Obtained Orphan Drug and Fast Track designations in response to effective applications
Successfully prepared IBs and INDs for new medicines for Orphan Diseases/Neglected Tropical Diseases
Wrote ISS and ISE for successful NDA for drug for a Neglected Tropical DIsease
As project Regulatory Representative, effectively engaged in oral and written communication with the FDA; anticipated FDA concerns and designed effective strategic resolutions
Interfaced with the NIH, CROs, pharmaceutical companies and clinical site to bring projects to FIH (First in Human)/Phase II study
Versatile in meeting project needs: obtained permission to reference pharma NADA data in project IND; negotiated with CROs/pharma regarding manufacture of clinical supplies for FIH study; critically reviewed analytical data on study drug from multiple manufacturing sites, building bridge to approved use in clinical trial
Collaboratively prepared and submitted Letter of Intent to large foundation for multimillion dollar funding of Phase II clinical trial for new medicine for a Neglected Tropical Disease. in collaboration, wrote successful application for R34 clinical trial planning grant.
Collaborated with global health professionals in North and South America and Europe to bring projects to fruition
CoddConsultingLLC 