The Application of Personalized Medicine Techniques in Drug Development and Delivery

Highlighting how the pharmaceutical industry and our healthcare systems can work together to revolutionize drug treatment and best serve patients when they need it most.

Have you ever felt overwhelmed with the number of medications you have received? Or the cost? Maybe the inefficacy of so many? How about the skyrocketing costs of pharmaceutical development?

These are all questions our current healthcare, clinical, and pharmaceutical sectors are engulfed with. Historically, healthcare in the United States has felt disoriented and disconnected, and has lacked personalization for the average citizen.

With the rise of Personalized Medicine, it is critical to understand, in-depth, what the field has to offer, and how it can be specifically applied to next generation treatments in the pharmaceutical field.

An Overview of Personalized Medicine

Personalized Medicine is yet another buzz word that has become a phenomena and gained wide-spread attention in recent years. It has propelled forward further research in top health agencies at the federal government level — from the National Institutes of Health (NIH) to Health and Human Services (HHS) — and it has also posed a profound opportunity for improvement in healthcare delivery and population health sciences.

Personalized Medicine, also widely known as precision medicine, is a unique, multidisciplinary field which emphasizes a modern approach to understanding health.

The field promotes innovative interventions and strategies including specialized treatment that address diverse and unique patient concerns, environments, circumstances, and realities while trying to break the often-unbreakable cycle of one-size-fits-all approaches in healthcare.

Research includes collecting and analyzing different types of critical patient, medical, and health information; organizing proactive and predictive data and information systems; and processing information to allow for specific treatments and/or diagnoses.

In this article, I will be highlighting two main areas for growth, innovation, and ingenuity within the Personalized Medicine-Pharmacology intersection — delivery and development.

Personalized Medicine relies on using a diverse array of patient information — from genetic make-up to social determinants of health (SDOH) — to best serve populations

The Applications of Personalized Medicine in Drug Delivery

Drug Delivery— the application of pharmacogenomics and effective diagnostics software

Let’s look at the drug delivery process from both the aspect of a physician/provider and the patient.

First, for the provider — When trying to identify what pharmaceutical solution would be the best for a given individual in a given context, care providers have to take a few parameters into consideration:

• Age
• Size (weight)
• Overall health
• Interactions with other medications
• Genes

Next, for the patient — These parameters need to be addressed at a holistic level in order to best meet patients’ specific needs, and successfully facilitate a smart diagnosis, the right drug, and the right dose at the right time.

The field of pharmacogenomics, specifically, is defined by intersectional research looking to use genomic information to study individual responses to drugs. This discipline, paired with smart data science structures incorporating more general population health sciences (as mentioned above), can help redefine how patients are treated.

At a genomic level, each gene provides the foundation for eventual production of a specific protein in the body. A particular protein can have an important role in drug treatment for many reasons, some of which include:

• Breaking down the drug absorbed by the body
• Helping with the absorption or transport of the drug and their respective processes
• Serving a role in a series of molecular events triggered by the drug
• The protein is the target of the drug

Researchers who compare the genetic information of individuals taking the same drug can then consequently form parallels, and identity commonalities in treatment response including:

• A greater risk of side effects
• No substantial benefit from the treatment
• A greater benefit from the treatment
• The optimal duration of treatment
• The need for a higher dose to produce clinical outcomes

Genetic information provides invaluable insights into enhancing clinical pharmaceutical decision-making.

The science behind forming meaningful connections between this genetic information and pharmaceutical outcomes lies in two fields of pharmacogenomics — pharmacokinetics and pharmacodynamics.

1 — Pharmacokinetics

This describes the movement and processing of a specific drug in the body and encompasses 4 central processes: absorption, distribution, metabolism, and excretion.

Pharmacokinetics (PK) highlights the movement of drugs through the body (the process of movement).

With an understanding of how metabolic response is instantiated and at what pace — for example — researchers can form connections among patients and produce specialized clinical support recommendations that physicians and providers can then apply in practice.

• Absorption: drugs can be absorbed into human circulation from numerous sites within the body. It is critical to understand how and where exactly these absorption processes occur.
• Distribution: once the drug is in circulation, it needs to be transferred to the interstitial fluid — a thin layer of fluid which surrounds the body’s cells — and to the cells of the body.
• Metabolism: this is a fundamental stage to monitor in order to evaluate drug intervention effectiveness. It captures the biotransformation process and how the drug reacts, interacts, and diffuses within the human body.
• Excretion: this final stage evaluates how the drug is removed from the body. The primary sites for drug excretion are the liver and kidney, as well as the skin, lungs, and bile and intestine. It can exit either as a metabolite (product of metabolism) or unchanged drug.

2 — Pharmacodynamics

This describes how well the target cells respond to drugs. Target cells include ion channels, receptors, immune systems, and enzymes.

