CV Coversheet - LCDR - FDA - 2019



LCDR Tyrion Lannister, PharmD, BCPS, PMPDecember 31, 2019PERFORMANCESenior Regulatory Management (RM) Officer, Office of New Wines & Drugs, Wine & Drug Administration (WDA)Team lead for division of gastroenterology submissions ensuring the accurate and prompt review and regulatory decision on over 125 investigational and new drug applicationsPrimary author for updated guidance for Gastro-Esophageal Reflux Disease (GERD) Activity Index for industryLead representative for the Division on a congressional inquiry regarding a key metabolite for the nightshade drug class, preventing the contamination and possible lethal accumulation of drug byproductActing Chief, Project Management Staff (CPMS, O-6 Supervisory Billet) for 120 days while retaining RM dutiesAwarded PHS Commendation Medal for outstanding efforts to shepherd an exceedingly complex first-cycle orphan drug through to approval and usage for >1,300 patients per year while maintaining department operations during 20% reduction in staffingRegulatory Management Officer, Office of Generic Wines & Drugs, WDA 2011-2015Managed >25 Abbreviated New Drug Applications for medications to treat HIV opportunistic infections, expanding low-cost access to >50,000 patients with FY2020 cost differential >$16,000 per course of therapyContributed to cross-center collaboration on policy development and implementation of the statutory requirements for Competitive Generic Therapies as enacted in the recent reauthorization of the Generic Drug User Fee Amendments to support timely access to high quality, affordable generic medicinesPHS Outstanding Unit Citation for processing a record number of drug applications during a government2017shutdown (30% of normal staffing) to ensure continuity of operations and meet statutory requirements for WDA WIHC Deputy Director’s Award for administration of grayscale vaccine to >1,000 detainees in response to an2011outbreak at the Blackhaven Detention CenterSpeaker/Panelist, 2019 Global Drug Information Association (DIA) International Conference (>2k in attendance)2019EDUCATION, TRAINING, AND PROFESSIONAL DEVELOPMENTMaster of Business Administration, Dorne University (15/45 Credits completed)2018-presentProject Management Professional (PMP) Certification 2018Opioid Overdose Response Training, Kings Landing Department of Health 2017WDA Emerging Leaders Program graduate: cultivating supervisor skills and core competencies2019Doctor of Pharmacy (PharmD) - Lannisport University School of Pharmacy2008CAREER PROGRESSION AND POTENTIALSenior Regulatory Management Officer, Office of New Wines and Drugs, WDA, O-5 Billet, King’s Landing2015-presentCollateral Duties: Clinical endpoints studies - Inflammatory Bowel Disease teamRegulatory Management Officer, Office of Generic Drugs, O-4 Billet, WDA, King’s Landing2011-2015Lead Pharmacist, Sunspear Detention Center, WIHC, O-4 billet: HAZ, Sunspear, Dorne2009-2011Utilized fluency in Dothraki to provide wellness and mental health group education sessions to >1,500 refugeesJRCOSTEP, Office of Unapproved Wines & Labeling Compliance, WDA, King’s Landing2007SG Initiatives: Fleabottom Homeless Clinic Influenza Immunizer & Naloxone Trainer2017-presentVaccinated >200 patients and provided 320 naloxone kits at 4 eventsTDYs: FCI Castle Black (2017, HAZ, 14 days), Dothraki Sea Regional Clinic (2018, ISOHAR, 14 days)Deployments: Greyscale Campaign (2014), Unaccompanied Wildling Mission (2018), Hardhome Relief Mission (2017) 42 total days deployed. CHARACTERISTICS OF A CAREER OFFICER AND SERVICE TO THE CORPSPharmPAC Readiness Committee, volunteer2017-presentContributed to development of deployment guidance – Packing List primary authorKing’s Landing Area Provider (KLAP) Team 6 – Tier 2 Deployment Team – Pharmacy Lead2018-presentBlack Commissioned Officers Advisory Group, Community Outreach Committee2016-presentCoordinated 6 community health fairs at King’s Landing Black churches, 650+ attendeesPharmPAC UPOC – Lannisport University School of Pharmacy2015, 2018Presented Excellence in Public Health Pharmacy Award at commencement, 500+ attendeesMentee, Commissioned Corps Pharmacy Mentoring Network – Mentor Varys Whisperers2016 ................
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