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AACR Genomics in Clinical Medicine Think TankJuly 13-14, 2016

Park Hyatt Washington1201 24th Street, NWWashington, DC, USA

AACR Genomics in Clinical Medicine Think Tank Leadership

José Baselga, MD, PhDPhysician-in-Chief and Chief Medical OfficerMemorial Sloan Kettering Cancer Center

José Baselga is the Physician-in-Chief and Chief Medical Officer at Memorial Sloan Kettering Cancer Center (MSKCC) and Professor of Medicine at Weil Cornell Medical College. His long standing research interests are in the development of targeted agents for the treatment of breast cancer and in studying strategies to overcome mechanisms of resistance, with 405 peer-reviewed publications to date. Prior to joining MSKCC, Dr. Baselga was Chief

of the Division of Hematology / Oncology and Associate Director at the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School. He was also the Chairman of Medical Oncology and Founding Director of the Vall d ‘Hebron Institute of Oncology in Barcelona, Spain. As the most recent former President of the American Association of Cancer Research (AACR), Dr. Baselga worked collaboratively with the AACR Board of Directors and the AACR membership to further the mission to cure cancer through research. He is an elected member of the National Academy of Medicine, the American Society of Clinical Investigation, the Association of American Physicians, and a Fellow of the AACR Academy. He is a past President of the European Society for Medical Oncology (ESMO), a past member of the Board of Directors for the American Society of Clinical Oncology (ASCO) and AACR, member of the Editorial Boards of Cancer Cell, Journal of Clinical Oncology, and Clinical Cancer Research and is the founding Editor-in-Chief for the AACR flagship journal, Cancer Discovery. Dr. Baselga received his MD and PhD degree from the Universidad Autonoma de Barcelona.

Susan M. Domchek, MDDirector, Basser Research CenterAbramson Cancer Center of University of Pennsylvania

Susan M. Domchek, MD is the Basser Professor in Oncology at the Perelman School of Medicine of the University of Pennsylvania. She serves as Executive Director of the Basser Center for BRCA1/2 at the Abramson

AACR Think Tank on Genomics in Clinical MedicineJuly 13-14, 2016 · Washington, DC

Cancer Center and Director of the Marianne and Robert MacDonald Women's Cancer Risk Evaluation Program, which focuses on genetic evaluation and medical management of individuals with inherited risk factors for cancer. She is a Senior Fellow at the Leonard Davis Institute of Health Economics. An elected member of the American Society of Clinical Investigation, Dr. Domchek is also a member of the American Society of Clinical Oncology for which she had served on a number of committees. A significant contributor to the oncology literature, she has authored/co-authored more than 200 articles appearing in scholarly journals including the New England Journal of Medicine, the Journal of the American Medical Association and the Journal of Clinical Oncology. Dr. Domchek also serves on a number of editorial review boards, including the Journal of Clinical Oncology.

Louis M. Staudt, MD, PhDDirectorNational Cancer Institute, National Institutes of Health


Levi A. Garraway, MD, PhDAssociate ProfessorDana-Farber Cancer Institute/Harvard Medical School

Dr. Levi Garraway is Associate Professor of Medicine in the Department of Medical Oncology at Dana-Farber Cancer Institute, Associate Professor at Harvard Medical School, and an Institute Member of the Broad Institute. He is the Director of the Joint Center for Cancer Precision Medicine at the Dana-Farber, Brigham and Women’s Hospital, and the Broad Institute, and co-Director of the Cancer Genetics Program at the Dana-Farber/Harvard Cancer Center. He received his AB in Biochemical Sciences from Harvard

College in 1990, and his MD and PhD degrees from Harvard Medical School in 1999. Dr. Garraway has made seminal research contributions in cancer genomics, drug resistance, and cancer precision medicine. He published multiple seminal studies of prostate cancer, melanoma, and other cancer types. This work has identified multiple new cancer genes and several fundamental mechanisms by which cancer may arise, and has guided precision medicine initiatives at many cancer centers worldwide. In 2015 he was named a Howard Hughes Medical Institute investigator in recognition of his scientific accomplishments. A recipient of numerous awards and honors, Dr. Garraway is immediate past President of the American Society for Clinical Investigation and was recently named by the National Cancer Institute (NCI) to a Blue Ribbon Panel of scientific experts, cancer leaders, and patient advocates to inform Vice President Joe Biden’s National Cancer Moonshot Initiative.

Dr. Staudt received his BA from Harvard College in 1976, graduating Cum Laude in Biochemistry. He was awarded a Medical Scientist Training Program fellowship at the University of Pennsylvania School of Medicine and received his MD and PhD degrees in 1982. His PhD thesis in the field of immunology, performed in the laboratory of Walter Gerhard, revealed somatic hypermutation as a mechanism of rapid antibody diversification during normal immune responses. Following Internal Medicine training, he joined Nobel Laureate David Baltimore’s laboratory at the Whitehead Institute as a Jane Coffin Childs Fellow. There he cloned and characterized the first tissue

specific transcription factor, Oct-2. He established his laboratory in the Metabolism Branch, National Cancer Institute (NCI) in 1988 and is currently Co-Chief of the NCI Lymphoid Malignancies Branch. He is also Director of the NCI Center for Cancer Genomics, which oversees several large-scale managed programs studying the genomic aberrations in cancer. In 2011, Dr. Staudt was given the honorary title of NIH Distinguished Investigator. Dr. Staudt serves on the Editorial Boards of Cancer Cell and the Journal of Experimental Medicine. He has received numerous awards for his research, including the 2009 Dameshek Prize from the American Society of Hematology for outstanding contribution in hematology and election to the National Academy of Sciences in 2013. Dr. Staudt’s laboratory uses genomics to improve the diagnosis and treatment of lymphomas.


American Association for Cancer Research

Margaret Foti, PhD, MD (hc)Chief Executive Officer, American Association for Cancer ResearchSecretary-Treasurer, AACR Foundation

Margaret Foti, PhD, MD (hc), is the chief executive officer of the American Association for Cancer Research (AACR), the first and largest cancer research organization in the world. Under her visionary leadership, membership has grown from about 3,000 members to 36,000 in 107 countries and the AACR’s portfolio of peer-reviewed scientific journals has increased from one to eight.

Foti progressed through several key management roles in scientific publishing to become chief executive officer. She joined the AACR as an editorial assistant for Cancer Research under the editorship of her first mentor, Michael B. Shimkin, MD. She was rapidly promoted to managing editor under the editorship of Sidney Weinhouse, PhD, and became the youngest managing editor of a major scientific journal in the country. Foti has since launched seven major peer-reviewed scientific journals: Cancer Epidemiology, Biomarkers & Prevention; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; Cancer Prevention Research; Cancer Discovery; and Cancer Immunology Research. She also helped launch Cancer Today, a magazine for cancer patients, survivors, and their families and caregivers.

Under Foti’s leadership, the AACR has served with distinction as the Scientific Partner of Stand Up To Cancer (SU2C). In this capacity, Foti and the AACR have brought expertise to their work with SU2C, especially in the scientific peer review of projects, scientific project management, and administration.

Foti’s leadership was instrumental in the production of the landmark AACR Cancer Progress Report 2011 and the equally impactful subsequent reports in 2012, 2013, 2014, and 2015, all of which celebrate the many ways that our members have made research count for cancer patients, with a focus on advances in the field.

Foti’s contributions have been widely recognized by numerous awards from organizations around the world. Most recently, she was recognized with the Ovarcome Excellence 2016 Award, the 2016 James Ewing Layperson’s Award from the Society of Surgical Oncology, and as a 2015 honoree of “the one hundred” by Massachusetts General Hospital Cancer Center. Additionally, she has received the 2015 Children’s Champion Award from the Children’s Hospital of Philadelphia, the 2014 Ellen V. Sigal Advocacy Leadership Award from Friends of Cancer Research, and the 2014 Morton M. Kligerman Visiting Professorship Award from the University of Pennsylvania.


Participants

Amy P. Abernethy, MD, PhDChief Medical Officer/Chief Scientific Officer & SVP OncologyFlatiron Health

Amy P. Abernethy, MD PhD is the Chief Medical Officer and Chief Scientific Officer at Flatiron Health, a healthcare technology company focused on organizing the world's cancer data and making it actionable for providers, patients, researchers and life sciences. At Flatiron, Dr. Abernethy leads the

Oncology and Science parts of the organization. She is a hematologist/oncologist and palliative medicine physician, and internationally recognized cancer clinical researcher with over 400 publications. Dr. Abernethy is an appointee to the National Academy of Medicine’s (formerly the Institute of Medicine) National Cancer Policy Forum, on the Executive Board for the Personalized Medicine Coalition, and Past President of the American Academy of Hospice & Palliative Medicine. Before joining Flatiron, Dr. Abernethy was Professor of Medicine at Duke University School of Medicine, and ran the Center for Learning Health Care in the Duke Clinical Research Institute and Duke Cancer Care Research Program in the Duke Cancer Institute. She is also on the Board of Directors of athenahealth, Inc.

