Pharmaceutical companies Lundbeck and Otsuka have formed a global alliance to deliver up to five new psychiatric and neuroscience drugs.

The Danish and Japanese pharma companies, both of which have a strong record in CNS products, have signed a sales and cost share agreement.

The alliance covers two near-term projects from Otsuka and an earlier-stage portfolio of psychiatric disorder treatments, encompassing psychotic, mood and behavioural disorders at all levels of severity, from Lundbeck.

The two companies have identified psychiatric disorders as a major area of unmet need.

Lundbeck is granted co-development and co-commercialisation rights to two Otsuka drugs: aripiprazole depot formulation (which improves compliance in users of the drug) and OPC-34712 (for schizophrenia and major depressive disorder).

Otsuka will have an option to co-develop and co-commercialise up to three early-stage compounds in Lundbeck’s R&D pipeline.

“With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, Lundbeck’s President and CEO.

“This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013."

Dr. Taro Iwamoto, President and Representative Director, Otsuka, commented: “We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business.

“Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them.”

Through the sales and cost share agreement, Otsuka will receive up to US$1.8 billion from Lundbeck – which will see its psychiatry portfolio and US market penetration increase.

The combination of Otsuka’s strong presence in North America and Asia with Lundbeck’s strong presence in Europe, Canada and Latin America mean that the alliance will reach most of the global psychiatric market.

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.

Between 1,000 and 1,500 jobs are expected to be lost at Teva Pharmaceutical Industries as part of the company’s cost-cutting measures.

Reports from Israel claim the majority of the layoffs will be made in the US and Europe and mainly focused in Teva’s recently acquired Cephalon’s generic business.

The reports say that Teva is hoping to raise $500 million in synergies from its takeover with job losses expected to raise the majority of its target.

Teva has already said it is planning to cut sales, marketing and administrative expenses by $300 million, R&D by between $120 million and $150 million, and production costs by $50 million to $80 million. R&D savings would be achieved by cutting duplicate operations, the company said.

Teva has a history of job losses following takeovers of generic companies. In 2008 it bought US generic specialist Barr and reduced its workforce by 10%, reports say.

A reduction of 1,000 jobs at Cephalon would represent a loss of 27% roles before the takeover. But one company where job losses will be made, the reports say, is at Mepha, the Swiss generics manufacturer Cephalon bought last year. The company had 620 jobs prior to the acquisition.

The Government needs to do more to support life sciences in the UK and create an environment where the industry can flourish, a new survey has found.

RSA’s The UK Life Sciences Leaders’ Survey 2011 revealed worries over the NHS reforms, medicine pricing and reimbursement, employment issues and the cost of research amongst its leaders.

Nick Stephens, CEO of RSA, says the Government “urgently needs to do more to ensure that education, regulation, access to medicines and the NHS research base align to support the industry’s continued contribution to the UK economy”.

The report is the second annual survey of industry bosses. Last year the general feeling was of optimism with leaders believing the recently elected coalition Government would improve the business environment.

But twelve months later the mood has changed with results finding leaders claim the UK is not competing effectively globally, creating opportunities for early phase/smaller companies or making the most of its unique selling points: the NHS and skills in innovation and discovery.

Leaders also raised concerns about the increasing cost of working in the UK, the implication of R&D as a result of the NHS reforms, the regulatory burden on operations and the process from development to market. They also advised that fiscal and tax incentives should be given to SMEs to help their growth and the UK compete globally.

Worries were also raised about the introduction of value-based pricing. However, in contrast, health technology assessments were broadly welcomed as a means of enhancing value and meeting therapeutic requirements, the report found.

During the tough economic environment, the survey found that leaders would focus on innovation, creating flexible organisations and processes, and refocusing research and development to weather the current storm.

In a perfect world, leaders revealed they would investing in R&D and make the healthcare sector, regulatory and commercial environment work closer together to achieve better outcomes for patients and the pharmaceutical industry.

Stephen Whitehead, CEO, ABPI, says the survey shows more support is needed for biopharmaceutical companies in the ever-changing NHS. “There is much that the Government has done to support the industry, particularly through the Growth Review and the Office for Life Sciences,” he said. “But we need to build on this as part of a continuing relationship with NHS and Government to explore how unnecessary bureaucracy can be eliminated from the healthcare system so that new treatments can reach patients as quickly as possible.”

