Luke Fostvedt CV

Download: Luke-Fostvedt-CV.pdf

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, Cambridge, MA, USA

  • Director
    Clinical Pharmacology / Pharmacometrics
    2022-
  • Associate Director
    Clinical Pharmacology / Pharmacometrics
    2019-2021
  • 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

  • VELSIPITY® (etrasimod): moderate to severely active ulcerative colitis
    – Pharmacometrics Lead
  • CIBINQO® (abrocitinib): moderate to severe atopic dermatitis
    – Pharmacometrics Lead
  • 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

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
  • Clinician: 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. Tumor growth inhibition modeling to support the starting dose of dacomitinib
    Fostvedt, LK., Nickens, DJ. Tan, W., Parivar, K. CPT Pharmacometrics Syst Pharmacol. 2022; 00:1-12.
    DOI: https://doi.org/10.1002/psp4.12841
  2. Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib.
    Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Br J ClinPharmacol. 2022;88(8):3856‐3871.
    DOI: https://doi.org/doi:10.1111/bcp.15334
  3. Population pharmacokinetics of abrocitinib in healthy individuals and patients with psoriasis or atopic dermatitis
    Wojciechowski, J., Malhotra, BK., Wang, X., Fostvedt, LK., Valdez, H., Nicholas, T. Clinical Pharmacokinetics, 2022
    DOI: https://doi.org/10.1007/s40262-021-01104-z
  4. Exposure response modeling of the effect of glasdegib on cardiac repolarization in cancer patients.
    Fostvedt, L., Shaik, N., Martinelli, G., Wagner, A., Ruiz-Garcia, A.
    Expert Review of Clinical Pharmacology, Volume 14, Number 9, 927-935, 2021
    DOI: https://doi.org/10.1080/17512433.2021.1925538
  5. Metabolism, excretion and pharmacokinetics of lorlatinib (PF-06463922) and evaluation of the impact of radiolabel position and other factors on comparability of data across two ADME studies.
    Stypinski, D., Fostvedt, L., Lam, J., Vaz, A., Johnson, T.R., Boerma, J., Pithavala, Y. Journal of Clinical Pharmacology, 2020
    DOI: https://doi.org/10.1002/jcph.1621
  6. 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. Volume 106, Number 5, 2019.
    DOI: 10.1002/cpt.1500
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. Mixed effects modeling with missing data using quantile regression and joint modeling.
    Luke Fostvedt. Dissertation. 2014
    DOI: 10.31274/etd-180810-3700
  13. 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

  • Steering Committee Member, Joint ASA and ISoP Special Interest Group on Statistics and Pharmacometrics (SxP), 2019-present
    • Statistics Co-chair, 2022-2024
    • SIG representative for the ACOP11 scientific programming review committee
    • ACoP abstract awards committee member: 2020, 2021, 2022
  • Vice President of Professional Affairs, San Diego Chapter of the ASA, 2015-2019
    • 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
  • Articles Reviewed
    • Journal of Veterinary Dentistry
      Editorial Board, Official statistics reviewer
      Reviewed 12 articles
    • Journal of Pharmacology and Toxicology.
      Reviewed 1 article
    • Clinical Pharmacology and Therapeutic: Pharmacometrics & Systems Pharmacology.
      Reviewed 3 article
  • Sessions Chaired at Conferences
    • Integration of PMx approaches to model-informed decision making: Across SIG Perspectives. Session Co-chair. American Conference on Pharmacometrics. National Harbor, MD, 2023.
    • Model Informed Drug Development to Support New Drug Development and Regulatory Decision-Making. Session Co-chair. The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop. Rockville, MD, 2023.

Presentations

  1. An overview of joint modeling of longitudinal data and time to event data
    Fostvedt, LK. Oral presentation at the American Conference on Pharmacometrics. Aurora, CO, 2022.
  2. PK/PD modeling of abrocitinib exposure and peak pruritus NRS score
    Fostvedt, LK., Nicholas, T., Valdez, H., Wang, Y.
    Poster presentation at the American Conference on Pharmacometrics. 2022.
  3. Population PK analysis of somatrogon using a bayesian approach with informative priors.
    Pei, X., Niu, T., Fostvedt, LK., Wang, Y. Korth-Bradley, J.
    Poster presentation at the American Conference on Pharmacometrics. 2022.
  4. ERmod: a semi-automated exposure-response (E-R) analysis and reporting tool to support decision making while increasing time and cost savings in drug development
    Irby, D., Fostvedt, LK, Nickens, DJ., Nicholas, T.
    Poster presentation at the American Conference on Pharmacometrics. 2022.
  5. Integrated Parent/Metabolite Population PK Model of Abrocitinib to Support Dose Recommendations
    Fostvedt, LK., Malhotra, BK., Wang, X., Valdez, H., Nicholas, T.
    American Conference on Pharmacometrics. 2021, Virtual Conference.
  6. Zero-inflated beta regression exposure-response modeling of the Eczema Area and Severity Index for patients taking abrocitinib
    Fostvedt, LK., Wojciechowski, J., Wang, X, Malhotra, B., Valdez, H., Rojo, R., Nicholas, TJ. American Conference on Pharmacometrics. 2020, Virtual Conference.
  7. The pharmaceutical industry’s polyamorous relationship with R.
    Fostvedt, LK.
    Enterprise Applications of the R Language, 2017, San Francisco, CA
  8. 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
  9. Using R to improve compliance in clinical trials.
    Fostvedt, LK.
    UseR! Conference, 2015, Aalborg, Denmark
  10. 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
  11. Data imputation in multi-level quantile regression
    Fostvedt, L., Shelley, M.
    Joint Statistical Meetings, 2014, Boston, USA, (to be presented)
  12. 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
  13. 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,

  14. 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

  15. 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
  16. 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
  17. 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
  18. 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
  19. 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
  20. 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
  21. 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
  22. An Example of Performance Analysis for Network Community Detection
    Fostvedt, L., Nordman, D., Wilson, A.
    Joint Statistical Meetings, 2010, Vancouver, B.C., Canada
  23. Post-Election Audit Project
    Fostvedt, L., Hobbs, J., Pintar, A., Rockoff, D., Kim, E., Griffiths, R.
    Survey Working Group, Iowa State Univ., 2009
  24. 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/Under Review

  • The Effect of CYP2C19 and CYP2C9 Allele Variants on Abrocitinib Pharmacology.
    Fostvedt, LK; Liu, J; Dowty, M; Johnson, J; Wang, X; Malhotra, B; Nicholas, T; (under review)
  • Population PK Analysis of Somatrogon Using a Bayesian Approach with Informative Priors.
    Wang, Y., Pei, X. Fostvedt, L., Niu, T., Korth-Bradley, J. (under review)
  • Automated Poisson Regression Exposure-Response Modeling with R package: PoissonERM.
    Wang, Y., Fostvedt, L., Wojciechowski, J., Irby, D., Nicholas, T. (in preparation)

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