Providing leadership and global regulatory strategy for the development of biomarkers, companion diagnostic tests, digital health, and other devices to enhance the value of pharmaceutical products.Resolves complex regulatory issues, accelerating speed to patients and ensuring compliance with regulatory requirements.Developed precision medicine approaches, including integrated drug/diagnostic regulatory and submission plans, in collaboration with health authorities.Collaborates with global regulatory leads, regional strategists, and cross-functional teams to ensure high-quality collaboration and alignment.Represents the company in key interactions with health authorities, leveraging expertise in the regulatory process.Provides strategic input on key development documents and leads global regulatory submissions, including INDs, SRDs, Q-Submission, PMAs, MAs (EU), PSs (EU) and labeling for drug and diagnostic health products.

Oversee diagnostic regulatory portfolio and manage regulatory leads, supporting targeted oncology and general medicine pipelines, providing strategic guidance and mentorship on CDx co-development.Diagnostic regulatory lead for first in class therapy, sotorasib, to treat 2L+ NSCLC, that recently achieved simultaneous FDA approval for two companion diagnostics from distinct IVD partners.Collaborates with external partners to strategize global health authority fillings, including SRDs, CTA filings, pre-submissions, RTQ support and marketing authorizations.

Regulatory Affairs Manager specializing in in vitro diagnostics.

Executed validation studies and author FDA submission content for a qPCR based follow-on companion diagnostic for cetuximab and panitumumab. Developed and led cross-functional project plans for product validation and launch. Maintained company timelines and project goals by collaboration with manufacturing, quality control, regulatory and management.

Research was focused on generating cell models for Autism Spectrum Disorders (ASD) and Spinocerebellar Ataxia (SCA). I characterized neuronal development and disease phenotypes in relation to changes in RNA splicing. In addition to standard molecular and cell culture assays, I performed detailed RNA-Seq expression analysis along with generation of weighted gene co-expression network analysis (WGCNA). Additionally, I investigated potentially causative mutations identified from patient exome sequencing. Once identified, I characterized the molecular and developmental effects of the mutation. This allowed for identification of novel genes that can be utilized both for diagnosis and potential targets for therapy.

In Professor Susan Forsburg's lab, I investigated the role heterochromatin proteins play in DNA damage repair using the model organism Schizosaccharomyces pombe. During my research I used many cutting edge techniques to induce DNA breaks and visualize the results both microscopically and genetically. Understanding the mechanism of DNA damage repair is paramount to understanding the mechanism behind cancer formation. The triggering step for many cancers comes from DNA damage being improperly repaired causing a misregulation of important genes and RNA's. Additionally a number of human cancers have been associated with up or down regulation of a number of heterochromatin proteins.

I joined the Terrence Town Alzheimers lab in 2009. I was in charge of expanding and maintaining an extremely large mouse colony while also acting as lab manager. I bred, genotyped and catalogued mice, and maintained lab organization, supplies and daily business.

My previous research was conducted at Cedars Sinai Medical Center where I belonged to the Sumner Redstone Prostate Cancer Center. In this center I conducted many projects focused at understanding the roles of androgen dependent and independent tumor formation. These projects were carried out in mammalian cell cultures from mice, cell cultures from primary human tumor samples, and also in live murine studies.

Intern/Research Assistant: I began my role here as an intern with typical duties such as bottle washing, media/buffer making and plasmid preparations. I eventually was promoted to work on a project assaying the efficacy of in house compounds on pain/inflammation. Helped develop high throughput screening assays.