Pf’s Iain Bate examines how contract sales organisations are taking their place among the industry heavyweights.

There can be little doubt that pharmaceutical employees – in particular sales and marketing executives – have taken some metaphorical hefty blows in recent times. All of pharma’s biggest heavyweights have announced ‘austerity’ measures as part of widespread job cuts across the majority of divisions in recent times.

Whilst pharmaceutical CEOs have enjoyed champion pay rises, the humble employee at ground level has been unable to duck and weave away from the dreaded knockout blow. As a result, the job market has been on the ropes. However, candidates searching for a career in the medical sales industry do not have to throw the towel in just yet.

The employment market has suffered many bumps and bruises in recent years – but Contract Sales Organisations (CSOs) are leading the fightback. Now regarded as a leading contender for those looking for a prolonged career in the medical sales industry, CSOs continue to punch above their
weight in a challenging environment.

Pf spoke to four leading CSO companies to provide a blow-by-blow account of how contract organisations have boxed clever in recent years. Why have they gained in popularity despite the employment market suffering a bloody nose? And what does the future hold for the contract sales movement?

The gloves are off

In the modern working environment, when uncertainty accompanies everyday challenges, the flexibility CSOs offer clients is a major attraction. “The fundamental driver is the requirement for an increase in flexibility from our biopharma customers,” says Helen Molloy, HR Director at Quintiles Commercial. “This is nothing new – but what has changed is the nature of that flexibility. It’s not just about numbers of people, it’s about expert teams with specific skill sets and evidence tailored address local priorities.

“Customers are increasingly looking to partner with us to help navigate challenges around proving cost effectiveness and long term value of a drug to a wider range of stakeholders. We are moving away from what has historically been seen to be the fundamental core of our services, and into much more specialised areas.”

Flexibility is certainly an attractive proposition for clients who have slimmed down sales teams yet still require the prowess to impress customers. However, flexibility isn’t the only factor driving CSO growth. Specialist skills are now required by clients to outwit the opposition. “Contract sales organisations are moving away from large-scale build, high noise proposition and are becoming much more specialist,”
says Emma Busby, Project Director at CHASE. “Organisations are demanding to have specialist skills and capabilities either to be equitable to their teams, or, in most cases, to offer more opportunity and more value within their teams. Their key objective is to heighten the level of capability that they have got on their headcount team.”

Pharma’s increased reliance on contract methodology is now reflected in the number of candidates turning to CSOs to develop a career in UK medical sales. “CSOs are becoming the only way into the industry,” says Emma. “We work with many blue-chip companies to provide an influx of trainees every year. Again those people go through organisations and develop. The trend went away from that for a few years, but it’s definitely coming back now. Companies recognise they need high-quality sales engagement. We can regurgitate skills but fresh attitudes and capabilities coming in will actually challenge the status quo.”

At a time when, as far as job security is concerned, pharmaceutical representatives fear the next barrage of punches, CSOs are doing more than ever to provide a shot at the big time in the industry. David Alexander, Contract Business Unit Team Leader at Star, says there are a number of reasons why CSOs have gained
in popularity recently. “Security, variety and skill development are key,” he said. “Working for a CSO
means people can move from one assignment to another and gather experience with different companies,
in different therapeutic areas and with different customers over time. Transferable skills and flexibility
are important qualities in today’s environment and working with a CSO will help people profile both.”

Swapping gloves

That value is also being recognised by clients seeking to boost sales at various stages of a brand’s life cycle. With the industry well on the way to manoeuvring itself away from the traditional sales model to a sophisticated fighting-fit key account approach, contract sales organisations are perfectly placed to augment teams or, in some cases, replace them. “A CSO can help do both,” says David. “It can either enhance a team or, if necessary, it can replace it. You can either have a bolt-on campaign, where contract reps target specific areas in fixed time periods, or, you can replace an entire team with a CSO key account team, enabling flexibility and resource in particular areas of the UK. This allows clients to be much more outcomes-focused.”

The next round

But what next for contract sales organisations? Will pharmaceutical companies decide to completely
shed their entire headcount and outsource functions to specialist organisations? Andy Holgate, Business
Unit Director from Ashfield In2Focus, believes this may be the case. “Contract sales organisations are expanding into new areas,” he says. “The model for CSOs in the next 20 years could be where pharmaceutical companies simply concentrate on research and development and strategic marketing and finance. Contract sales organisations will, potentially, then do all of the rest. I think that is the trend that CSOs are driving towards.

“We may be in a bit of a perfect storm at the moment where pharmaceutical companies, many of whom are being squeezed from above and are tinkering around the edges, are considering outsourcing services in areas where they would never previously have allocated external resource. Contract sales organisations are extremely good at being able to help pharma companies, and other clients, differentially resource people when and where they want them and when and where they don’t, be that in sales or other value-adding roles.”

In an austere environment when pharmaceutical companies are fighting against a whole host of external
pressures, it’s difficult to see how contract sales organisation will fail to grow in the coming years. The powerful combination of being an inviting proposition for individuals seeking a career in medical sales industry, and strategic allies for companies in need of flexible and specialist commercial expertise, CSOs are rapidly establishing themselves among the industry heavyweights.

