Dr. Adam Ruskin, Senior Associate, Program Manager, at Shabas Solutions LLC, is a leading pharmaceutical, medical device, and diagnostics developer for over 30 years. He has worked mainly on novel investigational products, including leading the development of the first FDA-approved therapeutic for MRSA, the first FDA-cleared multiplexed sample-to-answer PCR test, the first FDA-cleared diagnostics for leukemia and autism, and lead the clinical operations for the largest successful US-only Phase 3 clinical trial ever conducted, the Moderna COVID-19 trial, leading to an Emergency Use Authorization (EUA) in record time.
By training as a veterinary epidemiologist, he previously worked with the Centers for Disease Control (CDC) to help standardize reporting requirements for mandatory reportable infectious diseases on a national scale. He was also the first epidemiologist at the new HIV treatment facility of Grady Memorial Hospital where he worked with sponsor companies to design effective clinical trial protocols, leading to the first FDA-approved therapeutic for HIV, and built the programming used for the Ryan White CARE Act for national funds distribution for HRSA.
As a leading industry speaker, he instructs early-stage pharmaceutical, biotechnology, and diagnostic companies on how to get their investigational products into the clinical testing phase towards successful outcomes with minimal financial and staffing resources. Prior to this role he had lead clinical operations, clinical development, clinical data management, and biostatistics and 5 successful early-stage companies leading to 1 IPO and 4 acquisitions, 3 each by one of the top 10 largest biotech companies in the world.
He is a Subject Matter Expert in Clinical Operations, understanding and speaking on unique challenges of the large majority of industry companies which are early-stage companies, as well as integration of technologies and functions between clinical operations and clinical data management. As head of Clinical Development for several companies he has written clinical trial protocols, and as head of Biometrics for those companies has built the Electronic Data Capture (EDC) systems which have captured that data. As head of Clinical Operations he performed the site trainings and monitoring, and maintained the electronic Trial Master Files (eTMFs) which were submitted to FDA with successful outcomes.
Prior to Shabas Solutions Dr. Ruskin is a leading consultant for early-stage pharmaceutical, biotech, medical device, and diagnostics companies. He attended Pennsylvania State University with Honors degrees in both Animal Bioscience and Environmental Resource Management, Kansas State University for a Doctorate in Veterinary Medicine, and Emory University for MPH and PhD degrees in Epidemiology. He maintains active veterinary licenses in the states of California and Florida.