In the UK joint working is being encouraged to develop innovative services and propagate best practice. But in France, new legislation is placing significant barriers between pharma and its clients. Jérôme Guermonprez explains the implications for market access strategies in the country.

Across Europe pharmaceutical companies have been looking to underpin market access strategies with strong links to healthcare professionals. And while most pharmaceutical companies admit there are significant national differences that demand specific market access strategies, there has been a push, where possible, to leverage expertise, messaging and strategy to drive economies of scale.

Many organisations are now actively embarking upon innovative, cooperative working with regional decision-making bodies – such as the Clinical Commissioning Groups (CCG) in the UK; whilst doctors and pharmacists are increasingly involved in research projects, from clinical research to patient care, patient outcomes and procedures. Indeed, the UK’s amended Health and Social Care Bill strongly encourages pharmaceutical research, innovation and the use of scientific evidence in decision-making.

In France, the forthcoming radical overhaul of the drug regulatory system will significantly change relations between pharmaceutical companies, healthcare professionals, patient associations and physician associations. The “Reforme du Medicament” legislation aims to crack down on health practitioner conflicts of interest, restructure the country’s drug regulator and tighten the process for licensing drugs and for monitoring their effects once in use.

The proposed bill creates compliance requirements that far outstrip the UK anti-bribery laws and includes a number of significant changes which will directly affect the way pharmaceutical companies interact with opinion leaders across the French health service.

To minimise the risk of conflict of interest, the new legislation mirrors the US Sunshine Act by requiring pharmaceutical companies to disclose all financial relationships with healthcare professionals, patient associations and scientific experts.

With an emphasis on patient safety, the bill also requires far more detailed information and discussions about indications – from the provision of a helpline number on every drug packet to enable patients to report problems, to the creation of a government watch list of drugs under review.

It also demands pharmaceutical companies no longer undertake direct physician training but instead provide the funding for training to the government, which will then oversee independent training programmes.

 

Restricted access

Critically, from a market access perspective, the bill will prohibit individual medical representative visits to physicians within a hospital; visits must be collective to avoid any one-to-one relationships and ensure discussions are open and transparent.

The impact of this legislation – which is currently being discussed and should be passed by the French government by the end of 2011 – will be significant for pharmaceutical market access policies and demand companies gain new insight into key opinion leaders (KOL).

Under this new model, the industry will have to be incredibly careful about the type of relationships that are put in place with stakeholders; indeed, at least one pharmaceutical company has already announced it will no longer pay physicians directly in the future or invest directly in physician grants to avoid any regulatory compliance issues.

Furthermore, with many physicians likely to back away from any interaction with the pharmaceutical industry, at least in the short term, patient and physician associations will have a far greater role to play. Pharmaceutical companies will have to rapidly assess the way these associations and individual physicians respond to the new legislation and amend market access strategies accordingly.

 

Regional structure

This new challenge comes at a time when pharmaceutical companies are still adjusting to the major overhaul of the French healthcare system – which has seen the creation of 26 Regional Health Authorities (RHA).

While drug reimbursement is still set nationally as in the UK, since 2009, each region has found the responsibility to adapt national objectives to local or regional health and demographic problematic. Over the past year, each region has had to sign multiple year contracts between the  state and the region to deploy the health strategy.

As in the UK, over the past two years, pharmaceutical companies have realigned resources to create a regional approach based on a key account management (KAM) model. The regional structure has significantly broadened the number of stakeholders involved in decision-making, both financial and medical.

Furthermore, each RHA has a different demographic breakdown and health issues, creating very diverse goals for each region. This change has required a far greater insight into decision-makers and regional objectives; it has also demanded pharmaceutical companies use the KAM approach and strong CRM tools to drive synergies between teams at local, regional and national level.

Pharmaceutical companies in both France and the UK are now actively seeking in-depth insight into the KOLs within new regional structures. Information from the structure of the new organisations, including the multiple drug, technical and price commissions, to identifying specific members, roles and drivers is proving key to create the right regional messaging.

