Georgea Pasedis
Senior Vice President, Global Biotech Head of Medical and Clinical Affairs Dompé
What role does Research & Development (R&D) play in Dompé’s success?
At Dompé, we take a science-first approach and invest heavily in R&D to bring innovative therapies to patients in need. The R&D team at Dompé was responsible for developing and executing the clinical trials, as well as working closely with the FDA to get the first approval label for rhNGF, a topical biologic to treat neurotrophic keratitis. Due to these R&D efforts, the company has now been able to treat thousands of patients who suffer from this vision threatening disease.
Our investment in R&D extends beyond ophthalmics to include exploration into several areas of profound unmet medical need. This includes increasing the number of active clinical trials from nine in 2020 to 17 in 2022, in such areas as Type 1 Diabetes, Cancer Related Fatigue, COVID-19 and ARDS. Dompé remains deeply committed to ophthalmics and as such has initiated two parallel phase III trials in patients with severe Sjögren’s dry eye disease, in addition to our ongoing study in patients with Stage I Neurotrophic Keratitis, which is now fully enrolled. Dompé has also provided independent grants to support several investigatorinitiated clinical trials to further scientific advancement in multiple therapeutic areas.
What are the biggest challenges in running a successful R&D program?
In the pharmaceutical industry today, only 13 percent of new molecules that enter Phase I of clinical trials go on to commercialization (1) – and the journey from the start of the R&D program to market can take, on average, 5-15 years. Some of the more recent challenges stemming from the pandemic have shifted the way in which clinical trial programs can recruit patients, and the qualified research staffing at healthcare facilities. In the last two years, we have seen lower than normal enrolment, with fewer patients interested in enrolling in clinical trials. Additionally, it has become even harder to recruit diverse patient populations.
Pandemic-related staffing complications have also impacted the clinics, private practices, and institutions that play such a critical role in the seamless execution of clinical research. Dompé remains committed to overcoming these barriers so that innovation can make it to market through the R&D process. Initiatives that Dompé has kicked off include a patient-centric study website with digital tools on social media to allow patients to learn more about their condition and submit their medical information to a site nearby, investing in several resources to find sites that serve underserved communities, and providing additional staff to subsidize the staffing limitations.
References
DB Fogel, Contemp Clin Trials Commun, 11, 156 (2018). PMID: 30112460.
Dompé at a Glance. Available at: bit.ly/35FeAc3.
OXERVATE™ [package insert]. Boston, MA: Dompé U.S. Inc.; 2019.
