Dan K. Email & Phone Number

Durham, Nc, Us

Durham, North Carolina, United States

Durham, North Carolina, United States

AskBio is a gene therapy company that covers a broad range of genetic diseases targeting central nervous system, muscle and heart tissues.Coordinate and manage research, proof-of-concept and GLP non-clinical & bioanalytical studies leading to filings of pre-IND packages, INDs and eventually BLAs for a broad array of projects in clinical development. Supervise a team of translational medicine scientists (Bioanalytical, Biomarker, Pharmacology and Pathology) and technicians in the conduct of preclinical and early clinical (Phase I/II) studies supporting rare disease, CNS (Parkinson's & Huntington's), and metabolic indications.Provide pharmacological insight (disease mechanisms, biodistribution/pharmacokinetics, protein targeting, etc) to R&D and Translational Medicine and clinical teams in development of new capsid and cassettes with the aim of providing the most effective vectors and streamlined strategies.

- Provide strategic regulatory safety guidance, including integrating non-clinical informationto appropriately time and design clinical studies to address safety related issues,in particular safety & efficacy interactions- Develop gap analysis to highlight safety concerns or regulatory guidance omissions prior to INTERACT, pre-IND and/or IND submissions- Design, execute and oversee protocol development from start to finish. Provideinterpretive guidance for strategic decision-making critical for safety, marketabilityand regulatory requirements.- Prepare IB/IND and attend type A, B and C meeting with FDA- Lead programs from Discovery through Phase I/II- Utilize extensive expertise in toxicology & DMPK to evaluate toxicokineticresponses and guide safety related issues (e.g. liver enzyme elevations, transportinteractions, etc).- Establish drug-drug interaction strategies and determine co-medication restrictionsrelevant to safety or efficacy.- Provide guidance on dosing related to human equivalent dose in Phase I studies and in special populations.- Capture non-clinical and clinical outcomes and fully integrate into regulatorydocuments (IND, NDA, MAA). Evaluate and author key sections of regulatorydocuments related to non-clinical and clinical safety and efficacy.- Prepare information related to safety and efficacy for presentation and response toregulatory agencies (briefing books, Advisory Committee, regulatory questions).- Serve on Medical Safety Review Group to determine safety profile prior to IRB review- Member of cell and gene therapy strategic initiative- Expertise with small molecules, biologics, cell/gene therapy, vaccines and peptides- Therapeutic areas: infectious disease, metabolism, oncology, ophthalmology, neurology, dermatology

Chapel Hill, Nc

Developed and Direct regulatory toxicology (TOX735) course that will furtherdevelop the students ability to apply their skills in a regulated environment• Chair the admissions committee and communicate with incoming students thestatus of their application• Collaborate with the director of the curriculum of toxicology, to ensure eachstudent has a faculty advisor and resources to be successful in the program• Provide a resource for students to ensure they have a breadth of knowledge intoxicology and the personal and professional skills to thrive in a rapidly changingwork environment• Contributing member of the PSM internal Advisory Board Meetings, ExecutiveCommittee meetings for the Curriculum of Toxicology, and External Advisory Board Meetings to ensure the program is constantly meeting the needs andrequirements of the business and scientific communities.• Ensure students maintain on-track for graduation

Doctor Of Philosophy - Phd, Pharmacology And Toxicology

Bachelor'S Degree, Biochemistry