Taili Thula, PhD

• Serve as a lead reviewer/biomedical engineer of a variety of total product life-cycle actions (premarket, compliance, and post-market surveillance) related to medical devices, such as premarket notification of new medical devices (510(k) submissions), premarket approval applications (PMAs), product development protocols (PDPs), investigational device exemptions (IDEs), pre-IDE submissions, recalls and complaint submissions. • Review and evaluate scientific data in medical device submissions and other regulated articles to ensure safety and effectiveness of medical devices, including combination products. • Plan, review, and evaluate data for Pre-submissions, IDEs, 510(k)s and PMAs pertaining to plastic surgery and skin and wound devices. • Work on the strategies and planning of scientific PMA panel. • Collaborate with multiple teams to strategize plans for updating communications to the public related to the safe use of dermal fillers. • Serve as a source of information and guidance on medical device-related issues applicable to reporting of adverse events and patient engagement. • Act as assistant director and contribute in regulatory strategy implementation, planning, coordinating, and evaluating the program activities of the team.

• Active reviewer for Acta of Bioamaterialia and Archives of Oral Biology journals. A total of 13 reviewed articles. • Teach English as a second language. Prepare assessment tests and customized classes to meet each student’s needs. • Coached PhD students and post docs. Assisted students in writing their dissertation as well as to get ready for their proposal and final defense. Collaborated with postdoctoral associate and physician to write a proposal for funding.

• Promoted from a Lead Scientist position to Director of R&D in 4 months. • Generated IP technology of a new biopolymer extraction process. • Led the formulation and optimization of a new biopolymer extraction process, reducing time, costs, and bottlenecks. The new extraction process was the company’s core process for the manufacturing of bio-based raw materials to be used in different product lines. • Designed and developed the first seaweed-based emulsifier for cosmetics applications and took it to beta testing in a period of 8 months. • Worked directly with Director of Product Management and VP of Sales of the Personal Care Division in defining product prototype and transitioning it into customer validation stages. • Collaborated with multiple departments to strategize plans for scaling-up the biopolymer extraction process and two other product line processes for the successful transition to a large manufacturing plant. • Worked on the strategies for multiple research projects and kept a team of 10 professionals aligned with the company goals. • Managed and implemented the organization, training, development, scheduling, oversight, and prioritization of work plan resources for the R&D team to be able to deliver on the commercial goals of a fast-paced organization. • Implemented and evaluated QC/QA methods and SOPs for the R&D, Product Development, and Quality Control and Safety departments. • Provided guidance and training to the Personal Care Sales team in pitching the product to potential customers from mid-to-large cosmetics companies around the globe.

•Design and develop optimized formulations to achieve collagen intrafibrillar mineralization via a patented technology, consisting on the promotion of an amorphous calcium phosphate precursor. •Determine the effects of various polymers, material concentrations, and environmental conditions on the process at small laboratory scale. •Work on the extraction and purification of collagen from biological samples. •Perform characterization studies on developed composites via scanning electron microscopy, X-ray diffraction and thermo gravimetric analysis. •Test cells’ response to exposure of diverse scaffolds mineralized with the patented technology. PRESENTATIONS - Invited Presentation at the 8th Pacific Rim Conference on Ceramic and Glass Technology in Vancouver, Canada on “Mimicking the Nanostructured Architecture of Bone”. Thula, Taili; Jee, Sang Soo; Gower, Laurie. May 2009. - Poster presentation at the Society For Biomaterials 2008 Translational Biomaterial Research Symposium in Atlanta on “Development of a Multi-functional Red Blood Cell Analog Using Polyelectrolyte Complex Microparticles”. September 2008. - Poster presentation at the Gordon Research Conference on Biomineralization 2008 in New Hampshire on “Development of a Collagen-mineral Composite via the Polymer-induced Liquid-precursor (PILP) Process”. August 2008. - Oral presentation at the MRS Spring Meeting in San Francisco on “Fabrication of Hydroxyapatite-collagen Composites with Bone Nanostructure via a Fluidic Amorphous Precursor to Hydroxyapatite”. March 2008. - Oral presentation (abstract co-author) at the Composites at Lake Louise 2007 Conference in Alberta, Canada on “Interpenetrant Composites Mimicking the Nanostructure of Bone”. October 2007.

•Worked on the development of biodegradable, biocompatible, and multi-functional particles with similar erythrocyte’s rheological characteristics to be used for drug delivery. •Worked on the decellularization of rat kidneys for future use as biologic scaffolds for blood borne stem cells. •Worked on the regeneration of irradiated rat parotid glands. Harvested and cultured of rat glands and epithelial cells. Delivered growth factors to irradiated parotid gland organ cultures. Characterized treatment effect via TUNEL assays, cell proliferation and amylase analyses and ELISAs. •Prepared and characterized protein-loaded polymeric microspheres for various applications.

•Worked on feasibility studies at the cellular level in the Research & Development area. •Tested cells’ response to exposure of different proteins and tissues as well as cell attachment to diverse scaffolds. •Performed alkaline phosphatase activity and bone mineralization assays. •Performed ELISAs and MTT cell proliferation, total protein, live/dead, and cell tracker assays.

- University of Florida Alumni Fellowship, International Student Academic Award, and All-American Scholar Collegiate Award. - Recruited students for the undergraduate/graduate programs for the College of Engineering. Helped incoming engineering freshmen student to adjust to college life. Taught, graded, and prepared tests for the STEPUP program chemistry course. - Dissertation titled: "Deformable Microparticles with Multiple Functions for Drug Delivery”, 2007. Published in VDM Verlag Dr. Muller e.k., Saarbrucken: Germany, 132 pp, November 2008. - Poster presentation at the SFB Conference in Chicago on “Effects of heavy metals in the development of multi-functional microparticles with deformable properties”, 2007. - Poster presentation at the BMES Meeting on “Effects of calcium, zinc, and copper in the production of deformable alginate-chitosan microspheres”, 2006. - Oral presentation at the SFB Conference on “Development of a Multi-functional Red Blood Cell Analog”, 2006.

- Worked on budget for development of the cellular and tissue lab of the University of Florida Biomedical Engineering department. Kept control of lab inventory. Organized lab space to be shared by 17 students under the supervision of five different principal investigators. Promoted a friendly environment among all people sharing the lab facilities. - Thesis titled: "The Effects of Epidermal Growth Factor (EGF) and Basic Fibroblast Growth Factor (bFGF) on Irradiated Rat Parotid Glands”, 2003. Published in Annals of Biomedical Engineering, 33(5), pp.685-695, May 2005. - Poster presentation at the ASME Summer Bioengineering Conference in Key Biscayne on “The effects of epidermal growth factor (EGF) and basic fibroblast growth factor (bFGF) on irradiated rat parotid glands”. June 2003.

Minor in Biomechanics. GPA: 3.54