January 30-31, 2018
San Diego, CA

Speakers

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Agnes Ang
Principal Scientist
Amgen

Agnes Ang is a Principal Scientist at Amgen Inc. She has been with the company for over 9 years working in Translational Sciences, specifically in Clinical Biomarker and Diagnostics where she supports the development and execution of the clinical biomarker strategy for early and late stage oncology programs as well as marketed products. She holds a Ph.D. in Cell Biology from Yale University and a B.A. in Biology from the University of Chicago.

Day Two

Wednesday, January 31, 2018

09.25 | Analysis of RAS Mutational Status by ctDNA and Clinical Outcomes for Patients with Metastatic Colorectal Cancer Treated with Panitumumab

11.40 | Session Q&A

Dave Hoon
Director, Department of Molecular Oncology
John Wayne Cancer Institute

Dave S.B. Hoon, Professor and Director of Dept. of Molecular Oncology, and Chief of Scientific Intelligence at the John Wayne Cancer Institute, interacts with external academic, industry, government agencies, and international cancer centers to develop innovative translational cancer research opportunities. He has over 30 patents on his studies and has co-authored over 300 peer-reviewed articles and reviews, primarily related to translational molecular oncology of human solid tumors. As founding Director of the Department of Molecular Oncology, Dr. Hoon continues to pioneer investigations of RNA/genomic/epigenomic biomarkers for diagnostic, prognostic and predictive assessment of residual tumor cells. Dr. Hoon pioneered investigations of CTC and circulating cell-free DNA/miRNA biomarkers for monitoring cancer in patients enrolled in phase II/III clinical trials. Since early 1990’s Dr. Hoon’s team has developed molecular biomarkers for molecular staging of sentinel lymph nodes and classification of human solid tumors including CRC, melanoma and breast cancer. In the last decade he and his team have developed programs for assessment of epigenetic regulatory pathways of aggressive breast cancers (TNBC). On the therapeutic front, Dr. Hoon is examining functional epigenomic drugs for treatment approaches for solid tumor cancers. Dr. Hoon has trained over 70 fellows and a dozen graduate students.

Day One

Tuesday, January 30, 2018

14.40 | Session Q&A

12.00 | Evaluating the Evolving Use of Circulating Tumor Cells for Liquid Biopsy

Hatim Husain
Assistant Professor of Medicine
UCSD Moores Cancer Center

Day Two

Wednesday, January 31, 2018

11.15 | Why Molecular Diagnostic Testing is Important in Lung Cancer

11.40 | Session Q&A

Chris Jones
Strategic Alliance Lead
Horizon Diagnostics

Chris has over 15 years’ experience working in life science and biotechnology sectors, with in-depth knowledge of DNA sequencing, qPCR, medical device and diagnostic solutions. Horizon's portfolio of products includes a range of genetically defined, human genomic Reference Standards for qPCR, Sanger Sequencing, and Next Gen Sequencing applications.

Day One

Tuesday, January 30, 2018

16.10 | Product Development Updates for Liquid Biopsy Reference Standards

Gary Kelloff
Special Advisor
NIH

Gary J. Kelloff, MD has had over 40 years in cancer research at the National Cancer Institute (NCI), authoring more than 400 publications. Dr. Kelloff is a graduate of the University of Colorado (BS and MD degrees). After post-graduate training in medicine at Emory University, he began his NCI career as an intramural scientist and section head in viral immunology working on retroviruses and oncogenes. After fifteen years in NCI’s intramural program he moved to what is now the Division of Cancer Prevention (DCP), where he developed a basic science, translational research, and clinical development program in chemoprevention. Since 2001, he has been a special advisor for the NCI Division of Cancer Treatment and Diagnosis working on strategies for developing imaging-based and clinical biomarkers for oncology drug development and cancer patient management. He previously led and currently leads several collaborations with FDA and the pharmaceutical industry on drug development strategies and co-chairs on-going efforts under NCI/FDA Intra-agency Oncology Task Force (IOTF) and the Foundation for the National Institutes for Health Biomarkers Consortium (BC) to define biomarker use in cancer drug development and patient management. Past work has included establishment of a developmental pathway for approval of cancer prevention drugs as part of an AACR initiative and evaluation of tumor burden markers (PSA-doubling time prostate cancer, Ca-125 in ovary) and precancerous histopathology (colorectal adenomas) as part of a C-Change initiative. Current efforts under the NCI/FDA IOTF and BC include consideration of functional and molecular imaging (FDG-PET/CT, DCE-MRI, volumetric CT, molecular probes) and new technologies for measuring circulating tumor cells, minimal residual disease, novel trial designs for evaluating prognostic and predictive biomarkers, molecular signatures and new drugs, including gene expression and proteomic biomarkers. All this work has involved collaboration with leaders in industry, academia, and the pharmaceutical industry and has resulted in many publications addressing specific biomarkers and general drug development strategies.

