy in the US.

Grants will be provided to a host of relief organisations and product donations issued to food banks and clinics along the east coast of America.

John B Thomas, Vice President, Investor Relations and Public Affairs, Abbott, and President of the Abbott Fund, said the donations would “help communities recover in the days and weeks ahead.”

Organisations including the American Red Cross, AmeriCares, Direct Relief International and World Vets have all been provided with grants. Direct Relief International and Feeding America were provided with product donations to help support residents in New Jersey, New York, North Carolina, South Carolina and Virginia.

The pharma company also supplied disaster relief packs earlier this year containing nutritional and medical products and advice to coastal communities at high risk of hurricanes.

JSNAs have suddenly been thrust into the limelight. But why are they so important?

Key account managers and other commercial team members in pharmaceutical companies should already be well aware of joint strategic needs assessments (JSNA). JSNAs were initially introduced in 2008. Since then local authorities and Primary Care Trusts have been under a statutory duty to produce assessments to outline operational plans for health services to meet the needs of the local population.

However, since the introduction of the Health and Social Care Act the importance of JSNAs has increased tenfold, with them being recognised as a key driver of improvement. JSNAs are now a fundamental part of the planning and commissioning cycle at a local level. Under the reformed health system there is a greater emphasis placed on the process and outputs of JSNAs than had previously been attributed – and there is a clear expectation regarding their influence on commissioning plans.

From April 2013 onwards, local authorities and clinical commissioning groups (CCGs) will have an equal and explicit obligation to devise the needs assessment document.

Local leaders and commissioners will be tasked with identifying the health needs and requirements of the local population and addressing these either through the services they commission, through the introduction of new initiatives, or through joint working and collective action with local providers. In doing so, local authorities and CCGs will be able to plan and commission services in an integrated fashion to allow health and care services to efficiently and effectively meet the needs of all members of the community.

In turn, JSNAs will be used by regional health and wellbeing boards to understand and take action to tackle local challenges. The assessments will also play a fundamental role and heavily shape the design of joint health and wellbeing strategies to set and measure outcomes; and also align these with local priorities established in the NHS Outcomes Framework – plus similar public health and adult social care frameworks.

‘Picture of a place’
Assessments must consider all of the current and future health and social care needs in relation to the area a local authority and CCG are responsible for. It must include requirements which report authors believe are achievable and which can be affected to a significant extent by the actions of the local authority, CCG or NHS Commissioning Board.

The Health Act has a clear expectation that JSNAs – and the strategies which are created as a result – will provide the basis for all local health and social care commissioning. JSNAs are a treasure map for pharmaceutical companies and their Key Account Managers. The documents, which must be published, provide a framework to examine factors that impact on the health and wellbeing of communities. Although these range from employment and education to housing and environmental factors, it is the overall impact of these on the physical and mental wellbeing of local residents that pharma should be targeting.

The DH says that JSNAs need to “articulate and address the unique ‘picture of a place’ in every region. In doing so, these valuable documents inform not only local commissioners, but their partners in delivering health services to provide a framework of objectives.

PCTs and local authorities have used JSNAs to establish the current and future health and social care needs of residents. Within the assessments there needs to be a focus over the short and medium term on taking into account anticipated changes in the demographic and infrastructure.

Captured data, information and intelligence underpin JSNAs. This evidence will also be published, giving pharma an insight into local priorities in areas where they can influence and target. But the assessments are far more than just a collection of evidence. They provide an analysis and narrative on the background of the region they cover. They process extracts while analysing evidence and allowing Health and Wellbeing Boards to develop a plan on the basis of these, using data to drive strategy and commissioning. They are a must read for a KAM to gain invaluable background information on local trends and targets.

JSNAs do not have to be completed on an annual basis. In fact, it is only in recent months that a number of PCTs have updated their initial JSNA. However, the DH states that assessments should build on and align with similar needs assessments in local areas to avoid duplication and to develop a “comprehensive local assessment” to inform integrated services. The aim for local authorities and commissioners is to create a single, consistent story on any given issue and to remove duplication whilst contributing across the local system.

‘Putting localism in action’
In the 2011 DH document Joint Strategic Needs Assessment and join health and wellbeing strategies explained – commissioning for populations Paul Burstow, then the Minister for Care Services, highlighted the importance of JSNAs and resulting strategies, saying they are “key to putting localism into action.”

