This focus group looks at the nonclinical and clinical applications of various technologies (bioanalytical, imaging, animal models, and cell-based systems) to help understand ADME properties of therapeutic proteins. The focus group looks at a broad range of therapeutic proteins from peptides to antibody-drug conjugates.
Despite an ever increasing number of therapeutic proteins (e.g. peptides, proteins, fusion-molecules, monoclonal antibodies, antibody-drug conjugates, oligonucleotides) under development, a thorough understanding of the ADME properties of these different types of proteins is still lacking, this may partly be due to the lack of analytical tools/techniques that are available. Therefore, if this area is to advance, there is a need for such a focus group to help facilitate a dialogue of information exchange between academic institutions, pharmaceutical companies, regulatory agencies and companied involved in developing new technologies. The focus group will support the membership by providing quarterly updates in this area through the use of a newsletter, and helping to ensuring that this topic is adequately represented at future AAPS annual and NBC meetings through the use of sunrise sessions, symposia, roundtables, short courses and workshops.
- Identify chairs for each working group and actively host meeting/telecoms in 2011.
- Increase membership of the focus group by 20 percent to achieve critical mass with good coverage from pharma, biotech, academia, regulators, and students.
- Develop educational materials for AAPS membership; submit one webinar proposal to cover relevant ADME topics in 2011.
- Distribute a Biotherapeutics ADME focus group newsletter twice a year.
- Increase networking and collaborations with other focus groups and external organizations.
Section affiliations: BIOTEC | CPTR | PPDM