Apex Innovative Sciences Supports Three Major COVID-19 Vaccine Trials

Apex Innovative Sciences (Apex) and its affiliates are proud to announce their participation in three COVID-19 vaccine studies. With East and West Coast operations and six state-of-the-art clinical trial facilities, Apex is strongly positioned to pivot from its core central nervous system (CNS) business and expand into the management of these landmark COVID-19 vaccine trials. Apex and its affiliates are supporting COVID-19 vaccine trials sponsored by Janssen, AstraZeneca, and Pfizer. 

The ultimate goal of these studies is to ensure the rapid development of a safe and effective vaccine for the prevention of COVID-19, and as a result, accelerating our ability to move past the pandemic and resume normal activities of life.

"Our selection to participate in these important trials illustrates our steadfast commitment to the advancement of health and wellness, and we are extremely proud that one of the vaccines we worked on has already been FDA approved," said Dr. Howard Hassman, Chief Executive Officer, Apex. "In the face of the pandemic, continuation of enrollment and completion of our clinical trials has remained uninterrupted.  And, as these vaccines become available, and recruitment becomes more challenging, we will distinguish ourselves once again by ensuring the successful completion of these vaccine trials."

One of the vaccine candidates under Apex's management, Pfizer and BioNTech's mRNA vaccine, BNT162b2, received approval under the Food and Drug Administration's Emergency Use Authorization (EUA) program on December 13. This EUA allows Pfizer and BioNTech to distribute their vaccine to eligible patients over 16 years of age. In order for Pfizer and BioNTech to file a Biologics License Application (BLA) with the FDA for a possible full regulatory approval, they must continue to gather data and complete their trial.

"Enrollment in these vaccine trials will become more challenging as vaccines become commercially available, such as the Moderna COVID-19 vaccine that also received an EUA on December 18," added Hassman. "That is why major sponsors rely on Apex. The completion of trials – especially these COVID-19 vaccine trials – is the only true way for science and medicine to advance safely and effectively."

Combined, these three COVID-19 vaccine trials will enroll nearly 150,000 global volunteers.1 Apex facilities will be responsible for enrolling a percentage of volunteers into these trials. Each study design is unique and will explore different vaccine technologies. Volunteers interested in participating in these studies should visit:

1. Pfizer/BioNTech

2. Janssen (a Johnson & Johnson company)

3. AstraZeneca

"What we do every day is vital to the development of medicines that can improve patients' lives, but helping develop the COVID-19 vaccine has the potential to change all of our lives and to change history," said David P. Walling, Ph.D., Chief Clinical Officer, Apex. "By doing these trials and doing them right, we are advancing a COVID-19 vaccine that will change the world."

In context, Tufts Center for the Study of Drug Development reports that it takes approximately 10 years and $2.6 billion to advance a drug from the lab to the pharmacy shelf.2 The SARS-CoV-2 virus was sequenced in January 2020 and the first patient was entered into human trials on March 16, 2020.3 The speed of development of these vaccines is unprecedented and reflects positively on the humanitarian efforts of countless life science researchers and the courageous volunteers who enroll in these studies.

Apex Innovative Sciences is primarily known for its global expertise in supporting trials for the development of drugs for diseases of the central nervous system.  Despite the COVID-19 global pandemic, in the past year, Apex has maintained its core CNS business, while broadening multi-faceted capabilities in research areas, including COVID-19 vaccines, Human Abuse Liability, Addiction, Asian Bridging, Psychedelics, and Driving Simulation. In line with this expansion, Apex's leadership in clinical trial continuity during the pandemic distinguished them as ideal partners to enroll COVID-19 vaccine trials.

About Apex Innovative Sciences

Apex Innovative Sciences is a global provider of clinical development and site services. Apex represents the consolidation of core businesses including Hassman Research Institute, CNS Network and Clinical Trial Centers Alliance.  The expanded team collaborates to provide quality, efficiency, and value in the development of innovative medicines. Apex helps sponsors achieve go/no-go decisions, reduce development costs, and deliver high quality results.  Apex is committed to providing scientific, technological, and organizational expertise in phase I - IV clinical trials, including neurology, psychiatry, addiction, Asian bridging, pain, healthy subjects and general medicine. The company prides itself on delivering the highest scientific and clinical quality for its client partners and participants.