By Deb Borfitz
July 6, 2009 | Increasingly, drugs in clinical development incorporate some sort of specialized delivery technology that couples therapeutic benefit with greater ease of use. The demand for this enhanced product profile is changing the way the pharmaceutical industry approaches the discovery, development, and delivery of new medicines. William Heath, vice president of product research and development at Eli Lilly and Company, talked to eCliniqua about the rise in clinical trial activity around new modes of drug delivery.
eCliniqua: Why have new drug delivery technologies become so important to Big Pharma?
Heath: The flurry of activity is most notably driven by the emergence of biologic medications, which are derived from large protein molecules and tend to be injectable entities. This is clearly not patients’ favored administration route, so there has been focused attention on developing other delivery technologies that either minimize or avoid the injection altogether. Examples include “pen” injection systems and transdermal patches.
eCliniqua: These types of combination products pre-suppose drug delivery and materials science expertise. Where does that originate?
Heath: An extraordinary number of collaborative partnerships have emerged between major pharmaceutical companies and delivery technology specialists. Early on, technology specialists establish the feasibility of the technological approach. Clinical studies are used to test the suitability of these technologies for particular molecules, which is often an iterative process. This means that clinical data are used to tweak the technological approach to optimize the performance of the delivery system.
eCliniqua: Does the clinical trial process for combination products differ in any significant way from a traditional drug study?
Heath: A lot depends on the medicine being studied. If it’s a registered drug, the primary emphasis of regulatory agencies is whether or not the new route of administration gives comparable efficacy and safety to the established, marketed therapeutic. If a new molecule is being tested, the challenge is to look at the molecule’s performance in the context of the delivery option or technology chosen. Regulators also want to see data as to how patients interact with the device or delivery technology; for example, do they have to be Albert Einstein to figure out how the device works? What happens if they drop the device on the floor or accidentally put it in the freezer? Additionally, regulators look for clear understanding of the failure modes.
eCliniqua: What types of delivery technologies are under development and do they cut across all therapeutic areas?
Heath: Most of the focus is on chronic diseases like diabetes, rheumatoid arthritis, and osteoporosis where the course of therapy is long and self-administered by patients. The goal is to make delivery technologies more convenient and something that fits into the lifestyle of patients. For example, diabetic patients want devices that are small and elegant. In contrast, small and elegant are highly problematic for patients with limited dexterity, such as those with rheumatoid arthritis. If a medical device is too difficult to use, it will likely reduce patient adherence to the medication.
eCliniqua: Since we’re talking about products that are part drug and part device, doesn’t this represent a departure from the standard regulatory submission process with the Food and Drug Administration (FDA)?
Heath: Yes. For combination products, the FDA expects companies to submit a new drug and new device application simultaneously. The FDA Center for Drug Evaluation and Research and the FDA Center for Devices and Radiological Health review the applications in tandem.