Jeffrey S. Abrams, MDAssociate Director, Cancer Therapy Evaluation ProgramNational Cancer Institute-Division of Cancer Treatment and Diagnosis

Dr. Abrams is currently the Acting Director for Clinical Research in the Division of Cancer Treatment and Diagnosis (DCTD) at NCI and also is Associate Director of the Cancer Therapy Evaluation Program (CTEP). After completing his medical oncology fellowship (University of Maryland, 1984), Dr. Abrams joined the University of Maryland faculty from 1985-1992 where he directed their Breast Cancer Evaluation Program and was

Associate Professor of Medicine and Oncology. In 1993, he joined NCI and was responsible for managing the breast cancer treatment trials portfolio for the Cancer Therapy Evaluation Program. In 2004, he was appointed Chief of the Clinical Investigations Branch which directs the NCI-supported Clinical Trials Cooperative Group program. In 2008, Dr. Abrams became Associate Director of CTEP, DCTD and in 2010, was named Acting Director for Clinical Research, DCTD. Dr. Abrams is responsible for leading a broad, multidisciplinary clinical research effort to coordinate a nationwide, and international, phase 1-3 clinical trials program testing new treatment approaches for cancer. Dr.


Abrams has authored over 95 original publications in the field of breast cancer and clinical trials in general.

James P. Almas, MDMedical OfficerCMS - Coverage Analysis Group (CAG)

Born in Montana, Dr. Almas received his undergraduate degree (with honors) from Stanford University. He attended and graduated from Columbia University's College of Physicians and Surgeons (P&S) and completed his residency in Anatomic and Clinical Pathology. He is board certified in both. Dr. Almas was the Medical Director of Pathology and served as Chief of the Medical Staff at Pomona Valley Medical Center in Los

Angeles County. He then served as Medical Director of Pathology and Chief of Staff at St. Dominic/Jackson Memorial Hospital in Jackson, MS. He served for many years as the College of American Pathologists' CPT Advisor and has written CPT codes which he presented to the CPT Panel. He has served as a consultant to a number of organizations in the area of reimbursement. He has served as a consultant to the MolDX Program at PalmettoGBA and for Blue Cross Blue Shield of MS. He is currently a Medical Officer in the Coverage Analysis Group (CAG) at CMS in Baltimore.

Allen E. Bale, MDProfessor of GeneticsYale University

Dr. Bale’s educational background includes a six-year postgraduate fellowship at NIH in the Clinical Epidemiology Branch of NCI and the Inter Institute Genetics Program. Dr. Bale’s subsequent experience has focused on molecular diagnostics and clinical genetics. He has directed the CLIA-

certified DNA Diagnostics Laboratory at Yale for over 25 years, which is currently overseeing CLIA-certified sequencing in the new Yale Center for Genome Analysis. For the past three years, Dr. Bale has been using high-throughput sequencing in research to identify the genes underlying a variety of genetic syndromes as well as in clinical diagnostic testing.


Alberto Bardelli, PhDAssociate ProfessorUniversity of Turin - Candiolo Cancer Institute IRCCS

Dr. Bardellis is Associate Professor in the Department of Oncology, University of Torino, Director of the Laboratory of Molecular Oncology and deputy Director of the Candiolo Cancer Institute-IRCCS, Torino, Italy. His work is aimed at developing precision medicines for cancer patients. As a postdoc at the Johns Hopkins University (USA), in the group led by Bert Vogelstein, he performed the first comprehensive mutational profile of kinases in colorectal cancers (CRC). As an independent investigator he has then translated these findings into clinical practice by discovering the

molecular landscape of response and resistance to EGFR and HER2 blockade in CRC. These findings have found clinical applicability and were translated in blood-based tests (liquid biopsies) that are presently used to monitor patient’s response during treatment. A future focus of his lab is to study how the emergence and evolution of drug-resistant clones can be restrained to improve the efficacy of anticancer agents, that is to develop therapies that adapt to tumor’s evolution. In 2014 Prof Bardelli has been listed in the Thomson Reuters List of Highly Cited Researchers. He is the author of over 150 peer-reviewed manuscripts (H factor 68).

Julia A. Beaver, MDClinical Team LeaderU.S. Food and Drug Administration

Dr. Julia A. Beaver is the Clinical Team Leader of the Breast and Gynecologic Malignancies Group 1 in the Office of Hematology Oncology Products at the U.S. Food and Drug Administration. She is also an Assistant Professor of Oncology, part-time, at Johns Hopkins University and practices medical oncology at Sibley Memorial Hospital where she sees breast cancer patients. Dr. Beaver earned her medical degree from the University of Pennsylvania School of Medicine. She completed a residency in internal medicine at Johns

Hopkins University School of Medicine, followed by a fellowship in medical oncology at The Johns Hopkins Sidney Kimmel Cancer Center.

Gideon Blumenthal, MD


Lead Medical Officer, Lung, Head and Neck CancerOffice of Hematology Oncology Products, U.S. Food and Administration

Dr. Blumenthal received his Internal Medicine internship and residency training at University of Maryland Medical Center. He received his Hematology and Medical Oncology fellowship training at the National Cancer Institute. In his fellowship and as an attending physician at the National Cancer Institute, Dr. Blumenthal served as lead associate investigator for multiple clinical trials, focusing mainly on targeting the pi3k/AKT/mTOR pathway in lung cancer and in other familial cancer predisposition syndromes. He joined the U.S. Food and Drug Administration as a Medical Officer in 2009. In 2013, he was appointed as the Clinical Team leader for lung cancer and head and neck cancer. As lung cancer scientific liaison, he performed outreach to other government agencies, patient advocacy groups, national organizations and steering committees, and assumes leadership roles in disease-specific activities and advisory committee meetings.

Dr. Blumenthal is a member of the American Society of Clinical Oncology and the International Association for the Study of Lung Cancer. He has numerous publications in peer reviewed journals, and has presented at international forums such as the ASCO annual meeting, the American Association for Clinical Research annual meeting, and the European Society for Medical Oncology-European Medicines Agency workshop on Single Arm Trials. He has served on the faculty for international meetings including the Accelerating Anticancer Agent Development and Validation workshop, and the ASCO Markers in Cancer Diagnostic Development tutorial. In 2014, he received the FDA Commissioner’s Special Citation for his role in patient-focused drug development in lung cancer, and in 2016, he received the Center Director’s Special Citation for outstanding performance in the support of novel clinical trial designs to maximize efficiency of drug development in rare lung cancer subtypes.

John C. Byrd, MDProfessor and Director, Division of HematologyThe Ohio State University

John C. Byrd, MD, is a nationally known researcher and clinical specialist in leukemia and other hematologic malignancies at Ohio State’s Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute; he is also the head of the Division of Hematology. He is a professor of Medicine and Medicinal Chemistry and holds the D. Warren Brown Chair in Leukemia Research. Dr. Byrd received his medical degree from the


University of Arkansas for Medical Sciences. His education and experience continued in hematology and oncology at Walter Reed Army Medical Center and Johns Hopkins University before he moved to Columbus to join the faculty in Ohio State’s College of Medicine and Comprehensive Cancer Center. Dr. Byrd has over 375 publications in the area of leukemia and experimental therapeutics research. He runs a highly translational laboratory focused on drug development in CLL and related lymphoproliferative disorders. He has been part of the successful development of multiple therapeutics in acute myeloid leukemia and chronic lymphocytic leukemia. At a national level, Dr. Byrd is the co-Chair of the Leukemia Committee and Leukemia Correlative Science Committee in the Alliance for Clinical Trials in Oncology (former CALGB). He also is a member of the NCI Leukemia Steering Committee. Despite his passion for clinical and translational research, Dr. Byrd’s favorite day of the week is Tuesday, when he spends eight to 12 hours in the clinic providing care for patients with CLL and other types of leukemia.

Carlos Caldas, MD, PhDProfessorUniversity of Cambridge

Dr. Caldas is Professor of Cancer Medicine at the University of Cambridge; and heads the Breast Cancer Functional Genomics Laboratory at the CRUK Cambridge Institute. Dr. Caldas is also Consultant Medical Oncologist at Addenbrooke’s Hospital, Lead of the Cambridge Experimental Cancer Medicine Centre, and Director of the Breast Cancer Research Unit. He is Fellow of the Academy of the Medical Sciences, Fellow of the European

Academy of Cancer Sciences, EMBO Member, and recipient of an ERC Advanced Grant. His research focus is in the functional genomics of breast cancer and its biological and clinical implications. His laboratory redefined the molecular taxonomy of breast cancer [Curtis et al, Nature 2012, Dawson et al, EMBO J 2013], and subsequently robustly validated this new classification and its SNV landscape [Ali et al, Genome Biology 2014; Pereira et al, Nature Communications 2016]. His group also uncovered a new role for miRNAs as modulators of the immune response in a subset of breast cancers [Dvinge et al, Nature 2013] and co-lead seminal studies that define the clonal heterogeneity of breast cancers [Shah et al, Nature 2012] and the ER cistrome in primary tumors, which revealed new biology [Ross-Ines, Nature 2012]. Finally his group lead studies that established ctDNA as a monitoring biomarker [Dawson et al, NEJM 2013] and a liquid biopsy to unravel therapy resistance [Murtaza et al, Nature 2013; Murtaza el al, Nature Communications 2015]. More recently his laboratory has been developing the use of patient-derived tumor explants as a model system [Eirew et al, Nature 2015].