And with this regional, KAM-based model still in its infancy in France, pharmaceutical companies face a tough challenge to ensure the implications of the new medical reform legislation are incorporated.

Messaging, for example, must now be amended to include product safety, as well as quality and efficacy; while companies must ensure information is up to date to ensure changes in physician attitude to the pharmaceutical industry as a result of the new regulations are flagged to remove the chance of inappropriate or unwanted contact. CRM tools will also be essential to coordinate group visits to physicians to avoid any chance of the forbidden one-to-one interaction.

As in the US following the introduction of the Physician Payment Sunshine Act in 2009, pharmaceutical companies will also need help to meet their obligations to declare all activity with physicians.

 

What next?

It is tough to predict how the health service in France will respond to the new legislation over the next 12 months. For pharmaceutical companies there is no doubt that direct physician contact will decline and organisations will have to refocus efforts towards the increasingly influential patient associations and physician associations.

But for those organisations operating across Europe, the changes must demand very different approaches towards health service co-operation. As the UK market looks to drive service innovation and close ties with practitioners at every level, counterparts in France are being compelled to be transparent and improve patient safety. The concept of the global, or even pan–European, market access strategy looks ever less practical.

Jérôme Guermonprez is the Vice President and General Manager, France, Cegedim Relationship Management.

John Wilkinson (pictured), Chief Executive of Eucomed, has received a special Career award from the International Vascular and Endovascular Course (IVEC) in Milan.

The award recognises the medtech industry’s contribution to the development of vascular and endovascular surgery.

IVEC Chairman Giorgio Biasi presented the award to John Wilkinson to “honour the excellence of a distinguished scientist and eminent colleague who has contributed enormously in promoting, divulging and spreading culture, development and achievements in the field of vascular and endovascular techniques.”

Following the award presentation, Wilkinson gave the Edmondo Malan Lecture on ‘Development and Achievements in Endovascular Procedures as a Result of a Continuous and Ingenious Co-operation between Physicians and Industry’.

He discussed the long history of collaborative working between clinicians and industry over 200 years, with ideas from doctors and surgeons being developed by companies, culminating in such revolutionary devices as the drug-eluting stent.

Wilkinson also emphasised the need for innovation to be built on a platform of ethical interaction and transparency, and for industry to support education and training in the delivery of new therapies.

Finally, he drew attention to the demographic and economic challenges facing Europe’s health systems, and called for a collaborative approach between all stakeholders to support innovative solutions to these urgent problems.

Eucomed is the leading European medical technology industry association. It represents 4,500 designers, manufacturers and suppliers of medical technologies.

What level of medical device failure is acceptable? Brad Abbey argues that the industry needs to arm itself against the threat of litigation – not with lawyers, but with the right kind of evidence.

I was somewhat taken aback by a letter in the British Medical Journal last December, where under the unlikely-sounding title ‘FDA is gold standard of review’, Mark B. Leahy, president and CEO of the US Medical Device Manufacturers Association, while singing the praises of the industry, said that a recent study of FDA-approved medical devices from the past 5 years showed that fewer than 1% had been recalled.

Most recalls, he said, were due to manufacturing and design problems in a post-marketing setting. This was in response to an article that had been highly critical of the safety surveillance of medical devices in the US and the low hurdles that have to be jumped to get a device approved (seemingly true on both sides of the Atlantic).

I am a generalist in the healthcare industry, mainly involved with medicines, but to say I was surprised by that figure is an understatement. I realise that the number of car recalls may be higher – but with a surgically implanted device, the owner cannot check it in at the service centre and pick it up at the end of the day.

I know that MHRA gives daily warnings about medical devices, from wheelchairs to drug-eluting stents; but given that the level of adverse event risk that is acceptable to the public for a medicine is somewhere between 1 in 10,000 and 1 in 100,000, the 1% risk seems difficult to accept.

A lead article in the May 2011 BMJ, by Peter Wilmshurst of STARFlex fame, opened with the comment that the regulation of medical devices is (in his opinion) unsatisfactory, unscientific and in need of a major overhaul. Pretty damning stuff.

 

Duty of care

The registration of medicines requires data on the safety, efficacy and quality of products, and the numbers of patients needed to demonstrate an acceptable risk/benefit profile can be dauntingly high. The same level of scrutiny does not happen in Europe for medical devices, where a single approval can trigger cross-community acceptance.

