Microsoft word - tenyearsarticlepp.doc

SPECIAL FEATURE:
The Role Of The Consultant
Pharmaceutical Physician

How Has It Changed Over The Last Ten Years?
By Ms Lesley Crosland, Crosland Communications

WORKING IN THE PHARMA INDUSTRY AS A CONSULTANT
PHARMACEUTICAL PHYSICIAN, WHAT CHANGES HAVE YOU
WITNESSED OVER THE LAST TEN YEARS? HOW EASY IS IT TO GET
INTERESTING ASSIGNMENTS? WHAT ARE THE CURRENT
CHALLENGES WITHIN THE ROLE VERSUS TEN YEARS AGO? ARE THE
CHANGES IN THE INDUSTRY FOR THE BETTER – OR NOT? IS THERE
MORE WORK FOR CONSULTANTS?
HARTEN GROUP, A PROVIDER OF INTERIM MANAGEMENT SERVICES
TO THE PHARMA AND BIOTECH INDUSTRIES, HAS CONDUCTED A
SURVEY AMONG 400 PHYSICIANS TO FIND OUT.
OF MAJOR IMPORTANCE TO ANY consultant is the ability to get stimulating
assignments. So is there more work on offer than in 1997? The overwhelming
response to this questions was happily a positive one.
CLEAR BENEFITS
However in finding out why this should be the case, a whole range of reasons
were given. Dr Jay Herbert, who works as an interim in the industry, puts it
down to specialist interim management and client companies recognising the
interim market for industry physicians and seeing the clear benefits they can
bring to their business.
Tim Ewbank agrees with this, adding that things have changed hugely since
the Tech Boom & Bust in 2000-1. He says: “Large companies had previously
been shy of working with individuals directly or with small firms. Since 2001
they have come to question the value of large, high-cost fee firms which
provide generic solutions, preferring instead smaller specialist, niche players.
The situation has also become easier in relation to the use of interims.
Companies are now more willing to use contract staff in managerial as well as
technical roles.”
There could be another reason why there is more work. Iain Cockburn, as an
interim physician, has found it easier to get projects but believes that it is
because large pharma companies are having difficulties in terms of finding
experienced physicians for permanent roles.
CHALLENGES
So there’s more work around and stimulating projects can be found through using the right provider, but is the role of the consultant more demanding than a decade ago? And what factors present the greatest challenges? The growing incidence of mergers and acquisitions within the pharma industry was overwhelmingly quoted as a factor. The need for a wider knowledge base and increase in regulations followed a close second. However, not all projects are stimulating. “Often the work can be limited in terms of providing a challenge for you personally”, said one consultant. “In my case, as an ex-Medical Director, filling in for a missing entry-level physician can hardly be described as stretching. It also requires restraint when coming across misguided attempts by less-experienced managers to achieve their objectives”. Iain Cockburn finds that increasing expectations on the availability and flexibility of the consultant have made things more demanding over the last ten years. He also highlights the growing need to be able to diversify and not stay within a specialist role to maximise the projects you do. This is with the exception of medical affairs, pharmacovigilance and clinical research where specialism is all and clearly this would not be appropriate. KEY CHANGES Harten Group asked consultants what they felt had been the key changes in the pharmaceutical industry over the period. Increased regulation was most often quoted and the growing number of audits and inspections to ensure compliance. Another response focussed on the changes that have occurred in terms of patients and the demographic shift, with the ageing of the population and the rising use of lifestyle medicines such as Viagra. On the supply side, the industry today, as ten years ago, has the same fundamental objectives – seeking new medicines to treat disease in an increasingly competitive market. Growing pressure to make ‘products work’ was cited a number of times, with tighter timescales to gain approvals irrespective of the resource available. Product development driven by investors seems to have taken over said one consultant. Another added: “There is so much pressure on both time and cost as there is considerable ‘first mover advantage’ in being first to market with a new drug in a new therapeutic area or using a novel approach.” The increase in regulations has had a positive effect in terms of creating a need for QA specialists to help support companies through regulatory inspections. “I have worked on the preparations for several and am constantly amazed at how much difference quality advice can make when companies face an audit from the MHRA, for example”, said one consultant. COMPETITION When the survey probed what had brought about these changes, we received a range of different reasons. Competition was top of the agenda. Most of the major disease classes now have established treatments so the search is for cures in more difficult disease settings or rarer conditions. Also, the increase in regulation has made drugs more difficult to develop which in turn adds to the industry’s costs at a time when providers are exerting downward pressure on prices. From the patient perspective if increased regulation leads to fewer product recalls or mishaps, it is all worthwhile. Other reasons highlighted for the changes included a reducing portfolio of novel agents, increasing development costs and escalating demands to see a fast return on investment. PLUSES AND MINUSES So are the changes positive or negative? Most people thought there were both pluses and minuses. A positive change is the way the pharma industry has played a major role in improving the country’s approach to health issues at both a local and national level. Greater regulation is felt to have improved patient safety. On the downside, the increasing need for a fast return on investment has increased the pressure and companies might be tempted to take shortcuts or bully teams to deliver the results faster. The poor image of the pharma industry remains, as one consultant says: “We have failed to capitalise on the way the industry has improved the approach to health issues so the general public still sees us as corporations profiteering from people’s suffering”. So overall what would consultants highlight as most positive thing to come out of the pharma industry in the last ten years? Data on the new drugs released has increased, the number of patients treated has grown and cancer survival rates are also considerably greater than ten years ago. “Pharmacovigilance has evolved from portakabin to boardroom”, says one. But there are negatives too. A diminution of the level of trust between the public and the industry – maybe even a breakdown? There is still a perception that the industry is too close to government and that as a result some products are being approved which should not be. The emphasis on cost and time has also led some consultants to question standards of practice. One has resigned from a project because he felt the practices that were being imposed were unreasonable. Inspections are driving a vicious spiral of identified best practice, with these inspections constantly resetting the expected standards. Interpretation is now becoming based upon these inspections and as a result increasingly detached from published regulation. So what will happen over the next ten years? Any thoughts or comments would be welcomed (please email info@hartengroup.co.uk) and who knows, they may provide material for another article in due course!

Source: http://www.hartengroup.co.uk/resources/files/TenYearsArticlePP.pdf