John Carpten, PhDProfessor and Chair, Department of Translational GenomicsDirector of the Institute for Translational GenomicsKeck School of Medicine, University of Southern California

Dr. Carpten’s research background spans a broad range of topics including work in germline genetics, tumor genome analysis, cancer cell biology, and health disparities. Dr. Carpten has an intense focus on understanding the role of biology in disparate cancer incidence and mortality rates seem

among underrepresented populations. Through his leadership, the African American Hereditary Prostate Cancer Study (AAHPC) Network was conceived. Dr. Carpten was named a Science Trailblazer by Spectrum Magazine in 2006, and was awarded the AACR and Susan G. Komen Distinguished Lectureship on the Science of Cancer Health Disparities in 2014 for his untiring work in ensuring that all people are equally represented in science and innovative healthcare.

To improve the discovery of important alterations associated with cancer, Dr. Carpten led the implementation, development, and application of genomic technologies such as Next Generation Sequencing (NGS) at TGen. His work led to the discovery of HOXB13 germline variants in hereditary prostate cancer, published in the New England Journal of Medicine. He also led a landmark study, which culminated in the discovery of the AKT1(E17K) activating mutation in human cancers, published in Nature.

Currently, the largest efforts of the Carpten laboratory are in applying NGS for Precision Medicine approaches, where cancer genomes and transcriptomes are sequenced and used to identify targetable events for select therapeutics. The resulting paper was the most cited article in the journal Molecular Cancer Therapeutics in 2014. It is his hope that this work will lead to improvements in knowledge based therapeutics toward improvements in outcomes for cancer patients.

Dr. Carpten has received research funding from the NIH, NCI, Prostate Cancer Foundation, Susan G. Komen for the Cure, Multiple Myeloma Research Foundation, and a number of pharmaceutical companies.

Stephen J. Chanock, MDDirector, Division of Cancer Epidemiology and GeneticsNational Cancer Institute, National Institutes of Health

Dr. Stephen Chanock is a leading expert in the discovery and characterization of cancer susceptibility regions in the human genome. He


has received numerous awards for his scientific contributions to our understanding of common inherited genetic variants associated with cancer risk and outcomes. Dr. Chanock received his MD from Harvard Medical School in 1983 and completed clinical training in pediatrics, pediatric infectious diseases, and pediatric hematology/oncology and research training in molecular genetics at Boston Children’s Hospital and the Dana-Farber Cancer Institute, Boston. Since 1995, Dr. Chanock has served as the Medical Director for Camp Fantastic, a week-long recreational camp for pediatric cancer patients, which is a joint venture of the NCI and Special Love, Inc. From 2001-2007, he was a tenured investigator in the Genomic Variation Section of the Pediatric Oncology Branch in the NCI Center for Cancer Research. He also served as co-chair of NCI's Genetics, Genomics and Proteomics Faculty for five years. In 2001, he was appointed as Chief of the Cancer Genomics Research Laboratory (formerly Core Genotyping Facility), and in 2007 as Chief of the Laboratory of Translational Genomics, both within the NCI Division of Cancer Epidemiology and Genetics (DCEG). Dr. Chanock co-led the Cancer Genetic Markers of Susceptibility project. From 2012 to 2013, he also served as Acting Co-Director of the NCI Center for Cancer Genomics. Dr. Chanock was appointed Director of DCEG in August 2013.

Barbara A. Conley, MDAssociate Director, Cancer Diagnosis ProgramNational Cancer Institute-Division of Cancer Treatment and Diagnosis

Barbara A. Conley, MD, a medical oncologist, received her MD from Michigan State University. She is Associate Director, Cancer Diagnosis Program, Division of Cancer Treatment & Diagnosis, National Cancer Institute (NCI). Her work focuses on exploring the clinical utility and clinical use of diagnostics for clinical trials. She leads two NCI precision medicine initiatives – the Exceptional Responders initiative, which uses nucleic acid sequencing on tissues from patients who had remarkable responses to systemic treatments to which few patients respond, and the NCI MATCH

(Molecular Analysis for Therapy Choice) trial, an umbrella basket trial in patients with refractory solid tumors and lymphomas, which screens patients for actionable mutations and assigns appropriate targeted treatment. NCI-MATCH opened in August 2015 through the National Clinical Trials Network.

George D. Demetri, MDDirector, Ludwig Center at HarvardDana-Farber Cancer Institute

George Demetri, MD has long been a leader in translational research aimed


at developing the most rational practical applications of new discoveries to understand and treat sarcomas. He was a pioneer in the development of the Gleevec as one of the first examples of targeted cancer therapies focused on a molecularly-defined subset of sarcoma: gastrointestinal stromal tumor (GIST). Subsequently, his work has led to the FDA and worldwide regulatory approval of several other “smart drugs” for cancer, including Sutent and Stivarga for GIST, as well as Votrient and Yondelis for other sarcomas. In a related contribution, Dr. Demetri served on the Scientific Advisory Board for Plexxikon and was a critical member of the team which developed the mutant BRAF inhibitor, Zelboraf, as the first mutation-targeted therapy for a molecularly-defined subset of melanomas. At Dana-Farber and Harvard, Dr. Demetri leads a large multidisciplinary center focused on the specialty cancer care and science of sarcomas with a team that has consistently been at the cutting edge of developing personalized cancer therapeutics for sarcomas as a model for all cancers. Dr. Demetri also developed and teaches an innovative Freshman Seminar at Harvard College to introduce undergraduates to the social, ethical, scientific and humanistic aspects of cancer. Dr. Demetri received his undergraduate degree in Biochemistry from Harvard College and medical degree from Stanford University School of Medicine, after which he completed his internal medicine residency and chief residency at the University of Washington Hospitals in Seattle. He completed a fellowship in Medical Oncology at the Dana-Farber Cancer Institute and Harvard Medical School. Dr. Demetri has received many awards, including a Focused Giving Program Award from the Johnson and Johnson Foundation, the Emil J. Freireich Award in Clinical Cancer Research from the MD Anderson Cancer Center, Dana-Farber’s Claire W. and Richard P. Morse Research Award and Tisch Family Outstanding Achievement Award, the Alexander Bodini Foundation Prize for Scientific Excellence in Medicine, and the Hope Funds for Cancer Research Award for Developmental Therapeutics.

Luis A. Diaz, MDAssociate Professor, OncologyJohns Hopkins Kimmel Comprehensive Cancer Center

Dr. Luis Diaz is a leading authority in oncology, having pioneered several genomic diagnostic and therapeutic approaches for cancer. He is an attending physician at the Johns Hopkins Hospital where he specializes in the treatment of advanced pancreatic and colorectal cancers. He is a member of the Ludwig Center for Cancer Genetics and Therapeutics and is the Director of the Swim Across America Lab. He is also founder of several

entities that focus on genomic analyses of cancers including Inostics, PapGene and Personal Genome Diagnostics (PGDx). Dr. Diaz has undergraduate and medical degrees from the University of Michigan, and completed residency training at the Osler Medical Service at Johns Hopkins and medical oncology training at the Sidney Kimmel Cancer Center at Johns Hopkins. Dr. Diaz is involved in near-patient


translational studies with the goal of bringing diagnostic and therapeutic studies to patients. His work has involved the clinical development of tumor-derived DNA as a biomarker for cancer screening, early detection, monitoring and measurement of early residual disease. The preliminary studies served as the basis for his most recent invention, the ‘molecular pap smear’, which is a promising approach for the early detection of ovarian and endometrial cancers. He has also harnessed the power of cancer mutations as potent antigens and championed the use of checkpoint inhibitors in the treatment of patients with tumors with high mutational burden. His landmark proof-of this principle study used PD-1 blockade in patients with mismatch repair deficiency and showing dramatic and potentially curative responses in 90% of metastatic patients, which resulted in breakthrough status designation by the FDA.

James H. Doroshow, MDDeputy Director for Clinical and Translational ResearchNational Cancer Institute, National Institutes of Health


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Dr. James H. Doroshow has been the Deputy Director for Clinical and Translational Research of the National Cancer Institute since 2011, and the Director of NCI’s Division of Cancer Treatment and Diagnosis since 2004. He continues to pursue his own research program in cancer pharmacology as a Senior Investigator in the Developmental Therapeutics Branch of the NCI’s intramural Center for Cancer Research. He is the author of over 400 full-length publications in the areas of molecular pharmacology, the role of oxidant stress in tumor cell signal transduction, and novel therapeutic approaches to solid tumors. From 1983 to 2004, Dr. Doroshow was the Chairman of the City of Hope Comprehensive Cancer Center’s Department of Medical Oncology and Therapeutics Research, and Associate Cancer Center Director for Clinical Investigation. He is currently a member of both the Forum on Drug Discovery, Development, and Translation and the National Cancer Policy Forum of the Institute of Medicine of the National Academies of Science and the Associate Editor for Oncology of the 25th Edition of the Cecil Textbook of Medicine. He received his AB degree magna cum laude from Harvard College in 1969 and graduated from Harvard Medical School in 1973. Following an Internal Medicine residency at the Massachusetts General Hospital, he completed a fellowship in Medical Oncology at the Medicine and Clinical Pharmacology Branches of the National Cancer Institute, NIH.