With the increasing complexity of devices and the high levels of patient expectation, it is hardly surprising that when seemingly good devices go wrong the patients want compensation – and, where there is a suitable arena, for punishment to be meted out.

In the US, where many complex medical devices are developed and initially marketed, the ‘learned intermediary’ doctrine has been used by healthcare product manufacturers in recent times to protect themselves in the event of something going wrong. This doctrine, used in the US legal system, states that the manufacturer of a product has fulfilled their duty of care when they provide all the necessary information to a ‘learned intermediary’, who then interacts with the consumer.

This doctrine has been used primarily by pharmaceutical and medical device manufacturers in defence against tort suits. In a majority of American states, the courts have accepted this as a liability shield for pharmaceutical companies.

However, drug and medical device manufacturers sustained an unexpected blow in August 2008 in Rimbert v Eli Lilly and Company: in a federal court decision, for the first time, there was a rejection of the learned intermediary doctrine in its entirety. The decision rejected the notion that the manufacturers of drugs and medical devices do not have to make the patient fully aware of the risks associated with them and that this can be delegated to the prescriber.

The idea underlying the ‘learned intermediary’ doctrine is that the prescriber, who has expert knowledge and skill, should make the decision about risk. But changes in the consumer environment whereby prescription products can be advertised directly to potential patients have rendered this justification obsolete, and so it was predictable that for medical devices – some of them traditionally never coming ‘into the hands’ of the patient – the risk scenario would be influenced by the lesser amount of risk/benefit information needed before approval for marketing. While the doctrine has not been used in Europe, the risk information relating to devices is lagging behind that for medicines.

In order to be vigilant about the risks of medical devices, companies will be best served by surveillance systems that monitor the risk/benefit profile of products from the moment they are first evaluated (even if that takes place in animal models). This is not always easy.

A letter in the BMJ (in the same issue as Leahy’s letter) from a Welsh group of doctors highlights the problems of post-marketing surveillance for medical instruments, and in particular the use of single-use devices for tonsillectomy from 2001 in the wake of the variant Creuzfeldt-Jakob disease that followed the ‘mad cow’ scare of the 1990s.

Widespread adverse events were associated with these non-reusable instruments despite their CE marking, and they were deemed not fit for purpose. The case for reform of medical device regulation therefore seems a given.

 

Hip or lame?

In the meantime it seems that the visible portion of the iceberg of device regulation-related problems is giving rise to a stream of litigation that could possibly become a tide. Recent Medtech Business news reports have followed the fate of orthopaedic company DePuy and its ASR hip replacement.

Hip replacement is one of the clinical successes of the marriage between orthopaedic surgeons and the medical device industry, and it was estimated (before this year’s NHS rationing) that about 70,000 patients were undergoing total hip replacement each year in the UK.

I remember metal-on-metal hip replacements from the 1970s (I have one in a drawer at home that came to me as a result of its breaking), and they became popular again in the 1990s. However, the most recent generation have not fared so well, with higher than expected rates of failure and concerns about excessive levels of metal ions (cobalt and chromium) in the blood of patients.

According to 2010 data from the National Joint Registry of England and Wales, the DePuy ASR Hip Resurfacing System has a revision rate of 12% at 5 years after surgery and the DePuy ASR XL Acetabular System has a revision rate of 13%.

That means that during the first 5 years after a hip replacement with the DePuy ASR hip, at least 1 in 8 patients will experience hip failure requiring painful and expensive revision surgery. With more than 90,000 DePuy ASR hips in patients worldwide, over 11,000 people could require additional surgery due to the defective design of this implant and DePuy’s failure to remove it from the market earlier.

One of the questions that remains unanswered was whether there were potential conflicts of interest between the supplier and the healthcare professionals who developed and were involved in promoting these devices. The key issue in litigants’ minds is that the device did not perform as well as such a device might be expected to, and it seems that the device’s registration in the US was obtained without clinical trials to prove its long-term safety and efficacy. In a litigious society such as the US, where someone must pay for any mistake, the supplier appears to have suffered with the rolling of heads and the decision to remove the offending brand from the market.

