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Tatiana M. Prowell, MD

Tanya Michelle Prowell, MD
Part-time Medical Oncology Faculty
Assistant Professor of Oncology
Female
Appointment Phone

410-955-8964

Main Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

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Call 410-464-6641 (8a.m. to 6p.m., EST, Mon-Fri)

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Call +1-410-502-0773 (7a.m. to 6p.m., EST, Mon-Fri)

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Titles

  • Part-time Medical Oncology Faculty
  • Assistant Professor of Oncology

Centers & Institutes

  • Breast Center

Expertise

Breast Cancer, Medical Oncology

Research Interests

Breast cancer in young women; Triple-negative breast cancer; Neoadjuvant therapy for breast cancer; Novel therapies for breast cancer

Biography

Dr. Prowell received her B.A. degree in Languages & Literature with honors from Bard College. She received her M.D. degree from Johns Hopkins University School of Medicine in Baltimore, Maryland, where she was elected to the Phi Beta Kappa and Alpha Omega Alpha honor societies. She subsequently completed an internal medicine residency in the Osler Housestaff Training Program at Johns Hopkins Hospital and a medical oncology fellowship within the Breast Cancer Research Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital. During fellowship, she wrote and conducted three investigator-initiated translational breast cancer trials. Dr. Prowell was awarded a Young Investigator Award from the American Society of Clinical Oncology (ASCO) and twice awarded the Pearl M. Stetler Research Fund for Women for her breast cancer research.

In 2006, Dr. Prowell accepted a joint appointment as faculty at the Johns Hopkins School of Medicine in the Breast Cancer Program and as a Medical Officer at the FDA.  She currently serves as the Scientific Lead for Breast Cancer in the Office of Hematology & Oncology Products at the FDA and is an Assistant Professor of Oncology in the Johns Hopkins Breast Cancer Program.  Dr. Prowell has been an invited speaker at numerous academic institutions, national medical conferences, and patient advocacy gatherings and is a three-time recipient of FDA's Excellence in Communication Award.  Recently she has helped to pioneer a pathway to accelerated approval for drugs used to treat patients with high-risk, early-stage breast cancers, such as triple-negative breast cancer, in the neoadjuvant setting.

Dr. Prowell remains committed to the clinical care of women and men with breast cancer and practices at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, where she staffs the second opinion breast cancer clinic.  Her particular areas of clinical and research interest include:  triple-negative breast cancer, development of novel agents for breast cancer treatment, neoadjuvant therapy for breast cancer, and the unique challenges of breast cancer in younger women. 

Dr. Prowell is passionate about her work.  When asked what motivated her to pursue the joint appointment she currently holds at Johns Hopkins and the FDA, Dr. Prowell said, "The two positions really complement one another.  In my clinical practice, I have the privilege of spending as much time as it takes to help my patients make the most informed choices possible about their treatment.   I see the challenges that my patients face up close, and I feel the urgency to get novel therapies to them.  At the FDA, I have the opportunity to shape at a very high level drug development programs to ensure that the most promising treatments will reach patients as rapidly as possible.  I love what I do.  I feel thankful every day to wear both of these hats as an oncologist to make things better for patients living with this disease.  I couldn't imagine doing anything different."  She pauses before adding, "though I would be very happy to be put out of business.  I guess if we do our jobs well enough, that's precisely what will happen!  I hope I live to see that day."

Languages

  • English

Memberships

American Society of Clinical Oncology

Clinical Trial Keywords

  • breast cancer

Additional Resources

Additional Resources +
  • Education +

    Training

    • Johns Hopkins University School of Medicine (Baltimore MD) (1999)

    Residencies

    • Johns Hopkins University School of Medicine / Internal Medicine (Baltimore MD) (2002)

    Fellowships

    • Johns Hopkins University School of Medicine / Oncology (Baltimore MD) (2006)

    Certifications

    • American Board of Internal Medicine / Internal Medicine (2012)
    • American Board of Internal Medicine / Medical Oncology (2004)
  • Research & Publications +

