It’s no secret that developing drugs of any kind isn’t an easy process. Between massive R&D efforts, complex clinical trials, long FDA approval times, and strenuous regulatory requirements, it’s no wonder drugs cost so much to the end user.
With the costs of developing a prescription grade drug and bringing it to the market exceeding $2.6 billion, it’s critical that each stage of the clinical trials has data to back and validate the results of the drug. With conventional chemical compound drugs, understanding what the compound is composed of is much easier given that most are synthetically created in a lab. Conversely, biologics (drugs that are chemical compounds with a biological origin) are much harder to perfect. With biologics, we know to a degree what the genetic structure of the biologic is but have a much harder time making the compound predictable and reproducible given the potential for nature to interfere.
The challenge is that with any biologics development there is a chance that it could have a random change in its structure that is unknown to the manufacturer before being administered to a patient. For obvious reasons, this can be both risky and dangerous. Biologics are typically required by the FDA and NIH to have genetic sequencing performed throughout the drug development process to meet regulatory requirements.
Apart from a regulatory requirement, we believe there are three other incredibly valuable reasons to sequencing your biologics:
- Insight into the composition of the strain you’re working with
- Historical data on each biologic version for strain optimization
- Historical data for audit protection
Insight into the composition of the strain you’re working with
Many companies are still operating in the dark on how their biologic drug is operating or how it will act once prescribed to a patient. This is a less than ideal scenario for obvious reasons. With Next Generation Sequencing and Bioinformatics, we can get insight into the genetic structure of the current biologic strain we’re looking at to ensure acceptable integrity.
Additionally, getting this data can lead to large insight into how the biologic will perform through bioinformatics. Bioinformatics allows us to identify where SNPs are located, how they modify protein generation, and whether or not they modify the pathway interaction of the biologic. All of these are critically important towards understanding the driving success of the drug.
Historical data on each biologic version for strain optimization
Biologics, by nature, have the potential to introduce random mutations and changes by nature. Ensuring predictability and stability of a biologic drug is important to understand when working to find the best patient outcome. By sequencing each biologic strain, we can track of the successful versus failure outcomes of our patients and map back to which biologic strain was introduced.
In current times, many strain optimization efforts are still performed in the mendelian format which often requires long lead times of optimization. This format still keeps investigators in the dark as to why a strain was successful or not. By performing Next Generation Sequencing and bioinformatics, investigators are able to get much better data tracking an insight on how and why a strain was successful, providing a more rapid and data driven approach to strain optimization.
Historical data for audit protection
With the average likelihood of approval for biologics at around 12% from Phase 1 to Phase 2, ensuring that the data provided to the FDA is complete and convincing is paramount. Additionally, biologics that make it to clinical trial stage 3 (like all drugs) run the risk of a high failure rate leaving corporations millions of dollars in the hole with nothing to show. Furthermore, even drugs that get through phase 3 are still required to to undergo an FDA review in which the data supporting the success of a biologic drug is the most critical factor.
By performing both Next Generation Sequencing and bioinformatics, companies will have granular level of support data and evidence that the FDA can review. In a way, this data collection acts as an insurance policy for when a company gets audited or needs to present both clinical trial and drug-related information to regulatory departments.
As a whole, organizations who invest in Next Generation Sequencing and bioinformatics stand a much better chance of knowing their drug, optimizing the success of it to save costs, and have the granular data to support their successes.