FDA Collaborations

The Center collaborates with the Food and Drug administration through our Fellowship Program and through jointly developed research collaborations with our faculty and students. A few of these research collaborations are featured below.

Detecting Postmarket Safety Signals for Medical Devices

Susmitha Wunnava, Harvard-MIT Center for Regulatory Science Fellow
Florence Bourgeois, Associate Professor of Pediatrics at Harvard Medical School
Collaborating with FDA’s Center for Devices and Radiological Health (CDRH)

This project aims to employ automated tools and methodologies for detection and evaluation of safety issues for medical devices in large volume pre- and post-market data sources.

Safety Signal Discernment and Biostatistics (SANEST) for Paclitaxel

Alejandra Avalos Pacheco, Harvard-FDA Regulatory Science Fellow
Collaborating with the FDA CDRH & the National Evaluation Systems for health Technology (NEST)

This project aims to provide recommendations on the analyses and necessary regulatory actions for the integration of randomized controlled trials (RCT) and real world data (RWD) for patients treated with paclitaxel-coated devices, including drug-coated balloons and drug-eluting stents. 

The work investigates the impact of misclassified devices on paclitaxel-coated device data as well as the limitations of data integration. Outputs include the development of guidelines for misclassification methods, data source quality assessment, and data integration methods.

Gressler, Laura Elisabeth, Erika Avila-Tang, Jialin Mao, Alejandra Avalos-Pacheco, Fadia T. Shaya, Yelizaveta Torosyan, Alexander Liebeskind, et al.
Frontiers in Cardiovascular Medicine 10 (2024)

Assessing Targets on the Pediatric Molecular Target List Under the RACE Act

Florence Bourgeois, Associate Professor of Pediatrics at Harvard Medical School
Collaborating with the FDA Office of Hematology and Oncology Products & FDA CDER

Under the newly enacted RACE Act, the FDA is authorized to require pediatric studies for oncology drugs developed for adult populations if the drug targets a molecular target relevant to a pediatric cancer. 

This project aims to apply methods in natural language processing to identify emerging biomarkers that may be relevant to pediatric cancers, and to further characterize the scientific evidence underlying inclusion or exclusion of molecular targets on the Pediatric Molecular Target List. The project also involves a systematic review of pediatric oncology trial and drug development activities to establish benchmarks for assessing the impact of the RACE Act.

Find Relevant Publications for the Project:
Clinical trials for paediatric cancers under new legislation in the USA.

Hwang TJ, Reaman GH, Bourgeois FT.Lancet Child Adolesc Health. 2023 Jul;7(7):e13. doi: 10.1016/S2352-4642(23)00125-6.PMID: 37349019 No abstract available.

Clinical development of new drugs for adults and children with cancer, 2010-2020.

Arfè A, Narang C, DuBois SG, Reaman G, Bourgeois FT.J Natl Cancer Inst. 2023 Aug 8;115(8):917-925. doi: 10.1093/jnci/djad082.PMID: 37171887

New legislation to promote paediatric studies for new cancer medicines.

Hwang TJ, Bourgeois FT.Lancet Oncol. 2022 Aug;23(8):e368-e369. doi: 10.1016/S1470-2045(22)00376-X.PMID: 35901829 No abstract available.

Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers.

Hwang TJ, Orenstein L, DuBois SG, Janeway KA, Bourgeois FT.J Natl Cancer Inst. 2020 Mar 1;112(3):224-228. doi: 10.1093/jnci/djz207.PMID: 31665394 Free PMC article.

Safety Events Associated with Endovascular Aneurysm Repair Devices

Tianxi Cai, John Rock Professor of Population and Translational Data Science at Harvard T. H. Chan School of Public Health
Tianrun Cai, Associate Bioinformatician, Brigham and Women’s Hospital
Florence Bourgeois, Associate Professor of Pediatrics at Harvard Medical School

Using real-world data derived from electronic healthcare records, this project applies advanced informatics and statistical learning pipelines to assess the association of endovascular aneurysm repair devices with rare and long-term safety outcomes.

Read the full piece from JAMA Internal Medicine here

Read the accompanying editorial and viewpoint

Additional information on the endovascular device safety can be found on the FDA website.

Generating Reproducible Real-World Evidence with Multi-Source Data to Capture Unstructured Clinical Endpoints for Chronic Diseases

Tianxi Cai, John Rock Professor of Population and Translational Data Science at Harvard T. H. Chan School of Public Health
Tianrun Cai, Associate Bioinformatician, Brigham and Women’s Hospital
Kelly Cho, Associate Professor of Medicine, Director Data Science Analytics, Boston VA Research Institute
Florence Bourgeois, Associate Professor of Pediatrics at Harvard Medical School

This project aims to develop statistical approaches to enable use of real-world clinical data to define treatment responses in large and heterogenous patient populations and inform product labeling for specific indications and patient groups. 

More information on the FDA’s Advancing Real-World Evidence Program can be found here.