Session Abstract – PMWC 2024 Silicon Valley

Track 1 - January 26 9.00 A.M.-4.15 P.M.


Track Chair:
Kelly E. Caudle, St. Jude

The PMWC 2024 Pharmacogenomics (PGx) Track focuses on advancing standardization in pharmacogenomics to achieve better clinical outcomes. The importance of standardization in PGx cannot be overstated as it can help to improve patient care in several ways. Standardization of clinical laboratory processes can help ensure consistent and accurate test results, which is crucial for making informed clinical decisions. Standardization of reporting can help to ensure that test results are communicated in a clear and understandable manner to clinicians and patients. Standardization of pharmacogenomic test ordering and reimbursement can help to ensure that patients have access to the tests they need, regardless of their location or financial situation. Standardization of PGx education can help to ensure that healthcare professionals have the knowledge and skills they need to use PGx in clinical practice effectively. Finally, clinical pearls and outcome data can help to demonstrate the value of PGx in improving patient outcomes and informing clinical decision-making.

  • PMWC 2024 PGx Award Ceremony:
    Pioneer Honoree: Andrea Gaedigk, Children’s Mercy Research Institute (CMRI)
    Luminary Honoree: Teri E. Klein, Stanford
  • Standardization: Key to Advancing Precision Medicine
    Opening Talk: Kelly E. Caudle, St. Jude
  • Current and Desired States of Standardization of Clinical Laboratory Processes
    Chair: Andrea Gaedigk, Children’s Mercy Research Institute (CMRI)
    - Vicky Pratt, Agena Bioscience
  • FIRESIDE CHAT
    Chair: Damon Hostin, Illumina
    - Howard McLeod, Utah Tech University
  • Current and Desired States of Standardization of Reporting (PANEL)
    Chair: Chad Bousman, University of Calgary
    - Lisa Brown, Great Scott!
    - Vicky Pratt, Agena Bioscience
  • Current and Desired States of Standardization of Pharmacogenomic Test Ordering and Reimbursement (PANEL)
    Chair: Sara Rogers, American Society of Pharmacovigilance
    - Jai Patel, Atrium Health
    - Greg Warren, Axene Health Partners
  • Current and Desired State of PGx Education
    Chair: Phil Empey, University of Pittsburgh
    - Michelle Whirl Carrillo, Stanford
  • Current and Desired State of the Patient Experience in Precision Medicine (PANEL)
    Chair: Avni Santani, LetsGetChecked
    - Kristy Crooks, University of Colorado - Stuart Scott, Stanford
  • Clinical Pearls and Outcome Data: Advancing the Adoption of Pharmacogenomics in Clinical Practice
    Chair: Kelly E. Caudle, St. Jude
    - Larisa H Cavallari, University of Florida
    - Jeff Bishop, University of Minnesota
  • PMWC Showcase
    - Bani Tamraz, UCSF

 Speaker Profile

PhD, PharmD, BCPS, FCCP, Clinical Pharmacogenetics Implementation Consortium (CPIC), Co-PI and Director, St. Jude

Biography
Kelly E. Caudle, Pharm.D., Ph.D., BCPS, FCCP is the Clinical Pharmacogenetics Implementation Consortium (CPIC) Principal Investigator and Director. CPIC provides guidelines that enable the translation of genetic laboratory test results into actionable prescribing decisions for specific drugs. To date, CPIC has published 26 gene based clinical guidelines covering 25 genes and over 100 drugs. Dr. Caudle oversees all CPIC-related projects and the CPIC guideline development process including the coordination of the guideline writing committees, the guideline evidence reviews, and the writing of the guideline manuscript and supplement. Furthermore, Dr. Caudle is involved in the clinical implementation of pharmacogenetics at St. Jude Children's Research Hospital. Dr. Caudle received her Pharm.D. and Ph.D. from The University of Tennessee Health Science Center and completed an ASHPaccredited PGY2 residency at Le Bonheur Children's Hospital. She is also a board certified Pharmacotherapy Specialist. Dr. Caudle is currently an affiliate Assistant Professor at The University of Tennessee Health Science Center.


