Inge Tarnow

Kiox is a Danish biotech start-up developing inhaled treatments for rare lung diseases

DeepTech Mentoring supports pre-startups, startups, SMEs and established companies within the community at DTU Science Park by matching founders/CEOs with volunteer experienced mentors. Through a team mentoring approach with groups of three mentors, mentees get competent sharing on day-to-day challenges as well as on strategic issues.

Savara is an American biotech company specialised in developing drugs for orphan lung diseases. My tasks/responsibilities as Project Lead for Molgradex - an inhaled biological treatment currently in Phase 3: - Led project core team and developed strategic plans and ensured that the project ran according to plan and resources adequate. Key role in startup of Phase III trial, including data management oversight lead and central lab lead - Project Lead oversight of completed Phase II/III clinical trial (IMPALA) including article published in New England Journal of Medicine, for which I acted as the main Sponsor driver and contributor. Special involvement in biometrics including delivery of final CDISC package - Planned and developed briefing packages and meeting attendance for FDA Type C and B scientific advice meetings, EMA scientific advice and PMDA End-of-Phase II meeting - Qualified, selected and negotiated contracts with both nonclinical and clinical vendors - Supported financial planning and short- and long-term forecasting My tasks/responsibilities as Head of R&D Operations: - Identified and implemented new Project Management Tools - Designed and built the infrastructure of Savara’s drug development project organisation. Led project leader forum at Savara to ensure best practices shared across programs. - Led and maintained oversight of R&D data integrity and GxP compliance functions including data governance arrangements including strategic initiatives within process and systems improvements

Tasks/responsibilities: - Wrote and prepared complete IND enabling nonclinical package - Main Sponsor/CRO contact for development and validation of bioanalytical assays (ADA/PK) - Conducted and reported several GLP toxicology studies including reproductive toxicity studies and repeat-dose inhalation toxicity studies (including CRO selection)

Task/responsibilities: - Successfully planned, conducted and reported Molgradex Phase I clinical trial - Key role in start-up of Phase II/III multicenter, multinational clinical trial