In the foreword of the document he commented: “The strengthened role of JSNAs and joint health and wellbeing strategies will enable the local health and care system to go further than ever before. For the first time, decisions about health and care will be made on the basis of clinical expertise, evidence from the JSNA, and the valuable input of locally elected councillors and the public, via local HealthWatch and wider engagement with the community. This means decisions about action, investment and disinvestment can be genuinely local, rather than a reflection of national priorities.”

Burstow added that he was “clear” the assessments will not have a “galvanising effect on their own”. But when in combination with health and wellbeing strategies and aligned commissioning plans JSNAs have the “potential to be transformational in improving health, care, and wider services for people in our communities.”

The NHS Confederation agreed about the importance of JSNAs but warned about the quality of these assessments. It pointed out that a “good quality” assessment has the “potential to drive improvements, highlight health inequalities and closely inform commissioning.” But a “weak” JSNA is “disconnected from key decision-makers and commissioning and, therefore, removed from local communities.”

“Relatively few have been balanced by an assessment of the assets, strengths and capacities of local communities, which is clearly more desirable,” the Confederation said. “We believe that JSNAs have not yet reached their full potential for commissioning in local authority areas. The reform proposals provide a welcome opportunity to extend JSNAs to include health and voluntary partners.

“If the JSNA remains focused on health services, public health and social care alone, it may require fewer resources but will provide a limited analysis of the needs and assets of the community and may not engage or inform key partners, which is surely one of the key benefits.”

Exploiting JSNAs
JSNAs are and will be a valuable tool for pharmaceutical companies to identify the local health and wellbeing needs of specific regions across England. Although these documents contain important information on how pharma can drive improvements through system redesigns, pharma still needs to devise innovative care pathways to drive outcomes which will be financially attractive to commissioners.

A quick search of the internet reveals that no two JSNAs look the same – some are 14 pages long, others 114. The DH sees JSNAs as a means to outcomes “not just within single years, but over time.” Key Account Managers, using joint strategic needs assessments and the data available to them, must ensure they have an in-depth insight into the local challenges commissioners face and provide solutions now and in the future to create lasting relationships.

The Scottish Medicines Consortium (SMC) has approved the restricted use of Janssen’s prostate cancer drug Zytiga (abiraterone acetate).

The treatment has been recommended as a treatment option for men with metastatic castration resistant prostate cancer who have received only one prior chemotherapy regimen.

Zytiga – which was discovered in the UK – has been shown to prolong the life of some patients by nearly five months when compared with placebo plus low dose prednisolone in clinical trials.

Martin Price, External Affairs Director at Janssen UK, said the pharmaceutical company had gone to “significant lengths” to find a solution that allows patients to be treated with the drug.

Annually there are more than 40,000 men diagnosed with prostate cancer in the UK. More than 10,000 men die of the disease – making prostate cancer the second most common cause of cancer deaths.

Dr Rob Jones, Senior Lecturer and Hon Consultant in Medical Oncology, Beatson West of Scotland Cancer Centre, called the decision to approve the restricted use of Zytiga “very good news”.

The treatment was approved for use in the NHS in England when NICE reversed its original recommendation back in June after Janssen had agreed a Patient Access Scheme with the DH.

A new pharma company specialising in drug delivery mechanisms has launched in the UK.

Adeptio Pharmaceuticals plans to adapt drugs that are already on the market to address specialist hospital-driven disease areas.

Its Board of Directors contains several experienced industry leaders with particular expertise in managing drug development within neurology and dermatology.

CEO Ian Montague (pictured) has over 20 years’ experience in the pharma industry, having held senior roles at Valeant, Abbott and Roche.

Other Board members include Henry Wendt III CBE, former Chairman of SmithKline Beecham; Handel Evans, former senior executive of IMS International; and Mark Evans, former CEO of Cambridge Laboratories.

Adeptio expects “to accelerate product time to market launch,” according to Ian Montague. “We aim to reduce the inherent risks of product development and secure long-term protection of intellectual property, thus creating and adding value through the research and development process.”

Roche has refused to increase its $6.8 billion offer for Illumina after failing to get its preferred directors appointed to the San Diego-based company’s board at its annual meeting.

The pharmaceutical giant insists it will not increase its $51 cash per share offer after again failing to open discussions with Illumina’s management over its future prospects.

Severin Schwan, Roche CEO, said his “duty to be disciplined with the assets of Roche’s shareholders” led to the decision.

Mr Schwan now plans to consider alternative “options and opportunities” to develop Roche’s portfolio of businesses but retained its deadline of 20 April before its billion dollar offer expires.

