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Navigating Highly Potent Drugs To Clinic: Best Practices From API To Drug Product

Developing and manufacturing highly potent drugs presents significant challenges but it also represents a major opportunity for biotech companies looking to bring new treatments to patients. However, handling these highly potent materials requires expertise, specific equipment and organizational and technical measures to ensure control occupational exposure and to avoid cross-contamination to ensure worker safety and patient safety. Navigating the journey of a highly potent drug from Active Pharmaceutical Ingredient (HPAPI) to a finished drug product can be complex and risky. This webinar aims to provide a comprehensive overview of the best practices applied at Ardena, offering pharmaceutical companies effective control strategies to ensure safe process development and manufacture.

Topics to be covered include: the regulatory framework for HPAPI handling, the assessment of occupational exposure limits, the selection of phase-appropriate manufacturing strategies for HPAPI and potent drugs with focus on effective handling and containment strategies to minimize the risk of exposure to personnel and cross contamination.

By attending this webinar, you will gain a comprehensive understanding of the key factors to consider when developing and manufacturing highly potent drugs, as well as the best practices to ensure their success. Whether you are a startup or an established biotech company, this webinar will provide you with the knowledge and skills you need to make informed decisions and take your highly potent drugs from the laboratory to the clinic.
Presenters

Rob Abbenhuis, PhD
​​​​​​​Chemistry Division Manager
Obtained a PhD in metal-mediated organic synthesis from Utrecht University in 1997 and started his industrial career in Process Development and Commercialization of small molecule API’s. Rob headed a chemical pilot plant and has been a Director Process R&D on Steroids & Heterocyclic molecules. After two years in Biotech (upstream and downstream processing), he worked for six years as Director Operations in a commercial sterile Fill & Finish plant. He joined Ardena in 2018, initially as Director Process R&D & Manufacturing and in 2020 he transitioned into the role of Business Unit Director of Ardena Oss. In July 2022 he was appointed CHEM Division Manager of Ardena. In his current role, Rob is responsible for Ardena’s drug substance activities at the sites in Oss (The Netherlands), Sodertalje (Sweden) and Pinki (Latvia). Rob brings experience in working with API’s in highly potent DS and DP facilities.  
 
Arno Vermote, PhD
​​​​​​​CMC Regulatory BD Manager
Graduated in Pharmaceutical Sciences and having obtained a PhD in medicinal chemistry, he started his career as a medical writer for a Belgian CRO. Later he joined Ardena as a CMC Writer and rapidly grew to Senior CMC Writer. His role was to provide regulatory advice to clients as well as to write regulatory documentation for new chemical entities in clinical studies. Next to providing assistance and support to clients, he also fulfilled a role in technical sales for the Ardena CMC Regulatory team. This technical sales role eventually culminated in a full-time business development function. Having a background in medicinal chemistry and being a pharmacist by training, Arno combines knowledge and expertise in both drug substance and drug product development.​​​​​​​

Ben Vermeulen, PhD
​​​​​​​Drug Product BD Manager
Graduated as a Bio-engineer cell-and gene biotechnology and having obtained a PhD in veterinary microbiology and immunobiology, he started his career as a technology developer for a Belgian/Australian small start-up biotech. Later he worked as an analyst for a private investor looking for new promising therapeutics in the oncology field. In 2016 Ben joined the Ardena Gent project management office first as a project officer and later as a Project Manager, where his main responsibilities were to guide Contract Givers through all stages of CMC drug development (formulation development, GMP manufacturing and analytical development/validation as well as clinical supply). In a next phase, Ben took up a role in the business development department where he evolved into a CMC technical sales role. In parallel to his other activities at Ardena Ben also took up the role of Safety Coordinator where he is responsible for all API safety-related matters. Having gained experience in multiple drug development domains  (Immunobiology, clinical, CMC and safety) Ben has acquired a broad expertise throughout a big portion of the drug development process, including working with HPAPIs.


Duration
60 min.

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