Jeffrey A. Engelman, MD, PhDVice President and Global Head of OncologyNovartis Institutes for BioMedical Research, Inc.

Dr. Jeffrey Engelman is Vice President and Global Head of Oncology, directs cancer drug discovery at the Novartis Institutes for BioMedical Research, Inc.

He received his Bachelor of Arts in Chemistry from Northwestern University and his MD and PhD degrees from the Albert Einstein College of Medicine.

Dr. Engelman completed his medical residency in Internal Medicine at Brigham and Women’s Hospital and his fellowship in Hematology and Oncology at the Dana-Farber Cancer Institute/Massachusetts General Hospital combined program. Before joining Novartis, he was the Director of the Center for Thoracic Oncology and Molecular Therapeutics at Massachusetts General Hospital, where he directed the research program of the thoracic oncology team which integrated laboratory studies, clinical trials, and comprehensive molecular analyses of cancers to pioneer individualized therapies. Dr. Engelman was also an Associate Professor of Medicine at Harvard Medical School.

Andrea Ferris, MBAPresident and Chairman


LUNGevity Foundation

Andrea became involved with lung cancer advocacy following her mother’s death from the disease in 2008. After receiving a diagnosis of stage IV lung cancer in 2006, Andrea’s mother underwent numerous treatments and clinical trials at several major academic institutions to no avail. Together with her father, Andrea was her mother’s primary caregiver during this time. Determined to drive more money into lung cancer research, Andrea left the successful software company that she helped launch, to found Protect Your Lungs, an organization focused 100% on funding early detection research. In 2010, Andrea merged Protect Your Lungs with LUNGevity, a Chicago based organization, to form the nation’s leading lung cancer focused non-profit. Andrea’s strong business background combined with her connections to the worlds of research and advocacy have enabled her to build the preeminent patient advocacy organization in the lung cancer space. LUNGevity funds translational research into both early detection and more effective treatments of lung cancer as well as a highly coveted Career Development Awards program. LUNGevity also fills unmet needs for people diagnosed with lung cancer by providing education, support and survivorship programs. Recognizing the need to build awareness and understanding about lung cancer, LUNGevity has built the largest grassroots network of events and advocates across the country.

Keith Thomas Flaherty, MDDirector, Henri and Belinda Termeer Center for Targeted Therapies; Director, Clinical Research, Massachusetts General Hospital Cancer CenterMassachusetts General Hospital Cancer Center

Keith T. Flaherty, MD, is Director of the Henri and Belinda Termeer Center for Targeted Therapies at the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School. Dr. Flaherty’s research and clinical focus is therapies for melanoma, with a particular expertise in targeted therapies. Dr. Flaherty has been awarded numerous grants from the National Cancer Institute, including K23, RO1, and PO1 grants. He has been the principal investigator of many clinical trials, including first-in-human trials of novel targeted therapies, and two NCI cooperative group trials. He is a member of numerous scientific cancer societies and national committees and has authored many research articles, abstracts, and reviews in peer-reviewed literature; including three first-author New England Journal of Medicine papers. He serves as a Senior Editor for Clinical Cancer Research and a member of the editorial boards for Cancer Discovery, Journal of Clinical Oncology, Cancer, and Pigment Cell and Melanoma Biology. Dr. Flaherty obtained his undergraduate degree from Yale University in 1993 and his MD from Johns Hopkins University in 1997. He completed his internship in medicine, followed by a residency in medicine, at Brigham and Women’s Hospital (Harvard Medical


School) in Boston. He went on to complete a fellowship in medical oncology at the Hospital of the University of Pennsylvania. Dr. Flaherty came to Mass General from the University of Pennsylvania’s Abramson Cancer Center, where he was an Assistant Professor of Medicine at the University of Pennsylvania School of Medicine and an adjunct professor at The Wistar Institute.

Susan M. Galbraith, MBBCh, PhDSVP and Head of Oncology iMed at AstraZenecaAstraZeneca

Susan Galbraith trained as a Clinical Oncologist in the United Kingdom. She studied Medicine at Manchester and Cambridge Universities. She was admitted to Membership of the Royal College of Physicians in 1992, and then trained in Clinical Oncology in London. She gained Fellowship of the Royal College of Radiologists in 1997. She then completed a PhD at the University of London involving translational work on a vascular-targeting

agent. Susan joined the Clinical Discovery Oncology group at Bristol-Myers Squibb in 2001. Susan was closely involved in the in-licensing of ipilimumab from Medarex, elotuzumab from PDL, the acquisitions of Adnexus and Medarex and research collaborations with Exelixis. She held increasing levels of responsibility becoming VP for Oncology and Immunology Early Development, and then taking on responsibility for the Clinical Biomarker team. Susan joined AZ in September 2010, as Head of the Oncology Innovative Medicines group (iMed) responsible for Oncology Small Molecules Discovery and Early Development. Since then the Oncology iMed has moved 3 programs into Phase 3 trials; olaparib (now approved in USA and EU), selumetinib, and AZD9291 a mutant-selective EGFR inhibitor.

Judy E. Garber, MD, MPHProfessor of Medicine, Harvard Medical SchoolDirector, Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute

Dr. Garber is the Director of the Center for Cancer Genetics and Prevention at Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Medical School. Dr. Garber conducts research in clinical cancer genetics, with a special focus in the genetics of breast cancer. She has played a major role in the development of national guidelines in cancer genetics. Dr. Garber is also a leader in research into the characteristics and treatment of

triple negative or basal-like breast cancer, the most common form in women with BRCA1 mutations.


Her translational research focuses on the evaluation of novel agents targeting DNA repair defects in breast cancer, including PARP inhibitors for treatment and prevention of breast cancer and other BRCA-associated cancers. Dr. Garber is a past President of American Association for Cancer Research (AACR), the largest organization of cancer researchers in the world. She is a member of the National Cancer Advisory Board, the National Academy of Medicine, and is now serving as the Chair of the Breast Cancer Research Foundation (BCRF) Scientific Advisory Board.

Todd R. Golub, MDFounding Core Member, CSO, Director of Cancer ProgramBroad Institute of MIT and Harvard

Todd Golub is a Founding Core Member of the Broad Institute and serves as the Institute's Chief Scientific Officer and Director of its Cancer Program. He is also a Professor of Pediatrics at Harvard Medical School, Charles A. Dana Investigator in Human Cancer Genetics at the Dana-Farber Cancer Institute, and Investigator at Howard Hughes Medical Institute. Golub is a world leader in understanding the basis of cancer, by creating and applying tools of genomics. He has made fundamental discoveries in the molecular basis

of childhood leukemia, and laid the foundation for the diagnosis and classification of human cancers using gene expression analysis. He also pioneered the development of chemical screening approaches based on gene expression. Golub received his BA from Carleton College and his MD from the University of Chicago Pritzker School of Medicine. He completed his residency and fellowship training at Boston Children’s Hospital and Dana-Farber Cancer Institute.

Robert Grossman, PhDChief Research Informatics Officer (CRIO), Biological Sciences DivisionDirector of the Center for Data Intensive Science (CDIS)Senior Fellow and Core Faculty, Institute for Genomics and Systems Biology and the Computation InstituteProfessor, Department of Medicine in the Section of Genetic MedicineUniversity of ChicagoDr. Grossman’s research group focuses on data science, data intensive computing, biomedical informatics and related areas. Dr. Grossman is the

Director of the not-for-profit Open Commons Consortium that develops and operates data commons and data clouds to support research in science, medicine, health care, and the environment. He is also the Founder and Chief Data Scientist of Open Data Group that provides technology for deploying


predictive models into operational systems. For his contributions to big data and data science, he was elected a Fellow of the AAAS in 2013.

Sandra J. Horning, MDExecutive Vice President, Head of Global Product Development and Chief Medical OfficerRoche/Genentech

Sandra J. Horning, MD, FACP, FASCO, was appointed Chief Medical Officer and head of Global Product Development in January 2014. She oversees late stage clinical development and co-chairs the Late Stage Portfolio Committee. Sandra joined Roche in late 2009 as senior vice president, global head of clinical oncology and hematology product development. She is an Emerita Professor of Medicine (Oncology and Blood and Bone Marrow Transplantation) at Stanford University School of Medicine where she served as a tenured professor, practicing oncologist and investigator, and held multiple leadership positions including Vice-Chair of the Department of

Medicine prior to joining Roche/Genentech. Sandra has authored 300 peer-reviewed journal articles, book chapters, reviews and editorials, and has served on the editorial boards of multiple peer-reviewed medical journals. She was named a Best Doctor in America consecutively from 1992-2008 and served as Chairman of the Eastern Cooperative Oncology Group lymphoma committee and 2005-6 President of the American Society of Clinical Oncology. Sandra received Bachelor of Arts and Doctor of Medicine degrees at the University of Iowa and completed post-doctoral training in internal medicine at the University of Rochester and in medical oncology at Stanford University.

