Science, service, solutions
According to the World Health Organization (WHO) it is estimated, 235 million people suffer from asthma worldwide, and it is the most common chronic disease among children. The disease is multidimensional in nature, is often under-diagnosed and under-treated, and creates a substantial burden to individuals and families. An estimated 39.5 million people, including 10.5 million children in the United States had been diagnosed with asthma in their lifetimes.1,2
Asthma is a complicated condition for doctors and patients to manage, and its prevalence is on the rise, especially in developing countries and children. Asthma control focuses on two areas: (1) reducing the frequency and intensity of symptoms and functional limitations experienced by a patient; and (2) reducing the risks of future asthma attacks, progressive decline in lung function, or medication side effects.
Achieving and maintaining asthma control requires providing appropriate medication, addressing environmental factors that cause worsening symptoms, helping patients learn self-management skills, and monitoring over the long term to assess control and adjust therapy accordingly.
FDA and generics:
Due to patent expiration, clinical development of biosimilars has been increasing. At present, there is only one FDA approved version of generic albuterol, but if more manufacturers submit their own generic inhalers, prices should drop giving asthmatics more affordable options for treatment. 3
Such clinical programs, although less complex than those of originators, are still demanding in terms of cost and need for patients. This underscores the importance of identifying and engaging not only the Sponsor but today’s Investigators and Investigators of the future. Study design, patient populations and site selection are pivotal points in a successful clinical trial.
Novum has experience managing both small and large scale, multi-site asthma trials and access to a large network of experienced Investigators.
Novum is developing and nurturing relationships with emerging investigator sites globally, and provide them with the proper guidance and training to ensure completion of intricate and often times complicated pulmonary studies. The sites we partner with include Investigators who are key opinion leaders in the field, along with our strong vendor network and in house expertise ensures high quality, timely clinical trials. This includes experience managing complex bronchoprovication studies involving methacholine. Centralized spirometry, the development of timelines and processes for methacholine production activities is a key component of our services. Our recent asthma studies have included oversight during the methacholine production stage and compounding, centralized serial spirometry and IWRS. The quality of the data captured during the conduct of each study depends on thorough training and experienced staff. Training, on site and centralized monitoring along with blind data review ensure the highest quality data when collecting pulmonary function tests and other relevant data. Integration and management of multiple electronic systems is also an important skill due to the technical challenges of these types of studies.
Future successful drug development is dependent on the close collaboration between our Sponsors that are uncovering new compounds for study, and Novum that often lead the execution of these important clinical research programs. The quality and conduct of each study depends on experience and thorough training to ensure success. Sponsors leveraging Novum’s experience and expertise will ensure new, affordable therapies can one day reach all of those who are suffering from asthma around the world.
- World Health Organization. Asthma (2017).
- Centers for Disease Control and Prevention. Asthma Facts—CDC’s National Asthma Control Program Grantees (2013).
- Global Asthma Clinical Trial Pipeline Highlights –ID: 4773862 Region: Global Fore Pharma (2019).