Medicon Valley Alliance and Celerion would like to welcome you to a Good Morning Meeting.
Abstract: Transitioning an experimental drug from preclinical animal models to the clinic is a critical milestone in bringing new medications to the market. First-in-Human (FiH) clinical studies have undergone a significant evolution, from a basic “feed-and-bleed” model in the 1970s, to the more complex and comprehensive study designs being conducted today. By taking advantage of sophisticated technologies, adaptive designs and the application of biomarkers, Sponsors can obtain early signals of efficacy sooner, while gaining a better understanding of their drug’s safety profile. Join us to hear Celerion share their recommendations on how to best design and execute a FiH study, based on their 50 years’ experience in translational drug development.
Date: Thursday 11th of April 2024
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub2 Auditorium
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | Introduction of speakers Nathan McCavery, Senior Director, Business Development, Celerion |
| 9:10 | Optimising the design of an early stage clinical study – setting up for success Aernout van Haarst, Ph.D., Director, Scientific Affairs, Celerion |
| 9:30 | Clinical Operations: Practical considerations for complex FiH protocols. What makes sense and when? Staci McDonald, PharmD, Vice President of Global Scientific Clinical Operations, Celerion |
| 9:50 | Benefitting from Onsite Bioanalytical Services: Integrating with the CPU to make informed decisions faster Chad Briscoe, Ph.D., Executive Vice President, Global Bioanalytical Sciences, Celerion |
| 10:10 | Q&A / Discussion |
| 10:30 | Networking |
| 11:00 | End of Good Morning Meeting |
Sessions
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Aernout van Haarst, Ph.D., Director, Scientific Affairs, Celerion Aernout is Director, Scientific Affairs at Celerion. In this key leadership position, Aernout provides scientific, operational and regulatory support for early phase clinical studies. Aernout van Haarst is a subject matter expert in Celerion’s respiratory research team and works closely with external experts in the field of pulmonology to support drug development programs of Celerion’s clients. Aernout joined Celerion in 2015 and has over 25 years of drug development experience at biotechnology companies and CROs. He received his PhD from the School of Medicine at Leiden University and is qualified as a Clinical Pharmacologist in The Netherlands. |
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Staci McDonald, PharmD, Vice President of Global Scientific Clinical Operations, Celerion Staci has a diverse work experience in the clinical research industry, starting her career in 2001 as a Clinical Research Pharmacist at MDS Pharma Services. From 2001 to 2007, Staci worked in various scientific affairs and operational resource management roles at MDS Pharma Services. In 2008, Staci became the Director of Operational Resource Management, a position she held until 2010 when she was promoted to Senior Director of Scientific Clinical Operations. In 2012, Staci became the Executive Director of Scientific Clinical Operations at Celerion. Currently, Staci holds the position of Vice President of Global Scientific Clinical Operations at Celerion, a position they have held since April 2022. Staci McDonald completed her undergraduate education at Nebraska Wesleyan University, where they earned a Bachelor of Science (BS) degree in Biology and Chemistry. Following this, she pursued further studies at the University of Nebraska Medical Center from 1997 to 2001, obtaining a Doctor of Pharmacy (PharmD) degree with a focus on Pharmacy. |
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Chad Briscoe, Ph.D., Executive Vice President, Global Bioanalytical Sciences, Celerion As Executive Vice President of Global Bioanalytical Sciences, Dr. Briscoe leads one of the preeminent and oldest bioanalytical groups in the industry. In this role he is responsible for the bioanalytical groups in Lincoln, NE and Zurich, Switzerland. These groups offer exceptional expertise in both small and large molecule bioanalysis in highly automated and compliant laboratories. Dr. Briscoe has over 25 years of experience in the CRO industry. He has held leadership positions at various CROs including VP Operations, Chief Scientific Officer and VP of Business Development. Dr. Briscoe has in-depth knowledge of both large and small molecule bioanalysis, DMPK, regulatory strategies, and GLP/GCP regulations as they apply to Bioanalysis. He is a highly respected thought leader in the Bioanalytical Industry with over 90 industry publications and presentations. He has held voluntary leadership roles in such esteemed organizations as the Global Bioanalysis Consortium and within the AAPS Bioanalytical Community. Dr. Briscoe earned his doctorate in chemistry from the University of Nebraska and additionally has a Master’s degree in Chemistry from the University of Michigan and Bachelors of Science degree from Alma college. |
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