AMBER N. BRACY PROFESSIONAL SUMMARY Expert in: Financial Reporting  Strategic Budgeting  Implementing Marketing Strategies Strategic problem solver who envisions productive solutions and implements them into daily tasks. Self-motivated leader who is experienced in managing large, mid-size and small teams to ensure that the target goals are clear & precise, so that all parties remain focused and effective. Organized professional who constantly keeps the best interest of both the consumer, companies & stake holder’s interest a main priority. A visionary with the social skills to restore the American heritage & vision by achieving the simplicity of its intended textual form as it was written. CORE COMPENTCIES Relationship Building by Breaking Through Social & Economical Lines  Calculating daily exchange rates & currencies  Maximizing Quantitative & Qualitative Available Assets  AP & AR Task  Analyzing Market Trends & Forecasting Upcoming Changes  Predictive Analytics  Collections & Payroll  Budget Planning & Marketing Strategies  Detailed Expense Reporting Cloud Service  Managing Multiple Domestic & International Billing Systems  VPN  VoIP  Cost Reduction  Team Development EDUCATION CREDENTIALS Bachelor’s Degree in Political Science with a Concentration in Public Administration & International Affairs Graduated with cumulative GPA of 3.8 Kennesaw State University, Kennesaw, Georgia PROFESSIONAL AWARDS & CERTIFICATES ➢ Creator of ‘#123 Set Them Free Campaign’; a tool designed to assist in eradicating human trafficking ➢ Achieved Six Sigma Green Belt Certificate ➢ President Volunteer Service Award received, 2015-2018 ➢ Board Member of AT&T Global Diversity & Inclusion Leadership Team ➢ Recipient of the AT&T Finance Wall of Stars Recognition Award COMMUNITY SERVICE & PARTNERSHIPS ➢ Member of Victory World Church, Norcross & Buford Georgia ➢ Volunteer, C.A.S.A (Court Appointed Special Advocate) Forsyth Georgia ➢ Volunteer, Actively Coached multiple YMCA Youth Soccer Teams, Alpharetta ➢ Advocate, Free the Slaves, International NPO ➢ PAC (Political Actions Committee) Member with AT&T AMBER BRACY PAGE TWO ➢ Advocate, Not for Sale in Atlanta, Georgia Educated the public and local educational institutes on the human trafficking crisis worldwide. Assisted in mobilizing an international grassroots social movement that effectively combats human trafficking and modernday slavery through "Smart Activism". Key Achievements • Contributed to the organization of the Student Abolitionist Movement (SAM), which is a network of students fighting to end modern-day slavery. It is designed to help collaborate students and their ideas in efforts to combat human trafficking in solidarity. SAM provides students with key programs and resources to take action, educate, and advocate for the end of the global slave trade. • Published news articles that encouraged communities to become more aware and involved in cause RECENT CAREER TRACK Senior Finance Billing Analyst, Finance Department in Atlanta Georgia, 2014 – Current Successfully reconciled various billing issues within both external & internal billing systems, while partnering with IT and Cash Ops teams to properly bring attention to the financial matters that had been carried on for multiple cycles. Successfully delegated job task to team members to ensure all areas of business were completed in the event of any team member absences. Monthly provided a high-level summary outlining key details of matters that occurred; the report included items that needed further attention. Developed and updated tools, queries, and reports in conjunction with ongoing business changes & mergers. Key Achievements • Currently leading ERG (Employee Resource Group) as the appointed National Chair to Eradicate Human Trafficking; collaborating with various resources to bridge the gap among global corporate companies, community outreach organizations and law enforcement agencies to effectively combat modern day slavery & human trafficking. • Successfully worked with domestic & international team members to allow FBO ability to send in foreign payment approvals electronically, compared to the previous task which included physically shipping management approvals to the assigned locations. Correctly processed AP and AR transactions accurately within (3) work days for over (154) wholesale accounts. • Collaborated with multiple groups on a highly time sensitive project (PID 304043 - Syniverse SMS Aggregators Collection Project); which allowed AT&T to collect millions in revenue for SMS charges accrued on multiple off portal aggregator accounts. • Diligently trained team members to properly complete high important FBO job task; which included weekly training sessions to review the job task at a pace to ensure the opportunity to absorb the information, ask questions and ultimately exercise the new obtained skill. • Collaborated with other contacts to ensure that the FBO projects are archived correctly in Archer and on the AT&T P-8 database; task needed for a positive internal or external audit & to ensure that we are compliant with the Sarbanes Oxley laws. AMBER BRACY PAGE THREE Revenue Assurance Analyst, AT&T Mobility in Atlanta Georgia, 2012 – 2014 Completed relatively complex revenue related audits, issue research and resolution, complex and strategic project support, analytical assignments, and designs and prepares audits and reports. Designed & Implemented Proactive and new Risk Based audits. Implemented and tracked preventative revenue findings and new reporting for the National Revenue Assurance Team. Completed validations on all automated call tests performed by Message Processing Teams as required by SOX compliance guidelines. Ensured that the validations included reporting and tracking of all billing issues. Focused on current audit roles to enhance test scenario's and/or quantify issues discovered. Participated in adhoc testing for successful launches of new products and services for the Product Development teams as requested. Created more efficient reporting tools to better report any issues discovered to the project managers, and ensured they followed until a resolution was completed. Key Achievements • Completed validations for (141) SOX audits; all audits were completed within the required SLA guidelines and following company procedures; led FBO group to achieve surpassing audit ratings • Created a validation tool that simplified multiple ‘Big Data’ search engines to better report & track years of extensive records from consumer usages over various rate plans & markets. • Successfully assisted in HLR/ MSISDN job tasks; confirming whether the accounts are active in Snooper & Telegence if not deleting them and documenting the status • Researched records pertaining to the revenue stream and collaborated with current process owners to take corrective action that better ensured a timely and accurate billing methods Community Director, Wilkinson Real Estate Advisors Atlanta, Georgia, 2009 – 2012 Focusing on creating a team atmosphere that promotes goals which are directed towards achieving high occupancy levels. Constantly staying informed of market conditions, competitive pricing, and utilizing appropriate resources. Establish and achieve financial goals by effectively qualifying prospective residents and verifying applications. Diligently working to assist both the Regional Manager & investors, as needed in long-range planning, communications, and other tasks, while keeping Bell philosophies as a focal point. Key Achievements • Successfully thrived to maintain and improve the value of the community's features within the scope of its inherent design. • Promoted positive, proactive resident relations by demonstrating a “firm, fair, and consistent” manner in all resident contacts, keeping in mind the current economical recession that effected the community & social impacts of the housing decisions. PERSONAL ATTRIBUTES Multi-tasked  Self Motivated  Highly Responsible  Well Organized  Very Reliable  80+ wpm  Great Communication Skills  Extraordinary Leadership Abilities  Seasoned Management and Accounting experience  Personable & Approachable  Highly Disciplined  Punctual  Attention to Detail to avoid future complications  Honest  Holds integrity at a high level Casey Thomas Cato Overview Present markets dictate that today’s IT professional not only require a solid foundation in technical expertise, but also a fundamental understanding of the challenges facing today’s business managers. The task is to bridge these two solitudes by providing solutions based on a thorough understanding of the problem. Professional Profile A highly accomplished professional with over twenty years of progressive, successful achievement through applying a hands-on, team oriented approach in areas including project management, business functional process, resource management, information technology, and the software development lifecycle. Positioned to provide expertise in technology and non-technology related initiatives and to be afforded the opportunity to learn new skills and reinforce developed ones in a dynamic and challenging environment. 20+ years Data integration Experience 20+ years Healthcare Experience 15+ years Project Management Experience 15+ years HL7/EDI Developer Experience 15+ years Multi Interface Engine Experience 15+ years QA, automated test scripting, HL7, HCPCS, ICD 9 Highlights of Professional Experience Northrop Grumman Corporation - Atlanta, Georgia 07/17 to Present Technology Manager – Contractor to Centers for Disease Control (CDC) Provided leadership for the Microsoft (Northrop Grumman) team at the CDC (about 12 staff) for various software development projects within the CDC’s National Center for HIV, Hepatitis, STD, Tuberculosis Prevention (NCHHSTP) division of Informatics. Managed and directed staff and projects embracing the CDC’s migration from on premise Microsoft technologies to cloud based Azure based technologies. Many projects our teams worked upon were NCHHSTP wide (1500+ staff) to agency-wide initiatives throughout the CDC and other entities such as HHS (Health and Human Services) and the WHO (World Health Organization). Primary Technologies/Skills: project management, business analysis, software development & implementation, Microsoft SQL Server, Microsoft Power BI, Microsoft Dynamics 365, Microsoft SharePoint, data analytics, Informatics Children’s Healthcare of Atlanta - Atlanta, Georgia 08/12 to 07/17 Project Manager - IS&T Provided leadership for Children’s Healthcare of Atlanta (Egleston, Scottish Rite and Hughes Spalding hospitals) in demonstrating superior customer service and support of business specific projects, initiatives, hardware and application requirements. Managed various teams of IT professionals that implement solutions and provide technical and functional support of new/existing software applications and hardware platforms. Work with business groups to ensure operational stability and that applications meet the practical needs of the organization. Primary Technologies/Skills: project management, business analysis, software development & implementation, Microsoft Exchange, Ascom, Cisco, video conferencing, wired/wireless networking, call center, data/tape backups, Norton Symantec, Microsoft Active Directory, Lawson, Chartmaxx, Epic, IBM PureFlex, HP UX, IBM AIX, patch management, IBM Endpoint Manager, Microsoft Sharepoint, Microsoft Project; Qlikview, Interface Engines, Corepoint, Windows OS upgrades, EMC Data Domain/Avamar, EMC VNX/Isilon, Philips device integration, facility construction, cabling Engage Inc. - Atlanta, Georgia 02/10 to 08/12 Lead Health Practice Project Manager and Business Analyst – Engage Development Quality Assurance Department Manager – Engage Development Manager of the Quality Assurance department. Developed processes and initiatives for Engage Agile/SCRUM development processes. Managed projects and initiatives, and conducted business analysis with regards to all healthcare related accounts, including the complete development of a healthcare scheduling and billing solution with associated integration to downstream third party systems. Developed technical and user documentation, as well as, customer training/education materials, including training videos and real time online seminars. A Microsoft Certified Gold Partner and Professional. Recently finished Project Management of and Business Analysis of Aston Martin Lagonda's development of their website, including eCommerce, web analytics, social media, streaming video, content management system and gaming/badging layer. This was Engage's largest web deployment to date. Primary Technologies/Skills: project management, QA, business analysis, software product development & implementation, technical writing, Scrum/Agile, Microsoft Dynamics CRM, Microsoft SQL Server, web content management system, web analytics, javascript programming, healthcare scheduling and billing, ICD 9/10, HCPCS, HL7, Javascript McKesson Corporation - Alpharetta, Georgia 02/08 to 02/10 HzERM (Horizon Enterprise Revenue Management) Senior Quality Assurance Analyst – HzERM QA Integration Utilizing Mercury Quality Center, wrote and executed various types of test cases, both manual as well as automated, with a focus upon HzERM integration and interfaces. Analyzed HL7 (Health Level 7) data for inbound and outbound interfaces per customer specifications and HL7 guidelines. Conducted testing of interfaces within company configured test environments, as well as customer test environments, including development and configuration of interfaces for compatibility with third party downstream hospital applications and interface engines. Provided onsite customer assistance for product go lives. Coordinated some administrative tasks for group. Primary Technologies/Skills: QA, automated test scripting, software product development & implementation, HL7, HCPCS, ICD 9, interface engines, Java, implementation specialist McKesson Corporation - Alpharetta, Georgia 09/06 to 02/08 STAR Services Application Programmer Analyst – STAR Services Integration Project managed, coded and implemented STAR HL7 interfaces for various McKesson and non-McKesson hospital products. Customized interfaces per customer work orders for compatibility with various third party hospital applications and interface engines. Coordinated the testing of customizations and implementations for customers within development, QA and production environments. Supported implementations on on-call basis 24/7. Primary Technologies/Skills: Software product development, MUMPS, Visual Basic, HL7, interface engines, ICD 9, HCPCS Navicure Inc - Duluth, Georgia 2/06 to 09/06 Senior EDI Implementation and Software Engineer Company responsibilities include Project Management, Development, QA, and Implementation into Production of new EDI interfaces to insurance payers for customers/providers. Additionally, analyzing ANSI X12 837, 277, 997, and 835 data both to and from payers. Coordinated with customer and third party vendors the project development of new EDI interfaces to new insurance payers. Primary Technologies/Skills: Software product development, software interface & integration development, EDI X-12, Java, healthcare billing and claims, insurance providers; QA Allscripts (Eclipsys) Corporation - Atlanta, Georgia 11/04 to 2/06 Enterprise Integration Configuration Manager – eLink/Sunrise Integration Module Senior Test Engineer Setup and maintain an integrated test environment for QA of the Eclipsys products eLink and SIM (Sunrise Integration Module), including the installation and configuration management of all Eclipsys products (Sunrise Clinical Manager, Sunrise Medication Management, Sunrise Record Manager, Access Manager, Patient Financial Management, etc.). QA of new eLink and SIM releases, including the integration into other products via HL7 messages. Programming of automated testing scripts in Mercury Quick Test Professional and execution through Mercury Test Director. QA of Pocket PC versions of eLink and SIM. Primary Technologies/Skills: Software product development, HL7, interface engines; Mercury (HP) Test Center McKesson Corporation - Alpharetta, Georgia 3/01 to 11/04 Interface Analyst – Horizon Meds Manager (Pharmacy) STAR Team Leader for Medical Records, Order Management, Patient Processing and Integration Teams STAR Interface Specialist- Integration Team Managed Medical Records, Order Management, Patient Processing and Integration teams within STAR HIS. Project management of development projects for these teams. Utilized Maxi-MUMPS and Visual Basic in programming efforts, which included HL7, X-12, HIPAA and Equifax related projects. Primary Technologies/Skills: Software product development, HL7, interfaces engines; healthcare IT; programming; MUMPS; Visual Basic; EDI X-12 Allscripts (Eclipsys) Corporation – Marietta, Georgia 3/99 to 9/99 Technical Consultant Authored SQL database interfaces using TLink product suite for corporate clients. Additionally, authored TView applications for deployment within a Web interactive environment. Assisted in the development of and testing of project implementation. Primary Technologies/Skills: HL7, interface engines, SQL Server; healthcare IT Application Interfacing Corporation (AIC) – Duluth, Georgia 2/98 to 3/99 and 9/99 to 3/01 Systems Engineer Assembled and authored HL7 compliant technical documents for various medical information system interfaces. Programmed HL7 compliant application interfaces for medical information system clients as well as integration with customer interface engines. Aided in the installation and configuration of corporation local area network and wide area network. Installed and configured corporation Windows NT LAN and workstations. Aided in daily office management procedures. Primary Technologies/Skills: project management, IBM Websphere, HL7, interface engines, C/C##, Perl, Visual Basic Gwinnett County Planning and Development – Lawrenceville, Georgia 9/92 to 2/98 Principal Planner and Geographic Information Systems Liaison, Planning Data Services Division Senior Planner, Planning Data Services Division Senior Planner, Long Range Planning Division Managed Planning Division staff in the development of the Planning Division’s responsibilities for the county’s Geographic Information System (GIS). Utilized project