Session Abstract – PMWC 2023 Silicon Valley

Track 3 - January 25 9.00 A.M.-4.30 P.M.


Track Chair: Hakan Sakul, Pfizer

  • PMWC Award Ceremony:
    Honoree: Todd Golub, Broad Institute
  • Fireside Chat: Precision Medicine: Past, Present and Future
    - Todd Golub, Broad Institute
    - Hakan Sakul, Pfizer
  • Challenges in Providing Global Access to Precision Health (PANEL)
    Chair: Mike Pellini, Section32
    - Peter Kuhn, USC
    - Steven Rosen,
    - Sarah Hersey, BMS
    - Ed Abrahams, PMC
  • Regulatory and Reimbursement Challenges for Precision Medicines (PANEL)
    Chair: Cynthia Bens, PMC
    - Robert Dumanois, ThermoFisher
    - Kaska Kowanetz, Pfizer
    - Sarah Hersey, BMS
    - Elaine Katrivanos, Tempus
    - Elizabeth Mansfield, Foundation Medicine
  • Early Cancer Detection 360 Degree View
    Chair: Christian Wolfrum, Siemens Healthineers
    - Christian Eusemann, Siemens Healthineers
  • Novel Clinical Trial Designs (PANEL)
    Chair: Razelle Kurzrock, Medical College of Wisconsin
    - Jim Palma, Target Cancer Foundation
    - Corrie Painter, TBA
  • Expanding Precision Medicine into Non-Traditional Settings
    - Ed Kim, City of Hope
  • Equity in Delivery of Precision Cancer Care through Community-Academic Partnerships
    - Manali Patel, Stanford
  • Challanges in Genomic Profiling of Pediatric Cancers
    - Andrew Kung, MSK
    - Christina Curtis, Stanford
  • PMWC NCI Showcase
    - Solomon Diamond, Lodestone
    - Jennifer Smith, PreCyte

 Session Chair Profile

M.D., Managing Partner, Section 32

Biography
Mike is a Managing Partner of Section 32, a venture capital fund investing at the frontiers of technology and healthcare. Prior to joining Section 32 in 2017, he served as CEO of Foundation Medicine, a company which transformed the way pharmaceutical companies and physicians evaluate the genomic changes underlying a patient’s cancer, until he transitioned to chairman through the close of Roche’s (NASDAQ:RHHBY) acquisition of FMI in August 2018. Previously, he was President and COO of Clarient, a national leader in molecular pathology, which was acquired by GE Healthcare in 2010. He currently serves as a member of the Board of Directors for Nusano, Singular Genomics, Adaptive Biotechnologies, Octave BioSciences, Sema4, TwinStrand Genomics, and the Personalized Medicine Coalition. He previously served on the board of Thrive Earlier Detection, which was acquired by Exact Sciences (NASDAQ: EXACT) in January, 2021.


 Session Chair Profile

Ph.D., Ph.D., Head New Business Development & Planning, Siemens Healthineers

Biography
Christian is responsible for driving business development and incubation in adjacent fields and white spaces at Siemens Healthineers. Christian and his team evaluate opportunities, trigger investments in start-ups, and drive partnership projects – with a particular focus on the field of precision medicine. Christian also serves on the board of associations and start-up companies focusing on precision medicine. Christian brings more than 15 years of experience in new business development and has successfully incubated a variety of new products, developed strategies for leading global companies, and is the (co)-inventor of assorted patent families. He is driven by his passion to bridge the chasm between innovative ideas and the commercialization of new technologies.


