2018 September Land O’ Lakes Recap

The fourth Land O’ Lakes Conference of 2018 wrapped up September 20th and was filled with productive discussions and varied topics in the drug metabolism and pharmacokinetics realm. The theme of the 21st Annual Drug Metabolism and Applied Pharmacokinetics conference was “New Opportunities for DMPK: The 21st Century Cures Act.” The Conference Program Coordinator was Eric Buxton, PhD, from the Division of Pharmacy Professional Development and the Co-Chairs were Robert Guttendorf, PhD, of Aclairo Pharmaceutical Development Group, Inc. and Gordon Loewen, PhD, of Neurocrine Biosciences. The conference began Monday September 17th with an opening reception sponsored by Charles River Lab, a dinner sponsored by Nuventra Pharma Sciences, and a presentation at the Fluno Center on the UW-Madison Campus.

Nancy Keller, PhD, from the Department of Medical Microbiology and Immunology at UW gave the David Hartman memorial presentation at the opening dinner, titled “Translating Biosynthetic Gene Clusters into Fungal Armor and Weaponry: A Source for Pharmaceutical Development.” She explained how gene clusters are used for obtaining compounds from fungi that can be used as medicines, antimicrobials and other useful compounds. She showed attendees that humans are more similar to fungi than we might imagine and how incredibly complex and helpful they are.

Tuesday morning began with the first plenary session on Mechanistic PK/PD. These talks focused on different types of modeling with PK/PD. The afternoon session on was on new regulatory considerations (New FDA/EMA Guidances). Mike Sinz, PhD, from Bristol-Myers Squibb gave a presentation titled, “In Vitro DDI Guidance: The In Vitro DDI Guidance Covering Inhibition and Induction.” He addressed changes in DDI guidance released in 2017 covering various mechanisms including reversible inhibition, irreversible inhibition and enzyme induction from basic models to clinical DDI studies. He also discussed enzyme induction changes in DDI guidance and differences between FDA, PMDA and EMA DDI guidance.

After a full day of presentations and discussions, the attendees went to a reception at the Pyle center sponsored by Corning. They enjoyed appetizers and networked with a view of Lake Mendota and the UW Campus.

The Fluno Center is a mere 2 blocks from the lake so on at least one of the nights many attendees made their way over to the Memorial Union Terrace on Lake Mendota.  The Terrace is a favorite lakeside biergarten-like spot on campus perfect for conversation with colleagues old and new.

The third plenary session on Special Topics in Metabolism occurred on Wednesday morning. Topics included metabolite profiles, identifying metabolites via NMR, and hepatic enzymes with liver targeted drug delivery. Angela Doran, PhD, from Pfizer presented “The Challenges of Reaction Phenotyping and Enzyme Identification: It’s Harder Than It Used to Be.” She discussed reasons why phenotyping is more difficult such as that PBPK modeling seeks a greater level of detail and resolution, phenotyping today requires a holistic approach with high level of sensitivity and specificity and the quantitative contribution of each enzyme involved in the total consumption of a parent drug. She described challenges with examples and the means for overcoming these challenges. These include choosing your methodology wisely, using certain reagents such as radiolabeling a parent drug and authentic metabolite standards. Dr. Doran also introduced a different tactical approach to consider: enzyme mapping and detailing.

The afternoon session theme was Microbiome Influences on Drug Disposition. Speakers discussed gut microbial metabolism, human microbiota and microbial impactors of human health. While still in early stages of exploration this area has the potential to play a much greater role in drug development in the future.

On Wednesday evening, attendees participated in another networking event: a poster session and reception featuring graduate research presentations sponsored by Eurofins Pharma Discovery Services. It was great to see what young scientist are bringing to the field. 

The conference wrapped up with the final plenary session on Thursday morning: Optimizing Translational Drug Development (Early Drug Development Preclinical-Clinical). Dean Knuth from Phase One Forward, LLC discussed “Considerations for the Use of Adaptive Trial Designs in Early Clinical Development.” He began with the emergence of early clinical adaptive designs before 21st Century Cures Act (21CCA) and discussed opportunities for adaptive design such as early-phase trials which may be the most favorable arena for adaptive designs and how simulation will play an important role in planning of adaptive trials. He went over FDA’s guidance on Adaptive Design Clinical Trials for Drugs and Biologics along with a few successful case studies.

As the conference concluded, attendees noted that they had many great networking opportunities and wonderful discussions with their colleagues. The thought-provoking presentations and engaged attendees made the conference a success. The Land O’ Lakes conferences are an ideal learning environment for sharing innovation and collaboration across the industry. Mark your calendars as next year’s conference will be held September 9-12 2019!

 

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