Terri Cornelison

Terri Cornelison

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  • Timeline

  • About me

    Director, Office of Innovative Development @ FDA | MD | PhD in Molecular and Cellular Oncology

  • Education

    • The George Washington University

      1995 - 2000
      Doctor of Philosophy - PhD Molecular and Cellular Oncology

      Dissertation: A Cytokine Mechanism of Radiation Fibrosis

    • Yale University School of Medicine

      1981 - 1985
      Doctor of Medicine - MD Medicine

      Thesis: Preventing Postoperative Pelvic Adhesions

    • Bryn Mawr College

      1977 - 1981
      Bachelor of Arts - BA Chemistry

      Research: The Chemically Cross-Linked Crystal Aggregate of Sickle Cell Hemoglobin

  • Experience

    • The Johns Hopkins University School of Medicine

      Aug 1998 - now

      • Managed surgical, inpatient, and ambulatory patient care at Johns Hopkins University School of Medicine.• Trained resident and fellow physicians on The Kelly Gynecologic Oncology Service.• Instructed medical students from Johns Hopkins University School of Medicine.

      • Associate Professor

        Jul 2016 - now
      • Assistant Professor

        Aug 1998 - Jun 2016
    • Commissioned Corps of the U.S. Public Health Service

      Jan 2009 - Jul 2023

      Captain in the United States Public Health Service Commissioned Corps.• Led the first USPHS team deployed for COVID-19 in the continental US into the Life Care Center at Kirkland to help take care of residents with COVID-19 in what was then the Nation’s epicenter, successfully stabilizing the facility and bringing all officers home safely and COVID negative• Led USPHS in first of its kind White House trans-agency initiative DHHS COVID-19 Nursing Home Engagement Team Mission, worked with CMS and CDC partners, successfully integrated USPHS officers as full members in 39 tri-agency strike teams deployed into 84 long-term care facilities in 27 states, providing technical assistance on safety and infection control to help reduce COVID-19 transmission and risk of COVID-19 complications in long-term care facility residents.• Served in leadership roles in USPHS deployments from Katrina to Operation Allies Welcome:• Operation Allies Welcome, Herndon, VA, Chief Medical Officer, OAW Incident Command-Dulles, 2021• COVID-19, Rockville, MD, USPHS Mission Lead, HHS COVID-19 Nursing Home Engagement Team, 2020• COVID-19, Kirkland, WA, Team Lead, Kirkland Mission, 2020• Hurricanes Irma/Maria, Miami, FL, Medical Branch Deputy Director, Lead Provider, RDF PHS1α, 2017• Hurricane Sandy, Brooklyn, NY, Medical Branch Deputy Director, Lead Provider, RDF PHS1, 2012• Operation Lone Star, San Juan, TX, Dual Role as Strike Team Lead, Lead Provider, RDF PHS1, 2011• Hurricane Ike, College Station, TX, Medical Branch Director, PHS Field Medical Station, 2008• Hurricane Katrina, Pascagoula, MS, Chief Medical Officer aboard the MS Holiday, 2005/6 Show less

      • Commissioned Corps Officer

        Aug 1995 - Jul 2023
      • Medical Branch Deputy Director and Lead Provider, Rapid Deployment Force 1

        Jan 2009 - Dec 2017
    • National Cancer Institute (NCI)

      Jan 2011 - Jul 2013

      Developed, implemented, and monitored clinical trials on prevention or early detection of gynecologic and breast malignancies: NCI-funded contract protocols and NCI-funded R-type grants and grant applications relating to prevention trials in cervical, endometrial, and breast cancer, representing awards totaling $21.4 million• Chaired Early Detection for Ovarian Cancer Working Group• Co-Founded and Co-Chaired Division of Cancer Prevention Human Papillomavirus (HPV) Vaccine Project Team, forerunner organization of the trans-institute HPV-Cervix Working Group• Invited expert for NCI Gynecologic Cancers Progress Review Group; advisory member to Cancer Prevention and Control Committee and Vaccine Sub-Committee of Gynecologic Oncology Group (NRG Oncology); appointed delegate to Strategy Conference for Office of Women’s Health, Department of Health and Human Services Show less

      • Program Director, Breast and Gynecologic Cancer Research Group/Branch, Division of Cancer Prevention

        Jul 1999 - Jul 2013
      • Acting Chief, Breast and Gynecologic Cancer Research Group/Branch, Division of Cancer Prevention

        Jan 2011 - Mar 2013
    • The National Institutes of Health

      Jul 2013 - Apr 2017
      Associate Director for Clinical Research, Office of Research on Women's Health

      First Associate Director for Clinical Research, Office of Research on Women's Health (ORWH).• Directed clinical oversight of $32 million complex biomedical national research program involving basic, clinical, and epidemiological studies of broad complexity, and collaboration across all institutes of National Institutes of Health• Created new scientific effort, strengthened the scientific face of the office, and led inaugural team of medical officers• Built multi-disciplinary ORWH Medical Officer team into a solidly cohesive unit and established them as the Clinical Research Core (CRC); directed their efforts in the management of research activities including during a critical transition period with very limited staff and resources• Expanded leadership role to include scientific and administrative duties of both Deputy Director and Associate Director for Special Projects and Centers• Executed management of ORWH administrative operations and budget procedures• Accountable for entire ORWH scientific program (representing 75% of ORWH budget)• Supervised and mentored all ORWH scientific program staff; became requested supervisor by scientific staff; sought-after mentor by scientific and administrative staff • Directed ORWH keystone programs: Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) K12 Physician Scientist Award Program and the Specialized Centers of Research (SCOR) on Sex Differences Program, Strategic Research Planning (SRP) Program, Research Enhancement Awards Program (REAP), Trans-NIH High Priority, Short-Term Awards (R56) in Women’s Health Program, Administrative Supplements for Research on Sex/Gender Differences Program, ORWH Reentry Program, career development, health disparities, men’s health, global health, and inclusion of women in clinical trials Show less