 Session Chair Profile

PMWC PIONEER AWARD
Pioneering precision medicine clinical trials & studies in the US and around the world, and the use of liquid biopsy to predict immunotherapy

M.D., FACP, Center Associate Director, Professor, Medical College of Wisconsin

Biography
Dr. Kurzrock is a board-certified medical oncologist and a renowned expert in precision medicine. She is known for developing one of the largest and best known Phase I clinical trial programs in the United States while at MD Anderson Cancer Center in Texas. Dr. Kurzrock established the UCSD’s Center for Personalized Cancer Therapy at the Moores Cancer Center. The center focuses on genomically-driven therapy as well as precision immunotherapy, especially in rare cancers. Dr. Kurzrock is a global leader in personalized medicine, bringing the first transcriptomic study to the clinic in an international setting spanning five countries (WINTHER), as well as the first study of individually customized combination therapy (IPREDICT). Dr. Kurzrock received her MD from the University of Toronto, Canada. She has over 800 PubMed publications, an H-index of 122, has been named to the lists of most highly cited scientists in the world and the 25 world leaders in precision medicine, and she has a uniquely strong record of competitive funding with more than 100 million dollars in lifetime funding.


 Session Chair Profile

Ph.D., VP, Head of Diagnostics, Pfizer

Biography
Dr. Sakul led implementation of Pfizer’s diagnostics strategy and currently directs its Diagnostics programs. Under his leadership, FDA approvals were achieved for 7 CDx tests accompanying Pfizer oncology drugs to markets. Hakan serves on the Boards of Progentec Diagnostics and BASH Biotech, and a member of California Governor Newsom’s Precision Medicine Advisory Council. Hakan received his BS and MSc degrees from Ankara University in Turkey, PhD in Quantitative Genetics from the University of Minnesota as a Rotary Foundation Scholar, and conducted postdoctoral studies at the University of California-Davis. He worked in biotech in human genetics and statistical genetics early in his career before moving to pharma. He is the author of over 30 refereed scientific articles as well as many other papers and abstracts. Hakan is keenly interested in molecular diagnostics, liquid biopsy, near-patient testing and related medical technologies to advance Precision Medicine for the improvement of individualized healthcare.


 Speaker Profile

M.D., Director, UCSF Breast Care Center, UCSF

Biography
Dr. Esserman's work spans the spectrum from basic science to public policy issues, and the impact of both on the delivery of clinical care. She is recognized as a thought leader in cancer screening and over-diagnosis, as well as innovative clinical trial design. She led the creation of the University of California-wide Athena Breast Health Network, a learning system designed to integrate clinical care and research as it follows 150,000 women from screening through treatment and outcomes. The Athena Network launched the PCORI-funded Wisdom Study, which tests a personalized approach to breast cancer screening in 100,000 women. She is also a leader of the innovative I-SPY TRIAL model, designed to accelerate the identification and approval of effective new agents for women with high risk breast cancers. In 2020 she got FDA approval for an I-SPY Covid trial, designed to rapidly screen and confirm high impact treatments to reduce mortality and time on ventilators.


 Speaker Profile

PMWC LUMINARY AWARD
Pioneering the use of genomic approaches to molecularly characterize human tumors, laying the foundation for the use of genomics to classify, diagnose, and treat cancer

MD, Director, Broad Institute

Biography
Todd Golub is director and a founding core member of the Broad Institute of MIT and Harvard. Golub is a world leader in using genomics tools to understand the basis of cancer. He also pioneered the development of new cell-based approaches to drug discovery for cancer and other diseases. Golub is also the Charles A. Dana Investigator in Human Cancer Genetics at the Dana-Farber Cancer Institute and professor of pediatrics at Harvard Medical School. He is the recipient of multiple awards, including the Outstanding Achievement Award from the American Association for Cancer Research, the Paul Marks Prize for Cancer Research, and the Daland Prize from the American Philosophical Society. In 2014 he was elected to the National Academy of Medicine.


 Session Chair Profile

M.D., Senior Vice President & Physician-in-Chief, City of Hope

Biography
Dr. Kim is physician-in-chief and senior vice president at City of Hope Orange County and vice physician-in-chief and professor at City of Hope National Medical Center. Dr. Kim is an international leader in lung cancer having published over 200 peer-reviewed articles in top tier journals. He has previously served as an associate tenured professor at The University of Texas MD Anderson Cancer Center, Chair of Solid Tumor Oncology at Levine Cancer Institute, Atrium Health, and obtained his MBA at the University of North Carolina Kenan-Flagler School of Business, Chapel Hill, NC.


