Ryan Ortega Email & Phone Number

Silver Spring, Maryland, United States

Silver Spring, Maryland, United States

I served in an acting position as the Team Lead for the Personal Protective Equipment, Reprocessing and Disinfection Devices Team in the Office of Surgical and Infection Control Devices. In addition to my role reviewing regulatory submissions for Infection Control Devices, I mentored other reviewers for their reviews of our devices and their consulting reviews across the Center. I provided support for the Assistant Division Director managing my team by assigning and reviewing work product for the infection control teams and participate in strategic planning for regulation of infection control devices. As part of the FDA/CDRH response to the novel coronavirus, SARS-CoV-2, I am helping provide feedback to other Agencies and the public, and writing/reviewing public communications related to personal protective equipment. I am also participating in and helping guide my Team’s responses to urgent requests related to mitigating PPE shortages in response to the ongoing public health emergency. I provide input and subject matter expertise on Emergency Use Authorizations (EUA) and other mitigation measures related to SARS-CoV-2.

I am a Lead Reviewer at FDA Center for Devices and Radiological Health (CDRH) in the Office of Surgical and Infection Control Devices (OHT4). I serve in the Sterility Devices Team in the Division of Infection Control and Plastic and Reconstructive Surgery (DHT4B). I review regulatory submissions for sterility, PPE, and reprocessing devices, and provide nanotechnology, biocompatibility, reprocessing, and sterility consults to groups across the Center. I also am proud to serve on CDRH's employee engagement council as well as on FDA's Computational Modeling and Simulation Working Group, which I help found.

Silver Spring, Md

I was a Regenerative Medicine Commissioner's Fellow at the Food and Drug Administration. I operated in both the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH). I also served as a pharmacology/toxicology reviewer for cell, tissue and gene therapies for CBER, and previously served as a cardiovascular device reviewer for CDRH. I worked on a project that will translated the computational/mathematical modeling expertise that exists in CDRH for use in CBER. My hope is that by developing modeling expertise in CBER as well as guidelines (formal or informal) for validating models, the cost of developing life saving biologic products will be decreased and the development timeline for these products will be shortened, all while protecting public health and safety. Deliverables included:- Internal training/educational presentations and materials about the regulatory utility and scientific foundation of modeling and simulation- External scientific presentations and posters at international conferences- Stakeholder engagement at conferences and workshops- Helped found the FDA's Computational Modeling and Simulation Working Group- As co-Chair of the FDA Regenerative Medicine Seminar Series, I helped organized quarterly seminars & symposiums in the area of regenerative medicine- I developed a mechanism of engaging academic stakeholders by working with undergraduate engineering student senior design groups to develop computational models of medical products relevant to product regulation

Silver Spring, Md

The FDA's Computational Modeling and Simulation Working Group (ModSim WG) was chartered in Dec. 2016 with the goal of ensuring consistent and timely review of modeling and simulation supporting regulatory decision making, and to foster cross-center collaboration on modeling and simulation regulatory science efforts. In order to support the formation of this group, I developed an Agency-wide survey of modeling interest and expertise. The other co-founders and I presented the results of this survey as well as a draft charter to the FDA's Senior Science Council who agreed to support the formation of the ModSim WG. Since its foundation, I served as co-Chair in the following capacity:- I worked with the leadership of the ModSim WG (2 representatives from each Center at FDA) to guide the vision and objectives of the group.- I participated in international stakeholder engagement by planning and implementing meetings with the Avicenna Alliance, an international group supporting in silico medicine. These meetings consisted of curated tours of the FDA and scientific presentations from both groups regarding modeling and simulation for medical product development. - The meetings with the Avicenna Alliance resulted in a signed MOU with the Alliance and the FDA's Chief Scientist. The FDA is now an observer member of the Alliance. (May 2017)- I have helped organize multiple day-long meetings of the ModSim WG (approximately 160 members) which included general sessions, science sharing, and break-out sessions for specific interest groups.- I helped organize a session on modeling and simulation at the FDA Science Forum (June 2017)- I am working with the group to develop a cohesive communications plan for internal and external communication that is consistent with the goals of the ModSim WG.