management skills to develop and maintain a Planning Division land use, existing land use, area policy, long range road classification, zoning and various other specialized drawing and data layers for use within the county’s Geographic Information System. Engineered specialized program applications for the county’s Geographic Information System. Assisted in the development and maintenance of manual and computerized databases, including the GIS database. Provided PC hardware and software technical support to department staff. Assisted in the coordination and composition of the annual updates to Gwinnett’s Comprehensive Plan. Developed and conducted presentations to the Planning Commission, Board of Commissioners, other departments and the public at large. Researched and tabulated data to produce technical reports, brochures and maps for county and public use addressing land use, transportational, environmental and other planning concerns. IBM Corporation – Marietta, Georgia 5/92 to 9/92 Technical Support Representative, IBM PS/1 Personal Computers IBM PS/1 Personal Computer support implemented through various on-line services and via the telephone. Conducted various problem-solving techniques with computer software programs and hardware peripherals in order to answer a variety of IBM PS/1 computer questions for customers. Constructed “Help” files for customers for Frequently Asked Questions, PC maintenance and installation topics. City of Alpharetta – Alpharetta, Georgia Summer 1991 Georgia State University Internship, City Planning Department Created land use profiles for amendment to official city ordinance. Identified and investigated legal parcels by land use for potential city annexation. Researched and updated the official land use and zoning maps. Reviewed and evaluated engineering plans for potential development. IBM Corporation – Marietta, Georgia Co-Op while attending classes (Summer 1986 to 1992) Technical Writer, Integrated Systems Solution Corporation – Selected International Accounts Developed and edited custom Script files. Authored technical guides for internal and customer use. Aided in the development of internal and customer technical and marketing presentations. Education Georgia State University Master of Science in Public and Urban Affairs - 1992 Related Coursework Community Organizing, Demographics, Government and Non-Profit Planning, Measurements and Statistics, Public-Private Partnerships University of Georgia Bachelor of Arts in Geography - 1990 Related Coursework Economics, Geographic Information Systems, Graphic Cartography, Information Processing and Microcomputers, Money and Banking, Philosophy, Spanish Honors, Awards and Leadership Dean’s List, Gamma Theta Upsilon – National Geography Honor Society, Geography Club Gwinnett Technical Institute Associate in Applied Technology in Computer Programming Technology – In Progress Related Coursework Accounting, “C”, Computer Installation and Maintenance, Microsoft Visual Basic, Networking Concepts, Operating Systems, Program Design and Development, TCP/IP, Installing and Administering Windows NT Server 4.0, Installing and Administering Windows NT Workstation 4.0, Installing and Administering Windows NT Enterprise Server 4.0, Networking Essentials, Microsoft Internet Information Server Certifications Microsoft Corporation Microsoft Certified Professional Microsoft Certified Professional Plus Internet Microsoft Certified Systems Engineer – currently obtaining Implementing and Supporting Windows NT Server 4.0 (70- 067) passed Implementing and Supporting Windows NT Workstation 4.0 (70-073) passed Implementing and Supporting Windows NT Server 4.0 in the Enterprise (70-068) passed Networking Essentials (70-058) Internetworking with Microsoft TCP/IP on Windows NT 4.0 (70-059) Implementing and Supporting Microsoft Internet Information Server 4.0 (70-087) CRM 4.0 Applications (MB2-632) McKesson Corporation Horizon Web Solutions Technical Certification Leadership Certification Health Level Seven Organization HL7 Certified PMP PMP Certification candidate – in progress ETA November 2016 (Project Management Academy boot camp) Keywords Windows 2000, Windows XP, SQL, TLink, Mercator, Unix, OS/2, VMS, Visual Basic, HTML, JavaScript, IIS, Microsoft Internet Information Server, “C”, Web Design/Development, Microsoft Office, Visual Source Safe, Seagate Backup Exec, PC Maintenance and Installation, Network Installation/Support, Communication Protocols, TCP/IP, Training, Multimedia, Application Development, Project Management, Manager, Technical Documentation, Resource Management, Infrastructure Implementation, Technical Management, Health Level Seven, HL7, STAR, MUMPS, EDI X-12, HIPAA, HBOCHI, eLink, SIM, SCM, SMM, Sunrise Clinical Manager, Sunrise Integration Module Diane Barton Marketing Executive – Long-Time Georgia Resident, Family-Centric Community Leader • Experienced change & communications strategist and writer • Built CX (customer experience) practice – Deep understanding of serving customers, constituents and communities • Ran multi-million dollar customer-facing technology projects • Managed high-performing teams ENDEAVORS Community Board Member & Development Volunteer Children’s Healthcare of Atlanta: 1998 - Present Led campaign to name and endow Cardiac Intensive Care Unit. More than $9 million raised to date. Board of Directors: Marketing & Development Committees Chattahoochee Nature Center: 2011 - Present Helping team expand mission of educating community about the watershed, conservation and sustainability with a special focus on marketing and communications. EXPERIENCE C3: 2013 – Present Consulting firm specializing in marketing and communications strategy, planning, and implementation designed to grow employee and customer loyalty while increasing revenue. Expertise includes aligning marketing function with an organization’s strategic plan and goals, communications, change management, customer research, competitive analysis, customer touchpoint design, marketing, and success metrics implementation. Recent projects include change management and communications strategy and execution for a large cloud migration project, corporate rebranding and corporate website update. Vice President - Customer Experience / Marketing Cox Enterprises/Manheim: 2002 – 2013 • • • Successfully built customer experience organization in an international, operations-driven corporation. Included introducing customer satisfaction metrics, process improvements, customer self-service, front-line employee empowerment, and a comprehensive change management program. Managed 60+ person call center. Managed relationship with Ford Motor Company, Manheim’s largest customer. Responsible for strategic planning, contract negotiations, new product introductions, sales, and profitability analysis. Led 25+ person marketing organization for the global wholesale automobile auction and services division of Cox Enterprises, Inc. Included internal and external communications, advertising, research, trade shows, delivering results, and meeting budget. Director - Marketing, Manager - Marketing Cox Enterprises/Manheim: 1991 - 2002 As the first member of the marketing communications organization for Manheim, responsibilities included creating strategy, branding, organizational alignment, hiring and managing agencies, and building the marketing communications department. Assistant Manager - Corporate Communications Cox Enterprises: 1989 - 1991 Handled all corporate communications needs for two divisions of Cox Enterprises. This included developing and implementing the strategy for internal and external communications, newsletters, annual reports, and leadership presentations. Marketing Writer The Atlanta Journal-Constitution: 1987 - 1989 Wrote and managed the production of sales collateral for the advertising sales team. Created and delivered research-driven presentations to clients. For additional employment experience please see Diane Barton’s LinkedIn profile. http://www.linkedin.com/pub/diane-barton/35/a23/91 EDUCATION Emerson College Bachelor of Science - Mass Communications Toyota University Kaizen Certification Emory University - Goizueta Business School Certificate in Strategic Marketing EXTRAS Family Son graduated from UGA in 2019, Daughter graduates from Tulane University in 2020. Widowed in 2018 unexpectedly. Husband was an elementary school teacher in Sandy Springs. Life experience has uniquely prepared me to serve and represent the people of Georgia. Clinical Assistant Professor University of Georgia College of Pharmacy December 2005 – July 2006 Medical Science Liaison Alexion Pharmaceuticals, Inc. July 2006 – May 2007 Assistant Professor Department of Hematology and Medical Oncology Emory University School of Medicine May 2007 – September 2013 Associate Professor Department of Hematology and Medical Oncology Emory University School of Medicine September 2013 – September 2019 Associate Professor Department of Pharmacology Emory University School of Medicine February 2016 – present 7. Previous Administrative and/or Clinical Appointments: Clinical Specialist Stem Cell Transplantation and Hematology/Oncology/Coagulation Consult Service University of North Carolina Hospitals July 1998 – June 2000 Senior Clinical Specialist Hematology/Oncology/Coagulation University of North Carolina Hospitals June 2000 – June 2005 Co-Director, Hematology/Oncology Specialty Residency University of North Carolina Hospitals and School of Pharmacy July 2001 – June 2005 Clinical Specialist in Hematology/Oncology Director, Hematology/Oncology Specialty Residency Georgia Cancer Center/Grady Health System July 2005 – June 2006 8. Licensures/Boards: North Carolina Board of Pharmacy, issued June 1994 Georgia Board of Pharmacy, issued June 2005 9. Specialty Boards: Board Certified Pharmacotherapy Specialist, 1997 – 2011 Board Certified Oncology Pharmacist, 2000 – present 10. Education: R. Dona d Harvey, III September 1, 2019 2 BS with Honors, Pharmacy, University of North Carolina, Chapel Hill, 1989 – 1994 PharmD, University of North Carolina, Chapel Hill, 1994 – 1996 11. Postgraduate Training: Pharmacy Practice Resident (R237), University of Kentucky Medical Center and College of Pharmacy, Lexington, KY Director: Mick Hunt, MS July 1996 – June 1997 Hematology/Oncology Specialty Resident, University of North Carolina Hospitals and School of Pharmacy Chapel Hill, NC Director: Celeste Lindley, MS, PharmD, BCOP, FASHP, FCCP July 1997 – June 1998 12. Committee Memberships: a. National and International: American College of Clinical Pharmacy (ACCP) Programming Committee 2001-2002 Awards Committee 2004-2007 Hematology Oncology Pharmacy Association (HOPA) Education and Standards Committee 2005-2008 Co-chair, Professional Affairs Committee 2008-2009 Chair, Professional Affairs Committee 2009-2010 President, 2010-2013 Vice Chair, Research Committee 2013-2015 Chair, Research Committee 2015-2017 Committee Restructuring Task Force 2016 Chair, External/Professional Affairs Committee 2017-2018 Recognition Committee 2018-present American Society of Health-System Pharmacists (ASHP) Chair, Special Interest Group on Emerging Sciences, 2013-2014 American Society of Clinical Oncology (ASCO) Advocacy Champion for Hill Day 2015-present Clinical Trials Eligibility Criteria Initiative: Organ Function 2015-2016 ASCO University Pharmacology Representative 2015-2017 Annual Meeting Programming Committee – Developmental Therapeutics 2017-present Roundtable on Addressing Financial Barriers to Clinical Trials Participation – Steering Group member 2017 Biosimilars Brief Development 2017 Research Hill Day participant 2017 Cancer Research Committee Member 2017-present Chair 2019-2020 Joint ASCO/FDA Workshop on Research Biopsies in Phase I Trials Speaker, organizing committee, 2018-present Building Consensus for a Clinical Trial Data Sharing Policy Among Oncology Journals Workshop Panelist 2018 American Society for Clinical Pharmacology and Therapeutics (ASCPT) Chair, Oncology Scientific Section 2014-2015 Alliance for Clinical Trials in Oncology R. Dona d Harvey, III September 1, 2019 3 Member, Pharmacogenomics and Population Pharmacology Committee 2018-present b. Regional: North Carolina Association of Pharmacists (NCAP) Pharmacotherapy Advisory Committee, 2000-2004 Acute Care Practice Forum, 2001-2005 Triangle College of Clinical Pharmacy (TCCP) President 2004-2005 c. Institutional: Resident Advisory Committee, University of North Carolina Hospitals and School of Pharmacy 1999-2005 Transfusion Committee, University of North Carolina Hospitals 1999-2005 Palliative Care Advisory Committee, University of North Carolina Hospitals 2000-2003 Lineberger Comprehensive Cancer Center Protocol Review Committee, University of North Carolina Hospitals 2000-2005 Lineberger Comprehensive Cancer Center Data Safety and Monitoring Committee, University of North Carolina 2002-2005 Bone Marrow Transplant Continuous Quality Improvement Committee, University of North Carolina Hospitals 2003-2005 Co-Coordinator, Residency Research Committee, University of North Carolina Hospitals 20032005 Pharmacy Administration Leadership Committee, Grady Health System Cancer Center Operations Committee, Grady Health System 2005-2006 Clinical Molecular Testing Utilization Committee, Emory University 2007-2012 Clinical Translational Research Committee, Winship Cancer Institute 2007-present Vice Chair, Data Safety and Monitoring Committee, Winship Cancer Institute 2007-2016 Hematology/Medical Oncology Fellowship Research Committee, Winship Cancer Institute 2010present Pediatric Hematology/Medical Oncology Scholarship Oversight Committee 2013-2016 Chair, Data Safety and Monitoring Committee, Winship Cancer Institute 2016-present Faculty Recruitment Committee, Department of Pharmacology, 2018-present 13. Peer Review Activities: a. Grants: i. National and International: National Cancer Institute, The Experimental Therapeutics Clinical Trials Network (UM1/U24) Study Section, September 2019. HOPA Grant Review Committee – Chair, 2015 – 2017 Drug Discovery Review Section, American Cancer Society, Fall 2013, Spring 2014 b. Manuscripts: Pharmacotherapy, 1999 – 2012, 2015- present. Journal of Clinical Pharmacology, 2010 – present. Cancer, 2009 – present. Cancer Chemotherapy and Pharmacology, 2010 – present. Journal of Pharmaceutical and Biomedical Analysis, 2011 – present. British Journal of Cancer, 2012 – present. Journal of Clinical Apheresis 2013 – present. R. Dona d Harvey, III September 1, 2019 4 Journal of Oncology Pharmacy Practice 2013-present. Investigational New Drugs 2015-present. Annals of Oncology, 2010 – present. Clinical Cancer Research 2015-present. British Journal of Clinical Pharmacology 2016-present. PloS One 2016-present. c. Conference Abstracts: i. National and International: HOPA Annual Meeting, Multiple locations, June 2012-2017 International Society of Oncology Pharmacy Practitioners (ISOPP) Annual Meeting Santiago, Chile, April 2016 ASCO Annual Meeting, Developmental Therapeutics – Clinical Pharmacology, Chicago, IL, June 2018 ASCO Annual Meeting, Developmental Therapeutics – Tumor Biology and Clinical Pharmacology, Chicago, IL, June 2019 14. Consultantships/Advisory Boards External Advisory Board Member, University of Mississippi Medical Center (UMMC) Cancer Institute, April 2015 – April 2017 External Advisory Board Member, Blood Cancer Network Ireland (BCNI), November 2015 – November 2019 Consultant, Oncology Pharmacology, Genentech Pharmaceuticals, February 2018 – February 2023 Research Team Member, US Food and Drug Administration Project Renewal, April 2019 – present 15. Editorships and Editorial Boards: Section Editor, Original Research, Journal of Hematology Oncology Pharmacy, 2010 – 2016 Editorial Board member, Journal of Oncology Pharmacy Practice, 2015 – present Editorial Board member, Pharmacotherapy, 2015 – present 16. Honors and Awards: Eagle Scout, 1986 Honors Program, University of North Carolina School of Pharmacy, 1991 – 1994 North Carolina Pharmaceutical Association Women’s Auxiliary Scholarship, 1993 Merck Award for Best Honors Project Paper, 1994 William Julius and Vivian Spradlin Smith Scholarship Recipient, 1994 Rho Chi Honor Society, 1996 University of Kentucky Pharmacy Residents Impact Award, 1997 R. Dona d Harvey, III September 1, 2019 5 University of North Carolina Residency Award for Excellence in Clinical Practice, 1998 Instructor of the Year, University of North Carolina School of Pharmacy, 2003 – 2004 Fellow, American College of Clinical Pharmacy, 2008 President, Hematology/Oncology Pharmacy Association, 3-year term, 2010 Scholarship grant recipient, Hematology Oncology Practice and Research Network to attend the Focused Investigator Training, American College of Clinical Pharmacy Research Institute, 2013 James R. Eckman Award for Teaching Excellence, 2014 Fellow, Inaugural Class, Hematology/Oncology Pharmacy Association, 2016 Distinguished Graduate, University of North Carolina Hospitals Residency Program, 2017 Appointed to University of North Carolina School of Pharmacy Alumni Association Board of Directors, 2018 Hematology/Oncology Pharmacy Association Award of Excellence, 2018 Clinical Pharmacology member, National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP), pevonedistat and ixazomib project team, 2018 Woodruff Leadership Academy, Fellow, 2019 17. Society Memberships: Triangle College of Clinical Pharmacy (TCCP), President 2004 – 2005, 1994 – 2005 North Carolina Association of Pharmacists (NCAP), 1994 – 2005 American Society of Health-System Pharmacists (ASHP), 1993 – present American College of Clinical Pharmacy (ACCP), 1994 – present American Society of Hematology (ASH), 2008 – present American Association for Cancer Research, 2010 – present American Society of Clinical Pharmacology and Therapeutics, 2016 – present 18. Organization of Conferences: a. National and International: i. Administrative Positions: Organizer, “Phase I Clinical Trials: Establishing a Culture and Infrastructure for Conducting Drug Development Studies”. Preconference to the 12th Annual Meeting of the Hematology/Oncology Pharmacy Association. Winship Cancer Institute of Emory University, Atlanta, March 2016. ii. Sessions as Chair: “IGIV Therapy: The Process, The Product, The Patient, and The Pocketbook.” Moderator and presenter (“Intravenous Immune Globulins: Emerging Clinical Applications”), American College of Clinical Pharmacy Annual Meeting, Atlanta, November 2003. “Controlling Massive Bleeding Episodes: Pharmacoeconomic Issues and Potential Solutions.” Moderator and presenter (“Associated Costs of Transfusion Practices”), American College of Clinical Pharmacy Updates in Therapeutics, Austin, June 2004. R. Dona d Harvey, III September 1, 2019 6 “Practice Panel: Ethics in Oncology. ” Hematology Oncology Pharmacy Association 13th Annual Meeting, Anaheim, March 2017. “The Role of Biomarkers in Immunotherapy.” Hematology Oncology Pharmacy Association 14th Annual Meeting, Denver, March 2018. “Preclinical and Clinical Development of Oncology Biosimilars.” American Society of Clinical Oncology, Chicago, June 2018. 