Simon Mazza-Lunn
Director of Program Management @ Myrobalan Therapeutics
About
I have over 15 years’ studying and developing therapies across multiple indications, focusing on neurological and rare diseases. I have led and managed teams in contract research and project management organizations to develop therapeutics from hit through IND-ready, with a strong background in cell biology, stem cell biology and regenerative processes. I have worked in start-ups and company formation for 10 years working to apply industry standard drug development project management solutions to facilitate program progress. As a Director R&D Project Manager, I work with stakeholders to develop project plans, budgets, and track risks. Working in remote outsources echo systems I work to manage CROs and vendors to design and tract study activities. I am a dynamic communicator with exceptional interpersonal skills who enjoys mentoring and building strong teams. Scopus Author profile http://www.scopus.com/authid/detail.url?authorId=9041746700
United States
Columbus
Biotechnology
Smartsheet, Gantt, Data Analysis, Drug Discovery, Project Planning, Problem Solving, Research and Development (R&D), Program Management, Research Skills, Cell Culture, Cell, Cell Biology, Molecular Biology, Immunohistochemistry, Research, Stem Cells, Life Sciences, Biochemistry, Confocal Microscopy, Western Blotting
Experience

Director, R&D Project Management
• Facilitate and lead 3-4 R&D programs • Develop R&D strategy, project plans and budgets to major milestones with cross-functional stakeholders • Track project progress, risks and deliverables. • Work with CROs to design, and execute studies • Develop project management tools for adoption across the company • Report and present findings to leadership.

Project Manager
Harrington Discovery Institute at University Hospitals
Cleveland, Ohio
Responsible for the coordination of academic grant awardees and drug discovery experts as part of an interdisciplinary team to accelerate drug discovery pipelines. Conduct strategic and project planning, track project metric and conduct reporting. Disease and modality agnostic with a strong focus on neuroscience and rare disease portfolio management.

Director of Laboratory Operations
Renovo Neural Inc.
Cleveland/Akron, Ohio Area
• Directing and providing scientific and technical leadership for overall client based activities in support of CRO functions • Ensure a high quality of service and effective operation in in vivo animal studies, in vitro cell drug screening assays, histological and 3D electron microscopy services • Coordinate with Business Development personnel to establish study proposals and timelines • Evaluating, interpreting and reporting study findings • Prepare and review standard operating procedures, performance evaluations, work schedules, recruitment, orientation, employee development and retention.

Scientist II / Laboratory Manager
Renovo Neural Inc.
Cleveland/Akron, Ohio Area
There is a critical need to develop therapies that target the remyelination of axons following injury in multiple sclerosis. The goal of this work is to evaluate remyelination and neuroprotection following interventions in our models of multiple sclerosis. Lab Operational Management: • Project Management; resource management, timelines, quality control, data interpretation, data summary and report building for client projects. • Consult on client study design including feasibility and scientific rationale. • Ensure high quality immunohistochemistry staining as part of Renovo’s service portfolio. • Implemented protocols to increase productivity including project summaries, schedules, SOPs, and laboratory organization. • Manage and coordinate all IACUC related functions. • Managed and mentor a team of 10 direct reports to complete experimental endpoints covering both in-life and tissue processing phases of projects. Research and Discovery: • Conduct primary culture of mouse and rat neurons and oligodendorcytes to perform small molecule high content screening (HCS). • Develop new assays as part of R&D including HCS dorsal root ganglion:oligodendrocyte co-cultures and neurite outgrowth assays. • Mentored postdoc scientists developing new assays including primary slice culture assays. • Work with imaging specialist to develop new automated methods for image analysis. • Direct experience working with automated systems including; Cellomics automated plate reader, AxioScan and Mirax slide scanner.

Director of Stem Cell Operations
Ann Arbor
Michigan ALS Consortium, Director (2012 – 2014) Spearheaded the creation of a BioBank to provide viable biological samples from patients suffering with ALS. The BioBank contains primary fibroblasts, lymphocytes, and blood derivatives from individuals with sporadic and familial ALS to facilitate the development of therapeutic options. • Developed and implemented standard operating protocols, budgets, and coordinated vendor services and procurement. • Coordinate the review of applications, dissemination of information and samples with scientists who apply to receive samples for research use. • Develop relationships with scientists to discuss available samples. • Initiated active collaborative projects and internal research projects. • Successfully obtained funding to support operations for four years. Primary research program, Research Specialist (2009-2014) Conceptualized and launched innovative research program to evaluate the therapeutic potential of four novel stem cell lines as cellular therapies for ALS in collaboration with industry partners. Primary research question focused on the benefits of combining stem cell therapies with growth factor treatments to promote neuroprotection. • Develop and manage collaborative relationships with research partners to facilitate the successful completion of research goals in a timely manner. • Serve as program liaison and initial point of contact for all research initiatives. • Designed and executed experimental pipeline for multiple cell lines. • Directly mentored junior Post docs including project design, and data interpretation Key skills: Biobanking, standardized procedures, human sample collection and culture, organization, science communication.

Postdoctoral Fellow
University of Michigan
Initiated, planned and led multiple research projects to investigate the cellular and molecular mechanisms and potential therapies for significant neurological diseases such as Amyotrophic Lateral Sclerosis (ALS) and Alzheimer’s disease. Post-translational modifications of TDP-43 in disease Hypothesis: Increase TDP-43 SUMOylation leads to increased protein stability and the formation of TDP-43 stress granules leading to the accumulation of intracellular aggrigation • Create a novel mES cell line with doxycycline inducible expression of various TDP43 constructs • Focus on SUMOylation and Ubiquitination of TDP-43 during formation of aggregations. Development of cellular therapies for ALS Hypothesis: Combining cellular therapies with enhanced growth factor production increase the therapeutic potential of stem cell therapies. • Characterized human neural progenitor cell lines including; proliferation, differentiation and sensitivity to cellular stress in response to growth factor treatments. • Key findings in this study supported the application of both phases 1 & 2 FDA approved clinical trial for ALS. In situ reprogramming of stem cells in the spinal cord Hypothesis: Overexpression of Neurogenin1 is sufficient to drive in situ differentiation of mES. • Intraspinal injection of mES in rat spinal cord • Demonstrated the de novo tissue generation of appropriate spinal cord lineages from mES in the rat spinal cord. Role of growth factors in protecting motor neurons in ALS Hypothesis: VEGF is a potent neuroprotective therapeutic agent to prevent motor neuron loss in ALS. • Tested the neuroprotective effect of AAV and lenti overexpression of a zinc finger transcription factor that leads to the expression of the full biological array of VEGF isoforms in primary rat motor neurons • Assessed slow release polymer based delivery of VEGF to protect primary motor neurons from excitotoxic stress and in a G93A SOD1 in vitro model of ALS.

Postdoctoral Research Fellow
Post
University of Michigan
Center for Organogenesis Non-traditional Research Fellow The role of EphrinA5 in axon guidance into the limb Training fellowship to gain expertise in axon guidance and demonstrate the relationship of EphrinA5 in neuronal projection to the limb. Design and validate shRNA knockdown of EphrinA5, develop skills in electroportaion of the chick limb. Key Skills: Chick embryogenesis, molecular biology, shRNA, electroporation, in situ hybridization

Ph.D Student
Investigation into the role of MAPK signalling during neural induction in the chick. This project focused on discovering and characterizing a novel feedback mechanism to regulate MAPK signaling during the formation of the neural plate. Skill set included: Embryology IHC In Situ hybridization micro dissection Cell culture
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