Early Drug Discovery Services: Why Do You Need A CRO?

Several market reviews indicate a growing rate of early drug discovery outsourcing services to CRO providers. This rise can be attributed to the increasing aging population, the prevalence of chronic diseases, lifestyle-related disorders, and the pressure on pharmaceutical companies to develop innovative drugs within strict budgets and shorter timeframes. Many biotech and pharmaceutical firms have recognized that outsourcing early drug discovery and design can help reduce costs and timelines. Consequently, the global drug discovery CRO market is projected to reach USD 77 billion by 2025 and grow to approximately USD 149 billion by 2034 (Precedence Research).

To understand the role of structural biology in drug discovery and the advantages of outsourcing early drug development and design, it’s important to examine the small-molecule drug discovery process. The schematic above illustrates that this process is highly interdisciplinary, requiring input from various scientific fields at different stages. Initially, we must identify the target protein, which involves molecular and cell biology studies. The three-dimensional structure of the protein can be extremely valuable at this stage, as it helps us understand the specifics of the target, particularly its druggability and the molecular mechanisms governing its function.

Once the target has been structurally characterized and its druggability confirmed, we proceed to identify molecules that bind to it, a process known as hit identification. This can be accomplished using several compound screening methods, with fragment screening being one of the most popular. An example of this is crystallographic fragment screening, which relies on having crystals of the target available. This method enables the mapping of interactions between weak binders and the protein, thereby facilitating subsequent stages of fragment expansion and lead generation.

To design an appropriate lead molecule, we require substantial expertise in chemistry, including computational, synthetic, medicinal, and biochemistry. At a later stage, pharmacology and toxicology studies are conducted to understand the molecule’s behavior in organisms. And, of course, there is a need for project management, data collection, medical testing, regulatory compliance, safety reporting, quality analysis, and other related tasks. This indicates that a biotech or pharmaceutical company planning a drug discovery and development project requires a large, multidisciplinary expert team with access to laboratories, essential instrumentation, and materials, and must plan and cover all operational costs associated with the project. This entails significant expenditures and a long-term commitment. We must also consider that only a small fraction of all projects actually succeed in bringing a new drug to the market. Therefore, outsource drug discovery! Any means and technologies that accelerate a drug discovery project, reduce its costs, and shorten its timeline are invaluable to the company. In other words, outsourcing the early stages of the drug discovery process to a CRO has become an attractive strategy.

There is a strong consensus that applying structural biology methods to drug discovery can significantly accelerate the early stages of the process. A structural analysis provides direct insights into how ligands interact with the binding sites of target proteins, which enhances design efficiency. To address the challenges associated with the process, approximately 20 to 25 years ago, several technology-focused CRO companies specializing in integrated drug discovery—including chemical library screening, modeling, and protein crystallography and NMR spectroscopy services—were established. Once the structural framework has been established, various structure-based drug design strategies can be followed.

In an analysis of the advantages of drug discovery outsourcing by de Villemeur et al. (2022), the following common factors were named as making substantial contributions:

• More flexibility is attained when fixed costs are transformed into variable costs.
• Easier exit from unsuccessful projects.
• Improved management and lower uncertainty costs are attained through milestone payment schemes.
• Outsourcing to a CRO makes the costs more transparent, enabling customers to consume only essential services, thus improving capital efficiency.
• Higher productivity and lower unit costs are achieved since the service provider with a distinctive technology platform takes on more work from multiple customers and has broad experience working with different drug targets.

Competition in the market also compels CRO companies to develop or seek out unique selling points, such as disruptive technologies, and to engage in various partnerships that set them apart from competitors. For example, SARomics Biostructures and RG Discovery acquired the rights to the weak-affinity chromatography (WAC) fragment screening technology. This technique has significantly expanded our business opportunities and has become one of the key drivers of our growth. Furthermore, SARomics recently partnered with the Danish company Vipergen ApS. The collaboration provides an opportunity for the two companies to enhance their integrated drug discovery services by combining Vipergen’s unique DNA-encoded library (DEL) screening technologies with SARomics’ integrated structural biology capabilities to facilitate hit identification and lead generation. In addition, our team, in collaboration with the FragMax facility at the MAX IV synchrotron, can now offer crystallographic fragment screening and a kinase-focused fragment library option. All the above allowed us to become one of the best-rated CROs for early drug discovery and small-molecule screening.

Our integrated structural biology services benefit from a unique list of off-the-shelf protein structures (FastLane structures). The list includes drug target proteins from various classes, such as kinases, oxidoreductases, phosphatases, enzymes involved in amino acid metabolism, ATPases, GTPases, G-protein regulators, bromodomains, hydrolases, linker PDZ domains, enzymes participating in lipid and nucleotide metabolism, poly (ADP-ribose) polymerases (PARP), numerous signaling proteins, and many more. This list is continually updated and features a wide variety of proteins that can be co-crystallized with clients’ ligands, with a turnaround time of just a few weeks.

When considering outsourcing early drug discovery to a CRO, we should also recognize the advantages of the CRO team’s expertise. The SARomics Biostructures team has built extensive expertise across structural biology, including protein crystallography, NMR spectroscopy, and other methods, which they apply to numerous protein classes each year. Such expertise is challenging to gain when working on a limited number of discovery projects, as is typically the case at smaller biotech companies or academic institutions. As discussed in our blog on the impact of synchrotron radiation on early drug discovery, our location, close to the MAX IV synchrotron, offers additional advantages by eliminating the need for sample shipping, thereby reducing the potential pitfalls of shipping.

Please visit our services section for more information about our fragment screening and fragment-based drug discovery services. And don’t forget to follow us on LinkedIn to ensure you don’t miss our future posts!