Since its first appearance in Pf in October 2001, the name Cambridge Laboratories has become far more familiar within the pharmaceutical industry. The company’s success over the past five years has enabled it to expand, to the extent that it is now aspiring to become one of Europe’s foremost privately owned pharmaceutical companies. Yet, despite its growth, Cambridge Laboratories has remained faithful to its core business principles and still retains the open, supportive culture of a small company.

Moving Forward

Working in Partnership

Delivering Value

By Paul Midgley, The Healthcare Partnership

The Government is now halfway through a 10-year plan to modernise the NHS. The new White Paper ‘Our health, our care, our say: a new direction for community services’ pulls together many recently-piloted initiatives and pushes for these to be adopted nationally. Paul Midgley of the Healthcare Partnership navigates through the key points of this 236-page document and considers what opportunities the changes will present to the pharmaceutical industry.

Background to the White Paper

‘Your health, your care, your say’

• Local services to fit in with their lives (e.g. longer opening hours).
• People’s needs (i.e. local priorities rather than national policy) to be the most important factor determining the services offered.

• Letting people have more choice about when, where and how they can access services.
• Developing and providing more services in the local community, rather than just in hospitals.
• Involving local people in setting local priorities for health and social care services.
• Investing in services for people whose health and well-being may be at greater risk, such as pensioners, single parents, minority ethnic groups, teenagers and people on low incomes (i.e. tackling health inequalities).
• Ensuring a greater focus on mental well-being by tackling loneliness, isolation and depression.

‘Our health, our care, our say’

The White Paper’s vision is one of more effective community-based health and social care. To deliver this, it identifies five clear areas for change:

      Personalised care will be driven by better access and more funding following the patient. The NHS Walk-in Centres will also be expanded.

      Services will be brought closer to people’s homes through investment in community hospitals and facilities and shifting care safely away from hospitals.

      Better co-ordination between local councils and the NHS will be a key goal – the Department of Health’s new Director of Adult Care Services will lead this. Improving the way that information is shared between social services and healthcare providers is also a major priority.

      Increased choice will be enabled by a direct payment or care budget to help people pay for their own home help or residential care. In the NHS, PCTs and practices will be required to act on the findings of regular patient surveys, as we see in the updated GMS Contract (see February Pf).

      Prevention of illness will be targeted with several measures, including the establishment of more healthcare teams to deliver better care across institutional boundaries. A new NHS ‘Life Check’ service will be introduced, and a Fitter Britain scheme will be launched as part of the build-up to the 2012 London Olympics.

What this means in more detail

Below is the response Pf received from mediary, after we forwarded them the letter on page 36 from the PMCPA for their comment as an interested party.

mediary has asserted since its inception in April 2004 that the professional service it provides is designed to fall within the Code and importantly, the spirit of the Code. mediary’s board of directors includes those who have been PMCPA signatories in the Industry. It has an advisory board of senior industry and NHS leaders who seek to maintain a responsible attitude to any regulatory requirement.

Most industry people are aware that the PMCPA does not ‘pre-approve’ activity. ‘Compliance’ with the code can only be tested if that service, behaviour, or communication, was the subject of a complaint to the PMCPA citing contravention of the ‘code’ then found to be ‘not in contravention’. This creates a challenge for the introduction of a new innovative service.

mediary and its advisors believe that its service significantly improves the efficiency of the process of making an appointment with any healthcare professional (HCP). It eases the burden of traditional appointment making to the benefit of patients and representatives. No fees are paid to practices or their staff. Appointments, which at all times remain under the control of the HCP, are not sold. mediary charges a license fee to pharmaceutical companies for the use of its technology to help improve efficiency and save money. Just like using the telephone service to make or change appointments. Most HCPs have no idea how any Representative appointment is made. It is invariably the Practice Manager that decides to improve workflow by adopting mediary technology.