    Selected Publications

    1. Prowell T, Smith B. Neutropenic Fever. In: Cheng A, Zaas A., eds. The Osler Medical Handbook, First Edition. Philadelphia: Mosby, 2003: 537-544.
    2. Prowell T, Liu M. Asthma. In: Cheng A, Zaas A., eds. The Osler Medical Handbook, First Edition. Philadelphia: Mosby, 2003: 867-880.
    3. Prowell T, Davidson N. What is the role of ovarian ablation in the management of primary and metastatic breast cancer today? The Oncologist 2004; 9(5): 507-517.
    4. Prowell T, Stearns V. Commentary on: “Are breast density and bone mineral density independent risk factors for breast cancer?” (Kerlikowske et al, J Natl Cancer Inst 2005;97:368-374). The North America Menopausal Society (NAMS): First to Know. April 2005. www.menopause.org/news.html
    5. Sheth A, Prowell T, Krishnan J. Asthma. In: Nilsson K, Piccini J., eds. The Osler Medical Handbook, Second Edition. Philadelphia: Saunders Elsevier, 2006: 865-876.
    6. Prowell T, Stearns V, Trock B. Lipophilic statins merit additional study for breast cancer chemoprevention. Journal of Clinical Oncology, 2006; 24(13): 2128-2129.
    7. Prowell T, Stearns V. Disease-free survival was greater with letrozole than tamoxifen in postmenopausal women with early breast cancer. ACP Journal Club, 2006: 145(1): 11.
    8. Bao T, Prowell T, Stearns V. Chemoprevention of breast cancer: Tamoxifen, raloxifene, and beyond. American Journal of Therapeutics, 2006; 13(4): 337-348.
    9. Prowell T, Davidson N. Metastatic breast cancer: Tailored endocrine therapy for premenopausal women. In: Piccart M, Wood W, Hung M-C, Solin L, Cardoso F., eds. Breast Cancer Management and Molecular Medicine: Towards Tailored Approaches. Springer-Verlag, 2006: 445-458.
    10. Prowell T, Armstrong D. Selecting endocrine therapy for breast cancer: What role does HER-2/neu status play? Seminars in Oncology, 2006; 33(6): 681-687.
    11. Prowell T, Stearns V. Extended adjuvant therapy for breast cancer—how much is enough? J Natl Cancer Inst. 2007 99: 1825-1827.
    12. Prowell T, Fackler M, Argani P, Khouri N, Blackford A, Shahverdi K, Wolff A, Davidson N, Sukumar S, Stearns V. A prospective study of adjuvant anastrozole and gene promoter methylation in the contralateral breast of high-risk women. J Clin Oncol 26: 2008 (May 20 suppl; abstr 1514).
    13. Bao T, Shahverdi K, Blackford A, Prowell T, Jeter S, Powers P, Wright L,. Snyder C, Stearns V, Visvanathan K.Quality of life changes in breast cancer patients participating in an anastrozole secondary prevention trial.J Clin Oncol 26: 2008 (May 20 suppl; abstr 1515).
    14. Prowell T, Ibrahim A, Farrell A, Justice R, Sun Mitchell S, Sridhara R, and Pazdur R. FDA Approval Summary: Temsirolimus as Treatment for Advanced Renal Cell Carcinoma. The Oncologist 2010; 15:428-35.
    15. Prowell T, Blackford A, Byrne C, Khouri N, Dowsett M, Folkerd E, Tarpinian K, Powers P, Wright L, Donehower M, Jeter S, Armstrong D, Emens L, Fetting J, Wolff A, Garrett-Mayer E, Skaar T, Davidson N, Stearns V. Changes in breast density and circulating estrogens in postmenopausal women receiving adjuvant anastrozole. Cancer Prev Res 2011; 4:1993-2001.
    16. Higgins M, Prowell T, Blackford A, Byrne C, Khouri N, Slater S, Jeter S, Armstrong D, Davidson N, Emens L, Fetting J, Powers P, Wolff A, Green H, Thibert J, Rae J, Folkerd E, Dowsett M, Blumenthal R, Garber J, Stearns V. A Short-Term Biomarker Modulation Study of Simvastatin in Women at Increased Risk of a New Breast Cancer. Breast Cancer Res Treat 2012; 131: 915-924
    17. Prowell T, Pazdur R. Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer. N Engl J Med. 2012; 366:2438-41.
    18. Prowell T. Guidance for Industry: Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf.
    19. Zhang L, Untch M, Mehta K, Costantino J, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Zujewski J, Justice R, Loibl S, Wickerham L, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas E, Bergh J, Semiglazov V, Prowell T, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching P, Swain S, Slaets L, Tang S, Gerber B, Geyer C, Pazdur R, Ditsch N, Rastogi P, Eiermann W, and von MinckwitzG. Meta-analysis Results from the Collaborative Trials in Neoadjuvant Breast Cancer (CTneoBC). Cancer Res 2012;72 (24 Suppl):Abstract P114-20.
    20. Prowell T, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching P, Swain S, Slaets L, Tang S, Gerber B, Geyer C, Pazdur R, Ditsch N, Rastogi P, Eiermann W, and von Minckwitz G. A Definition of a High-Risk Early-Breast Cancer Population Based on Data from the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) meta-analysis.  Cancer Res 2013; Abstract P5-17-01.
    21. Prowell T, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching P, Swain SM, Slaets L, Tang S, Gerber B, Geyer C, Pazdur R, Ditsch N, Rastogi P, Eiermann W, vonMincwitz G. Pathological complete response in breast cancer: CTNeoBC pooled-analysis. The Lancet. Epub ahead of print Feb 14, 2014.
  • Academic Affiliations & Courses +
  • Activities & Honors +