Day One

Tuesday, January 30, 2018

09.50 | Session Q&A

09.00 | The Liquid Biopsy State of Play: From Prognostic to Predictive

Fred Kramer
Professor of Microbiology, Biochemistry & Molecular Genetics
Rutgers University

Fred Russell Kramer is Professor of Microbiology, Biochemistry and Molecular Genetics at the Public Health Research Institute of the New Jersey Medical School of Rutgers University.  He graduated from the University of Michigan in 1964 and received his doctorate from the Rockefeller University in 1969.  He was on the faculty of the Department of Genetics and Development at the Columbia University College of Physicians and Surgeons for 17 years, and was a Research Professor in the Department of Microbiology at New York University School of Medicine for 27 years.  He is the co-recipient, along with Sanjay Tyagi, of the 2005 Jacob Heskel Gabbay Award in Biotechnology and Medicine.

Day One

Tuesday, January 30, 2018

16.45 | Session Q&A

16.20 | Super Selective Primers for Multiplex Real-time PCR Assays that Assess the Abundance of Rare Mutations Associated with Cancer

Razelle Kurzrock
Chief, Division of Hematology & Oncology, Director, Center for Personalized
Cancer Therapy & Clinical Trials Office, UCSD

Dr. Razelle Kurzrock is known for developing one of the largest and best phase 1 clinical trials programs in the nation while at the University of Texas MD Anderson Cancer Center. A central theme of that program was the personalized medicine strategy, embodied in a protocol called PREDICT (Profile-Related Evidence Determining Individualized Cancer Therapy). This approach utilized advanced molecular technologies to match patients with targeted cancer treatment that optimized chances for response. At Moores Cancer Center at UC San Diego Health, Dr. Kurzrock’s charge is broad, including not just growing and innovating the Center’s clinical trials program, but also heading its newly established Center for Personalized Cancer Therapy. As a physician-scientist, she brings extraordinary expertise and experience in clinical research, business operations, regulatory operations, financial and budget planning, and administrative oversight, in addition to her world-recognized work in translational science. Dr. Kurzrock is also Chief of the Hematology & Oncology Division in the UC San Diego School of Medicine. Dr. Kurzrock received her MD from the University of Toronto and has about 450 peer-reviewed publications and a uniquely strong record of competitive grant funding within the setting of phase I program building. She has been the principal investigator of the National Cancer Institute U01 Phase I Studies of Targeted Anti-Cancer Agents.

Day Two

Wednesday, January 31, 2018

11.40 | Session Q&A

08.30 | Utilizing ctDNA to Predict and Inform Response to Immune Targeted Therapeutics

Julie Lang
Associate Professor of Surgery
Keck School of Medicine, USC, speaking on behalf of ANGLE plc

Dr. Lang is an Associate Professor of Surgery at the Keck School of Medicine of the University of Southern California (USC). She is the Director of the Breast Cancer Research Program at USC. She earned her medical degree from the University of North Carolina, Chapel Hill. She then went on to complete a Surgery residency and a postdoctoral research fellowship in breast cancer research at the University of California, San Francisco. She completed her breast surgical oncology fellowship at the UT-MD Anderson Cancer Center in 2007. She served as the Director of Breast Surgical Oncology at the Arizona Cancer Center for 5 years, then joined the faculty of USC in 2012. Dr. Lang is an expert in the field of breast surgical oncology, with strong expertise in both clinical care and research in the field of breast cancer.  Her research focuses on clinical trials as well as translational research on the topic of utilizing circulating tumor cells as predictive biomarkers in breast cancer. The Lang laboratory focuses on incorporating translational genomics and biomarker driven research strategies to improve outcomes for breast cancer patients.  

