Commercialising a vaccine, even one that targets an unmet need, is a challenging task for companies. To bring therapies and medicines to patients with unmet needs, forming new strategic partnerships can be key, giving smaller organisations access to the information, resources, and reach needed to support a vaccine launch. Finding the right partner is not always a smooth process, but as Lee Taurman, executive vice president, global head of full-service commercial, Syneos Health, and Jeff Baxter, president and CEO for VBI Vaccines, discuss, exploring non-traditional partnership models can open up even greater opportunities to advance public health efforts.
To illustrate how such a partnership model can help companies to thrive, Baxter and Taurman share their experience of industry collaboration, and detail how Syneos Health and VBI Vaccines took a somewhat unconventional approach to prepare for the launch of VBI’s 3-antigen hepatitis B vaccine in the US, Europe, and Canada.
Preventing infection is a critical healthcare challenge. Yet, the WHO estimates that only 40% of newborn children receive their first dose. Adult vaccination rates drop off from there, and surveillance varies by country. In the US, the Centers for Disease Control and Prevention (CDC) estimates that just 30% of adults are vaccinated against HBV. As such, there is a huge opportunity to improve vaccination rates and protect people from that initial infection.
“Hep B is known as the silent killer because people don’t actually see symptoms manifest physically, usually until they are in their early 40s or 50s,” says Baxter. “In fact, the WHO estimates that only 10% of that 296 million people who are chronically infected across the globe are actually aware that they have HBV. So, if people in their teens, 20s, and 30s are living their lives, unaware that they have HBV, there is a higher potential for HBV to be spread.”
Having identified the unmet need for preventative vaccines for HBV, VBI Vaccines developed PreHevbrio, a 3-antigen adult hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus.
But, as VBI Vaccines understood, while PreHevbrio had clear potential to help reduce the risk of infection, the company would need to partner with an external organisation to successfully differentiate the product from competitors on the US market.
As VBI Vaccines began to explore potential partnership options, one company emerged as a clear frontrunner: Syneos Health. The two companies had already been working together on the pre-launch strategy and activity for a little over a year, beginning in 2019. However, unlike more traditional commercialisation partnerships, both Syneos Health and VBI Vaccines were keen to establish a new method of collaboration.
“As you take things to market, I think there has always been this binary choice of either, you licence the product away or build everything yourself in house,” says Taurman. “Ultimately what we have been able to do is create an alternative to that – a middle ground if you will – where you retain the asset chain, the strategic decision making, the optionality associated with what you do with that product moving forward, but you build towards a commercialisation programme really allowing you to focus on the strategic area that you chose.”
For Baxter, it was a true meeting of minds. Having previously worked alongside each other, the teams came to the partnership with a mutual understanding of what they were aiming to achieve. It was, as he describes it, “a single vision and model of a successful launch and commercialisation of PreHevbrio.”
“Traditionally, you would just sell a consulting project, do it, and move on, hoping that maybe there’s another one after, but really we are unique in that we have agency capabilities, field funding capabilities, and we have a lot of people who are from the industry with service backgrounds,” says Taurman. “So, how do we meet VBI where they are, with what they need and have a broader relationship, perhaps, where we can help them in a more meaningful way than just as a simple single service provider?”
By approaching the partnership as a truly collaborative process, Baxter notes that each organisation was able to focus where they would provide the most value. As a smaller biotech, the process of attracting and recruiting the right team members is a lengthy and consuming process, one that detracts from the important focus of internally and organically developing new assets to address unmet needs.
“As a one product bag, or even two product bag biotech, it would be difficult to attract the very best people in our industry,” he explains. “Partnering with Syneos Health gave us access to talent, operational effectiveness and efficiency, and delivery. But also – at the time and even now – because of the pressure workload and opportunity in our pipeline, I didn’t want the distraction of having to hire 80 people and manage those people.”
With the team in place, VBI and Syneos Health leveraged their combined expertise to develop a commercialisation strategy that addressed a critical challenge for prophylactic vaccines, using PreHevbrio’s key differentiator. As Taurman and Baxter both acknowledge, launching a preventative vaccine is a unique process as, unlike therapeutic products, a prophylactic either works or it doesn’t, which makes it difficult to demonstrate why clinicians should favour a new product.
Leveraging Syneos Health’s prior commercialisation experience, the partnership elected to spotlight PreHevbrio’s position as the only 3-antigen hepatitis B vaccine.
“With the Syneos Health team, in terms of the value proposition of this product, we were able to recognise very early on that we were going to have to differentiate by focusing on the 3-antigen composition – i.e., the Pre-S1, Pre-S2, and S antigens of HBV. We then recruited a team of Medical Science Liaisons (MSLs) in North America to start talking to Key Opinion Leaders (KOLs) using our clinical data and peer-reviewed publications,” explains Baxter.
“It’s inherently a scientific debate. But you only get those insights by working with people who understand the scientific proposition – and then Syneos Health’s commercialisation expertise told us that we should get MSLs in the field as soon as they are able to start sharing this published data to get KOLs aware that this product is coming,” he says.
While progressing through the initial phases of a vaccine launch have provided achievements worth celebrating for both VBI and Syneos Health, Taurman notes the importance of growing together as smaller biotechs may choose an external partner to mitigate risk early on, but as they build and grow, may choose to develop resources internally.
“Our model and the way we work with people recognises that. We understand that the relationship needs to evolve as the company’s strategy and position evolves over time,” he says. “There is a back and forth in the evolution of that, so it is a pretty attractive model that gives you a good amount of flexibility and dynamic changing over time, as market conditions and strategic priorities change over time.”
“In some of the relationships that we have with non-partnership clients, it is transactional to an extent. There is a job to be done and there is an order given and an execution to be done. That’s a fine relationship. It is the basis of the services industry,” says Taurman.
“But in the relationship that we have with VBI, it is a partnership, and we work together to accomplish the goals that were set, there is an ongoing dialogue, neither of us sees this as a transactional relationship – even though there are transactions that occur between the companies. Everything is done in the spirit of partnership,” he says.
Baxter echoes his faith and trust in this sentiment. He notes that, while Syneos Health and VBI are yet in the early days of the commercial launch, it is clear to all involved that the partnership is building towards something greater, capable of matching or exceeding the level of tangible results expected of conventional service provider transactions.
Taurman agrees: “There is a mindset shift when you are in that kind of relationship because you can make an investment in a person or in something and that can pay off down the road. We can take chances on things and know that if they don’t work out that we’ll respond to those challenges together.”
“I think there is a real opportunity to look back and say we really were at the forefront of something new. That’s pretty exciting.”