James Goss Email and Phone Number
James Goss work email
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James Goss personal email
I’m a neuroscientist with over 25 years of experience focused on using my varied skill set to advance and develop therapies to treat CNS and PNS disorders and expand our understanding of the brain and nervous system in general.
Stxbp1 Foundation
View- Website:
- stxbp1disorders.org
- Employees:
- 3
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Scientific DirectorStxbp1 Foundation Nov 2021 - Present
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Scientific Project ManagerGilbert Family Foundation May 2020 - Nov 2021 -
Director Of Preclinical DevelopmentInternational Partnership For Microbicides Nov 2017 - Dec 2019Planned and monitored preclinical studies to evaluate biological activity of candidate microbicide drugs and microbicide drug / device combinations for HIV prevention. Provided preclinical support for European Medical Agency (EMA) and U.S. Food and Drug Administration (FDA) regulatory filings. -
Senior Scientist - BiologicsMylan Sep 2016 - Oct 2017Morgantown, WvProvided pharmacology and toxicology support for global research and preclinical development of biologics and biosimilars. Collaborated with Mylan team members in global regulatory submission and support for biologics and biosimilars including CTD submissions, INDs, NDAs and ANDAs, BLAs and ABLAs.• Supplied preclinical support for 2 biosimilars that received FDA approval.• Represented Mylan as preclinical subject matter expert (SME) for FDA advisory committee review of a biosimilar that received a unanimous positive vote.• Provided written qualifications and Acceptable Daily Exposure (ADE) monographs used for cleaning validations in drug manufacturing. -
Vice President, Neuroscience And Preclinical DevelopmentPeriphagen Inc Nov 2012 - Sep 2016Pittsburgh, PaFacilitated and managed CROs and collaborator laboratories for all preclinical activities, including efficacy studies, toxicology / biodistribution studies, and drug delivery optimization studies in support of PeriphaGen’s Neuronal Therapeutic (NET) gene therapy drug delivery platform. Directed and guided research laboratory personnel.• Collaborated with PeriphaGen team members in development of new HSV-based drug delivery platform, filing of intellectual property documentation, and drafting of regulatory filings including Pre-IND. • Met with and presented to potential investors, partners, bankers, and KOLs, resulting in $6M series A funding.• Worked with local animal vendor / CRO to allow PeriphaGen to conduct ‘in-house’ preclinical animal experiments, which significantly increased speed of drug development at substantially decreased costs.• Established data room and drafted study reports for potential partnering. Performed due diligence for potential company merger.• Oversaw / analyzed vector / viral sequencing in support of drug manufacturing and certification. -
Director Preclinical DevelopmentDiamyd Medical Feb 2011 - Nov 2012Pittsburgh, PaDrafted regulatory filings, including Pre-IND, IND, FDA Annual Reports, clinical trial protocols, and statistical analysis plans in support of Phase I and Phase II clinical trials for gene therapy to treat chronic pain.• Evaluated potential clinical sites in support of Phase II study, trained clinical sites on preparation and application of lead candidate drug for Phase II study. -
Research Assistant ProfessorUniversity Of Pittsburgh Apr 1998 - Feb 2011Pittsburgh, PaAs a faculty in first the Department of Neurology and then Molecular Genetics and Biochemistry, conducted basic and applied research primarily focused on developing a Herpes Simplex Virus (HSV)-based gene delivery platform for the treatment of neurological disorders. Taught undergraduate and graduate courses.• Collaborated with team of virologists, engineers, and neurologists to develop HSV-based gene delivery platform that provided the basis for similar gene therapy drugs developed at Diamyd and Periphagen.• Established several animal models of neurological disorders including acute and chronic pain, neurodegeneration, and peripheral neuropathy used to establish efficacy of several gene therapy drug candidates.• Created large animal (swine) model of diabetic peripheral neuropathy that closely mimics the human condition as a better surrogate for drug development and testing compared to other preclinical models.• Brought in over $5M in public and private grant monies as Principal Investigator or Co-Principal Investigator. -
Research BiologistVeterans Health Administration Aug 2002 - Jun 2004• Conducted research on HSV-based gene transfer vectors that lead to novel treatments for chronic pain and neuropathy caused by diabetes or chemotherapeutic agents.• Served as Chair, Safety/Biosafety Subcommittee and instituted first annual laboratory safety inspections
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Research Associate, Dept. Of PsychiatryUniversity Of Pittsburgh Oct 1992 - Mar 1996Greater Pittsburgh Area• Conducted research on neurotrophic factor expression in the brain that demonstrated potential negative effects of whole body hypothermia that was currently being tested as a treatment for traumatic brain injury.• Developed whole genome method to identify and clone differentially methylated genes
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Graduate Student In NeurobiologyUniversity Of Southern California 1985 - 1992
James Goss Skills
James Goss Education Details
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Neurobiology
Frequently Asked Questions about James Goss
What company does James Goss work for?
James Goss works for Stxbp1 Foundation
What is James Goss's role at the current company?
James Goss's current role is Scientific Director, STXBP1 Disorders Foundation.
What is James Goss's email address?
James Goss's email address is ja****@****myd.com
What schools did James Goss attend?
James Goss attended University Of Southern California, Michigan Technological University.
What skills is James Goss known for?
James Goss has skills like Neuroscience, Drug Development, Clinical Development, Clinical Trials, Clinical Research, Life Sciences, Molecular Genetics, Animal Models, Molecular Biology, Cell Culture, Biotechnology, In Vivo.
Who are James Goss's colleagues?
James Goss's colleagues are Cristina Brennan.
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