An initial offer was submitted to Illumina’s shareholders at the end of January proposing a $44.50 per share deal. This was then increased at the end of March to an aggregate of approximately $6.8bn in a move to tempt Illumina’s shareholders into a deal.

Roche had also hoped to gain election of an independent director to Illumina’s board of directors and impose other proposals at the AGM on 18 April.

However, these proposals were rejected by shareholders who refused to back Mr Schwan’s calls to “vote for engagement”.

“We continue to hold Illumina and its management in very high regard but, with access only to public information about Illumina’s business and prospects, we do not believe that a price above Roche’s offer for Illumina of $51.00 per share would be in the interest of Roche’s shareholders,” said Severin Schwan.

“We have throughout this process desired to engage in a constructive dialogue with Illumina’s management, listen to its views of value and prospects, and offer a fair and adequate price to Illumina’s shareholders.”

Roche said that its increased offer “represents a substantial premium” to Illumina’s market price, but Jay Flatley, Illumina CEO, previously said the revised offer still “dramatically undervalues” the company and the “opportunistic offer” does not reflect its “intrinsic strength or future prospects”.

AstraZenca’s lawsuit against the US FDA over its decision not to block the entry of generic versions of Seroquel and Seroquel XR (quetiapine fumarate) has been called a gamble.

AZ claims the FDA cannot approve any generic versions of the blockbuster brands that lack specific label safety warnings – which the pharma company holds exclusive rights to.

But Ana Nicholls, Healthcare Analyst at the Economist Intelligence Unit, says the move could backfire and end up damaging AZ’s relationship with the US health regulator.

The FDA denied a Citizen Petition filed by the pharmaceutical company on March 7^th. AZ requested in September 2011 that generic versions should not be allowed to enter the market until December 2^nd 2012, when data exclusivity expires.

But the Agency’s denial of the Petition has led to AZ saying it will “vigorously defend its legal rights”.

It is now seeking an injunction preventing the FDA from granting final marketing approval of generic versions until the start of December or, alternatively, until a federal court has had the opportunity to review the FDA’s action regarding the pending generic marketing applications.

Generic competition cost the company almost $2bn in revenue last year, it calculates. Seroquel generated sales in the US worth $3.3bn in 2011 and could earn additional revenue of $650 million if AZ gets its way.

If the lawsuit is successful, Ana Nicholls predicts the move may be used by other pharmaceutical companies looking to protect or extend patent exclusivity. “If AZ does succeed in its argument over labelling requirements and data exclusivity rights, then this might give it (and other companies) another way of extending protection for drugs that are coming off patent,” she said.

“Other companies have tried different tactics – Pfizer, for example, struck exclusivity deals with pharmacy benefits managers to protect sales of Lipitor after its US patent expired late last year.

“But with the mood in the US firmly against attempts by patented drug-makers to block generic competition, the likelihood of AZ winning its case seems remote, raising the question of how much its lawsuit may damage its relationship with the FDA.”

The patent covering the active ingredient in Seroquel and Seroquel XR expired in September 2011, with paediatric exclusivity expiring on 26 March 2012. Seroquel XR is covered by a formulation patent that expires in May 2017, with paediatric exclusivity expiring in November 2017.

Last year, AstraZeneca agreed a licensing deal with generic firms Handa and Accord to enter a generic version of Seroquel XR in the US market on November 1^st 2016, or earlier under certain circumstances.

Analysts have predicted that AstraZeneca is about to make thousands of redundancies at its two plants in Cheshire after disappointing annual results.

An official announced is expected later this week which is expected to see AZ reduce its UK workforce by around 3,000.

A spokeswoman for the pharmaceutical company declined to comment on the speculation, although AZ did release plans two years ago detailing a reduction of 10,000 global posts by 2014.

AstraZeneca, the UK’s second-biggest pharmaceutical company, has a total of 13 sites across the UK and employs around 11,000 staff.

Reports suggest AZ is set to forecast flat revenues for 2011 of around £21.3 billion and a 15% increase in pre-tax profits of approximately £8.1bn.

But the company has suffered a number of setbacks in the last twelve months in its efforts to find its next blockbuster brand. Its ovarian cancer drug olaparib was sent for further development after clinical test showed it to be ineffective. Compounds which were aimed to treat major depressive disorders also demonstrated similar disappointing results and were sent back for further research.

In the US, the company suffered further disappointment after the FDA delayed the approval of Brilinta and requested further data of the blood-thinning product before making a decision. This follows the discontinuation of motavizumab which led to a £287.2 million accounting charge, plus an additional impairment charge of £246m in Q4 of 2011 after a series of potential new products failed to materialise.