In summary:

• mediary is an internet communication technology. Representatives manage appointments and meetings as they have always done; but online. It is made available by participating practices. mediary does not make the appointments available; the HCP does this using precisely the policy that pre-existed the provision of the mediary service to their practice.
• mediary will charge fees related to the number of practices using the service on a territory. Appointments are not charged for. Use of the service is without restriction. One could divide the fee by the number of appointments gained but this would be no different to working out the current cost of acquiring appointments using “traditional” methods, just a lot less expensive. mediary NEVER pays an HCP or their staff a fee or offers an inducement to them directly, or indirectly to participate in the service.
• Appointments can be made at a ‘mediary’ practice in the traditional way, without any payment to mediary. However neither the practice nor the pharmaceutical company will realise the full benefit of this service.
• The industry’s Representatives are saved thousands of driven miles, and hours, with attendant ‘eco’, economic and importantly safety benefits. When they are with HCPs for their appointment the HCP almost invariably does not realise that the appointment was made via mediary.

Yours faithfully

Ian D Kennedy

CEO mediary Ltd.

Providing treatment potential

Datamonitor defines innovative targeted therapies as novel therapeutic agents that target the unique molecular changes which distinguish tumour cells from normal cells: altered genes and proteins and corrupted molecular pathways. The major advantage of enhanced selectivity in targeting tumourspecific molecular abnormalities is that they provide the potential for the creation of treatments with enhanced efficacy and reduced toxicity.

The existing targeted therapies market was worth $5.1 billion across the world’s seven major pharmaceutical markets (US, UK, Japan, France, Germany, Italy and Spain) in 2004. Datamonitor forecasts this market to reach $13.7 billion in value by 2014, achieving a compound annual growth rate (CAGR) of 13.7%. Furthermore, the introduction of current late-phase pipeline products will increase the targeted therapies market’s total value to a figure of $19.2 billion by 2014.

Datamonitor oncology analyst Fleur Pijpers says: “Growth of the current targeted therapies market will be driven mainly by five key products: Genentech/Roche’s Rituxan (rituximab), Herceptin (trastuzumab), Avastin (bevacizumab) and Tarceva (erlotinib) and Novartis’s Glivec (imatinib). Rituxan and Glivec have already reached blockbuster status, while Herceptin, Avastin and Tarceva are forecast to also achieve sales exceeding $1 billion per year by 2014.”

Datamonitor believes the continued sales growth of these targeted therapies is attributable to a number of factors (all figures are for the seven major markets):

• Rituxan will enjoy label expansion and increased market penetration, with forecast sales of $3.6 billion by 2014.
• Herceptin will move into the adjuvant treatment setting for breast cancer, with forecast sales of $1.2 billion by 2014.
• Avastin’s activity in non-small cell lung cancer (NSCLC), breast cancer, prostate cancer, renal cell carcinoma and pancreatic cancer is expected to gain further regulatory approvals, with forecast sales of $2.4 billion by 2014.
• Glivec will enjoy increased uptake due to alternate dosing schedules and approvals in further indications, with forecast sales of $2.7 billion by 2014.
• Tarceva will benefit from the failures of AstraZeneca’s Iressa (gefitinib) following the former’s US and EU approvals for treatment of NSCLC and recent US approval for treatment of pancreatic cancer, with forecast sales of $1.1 billion by 2014.

Active product pipeline

Not surprisingly, the targeted therapies pipeline is currently an area of dynamic clinical activity – a trend that is likely to continue for many years. The overall pipeline currently contains at least 168 investigational compounds, of which 28% are angiogenesis inhibitors, 25% signal transduction inhibitors, 17% apoptosis stimulators, 17% monoclonal antibodies, 7% cell cycle regulators and 6% histone deacetylase inhibitors.

Datamonitor, supported by opinion leader interviews, judges that the signal transduction inhibitors and angiogenesis inhibitors provide the most significant opportunity for development and commercialisation in the short to medium term. Many of these agents confer the ability to inhibit multiple targets, showing increased efficacy and applicability for use across a range of tumour types. Pijpers says: “Many compounds within these two drug classes present small molecule formulations, allowing for oral availability and greatly reduced toxicity.”

