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 contingency plans.• Ensured effective, accurate and timely communication of key issues and progress to the team and Sr. Management.• Lead an integrated product development program consisting of clinical, preclinical, chemistry, manufacturing and controls, and regulatory components.• Provided in-depth technical expertise and leadership• Managed external vendors to include but not limited to contract manufacturers, package and labelers, preclinical toxicology houses, and central laboratories• Authored regulatory documents including integrated product development plans and integrated summaries for NDA• Mentored staff in regulatory affairs and integrated product development.~90% Commercial clients, primarily small to mid-size biotech/pharmaceutical companies~10% Federal clients, National Institutes of Health Principal Investigator, Regulatory Affairs Consulting Services for National Institutes of Health, National Institute of Neurological Disorders and Stroke Biotechnology Products and Biologics; 2016 - 2021.

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 auditing/site visits of CRO's, preparation of statements of work, proposal review, study design, protocols, draft reports and project management. Preparation of briefing documents for FDA meetings and preparation for and participation in FDA meetings. Provide advice on scientific and regulatory issues for development programs.Led regulatory affairs support including integrated product development and nonclinical development for the following collaborations:- Global Alliance for Tuberculosis drug development programs- Eli Lilly Tuberculosis Initiative - National Institutes of Health, National Heart, Lung and Blood Institute, Science Moving toWards Research Translation and Therapy - Clinical and Translational Science Award, University of North Carolina - RTI - Antiretroviral-based Preexposure Prophylaxis Against HIV-1 Infection - Drug Development and Novel Delivery Systems - Bill and Melinda Gates Foundation - RTI International

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 Annual Reports.Designed and managed nonclinical development programs from candidate selection through post marketing for clients including protocol design, study monitoring, report review and integration of all nonclinical data with clinical program.Preparation for and participation in FDA meetings. Design and management of nonclinical development programs.Provide advice on scientific and regulatory issues for preclinical development programs.

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 briefing documents, INDs and Investigator Brochures.Participated in FDA meetings as nonclinical and regulatory representative.

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 IND-enabling studies to IND and exit. This program was licensed to Sanofi-Aventis. Responsible for conducting scientifict due diligence for more than 20 assets including in-licensing a molecule for wet age related macular degeneration. Identified gaps, created integrated development plan including clinical, CMC and nonclinal, selected and managed preclinical vendors for formulation development and IND enabling studies.

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 biomarkers for early indications of efficacy and toxicity in clinical studies. Received GSK Excellence in Science Award for scientific validation of projects in animal models and excellent ability to drive projects forward to milestone decisions. Prepared scientific manuscripts and documents for regulatory submissions.- Project Team Leader for several metabolic disease diabetes and obesity multidisciplinary product development teams from concept through Phase 2a clinical trials- Managed nonclinical group of toxicologists and scientists from discovery though post marketing- Nonclinical Representative for projects from concept through post marketing- Provided due diligence critical evaluation of several potential in-licensing assets contributing to in-licensing a few development stage assets- Liver and Adipose Focus Group leader- Metabolic Disease Target Identification and Literature Team leader- PPAR Investigative Pharmacology/Toxicology Team Leader- Safety Assessment Lead for Global Combinatorial Lead Optimization Program- Predictive Toxicology Team Lead- ILSI/HESI GW/GSK Safety Assessment representative Proteomics and Genomics in Risk Assessment Working Group- Nonclinical dose formulation focus group member

- 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 programs- Prepared regulatory documents to support project teams and regulatory filings-GSK Safety Assessment Representative for ILSI/HESI working group evaluating the use of genomics and proteomics in risk assessment.

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. Lester, Jr.. Preparation of water soluble cellulose acetate microspheres; Patent number: 4997599; August 1989.Thomas L. Steiner, Dana T. Minnick, Kenneth A. Domeshek, Donald H. Lester, Jr.. Water soluble cellulose acetate microspheres; Patent number: 4888420 , December 1989.