Company
Our Mission
Direct Biologics is a pioneering leader and cGMP manufacturer of regenerative biologic products, driven by science and innovation. Our company is dedicated to delivering cutting-edge clinical and scientific solutions through meticulous research efforts.
Our Values
Safety
Direct Biologics prioritizes patient safety above all else. All regulated processes adhere to cGxP standards, guaranteeing the utmost safety and quality at every phase of product development.
Quality
Direct Biologics delivers high-quality products for healthcare providers and patients alike. Our commitment to excellence is upheld through our quality systems, ensuring the consistent provision of safe products.
Innovation
Direct Biologics was established with the goal of advancing the frontier of cutting-edge human cell and tissue technologies. Our company has amassed substantial intellectual property focused on stem cell secretomes and their applications.
Our Journey
2017
Direct Biologics was founded by Mark Adams and Joe Schmidt
2019
Commercialized a cGMP product under FDA’s HCT/P 361 tissue regulations
2020
Investigator Initiated Trial commenced for COVID-19 patients at Christ Hospital
Initiated a Phase II clinical trial for Mod-Severe ARDS associated with COVID-19
Initiated clinical trials for 6 additional indications
Admitted into project “Warp Speed”
2021
Completed Phase II trial for Mod-Severe ARDS associated with COVID-19
2022
Opened full-time corporate office in Austin
Launched Phase I clinical trials for ulcerative colitis and Crohn’s disease
FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to expedite regulatory process
Initiated Phase III clinical trial for Covid-19 associated ARDS
2023
Received FDA agreement to include All-Causes of ARDS to the Phase III trial
Initiated a Phase IB/IIA study for the treatment of perianal fistulizing Crohn’s disease
2024
Moved into a new combined Quality Control and R&D laboratory facility in San Diego, CA
Our Team
With a wealth of experience in biologics research, development, and commercialization, Direct Biologics is positioned as a frontrunner in the rapidly evolving next-generation segment of the biotherapeutics industry.
Direct Biologics Management Team
Executives
Mark Adams
Co-Founder, Chairman and Chief Executive Officer
John Vacalis, JD
President & Chief Legal Officer
Paul Tebbey, PhD
Chief Operating Officer
Jeff Mims
Chief Financial Officer
Tim Moseley, PhD
Chief Scientific Officer
Direct Biologics
Direct Biologics is a science-based market leading innovator and certified cGMP manufacturer of regenerative biologic products.
© 2024 Direct Biologics LLC