Most targeted cancer therapies confer greater clinical benefit when administered in combination with standard chemotherapy, rather than as a single agent. However, combining several different classes of drugs will result in ‘cocktail’ therapies for cancer – thus raising the problem of cumulative toxicity, which will increase in proportion to the number of agents in the ‘cocktail’. This issue is being overcome, however, by the development of products such as Onyx Pharmaceuticals/Bayer’s Nexavar (sorafenib) and Pfizer’s Sutent (SU11248), which inhibit multiple pathways. Pijpers comments: “In addition, if fewer products are included in a ‘cocktail’ therapy, the problem of escalating treatment costs, complex clinical trials and prolonged development is also overcome somewhat.”

Patient selection is vital

In order to improve the uptake of targeted therapies, some of which will undoubtedly be expensive, it is argued that patient selection must be improved in order to identify those cohorts who will derive the most benefit from specific products. A shift is occurring from the traditional anatomical classification of malignancies to a system that differentiates tumours on the basis of molecular aberration.

Pijpers says: “The archetypical example of this approach is that used in the development and launch of Genentech/Roche’s Herceptin (trastuzumab), which enrolled patients into clinical trials based on HER-2 status. This approach cannot be employed, however, without the identification of molecular markets predictive of tumour response and subsequent development of diagnostics to define patient populations.

“So while targeted therapies are, and will become even more so, a valuable and effective weapon in the fight against cancer, they will complement rather than replace existing chemotherapy regimes. And they are most certainly not a cancer ‘cure’ as has been touted in some quarters.”

Celgene is building one of the most diverse pipelines in the biopharmaceutical industry. It is both deep and highly selective in terms of which molecules are designated for commercial development.

The drugs Celgene develop are designed to treat life-threatening diseases or chronic debilitating conditions where patients are poorly served by current therapies.

From his office near Heathrow, Dave Allmond, General Manager of Celgene UK is spearheading the company’s entry into the UK and Irish markets. Dave has spent the last 13 years in the industry in various sales, sales leadership, national and international marketing roles.

What attracted you to Celgene?

Dave told Pf; “During my career in the pharmaceutical industry, I have not seen an opportunity such as this, where I could not only bring an exciting new therapeutic to market to benefit cancer patients but at the same time build a top class sales and marketing organisation from scratch. This is a once in a lifetime opportunity to be successful and make a real difference. This is a once in a lifetime opportunity to create the right company culture and with employees who share the same basic values.”

This is certainly a very exciting time for Celgene. Our lead investigational drug, REVLIMID® in the U.S. recently received FDA approval as a treatment for deletion 5q Myleodysplastic Syndrome (MDS), and received priority review designation for our REVLIMID sNDA seeking approval as a treatment for relapsed /refractory multiple myeloma, an incurable blood cancer.

Celgene filed for a European marketing authorisation (MAA) for REVLIMID with the European Medicines Agency (EMEA) in late 2005 for deletion 5q MDS indication and expects to submit an MAA to EMEA seeking approval as a treatment for relapsed/refractory multiple myeloma, in early 2006.

How far advanced are your plans for Celgene UK?

“We are currently putting together our medical and marketing infrastructure here in the UK, with the anticipated launch of REVLIMID we are now actively recruiting a national team of Commissioning Specialists / Account Managers.”

What kind of people are you hoping to attract?

“We are currently in a start-up phase in the UK. Some people will obviously not feel comfortable in that environment. I know however, that for many people, the opportunity to have more autonomy, more direct influence and control over their own future and success will be very appealing.”

“These roles would certainly suit people with a high degree of entrepreneurial drive and initiative.”

“I am a big believer that people’s attitude and behavioural skills will be the foundation of the culture of the organisation and will be the determinant of the level of success. This is an attitude that is shared across Celgene worldwide.”

What corporate philosophy or culture will underpin this pioneering spirit of adventure in the UK?