Don’t get the idea that this case is a one-off: the recent history of medical devices suggests that arrivals on the market may sometimes be premature, as real risks may not have become apparent. Whether this is related to inappropriate endorsements from the medical profession is difficult to judge, but there are known examples of high-level payments to medical inventors who ‘sell’ their developments to industry and subsequently endorse them.

On the other hand, everyone is aware of what happened to Peter Wilmshurst when he took the opposite stance against a device manufacturer: there was a serious attempt to punish his critical views (which seemed to be well founded) and personally break him through the English court system.

 

Evidence is strength

Litigation against medical device companies is nothing new. However, in an age when people with problems can readily find lawyers willing to take on their problems, and some lawyers (particularly in the US) go looking for people who did not even know they had problems, access to litigation seems to be easier – and it is oiled by the possibility of compensation (which may be deserved when devices turn out to be inadequate or unsafe).

A Google search for the term ‘medical device litigation’ returned 640,000 hits; most of the leading ones were to do with lawyers offering their services in the pursuit of such litigation, or training sessions for lawyers who want to become involved in such cases, or training for companies who want to avoid them. I don’t believe a wake-up call about the risks of being sued is necessary, but what is well worth thinking about is the possible root causes of the current danger, which can ruin a company that believed it had a good product.

The message I am offering is consistent. The products of the healthcare industry must be subject to close and continuous scrutiny for their risk/benefit profile, and this should be done prior to marketing and continue in a structured manner post-marketing. NICE advisory policy on the best devices to use is still in its early stages.

There seems to be a raft of opinion supporting the idea that the regulation of medical devices (in Europe, and probably also in the US) needs to be overhauled to eliminate the placing of devices on the market with inadequate safety and efficacy monitoring.

Rather than finding ways of avoiding expenditure during a product’s development and launch by minimising the collection of such data, companies need to embrace the need for resilient data sets and continual risk/benefit signal monitoring. The competent authorities will wake up to this need, and those with effective systems in place will withstand the culture change best.

Brad Abbey is an industry observer, or the pen-name of an industry observer. The views expressed in this article are those of Brad Abbey, and do not necessarily reflect the views of Medtech Business.

Despite huge investments into CRM systems some pharma companies still struggle to get all of their staff to embrace and fully interact with them. Pf’s Iain Bate explores why, and what the future holds for technology in the industry.

There’s no doubt that technological developments have changed the way we live and work from year to year – maybe even from month to month in the 21st Century. But has the world of healthcare been travelling in the slow lane of the intergalactic highway?

The potential that technology offers to pharma, and the general world of healthcare, is enormous. But is the pharmaceutical industry, and its staff in particular, using it to maximise the returns of billion-dollar investments?

It would seem that technology is the ‘buzz word’ on the lips of a few of healthcare’s major players at present. The DH recently invited people to nominate their favourite health-related mobile phone ‘app’ – be it for keeping fit, to locate a hospital or chemist, or helping to manage an illness. Creative minds were also asked to design their own health app with a panel of DH judges deciding on their favourite from the most popular entries.

Health Secretary Andrew Lansley says it’s the Government’s intention to give people better access to information using modern technology and the exercise is a “unique opportunity for the NHS and those who develop apps to not only showcase their work, but to bring to life new ideas and realise true innovation in healthcare”.

As part of the DH’s technology revolution, patients may also soon be offered online consultations with their GPs using programmes such as Skype. Clearly the Government is embracing the convenience technology offers to patients, but are other sectors in healthcare as interested? It would seem there is still some way to go.

 

In two minds

Pf ’s 2010/11 annual Company Perception, Motivation and Satisfaction Survey suggests that not all respondents are completely convinced by the power of technology in the workplace. Although the Survey – which relates to 2010 and the early part of this year – found that nearly 90% of respondents have access to a CRM system, only 43% find time to use it in the field and more than a fifth of people fail to accurately record post-call reports with important clients.

Questions have to be asked as to why, despite multimillion pound investment and training by pharma companies, there remains a percentage of staff that still ignore the power and potential of the technology at their finger tips.