 Speaker Profile

Ph.D., PHARMD, Associate Professor; Director, PGx Center of Excellence, U. of Pittsburgh

Biography
Dr. Philip Empey is the Associate Director of the Institute for Precision Medicine at the University of Pittsburgh and UPMC and an Associate Professor at the School of Pharmacy. He directs the Pharmacogenomics Center of Excellence and leads the PreCISE-Rx and Test2Learn teams to implement pharmacogenomics clinical, research, and educational initiatives. As a clinician-scientist, Dr. Empey conducts NIH-funded clinical and translational research aimed at understanding the mechanisms of the variability in drug response to improve medication-related outcomes in critically-ill patients.


Talk
Current and Desired State of PGx Education
Education is critical to training a workforce skilled in deploying precision medicine at-scale. The presentation will cover the current state of PGx education including needs of students and busy professionals, competency standards, cutting edge resources currently available, and what's new on the horizon for innovation educational models.


 Speaker Profile

PhD, Director, Scientific Affairs for Pharmacogenetics, Agena Bioscience

Biography
Dr. Pratt is a Medical and Clinical Molecular Geneticist board-certified by the American College of Medical Genetics. Dr. Pratt is the Past President of Association for Molecular Pathology. Dr. Pratt is on the National Academy of Medicine’s Roundtable on Genomics and Precision Health, and the American Medical Association’s (AMA) Molecular Pathology Current Procedural Terminology (CPT) Advisory committee. Dr. Pratt has authored over 75 peer-reviewed manuscripts and book chapters. She is also an Associate Editor for the Journal of Molecular Diagnostics. Dr. Pratt graduated with a Ph.D. in Medical and Molecular Genetics from Indiana University School of Medicine, Indianapolis, IN in 1994. Her fellowship training was in Ph.D. Medical and Clinical Molecular Genetics at Henry Ford Hospital, Detroit MI.


Talk
AMP's Recommendations for Clinical Pharmacogenotyping Allele Selection
The goals of the Association for Molecular Pathology (AMP) Clinical Practice Committees Pharmacogenomics (PGx) Working Group are to define the key attributes of pharmacogenetic alleles recommended for clinical testing and a minimum set of variants that should be included in clinical PGx genotyping assays.


 Speaker Profile

PMWC PIONEER AWARD
Significantly advanced pharmacogenomics through groundbreaking CYP2D6 research and development of the Activity Score to improve clinical predictions for precision therapeutics

PhD, Professor, Laboratory Director, Children’s Mercy Research Inst.

Biography
Dr Gaedigk, a distinguished researcher and professor, has made significant contributions to the field of pharmacogenomics. Her work has been instrumental in advancing our understanding of drug metabolism and its implications for personalized medicine. She has characterized the CYP2D6 gene locus across ethnically diverse populations discovering numerous allelic variants, enhancing our understanding of genetic diversity and its impact on drug response. Dr. Gaedigk has also developed the activity score system, a method facilitating genotype interpretation, which has been adopted in Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines and is widely used in pharmacogenomics implementation. This innovative approach has significantly improved the accuracy of pharmacogenomic testing, enabling more precise predictions of individual drug responses. In addition to her research, Dr. Gaedigk serves as the Director of the Pharmacogene Variation Consortium (PharmVar), a pharmacogene data repository. Under her leadership, PharmVar provides pharmacogenomics gene nomenclature, serving as a vital resource for researchers and clinicians worldwide.


 Speaker Profile

PhD, MPH, Founder, Sequence2Script

Biography
Dr. Bousman is the founder of Sequence2Script Inc., a software company that provides tools for translating pharmacogenomic data into clinical action. Dr. Bousman also leads the Psychiatric Pharmacogenomics Laboratory at the University of Calgary, which is focused on optimizing the selection and dosing of drug therapies used to improve mental health across the lifespan. He is a member of the American College of Neuropsychopharmacology (ACNP), Clinical Pharmacogenetics Implementation Consortium (CPIC), Pharmacogene Variation (PharmVar) Consortium, Pharmacogenomics Global Research Network (PGRN), and the Standardized Laboratory Practices in Pharmacogenomics (STRIPE) Collaborative.