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.

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.”

Bristol-Myers Squibb has entered into a strategic partnership with Singapore-based ASLAN Pharmaceuticals for the licensing and development of one of its investigational oncology compounds.

Under the agreement, ASLAN has the rights to develop and commercialise BMS-777607, a small molecule inhibitor of the MET receptor tyrosine kinase for treatment of solid tumours, in China, Australia, Korea, Taiwan and other selected Asian countries. BMS will retain rights for the rest of the world.

ASLAN will also complete and fund the development of the compound under a pre-agreed programme that will initially target gastric and lung cancers.

Francis Cuss, Senior Vice President, Research, BMS, says the agreement is part of the company’s “Oyster strategy” which aims to produce “high-quality data that may be used to further develop and commercialise the medicine worldwide”.

“As part of our biopharma strategy, Bristol-Myers Squibb seeks to seed companies in key markets with promising investigational medicines of continued interest to Bristol-Myers Squibb,” he said.

Bristol-Myers Squibb (BMS) has made alterations to its Senior Management Team.

Giovanni Caforio has been promoted to President of US Pharmaceuticals from senior vice president of Oncology and Immunology Global Commercialisation, replacing Anthony Hooper, who has decided to leave the company.

In addition, Charles Bancroft and Béatrice Cazala have both been appointed as Executive Vice Presidents of the company, reporting to Lamberto Andreotti, CEO of BMS.

Mr Andreotti said that he looked forward “to working with these three senior leaders and the rest of my management team to continue to successfully execute our BioPharma strategy”.

Bristol-Myers Squibb is a global biopharmaceutical company aiming to discover, develop and deliver medicines to patients with serious diseases.

Cubist Pharmaceuticals has appointed Dr Jennifer Jackson as its new Senior Vice President of Regulatory Affairs.

Dr Jackson will oversee all aspects of Cubist’s Regulatory Affairs, providing oversight for all regulatory matters, reporting to Dr Steve Gilman, the company’s Executive Vice President of R&D and CSO.

Dr Gilman said: “Jennifer’s extensive international experience, collaborative nature, and focus on disciplined execution will help us as we advance our exciting pipeline in the years ahead.”

Dr Jackson joins Cubist from Biogen Idec Hemophilia, where she worked as vice president of Regulatory Affairs and Clinical Compliance. She has also worked at Vertex Pharmaceuticals and Bristol-Myers Squibb.

Cubist Pharmaceuticals is a biopharmaceutical company focused on the research, development and commercialisation of pharmaceutical products that address the unmet medical needs in acute care.

The CHMP has recommended Astellas Pharma and Optimer Pharmaceuticals’ Dificlir (fidaxomicin) to treat adults with colon disease.

The drug specifically targets the bacteria causing the infection in the colon whilst avoiding ‘friendly’ bacteria in the gut of patients with the disease, which is also known as Clostridium difficile-associated diarrhoea (CDAD).

Ken Jones, President and CEO of Astellas Pharma Europe, said: “European patients with this potentially fatal disease can take encouragement from the positive CHMP opinion for Dificlir that a new medication for clostridium difficile infection may soon be available.”

Dificlir’s active substance is fidaxomicin, which belongs to the macrocyclic class of antibacterials and inhibits RNA synthesis by bacterial RNA polymerase.

Dr Xavier Luria, Head of Safety and Efficacy at the EMA, said: “This is a promising step forward in the Agency's drive for addressing patients' needs in infectious diseases.”

The positive opinion is based on Phase III clinical research data comparing fidaxomicin with oral vancomycin on patients in the US and Canada. Results of the studies showed that clinical cure was achieved at the end of ten days of treatment with both treatments. Furthermore, fidaxomicin had a significantly lower rate of recurrence of CDI compared to vancomycin.

Dificlir, known as Dificid in the US, was approved by the FDA in May for the treatment of CDAD in adults.

The European Commission will deliver its final decision within three months.

CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.

UK-based Astellas Pharma Europe manufactures and distributes pharmaceuticals globally with the intention to improve lives through the introduction of innovative and reliable pharmaceutical products.

Optimer Pharmaceuticals, is a biopharmaceutical company focused on developing and commercialising hospital specialty products to treat serious infections and address unmet medical needs.

Quintiles has appointed Oren Cohen (pictured) is its new Senior Vice President and Global Head of its Phase I Clinical Research division.

Mr Cohen has been promoted from his position as Chief Medical and Scientific Officer (CMSO) and will leverage the company’s clinical trial services and deep expertise in biomarker development.

Paula Brown Stafford, President of Quintiles Clinical Development, says Mr Cohen brings a “wealth of clinical and scientific expertise” after his former roles at the company.

The former medical advisor joined the company back in 2001 and was appointed CMSO in 2004.

“The Phase I clinical research space is changing rapidly, with fewer new molecules entering development and a fundamental shift in target study populations from healthy volunteers to patient groups,” said Mr Cohen.

“Biopharma companies are looking for an ally to help them manage these complexities, ensure patient safety and reduce costs, and Quintiles offers best-in-class early clinical development solutions to meet our customers’ needs.”