James Goss Email & Phone Number

Planned 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.

Morgantown, WV

• Provided 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.
• 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.

Pittsburgh, PA

• Facilitated and managed CROs and collaborator laboratories for all preclinical activities, including efficacy studies, toxicology / biodistribution studies, and drug delivery optimization studies in support of.
• 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.

Pittsburgh, PA

• Drafted 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.

Pittsburgh, PA

• As 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.
• 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.

• 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

Greater 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

Ph.D., Neurobiology

• Received the 1992 Walter Nicolai Award for Excellence in Research by a Graduate or Medical Student in the Field of Aging: American Aging.

B.S., Biology