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2013 Archived Content

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 Featured Presentation

Analytical Strategies for Early IND Filings of PET Imaging Agents as Potential Companion Diagnostics

 Mei May ZhuMei May Zhu, Ph.D., Senior Scientist, Analytical Development-Biologics, Millennium: The Takeda Oncology Company

More and more biopharmaceutical companies have started in house efforts to establish drug-companion diagnostic co-development towards better personalized medicine. Imaging tools are one of the commonly explored diagnostic technical platforms and are particularly useful for hard-to-assess tissues such as tumor or brain.  This presentation will provide examples on CMC challenges and define analytical testing strategies supporting the early IND filing of positron emission tomography (PET) imaging agent drugs as potential companion diagnostics for cancer treatment.  


 

Developability Assessment in the Discovery-Development Handoff 

2:30 Developability Assessment from a Drug Product Perspective

Dingjiang LiuDingjiang (Dean) Liu, Ph.D., Associate Director, Formulation Development, Regeneron Pharmaceuticals, Inc.

Developability assessment has become an important part of candidate selection process for protein drug development.  During the assessment study, the critical properties of the drug candidates, such as stability, solubility and viscosity, are evaluated.  This ensures the risks associated with the selected candidate for bulk production, drug product manufacturing and drug delivery are understood and minimized. This presentation will focus on developability assessment of monoclonal antibody drug candidates from the perspectives of drug product development and delivery.  Three case studies will be presented to highlight the common issues observed during developability assessment.  An efficient harmonized approach in selecting the best molecule for clinical development and commercialization will be discussed.


  3:00 High-Throughput Screening for Selection of Candidates for Successful Technical Development  

Amitabha DebAmitabha 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 IyerVidyashankara 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