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Drug Delivery: BIOEQUIVALENCE in Inhaled Drugs, September 15-16, 2014, Hyatt Regency, Cambridge, MA

June 5, 2014 by 2012pharmaceutical

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
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
4:15PM		Novel PK/PD Modeling Approaches to Establishing IVIVC•John Crison, Research Fellow, BRISTOL-MYERS SQUIBB •Arijit Chakravarty, Director, Modeling & Simulation (DMPK), TAKEDA
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
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
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

http://www.exlpharma.com/event-agenda/5016?mkt_tok=3RkMMJWWfF9wsRonu63Kd%2B%2FhmjTEU5z16e8rWqGxiokz2EFye%2BLIHETpodcMTcRiNLrYDBceEJhqyQJxPr3EJdUN1NBvRhjlCQ%3D%3D

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