From Preclinical to Clinical: Essential Steps Toward First-In-Human Studies Understanding the non-clinical development roadmap and overcoming key challenges

Practical Solutions For Complex Drug Development

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.

Key objective

This hands-on workshop is designed to give you a clear overview of the road to First-In-Human (FIH) study, with clear practical examples of challenges in non-clinical 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.

Agenda

Introductions (10 mins)

Theory (20 mins)

• Overview of the road to First-In-Human (FIH) study
• Learn the key milestones and common challenges in progressing to First-In-Human

Practical Workshop Session (150mins)

Using real world scenarios you will learn about important topics such as:

• Overall nonclinical development and transitioning to FIH entry
• How to deal with challenges- and making (the right!) choices in various aspects of non-clinical development,
• What to consider when setting a safe starting-dose for first-in-human trial

Interactive Discussion and Q&A (30mins)

 

Speaker: 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.

 

Speaker: 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.

 

Speaker: Arthur Noach – Senior Consultant / Non-Clinical Expert

Arthur Noach has over 30 years experience in pharmaceutical industry of which more than 25 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.

 

Speaker: 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.

Register for free using the link below.