 Speaker Profile

Ph.D., Director, Global Regulatory Affairs, Pfizer

Biography
Kaska Kowanetz is a RAC (Global)-certified Regulatory Affairs professional with over 17 years of experience in the biotechnology/pharma industry, currently holding a position of a Global Regulatory Lead in Pfizer Global Regulatory Affairs Oncology. In addition to her roles leading regulatory strategy development for both early and late-stage oncology programs, Kaska serves as a cross-portfolio expert for the regulatory aspects of drug and companion diagnostics co-development.


 Speaker Profile

Director, Reimbursement Strategy, Thermo Fisher

Biography
Rob leads reimbursement and HEOR activities for Thermo Fisher Scientific’s clinical sequencing division. Experienced in all facets of NGS testing’s coverage, coding, and billing – Rob works with CLIA labs, pharma partners and coalitions to explain the complex and often contradictory U.S. environment and devise pathways to achieve their desired goals. He’s also worked with Oncomine™ Dx Target Test: the first FDA-approved next-generation sequencing (NGS) in vitro diagnostic test for non-small cell lung cancer. This companion diagnostic is now covered nationally by Medicare and dozens of commercial payers. Rob joined Thermo Fisher (Life Technologies) in 2012 through an acquisition of Navigenics, where he led development and growth of payers and employers. Rob was also a Territory Vice President at RelayHealth, with duties that included payer-facing sales of secure messaging and e-prescribing. He also held senior sales and sales management positions with UnitedHealthcare.


 Speaker Profile

Ph.D., Professor, USC

Biography
Peter is a scientist, educator and entrepreneur with a career long commitment in personalized medicine and individualized cancer patient care. He is focused on the redesign of cancer care. The first product from technology developed by Dr. Kuhn became available for prostate cancer care in June 2016. Dr. Kuhn’s strategy is to advance our understanding of the human body to improve the human condition for those affected by cancer. His research is shedding new light at how cancer spreads through the body and evolves over time. This new science leads to a personalized care strategy that is biologically informed and clinically actionable. Dr. Kuhn has published over 300 peer reviewed manuscripts and his work has been cited over 22k times. His research has resulted in the creation of multiple companies including Epic Sciences and Cansera.


 Speaker Profile

B.A., Senior Vice President, Public Policy, Personalized Medicin

Biography
Cynthia A. Bens leads the Personalized Medicine Coalition’s policy development and government relations efforts and serves as its primary liaison with the U.S. Congress and federal regulators. Ms. Bens is responsible for implementing research, regulatory and reimbursement policy strategies that promote the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. Before joining PMC, Ms. Bens was the Vice President of Public Policy at the Alliance for Aging Research. Ms. Bens guided the Alliance’s federal policy work, represented the organization in multiple national coalitions and directed all aspects of coalitions led by the Alliance. Through various other positions on Capitol Hill and in the private sector, she has acquired extensive experience researching and analyzing federal legislation and regulations. Ms. Bens holds a bachelors degree from New York University with concentrations in political science and women’s studies.


 Speaker Profile

M.D., Director, Broad Inst.

Biography
Todd Golub is director and a founding core member of the Broad Institute of MIT and Harvard. Golub is a world leader in using genomics tools to understand the basis of cancer. He also pioneered the development of new cell-based approaches to drug discovery for cancer and other diseases. Golub is also the Charles A. Dana Investigator in Human Cancer Genetics at the Dana-Farber Cancer Institute and professor of pediatrics at Harvard Medical School. He is the recipient of multiple awards, including the Outstanding Achievement Award from the American Association for Cancer Research, the Paul Marks Prize for Cancer Research, and the Daland Prize from the American Philosophical Society. In 2014 he was elected to the National Academy of Medicine.


