Summary

Skilled medical communications professional with over 19 years of professional experience across product development cycle, therapeutic areas, and topics including efficacy, safety, bioequivalence, pharmacokinetics, pharmacodynamics, and health economics, and outcomes research. Key therapeutic areas of experience include oncology supportive care (hematology), oncology, rheumatology, dermatology, and nephrology. Expert in managing and delivering small to large documents, working with authors and content sources across various technological platforms, serving the needs of multiple stakeholders.

Experience

JULY 2015 - PRESENT

Helen M Wilfehrt, PhD, Coaching & Communications, San Diego, CA - Owner

  • Provide freelance writing and editing support.

  • Coach clients on reworking disempowering stories.

JULY 2017 - PRESENT

International Society of Medical Publication Professionals - Education Content Manager (Contract)

  • Partner with expert volunteers to produce educational content for membership:

    • Supporting ISMPP University committee to produce monthly webinars.

    • Work with program committees to develop:

      • Workshops at the 15th Annual Meeting of ISMPP 2018
        (April 15-17, 2019; National Harbor, MD).

      • Educational content and workshops for 2018 ISMPP West Conference
        (October 11-12, 2018; San Diego, CA)

      • Workshops at the 14th Annual Meeting of ISMPP 2018
        (April 29-May 2, 2018; National Harbor, MD)

      • Educational content for 2017 Asia Pacific Meeting of ISMPP
        (September 2017; Tokyo, Japan).

2013 - 2015

Covance Market Access, San Diego, CA - Director, Value Communications

  • Provided expertise on communicating a product's value in terms of its clinical, economic, and patient-reported outcomes to target audiences.

  • Functioned as a client lead to execute on deliverables and advised on potential communication opportunities and approaches.

  • Contributed to global value dossiers and submissions to regulatory bodies related to health economics and outcomes research, including request letters, briefing documents, and patient-reported outcome dossiers.

2012 - 2013

DaVita Clinical Research, Remote - Director, Medical Communications

  • Led a team providing medical communications and publications services for external and
    internal clients.

  • Managed client relationships to ensure delivery of quality deliverables.

  • Liaised with clients, functional experts, and opinion leaders to provide timely and effective execution of project goals.

  • Delivered scientific documents on behalf of DaVita Healthcare Partners and its clients, including a comment letter to Centers for Medicaid and Medicare Services.

  • Edited documents produced by others for grammar, compliance with client style guide,
    and accuracy.

  • Developed major update to quality control processes for medical communication deliverables.

2010 - 2012

Sanofi Oncology, Cambridge, MA - Senior Director, Global Publication Lead - Multiple products

  • Worked in Global Medical Affairs in the Oncology Division.

  • Responsible for planning and coordinating global scientific publication activity for multiple pipeline products, including the launch of a therapeutic agent,  and liaising with
    corporate partners.

  • Also responsible for contributing to medical affairs activities such as the development of product narratives and literature alerts.

2002 - 2010

Amgen Inc. - Multiple Positions

  • Amgen Ltd. (Uxbridge, United Kingdom) - Senior Manager Clinical Development - 2009 - 2010

    • Worked in Oncology Therapeutic Area within the medical organization, supporting clinical studies, investigator-initiated studies, protocol writing, and other scientific activities. This included contributing to international regulatory application submissions.

  • Amgen (Europe) GmBH (Zug, Switzerland) - Senior Manager Publications - 2006 - 2009

    • Managed and executed regional publication plan for multiple in-line and pipeline products in collaboration with the Global Publication team. Also provided medical writing support for reimbursement submissions. Worked in oncology and osteoporosis.

  • Amgen Inc. (Thousand Oaks, CA) - Senior Manager Medical Writing - 2002 - 2006

    • Last position held involved leading writing teams that supported publications for both in-line and pipeline products across multiple therapeutic areas. Experienced in managing direct reports, external contract organizations, and individual contractors. Provided medical writing support to multiple reimbursement submissions, including AMCP and Global Value Dossiers. Also supported clinical study reports for phase 3b and 4 studies. Worked in oncology supportive care, dermatology, rheumatology, and nephrology.

1999 - 2002

IQVIA (was Quintiles Inc.) - Multiple positions held

  • Associate Director, Regulatory and Technical Services

    • Last position held was site medical writing lead (beginning March 2002) with up to
      4 direct reports. Provided medical writing support on over 30 regulatory documents, including those supporting 3 biologic license applications.

Education

University of North Carolina, Chapel Hill, NC
Postdoctoral Research in Urology

Northwestern University, Chicago, IL
PhD in Cellular & Integrative Biology (Neurobiology)

John Hopkins University, Baltimore, MD
BS in Biomedical Engineering (Electrical Engineering)

Qualifications

  • Expertise in Microsoft Office Suite, EndNote, Electronic document management systems, among others. Also experienced with various implementations of DataVision.

  • Specialized Certificate in Copyediting, University of California San Diego (March 2018).

  • Certified Medical Publications Professional from ISMPP (April 2013).

  • American Medical Writers Association

    • Advanced Certificate (October 2009).

    • Core Certificate in Pharmaceutical Specialty (October 2009).

    • Core Certificate in Editing/Writing (May 2004).

Authored Publications

  • Doctoral Thesis

    • Wilfehrt HM. The role of the caudal ventrolateral medulla in the regulation of sympathetic nerve activity and arterial blood pressure in normotensive and spontaneously hypertensive rats. Evanston, IL: Northwestern University, 1996.

  • Authored Journal Articles

    • 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.

    • Wilfehrt HM, Carson CC 3rd, Marson L. Bladder function in female rats: effects of aging and pregnancy. Physiol Behav. 1999;1-15;68(1-2):195-203.

    • Morrison SF, Cravo SL, Wilfehrt HM. Pontine lesions produce apneusis in the rat. Brain Res. 1994;25;652(1):83-6.

  • Other Presentations

    • Faculty member, Various topics. Introduction to People Management. Covance Market Access, 2012-2014.

    • Wilfehrt HM, Mutell R, Lubeck D, Hine J. Overview of Drug Development. DaVita Clinical Research Internal Training August 2012. Denver, Colorado.

    • Faculty, Electronic Submissions Course, 2001.Regulatory Affairs Professionals Society, San Diego, CA

  • LinkedIn Articles

  • Quoted

  • Book Acknowledgements

    • Gupta S. Quick Results with the Output Delivery System (Art Carpenter's SAS Software). Cary, NC: SAS Institute. 2003. ISBN-13: 978-1590471630

    • Dworkin BD. Learning and Physiological Regulation (The John D. and Catherine T. MacArthur Foundation Series on Mental Health and Development). Chicago, IL: University of Chicago Press, 1993. ISBN-13: 978-0226176000

  • 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.

    • 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.

    • 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.

    • Sura AC, Marson L, Wilfehrt HM, et al. Role of endogenous 5HT1A 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. Effect of lesions in the caudal ventrolateral medulla on frequency components of sympathetic nerve activities. Society for Neuroscience Annual Meeting 1993. Washington, District of Columbia.

    • Hunt JM, Wilfehrt HM, Silinsky EM. Adenosine inhibits the calcium-dependent acetylcholine secretion induced by ionomycin. Society for Neuroscience Annual Meeting 1992. Anaheim, California.