Results from the Survey reveal there’s no difference in uptake by key account managers, primary and secondary care representatives, those in primary care roles only, firstline sales managers and secondline sales managers and the use of CRM technology between differing age groups – although surprisingly 10% of respondents in these positions with less than two years of experience said they did not have a CRM system, compared to just 5% more experienced colleagues.

The launch of the iPad in March 2010 promised to revolutionise the way sales representatives, and those in similar roles, use CRM systems in the field. However, nearly three-quarters (70%) of respondents from the Survey are still presently sent out with laptops containing their customer-relationship systems.

When quizzed on what they’d change about the hardware which houses their system, the majority of respondents said that their CRM was too awkward to carry, with poor running systems an issue and that batteries ran out too quickly. Apple claims its second-generation iPad now enjoys ten hours of use away from a plug socket in the field.

Yet the switch to the latest convenient tablet devices may not necessarily be about high levels of investment, it may be down to maximising value for money as Paul Shawah, Vice President, Multi Channel Strategy, Veeva Systems explains. “I would say the life cycle of devices within the industry is generally about three years, sometimes a little bit longer,” he said. “When a company invests in new technology they typically depreciate that over that period, so they don’t want to replace it in the field for that time to maximise their investment.

“However, with the introduction of game changing technology like the iPad, this has changed. We see a number of our pharmaceutical customers are justifying the business case to move to the iPad even before their tablets are fully depreciated. This speaks to the business benefit that pharma expects to achieve from the iPad and the related applications only available on that device.”

A convenient shield

Despite technology eliminating mundane process in the workplace and offering the potential to assist employees and improve their efficiency at work, it has historically been used as a shield to mask poor performance and abused as a means to waste company time – a recent online survey by AOL found that nearly half of Americans (44.7%) rank surfing the web as their primary activity during the two hours they ‘waste’ each day at work.

But it would seem that a high number of respondents do value the opportunities CRM offers. Almost two-thirds (64%) said they always enter correctly the amount of customer sales they make into their CRM. But 21% admitted they fail to always report face-to-face meetings with clients. More surprisingly, over a fifth of participants said they do not always record the number of products they had sold to clients.

The lack of honest accuracy is surprising considering the amount of time spent using CRM systems each day. A third said they spend between one and two hours a day on their system with a fifth spending three hours or more on their CRM. During their time using the management system, more than half (55%) said that call reporting was the most useful feature.

Although respondents were less impressed with the KAM abilities of their software with only 19% believing it to be the most useful facility. When questioned about what they would change given the chance, 45% said they wanted an improved database, over a quarter (28%) called for their system to be overall more useful, and 18% said they would prefer their CRM to be easier to use.

 

The next level

But what of the future of CRM systems? Will they be easier to use and have improved customer databases? David Round, General Manager, UK, Cegedim Relationship Management, says the regular interaction we now have with technology means we’ve all come to expect the latest developments.

“End users are significantly more ‘technology-savvy’ than their counterparts of even five years ago,” he explained. “If anything, the challenge for companies is to ensure that they provide their end users with the types of technology that they use as consumers. It’s also important to focus on the usability of your software to ensure maximum use. Technology companies – and pharma – must work together to develop a better understanding of the interaction, to ensure it meets users’ needs in the field.”

One main reason that users have become more ‘savvy’ is down to the use and interaction with social media. Whether at home or at work, websites such as Twitter, Facebook, LinkedIn and most recently Google+ have driven an increased use of various forms of technology – especially on devices such as smartphones or tablet devices which reps are calling for in the field.

Pharma companies, both in the US and UK, have flirted with the idea of fully embracing the power social media harnesses, but at present are restricted by the PMCPA’s Code of Practice and by the FDA – who has again delayed the publication of its guidance.

The FDA says it is “difficult to provide a timeframe... due to the extensive work and review process, or ‘Good Guidance Practices’, which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic”.

Although the FDA may be unsure on how to direct healthcare companies, David Round believes the introduction, both professionally and personally, of social media has had an impact on staff and their expectations.

“For the modern professional person, much of their everyday life is conducted online – for example on shopping, utilities, insurance or booking a holiday – and many users then want the same level of capability from the tools they use in their job,” he added.

