We recently had the opportunity to speak at the Combination Product Life Cycle Management Summit, which was held in Boston earlier this month. Our co-founder and COO, Phil Burke, presented best practices for developing a dedicated, medical device designed to deliver a therapeutic drug. In attendance were quality, regulatory and device strategy/management professionals from a veritable Who’s Who of Big Pharma.
The drug/device combination products market is, in many ways, still relatively nascent. It’s also somewhat tethered to aging device technology designed for subcutaneous delivery. Yet, the market segment is projected to exceed $260 billion in annual, global sales within ten years. Precision medicine, the delivery of therapeutics directly to targeted tissue, is a key growth subcategory within the segment.
Interestingly, the two industry segments, device and drug, initiate their respective roads to market from what could be considered opposite ends of the developmental spectrum. Pharmaceuticals begin at the research bench. Molecules of interest are explored, and, on average, one out of every 5,000 investigated move to the next phase of testing. Device begins in the clinic. User Requirement Specifications, guided by Human Factors Analysis, initiate the device development process. While drugs emerge from research, devices emerge from development.
One speaker from a major pharmaceutical company summed it up, “The “R” side of drug is well established and funded. The “D” side should be equally important and properly funded as well.”
The other challenge is that the regulatory paths and FDA (for the U.S. market) have evolved to address the unique attributes of traditional drugs (CDER), biologicals (CBER), and medical devices (CDRH). Depending on the therapeutic molecule in a combination product (e.g., a drug/biological conjugate), all three centers of the FDA will be involved in the approval process.
These differences introduce unfamiliarity, which leads to ambiguity, which results in a perception of risk. This risk aversion has guided Big Pharma’s approach to combination products and guides its approach to Life Cycle Management. Never risk the value of the drug. Get the drug to market ASAP, in as simple and historically familiar a device as possible (e.g., a syringe & vial kit or pre-filled syringe). As the drug matures in the marketplace, they release it in pens and auto-injectors. The final phase of the product’s market life may introduce it in a wearable, automated device (e.g., an insulin pump).
Outside of Precision Medicine (e.g., targeted delivery of a biological or therapeutic directly into a solid tumor to avoid systemic toxicity), devices have historically been incorporated late in the drug commercialization pathway. This contributes to the dependency on legacy technologies.
The final takeaway was emphasized by multiple speakers throughout the conference – Start incorporating device development earlier in the process. We’re rapidly approaching a critical inflection point in the combination product marketplace. One in which device technology will enable and empower the application of highly innovative molecules that will drive precision, personalized, medicine. The next several years will shape the trajectory of next generation therapies and how they are administered in the clinic and patient’s home.