ResMed has promoted Lucile Blaise to president of sleep & respiratory care.
Blaise, currently ResMed’s vice president of sleep & respiratory care for Western Europe, has more than 25 years’ experience in medical device sales, marketing, finance, and business development. With ResMed since 2006, she has led her team’s efforts with industry and public partners to establish payer market access and reimbursements for digital health telemonitoring in France and Belgium, is an outspoken advocate for real-world evidence and applying it to value-based healthcare systems. Blaise is also dedicated to maintaining patient data privacy and security, according to a release. Blaise has served for 6 years on the board of Snitem, a medtech association in France, and was elected its president in June 2022. She has also served on the board of MedTech Europe since 2020.
“I’m thrilled that Lucile—one of Europe’s leading champions of digital health innovation and adoption, as well as data privacy and security—has accepted this promotion to lead ResMed’s global Sleep & Respiratory Care business,” says ResMed CEO Mick Farrell, in a release. “Throughout her 16 years at ResMed and over 25 years in the medtech industry, Lucile has been a key player in improving chronic disease treatment for millions of people with sleep apnea and respiratory insufficiency, as well as supporting physicians, providers, and healthcare systems across Europe, and beyond, through evidence-based decision making. Lucile is committed to collaboration across the company, and the industry, and always places the needs of the patient first. She exemplifies the deep bench of innovative, accomplished leaders across ResMed, bringing in-depth market knowledge, customer insight, and commercial skills to our CEO operations leadership team, as together we continue to transform our business and the market through digital health.” Read more here.
Sleep Disordered Breathing and Heart Health
Treating sleep apnea has also helped reverse or reduce the incidence of arrhythmias, which means that sleep apnea is a likely cause of arrhythmia in some people.
People with heart disease also experience sleep apnea in greater proportions. This means it’s likely that some people with sleep apnea may have already had some heart problems. Sleep apnea can worsen this damage which can further increase someone’s risk of abnormal heart rhythms. Read more here.
FDA Grants Fast Track Designation to Apnimed Sleep Apnea Drug Candidate AD109
The US Food and Drug Administration (FDA) has granted Fast Track designation for Apnimed’s oral pharmacologic AD109 for the treatment of obstructive sleep apnea (OSA).
“Fast Track designation is a significant milestone in the development of AD109 and provides an accelerated regulatory pathway that recognizes the urgent need for new pharmacologic treatments for OSA that are easier for people to tolerate,” says Larry Miller, MD, Apnimed CEO, in a release. “Currently the vast majority of more than 35 million Americans who have OSA remain untreated despite the potential for serious health risks associated with the condition, including cardiovascular disease and diabetes. We will continue to work closely with the FDA to support the development and review of AD109 beginning with the trial design for our Phase 3 program, which we anticipate initiating at the end of 2022.”
FDA’s Fast Track designation is intended to facilitate the development and expedite the review of new drugs to treat serious conditions and that fill an unmet medical need. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss development plans, trial design, and data needed to support drug approval, as well as the ability to submit a New Drug Application on a rolling basis, and eligibility for priority review, if relevant criteria are met.
Apnimed’s AD109 has the potential to be the first oral pharmacologic that treats OSA airway obstruction at night. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity. Read more here.