RGC Winner 2021

Dear CCI,

We are pleased to announce the winner of the 7th Annual Richard Carroll Excellence in Research Award.  

This year’s winner is Sophia Ngo.  Sophia is the Manager of the Regulatory and Cell Manufacturing and Controls (CMC) Unit on Smilow 8.  Sophia ensures cGMP compliance to release all cell and gene therapy products manufactured within the CVPF.  In this capacity, Sophia works closely with CCI Science Operations and the UPenn Office of Clinical Research to create and manage the CMC strategy for IND applications, including supporting INDs, change controls, supplier qualifications, data safety and monitoring board data, and annual reporting to regulatory bodies, and any FDA requests for information.

In other words, every clinical product and release test is tracked by Sophia’s careful eyes. We are talking about deviations, investigations, change controls, corrective and preventive actions, IND review, batch record review, SOP writing and review, validation plans.  The scope of responsibility for Sophia and her team is broad, deep and high impact, ensuring accuracy and safety for experimental therapies manufactured by CVPF for Penn and CHOP patients and those at collaborating clinical centers.  In essence, Sophia is the Maestro of clinical product release, working with CVPF manufacturing, Quality Control, the Translational and Correlative Studies Lab, clinical teams, CCI Scientific Operations, and many more within CCI, Penn Medicine, and CHOP.

Sophia is special in so many ways.  Let’s start with her devotion to the mission and to patients enrolled in our clinical trials.  She has been at her desk in Smilow consistently throughout the pandemic.  She is a master of details with an incredible recall for patient records.  She is a passionate and steady hand working under pressure to ensure patients can safely receive their cells.  As is so important in a position safeguarding patient safety, Sophia is not afraid to speak up and offer suggestions, solutions, and objective critiques. She serves as a positive example and as a mentor.  

The purpose of this award as you may remember is to acknowledge the folks behind the scenes that make things happen but often do not get recognized for their efforts-like the award’s namesake Richard Carroll.   Richard was a wonderful scientist who had an infectious love of science and working in the lab. Richard often did the jobs that did not get much fanfare to make the entire CCI program more successful in getting therapies to patients.  Richard would have been impressed with Sophia’s passion and persistence, admiring her photographic recall and her humility.  Sophia is a quintessential team player who is truly following in Richard’s footsteps by making the CCI output greater than the sum of its individual parts.

Sophia will get a plaque acknowledging her as the winner of the award and her name will join Shannon’s, Hong’s, Simon’s, Cynthia’s, Tony’s, and January’s on wall near the elevator.   Sophia will also be able to attend a meeting or workshop of her choice, at the post-pandemic timing of her choice, to improve her skills as a regulatory scientist.  Richard was a firm believer that everyone doing science should always be learning new things and by allowing folks who normally don’t attend meetings to go, we further pay tribute to Richard’s ideals and values.

 

Please join us in congratulating Sophia on being recognized by this award.

All the best,

Richard Carroll Award Selection Committee.