Inactive

Description of Services: ICON Government and Public Health Solutions, Inc. (ICON GPHS) is one of the CSN Clinical Trial Planning and Execution (CTPE) Contract Research Organizations (CRO) awardees to ... Description of Services: ICON Government and Public Health Solutions, Inc. (ICON GPHS) is one of the CSN Clinical Trial Planning and Execution (CTPE) Contract Research Organizations (CRO) awardees to execute routine and response clinical services for advanced development of MCMs in support of the BARDA mission. Independent of the BARDA CSN CTPE contract, ICON GPHS was awarded a contract by Novavax to provide clinical research services that include coordination, management and conduct of a Phase III clinical study in support of Novavax’s SARS-CoV-2 vaccine protocol in the 18 and older population. The latest public health focus on subjects under 18 years old has prompted Novavax to conduct a SARS-CoV-2 vaccine study on subjects less than 18 years old. The study is proceeding in an accelerated pace with enrollment scheduled to begin by the end of April 2021. ICON GPHS is in the process of selecting clinical study sites, which will be a combination of government sponsoredsites known as CoVPN and industry-sponsored sites directly sub-contracted by ICON. The COVID-19 pandemic has created a public health challenge to develop preventative measures for SARS-CoV-2 as well as an opportunity for collecting data to further understand and manage the pandemic. Very little data are available on incidence rates of SARS-CoV-2 infection in children and there is an urgent need to assess the efficacy of vaccination in the prevention of SARS-CoV-2 infection from the pediatric population. A nested sub study developed by the University of Maryland (UMD) entitled “A nasal swab study to assess the efficacy of vaccination in the prevention of SARS-CoV-2 infection among individuals enrolled in a Phase 3 efficacy trial of a SARS-CoV-2 recombinant spike protein (rS) vaccine with Matrix-M1™ (M1) adjuvant”, also known as the SNIFF study, plans to obtain nasal swabs in a serial fashion beginning with the second COVID-19 vaccination dose in pediatric subjects to address this important public health need. Based upon the start date of the pediatric enrollment, the SNIFF study must begin no later than mid-May of 2021 in order to obtain the optimal amount of samples needed. To obtain the samples, all sites participating in the pediatric study will need to be recruited, organized and compensated for their work under the SNIFF study. Due to ICON GPHS’s work on both the adult and pediatric SARS-CoV-2 vaccine trials, ICON has already developed a rapidly deployable operational infrastructure and resources to support the SNIFF sub-study. ICON GPHS is uniquely positioned to provide continuity of service and start performance immediately, ensuring that US government interagency partners and affiliated stakeholders optimize the opportunity to address this important, time-sensitive public health need. ICON GPHS shall provide the Government with clinical research operations and management services in support of the UMD SNIFF protocol. ICON GPHS will provide project management, study start up, site training support, site selection, safety oversight, clinical monitoring, as well as investigator payment for sponsored sites. All activities will require coordination with the UMD SNIFF Investigator team. Authority and Rationale: The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays [FAR 16.505(b)(2)(i)(A)]. The Program team identified ICON as uniquely qualified and positioned to execute this time-sensitive study based on the following technical highlights. The key variable is timing for the successful coordination with the Novavax COVID19 phase 3 pediatric study. ICON is currently executing the Novavax COVID19 phase 3 megatrial for adults and will be executing the pediatric study that is linked to the SNIFF Study. The SNIFF study will be seeking to enroll subjects that are enrolled and receiving the Novavax vaccine, sampling subjects following the second vaccine injection. There are a finite number of subjects that will be enrolled for the Novavax study which will be the upper limit of potential subjects that will be available to recruit for the SNIFF study. Sites are limited to those already enrolling in the Novavax pediatric study. ICON will already have site agreements with the 75 sites and automated payment systems set up for the Novavax pediatric study, which can be leveraged to improve the efficiency of getting sites on board to position the SNIFF study with the best chance to be prepared to enroll with the correct timing. The SNIFF study success is contingent on being able to have the site agreements in place and the SNIFF protocol approved before the Novavax pediatric study is enrolling. The ICON project management team is best positioned to coordinate a sister protocol execution and minimize any negative impact that could result from uncoordinated management of studies that are so closely linked. The Program team also anticipates that there would be a substantial duplication of cost that would not be expected to be recovered through competition. Agency Actions to Take or Remove Barriers That Led to Fair Opportunity Exception: After the Program team engaged in stakeholder discussions, they determined that the primary barrier to fair opportunity exception is due to the uncompromising time limitations needed to support on-going COVID-19 research. The major restrictive limitation is the time element, where the contractor has to establish clinical trial services for the SNIFF study no later than mid-May. In the midst of the current COVID-19 pandemic emergency response, BARDA program determined that any delay in this acquisition effort would be against the best interest of public health and should not be undertaken. Fair and Reasonable Price/Cost Determination: Fair and reasonable pricing will be determined after proposal receipt and prior to contract award. To determine whether the proposed price is fair and reasonable, the Contracting Officer will: (1) compare the proposed price with the IGCE; (2) compare the proposed prices to historical prices paid; and (3) rely on expert technical advice.