Luke Fostvedt CV

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Contact Information
Luke Fostvedt
Email: lukefostvedt@gmail.com

Education
2014   Ph.D. Statistics Iowa State University, Ames, Iowa, USA
2010   M.S. Statistics, Iowa State University, Ames, Iowa, USA
2008   B.S. Mathematics, University of Redlands, Redlands, CA, USA

Employment
Pfizer, Global Product Development, La Jolla, CA, USA

  • Associate Director
    Clinical Pharmacology / Pharmacometrics
    2019-Present
  • Manager
    Clinical Pharmacology – Oncology
    2014-2018

Responsibilities: designing and implementing clinical pharmacology plans, summarizing and interpreting results of PK/PD analyses, evaluating and applying new techniques in PK/PD data analysis that improve information quality and utility, present study results both internally and externally, write summary documents for regulatory submission and interact with regulatory agencies, etc.

Approved Drugs

  • DAURISMO® (glasdegib): acute myeloid leukemia
    – authored the PK-QTc analysis report included in the NDA
  • LORBRENA® (lorlatinib): ALK-positive non small cell lung cancer
    – authored the QTc/PR analysis report included in the NDA
    – Clinician for the mass balance study B7461004.
  • VIZIMPRO® (dacomitinib): EGFR-mutant non small cell lung cancer
    – authored the Adverse Event PK/PD exposure response analysis report included in the NDA
    – authored a PK/PD exposure response analysis report on the tumor size over time using a tumor growth inhibition model
    – authored a PK/PD exposure response analysis report modeling the occurrence of dose-altering AEs and the effect of a 30 mg QD versus a 45 mg QD dosing regimen on tumor size
  • MYLOTARG® (gemtuzumab ozogamicin): CD33-positive acute myeloid leukemia
    – authored a PK/PD exposure response analysis of safety and efficacy report included in the BLA
  • BAVENCIO® (avelumab): Merkel cell carcinoma
    – authored a PK/PD exposure response analysis report on efficacy (OR, PFS, and OS) included in the BLA
  • BESPONSA® (inotuzumab ozogamicin): CD22-positive acute lymphatic leukemia
    – author a PK/PD exposure response analysis evaluating efficacy and safety. Not included in the BLA

Current Submission Work

  • PF-04965842 (JAK1 inhibitor): moderate to severe atopic dermatitis (planned July 2020 submission)
    – PMx lead overseeing modeling and simulation deliverables.
    – author of the PK/PD analysis of the Eczema Area and Severity Index (EASI) report.
  • PF-06651600 (JAK3 inhibitor): moderate to severe alopecia areata
    – supporting the modeling and simulation activities.

Clinical Trial Roles

  • Clinical Pharmacology Lead (May ’16 – Feb ’19): Study B7461006: A Phase 3 study comparing the efficacy of lorlatinib to crizotinib in treatment naive ALK-positive non small cell lung cancer.
    Status: Fully Enrolled in February 2019. ClinicalTrials.gov Identifier: NCT03052608
  • Clinican: Study B7461004: Single-dose study of [14C] lorlatinib (PF-06463922) metabolism In healthy male volunteers.
    Status: Completed and Reported. ClinicalTrials.gov Identifier: NCT02564562

Publications

  1. Pharmacokinetic/pharmacodynamic modeling to support the re-approval of gemtuzumab ozogamicin.
    Fostvedt, LK., Hibma, JE., Masters, JC., Vandendries E, Ruiz-Garcia, A. Clinical Pharmacology and Therapeutics (2019) (accepted)
  2. PharmTeX: a LaTeX-Based Open-Source Platform for Automated Reporting Workflow.
    Rasmussen CH, Smith MK, Ito K, Sundararajan V, Magnusson MO, Jonsson EN, Fostvedt L, Burger P, McFadyen L, Tensfeldt TG, Nicholas T. The AAPS journal. 2018 May 1;20(3):52.
    DOI: 10.1208/s12248-018-0202-0
  3. Improving critical thinking growth for disadvantaged groups within elementary school science: A randomized controlled trial using the Science Writing Heuristic approach.
    Hand B, Shelley MC, Laugerman M, Fostvedt L, Therrien W. Science Education. 2018.
    DOI: 10.1002/sce.21341
  4. Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study.
    DeAngelo, D.J., Stock, W., Stein, A.S., Shustov, A., Liedtke, M., Schiffer, C.A., Vandendries, E., Liau, K., Ananthakrishnan, R., Boni, J., Laird, A.D., Fostvedt, L., Kantarjian, H.M, Advani, A.S., Blood Advances. 2017, 1:1167-1180.
    DOI: 10.1182/bloodadvances.2016001925
  5. Why do simple algorithms for triangle enumeration work in the real world?
    Berry, J., Fostvedt, L., Nordman, D., Phillips, C., Seshadhri C., and Wilson, A.
    Internet Mathematics. 2015.
    DOI: 10.1080/15427951.2015.1037030
  6. Fixed-cost versus fixed-risk post-election audits in Iowa.
    Hobbs, J., Fostvedt, L., Pintar, A., Rockoff, D., Kim, E., Griffiths, R. Chance. Volume 23, Issue 3, 2010
    DOI: 10.1080/09332480.2010.10739817
  7. Mixed effects modeling with missing data using quantile regression and joint modeling.
    Luke Fostvedt. Dissertation. 2014
    DOI: 10.31274/etd-180810-3700
  8. Asymptotic results for configuration model random graphs with arbitrary degree distributions
    Fostvedt, L., Nordman, D., Wilson, A.
    Tech. Rep. 2010-09, Iowa State University Department of Statistics Preprint, 2010

