Global summit highlighting oral drugs of the future

2023-10-25

Just a minute... Hans Lennernäs, Professor of Biopharmacy at Uppsala University, and Erik Sjögren, Associate Professor and Principal consultant at Pharmetheus, one half of Sweden's delegation at the international conference in Maryland (US) highlighting digital methods in the development of orally administered drugs.

Hans Lennernäs and Erik Sjögren
Hans Lennernäs and Erik Sjögren, Uppsala University and Pharmetheus

Who teamed up in Maryland?
Close to 300 participants from all over the world that discussed the development and application of computer programs to calculate important parameters – such as bioavailability and absorption – in the development of new drugs for oral use. The three day-meeting was initiated on behalf of the U.S. Food and Drug Administration (FDA) and the list of participants included several leading universities and pharmaceutical companies, regulatory authorities and a number of software developers.

How did the invitation find its way to Uppsala?
In part, due to our central role in the development of the Biopharmaceutics Classification System that is currently used by pharmaceutical companies, the WHO and regulatory authorities worldwide. And above all, that we - albeit in different ways - work actively with these issues. With the invitation came the opportunity for us in the Swedish delegation to give three presentations on site in Maryland.

What makes this an international prioritized issue?
Swallowing a drug is often most comfortable for the patient, but the complex and dynamic environment of the gastrointestinal tract, as well as the dense intestinal wall can pose major challenges in drug development. It is also required that manufacturers have a certain level of knowledge in these processes for their products. Carrying out in vivo studies in animals or humans is both difficult and resource demanding, so with well-functioning data models we can both simplify, speed up and lower the costs of developing and managing new drugs.

What did you come up with at the conference?
The meeting was an important opportunity to highlight current progress and opportunities, but also to identify the common limitations and challenges of our field. If we are to reach consensus on which methods hold the greatest potential – for example to calculate the release and absorption of potential drugs – physical forums for constructive conversations are necessary, of which this conference is an example.

So what happens next?
Currently, a number of scientific articles are being written based on what the meeting generated. The material will be published in 2024, but should primarily be seen as steps in a continuous process where the conference in Maryland is part of a series of meetings that is arranged every few years.

And what awaits at the rainbow’s end?
A lot. For example, it can streamline the development of new pharmaceutical preparations and increase the possibilities of new active drug substances, for example PROTACs, which possess enormous therapeutic potential but whose complexity means that with today's knowledge they cannot be given orally in effective ways. With high-quality data and validated models, the way would be open to reduce the need for certain bridging studies in both humans and animals.

FACTS

  • The conference Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives was held in Rockville, Maryland (USA) 29–31 August 2023.
  • The Swedish delegation included: Hans Lennernäs, Uppsala University • Anders Lindahl, The Swedish Medical Products Agency • Erik Sjögren, Uppsala University and Pharmetheus • Christer Tannergren, AstraZeneca
  • Hans Lennernäs' research in Translational drug development has a pharmacokinetic-pharmacodynamic focus on improving medical therapies (translating innovation for delivery to patients).
  • The performance of pharmaceutical products is optimized using various experimental models and clinical studies together with theoretical modeling and simulation.

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CONTACT

Hans LennernäsHans Lennernäs, Professor
Department of Pharmaceutical Biosciences
Hans.Lennernas@farmbio.uu.se

Erik SjögrenErik Sjögren, Principal consultant/Associate Prof.
Pharmetheus/Uppsala University
erik.sjogren@pharmetheus.com

text: Magnus Alsne, photo: Mikael Wallerstedt, Pharmetheus, Univ. of Maryland

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Last modified: 2022-11-08