Dan Goldsmith, General Manager, Veeva Europe, agrees there has been a significant shift in the way we operate and interact due to our experiences online through tagged posts or hash-tagged searches. But although the 800 million users on Facebook – more than half which ‘log-on’ every day – and 175 million people on Twitter have no problem saying hello to friends, pharma finds it more difficult reaching out to people.

“Social media create a new avenue for healthcare dialogue and will only continue to pervade our lives,” said Dan. “Consequently, I believe that pharma faces two challenges. The first is to decide how to participate in the online dialogue with stakeholders and then to create those interactions through the channels we’re all familiar with, such as Facebook and Twitter.

“The second is to figure out how to leverage the model of social dialogue internally to support stronger collaboration and more focused communication among employees. Already, we see some companies taking advantage of the latest social business tools to connect employees with one another and to access and share information in real time.”

Clearly CRM solution providers understand the potential modern technology and social media platforms offer to companies. Whether pharma and its workforce get fully up to speed on the intergalactic highway sooner or later remains to be seen.

New funding for medical technology research by companies, clinicians and academics aims to promote innovative approaches to the prevention, diagnosis and treatment of diseases in the NHS.

The National Institute for Health Research (NIHR) Invention for Innovation (i4i) programme has allocated up to £13m for research projects, and has launched a call for proposals.

The NIHR i4i programme funds projects through prototype and commercial development until a technology is ready for clinical testing, bringing together academic or clinical researchers and technical experts from industry.

The programme has been updated in two ways:

• Research projects in Wales, as well as in England, are now eligible for i4i.
• Instead of being divided between early- and late-stage product development awards, applications will all be submitted through a single route.

As well as looking for technologies that will benefit NHS patients, the NIHR i4i programme supports collaboration between researchers in industry, the NHS and the academic field. Each approved proposal will bring together researchers from at least two of these sectors.

NIHR particularly welcomes proposals from SMEs and from teams that have previously succeeded in developing and commercialising new technologies.

Martin Hunt, NIHR i4i Programme Director, said: “In the present economic climate, it is becoming increasingly difficult for medtech companies to secure funding for new, innovative technologies. The NIHR i4i programme provides a valuable funding opportunity for the medtech sector.”

This year’s i4i funding covers a “much broader” range of projects than last year’s, he noted. “The amount of funding awarded is determined by the nature and scale of the proposed research activity and we are considering projects seeking larger funding amounts than before.”

Outline research proposals must be submitted by 5pm on Wednesday 7 December 2011. Further details are available at www.i4i.nihr.ac.uk.

The switch to Key Account Management is one more companies are introducing to tackle current challenges. Apodi’s Tony Swift highlights the principles of effective execution and making a strategy work for a smooth transition.

More and more companies are now addressing the changing healthcare market by transitioning the sales process from one which primarily involves representatives engaging with healthcare practitioners on a ‘one-to-one’ basis, to the establishment of Key Account Management (KAM) teams.

The rationale for this change is irrefutable. Access to GPs is increasingly difficult and the ‘customer’ now represents a series of more complex accounts with numerous stakeholders and influencers. Furthermore, decision making is both at a national and regional level and there is now a greater need than ever to focus on local healthcare economy needs and requirements.

As a result, pharmaceutical companies have established, or are in the process of doing so, KAM teams in which individuals have increasing responsibility and autonomy in addressing the needs of their customers at a local level. Some pharmaceutical companies have even taken the model further and given team members, or a small collection of them in a specific locality, P&L responsibility – essentially establishing micro business units within the team itself.

 

A different approach

Some years ago it could have been argued that any company transitioning to the KAM model was differentiating itself from the competition. This argument is much more difficult today because most pharmaceutical companies have moved, or are moving this way – in short, almost everybody’s doing it.

However, there is still a key source of competitive advantage in this environment – and that is to actually make the new model succeed.

Our research, and the feedback we have received from companies trying to adopt the new model, is that the execution process is much more difficult than originally anticipated. The type of feedback we receive often includes the following observations:

• Account managers do not appear to be acting in any materially different way than the sales representatives of the past
• They are adopting the new model at vastly different rates with a small number leading the way and the rest struggling to come to terms with the new strategy
• The move to more local autonomy is creating confusion about the role of the centre and its interaction with the decentralised function.

