Seminar Series

Clinical Decision Support for Pharmacogenomics

PRECISION MEDICINE SEMINAR SERIES

December 4, 2020 | 2:00 to 3:00 p.m. CT | presented online via Zoom

Steve Johnson, PhD is an Assistant Professor in the Institute for Health Informatics (IHI) and Scientific Director, CTSI Clinical Informatics at the University of Minnesota. He has had an extensive career in the healthcare industry with a successful record of leading technology, product development and data analytics teams. He was most recently VP of Technology and Clinical Informatics at Wolters Kluwer where he oversaw product development and medical content for clinical documentation and clinical decision support products. Prior to that, he was Chief Technology Officer (CTO) and VP of Data Analytics for Experian Health where he oversaw technology and architecture for all healthcare products, including data and analytics for a 150M patient data repository. Dr. Johnson’s research is focused on advancing the secondary use of EHR data using healthcare data science and machine learning, improving clinical decision support and using rich ontologies to model clinical knowledge. He currently leads the CDS and Technology Workgroup for the University of Minnesota Pharmacogenomics Grand Challenge Grant.

The webinar is offered to attendees at no cost. We hope you’ll join us!

Join the seminar via Zoom:  z.umn.edu/pmseminar

(The above link will redirect to the live seminar on Zoom approximately 10 minutes before the start time)

Real-World Data of Immunotherapy in Non-Small Cell Lung Cancer: Evidence for a Precision Medicine Approach?

PRECISION MEDICINE SEMINAR SERIES

October 2, 2020 | 2:00 to 3:00 p.m. CT | presented online via Zoom

David Stenehjem, PharmD, BCOP is an Associate Professor and Associate Department Head in the Department of Pharmacy Practice and Pharmaceutical Sciences at the University of Minnesota, College of Pharmacy. He is a member of the Masonic Cancer Center at the University of Minnesota, a Comprehensive Cancer Center designated by the National Cancer Institute. Dr. Stenehjem's outcomes-based research agenda is centered around assessing the role and value of oncology therapeutics and precision oncology in improving outcomes for cancer patients. His research strategy uses real world data collected from major cancer centers across the nation to assess clinical and economic outcomes of cancer patients treated with specific therapeutic agents. This approach allows for the molecular stratification of patients while assessing meaningful outcomes to demonstrate the value of precision oncology and specific cancer treatments. Additionally, translational research is supported by assessing the implications of novel biomarkers with treatment response. He is also a co-director of a pharmacogenomic implementation fellowship program in partnership with Essentia Health in Duluth.

The webinar is offered to attendees at no cost. We hope you’ll join us!

Join the seminar via Zoom:  z.umn.edu/pmseminar

(The above link will redirect to the live seminar on Zoom approximately 10 minutes before the start time)

Gene-Based Dose Optimization in Children

PRECISION MEDICINE SEMINAR SERIES

December 6, 2019 | 2:00 to 3:00 p.m. | 5-125 Moos Tower (TC); 302 Heller Hall (Duluth)

Dr. Jacob Brown’s expertise lies primarily within pediatric pharmacotherapy, pharmacogenetics, pharmacogenomics, and pharmacokinetics. He completed his undergraduate coursework and doctor of pharmacy at Creighton University. Upon graduation, he completed a post-graduate Year 1 Pharmacy Residency at Children’s Mercy Kansas City, followed by a T32-funded fellowship in Pediatric Clinical Pharmacology. During his fellowship, he also completed a Master of Science in Clinical Research through the University of Kansas School of Medicine. Dr. Brown joined the faculty of the University of Minnesota College of Pharmacy on its Duluth campus in 2014. He is one of the investigators on the University’s Grand Challenge Research Initiative working towards statewide PGx implementation.

