3 TOP CEO PICKS FROM MVIS 2018: The regulatory power of improved precision
A revelatory talk on inhaled drug assessment is one of ISAB CEO Lena Heffler’s Top Three picks from the 7th MVIC Symposium in Lund, Oct 3-4. It asked: what is the real reason a candidate drug fails approval in the early stages–a regulatory bottleneck, or a lack of precision?
135 inhalation professionals from 25 different countries gathered in Lund, Southern Sweden for the 7th Inhalation Symposium. It was organised by MVIC, the Medicon Valley Inhalation Consortium. The event has grown hugely since its first outing in 2012.
ISAB CEO Lena Heffler: “There was a fantastic mix of attendants, and so many excellent seminars! I met people from India, the US, UK, Germany—and many more. It shows how the MVIC Consortium has succeeded in uniting a growing number of inhalation companies into an effective umbrella organisation. The best incubator area we have for inhalation science here in Sweden right now is Medicon Valley. For all of us in inhalation, collaboration is the key to success.”
IVIVC remains a crucial priority
Hot topics at the event included inhalable biomolecules, the growing range of inhaler devices, and IVIVC, in-vitro in-vivo correlation: “Being able to understand and evaluate candidate drugs early on with dissolution tests, and then correlate that to in vivo results—for all pharma developers this will mean less risk, lower costs and more effective, accurate candidates early on,” says Lena Heffler.
DR. ANDERS FUGLSANG. Missing Approvals for Abridge Products in the EU + US: Why the Bottleneck is Not Regulatory
Former Clinical Assessor at the Norwegian Medicine Agency and now Expert Advisor to the WHO, Anders Fuglsang presented on how achieving precision data early in the drug development process. “Dr Fuglsang wrote the 2009 regulatory scheme still in use in Europe to evaluate inhaled drugs,” says Lena Heffler. “His message was that missing approvals are not because of a bureaucratic or regulatory bottleneck – but because the Deviations in findings are too large. There are still too many errors. Precision could be better.”
A key part of his presentation was on the need to reduce Error bars. “Technology which can pinpoint errors and systematically reduce them early-on are key to approval,” says Heffler. “With PreciseInhale that’s exactly what we do. PreciseInhale typically delivers smaller error bars, we are in control of aerosol and dispersal, and we can pinpoint and predict dispersal—bringing control, accuracy and IVIVC together.”
PROF. ROBERT PRICE, University of Bath: Developing Alternative In Vitro Approaches for Bioequivalence Testing of Orally Inhaled Drug Products
Also speaking on issues closely intersecting with IVIVC was Dr. Robert Price. His in vitro approach is currently being funded and developed for possible use by the FDA.
“Obviously any technology that is being funded by the FDA is of urgent interest to us all,” says Heffler. “But as Dr. Price himself pointed out during his talk, his approach is a QC test rather than an IVIVC technology. So whether it will aim to or achieve reliable early-on in-vitro in-vivo correlating results remains to be seen. But for all pharma professionals and future patients, improving quality control testing early on, to any degree, can only be good. It will be an interesting technology to see develop.”
PROF. BEN FORBES, King’s College London: Do we understand absorptive clearance of inhaled drugs in lung?
King’s College London is widely considered a leader in inhalation research. Prof. Ben Forbes leads the research team at the University’s Institute of Pharmaceutical Science. They use PreciseInhale to help maintain their position. This presentation elaborated on how much we know about the processes of absorption of inhaled drugs in the lung. PreciseInhale was mentioned as an important tool for aerosol generation.
“We’ve worked with the team at Kings since 2014, and like us they take a strong collaborative approach,” says Lena Heffler. “So it’s always good to look at such discussions and research and know your technology enabled it. But even more importantly it’s great to know that the team are still holding their position as leading innovators and authority—and that PreciseInhale is still an important and credited part of that.”
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