Learn from Venn experts who have helped dozens of innovators like you develop the right plan that helped them get funding and approval.
Sign up now to our Kickstart Workshop on building a Drug Development Plan: Don’t do too much but do it right
Join us for an afternoon of knowledge sharing, networking, and taking your drug development journey to new heights.
Date: 21 November 2023
Time: 12:30 PM – 6:00 PM
Location: Plus Ultra Leiden, Emmy Noetherweg 2, Leiden, Zuid-Holland, NL, 2333 BK
Katsuhiro Mihara, RPh, PhD is a registered pharmacist and with a PhD in pharmaceutical sciences from the University of Tokushima. He joined Venn in 2016 to lead the Clinical Development department and is currently also leading Venn’s business in the Netherlands.
Before joining Venn, he held leadership and senior scientist positions in clinical development and pharmacology at Abbott, Merck Sharp and Dohme, Schering Plough and Organon, giving him over 25 years of experience in preclinical/early clinical drug development in big pharma, biotech and provider alike.
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 drug development projects with primary focus on risk assessments including evaluation of regulatory documents at major milestones (e.g. pre-IND, End of Phase I/II meetings) for investors.
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.
Anneke Blom has over 20 years of experience in the pharmaceutical industry. She held positions at CMO’s and ‘big pharma’ in the field of drug product development, and here main expertise is sterile injectables. She has managed projects that included formulation and process development, analytical method development and validation, GMP manufacturing including batch record, deviation and change control handling. She has a Thorough understanding of early stage and late stage drug product development by Quality by Design approach including Quality Risk Management. In addition, she has good knowledge of GMP, ICH guidelines and regulatory requirements. She is currently senior consultant Chemistry Manufacturing and Control (CMC) and Head of CMC department.
Marijke Steenvoorde is an experienced GCP Quality Assurance Manager. She joined Venn in 2022 to lead the Quality Assurance department.
Before joining Venn, she held positions in Quality Assurance as an owner and consultant of her own company and at Astellas, giving her 20 years of experience in clinical drug development in pharma and provider alike.
She has been involved in numerous clinical drug development projects as a Global Quality Lead and as an Quality Assurance manager in multiple therapeutic areas, including, but not limited to, urology, dermatology, oncology and gynaecology from early discovery to marketing.
Her experiences also include implementation, improvement and maintenance of a Quality Management System and an audit database as well as management of an audit program and the organization, conduct, reporting and follow up of investigator site, vendor and internal audits as well as the preparation, hosting and follow up of regulatory inspections and the identification of deviations and CAPA follow up.
She's a member of RQA and DARQA and has been chair of DARQA for the last 7 years.