David M. Hyman, MDDirector, Developmental TherapeuticsMemorial Sloan Kettering Cancer Center

David Hyman is Director of the Developmental Therapeutics at Memorial Sloan Kettering. He leads a large multidisciplinary group of researchers and physicians to conduct a variety of early phase clinical studies including first-in-human studies, novel combinations of investigational therapy, and histology-independent, molecularly selected “basket” studies. Under his direction, this service enrolls approximately 300 patients each year to a clinical trial portfolio of 35-40 early phase studies. Dr. Hyman also serves as

Medical Director of Memorial Sloan Kettering’s Developmental Treatment Unit, a fully equipped


outpatient clinical research facility staffed by highly trained individuals who administer cytotoxic or biologic therapies to patients and perform serial pharmacokinetic and pharmacodynamic blood sampling. In addition to first-in-human studies, his personal research has focused on multi-histology, genomically selected, “basket” studies. He led the first-in-kind basket study that evaluated vemurafenib in BRAFV600 mutant cancers and published his initial findings in the New England Journal of Medicine. Dr. Hyman currently serves as Global Principal Investigator on three additional multi-national basket studies evaluating targeted therapy for patients whose tumors harbor AKT1, ERBB2, or NTRK1/2/3 alterations. His translational research is focused on understanding how the consequences of pathway inhibition vary as a function of tumor cell lineage and the complement of co-mutations within tumor cells. Dr. Hyman has also published numerous articles on the design and conduct of precision medicine and basket studies.

Steven Joffe, MD, MPHEmanuel and Robert Hart Associate Professor of Medical Ethics & Health PolicyUniversity of Pennsylvania Perelman School of Medicine

Steven Joffe, MD, MPH, is the Emanuel and Robert Hart Associate Professor of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine. He serves as Vice-Chair of the Department, leading the medical ethics division, and directs the Penn Fellowship in Advanced Biomedical Ethics. He is also Associate Professor of Pediatrics at the Perelman School of Medicine. Dr. Joffe attended Harvard College, received his medical degree from the University of California at San Francisco (UCSF), and received his public health degree from UC Berkeley.

He trained in pediatrics at UCSF and undertook fellowship training in pediatric hematology/oncology at the Dana-Farber Cancer Institute and Boston Children’s Hospital. Dr. Joffe’s clinical work is in the area of stem cell transplantation in children. His research addresses the many ethical challenges that arise in the conduct of clinical and translational investigation, both in pediatric oncology and other areas of medicine and science. He has been the principal investigator (PI) of studies that examine the roles and responsibilities of PIs in multicenter randomized trials, accountability in the clinical research enterprise, return of individual genetic results to participants in epidemiologic cohort studies, and the integration of genomic sequencing technologies into the clinical care of cancer patients. He currently serves as Chair of the Children’s Oncology Group Bioethics Committee, as a member of the U.S. Food and Drug Administration’s (FDA) Pediatrics Ethics Subcommittee, and as a member of the National Academy of Sciences Committee on Federal Research Regulations and Reporting Requirements.


Raghu Kalluri, MD, PhDChairman and ProfessorThe University of Texas MD Anderson Cancer Center

Dr. Raghu Kalluri was born in St. Louis, Missouri. He received his PhD in Biochemistry and Molecular Biology from the University of Kansas Medical Center and his MD degree from Brown University Medical School. Dr. Kalluri was a research associate at the University of Pennsylvania Medical School and studied immunology and organ fibrosis. In 1997, he moved to Harvard Medical School as an Assistant Professor of Medicine and as a faculty based in the Department of Medicine at the Beth Israel Deaconess Medical Center. In 2006, Dr. Kalluri was appointed the Chief of the Division

of Matrix Biology and was promoted to Professor of Medicine at Harvard Medical School. He holds an appointment in the Department of Biological Chemistry and Molecular Pharmacology, Harvard MIT Division of Health Sciences and Technology, and Harvard Stem Cell Institute. Dr. Kalluri was recruited to the MD Anderson Cancer Center in 2012 as the Chairman of the Cancer Biology Department and as the Director of the Metastasis Research Center. His laboratory is broadly interested in the study of cell and tissue microenvironment and its impact on cancer progression and tissue fibrosis.

Ronald M. Kline, MD, FAAPMedical Officer, Patient Care Models GroupCenter for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services

Ron Kline is a board certified pediatric hematologist-oncologist. He has been a medical officer in the Patient Care Models Group at the Center for Medicare and Medicaid Innovation (CMMI) since 2014, and part of the program team directing CMS’s new Oncology Care Model. As a Robert Wood Johnson Foundation (RWJF) Health Policy Fellow in 2013-14, he focused on health policy in the office of Senate Finance Committee Chair Ron Wyden and at CMMI. He has been a clinical pediatric hematologist–

oncologist for over 20 years, serving as the medical director of the Pediatric Division of Comprehensive Cancer Centers of Nevada, the largest multispecialty oncology group in Nevada, immediately prior to accepting his RWJF fellowship. He was also a clinical associate professor at the University of Nevada School of Medicine. Kline has held leadership positions in local and statewide organizations, primarily focusing on health policy and children’s issues. He is past president of the Clark County Medical Society and the Nevada State Medical Association, a former alternate delegate to the American Medical Association House of Delegates, a past gubernatorial appointee to the Silver


State Health Insurance Exchange board of directors, and a former member of the Nevada Board of Medical Examiners. He was the founding chair of the Children’s Medical Advocacy Coalition and president elect of Las Vegas HEALS (Health, Education, Advocacy, and Leadership of southern Nevada), a medical industry coalition. In addition to his medical and health policy pursuits, Kline has a strong interest in history and international relations, having served as an officer of the World Affairs Council of Las Vegas from 2008-2013. Kline has broad experience directing clinical programs in multiple states and in university, hospital-based, and private practice settings. He is the author of over 20 scientific publications, and the editor of a textbook on pediatric hematopoietic stem cell transplantation. Kline received his MD and BA from the University of California, Los Angeles, and did his pediatric residency training at the Children’s Hospital of Los Angeles. He completed a biotechnology fellowship at the National Cancer Institute and a clinical fellowship in pediatric hematology-oncology and hematopoietic stem cell transplantation at the University of California, San Francisco.

Mark Lee, MD, PhDHead of Clinical Development and Medical AffairsGRAIL, Inc.

Mark Lee, MD, PhD, is a medical oncologist and Head of Clinical Development and Medical Affairs at GRAIL, which is developing circulating cell-free nucleic acid technology for early cancer detection. Previously, Mark served as Lead for Oncology Clinical Sciences at Google Life Sciences, Chief Medical Officer at Boreal Genomics, and Vice President of Oncology Development at Genomic Health, where he led the successful development and validation of the Oncotype DX Colon and Prostate Cancer Assays. His

prior work also includes design and conduct of clinical trials for tissue-based and molecular imaging biomarker discovery at Genentech. Mark holds a PhD in Biological Chemistry and Molecular Pharmacology from Harvard, and a MD from Stanford University, where he completed his internal medicine training and medical oncology fellowship and where he continues to serve as adjunct faculty.

John Leite, PhD.Vice President of Oncology, Market Development & Product Marketing Illumina Oncology Business Unit


Prior to joining Illumina, John was Vice President of Commercial Strategy and Market Access for Genoptix Inc., a Novartis company where, from 2008 until 2014, he drove several functions including Marketing and Business Development, building the portfolio of oncology diagnostic services. John began his career as a scientist for Invitrogen (now Thermo Fisher Scientific) before transitioning to the business team as a marketer overseeing product management of the proteomics portfolio. He earned his Ph.D. in Molecular Genetics & Biochemistry from the University of Pittsburgh, School of Medicine in 2000, and was a National Research Service Award Scholar at the California Institute of Technology from 2000 to 2003.

Mia A. Levy, MD, PhDDirector, Cancer Clinical Informatics, and Assistant Professor of Biomedical Informatics and Medicine, Vanderbilt UniversityPrincipal Investigator, My Cancer GenomeVanderbilt-Ingram Cancer Center

Dr. Mia A. Levy is the Director of Cancer Clinical Informatics for the Vanderbilt-Ingram Cancer Center and an Assistant Professor of Biomedical Informatics and Medicine at Vanderbilt University. Dr. Levy received her undergraduate degree in Bioengineering from The University of Pennsylvania in 1997 and her Medical Doctorate from Rush University in

2003. She then spent 6 years at Stanford University completing post-graduate training in Internal Medicine and Medical Oncology while completing her PhD in Biomedical Informatics. She joined the faculty at Vanderbilt as an Assistant Professor in Biomedical Informatics and Medicine in August 2009. She is a practicing medical oncologist specializing in the treatment of breast cancer. Dr. Levy’s research interests include biomedical informatics methods to support the continuum of cancer care and cancer research. Current research projects include informatics methods for 1) clinical decision support for treatment prioritization of molecular subtypes of cancer, 2) longitudinal clinical plan management, 3) image based cancer treatment response assessment using quantitative imaging, and 4) learning cancer systems. She is the principle investigator for MyCancerGenome.org, a publically available knowledge resource for genome directed cancer treatment selection.