Washington D.C. Metro Area

The Fellows in Innovation is a grass-roots innovation community of executive branch fellows, initiated by The White House Office of Science and Technology Policy (OSTP) that unites fellows to address complex and cross-cutting challenges. As a FIN, I served on a part-time detail with OSTP in the area of open federal data and data science. During the detail, I accomplished the following:- Served on the planning and implementation team for the first White House Open Data Innovations Summit, led by OSTP Policy Advisor Kristen Honey. The Summit brought together government trailblazers, entrepreneurs, companies, advocates, and civic innovators who are using Federal open data across all sectors.- I helped select, organize, and track vetting for speakers for the Summit. I helped plan, manage, and organize the presentations for the Health Data Session. I participated in development of the Summit's communication plan under the leadership of Presidential Innovation Fellow, Amy Wilson, and developed handouts and materials for Summit Attendees.- I developed talking points for US CTO Megan Smith for a short video supporting the 2016 Texas Suicide Prevention Symposium. The video highlighted the role of open data, innovation, and collaboration for suicide prevention. I gave a keynote speech at the symposium on using big data and data storytelling to help address chronic and invisible illness.- I served as a note-taker for the 2016 US Open Data Roundtables which brought together data providers in government and data users in business and the nonprofit sector to determine what is needed to make federal datasets as useful as possible.

Nashville, Tn

I coordinated a multi-disciplinary venture by a nanotechnology lab in Biomedical Engineering and a cancer immunology group in Cancer Biology aimed at developing a targeted nanotherapeutic to facilitate cancer immunology and immunological engineering. I became proficient in the techniques, technical language, and academic standards of both groups. Our methods entailed engineering immune cells to adopt an anti-tumor phenotype. I used multiple in vitro, primary cell models, as well as in vivo mouse models to optimize materials and methods, test targeting efficiency, and confirm biocompatibility of the nanoparticles.

Nashville, Tn

I worked in a nanotechnology laboratory to develop a mathematical model of iron oxide nanoparticles in a magnetic field. I combined macro-scale and quantum physics to develop this model with the intent to have it serve as a design tool for material synthesis. I used high level, first-principles physics to successfully predict nanomaterial behavior. The model was designed to be optimizable with respect to controllable material properties.

Nashville, Tn

I worked in a biomaterials laboratory to design a method of coating polymer vascular stents with drug eluting coatings. This was an industry oriented project performed in association with Abbott Vascular. I designed drug loaded polymeric and lipid nanoparticles used to coat polymer stents via layer-by-layer assembly. The particles were fabricated using a novel, one-step rapid synthesis.

Nashville, Tn

I worked in the Biomedical Engineering Department on developing solid-lipid nanoparticals for drug encapsulation and delivery as well as for vascular stent functionalization using layer-by-layer assembly

Nashville, Tn

As a Teaching Affiliate at the Vanderbilt Center for Teaching (CFT) I instructed incoming graduate student teaching assistants in best practices for teaching undergraduate students and performing their TA duties. This position also resulted in a scientific collaboration with one of the CFT faculty members. We developed a new learning/assessment technique called synthesis mapping designed to teach complex STEM topics to students. The technique uses multidimensional presentation software to allow students to map their hierarchical knowledge structures about a scientific topic.In addition to my teaching work at the CFT, I also have 3 years experience as a teaching assistant for various biomedical engineering courses including physiology and nanobiotechnology.

Nashville, Tn

I performed data entry and lab upkeep in the Biological Science department in a lab monitoring food supply dependent speciation in beetles.

Doctor Of Philosophy (Ph.D.), Biomedical Engineering

Activities and Societies: Graduate Teaching Affiliate, volunteer at project C.U.R.E., volunteer with the Juvenile Diabetes Research.

Master'S Degree, Biomedical/Medical Engineering

Activities and Societies: see PhD sectionIn my first year, I worked in a biomaterials and tissue engineering lab. I worked on a project.

Bachelor'S Degree, Biomedical Engineeing, Cum Laude

Activities and Societies: Undergraduate Honor Council, Engineering Newsletter, Fencing Team, Phi Kappa Sigma FraternityMy undergraduate.

Education record