Dana Minnick Email & Phone Number

Cary, NC, US

Herndon, Virginia, US

Durham, North Carolina, US

• Responsible for participating in business development activities, program management support and education within the company.
• Provided leadership, guidance and support to a team, program, or project of large scope, as well as to the Program Management discipline within the company
• Proactively identified and critically analyzed problems affecting the programs.
• Develops viable and long-lasting solutions to cross-program, cross-functional or organizational issues.
• Developed contingency plans as needed.
• Facilitated achievement of strategic goals for a program. Monitored ongoing progress of key deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and.

Research Triangle Park, NC, US

Managed drug development programs through marketing authorization. Regulatory supportDesigned and managed drug development programs to support regulatory submissions. Preparation of position papers, INDs, Investigator Brochures, Orphan Drug Designation applications, Fast Track Designation applications, and Annual Reports. Managed nonclinical CROs including.

Preparation of position papers to support regulatory submissions.Safety assessment / qualification of impurities, excipients, degradants, leachables and extractables.Preparation of nonclinical summaries for Investigator Brochures, carcinogenicity waivers, Special Protocol Assessment for carcinogenicity studies, nonclinical sections for INDs, NDAs, and.

Durham, NC, US

Responsible for regulatory, non clinical safety assessment and DMPK strategy and management of IND enabling studies through Phase 2b.Led the design and conduct of nonclinical development programs for an CYP51 inhibitor small molecule for onychomycosis and a CYP 17 inhibitor small molecule for prostate cancer. Prepared nonclinical sections for preIND.

Evaluated in-licensing opportunities and oversaw in-licensed assets beginning with drug discovery through IND to exit. Managed relationships with CRO vendors including selection, study monitoring, evaluation and budget. Successfully led the integrated drug development for collaborative diabetes program with CureDM including nonclinical safety assessment.

Brentford, Middlesex, GB

Led multi-site multidisciplinary matrix drug discovery and development teams from concept through candidate selection and proof of concept clinical trials for Metabolic Diseases. Provided critical evaluation of new therapeutic opportunities. Designed, conducted, and interpreted nonclinical development and research programs. Assessed PD/PK relationships and.

Brentford, Middlesex, GB

- Study director GLP toxicology studies- Developed and validated medium to high throughput in vitro genetic toxicology and in vivo general toxicology studies with focus on triaging scaffolds and molecules to select best molecules to move forward - Designed and directed general, investigative, and genetic toxicology studies and nonclinical development.

US

Focus of group was to identify and develop pesticide targets and develop gene transfer technologies in tobacco. Led group focused on assay development for high throughput screening, and gene transfer into Tobacco nicotiana via gold particles for gene expression and protein purification. Left for position at GlaxoWellcome.

Bench to pilot plantDeveloped cellulose acetate microspheres for various applications including control release matrix (water soluble microspheres), adsorption to carbon loaded matrix, and enzyme immobilization. Left position to attend graduate school.Two patents resulted from this work: Thomas L. Steiner, Dana T. Minnick, Kenneth A. Domeshek, Donald H..

Phd, Toxicology

Clinical Research

Irta Fellow

Ba, Biology