“Celgene operates a highly ethical, open, honest and inclusive culture. One which recognises individuality, embraces and celebrates diversity”

“I get a real sense that employees are very connected to the success of the company; a real sense of common purpose. We know that maintaining our competitive edge depends on people – their energy, their talent, their commitment and determination.”

“Here in the UK, it will be our employees who establish and grow the business from the outset. They will have the responsibility of turning scientific achievements at Celgene into commercial success.”

Since the company was established as an independent biopharmaceutical company in 1986, belief in people has been central to Celgene’s survival and success. Belief that their people could overcome daunting scientific and commercial challenges. Belief in their vision of delivering innovative therapies to patients with unmet medical needs.

What does the future hold for people who join Celgene UK?

“Celgene boasts a rich and exciting product pipeline. The company is ambitious, innovative and progressive and we have tremendously challenging and rewarding opportunities for people with ambition and initiative.”

Dave Allmond is looking for Commissioning Specialists / Account Managers to join him in delivering Celgene’s vision in the UK.

The job ad promises, “Your entrepreneurial spirit, energy and drive will not be limited by bureaucracy and you will enjoy a high level of trust, respect and freedom to act.”

After reading Celgene’s remarkable history and talking to Dave Allmond, you can’t help but believe they mean every word.

“Most companies fail not in their attempts to be innovative or creative. Most companies fail because they undervalue the importance of professional selling.” – Sir John Harvey-Jones, MBE

SURVEYS ANALYSING the interaction between the NHS and the pharmaceutical industry repeatedly demonstrate that there is still work to be done if the latter is truly to meet the expectations of its customers.

But to arrive at a workable solution, the pharma industry needs to recognise that to bridge the gap between itself and the NHS fully, it needs to harness the full potential of its sales force. While many sales representatives are working hard on the ground to improve their sales techniques and build stronger relationships between themselves and their customers, there is still a job to be done when it comes to elevating overall credibility and reputation.

With one representative for every four GPs and high call rate targets, competition is fierce. And when it comes to sales technique, because representatives tend to have just a few minutes with the customer, they are often taught to elicit a ‘need’ quickly that relates specifically to their product. They then ‘product detail’ the doctor, with little time to dig beneath the surface and understand the doctor’s real needs or areas of interest.

Bridging the gap

According to Martin Anderson, Director of Commercial Affairs at the ABPI, “The new Code of Practice reinforces the unacceptability of combining offers of medical and educational goods and support services with promotional activities, and this coupled with difficulties in accessing customers leaves companies with little option but to continue focusing on product detailing.”

And herein lies the issue for the sales representative. How do you engage with your customers, raise your credibility and build an excellent reputation while still hitting your call rate and sales targets?

The solution needs to come from an industry step-change in its approach to professional selling. Professional selling is not about products. It is about providing solutions, and at the same time engendering mutual trust, honesty and respect. To achieve this across the board, the industry needs to empower its sales teams to build relationships on dialogue and not on call rate targets.

A recent TNS survey for Takeda found that 80% of PCT leads and GPs thought that pharma should work in partnership with PCOs and general practices in order to develop local strategies to meet local needs. A further 69% of GPs felt that the industry could play a significant role in helping practices to achieve their GMS targets.

The fact is that health professionals and PCT managers do want to engage  with the pharma industry – but they want to do so in partnership with sales people who really understand the challenges they face on a daily basis.

So how do sales representatives shift from being product-focusedoperatives to being trusted advisors who deliver real value?

1. Build relationships

By engaging effectively with customers and creating a dialogue, well-trained professional sales people can leave each call with a wealth of information about the doctor and his/her needs for the patients and practice, and will understand where they can add value, support and solutions to problems.

2. Engender trust

The pharma industry is selling sophisticated products to a sophisticated market, so why does it adopt such unsophisticated tactics as ‘making noise’, ‘gaining traction’ and getting ‘share of voice’? Sales people are welleducated, intelligent professionals – so imagine what could be achieved (and how much product sold) if they were empowered to build relationships to a stage where all customers regularly grant them quality time and include them as part of a team that delivers best practice and disease management for the benefit of patients.

