IND Filing at a start-up

Provided senior level program management to a biotech start-up to ensure a major goal of their first IND filing for a first in human solid tumor therapeutic stayed on track. Client goals were met by setting achievable but aggressive goals to ensure all IND authors and reviewers would have sufficient time resourced to complete writing and review of the filing as well as ensuring any key gaps were addressed.

Embedded with a VC funded biotech to provide expert project management oversight to the CMC and regulatory teams for the successful tech transfer to a new drug product manufacturer. Set-up internal timelines and dashboards to communicate project status internal stakeholders. Tracked all tech transfer documents assigning primary authors and reviewers and worked with the internal team to develop gap analysis and risk overview. As tech transfer was moving towards completion worked with regulatory lead to completed authoring of IND amendment and IMPD amendments for the new DP site. 

Integrated with a small biotech to provide executive level cross-functional leadership of their lead clinical program. Client goals were met by embedding with the internal clinical team to track program timelines and KPIs as well as ensuring clinical supply chain was sufficiently managed to provide uninterrupted supply of study drug to patients. Successfully oversaw multiple protocol amendments and subsequent filing to the IND. 

Provided executive level team leadership to successfully bring an asset into a registration study sponsored by an external partner. With the internal project manager to ensure timelines and an activity tracker for review of all contracts, agreements, and clinical protocols were developed. Oversaw development of regulatory documents for study to be completed ex-US. Joined external meetings with the partner to ensure companies’ interests were represented.