Day One

Tuesday, January 30, 2018

08.30 | The Whole Transcriptional Landscape of Circulating Tumor Cells Compared to Metastases in Stage IV Breast Cancer

09.50 | Session Q&A

Kim Langone
Senior Director, Product Sciences
Genomic Health

Kim is Senior Director, Product Sciences at Genomic Health Inc. She has been with the company for over 16 years, during which time she was involved in the development and validation of Oncotype DX® gene expression tests for Breast Cancer (Breast Recurrence Score), Colon Cancer (Colon Recurrence Score) and Prostate Cancer (Genomic Prostate Score). More recently, she led the development of Oncotype SEQ® Liquid Select™, the first liquid and NGS-based product offering from Genomic Health. Kim was instrumental in developing the various platforms for these pioneering tests, leading both analytical and clinical validation studies and transitioning them from Development to the CLIA certified laboratory. Kim therefore has a wealth of experience in what it takes to develop accurate, reliable and clinically actionable molecular diagnostic assays. Kim has been part of the Technical Application Group for The Blood Profiling Atlas in Cancer (Blood PAC) Consortium since 2016, as part of Biden’s Cancer Moonshot Initiative. Prior to joining Genomic Health, Kim studied the role of mitochondrial DNA dimers in cancer at Stanford University. Kim received her B.Sc. in Genetics and Ph.D. in Mitochondrial Genetics at the University of Newcastle Upon Tyne, England.

Day One

Tuesday, January 30, 2018

16.45 | Session Q&A

Alexander Lazar
Professor, Department of Pathology, Division of Pathology/Lab Medicine
MD Anderson

Day One

Tuesday, January 30, 2018

17.35 | End of Day One

08.20 | Chairs’ Opening Remarks

Lauren Leiman
Executive Director
BloodPAC

Day One

Tuesday, January 30, 2018

16.45 | Session Q&A

Philip Mack
Director of Molecular Pharmacology
UC Davis

Day One

Tuesday, January 30, 2018

14.40 | Session Q&A

11.20 | Analyzing the Clinical Impact of ctDNA Based Testing

G. Mike Makrigiorgos
Professor & Director, Medical Physics & Biophysics Division, Radiation
Oncology, Dana Farber Cancer Institute & Harvard Medical School

Dr. Makrigiorgos is a Professor of Radiation Oncology and Director of the Medical Physics & Biophysics division at Dana Farber Cancer Institute and Brigham and Women’s Hospitals, Harvard Medical School.  He also directs the DNA technology laboratory and the radiation pre-clinical facility. His research interests include the development of novel DNA technologies for molecular diagnostics in Oncology and he identification of circulating cancer biomarkers.  He is the inventor of several PCR-based techniques for molecular diagnostics, including COLD-PCR and NaME-PrO technologies.  He is a Member of the Editorial Board of Clinical Chemistry and has published over 150 articles, reviews and book chapters.

Day One

Tuesday, January 30, 2018

16.45 | Session Q&A

15.45 | Improving Sensitivity and Accuracy While Reducing Cost: HRM Enables Rapid Mutation Assessment Prior to Targeted Re-Sequencing

Jean-Francois Martini
Senior Director, IO,EDTO
Pfizer

Jean-Francois Martini has over 16 years of biotech and pharma industry experience in pharmacology and translational sciences; he is currently Sr. Director, Translational Oncology, Global Product Development-Oncology and has been at Pfizer, in La Jolla, California, since December 2011. He was previously Sr. Director, Translational Medicine, at Exelixis, South San Francisco, California. He completed his postdoctoral training at University of California, San Francisco where he studied the antiangiogenic properties of fragments of Prolactin and Growth Hormone, after obtaining a PhD in Biochemistry and Molecular Biology from University of Paris XI, France. At Pfizer, he currently leads and/or oversees the translational strategy for the Renal Cell Cancer franchise (sunitinib and axitinib); crizotinib, and lorlatinib in Lung Cancer; and palbociclib (Ibrance) in Breast Cancer and in other tumor types. He also leads the cross functional efforts in the area of liquid biopsy/cfDNA analysis

