Velsera Is Building an Ecosystem that Accelerates the R&D Loop and Democratizes Omics Data to Propel the Next Era of Precision Medicine

My most recent interview is with Gavin Nichols, the CEO of the newly formed company Velsera. Velsera launched in January 2023, after quietly acquiring the three companies Seven Bridges, UgenTec, and Pierian in mid-2022, with Summa Equity being the primary investor behind it. Since these acquisitions, Velsera has spent a lot of time integrating and reorganizing the three companies into one with an established, new executive team for their sales and operating model. The reorganization led to the creation of a platform for growth that is both scalable and extensible and allows Velsera to build an integrated ecosystem. The goal is to power this ecosystem with actionable insights using AI and technology solutions that accelerate the R&D and clinical adoption loop through the democratization of ‘omics data to create the next era of precision medicine.

The following summarizes my dialogue with Gavin Nichols.

Enlightenbio: Congratulations on the recent formation of Velsera, which is interesting as it unites established companies in the omics’ and life sciences sector – combining Seven Bridges, Pierian, and UgenTec.

How would you describe the gain for existing, individual customers of these various original companies that is expected to result from the formation of Velsera?

Gavin Nichols:

First, a few specifics of how we think about the overall value add and how we talk about it: It all starts in early drug discovery through clinical development, through the translational stage, into clinical care, then into the population, and then back to discovery. It’s not a linear process, it’s an integrated ecosystem..

To be successful in the precision medicine space, one needs to be good at three main elements:

1. You need to be really good with technology! The speed of change can only be encapsulated through technology. Since the space is moving fast, you need to be really good when it comes to technology innovation.
2. You’ve got to have deep science expertise as part of your core capabilities! To understand the context of science you need the knowledge and expertise in this domain. Especially, when dealing with aspects such as omics and precision medicine – you’ve got to understand the context of these things. We are very lucky when you look at our organization, with our employees being MDs or PhDs with that kind of expertise.
3. You’ve got to have the ability to extract insights from complex information! We live in a world of data explosion, and we need to make use of that data which is really important.

As we bring these three organizations together and look at those three dimensions – and this is what our clients will benefit from – you actually start to get best practices across the different teams that we’re going to reuse.

EB:  You mentioned UgenTec being fantastic at scalability. I presume predominantly in the analysis sector and not the instruments sector. Is that correct?

GN:  Yes, UgenTec takes data directly from the machine through a workflow, QC process, and all the way to analysis ready for interpretation by clinicians. And again, they proved that inside out for the COVID workflow, and if you extract that capability (i.e., you can go directly from the instrument all the way through to interpretation analysis for clinician in a fully automated way) then you should be able to apply and wrap that around what Seven Bridges and Pierian offer. In other words, the Seven Bridges solution can be scaled via an integration to support preclinical, translational, and clinical analytics. Today, Seven Bridges very much plays a role in early discovery, but by linking Seven Bridges analytics with UgenTec’s workflow automation and Pierian’s Knowledgebase, you then unlock its capabilities to power the translational and clinical development sectors.

EB:  How much of an overlap is there between UgenTec, Pierian, and Seven Bridges?

GN: If you think about Pierian and what they are really good at: it’s their world-class knowledgebase of how individual genetic traits interact with different therapies for somatic cancer treatment. One can take this knowledgebase into the discovery setting which helps understand what response different patients elicit towards different therapies, and where there is an unmet need. Identifying non-responsive populations to current therapies can help drug developers target not just therapies, but genes or families of genes as novel targets for new potential therapies. It’s not necessarily an overlap but rather an adjacency that results in a compounded benefit.

“I’d like to say there is adjacency between the offerings of these three companies.”

EB: How many individuals are now working at the combined company Velsera, and how will the company grow over time?

GN:  I believe we’re around 850. We think scale is important with too much subscale or fragmentation in this industry. We’ve got to get to scale if we’re going to really address the needs of precision medicine. Over time, we’ll grow by acquisitions and via organic natural growth. We don’t have a fixed target size for the organization.

