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
2012pharmaceutical
Amandeep Kaur
Aashir Awan, Phd
Abhisar Anand
Adina Hazan
Alan F. Kaul, PharmD., MS, MBA, FCCP
alexcrystal6
anamikasarkar
apreconasia
aviralvatsa
David Orchard-Webb, PhD
danutdaagmailcom
Demet Sag, Ph.D., CRA, GCP
Daniel Menzin
Dror Nir
dsmolyar
Ethan Coomber
evelinacohn
Gail S Thornton
Irina Robu
jayzmit48
jdpmd
jshertok
kellyperlman
Ed Kislauskis
komal23ingle
larryhbern
Madison Davis
marzankhan
megbaker58
ofermar2020
Dr. Pati
pkandala
Rosalind Codrington, PhD
ritusaxena
Rick Mandahl
sjwilliamspa
Srinivas Sriram
stuartlpbi
Dr. Sudipta Saha
tildabarliya
vaishnavee24
zraviv06
zs22
Leave a Reply