 Speaker Profile

Vice President of Regulatory Affairs, Tempus

Biography
Elaine Katrivanos is Vice President, Regulatory Affairs at Tempus Labs, Inc. and, in this role, is responsible for leading the Regulatory Affairs department. Prior to joining Tempus, Elaine was a global regulatory lead in pharmaceutical drug development at AstraZeneca. Before that, Elaine worked at CDRH/FDA for 12 years and served in a variety of key roles including premarket and post-market device review, policy development, and management. Elaine earned a degree in biomedical engineering from the University of Pittsburgh.


 Speaker Profile

Executive Director, TargetCancer Foundation

Biography
Since joining TargetCancer Foundation in 2010, Jim has overseen its growth from a small start-up to a nationally recognized foundation supporting comprehensive rare cancer research programs and patient support services. Prior to joining TargetCancer Foundation, he spent eleven years at Fidelity Investments in Boston, MA. Jim is a member of the Board of Directors of the National Organization for Rare Disorders (NORD), and is a founding Co-Chair of the NORD Rare Cancers Coalition. In addition, Jim is a Steering Committee member at the GI Cancers Alliance and the Global Cholangiocarcinoma Alliance. Jim completed studies at the Institute for Nonprofit Management and Leadership at the Questrom School of Business at Boston University, and received his B.A. from Loyola University Maryland.


 Speaker Profile

MD, Professor of Medicine, MCW Cancer Ctr.

Biography
Razelle Kurzrock, MD, is a world leader in precision medicine and immunotherapy. As a medical oncologist/researcher, she is recognized as one of the most important voices in precision medicine and one of the most highly cited scientists globally. Dr. Kurzrock is known for founding and chairing the largest Phase 1 clinical trials department in the world while at the MD Anderson Cancer Center. More recently, at the University of California, Dr. Kurzrock founded and led the Rare Tumor Clinic and the Center for Personalized Cancer Therapy. Dr. Kurzrock has brought oversight to >500 clinical trials, with many agents yielding FDA approvals. She has authored >900 peer-reviewed paper with an exception Hirsch index (h-index) score of 136 (>77,000 citations). Her strong record of competitive funding is comprised of ~$125 million in lifetime funding. She has four children, two Basenjis (dogs) and is married to Philip Cohen, MD, who is a dermatologist.


 Speaker Profile

M.D., Professor of Surgery and Pharmacology, UC San Diego Health

Biography
Dr. Jason Sicklick is an NIH and FDA R01 funded investigator, Executive Vice Chair of Research in the Department of Surgery, and Leader of the Sarcoma Disease Team at the UC San Diego Moores Cancer Center. He is a board-certified general surgeon and surgical oncologist specializing in the treatment of complex retroperitoneal and abdominal sarcomas, including gastrointestinal stromal tumors (GIST), as well as hepatobiliary oncology. His translational and clinical research focus on molecular mechanisms of GIST, as well as precision medicine approaches to cancer therapy for advanced cancers.


 Speaker Profile

MBA, RAC, Vice President, Head of Translational Sciences & Diagnostics, BMS

Biography
Sarah has more than 20 years of industry experience in leading R&D organizations, CLIA and GLP laboratories, device manufacturing, consortiums, assessment and implementation of technology strategies, and development of in vitro diagnostics. In addition, she continuously works to further education and awareness in Precision Medicine and Companion Diagnostic spaces. Prior to joining BMS, Sarah was the Vice President, Precision Medicine & Companion Diagnostics for Celgene, where she founded their Precision Medicine Organization in 2016. She joined Celgene after having held the position as the Global Head of Future Precision Medicine for Novartis, where the team submitted and gained approval for multiple Health Authority applications; including the first pre-market approval for a distributable NGS CDx.Sarah has also held multiple roles with increasing responsibility within Johnson and Johnson (JNJ) including Global Head of Operations, Assay Program Leader for Companion Diagnostics Center of Excellence, Director of Materials Process Development and Enabling Technologies.


