James Cummings Email and Phone Number

ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced the rebranding of their acquired ClinicalRM division into ICON Government and Public Health Solutions (GPHS). ICON GPHS provide full service clinical development and staffing services across multiple agencies in the US Government, Global Non-Government Organizations (NGOs), Academic Institutions and others in the global health space, and have extensive experience working with multi-national public health organizations.Following ICON’s acquisition of ClinicalRM in 2016, the rebrand demonstrates ICON’s commitment to solving global health issues through enhancing capabilities in vaccines and infectious diseases. With extensive experience supporting over 200 clinical vaccine trials in over 40 countries worldwide, ICON is building a legacy in supporting global public health, and is recognised as a qualified provider for the Bill and Melinda Gates Foundation.“The rebrand of ClinicalRM to ICON Government and Public Health Solutions will both extend and solidify ICON’s offering to government services and all those in the global health arena,” commented Dr. James F. Cummings, President ICON Government and Public Health Solutions. “It will also help ICON to further leverage our extensive network in Africa, Asia and the Americas, to help solve some of the most pressing global health challenges we face today.”ICON’s Government and Public Health Solutions will continue to support US Federal Research, the Public Health Sector including NGOs, to serve a common mission of generating new and safe medical products for federal and commercial clients worldwide. ICON GPHS provides expertise across basic and applied research, infectious and neglected tropical diseases, oncology, vaccines development and testing the response to biothreats.www.iconplc.com/GPHS

James F. Cummings, MD is the President of ClinicalRM, Inc., a global clinical research organization, providing clinical trial and functional services to government, NGOs and commercial customers. From international partnerships and affiliations to government relations and local alliances, ICON GPHS delivers projects spanning the government, academic and commercial marketplaces in support of Global Health. The company, with over 380 personnel world-wide, has a distinct ability to provide boots-on-the-ground and rapid response efforts to global health crises. ICON GPHS is a wholly-owned subsidiary of ICON, plc.

Leads all Influenza-related programs at Novavax, Inc. Directs Clinical development programs for all Emerging Infectious Diseases, to include human and veterinary vaccine development and polyclonal human antibody development, as part of a “One-Health” response to emerging pathogens. This holistic program leverages Novavax’s agile vaccine development platforms, proprietary Matrix Mtm (human) and Matrix Ctm(veterinary) adjuvants, as well as human polyclonal antibody production, to provide a timely, broad response across the spectrum of emerging infectious diseases. Leads a team of 140 personnel and directly reports to the Novavax’ CEO, CSO and CMO.

Directs Clinical development programs for all Emerging Infectious Diseases, to include human and veterinary vaccine development and polyclonal human antibody development, as part of a “One-Health” response to emerging pathogens. This holistic program leverages Novavax’s agile vaccine development platforms, proprietary Matrix-M (human) and Matrix-C (veterinary) adjuvants, as well as human polyclonal antibody production, to provide a timely, broad response across the spectrum of emerging infectious diseases and pathogens of interest.

Serves as the Director for the Global Emerging Infections Surveillance and Response System(GEIS) at the Armed Forces Health Surveillance Center providing supervisory and technical control of local personnel (microbiologists, physicians, veterinarians, and epidemiologists). Responsible for oversight, development, functionality, and fiscal accountability of the DoD's global surveillance program for emerging infectious disease with over 130 projects conducting activities at more than 500 sites in 70 countries world-wide and a $54M annual budget. Supports and ensures the timely analysis and reporting of surveillance findings for military important diseases to support DoD and USG pandemic planning and response efforts. Interfaces, collaborates and leads efforts with representatives from DoD, CDC, and DoS and other government and civilian agencies. Provides physician support to WRAIR clinical trials and to the WRNMMC Department of Medicine and its Infectious Diseases Service. Serves as Associate Professor of Medicine at the Uniformed Services University of Health Sciences (USUHS). Serves as Consultant to the Surgeon General for all Medical Research and Development, advising and focusing DoD sponsored bench and clinical research for drugs, vaccines, diagnostics and global health programs.

Translational Medicine Branch, consisting of the Pilot Bioproduction Facility, and the Departments of Clinical Trials, Regulatory Affairs, and Regulated Laboratories at the Walter Reed Army Institute of Research. Led 77 professional military, government civilians, and contractors; executed a $4M annual budget and directed $32.2 M annual support contract. Directed an integrated, ongoing program of total quality improvement to sustain all aspects of product development for the Soldier. Served the Institute as a senior principal investigator and mentor for junior investigators. Supported the ethical and scientific reviewprocesses of clinical research for WRAIR, the OCONUS Medical Research Units in Africa, South America & Asia, and for the Congressionally Directed Medical Research Program. Providedphysician support to WRAIR clinical trials and to the WRAMC Department of Medicine and its Infectious Disease Service.Served as Assistant Professor of Medicine at the Uniformed Services University of Health Sciences (USUHS).

Served as director of the only comprehensive clinical trials center in the Department of Defense, with a budget of approximately $10-15 million (depending on active clinical trials), and a staff of professionals and support staff of 22.• Standardized study budgeting and planning factors• Developed collaborative ties with clinical researchers assigned to the Naval Medical Research Center (NMRC) such that the WRAIR Clinical Trials Center became their preferred venue for the conduct of Navy clinical trials• Conducted multiple clinical trials as principal investigator

Served as the lead for clinical development of US Army-sponsored malaria vaccines, notably RTS,S; conducted multiple clinical trials of malaria vaccines as principal investigator. Directed 25 professional clinical and scientific staff with an average annual budget of $800 thousand (core) and $2.3 million (operational), leading a complex international coalition of partners (industry, government, academic and regulatory) to advance the malaria vaccine development program.• Drove the clinical development for the U.S. Army of the lead malaria vaccine candidate, known as RTS,S• Conducted multiple clinical trials in support of this malaria vaccine development program• Regular interaction with regulatory agencies, as well as with corporate and other partners in support of product development imperatives

Served as physician-scientist, responsible for the design, execution and direction of clinical malaria studies at WRAIR and abroad. Supervised a staff of 20 with an average annual budget of $700 thousand (core) and $1.1 million (operational) in the conduction of clinical trials.• Provided support to Department of Medicine at the Walter Reed Army Medical Center and the Uniformed Services University School of Medicine as clinician and educator

Served as Senior Medical Officer for an Airborne Infantry Brigade of approximately 3200 paratroopers ready to deploy worldwide within 18 hours of notification. Responsible for Unit medical readiness, determining medical threats for deployment areas and implementing healthcare and disease prevention measures. Responsible for 1/3 of the Robinson Health Clinic, (12,000 patients) supervising care for adult medicine, pediatrics, behavioral health, obstetrics/gynecology and ancillary services of laboratory, radiology and pharmacy.

Provided specialty medical care (Internal Medicine) to US military healthcare beneficiaries• Contributed materially to the development of enhanced automation approaches to the management of medical care in a large tertiary care military medical center

Provided specialty medical care (Internal Medicine and Emergency Medicine) to US military healthcare beneficiaries• Contributed materially to the development of enhanced automation approaches to the management of medical care in a large tertiary care military medical center