Flexible GMP manufacturing meeting the needs of adaptive, pharmacology-guided designs
How will you reach your early clinical milestones in 2020? Companies today are looking for ways to accelerate their drug development programs. How do you do that under such tight timelines? PRA Health Sciences works across the US and Europe to provide effective tools to help meet these timelines.
To advance your drug into first-in-human (FIH) clinical trials, you must invest carefully in drug substance, which can be in scarce supply. It is important to integrate formulation development and adaptive GMP manufacturing with clinical research.
In this webinar, you will learn how having the right flexibility with drug formulation can help you accelerate your program. PRA has been manufacturing investigational medicinal products (IMPs) in early clinical trials for more than 15 years as this trend has evolved.
Understanding the dose selection process is key in drug development. The dose escalation scheme in first-in-human studies is often of traditional design, with fixed cohort sizes throughout the escalation scheme. PRA is currently exploring a pharmacology-guided rule-based adaptive dose escalation design that aims at making ‘best use’ of healthy subjects participating in early clinical programs.
This session will cover the following:
- CMC within Early Clinical Development
- How identifying and selecting key formulation can help in choosing the right dose levels
- The audience will be updated on prospective testing of the adaptive dose escalation design, to further justify this method in future first-in-human studies, to make ‘best use’ of our trial subjects
- The benefits of using a CRO with integrated CMO services
- Various approaches to achieving the targeted Phamacokinetic profile
- How to optimize dose levels quickly during SAD/MAD trials
- Regulatory environment and its challenges
Arjen Akkerman, Senior Manager, CMC QP, PRA Health Sciences
Arjen Akkerman graduated as a Registered Pharmacist in 2002 at the School of Pharmacy, Groningen University, The Netherlands. Akkerman is Qualified Person and Radiation Officer at PRA’s Early Development Services in The Netherlands, and heads the GMP-grade pharmacy in our Clinical Pharmacology Center. In 2003, he joined PRA’s Early Development Services as a QP for a GMP-compliant production pharmacy, where (radiolabeled) investigational medicinal products (IMPs) are manufactured for use in early phase clinical trials. In his current position, he also acts as external consulting advisor for issues concerning manufacturing and GMP during early drug development.Message Presenter
Ewoud-Jan van Hoogdalem, PharmD, PhD, Vice President, Scientific Affairs – Clinical Pharmacology, PRA Health Sciences
Ewoud-Jan van Hoogdalem has expertise in drug development with three decades of experience in large pharma companies and small biotech. In his reality-based approach to drug development, he connects business case, the best in current science and standards, as well as stakeholder expectations. In 2013, van Hoogdalem joined PRA International as VP Scientific Affairs – Clinical Pharmacology, leading an international expert team that supports PRA clients in maximizing the success rate of their early clinical programs. In 2009, he established Clinical Reach Drug Development by an independent advisory firm delivering focused, strategic drug development expertise. He was Chief Medical Officer of OctoPlus (Leiden, NL; 2006 – 2009) and oversaw the company’s clinical development portfolio.
At Johnson & Johnson (2000 – 2006), van Hoogdalem designed and executed clinical proof-of-concept programs in different therapeutic areas. At Yamanouchi Europe (Leiderdorp, NL), he was European project leader in urology, CNS and GI (1998-2000). He headed the Yamanouchi Europe Bioanalysis & Drug Metabolism department (1994 – 1998) and was scientist in bioanalysis and pharmacokinetics at Brocades Pharma B.V. (Delft, The Netherlands; 1989 – 1994). van Hoogdalem is a board certified clinical pharmacologist and licensed pharmacist who earned his PhD degree from Leiden University. He is a member of various professional organizations and has authored and co-authored over 30 publications in peer-reviewed journals or book chapters.Message Presenter
Who Should Attend?
- Regulatory Affairs
- Drug Safety/Pharmacovigilance
- Risk Management
- Project Management
- Clinical Research
- Medical Affairs
- Clinical Affairs
- Research and Development
- Clinical Pharmacology
- Clinical Operations
- Project Management
PRA Health Sciences
PRA Health Sciences is a full-service, drug development organization, providing a broad range of product development and data solution services across all phases and a wide array of therapeutic areas to biopharmaceutical companies. PRA operates in 85+ countries, with over 15,800 employees worldwide. PRA’s Real World Solutions team works exclusively in the real world research arena. Our real world evidence studies connect the companies that design and market revolutionary therapies with the patients who benefit from them and our teams innovate ways to capture, analyze and qualify product performance — and patient experience — in the real world.