19. Clinical Service Contributions: a. Phase I Clinical Trials Program and Unit Growth at the Winship Cancer Institute o o Since joining in 2007, I have overseen the origination and expansion of the phase I section, with 40 subjects accrued in 2006 to a peak of 251 accrued in 2016. I led the design and opening of the first phase I clinical trials unit in 2009 and oversaw the transition to a new facility this year in the Tower, with growth from 11 to 22 treatment areas and 2200 to over 8000 square feet of space. We moved in January 2019. b. Data Safety and Monitoring Committee (DSMC) o I assumed the chair role of the DSMC in May 2016 and have improved the focus and depth of knowledge of the manager and monitors through strategic hiring and oversight. We have spurred educational initiatives and quality improvement processes driven by trial findings; and updated the Data Safety and Monitoring Plan for the P30 that led to cancer center comprehensive status designation in 2017. 20. Community Outreach: a. General: Assistant Den Leader, Den 4, Cub Scout Pack 175, Decatur, 2011-2019. “New Therapies for Multiple Myeloma”. North Atlanta Multiple Myeloma Support Group. Briarcliff United Methodist Church, August 2015, May 2016, May 2017, May 2018, May 2019. “Optimizing Medicines in People Living with Myeloma”. Southside Atlanta Multiple Myeloma Support Group. Macy’s, Greenbriar Mall. August 2016. b. Media Appearances: American Society of Clinical Oncology (ASCO) sponsored discussion on the role of the oncology pharmacist in cancer care. http://www.cancer.net/all-about-cancer/cancernet-feature-articles/expertinformation-asco/asco-expert-corner-role-oncology-pharmacist, 2013 American Society of Hematology (ASH) Clinical News, “The Evolving Role of the Hematology/Oncology Pharmacist”. https://www.ashclinicalnews.org/perspectives/evolving-rolehematologyoncology-pharmacist/, 2017. Hematology/Oncology Pharmacy Association (HOPA) interview on the role of biomarkers in predicting response in lung and gastric cancers. http://www.oncologytube.com/video/pharmacists-advice-on-biomarkers-for-immunotherapy/10003616, 2018. Fox 5 News, story on novel planning strategy for the Phase I Unit move. http://www.fox5atlanta.com/health/fox-medical-team/a-cardboard-cancer-clinic-gives-patients-ataste-of-what-s-to-come, 2018. Medpage, story on survey of oncologists’ perceptions of biosimilars. https://www.medpagetoday.com/resource-centers/biosimilars/oncologists-biosimilars-interviewrebecca-pentz-phd-and-r-donald-harvey-pharmd/2426, 2019. R. Dona d Harvey, III September 1, 2019 7 ASCO Post, interview on data expanding clinical trial eligibility criteria, https://www.ascopost.com/videos/2019-asco-annual-meeting/richard-schilsky-and-r-donaldharvey-on-expanding-criteria-for-clinical-trial-eligibility/, 2019. 21. Formal Teaching: a. Graduate Programs: i. Residency Programs: Lecture, Medicine Resident Lecture Series, “Design and Conduct of Cancer Clinical Trials.” Emory University, May 2015. ii. Fellowship Programs: Lecture, Hematology/Oncology Fellows, “High Dose Methotrexate with Leucovorin Rescue: Pharmacokinetic/Dynamic Considerations.” University of North Carolina, July 1997. Lecture, Geriatric Fellows, “Pain Management in the Elderly Cancer Patient.” University of North Carolina Department of Medicine, April 2002. Lecture, Pediatric Hematology/Oncology Fellows, “Overview of Antineoplastic Therapy in Pediatrics.” University of North Carolina, July and August 2002. Lecture, Hematology/Oncology Fellows Lecture Series, “Overview of Antiemetic Therapy.” Emory University, August 2007-2013. Lecture, Hematology/Oncology Fellows Lecture Series, Pharmacology.” Emory University, August 2007-2017. “Overview of Antineoplastic Lecture, Pediatric Hematology/Oncology Fellows, “Clinical Pharmacology of Antineoplastic Therapy in Pediatrics.” Emory University, August 2008-2016. Co-Coordinator, with Drs. Pentz and Owonikoko - Fundamentals of Clinical Research, 3-month course for hematology/medical oncology fellows, radiation oncology residents, and surgery fellows. 2009-2018. iii. Master’s and PhD Programs: Lecturer, Cancer Biology Graduate Students. IBS761. “Anticancer Drug Development: From Compound Selection to Clinical Trials”. Emory University 2008 – present. b. Other Categories: Lecture, Pharmacy PY-3 Students, “Transfusion Therapy and Blood and Marrow Transplantation.” University of North Carolina School of Pharmacy, September 1997-2004. Lecture, Pharmacy PY-3 Students, “Acquired and Inherited Bleeding Disorders.” University of North Carolina School of Pharmacy, September 1998 - 2004. Lecture, Pharmacy PY-3 Students, “Nutrition Support in Cancer Patients.” University of North Carolina School of Pharmacy, February 1999, 2000. Lecture, Pharmacy PY-3 Students, “Infectious Complications of Chemotherapy.” University of North Carolina School of Pharmacy, February 2000-2004. R. Dona d Harvey, III September 1, 2019 8 Lecture, Pharmacy PY-3 Students, “Pediatric Malignancies.” University of North Carolina School of Pharmacy, March 2000, 2001. Lecture, Pharmacists, “Acquired and Inherited Bleeding Disorders.” University of North Carolina Hospitals and School of Pharmacy, May 2000. Lecture, Pharmacists, “Recognition and Management of Heparin-Induced Thrombocytopenia.” University of North Carolina Hospitals and School of Pharmacy, August 2000. Lecture, Pharmacy PY-3 Students, “Acute Leukemias.” University of North Carolina School of Pharmacy, October 2000 - 2004. Lecture, Pharmacy PY-3 Students, “Aplastic Anemia and Myelodysplastic Syndromes.” University of North Carolina School of Pharmacy, October 2000. Lecture, Pharmacy PY-3 Students, “Myeloproliferative Disorders.” School of Pharmacy, March 2001. University of North Carolina Lecture, Pharmacy PY-3 Students, “Phase II Metabolism of Antineoplastic Agents: Focus on Irinotecan.” University of North Carolina School of Pharmacy, March 2002, 2004. Lecture, Pharmacy PY-2 Students, “Overview of Platelet Physiology.” University of North Carolina School of Pharmacy, February 2004. Lecture, Pharmacy PY-2 Students, “Overview of Blood Coagulation.” University of North Carolina School of Pharmacy, March 2004. 22. Supervisory Teaching: a. Other: Rebekah Matthews, Pharm.D., BCOP, PGY-2 Hematology and Oncology Resident, University of North Carolina, Chapel Hill, 2001-2002. Currently Manager, Pharmacy, Wesley Long Hospital, Greensboro, NC Stacy (Shifflett) Shord, Pharm.D., FCCP, BCOP (PGY-2 Hematology and Oncology Resident, University of North Carolina, Chapel Hill, 2002-2003). Currently, Associate Director of Labeling, Division of Oncology Products II, Office of Hematology Oncology Products, US Food and Drug Administration, Rockville, MD. Christine Walko, Pharm.D., BCOP (PGY-2 Hematology and Oncology Resident, University of North Carolina, Chapel Hill, 2003-2004). Currently, Personalized Medicine Specialist, Moffitt Cancer Center, Associate Professor, University of South Florida Morsani College of Medicine, Tampa, FL. Hillary Prescott, Pharm.D., BCOP (PGY-2 Hematology and Oncology Resident, University of North Carolina, Chapel Hill, 2004-2005). Currently, Manager, Clinical Pharmacy Services and PGY2 Residency Director, Dana-Farber Cancer Institute, Boston. Marjorie Curry, Pharm.D., BCOP (PGY-2 Hematology and Oncology Resident, Grady Health System Department of Pharmacy, Atlanta, 2005-2006). Currently, Hematology/Oncology Clinical Pharmacy Specialist, Grady Health System, Atlanta. Colleen Lewis, MSN, ANP-BC, AOCNP, Phase I Program Advanced Practice Provider, Winship Cancer Institute, Atlanta, 2008-present. R. Dona d Harvey, III September 1, 2019 9 Haley Ruffin, Summer Scholars Program 2008. http://www.mdjonline.com/news/north-cobb-s-ruffinwill-make-medicine-her-life-s/article 64470896-c5f9-5cd0-85e7-3f585633dd09.html, 2011. Currently, Intern, Quality Improvement Department, Saint Alphonsus Hospital, Boise, ID. Elisavet Paplomata, M.D. (Chief Fellow, 2013-2014. Emory University School of Medicine, Atlanta). Currently, Assistant Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta Conor Steuer, M.D. (Chief Fellow, 2014-2015. Emory University School of Medicine, Atlanta). Currently, Assistant Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta Meagan Barbee, Pharm.D., BCOP (PGY-2 Hematology and Oncology Resident, Emory Department of Pharmaceutical Services, Atlanta, 2014-2015). Currently, Clinical Coordinator, Oncology Pharmacy, Emory Healthcare and Winship Cancer Institute, Atlanta. Sarah Wheeler, Pharm.D., BCOP (Chief Resident, PGY-2 Hematology and Oncology, Emory Department of Pharmaceutical Services, Atlanta, 2014-2015). Currently, BMT/Leukemia Clinical Specialist, University of Florida, Gainesville. Danielle Schlafer, Pharm.D. (PGY-2 Hematology and Oncology Resident, Emory Department of Pharmaceutical Services, Atlanta, 2015-2016.) Currently, Clinical Specialist, Oncology Pharmacy, Emory Healthcare and Winship Cancer Institute, Atlanta. M. Asim Bilen, M.D. (Assistant Professor, Emory University School of Medicine, Atlanta, Georgia 2016-present) Sarah Chehab, Pharm.D. (PGY-2 Hematology and Oncology Resident, Emory Department of Pharmaceutical Services, Atlanta, 2016-2017). Currently, Clinical Specialist, Oncology Pharmacy, Moffitt Cancer Center, Tampa, FL. Kevin Hall, Pharm.D. (PGY-2 Hematology and Oncology Resident, Emory Department of Pharmaceutical Services, Atlanta, 2017-2018). Currently, Clinical Specialist, Oncology Pharmacy, Emory Healthcare and Winship Cancer Institute, Atlanta. Caroline Redick, Summer Scholars Program at the Winship Cancer Institute, 2018. Currently, Senior at Cambridge High School, Milton. Lawrence He, Summer Scholars Program at the Winship Cancer Institute, 2019. Currently, Senior at . 23. Lectureships, Seminar Invitations, and Visiting Professorships: a. National and International: 1. The Peggy and Charles Stephenson Cancer Center at the University of Oklahoma, “The Use of Pharmacodynamic Endpoints in Early Phase Clinical Trials”. Oklahoma City, May 2013. 2. Inaugural Symposium of the Blood Cancer Network in Ireland, “The Recent Evolution of Phase I Trials in Oncology Drug Development”, National University of Ireland, Galway, May 2016. 3. National Academy of Sciences, The Drug Development Paradigm in Oncology: A Workshop, “Challenges in Accelerating the Drug Development Paradigm in Oncology”, Washington, DC, December 2016. R. Dona d Harvey, III September 1, 2019 10 4. National Academy of Sciences and US Food and Drug Administration, “Updating Labels for Generic Drugs in Oncology”, Washington, DC, March 2019. b. Regional: 1. Atlanta CTSA Conference on Ethics and Translational Research: From Discovery to Implementation, “Ethical Issues in Anti-Cancer Drug Development: Translating Internal Science.” May 2008. 2. University of North Carolina Lineberger Comprehensive Cancer Center Grand Rounds, “Developmental Immunotherapeutics in Cancer: Clinical Pharmacology Implications”, Chapel Hill, October 2013. 3. 24th Annual Fall Cancer Conference, Mary Babb Randolph Cancer Center of West Virginia University, “Cancer, Inflammation, and Therapy: Clinical Pharmacology and Novel Immunotherapeutics”, Morgantown, September 2014. 4. Invited speaker series, Carol and Ray Neag Comprehensive Cancer Center at the University of Connecticut, “Cancer, Inflammation, and Therapy: Clinical Pharmacology and Novel Immunotherapeutics”, Farmington, October 2014. 5. The University of Kentucky Markey Cancer Center Annual Retreat “Establishing a Phase I Trials Unit and Section: The Emory Experience”, Berea, Kentucky, September 2015. 6. The University of Houston College of Pharmacy Seminar Series, “Cancer, Inflammation, and Therapy: Clinical Pharmacology and Novel Immunotherapeutics”, Houston, September 2015. 7. Mercer University College of Pharmacy, “Opportunities for Trainees in Anticancer Drug Development”, Atlanta, October 2017. 8. Department of Pharmacotherapy and Experimental Therapeutics Seminar Series, University of North Carolina School of Pharmacy “Precision, Accuracy, and Resolution: Improving Anticancer Therapies”, Chapel Hill, February 2018. 9. University of Wisconsin Carbone Cancer Center Grand Rounds, “Biosimilars in Oncology: Development, Regulation, and Utilization”, Madison, October 2018. c. Institutional: 1. Aflac Cancer Center and Blood Disorders Service Research Meeting, Emory University School of Medicine, “Pharmacokinetic and Pharmacodynamic Modeling: Case Studies in Anticancer Drug Development”, January 2008. 2. Cancer Biology Graduate Students Cancer Colloquium, “Drug Development in Cancer – From Preclinical Evaluation to FDA Approval”, February 2013. 3. Discovery and Developmental Therapeutics Program Meeting of the Winship Cancer Institute, “Cancer, Inflammation, and Therapy: Effects on Cytochrome P450-Mediated Drug Metabolism and Implications for Novel Immunotherapeutic Approaches”, July 2014. 4. Pediatric Hematology Oncology Research Group Seminar Series, Aflac Cancer Center of Children’s Healthcare of Atlanta, “Phase I Trials in Adults at the Winship Cancer Institute: A Five-Year Retrospective”, June 2015. 24. Invitations to National/International, Regional, and Institutional Conferences: R. Dona d Harvey, III September 1, 2019 11 a. National and International: 1. American Society of Health-System Pharmacists Midyear Clinical Meeting, Clinical Pearls Session, "Too Hot to Trot”, Atlanta, December 1997. 2. American College of Clinical Pharmacy Annual Meeting, “IGIV Therapy: The Process, The Product, The Patient, and The Pocketbook.” Moderator and presenter (“Intravenous Immune Globulins: Emerging Clinical Applications”), Atlanta, November 2003. 3. American Society of Health-Systems Pharmacists Midyear Clinical Meeting, “Therapeutic Debates in Hematology.” Moderator and debater (“Recombinant Factor VIIa is a CostEffective Universal Hemostatic Agent”), New Orleans, December 2003. 4. NovoNordisk Pharmaceuticals Workshop On Procoagulants, “Potential Methods of Pharmacodynamic Monitoring of Recombinant Factor VIIa – Opportunities and Pitfalls.” Copenhagen, Denmark. January 2004. 5. American College of Clinical Pharmacy 2004 Updates in Therapeutics, “Controlling Massive Bleeding Episodes: Pharmacoeconomic Issues and Potential Solutions.” Moderator and presenter (“Associated Costs of Transfusion Practices”), Austin, June 2004. 6. American College of Clinical Pharmacy Annual Meeting, “Managing Acquired and Congenital Bleeding Disorders.” Dallas, October 2004. 7. 19th Annual Pharmacy Invitational Conference on Antithrombotic Therapy, “Reversal of Excessive Anticoagulation Using Recombinant Factor VIIa: A Case Study.” Orlando, Dec 2004. 8. Hematology Oncology Pharmacy Association 1st Annual Meeting, “Non-Malignant Hematology: Hemophilia.” San Diego, June 2005. 9. American Society of Health-System Pharmacists Midyear Clinical Meeting, “Clinical Considerations in Immune Thrombocytopenic Purpura Therapy Selection.” Las Vegas, December 2005. 10. The Oncology Pharmacy Preparatory Review Course. Co-sponsored by the American College of Clinical Pharmacy and the American Society of Health-System Pharmacists, “Acute Leukemia” and “Head, Neck, and Adult CNS Tumors” Fort Lauderdale, May 2006 and Scottsdale, May 2005. 11. Hematology Oncology Pharmacy Association 2nd Annual Meeting, “Significant Papers in Hematology: Leukemia and Myelodysplastic Syndromes.” Orlando, June 2006. 12. Hematology Oncology Pharmacy Association 3rd Annual Meeting, “Therapeutic Debate: Fondaparinux is Safe and Effective in Patients with HIT” Denver, June 2007 13. American College of Clinical Pharmacy Annual Meeting, “Iron Chelation Therapy: An Update on Options”, Denver, October 2007. 14. American Society of Health-Systems Pharmacists Midyear Clinical Meeting, “Case Studies in Colorectal Cancer: Targeting EGFRs”, Las Vegas, December 2007. 15. Hematology Oncology Pharmacy Association 4th Annual Meeting, “Epigenetics in Cancer Medicine”. Anaheim, June 2008. 16. American College of Clinical Pharmacy Annual Meeting, “Late Breakers Session – Hematology/Oncology and Transplant/Immunology”, Louisville, October 2008. R. Dona d Harvey, III September 1, 2019 12 17. “Novel Treatments in Myelodysplastic Syndromes”, American Society of Health-System Pharmacists Annual Meeting, Orlando, December 2008; American College of Clinical Pharmacy Annual Meeting, Louisville, October 2008; and Hematology Oncology Pharmacy Association 4th Annual Meeting, Anaheim, June 2008. 18. Hematology Oncology Pharmacy Association 5th Annual Meeting, “Best Practices in Investigational Oncology Pharmacy – Phase I Trial Conduct”, Miami, June 2009. 19. Hematology Oncology Pharmacy Association 5th Annual Meeting, “Iron Overload Management and its Role in Myelodysplastic Syndromes”, Miami, June 2009. 20. Hematology Oncology Pharmacy Association 6th Annual Meeting, “From Bench to Bedside: Pharmacist Perspectives on Head and Neck Cancer”, New Orleans, March 2010. 21. The Board Certification in Oncology Pharmacy (BCOP) Preparatory Review Course. Co-sponsored by the American College of Clinical Pharmacy and the American Society of Health-System Pharmacists, “Lung Cancer” and “Adult Sarcomas”. San Diego May 2010, Baltimore, 2009, Tampa 2008. 22. The Board Certification in Oncology Pharmacy (BCOP) Preparatory Review Course. Co-sponsored by the American College of Clinical Pharmacy and the American Society of Health-System Pharmacists, “Lung Cancer” and “Anticancer Drug Development”. San Antonio May 2011. 23. Japanese Society of Oncology Pharmacists, “The History and Current Status of Hematology/Oncology Pharmacy Organizations in the United States”. Tokyo, December 2011. 