The pharmaceutical industry has to deal with risk on a daily basis. For all the advances in high-throughput screening or genome sequencing, just getting a new drug to market remains a long shot.The Tufts Center for the Study of Drug Development looked at the development status come end-2013 of 1,442 investigational compounds that first entered clinical trials between 1995 and 2007. Only 7.1% of these compounds had been approved, while 12.6% remained in active development and 80.3% had been discontinued.
In recent years the burden of risk has also become more diffuse, with a palpable shift to market-access issues and an escalation of pre-launch challenges for new medicines.
These include the intervention of health-technology assessment (HTA) agencies in several markets, downward pressure on prices, demand for meaningful product value, a widening range of stakeholders in drug uptake, and increasingly aggressive generic competition.
Any or all of these factors can reduce great expectations to a costly and demoralising damp squib. According to estimates by McKinsey and EvaluatePharma, up to two thirds of drug launches fall short of pre-launch sales expectations in their first year on the market.
Launch risks multiply exponentially when a new drug rolls out worldwide. Even in a notionally harmonised marketplace, market-access conditions are likely to fluctuate significantly from one country to another.
Among the variables are approval timings, access to key opinion leaders, pricing and reimbursement negotiations, levels of need, affordability, currency movements, media coverage and political attitudes.
That is to say nothing of the risks inherent in manufacturing processes, unforeseen adverse reactions, discrepancies between clinical-trial evidence and real-life product usage, or the complexity of the pharmaceutical supply chain.
Our guide and checklist to risk management and product launches will tell you more about whether your organisation is meeting the challenges of mitigating risk in today’s ever more complex launch environment.
Any one of the above factors can have a domino effect across national markets, particularly in an information age that easily turns a little local difficulty into a global crisis.
The result may be dilutive reference pricing, damage to branding and messaging, competitor realignment or, with substantial delays, changes in market conditions that can throw the whole launch readiness programme off course.
These are all reasons for making sure all concerned parties in your company, across national boundaries, layers of management and functional silos, know exactly what is going on with a new product roll-out – and at all times.
Launch risks can only be controlled so far. The recent US feeding frenzy over the massive price hike for Turing Pharmaceutical’s acquired toxoplasmosis drug, Daraprim, was a case in point.
Until the dust clears, one single event – not even that exceptional yet disastrously managed – has changed the whole pricing environment in the key debut market for medicines.
It is imperative, then, that internal risk-management procedures are as comprehensive, transparent, globally aligned and flexible as possible. That means full, real-time visibility of all launch planning and activities, so no-one is caught unawares when problems inevitably arise in translating global strategy into local actuality.
By planning, executing and tracking product launches in a single digital business intelligence tool, you can optimise visibility across countries and portfolios while enabling seamless communication and collaboration between brand teams worldwide.
Emerging issues or progress towards milestones are flagged up on the spot and reviewed intuitively via a dashboard format. The launch programme becomes an open forum in which launch risks are communicated rapidly from one market to the next, while solutions can be agreed and tailored locally with full organisational input.
The right launch tools can make the difference between a game-changer and an also-ran in a mercurial sector where risk is a constant. Why leave that to chance?
TRiBECA® Knowledge is a market leader in smart digital launch tools that help pharmaceutical companies to optimise launch readiness.