 Speaker Profile

Ph.D., Vice Pres, RA, Foundation Medicine

Biography
Elizabeth "Liz" Mansfield manages regulatory strategy for innovative IVD products in a global market. Liz previously led the Personalized Medicine staff in CDRH at FDA. She was VP of Regulatory Affairs at GRAIL, Inc, and offered consulting for IVD sponsors prior to joining FMI in 2020.


 Speaker Profile

M.D., Ph.D., Chair, MSKCC

Biography
Dr. Andrew Kung is a physician-scientist whose clinical practice is focused on cancer genomics, precision cancer medicine and stem cell transplantation. The overarching goal of his patient-driven research program is to identify new causes of and treatments for childhood and young adult cancers. The translational oncology research in his laboratory is powered by the integration of diverse experimental approaches including genomics, data science, experimental therapeutics, and human clinical studies. His laboratory has advanced several novel therapeutic strategies to the clinic for hematologic malignancies, solid tumors, and brain tumors.


 Speaker Profile

Ph.D., VP External Research & Partnerships, Precede Bio

Biography
Painter is the VP of External Research & Partnerships with Precede Biosciences, an early stage liquid biopsy company, where she drives external research and collaborations focused on maximizing the impact of a novel technology to improve the lives of patients. Painter is the former Deputy Director and remains a Strategic Advisor to Count Me In, a patient-partnered genomics initiative of the Broad Institute of MIT and Harvard. A trained cancer research scientist with a Ph.D. in biochemistry, Painter co-developed and oversaw the creation of a nation-wide clinico-genomics data platform built in lockstep with the community of cancer patients reflected in each study. Painter, an angiosarcoma survivor, is also a passionate leading patient advocate who co-founded and serves as the President of Angiosarcoma Awareness, an organization that supports research and awareness efforts surrounding this disease.


 Speaker Profile

Ph.D., CEO, Lodestone Biomedical

Biography
Sol is an inventor and entrepreneur with 20 years experience in medical imaging research and the co-founder of Lodestone Biomedical. He is also an Associate Professor of Engineering at Dartmouth College where he is a Member of the Translational Engineering in Cancer Research Program at the Dartmouth-Hitchcock Medical Center. Sol has over 50 publications, 2500 citations, and holds 8 US patents.

Talk
A Platform Technology for In Vivo Biomarker Monitoring
Lodestone has developed a biosensor platform for in vivo monitoring of treatment response from within the tumor-immune microenvironment. Our preclinical reader provides non-invasive measurements of cytokine levels to help drug developers accelerate their research and confirm treatment efficacy. The nanoparticle-based assay within the implantable biosensor can be adapted to measure various molecular targets.


 Speaker Profile

M.D., Assistant Professor , Stanford

Biography
Dr. Manali Patel is an Assistant Professor at Stanford in the Division of Oncology and a Staff Thoracic Oncologist at the VA Palo Alto Health Care System. She is a health services researcher and directs a research program that focuses on improving equitable delivery of value-based cancer care. She uses principles of community-based participatory research in her work and is the principal investigator of multiple externally funded awards such as the California Initiative to Advance Precision Medicine, the Patient Centered outcomes Research Institute, and the National Institutes of Health. Dr. Patel serves on several national committees focused on improving cancer care delivery and value-based care. She earned her MD and Masters in Public Health at the University of North Carolina at Chapel Hill, followed by Internal Medicine Residency, Hematology and Oncology Fellowship and several research fellowships in addition to obtaining a Masters in Health Services Research at Stanford.

Talk
Precision Cancer Care Equity through Community-Academic Partnerships
The routine integration of precision medicine has vastly reduced cancer mortality, but have also widened disparities gaps by race and ethnicity. Multilevel etiologies include lack of equitable delivery of precision cancer care among racial and ethnic minorities and populations with low income. Partnerships with stakeholders at each level can overcome such disparities.


