Hi, I’m Helen Wilfehrt, PhD, ISMPP CMPP™
- Training Program in Health Outcomes and Pharmacoeconomic Research, Part 1. University of Arizona.
- Certified Medical Publication Professional™, ISMPP.
- Certificate in Copyediting, UC San Diego Extended Studies
- PhD in Cellular & Integrative Biology, Northwestern University.
- BS in Biomedical Engineering, Johns Hopkins University.
I offer:
- Medical and regulatory writing.
- Medical communications.
- Medical affairs research and other activities.
- Medical-legal-regulatory review.
About
I bring more than 25 years of experience in drug development and medical communications, working as a medical writer, publications lead, and medical affairs director, serving at both global and regional levels. I have experience at both large and small pharmaceutical companies like Amgen, Sanofi, and Dendreon. I also worked at vendors such as IQVIA (formerly Quintiles, Inc), DaVita Clinical Research, and Covance Market Access.
Throughout that career I managed budgets of varying sizes, strategically outsourcing with freelancers and medical communications agencies, and worked directly with legal and accounts payable teams. I also worked as a consultant, performing business development activities, client engagement and management, and proposal and project development. Understanding how both sides operate shapes every engagement.
Pharmaceutical drug development involves generating a lot data. Then these data need to be communicated to a range of audiences. The story needs to be told. I’ve done that, working across multiple therapeutic areas, multiple drug stages, and multiple data types. Efficacy and safety data are only part of the story. Health economics and outcomes research (HEOR) research are another. I understand how the parts fit together across functions and audiences.
Learn more about me here.
Capabilities
Publications: Planning and Writing
Lifecycle-aligned and RWE-aligned publication strategies, authorship engagement, congress planning, and manuscript development in accordance with GPP and ICMJE guidelines.
Medical Content: Writing and Editing
Peer-reviewed manuscripts, congress materials, slide decks, value dossiers, and field-facing resources tailored to target audiences.
Medical Affairs Support
Advisory board planning and execution, insight synthesis, and cross-functional collaboration across medical, clinical, HEOR, and commercial functions.
Medical-Legal-Regulatory Review
Medical reviewer of medical affairs and marketing materials ensuring scientific accuracy and language clarity.
Therapeutic Areas
- Oncology/Hematology
- Rheumatology
- Dermatology
- Nephrology
- Immunotherapy
Portfolio
- Co-authored Journal Articles
- Antonarakis ES, Subudhi SK, Pieczonka CM, Karsh LI, Quinn DI, Hafron JM, Wilfehrt HM, Harmon M, Sheikh NA, Shore ND, Petrylak DP. Combination treatment with sipuleucel-T and abiraterone acetate or enzalutamide for metastatic castration-resistant prostate cancer: STAMP and STRIDE trials. Clin Cancer Res 2023;29(13):2426-34. doi:10.1158/1078-0432.CCR-22-3832.
- Hafron JM, Wilfehrt HM, Ferro C, Harmon M, Flanders SC, McKay RR. Real-world effectiveness of sipuleucel-T on overall survival in men with advanced prostate cancer treated with androgen receptor-targeting agents. Adv Ther. 2022;37:4910–492. https://link.springer.com/article/10.1007/s12325-022-02085-6.
- McKay RR, Hafron JM, Ferro C, Wilfehrt HM, Fitch K, Flanders SC, Fabrizio MD, Schweizer MT. A retrospective observational analysis of overall survival with sipuleucel-T in Medicare beneficiaries treated for advanced prostate cancer. Adv Ther. 2020;37(12):4910-4929; doi:0.1007/s12325-020-01509-5.
- Krishnan M, Wilfehrt HM, Lacson Jr E. In data we trust: The role and utility of dialysis provider databases in the policy process. Clin J Am Soc Nephrol. 2012;7(11):1891-6. doi:10.2215/CJN.03220312.
- Hazard E, Cherry SB, Lalla D, Woolley JM, Wilfehrt H, Chiou CF. Clinical and economic burden of psoriasis. Manag Care Interface. 2006;19(4):20-6. PMID: 16689023. https://pubmed.ncbi.nlm.nih.gov/16689023/
- Wilfehrt HM, Carson CC 3rd, Marson L. Bladder function in female rats: effects of aging and pregnancy. Physiol Behav. 1999;(1-2):195-203. doi:10.1016/s0031-9384(99)00175-4
- Morrison SF, Cravo SL, Wilfehrt HM. Pontine lesions produce apneusis in the rat. Brain Res. 1994;25;652(1):83-86. doi:10.1016/0006-8993(94)90320-4
- Co-authored Conference Publications
- Bond TC, Mutell R, Wilfehrt HM , and Krishnan M. Association of pruritis and quality of life (QOL) among patients at a large dialysis provider. 33rd Annual Dialysis Conference (ADC) . Seattle, WA. 2013. https://davitaclinicalresearch.com/wp-content/uploads/pdfs/ASN_2012/Bond_pruritusinfection.pdf
- Sibbel S, Bond TC, Wilfehrt HM , Nissenson A, Krishnan M. Decreased population hemoglobin (HB) levels and increased transfusion (TFN) rates under new ESA guidelines in patients (PTS) with ESRD at a large dialysis organization (LDO). Am J Kidney Dis. 2013; 61. Presented at International Conference on Glomerular Diseases. https://network.davitaclinicalresearch.com/wp-content/uploads/pdfs/NKF_2013/Sibbel_Hemoglobin.pdf
- Bond TC, Marlowe G, Wilfehrt HM , Young A, Krishnan M, Mayne TJ. Patient-reported pruritus rates and indicators of infection co-vary directly among patients receiving dialysis. American Society of Nephrology Kidney Week. San Diego, CA, Oct 30 – Nov 4, 2012. Abstract TH-PO267. https://davitaclinicalresearch.com/wp-content/uploads/pdfs/ASN_2012/Bond_pruritusinfection.pdf
- Sura AC, Marson L, Wilfehrt HM, et al. Role of endogenous 5 HT1A receptors in male sexual behavior. Society for Neuroscience Annual Meeting. 1999. Miami, Florida.
