“Personalized medicine” is an increasingly popular catchphrase in modern health care and advocates of this approach argue that doctors should not assume that one treatment will work for every patient with a certain disease or condition. Instead, it’s believed that doctors should prescribe individualized medical treatments based on an evaluation of the patient’s condition in the context of the patient’s personal medical history. Recent research indicates that approaching biologics treatments from the perspective of personalized medicine has the potential to improve existing biologics treatments.
Considering the Context
Biologics therapy is much more likely to be effective if the patient’s genetic background is considered when prescribing the treatment. Three biologic antibodies that work as TNF-alpha antagonists—infliximab, adalimumab and etanercept—have been shown to successfully treat rheumatoid arthritis and Crohn’s Disease, but only in some patients. Thirty percent of patients will show no response and some have even experienced adverse effects as a result of the treatment. Studies of patients’ genotypes correlate the presence of specific genetic markers with the likelihood that the patient will respond positively to treatment.[1] Similarly, treatment with the biologics IFN-B-1a and IFN-B-1b can slow the effects of multiple sclerosis and prevent relapses, but only in patients where certain genes are downregulated.[2]
Doctors who prescribe biologics therapy must also consider the molecular manifestation of the disease itself. For instance, the biologic antibody trastuzumab has been shown to effectively treat breast cancer, but only in certain patients. The drug binds to the HER2 protein on the surface of a cancer cell, resulting in the downregulation of two key cell proliferation pathways. Because it specifically targets HER2, trastuzumab can only treat HER2-positive breast cancer, which only accounts for about thirty percent of breast cancers. Likewise, the cell surface receptor EGFR activates several cell growth and proliferation pathways, and it is often overexpressed in solid tumors. The biologic antibody cetuximab, which blocks EGFR, is only effective for treating cancers where EGFR is overexpressed.[3]
Clearly, the personalized medicine approach has the potential to improve existing biologics therapy. Because many existing biologics treatments only work for patients with specific genetic markers, scientists have to start searching for biologics that successfully treat the non-responders who have different genetic backgrounds. Given the complexity of the human genome, this might seem an impossible task, but modern biologics discovery software makes the process feasible. Researchers today are able to process much higher volumes of data than they have in the past, which makes it easier for them to find new biologics that work in different genetic contexts. The same is true for researchers trying to find biologics that target a form of a disease that doesn’t respond to existing biologics treatments, such as HER2-negative breast cancer. Biologics software platforms can process more data, reduce errors and speed workflow so that new treatments can move forward to clinical trials as quickly as possible.
Considering the Costs of Care
Patients are becoming increasingly interested in personalized biologics therapy, but for many, biologics treatment is prohibitively expensive. In order to try to make it more affordable, Congress passed the Biologics Price Competition and Innovation Act as part of the Affordable Care Act of 2010. This gave the FDA the authority to approve “biosimilars,” which are intended to mimic biologic drugs.[4] However, biosimilars are not always interchangeable with the original biologic drugs, so they may not have the same “personalized” effects as treatments that account for the patient’s genetic background and the molecular signature of the disease. There’s a chance that a biosimilar will work, but there’s also a chance that the patient will respond negatively or not at all.
Life sciences firms must be ready to design personalized biologics treatments that meet the needs of every patient—both medically and financially. Once again, shifting to biologics discovery and development software platforms will make this possible by streamlining workflow. These platforms speed the processing of large amounts of data and facilitate collaboration by ensuring that every member of the design team has real-time access to experimental results. They also make it easier to avoid errors and experiment duplication, which drain lab resources. These efficiency gains can significantly reduce overhead costs for life sciences firms, and they will be able to pass those cost savings on to the patients who need it. As a result, patients will have access to personalized biologics treatments without breaking the bank or risking a biosimilar treatment that could have negative effects.
The Designed to Cure Industry Solution Experience from Dassault Systèmes provides discovery and development tools that enable researchers to identify and develop new biologics treatments that correspond to specific genomic landscapes and disease manifestations. The software also makes the overall development process more efficient, so more patients will be able to afford the biologics therapies that they need. Contact us today to learn more about how your lab can help make personalized medicine a greater reality for more patients.
References
[1] “Pharmacogenomics of tumor necrosis factor antagonists in rheumatoid arthritis,” July 2005, http://www.ncbi.nlm.nih.gov/pubmed/16013998
[2] “Expression profiling identifies responder and non-responder phenotypes to interferon-beta in multiple sclerosis,” June 2003, http://www.ncbi.nlm.nih.gov/pubmed/12764062
[3] “The Emerging Role of Pharmacogenomics in Biologics,” October 2007, http://www.ncbi.nlm.nih.gov/pubmed/17713469
[4] “Information on Biosimilars,” May 10, 2016, http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/