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The Gavegnano Drug Discovery Program


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ENGAGING THE UNDERGRADUATE STUDENT IN LIFE-SAVING DISCOVERIES

The Gavegnano Drug Discovery Program in collaboration with the Center for the Study of Human Health offers students a front row seat in the process of drug discovery, from idea to FDA-approved agent. Led by Dr. Christina Gavegnano, who has a strong track record of invention and bench to bedside success in the viral infection space, including COVID-19 and HIV-1, students will have the opportunity for hands-on experiences in laboratory discovery, human trial design, clinical shadowing of our team’s ongoing trials, and ongoing collaborations with both the FDA and pharma to advance common goals of saving lives in real time.

Active Epicenters

Active plug-in points for students include the following:

Laboratory Discovery Team

Students will learn how candidate therapeutic agents are discovered and validated in a laboratory setting, and how the data generated in these steps are analyzed and prepared for publication. Students will assist in work ongoing in the lab as a part of partnerships with the National Institutes of Health, and pharmaceutical enterprises to further develop candidate agents for eventual human use.

Clinical Protocol Team

Students will learn how to assemble a pre-clinical package from data generated on lead drug candidates, and will actively engage in writing documents required for human clinical trial protocols that are submitted for review and approval processes by the FDA prior to the launch of human clinical trials.

Clinical Trial Data Analysis Team

Students will learn how to perform “big data analysis” on data generated from human trials, that ultimately helps to shape the understanding of how novel agents impact humans during the trial. Students will assist in the preparation of datasets for publication, and for the continued collaborative discovery and human trial efforts with pharma, NIH, and other partners. Data will also be used to help inform larger clinical trials built upon data collected from the Clinical Trial Data Analysis Team.

Clinical Trial Shadowing Team

Students will have the unique opportunity to shadow our clinical team as the clinical trials from agents discovered in our group are launched at Emory sites. Shadowing will encompass clinical visits, specimen collection, and collection of data for endpoints for the human studies launched in our group.

COMING SOON
Bioethics in drug discovery interface
COMING SOON

Outreach Collaborative Partners:

• Atlanta Trauma Alliance
Dennis Liotta Laboratory
• Emory BDCI
• Emory Center for Contemplative Science and Compassion-Based Ethics
• Harvard Interface

Taught By

Dr. Christina Gavegnano, PhD

Dr. Gavegnano made the original discovery that a novel class of agents called Jak inhibitors, including Ruxolitinib and Baricitinib, confer antiviral effects. She also invented the technology for treating viral infections, including HIV-1, with Jak inhibitors and has an internationally-issued patent and executed license agreement with Eli Lilly and Company for the technology for the indication of COVID-19, which received Emergency Use Approval in November, 2020, and garnered full FDA approved status in May, 2022. Baricitinib is the first (and currently only) immunomodulator based agent that has received the status of full FDA approval for COVID-19.

In bench to bedside translation, Dr. Gavegnano’s PhD thesis and continuing collaboration with Emory infectious disease physician Vincent Marconi, MD has led to the streamlining of multiple, multi-national HIV-1 and SARS-CoV-2 clinical studies, with life-saving results on a global scale. In a recent example, their work led the FDA to grant Emergency Use Approval of Baricitinib as a monotherapy for COVID-19 only months into the pandemic (November 2020), followed by issuance of the full FDA approval (May 2022). The World Health Organization has also issued a global “strong recommendation” for the use of Baricitinib as a first-line treatment for SARS-CoV-2. Dr. Gavegnano and her collaborators are also focusing on human trials that examine the use of Baricitinib for HIV-1 treatment and viral cures for people living with HIV and other chronic, life-threatening diseases.

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