EB:  When you think of the end user experience of the combined solution, how will you approach that from a product perspective?

GN:  Our approach is market driven. We’ve talked to a lot of our clients, both in biopharma and in healthcare. We observed that our focus today is improving what they currently have. But they need to move faster, they need to be better, and they need to have more precision.

• As a result, we talk about how to improve the precision of R&D?
• How to democratize omics?
• How to bring clinical decision making to the bedside?

These are our strategic themes that are enabled by our platform, products, and services and we want to make sure that we are addressing those different needs.

We believe the first phase is really about improving what we do today by using the combination of the three companies that is Velsera. We think there is a benefit in what we call horizontal integration. The questions asked in discovery, from a precision medicine point of view, can get improved upon and curated through the life cycle of development. Think about a dosing question, which is really important when you’re thinking about early drug development. But as you move through the development cycle, you only start to understand more about dosing once it gets into clinical development. And actually, when you get into real world populations, you start to see different responses to different dosing aspects. Over time as we think about the user experience, there will be the direct user experience because we’ll bring in new technology, but a lot of the value we’ll bring will be in the context of  working with multiple stakeholders and bringing the population context into discovery, bringing the scientific and clinical development context into clinical care, and eventually into clinical decision support. The goal is to create a framework that addresses the unmet needs across these different elements. Hence, we want to be the enabler of a flow. We talk about the flow of knowledge. We want to make sure that knowledge flows to all of those different players and isn’t siloed in a single location. At the moment, what we see is an awful lot of knowledge about molecules that is held siloed within a biopharma organization. There is also a lot of knowledge about patients and patient populations held within healthcare organizations, or a lot of information about regulatory pathways and how the regulatory sector is going to have to change is held in large payer organizations. One of our main foci is to be able to democratize access to this knowledge, and there is a direct approach to achieve this, but more importantly, there is an indirect approach we think we need to take to get there.

“We want to be the enabler of a flow. We talk about the flow of knowledge. We want to make sure that knowledge flows to all of those different players and isn’t siloed in a single location.”

EB:  Indeed, there is all this information, as you pointed out in silos, which is a very unfortunate thing, with pharma not sharing, healthcare organizations not sharing, and private companies holding on to valuable information because it’s their intellectual property. What do you think about how these processes could change over time, if at all? Will more data be shared down the road, and what is the incentive to do so?

GN:  I believe one of the things that we are going to have to do is being very deliberate about what information is unique and critical and needs to be protected, as opposed to what information is of benefit to everybody. Let’s take the example of understanding the prevalence of disease progression in a population. That kind of information, of course, would be beneficial to everybody, but that’s held within healthcare organizations. Back to my point, understanding target drug response is beneficial for everyone, but that’s held within biopharma organizations. One of the things that we are not advocating for is the exposure of IP information or privacy information. You’ve got to protect patient information, and all of those things. But we need to enable information exchange when the information is beneficial for all across a continuum. In my previous life I worked at Quintiles, a big CRO (now IQVIA) where we understood that normal secondary information, the meta information, was important and valuable to the whole community which could be shared. Or look at TransCelerate, which is an industry consortium of all big pharma companies which shares investigator data and operational performance data. Clearly, there is a realization out there that some data needs to be shared because it is of benefit to everyone.

“We need to enable information exchange when the information is beneficial for all across a continuum…..we need to be very deliberate about what information is unique and critical and needs to be protected, as opposed to what information is of benefit to everybody.”

EB:  As you are building these capabilities out over time, what happens to existing customers of the various company products? Or in other words, what if there are individual organizations that just want to use the Seven Bridges platform? Is that going to be possible?

