21 May 2012

 

The American Association of Pharmaceutical Scientists (AAPS) 2012 Conference scientific programming will feature 19 symposia, 17 roundtables and mini-symposia, 8 sunrise sessions, 3 short courses, 2 workshops, and 1 brand new Advanced Immunogenicity training course. More information

Intertek Participation:

Connect with the speakers on the Pavilion Walkway 12:00–1:00 PM
Immunogenicity Group

Dominique Gouty, Ph.D.
Intertek Pharmaceutical Services


Join conference symposia and roundtable speakers to share ideas, experiences, and pose questions about the speakers’ research and presentations. All attendees at the National Biotechnology Conference are invited to participate in this event. Bio Talk is an informal luncheon networking opportunity in the exhibit hall. Tables will be identified with the speaker’s topic. Share ideas about complementary technology, new business ideas, or simply pose questions to clarify the speakers’ presentation.



Hot Topic Interactive Session 4:15-5:45 PM
Recommendations/Requirements for Pharmacokinetic Bioanalytical Testing Used in Comparability Studies for Biosimilar Drug Development

Dominique Gouty, Ph.D.
Intertek Pharmaceutical Services



This Hot Topic interactive session will present a newly formed Biosimilars Action Program Committee (APC) that has been formed through the Ligand Binding Assay Bioanalytical focus group. The Biosimilars APC Lead will present the goals and objectives of the team, and speakers will set the stage for the discussion of issues surrounding the development, validation, and bioanalysis of pharmacokinetic and immunogenicity assays that support biosimilar drug development. Feedback will be solicited from participants that will be taken back to the team so that they can provide appropriate recommendations for the bioanalytical community and regulatory authorities.