Meeting an Aging Population’s Evolving Needs

Seventy years ago, scientists first identified DNA as hereditary material, setting the stage for Watson and Crick’s seminal article in Nature a decade later, in which the scientists proposed its helical structure. Consider how far we’ve come since then, with the development of PCR and high throughput screening technology, and, especially, since 2001, when the International Human Genomic Sequencing Consortium published its first sequence of the human genome. These discoveries have led to the introduction of many new therapeutic classes of drugs for treating acute and chronic diseases, helping to extend life expectancy.

Slowly, we are beginning to understand diseases and disease networks on a molecular and genetic level for individual patients and can now intervene with personalized drug therapies. While we are increasingly able to treat patients more precisely based on their personal disease and metabolic characteristics, these patients are also much older, have multiple diseases and need to receive several drugs to manage their health and quality of life.

These factors can present barriers to adherence to a prescribed drug regimen. Older adults may be subject to more drug-to-drug interactions and medication errors that threaten their therapeutic outcomes due to declining cognitive abilities and functional limitations like vision and swallowing issues or even difficulty opening pill boxes. Some older patients may have a regimen composed of 10 drugs or more — of which, some need to be taken once a day, twice or three times a day, before or after a meal, or at a reduced dosage strength. These unique needs challenge the traditional development, design and manufacture of medicines. To address these challenges, future drug therapies need to be tailored to the individual patient in terms of drug and dose selection and regimen complexity.

Existing pharmaceutical product development and manufacturing is focused on patients with a single acute or chronic disease, which is treated with one drug at two or three different dosage strengths in a standard dosage form. However, this concept is becoming less suitable when pharmacogenomics are applied to prescribing or for patients with multiple diseases that require many drugs. While the drugs for the treatment might be the same, the doses and the appropriate dosage forms will differ from today’s standard formula. This leaves the “one-size-fits-all” concept in pharmaceutical products incompatible with the blockbuster manufacturing of the pharmaceutical industry today, where two or three global manufacturing sites are dedicated to the global supply of a specific product.

Further, health care systems worldwide are beginning to refuse current drug prices without proof of benefit. Instead, they are moving to a pay-for-performance model. This is forcing the pharmaceutical industry to become more involved with patients and provide patient-centered health care solutions rather than just selling therapies.

The result has been increasing demand for flexibility in manufacturing platforms to customize medicines that meet specific patient population needs. This includes manufacturing medicines that allow for easy adjustments of the dose and the ability to combine different drugs and release profiles. For instance, multiparticulates can be combined and adjusted to the required dose on an individual basis. When filled in an easy-to-open capsule, it is possible to provide a pharmaceutical dosage form that delivers multiple drugs in one unit that can be swallowed as a whole or administered in a beverage or soft food like apple sauce. The requirement for manufacturing flexibility extends further to the differentiation of drug products to prevent medication errors for those with visual impairment or cognitive challenges. In this regard, the use of colored capsules coupled with product specific imprints in the form of bars, numbers or letters can help to deliver patient-centric medicines.
    
Other industries have already taken this path to personalizing products for customers. Consider, for example, the automotive industry, which can now customize cars to meet exact requirements.

Advances in pharmaceutical engineering and manufacturing, coupled with the use of quality by design (QbD) principles, offer interesting roadmaps to establish highly flexible manufacturing platforms for patient-centric drug products. As Charles Darwin stated two centuries ago: “It is not the strongest of the species, nor the most intelligent, that survives. It is the one that is the most adaptable to change.” Pharmaceutical manufacturers who adopt a more patient-centric platform will be better positioned for future success.