David Litwack, PhDPolicy AdvisorU.S. Food and Drug Administration


Dr. Litwack received a BS in Chemistry from the University of Chicago, and a PhD in Biology from MIT. After postdoctoral studies at the Salk Institute for Biological Studies, he joined the faculty of the University of Maryland School of Medicine as an Assistant Professor in the Department of Anatomy and Neurobiology and a member of the Program in Neuroscience. In that role, Dr. Litwack directed an NIH-funded lab that studied the role of transcription factors in neurogenesis in the mammalian brain and in human embryonic stem cells, and was a founding member of the School’s Center for Stem Cell Biology and Regenerative Medicine. In 2010, Dr. Litwack was awarded an AAAS Science and Technology Policy Fellowship in NCI’s Office of Biorepositories and Biospecimen Research. During this fellowship, he led several efforts to develop policy and programs to advance the use of biobanking for personalized medicine. In 2012, Dr. Litwack joined the Personalized Medicine Staff of the Office of In Vitro Diagnostics and Radiological Health at the FDA, where he develops policies to guide the review of investigational biomarker tests, companion diagnostics, and next generation technologies.

Elizabeth Mansfield, PhDDirector of Personalized MedicineU. S. Food and Drug Administration

Dr. Mansfield is the Deputy Office Director for Personalized Medicine in the Office of In Vitro Diagnostics and Radiological Health (OIR) in the Center for Devices and Radiological Health (CDRH). Dr. Mansfield has extensive experience in regulation and policy regarding in vitro diagnostic devices, and has led the development of a personalized medicine program in CDRH. Dr. Mansfield received her PhD from the Johns Hopkins University, and completed postdoctoral training at NCI and NIAMS. She was the Director of Regulatory Affairs at Affymetrix, Inc. from 2004-2006.

Elaine R. Mardis, PhDRobert E. and Louise F. Dunn Distinguished Professor of Medicine Co-director, McDonnell Genome Institute at Washington UniversityWashington University School of Medicine

Elaine Mardis graduated Phi Beta Kappa from the University of Oklahoma with a BS degree in zoology. She then completed her PhD in Chemistry and Biochemistry in 1989, also at Oklahoma. Following graduation, Dr. Mardis was a senior research scientist for four years at BioRad Laboratories in Hercules, CA. In 1993, Dr. Mardis joined the faculty at Washington

University School of Medicine. Recruited for her expertise in DNA sequencing and automation technology, she served as Director of Technology Development at the (then) Washington University Genome Sequencing Center, helping create methods and automation pipelines for sequencing the


Human Genome. She has served as Co-director of the McDonnell Genome Institute since 2002. In 2014, Dr. Mardis was named the Robert E. and Louise F. Dunn Distinguished Professor of Medicine. Dr. Mardis has research interests in the application of next-generation sequencing to characterize cancer genomes and transcriptomes, and using these data to support therapeutic decision-making. She co-led the teams that first used next-generation sequencing to characterize the whole genome of an AML patient (Nature 2008), first sequenced and compared a primary tumor to its metastasis and xenograft, and first reported whole genome sequencing of samples from a breast cancer clinical trial. Beyond cancer genomics discoveries, Dr. Mardis is leading efforts to facilitate the translation of basic science discoveries about human genetic diseases into the clinical setting, especially focused on the use of next-generation sequencing. Her translational research efforts aim to devise NGS-based diagnostics, decision-support tools and databases, and the use of genomics to design personalized cancer vaccines. Dr. Mardis was elected to the AACR Board of Directors in 2015. She serves on the scientific advisory boards of Qiagen Ingenuity, DNA Nexus, and ZS Genetics, and is a member of the Supervisory Board of Qiagen N.V. Dr. Mardis received the 2010 Scripps Translational Research award for her work on cancer genomics, and was named a Distinguished Alumni of the University of Oklahoma College of Arts and Sciences in 2011. Discover Magazine featured her work in cancer genomics as one of their top 100 science stories of 2013. In 2014 and 2015, she was one of the most highly cited researchers in the world, according to Thompson-Reuters. She will receive the Morton K. Schwartz award from the American Association of Clinical Chemistry for Significant Contributions in Cancer Research Diagnostics in 2016.

Funda Meric-Bernstam, MDProfessor and ChairThe University of Texas MD Anderson Cancer Center

Funda Meric-Bernstam is Chair of the Department of Investigational Cancer Therapeutics -- the Phase I Program at MD Anderson Cancer Center, the Medical Director of the Institute for Personalized Cancer Therapy (IPCT), Professor in the Division of Cancer Medicine, and Surgery. She has a basic and translational research program that is focused on molecular therapeutics, to delineate the mechanism of action of each agent targeting this pathway and the molecular alterations useful to prospectively identify patients who will benefit most from each agent, and optimal combination

therapies. As Medical Director of IPCT, she has not only led large efforts of genomic testing within the institution, but has a) helped build a framework for rapid assessment of actionability of genomic alterations; b) established a Precision Oncology Decision Support Team who can provide point of care input for actionability; c) launched the public website “www.personalizedcancertherapy.org”


providing access to expert curation of information on therapeutic relevance of specific genes/variants; d) created databases and clinical trial alert systems to facilitate accrual to genotype-selected trials across the institution; and e) monitors trial enrollment after genomic testing to identify approaches to obstacles to trial enrollment. She has participated in, as well as led, trials including biomarker-driven investigator-initiated trials, cooperative group trials, and industry sponsored trials.

Katherine L. Nathanson, MDProfessor of MedicinePerelman School of Medicine, University of Pennsylvania

Katherine (Kate) L. Nathanson, MD is a Professor of Medicine, in the Division of Translational Medicine and Human Genetics at the Perelman School of Medicine at the University of Pennsylvania. She also is Associate Director for Population Sciences in Abramson Cancer Center, as well as co-Leader of the Cancer Control Program and Chief Oncogenomics Physician, as well as Director of Genetics for the Basser Center for BRCA Research. Dr. Nathanson is an internationally recognized cancer geneticist for both her

clinical and research expertise. Her research focuses on both inherited susceptibility to cancer and somatic genetic characterization of tumors, with interests across multiple tumor types, including testicular germ cell tumors, breast and ovarian cancers, melanoma and neuroendocrine tumors.

Lee N. Newcomer, MDSVP UnitedHealthcare Oncology and GeneticsUnitedHealthcare

Lee N. Newcomer, MD, MHA is the UnitedHealthcare Senior Vice President for Oncology and Genetics. His career with UnitedHealth Group started in 1991 as the Chief Medical Officer with responsibilities for clinical services, Medicare and Medicaid. He focused his later work on the development of performance measures and incentives for the improvement of clinical care until 2001. He returned in 2006 to lead a pilot initiative combining clinical, financial and program management experts to improve the quality and affordability of cancer care. This team was the first

to complete an episode payment program for cancer treatment and it has built the only commercial database combining clinical and claims information for cancer patients. Prior to his work at


UnitedHealth Group, Dr. Newcomer practiced medical oncology for nine years in Minneapolis and Tulsa, Oklahoma. He served as the Medical Director for Cigna Healthcare, in Kansas City and he was a founding executive of Vivius, a consumer directed venture that allowed consumers to create their own personalized health plans. He is a former Chairman of Park Nicollet Health Services (HealthPartners), an integrated system of physicians and hospitals based in Minnesota with national recognition for its leadership in quality, safety and cost effectiveness. Dr. Newcomer holds a BA degree from Nebraska Wesleyan University, a MD degree from the University of Nebraska College of Medicine and a Masters of Health Administration from the University of Wisconsin at Madison. His clinical training included an internal medicine residency at the University of Nebraska Medical Center and a medical oncology fellowship at the Yale University School of Medicine.

Michael J. Pellini, MDCEOFoundation Medicine

Dr. Pellini joined Foundation Medicine as President and Chief Executive Officer in May 2011, bringing a breadth of experience in life sciences and the clinical diagnostics and laboratory industries to the company. Dr. Pellini came to Foundation Medicine from Clarient, a GE Healthcare Company, where he held the position of President and Chief Operating Officer. Dr. Pellini joined GE Healthcare through the integration of Clarient, Inc., where

he worked with the company’s leadership team to drive operational excellence and reimbursement strategies in parallel with the development and commercialization of multiple diagnostic tests. Dr. Pellini’s leadership was instrumental in building Clarient to the highly successful acquisition by GE Healthcare in October 2010. Prior to his tenure with Clarient, Dr. Pellini served as Vice President, Life Sciences at Safeguard Scientifics, Inc. where he leveraged his business and medical expertise to explore new market opportunities and to support Safeguard’s partner companies. Prior to Safeguard, he was Executive Vice President and Chief Operating Officer at Lakewood Pathology Associates, a national molecular pathology services company, which was acquired by Water Street Healthcare Partners in 2006. Previously, Dr. Pellini was an Entrepreneur-in-Residence at BioAdvance, where he was responsible for identifying early-stage life science opportunities. He also served as President and Chief Executive Officer of Genomics Collaborative, Inc., a Boston-based biotech firm that was acquired by SeraCare Life Sciences, Inc. in 2004. Dr. Pellini received a BA from Boston College, an MBA from Drexel University and an MD from Sidney Kimmel Medical of Thomas Jefferson University. He currently serves as a member of the Board of Directors for Mass BIO and the Personalized Medicine Coalition, and on the President’s Advisory Board of the Kimmel Medical College.


