From Big Pharma to Startup: What are the Challenges?

SK Life Science, Inc. Exec Sebby Borriello

Sebby Borriello has had a fascinating ride. Even before he entered healthcare, he traded on his athletic skills and was drafted by the Minnesota Twins, where he played for several years. “Take a job or go with the MLB? No question,” he says.

But of course, athletic careers don’t last long, and he eventually joined Johnson & Johnson, holding various positions in J&J Advanced Wound Care, J&J Biosurgicals, J&J Wound Management, and J&J Health Care Systems. He also worked at J&J subsidiaries Ortho-McNeil Pharmaceutical and Ethicon, along with Mentor Worldwide LLC, a subsidiary of Ethicon. In 2016, he brought the vast library of knowledge and skills he had attained in those positions to a new challenge at SK Life Science, Inc., a startup biotech: to evolve the company from a drug discovery and R&D-only entity to a commercial organization.

When he got the offer from SK life science, Sebby says he asked himself two questions: “Can I learn from the opportunity, and can I make a contribution?” The answer to both was yes, so he signed on. The vision for SK life science was to use the strategies of big pharma while maintaining the nimble processes of an emerging company.

Sebby described four distinct targets that they had to hit in getting a foothold in the U.S. marketplace. The first was to establish who they were as a company before cenobamate, a treatment for adults with partial-onset seizures, was approved by the U.S. Food and Drug Administration and introduced to the epilepsy market. The second was to morph from a drug discovery/clinical company to a commercial organization – a fully-integrated pharmaceutical company. The third was to build a vibrant sales organization. And the fourth – unanticipated at the beginning – was how to launch in the midst of a pandemic.

DEFINING SK LIFE SCIENCE IN THE U.S.

“People need to trust the company brand if they’re to trust what you’re selling. We needed to communicate what our culture was,” he says. The good news was that they were backed by SK Biopharmaceuticals, Co., Ltd., a subsidiary of the SK Group, one of the largest conglomerates in South Korea. The bad news was that SK Group was virtually unknown as a healthcare company in the U.S. It was a giant in microchips, electric car batteries, telecom, oil and gas – but not in pharmaceuticals.

One of the ways they laid down a footprint was to zig where others were zagging. Their first campaign, introduced at a trade show, “did not feature a mom pushing a baby carriage while walking a dog.” That would have been the norm, and boring. Instead, SK life science announced that they were too busy to worry about creative ad campaigns while they were devoting their energies to moving epilepsy treatment forward. This unique approach triggered a “Who are these guys?” reaction that attracted people to their exhibit, where there was an escape room that you unlocked by answering some questions – an interactive idea that engaged professionals by delivering information they wanted to hear.

Sebby notes that one factor working for them was that they were aimed at a relatively small sector of the industry, with a target audience of 12,000+ practitioners. They attend only two big conferences a year, the American Epilepsy Society and the American Academy of Neurology annual meetings. This helped them connect with HCPs very personally. It also helped that they did not have a me-too or established product that people thought they already understood.

They started with a long timeline. SK life science built their exhibits and created their messaging two and a half years before launch. Their vision was to be a CNS leader in five to ten years, but that meant being deliberate and detailed about all of their markers along the way.

BUILDING A COMMERCIAL ORGANIZATION

To be the unique enterprise they envisioned, they had to start with a clean sheet of paper. They wanted people who were experienced, ready and eager to fill in the blanks. Not people who needed to be told what to do, but a group of leaders who understood the vision and were able to create their own teams and goals within the larger picture.

Fortunately, the parent company gave them every resource and opportunity to do this. For both their internal staff and their support organizations, like agency and public relations partners, they were able to draw up the blueprints with expert help.

They were milestone driven. Area sales directors, regional sales directors and others were brought in early to get them accustomed to the company culture. They were trained on the product and the science. They recruited sales reps far in advance, and told them not to leave their companies immediately, but to be ready upon FDA approval of cenobamate. This was a signal that they weren’t looking for revolving door employees, but people committed to a long-term dedication to the company and its products.

BUILDING THE SALES ORGANIZATION

They wanted their own people, not a contract sales organization. They also resisted partnering with bigger enterprises, although they had many offers. Building their own company from a clear strategy worked better than having to compromise with the ideas of others who had their own existing cultures and ideas.

The concept was to build a new entity with its own profile. All the people brought on were top talent who were excited to start on the ground floor and help build an organization that had real potential in the epilepsy space.

Sebby says “Attracting talent is a skill in itself. We wanted people who know that there will be bumps in the road and are prepared for that, ready to improvise and invent because they believe in the company and the product. If you don’t have the appetite for that, this is not the career move for you. We actually talked people out of taking the job, making sure that before they said yes, they were ready to deal with the challenges that came with building this organization.”

Openness, honesty and transparency were key to their outlook, and everyone who signed on had to honor those values.

LAUNCHING IN A PANDEMIC

In November 2019, the FDA approved XCOPRI® (cenobamate tablets) CV as a treatment for partial-onset seizures in adults. Then, of course, the coronavirus hit, just as SK life science was setting up for a May 2020 launch. People were on board, excitement was building, buzz had started to spread in the industry. But now a major decision needed to be made: launch now, or wait?

“We examined the pros and cons,” says Sebby. “What if it doesn’t subside, or there’s no vaccine for a while? On the other hand, there was a market out there ready for XCOPRI®. And epilepsy patients were even more at risk from the threat of Covid-19. Seizures don’t stop in a pandemic, and stress only exacerbates the condition. At the same time, we had to consider how we would coordinate with the physician’s changing workflow. In the end, we decided to launch as originally planned, and serve both the patients and the HCPs properly.”

They decided that there would be some physicians not ready for their launch, but that there would be more who recognized the value of a new therapeutic advantage. One benefit of launching in a pandemic is that there was no fatigue associated with the product messaging. XCOPRI® was new and welcome. And the proof was that reps attained a high level of communication with physicians.

The first priority was safety, especially for their reps. They instituted processes and tools by which reps could stay home yet still communicate with physicians who were adapting to digital communication. “We told them that we understood their challenges in managing their patients and practice, and that we were here to help. If they were ready immediately, so were we. If they needed to wait, we’d be ready when they were.”

Those who were technologically up to speed signed on quickly and eagerly. The conversations were encouraging, because the HCPs were ready to learn. Others needed time to figure out their workflow. “But we saw this as a marathon, not a sprint. True to our original plan, we were here for the long term, and that helped us build credibility.” Where physicians were available to see reps, they distributed PPE to facilitate those meetings.

SK life science was careful in reaching out to patients. They didn’t want doctors blindsided by patient questions before they were ready to address them. At the same time, they prepared patient materials and had them ready for a wider launch in September.

DOING IT RIGHT

The initial success of the launch is borne out by the lessons learned. “Before you make the jump be sure you know what your culture is,” says Sebby. “What autonomy and flexibility will you have?”

Sebby is confident that, although the pandemic has accelerated digital communications, face-to-face is not going away. And with their targeted healthcare professionals treating epilepsy, this works in their favor.

“Our goal is to not be big pharma; more like big biotech, operating in the spirit of big pharma but be more of an advocate for HCPs, patients and caregivers,” says Sebby. “The philosophy was to build from the top down and bring in people who are excited to roll up their sleeves and get to work.”