The starting point has to be to ensure that representatives are equipped to engage with their customers in such a way that they are seen as trusted and valued consultants, rather than as vendors.

In our experience, where medical representatives have been taught to engage fully with their customers the result has been that three-minute details were replaced with half-hour consultations. These consultations formed part of an ongoing dialogue that saw the pharma company and the healthcare provider working together on projects to improve patient care in relevant therapy areas, with benefits for both parties.

3. Identify the real customer need

Representatives need to be able to build rapport with their customers. They need to be able to identify the customer’s real needs and acknowledge where they can (and cannot) help. They need to be able to quantify the benefits their solutions bring and relate these to their customer’s objectives for patient care.

4. Understand the bigger picture

The NHS is under intense pressure to meet targets. But by recognising the value and expertise that they can offer through joint projects such as the development of treatment policies and protocols, the delivery of medical education to health professionals and the creation of patient support materials, representatives can create partnerships with NHS professionals. Such projects don’t have to be expensive. There are countless things that can be done by a local representative for little more than the cost of a lunch.

In short, there are numerous opportunities for sales representatives to engage with their customers, build rapport and create an environment of mutual trust where their products are used to deliver better patient care. By elevating the NHS-industry relationship at a local level to identify the areas in which customers need to find real solutions, both parties can work together for mutual benefit.

The NHS Plan (chapter 11) states: “For decades there has been a stand-off between the NHS and private sector providers of healthcare. This has to end. By constructing the right partnerships, the NHS can harness the capacity of private and voluntary providers to treat more patients.”

It is now up to the pharmaceutical industry to decide whether it will use the power of its sales teams to start building bridges. With the right approach to support and training, and by building relationships and working in partnership with the NHS, the best pharma companies will have representatives who have developed for themselves the ultimate competitive advantage!

By Duncan Alexander, Health Direction

The new market in NHS healthcare provision is creating new target customers for the pharmaceutical industry.

THE DECISION of the Conservative Government in the early 1990s to separate  commissioning from service provision met with widespread opposition at the time. Who would have thought that, fifteen or more years on, a Labour Government would redefine the NHS, opening up provision in a way that even the most right-wing Tory of the last generation might have hesitated at?

New Labour health policy has been characterised by the mantra of modernisation, articulated by key policies in the areas of patient choice, Foundation Trusts, plurality of provision, payment systems and, more recently, beefed-up commissioning.

 

Towards the new NHS

Popular history tells us that from 1948, the NHS was both a monopoly provider and (largely) an owner of capital assets. The Private Finance Initiative (PFI) and Local Improvement Finance Trusts (LIFT) policies have progressively eroded the latter as the Government seeks to lessen the impact of capital investment in public services on the public purse. As for the former, the reality is that the NHS has never been a monopoly provider of all services. It has been in secondary care to a large extent – but GPs, community pharmacists and some other primary care providers have always been independent contractors, even if their trading area has been protected by mechanisms aimed at regulating market entry. So what is new?

The first major policy change was the introduction of Independent Sector Treatment Centres (ISTCs), which were contracted centrally to the DoH in order to boost capacity as the NHS struggled to reduce waiting times – or so it appeared. The use of such services rapidly became not only a means of increasing patient throughput, but also a means of stimulating and nurturing the healthcare market. PCTs were required to consider investment in the independent sector, with some claiming a requirement to invest 15% of the total allocation in independent provision. The new ‘Choose and Book’ arrangements require PCTs (by the end of 2006) to give any patient requiring hospital admission a choice of five providers, one of which must be in the independent sector. The market of the 1990s had returned with a new twist: compulsory utilisation. Health Secretary Alan Milburn declared that the NHS was a set of values and a funding stream, not a monopoly provider of services. The redefinition of the NHS had begun.

All of this reflects the Government’s need to create a new market in order to modernise healthcare provision funded by the state. So as long as the provider can deliver services that meet national standards at a price that commissioners are willing to pay, the doors are open – welcome to the new NHS.

