Experience

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  Howard hughes medical institute (hhmi)

  May 2003 - Aug 2003

  Summer undergraduate researcher

  Studied the effect of mutations on the Cdk5 phosphorylation site of Presinilin on Amyloid Precursor Protein (APP) cleavage using cell culture, transfection, and western blotting methods.

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  Florida state university

  Sept 2004 - Jun 2005

  Conducted Direct Individual Studies for course credits. Projects focused on studying the role of individual differences in responses to cocaine following a stressor. Also performed studies comparing the rewarding effect of cocaine between adult and adolescent rats and how this correlates with the expression of an early-activating gene in the brain (using conditioned place preference, rtPCR and in situ hybridization). This work resulted in one first-author publication and first-author poster at a national conference and one publication as a co-author. Show less

  • Undergraduate Researcher

    Sept 2002 - Jun 2005

  • Lab Technician

    Sept 2004 - Apr 2005
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  Emory university

  Aug 2005 - Dec 2011

  Graduate research assistant

  My dissertation work examined the mechanism of action of disulfiram (Antabuse), a potential pharmacotherapy for the treatment of addiction disorders, with limited clinical utility given its multiple pharmacological targets. This work suggested a selective molecular target and strategy as an addiction pharmacotherapy (dopamine beta-hydroxylase inhibition), currently tested in nation-wide clinical trials. Used behavioral pharmacology (radioligand binding assays, HPLC, microdialysis), molecular biology (western blotting, cAMP assays, immunohistochemistry), and systems neuroscience techniques (brain cannulation, intracranial infusions). Wrote and edited manuscripts, grants, and grant progress reports. Dissertation work resulted in 1 funded NIH individual training grant, 3 first-author peer-reviewed publications and one first-author review article on addiction therapeutic strategies. Work on collaborations resulted in 3 peer-reviewed publications as a co-author. Presented 6 posters and 2 talks at international conferences. Trained and supervised junior graduate students, 4 undergraduate students, including assistance with their senior thesis projects. Teaching service includes K-12 neuroscience education in the classroom (4-8 hours/semester), lab tours, and serving as a teaching assistant in 2 graduate courses (Biological Basis of Neurological Disease and Statistics for Experimental Biologists). Show less

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  University of maryland, baltimore (umb)

  Jan 2012 - Jan 2014

  Postdoctoral fellow

  Used whole-cell patch-clamping to characterize induced neurons derived from patients with metabolic diseases with neurological symptoms and clinical addiction phenotypes. Assisted in the writing of one manuscript as a co-author. Presented posters at two international conferences. Teaching service includes lab tours and serving as a judge at the NIH STEP-UP (Short-Term Education Program for Underrepresented Persons) Scientific Research Symposium.

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  The national institute on drug abuse (nida)

  Mar 2014 - Dec 2014

  Scientific director scholar/postdoctoral fellow

  Neuronal Networks SectionUsed neuroanatomical tracing techniques, in situ hybridization, and whole-cell patch-clamping to examine phenotypic cell diversity in reward-related neuronal circuits.

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  Coté orphan llc

  Jan 2015 - Jan 2017

  Senior regulatory science specialist

  Helped biotech and pharmaceutical companies successfully navigate FDA and EMA regulatory processes by providing regulatory consulting services. These included Agency submissions such as orphan designation applications, breakthrough therapy designations, pediatric priority review designations, INDs, communications and meetings with the FDA and EMA, and regulatory strategic planning. Specialized in orphan (rare) diseases.

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  University of maryland, baltimore (umb)

  Jan 2017 - Oct 2019

  I work within the Office of Technology Transfer (OTT) and the recently-established Institute for Clinical and Translational Research (ICTR) at UMB. My main goal is to facilitate the translation of academic research into the clinic and into commercial opportunities. To do so, I help evaluate the commercial potential of university discoveries and establish and manage strategic relationships between university and industry partners. I also help identify UMB collaborators, specialized equipment, and sources of internal and external funding. Show less I evaluate the commercial potential of university discoveries and products to ensure the university optimizes and protects its materials and discoveries; research, develop, and author non-confidential summaries for marketing university intellectual properties; identify and develop new strategic business opportunities and relationships between university and industry partners and manage these corporate alliances to ensure productive collaborations, and; contribute to initial business plan development for potential university-based start-up companies. Show less

  • Research and Alliances Officer

    Jul 2018 - Oct 2019

  • Technology Licensing Analyst

    Jan 2017 - Oct 2019
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  Dunn regulatory associates, llc

  Oct 2019 - Mar 2021

  Associate director regulatory affairs

  • Coordinated with industry scientists and pharmaceutical officials and provide regulatory support to facilitate applications for approvals and permits from US and European regulatory agencies • Provided FDA meeting support to sponsors• Establish and implement regulatory strategy and ensure milestones are met with quality, compliant deliverables• Storyboard/identify key messages for global product development strategy• Medical writing: investigator’s brochures, clinical study reports, protocol development • Regulatory writing: core submission preparation and authoring with focus on nonclinical and clinical modules (INDs, BLA, expedited review programs, meeting requests, briefing books, information amendments)• Led the successful, timely submission of a subsequently approved BLA, including project management, compilation of administrative modules, and authoring and reviewing Module 2 nonclinical and clinical summaries and Module 5 clinical study reports. Show less

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  Biogen

  Apr 2021 - May 2024

  Associate director, us regulatory lead

  • Responsible for US regulatory strategy for 3 drugs in development, incorporating US regulatory strategies into global strategies as they are developed • Primary indications in mood disorders, movement disorders, and neurodegeneration • US Regulatory Lead for one approved NDA ▪ Primary contributor to regulatory strategy and content planning ▪ Review and approval of nonclinical, clinical, and administrative documents ▪ Author, review, and coordinate responses to information requests • Contribute to the Regulatory Product Team and Product Cross Functional Teams with US regulatory framework knowledge, global strategy coordination, and sharing awareness of external regulatory initiatives • Responsible for FDA submissions and key direct contact for FDA interactions, leading FDA interactions, disseminating feedback internally, assessing the feedback, and outlining next steps • Storyboard/identify key messages for global product development strategy • Work on programs partnered with other Sponsors, as co-development partners; continuously engage multiple cross-functional external stakeholders and support alliance management activities to drive alignment cross companies and ensure milestones are met per collaboration agreement timelines Show less

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  Novo nordisk

  Jun 2024 - now

  Director, global regulatory lead