Short Courses

Monday, August 31, 2020   10:00 - 12:30 PM |

SC10: CAR T-Cell Therapy from A-Z

Detailed Agenda
This course will provide an overview of the history of the CAR T cell platform including early successes and failures. It will review learnings from the non-clinical and clinical evaluation of CAR T cells in hematologic malignancies and solid tumors. It will discuss challenges encountered with the current CAR T cell formats and approaches to address these challenges followed by discussion of the next generation CAR T cells including technical improvements and therapeutic opportunities.

Tara Arvedson, PhD, Executive Director, Oncology Research, Amgen, Inc.

INSTRUCTOR BIOGRAPHY:

Tara Arvedson, PhD, Executive Director, Oncology Research, Amgen, Inc.

Tara Arvedson, Executive Director in Oncology Research at Amgen, has led multiple T cell therapeutic programs and is currently responsible for a large portfolio of T cell therapeutic assets and platform strategy. She received her Ph.D. at Caltech and was later a Damon Runyon Cancer Research Fellow at UC San Diego.

Monday, August 31, 2020   1:00 - 3:30 PM |

SC15: Introduction to Gene Therapy Products Manufacturing and Analytics

Detailed Agenda

This short course introduces concepts that can be used to facilitate CMC development for gene therapy products.  The instructors will review regulatory guidance and present phase-appropriate control strategies. Several CMC challenges unique to this modality will also be discussed, along with different manufacturing platforms. The workshop will include an interactive session on developing an integrated control strategy.

Course Agenda:

  • Overview of Manufacturing for Gene Therapy Products and Parallels with Protein Therapeutics        
  • Analytical Development Strategies
  • Phase-Appropriate Control strategy
  • Regulatory Guidance and Expectations for Gene Therapy Products
  • Specific Challenges in Comparison to Protein Therapeutics
  • Potential for Leveraging Platforms and Benefits
  • Interactive workshop on developing a control strategy

Claire Davies, PhD, Associate Vice President, Bioanalytics, Sanofi

Scott Dooley, Scientist, Analytical Development, Sanofi

INSTRUCTOR BIOGRAPHIES:

Claire Davies, PhD, Associate Vice President, Bioanalytics, Sanofi

After obtaining her PhD from the University of London in 2001, Claire Davies performed her postdoctoral work at the William Harvey Research Institute (WHRI) at Bart’s and The London, Queen Mary's School of Medicine and Dentistry and Joslin Diabetes Center, Harvard Medical School, Boston. Over the last 18 years, Dr Davies has led analytical and CMC teams in product development and analytical method development and validation. Currently, Dr Davies leads Bioanalytics, a group responsible for developing methods and strategies to support process development, product characterization and release and stability testing for therapeutic proteins and gene therapy products in preclinical and clinical development.

Scott Dooley, Scientist, Analytical Development, Sanofi

After obtaining his master’s degree from the University of Massachusetts Amherst in 2013, Scott Dooley began working for the Analytical Development department at Sanofi. Over the past 7 years, Mr. Dooley has supported analytical method development and validation for enzyme-replacement therapies, antibodies, and gene therapy products. Currently, Mr. Dooley acts as the analytical team leader within CMC for two products in clinical development.






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