Angela Noah, Ph.D. Email and Phone Number

• Coordinate and prepare product submissions for FDA and other major market regulatory agencies.• Provide support to market-released products as necessary. This includes reviewing labeling, promotional materials, product/manufacturing process changes and documentation for changes requiring government approval. Assist in the preparation of periodic reports for FDA and other major market regulatory agencies as required by product status. • Develop and create regulatory strategies to ensure business goals are met.• Interface with governmental agency on projects/products. Negotiate directly with FDA at the reviewer level, as needed.• Review advertising and promotional materials.

I received my Ph.D. degree in Molecular Cancer Biology. I was a member of Dr. Gerry Blobe's lab where I studied the regulation of heparan sulfate proteogylcan-mediated signaling and differentiation in high-risk neuroblastoma models. High-risk neuroblastoma patients have a very low survival rate and a high tendency for relapse. Current treatments are largely ineffective due to drug resistance and poor understanding of disease subtypes. Agents currently in clinical trials show promise, though combination therapies will likely be necessary. Heparan sulfate proteoglycans (HSPGs) play a major role in promoting neuroblast differentiation and my project aims to understand how these HSPGs are regulated in order to inform the use of epigenetic-targeted therapies for high-risk patients. During my time in the lab, I identified a new stromal-derived factor that was suppressed in high-risk neuroblastoma patients. This factor normally functions to promote neuroblast differentiation. This work informed the use of several targeted agents that could be combined to inhibit neuroblastoma tumor growth in mouse models of neurolastoma.PROJECTSOngoing: Epigenetic regulation of neuroblast differentiation in neuroblastomaIn Revision: Role of heparin-binding EGF-like growth factor in neuroblast differentiation Published: Role of stromal heparins in neuroblast differentiation in neuroblastoma Published: Role of TβRIII in FGF2-induced differentiation in neuroblastomaAdditionally, I mentor an undergraduate student and a 3rd year medical student, as well as organize their research projects and assist with generation of both written and oral presentations for poster sessions and lab meetings.

I edit abstracts and titles of accepted articles to ensure the format, content, and grammar fit the standards of The Journal of Clinical Investigation. I also write "Scientific Show Stoppers" with the goal of summarizing accepted articles for those without in depth knowledge of the subject matter. Writing samples:http://www.jci.org/posts/240http://www.jci.org/posts/242http://www.jci.org/posts/258http://www.jci.org/posts/263http://www.jci.org/posts/274http://www.jci.org/posts/278

I attended weekly online seminars to learn more about device development and regulations and completed a practice IDE to learn how to prepare these complex documents per FDA regulations. I also reviewed archived IDE submissions, FDA correspondence, and FDA guidances.

I reviewed archived investigational drug and device submissions to the FDA in order to increase knowledge of FDA regulations for the healthcare industry. Further, I completed a practice IND submission to learn how to put together these complex documents according to FDA regulations. I also attended an International Review Board meeting to discuss new drug and device submissions, as well as how patients’ rights are protected in clinical research studies per FDA recommendations.

I developed projects, designed and completed experiments, analyzed data, and wrote manuscripts; attended and presented at weekly lab meetings, attended seminars, and presented at a breast cancer journal club. I also ordered supplies, supervised an undergraduate student, and oversaw lab organization.PROJECTS-Published: Characterization of progesterone receptor hinge region-Published: Estrogen receptor/progesterone receptor/insulin-like growth factor receptor 1 crosstalk and regulation in breast cancer cells

I stocked supplies, made buffers, and managed overall lab organization, as well as performed experiments for graduate students which involved keeping a detailed lab notebook.PROJECTS-Published: Characterization of progesterone receptor hinge region

I instructed several classes of elementary students about neuroscience.