SC1: Translating CTCs to Clinical Use

Sunday, March 6 | 2:00 – 5:00 pm

INSTRUCTORS:

Joshua M. Lang, M.D., MS, Assistant Professor of Medicine, Carbone Cancer Center, University of Wisconsin

Allison Welsh, Ph.D., CTC Scientist, Foundation Medicine, Inc.

Benjamin Casavant, Ph.D., Vice President, Tasso

DETAILED AGENDA:

2:00 Contexts of Use for Circulating Tumor Cell Biomarkers in Solid Tumors

Joshua M. Lang, M.D., MS, Assistant Professor of Medicine, Carbone Cancer Center, University of Wisconsin

This session will discuss the range of clinical opportunities in which circulating tumor cells can be employed. Specific attention to predictive and pharmacodynamic biomarkers will be discussed across a range of tumors and therapeutic interventions.

2:50 Challenges of Developing and Validating A Next-Generation Sequencing Assay For CTCs

Allison Welsh, Ph.D., CTC Scientist, Foundation Medicine, Inc.

This talk will describe challenges of isolating and genomically profiling circulating tumor cells (CTCs), highlighting multiple methods for CTC isolation (positive, negative selection) and their pros and cons in the context comprehensive genomic profiling. The presentation will describe development and validation of a research-grade assay used to characterize all classes of genomic alterations in CTCs and understand concordance with patient-matched primary tissue.

3:40 Refreshment Break

4:00 Translating CTCs from the Lab to the Clinic: Understanding the Balance Between Biomarker Validation and FDA Device Clearance

Benjamin Casavant, Ph.D., Vice President, Tasso

This talk will discuss the commercial and regulatory perspective of bringing a medical device from the lab to the clinic. The presentation will discuss important considerations for CTC technologies as they prepare for FDA clearance, as well as explore steps toward expanded validation of CTCs as a biomarker.

4:50 Q&A with Speakers

5:00 End of Course

INSTRUCTOR BIOGRAPHIES:

Joshua M. Lang, M.D., MS, Assistant Professor of Medicine, Carbone Cancer Center, University of Wisconsin

Dr. Lang is a medical oncologist specializing in the care of patients with genitourinary malignancies at the University of Wisconsin Carbone Cancer Center. His laboratory develops engineering tools that can be utilized in the development of predictive and pharmacodynamic biomarkers for patients with solid tumors. He has specific interest in immune based therapies and epigenetic modifying agents. He also serves as the principal investigator on multiple Phase I/Phase II therapeutic and biomarker clinical trials. His research is funded by the Prostate Cancer Foundation, NIH and the Department of Defense.

Allison Welsh, Ph.D., CTC Scientist, Foundation Medicine, Inc.

Alley is a scientist leading the CTC research and development efforts at Foundation Medicine in Cambridge, MA. She has been focused on CTC biology and NGS-based approaches since working as a Postdoctoral Fellow studying single-cell genomics in metastatic prostate and breast cancer at Memorial Sloan-Kettering Cancer Center and Cold Spring Harbor Laboratory between 2011-2013. Alley has had a longstanding interest in the development and validation of clinical assays, and originally obtained her Ph.D. in Pathology from Yale University, studying the role of Estrogen Receptor (ER) in breast cancer.

Benjamin Casavant, Ph.D., Vice President, Tasso

Dr. Ben Casavant is a biomedical engineer that is a co-founder and Vice President of Tasso, Inc., handling the day-to-day operations and engineering. He is dedicated to translating technologies from the lab to the clinic, working with translational medical devices. Ben finished his PhD at the University of Wisconsin - Madison in 2014, where his thesis work was with a device and assay for CTC evaluation with Dr. Lang and Dr. Dave Beebe. While at Tasso, Ben has been the PI of multiple DARPA and NIH grants and focuses on bringing their blood collection device through FDA clearance and into clinical use.