Bringing Genomics to the Front Lines of Care: The NorthShore Experience

PRECISION MEDICINE SEMINAR SERIES

Thursday, October 3, 2019 | 2:00 to 3:00 p.m. | 2-650 Moos Tower (TC)
(Note special time and location)

Dr. Dunnenberger is Director of Pharmacogenomics in the Center for Molecular Medicine at NorthShore University HealthSystem (NorthShore), and leads the various clinical pharmacogenomics implementation projects within the Center for Personalized Medicine. The goal of these projects is to improve the care and health outcomes of NorthShore University HealthSystem patients through pharmacogenomics-based strategies. He joined NorthShore in 2014. Dr. Dunnenberger leads the Pharmacogenomics Clinic, which serves as part of a system-wide initiative building upon the health system’s strong foundation in genetics and molecular medicine. The Clinic is among only a few across the country, and the first of its kind in the Chicagoland area that pre-emptively screens patients for responses to medications based on genetic makeup. His clinical expertise and research interests include translating pharmacogenomics into clinical practice, developing information technology solutions for delivering genetic information to both clinicians and patients in a practical manner, and evaluating methods for educating healthcare professionals about pharmacogenetics Dr. Dunnenberger has co-authored sixteen original publications, including several CPIC guidelines. He earned his PharmD from the University of Tennessee Health Science Center College of Pharmacy in 2012. He completed a PGY1 Pharmacy Practice Residency at Mission Hospital in Asheville, North Carolina, and a PGY2 Clinical Pharmacogenetics Residency in the Department of Pharmaceutical Sciences at St. Jude Children’s Research Hospital in Memphis, Tennessee.

Making Sense of the Recent FDA Actions on Pharmacogenomic Laboratory-Developed Test (LDT) Companies

PRECISION MEDICINE SEMINAR SERIES

September 6, 2019 | 2:00 to 3:00 p.m. | 5-125 Moos Tower (TC); 144 Life Science (Duluth)

FDA oversight over laboratory-developed tests (LDTs), specifically recent action with pharmacogenomic tests, has left many laboratories, providers, researchers and regulatory professionals with unanswered questions. FDA has historically exercised enforcement discretion with LDTs given over-lapping regulatory requirements with the Centers for Medicare and Medicaid Services (CMS). Since 2010, FDA has consistently took the stance that it can—and will—hold clinical laboratories to all applicable regulations for in vitro diagnostic medical devices.

In a Safety Communication issued November 1, 2018, FDA publicized the Agency's concern that pharmacogenomic LDTs are overreaching in terms of their clinical interpretation of test results, prompting safety alerts and enforcement action. More recently pharmacogenomic laboratories and companies have received informal communication from FDA that has prompted major changes in service offerings.  

Dr. Teeple will describe the history of regulatory oversight over LDTs, discuss the current environment for LDTs and provide high-level guidance for those developing pharmacogenomic LDTs or using LDTs in research or practice.

Dr. Wrenda Teeple graduated from the University of Minnesota College of Pharmacy with a Research Emphasis in Experimental and Clinical Pharmacology. Following the completion of the residency program at Regions Hospital, Wrenda joined Arbit Consulting as a Senior Regulatory Affairs Specialist. She holds additional positions as a Clinical Development Pharmacist at OneOme and an adjunct assistant professor at Albany College of Pharmacy. As a regulatory affairs professional, Wrenda provides regulatory strategy and support for investigator-initiated clinical research, investigational new drug and device submissions, Early Feasibility studies and Expanded Access studies. She supports clients with grant applications, clinical trial monitoring, IRB submissions, annual reports, adverse event reporting, protocol development and amendments. Her primary areas of interest are regulatory affairs, teaching and pharmacogenomics.

A Functional Genomic Platform for Discovery of Novel Targeting Strategies in Acute Myeloid Leukemia

PRECISION MEDICINE SEMINAR SERIES

May 3, 2019 | 2:00 to 3:00 p.m. | 5-125 Moos Tower (TC); 302 Heller Hall (Duluth via ITV)

Jeffrey Tyner is an associate professor in the Department of Cell & Developmental Biology and co-director of the translational oncology program at the Knight Cancer Institute at Oregon Health & Science University (OHSU). He attended undergraduate school at Grinnell College in Grinnell, Iowa, and graduate school at Washington University in St. Louis. His graduate work, focusing on asthma and respiratory viral infections, was conducted under the mentorship of Dr. Michael Holtzman. For his post-doctoral fellowship, Jeff joined Dr. Brian Druker’s laboratory at OHSU where he studied molecular mechanisms of leukemogenesis.

