Kurt Nielsen Ph.D., Chairman of the Catalent Applied Drug Delivery Institute and Senior Vice President of R&D at Catalent, shares founding philosophies, objectives achieved and future ambitions.
What’s the background to the Institute? We have a fundamental belief that the pharmaceutical industry should compete on the application of knowledge, not the existence of knowledge itself. By becoming an educator and disseminator of information, we believe we can help expand the industry’s toolkit and allow more drug delivery problems to be solved. We also felt that there was a connection missing between the drug development process and the patient. When a product is being developed, the focus tends to be firmly on clinical efficacy and safety. Making a drug product that is as easy as possible for the patient to take is not usually on the radar at such an early stage. We want to start the conversation about the needs of patients earlier, when the clinical protocols are being developed. In short, we don’t want drug delivery to be an afterthought in the development cycle. Finally, we want to be a connection point, bringing together industry, academia and the healthcare authorities to share information about new technologies and help move them into the toolkit as quickly as possible.
It’s a grand ambition – what are you doing to achieve it? We hold complimentary one-day symposia, organized around a specific drug delivery topic, such as bioavailability or controlled release, with invited speakers from academia and industry to start discussions. Past sessions have all attracted over 100 attendees, including everyone from vice presidents to principal scientists to graduate students. It’s an opportunity for scientists to learn, to network and to be exposed to new technologies. We have also formed working groups and consortia that bring companies and academics together to address key issues. In terms of patient advocacy, we just kicked off a project with the Lung Cancer Alliance to gather information from patients on their feelings about the current treatment regimens. We hope to discover ways of improving their experience.
Which initiatives are you most proud of? Our symposia have been a real success; fantastic collaborators, such as the Royal Society of Chemistry, and speakers made sure of that. There have been five so far, but more are planned (see “Delivering Events”). Participants have reported that the content was meaningful and provided a solid opportunity for learning. We have also used their feedback on their most significant delivery challenges as a guide to shape the content of future symposia, which will cover solubility issues, drug release profiles, stability of API and targeted delivery. Ninety five percent of participants believe that drug delivery technology solutions should be determined during pre-clinical and Phase I development. We’re also proud of progress made within the Non-invasive Macromolecule Delivery Consortium (NMDC). We’re very interested in how we can improve the adherence for these large-molecule injectable drugs. How do you make administration as easy and painless as possible, so that patients don’t see taking the drug as such a hurdle? There is real enthusiasm from our collaborators in the consortium, including founding co-sponsors Takeda Pharmaceuticals, Genentech, 3M and Allergan. The more we talk to each other the more we find that the challenges we face are very similar, so it makes sense to work together rather than solve the same problem five times at different companies. We now have working groups set up to address oral, pulmonary/nasal, transdermal and ocular delivery, and efforts are continuing to spread the word and get more and more organizations participating.
What are your plans for the future? We’re particularly enthusiastic about doing more on the education front, and about working to accelerate new technologies (see “Tech Incubator”). We’re also really excited about our work with the Lung Cancer Alliance. We want to see patients brought into the development process earlier, so that all the features that lead to maximum adherence can be included in the first generation product, rather than after commercialization. That can only happen when there is data on what patients need, so getting involved with that research is a logical next step for the Institute. For more information, visit www.drugdeliveryinstitute.com.
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