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By Sven Stegemann

Sven StegemannOver the past 20 years, pharmaceutical and medical sciences have made significant progress that has silently changed the health care environment. With hundreds of new drugs and many new therapeutic classes of drugs launched, we are now able to effectively treat many acute and chronic diseases. As a result, life expectancy continues to grow by an additional three months every year, creating an ever-increasing set of health care challenges. And baby boomers will significantly expand the ranks of this population over the coming decades.

At the same time, we are beginning to understand diseases and disease networks on a molecular and genetic level for individual patients, and we can now intervene with stratified personalized drug therapies. However, while we are increasingly able to treat patients more precisely based on their personal disease and metabolic characteristics, we will also have to recognize that these patients are much older. In the United States, the number of people 85 years and older will grow from 5.8 million today to 19 million by 2050. Furthermore, the majority of people older than 65 have multiple diseases and need to receive several drugs to manage their health and quality of life.

In contrast, drug product design, development and manufacturing, has not changed much over the past decades and still relies on the one-size-fits-all product concept. Poor adherence, medication errors, inappropriate medication alterations, and medication management issues are increasingly recognized to be responsible for safety issues and poor therapeutic outcomes in special patient populations.

It is not surprising that health care systems worldwide are beginning to refuse current drug prices without proof of benefit to the patient in the real world. 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 being a provider of therapies.

Considering how patients interact with, understand, and use the drug product is a critical prerequisite to conceptualize, design, and develop patient-centered drug products. Patient-centered drug products can fulfill the therapeutic needs of the patient as well as take into consideration the personal patient factors that are important in managing drug therapy. The ultimate goal is to develop drug products that are used intuitively as intended.

The new AAPS Patient-Centric Drug Development, Drug Product Design, and Manufacturing Focus Group aims to develop the science around patients, their needs, and their interface with drug products. This will cover the development of targeted product performance, product design, product characteristics, manufacturing, and regulatory framework. The objective is to “make the product fit for the patient,“ to increase the product safety and effectiveness in the real world of patients managing their own increasingly complex therapy. If you are interested in joining please sign in at members.aaps.org/or email me directly, or via LinkedIn.

Sven Stegemann, Ph.D., is director of Pharmaceutical Business Development at Capsugel, the world’s leading provider of dosage form solutions to the healthcare industry. Stegemann is a pharmacist by training and holds a doctorate in pharmacology. His scientific interest is in improving drug therapy in older adults through multidisciplinary and patient-centered science.