One of the most amazing things about the human species—population 7.7 billion and rising—is that everyone is unique. In healthcare, that offers both a challenge and an opportunity. Precision medicine, where people are given treatments explicitly designed for their bodies, could revolutionize how we treat disease, but there are significant hurdles to overcome.
Fortunately, using protein biomarkers makes the future of therapeutic alternatives very bright.
What is precision medicine?
Precision medicine isn’t as new as it sounds. When patients need a blood transfusion, they aren’t given any available blood; they’re given what is best suited to their body. However, the next wave of precision medicine innovation promises to take the concept much further.
Precision medicine can improve both treatment and prevention of disease by considering an individual’s genetics, environment and lifestyle to address health concerns in the most effective way possible.
In the United States, the All of Us Research Program looks to advance the field of precision medicine through its health database, which contains a million participants, but there’s still a long way to go.
How can biomarkers help?
Protein biomarkers are a crucial tool in the quest to advance precision medicine. It’s impossible to keep track of everything that is going on in the human body. However, protein biomarkers provide valuable, measurable indicators, including the presence of a disease and its stage of progression.
When a disease begins to affect the human body, it can be hard to track the chain reaction of events that ultimately make humans sick. But proteins are much easier to measure. Protein biomarkers can be a single protein or a panel of multiple proteins that can help in three ways: diagnose illness, inform prognosis and monitor a patient’s response to a treatment.
The human body contains hundreds of thousands of proteins, but only a handful of protein biomarkers have been identified. If we can identify more useful protein biomarkers and make proper use of the ones we know of, the benefits to patients are multiple:
- More effective treatments
- Fewer side effects
- Better outcomes for patients across a wide range of diseases
For industry researchers, protein biomarkers can be essential in drug development. They can help identify promising pathways and potentially adverse reactions early in the development process, which speeds up the entire journey through regulatory applications and approvals.
The challenges of implementing protein biomarkers
While the benefits of using protein biomarkers are clear, there are still some significant hurdles to be overcome if they are to help precision medicine development. The greatest of these is cost. Identifying and validating biomarkers can often be lengthy and generate large amounts of complex data. This needs a large, experienced team to interpret the results.
The biomarker validation process also poses challenges. Collecting the biological samples needed to assess protein biomarkers in certain patients can be difficult. Children or people with severe illnesses can’t always spare large amounts of blood, plasma or serum necessary.
Regulation is also an issue. United States regulatory authorities do not regulate protein biomarker assays, and researchers do not often share development data in this field with the broader scientific community. The Biomarker Qualification Program, an initiative of U.S. regulatory authorities, looks to address that challenge by working with external stakeholders to develop and evaluate biomarkers. Qualified biomarkers from within the program are awarded formal regulatory recognition.
Qualified biomarkers are designated for a specific Context of Use (CoU) by U.S. regulatory authorities, which defines their purpose. However, drug developers can provide additional data to expand the CoU as they follow up with further studies.
The future of protein biomarkers
Up to this point, precision medicine has made the most significant impact in oncology. But with the help of protein biomarkers and their continued development, this exciting branch of healthcare can impact other areas of medicine, including autoimmunity, cardiovascular disease and infectious disease.
Although the development, validation and measurement of biomarkers could be challenging, an experienced laboratory partner with expertise in various assay platforms, validation procedures and regulatory dynamics would greatly ease these processes. A lab testing partner can also help drug developers and sponsors navigate regulatory milestones like Investigational New Drug (IND) submissions, New Drug Applications (NDA) or Biologic License Application (BLA) inquiries, ultimately making medicine more personalized and effective.
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2022 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made, and every disease can be treated.”