    Honors

    1990                Asher B. Edelman Excellence and Equal Cost Scholarship (full academic scholarship), Bard College

    1993                Summer Intramural Research Training Award, NIH

    1993                Heinrich Blücher Scholar (for excellence in the Division of Languages and Literature), Bard College

    1994                Bishop-Jervis Prize (for four years of overall academic excellence), Bard College

    1999                Phi Beta Kappa Society, Johns Hopkins University

    1999                Alpha Omega Alpha Honor Medical Society, Johns Hopkins University School of Medicine

    2004                Pearl M. Stetler Research Fund Award

    2004                Young Investigator Award, American Society of Clinical Oncology

    2005                Pearl M. Stetler Research Fund Award

    2010                Award for Excellence in Communication, Food & Drug Administration

    2011                FDA Group Recognition Award

    2012                Award for Excellence in Communication, Food & Drug Administration

    2014                Award for Excellence in Communication, Food & Drug Administration

  • Videos & Media +

    Video Links

    Lectures and Presentations

    1. “Treatment with adjuvant anastrozole decreases cumulative gene methylation in the contralateral breast of women at increased risk for a second breast cancer.” ASCO Breast Cancer Symposium; oral abstract presentation (Abstract 1). San Francisco, CA. September 7, 2007.
    2. “Why have we not prevented or cured breast cancer, and what are we going to do about it?” Vision Panel Speaker, Collaborative Summit on Breast Cancer Research. Leesburg, VA. November 1-2, 2007.
    3. “Write Your Ticket: Career Options in Medical Oncology--A Session for Fellows and Junior Faculty.” ASCO Annual Meeting. Orlando, FL. June 5, 2009.
    4. “Doxil in Advanced Breast Cancer.” FDA Presentation, Oncology Drugs Advisory Committee Meeting. Gaithersburg, MD. July 15, 2009.
    5. “Neoadjuvant Chemotherapy—Pros and Cons.” The Fifth Bi-Annual Johns Hopkins Breast Cancer Conference. Baltimore, MD. March 27, 2010.
    6. “FDA History and Regulatory Authority”. National Breast Cancer Coalition, Project LEAD Conference. Lansdowne, VA. November 4, 2010.
    7. “Oncology Drug Development: A Regulatory Perspective”. Clinical Investigator Seminar Series, Dana Farber Cancer Institute. Boston, MA. March 22, 2011.
    8. “Challenges in Oncology Drug Development.” Presentation to Congressional Staff. FDA. Silver Spring, MD. March 28, 2011.
    9. Clinical Trials Module, Accelerating Anticancer Agent Development and Validation (AAADV) Workshop. Bethesda, MD. May 18-19, 2011.
    10. “Clinical Trials Versus Standard of Care.” Metastatic Breast Cancer Network National Conference. Baltimore, MD. October 29, 2011.
    11. “FDA and Cancer: The Inside View.” CBS Biocentury TV. Washington, D.C. February 5, 2012.
    12. “Regulatory Considerations in Oncology Drug Development.” Clinical Investigator Seminar Series, Dana Farber Cancer Institute. Boston, MA. March 5, 2012.
    13. “Are Anthracyclines Past Their Prime?” The Sixth Bi-Annual Johns Hopkins Breast Cancer Conference: Controversies in Management—A Multidisciplinary Perspective. Annapolis, MD. March 30, 2012.
