“Being able to partner with Envision, which has a world-class competency in medical communications and medical affairs services lines, and a global presence, makes us a premier partner for manufacturers preparing for a US launch,” says Howard. “Even when only looking at the US market, it’s ideal to contextualise a launch globally. The decisions you’re going to make in one part of the world will impact the other markets you are going to serve.

“While we work with large and mid-size pharma organizations, our true sweet spot is with an emerging manufacturer that is bringing their first product to market. In these cases, we serve as an outsourced commercial launch team for our clients for potentially up to five years. Being able to maintain a team throughout a multi-year engagement is especially key to success.”

Taking a longer-term approach means that the entire team becomes invested in understanding the product, the client team, the competitive landscape and, most importantly, the needs of prospective patients, who might number in the tens or the millions. The promise of cell and gene therapy, in particular, will then provide an opportunity to develop effective, individual solutions for patients.

“As an industry, we need to continue to evolve in order to meet those needs,” says Howard. “While the challenges and requirements to launch a new drug are relatively the same for manufacturers looking to launch first in the US or bring their established EU drug to the US market, there is not a one-size-fits-all solution. The commercialisation strategy should be built for each drug’s journey to market access, curated and customised based on the needs and requirements of payer, prescriber, pharmacy, and patient population for that specific drug.”