 Speaker Profile

Ph.D., VP Research and Innovation, Siemens Healthineers

Biography
Christian Eusemann, PhD, has a long history of overseeingresearch and innovation in the areas of medical imaging, laboratory diagnostics, therapies, and health economics, both in academia and the medical device industry, and with areas of expertise that range from medical physics to artificial intelligence. Having held academic positions at Harvard Medical School and the Mayo Clinic College of Medicine, Eusemann is currently a Board Member of the University City Science Center in Philadelphia in addition to serving on the advisory boards of various societies, hospitals, and universities. He holds multiple patents, including several related to computed tomography, medical imaging display, and image reconstruction and sequencing. Eusemann has been published in numerous peer review journals and presented at many conferences across the globe.


 Speaker Profile

Ph.D., Professor of Medicine, Stanford

Biography
Dr. Curtis’ laboratory leverages data analytics, high-throughput molecular profiling and experimentation to develop new ways to prevent, diagnose and treat cancer. Her research has led to new paradigms in understanding how human tumors evolve and metastasize and has redefined the molecular map of breast cancer. She has been the recipient of numerous awards, including those from the V Foundation for Cancer Research, STOP Cancer, the American Association for Cancer Research (AACR). She received the National Institutes of Health Directors Pioneer Award in 2018 and was named an In Vivo Rising Star in 2021. She is a Kavli Fellow of the National Academy of Sciences, a Susan G. Komen Scholar, and a Chan Zuckerberg Biohub Investigator. In 2022, she received the AACR Award for Outstanding Achievement in Basic Science. She is a scientific advisor to multiple academic institutes, biotech and biopharma, and is a member of the AACR Board of Directors.


 Speaker Profile

Ph.D., President, PMC

Biography
Under Edward Abrahams leadership, the Personalized Medicine Coalition, an education and advocacy organization based in Washington, DC, has grown from its original 18 founding members in 2004 to more than 220 today. Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services, and products for the benefit of patients and health systems. Previously, Dr. Abrahams was the Executive Director of the Pennsylvania Biotechnology Association, where he spearheaded the successful effort that led to the Commonwealth of Pennsylvania’s investment of $200 million to commercialize biotechnology in the state. He is the author of The Lyrical Left: Randolph Bourne, Alfred Stieglitz and the Origins of Cultural Radicalism in America. He serves on the editorial board of Personalized Medicine, and has also taught history and public policy at Brown University and the University of Pennsylvania.


 Speaker Profile

Ph.D., CSO Twin Orbit, Wyss Harvard

Biography
During his 35 year career in the medical device and pharmaceutical fields, Steve has focused on Innovation and strategy development for several well-known healthcare companies such as Roche Diagnostics, Johnson and Johnson and Novartis, as well as starting his own management consulting firm focused on early stage business formation, fundraising and transaction execution. Steve regards himself as a generalist who enables innovative science in healthcare systems with multiple stakeholders. He is enthusiastic about working with both small and large companies and driving their success using focused strategies and the efficient use of capital. Steve received his bachelor’s degree in biochemistry from Brandeis University and his Ph.D. from The Sacker Institute of Biomedical Science at New York University Medical Center.


 Speaker Profile

Ph.D., Founder, President and CSO, PreCyte

Biography
My career has focused on cell biology and the development and application of systems biology approaches to understand cellular mechanisms. In 2014, I began apply these skills to the challenging problem of blood-based diagnostics. Identification of blood biomarkers is challenging because of very weak signal to noise ratios. Using cultured cells as biosensors can overcome this problem by capitalizing on the natural ability of cells to detect and respond to weak signals in noisy environments. Over the past 8 years at PreCyte, I have lead the development of the indicator cell assay platform (iCAP), a novel diagnostic tool that uses cells as biosensors to detect and respond to disease indicators in blood. We use machine learning tools to identify cell responses that can robustly indicate early stage disease in the patients. We are initially applying the assay for early detection of lung cancer and Alzheimers disease.

Talk
Elevating Blood-based Diagnostics Using Cells as Biosensors
We are developing a novel tool for blood-based diagnostics called the indicator cell assay platform (iCAP). The assay uses cultured cells as biosensors that detect and respond to weak disease signals in patient blood samples and machine learning tools to find reliable disease indicators in the cell response.