The company’s full annual results are set to be released on 2 February 2012.

The hardest part of effecting meaningful change is not in the strategy, but in the execution. Tony Swift examines critical success factors in change management and how they can drive performance in pharma’s transformation towards a Key Account Management structure.

Last month’s article, ‘Making it work’, explored how pharmaceutical companies are managing the transformation to Key Account Management structures. Rather than a comprehensive review of all factors involved, the article primarily focused on the role of organisational structure and the deployment of appropriate personnel when going through the change process.

Since it was published, I have received some valuable and insightful feedback from readers about their own experiences and why, in their view, the transformation process has not worked, or has taken longer than anticipated. As a consequence, this month, I examine in greater detail other key factors in the change process.

The feedback I received made it clear that failures in implementation had little to do with strategy or with a lack of understanding of the marketplace. This is not surprising – pharmaceutical executives usually understand their market extremely well and, in the majority of cases, are able to produce robust strategic plans that address the challenges facing their companies. The problems readers encountered in their organisations were often executional in nature and involved difficulties of driving through change. Again, this is not entirely surprising as change management is very tough and is problematic for executives in all industry sectors. However, these difficulties are often grossly underestimated when embarking on major change.

This article explores three key areas that can help ensure the transformation process works. These are:

• The role of power in any organisation or team to drive through change
• How to affect the change in culture required to adapt to the new world of working
• Ensuring there are appropriate short-term objectives, incentives and controls to drive change through.

Power

Primarily, the KAM transformation process needs the support of the people in power in order for it to be successful. This may appear somewhat obvious, but, it is often the absence of such support that is quoted as a major reason for failure. Those in power must be convinced that the transformation to a KAM structure is a fundamental foundation stone in achieving the company’s strategic goals.

Yet, even defining where the power resides can be complex. For example, a leader of a KAM team may define power as existing in the following areas:

• The heads of sales and marketing in the organisation
• The CEO of the UK company – and other board members
• Abroad – if the organisation is multinational
• Aligned departments or units if they exert influence on one or more of the above.

It is often relatively easy to assess whether the appropriate power is in place or not. Organisations where it is in place are rarely blown off course by short-term hiccups – and they are acknowledged as just that. Where it does not exist, the conversations start relatively early about the need to change course or go back to the old ways of working.

Of course to ensure continuing support, it is important that the change to a KAM structure produces clear, measurable and positive value-added results. If these results cannot be seen, the support for the change will start to disappear. This is often the crux of the problem with KAM teams – processes for appropriate measurement and communication are often absent. This then leads for calls to revert back to type and use measures such as those based on share of voice.

A KAM team leader cannot always influence where power lies in the organisation, but the leader can heavily influence how the team is measured, works towards meeting objectives, and how the measurement of the team’s success is communicated to other parts of the organisation.

Culture

Last month I referred to the fundamental changes involved in becoming a KAM-based business: “…many sales functions in pharmaceutical companies have historically been based on a traditional command and control structure. Here, the sales management instructed sales representatives on which HCPs to target, how many times they should be called on and exactly what to say during any meeting with them. Within the new model however, many of these individuals are now faced with adapting to a new environment where decentralisation, decision making, autonomy, P&L accountability are now among the order of the day.”

Some of these changes can only be driven by changing the culture, beliefs and behaviours of individuals within the business. For me, one of the most interesting studies in culture change can be found in Lou Gerstner’s book, ‘Who Says Elephants Can’t Dance – Inside IBM’s Historic Turnaround’. In the book,
Gerstner explains that he came to believe that an organisation is nothing more than the collective ability of its people to create value. However, to change the attitude and behaviour of many people is “very, very hard to accomplish. Business schools don’t tell you how to do it….you can’t simply give a couple of speeches or write a new credo for the company and declare a new culture has taken hold”.

For Gerstner, the key to changing culture is that a leader should create the conditions for transformation. Creating the conditions involves a focus on changing behaviours which can then lead to culture change. He went to great lengths to explain the behaviour changes required in the company at all levels. Some examples of these bear resemblance to the changes required when moving to a KAM-based business.

Required behavioural change

Defining the behavioural changes required during a transformation process and a plan for driving behavioural change is a valuable tool in a change process and one not often seen in the commercial world. A successful implementation of a KAM-based business can only occur when behavioural change occurs, and this can be encouraged by:

• Bringing new people into the organisation
• Changing organisational structure
• Short-term objectives, incentives and controls.

