International Pharmaceutical Industry journal speaks with Symeres’ Chief Commercial Officer, Philip Payne, and Head of Drug Development, Goran Verspui, on the company’s evolution into a fully integrated CRO/CDMO, its focus on new modalities, and how it is helping biotech and pharma advance programmes efficiently in a challenging funding environment.
What sets Symeres apart from other CRO/CDMO companies in the industry?
We are a CRO and CDMO with activities in discovery, early drug substance and development. We design molecules and at the same time, we also prepare the whole trajectory for Phase 1 and Phase 2 clinical trials. We also work with our clients in a very collaborative, open and transparent way, which we know is unique based on feedback we receive. We apply our expertise across the drug development lifecycle to help customers move forward with their programmes with minimal delays or programme failures.
How would you describe Symeres’ mission and core values?
Our mission is to move therapies forward by thinking ahead. We operate under a concise range of core values. Our key values play to our strengths, areas and are framed around feedback from our existing customers who repeatedly say we excel compared to others in the market. We are open in our communication to be proactively transparent; we are nimble and flexible in our approach to pivot fast when plans evolve and are expert to provide depth across all disciplines from hit finding to clinical development and beyond. These values take shape and can be referred to us as operating as O.N.E Symeres (Open. Nimble. Experts.)
What types of clients does Symeres typically work with, and what kinds of projects do you support?
From biotech all the way through to large pharma — we cover the full spectrum of the pharmaceutical sector. We truly understand that the support different companies need should be personalised to their programme needs. Biotech companies look for an integrated approach that can take them to IND and beyond. It may be that they don’t have the expertise across disciplines so by working with an external partner they benefit from additional resource and knowledge to help their programme progress. On the other hand, large pharma companies are looking for expertise in specific areas, often with additional resource through a flexible FTE model to add expertise without additional internal overheads.
How has the company evolved in recent years, especially with your expansion into North America and the acquisition of DGr Pharma?
We are owned by Keensight Capital and they have supported us in developing the company further with acquisitions of two sites in the US and one in Europe. The US sites focus on discovery and lipids, and delivering projects and expertise in drug substance development and drug product manufacturing. The most recent acquisition in Europe, DGr Pharma, adds specialism in end-to-end drug development support including regulatory, CMC, non-clinical, clinical and QA consultancy services.
Our core values underpin our delivery of a seamless experience across all locations and sites. We operate by providing value to our customers through our expert transatlantic teams, not working in silos. That is an important development that we know is crucial to both biotech and pharma when outsourcing projects.
The transatlantic part of Symeres means we can get in and out of the US with ease, especially in the current geopolitical climate. It gives our customers access to both markets. It makes it easier to do a clinical trial, for example, in both the US and Europe. The follow-on to that is the FDA regulatory approval, especially as it becomes more complex.
We help biotech and pharma establish the best and quickest way with the shortest timeline to get to regulatory approval as confidently as possible. Even though it’s only been two or three months, we’re already seeing a lot of activity in that field, but the funding is limited.
What are some of the biggest challenges your clients face in drug discovery and development, and how does Symeres help address them?
The biggest challenge our clients face is the shortage of capital. They are constantly figuring out how to finance their company and their programmes. They are focusing on the late-stage projects as they bring the most value to the company and they are focusing on only those activities that are really adding value to the project. Symeres can help by applying our experience, grounded in scientific expertise, to give them actionable advice to help transform their project and move forward with the highest value.
We have a lot of experience in the minimum requirements that are needed to bring your project to an IND or an INPD submission. There are a lot of extras that you can add to give a lot of comfort too. Our standard way of working is focused on providing minimal requirements that deliver the best possible outcomes. We are proactively flexible to adjust as necessary for each programme and truly partner with each organisation to ensure the best possible outcome matched to their objectives.
With biotech companies, we can give a lot of advice, but big pharma is looking for efficiency. Especially discussions on how we can save time from selecting a clinical candidate to start a GLP tox programme. That’s usually the most important time driver in a drug development project. Can we squeeze the time between the selection of a molecule and going into a GLP tox study?
With DGr Pharma’s expertise now in-house, how is Symeres strengthening its ability to offer GLP and GCP-compliant services for increasingly complex programmes?
DGr Pharma adds an additional service for our customers who are needing expertise in how to reach their regulatory development milestones. A development project is not a simple operation. It’s a very complex programme and having experts by your side who fully understand and have implemented regulatory programmes will ensure easy navigation through a complex GXP environment. This is all done in-house at Symeres making end-to-end development truly end-to-end.
With over 30 years in the field, how has the industry changed, and how has Symeres adapted over time?
In the 90s, the outsourcing market really just started and we did not make final compounds, just building blocks for pharma companies and agrochemical companies. Slowly but steadily, we made some FTE agreements where we could also develop chemistry and then make compounds. We started to contribute to the intellectual property of the product that we were developing.
That contribution to intellectual property has only increased. However, the client is always making the final decisions. Now the ask is, we have a target in mind and we need a compound with a certain activity and all of its properties. Please design it for us and test it. When you have reached that milestone, we will talk further.
The other part is the change in focus on small molecules. We’re going into new modalities like ADCs and radiotherapy. That has been a significant change over the last 15 years or so. It’s going from small molecules to more complex molecules.
In the current political setting, how do you see vaccine research moving forward and if it may face new challenges?
We don’t make vaccines, but we can support them by preparing adjuvants. With these vaccines, Symeres can contribute by making lipid molecules that are used to make the package in which the RNA molecule is covered.
The geopolitical part is the key part here. There is uncertainty. In the US, we’ve already seen certain interactions happen and research being cut. That has resulted in a move to Europe and other places. I think the challenge is going to be when the product gets through, how they get back into the US through the FDA approval process and whether the FDA is going to be flexible enough to accept them or not.
How much of the work you do is pre-clinical and how much is clinical?
About 60% of our work is pre-clinical. We can support our clients as far as we can, going into phase two and phase three. We have some isolated projects on the commercial production of an API as well. We are splitting the field between discovery and development.
And this is really what we want to specialise in and build out. We really want to build out our expertise in new modalities.
What excites you most about where Symeres is headed in the next few years?
New modalities and expanding into growth areas, such as LNPs and ADCs. The LNP space has changed a lot with the expansion of technologies. We’ll also increase our footprint in the US to be more transatlantic for our customers.
There is also a lot of development in AI and we see some opportunities to apply AI to the improvement of chemistry, the quick optimisation of chemical processes and the interpretation of large sets of data. We are embracing those new technologies to make us more efficient and faster and better at supporting our clients.
The challenge with AI is the regulatory route. Not many products have gone through with AI, so it’s using it more as a data point rather than as an actual test.
For more information – https://symeres.com/