Providers: the next generation

We are getting used to the new market in hospital services. What comes next is even more interesting: the opening up of provision in community and primary care to the competition of the ‘new providers’. In a recent survey by the Health Service Journal, 60% of PCT Chief Executives thought the private sector would have a significant role in the NHS by 2006/7. Calderdale PCT is already inviting organisations interested in providing community-based services to undergo a pre-qualification process.

In primary care, this shift is made possible by section 16CC(2)(b) of the NHS Act 1977 with specific provision for individuals, companies, partnerships and societies. It has led to the current expanded routes of contracting from the GMS – initially to personal, alternative personal and specialist personal medical services. Now the discussion has turned to the ‘new providers’, with attention being focused on the White Paper ‘Our health, our care, our say: a new direction for community services’.

Who are these new providers? The message is: anyone. NHS Trusts will continue for the time being; but Sir Nigel Crisp, Chief Executive of the NHS, has made it clear that foundation status is a target for all by 2008. A new breed of independent providers can be seen warming up in the wings, and includes:

• Private companies such as BUPA and United Healthcare, as well as new entrants to healthcare – perhaps even supermarkets.
• Pharmaceutical companies – for example, Pfizer Healthcare Solutions already have half a foot under the table in Birmingham.
• The voluntary sector – if they could only get their act together.
• New social enterprise models – largely not-for-profit organisations with a co-operative approach. This includes new models of doctors, nurses andpharmacists working together, both in general care and in the managementof long-term conditions.
• Self-management models of clinicians banding together in limitedcompanies or other organisations, perhaps even including ‘chambers’, andperhaps bridging primary and secondary care.
• Industrial and provident societies and friendly societies.
• Foundation Trusts looking to ‘vertically integrate’ care.
• Walk-in Centres and Commuter Centres.
• NHS Direct.

  The limits are only bounded by imagination – and the ability to deliver the right quality at the right price.

Permanent revolution

What of the future? The White Paper allows more flexible registration, which may well be the key to real plurality of provision in primary and community care. Patients will be encouraged to exercise choice in order to create the market outside hospitals. There remain, however, two major problems to be overcome: regulation and robust commissioning.

The regulation of healthcare provision in England is duplicative and confused. Monitor and the Healthcare Commission vie for roles, and the field is crowded with other bit players such as the Audit Commission and the Royal Colleges. Even the Department of Health and the Strategic Health Authorities fail to clarify their exact roles in making and implementing policy with regard to regulation, and some see the future of regulation as lying more with commissioners than with third party quangos.

Commissioning has its own deficiencies and problems. It was introduced in 1990, and in this author’s view has yet to make a real difference and to demonstrate that it works in practice. Commissioning of primary care outside the ‘mainstream’ has been possible since 1997, but is not yet widely used. Decommissioning of poor providers is even less so.

This is not only, or even mainly, the fault of commissioners through the ages – Health Authorities, Fund Holders, locality commissioners, total purchasing pilots, PCGs, PCTs and now Practice-based Commissioners (surely a misnomer, as most form around localities or equivalent) – but rather the fault of successive governments failing to allow policies to mature and unable to resist the urge to tinker on a daily basis with the NHS. This time, once the new commissioners are in place, they must be allowed to get on with the job if we really want to see an NHS revolution. This will involve tough decisions, with unnecessary and poor-performing providers going to the wall.

A modernised NHS with strong commissioners, multiple providers, tough regulators and national tariff pricing is a far cry from the NHS envisaged by its founding fathers. The future is here, and a multiplicity of providers in a market environment is a key ingredient of New Labour’s NHS. The key test, of course, will be: does it produce better healthcare?

Implications for the pharma industry

The fragmentation of provision will mean different types of customer with different roles, motivations, wants and needs. The roles of the new commissioners and their relationships with PCTs and each other will also be key factors in the new NHS.

The ability of the industry to understand these changes as it seeks to maintain and develop new relationships and strategies for influence will, in large part, dictate the success of pharma companies in the future. Turning data into knowledge, understanding it and acting accordingly are of critical importance.