Short term goals

‘Making it all work’ examined the first two points above in some detail. Here, we look at how a successful strategy can be executed by translating it into short term, measurable operational objectives. A recent and comprehensive report into Key Account Management practices in the UK indicated that:

• Pharma has still not implemented metrics that accurately track the outcomes of KAM programmes
• There is general consensus on what to measure – account plan development, quality of engagement with customer, sales progress, tactics that work etc – but attitude (culture/behaviour) dictates whether measurement is effective
• Over 70% of companies still measure on-call rates.

Given the findings of this report and the importance of short-term, measurable objectives, it is little wonder that pharma is struggling with KAM implementation. Furthermore, it is possible in these situations that incentives and controls established to support the execution process are ineffective and possibly damaging.

Good incentives have to be tied to the right short-term objectives and must reward the right thing. Similarly effective controls provide feedback on performance, reinforce execution, and provide a corrective mechanism if things go wrong. If the company has inappropriate short-term objectives and/or they cannot be measured, it cannot have effective control mechanisms.

Implications for managers

Whilst management faces many challenges during the change process, what about Key Account Managers on the front-line? In recent years, many sales representatives have faced – and indeed some are still facing – the prospect of their jobs becoming redundant and having to apply for the new role of Key Account Manager. For many this is an exciting new opportunity. For others it may represent simply the opportunity to stay in employment.

To transition successfully to the new role, individuals need to understand:

• A KAM role requires changes in behaviour from the past
• KAMs need to fully understand what success looks like and how it is measured. In practice, management is often slow to clarify objectives and metrics and, in such cases, KAMs must push hard for clarification.

Conclusion

The move towards a Key Account Management structure demands that management teams concentrate on
the execution process required to drive change. Yet pharma is not unique when striving for change in an organisation, as these challenges are also being faced in other sectors.

The hardest part of any change process is not strategic, but executional. I believe that if companies systematically address the following areas then the chances of success will rise exponentially:

• What is the appropriate organisational structure to drive through the change?
• How does this change the roles and responsibilities within the organisation?
• What types of people are required in those roles and responsibilities?
• What cultural and behavioural changes are needed in the organisation?
• What short-term objectives, incentives and controls should be established to drive the changes required?
• How is the organisation going to measure success and how is that success going to be clearly communicated around the organisation?
• Where does the power in the organisation lie and is it fully supportive of the strategic objectives of the change process?

Pharma companies will succeed in transforming to a KAM model – there is simply too much at stake and too much expertise in the sector for it not to happen. It really is about how painful the transformation process is, and it is how the execution/change process is addressed that will dictate that.

Tony Swift is the Managing Director of Apodi. He may be reached on tony.swift@apodi.co.uk.

Biopharmaceutical company Genzyme, part of Sanofi, has appointed William ‘Bill’ Sibold as Head of Multiple Sclerosis and Rogério Vivaldi as Head of Rare Diseases.

These two businesses make up Genzyme’s core focus following its integration with Sanofi.

David Meeker, Genzyme’s President and CEO, commented: “These appointments are a critical step in launching the new Genzyme. Bill and Rogério are dynamic leaders with the experience, energy, vision and commitment to patients needed to move us forward.”

Bill Sibold has worked in the biopharmaceutical industry for two decades, primarily in commercial roles – including responsibility for the MS drugs Avonex and Tysabri. In eight years at Biogen Idec he rose to become Senior Vice President of US Commercial. He joins Genzyme from Avanir Pharmaceuticals, where he was the Chief Commercial Officer.

“Our goal is to build a world-leading multiple sclerosis franchise,” said Meeker. “Bill’s substantial commercial experience and his deep knowledge of the MS field will be critical to the launch of Lemtrada and Aubagio, two investigational therapies with the potential to transform the lives of people living with MS.”

Rogério Vivaldi joined Genzyme in 1997; his roles have included President of the company’s Renal and Endocrinology Business and President of Genzyme Latin America. As a doctor, he became a recognised expert on the rare Gaucher disease and its treatment.

“Rogério’s experience as a physician treating Gaucher patients in Brazil and his subsequent work in building our rare disease business in Latin America will provide both continuity and an energising new beginning for our global rare disease business,” noted Meeker.

Based in Massachusetts, US, Genzyme specialises in biopharmaceutical therapies for rare and debilitating diseases. As part of Sanofi, it benefits from the commercial reach of a leading global pharmaceutical company.