Dr. Tyner’s research is focused towards: 1) identification of cancer-causing gene targets in cancer patients and 2) identification of patient-tailored, gene-targeted therapies. To accomplish these objectives, he has spent the past decade developing and implementing a functional screening approach whereby primary cells from hematologic malignancy patients can be tested ex vivo for sensitivity to a library of small-molecule inhibitors. This assay has now been cumulatively applied to over 2,000 patient specimens, and this large data set has been leveraged to inform findings that offer new diagnostic and therapeutic options.

Precision Medicine in Mental Health: Challenges and Opportunities for Pharmacogenomics

PRECISION MEDICINE SEMINAR SERIES

April 5, 2019 | 2:00 to 3:00 p.m. | 5-125 Moos Tower (TC); 302 Heller Hall (Duluth via ITV)

Dr. Bishop is associate professor of pharmacy and psychiatry at the University of Minnesota. In this role he conducts psychopharmacology and pharmacogenomics research with a focus on examining genetic relationships with symptom improvement, side effects, and cognitive effects of medications. He is a Board Certified Psychiatric Pharmacist, providing clinical and didactic education to pharmacy and medical trainees. Dr. Bishop 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.

"Pharmacogenomics at Mayo Clinic: The Intersection of Patient Care and Research"

PRECISION MEDICINE SEMINAR SERIES

February 1, 2019 | 2:00 to 3:00 p.m. | 5-125 Moos Tower (TC); 302 Heller Hall (Duluth via ITV)

Dr. Suzette Bielinski received a BS at the College of Saint Catherine, and a Master’s degree in Education and PhD in Epidemiology with a minor in Human Genetics at the University of Minnesota. She was a NIH Cardiovascular Disease Genetic Pre-doctoral and Post-doctoral Fellow at the University of Minnesota and joined Mayo Clinic in 2008. Dr. Bielinski’s research program focuses on the molecular biomarkers of cardiovascular disease with funding from the National Institutes of Health and the Mayo Foundation. Dr. Bielinski has been at the forefront of Mayo Clinic’s interactions with several important cardiovascular cohort studies and consortia including the Atherosclerosis Risk in Communities (ARIC), Coronary Artery Risk Development in Young Adults (CARDIA) Study, and Multi-Ethnic Study of Atherosclerosis (MESA). She is a leader of the Mayo Clinic’s RIGHT Protocol Study that is designed to implement pharmacogenomic sequence data into clinical systems to improve patient outcomes. The RIGHT Protocol is a collaboration between the Mayo Clinic Centers for Individualized Medicine and Science of Health Care Delivery. Notably, this collaboration, with over 11,000 participants, is one of the largest and most extensive preemptive pharmacogenomic studies in the world.

"Pharmacogenetic Studies in Special Populations: Lessons from Research Partnerships in the Hmong Community"

PRECISION MEDICINE SEMINAR SERIES

December 7, 2018 | 2:00 to 3:00 p.m. | 1-451 Moos Tower (TC); 302 Heller Hall (Duluth via ITV)

Dr. Robert Straka is professor and head of the Department of Experimental and Clinical Pharmacology and a member of the Institute of Personalized Medicine in the College of Pharmacy. His research is focused on optimizing the use of therapeutic agents for prevention and treatment of cardiovascular disease by investigating pharmacogenetic, pharmacokinetic and pharmacodynamic sources of variability in drug response, including those that are ethnicity-based. He has partnered in collaborative research with the Minnesota Hmong community for many years and was a 2018 recipient of the UMN President's Community-Engaged Scholar Award.

Bridging Pre-Clinical Drug Screening with Patient Molecular Profiles for Biomarker Discovery and Drug Repurposing

PRECISION MEDICINE SEMINAR SERIES

November 2, 2018 | 2:00 to 3:00 p.m. | 2-650 Moos Tower

Note special location for this seminar

Dr. Huang’s research focuses on translational pharmacogenomics with particular interest in anticancer agents. By systematically evaluating the human genomes and their relationships to drug response and toxicity, her goal is to develop clinically useful models that predict risks for adverse drug reactions and non-response prior to administration of chemotherapy. Her lab conducts research through cutting-edge computational and experimental methods. Utilizing cell lines (derived from healthy and disease individuals as well as commercially available cancer cell lines), and clinical samples, the Huang lab discovers and functionally characterizes genetic variations, gene and non-coding RNA (i.e., microRNA, lncRNA) expression for their role in chemotherapeutic sensitivity.