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Austin Bio Consulting is a global consulting practice headquartered in the greater Washington DC metropolitan area of the United States of America.  Originally established in 2010, Austin Bio is comprised of seasoned regulatory professionals with current experience in global regulatory affairs, including work with regulators in the Caribbean and Africa. 



Dr. Olúwágbémilékè (Gbemi) Ijeoma Jamie L. Austin is the Founder and President of Austin Bio Consulting.


Dr. Austin is a global consultant, advisor, and biotech executive.  Gbemi is a versatile, strategic leader with nearly 20 years of experience in the biopharmaceutical industry.  She possesses a sharp ability to direct/negotiate development pathways for novel products and new modalities without clear precedents.  Dr. Austin has served in various roles at several prominent pharma/biotech companies (AbbVie, AstraZeneca, and bluebird bio).  


Gbemi’s biopharmaceutical industry experience spans small molecule pharmaceuticals, biologics, biosimilars, cell and gene therapies, medical devices, live biotherapeutics, and combination products in various therapeutic areas.  She has navigated the regulatory framework over 7 novel cell and gene therapy programs as well as 4 unique biosimilar products in the US and abroad.  Gbemi has helped to advance the field of genetically modified microorganisms, supporting the development of 4 distinct live bacterial products for different therapeutic uses.  Over the course of her career, Dr. Austin has also had the opportunity to execute strategies facilitating global approvals for VIEKIRA / HOLKIRA PAK, TAGRISSO, and FASLODEX, as well as numerous medical devices and combination products.  

Within the public sector, Gbemi has led projects in collaboration with funding from the World Health Organization / Pan American Health Organization as well as country-level Ministries of Health.  She contributed to various projects in support of the COVID-19 pandemic response. 


Dr. Austin earned her B.S. in Chemical Engineering from the University of Notre Dame and M.S. in Bioscience Regulatory Affairs from the Johns Hopkins University.  Her Ph.D. in Pharmaceutical Sciences was earned from the University of Michigan, where she studied biological aspects of the Human Immunodeficiency Virus (HIV) along with the pharmaceutical properties of available treatments in a practical context to accelerate availability of new therapies, with a thesis entitled, Antiretroviral Therapy: New Mechanistic and Therapeutic Insights for HIV Single-Entity and Combination Drug Products.  

Gbemi is an active volunteer, board member, and mentor.  She has keen interests in ethical biotechnology innovation in the Caribbean and Africa. Dr. Austin is Regulatory Affairs Certified (by the Regulatory Affairs Professional Society) in both US and Canadian regulatory affairs.  She has held several faculty roles at the Johns Hopkins University, at various times leading focused concentrations in Regulatory Science and / or Regenerative and Stem Cell Technologies within the Center for Biotechnology Education. Dr. Austin currently serves as an appointed member of the National Stem Cell Ethics Committee of the Bahamas.

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