Lola Fashoyin-Aje: An amazing first week at the FDA Center for Biologics Evaluation and Research

“It has been an amazing first week at the FDA Center for Biologics Evaluation and Research (CBER). A week ago, I started a new position as the Director of the Office of Clinical Evaluation (OCE) in the Super Office of Therapeutic Products (OTP).

In taking this new role, I simply followed where the science is leading as we edge ever closer to fulfilling the promise of bringing more individualized and precise medicines to patients who need them, especially for those patients who have rare diseases. After over a decade spent working to bring safe and effective cancer therapeutics to patients with cancer, I have a renewed commitment to continuing this important work in a space that is rapidly growing and evolving, and that has great potential to revolutionize clinical care across so many diseases.

My first week capped off with the approval of the first systemic and cellular therapy approved for the treatment of metastatic melanoma in a post-PD1 therapy clinical setting (see below), a credit to the amazing staff in the OTP; it is such a privilege to join the team, especially the clinical staff at CBER_OCE and to work with esteemed colleagues across CBER in this next phase of my career at FDA. I look forward to sharing our work with you.”