Girish Putcha, MA, MS, MD, PhDDirector of Laboratory Science, MolDXPalmetto GBA

Girish Putcha is currently Director of Laboratory Science for Palmetto GBA’s MolDX program, the founding Medical Director for Orion Genomics, and Managing Director at Personalized Medicine & Diagnostic Solutions. Previously, Girish was the founding Laboratory Director and/or Chief Medical Officer at Ariosa Diagnostics, Crescendo Bioscience, Life Technologies, and VitaPath Genetics. Prior to this, he focused on

investments across healthcare, from biopharmaceuticals and medical devices to diagnostics and services, at Panorama Capital and RiverVest Venture Partners, where he also served on the boards of several portfolio companies, including Presidio Pharmaceuticals, PowerVision, and Phenomix. He was also a founding team member at VeraCyte and a clinical development fellow at CardioDx, both venture-funded personalized medicine companies. Girish received a bachelor's degree from Rice University and master's degrees from the University of London and the Welcome Institute as a Marshall Scholar. He holds medical and doctoral degrees from Washington University School of Medicine, where he also completed a postdoctoral fellowship in molecular neuroscience. Girish completed his postgraduate medical training at the Stanford University School of Medicine, where he also served as adjunct clinical faculty, specializing in molecular genetic pathology.

Scott Ramsey, MD, PhDMemberFred Hutchinson Cancer Research Center

Dr. Ramsey is a general internist and health economist. He is a Full Member in the Cancer Prevention Program, Public Health Sciences Division at the Fred Hutchinson Cancer Research Center, where he directs Hutchinson Institute for Cancer Outcomes Research, a multidisciplinary team devoted to clinical and economic evaluations of new and existing cancer prevention, screening and treatment technologies. In addition, Dr. Ramsey is a Professor in the School of Medicine, School of Pharmacy, and the Institute for Public Health Genetics at the University of Washington. Trained in Medicine and economics, Dr. Ramsey’s research focuses on economic evaluations in cancer. He has published widely on patterns of care, costs, and cost-effectiveness of treatments for lung, colorectal, and prostate cancer. His research portfolio and interests include: large scale SEER-Medicare/Cancer Registry data linkages, patient reported outcomes, economic modeling of health


care interventions, cost-effectiveness analysis, quality of life assessment, patterns of care, health care utilization, economic burden of disease for patients and society, pragmatic trial design, early technology assessment, and stakeholder engagement.

Mark E. Robson, MDMedical OncologistMemorial Sloan Kettering Cancer Center

Mark Robson, MD is a Member and Attending Physician of the Clinical Genetics and Breast Medicine Services in the Department of Medicine at Memorial Sloan Kettering Cancer Center. He is also Professor of Medicine at Weill Cornell Medical College. He received his BSc from Washington and Lee University and his MD from the University of Virginia. He performed residency and fellowship training at Walter Reed Army Medical center before coming to Memorial Sloan-Kettering in 1996. He is currently the

Clinic Director of the Clinical Genetics Service. He serves on the Cancer Prevention and Ethics Committees of ASCO, is an Associate Editor for JNCI and is on the editorial board of the Journal of Clinical Oncology. Dr. Robson’s research is primarily directed toward improving the integration of genetic information into the clinical management of women with breast cancer. He and his colleagues have conducted a number of studies examining outcomes in women with hereditary breast cancer to better define the risks and benefits of treatments such as breast conserving therapy and adjuvant chemotherapy in this group. He is also coordinating studies of PARP inhibitors in women with BRCA mutation-associated breast cancer. He and his coworkers have also conducted a number of studies examining the effectiveness of screening interventions such as breast MRI or ovarian cancer screening in women at hereditary risk. He is also investigating the optimal integration of new genetic technologies, such as genomic profiling and multi-gene testing, into the care of women at risk for breast cancer.

Michael V. Seiden, MD, PhDSr. Vice President & Chief Medical OfficerMcKesson Specialty Health & The US Oncology Network

Dr. Seiden earned his undergraduate degree at Oberlin College and graduated magna cum laude in Chemistry. He subsequently completed an MD and PhD in 1986 with his principal area of research in the field of immunology. He completed his medical internship, residency,


and chief residency at the Massachusetts General Hospital followed by clinical oncology training at the Dana Farber Cancer Institute and the Brigham and Women’s hospital with a focus in molecular diagnostics. From 1994 to 2007 he served on the faculty of the Massachusetts General Hospital, the Dana Farber Cancer Institute, and the Harvard Medical School serving in a variety of capacities in training, research, clinical care, and research administration. His research interests at MGH included translational research in gynecologic malignancies with a focus on ovarian cancer. In June 2007, he assumed the position of President and Chief Executive Officer of the Fox Chase Cancer Center as well as the Principal Investigator for the NCI-sponsored Comprehensive Cancer Center grant and the NCI-funded ovarian SPORE grant shared between Fox Chase Cancer Center and the University of Pennsylvania. In 2013, he joined McKesson Specialty Health as a Senior Vice President and Chief Medical Officer as well as the Chief Medical Officer of the US Oncology Network. In these roles he has responsibility for bringing the assets of McKesson to The US Oncology Network with a goal of providing high value oncology care in the community and strategically planning and delivering cutting edge care in a rapidly evolving healthcare landscape.

Lillian L. Siu, MDProfessor of MedicinePrincess Margaret Cancer Centre

Dr. Siu is a senior staff medical oncologist at Princess Margaret Cancer Centre since 1998, and has been a Professor of Medicine at the University of Toronto since 2009. She is the Director of the Phase I Program and Co-Director of the Bras and Family Drug Development Program at Princess Margaret Cancer Centre. Dr. Siu currently serves on the Board of Directors for the American Society of Clinical Oncology (ASCO) for a four-year term

(2012-2016). She also served as a member of the Nomination Committee for the American Association for Cancer Research (AACR) (2014-2016). Dr. Siu’s major research focus is in the area of new anticancer drug development, particularly with respect to phase I trials and head and neck malignancies. She is the Principal Investigator of a phase I cooperative agreement UM1 award (2014-2019) sponsored by the United States National Cancer Institute. In addition to her active research in early phase clinical trials, she has been leading genomics initiatives and immuno-oncology trials at the Princess Margaret Cancer Centre. Internationally, Dr. Siu was the recipient of the US NCI Michaele C. Christian Award in Oncology Drug Development in 2010. She was the ASCO Conquer Cancer Foundation Grants Selection Committee Chair in 2009-10, and the Chairperson of the AACR Education Committee and Co-Chairperson of the Scientific Committee for the 2012 Annual Meeting. Dr. Siu has published over 240 peer-reviewed manuscripts, and she is currently a scientific editor for Cancer Discovery and is on the editorial board for the Journal of Clinical Oncology and JAMA Oncology.


AmirAli Talasaz, MSc, PhDPresident and Chief Operating OfficerGuardant Health Inc.

AmirAli is an entrepreneur in the sample preparation and clinical research fields. Prior to co-founding Guardant, he was Senior Director of Diagnostics Research at Illumina and led the research efforts for emerging clinical applications of next-generation genomic analysis. During that time, he developed different sample preparation technologies suitable for clinical applications. Before Illumina, he founded Auriphex Biosciences, which focused

on purification and genetic analysis of circulating tumor cells for cancer management. The technology was acquired by Illumina in 2009. He led the Technology Development group at Stanford Genome Technology Center. AmirAli received his PhD in electrical engineering and MSc in management science from Stanford University.

Roman K. Thomas, MDPrincipal InvestigatorUniversity of Cologne

Roman Thomas has received his MD degree from the University of Cologne, Germany, in 2000. He has worked as a physician scientist with Jürgen Wolf and Volker Diehl at the University Hospital of Cologne. In 2004, he joined the Cancer Genome Project at the Broad Institute of MIT and Harvard as a

Postdoctoral Fellow with Matthew Meyerson, funded by a fellowship of the Deutsche Krebshilfe. In 2007 Roman Thomas returned to Cologne as a Principal Investigator at the Max-Planck Institute for Neurological Research in Cologne Germany. In 2012 Roman Thomas was appointed Full Professor of Translational Genomics at the University of Cologne. His scientific focus is on the characterization of cancer genome alterations in lung cancer and on the cell biology implications of such alterations. He has furthermore spearheaded efforts aimed at the translation of cancer genome findings into diagnostic as well as therapeutic applications.