24. American College of Clinical Pharmacy Annual Meeting, “Modulating the Immune System in Oncology: The Evolution of Therapy”, Pittsburgh, October 2011. 25. American Society of Health-Systems Pharmacy Annual Meeting, “Expanding the Treatment Armamentarium for Non-Small Cell Lung Cancer: Pharmacist Perspectives”, New Orleans, December 2011. 26. International Society of Oncology Pharmacy Practitioners Annual Meeting, “Establishment of a Pharmacist-Led Phase 1 Clinical Trials Section”, Melbourne, Australia, May 2012. 27. The Board Certification in Oncology Pharmacy (BCOP) Preparatory Review Course. Co-sponsored by the American College of Clinical Pharmacy and the American Society of Health-System Pharmacists, “Lung Cancer” and “Anticancer Drug Development”. San Antonio May 2012. 28. American Society of Health-Systems Pharmacy Annual Meeting, “Stop the Bleeding: Updates in Hemophilia Management”. Las Vegas, December 2012. 29. American Cancer Executives Annual Meeting, “What Do We Do When The Drugs Run Out? A Pharmacist’s Approach to Chemotherapy Shortages”. San Antonio, January 2013. 30. Japanese Society of Pharmaceutical Oncology, “The Road Not Travelled: Current and Future Opportunities for Oncology Pharmacists”. Tokyo, Japan, March 2013. 31. The Association of Community Cancer Centers (ACCC) National Oncology Conference, “Philadelphia (Chromosome) Freedom?: An Update on Novel Therapies for CML”. Boston, October 2013. R. Dona d Harvey, III September 1, 2019 13 32. BMT Tandem Meetings. “Practice Management Strategies for Dosing and Drug Administration in Multiple Myeloma”, Grapevine, Texas. February 2014. 33. Hematology Oncology Pharmacy Association 10th Annual Meeting, “How to Develop and Submit a High Quality Research Proposal”. New Orleans, March 2014. 34. Hematology Oncology Pharmacy Association 10th Annual Meeting, “Selected Agents in Development for Hematologic and Solid Tumor Malignancies”. New Orleans, March 2014. 35. American Society of Health-Systems Pharmacy Annual Meeting, “New and Emerging Strategies for the Treatment of Advanced Melanoma”. Anaheim, December 2014. 36. Hematology Oncology Pharmacy Association 11th Annual Meeting, “Clinical Considerations in Patients with Myeloma and Renal Impairment”. Austin, March 2015. 37. International Pharmaceutical Federation (FIP) World Congress, “Targeting Programmed Cell Death-1 (PD-1) in Cancer Treatment”. Dusseldorf, Germany, October 2015. 38. Annual Meeting of the Advanced Practitioner Society for Hematology and Oncology, “Navigating Targeted Therapies for Advanced Non-Small Cell Lung Cancer”, Phoenix, November 2015. 39. American Society of Health System Pharmacists, “Novel Approaches and Interventions in Acquired Hemophilia.” New Orleans, December 2015. 40. Armada Specialty Pharmacy Summit, “Testing to Target in Non-Small Cell Lung Cancer – Managed Care Perspectives.” Las Vegas, May 2016. 41. American College of Clinical Pharmacology Annual Meeting, “Clinical Perspectives in Combinations, Requirements and Challenges in Small- and Large-Molecule Oncology Drug Development.” Bethesda, September 2016. 42. Advanced Practitioner Society for Hematology and Oncology (APSHO) Annual Meeting, “Newly Approved Agents in Hematologic Malignancies 2015-2016.” Washington, DC, November 2016. 43. Hematology Oncology Pharmacy Association 13th Annual Meeting, “Practice Panel: Ethics in Oncology. ” Anaheim, March 2017. 44. International Society of Oncology Pharmacy Practitioners XVI Annual Meeting, “Immunotherapeutic Strategies in Myeloma.“ Budapest, April 2017. 45. American College of Clinical Pharmacology Annual Meeting, “Pharmacodynamics of Kinase Inhibitors in Children: Markers of Effect and Mechanisms of Resistance”. San Diego, September 2017. 46. International Society of Oncology Pharmacy Practitioners XVII Annual Meeting, “Novel Trial Designs in Oncology.“ Shanghai, April 2018. 47. American Association of Cancer Institutes Annual Meeting, “Modernizing Eligibility Criteria in Oncology Trials.” Chicago, May 2018. 48. American Society of Clinical Oncology Annual Meeting, “The Science and Process for Biosimilars.” Chicago, June 2018. 49. Quality Cancer Care Alliance Leadership Meeting, “The Science and Process of Biosimilar Development and Use.” Chicago, August 2018. R. Dona d Harvey, III September 1, 2019 14 50. International Society for Pharmacoepidemiology Mid-year Meeting, “Perspectives from Scientific Societies on Biologic and Biosimilar Use: The American Society of Clinical Oncology”. Rome, Italy, April 2019. b. Regional: 1. North Carolina Association of Pharmacists Winter Meeting, “Novel Approaches to Anticoagulation: The Pharmacist’s Role.” Greensboro, March 2001. 2. Triangle chapter of The Leukemia and Lymphoma Society, “Novel Agents for the Treatment of Hematologic Malignancies.” Raleigh, December 2003. 3. North Carolina Area Health Education Centers, “Novel Approaches to Thromboembolic Disease Prevention and Treatment.” February-April 2004. 4. Coastal Area Health Education Center, “Update in Oncology Therapeutics.” Wilmington, April 2004. 5. North Carolina Oncology Pharmacists Network, “Update in Supportive Nausea/Vomiting and Pain Management.” Greensboro, August 2004. Care: 6. Fourth Annual Oncology Nurses Association Curriculum, “Toxicities and Tolerability of Antineoplastic Therapy.” March 2005. 7. North Carolina Association of Pharmacists Acute Care Meeting, “An Update on NonHemophilia Uses of Recombinant Factor VIIa.” March 2005. 8. North Carolina Oncology Pharmacists Network, “Update in Hematological Malignancies.” Greensboro, August 2005. 9. South Carolina Oncology Nursing Society, “Update on the Management of Chronic Myeloid Leukemia.” Greenville, April 2006. 10. North Carolina Oncology Pharmacists Network, “Therapeutic Debate: FCR is Optimal Initial Therapy in Chronic Lymphocytic Leukemia.” Greensboro, August 2006. 11. North Carolina Oncology Pharmacists Network, “Challenging Hematology/Oncology Pharmacotherapy.” Greensboro, August 2007. Cases in 12. North Carolina Oncology Pharmacists Network, “Update on Procoagulant Use.” Greensboro, August 2008. 13. Oklahoma Society of Clinical Oncology, “Non-Small Cell Lung Cancer: Focus on the Integration of New Agents”, Oklahoma City, January 2009. 14. Oncology Nursing Symposium, “Update on Novel Therapies in the Management of Hematologic and Oncologic Disorders”, Stone Mountain, Georgia, March 2009. 15. Kansas Oncology Nursing Society Annual Meeting, “Drug Development in Hematologic Malignancies – Novel Target Inhibition”, Lawrence, July 2009. 16. North Carolina Oncology Pharmacists Network, “Emerging Pathways and Drug Development in Cancer”, Greensboro, August 2009. 17. Oncology Nursing Symposium, “Anticancer Drug Development: Emerging Pathways and Clinical Trial Data”, Stone Mountain, Georgia, March 2010. R. Dona d Harvey, III September 1, 2019 15 18. Georgia Chapter of the Leukemia and Lymphoma Society Patient Conference, “Drug Development in Hematologic Malignancies: Novel Compounds on the Horizon”, Atlanta, March 2010. 19. “Chronic Myeloid Leukemia: Considerations for Selecting and Managing Therapy”, Georgia Society of Health-System Pharmacists Annual Meeting, Helen, October 2010, Alabama Society of Health-System Pharmacists Annual Meeting, Birmingham, October 2010; American Society of Health-System Pharmacists Summer Meeting, Tampa, June 2010; Ohio Society of Health-System Pharmacists Annual Meeting, Columbus, April 2010. 20. Cancer and Leukemia Group B Summer Meeting, “Pharmacogenomics and Treatment Implications in Cancer”, Chicago, June 2010. 21. North Carolina Oncology Pharmacists Association, “Therapeutic Debate: Remains the Gold Standard for Follicular Lymphoma”, Cary, August 2010. R-CHOP 22. North Carolina Oncology Pharmacists Association, “Therapeutic Debate: Cisplatin is the Superior Platinum Agent in the Initial Treatment of Unresectable NSCLC”, Cary, August 2011. 23. Northeast Regional Hematology/Oncology Pharmacists Symposium, “Pursuing the Plasma Cell: Novel Approaches in Multiple Myeloma Therapeutics”, Boston, October 2011. 24. Smith Drug Regional Meeting, “Novel Approaches Using Immunotherapy in Advanced Melanoma”, Asheville, NC, July 2012. 25. North Carolina Oncology Pharmacists Association, “Therapeutic Debate: Second Generation Tyrosine Kinase Inhibitors are Superior to Imatinib in the Initial Treatment of Chronic Phase CML”, Cary, August 2012. 26. Pharmacy Learning Network, “Advances in the Treatment of Non-Small Cell Lung Cancer”, Washington, DC, August 2012; Los Angeles, September 2012. 27. Northeast Regional Hematology/Oncology Pharmacists Symposium, “Treating Patients with Relapsed or Refractory Multiple Myeloma: Current and Emerging Options”, Boston, October 2012. 28. Pharmacy Learning Network, “Advances in the Treatment of Non-Small Cell Lung Cancer”, Philadelphia, November 2012, Orlando, March 2013; Pittsburgh, September 2013. 29. Northeast Regional Hematology/Oncology Pharmacists Symposium, “Novel Treatment Approaches to Patients Across the Myeloma Spectrum”, Boston, October 2013. 30. North Carolina Oncology Pharmacists Association, “Therapeutic Debate: ChemoBrain: Real or Imagined?”. Cary, August 2014. 31. Northeast Regional Hematology/Oncology Pharmacists Symposium, “How We Treat Multiple Myeloma Patients with Renal Dysfunction”. Boston, October 2014. 32. Kentucky Society of Health-System Pharmacists Annual Meeting, “New and Emerging Strategies for the Treatment of Advanced Melanoma”. Lexington, May 2015. 33. Oncology Pharmacy Education Network (OPEN) Regional Clinical Meeting, “Case Studies in Multiple Myeloma: Integrating Novel Agents into Practice”. New Brunswick, NJ, May 2015, Fort Lauderdale, June 2015. R. Dona d Harvey, III September 1, 2019 16 34. Louisiana Society of Health-System Pharmacists Annual Meeting, “New and Emerging Strategies for the Treatment of Advanced Melanoma”. New Orleans, May 2015. 35. North Carolina Oncology Pharmacists Association, “Therapeutic Debate: PD-L1 Testing Predicts Outcome in Non-Small Cell Lung Cancer Treatment”. Cary, August 2016. 36. Northeast Regional Hematology/Oncology Pharmacists Symposium, “Immune Based Strategies for Myeloma: Combining Antibodies for Optimal Outcomes”, Boston, October 2016. 37. JADPRO Regional Lectures: Immunotherapy, “Overview of the Immune System” “Case Studies in NSCLC and RCC”. Chicago, September 2017; Pittsburgh, October 2017; New York, April 2018; Anaheim October 2018. 38. Northeast Regional Hematology/Oncology Pharmacists Symposium, “Updates in Myeloma Therapeutics: Bone Health, Smoldering Disease, and CAR-T Cells”, Boston, October 2018. c. Institutional: 1. Winship Cancer Institute of Emory University Grand Rounds, "Rapid Immunoassays for Pharmacokinetically-Guided Antineoplastic Individualization", Atlanta, February 2008. 2. Winship Cancer Institute of Emory University Grand Rounds, “The Art and Science of Phase I Trials”, Atlanta, June 2011. 3. 5th Annual Gastrointestinal Cancers Symposium, Emory Department of Hematology and Medical Oncology, “Immunotherapy and Novel Targeted Agents for GI Malignancies”, Atlanta, November 2014. 4. Winship Cancer Institute of Emory University Grand Rounds, “Precision, Accuracy, and Resolution – Dose Selection of Oral Anticancer Agents”. Atlanta, May 2015. 5. Winship Cancer Institute of Emory University Debates and Didactics in Hematology and Oncology, “The Evolution of the Phase I Trial in Oncology”. Sea Island, July 2017. 6. Winship Cancer Institute of Emory University Grand Rounds, “Biosimilars in Oncology: Considerations from Development to Treatment”. Atlanta, September 2017. 7. Winship Cancer Institute of Emory University Debates and Didactics in Hematology and Oncology, “How Phase I Trials Can Improve your Patient Outcomes”. Sea Island, July 2018. 25. Abstract Presentations at National/International, Regional, and Institutional Conferences: a. National and International: Harvey RD*, Shea T, Walko C, Krasnov C, Patel L, Serody J, Gabriel D, Comeau T, Lindley C. Intravenous busulfan test dose clearance comparison with first and thirteenth dose systemic exposure in allogeneic bone marrow transplant recipients. American Society of Clinical Oncology Annual Meeting, Chicago, IL, 2005 (poster presentation). Harvey RD*, Kauh JS, Ramalingam SS, Lewis CM, Chen Z, Lonial S, Blount IC, Shin DM, Khuri FR, Owonikoko TK. Combination therapy with sunitinib and bortezomib in adult patients with radioiodine refractory thyroid cancer. American Society of Clinical Oncology Annual Meeting, Chicago, IL, 2010 (poster presentation). R. Dona d Harvey, III September 1, 2019 17 Harvey RD*, Lewis CM, Kauh JS, Owonikoko TS, Akintayo A, Karol M, Teofilovici F, Khuri FR, Ramalingam SS. A phase 1 and pharmacokinetic study of ganetespib (STA-9090), a heat shock protein 90 inhibitor, in combination with docetaxel in patients with advanced solid tumor malignancies. European Society of Medical Oncology Annual Meeting, Amsterdam, 2011 (poster presentation). Harvey RD*, Lonial S, Renfroe H, Sinha R, Flowers CR, Lechowicz MJ, Khoury HJ, Langston A, Waller EK, Kaufman JL. Temporal changes in plerixafor administration do not impact hematopoietic stem cell mobilization efficacy: Results of a prospective clinical trial. American Society of Hematology Annual Meeting, San Diego, CA, 2011 (poster presentation). Harvey RD*, Jacobus SJ, Rajkumar SV, Greipp PR, Lonial S. Renal function measures improve on lenalidomide and dexamethasone and compete with patient characteristics to predict lenalidomide dose density and hematologic toxicity: An E4A03 analysis. American Society of Hematology Annual Meeting, San Diego, CA, 2011 (poster presentation). Harvey RD*, Lewis CM, Pillai R, Lawson D, Ramalingam SS, Morgan ET. Novel Immunotherapeutics and Concurrent CYP Substrate Use in Advanced Cancer. International Society of Oncology Pharmacy Practitioners Annual Meeting, Santiago, Chile, 2014 (poster presentation). Harvey RD*, Chen YJ, Lethen J, Mahue M. Relationship of carfilzomib dosing and duration of therapy (DOT) in patients with relapsed and refractory multiple myeloma (RRMM). American Society of Hematology Annual Meeting, Orlando, FL, 2015 (poster presentation). Harvey RD*, Gore L, Wang D, Mita A, Sharma S, Nemunaitis J, Papadopoulos K, Pinchasik D, Ou Y, Demirhan E, Cutler RE, Tsimberidou AM. A phase I study to assess food effect on oprozomib in patients with advanced malignancies. American Society of Clin Pharmacol Ther 2016: PII-090 (poster presentation). Harvey RD*, Kaufman JL, Heffner LT, Hofmeister CC, Dhodapkar MV, Lonial S, Nooka AK. Impact of obesity on response in 751 myeloma patients receiving lenalidomide, bortezomib, and dexamethasone (RVd) induction. American Society of Clinical Oncology Annual Meeting, Chicago, IL, 2018 (poster presentation). 26. Research Focus: My research focuses on the application of clinical pharmacology principles to improve cancer treatment outcomes. Investigations of drug disposition, novel agents and development strategies, and social aspects of care drives the work we do in our Phase I Clinical Trials Program. 27. Grant Support: a. Active Support (PI or Co-PI role): i. Contracts: PI: Halozyme, A Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with Pembrolizumab in Subjects with Selected Hylauronan-High Solid Tumors, $23,330/patient enrolled, 2015 – 2021. PI: Incyte, A Phase 1/2 Study of INCB053914 in Subjects with Advanced Malignancies, $31,626/patient enrolled, 2015 – 2021. PI: Celgene (Acetylon Pharmaceuticals), A Phase 1b Study of the Safety, Pharmacokinetics, and Preliminary Antitumor Activity of ACY-241 in Combination with Paclitaxel in Patients with Advanced Solid Tumors, $17,830/patient enrolled, 2016 – 2022. R. Dona d Harvey, III September 1, 2019 18 Co-PI: Pfizer, A Phase I Study of Palbociclib in Combination with Cisplatin or Carboplatin in Advanced Solid Malignancies, $1,286,955, 2016 – 2022. Co-PI: Genmab, First-in-Human, Open-Label, Dose Escalation Trial with Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate (HuMax®-AXL-ADC) in Patients with Solid Tumors, $85,531/patient enrolled, 2017 – 2027 PI: Rgenix, A Phase I Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma, $28,671/patient enrolled, 2017 – 2027. PI: Takeda, A Phase Ib Study to Evaluate TAK-659 in Combination with Nivolumab in Patients With Advanced Solid Tumors, $60,424/patient enrolled, 2017 – 2027. PI: Meryx, A Phase I Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of MRX-2843 in Adult Subjects With Relapsed/Refractory Advanced and/or Metastatic Solid Tumors, 2018 – 2028. $730,105 PI: Xencor, A Phase I Multiple Dose Study to Evaluate the Safety and Tolerability of XmAbÒ20717 in Subjects With Selected Advanced Solid Tumors, $54,389/patient enrolled, 2018 – 2028. PI: Tesaro, An Open-Label, Randomized-Sequence, Multicenter, Single-Crossover Study to Assess the Relative Bioavailability of Niraparib Tablet Formulation Compared to Niraparib Capsule Formulation in Patients with Advanced Solid Tumors, $9,173/patient enrolled, 2018 – 2028. b. Active Support (Co-Investigator role) i. Federally Funded Co-I: NIH,4UH3AI122320-03, Development of Gleevec for TB and TB/HIV, $ 3,162,269, 2015-2020. ii. Contracts Co-I: AstraZeneca Pharmaceuticals, An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 following a Single Oral Dose to Patients with Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment, $15,116/patient enrolled, 20142020 Co-I: AstraZeneca Pharmaceuticals, An Open-label, Randomised, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of AZD9291 in Patients with EGFRm Positive NSCLC whose Disease has Progressed on an EGFR TKI, $19,721/patient enrolled, 2014-2020 Co-I: AstraZeneca Pharmaceuticals, A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral Dose of AZD9291 in Patients with EGFRm Positive NSCLC Whose Disease has Progressed on an EGFR TKI, $22,926/patient enrolled 2014-2020 Co-I: AstraZeneca Pharmaceuticals, A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of Rifampicin (a CYP3A4 Inducer) on the Pharmacokinetics of AZD9291 in Patients with EGFRm Positive NSCLC whose disease has Progressed on an EGFR TKI, $19,750/patient enrolled, 2014-2020 R. Dona d Harvey, III September 1, 2019 19 Co-I: AstraZeneca Pharmaceuticals, A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Simvastatin (a Sensitive CYP3A4 Substrate) in Patients with EGFRm Positive NSCLC