Brandon Burch

Experience

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  University of North Carolina at Chapel Hill Institute of Marine Sciences

  Jan 1998 - Jan 1998

  Research Intern

  I worked in the laboratory of Dr. Charles H. Peterson at the University of North Carolina Institute of Marine Sciences. During this time, I gained broad experience in marine biology, including work on projects focused on oyster reef restoration, population sampling of crustaceans, bivalves, and fish, beach profiling, aquaculture, and others.

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  University of North Carolina at Chapel Hill Institute of Marine Sciences

  Jan 1999 - Jan 1999

  Laboratory Technician

  I worked in the laboratory of Dr. Charles H. Peterson at the University of North Carolina Institute of Marine Sciences, with my research focusing on the benthic ecology of saltwater marsh environments, specifically on the effect of the benthic environment on predation and juvenile recruitment of the bay scallop. During this time, I performed field experiments, including construction of experimental hardware and models, data collection, and data analysis. I also processed and analyzed samples in the laboratory and participated in aquacuture of mollusks and crustaceans. While in this role, I personally developed and implemented a novel method for marking bivalves for release and recapture experiments, which was subsequently adopted as a method of choice for this application by other researchers. Show less

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  East Carolina University

  Jan 2001 - Jan 2003

  My research focused on phenotypic and biochemical/enzymatic characterization of complete, active photosystems purified from site-directed cyanobacteria mutants. During this time, I gained experience with protein purification techniques, oxygen evolution assays, photoinactivation assays, spectrophotometric structural assays, bacterial and cyanobacterial cell culture, molecular cloning, site-directed mutagenesis, and western blotting. This work led to a first author publication (Burch et al., Artificial Photosynthesis, 2012). During this time, I also mentored undergraduate and graduate students in the lab. Show less

  • Graduate Research Assistant

    Jan 2001 - Jan 2003

  • Graduate Teaching Assistant

    Jan 2001 - Jan 2001
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  University of North Carolina at Chapel Hill

  Jan 2003 - Jan 2004

  Graduate Research Trainee

  My research was divided among three different labs, including the labs of Dr. Albert Baldwin, Dr. Terry A. Van Dyke, and Dr. William F. Marzluff. My research in Dr. Baldwin's lab, which studies cell signaling as it pertains to cancer and cancer therapy, focused on purification of HIV Tat protein and included experience with protein purification techniques, western blotting, and mammalian cell culture. In Dr. Van Dyke's lab, which studies cancer mechanisms utilizing mouse models, I performed experiments to characterize olfactory bulb tumors related to astrocytomas in an effort to better understand the nature of this type of brain cancer. This work gave me experience with immunohistochemistry, histological slide preparation, tissue staining, and microscopy. My work in Dr. Marzluff's lab, which has interests in all aspects of histone mRNA metabolism, focused on better understanding histone pre-mRNA processing using Drosophila cultured cells as a model. During this time, I gained experience with RNA interference, western blotting, S1 nuclease protection assays, flow cytometry, fluorescence microscopy, and insect cell culture, among others. Show less

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  University of North Carolina at Chapel Hill

  Jan 2005 - Jan 2010

  My research focused on identification and characterization of histone pre-mRNA processing factors in Drosophila melanogaster. During this time, I utilized many biochemistry and molecular biology techniques including DNA, RNA, and protein purification, RT-PCR, S1 nuclease protection assays, western blotting, in vitro transcription and translation, immunoprecipitation, fluorescence and confocal microscopy, and many others, as well as cell culture and fly culture. I also participated in a high-throughput, genome-wide RNAi screen at Harvard Medical School that led to a first author publication (Wagner and Burch, et al., Molecular Cell, 2007). I had three total publications during this period, including one first author publication. I also served as a research mentor for five student researchers. Show less

  • Laboratory Manager

    Jan 2007 - Jan 2010

  • Graduate Research Assistant

    Jan 2004 - Jan 2010

  • Graduate Teaching Assistant

    Jan 2005 - Jan 2005
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  University of North Carolina at Chapel Hill

  Aug 2010 - Apr 2011

  Postdoctoral Researcher

  Project: "Characterization of Drosophila FLASH and its role in histone pre-mRNA processing." Mentors: Dr. William F. Marzluff and Dr. Zbigniew Dominski, UNC Program in Molecular Biology and Biotechnology. The focus of my postdoctoral research was on characterization of the histone pre-mRNA processing factor FLASH (Burch et al., RNA, 2011, Yang et al., MCB, 2011). I created site-directed and deletion mutations in Drosophila melanogaster FLASH and its binding partner and fellow processing factor, Lsm11, and defined critical amino acid residues required for the interaction of these proteins in vitro and for the proper localization and mRNA processing activity of FLASH in cultured cells (Burch et al., RNA, 2011). I participated in reporter-based functional screening of factors identified in a genome-wide RNA screen (Wagner and Burch, et al., 2007) for factors required for formation and stability of a subnuclear structure known as the histone locus body (White et al., JCB, 2011), as well as in efforts to characterize the U7 snRNA processing reaction (Ezzedine et al., 2011). In total, I had four publications during this time, including one first author publication. I also served as a research mentor for a graduate student researcher. Show less

