The Oral Drug Delivery 2021 Conference is a 3-day event that will exhibit the most recent and cutting-edge findings on human physiology and drug development. Day 1 and Day 2 will host the 4th International Symposium on the BA/BE of oral drug products and their journey from API’s to marketed products. A series of speakers, panel discussions, and poster presentations will offer insight and information on formulation development, advancements in biopharmaceutical sciences, and future drug delivery technologies. Day 3 will be a celebratory workshop to honor the lifetime achievements of Professor Gordon L. Amidon. This event will reflect on the history of pharmaceutical sciences and the process of pioneering a vision for future drug delivery strategies.

Program details with speaker information

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Monday, December 16, 2019
Monday, December 16, 2019
  • Day 1 Schedule - Tuesday, July 27th, 2021 (Sessions 1 & 2)
    Breakfast / Opening Remarks (Yasuhiro Tsume, Merck, USA)
    8:00am - 9:00am
    Session 1 - How to design/optimize oral formulations based on API's properties
    9:00am - 11:30am
    Speaker Topic
    David Lyon (Lonza, OR, USA) Drug development and selection based on physicochemical properties of API
    Nair Rodriguez (University of Michigan, MI, USA) Co-Crystal, selection of API and co-formers and the improved API potential as an oral drug
    Kambayashi Atsushi (Astellas Pharma, Shizuoka, Japan) Formulation development and in vivo prediction
    Martin Kuentz (University of Applied Sciences and Arts Northwestern, Switzerland) Methodology of oral formulation selection in the pharmaceutical industry
    Panel discussion & Wrap up
    Lunch
    11:30am - 1:00pm
    Special Lecture-GI physiology (I)
    1:00pm - 1:45pm
    Speaker Topic
    W Weitschies (University of Greifswald) Knowing the GI physiology using MRI
    Session 2 How to evaluate/guarantee the quality of oral drug products
    2:00pm - 4:20pm
    Speaker Topic
    Marija Bogataj (University of Ljubljana, Slovenia) Biopredictive in vitro dissolution methods for enteric coated tablets/capsules/td>
    Marival Bermejo (Miguel Hernandez University, ES) Accuracy of Biowaiver for BCS Class 1 and Class 3 drugs, false positive or false negative?
    Hannah Batchelor (University of Birmingham, UK) Improving paediatric drug product performance
    Hiromu Kondo (University of Shizuoka, Japan) How to design and evaluate potential oral drug products based on drug absorption variance in different species
    Panel discussion & Wrap up (~20 minutes)
    Oral Presentations from selected poster sessions (10-12 min presentation and 3-5 min Q&A)
    4:30pm - 5:30pm
    Poster session (includes appetizers and non-alcoholic beverages)
    5:30pm - 6:30pm

     

  • Day 2 Schedule - Wednesday, July 28th, 2021 (Sessions 3 & 4)
    Breakfast
    8:00am - 9:00am
    Session 3 - Innovative concept/technology for oral drug development
    9:00am - 11:30am
    Speaker Topic
    Don Wetherhold (Aprecia Pharma, OH, USA) 3D printing in pharmaceutical development and manufacturing
    Hiroshi Kimura (Tokai University, Kanagawa, Japan) Human Organs-on-Chips for the design of oral drug products
    Stephen Buckley (Novo Nordisk, Denmerk) Oral drug delivery of peptide, Semaglutide, in human subjects
    Duxin Sun (University of Michigan, Michigan, USA) New drug delivery system/Nano particles
    Panel discussion & Wrap up
    Lunch
    11:30am - 1:00pm
    Special Lecture-GI physiology (II)
    1:15pm - 2:00pm
    Speaker Topic
    Gail Bornhorst (University of California, Davis) Understanding GI Function and the Role of Food in the Design of Oral Products
    Oral Presentations from selected posters (10-12 min presentation; 3-5 min Q&A)
    2:00pm - 2:30pm
    Session 4 - Future challenges for regulatory agencies and harmonization
    2:30pm - 4:50pm
    Speaker Topic
    Susana Almeida (European Generic Medicines Association, and ICH) Harmonization for drug development
    Ryosuke Kuribayashi, Ph.D (Office of Generic Product, PMDA, Japan) New guideline for BE test of Generic Product in Japan: comparison with FDA and EMA
    Yaning Wang (FDA, USA) How to receive drug approvals through 505(b)2 with PK bridging?
    Sally Choe (Office of Generic Product, FDA, USA) Next challenge of FDA to harmonize the guideline for generic drug products.
    Panel discussion & Wrap Up (~20 minutes)
    Closing remarks (Shinji Yamashita, Setunan University, Japan)
    Following Session 4
  • Day 3 Schedule - Thursday, July 29th, 2021 (Celebratory Workshop)
    Breakfast
    8:00am - 9:00am
    Opening Remarks (Lawrence Yu, PhD)
    9:00am - 9:15am
    Lessons from the Past (30 minutes each)
    9:15am - 10:15am
    Speaker
    Leslie Benet (University of California at San Francisco, USA)
    Yuichi Sugiyama (Riken, Japan)
    Lessons from Gordon Amidon (15 minutes each)
    10:15am - 12:30pm
    Speaker
    Peter Langguth
    Hans Lennernas
    Marival Bermejo
    Bertil Abrahamsson
    Jim Polli
    Ikumi Tamai
    Raimar Loebenberg
    Luca Marciani
    Elke Lipka
    Lunch
    12:30pm - 2:00pm
    Empowered Patients and New Technologies Shape the Future of Pharmaceutical Sciences (Panel Session with KOL Guest speaker)
    2:00pm - 3:30pm
    Speaker Topic
    Invited speaker / Duxin Sun response (Panelist: invited speaker, Duxin Sun, Lawrence Yu) Artificial Intelligence/Big Data and PK/Biopharm
    Invited speaker / Elke Lipka response (Panelist: invited speaker, Elke Lipka, Greg Amidon) 3D Printing and Microneedle Drug Delivery and Monitoring
    Final Lectures (30 minutes each)
    3:00pm - 4:30pm
    Speaker
    Greg Amidon (University of Michigan, USA)
    Gordon Amidon (University of Michigan, USA)
    Closing Remarks (James Dalton (University of Michigan, USA)
    4:30pm - 4:40pm
    Celebratory Party (Weber's Hotel, 3050 Jackson Avenue, Ann Arbor, MI 48103)
    6:00pm - 11:00pm