August 22-23, 2013
Cambridge Healthtech Institute’s Inaugural
Early IND Strategies: Analytical Development
Optimizing the Selection and Performance of Preclinical Analytical Studies
Day 1 | Day 2 | Short Courses | Download Brochure
Thursday,
August 22, 2013
1:55 pm Chairperson’s Remarks
Dingjiang (Dean) Liu, Ph.D., Fellow
Scientist, Formulation Development Regeneron Pharmaceuticals, Inc.
2:00 Keynote Presentation
Palani Palaniappan, Ph.D., Vice
President and Global Head, Biologics CMC, Takeda Pharmaceuticals
2:30 Developability Assessment from
a Drug Product Perspective
Dingjiang (Dean) Liu, Ph.D., Fellow
Scientist, Formulation Development, Regeneron Pharmaceuticals, Inc.
3:00 High-Throughput Screening for
Selection of Candidates for Successful Technical Development
Amitabha Deb, Ph.D., Fellow,
Integrated Biologics Profiling Group, Novartis Pharma
High-throughput strategies to
support candidate selection at preclinical stage will be discussed. During
profiling activities, the approach to guide candidate selection process focuses
on key characteristics of the molecule to assure stability, safety and efficacy.
To assure the selected molecule matches standard platform process,
‘compatibility with DS & DP Platform Processes’ is tested. Case studies
will be presented on mAbs and non-mAbs to elaborate further on molecular
profiling activities. It helps to identify resource-intensive molecules and
brings ‘process research’ to the area of early candidate development.
3:30 Refreshment Break in the
Exhibit Hall with Poster Viewing
4:15 Case Study: Comparative
Signature Diagrams as a Tool to Aid Comparability and Developability of Protein
Therapeutics
Vidyashankara Iyer, Ph.D.,
Scientist, Formulation Sciences, MedImmune
Combination products that contain
more than one protein (therapeutic proteins and vaccine antigens) can be
difficult to develop due to the possibility of protein-protein interactions.
Developability assessments of such products require tools to identify and
characterize such interactions efficiently. Comparative signature diagrams
(CSDs) are pictorial representations of statistically significant differences
between two data sets that fingerprint one molecule or a combination of
molecules. This presentation covers the concept of CSD and their uses in
comparability and developability of protein therapeutics and combination
products.
4:45 Analytical Support for a New
IND Submission
Xiaoyang Zheng, Ph.D., Staff
Scientist II, Genzyme (Sanofi)
Effective analytical support is
critical to the evaluation of safety, efficacy, purity, and product consistency
of a new therapeutic and the optimization of its process development. Examples
will be presented of the analytical characterization used to support IND
submissions for complex glycoprotein and protein conjugate candidate molecules.
This talk will focus on the strategies used to assess critical quality
attributes, as well as the use of characterization knowledge to optimize the
production process and better understand the degradation profile at an early
stage in development.
5:15 End of Day & Registration
for Dinner Short Courses
6:00 Dinner Short Courses*
*Separate registration required
Day 1 | Day 2 | Short Courses | Download Brochure