Short Communication: Dolutegravir-Based Regimens Are Active in Integrase Strand Transfer Inhibitor–Naive Patients with Nucleoside Reverse Transcriptase Inhibitor Resistance

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