An update on the progress of galidesivir (BCX4430), a broad-spectrum antiviral.
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2021-09-20
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Galidesivir (BCX4430) is an adenosine nucleoside analog that is broadly active in cell culture against several RNA viruses of various families. This activity has also been shown in animal models of viral disease associated with Ebola, Marburg, yellow fever, Zika, and Rift Valley fever viruses. In many cases, the compound is more efficacious in animal models than cell culture activity would predict. Based on favorable data from in vivo animal studies, galidesivir has recently undergone evaluation in several phase I clinical trials, including against severe acute respiratory syndrome coronavirus 2, and as a medical countermeasure for the treatment of Marburg virus disease.
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Julander, Justin G, James F Demarest, Ray Taylor, Brian B Gowen, Dennis M Walling, Amanda Mathis and YS Babu (2021). An update on the progress of galidesivir (BCX4430), a broad-spectrum antiviral. Antiviral research, 195. p. 105180. 10.1016/j.antiviral.2021.105180 Retrieved from https://hdl.handle.net/10161/24538.
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Scholars@Duke
James Francis Demarest
I have >30 years of experience in the pre-clinical, clinical, and translational research space. Twenty-three of those years are in the pharma R&D context where I also gained experience in diagnostics, product commercialization and life-cycle management, interactions with Regulatory Authorities, Key Opinion Leaders (globally), and establishment/maintenance of public-private partnerships. My career trajectory took me from NIH (Dr. Anthony Fauci’s laboratory), to Duke University, to GlaxoWellcome/GSK, ViiV Healthcare, AbbVie Immunology and consultancies. I was a founding member of the scientific and medical organization at ViiV Healthcare (launched in Nov 2009; www.viivhealthcare.com ) and contributed significantly to shaping its evolving strategy and associated success. I know from firsthand experience the technical and business aspects of building a successful company delivering medicines that meet unmet medical needs. Through my involvement with establishment/launch of collaborations via public-private partnerships and/or business development, I understand what pharma companies expect from partnerships with biotech and/or academia. I have also worked closely with the medical affairs and commercial/marketing organizations on numerous international, regional, and local market projects/campaigns. I bring this breadth of experience to advance innovative approaches for R&D.
The following highlights my general skill set and experience:
R&D Innovation:
- Led and supported research programs, translational research teams, and impact(ed) the business strategy for building a forward-looking R&D pipeline; small molecule, biologic, and vaccine platforms
- Co-developed governance processes to safely expedite compound progression from discovery through clinical development
- Accountable for virology data packages included in 4 successful approvals and global launches (TIVICAY, TRIUMEQ, JULUCA, and DOVATO) and updates to inflammatory bowel disease indications for Humira
- Applying expertise to advancing preventative and therapeutic approaches for SARS-CoV-2 infection and antiviral medical countermeasures
Business Development:
- Subject matter expert for in-licensing review and advisory role informing business development strategy for pre-clinical and clinical R&D platforms/assets and diagnostics
- Member of Integration teams post deal closure
- Advisor for academic-based biotech and entrepreneurial start-ups
Strategic Partnerships:
- Defined and launched multi-year/multi-million-dollar global research collaborations with key academic institutions, including integrated analyses of laboratory generated data with longitudinal patient clinical data
- Initiated, led, or supported in vitro, pre-clinical, and clinical phase global research studies
Commercialization:
- Scientific lead or advisor for commercial/marketing and medical affairs efforts associated with product launches and life cycle management
Diagnostics:
- Directed diagnostic collaborations associated with investigative agents or marketed products
- Provided technical advice for assays and algorithms used in clinical care across diverse geographic regions
Regulatory:
- Written and face-to-face interactions with regulatory authorities pre- and post-market authorization
Scientific Communication:
- Explaining disease area science and medicine mechanisms of action to a broad spectrum of audiences, ranging from key opinion leaders to clinicians/scientists to patient advocates to the lay public
- Graduate and Medical Student mentoring at Duke University
- Freshman Experience Course co-creator/co-lecturer at High Point University
- UNCW OLLI and Duke OLLI invited lecturer
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