 Speaker Profile

PHARMD, Professor, U. of Florida

Biography
Larisa Cavallari is co-director of the Center for Pharmacogenomics and Precision Medicine at the University of Florida (UF) College of Pharmacy and director of the UF Health Precision Medicine Program. Her research focuses on discovery of genetic variants contributing to drug response, translation of pharmacogenetic evidence into clinical practice, and examination of outcomes with pharmacogenetic implementation. She has a special interest in pharmacogenetics in underserved populations, and her research has been funded by the National Institutes of Health, US Food and Drug Administration, American Heart Association, and other foundation awards.


 Speaker Profile

PhD, Founder and Principal Consultant, Great Scott!

Biography
Lisa Brown, PhD has spent the past 8 years working within industry and consulting in the psychiatric pharmacogenomics space. She is passionate about patient and provider education around the benefits and limitations of pharmacogenomics. Lisa has published multiple papers in the pharmacogenomics space including clinical trial results, systematic reviews, meta analysis, health economic outcomes, and book chapters. She has also worked in infectious disease and microbiome and has a special interest in the interaction among the gut, genes, bugs, drugs, and brains.


 Speaker Profile

FSA, FCA, MAAA, Partner and Consulting Actuary, Axene Health Partners

Biography
Gregory Warren serves as Partner and Consulting Actuary at Axene Health Partners. He previously served as SVP and Chief Actuary for Optum Advisory Services, leading over 270 associates in the global provision of actuarial, underwriting and pharmacy advisory services and StepWise underwriting software. He also founded and led the Pharmacy Advisory Services group at Optum. Before Optum, Greg spent over 8 years at Walgreens including responsibility for all of Walgreens Health Initiatives PBM finance, pricing and underwriting, reporting and analytics and pharmacy network functions. He also previously served as a Senior Health Actuary and pharmacy benefits consultant at The Segal Company where he coordinated Segals Midwest region pharmacy benefits consulting services. Greg started his career as an actuarial analyst at Trustmark Insurance Company and then Celtic Insurance Company. Greg founded and leads the Pharmacy Subgroup for the Society of Actuaries leading most of the SOAs pharmacy related research and educational efforts.


 Speaker Profile

PhD, Director, Scientific Affairs for Pharmacogenetics, Agena Bioscience

Biography
Dr. Pratt is a Medical and Clinical Molecular Geneticist boardcertified by the American College of Medical Genetics. Dr. Pratt is the Past President of Association for Molecular Pathology. Dr. Pratt on the National Academy of Medicines Roundtable on Genomics and Precision Health, and the American Medical Associations (AMA) Molecular Pathology Current Procedural Terminology (CPT) Advisory committee. Dr. Pratt has authored over 75 peerreviewed manuscripts and book chapters. She is also an Associate Editor for the Journal of Molecular Diagnostics. Dr. Pratt graduated with a Ph.D. in Medical and Molecular Genetics from Indiana University School of Medicine, Indianapolis, IN in 1994. Her fellowship training was in Ph.D. Medical and Clinical Molecular Genetics at Henry Ford Hospital, Detroit MI.


Talk
Differences in pharmacogenomics (PGx) testing and platform design can lead to discrepancies in reporting, interpretation and ultimately patient care. Efforts are underway to improve standardization especially which PGx alleles should be included in clinical tests. This talk will focus on standardization efforts.


