Jennifer Swanton Brown, RN

All Publications

• Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic. Journal of clinical and translational science Gravelin, M., Wright, J., Holbein, M. E., Berro, M., Brown, J. S., Mashour, G. A., Weatherwax, K. J. 2021; 5 (1): e94

  Abstract

  With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials. Regulatory units within an Academic Medical Center (AMC), including those part of the Clinical and Translational Science Award (CTSA) consortium, have provided support for clinicians in navigating these options prior to the pandemic. As such, they were positioned to be a resource for accessing therapies during the COVID-19 public health emergency.A small survey and a follow-on poll of the national Investigational New Drug (IND)/Investigational Device Exemption (IDE) Workgroup were conducted in October and December 2020 to determine whether CTSA regulatory units assisted in facilitating access to COVID-19 therapies and the extent of pandemic-related challenges these units faced.Fifteen survey and 21 poll responses were received, which provided insights into the demands placed on these regulatory support units due to the pandemic and the changes required to provide critical support during this and future crises. Key changes and lessons learned included the importance of regulatory knowledge to support the institutional response, the critical need for electronic submission capacity for Food and Drug Administration (FDA) documents, and the nimble reallocation of regulatory and legal resources to support patient access to investigational agents and/or medical devices during the pandemic.AMC- and CTSA-based regulatory units played a meaningful role in the COVID-19 pandemic but further unit modifications are needed for enabling more robust regulatory support in the future.

  View details for DOI 10.1017/cts.2021.15

  View details for PubMedID 34192051

  View details for PubMedCentralID PMC8134898

• Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products. Journal of clinical and translational science Adamo, J. E., Grayson, W. L., Hatcher, H., Brown, J. S., Thomas, A., Hollister, S., Steele, S. J. 2018; 2 (5): 301-304

  Abstract

  Rapidly advancing technology often pulls the regulatory field along as it evolves to incorporate new concepts, better tools, and more finely honed equipment. When the area impacted by the technological advancement is regulated by the Food and Drug Administration (FDA), a gap develops between the technology and the guidelines that govern its application. Subsequently, there are challenges in determining appropriate regulatory pathways for evolving products at the initial research and developmental stages. Myriad factors necessitate several rounds of iterative review and the involvement of multiple divisions within the FDA. To better understand the regulatory science issues roiling around the area of additive manufacturing of medical products, a group of experts, led by a Clinical and Translational Science Award working group, convened the Regulatory Science to Advance Precision Medicine at the Fall Forum to discuss some of the current regulatory science roadblocks.

  View details for DOI 10.1017/cts.2018.331

  View details for PubMedID 30828471

  View details for PubMedCentralID PMC6390384

• Recommendations From the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program. Journal of investigative medicine : the official publication of the American Federation for Clinical Research Holbein, M. E., Berglund, J. P., O'Reilly, E. K., Hartman, K., Speicher, L. A., Adamo, J. E., O'Riordan, G., Brown, J. S., Schuff, K. G. 2014; 62 (5): 797-803

  Abstract

  The objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers.A subgroup of the Investigational New Drug/Investigational Device Exemption (IND/IDE) Task Force of the Clinical and Translational Science Award (CTSA) program Regulatory Knowledge Key Function Committee was assembled to specifically address how clinical investigators who hold an IND/IDE and thus assume the role of sponsor-investigators are adequately trained to meet the additional regulatory requirements of this role.The participants who developed the recommendations were representatives of institutions with IND/IDE support programs. Through an informal survey, the task force determined that a variety and mix of models are used to provide support for IND/IDE holders within CTSA institutions. In addition, a CTSA consortium-wide resources survey was used. The participants worked from the models and survey results to develop consensus recommendations to address institutional support, training content, and implementation.The CTSA IND/IDE Task Force recommendations are as follows: (1) Institutions should assess the scope of Food and Drug Administration-regulated research, perform a needs analysis, and provide resources to implement a suitable training program; (2) The model of training program should be tailored to each institution; (3) The training should specifically address the unique role of sponsor-investigators, and the effectiveness of training should be evaluated regularly by methods that fit the model adopted by the institution; and (4) Institutional leadership should mandate sponsor-investigator training and effectively communicate the necessity and availability of training.

  View details for DOI 10.231/JIM.0000000000000083

  View details for PubMedID 24831858

  View details for PubMedCentralID PMC4029858