What is Personalized Medicine?
As technology and medicine capabilities expand, we are able to explore a personalized approach to medicine. Learn how treatments are being tailored to individuals based on their unique genomic composition, and more.
The “One-Size-Fits-All” Approach to Medicine
Undeniably, we have advanced leaps and bounds in medicine in the past century. However, traditional approaches to medicine tend to utilize general population averages, as we do not yet fully understand how an individual's genetic makeup affects their response to treatment. Although treatments discovered with a “one-size-fits-all” approach can be effective, their results can vary from person to person.
In addition to medicine being tailored for a “one-size-fits-all” approach, research studies and clinical trials can fail to include a diverse trial pool. This can mean individuals not represented in critical studies may be affected by the treatment in a totally different way than the trial group, could experience different side effects, or may not even see any significant improvements.
One eye-opening example of the limitation of clinical trials and general averages is the fact that, in the United States, congress did not pass a law requiring the inclusion of women in NIH-funded clinical research as a mandate until the 1993 NIH Revitalization Act. Multiple factors, such as therapeutic response and disease presentation, can vary depending on an individual's sex assigned at birth.
Women comprise approximately half of the United States population. Given that their inclusion in clinical trials was only legally mandated about three decades ago, it's clear that the historically dominant “one-size-fits-all' approach in medicine may not be optimal for many people. Additionally, many racial and ethnic minorities have also been historically excluded from clinical trials.
The “one-size-fits-all” approach has many pitfalls, but it would be an injustice to not acknowledge that it has been critical for the development of many life-saving treatments and significant medical advances. Personalized medicine simply aims to address the pitfalls of generalized medicine.
Defining Personalized Medicine
In response to the pitfalls of “one-size-fits-all” medicine, there has been an emergence of personalized medicine, which accounts for factors such as a person's genomic and biochemical composition, lifestyle, and more while creating a treatment plan. These factors can determine which medicines would provide the highest probability of success, optimal dosage values, and more.
In addition to treatment, personalized medicine has the possibility to change how we approach preventative care. Early genetic testing could help us predict risk levels of individuals for various life-altering disorders.
The formalization and widespread application of this term are relatively new in the biopharma world, with an example of an early article popularizing the term being the 1999 Wall Street Journal article titled “New Era of Personalized Medicine: Targeting Drugs for Each Unique Genetic Profile”.
Benefits of personalized medicine include increasing the effectiveness of the treatment being used, minimizing the risk of drug toxicity. Treatment plans can also be built to optimally fit the lifestyle of the individual.
Through new technologies such as DNA sequencing, wireless health monitoring devices, imaging protocols, and more, we can now confidently identify minute and nuanced differences in someone's characteristics at physiological, molecular, behavioral, and other levels. As we discover more variations and differences, the need for personalized medicine approaches becomes more apparent.
Currently, personalized medicine is a general concept, and the procedure is constantly evolving as researchers discover the most efficient way to determine the best treatment for an individual.
Potential Challenges of Personalized Medicine
One of the biggest challenges presented in conversations around personalized medicine is cost. In order to fully understand an individual's genetic biome, more time, tests, and doctors may be necessary. Additionally, it could be discovered that a combination of treatments would be most effective, raising the cost of the treatment. These additional cost factors could lead to personalized medicine treatment not being accessible to the general population due to a cost barrier.
Researchers are in the process of developing solutions to reduce costs such as more affordable diagnostic techniques and streamlining data analysis, and more. However, it may be a while until cost-effective personalized medicine is a reality. It is also important to acknowledge that personalized medicine has the possibility to reduce costs, as it prevents individuals from undergoing treatments that would not be effective for them.
From an ethical perspective, patients may feel hesitant to provide personal genetic information to physicians depending on what ailment is being treated. New disclosure agreements and protocols would need to be established if thorough genetic testing is on file for individuals.
Another issue arises in terms of insurance. Would insurance agencies have access to information, such as genetic predispositions for diseases like schizophrenia or Alzheimer’s, before offering health insurance or life insurance policies? If genetic biome testing becomes commonplace, parameters on insurance’s access to this personal information would need to be established.
Regulation of personalized medicine can also be difficult, as it would potentially require FDA, or other regulatory bodies, approval of individualized treatments. These agencies would have to determine a standard approval process, which poses the potential to delay critical treatment.
Lastly, any time large bodies of data with personal information are stored, there is the potential for sensitive information to be leaked. Data security would be an ongoing concern if critical genetic information is on record for a large volume of people.
Companies Investing in Research & Treatment
One company specializing in personalized medicine for chronic disease is OM1. They utilize big data and AI technologies to provide more robust insights into clinical care. Their AI tools offer a detailed perspective into factors such as patient journey, disease progression, tailored treatments, and more that would not be accessible with traditional analysis tools. Chronic disease categories they are helping to treat include neuroscience, cardiometabolic, immunology, and ENT/respiratory disorders.
Roche considers themselves “a pioneer in personalized healthcare”, focusing on areas such as data-driven medicine, and companion diagnostics. To further strengthen their approach to companion diagnostics, in 2023, Roche expanded their collaboration with Janssen Biotech Inc., allowing the companies to strengthen research capabilities. They offer a variety of assays for biomarker testing, such as robust prototype assay (RPA), formulation locked assay (FLA), and investigational assay.
The Future of Personalized Medicine
According to BioSpace, the global personalized medicine market in 2023 was $530.11 billion USD and is expected to be valued at $1,176.66 billion USD by 2033. The predicted compound annual growth rate (CAGR) from 2024 and 2033 is 8.30%.
With the rise of other emerging technologies such as AI, gene editing, CRISPR therapy, and cell & gene therapy, the possibilities of personalized medicine continue to expand. Companies, like the previously mentioned Roche and Janssen, continue to form partnerships with the goal of innovating personalized medicine in new ways.
Getting Your Tailored Therapies to Market
At High Purity New England, a Getinge Company (HPNE), we provide top-of-the-line bioprocessing solutions that can scale with you from discovery to fill-finish. Our HPConnexx™ Single-Use Assemblies are brand agnostic, meaning you will never be limited in a design because of a parts brand or company.
Constructed in our ISO Class 7 cleanrooms, HPConnexx™ can be made specifically to your process needs. With over twenty years of experience, our team has an unparalleled understanding of unit operations, and are dedicated to using that knowledge to design the strongest solution for each customer.
Interested in upgrading your bioprocess? Reach out to one of our expert Product Managers at info@hp-ne.com to learn more, or visit our contact us page.
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About HPNE
As the industry needs grow, High Purity New England, Inc. continues to supply the biopharmaceutical industry with a range of innovative products, from drug discovery and development to fill-finish, including their flagship product, custom single-use assemblies, as well as pumps, sensors, bioreactor systems, storage and handling solutions and other single-use solutions. Along with their own manufactured products for the global market, they are also a distributor for more than 18 brands in North America.
