Words by James Coker
When Eliud Kipchoge completed his momentous sub 2-hour marathon in October 2019, an estimated 500 million people tuned in around the world to watch this astonishing piece of sporting history. Yet, as Kipchoge himself acknowledges, this seminal moment was only possible due to the meticulous, unseen preparation far in advance, ranging from his intensive training regime to the large team of pacers and drink carriers working in perfect harmony.
The principle is no different when bringing a pharmaceutical product to market, with the commercial success often determined by the depth and detail of the behind-the-scenes planning in the months, and even years, prior to launch. “In general, the pre-launch phase has become much more prominent as companies realise the importance of this period,” notes Alice Dietrich, Head, Global Medical Affairs, Galapagos. With regulations tightening and expectations of stakeholders becoming more demanding, pharma is waking up to the need to put a greater medical emphasis on this traditionally commercial-based domain. It is unsurprising, therefore, that medical affairs have donned their running shoes and made themselves a crucial member of the relay team carrying new products across the launch line.
The need for MA to take on a more strategic, leading role in launch preparation is greater than ever
“Launch preparation activities in the pharma industry have evolved in recent years in two pronounced ways: earlier engagement with thought leaders through MA, along with clearer and earlier communication of the value proposition an eventual product is anticipated to represent,” explains Alex Flint, Director, Medical and Regulatory Affairs, Eisai. “Both of these improvements were made following the realisation that the success of a product is determined before it is even launched.”
Dietrich adds: “In recent years our compliance landscape has become more complex with very strict regulations, especially on what commercial can speak about in the pre-launch phase. MA now has a much bigger role in pre-launch activities than before, as the medics/medical science liaisons are the only ones that can actually prepare the market and have scientific exchange with healthcare professionals.”
Yet suboptimal launches continue to plague the industry; for instance, in the period from 2010–2017, half of new drugs underperformed against their pre-launch ambitions. This record must improve drastically for the pharma industry to effectively cover the needs of patients over the coming decades. A powerful case can now be made for MA to direct pharma’s pre-launch approach. “The need for MA to take on a more strategic, leading role in launch preparation is greater than ever,” states Flint.
MA should be under no illusion that such a profound change to existing practices will be straightforward. As with any organisation, the case for reducing the role of commercial departments, the breadwinners, is not an easy one to make. “Some companies still think it is all driven by sales,” says Dietrich. “But there needs to be a very close collaboration between medical and commercial as the overall product strategy needs to be developed together.”
It is incumbent upon MA to demonstrate exactly why they should take on this strategic mantle. The crucial point is that in an increasingly fragmented marketplace, encompassing a growing number of drug makers, ensuring a product stands out from the crowd has never been more difficult. For instance, it is insufficient to solely disseminate clinical trial data regarding new products. “In recent years, the focus on real-world evidence has evolved and is now a cornerstone of MA work pre and post-launch as a lot of questions cannot be answered by Phase III trials,” comments Dietrich.
Therefore, close lines of communication with HCPs, thought leaders, and, of course, patients, must be established throughout a lengthy pre-launch phase. MA, more so than any other department, has the knowledge and ability to direct this kind of operation. “MA represent the intersection of both internal clinical development and commercial operations (marketing, sales, market access) and the external key opinion leader community within a given therapeutic area. Successful launches start with active listening programmes to patient and customer needs and correspondingly shaping meaningful product differentiation in the eyes of the patient and customer,” says Flint.
Whilst MA is, in the main, becoming well-established in the pre-launch process, this is still often not enough to ensure new products are meeting pre-launch expectations. The move towards drug launch being a medically focussed operation has taken its first steps; this quickly needs to evolve into purposeful strides, closer to Kipchoge’s marathon pace. A MA-led pre-launch phase, built upon demonstrating value to match stakeholder needs, should become standard practice across pharma: the industry’s long-term future could well depend on it.