    • FDA

      Apr 2017 - now

      First Director of the Office of Innovative Development (formerly Office of Equity and Innovative Development) at the FDA's Center for Devices and Radiological Health. Built and led brand-new office charged to provide leadership and strategic direction in health equity, patient science. Spearheaded cross-cutting activities and initiatives related to heath equity, innovation, patient-centeredness, patient science including patient reported outcomes, patient preference information, patient-generated health data, patient engagement, Patient Engagement Advisory Committee, Patient & Caregiver Connection, health of women, pediatrics, special populations including underrepresented and underserved populations, Public-Private partnerships, Collaborative Communities, Network of Experts, technology transfer, medical device development tools, research fellowships, Centers for Excellence and Regulatory Science Research grant programs, broad agency research contact programs, and many other strategic partnerships.• Established strategic framework with mission, vision, highest priorities and goals, through a co-creative process • Established senior leadership, transition, and branding teams• Implemented new tracking methods to improve efficiencies• Launched and completed strategic visioning project for Division of Patient-Centered Development to establish Future-State Blueprint for patient science and patient engagement• Completed landscape analysis & research roadmap for patient science• Convened cross-agency Patient Engagement Advisory Committee; Patient Engagement Town Hall; Health of Women Community of Practice• Qualified 4 Medical Device Development Tools in CY24; exceeded projections by 33%; MDDTs cited in over 1300 pre-market submissions• Initiated FDA participation in 5 new Collaborative Communities in CY24; exceeded projections by 67%• Streamlined Regulatory Science Program• Trained 1940 CDRH staff Show less First Chief Medical Officer for the Health of Women. Built, led, and expanded modernized Health of Women Program with an overarching mission to improve the health of all women and meet the steadily growing national and global impact of sex- and gender-specific issues arising in medical technology design and development through center activities with nearly 2200 staff, 250,000 regulated devices, and 21,500 manufacturing firms.• Consistently exceeded expectation in creating vision, innovative approach to engagement, inclusivity in collaboration, empowerment style of leadership, attention to excellence, and vivacious capacity to mobilize people to operationalize vision:• Established and led Health of Women Steering Committee to ensure success of the program; refined and prioritized program strategies, and defined measures of success• Developed Health of Women Program Strategic Plan and Action Plan• Designed and executed multi-phased program launch to Center and public • Positioned program on a global medical device ecosystem, poised to explore the unique issues related to the performance of medical devices in women• Improved availability, analysis, and communication of sex- and gender-specific information for the safe and effective use of medical devices in women and in men• Leveraged organizational resources to assemble multi-disciplinary staff throughout the center• Established working group on sex/gender-specific analysis and reporting; developed CDRH improvement plan blueprint• Established Health of Women Community of Practice • Developed Research Roadmap for Regulatory Science: expanded CDRH Research Portfolio, achieved 50% increase in funded projects representing grants totaling $3.2 million• Collateral Duties: COVID-19 Response: Conceptualized and led creation of CDRH Information and Data Operations Center, a center-wide emergency response construct, using a service-design approach that involved work of over 150 people Show less First Associate Director for the Health of Women and Director of the Health of Women Program.• Created and implemented the Health of Women Program at FDA to explore the unique issues related to the performance of medical devices in women and to address the steadily growing importance of sex- and gender-specific issues arising regarding medical technology design and development, clinical and non-clinical study design, and other medical device-related matters.• Led initiatives to improve availability, analysis, and communication of sex- and gender-specific information for the safe and effective use of medical devices to improve the performance of medical devices in women and in men• Developed research priorities for the device health of women ecosystem• Coordinated major health science and medical programs and initiatives across the Center Show less

      • Director, Office of Innovative Development, CDRH

        Jan 2024 - now
      • Director & Chief Medical Officer, Health of Women, CDRH

        Mar 2019 - now
      • Associate Director, Health of Women, Center for Devices and Radiological Health

        Apr 2017 - Mar 2019
  • Licenses & Certifications

    • Subspecialty Certification in Gynecologic Oncology

      American Board of Obstetrics and Gynecology (ABOG)
      Apr 2009
    • Subspecialty Certification in Gynecologic Oncology

      Roswell Park Comprehensive Cancer Center
      Jun 1995
    • Research Fellowship

      National Cancer Institute (NCI)
      Jun 1992
    • Research Fellowship

      Uniformed Services University of the Health Sciences
      Jun 1993
    • Gynecologic Cancer Foundation/NCI Research Fellowship

      National Cancer Institute (NCI)
      Jan 1998
    • Certification in Obstetrics and Gynecology

      American Board of Obstetrics and Gynecology (ABOG)
      Nov 1993
    • Obstetrics and Gynecology

      Beth Israel Deaconess Medical Center
      Jun 1989