Drug Delivery: BIOEQUIVALENCE in Inhaled Drugs, September 15-16, 2014, Hyatt Regency, Cambridge, MA
Reporter: Aviva Lev-Ari, PhD, RN
http://www.exlpharma.com/event-home/5016
Bioequivalence Summit
Agenda
| MONDAY, SEPTEMBER 15, 2014: MAIN CONFERENCE DAY ONE | |||
| 8:00AM | Registration & Continental Breakfast | ||
| 8:45AM | Introduction from Chairperson | ||
| SCIENTIFIC BEST PRACTICE IN BIOEQUIVALENCE TEST DESIGN | |||
| 9:00AM | Adapting your Testing Methdos for NTI Drugs with High Dosage Units•Chandra Vattikonda, Executive Director, Biopharmaceutics, PAR PHARMA | ||
| 9:45AM | CASE STUDY: In Vivo Modeling and Simulation (IVMS) Approach for Establishing Bioequivalence•Jeffery Liu, Principal Clinical Investigator, Medical Affairs, GLAXOSMITHKLINE |
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| 10:30AM | Networking Refreshment Break | ||
| 11:00AM | Complication of Food in Bioequivalence Testing: Regulatory Requirements and Design Implications•Henry Wu, Director, Biopharmaceutics, MERCK | ||
| 11:45AM | Sample Size Adaptive Sequential Design for Bioequivalence Studies with Crossover Designs: An Optimized Approach•Diane Potvin, President, EXCELSUS STATISTICS | ||
| 12:30PM | Luncheon | ||
| 1:30PM | Feedback Loops between Patient Health and Drug Performance•Raimar Loebenberg, Chair, Division of Pharmaceutical Sciences, UNIVERSITY OF ALBERTA | ||
| 2:15PM | Biorelevant Approaches to In-Vitro Characterization•Magali Hickey, Director, Formulation Development, ALKERMES | ||
| 3:00PM | Networking Refreshment Break | ||
| 3:30PM | CASE STUDY: Determining when to use In Vitro Characterization versus Comparative Clinical Trials during Oncology Drug Development•Elizabeth Hewitt, Senior Scientist, Analytical Development, Small Molecules, TAKEDA |
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| 4:15PM | Novel PK/PD Modeling Approaches to Establishing IVIVC•John Crison, Research Fellow, BRISTOL-MYERS SQUIBB •Arijit Chakravarty, Director, Modeling & Simulation (DMPK), TAKEDA |
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| 5:00PM | End of Day One | ||
| TUESDAY, SEPTEMBER 16, 2014: MAIN CONFERENCE DAY TWO | |||
| 8:00AM | Continental Breakfast | ||
| 8:45AM | Recap of Day One from Chairperson | ||
| TESTING TACTICS FOR THE MOST CHALLENGING COMPOUNDS AND DELIVERY METHODS | |||
| 9:00AM | KEYNOTE – CASE STUDY – Inhalation Drug Delivery for Systemic Exposure: MannKind’s Experience with Inhaled Insulin•Robert Baughman, Senior VP, Clinical Sciences, MANNKIND CORPORATION | ||
| 9:45AM | Multi-Pronged Approaches towards Establishing Bioequivalence of Drugs with Paired Delivery Devices•Martin Oliver, Director, Branded Generics, VECTURA | ||
| 10:30AM | Networking Refreshment Break | ||
| 11:00AM | Approaches for Inhaled and Suspension Formulations that Avoid In-Vivo Bioequivalence•Guenther Hochhaus, Professor, Pharmaceutics, UNIVERSITY OF FLORIDA COLLEGE OF PHARMACY | ||
| 11:45AM | SPOTLIGHT: Drugs that are Unabsorbed in Local Activity in the GI Tract•Gary Buehler, VP, Regulatory Strategic Operations, TEVA •John Crison, Research Fellow, BRISTOL-MYERS SQUIB |
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| 12:30PM | Luncheon | ||
| 1:30PM | CASE STUDY: Biopharmaceutical Considerations, IVIVC, and Heat Effects in the Development of Generic Transdermal Delivery Systems•Audra Stinchcomb, CSO, ALLTRANZ |
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| 2:15PM | Unique Study Considerations for Intraoral Dosage Forms•Henry Wu, Director, Biopharmaceutics, MERCK | ||
| 3:00PM | Determining a Hierarchy of Parameters in Tests for Biosimilars•Shefali Kakar, Senior Director, Clinical Pharmacology, NOVARTIS | ||
| 3:45PM | End of Conference | ||
SOURCE
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Amandeep Kaur
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Adina Hazan
Alan F. Kaul, PharmD., MS, MBA, FCCP
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