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  UNC Department of Medicine

  Sept 2011 - Apr 2014

  Postdoctoral Research Fellow

  Project: "Understanding Human Immunodeficiency Virus-1 (HIV-1) latency using RNA-based approaches." Mentor: Dr. David M. Margolis, UNC Department of Medicine, Center for Infectious Diseases. My projects involved creation of novel HIV transcriptional reporters, identification of biomolecules involved in HIV latency, and the establishment and optimization of human primary lymphocyte models of HIV latency. I also mentored two student researchers, assisted with several collaborative projects within the lab, and served as laboratory webmaster. Show less

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  Nuventra Pharma Sciences

  May 2014 - Dec 2021

  - Lead scientific writing activities, including regulatory and clinical documents, required to support Client programs.- Manage the preparation, review, QC, and formatting of IND, NDA, and BLA sections (administrative, clinical, nonclinical, and CMC), Investigator Brochures, FDA meeting requests and briefing packets, pediatric study plans, orphan applications, and other documents.- Manage the writing, editing, and review of strategic plans, clinical study reports, study protocols, investigator brochures, and data summaries.- Participate in meetings with regulatory authorities to further client drug development programs.- Perform on-site program audits for clients (clinical, nonclinical, CMC) and prepare gap analysis reports.- Work with pharmacokineticists and clinical pharmacology consultants to write PK/PD deliverables for clients.- Assist in development of statistical and PK analysis plans and support production of standalone PK/PD reports that can be appended to clinical study reports.- Develop, implement, and manage templates required for document standardization. - Author and review internal SOPs.- Perform literature searches/reviews as needed to obtain background information for development of documents.- Maintain up-to-date training on cGLP regulations, appropriate company SOP's and guidances.- Function as the point of contact for regulatory agencies for clients needing such service.- Manage project deliverables, milestones, and resource allocation across multiple projects- Track project scope, budgets, and timelines- Lead both internal and client-centered meetings and teleconferences- Supervise subcontractor and outside professional service activities- Proactively work to prevent or otherwise seek resolution to any issues arising on a project- Act as a primary point of contact for clients and internal team members across multiple projects- Assist with developing proposals and change orders for clients Show less - Proactively manage project deliverables, milestones, personnel, and resource allocation across multiple projects- Track project scope, budgets, and timelines- Serve as a member of project teams, including participation in writing reports for clients and leading both internal and client-centered meetings and teleconferences- Supervise subcontractor and outside professional service activities- Proactively work to prevent or otherwise seek resolution to any issues arising on a project- Act as a primary point of contact for clients and internal team members across multiple projects- Assist with developing proposals and change orders for clients- Maintain current knowledge of PK and PK/PD science, regulatory guidance documents, FDA rulings, cGLP regulations, internal SOPs, and internal working practices, and help to author and edit internal SOPs and working practices- Assist with development of strategic advice for clients on clinical pharmacology trials and overall early phase drug development activities- Assist in development of statistical and PK analysis plans and standalone PK/PD reports- Actively participate in the authoring, review, QC, and formatting of clinical protocols, clinical study reports, clinical pharmacology strategic plans, investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), investigator brochures (IBs), FDA meeting requests and briefing packets, and other clinical and regulatory documents. Show less

  • Director, Scientific Writing and Regulatory Affairs

    Sept 2020 - Dec 2021

  • Associate Director, Scientific Writing and Regulatory Affairs

    Jan 2018 - Sept 2020

  • Senior Manager, Scientific Writing and Regulatory Affairs

    Apr 2017 - Dec 2017

  • Manager, Scientific Writing and Regulatory Affairs & Project Management Specialist

    Oct 2015 - Apr 2017

  • Project Management Specialist & Clinical Pharmacology Associate in Drug Development

    May 2014 - Sept 2015
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  CATO SMS

  Jan 2022 - Jul 2022

  Director, Medical Writing, and Regulatory Affairs Consultant
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  Kriya Therapeutics, Inc.

  Jul 2022 - now

  • Vice President, Regulatory Affairs

    Apr 2024 - now

  • Program Team Lead - Type 1 Diabetes

    Jun 2023 - now

  • Senior Director, Regulatory Affairs

    Jul 2022 - Apr 2024