CTTP Participant Spotlight

Participants

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  Archna Bajaj, MD, MSCE

  Clinical Trialist Training Program, 2018-2020
  

  Current Position: Assistant Professor, Department of Medicine, Division of Translational Medicine and Human Genetics, University of  Pennsylvania Perelman School of Medicine

  Archna applied to the program because she was interested in receiving more formal training to become a clinical trialist, and for the protected time it offered her to work on an early phase trial to get an in-depth experience in trial design and development. She is working on development of a phase I first-in-human clinical trial for a gene therapy product for LCAT deficiency — a very rare genetic disorder of cholesterol metabolism with high morbidity/mortality from early and progressive renal sequelae of the disease. She is working on the pre-IND submission, including development of the trial design which will involve using a non-traditional adaptive design given the rarity of the disorder. She has also found the fellowship to "be helpful for connecting with other fellows who share an interest in clinical trials and share experiences on trial development and the resources and/or educational opportunities we've each found to be useful."

  Check out Archna's publications on Pub Med.

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  David Fajgenbaum, MD, MBA, MSc

  Clinical Trialist Training Program, 2018-2020
  

  Current Position: Assistant Professor, Department of Medicine, Division of Translational Medicine and Human Genetics, University of  Pennsylvania Perelman School of Medicine
  
  David applied to the program because he identified a need for mentorship and protected time to effectively run a clinical trial. Data that he  generated using orthogonal basic and translational research techniques suggested that there was increased mammalian Target of Rapamycin  (mTOR) signaling in idiopathic multicentric Castleman disease (iMCD) and that it may be a critical therapeutic target for the disease. Off-  label use of an mTOR inhibitor in iMCD suggested that it may be a safe and effective approach for treatment-refractory patients. David is currently testing this hypothesis in a clinical trial with support from the Clinical Trials Fellowship. The program "has provided me with critical mentorship to prepare for launching my first interventional clinical trial as a PI. I have received targeted feedback on launch plans and enrollment strategies." David was able to take a bioinformatics course during his protected time, that the fellowship provided. He has also “enjoyed getting to know and connect with other ITMAT Clinical Trials Fellows."

  Check out David's publications on Pub Med.

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  Ethan Weinberg, MD, MS

  Clinical Trialist Training Program, 2018-2020
  

  Current Position: Assistant Professor in Clinical Medicine, Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine

  Ethan is interested in being a site PI for industry-sponsored trials and composing single-center and multi-center investigator-initiated clinical  trials. Since beginning the Clinical Trials Fellowship, he has opened a therapeutic trial for the use of ursodeoxycholic acid in hepatic sarcoid  (https://clinicaltrials.gov/ct2/show/NCT03602976) and successfully recruited subjects into the study. He is taking one graduate level course per  semester on clinical trials and has been able to publish some of his work from these classes. The Clinical Trialist Training Program has provided the  resources and salary-support for him to pursue an investigator-initiated clinical trial into a rare disease, hepatic sarcoid, that is understudied.  "This work and my studies would not have been possible without the support of this program."

  Check out Ethan's publications on Pub Med.

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  Gaia Coppock, MD

  Clinical Trialist Training Program, 2020-2022
  

  Current Position: Assistant Professor; Renal, Electrolyte, and Hypertension Division, University of  Pennsylvania Perelman School of Medicine

  Gaia applied to the program because she has a background in basic science immunology research and wanted to find an avenue to use that knowledge in more of a clinical space. Her formal project in the Clinical Trialist Training Program was working on the TRIDENT2.0 study, which is looking at the impact on gene expression in people with diabetic kidney disease who are being treated with SGLT2 inhibitors. During her program, she worked on the IRB proposal, CRFs, and MOP. She shared "being a [CTTP participant] during the height of the COVID pandemic taught me some important lessons about navigating trial development with limited resources." She took classes during the program to understand elements of study design like designing a budget, which she thought were incredibly useful when seeing budget negotiations happen in real time. As she's met people in the clinical trials space, they've shared with her they had to learn on the job. She shared "while hands on experience is an important part of every training program, the CTTP allowed me the chance to develop a strong foundation through coursework and mentorship that broke down many of the barriers that I otherwise would have faced in trying to learn how to navigate this process. I am very grateful for the mentorship and structure that is provided during that time so that I could grow into my current role."

  Check out Gaia's publications on PubMed.