    14. “Pitfalls in Oncology Drug Development.” Accelerating Anticancer Agent Development and Validation (AAADV) Workshop. Bethesda, MD. May 16-17, 2012.
    15. “Meet the Professor Session: Breast Cancer.” Topics in Clinical Medicine course, Johns Hopkins University School of Medicine. Baltimore, MD. May 9, 2012.
    16. “Emerging Concepts of Drug Safety in Oncology,” American Society of Clinical Oncology (ASCO) Annual Meeting. Chicago, IL. June 1, 2012.
    17. “Pathologic Complete Response as an Endpoint to Support Accelerated Approval,” iSPY2 Annual Investigators Meeting. Chicago, IL. June 1, 2012.
    18. “Oncology Drug Development: A Regulatory Perspective.” Grand Rounds, Medical Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Baltimore, MD. June 22, 2012.
    19. “Draft Guidance on Using Pathologic Complete Response as an Endpoint to Support Accelerated Approval of Drugs to Treat Early-Stage Breast Cancer.” Webinar, Office of Medical Policy, Center for Drug Evaluation and Research, Food & Drug Administration. Silver Spring, MD. June 28, 2012.
    20. “Accelerating the Search for Breast Cancer Therapies for Triple Negative Breast Cancer.” CBS Biocentury TV. Washington, D.C. July 29, 2012.
    21. “Regulatory Considerations in Oncology Drug Development.” Cancer Policy Roundtable, National Coalition for Cancer Survivorship. Washington, D.C. Oct 25, 2012.
    22. “Strategies to Expedite Oncology Drug Development.” American Society of Clinical Oncology Leadership Development Program. Silver Spring, MD. Nov 7, 2012.
    23. “Pathological Complete Response as an Endpoint to Support Accelerated Approval in High-Risk, Early-Stage Breast Cancer.” Chemotherapy Foundation Symposium, Mt. Sinai School of Medicine. New York, NY. Nov 8, 2012.
    24. “Exploiting the Preoperative Setting: Streamlining Drug Development in High-Risk, Early Stage Breast Cancer.” Grand Rounds, Internal Medicine, Johns Hopkins Hospital. Baltimore, MD. Jan 4, 2013.
    25. “Oncology Drug Development: A Regulatory Perspective.” Clinical Investigator Seminar Series, Dana Farber Cancer Institute. Boston, MA. March 5, 2013.
    26. “Understanding the FDA Drug Approval Process in Breast Cancer: How It Works and How It Could Work Better.” Breast Oncology Seminar Series, Dana Farber Cancer Institute. Boston, MA. March 6, 2013.
    27. “Considerations for Neoadjuvant Breast Cancer Trials to Support Accelerated Approval.” ASCO/FDA Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop. Silver Spring, MD. March 22, 2013.
    28. “Pitfalls in Oncology Drug Development.” American Association for Cancer Research (AACR) Annual Meeting. Washington, D.C. April 6, 2013.
    29. “The Promise and Challenges of Pathological Complete Response (pCR) as a Novel Endpoint for Drug Approval in High-Risk, Early-Stage Breast Cancer.” Panel Discussion. American Association for Cancer Research (AACR) Annual Meeting. Washington, D.C. April 8, 2013.
    30. “Drug-Induced Peripheral Neuropathy in Cancer Patients.” CASE Seminar on Drug-Induced Peripheral Neuropathy. Silver Spring, MD. April 11, 2013.
    31. “Pitfalls in Oncology Drug Development.” Accelerating Anticancer Agent Development and Validation (AAADV) Workshop. Bethesda, MD. May 8-10, 2013.
