Join us on June 27, 2023, at Kadans Plus Ultra Leiden for an exclusive, hands-on workshop: Roadmap To Early Clinical Entry: The Devil Is In The Detail.
Brought to you by Venn Life Sciences, part of hVIVO plc, Centre for Human Drug Research and Batavia Biosciences this workshop offers a comprehensive understanding of the drug development process and insights on creating a robust product development plan. The workshop includes real-world case studies and interactive sessions, featuring industry experts from Venn Life Sciences, CHDR, and Batavia Biosciences.
Katsuhiro Mihara is a registered pharmacist and PhD in pharmaceutical sciences with over 25 years of experience in preclinical/early clinical drug development in the pharmaceutical industry. He has been involved in numerous drug development projects as project leader, clinical trial manger and/or study director in multiple therapeutic areas, including, but not limited to, oncology, immunology, dermatology, urology, gynaecology and CNS from early discovery to marketing. His experiences also include due diligence of various projects with primary focus on evaluation of regulatory documents (e.g. pre-IND meeting minutes, End of Phase I/II meeting minutes) for investors. He is currently leading Venn Life Sciences business in the Netherlands.
LinkedIn: https://www.linkedin.com/in/katsuhiromihara/
Matthijs Moerland studied Biomedical Sciences and Molecular Sciences, and was trained at the department of Cell Biology at Erasmus University Rotterdam. He obtained his PhD investigating lipoprotein metabolism and atherogenesis in humanised animal models. He joined CHDR in 2007 as a Senior Clinical Scientist, and obtained his registration as clinical pharmacologist. Since 2014, Matthijs holds a positions as Research Director. He is leading CHDR’s in-house R&D lab, utilizing cell-based assays for monitoring of drug activity in clinical studies, and in mechanistic ex vivo studies on primary human cells. In addition, Matthijs is heading CHDR’s clinical immunoly research group, with as primary focus the development and application of in vivo immune challenge models (e.g. intravenous and intradermal endotoxin challenges, neoantigen vaccination, topical immune challenges), and cell-based methodology to monitor immune responses.
Linkedin: https://nl.linkedin.com/in/matthijs-moerland-ba619b17
Alfred Luitjens is Global Technical Sales Director at Batavia Biosciences. He has a profound background in development and production of vaccines and viral vectors, with more than 30 years of experience. He worked in R&D and GMP manufacturing at Solvay, DSM Biologics and Crucell (now J&J). He had a management position at the Animal Science Group and was senior manager process architecture at GSK.
LinkedIn: linkedin.com/in/alfred-
This workshop offers an unparalleled opportunity for biotech start-ups and scale-ups to learn from the best in the industry. You'll gain meaningful insights through a series of 3 interactive sessions, including real-world case studies.
Program
13:00 - Walk-In
13.30 - Opening and welcome
14:00 - Translation from preclinical to your first clinical trial, focusing on dose prediction in human - Venn Life Sciences
15:00 - Entry in to man – early proof-of-mechanism - CHDR
16:00 - Tech Transfer, Manufacturing & Scalability - Batavia Biosciences
17:00 - Networking and drinks on the terrace
Why Attend?
By attending this workshop, you will:
Finally, it is an excellent opportunity to network with like-minded professionals, share experiences, and foster collaborations. Take the first step towards developing your breakthrough biopharmaceutical product.
Register for this live event with your LinkedIn profile information.
Your path to success starts here!