 Speaker Profile

PhD, PHARMD, BCPS, FCCP, Clinical Pharmacogenetics Implementation Consortium (CPIC), Co-PI and Director, St. Jude

Biography
Kelly E. Caudle, Pharm.D., Ph.D., BCPS, FCCP is the Clinical Pharmacogenetics Implementation Consortium (CPIC) Principal Investigator and Director. CPIC provides guidelines that enable the translation of genetic laboratory test results into actionable prescribing decisions for specific drugs. To date, CPIC has published 26 gene based clinical guidelines covering 25 genes and over 100 drugs. Dr. Caudle oversees all CPIC-related projects and the CPIC guideline development process including the coordination of the guideline writing committees, the guideline evidence reviews, and the writing of the guideline manuscript and supplement. Furthermore, Dr. Caudle is involved in the clinical implementation of pharmacogenetics at St. Jude Children's Research Hospital. Dr. Caudle received her Pharm.D. and Ph.D. from The University of Tennessee Health Science Center and completed an ASHPaccredited PGY2 residency at Le Bonheur Children's Hospital. She is also a board certified Pharmacotherapy Specialist. Dr. Caudle is currently an affiliate Assistant Professor at The University of Tennessee Health Science Center.


 Speaker Profile

PHARMD, Associate Professor, U. of Minnesota

Biography
Dr. Bishop conducts psychopharmacology and pharmacogenomics research with a focus on examining genetic relationships with symptom improvement, side effects, and cognitive effects of mental health medications. Dr. Bishop also provides clinical and didactic education to pharmacy and medical trainees. He earned a degree in biology at Luther College and went on to complete his Doctor of Pharmacy degree at the University of Iowa. Subsequently, he completed a fellowship in clinical psychopharmacology and pharmacogenetics at the University of Iowa College of Pharmacy as well as a master’s degree in Clinical Investigation through the University of Iowa College of Medicine. His research work has been supported through local, foundation, and NIH funding mechanisms.


 Speaker Profile

PHARMD, BCOP, CPP, Chair, Cancer Pharmacology & Pharmacogenomics, Atrium Health

Biography
Dr. Patel received his Doctorate in Pharmacy from the University of North Carolina Eshelman School of Pharmacy and completed an oncology pharmacogenomics postdoctoral fellowship at the UNC Center for Pharmacogenomics and Individualized Therapy. Dr. Patel leads translational and clinical pharmacology research at Levine Cancer Institute, with an emphasis on pharmacogenomics research and implementation. His projects range from gene discovery and translational studies to prospective interventional trials using pharmacogenomics to optimize anticancer and supportive care therapies. Dr. Patel provides guest lectures on pharmacogenomics to Schools of Pharmacy across North Carolina, is the Pharmacology Editor for HemOnc Today, and Deputy Associate Editor for the Journal of Supportive Care in Cancer.


 Speaker 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 AM 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 InterSociety 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.


 Speaker Profile

PhD, Professor, Laboratory Director, Children’s Mercy Research Inst.

Biography
Andrea Gaedigk, a distinguished researcher and professor at the Childrens Mercy Research Institute and University of Missouri Kansas City, has made significant contributions to the field of pharmacogenomics, particularly in the study of Cytochrome P450 enzymes. Her work has been instrumental in advancing our understanding of drug metabolism and its implications for personalized medicine. Dr. Gaedigk's research has focused on CYP2D6, a key enzyme involved in the metabolism of many clinically used drugs. Over the course of her career, she has meticulously characterized the CYP2D6 gene locus across a wide range of ethnically diverse populations. Her efforts have led to the discovery of numerous allelic variants, enhancing our understanding of genetic diversity and its impact on drug response. In addition to recognizing the need for reliable identification of variant alleles, Dr. Gaedigk has also developed the activity score system facilitating the interpretation genotype data. This method has been since been adopted in the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines and is widely used in pharmacogenomics implementation. This innovative approach has significantly improved the accuracy of pharmacogenomic testing, enabling more precise predictions of individual drug responses. In addition to her research, Dr. Gaedigk serves as the Director of the Pharmacogene Variation Consortium (PharmVar), a nextgeneration pharmacogene data repository. Under her leadership, PharmVar provides pharmacogenomics gene nomenclature, serving as a vital resource for researchers and clinicians worldwide.