Day One

Tuesday, January 30, 2018

16.45 | Session Q&A

Morteza Minaee
Vice President, Regulatory Affairs
Guardant Health

Morteza Minaee has more than 25 years of experience in the FDA-regulated medical devices and global diagnostic industry leading regulatory, quality-systems, and clinical-affairs organizations. He is currently Vice President of Regulatory Affairs at Guardant Health in Red Wood City California. Prior to Guardant Health he served as Senior Director, Regulatory Affairs at Roche leading many FDA clearances in digital pathology applications including breast cancer biomarkers. He also held senior positions in Regulatory, Clinical Affairs, and Quality for companies such as Abbott Molecular and Siemens Healthcare. He holds a doctorate in law and policy from Northeastern University, and MS in administration from Boston University.

Day Two

Wednesday, January 31, 2018

13.25 | Regulatory Considerations for ctDNA as Biomarker Candidates Into Companion Diagnostics

14.10 | Session Q&A

Vishnu Mishra
Director, Diagnostics
Kura Oncology

 

Day Two

Wednesday, January 31, 2018

14.40 | Chairs’ Closing Remarks

08.20 | Chairs’ Opening Remarks

Irvin Modlin
Medical Consultant
Wren Laboratories

Irvin M. Modlin, MD, PhD, DSc, an expert in the area of Neuroendocrine Tumor (NET) disease, is the Medical Director of Wren Laboratories and is a Clinical Consultant to the testing laboratory. He is formerly the director of the Gastrointestinal Pathobiology Research Group and is now an Emeritus Professor at Yale University. Dr Modlin has studied Neuroendocrine Tumor (NET) disease for three decades, authored many of the seminal publications on the subject and has extensive global experience in novel therapeutic and diagnostic advances. His background also includes gastrointestinal surgery, endocrine surgery, endoscopy and gut hormone physiology. With over five hundred peer-reviewed publications and more than thirty years of experience working with neuroendocrine tumor and carcinoid patients, he has recently focused on the development and implementation of novel molecular testing protocols for these cancers.

Day One

Tuesday, January 30, 2018

11.45 | Multigene Blood mRNA Signatures for Diagnosis and Therapeutic Monitoring of Myeloma, Melanoma, Colon, Prostate, Neuroendocrine Gut and Lung tumors

14.40 | Session Q&A

Sandip Patel
Medical Oncologist & Assistant Professor of Medicine
UCSD

Sandip Patel, MD, is a board-certified medical oncologist who specializes in cancer immunotherapy and early phase clinical trials involving immunotherapy across all types of cancer. Dr. Patel is focused on developing personalized therapies that stimulate a patient’s immune system to attack their specific tumor. He believes in offering these promising immunotherapeutics across all tumor types. As an assistant professor in the Department of Medicine, Dr. Patel instructs medical students, residents and fellows. His research focuses on developing biomarkers for personalized immunotherapy to better determine which combination of therapies works best for each individual. Dr. Patel completed a fellowship in medical oncology and hematology at Duke University School of Medicine, Duke Medical Center, and a residency in internal medicine at UC Los Angeles School of Medicine, UCLA Medical Center. He earned his medical degree at Baylor College of Medicine, while performing research at MD Anderson Cancer Center. He is board-certified in internal medicine, medical oncology, and hematology.

Day Two

Wednesday, January 31, 2018

11.40 | Session Q&A

10.20 | Predictive Biomarkers for Immunotherapeutic Response in Cancer

Vicki Plaks
Scientist, Cancer Immunotherapy Drug Development
Genentech

Vicki holds the role of scientist in the Cancer Immunotherapy Drug Development team at Genentech, where she supports cancer immunotherapy drug development, designing, implementing and leading bioanalytical and circulating biomarker strategies and assay development. She previously held the position of Assistant Adjunct Professor at University of California, San Francisco, performing translational research on drug discovery and mechanism of action of targeted cancer immune therapeutics and biomarker investigation using small molecule inhibitors and biologics.

