Due diligence is a critical step in securing investment and partnerships in drug development. This panel will explore essentials, common pitfalls, and strategies to prepare your startup for success.
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What You’ll Learn:
The essentials of technical due diligence and gap analysis
How due diligence fits into the venture capital investment flow
Best practices for data sharing and preparation
Real-world case studies and lessons from 80+ projects
Practical tips to avoid common pitfalls and build investor trust
Katsuhiro 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.
Erik has over 40 years of experience in the pharmaceutical industry. He has been involved in numerous drug development projects as an 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.
Arthur has over 30 years of 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.
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