Session Abstract – PMWC 2023 Silicon Valley


Track 1, January 27

Track Co-Chair:
Mary Relling, St. Jude

Pharmacists have long recognized that using unique patient characteristics to guide pharmacotherapy decision-making can improve drug response and mitigate drug-associated risks. Age, weight, and dietary habits were among the first patient-specific characteristics used to individualize pharmacotherapy. As technologies advanced, analytic tools that measure surrogate markers of liver and renal function, together with drug concentrations in biological fluids, were adopted to optimize therapeutic regimens. Cutting-edge genomic technologies are now being integrated into patient care for the selection of targeted therapies and identification of those at increased risk of poor pharmacotherapy outcomes. We’re excited to bring together experts who are advancing pharmacogenomics at scale through cutting edge clinical implementation, research, and education.

  • Fireside Chat
    PMWC 2023 Pioneer Honoree Dan Roden, Vanderbilt University Medical Center with Mary Relling, St. Jude
  • PMWC 2023 Honoree Keynote
    - Kelly E. Caudle, St. Jude
  • Laboratory Testing and Reports
    Chair: Kristy Crooks, University of Colorado
    - Ann M. Moyer, Mayo Clinic
    - Stuart Scott, Stanford University
  • From Economics to Reimbursement
    Chair: Sara Rogers, American Society of Pharmacovigilance
    - Stirling Bryan, The University of British Columbia
    - Ray Stultz, Optum
  • Policy Efforts to Address Barriers to PGx Adoption
    Chair: Kristine Ashcraft, Invitae
    - Pam Traxel, ACS CAN
  • PGx Practice Liability
    - Dan Hertz, University of Michigan
    - Anthony Morreale, VA, San Diego
    - Karen Merritt, Patient Advocate
  • Diversity, Equity, and Inclusion in Pharmacogenomics Implementation
    - Carlos Bustamante, Galatea Bio
  • Implementation of PGx at UCSF
    - Bani Tamraz, UCSF

 Session Chair Profile

PHARM.D., Endowed Chair, St. Jude Children’s Research Hospital

Biography
Dr. Relling has been a pioneer in both the science and clinical application of pharmacogenomics. Her research has resulted in seminal laboratory discoveries that unraveled the mechanisms of drug-induced adverse effects, and the integration of biologic, genomic, and pharmacologic discoveries into comprehensive clinical protocols, leading to improved cure rates for children with acute lymphoblastic leukemia. In recognition for her work she was elected to the Institute of Medicine (now National Academies of Medicine) in 2009 and received the Pediatric Oncology Award from ASCO. Mary has been recognized by the American Society for Clinical Pharmacology and Therapeutics. Mary, along with Dr. Teri Klein of Stanford, co-led the formation of the Clinical Pharmacogenomics Implementation Consortium (CPIC) that has published pharmacogenetic guidelines for thirty-five drugs. These guidelines are now implemented around the globe. Mary received her Bachelor of Science degree from the University of Arizona and her PharmD from the University of Utah College of Pharmacy.


 Session Chair Profile

Medical Affairs Director, Pharmacogenomics, Invitae

Biography
Kristine Ashcraft is a molecular biologist by training and is the former CEO and founder of YouScript, recently acquired by Invitae. She has worked in pharmacogenomics since 2000 and was named one of the 25 leading voices in precision medicine. She serves on the STRIPE Steering Committee, the FDA collaborative community for pharmacogenomics. Kristine has authored multiple publications on the clinical and economic benefits of pharmacogenomic testing including one lauded as one of the most influential publications at an American Medical Informatics Association meeting. She has been interviewed by numerous media outlets including the New York Times, the Wall Street Journal, and NBC Nightly News and has spoken at SXSW, American Society of Human Genetics, and numerous precision medicine conferences. She is committed to catalyzing the adoption of precision medicine.

Talk
Policy Efforts to Address Barriers to PGx Adoption
A discussion of federal and state policy efforts to address known barriers to PGx adoption such as reimbursement, education, and healthcare IT infrastructure including the Right Drug Dose Now Act and American Cancer Societys state biomarker testing bills.


 Session Chair Profile

Ph.D., FACMG, Associate Professor of Pathology, University of Colorado Anschutz Medical Campus, Univ. of Colorado

Biography
Dr. Crooks is a board-certified clinical molecular and cytogeneticist and Director of the Colorado Center for Personalized Medicine (CCPM) Biobank, an institutional initiative for the development of sample cohorts and genetic and health record datasets for research and clinical use. With over 200,000 participants from across the United States, the CAP-accredited CCPM Biobank represents one of the largest and most diverse clinical biorepository cohorts generated to date. Dr. Crooks’ primary research interests include evaluating metrics of population-based genetic screening and return of clinically-actionable genetic test results, including pharmacogenetics and high-impact pathogenic constitutional variants, to advance precision medicine and improve patient outcomes.