whose disease has Progressed on an EGFR TKI, $19,187/patient enrolled 2014-2020 Co-I: Arqule, A Phase I Dose Escalation Study of ARQ 087 in Adult Subjects with Advanced Solid Tumors, $15,853/patient enrolled, 2015-2021 Co-I: Pfizer Pharmaceuticals, A Phase I Dose Escalation Study Evaluating the Safety and Tolerability of PF-06650808 in Patients with Advanced Solid Tumors, $19,756/patient enrolled 2015-2021 Co-I: Syndax Pharmaceuticals, A Phase 1b/2 Open-label, Dose Escalation Study of Entinostat in Combination with Pembrolizumab in Patients with Non-small Cell Lung Cancer, Melanoma, and Mismatch-Repair Proficient Colorectal Cancer, $14,442/patient enrolled 2015-2021 Co-I: Boston Biomedical, Inc. A Phase Ib/II Clinical Study of BBI608 Administered in Combination with Immune Checkpoint Inhibitors to Adult Patients with Advanced Cancers, $14,713/patient enrolled, 2015-2021 Co-I: BMS, Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab and Nivolumab plus Ipilimumab in Subjects with Virus-Positive and Virus-Negative Solid Tumors, $24,082/patient enrolled, 2015-2021 Co-I: Ignyta, STARTRK-2: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements, $9080/patient enrolled, 20152021 Co-I: Eli Lilly, Phase 1 Study of IMC-CS4, a Monoclonal Antibody Targeted to the CSF_1 Receptor (CSF-1R), in Subjects with Advanced Solid Tumors Refractory to Standard Therapy or for which No Standard Therapy is Available, $33,103/patient enrolled, 2016-2022 Co-I: Regeneron, A First-in-Human Study of Repeat Dosing with REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death 1 (PD-1), as Single Therapy and in Combination with Other Anticancer Therapies in Patients with Advanced Malignancies, $36,485/patient enrolled, 2016-2022 Co-I: Five Prime Therapeutics, A Phase 1a/1b Study of Cabiralizumab in Combination with Nivolumab in Patients with Selected Advanced Cancers, $37,508/patient enrolled, 2016-2022 Co-I: Vertex Pharmaceuticals, An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970 in Combination with Cytotoxic Chemotherapy in Subjects with Advanced Solid Tumors, $2,045,412.24, 2016-2022 Co-I: Pfizer, A Phase 1 Study of PF-05082566 as a Single Agent in Patients with Advanced Cancer, and in Combination with Rituximab in Patients with Non-Hodgkin’s Lymphoma, $2,035,815.02, 2016-2022 Co-I: BMS, A Phase 1/2a Study of BMS-986205 in Combination with Nivolumab and in Combination with both Nivolumab and Ipilimumab in Advanced Malignant Tumors, $34,185/patient enrolled, 2016-2022 Co-I: Corvus Pharmaceuticals, A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, DoseSelection Study of CPI-444 as Single Agent and in Combination with Atezolizumab in Patients with Selected Incurable Cancers, $29,608/patient enrolled, 2016-2022 R. Dona d Harvey, III September 1, 2019 20 Co-I: Eli Lilly, A Phase 1/1b Trial Investigating the CSF-1R Inhibitor LY3022855 in Combination with Durvalumab (MEDI4736) or Tremelimumab in Patients with Advanced Solid Tumors, $46,596/patient enrolled, 2016-2022 Co-I: Nektar Therapeutics, A Phase 1/2 Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-214 and Nivolumab in Patients with Select Locally Advanced or Metastatic Solid Tumor Malignancies, $35,624/patient enrolled, 2016-2018 Co-I: Abbvie (Stemcentrx), An Open-Label Study of Rovalpituzumab Tesirine in Subjects with Delta-Like Protein 3-Expressing Advanced Solid Tumors, $2,017,000, 2016-2022 Co-I: Amgen, A Phase 1b/2 Study Assessing Safety and Anti-Tumor Activity of AMG820 in Combination with Pembrolizumab in Select Advanced Solid Tumors, $39,897/patient enrolled, 2016-2022. Co-I: BMS, A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of anti-GITR Monoclonal Antibody (BMS-986156) Administered Alone and in Combination with Nivolumab in Advanced Solid Tumors, $42,455/patient enrolled, 2017-2027 c. Previous Support (PI or Co-PI role): i. Federally Funded Co-PI: H. Lee Moffitt Cancer Center and Research Institute (Southeast Phase 2 Consortium), NCI 8063: A Phase I and Pharmacokinetic Single Agent Study of Pazopanib in Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction, $4500/patient enrolled, 2008–2011 ii. Private Foundation PI: PPD Bioanalytical Fluid and Tissue Grant Award of the American College of Clinical Pharmacy (ACCP) Research Institute, Defining the Interaction of Docetaxel and Lonafarnib in Advanced Malignancies, $3000 award plus direct costs of docetaxel sample analysis, 2009 iii. Contracts PI: Onyx Pharmaceuticals, A Phase 1 Study of Oprozomib to Assess Food Effect, Drug-Drug Interaction with Midazolam and Safety and Tolerability in Patients with Advanced Malignancies, $20,535/patient enrolled, 2014 – 2018. Co-PI: ImClone Systems, A Study to Evaluate the Relationship Between Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes in Patients with Advanced Cancer, $142,802, 2010 – 2014. PI: Genzyme Corporation, Phase II Study of Time of Administration of Plerixafor (Mozobil®, AMD3100) in Combination with G-CSF on Safety and CD34+ Cell Mobilization, $214,917, 2010 – 2014. Co-PI: Genzyme Corporation, Evaluation of Plerixafor (Mozobil®, AMD3100) in Combination with Chemotherapy and G-CSF for CD34+ Cell Mobilization, $216,190, 2010 – 2014. Co-PI: Pfizer, A Phase I Study of Axitinib and Temsirolimus in Solid Tumors, $295,925, 2011 – 2012. R. Dona d Harvey, III September 1, 2019 21 Co-PI: H. Lee Moffitt Cancer Center and Research Institute (Southeast Phase 2 Consortium). NCI 8846: Phase I, Pharmacokinetic Study of Belinostat for Solid Tumors and Lymphomas in Patients with Varying Degrees of Hepatic Dysfunction. $46,780, 2011 – 2013. PI: Eisai Incorporated, An Open-Label Phase 1 Study to Assess the Pharmacokinetics and Safety of Eribulin in Subjects With Cancer Who Also Have Impaired Renal Function, $54,700, 2012-2016. PI: Novartis Pharmaceuticals, Phase II Evaluation of Real-Time, Pharmacokinetically Guided Everolimus in Patients with Hormone Receptor Positive Breast Cancer, Pancreatic Neuroendocrine Tumors (PNET), and Renal Cell Carcinoma”, $201,202. 2014 – 2016. PI: Millennium Pharmaceuticals, A Phase 1B, Open-Label, Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Patients with Solid Tumors, $11,085/patient enrolled, 2013 – 2017. PI: Millennium Pharmaceuticals, A Phase 1 Study to Evaluate the Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Patients With Advanced Solid Tumors, $236,886, 2014 – 2018. Co-PI: Onyx Pharmaceuticals, A Phase I Study of Extended Infusion Carfilzomib on a Weekly Schedule in Patients with Advanced Solid Malignancies.” $479,991. 2014 – 2018. d. Previous Support (Co-Investigator role): i. Federally Funded Co-I: NCI, 2 R56 CA094233-06A1, Vascular Targeted Pan PI-3 Kinase Inhibitor Prodrug, SF 1126, for Glioma Therapy, 2001 – 2009. Co-I: NIH/NCI, R21CA141836, Using Proton MRS to Predict Response of SAHA treatment in Glioblastoma.” 2010 – 2012 PI: N01-CM-62208-16 NCI CTEP Phase II Trial Consortium, $629,300, 2013 – 2016. ii. Contracts Co-I: Cleave Biosciences, A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CB-5083 in Patients with Advanced Solid Tumors, $28,702/patient enrolled, 2014-2018. Co-I: Cleave Biosciences, A Phase 1, Open-Label, Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CB-5083 in Patients with Relapsed/Refractory Multiple Myeloma, $24,853/patient enrolled, 2014-2018. Co-I: Calithera Biosciences, A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839 in Patients with Advanced and/or Treatment-Refractory Hematological Malignancies, $13,480/patient enrolled, 2014-2018. Co-I: Calithera Biosciences, A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839 in Patients with Advanced and/or Treatment-Refractory Solid Tumors, $18,016/patient enrolled, 20142018 R. Dona d Harvey, III September 1, 2019 22 Co-I: BMS Pharmaceuticals, Phase 1 Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-906024 in Subjects with Advanced Solid Tumors, $26,749/patient enrolled 2014-2018 Co-I: Sanofi Pharmaceuticals, A Phase I Dose Escalation Safety and Pharmacokinetic Study of Multiple Intravenous Administrations of Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients with Selected CD38+ Hematological Malignancies, $25,550/patient enrolled, 2014-2019 Co-I: Abbott Laboratories, A Phase I Study Evaluating the Safety and Pharmacokinetics of ABT-348 in Subjects with Advanced Hematologic Malignancies, $316,819, 2010 – 2014. Co-I: Acetylon Pharmaceuticals, A Phase I/II, Open-Label, Multi-Center Study of ACY-1215 Administered Orally As Monotherapy and in Combination with Bortezomib and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma, $11,365/patient enrolled, 2011 – 2015. Co-I: Celgene Corporation, Phase I Study of Everolimus (RAD001) in Combination with Lenalidomide in Patients with Advanced Solid Malignancies Enriched for Renal Cell Carcinoma, $247,136, 2010 – 2016. Co-I: Novartis Pharmaceuticals, A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies, $509,832, 2011 – 2015. Co-I: Aveo Pharmaceuticals, A Phase 1 Open-Label, Multiple Dose, Dose Escalation Study Of Monoclonal Antibody AV-203 Administered In Subjects With Metastatic or Advanced Solid Tumors, $17,062/patient enrolled, 2012 – 2016 Co-I: Onyx Pharmaceuticals, Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of ONX 0912 in Patients with Hematological Malignancies, $15,201/patient enrolled, 2012 – 2016. Co-I: Amgen, An Open-Label, Pharmacokinetic Study of AMG 386 in Advanced Cancer Subjects with Normal and Impaired Renal Function, $11,649/patient enrolled, 2012 – 2016. Co-I: Agensys Pharmaceuticals, A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of AGS-22M6E Given as Monotherapy Followed By Expansion Cohorts in Subjects with Malignant Solid Tumors that Express Nectin-4, $145,619, 2013 – 2016. Co-I: Merck Pharmaceuticals, Phase I Study of Single Agent MK-3475 in Patients with Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma, $746,762, 2013 – 2017. Co-I: Celgene, A Phase I Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics and Safety of Pomalidomide When Given in Combination with Low Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma and Impaired Renal Function, $23,344/patient enrolled, 2014 – 2018. Co-I: Millennium Pharmaceuticals, Phase 1/1b Pharmacokinetics Study of Oral MLN9708 Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients With Normal Renal Function or Severe Renal Impairment, $16,880/patient enrolled, 2014 – 2017. 28. Bibliography: a. Published and Accepted Research Articles (clinical, basic science, other) in Refereed Journals: R. Dona d Harvey, III September 1, 2019 23 1. Baker J, McCune JS, Harvey RD, Bonsignore C, Lindley CM. Granulocyte colony-stimulating factor use in cancer patients. Ann Pharmacother 2000;34:851-857. PMID: 10928394 2. Blatt J, Gold SH, Wiley JM, Monahan PE, Cooper HC, Harvey D. Off-label use of recombinant factor VIIa in patients following bone marrow transplantation. Bone Marrow Transplantation 2001;28:405-407. PMID: 11571515 3. Treish I, Shord S, Valgus J, Harvey D, Nagy J, Stegall J, Lindley C. Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderatelyhigh to highly emetogenic chemotherapy. Support Care Cancer 2003;11:516-521. PMID: 12836088 4. Lindley C, Shea T, McCune J, Shord S, Decker J, Harvey D, Petros WP, Gabriel D, Serody J, Kirby S, Wiley J. Intraindividual variability in busulfan pharmacokinetics in patients undergoing a bone marrow transplant: assessment of a test dose and first dose strategy. Anticancer Drugs. 2004;15:453-9. PMID: 15166618 5. Gabriel DA, Shea TC, Serody JS, Moore DT, Kirby SL, Harvey D, Krasnov C. Cytoprotection by amifostine during autologous stem cell transplantation for advanced refractory hematologic malignancies. Biol Blood Marrow Transplant 2005;11:1022-1030. PMID: 16338625 6. Kelly H, Harvey D, Moll S. A cautionary tale: Fatal outcome of methotrexate therapy given for management of ectopic pregnancy. Obstet Gynecol 2006;107:439-441. PMID: 16449141 7. Coghill J, Comeau T, Shea T, Braddy L, Bandarenko N, Afeni-Annan A, Harvey D. Acute hemolysis in a patient with cytomegalovirus pneumonitis treated with intravenous immunoglobulin (IVIG). Biol Blood Marrow Transplant 2006;12:786-788. PMID: 16785068 8. Harvey RD, Nettles J, Wang B, Sun S-Y, Lonial S. Commentary on Perrone et al.: “Vitamin C: not for breakfast anymore … if you have myeloma”. Leukemia 2009;23:1939-1940. PMID: 19904281 9. Harvey RD, Khuri FR, Kauh JS. Through the looking glass: the evolution of erythropoiesisstimulating agent use. Oncology (Williston Park) 2010;24:269-274. PMID: 20394139 10. Tong WG, Chen R, Plunkett W, Siegel D, Sinha R, Harvey RD, Badros AZ, Popplewell L, Coutre S, Fox JA, Mahadocon K, Chen T, Kegley P, Hoch U, Wierda WG. Phase I and pharmacologic study of SNS-032, a potent and selective Cdk2, 7, and 9 inhibitor, in patients with advanced chronic lymphocytic leukemia and multiple myeloma. J Clin Oncol 2010;28:3015-3022. PMID: 20479412 11. Ramalingam SS, Harvey RD, Saba N, Owonikoko TK, Kauh J, Shin DM, Sun SY, Strychor S, Tighiouart M, Egorin MJ, Fu H, Khuri FR. Phase 1 and pharmacokinetic study of everolimus, a mammalian target of rapamycin inhibitor, in combination with docetaxel for recurrent/refractory nonsmall cell lung cancer. Cancer 2010;116:3903-3909. PMID: 20564143 12. Lonial S, Kaufman J, Tighiouart M, Nooka A, Langston A, Heffner LT, Torre C, McMillan S, Renfroe H, Harvey RD, Lechowicz MJ, Khoury HJ, Flowers C, Waller EK. A phase I/II trial combining high dose melphalan and autologous transplant with bortezomib for multiple myeloma: A dose and schedule finding study. Clin Cancer Res 2010; 16:5079-5086. PMID: 20739431 13. Ramalingam SS, Kummar S, Sarantopoulos J, Shibata S, LoRusso P, Yerk M, Holleran J, Lin Y, Beumer JH, Harvey RD, Ivy SP, Belani CP, Egorin MJ. Phase I study of vorinostat in patients with advanced solid tumors and hepatic dysfunction: a National Cancer Institute Organ Dysfunction Working Group study. J Clin Oncol 2010;28:4507-4512. PMID: 20837947 14. Renfroe H, Arnold M, Vaughn L, Harvey RD, Hamilton E, Lonial S, Khoury HJ, Kaufman JL, Lechowicz MJ, Flowers CR, Waller EK. A randomized clinical trial comparing granulocyte-colonystimulating factor administration sites for mobilization of peripheral blood stem cells for patients with hematologic malignancies undergoing autologous stem cell transplantation. Transfusion. 2011;51:1779-1783. PMID: 21332729 R. Dona d Harvey, III September 1, 2019 24 15. Kempton CL, Meeks SL, Donald Harvey R 3rd, Abshire TC. Evaluation of factor VIII pharmacokinetics and anti-factor VIII antibodies in four boys with haemophilia A and a poor clinical response to factor VIII. Haemophilia. 2011;17:155-6. PMID: 20579112 16. Kauh J, Chanel-Vos C, Escuin D, Fanucchi MP, Harvey RD, Saba N, Shin DM, Gal A, Pan L, Kutner M, Ramalingam SS, Bender L, Marcus A, Giannakakou P, Khuri FR. Farnesyl transferase expression determines clinical response to the docetaxel-lonafarnib combination in patients with advanced malignancies. Cancer 2011;117:4049-4059. PMID: 21365629 17. Thaiparambil JT, Bender L, Ganesh T, Kline E, Patel P, Liu Y, Tighiouart M, Vertino PM, Harvey RD, Garcia A, Marcus AI. Withaferin A inhibits breast cancer invasion and metastasis at subcytotoxic doses by inhibiting vimentin disassembly and serine 56 phosphorylation. Int J Cancer 2011;129:2744-2755. PMID: 21538350 18. Pentz RD, White M, Harvey RD, Farmer ZL, Liu Y, Lewis C, Dashevskaya O, Owonikoko T, Khuri FR. Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials. Cancer 2012;118:4571-4578. PMID: 22294385 19. Pentz RD, Harvey RD, White M, Farmer ZL, Dashevskaya O, Chen Z, Lewis C, Owonikoko TK, Khuri FR. Research biopsies in phase I studies: Views and perspectives of participants and investigators. IRB 2012;34:1-8. PMID: 22512092 20. Bethelmie-Bryan B, Lord K, Holloway S, Safavi F, Shepard M, Rogers S, Harvey RD, Rodger K, Waller EK, El-Rayes B, Arellano M, Khoury HJ. Tools to optimize the functionality of a leukemia clinical trial team. Leuk Lymphoma 2013;54:110-116. PMID: 22762552 21. Wilson N, Surati M, Walker Bf, Kaufman JL, Harvey RD. Bortezomib administration with severe hyperbilirubinemia due to hepatic plasma cell infiltration: A case report. Clin Lymphoma Myeloma Leuk 2013;13:159-161. PMID: 23084405 22. Harvey RD, Owonikoko TK, Lewis CM, Akintayo A, Chen Z, Tighiouart M, Ramalingam SS, Fanucchi M, Nadella P, Rogatko A, Shin DM, El-Rayes B, Khuri FR, Kauh JS. A phase 1 Bayesian dose selection study of bortezomib and sunitinib in patients with refractory solid tumor malignancies. Br J Cancer 2013;108:762-765. PMID: 23322195 23. Ramalingam SS, Owonikoko TK, Behera M, Subramanian J, Saba N, Kono SA, Gal AA, Sica G, Harvey RD, Chen Z, Klass CM, Shin DM, Fu H, Sun SY, Govindan R, Khuri FR. Phase II study of docetaxel in combination with everolimus for second- or third-line therapy of advanced nonsmall-cell lung cancer. J Thorac Oncol 2013;8:369-372. PMID: 23407561 24. Shibata S, Chung V, Synold T, Longmate J, Suttle B, Lenz HJ, Kummar S, Harvey RD, Hamilton A, O’Neil B, Sarantopolous J, El-Khoueiry A, Lorusso P, Rudek M, Dowlati A, Mulkerin D, Ivy SP, Newman E. Phase 1 study of pazopanib in patients with advanced solid tumors and hepatic dysfunction: A National Cancer Institute Organ Dysfunction Working Group Study. Clin Cancer Res. 2013;19:3631-3639. PMID: 23653147 25. Harvey RD, Kaufman JL, Johnson HR, Vaughn L, Nooka A, Sinha R, Khoury HJ, Lechowicz MJ, Langston AA, Lonial S, Waller EK. Temporal changes in plerixafor administration do not impact hematopoietic stem cell mobilization efficacy: Results of a prospective clinical trial. Biol Blood Marrow Transplant. 2013;19:1393-1395. PMID: 23764455 26. Siegel D, Martin T, Nooka A, Harvey RD, Vij R, Niesvizky R, Badros AZ, Jagannath S, McCullough L, Rajangam K, Lonial S. Integrated safety profile of single-agent carfilzomib: experience from 526 patients enrolled in 4 phase 2 clinical studies. Haematologica 2013;98:17531761. PMID: 23935022 27. Koura DT, Horan JT, Langston A, Qayed M, Mehta A, Khoury HJ, Harvey RD, Suessmuth Y, Couture C, Carr J, Grizzle A, Johnson HR, Cheeseman JA, Conger JA, Robertson J, Stempora L, Johnson BE, Garrett A, Kirk AD, Larsen CP, Waller EK, Kean LS. In vivo T cell costimulation blockade with abatacept for acute graft-versus-host disease prevention: A first in disease trial. Biol Blood Marrow Transplant. 