Development of maraviroc, a CCR5 antagonist for treatment of HIV, using a novel tropism assay
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2015-06
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van der Ryst, Elna, Jayvant Heera, James Demarest and Charles Knirsch (2015). Development of maraviroc, a CCR5 antagonist for treatment of HIV, using a novel tropism assay. Annals of the New York Academy of Sciences, 1346(1). pp. 7–17. 10.1111/nyas.12777 Retrieved from https://hdl.handle.net/10161/16076.
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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
Unless otherwise indicated, scholarly articles published by Duke faculty members are made available here with a CC-BY-NC (Creative Commons Attribution Non-Commercial) license, as enabled by the Duke Open Access Policy. If you wish to use the materials in ways not already permitted under CC-BY-NC, please consult the copyright owner. Other materials are made available here through the author’s grant of a non-exclusive license to make their work openly accessible.