News & Events Consistent Quality Regulation Allow for Multiple COVID-19 Related EUAs

Consistent Quality Regulation Allows for Multiple COVID-19 Related EUAs

August 31, 2020

As we enter into the ninth month of the COVID-19 pandemic, new SARS-Cov-2 infections continue to occur, both at home in the United States and abroad. World leaders, global health organizations, national and state governments, medical professionals and leading experts in epidemiology virology, and biotechnology are collaborating in a truly unprecedented fashion in the effort to quell the COVID-19 outbreak. As a global clinical research organization and recognized leader in the pharmaceutical development industry, CTI has been and continues to be at the very forefront of the battle against COVID-19, both in the development of new therapies and treatment options for those suffering from this novel disease, and in the search for a vaccine that may ultimately eradicate this viral threat.

Expert Regulatory Consultation

In addition to leveraging our expertise in clinical trial management across more than 20 of COVID-19 related trials, CTI has been in constant communication with the FDA, ensuring that we are able to continue to provide our clients with unparalleled regulatory counsel. CTI's Regulatory and Scientific Affairs (RSA) department has taken the lead on navigating a dynamic regulatory landscape, tailoring clinical development plans and regulatory strategies specifically to our clients and their products in order to streamline the development of potential COVID-19 pharmacotherapies and provide enhanced access to patients in need across the globe in a safe, concerted, and ethical manner. In the past eight months, the RSA group has assisted many clients with agency submissions related to COVID-19, including protocol development, data safety monitoring boards, pre-IND meeting and briefing packages, IND authoring and submission, and expanded access programs.


Emergency Use Authorizations

In response to the COVID-19 pandemic, the FDA is utilizing every tool at their disposal to facilitate clinical research and to assist the medical community for additional therapies approved for the treatment of coronavirus. One such mechanism is the Emergency Use Authorization (EUA). The EUA authority grants the FDA the ability to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threat agents when there are no adequate, approved, and available alternatives.

This power is employed sparingly and with great deliberation by the agency; a mandatory prerequisite for declaration of an EUA is a formal determination by the Secretary of the Department of Health and Human Services that there either currently exists or is potential for a domestic, military or public health emergency involving a CBRN agent. On February 4, 2020, the HHS Secretary determined that the coronavirus outbreak had reached this threshold and declared the existence of  public health emergency, and on March 27, 2020, it was further determined that the ongoing public health emergency warranted the authorization of emergency use of drugs and biological products to combat the COVID-19 pandemic. 

There are currently five drug products that have been granted an active EUA (as of 30Aug2020), including remdesivir and COVID-19 convalescent plasma, the only therapeutic agents with an EUA for the treatment of COVID-19. Physicians around the world continue to look for additional drug products and therapies to address the unmet medical need presented by this disease. As noted above, CTI is engaged in multiple clinical trials for potential drug products and vaccines. Our team has initiated correspondence with the FDA seeking an EUA, and would suspect that as more data becomes available for other COVID-19 clinical trials, additional EUA requests will be processed. However, despite the constant pressure for new therapies in the fight against coronavirus, receipt of an EUA is an extremely high bar to clear. The agency continues to evaluate each applicant on a case-by-case basis, assessing potential effectiveness using a comprehensive risk-benefit analysis that factors patient safety as a top priority. CTI is one of the few companies in the world that has recent experience with COVID-19 related EUAs and other regulatory work.
Quality Comes First

In the same vein, in spite of the myriad pressures and considerations that are part and parcel of the clinical research industry, CTI never sacrifices on quality or attention to detail when executing its mission of delivering cutting edge therapeutic innovation to chronically and critically ill patients. This year, CTI was recognized as a Champion in five categories at the 2020 CRO Leadership Awards, and was the only global CRO to be recognized as a Champion for Quality. Clients across all levels of the pharmaceutical and biotechnology industries seek out CTI due to its proven track record of excellence, and repeatedly return to utilize CTI's expertise and experience in a variety of indications.

The Year of Hope

CTI Cares - Providing Hope to our Communities
The CTI Cares program was established in response to the great interest of our employees who want to give back to society, and in part due to the prior success we’ve had in charitable giving programs.  Each month, one or more employee-nominated charities is spotlighted and supported by our employees and the company as a whole. This month, we have chosen two charities to highlight. 

Elise Ellen Earley Scholarship | Saint Ursula Academy

Elise2Elise was a member of the CTI Marketing department and loving daughter to Pat Earley, CTI Chief International Business Officer. Her lively spirit, zest for life and wicked sense of humor left her mark on many in her short time with us. Elise cherished her four years at Saint Ursula Academy, an all-girl catholic high school in Cincinnati. In her memory, the Earley family created the Elise Earley Scholarship Fund to provide financial assistance to future Bulldogs attending the school. Elise was incredibly generous with her time and always has a spirit of giving, even generously donating her organs to allow others the gift to continue living. In this spirit of giving, we ask you to donate in her memory. You can find out more and donate to the scholarship fund here.


Additional Highlights

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New Hires & Promotions
CTI is thrilled to welcome all of our new employees, and to congratulate our recently promoted employees! 

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