2013;19:1638-1649. PMID: 24047754 R. Dona d Harvey, III September 1, 2019 25 28. Barbee MS, Harvey RD, Lonial S, Kaufman JL, Wilson NM, McKibbin T, Hutcherson DA, Surati M, Valla K, Shah KS. Subcutaneous versus intravenous bortezomib: efficiency practice variables and patient preferences. Ann Pharmacother 2013;47:1136-1192. PMID: 24259728 29. Nooka AK, Harvey RD, Langston A, Collins H, Lonial S, Kaufman JL. Optimal dosing of melphalan as high-dose therapy before autologous hematopoietic stem cell transplantation in myeloma patients with solitary kidney: A case series. Clin Lymphoma Myeloma Leuk 2014;14:e59-63. PMID: 24378319 30. Barbee MS, Owonikoko TK, Harvey RD. Taxanes: Vesicants, irritants, or just irritating? Ther Adv Med Oncol 2014;6:16-20. PMID: 24381657 31. Gu Y, Kaufman JL, Bernal L, Torre C, Matulis SM, Harvey RD, Chen J, Sun SY, Boise LH, Lonial S. MLN4924, an investigational NAE inhibitor, suppresses AKT and mTOR signaling pathway through up regulating REDD1 in human myeloma cells. Blood 2014;22:3269-3276. PMID: 24713927 32. Tran DQ, Harvey RD, Meeks SL, Chapman R, Kempton CL. Use of factor VIII after inhibitor clearance in patients with moderate hemophilia: A case series. Haemophilia 2014;20:e344-346. PMID: 24750497 33. Richardson PG, Baz R, Wang M, Jakubowiak AJ, Laubach JP, Harvey RD, Talpaz M, Berg D, Liu G, Yu J, Gupta N, Di Bacco A, Hui AM, Lonial S. Phase 1 study of twice-weekly dosing of investigational oral proteasome inhibitor ixazomib in patients with relapsed and/or refractory multiple myeloma. Blood 2014;14:1038-1046. PMID 24920586 34. Raje N, Faiman B, Harvey RD, Kurtin SE, Lonial S, Kumar SK, Cohen AD, Conde MA, Giralt SA, Recine MS, Tombler ER, Stadtmauer E, Jagannath S, Anderson KC. Identifying professional education gaps and barriers in multiple myeloma patient care: Findings of the Managing Myeloma continuing educational initiative advisory committee. Clin Lymphoma Myeloma Leuk 2014;14:356369. . PMID: 25066040 35. Saba NF, Hurwitz SJ, Magliocca K, Kim S, Owonikoko TK, Harvey D, Ramalingam SS, Chen Z, Rogerio J, Mendel J, Kono SA, Lewis C, Chen AY, Higgins K, El-Deiry M, Wadsworth T, Beitler JJ, Shin DM, Sun SY, Khuri FR. Phase 1 and pharmacokinetic study of everolimus in combination with cetuximab and carboplatin for recurrent/metastatic squamous cell carcinoma of the head and neck. Cancer 2014;120:3940-3951. PMID: 25103371 36. Goldstein DA, Chen Q, Ayer T, Howard DH, Lipscomb J, Harvey RD, El-Rayes BF, Flowers CR. Cost effectiveness analysis of pharmacokinetically-guided 5-fluorouracil in FOLFOX chemotherapy for metastatic colorectal cancer. Clin Colorectal Cancer 2014;13:219-225. PMID: 25306485 37. Soliman HH, Jackson E, Neuger T, Dees EC, Harvey RD, Han H, Ismail-Khan R, Minton S, Vahanian NN, Link C, Sullivan DM, Antonia S. A first in man trial of the oral immunomodulator, indoximod, combined with docetaxel in patients with metastatic solid tumors. Oncotarget 2014;5:8136-8146. PMID: 25327557 38. Singh K, Stempora L, Harvey RD, Kirk AD, Larsen CP, Blazar BR, Kean LS. Superiority of rapamycin over tacrolimus in preserving nonhuman primate Treg half-life and phenotype after adoptive transfer. Am J Transplant 2014;14:2691-2693. PMID: 25359003 39. Barbee MS, Nooka A, Kaufman JL, Kim S, Chen Z, Heffner LT Jr, Lonial S, Harvey RD. Predictors of survival outcomes in phase 1 relapsed or refractory multiple myeloma patients. Cancer 2014 Nov 6. doi: 10.1002/cncr.29136. [Epub ahead of print]. PMID: 25377852. 40. Pentz RD, Hendershot KA, Wall L, White TE, Peterson SK, Thomas CB, McCormick J, Green MJ, Lewis C, Farmer ZL, Hlubocky FJ, Dossul T, Dixon MD, Liu Y, Switchenko JM, Salvador C, R. Dona d Harvey, III September 1, 2019 26 Owonikoko TK, Harvey RD, Khuri FR. Development and testing of a tool to assess patient preferences for phase I clinical trial participation. Psychooncology 2014 Dec 19. doi: 10.1002/pon.3731. [Epub ahead of print]. PMID: 25530552. 41. McKibbin T, Donald Harvey R, Saba NF. Pre-medications for cetuximab induced infusion reactions – commentary. Oral Oncology 2014 Dec;50(12):e71. doi: 10.1016/j.oraloncology.2014.08.009. PMID: 25223595. 42. Owonikoko TK, Ramalingam SS, Miller DL, Force SD, Sica GL, Mendel J, Chen Z, Rogatko A, Tighiouart M, Harvey RD, Kim S, Saba NF, Pickens A, Behera M, Fu R, Rossi M, Auffermann WF, Torres WE, Bechara R, Deng X, Sun SY, Fu H, Gal AA, Khuri FR. A translational, pharmacokinetic and pharmacodynamic phase IB clinical study of everolimus in resectable nonsmall cell lung cancer. Clin Cancer Res 2015 Feb 11. pii: clincanres.1998.2014. [Epub ahead of print]. PMID: 25673697. 43. Baz R, Lin HM, Hui AM, Harvey RD, Colson K, Gallop K, Swinburn P, Laubach J, Berg D, Richardson P. Development of a conceptual model to illustrate the impact of multiple myeloma and its treatment on health-related quality of life. Support Care Cancer. 2015 Feb 24. [Epub ahead of print]. PMID: 25708126. 44. Harvey RD. Adverse event recognition and management in practice and on clinical trials: Translating the Common Terminology Criteria for Adverse Events (CTCAE) (editorial). Journal of Hematology Oncology Pharmacy. 2015;5:6-7. 45. Jagirdar N, Harvey RD, Nooka A, Flowers C, Kaufman J, Lonial S, Lechowicz MJ, Langston A, Lipscomb C, Gaylor C, Waller EK. Plerixafor in combination with granulocyte-colony-stimulating factor after chemotherapy increases mobilization efficiency in patients with lymphoma or myeloma: results of a Phase II clinical trial. Transfusion 2015. Sep 2. doi: 10.1111/trf.13186. [Epub ahead of print]. PMID: 26331348. 46. Sarantopoulos J, Shapiro GI, Cohen RB, Clark JW, Kauh JS, Weiss GJ, Cleary JM, Mahalingam D, Pickard MD, Faessel H, Berger AJ, Burke K, Mulligan G, Dezube BJ, Harvey RD. Phase I study of the investigational NEDD8-activating enzyme inhibitor pevonedistat (TAK-924/MLN4924) in patients with advanced solid tumors. Clin Cancer Res. 2015 Sep 30. pii: clincanres.1338.2015. [Epub ahead of print]. PMID: 26423795 47. Shah JJ, Jakubowiak AJ, O’Connor OA, Orlowski RZ, Harvey RD, Smith MR, Lebovic D, Diefenbach C, Kelly K, Hua Z, Berger AJ, Mulligan G, Faessel HM, Tirrell S, Dezube BJ, Lonial S. Phase I study of the novel investigational NEDD8-activating enzyme inhibitor pevonedistat (TAK924/MLN4924) in patients with relapsed/refractory multiple myeloma or lymphoma. Clin Cancer Res 2015 Nov 11. [Epub ahead of print]. PMID: 26561559 48. Olszanski AJ, Smith DC, Camacho LH, Thompson J, Ramalingam SS, Harvey RD, Campos L, Ferry D, Tang S, Gao L, Safran H. Electrocardiographic characterization of ramucirumab on the corrected QT interval in a phase II study of patients with advanced solid tumors. Oncologist 2016 Mar 16. pii: theoncologist.2015-0467. [Epub ahead of print]. PMID 26984445. 49. Lawson J, Switchenko JM, McKibbin T, Harvey RD. Impact of isotope dilution mass spectrometry (IDMS) standardization on carboplatin dose and adverse events. Pharmacotherapy 2016 Apr 30. doi: 10.1002/phar.1759. [Epub ahead of print]. PMID 27130286. 50. Harvey RD. Calcium and cancer: Of evil humors and innocent bystanders. J Oncol Pract 2016 May;12(5):433-4. doi: 10.1200/JOP.2016.012385. PMID 27170691. 51. Gupta N, Hanley MJ, Harvey RD, Badros A, Lipe B, Kukreti V, Berdeja J, Yang H, Hui AM, Qian M, Zhang X, Venkatakrishnan K, Chari A. A pharmacokinetics and safety phase 1/1b study of oral ixazomib in patients with multiple myeloma and severe renal impairment or end-stage renal disease requiring haemodialysis. Br J Haematol 2016;174:748-759. PMID 27196567. R. Dona d Harvey, III September 1, 2019 27 52. Mita MM, Nemunaitis J, Grilley-Olson J, El-Rayes B, Bekaii-Saab T, Harvey RD, Marshall J, Zhang X, Strout V. Phase 1 study of CEP-37250/KHK2804, a tumor-specific anti-glycoconjugate monoclonal antibody, in patients with advanced solid tumors. Target Oncol 2016;11:807-814. PMID: 27457707 53. Beardslee TJ, Harvey RD. Precision, accuracy, and resolution – Dose selection of oral anticancer agents. Cancer 2016 Aug 15. doi: 10.1002/cncr.30273. [Epub ahead of print]. PMID: 27526184 54. Wu B, Lewis LD, Harvey RD, Rasmussen E, Gamelin E, Sun YN, Friberg G, Koyner JL, Dowlati A, Maitland ML. A pharmacokinetic and safety study of trebananib, a Fc-fusion peptibody, in patients with advanced solid tumors and varying degrees of renal dysfunction. Clin Pharmacol Ther 2017 Jan 11. doi: 10.1002/cpt.617. [Epub ahead of print]. PMID: 28074547 55. Gupta N, Diderichsen PM, Hanley MJ, Berg D, van de Velde H, Harvey RD, Venkatakrishnan K. Population pharmacokinetic analysis of ixazomib, an oral proteasome inhibitor, including data from the phase III TOURMALINE-MM1 study to inform labeling. Clin Pharmacokinet 2017 Mar 13. doi: 10.1007/s40262-017-0526-4. [Epub ahead of print] PMID: 28290121 56. Papadopoulos KP, El-Rayes BF, Tolcher AW, Patnaik A, Rasco DW, Harvey RD, LoRusso PM, Sachdev JC. Abbadessa G, Savage RE, Hall T, Schwartz B, Wang Y, Kazakin J, Shaib WL. A Phase 1 study of ARQ 087, an oral pan-FGFR inhibitor in patients with advanced solid tumours. Br J Cancer 2017 Oct 3. doi: 10.1038/bjc.2017.330. [Epub ahead of print] PMID: 28972963. 57. Lichtman SM, Harvey RD, Damiette Smit MA, Rahman A, Thompson MA, Roach N, Schenkel C, Bruinooge SS, Cortazar P, Walker D, Fehrenbacher L. Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, Prior or Concurrent Malignancy, and Comorbidities Working Group. J Clin Oncol 2017 Oct 2:JCO2017744102. doi: 10.1200/JCO.2017.74.4102. [Epub ahead of print] PMID: 28968172. 58. Vishwanathan K, Dickinson PA, So K, Thomas K, Chen YM, De Castro Carpeño J, Dingemans AC, Kim HR, Kim JH, Krebs MG, Yang JC, Bui K, Weilert D, Harvey RD. The effect of itraconazole and rifampicin on the pharmacokinetics of osimertinib. Br J Clin Pharmacol 2018 Jan 30 doi: 10.1111/bcp.13534. [Epub ahead of print] PMID: 29381826 59. Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Harvey RD*, Schilsky RL* (co-senior authors). American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol 2018 Feb 14 JCO2017774893. doi: 10.1200/JCO.2017.77.4893.[Epub ahead of print] PMID: 29443651. 60. Szmulewitz RZ, Peer CJ, Ibraheem A, Martinez E, Kozloff MF, Carthon B, Harvey RD, Fishkin P, Yong WP, Chiong E, Nabhan C, Karrison T, Figg WD, Stadler WM, Ratain MJ. Prospective international randomized phase II study of low-dose abiraterone with food versus standard dose abiraterone in castration-resistant prostate cancer. J Clin Oncol 2018 Mar 28: JCO2017764381. doi: 10.1200/JCO.2017.76.4381. [Epub ahead of print] PMID 29590007 61. Lockhart AC, Bauer TM, Aggarwal C, Lee CB, Harvey RD, Cohen RB, Sedarati F, Nip TK, Faessel H, Dash AB, Dezube BJ, Faller DV, Dowlati A. Phase Ib study of pevonedistat, a NEDD8-activating enzyme inhibitor, in combination with docetaxel, carboplatin and paclitaxel, or gemcitabine, in patients with advanced solid tumors. Invest New Drugs. 2018 May 21. doi: 10.1007/s10637-018-0610-0. [Epub ahead of print] PMID: 29781056 62. Owonikoko TK, Busari AK, Kim S, Chen Z, Akintayo A, Lewis C, Carthon BC, Alese OB, El-Rayes BF, Ramalingam SS, Harvey RD. Race-, age-, and gender-based characteristics and toxicities of targeted therapies on phase I trials. Oncology 2018 Jun 18:1-9. doi: 10.1159/000488763. [Epub ahead of print] PMID: 29913438 R. Dona d Harvey, III September 1, 2019 28 63. Harvey RD, Aransay NR, Isambert N, Lee JS, Arkenau T, Vansteenkiste J, Dickinson PA, Bui K, Weilert D, So K, Thomas K, VIshwanathan K, Effect of multiple-dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin. Br J Clin Pharmacol 2018; Sep 1. doi: 10.1111/bcp.13753. [Epub ahead of print] PMID: 30171779 64. Nass SJ, Rothenberg ML, Pentz R, Hricak H, Abernethy A, Anderson K, Gee AW, Harvey RD, Piantadosi S, Bertagnolli M, Schrag D, Schilsky RL. Accelerating anticancer drug development: Opportunities and tradeoffs. Nat Rev Clin Oncol 2018 Oct 1. doi: 10.1038/s41571-018-0102-3. [Epub ahead of print]. PMID: 30275514 65. Chehab S, Zhang C, Panjic EH, Chen Z, Kaufman JL, Lonial S, Nooka A, Harvey RD. Response to therapeutic monoclonal antibodies for multiple myeloma in African Americans versus whites. Cancer 2018 Oct 10 doi: 10.1002/cncr.31746. [Epub ahead of print]. PMID: 30303526 66. Bilen MA, Martini DJ, Liu Y, Lewis C, Collins HH, Shabto JM, Akce M, Kissick HT, Carthon BC, Shaib WL, Alese OB, Pillai RN, Steuer CE, Wu CS, Lawson DH, Kudchadkar RR, El-Rayes BF, Master VA, Ramalingam SS, Owonikoko TK, Harvey RD. The prognostic and predictive impact of inflammatory biomarkers in patients who have advanced-stage cancer treated with immunotherapy. Cancer 2018 Oct 17. doi: 10.1002/cncr.31778. [Epub ahead of print] PMID: 30329148 67. Ou Y, Xu Y, Gore L, Harvey RD, Mita A, Papadopoulos KP, Wang Z, Cutler RE Jr, Pinchasik DE, Tsimberidou AM. Physiologically-based pharmacokinetic modeling to predict oprozomib CYP3A drug-drug interaction potential in patients with advanced malignancies. Br J Clin Pharmacol 2018 Nov 14. doi: 10.1111/bcp.13817. [Epub ahead of print] PMID: 30428505 68. Kaufman JL. Mina R. Jakubowiak TL, Wolf JJ, Lewis C, Gleason C, Sharp C, Martin T, Heffner LT, Nooka AK, Harvey RD, Lonial S. Combining carfilzomib and panobinostat to treat relapsed/refractory multiple myeloma: results of a Multiple Myeloma Research Consortium Phase I Study. Blood Cancer J 2019 Jan 4;9(1):3. doi: 10.1038/s41408-018-0154-8. PMID: 30610196 69. Cook JW, McGrath MK, Dixon MD, Switchenko JM, Harvey RD*, Pentz RD* (co-senior authors). Academic oncology clinicians’ understanding of biosimilars and information needed before prescribing. Ther Adv Med Oncol 2019 Jan 6;11:1758835918818335. doi: 10.1177/1758835918818335. eCollection 2019. PMID: 30671144. 70. Saba N, Force S, Staley C, Fernandez F, Willingham F, Pickens A, Cardona K, Chen Z, Goff L, Cardin D, Lambright E, Nesbitt J, Krasinskas A, Higgins K, Harvey RD, Owonikoko T, Ramalingam SS, Shin DM, Beitler JJ, El-Rayes BF, Salaria S, El-Rifai W, Landry J, Chakravarthy AB. Phase IB study of induction chemotherapy with XELOX, followed by radiation therapy, carboplatin, and everolimus in patients with locally advanced esophageal cancer. Am J Clin Oncol 2019 Feb 15. doi: 10.1097/COC.0000000000000524. [Epub ahead of print]. PMID: 30789414. 71. Faessel H, Nemunaitis J, Bauer TM, Lockhart AC, Faller DV, Sedarati F, Zhou X, Venkatakrishnan K, Harvey RD. Effect of CYP3A inhibitors on the pharmacokinetics of pevonedistat in patients with advanced solid tumours. Br J Clin Pharmacol 2019 Mar 7. doi: 10.1111/bcp.13915.[Epub ahead of print]. PMID: 30845347. 72. Grande E, Harvey RD, You B, Feliu Battle J, Galbraith H, Sarantopolous J, Ramalingam SS, Mann H, So K, Johnson M, Vishwanathan K. Pharmacokinetic study of osimertinib in cancer patients with mild or moderate hepatic impairment. J Pharmacol Exp Ther 2019 Mar 14. pii: jpet.118.255919. doi: 10.1124/jpet.118.255919. [Epub ahead of print]. PMID: 30872388. R. Dona d Harvey, III September 1, 2019 29 73. Harvey RD, Zhang C, Lonial S, Kaufman JL, Chen Z. Reply to African American patients may or may not have poorer response rates after monoclonal antibody treatment: Overreliance on P values in underpowered studies. Cancer 2019 Mar 28. doi: 10.1002/cncr.32080. [Epub ahead of print]. PMID: 30919409. 74. Shteamer JW, Harvey RD, Spektor B, Curseen K, Egan K, Chen Z, Gillespie TW, Sniecinski RM, Singh V. Safety of intranasal ketamine for reducing uncontrolled cancer-related pain: Protocol of a phase I/II clinical trial. JMIR Res Proto 2019 Apr 30; Apr 30;8(4):e12125. doi: 10.2196/12125. PMID: 31038469. 75. Mimche SM, Lee CM, Liu KH, Mimche PN, Harvey RD, Murphy TJ, Nyagode BA, Jones DP, Lamb TJ, Morgan ET. A non-lethal malarial infection results in reduced drug metabolizing enzyme expression and drug clearance in mice. Malar J. 2019 Jul 12;18(1):234. doi: 10.1186/s12936-0192860-5. PubMed PMID: 31299982; PubMed Central PMCID: PMC6624958. 76. Bilen MA, Shabto JM, Martini DJ, Liu Y, Lewis C, Collins H, Akce M, Kissick H, Carthon BC, Shaib WL, Alese OB, Steuer CE, Wu C, Lawson DH, Kudchadkar R, Master VA, El-Rayes B, Ramalingam SS, Owonikoko TK, Harvey RD. Sites of metastasis and association with clinical outcome in advanced stage cancer patients treated with immunotherapy. BMC Cancer. 2019 Aug 29;19(1):857. doi: 10.1186/s12885-019-6073-7. PubMed PMID: 31464611; PubMed Central PMCID: PMC6716879. 77. Vishwanathan K, Cantarini M, So K, Masson E, Fetterolf J, Ramalingam SS, Donald Harvey R. Impact of Disease and Treatment Response in Drug-Drug Interaction Studies: Osimertinib and Simvastatin in Advanced Non-Small Cell Lung Cancer. Clin Transl Sci. 2019 Sep 9;. doi: 10.1111/cts.12688. [Epub ahead of print] PubMed PMID: 31498564. b. Review Articles: 1. Harvey RD, Lindley C. Serotonin antagonists: an update. Cancer Pract. 