Regulatory, Science and Technology Innovation
The meeting concluded with a session titled “Regulatory, Science and Technology Innovation: Enabling Novel and Improved OINDP Design, Development and Manufacturing” that was organized in coordination with the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). While Prasad Peri from Teva covered “Perspectives on the Evolving Regulatory Landscape for Inhaled and Nasal Products,” the session included a range of topics from Richard Henderson’s talk on GSK’s development of Trelegy Ellipta to a presentation on the use of advanced data analytics in OINDP development by Nanopharm‘s Will Ganley.
Paul Upham from Genentech discussed the effectiveness of user centric device design for improving patient adherence/persistence, noting that over the past 10-15 years, the industry has focused on the use of digital and connected devices to remind patients to take medication based on a false assumption that most non-adherence results from forgetting.
In fact, he said, studies have shown that only about a quarter of non-adherence is due to forgetting; the rest is due to causes such as cost or logistical problems preventing access, wanting to avoid side effects, and denial that the medication is necessary. As a result, Upham suggests, requiring patients to log medication use simply adds another burden on patients with chronic disease.
Upham described a behavior design approach to the problem, starting with research in patients’ homes and clinics to better understand how patients used their devices. Among the findings were patient-initiated “hacks” such as using pulse oximeters to determine how well they were managing their disease. He concluded by saying, “If we focus on the patient and serving their unmet need and helping them improve self management and leave data integration with healthcare professionals and the payer and even the pharma company as secondary, we’re much more likely to increase medication adherence.”
Workshops in this knowledge space included Proveris Scientific‘s “Automated pMDI Handling For Dose Content Uniformity Testing And Aerodynamic Particle Size Distribution” and Aptar Pharma‘s workshop on “US & EU Drug-Device Combination Product Regulations in the OINDP Field.”
Exhibition
The RDD 2022 technical exhibition included more than 60 companies. Although few companies were promoting new products or services, several newly formed alliances took part, including RxPack, a joint venture between Coster and Lindal that officially launched in March 2021, and INTO, a CDMO comprised of DFE, Harro Höfliger, and Sterling that launched in March 2022.
Many exhibitors expressed satisfaction with the number of delegates visiting the tables and interacting with company representatives.
Companies participating in the exhibition included:
RDD Europe 2023 will take place in Antibes, France from May 2-5, 2023.