 

Difficulty of execution

So why is it that so many companies are finding the execution process more difficult than anticipated? The primary reason is that there is often an underestimation of the scale of the organisational change required.

For instance, 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 and P&L accountability are now among the order of the day. Given the above, managements’ task of transitioning the organisation from the old to the new model requires considerable skill, focus and expertise.

 

A decentralised approach

Many management commentators argue that decentralisation is a panacea for all ills. If executed effectively, in an appropriate environment, this structure can deliver enormous benefits to an organisation. However, the move towards decentralisation often creates a number of serious problems which, if not addressed directly and quickly, will significantly impact on performance.

These problems are as follows:

A lack of expertise: a decentralised structure almost always requires an increase in expertise in the key roles within the structure. For example, increased knowledge will be required by employees AND management to solve problems, address more complex customers and, in effect, run businesses – particularly if P&L account responsibility is part of the role.

Inertia: many employees enjoy going to work in an environment where they understand exactly what the day will bring; the common challenges they always face and, in exceptional circumstances, being able to refer any unusual problems to their line manager. In a new environment where their decision making authority is increased, many employees will be reluctant to do things differently and may continue behaving much as before.

Lack of responsibility: the new environment is a scary prospect for some people. The last thing they want is more responsibility and a fear of failure and an inability to work in the new way paralyses them – again leading to ineffective execution.

At Apodi we have looked at specific pharmaceutical companies that are struggling with the implementation of KAM teams and researched the reasons for their difficulties. In every single example, one or more of the problems outlined above was prevalent – and in most cases all three problems coexisted together.

In fact, some of our own executives have reported their own first-hand experiences of working with companies in which the almost evangelical zeal and enthusiasm of top management continued unabated whilst chaos reigned and they failed to achieve an effective transition.

 

The way forward

As we have seen, the execution process can be difficult. And because of this, it is critical that a clear procedure for managing an effective transition is implemented. This process needs to address the following:

1. Identify clearly the strategic intent of the company, including the projected benefits of changing the model and how these are to be measured

2. Given the strategy noted above, clearly identify the role of the centre and the role of the decentralised units and how these might evolve over time. In our view, companies are often too ambitious in managing the transfer of responsibilities from the centre to the divisions or KAMs. Clear standard operating procedures need to be driven from the centre in the early stages and KAMs need to understand the rules that they are expected to work to. Think carefully about giving newly formed KAM teams P&L account responsibility. It may be better to transition to this over time, and in some cases, not even to go this far

3. Identify very clearly the roles and responsibilities of management and KAMs at all stages in the change process

4. Given the roles identified in the new structure, carefully recruit the appropriate personnel. Implement a training and development programme focussed on areas such as the role of Key Account Management, the implementation of a complex sale, general business disciplines and other skills

5. Management need to quickly identify any KAM team member who cannot make the leap to the new world of working and deal with this appropriately

6. Instil best practices across the whole KAM team by establishing effective coordination and information sharing processes

7. Establish effective incentives to drive the performance required

8. Put in place appropriate controls, feedback, learning and corrective action processes to improve performance. Key to this is the management team that drives KAM performance. This team needs to be highly experienced and knowledgeable about the requirements of KAM teams and how to manage a change process.

 

Leading the way

As ever, the role of the leader is absolutely critical in driving through the changes to address the needs of the new healthcare economy. Whilst the development of a sound strategy is critical, it is also the relatively easy part of the process. In every pharma magazine, nearly all consultants and most competitors will support the notion of moving towards a KAM driven business.

However, it is the effective execution of this transition that the leader should focus on. They will also invariably experience many of the challenges that are common to such change programmes, such as internal politics, resistance to the new way of operating, lack of appropriate skills within the team and so forth.

It is because of this that a leader needs to draw on commonsense business disciplines to be successful. It is also crucial that the immediate management team are able to do the same. Therefore, before embarking on the process, it is important to make sure that the management team is capable and ready to execute change.

As I noted at the beginning of this article, many companies are implementing similar strategies. It is therefore logical to assume that, everything else being equal, it is the company that has the management capabilities to execute these changes most effectively that will gain a competitive advantage over its competitors.

 

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