Employees of the Month: Liza Torres-Alvarado, Shachi Shah, and Mei Chen

The Sanaria employees of the month for June 2021 are Liza Torres-Alvarado, Shachi Shah, and Mei Chen.  Liza is our Office Associate, responsible for working with our CEO and senior staff to support the smooth functioning of Sanaria’s operations, and Shachi is a member of the regulatory team, responsible for providing support in preparation of FDA and EMA submissions.  Mei is a member of the clinical team at Sanaria, responsible for managing trial master files and ensuring that documentation for Sanaria’s clinical studies is in compliance.

Liza and Shachi were nominated for employee of the month to recognize the tremendous effort that has gone in to authoring, reviewing, and compiling the Master File (MF) documentation for the mixed diluent for submission to FDA. In all, about 120 files were put together for this submission, with 50 of these being generated as the primary submission files.

Liza  graciously helped out by providing all the electronic scans of the multiple binders of documentation for the engineering and clinical lots. Liza went in over three weeks and not just scanned the documents, she meticulously organized and named over a thousand pages of documents that made it significantly easier for us to navigate and review these files. Liza, as always, stepped in to do this and as always does it with a smile. Liza, it is colleagues like you who ensure we are successful as a team. You step in to help and provide excellent work always with a professional and pleasant attitude.

Shachi  single handedly took on the huge task of authoring every single MF document. This meant reviewing all the manufacturing and testing documents, including batch records, SOPs, analytical test methods, materials, etc. and writing up the entire MF. This is not the first time that she has volunteered to take on something as extensive as this, and we know it will not be the last. She has always shown initiative, to learn and grow, no matter the task or her experience with it. She is a real asset and such an integral part of our team.

This spring, circumstances resulted in a change of clinical trial plans with our collaborators at the Malaria Research and Training Center in Bamako, Mali.  We cancelled a trial studying PfSPZ-CVac in Malian adults due to anticipated difficulty achieving recruitment goals and substituted a high priority trial of PfSPZ Vaccine in Malian children propelled by a recent communication from the FDA. Operating under an extremely tight timeline imposed by the incipient rainy season, we and our collaborators at MRTC and the Laboratory of Malaria Immunology and Vaccinology at NIH have moved at lightning speed to write a new research protocol and prepare the Bancoumana research site for the trial.

Mei has been exceptional in managing the preparations for clinical trial in Malian children.  The agreement to proceed with this trial was made very recently and, coupled with the inability of our and the NIH teams to travel to the site because of COVID and security concerns, all preparations have been performed remotely, providing additional layers of complexity.  Mei has handled all of this with thoughtfulness, careful interactions and tremendous attention to detail.  She has put in long hours during the past weeks to ensure that the preparations are as good as they can be and, in addition, does it all with calmness and a big smile. 

Liza  attended  Central University of Venezuela for her undergraduate degree in International Studies and then received her MS in International Service from American University.  Shachi earned her MS in Biotechnology from Georgetown University.  Mei holds a MS and BS from the National Cheng Kung University of Taiwan in Microbiology and Immunology, and Medical Laboratory Science and Biotechnology. Liza started at Sanaria in May 2018, Shachi in September 2018, and Mei in March 2017.