Biomarkers in IO: Challenges and Putative Benefits of Multi-omics Technologies

Theresa LaVallee, PhD, has more than 25 years of biopharmaceutical and research experience with a broad knowledge in the discovery and development of drugs. She has advanced diagnostics and drugs in oncology, immunology and inflammatory diseases from discovery through late state development. Prior to joining Coherus Biosciences as Chief Development Officer, she was Vice President, Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy (PICI).   Before PICI, Dr LaVallee held executive roles in drug development with Celldex Therapeutics and Kolltan Pharmaceuticals and was part of the team that built the immune-oncology (IO) portfolio at Medimmune/AstraZeneca working on the clinical development and regulatory packages for multiple checkpoint inhibitors and PD-L1 diagnostic. Dr LaVallee started her career at EntreMed and worked on the initial clinical development of thalidomide and thalidomide analogs. She has a depth of expertise in regulatory strategy to enable science driven development decisions and quality regulatory packages.   Dr LaVallee has spent most of her career working on advancing oncology drugs that can improve the survival and quality of life for cancer patients. She has been key in building successful teams, organizations and collaborations.She is author or co-author of more than 50 publications and abstracts. She received her PhD degree from University of California, Los Angeles and her BA degree from the University of California, Santa Barbara.

Jared Lunceford, Phd earned his BS and MS degrees in molecular biology from Brigham Young University and his PhD in statistics in 2001 from North Carolina State University.  He has worked in both late and early clinical development statistics groups while at Merck.  Since 2011 Dr Lunceford has served as the statistical lead for biomarker discovery and development for pembrolizumab, a cancer immunotherapy targeting the PD1/PD-L1 axis.  As Merck’s translational oncology program has grown, Dr Lunceford provides scientific oversight and strategic consultation to a set of statisticians working in translational oncology.  Dr Lunceford was the primary statistician involved in analyses for cut-off selection for the PD-L1 IHC based diagnostic device that led to the initial approvals of pembrolizumab for the treatment of NSCLC patients expressing high levels of PD-L1 on their tumors.  Dr Lunceford worked with a diverse set of researchers to provide some of the earliest evidence that T-cell inflammation was associated with propensity to respond to pembrolizumab with his modeling defining an 18-gene signature capturing key features defining this favorable immune profile.  Similarly, he was a part of the scientific team at Merck that established high tumor mutational burden as a biomarker of tumor response to pembrolizumab, and he supported both the drug and diagnostic device filings that led to the recent tumor agnostic approval for pembrolizumab in TMB-H tumors in the advanced setting where no other treatment options exist.  

Angel Augusto Rodriguez, MD is a board certified medical oncologist who specializes in breast medical oncology and conducted clinical research with circulating tumor DNA. Before joining Natera, Dr Rodriguez practiced at Austin Cancer Centers and Houston Methodist Cancer Center where he was Director of the Clinical Trials Office and the Triple Negative Breast Cancer Clinic.  While at Houston Methodist he was principal investigator of clinical trials and conducted clinical research with circulating tumor DNA.

Samik Upadhaya, PhD, is the assistant director of scientific affairs at the Cancer Research Institute. He is passionate about harnessing the full potential of scientific advances in cancer immunotherapy to help patients live better, longer lives. Together with the Anna-Maria Kellen Clinical Accelerator team, Dr Upadhaya leads the program’s scientific diligence efforts, including analyses of emerging trends and challenges in the global cancer immunotherapy landscape. He assists in the team’s collaborative ventures, clinical trial design, drug development plan, and maintenance of immuno-oncology landscape databases. Dr Upadhaya is also involved in all of CRI’s research programs, and closely follows the research done by CRI grantees, evaluating their potential contributions to the field as a whole.