‘I really enjoyed brainstorming with the CHDR team’ — Dr Beate Rohde, Bayer
Dr Beate Rohde and her team at Bayer Research and Development approached CHDR to help with the clinical development of a promising immunomodulatory agent. In close consultation with CHDR’s Dermatology and Immunology groups, a study was conducted in healthy volunteers, yielding new insights into the compound. ‘The information we’ve gained from this study has even enabled us to explore development opportunities in other indication areas.’
‘What initially attracted me to CHDR was their experience with human challenge models for studying the innate immune response,’ says Rohde. ‘Once we started talking, I found I really enjoyed the discussions with Robert Rissmann, Matthijs Moerland and colleagues. We brainstormed together, trying to come up with the best approach to answer our questions. I was impressed by how solutions-oriented they were, and by the depth of their scientific expertise. So our initial idea for the study evolved into something much more advanced, ultimately yielding much more meaningful information.’
Challenge models
The team decided to study the immunomodulatory compound both topically and systemically, using CHDR’s topical imiquimod challenge and the systemic bacterial lipopolysaccharide (LPS) challenge. To complement this, imiquimod and LPS challenges were also applied ex vivo. Both imiquimod and LPS trigger the innate immune response, but through different pathways: imiquimod binds to toll-like receptors (TLR) 7 and 8, while LPS activates TLR4.
Rohde and her colleagues at Bayer also wanted to get an impression of their compound’s pharmacokinetics within the skin. After discussing the possibility of conducting invasive procedures such as microdialysis, the team decided it was preferable to use suction blisters. ‘A major reason not to use microdialysis was that we wanted to avoid an unnecessary burden on participants, as this was already quite a complex study,’ says Rohde. ‘While creating this innovative study design, the CHDR team always kept the study participants’ comfort in mind.’
A protocol was agreed upon and given the green light by the medical ethics committee. But then, the team hit an unexpected roadblock: there were difficulties obtaining LPS. Rohde: ‘CHDR handled this challenge very professionally and got things back on track as soon as possible.’ Once the results were analysed, Rohde and her team could benefit from new insights into their compound. ‘The results confirmed our expectations, which made us more confident about our plans for the compound. But we also gained a wealth of additional information, which opened up discussions about other possible indication areas.’
Constructive collaboration
‘I have more than 20 years of experience in this industry and I’ve worked with many contract research organisations, including ones that specialise in early phase studies. What I appreciate about CHDR is that they are really curious and really want to advance the field. That’s not just something they put on their website — it genuinely underpins the way they work. And while they have a strong research background, they also understand the constraints of the commercial context, with its budgets and timelines.
‘All in all, this was a very constructive collaboration. I’d like to congratulate Robert Rissmann on his grant award and the academic network that he has managed to build. With the vast and varied expertise that this network can offer, we look forward to more opportunities to collaborate with CHDR in the future.’
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