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Cambridge Sciences Pharmaceuticals Case Study

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The regrettable but unavoidable incidences of the very many cancers affecting people in Ireland today is an area of medicine which harnesses, in union with pharmaceutical products, the skills of Specialist Consultant Oncologists at the very highest level. Bayer is an established link in this chain principally through the proven use of its product Nexavar, which is currently licensed for the treatment of kidney and liver cancers. It is anticipated however that Nexavar’s scope will be extended to include its use in further indications in Oncology subject to positive phase III clinical trial results. All of this theatre of activity, from the viewpoints of the medical practitioners, the regulatory agencies and the pharmaceutical companies, is necessarily driven by the continuum of verified product trial statistical endpoints. While the market for pharmaceutically assisted weight-loss products is both extensive and growing, it remains fundamentally different from cancer therapies in that overweight individuals have realistically much more discretion with regard to the decision as to what if anything to choose from within the wide menu of discretionary weight-loss products, while cancer sufferers firstly must attend specialist Oncology consultants whose diagnostic analysis will determine what if any Oncology treatment may be suitable and secondly, being a life-threatening condition, cancer requires immediate urgent non-discretionary specialist care.
While Nexavar currently is licensed for two indications, liver and kidney cancers, the prospect of its licensing complement being extended to include further Oncology indications is actively progressing. Ireland has approximately 29 practicing Consultant Oncologists. Because of the nature of Nexavar being a highly specialised drug treatment in a limited population country such as Ireland, all of these Oncologists have more than reasonable practicing knowledge of the wider spectrum of cancers affecting patients in Ireland today. It is important here to note that very many of these professionals have spent considerable time training abroad in highly respected centres of excellence such as the Memorial Sloan Kettering Cancer Centre in New York and others, where international key opinion leaders (KOLs) basically set the trend for the best and most modern procedures and treatment approaches. Furthermore, many of them return to Ireland having gained a wealth of experience in the conduct of clinical trials at these major U.S. centres. Being native English speakers many of our consultants also have strong networks of contacts among U.S. KOLs. They therefore have good potential for development as speakers or international thought-leaders. From a key note speaker and clinical trials perspective our consultants therefore represent a valuable resource to the company. Furthermore, Bayer’s link through Irish Oncologists to these U.S. KOLs, known as “tier one KOLs”, is of significant benefit particularly when planning and organising pre-launch speaker events. Like Cambridge Sciences Pharmaceuticals’ (CSP) plans for Metabical in the pre-launch stage, especially “high-profile medical education events”, Bayer would emulate this initiative especially at important national and international Oncology conferences.
It is significantly of benefit to Bayer that while the prospect of expanding its market base through additional Oncology licensing is probable, the existing community of Oncology consultants with which it has established links based on their working experience using Nexavar over the last 5 years serves as a strong foothold for successful expansion. The size of the country means that we have good access and good relationships with most of the Oncologists. This also means that we are closer to the market and can more quickly determine changing or emerging trends in treatment. From a market research perspective the broadening of Nexavar’s licensing range focuses our activities strongly to engage with consultants during their attendance at Irish-based and international conferences. Unlike CSP, Bayer in reality cannot directly conduct surveys with cancer sufferers, which would indeed really be quite fruitless. Just as CSP did for Metabical however in respect of their market research in the form of interviews with medical practitioners, Bayer could engage with Oncology consultants, possibly through advisory boards, with a view to getting first-hand feedback on their views regarding Nexavar’s latest phase III data for the new indication(s). These advisory boards would be sponsored by Bayer where key Oncologists from each of the established Irish centres of excellence would be invited to participate in a reciprocal capacity in so far as they would be financially compensated for their time and work while Bayer would benefit through feedback on the current treatment and referral patterns operating in each centre and also identifying potential new customers. Additionally we could seek their views on where Nexavar might be positioned within the current menu of treatment options employed by each of the centres with a focus on the new indication(s).
