A clear commercialization strategy is imperative for success, says expertA clear commercialization strategy is imperative for success, says expert

Founded in Ireland in 2018, Shorla Oncology is focused on the premise that reformulations of drugs can address both clinical burden and unmet patient needs. In that time, it has secured back-to-back US Food and Drug Administration approvals for the first oral formulations of oncology drugs imatinib and methotrexate, and in October 2023 the firm secured $35 million in Series B funding to support commercialization.

Sharon Cunningham, co-founder and CEO of Shorla Oncology, told the Biotech Showcase audience in San Francisco, California that there is a need for a clear commercialization strategy from the outset. "We had to plan very early on for how we were going to commercialize […] what the product market fit was, the strategy to get to market,” said Cunningham. 

 “And I do firmly believe that being very knowledgeable and clear about our commercialization strategy did help support a better valuation and a greater belief in what we were trying to achieve." 

The company chose Eversana, a third-party services provider for pharma commercialization, and its co-commercialization model to support its path to market, utilizing the company’s fee-for-service model that worked within its budget for much of the execution.  

“When we started, we were green. We're a European company, headquartered in Ireland. The US market was new to us,” explained Cunningham. “It is very complex. And it can be hard to decipher what activities are going to drive the most value. Some of it you learn along the way and it's probably almost impossible to understand at the outset.” 

Now, with training and gained experience under the Eversana team, Shorla’s approach to commercialization has evolved and they are now bringing some activities in house. Cunningham explained the firm is being very intentional on the activities they can and should control internally versus those that a vendor can handle. 

On the learned experience, Cunningham told delegates, "I'm investing in market access and market research earlier. I'm buying data earlier. All those things that I now know about, I can obviously apply them a lot earlier." 

Balance during early phase development

One of the challenges biotech companies can face is balancing the focus between technical development and commercial planning, said Abdullah. Cunningham agreed: “I see that as a pitfall all the time, where companies focus on the technical aspects and getting the product through the clinic but ignore how they're going to get it onto the market.”

She said no matter the path to commercialization (out-license, selling assets or go-to-market themselves) it is crucial to understand that path, its challenges, and have  a clear direction on how the product will be prescribed, reimbursed, distributed.

Cunningham shared that balance may have been inherently easier in her situation. Chief technical officer and co-founder of Shorla, Orlaith Ryan, focuses on product development with regulatory and clinical decisions.

As the only person making those decisions early on, she surrounded herself with experts in various fields, which she said was key. “If you're in a position to be able to appoint board members, ensure that you have a commercial presence early on. You need that voice and that person that will back you up when it comes to commercial discussions."

She also relied on a network of reimbursement, market access and other consultants and experts to build an advisory team. She noted that these are just some ways to make decisions cost-effectively, but you do have to focus on it.

Faruk Abdullah, president, professional services & CBO for Eversana, was clear that there is not one path to early commercialization choices, which are heavily dependent on the type of product and market dynamics. However, he shared that an iterative approach seems to work very well.

“Start with broad strokes […] the key points or topics that will have the greatest disproportionate impact on the commercial potential of the product.

“Usually around Phase II, Phase III that would be pricing and reimbursement. Make sure you get a healthy access environment based on the data you're generating that will connect to value.”