GN:  Absolutely. But again, as we come to market, we were looking for opportunities to help individual stakeholders with what they do today. And eventually, we’ll get very good at that vertical integration with our partner companies. Hence, we’ll make sure that the legacy Seven Bridges platform continues to be the preeminent best platform for drug discovery, no question about that. But we strongly believe that there is also a secondary need to integrate horizontally across the entire ecosystem. To achieve this, we are going to acquire, build, and partner within those two dimensions. That means that we’ll add new technological functionality, we’ll add new product functionality, we’ll extend the therapeutic range, and we’ll add new scientific capabilities both from a vertical point of view and horizontal point of view. Ultimately, we have more of a platform mindset than a product mindset, which we think is important, mostly because the product mindset creates artificial silos. If we look at those that have come before, it’s clear that they’ve created a kind of very fixed box, they’ve stayed in their box, and they’ve tried to compete within their box. There’s nothing wrong with that, that’s a good way of approaching the needs, but we think the potential for omics and precision medicine is so bold that one of the things that we need to do is to create an enabling platform. If we’re good at the three concepts – technology, science, and extracting insights from data – then we want to allow other people to come into that environment and develop their own capabilities for functions that we don’t work on. For example, it’s very unlikely we’ll focus on patient recruitment for clinical trials, as others are already very good at it. But we may create an environment that enables individuals – from an omics point of view – to come in and develop it on our platform. We certainly want anybody to do that and be able to get the benefit from it.

“Ultimately, we have more of a platform mindset than a product mindset, which we think is important, mostly because the product mindset creates artificial silos.”

I think we’re in a really interesting time when it comes to precision medicine economics. And as we are talking about the era of Velsera, we have to recognize that we are going from what I would call the second era of therapeutics into the third era of therapeutics.

• The first era of therapeutics was very much focused around small molecule chemistry with broad use, like your aspirins of this world. There was no need for precision medicine, the use was generic and that was fine.
• The second era of therapeutics happened truly in the last 15 to 20 years, which has been the emergence of biologics. Like the Humira of the world, all of your anti-TNF autoimmune drugs or biologics. When you look carefully, it’s clear that the biggest determinant of drug response in an individual has been their genetic profile. Now we see omics being a driving force in the diagnostics era to better utilize how biologics are deployed in individuals. So, omics plays and enables the second era.
• Now we hit the third era where omics themselves are the therapy with gene therapy, gene editing, etc. Just look at what CRISPR is doing with Vertex Therapeutics in sickle cell anemia. When you look at the shift in biopharma’s pipeline, last year they reduced a significant amount of phase two and phase three studies, but at the same time they massively increased their early phase one and pre-clinical studies based on gene sequencing and gene editing data.

There are three catalysts that make this happen:

• We see a shift now in biopharma from the kind of traditional chemical biological agents towards gene agents. That shift has happened over the last 12 months. That is one of the catalysts for change that we are looking at.
• The second catalyst for change has been described: as the need in the market to scale and bring consolidation around the capabilities that gene therapy companies require to bring forward their products.  
• The third driver of change is science. The science is moving faster than what clinicians can keep up with in real time. The knowledge that is being developed inside life science companies is moving faster than what is happening on the clinical side and we need to close that gap.

The knowledge which is required in healthcare is actually the knowledge which is being developed by pharma and vice versa. You’ve got this symbiotic relationship that’s forming especially around precision medicine, especially around omics, where you need to synergize the ability of what pharma does and what healthcare needs. Because as I stated earlier, it’s more of a circular activity.

• Biopharma is looking at real-world evidence (RWE) to drive this hypothesis of new therapies.
• Healthcare is looking at biopharma to understand how to make use of this evidence to drive diagnostics and therefore drive new therapies.

As we’re starting to see this synergy the regulatory landscape needs to change to support this change. On the tactical side we need to look at those drivers of change, such as new omics support for both diagnostics and biologics, and also being a therapy in itself, the integration of fragmented businesses to scale on a global basis, the collapse of knowledge boundaries between healthcare and the life sciences. These are the things we’re focusing on. To achieve the value of omics and medicine we at Velsera need to start to ask, “how do we improve knowledge and how do we drive insight across the whole place so we can drive these changes?”