Day One

Tuesday, January 30, 2018

14.40 | Session Q&A

13.50 | Getting Closer to the Site of Action: Extracellular Vesicles as Biomarkers for Cancer Immunotherapy Drug Development

Lou Riceberg
Owner
BioBridge Strategies

Lou is the Owner of BioBridge Strategies, experts in how pharmaceutical, biotech, diagnostic, health informatics and health services companies can optimally develop and position their unique technologies or products for maximum clinical and economic impact. He previously held positions at Chiron Diagnostics and Ciba Corning Diagnostics. He gained his PhD in Biochemistry from Brandeis University in 1979.

Day Two

Wednesday, January 31, 2018

14.10 | Session Q&A

13.45 | Proving Value for Reimbursement: The Bottleneck to the Impact of Liquid Biopsies on Personalized Healthcare?

Howard Scher
Co-Chair, Center for Mechanism Based Therapy &
Head of the Biomarker Development Initiative, Memorial Sloan Kettering

Dr Scher is a board-certified medical oncologist with special expertise in treating men with advanced prostate cancer. He served as Chief of the Genitourinary Oncology Service at the Sidney Kimmel Center for Urologic and Prostate Cancers at Memorial Sloan Kettering for 25 years. The Genitourinary Oncology Service program is dedicated to the treatment of prostate cancer, testicular cancer, bladder and upper-tract urothelial cancer, and kidney cancer. Our objective is to foster synergy between scientific research and clinical practice, and to ensure that promising scientific discoveries are used to develop new diagnostic tests and treatments for patients.

Stefan Scherer
Vice President, Head Early Development, Strategy & Innovation
Novartis

Day One

Tuesday, January 30, 2018

09.50 | Session Q&A

09.25 | Harnessing Liquid Biopsy Testing for Precision Medicine Patient Selection

John Simmons
Director, Translational Sciences & Diagnostics
Personal Genome Diagnostics

 

Day Two

Wednesday, January 31, 2018

10.45 | ctDNA Solutions Across the Oncology Drug Development Continuum

11.40 | Session Q&A

Daniel Simon
Vice President, BioPharma Business Development
Guardant Health

Daniel Simon is responsible for building Guardant’s partnerships with pharmaceutical and biotechnology companies using the Digital Sequencing technology platform. Daniel brings diverse experience in the life sciences industry across business development, strategy, and operations. Previously, Daniel served in roles at MyoKardia, Onyx Pharmaceuticals, McKinsey & Company, and Genentech. He holds an MBA from the University of Pennsylvania's Wharton School and an MA Hons. in Natural Sciences from the University of Cambridge.  

Day Two

Wednesday, January 31, 2018

08.55 | Circulating Tumor DNA and Oncology Immunotherapy – The Next Frontier

11.40 | Session Q&A

John Stille
Senior Clinical Research Advisor
Eli Lilly

John holds the role of  Senior Clinical Research Advisor at Lilly, where he utilizes innovative clinical trial designs, simulations, biomarker strategy, and analyses in order to evaluate the clinical asset benefit-risk profile..  He has worked at Lilly since 1994, holding various positions including Head of Chemical Process Research and Development and Head of Natural Products Discovery. He gained his BA in Chemistry from the University of Colorado in 1981 before completing a PhD in Organic Chemistry at the California Institute of Technology in 1986.

Day One

Tuesday, January 30, 2018

14.40 | Session Q&A

13.25 | The Clinical Application of CXCR4 Expression on Tumor and Circulating Tumor Cells as a Potential Prognostic and Predictive Response Marker in Extensive-Disease Small Cell Lung Cancer

Jo Vandesompele
CSO
Biogazelle

Day One

Tuesday, January 30, 2018

14.15 | Exploiting Extracellular Body Fluid RNA for Precision Medicine Purposes

14.40 | Session Q&A