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Combining a therapy with its delivery system means navigating two slippery, slowly converging roads en route to a successful launch.
October 1, 2024
By: Bill Welch
In the rapidly advancing realm of patient-centric healthcare, the convergence of drug products and medical devices has formed a distinct hybrid category: drug-device combination products (DDCPs). Such symbiotic solutions integrate either large or small molecule medicines with medical devices, all but erasing the increasingly blurred lines between drugs and their delivery systems while pioneering new pathways for therapeutic advancements. In the near future, the already substantial impact of drug-device combination products will only continue to increase. Among other value propositions, DDCPs provide efficiency-minded approaches to therapy by reducing the need for multiple interventions and promoting elevated patient compliance. Such streamlining attributes are arriving in the nick of time, with innovative DDCPs often employed on an expedited basis to address the increased prevalence of serious, often chronic diseases and conditions including cancer, heart disease, multiple sclerosis and diabetes. In fact, a recent report by Insightslice notes that the global drug-device combination products market, valued at just over $109 billion in 2022, is projected to eclipse $236 billion by 2033 via a hefty estimated CAGR of 7.2%. Thanks in part to careful and precise drug targeting, local administration and individualized therapy, DDCPs are leading to safer, more effective treatments, and carry potential for improved therapeutic outcomes given their seamless integration of drugs and their delivery devices. However, developing and commercializing DDCPs presents a range of complex challenges. This article explores crucial considerations for achieving successful commercialization of drug-device combination products. Human Factors and User Experience Human factors engineering (HFE) is a crucial element in the development of drug-device combination products. With a focus on patient-centric design, it is essential to understand how users interact with the product as-received, including the packaging, instructions for use (IFU) and, of course, the DDCP itself. This understanding is vital for optimizing usability, minimizing user errors and enhancing overall safety, efficacy, and adherence toward the overarching goal of improved patient outcomes. Conducting usability studies and integrating human factors considerations early in the design process can help identify potential issues and, from there, guide necessary design modifications. Human factors and usability engineering are integral components of regulatory submissions, essential for demonstrating the product’s usability and ensuring user comprehension. Indeed, the successful integration of a drug and delivery device requires meticulous design control elements to address the unique challenges of combination products. Compatibility between the drug product, drug container and the device, as well as the potential impact on the product’s stability and performance, must be thoroughly assessed during the development phase. Additionally, establishing a robust risk management plan is critical for identifying and mitigating potential issues that may arise during product development. This includes satisfying concerns related to drug product stability, device functionality, and potential adverse component interactions. Whether managed internally by pharmaceutical companies or through Contract Development and Manufacturing Organizations (CDMOs), it is imperative that multi-disciplinary teams collaborate to ensure drug product development and packaging design are aligned, compatible, and optimized. Quality and Manufacturing Considerations As with any healthcare scenario, maintaining consistent, uncompromising quality and efficacy for drug-device combination products is perpetually paramount. Both pharmaceutical companies and CDMO solution providers must strictly adhere to good manufacturing practices (GMP). Such guidelines are crucial for ensuring product reproducibility and reliability and involve implementing rigorous quality control measures at each stage of production – from raw material sourcing and sterile filling of the drug product into primary containers to final assembly, labeling, and packaging. Only through validation of robust and scalable manufacturing processes and controls can a pharma company or CDMO demonstrate that a DDCP maintains consistent quality and performance throughout its lifecycle, from clinical trial to commercial market supply. Near-Commercialization Considerations At Phase IIB clinical trials, pharmaceutical companies typically move toward final decisions regarding a therapy’s drug-device strategy. Considerations here, for example, include whether to continue with a prefilled syringe, convert to a needle safety device, or transition to an autoinjector. Always, the idea is to provide ultimate flexibility for various health care professionals, patient populations and reimbursement schemes. Considering the Target Product Profile (TPP) / Quality Target Product Profile (QTPP), it must eventually be determined whether the therapy mandates a novel device innovation for specific patient populations or, conversely, if traditional, readily available platforms will suffice for all potential patients. Naturally, selecting an established platform that received regulatory approval as part of a previous, now-established DDCP may be deemed lower risk for a new program. This avenue also may provide greater speed to market, allowing a lifechanging therapy to reach patients on an expedited timeline while gaining first-to-market advantages. When innovative platforms are necessary, part and parcel to any well-rounded device strategy is securing intellectual property (IP) rights. Companies must carefully navigate the patent landscape to protect their device innovations in today’s increasingly competitive landscape and establish a strong IP position. This involves considering both the drug and device components, as well as any novel aspects to the DDCP in question. As commercialization nears, a robust and secure supply chain also is crucial. Companies must establish firm relationships with suppliers and partnering CDMOs, implement risk mitigation strategies, and develop contingency plans to address potential disruptions. This is especially important given the interconnected nature of the drug and device components, each with distinct manufacturing and sourcing considerations. In such setups, the supply chain and the DDCP manufacturing process is truly only as strong as its weakest link. Five Key Takeaways With so many winding, integral considerations along the drug-device combination products commercialization journey, some bulleted best practices can be helpful.
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