Michael Abram Email & Phone Number

Raleigh, Nc, Us

Boston, Ma, Us

Cambridge, Cambridgeshire, Gb

Drive nonclinical and clinical pharmacology strategies on core global project teams for late-stage development through MAA/EUA regulatory approval of passive immunization mAb therapies against acute RSV (BEYFORTUS®) and SARS-CoV-2 (EVUSHELD®) infection. Oversee development, validation, and execution of clinical virology and immunology biomarker assays at CROs. Lead molecular epidemiology/genomic surveillance studies in 19 countries with a $3M annual budget to monitor temporal prevalence and geographic distribution of drug resistant escape variants. Partner cross-functionally to analyze, interpret, and report bioanalytical data from clinical study endpoints. Engage in pharmacology discussions during regulatory interactions. Build and maintain collaborative relationships with multinational academic (ReSViNET), government (CDC, NIH), alliance partner (Sanofi), and industry consortium (RESCEU, PROMISE) organizations. Accountable lead of a cross-functional translational sciences sub-team of 10 FTEs with a collaborative, empowerment-style approach.➤Developed and operationalized virology analysis plans to establish global early warning systems for emergence of resistant variants for disclosure of timely actionable intelligence to health authorities and academic / government partners➤Supported regulatory submissions under accelerated timelines by directing scientific evidence generation and authorship of >15 virology study reports and relevant pharmacology sections of common technical documents, core data sheets, briefing documents, investigator brochures, and clinical study reports➤Bolstered regulatory defense of EVUSHELD® clinical data by developing with evolutionary biologists a Pango lineage designation and assignment using SARS-CoV-2 spike gene nucleotide sequences➤Expediated expansion of RSV molecular surveillance clinical studies from 9 to 19 countries by partnering with ReSViNET and securing a separate research agreement and relationship with China CDC

Foster City, Ca, Us

Advanced to facilitate launch of HIV treatment (BIKTARVY®) and prevention (TRUVADA®) products along with HIV and HBV or HCV co-infection treatments by executing strategic goals and liaising with internal and external stakeholders. Fostered and managed relationships with 50+ regional key opinion leaders (KOLs), healthcare providers, and researchers, regularly providing medical and scientific information and responding to information requests. Trained and assisted regional sales team by conducting medical and commercial presentations in compliance with promotional and PhRMA guidelines. Entrusted as resistance SME for HIV Medical Affairs and Commercial divisions.➤Grew the Northern California / Hawaii territory of KOL influence to include stakeholder networking relationships with highly reputable, often-inaccessible scientific leaders and rural healthcare providers; surpassed standard threshold of regional KOL influence by 30+ (80 total) to maximize impact ➤Championed 6+ external sponsored research derived from regional leaders➤Played key role in enabling scientific issue discovery, diagnosis, and solution design by contributing to planning and implementation of advisory boards, educational programs, speaker training sessions and conference strategy➤Enabled reactive exchange with nationwide healthcare providers by developing and launching timely medical slide deck on integrase inhibitor resistance FAQs

Foster City, Ca, Us

Oversaw or supported nonclinical pharmacology and clinical virology strategies on core global project teams for late-stage development through NDA/MAA regulatory approval and lifecycle management of antiviral treatments for chronic HIV (STRIBILD®, TYBOST®, VITEKTA®, GENVOYA®, DESCOVY®), HBV (VEMLIDY®) and HCV (EPCLUSA®) infection. Played pivotal role facilitating IND-enabling studies for long-acting treatment (lenacapavir) and immunomodulatory (vesatolimod) candidates for HIV infection as member of core early discovery teams. Contributed to virology discussions with health authorities during regulatory interactions. Designated as resistance SME and educational trainer for HIV Medical Sciences division. Led 4 research associates in executing clinical virology data analysis / reporting and characterization of HIV drug resistance and HIV-specific CTL-mediated effector function.➤Supported VEMLIDY® NDA submission and approval by helping under-resourced HBV team to lead authorship of all nonclinical pharmacology common technical documents, Japan-based clinical virology study report, and response to questions➤Authored and delivered an integrated clinical virology study report to support EPCLUSA® NDA submission and approval by helping under-resourced HCV team in overcoming time constraints➤Illuminated potential mechanisms of antiviral synergy among HIV inhibitor components of single-tablet regimens by developing novel qPCR-based HIV assay➤Crafted comprehensive study guide for CRO negotiation / management and HIV clinical virology biomarker data monitoring, analysis, and reporting➤Synergized department colleagues nationwide to foster networking, collaboration, and knowledge sharing around science and technology by spearheading biannual Biology Open Lab Day (BOLD) event

Bethesda, Md, Us

Developed a novel viral-based vector assay to accurately measure HIV mutation rate, determine mutational hotspots, and assess the impact of drug resistance mutations on the nature, position and frequency of HIV errors. Established and managed internal collaborations to identify HIV proteolytic cleavage sites using mass spectrometry and screen for NNRTI resistant variants using a Ty1/HIV yeast expression system. Managed 2 research technicians in providing laboratory support.

Pittsburgh, Pa, Us

Led a screening campaign of novel N-acylhydrazone inhibitors of HIV RT RNase H for enzymatic, antiviral, and cytotoxic potency

Pittsburgh, Pa, Us

Determined the structural and functional importance of HIV p66/51 RT polymerase oligomers after proteolytic maturation using biochemical and virological assays. Immunized mice and screened hybridomas to discover potential therapeutic mAbs of HIV RT p51-RNH proteolytic maturation and oligomer dimerization. Managed 4 research technicians in providing laboratory support and instructed medical students in Medical Microbiology curriculum.

Winnipeg, Mb, Ca

Characterized growth, morphology, apoptosis, and differentiation of cell lines exposed to dexrazoxane (ZINECARD®) for treatment of metastatic breast cancer. Instructed second-year pharmacy students in Medicinal Chemistry laboratory curriculum.

Us

Formulated, developed, and QC tested chemical specialty products (e.g., engine oils, gear lubricants, engine coolants, transmission lubricants, and hydraulic oils) marketed in metal processing industries

Hamilton, Ontario, Ca

Assessed mRNA transcript stability in the presence of E.coli RNase E, for cat and prl coding regions containing the bovine preprolactin 3'UTR sequence. Instructed first-year engineering students in Introduction Chemistry curriculum

Toronto, Ontario, Ca

District Lead for residential home cleaning of interior and exterior windows, eaves trough and siding. Operated small business with training/coaching through the College Pro Leadership Skills Program. Developed, implemented, and monitored marketing and business plans to generate customer leads and achieve financial goals. Hired, trained, and supervised a team of 5 technicians. Managed on-site projects and monitored production schedules daily. Mediated client/employee relations, including negotiation, customer service, and conflict resolution. Managed financial budget, including: sales, services, production and marketing costs, bills, payroll, liability insurance and taxation.

Bachelor Of Science (Bsc) [Hons], Biochemistry

Master Of Science (Msc), Medicinal And Pharmaceutical Chemistry

Doctor Of Philosophy (Phd), Molecular Virology And Microbiology