EB:  I’m curious, how did the name Velsera come to be? What is the basis of the name in the context of how you envision changing therapeutics and diagnostics development?

GN:  Yes, there is some reasoning behind the name. We’ve played around with different things. And we talked about what we were trying to do. What are the questions and needs we are trying to answer/address? We talked about enablement, empowerment, knowledge, and the use of all these terms, and we actually focused on what we really need to do, which is to be a company that reveals insights. So, we took the term “reveals” and played around with it. Velsera is an anagram of “reveals.” If you look at the iconography of the way we spelled Velsera, the S is actually turned into an infinite loop, or the value loop going from discovery, clinical development into clinical care, into population, and back into discovery. And continuing this kind of infinite loop in the center with the S is really playing off that aspect of the infinite value that we’re trying to create (See also Figure 1).

“Velsera is an anagram of reveals. If you look at the iconography of the way we spelled Velsera, the S is actually turned into an infinite loop, or the value loop going from discovery, clinical development into clinical care, into population, and back into discovery.”

Figure 1: Velsera value loop (image source: Velsera)

EB:  Excellent! How about yourself? Why did you join Velsera and what excites you about your role at Velsera?

GN:  There were a couple of drivers for me. The driver for me personally, is my daughter. She got a rare disease and she had it all her life. We had her genome sequenced, by Navigenics, when she was less than one year old, which was 15 years ago. They identified a gene mutation that has never been reported before. So, she is an N-of-1, and therefore there was no diagnosis, no prognosis, and no treatment. This started my journey of saying “that’s not good enough” and there has to be a better way. We’ve got to be able to understand and provide capabilities and services for these individuals. Now fortunately, today my daughter’s health is very good, but for many others that is not the case.

Secondly, the cost of sequencing is no longer a challenge anymore. Illumina’s new NovaSeq will provide sequencing at $200 and there are others out there that are also doing it. Scientific understanding is also moving very fast – science is also not the barrier. I realized: the main barrier to overcome was moving knowledge from the scientific community to the clinical community, but how do we best achieve that? That’s an informatics question which is my domain. I started writing code 35 years ago. I’ve always worked on big data. Hence, there was a calling for me. I actually wrote a paper which was very much aligned with Summa Equity’s vision. Really, there was somewhat a call to arms for me around the promise of Velsera with Summa Equity being the prime investor behind us. We are very much aligned. I personally joined in June of 2022 and we quietly acquired the three companies through the middle of last year.

EB: Where do you see the biggest value add when it comes to Velsera, its product and services? I assume it’s the whole interplay between drug discovery, therapy development, and healthcare.

GN:  I think the question is really about what do we have to be good at? The answer is to be able to serve those markets. We can’t stay where we are right now. Like, if I say we are very good at somatic cancer, well we also need to be very good at germline, we need to be very good at CNS, immunology, and neurobiology. We’ve got to grow, whether that’s through building, acquiring, or partnering across different therapeutic areas. We need to expand more therapeutically. We also need to build out our technology platform concept. We’re very good at workflows, we’ve got very good at data analysis, but we also need to get better at deep learning. It’s not just AI and machine learning because we do that already, but understanding and executing deep learning, including the type of things that drive ChatGPT, and how you encapsulate scientific knowledge into the way that you build technology and insights.

Next, we will also focus on geographic expansion. We’ve got a good presence in the US, we’ve got a good presence in Europe, we’ve got some presence in India, but, at the right time, we need to expand more into Asia, South America, and other places.

The order is therapeutic expansion, technology platform expansion, followed by geographic expansion to be able to serve all those different markets.

EB:  Great! Let’s talk about the long-term vision of Velsera, especially in the realm of precision medicine. How will Velsera impact the advancement of precision medicine? How will the field advance and what are some of the challenges we are facing, and how will we overcome them?

GN:  Internally, we’ve got a lot of great scientists, including PhDs and MDs. In addition, we have established an internal incubation group underneath our chief scientific officer. Part of our incubation is to focus on the downstream questions and roadblocks that we have to overcome.