- Wilfehrt HM, Marson L. Aging and pregnancy effects on in vivo and in vitro bladder function in female rats. Society for Neuroscience Annual Meeting. 1998. Los Angeles, California.
- Wilfehrt HM, Marson L. Role of brainstem sites in the regulation of micturition in female rats. Society for Neuroscience Annual Meeting. 1997. New Orleans, Louisiana.
- Wilfehrt HM, Morrison SF. Diminished responses of spontaneously hypertensive rats to lesions of the caudal ventrolateral medulla. Society for Neuroscience Annual Meeting. 1994. Miami, Florida.
- Wilfehrt HM, Morrison SF. Diminished caudal ventrolateral medulla function in spontaneously hypertensive rats. 48th Annual Fall Conference and Scientific Sessions of the American Heart Association Council for High Blood Pressure Research. 1994. Chicago, Illinois.
- Wilfehrt HM, McCrimmon DR, Morrison SF. The effect of lesions in the caudal ventrolateral medulla on the frequency components of sympathetic nerve activities. Society for Neuroscience Annual Meeting, 1993, Washington, D.C.
- Samples of Publications Supported as Medical Writer
- Wei XX, Kwak L, Hamid A, He M, Sweeney C, Flanders SC, Harmon M, Choudhury AD. Outcomes in men with metastatic castration-resistant prostate cancer who received sipuleucel-T and no immediate subsequent therapy: experience at Dana Farber and in the PROCEED Registry. Prostate Can Prost Dis. 2022;25(2):314-9. doi: 10.1038/s41391-022-00493-x
- Hernandez E, Ganly P, Charu V, DiBenedetto J, Tomita D, Lillie T, Taylor K, ARANESP 20030232 Study Group. Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia. Curr Med Res Opin. 2009;25(9):2109-20. doi: 10.1185/03007990903084164
- Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Hamilton L, Bridges K, Pujol B. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level< 10 g/dL versus ≥ 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial. BMC Cancer. 2009;9(1):311. doi:10.1186/1471-2407-9-311
- Spaepen E, Demarteau N, Van Belle SI, Annemans L. Health Economic Evaluation of Treating Anemia in Cancer Patients Receiving Chemotherapy: A Study in Belgian Hospitals. The Oncologist. 2008;13:596-607. doi:10.1634/theoncologist.2007-0219
- Heatherington AC, Dittrich C, Sullivan JT, Rossi G, Schneller J. Pharmacokinetics of darbepoetin alfa after intravenous or subcutaneous administration in patients with non-myeloid malignancies undergoing chemotherapy. Clin Pharmacokin. 2006;45(2):199-211. doi:10.2165/00003088-200645020-00005
- Gottlieb AB, Mease PJ, Mark Jackson J, Eisen D, Amy Xia H, Asare C, Stevens SR. Clinical characteristics of psoriatic arthritis and psoriasis in dermatologists’ offices. Journal of dermatological treatment. 2006;17(5):279-87. doi:10.1080/09546630600823369
- Gottlieb AB, Kircik L, Eisen D, Mark Jackson J, Boh EE, Strober BE, Frankel E, Amt Xia H, Stevens SR. Use of etanercept for psoriatic arthritis in the dermatology clinic: the Experience Diagnosing, Understanding Care, and Treatment with Etanercept (EDUCATE) study. J Dermatolog Treat. 2006;17(6):343-52. doi: 10.1080/09546630600967166
- Harris Spiridonidis C, Brinkmannb K, Fridman M, Gupta S, Tannous∥ RE. Evaluating the effectiveness of epoetin alfa in community oncology practices. Hematology. 2003;8(4):243-8. doi: 10.1080/10245330310001594243
- Siena S, Piccart MJ, Holmes FA, Glaspy J, Hackett J, Renwick JJ. A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II-IV breast cancer. Oncology Rep. 2003;10(3):715-24. https://www.spandidos-publications.com/or/10/3/715#
Contacts
Phone
Address
2831 St Rose Parkway, Suite 200
Henderson, NV 89052
United States of America