    32. “Clinical Trials with Molecular Selection: Neoadjuvant Trial Design.” American Society of Clinical Oncology (ASCO) Pre-Annual Meeting, New Drugs in Oncology Seminar. Chicago, IL. May 30, 2013.
    33. “Impact of Phase I Trials on Safety and Optimal Dose for Future Clinical Practice.” American Society of Clinical Oncology (ASCO) Annual Meeting. Chicago, IL. June 1, 2013.
    34. “Understanding the U.S. FDA Guidance on Pathological Complete Response and Accelerated Approval” in Pushing the Limits of Upfront Care and Drug Development: Neoadjuvant Opportunities in Breast Cancer. American Society of Clinical Oncology (ASCO) Annual Meeting. Chicago, IL. June 1, 2013.
    35. “Implementation of the Final Guidance on Accelerated Approval in the Neoadjuvant Setting.” I-SPY 3 Planning Meeting. Washington, D.C. Nov 15, 2013.
    36. “Pertuzumab for High-Risk, Early Breast Cancer.” Breast Oncology Multidisciplinary Seminar. Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Baltimore, MD. Nov 20, 2013.
    37. “Compassionate Use of Investigational Agents.” Breast Oncology Multidisciplinary Seminar. Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Baltimore, MD. Dec 18, 2013.
    38. “Ethics of Oncology Drug Development.” Johns Hopkins University School of Medicine Ethics Course. February 12, 2014.
    39. “Preoperative Systemic Therapy for Breast Cancer: Considerations for Investigators, Clinicians, and Patients.” Norris Cotton Cancer Center Grand Rounds.   Dartmouth-Hitchcock Medical Center. Hanover, NH. Feb 18, 2014.
    40. “Pathological Complete Response: Is It the Holy Grail?” The Seventh Bi-Annual Johns Hopkins Breast Cancer Conference- A Multidisciplinary Perspective. Baltimore, MD.   Mar 7, 2014.
    41. “Oncology Drug Development: A Regulatory Perspective.” Clinical Investigator Seminar Series, Dana Farber Cancer Institute. Boston, MA. March 25, 2014.
    42. “Pathological Complete Response: Promise, Perils, and the Path Forward.” Breast Cancer Rounds. Massachusetts General Hospital. Boston, MA. March 25, 2014.
    43. “Use of Biopsies for Clinical and Regulatory Decision-Making in Late-Stage Drug Development.” American Association for Cancer Research (AACR) Annual Meeting. San Diego, CA. April 7, 2014.
    44. “Successful Oncology Drug Development: Balancing Knowledge, Speed, and Risk.” Session Co-Chair and Speaker. American Association for Cancer Research (AACR) Annual Meeting. San Diego, CA. April 8, 2014.
    45. “From Drug Activity to Meaningful Clinical Benefit.” Session Co-Chair and Speaker. Accelerating Anticancer Agent Development and Validation (AAADV) Workshop. Bethesda, MD. May 7-9, 2014.
    46. “Access to Data from Clinical Trials: A New Age of Clinical Trial Transparency.” Session Chair and Speaker. American Society of Clinical Oncology (ASCO) Annual Meeting. Chicago, IL. June 1, 2014.

    Recent News Articles & Media Coverage

  • Events +
  • Contact & Locations +

    Locations

    Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    401 N. Broadway
    Baltimore, MD 21231
    Phone: 410-955-8893
    Appointment Phone: 410-955-8964
    Location Map

    Department/Division

    • Oncology

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