 Session Chair Profile

PHARMD, President, ASP

Biography
Sara Rogers co-founded the American Society of Pharmacovigilance and co-led the formation of the Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative Community, a public-private multidisciplinary initiative to develop consensus-based industry standards for pharmacogenetics testing. She joined Texas A&M University in 2021, where she holds joint appointments with Institute of Biosciences and Technology, School of Medicine and Irma Lerma Rangel School of Pharmacy. Rogers co-chairs the Pharmacogenomics Access and Reimbursement Coalition and collaboratively develops the Coalition’s research agenda to understand the payment and policy landscape for pharmacogenetics testing and its role in disparities in patient access. Rogers is an organizational member of the NIH NHGRI Inter-Society Coordinating Committee and develops educational resources to help practitioners navigate coverage for pharmacogenetics testing. Rogers has served as co-investigator for a pilot study to identify ethical values and priorities related to pharmacogenomics. Her research focuses extensively on patient access to and reimbursement for pharmacogenetics testing.

Talk
From Economics to Reimbursement
While innovative precision technologies can improve patient outcomes; they present new information and price shocks to payers. Emerging clinical guidelines may add to the confusion and further hamper payer acceptance. During this session, we’ll explore payer perspectives in the evidence evaluation processes that guide coverage decisions.


 Speaker Profile

Ph.D., Professor, Stanford

Biography
Dr. Scott is a Professor in the Department of Pathology at Stanford University and Director of the Stanford Medicine Clinical Genomics Laboratory, where he oversees genomic test innovation and implementation. In addition, Dr. Scott is certified by the American Board of Medical Genetics and Genomics (ABMGG) in Clinical Molecular Genetics and Genomics, and Clinical Cytogenetics, and his research interests include human genomics, pharmacogenomics, cytogenomics, long-read sequencing, and the implementation of genomic medicine. He is a member of the Clinical Pharmacogenetics Implementation Consortium (CPIC), PharmGKB, PharmCAT, PharmVar, AMP Pharmacogenomics Working Group, International Union of Basic and Clinical Pharmacology (IUPHAR), and other national human genomics consortia (ClinGen, UDN, GREGoR). He has co-authored several CPIC practice guidelines and has published over 140 peer-reviewed manuscripts and book chapters on clinical genomics, pharmacogenomics, and genomic medicine implementation.


 Speaker Profile

PHARMD, Associate Chief Consultant Clinical Pharmacy, VA, San Diego

Biography
Dr. Morreale has been entrusted with organizing, standardizing and expanding the scope of clinical pharmacy practice nationally since 2010. In recent years this has included the integration of pharmacogenomics into clinical practice for pharmacists in all practice settings. In 2018 he took on the added responsibility of overseeing national policy development and maintenance for the which also involves developing and implementing practice changes, policy, regulations and guidance. Prior to this national position he served as Chief and Associate Chief of Pharmacy for a large Healthcare System and its satellite facilities for nearly 20 year giving him a great deal of experiencing in running and managing a highly complex pharmacy organization. He is well versed in the legal, regulatory, and operational aspects and challenges facing such organizations.

Talk
PGx Practice Liability
Integration of pharmacogenomic (PGx) testing into clinical practice has accelerated, moving it from a novelty to a standard part of patient care. As PGx testing becomes a standard of care, failure to integrate it into patient care practice could lead to instances where care may not be optimized, raising potential malpractice issues.


 Speaker Profile

Senior Vice President, ACS CAN

Biography
Pam is responsible for helping ACS CAN develop relationships with companies and individuals to help further the fight against cancer through dynamic partnerships, events, and forums. Pam began her career with ACS CAN in 2007. She has been integrally involved in helping to establish ACS CAN as a nationwide advocacy organization that influences and shapes public policy at all levels of government to impact our mission and to represent the voices of all cancer patients and their families.


 Speaker Profile

MD, Founder, Galatea Bio Inc

Biography
Focused on genomics technology and its application in medicine, agriculture, and evolutionary biology. I was Founding Director (with Marc Feldman) of the Center for Computational, Evolutionary, and Human Genomics. I serve as an advisor to the US federal government, private companies, startups, and non-profits in the areas of computational genomics, population and medical genetics, veterinary and plant genomics, and business strategy.


 Speaker Profile

PHD, PHARMD, Assistant Professor, U. of Michigan

Biography
Academic researcher focusing in cancer biomarkers including pharmacogenetics, with particular interest in chemotherapy-induced peripheral neuropathy and clinical uptake of pre-treatment DPYD testing.


 Speaker Profile

Product Director of Pharmacogenomics, Optum Rx

Biography
Ray currently works at Optum Rx within the Product & Strategy organization. Over the past 4 years he has been charged to explore the space of Pharmacogenomics, and how it could be utilized within the Pharmacy Benefit Manager space. In this work he has helped conduct 4 pilots and 1 clinical study. These studies have been targeted toward answering the companies killer questions. The last of which is what the clinical study was looking to answer, which is will the use of PGx drive down the total cost of care for a utilizing member. Ray has been at UnitedHealth Group for the better part of 15 years with roles Marketing, Research & Development, Operations, and Product Development.


 Speaker Profile

Ph.D., Professor / CSO, UBC

Biography
Stirling Bryan is a health economist with a passion for building and supporting patient-oriented learning health systems. Before emigrating to Canada in 2008, Stirling held academic positions in the U.K. at St Thomas’ Hospital, Brunel University, and the University of Birmingham. He was a Commonwealth Fund Harkness Fellow in 2005/06, spending a year at Stanford University, and in 2020 was elected as a Fellow of the Canadian Academy of Health Sciences.