Erin brings over 20 years of experience in the biotech industry in regulatory affairs, clinical affairs, quality management, and product development of both pharmaceuticals and medical devices. She leads Regulatory, Clinical, and Quality initiatives at Transverse Medical, where she is leading clinical trials and collaboratively ensuring compliance with regulatory requirements for innovative embolic protection devices.
Dr. Spiegel holds a PhD in Biophysics and Genetics from the University of Colorado Health Sciences Center. Her diverse scientific expertise encompasses complex genetic engineering, vaccine platform design, and the development and execution of preclinical and clinical studies. She has a proven track record in navigating regulatory landscapes, with multiple successful submissions for INDs, BLAs, 510(k)s, and PMAs.
Previously, Erin played a pivotal role at PharmaJet, managing clinical and regulatory affairs, securing over $15 million in non-dilutive funding for needle-free injection technology, and fostering strategic partnerships that expanded the company’s global presence and enabling advancements in nucleic acid-based vaccines and therapeutics.
In addition to her leadership roles, Dr. Spiegel is an active member of the Regulatory Affairs community and has contributed to numerous scientific publications and presentations. She is passionate about advancing public health through innovative solutions and is dedicated to fostering a culture of collaboration, integrity, and scientific rigor in the biotech field.
