Amy Ghering

Lead regulatory team to develop and execute global regulatory strategy for assets for multiple neuroscience indications. • Lead global regulatory team to develop strategy for Phase2b-ready externally-acquired asset indicated for treatment of impaired cognition across neuroscience indications. Established regulatory strategy for product to drive to original IND targeting Q3 2022 to enable proof-of-concept clinical study with dosing starting in December 2022. • Lead global regulatory team to develop and execute strategy for on market oral tablet indicated for acute migraine through the global registration expansion and label expansion lifecycle phase.

Global Regulatory Lead for Gastroenterology Therapeutic Area Unit.

Responsibilities include leading global regulatory activities to execute a proactive regulatory strategy aligned to Xeris portfolio and programmatic goals by partnering strongly with R&D, clinical development, manufacturing and commercial teams via and science-driven review of data to support regulatory submissions to FDA and worldwide regulatory bodies. Lead Regulatory Affairs organization to meet compliantly meet corporate goals and objectives, manages team to support all registrations and licenses. Lead in developing strategies to establish regulatory pathways for all development and life-cycle management projects.

Develop regulatory strategy and lead cross functional teams in the execution to validate and market class II and class II cardiovascular biomarkers. Reduce FDA review time by transforming process to resolve FDA concerns via enhanced understanding and communication of critical aspects of FDA concerns. Lead cross functional team to leverage FDA pre-submission process to speed development of complex class II toxicology IVDs.

Scientific reviewer of premarket submissions for medical devices in the Division of Chemistry and Toxicology in the Office of In Vitro Diagnostics and Radiological Health. Responsibilities include reviewing scientific data submitted in support of medical devices to evaluate data accuracy and sufficiency, reviewing proposed research protocols to determine appropriateness of protocol design in support of medical device claims, presenting results of analysis and evaluation to FDA team, providing feedback and reports on medical device submissions to support innovation of safe and effective devices.

I lead $2M multidisciplinary Air Force Research Laboratory (AFRL) program with University of Cincinnati and Battelle that develops small molecules as countermeasure drugs. Responsibilities include project and milestone design, leading AFRL laboratory technicians and motivating collaborators to meet project timeline, assay design and analysis, hit compound selection and transfer to collaborators at Battelle, and developing subcontractor relationships.

I launched and co-manage an Air Force Research Laboratory and University of Cincinnati joint laboratory working on small molecule drug discovery projects. I direct laboratory AFRL efforts on high throughput biological and biochemical screens to rapidly identify and optimize hit compounds. In addition I conduct our surface plasmon resonance experiments to rapidly optimize critical pharmalogical parameters of hit compounds.

My work in atherosclerosis and lipids focused on cardioprotective good cholesterol (high density lipoprotein, HDL). I targeted increasing the HDL pool by increasing the gatekeeper protein for its production and then characterized HDL subtypes and their beneficial antioxidative and anti-inflammatory properties.

Thesis: Spectroscopic Determination of the Thermodynamics of Lead, Zinc, and Cobalt Interactions with GATA Proteins I independently pioneered research into the developmental transcription factors GATA proteins as potential targets for lead towards determining the molecular underpinnings for lead poisoning. Throughout the course of this project I mastered protein chemistry and biophysical techniques, using absorbance spectroscopy and modeling to determine thermodynamic binding constants that regulate physiological systems.