In order to raise awareness of Nexavar’s proposed expanded use, within the eighteen months prior to anticipated license approval/launch Bayer could engage the services of a Medical Scientific Liaison Officer, which essentially circumvents the restriction currently in force barring Sales Reps from promoting unlicensed products/indications. It is of course entirely reasonable to expect that Oncology consultants, being aware of such proposed expansion within the use of Nexavar, would want to be well informed particularly with regard to up-to-date clinical trial data. The regulations allow for this service to assist Oncology teams strictly on the basis of an overture by consultants requesting same. Accordingly it behoves sales teams well to let Oncology units become aware that this important service is available from Bayer.
CSP’s excellent “medical research symposium” idea could be emulated to great advantage particularly to allow for assistance/penetration of the wider multidisciplinary medical teams, especially at the pre-launch stage. These would include, amongst others, surgeons, interventional radiologists, radiation oncologists, pathologists, urologists, hepatologists, specialist nurses and registrars. This would provide a valuable opportunity to invite key note speakers from these various clinical disciplines and, like CSP, create a certain heightened anticipation prior to the actual launch. This would of course be supervised by Bayer’s Medical department and channelled principally through the Medical Scientific Liaison Officer. Significantly, Bayer’s existing complement of Nexavar Sales Reps would not need to be increased as strong links with Oncologists and their teams already exist. CSP’s experience in this respect is identical to that of Bayer.
In a similar fashion to CSP in their Metabical Support Programme, Bayer could introduce a nursing-based home support programme for Nexavar patients who in many cases are elderly and would I feel benefit better from a person to person contact rather than an online support service. This would of course require participation from the Oncologists to authorize same, while surety of dosage compliance and side-effect management would contribute significantly to optimal patient care. Oncologists would benefit through the direct feedback from the Nurse Support Programme regarding patient status updates and Bayer’s product and company profiles would significantly be enhanced via this value-added service. Bayer’s Medical department would of course correctly supervise this service.
With a view to keeping the marketing team informed regarding feedback on the Nurse Support Programme, regular Medical – Marketing meetings would be set up. Here the Medical department would valuably update the Oncology Marketing function on prescribing patterns and average duration of therapy across Nexavar’s spectrum of indications. Should it be the case that a trend is discovered where under strength dosage is being prescribed for an extended period of time, perhaps to limit side-effects or in response to a once-off adverse reaction, the Bayer Nurse Manager could liaise with the Oncologist’s team in order to investigate the reason for the sub-optimal dosing pattern and advise regarding side-effect management.
Unlike CSP’s pre-launch advertising campaign for Metabical, in Ireland such practice is not legal, i.e. a product cannot be advertised for an indication until it has received its license and direct-to-consumer advertising is prohibited in Europe. Bayer would however, particularly around the time of international and local Oncology conferences, maintain a high advertising profile for Nexavar in its current licensed indications and also press releases regarding clinical trial data for its anticipated new indication(s). This principal advertising media would include the monthly publication “Cancer Professional”, the weekly medical journals “The Irish Medical Times”, “The Irish Medical News”, “The Medical Independent” and the Oncology edition of the consultant-targeted publication ”Scope”. Furthermore, Oncology being essentially about extending life expectancy with improved quality of life, Nexavar’s established tagline “More Time for Living” is highly appropriate and suitable to cover awareness of treatment for the new cancer indication(s).
Certainly the experiences of CSP in their 10 year ($400,000,000) pre-launch marathon with Metabical carries many valuable marketing lessons. For Bayer’s Nexavar these include a patient support programme in the form of a home nursing service, market research in the form of advisory boards with our key target customers, a comprehensive marketing communications strategy encompassing medical research symposia and Oncology educational events chaired by distinguished Irish and/or international KOLs. Like CSP, Bayer would also benefit from expanded use of its existing Oncology Sales and Marketing teams.

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