Let me give you an example: When we think about the field of gene editing we will need to start looking at it from a regulatory point of view, instead of how it would have been developed traditionally. The mechanism of action is not changing, the target of action is changing but not the mechanism. So how do you change the regulatory landscape? And also unless you are fully ablating the bone marrow, you’re already starting to see the reintroduction of the primary genes. So, the question now isn’t, is your treatment efficacious or not? The question is how long is it efficacious for and how do you test and approve that in the real world?.

As we see it, the whole regulatory approval process will have to change. We’re going to have to likely collapse what was considered a traditional phase three study into a real world phase three/phase four study where the pharmacovigilance in the real world now is less about safety and more about efficacy. One of the things that we were asking our internal scientific team to understand is: “how can we work with the government today to build and test an efficacy-based pharmacovigilance in different regulatory paradigms, and to understand what evidence is needed at different stages so to be able to advance large scale gene editing therapies into the marketplace.” Again, it’s not a scientific question, it’s an operational one that we have to overcome. That’s how we start to see the long-term vision for various scientific service capabilities. We are not a pharma company, we are not a payer, and we are not a provider, and therefore we don’t benefit necessarily from new therapies coming through, but enabling the ecosystem on behalf of all of the stakeholders is part of our mission (see also Figure 2).

Figure 2:  Capabilities across the Dx and Discovery Sample Workflow (Image source: Velsera)

We are looking at these roadblocks and focus on how to best achieve that, so that a pharma company can be confident in developing a gene therapy, applying the rigor that supports a regulatory filing and approval to ensure that when payers and providers make use of this therapy, they understand in what context.

Certainly, we are a for-profit company, but the way we think about it is to provide services to each of the stakeholders to improve each of those steps along the way. Driving improved precision in R&D is good for everyone, including lowering the cost and speeding up the entire process which means instead of looking at 50,000 candidates, you only have to look at ten, because we know the genetic profile. We strongly believe it is important to expand omics beyond a central lab and into the real world. Providing analysis, whether primary, secondary, or tertiary, not coupled to the sequence technology – the likes from Illumina or Thermo Fisher – is most relevant.

Lastly, we have to think about clinical decision support at the bedside using all of these capabilities so that a clinician on the ground wherever they are in the world can say, I’ve seen this patient, here’s a profile of this patient, I’ve got the insights from the sequence data and the results give me treatment guidance, and this all aligns with the different formularies inside whichever country I’m working in. I strongly believe that we are adding value to all of these steps along the way, and we’ll monetize that value which we’re adding.

EB:  Let’s talk a bit about the competition. Who out there is building a similar solution in the clinical research and diagnostics sector, and how does Velsera differentiate itself from other players in the sector?

GN:  Actually, there is partly a benefit and a curse to all of this, because one of the things we realize as we are talking to individuals for validation purposes, we are in a whole new category. Yes, there are a few companies that kind of play a little bit in the sector but most of these companies are very focused from a vertical/downstream point of view, what I would call deep vertical integration. While we are going to do some vertical integration, we will only do as much as is needed for us to create that horizontal value, because that’s where we think the needs and drivers are. Discovery is about how you get into the clinic. The clinic is about how you get it into regulatory submission. Submission is how you get it into formulary. Formulary is about how you get into patients. Once in patients, we’d like to understand if they get better and what we learned from this process. By definition, the whole biopharma healthcare space is very horizontally driven, it’s just that we don’t have service vendors that are thinking that way today. That is what we’re going to do, but nevertheless, we do go to market through some of those vertical touch points and we’ll continue to do so.

“By definition, the whole biopharma healthcare space is very horizontally driven, it’s just that we don’t have service vendors that are thinking that way today.

To sum it up, Velsera is a very mission-driven company, with part being driven by Summa Equity with a societal driver of what we do. We’ve got a good investment, or in other words, we’ve actually got the funds to achieve our vision.

“While we got the funding, it’s not only about making money, we also strive for a societal impact.”