Lola Fashoyin-Aje, MD, MPH

Provide oversight for clinical assessment of cellular, gene, and tissue therapy (CGT) products across all therapeutic areas. Led clinical policy development &initiatives to facilate CGT expansion to new indications, including rare diseases.

Direct FDA Oncology Center of Excellence scientific and policy initiatives including those with crosscutting implications for drug development (optimal use of accelerated approval pathway, optimizing evidence generation through trial design, patient population selection, multiregional sites).

Provide scientific, clinical, and regulatory oversight for the review and approval of drugs intended for the treatment of solid tumor malignancies.

Supervise clinical reviewers and provide cross supervision for marketing applications of drugs indicated for the treatment of solid tumor malignancies.

Conduct the primary clinical review of investigational new drug applications, new drug applications, and biologics license applications.