1998;6:133-135. PMID: 9573914 2. Ewend MG, Carey LA, Morris DE, Harvey RD, Hensing TA. Brain metastases. Curr Treat Options Oncol 2001;2:537-547. PMID: 12057099 3. Harvey RD 3rd. Intravenous immunoglobulin therapy: the process, the product, the patient, and the pocketbook. Introduction. Pharmacotherapy 2005;25:71S-72S. PMID: 16229676 4. Harvey RD 3rd. The patient: emerging clinical applications of intravenous immunoglobulin. Pharmacotherapy 2005;25:85S-93S. PMID: 16229679 5. Kempton CL, Harvey RD 3rd, Roberts HR. Novel therapeutic agents in the management of hemorrhage and thrombosis. Cardiovasc Hematol Agents Med Chem 2006;4:319-334. PMID: 17073609 6. Harvey RD, Lonial S. PI3 Kinase/Akt pathway as a therapeutic target in multiple myeloma. Future Oncol 2007;3:639-647. PMID: 18041916 7. Adams VR, Harvey RD. Histological and genetic markers for non-small-cell lung cancer: customizing treatment based on individual tumor biology. Am J Health-Syst Pharm 2010;67:(1 Suppl 1): S3-9. PMID: 20044377 8. Harvey RD, Fausel CA. Iron overload in myelodysplastic syndromes. Introduction. Am J Health-Syst Pharm 2010;67:(7 Suppl 2):S2. PMID: 20332502 R. Dona d Harvey, III September 1, 2019 30 9. Harvey RD. Myelodysplastic syndromes and the role of iron overload. Am J Health-Syst Pharm 2010;67:(7 Suppl 2):S3-9. PMID: 20332503 10. Harvey RD. Immunologic and Clinical Effects of Targeting PD-1 in Lung Cancer. Clin Pharmacol Ther 2014;96:214-223. PMID: 24690569 11. Harvey RD. Incidence and Management of Adverse Events in Patients with Relapsed and/or Refractory Multiple Myeloma Receiving Single-agent Carfilzomib. Clin Pharmacol 2014;8:87-96. PMID: 24855395 12. Harvey RD, Morgan ET. Cancer, inflammation, and therapy: Effects on cytochrome P450mediated drug metabolism and implications for novel immunotherapeutic agents. Clin Pharmacol Ther 2014;96:449-457. PMID: 24987833 13. Richardson PG, Harvey RD, Laubach JP, Moreau P, Lonial S, San-Miguel JF. Panobinostat for the treatment of relapsed or relapsed/refractory multiple myeloma: Pharmacology and clinical outcomes. Expert Rev Clin Pharmacol 2015 Oct 26:1-14. [Epub ahead of print]. PMID: 26503877 14. Howard SC, McCormick J, Pui CH, Buddington RK, Harvey RD. Preventing and managing toxicities of high-dose methotrexate. Oncologist 2016;21:1471-1482 PMID: 27496039 15. Harvey RD. Science of biosimilars. J Oncol Pract 2017; Sep;13(9_suppl):17s-23s. doi: 10.1200/JOP.2017.026062. PMID: 28898589 16. Singh V, Gillespie TW, Harvey RD. Intranasal ketamine and its potential role in cancer-related pain. Pharmacotherapy 2018; Feb 3. doi: 10.1002/phar.2090. [Epub ahead of print]. PMID: 29396996 17. Lyman GH, Zon R, Harvey RD, Schilsky RL. Rationale, opportunities, and reality of biosimilar medications. N Engl J Med 2018 May 24;378(21):2036-2044. doi: 10.1056/NEJMhle1800125. PMID: 29791832 18. Moore DC, Arnall JR, Harvey RD. Incidence and management of adverse events associated with panobinostat in the treatment of relapsed/refractory multiple myeloma. J Oncol Pharm Pract 2018 Jul 31:1078155218788706. doi: 10.1177/1078155218788706. [Epub ahead of print]. PMID: 30060709 19. Gupta N, Hanley MJ, Xia C, Labotka R, Harvey RD, Venkatakrishnan K. Clinical pharmacology of ixazomib: The first oral proteasome inhibitor. Clin Pharmacokinet 2018 Aug 17. doi: 10.1007/s40262-018-0702-1. [Epub ahead of print] Review. PMID: 30117017 c. Book Chapters: 1. Harvey RD. Chronic Myelogenous Leukemia. In Schwinghammer TL, ed. Pharmacotherapy Casebook: A Patient-Focused Approach, 5th ed. Stamford, Connecticut: Appleton and Lange, 2002:374-377. 2. Harvey RD. Sickle Cell Anemia. In Schwinghammer TL, ed. Pharmacotherapy Casebook: A Patient-Focused Approach. 5th ed. Stamford, Connecticut: Appleton and Lange, 2002:282284. 3. Harvey RD, Valgus JM. Hematologic Malignancies. In Koda-Kimble, et al., eds. Applied Therapeutics: The Clinical Use of Drugs. 8th ed. Philadelphia: Lippincott, Williams, and Wilkins, 2004:90-1 – 90-42. R. Dona d Harvey, III September 1, 2019 31 4. Haines ST, Dowling T, Harvey RD. Warfarin. In Burton, et al., eds. Applied Pharmacokinetics and Pharmacodynamics: Principles of Therapeutic Drug Monitoring, 4th ed. Philadelphia: Lippincott, Williams, and Wilkins, 2005:715-751. 5. Harvey RD, Walko CM. Chronic Myelogenous Leukemia. In Schwinghammer TL, ed. Pharmacotherapy Casebook: A Patient-Focused Approach, 6th ed. New York: McGraw-Hill, 2005:382-384. 6. Walko CM, Harvey RD. Sickle Cell Anemia. In Schwinghammer TL, ed. Pharmacotherapy Casebook: A Patient-Focused Approach, 6th ed. New York: McGraw-Hill, 2004:284-287. 7. Harvey RD, Brundage D. Hemophilias and Thrombophilias. In: Schumock G, Brundage D, Richardson M, et al, eds. Pharmacotherapy Self-Assessment Program, 5th ed. Hematology and Oncology. Kansas City, MO: American College of Clinical Pharmacy, 2006: 17-36. 8. Valgus JM, Haas M, Harvey RD. Hematologic Malignancies. In Koda-Kimble, et al., eds. Applied Therapeutics: The Clinical Use of Drugs. 9th ed. Philadelphia: Lippincott, Williams, and Wilkins, 2008: 90-1 – 90-44. 9. Harvey D, Silberman J, Lonial S. The PI3 Kinase/Akt Pathway as a Therapeutic Target in Multiple Myeloma. In: Lonial S, ed. Contemporary Hematology: Myeloma Therapy. 1st ed. Totowa, NJ: Humana Press, 2008:309-322. 10. Harvey RD, Khuri FR. Cytotoxic Chemotherapy. In Ades T, Brawley OW, Gansler T, et al. (Eds.), The American Cancer Society's Principles of Oncology: Prevention to Survivorship. Atlanta, GA: Wiley Blackwell, 2017:220-235. d. Published Abstracts: 1. Choksi NY, Hussain A, Myers AM, Owens CE, Harvey RD, Wyrick SD, Baldessarini RJ, Booth RG. Stimulation of brain cAMP and dopamine synthesis by adenosine A2 and s3 agonists. Society for Neuroscience Abstracts, Volume 20, 1994. 2. Choksi NY, Hussain A, Owens CE, Myers AM, Harvey RD, Baldessarini RJ, Wyrick SD, Booth RG. Adenosine A2 and PAT-s3 agonists affect adenylyl cyclase activity and dopamine synthesis in rat brain (abstract). Presented at the North Carolina Society for Neuroscience Spring Meeting, May 1994. 3. Valgus JM, Lindley C, Harvey RD, Poole ME, Shord SS, Bernard SA. Incidence and duration of oxaliplatin-induced nausea and vomiting. Proc Am Soc Clin Oncol 2001;20 1624a. 4. Escobar M, Harvey RD. Experience with the use of recombinant factor VIIa in a university hospital. Blood 2001; 101: 3902a. 5. Shea TC, Serody J, Gabriel D, Comeau T, Harvey D, Irons R, Morris D. High relapse rate following alemtuzumab use in allogeneic transplants for myeloid hematologic malignancies. Blood 2004; 104: 1826a. 6. Comeau T, Shea T, Gabriel D, Morris D, Irons R, Harvey D, Serody J. BK Viruria in patients undergoing allogeneic hematopoietic stem cell transplantation: Increased incidence in patients receiving alemtuzumab (ALEM) as conditioning therapy and lack of efficacy of cidofovir. Blood 2004; 104: 3160a. 7. Harvey RD, Shea T, Walko C, Krasnov C, Patel L, Serody J, Gabriel D, Comeau T, Lindley C. Intravenous busulfan test dose clearance comparison with first and thirteenth dose systemic exposure in allogeneic bone marrow transplant recipients. J Clin Oncol 2005; 23: 6658a. R. Dona d Harvey, III September 1, 2019 32 8. Walko CM, Lindley CM, Collins J, Krasnov C, Harvey RD, Gabriel DA, Serody J, Comeau T, Shea TC. 90 hour continuous intravenous busulfan infusion: PK and test dose predictability in allogeneic bone marrow transplant patients. J Clin Oncol 2005; 23: 6652a. 9. Lonial S, Francis D, Karanes C, Trudel S, Reece DE, Krishnan A, Buacharern M, Smith R, Zaman F, Gul E, Dollard AM, Harvey D, Kaufman J. A phase I MMRC clinical trial testing the combination of bortezomib and tipifarnib in relapsed/refractory multiple myeloma. Blood 2008; 112: 3706a. 10. Wierda WG, Chen R, Plunkett W, Coutre S, Badros AZ, Popplewell L, Siegel D, Sinha R, Harvey D, Fox J, Mahadocon K, Kegley P, Bolton MG. A phase 1 trial of SNS-032, a potent and specific CDK 2, 7 and 9 inhibitor, in chronic lymphocytic leukemia and multiple myeloma. Blood 2008; 112: 3178a. 11. Yoon Y, Wei L, Zhang Z, Harvey RD, Park JC, Olson JJ, Hu X, Shim H. Using proton MRS to predict responses of SAHA treatment in glioblastoma [abstract]. In: Proceedings of the 100th Annual Meeting of the American Association for Cancer Research; 2009 Apr 18-22; Denver, CO. Philadelphia (PA): AACR; 2009. Abstract nr 3993 12. Pentz RD, Khuri F, Kauh J, Owonikoko T, White MM, Harvey RD. Proportion of subjects with an ethically acceptable reason for enrolling in a phase I trial. J Clin Oncol 2009; 27: 2512a. 13. Kauh JS, Cohen R, Clarke JW, Harvey R, Mulligan G, Venkatakrishnan K, Berger A, Smith PG, Petruzelli L, Sarantopoulos J. Pharmacodynamic effects of MLN4924, a novel NAE inhibitor, on blood and skin. J Clin Oncol 2009; 27: 2562a. 14. Lonial S, Francis D, Karanes C, Trudel S, Dollard A, Harvey D, Kaufman J. A phase I MMRC clinical trial testing the combination of bortezomib and tipifarnib in relapsed/refractory multiple myeloma. J Clin Oncol 2009; 27: 8597a. 15. Khuri FR, Harvey RD, Saba NF, Owonikoko TK, Kauh J, Shin DM, Sun SY, Browning KM, Tighiouart M, Ramalingam SS. Everolimus, an mTOR inhibitor, in combination with docetaxel for recurrent/refractory NSCLC: A phase I study. J Clin Oncol 2009; 27: 8060a. 16. Lonial S, Harvey RD, Francis D, Gul E, Jagannath S, Farag S, Hoth D, Frumento R, Garlich JR, Trudel S. Preliminary results of a phase I study of the pan-PI3 kinase inhibitor SF1126 in patients with relapsed and refractory myeloma. Blood 2009; 114: 3879a. 17. Shah JJ, Jakubowiak AJ, O’Connor OA, Orlowski RZ, Patterson M, Harvey D, Berger AJ, McDonald A, Mulligan G, Petruzzelli L, Pickard MD, Smith PG, Venkatakrishnan K, Lonial S. Phase 1 dose-escalation study of MLN4924, a novel NAE inhibitor, in patients with multiple myeloma and non-Hodgkin lymphoma. Blood 2009; 114: 1854a 18. Jones SF, Cohen RB, Bendell JC, Denlinger CS, Harvey RD, Parasuraman S, Chi X, Scholz C, Wyant T, Kauh J. Safety, tolerability, and pharmacokinetics of TAK-701, a humanized anti-hepatocyte growth factor (HGF) monoclonal antibody, in patients with advanced nonhematologic malignancies: First-in-human phase I dose-escalation study. J Clin Oncol 2010; 28: 3081a. 19. Kauh JS, Harvey RD, Lawson DH, Owonikoko TK, Tighiouart M, Ramalingam SS, Shin DM, Lewis CM, El-Rayes BF, Khuri FR. Combination therapy with sunitinib and bortezomib in adult patients with radioiodine refractory thyroid cancer. J Clin Oncol 2010; 28: 2538a. 20. Harvey RD, Kauh JS, Ramalingam SS, Lewis CM, Chen Z, Lonial S, Blount IC, Shin DM, Khuri FR, Owonikoko TK. Combination therapy with sunitinib and bortezomib in adult patients with radioiodine refractory thyroid cancer. J Clin Oncol 2010; 28: 5589a. R. Dona d Harvey, III September 1, 2019 33 21. Kaufman JL, Shah JJ, Laubach JP, Heffner L, Francis D, Harvey RD, Lewis C, Tighiouart M, Richardson P, Orlowski RZ, Lonial S. Lenalidomide, bortezomib, and dexamethasone (RVD) in combination with vorinostat as front-line therapy for patients with multiple myeloma (MM): Initial results of a phase 1 study. Blood 2010; 116: 3034a. 22. Shah JJ, Harvey RD, O’Connor OA, Jakubowiak AJ, Smith MR, Orlowski RZ, Mulligan G, Smith PG, Pickard MD, Dezube BJ, Lonial S. Phase 1 dose-escalation study of multiple dosing schedules of the investigational drug MLN4924, a nedd-8-activating enzyme inhibitor, in patients with relapsed and/or refractory multiple myeloma or lymphoma. Blood 2010; 116: 2801a. 23. Kauh JS, Shapiro G, Cohen RB, Clark JW, Harvey RD, Cleary JM, Mahalingam D, Kuan S, McDonald A, Berger A, Dezube B, Sarantopoulos J. MLN4924, an investigational NEDD8activating enzyme (NAE) inhibitor, in patients (pts) with advanced solid tumors: Phase I study of multiple treatment schedules. J Clin Oncol 2011; 29: 3013a. 24. Pentz RD, Farmer ZL, Green ML, Daugherty C, Hlubocky FJ, Peterson SK, Sun CC, Lewis CM, Owonikoko TK, Khuri FR, Harvey RD. Assessing patients’ values when standard-ofcare options are exhausted. J Clin Oncol 2011; 29: 9108a. 25. Harvey RD, Lewis CM, Kauh JS, Owonikoko TS, Akintayo A, Karol M, Teofilovici F, Khuri FR, Ramalingam SS. A phase 1 and pharmacokinetic study of ganetespib (STA-9090), a heat shock protein 90 inhibitor, in combination with docetaxel in patients with advanced solid tumor malignancies. ESMO 2011, abstract 1230. 26. Lonial S, Cohen A, Zonder J, Bensinger WI, Kaufman JL, Orlowski RZ, Harvey RD, Alexanian R, Thomas SK, Weber D, Walker D, Hilder B, Ptaszynski A, Shah JJ. The novel KSP inhibitor ARRY-520 demonstrates single-agent activity in refractory myeloma: Results from a phase 2 trial in patients with relapsed/refractory multiple myeloma (MM). Blood 2011; 118: 2935a. 27. Shah JJ, Zonder J, Cohen A, Orlowski RZ, Alexanian R, Thomas SK, Weber D, Kaufman JL, Harvey RD, Walker D, Litwiler K, Karan S, Hilder B, Ptaszynski AM, Lonial S. ARRY-520 shows durable responses in patients with relapsed/refractory multiple myeloma in a phase 1 dose-escalation study. Blood 2011; 118: 1860a. 28. Nooka AJ, Muppidi S, Harvey RD, Kaufman JL, Langston A, Lewis C, Boise LH, Flowers CR, Lonial S. A predictive model of overall survival (OS) for patients with relapsed/refractory multiple myeloma (MM) enrolling in phase I clinical trials. Blood 2011; 118: 3954a. 29. Harvey RD, Lonial S, Renfroe H, Sinha R, Flowers CR, Lechowicz MJ, Khoury HJ, Langston A, Waller EK, Kaufman JL. Temporal changes in plerixafor administration do not impact hematopoietic stem cell mobilization efficacy: Results of a prospective clinical trial. Blood 2011; 118: 2988a. 30. Harvey RD, Jacobus SJ, Rajkumar SV, Greipp PR, Lonial S. Renal function measures improve on lenalidomide and dexamethasone and compete with patient characteristics to predict lenalidomide dose density and hematologic toxicity: An E4A03 analysis. Blood 2011; 118: 1882a. 31. Owonikoko TK, Harvey RD, Kauh JS, Lewis CM, Hossain MS, Akintayo AO, Merriewether AR, Chen Z, Hawk NN, Saba NF, Harris W, Shin DM, El-Rayes BF, Huang C, Lonial S. Lawson DH, Khuri FR, Waller EK, Ramalingam SS. A phase I study of the safety and pharmacodynamic effects of everolimus in combination with lenalidomide in patients with advanced solid malignancies. J Clin Oncol 2012; 30: 2576a. 32. Appleman LJ, Beumer JH, Jiang Y, Puhalla S, Lin Y, Owonikoko TK, Harvey RD, Stoller R, Petro DP, Tawbi HA, Argiris A, Strychor S, Kiesel B, Chu E, Shepherd SP, Giranda VL, Chen R. Dona d Harvey, III September 1, 2019 34 AP, Belani CP, Ramalingam SS. A phase I study of veliparib (ABT-888) in combination with carboplatin and paclitaxel in advanced solid malignancies. J Clin Oncol 2012; 30: 3049a. 33. Shim H, Voloschin AD, Wei L, Hwang SN, Miller AH, Guo Y, Brat D, Holder CA, Read WL, Kopcewicz K, Harvey RD, Barker P, Shu HG, Hu XP, Olson JJ. Using proton MRSI to predict response to vorinostat treatment in recurrent GBM. J Clin Oncol 2012; 30: 3055a. 34. Kauh JS, Harvey RD, Owonikoko TK, El-Rayes BF, Shin DM, Murali S, Lewis CM, Karol MD, Teofilovici F, Du Y, Fu H, Khuri FR, Ramalingam SS. A phase I and pharmacokinetic study of multiple schedules of ganetespib (STA-9090), a heat shock protein 90 inhibitor, in combination with docetaxel for subjects with advanced solid tumor malignancies. J Clin Oncol 2012; 30: 3094a. 35. Shah JJ, Zonder JA, Cohen A, Bensinger W, Kaufman JL, Orlowski RZ, Harvey RD, Abidi MH, Thomas SK, Walker D, Hilder B, Ptaszynski AM, Lonial S. The novel KSP inhibitor ARRY-520 is active both with and without low-dose dexamethasone in patients with multiple myeloma refractory to bortezomib and lenalidomide: Results from a phase 2 study. Blood 2012; 120: 449a. 36. Tiwari D, Horan J, Langston A, Qayed M, Carr J, Renfroe H, Cynthia C, Khoury HJ, Robertson J, Harvey RD, Mehta A, Waller EK, Kean LS. A first-in-disease trial of in vivo costimulation blockade for acute GvHD prevention: The addition of abatacept to standard GvHD prophylaxis controls early CD4+ T cell proliferation and is associated with low rates of severe acute GvHD. Blood 2012; 120: 741a. 37. Kaufman JL, Shah JJ, Laubach JP, Mitchell AR, Sharp C, Lewis C, Harvey RD, Gleason C, Casbourne D, Nooka AK, Heffner LT, Richardson PG, Orlowski RZ, Lonial S. Lenalidomide, bortezomib, and dexamethasone (RVD) in combination with vorinostat as front-line therapy for patients with multiple myeloma (MM): Results of a phase 1 study. Blood 2012; 120: 336a. 38. Kauh JS, Harvey RD, Owonikoko TK, El-Rayes BF, Shin DM, Murali S, Lewis CM, Karol MD, Teofilovici F, Du Y, Fu H, Khuri FR, Ramalingam SS. A phase I and pharmacokinetic study of multiple schedules of ganetespib (STA-9090), a heat shock protein 90 inhibitor, in combination with docetaxel for subjects with advanced solid tumor malignancies. J Clin Oncol 2012; 30: 3094a. 39. Jackson E, Dees EC, Kauh JS, Harvey RD, Neuger A, Lush R, Antonia SJ, Minton SE, Ismail-Kahn R, Han HS, Vahanian NN, Ramsey WJ, Link CJ, Streicher H, Sullivan D, Soliman HH. A phase I study of indoximod in combination with docetaxel in metastatic solid tumors. J Clin Oncol 2013; 31: 3026a. 40. Saba NF, Kono SA, Mendel JR, Hurwitz SJ, Owonikoko TK, Lewis CM, Harvey D, Rogerio JW, Chen Z, Wadsworth T, El-Deiry M, Chen AY, Higgins K, Ramalingam SS, Beitler JJ, Shin DM, Khuri FR. Carboplatin (C), cetuximab (Cet), and everolimus (E) in recurrent or metastatic squamous cell carcinoma of the head and neck (RMSCCHN). Results of a phase Ib study. J Clin Oncol 2013; 31: 6083a. 41. Kaufman J, Zimmerman T, Jakubowiak A, Rosenbaum C, Lewis C, Harvey D, Nooka A, Heffner L, Lonial S. Phase I study of the combination of carfilzomib and panobinostat for patients with relapsed and refractory myeloma: A multicenter MMRC clinical trial. Haematologica 2013; 98: suppl 1: P771. 42. Shah N, Kaufman J, Langston A, Waller E, Harvey R, Lonial S, Nooka A. Eliminating the need for 24-hour urine studies in phase 1 myeloma patients. Haematologica 2013; 98: suppl 1: B1498. 43. Harvey RD, Lewis CM, Pillai R, Lawson D, Ramalingam SS, Morgan ET. Novel Immunotherapeutics and Concurrent CYP Substrate Use in Advanced Cancer. J Oncol Pharm Pract 2014; 20 3(supplement): abstract 19. R. Dona d Harvey, III September 1, 2019 35 44. Sarantopoulos J, Gordon MS, Harvey RD, Sankhala KK, Malik L, Mahalingam D, Owonikoko TK, Lewis CM, Payumo F, Miller J, Powell C, Weng Z, Komarnitsky PK, Ramalingam SS. First-in-human phase 1 dose-escalation study of AV-203, a monoclonal antibody against ERBB3, in patients with metastatic or advanced solid tumors. J Clin Oncol 2014; 11113a. 45. Goldstein DA, Chen Q, Howard DH, Lipscomb J, Ayer T, Harvey D, El-Rayes BF, Flowers C. Cost-effectiveness analysis of pharmacokinetic-guided (PK) 5-fluorouracil (5FU) when combined with leucovorin and oxaliplatin (FOLFOX) chemotherapy for metastatic colorectal cancer (mCRC). J Clin Oncol 2014; 6527a. 46. Kaufman J, Zimmerman T, Rosenbaum CA, Nooka AK, Heffner LT, Harvey RD, Gleason CG, Lewis C, Sharp C, Barron KW, Lonial S. Phase I study of the combination of carfilzomib and panobinostat for patients with relapsed and refractory myeloma: A Multiple Myeloma Research Consortium (MMRC) clinical trial. Blood 2014; 124: 32a. 47. Matous J, Siegel DS, Lonial S, Harvey RD, Kasserra C, Li Y, Chen M, Doerr T, Sternas L, Zaki MH, Jacques C, Shah JJ. MM-008: A phase I trial evaluating pharmacokinetics and tolerability of pomalidomide with low dose dexamethasone in patients with relapsed or refractory and refractory multiple myeloma and renal impairment. Blood 2014;124:4730a. 48. Divino V, Dekoven M, Wang W, Kleinrock M, Harvey RD, Wade RL, Kaura S. The budget impact of orphan drugs in the US: A 2007-2013 MIDAS sales data analysis. Blood 2014;124:736a. 49. Gupta N, Hanley MJ, Harvey RD, Badros AZ, Lipe BC, Kukreti V, Berdeja JG, Yang H, Hui A-M, Zhang X, Venkatakrishnan K, Chari A. Phase 1/1b Pharmacokinetic (PK) and Safety Study of the Investigational Oral Proteasome Inhibitor (PI) Ixazomib in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (Pts) with Severe Renal Impairment or End-Stage Renal Disease (ESRD) Requiring Hemodialysis. Blood 2015; 126: 336a. 50. Harvey RD, Chen YJ, Lethen J, Mahue M. Relationship of carfilzomib dosing and duration of therapy (DOT) in patients with relapsed and refractory multiple myeloma (RRMM). Blood 2015;126:453a 51. Faessel HM, Harvey RD, Lockhart AC, Bauer TM, Wang L, Sedarati F, Santillana S, Nemunaitis JJ. Drug-drug interaction (DDI) study between the investigational NAE inhibitor pevonedistat (TAK-924) and fluconazole or itraconazole in patients with advanced solid tumors. Clin Pharmacol Ther 2016: PII084 52. Harvey RD, Gore L, Wang D, Mita A, Sharma S, Nemunaitis J, Papadopoulos K, Pinchasik D, Ou Y, Demirhan E, Cutler RE, Tsimberidou AM. A phase I study to assess food effect on oprozomib in patients with advanced malignancies. Clin Pharmacol Ther 2016: PII-090 53. Tsimberidou AM, Ou Y, Xu Y, Wang Z, Harvey RD, Mita A, Sharma S, Papadopoulos K, Wang D, Pinchasik D, Demirhan E, Cutler RE, Gore L. A phase I study of oprozomib to assess drug-drug interaction with midazolam patients with advanced malignancies. Clin Pharmacol Ther 2016: PII-096 54. Vishwanathan K, Cantarini M, So K, Masson E, Fetterolf J, Patel H, Morgan E, Ramalingam S, Harvey D. Impact of disease and treatment response in DDI studies: AZD9291 and simvastatin in advanced non-small cell lung cancer (ANSCLC). Clin Pharmacol Ther 2016: LB-003. 