Annie T Email and Phone Number

- Collaborate with multiple pharmaceutical companies in developing and launching Companion Diagnostics (CDx) products for gene therapy drugs in the US, EU and the rest of the world.- Lead cross functional team in assay transfer, assay validation, design control, regulatory submissions, and commercial launch readiness of multiple products. - Lead alliance management and strategic partnership activities with critical clients. - Led multiple work streams to establish the first CDx commercial sample testing program in the company. - Lead commercial activities including patient sample testing, customer support, and life cycle management.- Manage program/project timeline, budget, and support proposals.

- Experienced in developing immunodiagnostic In Vitro Diagnostics (IVD) assays (CE Mark and FDA approval) to provide insight for TB diagnostics, transplant patient management, Lyme disease and COVID19 (SARS-CoV-2 infection). - Experienced in working with cross-function teams and technology partners to develop products from concept/feasibility to verification/validation and eventually product launch following the design control process.- Line manager oversees and develops a high performing team of scientists with various technical expertise, industrial experience and background.- Participating in IVD assay development clinical studies including clinical strategy, study design, planning and execution. Experienced in clinical study protocols, IRB submissions, site selection, investigator brochure, site initiations, training and monitoring, data management, case report form reviews, data analysis and interpretations etc. - Participating in regulatory strategies and submissions, such as FDA De Nova pathway, EUA etc. - Strong data analysis capabilities and knowledgeable in statistics tools in compiling, analyzing, interpreting pre-clinical and clinical data. - Enterprise IVD and medical device product development process improvements.- Evaluating, developing and forming a technical partnership to develop potential new products in the innovation pipeline.

- Led the product development process improvement in developing cancer diagnosis IVD assays with a focus on solid tissue and ccfDNA liquid biopsy technology using Illumina next generation sequencing (NGS) instruments, MiSeq. - Participated in defining clinical and regulatory strategies, reviewing clinical protocol, and gathering clinical samples for testing. - Led the product development process improvement in developing cancer diagnosis IVD assays with a focus on solid tissue and ccfDNA liquid biopsy technology using Illumina next generation sequencing (NGS) instruments, MiSeq. - Participated in defining clinical and regulatory strategies, reviewing clinical protocol, and gathering clinical samples for testing.

- Project manager of Microbiology Business Platform Life Cycle Management program which comprised of more than a dozen of cross-functional projects to meet business strategies and objectives.- Experienced in understanding FDA guideline and researched competitor 510K submissions to support regulatory strategy formation for marketing claims of a proposed IVD product.- Project and technical report presentations to Business Leadership team.

• Led the innovation effort to synthesize a next generation blood culture product for sepsis diagnosis. Integrated and aligned voice of business, voice of customer and voice of technology and drove the effort from early concept phase to development and clinical study. Integrated reagents, consumables and instrument into a complete solution that were suitable for clinical study. Drove clinical study design, schedule, budget, implementation and data review. Provided guidance and review on clinical study protocol and training protocol for IRB submission and for collecting appropriate data and evidence for device performance. • Managed product requirements and design specifications for a FDA class II diagnostic instrument (bacterial identification and antibiotic susceptibility testing). Integrated inputs from Customers, Marketing, Operations, and Service functions. Collaborated closely with hardware and software engineers to drive product conceptualization, developed work plans to reduce concept to design and produced prototypes.• Led the clinical study for a new medical device, reviewed clinical protocols, SOPs, experienced in site selection, initiations, data management, case report form reviews and data analysis and interpretations.

- Product development experience (GPDS) in developing a new BACTEC blood culture product focus on reagent development and media optimization. Drove critical feasibility and qualification tests of critical media components (new resin material) to improve and optimize the clinical performance of blood culture products and to gain more competitive market advantages. Product was FDA 510K cleared. - TLDP (Technology Leadership Development Program) rotation: Team leader of a Technology Development project (budget over $1.5 MM, > 10 team members) to design and synthesize a next generation blood culture product for sepsis diagnosis. Led and managed all elements of technology development project including defining the scope, technical objectives, and technical performance criteria, synchronizing and managing overall project schedule and accompanying resource requirements, and fostering effective communication among core team members.- TLDP rotation: Drove cross-functional effort with R&D engineering, marketing and legal IP group to invent, identify, evaluate, and assess novel opportunities and concepts for a $500MM market in blood culture and microorganism ID/AST. - Solved customer complaints by developing and applying sequencing, molecular biology and microorganism structure genome analysis technologies. Technical support for BD product with microorganism detection, identification and antibiotic susceptibility testing capabilities.- Multiple IPs on sepsis detection, antibiotic resistance detections.