Welcome to the latest issue of the Celerion Science Newsletter, designed to provide to our readers information on the latest technologies, trends and stories specifically focused on early clinical development activities and professionals in clinical pharmacology and associated sciences. We invite you to share our vision, techniques and experiences learned through our accomplishments in all aspects of early clinical development. If there are any topics you would like to hear about, please email us at Marketing@Celerion.com.
We are also pleased to announce the launch of our new website! Our goal with this intuitively-designed website is to provide you with an easier way to access insightful information on our services and solutions. What’s more, you will find our new website features a contemporary look with enhanced capabilities and a responsive design so you can easily view it on your mobile device.
We encourage you to visit www.celerion.com. We are confident that you will have a valuable experience on our new website.
White Paper: Exploratory Studies in Cystic Fibrosis
Early stage, exploratory clinical trials involving cystic fibrosis patients are typically marred by a number of challenges. First, recruitment of cystic fibrosis patients may be cumbersome – due to the low prevalence of the disease, and to the often restrictive inclusion/exclusion criteria.
Chronic obstructive pulmonary disease (COPD) describes a cluster of diseases linked to breathing problems and airflow blockage, such as emphysema and chronic bronchitis. COPD is often associated with cigarette smoking, and prolonged exposure to poor air quality or toxic gaseous pollutants. This chronic disease affects over 3 million people in the US each year, and is currently the third leading cause of death worldwide.
Fact Sheet: Early Phase Clinic - Respiratory Center of Excellence, Belfast, UK
Celerion offers fully integrated early phase services and the industry’s most extensive facilities across Europe and North America, including three clinics with over 600 beds. This enables biopharmaceutical companies to design, execute and complete early phase studies quickly and with high-quality data.
Immune Monitoring assays, such as Flow cytometry and Elispot (Enzyme-linked immunosorbent spot) have been utilized in the research arena for decades. Adapting such complex assays into the clinical realm has a host of challenges, with an increasing emphasis on compliance to industry standards in a regulated environment being at the forefront (FDA BMV guidelines, May 2018).
Poster: Qualification of an IFN- g Elispot Assay in the Bioanalytical Laboratory, AAPS PharmSci 360 2018
Immune Monitoring assays, such as flow cytometry and Elispot (Enzyme-linked immunosorbent spot) have been utilized in the research arena for decades. Adapting such complex assays into the clinical realm has a host of challenges, with an increasing emphasis on compliance to industry standards in a regulated environment being at the forefront (FDA BMV guidelines, May 2018).
Meet Aernout van Haarst PhD, Director, Scientific Affairs
As Director, Scientific Affairs, Aernout plays a key role in leveraging Celerion’s scientific and drug development expertise to support drug development programs of Celerion’s clients. He is a member of Celerion’s respiratory and vaccine research teams and is the scientific liaison to various external experts in the fields of pulmonology and vaccine development.
Aernout has over 20 years of drug development experience at biotechnology companies as well as CROs. This experience includes designing drug development strategies through Proof-of-Concept as well as hands-on experience in the design and conduct of early clinical studies in a breadth of therapeutic areas.
Aernout earned his doctorate in pharmacology from the School of Medicine at Leiden University (Netherlands) and also qualified as clinical pharmacologist in Leiden. He has a doctoral degree in Medical Biology, from the School of Medicine at University of Utrecht (Netherlands).
A Randomized, Double-Blind, Placebo Controlled, Multicenter Phase 2a Study to Assess Safety, Daily Respiratory Symptoms, Pharmacokinetics, and Biomarker Variations after Administration of either YPL-001, or Placebo in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease