Amina Abbadi
Independent Consultant @ Independent Consultant
About
I am an experienced professional committed to advancing drug development and addressing critical unmet medical needs. I have a proven track record of developing and supervising nonclinical and translational activities with exceptional skills in managing external collaborations, CROs, direct reports and cross-functional teams. I am recognized for strategic leadership, project management, and am able to excel in dynamic fast paced environments. I have an extensive expertise in bioanalytical clinical chemistry with a cellular and molecular medicine specialization offering comprehensive knowledge in glycobiology, immunology, and inflammatory diseases. Key achievements: - I have successfully led nonclinical program development for groundbreaking therapeutic programs with remarkable efficiency delivering Investigational New Drug (IND) submissions within aggressive timeline. Concurrently, I led translational operations encompassing biomarker assay development, rigorous vendor selection for advanced biomarker analytical services, and lab readiness for first-in-human study. - I am an excellent communicator with track record of 10+ peer reviewed scientific publications, 1 book chapter, 15+ oral and poster presentations at international and national conferences, and recognition through 4 prestigious presentation awards. I am recognized for scholarly impact as a journal editor, demonstrating thought leadership in the scientific community. ***** Top 10 strengths/ skills: 1. known for consistently delivering results and driving projects to completion within aggressive timelines. 2. built a reputation for managing CRO partnerships with such effectiveness that partners consistently go above and beyond contractual obligations. 3. focused and composed demeanor even under significant pressure, enabling clear decision-making and team confidence during challenging situations. 4. easily adapt in rapidly changing environments, quickly assimilating new information and adjusting course as needed. 5. able to make data-driven decisions with demonstrated flexibility to adapt to modifications in project plans. 6. effectively communicate complex scientific concepts and research insights across diverse professional audiences and interdisciplinary specialty areas. 7. strong understanding of GLP, SOPs, protocols, biomarker assay development and nonclinical reports and stage-appropriate quality assurance. 8. Cultivate a dynamic team development approach. 9. Excellent organizational skills. 10. Comfortable with multi-tasking in a fast-paced environment
United States
Boston
Biotechnology
Nonclinical Program Development, Program Management, Translational Operations and Lab Readiness, IND submissions, Biomarker Assay Development, Nonclinical and Translational Program Development, Development of translational biomarker assays, Design and execution of nonclinical toxicology and safety studies, Development of Nonclinical and Translational Programs , Management of CROs, external collaborations, and cross-functional teams, Directing the authorship of regulatory documents, CROs, external collaborations, and cross-functional teams management, Excellent organizational skills and comfort with multi-tasking in a fast-paced environment, Excellent written and verbal communication, Cross-team Collaboration, Leadership Development, Regulatory Submissions, Study Reports, Interpersonal Skills, CRO Management
Experience

Independent Consultant
As an Independent Consultant, I specialize in offering strategic insights into non-clinical and translational program development. My focus includes advising clients on IND-enabling study design and regulatory strategies, while also enhancing operational excellence in early-stage therapeutic development. This role allows me to leverage my expertise to support innovative startups in navigating complex regulatory landscapes.

Director/ Associate Director, Research- Nonclinical and Translational Program Development Lead
Watertown, Massachusetts, United States
At Abata Therapeutics, I played a pivotal role in managing translational operations for two therapeutic programs, progressive multiple sclerosis and type 1 diabetes, ensuring they were primed for first-in-human studies. I developed a comprehensive nonclinical and translational strategy for an innovative autologous TCR Treg cell product, which resulted in two successful IND submissions and clearance. My collaboration with clinical teams focused on establishing data transmission protocols that adhered to regulatory standards, enhancing operational efficiency.

Scientific Group Lead (Junior Faculty)
Boston, Massachusetts, United States
At SHC, MGH and Harvard University, I played a pivotal role in advancing gene therapy research for Junctional Epidermolysis Bullosa (JEB). My responsibilities included developing the nonclinical strategy, collaborating with investigators, and authoring essential regulatory documents. I also managed research teams, focusing on data analysis and publication efforts to disseminate our findings effectively.

Research Associate (Junior Faculty)
Cleveland, OH
At Cleveland Clinic, I excelled as a Research Associate, where I guided multidisciplinary teams to surpass research milestones, securing grant renewals from the U.S. Department of Defense. I developed a 3-D culture model of gut epithelial organoids, facilitating drug efficacy studies. Additionally, I prepared animal research protocols for IACUC approval and designed breeding strategies for innovative transgenic mouse models.

Postdoctoral Fellow/ K12 Scholar- Immersive Training in Glycosciences
Cleveland, Ohio
At Cleveland Clinic Lerner Research Institute, I contributed to groundbreaking research on heparin's effects on inflammatory responses in diabetic renal failure. As a K12 fellowship recipient in the “Immersive Training in Glycosciences” program, I was part of an elite group aimed at nurturing future scientific leaders. Additionally, I played a pivotal role in establishing the Lerner Postdoctoral Association, fostering a collaborative environment for postdoctoral researchers.

NIH Program of Excellence in Glycosciences- Research Trainee
Department of Biomedical Engineering- Lerner Research Institute- Cleveland Clinic, Cleveland, Ohio
At Cleveland Clinic's Lerner Research Institute, I contributed to the NIH Program of Excellence in Glycosciences as a Research Trainee. My role involved analyzing proteoglycans and carbohydrates, organizing educational journal clubs, and training fellow scientists in glycobiology techniques. Interactions with visiting experts enriched my understanding of the field and facilitated knowledge exchange among peers.

Graduate Research Associate
Cleveland, Ohio, United States
At Cleveland Clinic, I contributed to groundbreaking research by developing an innovative model of lung airway epithelial cells, which facilitated drug testing in lung disease models. My work on IL-17A and IL-17E signaling pathways provided insights into pulmonary inflammatory responses. Additionally, I trained fellow researchers in glycobiology techniques and played a pivotal role in organizing the NIH GlycoGen meeting, fostering interdisciplinary collaboration.
Amina Abbadi's Contact Information
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