55. Bauer TM, Harvey RD, Lee CB, Aggarwal C, Cohen RB, Sedarati F, Teng Z, Faessel HM, Dash A, Dezube BJ, Santillana S, Dowlati A, Lockhart AC. Investigational NEDD8-activating enzyme inhibitor pevonedistat (Pev) plus chemotherapy in patients (Pts) with solid tumors (Phase 1b study): Antitumor activity of pev plus carboplatin (Carbo)/Paclitaxel (Pac). J Clin Oncol 34, 2016 (suppl; abstr 2580) R. Dona d Harvey, III September 1, 2019 36 56. Lassen UN, Ramalingam SS, Lopez JS, Harvey RD, Ameratunga M, de Hoon J, Losic N, Lisby S, Forssmann U, Vergote I. GCT1021-01, a first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (HuMax-Axl-ADC) in patients with solid tumors (NCT02988817). J Clin Oncol 35, 2017 (suppl; abstr TPS2605) 57. Bazhenova L, Gold PJ, Harvey RD, Spira AI, Nemunaitis J, Baranda JC, Gadgeel S. A Phase 1b study of PEGPH20 plus pembrolizumab in patients with selected hyaluronan-high solid tumors [abstract]. Cancer Res 2017;77(13 Suppl):Abstract nr CT032. doi:10.1158/15387445. AM2017-CT032 58. Dowlati A, Rugo HS, Harvey RD, Kudchadkar RR, Carvajal RD, Manji GA, Hamid O, Klempner SJ, Tang S, Yu D, Kauh JS, Schaer DA, Tate SC, Wesolowski R. A phase I study of LY3022855, a colony-stimulating factor-1 receptor (CSF-1R) inhibitor, in patients (pts) with advanced solid tumors. J Clin Oncol 35, 2017 (suppl; abstr 2523) 59. Gordon MS, Shapiro G, Sarantopoulos J, Juric D, Lu B, Chen P, Connarn J, Le Bruchec Y, Harvey RD. A phase 1b study of the safety, pharmacokinetics, and preliminary antitumor activity of citarinostat (ACY-241) in combination with paclitaxel (Pac) in patients (pts) with advanced solid tumors (AST). J Clin Oncol 36, 2018 (suppl; abstr 2547) 60. Harvey RD, Kaufman JL, Heffner LT, Hofmeister CC, Dhodapkar MV, Lonial S, Nooka AK. Impact of obesity on response in 751 myeloma patients receiving lenalidomide, bortezomib, and dexamethasone (RVd) induction. J Clin Oncol 36, 2018 (suppl; abstr 80456) 61. Martini DJ, Liu Y, Lewis C, Collins H, Akce M, Kissick H, Carthon BC, Shaib WL, Alese OB, Pillai R, Steuer CE, Wu C, Lawson DH, Kudchadkar R, El-Rayes B, Master VA, Ramalingam S, Owonikoko TK, Harvey RD, Bilen MA. Blood based biomarkers and association with clinical outcome (CO) in advanced stage patients (pts) treated with immunotherapy (IO) [abstract]. Cancer Res 2018;78(13 Suppl):Abstract nr 2607. R. Dona d Harvey, III September 1, 2019 37 Jeffery Neal Seymour WORK EXPERIENCE 2015-Present 2004-Present Director of History & Collections, The National Civil War Naval Museum Adjunct Professor, Columbus State University Duties include teaching United States History, Colonial to 1865 and 1865 to Present 2005-2015 Curator/Archivist/Historian, Port Columbus National Civil War Naval Museum Duties include, but not limited to, maintaining and cataloging the collections of the museum, archives, and library. I also routinely provide tours and a variety of programming for a wide variety of groups and educational levels. 2002-2007 Adjunct Professor, Chattahoochee Valley Community College 2014-2016 Duties included teaching classes in Early and Modern World History and United States History, Colonial to 1865 and 1865 to Present. 2007-2019 Reader for Advanced Placement U.S. History Exam, Educational Testing Services. Promoted to Table Leader in 2014. Promoted to Assistant Question Leader in 2018, which serves on the team that sets the grading rubric. 2008-2010 Online Adjunct Professor, American Military University Duties include teaching classes on the American Civil War and the American Revolution. 2004 Archivist, Montgomery County Historical Society Duties included acquiring, accessioning, preserving, and arranging material according to the needs of the society. The cataloguing was done on PastPerfect software. 2004-2008 Visitor Services, Port Columbus National Civil War Naval Museum Duties include maintaining the ticket booth, gift shop, and preparing financial reports. Summer 2003 Archival Internship at the Tuskegee University National Center of Bioethics Archives and Museums Duties included accessioning, arranging and preserving material according to the needs of Tuskegee University. 2002-2003 Instructor, Freshman Experience, Auburn University Duties included teaching study skills at the collegiate level. 2001-2004 Tour Guide & Living Historian, Port Columbus National Civil War Naval Museum 2001-2003 Adjunct Professor, Southern Union State Community College Duties included teaching Early and Modern Western Civilization classes. 2001 Substitute Teacher, Troup County, Georgia Schools. EDUCATION 2015 2006 2000 1998 M.A. Certificate, Archival Studies, Auburn University ABD Status, PhD Program, History Auburn University M.A., History Jacksonville State University Master’s Thesis: William C. Oates: Quintessential Bourbon Democrat or Unreconstructed Confederate B.A., History Jacksonville State University Graduated with honors STUDENT ACHIEVEMENTS Graduate: Graduate Assistant, Margaret Cole Award, named outstanding Graduate Assistant of the Year, Jacksonville State University, 2001. Undergraduate: Phi Alpha Theta History Honor Society, President; History Club, various offices held; Pinnacle Honor Society; Omicron Delta Kappa Honor Society; Model Arab League, Head Delegate; Phi Mu Alpha Professional Music Fraternity, various offices held; University Marching Band, section leader; Scholarship Pep Band member; various other music organizations. PROFESSIONAL ORGANIZATIONS Organization of American Historians Southern Historical Society Society of Civil War Historians Society for Military History Georgia Historical Society Phi Alpha Theta Society of Georgia Archivists Georgia Association of Museums and Galleries Association of Registrars and Collections Specialists PANELS AND PAPERS Georgia Association of Museums and Galleries, January 2019, Panel Chair Difficult History National Civil War Naval Museum Symposium, July 2016, Organizer and Moderator Wrecks, Recovery, and Conservation Tampa Civil War Round Table, February 2016 Yes, Virginia, There was a Confederate Navy Pensacola Civil War Round Table, Spring 2015 Confederate Ironclads Georgia Tech Technology and the American Civil War, April 2014 Panel on Curating Civil War Technology Society of Civil War Surgeons National Convention, March 2012 Presentation: The Autopsy of John Wilkes Booth Keynote Address: Civil War Naval Medicine: The Steam Engine Component Ashantilly Center in Cooperation with the Georgia Humanities Council’s Civil War Sesquicentennial Observation, February 2012 John McIntosh Kell: The “Luff” National Infantry Museum Civil War Sesquicentennial Symposium, April 2011 William C. Oates as a Non-West Point Trained Officer Northwest Louisiana Civil War Round Table, October 2010 The Navies During the Civil War Low Country Civil War Round Table, May 2009 Raphael Semmes Georgia Association of Historians Annual Meeting, February 2009 The Mysterious Case of the Dahlonega Diving Bell National Civil War Naval Museum Annual Symposium, November 2006 What Did You Know and When Did You Know It? The Story of the ORNs Georgia Association of Historians, April 2005 Panel Chair for On Georgia Waters: Some Influences on the War of 18611865 on Coastal Georgia Phi Alpha Theta Alabama State Convention, April 2003 Southern Capitalism: Lloyd G. Bowers and the Importing and Exporting Company of Georgia Alabama Historical Association, April 2000 William C. Oates: Politics During the Agrarian Revolt Phi Alpha Theta National Convention, December 1999 William C. Oates: Quintessential Bourbon Democrat or Unreconstructed Rebel? Southern Writers, Southern Writing, July 1999 The South and the Election of 1876 Various public presentations for a variety of organizations and other public venues, which include public schools, professional, and other organizations, such as historical societies. PUBLICATIONS Articles: Civil War Navy National Civil War Naval Museum: A National Treasure (Fall 2017) Port City Ram Regular contributor to the quarterly newsletter of the NCWNM. Book Reviews: History: Reviews of New Books Review of A Confederate Biography: The Cruise of the CSS Shenandoah (September 2017) H-Net for H-CivWar Review of Lincoln and His Admirals by Craig Symonds (February 2010) Review of My Dear Friend: The Civil War Letters of Alva Benjamin Spencer 3rd Georgia Regiment Company C by Clyde G. Wiggins (January 2008) Nautical Research Journal Review of The Officers of the CSS Shenandoah by Angus Curry (December 2006) Anniston Star Review of Confederate Homefront: Montgomery During the Civil War by William Warren Rogers, Jr. (July 2000) Encyclopedia Articles Encyclopedia of the War of 1812, ABC-Clio “Arthur Sinclair” “Melancthon Woolsey” “Ropewalk” “USS New Orleans” Encyclopedia of the Mexican War, ABC-Clio “Blockade” Encyclopedia of the Korean War, ABC-Clio “Mine Warfare” Gale Library of Daily Life: American Civil War “Shipbuilding” TELEVISION APPEARANCES AND PROFESSIONAL CONSULTATION 2017 Started series of YouTube videos on the Port Columbus channel entitled Curator’s Corner: Reproduction Blakely Rifle Museum Donations Pass Box Acquisition The Engines of the CSS Chattahoochee The CSS Jackson Fantail Exhibit Development Inside the CSS Jackson US Monitor Identification Paper Issues Why Is It So Dark In The Museum Cannon Conservation Project The VII in. Brooke Rifle and Markings 2017 On-air expert and consultant for Two-Egg Productions documentary CSS Chattahoochee. 2016 Interviewed by various media outlets about the CSS Georgia project 2016 On-air expert for airing of Colonial Williamsburg’s documentary about Civil War ironclads 2015 Interviewed by C-Span for the “Cities Tour” program on Columbus, GA 2013 Consultant on a documentary about Civil War ironclads produced by Colonial Williamsburg 2012 Consulting with various U.S. Army organizations at Fort Benning developing Officer Staff Rides, which include The Battle of Mobile Bay and The Battle of Columbus. 2012 Consultant and actor for documentary Savannah In the Civil War 2008 Interviewed by Channel 3 News Columbus, Georgia about the history of Independence Day. Aired July 4, 2008. 2007 Interviewed on Georgia Traveler about the National Civil War Naval Museum. Georgia Public Television 2006 Consultant for documentary entitled The Last Ditch about the Battle of Columbus. Georgia Public Television. The documentary is the winner of two regional Emmy Awards. PROFESSIONAL SERVICE 2019 Judge for National History Day for the State of Georgia 2011 Judge for National History Day for the State of Georgia 2009 Listserv Manager for Society of Georgia Archivists KIMBERLY SCOFI Summary Contact A dedicated nonprofit Executive Director with fifteen years of organizational leadership providing food, housing, and supportive services to a diverse population. Qualifications include development, and implementation of successful fundraising, marketing, and constituent programs with measurable growth year after year. Experience United Military Care / Marietta, GA / 07/2012 to Present President Executive Director Built a successful statewide nonprofit serving military veterans and their families from the ground up, increasing program services to 8,000 clients annually. Developed marketing plans to include web site, and social media platforms highlighting the organization with growth to over 17,000 impressions statewide per outreach. Successfully networked and cultivated partnerships with professional sports teams, major corporations, and influential community a iliates generating awareness throughout state, and southeastern region. Created diverse revenue generating platforms to include major gifts, grants, and corporate giving to successfully reach fundraising goals. Recruited and trained diverse Board of Directors committed to the organizational cause. Operation Homefront - Georgia / Marietta, Georgia / 11/2007 to 06/2012 Executive Director Created fundraising and marketing campaign for small independent chapter of a national organization expanding services from one military installation to statewide program coverage to include budget growth to over $2MM annually. Built and trained sta from one to seven, and created a volunteer program with 423 registered volunteers. Participated in major market radio and television interviews on a weekly basis highlighting organization, and harnessing support. Promoted from Development Director to Executive Director following ten months of employment. Education Nonprofit Management Northwestern University-Kellogg School of Nonprofit Management Evanston, IL Leadership Board Governance Finance Marketing and Communications Impact Measurement Paralegal Studies Kennesaw State University Kennesaw, Georgia Criminal & Civil Law Legal Research & Writing Real Estate & Family Law Skills Nonprofit Leadership Compassionate Fundraising Marketing Web Social Strategic Planning Program Development Growth Change Management Business Administration Team Building Management Board Volunteer Development Public Speaking Volunteer Programs Activities And Honors 2018 Congressional Medal of Honor Foundation Civilian Honoree Current Activities: American Legion Ladies Auxiliary Post 29 Former Activities: Honorary Commander (Military) Cobb Chamber of Commerce GA Chamber of Commerce Assoc of Fundraising Professionals National Assoc Professional Women Parent Teacher Student Assoc Speaker-National Day of Prayer Felony Victim Witness Protection Reserve Auxiliary Deputy SGT Sisters in Crime Atlanta Certifications Advanced Grant Writing Change Leadership Branding Organizational Analysis Thomas (Tommy) Smith Objective To work diligently to make Georgia the most desirable State in the United States of America in which to live and do business. Political Experience Served one and a half terms on the City Council of Forest Park, Georgia 2013-2017. Ran for Georgia Senate District 34 in 2018. Employment Border Equipment Conley, GA Heavy Rental Delivery Driver Responsible for pick-up and delivery of heavy equipment. Completing paperwork associated with rental agreements. Using good judgment in the everyday operation of heavy equipment in the Metro Atlanta Area traffic. J&J Exclusive Lake City, Ga Transport Driver Responsible for the safe transport of Carmax automobiles from point A to point B. Cowin Equipment Mableton, Ga Heavy Rental Delivery Driver Responsible for pick-up and delivery of heavy equipment. Completing paperwork associated with rental agreements. Using good judgment in the everyday operation of heavy equipment in the Metro Atlanta Area traffic. Southeastern Freight Lines P&D Driver/Line Haul Driver Conley, Ga Responsible for pickup and delivery of freight. Completing paperwork associated with shipping and receiving. Using good judgment in the everyday operation of heavy equipment in the Metro Atlanta Area traffic. Education University of Georgia Carl Vinson Government Studies Tifton, Georgia Atlanta Area Technical College Front End Alignment  Certificate of completion. Atlanta, Georgia Forest Park High School Forest Park, Georgia  Summary of qualifications Diploma Although I might not seem like an obvious choice to fill the unexpired term of Senator Isakson there would be no one more dedicated or diligent in the commitment to make the decisions that would be best for all of the Citizens of Georgia and the United States of America as a whole. The common sense approach from a non-career politician would be a definite asset in the Senate right now. Professional memberships  Clayton County Republican Party  Vice Chair District 5 Republican Party  General Motors Certified Technician  CDL Driver’s License  NHRA Super Gas Driver’s License  Georgia Motorsports Hall of Fame Law Office of VINCENT D. SOWERBY, P.C. Attorney at Law September 27, 2019 CAREER: 33 years general trial practice in Brunswick, Georgia, the last 23 of which have been selfemployed as a sole practitioner, the first 10 of which I was the associate for Joseph H. Ferrier in Brunswick. I have had only these two jobs since graduating law school, with no gaps in my work history. My area of practice is general civil litigation, from medical negligence to domestic relations. EDUCATION: - Juris Doctor, University of Georgia School of Law, Athens, Georgia 1986 - Bachelor of Arts in history, Duke University, Durham, North Carolina 1983 - Junior year abroad at Albert Ludwigs Universität, Freiburg im Breisgau, West Germany, 1981-1982 - High School Diploma, Pace Academy, Atlanta, Georgia 1979. SKILLS: - All phases of litigation. - Successful solo practice, both with and without a secretary. - Writes well, learns rapidly, high aptitude for all subjects, computer literate, independent, self sufficient, will follow instructions. - Difficult to intimidate. POLITICAL EXPERIENCE: None, other than running for election for Glynn County State Court judge in 2012. POLITICAL POSITIONS: - Republican, Smaller federal government, Return power to States (especially with regard to education, abortion, social transformation, etc.), Avoid war, Secure borders, Balance budget, I usually agree with Pat Buchanan’s columns. PERSONAL: Age 58. Divorced, one child, age 20, Home is on St. Simons Island. Hobbies are offshore fishing and scuba diving. Willing to relocate.