Professional Service

  • Vice President of Professional Affairs, San Diego Chapter of the ASA, 2015-present
    • Organized a local 1-day mini-conference (3/17, keynote speaker: Jessica Utts)
    • Responsible for organizing ASA travel courses
    • Responsible for organizing seminars (Sallie Keller 6/17, Hal Stern 2/18)
    • Participated in judging local high school projects for statistics awards
  • Steering Committee Member, Joint ASA and ISoP Special Interest Group on Statistics and Pharmacometrics (SxP), 2019-present
  • Articles Reviewed

Presentations

  1. Population pharmacokinetic/pharmacodynamic evaluation of the effect of glasdegib exposure on cardiac repolarization (QT interval) in cancer patients.
    Fostvedt, LK., Shaik, N., Martinelli, G., Wagner, A., Ruiz-Garcia, A.
    American Association of Cancer Research Annual Meeting, Atlanta, GA, 2019
  2. Metabolism of lorlatinib: a tale of two halves.
    Stypinski, D., Fostvedt, LK., Vaz, A., Lam, J., Pithavala, YK., Loi, CM.
    American Society for Clinical Pharmacology and Therapeutics Annual Meeting, 2019, Washington DC
  3. A tumor growth inhibition (TGI) model for long-term tumor measurements in ALK-positive NSCLC patients on crizotinib therapy.
    D’Cunha, R., Nickens, DJ., Fostvedt, LK., Tan, W.
    American Conference on Pharmacometrics. 2018, San Diego, CA.
  4. The pharmaceutical industry’s polyamorous relationship with R.
    Fostvedt, LK.
    Enterprise Applications of the R Language, 2017, San Francisco, CA
  5. Shiny_ncappc, A Shiny App for Non-Compartmental Analysis (NCA).
    Fostvedt, LK., Hibma, J, Acharya, C.
    American Society for Clinical Pharmacology and Therapeutics, 2016, San Diego, CA
  6. Using R to improve compliance in clinical trials.
    Fostvedt, LK.
    UseR! Conference, 2015, Aalborg, Denmark
  7. Why do simple algorithms for triangle enumeration work in the real world?
    Berry, J., Fostvedt, L., Nordman, D., Phillips, C., Seshadhri C., and Wilson, A.
    Proceedings of the 5th Innovations in Theoretical Computer Science (ITCS) Conference, 2014
  8. Data imputation in multi-level quantile regression
    Fostvedt, L., Shelley, M.
    Joint Statistical Meetings, 2014, Boston, USA, (to be presented)
  9. A longitudinal study of the effect of a new approach to teaching science based on multivariate mixed effects models.
    Fostvedt, L., Shelley, M., Baenziger, J., Laugerman, M., Gonwa-Reeves, C., Le, D., Hand, B., Therrien, W.
    Joint Statistical Meetings, 2013, Montreal, Canada
  10. An inquiry-based approach to teaching science: A multilevel mediation model
    Shelley, M., Fostvedt, L., Baenziger, J., Laugerman, M., Gonwa-Reeves, C., Le, D., Hand, B., Therrien, W., Joint Statistical Meetings, 2013, Montreal, Canada,
  11. Are Teachers to Blame?: Two-Level Quantile Regression of Teacher Quality on Student Performance

    Fostvedt, L., Shelley, M., Baenziger, J., Laugerman, M., Gonwa-Reeves, C., Le, D., Hand, B., Therrien, W.

