From Preclinical to Clinical: Essential Steps Toward First-In-Human Studies
Understanding the non-clinical development roadmap and overcoming key challenges
The road from concept to first-in-human trials is filled with complex decisions. Understanding how CMC, clinical, and non-clinical aspects connect is critical – but theory alone won’t get your product to the next stage. Hosted by our CMC, non-clinical and clinical experts at Venn Life Sciences we will look to help attendees find a clear way forward.
This hands-on workshop is designed to give you a clear overview of the road to First-In-Human (FIH) study and the interconnected roles of CMC, non-clinical, and clinical in drug development, with clear practical examples of challenges in preclinical development and the impact these have on the overall development.
You’ll leave with a clearer path forward, armed with the tools, insights, to navigate developmental hurdles. During the workshop there is ample opportunity to gain advice from our senior trainers and discuss with your peers.
Introductions (10 mins)
Theory (20 mins)
Overview of the road to First-In-Human (FIH) study
Practical Workshop Session (150 mins)
Using real world scenarios you will learn about important topics such as:
Interactive Discussion and Q&A (30 mins)
Tom Habraken - Consultant Clinical Pharmacokinetics
Tom studied Drug Innovation in Utrecht, with a focus on Pharmacology. He Joined Venn in 2019 as a clinical PK consultant and has been involved in clinical development since 2015.
Katsuhiro Mihara - Head of Clinical Development at Venn Life Sciences
Katsuhiro is the leader of the Clinical Development department at Venn Life Sciences, where he also oversees the business in the Netherlands. Joining Venn in 2016, Katsuhiro brings over 25 years of experience in preclinical and early clinical drug development from his leadership roles at Abbott, Merck Sharp & Dohme, Schering Plough, and Organon. His extensive experience spans oncology, immunology, dermatology, urology, gynaecology, and CNS, managing projects from early discovery to marketing. Katsuhiro's expertise includes conducting due diligence for drug development projects, focusing on risk assessments and regulatory evaluations at major milestones.
Arthur Noach – Senior Consultant / Non-Clinical Expert
Arthur Noach has over 25 years experience in pharmaceutical industry of which more than 23 years as a senior consultant for the non-clinical development of drug candidates, either small molecules or biologics and vaccines. His experience is in designing the package of non-clinical studies to be performed for starting clinical studies and beyond up to registration, based on OECD, ICH and FDA guidelines, as well as consulting on the set-up of the studies (protocols) and monitoring at contract labs where studies are actually performed. He has a vast experience in writing (non-clinical parts of) briefing books, Investigator Brochures and IND-modules (eCTD format). Furthermore, he is acting as consultant and principal investigator for pharmacokinetic and toxicokinetic studies, either as stand-alone studies or as part of toxicology studies, both non-GLP and GLP. He obtained a Msc in Pharmacy and a PhD in pharmacology/pharmacokinetics from Leiden University and a PharmD from Utrecht University.
André Wolterbeek - Head of Non-Clinical at Venn Life Sciences
André is a Senior Consultant in non-clinical development and leads the non-clinical department at Venn Life Sciences. He holds a PhD in Toxicology and brings over 25 years of CRO experience. André has served as a scientist, study director, and project leader, managing preclinical projects for the pharmaceutical, chemical, and food industries. His expertise includes conducting and evaluating preclinical IND-enabling studies and developing new methodologies. André is knowledgeable about OECD, ICH, and FDA guidelines and has contributed to drafting new or updated guidelines.
Erik Gout - Director and Senior Consultant of Chemistry, Manufacturing and Control
Erik has over 35 years of experience in the pharmaceutical industry. He has been involved in numerous drug development projects as analytical scientist, pharmaceutical development scientist, Quality Insurance engineer and CMC project leader. His experiences also include Technology Transfers, writing, reviewing, and approving regulatory CMC documents, GMP QA audits and due diligence of various projects.
Sara Armani - Head of Medical Affairs – Pharmacological Consultant at CRS Early Phase
Dr. Sara Armani, a board-certified clinical pharmacologist, leads our Medical Affairs division since February 2020. With over 20 years in the CRO industry, including at Parexel, she bridges Medical Affairs and Business Development. She specializes in clinical trial design, first-dose calculations, protocol development, and medical monitoring, and contributes to safety review meetings and data monitoring committees. Dr. Armani holds a Pharmacy degree from the Free University of Berlin, an MD, and a PhD from Charité University Medicine, along with board certification from the Berlin Physician Chamber.
