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Hurdles, caveats and recommendations for the drug development journey.

The workshop attracted scientists from acadaemic institutions and industry in the region. Source: BioRN

Heidelberg, 10.04.2019

The first Catalent Applied Drug Delivery Institute workshop co-hosted with BioRN, attracted a packed house of scientists from Heidelberg and the surrounding areas. An impressive line-up of speakers explained how the transition of molecule from discovery to clinic can be simplified and especially kept under control.

Established in 2012, the Catalent Institute employs a multi-tiered approach to accelerate the adoption of advanced drug delivery technologies to improve patient outcomes. Each year, the Institute partners with drug development and delivery experts around the world to bring free, informative seminars and training programs to the pharmaceutical industry, academia and regulators.

Last week’s workshop focused on key considerations for transitioning a molecule from discovery to phase 1 readiness including API and formulation development, pharmacokinetics, quality and CMC requirements, and incorporation of clinical supply services solutions to meet protocol, clinical site and patient needs.

Dr. Bernd Liepold (AbbVie) opened the workshop highlighting novel formulation approaches for poorly soluble drugs for oral administration. On the same line, Dr. Jan Neelissen (Catalent Pharma Solutions) explained how pharmacokinetic studies are essential to determine the developability of an oral drug. Dr. Rob Harris (Catalent Nottingham) closed the topic by underlining the importance of API characterisation in overcoming formulation challenges for drugs.

The afternoon session addressed other aspects in the drug development process, that are normally underestimated. Dr. David Elder (David P Elder Consultancy) demonstrated through his presentation how (quality) target product profile analysis should be integrated as early as possible in the process. Dr. Carsten Schmidt (Grünenthal), finally, analysed different potential strategies in optimising the alignment of the clinical supply chain to clinical trial design.

Beside the excellent presentations, the participants had extensive time to connect with Catalent representatives and peers from industry and academia. BioRN is very thankful to its industry member Catalent, for delivering such a high-quality and outstanding workshop.

About BioRN

BioRN is a life science research and industry cluster dedicated to the development of cell-specific, molecular and personalised innovative treatments. The BioRN Cluster stands for the development, networking, representation and promotion of the life science region into one of the leading life science clusters in Europe. The cluster-members include renowned academic research institutions such as the Universities of Heidelberg, the German Cancer Research Center (DKFZ) and the European Molecular Biology Laboratory (EMBL) and big pharmaceutical companies such as AbbVie, Boehringer Ingelheim, GSK, Johnson & Johnson, Merck, Roche, und Sanofi-Aventis, and about 80 small and medium-sized biotech enterprises. Beyond the members registered in the cluster, BioRN gives access to a wider network via partnerships and collaborations. In terms of the use of clusters for the internationalization of companies, BioRN has founded, together with Leuven (Belgium), Maastricht (Netherlands) and Copenhagen (Denmark), an alliance for the enforcement of biomedical innovation in Europe, called the Health Axis Europe.

About The Catalent Applied Drug Delivery Institute

The Catalent Applied Drug Delivery Institute was founded to serve as a link between industry and academia, advance education and training in drug delivery in academia and the industry, accelerate adoption of applied drug delivery technologies to develop better treatments, and foster industry collaboration on major issues pertaining to drug development, formulation, and delivery. It is pursuing a multi-tiered approach of research, strategic counsel, and educational programs to advance the adoption of emerging technologies. For more details on the Catalent Institute, visit and follow the Catalent Institute on Twitter: @DrugDeliveryIns.


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