Life Science Leader Magazine

MAR 2014

The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.

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insights LIFESCIENCELEADER.COM MARCH 2014 62 PHARMA BUSINESS insights PHARMA BUSINESS Patient-centric Design: The Next Frontier In Drug Delivery B Patient-centric is one of those terms we suddenly seem to hear mentioned often. Everyone in pharma wants patients to know that it's their comfort and well-being that are always at the forefront of development efforts for medicine and delivery devices. PATIENT-CENTRIC DESIGN: THE NEXT FRONTIER IN DRUG DELIVERY By E. Miseta E D M I S E T A Contributing Editor ut true patient centricity is not about saying the right things at the right time. Nor is it thinking about the patient only when it comes time to present a prod- uct to them. Rather, it involves thinking of the end user at the very beginning of the discovery process, and keeping them in focus throughout the product develop- ment cycle. Ralph Lipp, president and CEO of con- sulting firm Lipp Life Sciences LLC, has been advising clients on the importance of a patient-centered approach for years. He believes that when developing novel drugs, it is even more important to keep the patient in mind, as that focus will drive everything else involved in the drug development process. "When it comes to patient-centered drug delivery, topics like safety, minimization of side effects, and efficacy are all impor- tant topics in the development process," he says. "But some in the industry fail to understand that portability, social accept- ability, and a good understanding of how patients interact with the delivery device are topics that must also be considered. A better understanding of patient-centric drug delivery will lead to better patient outcomes, which is clearly the overall goal of what we do." Lipp defines patient centricity as think- ing of the patient at each and every phase of the development process. It involves moving beyond the most basic patient needs of safety and efficacy, and think- ing about the entire spectrum of patients who may be using the drug, and what their needs are. When dealing with medi- cines that must be self-administered, the human factor will have to play an even greater role in the area of drug and device development. Easier self-administration will lead to greater patient adherence, which in turn will significantly support reaching the ultimate goal of improved patient outcomes. ADHERENCE EQUATES TO SUCCESS The advantages of patients being able to self-administer a drug are many. First, it will cut down on the amount of time a patient must spend in a hospital or clinic. Patient-friendly devices mean medicines can be administered at home, whether by the patient or a nurse or home care professional. For example, Kurt Nielsen, CTO and SVP of R&D; at contract manu- facturer Catalent, notes being able to self- administer an anticoagulant at home can knock two days off a five-day hospital stay, resulting in a savings of thousands of dollars. Nielsen also believes a significant value of the patient-centric approach lies in adherence. "If patients understand why they need to take medicines, they are more likely to take them," he says. "Only then is the magic of the drug able to hap- pen. The more difficult the process of self-administration, the less likely it is to happen. And when patients stop taking their medicines, the magic can't happen." To increase acceptance, there are several factors to consider. Lipp starts with inva- siveness. "Users will more readily accept a medicine that is administered via a device that is comfortable to handle and easy to self-administer," he says. "With age, self- administration becomes one of the great- est challenges patients face. In addition to dexterity issues caused by the onset of arthritis in some patients, there will be challenges created by the deterioration of vision in other patients. Packages and devices with small writing and multiple steps that need to be performed will result in lower acceptance rates." When developing the device and the 0 3 1 4 _ P h a r m a _ B u s i n e s s _ D D . i n d d 1 0314_Pharma_Business_DD.indd 1 2 / 1 9 / 2 0 1 4 2 : 4 5 : 3 8 P M 2/19/2014 2:45:38 PM

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