    American Educational Research Association Annual Meeting, 2013, San Francisco, USA

  12. Effect of the Science Writing Heuristic learning approach on Future Achievement
    Fostvedt, L., Shelley, M., Baenziger, J., Laugerman, M., Gonwa-Reeves, C., Le, D., Hand, B., Therrien, W., National Association for Research in Science Teaching Annual International Conference, 2013, Puerto Rico
  13. The Effect of an Argument-Based Inquiry Approach on Students’ Critical Thinking Skills: A Two-year Study, Jang, J., Fostvedt, L., Hand, B., National Association for Research in Science Teaching Annual International Conference, 2013
  14. Structural Equation Modeling of Knowledge Content Improvement using Inquiry Based Instruction
    Laugerman, M., Gonwa-Reeves, C.,Shelley, M., Fostvedt, L., Baenziger, J., Hand, B., Therrien, W.
    Society for Research in Educational Effectiveness Spring Conference, 2013, Washington D.C., USA
  15. Balancing Self-Directed Learning with Expert Mentoring: The Science Writing Heuristic Approach
    Shelley, M., Hand, B., Therrien, W., Fostvedt, L., McGill, M., Baenziger, J.
    Society for Research in Educational Effectiveness Fall Conference, 2012, Washington D.C., USA
  16. Investigation of Cornell Critical Thinking Results as Affected by Science Writing Heuristic
    Fostvedt, L., McGill, M., Shelley, M., Baenziger, J., Hand, B., Therrien, W.
    European Association for Research on Learning and Instruction: SIG18, 2012, Zurich, Switzerland
  17. Assessing the Impact of a New Science Curriculum on Under- And Over-Achieving Students
    Fostvedt, L., Shelley, M., Baenziger, J., Hand, B., Therrien, W.
    Joint Statistical Meetings, 2012, San Diego, USA
  18. Student Learning and Inquiry-Based Science Instruction: Testing Effectiveness in a Randomized Trial
    Fostvedt, L., Shelley, M., Hand, B., Therrien, W., Gonwa-Reeves, C., Baenziger, J., Villanueva, M.
    American Educational Research Association Annual Meeting, 2012, Vancouver, B.C., Canada
  19. An Example of Performance Analysis for Network Community Detection
    Fostvedt, L., Nordman, D., Wilson, A.
    Joint Statistical Meetings, 2010, Vancouver, B.C., Canada
  20. Post-Election Audit Project
    Fostvedt, L., Hobbs, J., Pintar, A., Rockoff, D., Kim, E., Griffiths, R.
    Survey Working Group, Iowa State Univ., 2009
  21. The Pros of Pro Bono Statistical Consulting
    Fostvedt,L. – Panelist
    Joint Statistical Meetings, 2009, Washington D.C., USA

Tutorials

  1. Ordinal Regression using R.
    Lead with Tim Nicholas, Ana Ruiz, and Dana Nickens.
    October 21, 2018 at ACoP9, San Diego, CA
  2. Using LaTeX for Regulatory Reports
    Internal courses provided in Groton, Cambridge, and La Jolla.

Work In Progress

  • Mass balance studies to characterize the metabolism of lorlatinib.
    Stypinski, D., Fostvedt, LK., Pithavala, YK., James, L., Loi, CM. planned for 2019
  • Multi-level quantile regression: a bayesian approach.
    Fostvedt, LK., Shelley, M. in preparation
  • Dose selection using tumor inhibition modeling of dacomitinib in first line non small cell lung cancer patients.
    Fostvedt, LK., Nickens, DJ. planned for 2019
  • PK/PD modeling of the effect of glasdegib on QTc prolongation in cancer patients.
    Fostvedt, LK., Shaik, N., Martinelli, G., Wagner, A., Ruiz-Garcia, A. planned for 2019
  • PK/PD modeling of the effect of lorlatinib on PR prolongation in cancer patients.
    Fostvedt, LK., Pithavala, YK. planned for 2019
  • PK/PD modeling of the safety of dacomitinib in first line non small cell lung cancer patients.
    Fostvedt, LK., Mebus, C., Ruiz-Garcia, A., Tan, W. planned for 2019

Teaching Experience

Current Professional Memberships
American Statistical Association
International Society of Pharmacometrics

Miscellanea
Letter to the Editor of the New York Times: Using a Formula to Rate Teachers, Page A24 of the New York edition, March 14, 2011. link

Measure Theory and Probability Theory Study Guide, by Cory Lanker and Luke Fostvedt. This study guide is a good supplement to the Athreya Lahiri text and STAT 642 at Iowa State University. pdf