 Speaker Profile

PMWC LUMINARY AWARD
Contributions to advancing PM through your leadership in ClinGen, PharmGKB, and CPIC

PhD, Professor, Stanford

Biography
Dr. Klein is the MPI of the pharmacogenomics knowledgebase (PharmGKB), Clinical Implementation Pharmacogenetics Consortium (CPIC), the Pharmacogenomics Clinical Annotation Tool (PharmCAT) and the Clinical Genomics Resource (ClinGen). She is a Professor in the Departments of Biomedical Data Science and Medicine, and by courtesy, Genetics. Her professional expertise extends over pharmacogenomics, computational biology and bioinformatics. Applications include the development of the PharmGKB, CPIC, PharmCAT, ClinGen and de novo modeling and the structural basis of diseases. Dr. Klein received her from UCSF. She is a fellow in the American Association for the Advancement of Science and American College of Medical Informatics and is actively involved in the Pharmacogenetics Research Network (PGRN), ACMG Secondary Findings Committee and the ISCC PGx Project Group. Dr. Klein is the cofounding and senior chair of the international Pacific Symposium of Biocomputing now in its 29th year and an editor for AI in Precision Oncology.


 Speaker Profile

Lead, Healthcare Market Access, Illumina

Biography
Genomics and healthcare leader building clinical and population solutions supporting the healthcare ecosystem. Numerous precision medicine leadership roles in leading health systems, molecular diagnostics, therapeutic development, and genomics life science.


 Speaker Profile

PhD, Director and Professor, Utah Tech U.

Biography
Dr Howard McLeod is an internationally recognized expert in precision medicine, having made novel contributions at the discovery, translation, implementation, and policy levels. Dr McLeod has been recognized as a Fellow of both the American Society of Clinical Oncology and the American College of Clinical Pharmacy. He has also been an active Board Member and or Founder for over a dozen privately held and publicly traded companies. Howard has published over 600 peer reviewed papers on pharmacogenomics, applied therapeutics, or clinical pharmacology and continues to work to advance innovative healthcare.


 Speaker Profile

FACMG, Chief Medical Officer, LetsGetChecked

Biography
Dr. Santani holds over 20 years of experience in the diagnostics and healthcare industry sectors. Prior to Veritas, a LetsGetChecked company, she was most recently the Director of Clinical Laboratories and Strategic Initiatives at the Center for Applied Genomics at The Childrens Hospital of Philadelphia and an Associate Professor of Pathology at the University of Pennsylvania. She formerly held roles within CHOP including within the Division of Genomic Diagnostics and within the Molecular Genetics Laboratory. At CHOP, Dr. Santanis work focused on creating a comprehensive diagnostics program by developing innovative technologies for diagnostics, forming public private partnerships and discovery of novel genes associated with complex genetic disorders. At Veritas, she is responsible for the strategy, direction, and execution of clinical development plans and medical affairs. Under her leadership, the multidisciplinary programs at Veritas includes the clinical laboratory operations, research, and clinical development including whole genome sequencing programs, pharmacogenomics and high throughput Covid testing.


 Speaker Profile

PhD, 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

PhD, 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

FACMG, Associate Professor of Pathology, 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 CAPaccredited 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 opulation 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.


 Speaker Profile

President and Founder, YouScript

Biography
Kristine has worked in pharmacogenomics since 2000 and was named one of the 25 leading global voices in precision medicine. She is the Founder and President of YouScript, an award winning clinical decision support tool that has integrated PGxguided personalized prescribing in the clinical workflow for over a decade. Kristine has 25+ years of experience in various Clevel, board, customer success and business development roles. She has authored multiple publications on the clinical and economic benefits of pharmacogenomic testing and serves on numerous PGx advisory groups including the STRIPE Steering Committee, the FDA collaborative community for pharmacogenomics, CPIC, and the American Cancer Society Cancer Action Network PGx task force.


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