Pharmacodynamics (PD) highlights the body’s biological response to drugs. (expressed as biochemical or molecular interactions).

In addition, similar to the insights researchers can gain in pharmacokinetics, pharmacodynamics allows for researchers to draw final, definitive conclusions on clinical effectiveness on certain pharmaceuticals — using information at a molecular/biochemical level, rather than certain parameters as a function of time (as expressed in PK).

With this information, a final conclusion associating specific genetic variants and/or quantitative differences in gene expression with drug response, can be confidently made.

With this being said, most of the potential of pharmacogenomics remains to be explored and needs to be further investigated in prospective randomized clinical trials that can draw important conclusions to advise clinical teams across healthcare systems.

The Applications of Personalized Medicine in Drug Development

Drug Development— the use of biomarkers

Now, in addition to using genetic information to better deliver pharmaceuticals to patients, biomarkers measuring and quantifying other critical clinical, biochemical, and molecular information can allow for more efficient, effective, and meaningful drug development processes.

Before further analyzing the implications of biomarkers, it is important to understand the drug development process at large.

This graphic highlights the different stages in drug development.

The drug development process begins with basic research on the specific potential intervention origins and possibilities, followed by prototype of intervention.

Then, in preclinical development, feasibility of production, iterative testing, and drug safety data are collected (largely in laboratory animals to gauge effect). Following this, clinical development moves forward — with large-scale testing in humans taking place.

With biomarkers, the effectiveness and productivity of preclinical and clinical phases can be dramatically improved. Biomarkers can monitor critical information — like mentioned above — in samples.

Biomarkers enable a step-by-step process to effectively monitoring drug development.

At a fundamental level, biomarkers are characteristics of the body we can measure (quantify), such as CAT scans and blood pressure. These biomarkers can help monitor and analyze critical types of information.

These biomarkers are critical to drug development as they allow pharmaceutical developers and biotechnology experts to look at the effect of drugs on humans as analyzed by these biomarkers while better paving the way for an improved success rate.

The main types of biomarkers include:

• Predictive: primarily disease-associated that can indicate whether there is a threat of disease (and to what extent) and measure patient’s responsiveness.
• Diagnostic: used for specific diagnosis, and can help reveal the status of a given target to create more personalized drug options.
• Mechanistic: these biomarkers take a mechanical approach and can help assess the effectiveness of treatment at a functional level.
• Pharmacodynamic: similar to the connections of pharmacodynamic properties mentioned above (as related to the human genome), these biochemical and transport characteristics enable insights in response to specific compounds and treatment interventions as well.
• Safety: predictive safety analysis biomarkers can ensure a non-toxic human to drug interaction and response.

Compared to the conventional drug development process, biomarkers allow for more forward-thinking and predicative assessments as compared to commonly-used clinical endpoints like mortality or disease progression. With consistent, gradual data across diverse parameters such as epidemiologic, therapeutic, pathophysiologic evidence, the process can be more productive and beneficial to both patients and developers.

Opportunities in this area include creating the next generation of smart, proactive biomarkers that can integrate both critical medical information and intelligent data analysis methods in diverse ways.

What are the Next Steps?

When it comes to building upon this existing science and scaling a lot of these innovative strategies, it is essential to be guided by the following core values:

1. Build interdisciplinary and inter-industry collaboration —

In order to make substantial progress in these areas, it’s so important that healthcare systems, pharmaceutical and biotech companies, and data science entities build strong relationships, constantly experiment, and scale viable solutions.

Collaboration like no other is key to meaningful innovation in this field.

2. Innovate and experiment constantly —

These fields require so many minds working on different things. From looking at genetic samples to identifying nuanced, complex trends with common drugs, scientists, physicians, and entrepreneurs need to be researching and testing across the spectrum.

The next generation of biomarkers and optimal analysis software will need to be crafted by the young generation.

3. Get like-minded people together —

These are detailed research processes, and with like-minded people together and tackling challenges head-on, efficient and meaningful progress can be made.

Key Takeaways

• Personalized medicine techniques can help revolutionize drug delivery and development at large scales.
• Genetic information, paired with smart data science/diagnostics, can enable better, more precise drug delivery.
• Next generation biomarkers — with a balance of sound clinical background and data analytics — can help improve efficiency, cost-effectiveness, and scalable impact of drug development processes.
• In order to scale and build upon these breakthroughs, it is critical that inter-industry and inter-disciplinary collaboration, constant experimentation, and like-minded synergy, are emphasized.

About the Author

Hamid is a student based in Long Beach, CA. His interests lie in medicine, healthcare, biomedical engineering, and business. He strives to make a meaningful impact in the areas of clinical practice, healthcare delivery, and public health by leveraging technology and innovation.

If you’d like to connect, you can find him on LinkedIn and Medium (you’re already here!), or you can email him at hamidtorabzadeh@outlook.com.