Sean R. Tunis, MD, MScPresident & Chief Executive OfficerCenter for Medical Technology Policy


Sean Tunis is President and Chief Executive Officer of the Center for Medical Technology Policy in Baltimore, Maryland. CMTP is an independent, non-profit organization that provides a neutral platform for multi-stakeholder collaborations that promote high value innovation by improving the quality, relevance, and efficiency of clinical research. Through September of 2005, Dr. Tunis was the Director of the Office of Clinical Standards and Quality and Chief Medical Officer at the Centers for Medicare and Medicaid Services (CMS). He also served as the Director of the Health Program at the Congressional Office of Technology Assessment and as a health policy advisor to the U.S. Senate Committee on Labor and Human Resources. He received a BS degree in Biology and History of Science from the Cornell University School of Agriculture, and a medical degree and masters in Health Services Research from the Stanford University School of Medicine. Dr. Tunis did his residency training at UCLA and the University of Maryland in Emergency Medicine and Internal Medicine. Dr. Tunis serves as Vice-President of Health Technology Assessment International, a member of the Health Sciences Policy Council for ISPOR and on several other public and private governing and advisory boards.

Eliezer M. Van Allen, MDInstructor in MedicineDana-Farber Cancer Institute

Dr. Van Allen is an Assistant Professor of Medicine at Harvard Medical School, a clinician at Dana-Farber/Partners Cancer Care, and an Associate Member at the Broad Institute of MIT and Harvard. His research focuses on computational cancer genomics, the application of new technologies such as massively parallel sequencing to precision cancer medicine, and resistance to targeted therapeutics. As both a computational biologist and medical oncologist, he has specific expertise in clinical computational

oncology and the development of algorithms to analyze and interpret genomic data for clinically focused questions. Overall, his research will make important contributions to the field of precision cancer medicine and resistance to targeted therapeutics via expertise and study in translational and clinical bioinformatics. Originally from Los Angeles, CA, he studied Symbolic Systems at Stanford University, obtained his MD from UCLA, and completed a residency in internal medicine at UCSF before coming to Boston and completing a medical oncology fellowship at the Dana-Farber/Partners Cancer Care program.

Harold E. Varmus, MDDirector


Weill Cornell Medical College

Harold Varmus, MD, co-recipient of the Nobel Prize for studies of the genetic basis of cancer, joined the Meyer Cancer Center of Weill Cornell Medicine as the Lewis Thomas University Professor of Medicine on April 1, 2015. Prior to joining Meyer Cancer Center, Dr. Varmus was the Director of the National Cancer Institute for five years. He was also the President of Memorial Sloan-Kettering Cancer Center for 10 years and Director of the National Institutes of Health for six years. A graduate of Amherst College and Harvard University in English literature and Columbia University in Medicine, he trained at Columbia University Medical Center, the National Institutes of Health, and the University of California San Francisco (UCSF), before becoming a member of the UCSF basic science faculty for over two decades. He is a member of the U.S. National Academy of Sciences and the Institute of Medicine and is involved in several initiatives to promote science and health in developing countries. The author of over 350 scientific papers and five books, including a recent memoir titled The Art and Politics of Science, he was a co-chair of President Obama’s Council of Advisors on Science and Technology, a co-founder and Chairman of the Board of the Public Library of Science, and chair of the Scientific Board of the Gates Foundation Grand Challenges in Global Health.

Robert H. Vonderheide, DPhil, MDProfessor of Medicine; Hanna Wise Professor in Cancer ResearchAbramson Cancer Center of University of Pennsylvania

Dr. Vonderheide is the director of Penn’s Pancreatic Cancer Research Center and a national leader in pancreatic cancer immunobiology. He co-leads a SU2C Team on Pancreatic Cancer Immunotherapy and was co-chairperson for this year’s AACR conference on Pancreatic Cancer. Dr. Vonderheide’s laboratory combines efforts in both basic research and clinical investigation to advance the understanding of tumor immunology and to develop novel immunotherapies for cancer. His basic research includes deciphering the immunobiology of novel genetically engineered mouse models of pancreatic cancer, including the regulation of immune

surveillance and the tumor microenvironment by CD40 and other pathways. His translational work tests novel approaches such as vaccines, antibodies, and adoptive T cells for the treatment of patients with pancreatic cancer, as well as breast cancer and melanoma. He has studied ‘universal’ tumor antigens such as hTERT and immune modulatory pathways involving CD40, GM-CSF, PD-1, CTLA-4, and CD25.


Zach WeinbergCo-Founder, COOFlatiron Health

Zach is co-founder, president and COO of Flatiron Health, where he oversees all activities related to product development, software engineering, talent and operations. Before co-founding Flatiron Health, Zach was co-founder, president & COO of Invite Media, an advertising

technology company based in NYC. Invite Media was acquired by Google in 2010. An active angel investor, Zach has invested in over 50 technology and healthcare startups throughout the country, including Blue Apron, Clover Health, Color Genomics, Doctor Evidence, Oscar, Plaid and SwipeSense. Zach studied economics and entrepreneurship at The Wharton School at the University of Pennsylvania.

Peter P. Yu, MD, FACP, FASCOPhysician-in-ChiefHartford HealthCare Cancer Institute

Dr. Peter Paul Yu is Physician-in-Chief of the Hartford HealthCare Cancer Institute and Affiliate Member and Head of Health Informatics for the MSK Cancer Alliance at Memorial Sloan Kettering Cancer Center. He graduated from the combined undergraduate and medical school Program in Medicine at Brown University. His residency was at St. Luke’s-Roosevelt Medical Center in New York City where he was Chief Resident. After a fellowship at Mount Sinai Medical Center, Dr. Yu completed a postdoctoral fellowship at Memorial Sloan-Kettering Cancer Center in the laboratory of Dr. John

Mendelsohn. He has served as President of the Association of Northern California Oncologists, Chief of Medicine at El Camino Hospital in Mountain View, member of the Board of Directors of Pathways Homecare and Hospice and as member of the Audit Committee of the Alliance for Clinical Trials in Oncology. Dr. Yu served as President of the American Society of Clinical Oncology (ASCO) 2014-2015. Past ASCO activities have included Board Member, Chair of the Clinical Practice Committee, Chair HIT Work Group, Chair Awards Committee, member of the Cancer Research, Integrated Media, Grant Selection, Audit, Nominating, Scientific Program, Education and Quality of Care committees. Dr. Yu was Chair of the Best of ASCO San Francisco 2005; Chair ASCO EHR Symposium 2009; Annual Meeting Educational Session Chair in 2007, 2009, 2010 and 2014; and faculty of the Clinical Trials for the Community Oncology Team Workshop 2005. Dr. Yu has served as co-chair of the Commission for Certification of Health Information Technology (CCHIT) Oncology work group, co-chair of the AMA-RAND Clinical Decision Support Oncology work group under contract to the Office of the National


Coordinator for Health Information Technology, co-chair of the ASCO-NCI CORE informatics project and has participated in several Institute of Medicine health information technology workshops. He is a member of the College of American Pathologists Cancer Biomarker Reporting Committee, Epic Oncology Steering Board, Global Alliance for Genomics & Health, Hutchinson Institute for Cancer Outcomes Research External Advisory Board and the California Department of Health California Cancer Registry External Advisory Committee.

Mary M. Zutter, MDVice President for Integrative DiagnosticsLouise B. McGavock Professor of Pathology, Microbiology & ImmunologyProfessor of Cancer BiologyDirector, Host-Tumor Interaction ProgramVanderbilt Ingram Cancer CenterVanderbilt University Medical Center

A physician-scientist with clinical expertise in Pathology, Molecular Pathology and Hematopathology, Dr. Zutter’s research focuses on the role of cell adhesion molecules in host-tumor interactions. At Vanderbilt Univeristy Medical Center, in July 2011, Dr. Zutter assumed the role of Vice President for Integrative Diagnostics. The goal of this position is to enhance

the activities of Vanderbilt University Medical Center in emerging integrative diagnostics at the leading edge of personalized medicine. This role was designed and continues to integrate efforts across departments, centers, and disciplines to build the “best in class” personalized/precision medicine at Vanderbilt. Dr. Zutter’s team envisioned, developed and implemented an evidenced-based decision support system for oncologists within Vanderbilt Medical Center. The Diagnostic Management Team (DMT) serves as an exciting proof-of-concept that operationalizing real-time collaboration between oncologists and pathologists can improve diagnostic value and has been important in growing Vanderbilt’s position as a leader in precision medicine. Dr. Zutter has focused her research on the molecular basis of cell-matrix interactions and the mechanisms by which these interactions influence cancer progression and metastasis. The Zutter Laboratory has been funded continuously from the NIH for over 20 years. Much of this effort has been centered on the α2β1 integrin. The α2β1 integrin, a receptor for multiple cell adhesion and anti-angiogenesis molecules, has been implicated in normal developmental, inflammatory, and oncogenic processes. Ongoing work focuses on the role of the α2β1 integrin as a metastasis suppressor gene and the mechanisms by which the α2β1 integrin mediates its anti-metastatic role. Building on her expertise in host-tumor research, she is active within the leadership of the Vanderbilt Ingram Cancer Center (VICC) and serves as the co-leader of the Host Tumor Interaction Program in VICC.



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collaboration.aacr.orgcollaboration.aacr.org/sites/GenomicsThinkTank/Shared... · Web viewGirish Putcha, MA, MS, MD, PhD Director of Laboratory Science, MolDX Palmetto GBA Girish