William K.

President

Country

United States

City

Liberty

Industry

Pharmaceuticals

Skill

Toxicology, Drug Development, Product Development, Drug Discovery, Due Diligence, Pharmacology, Clinical Development, Biomarkers, IND, FDA, Biotechnology, Regulatory Affairs, Pharmaceutics, Pharmaceutical Industry, Immunology, Clinical Study Design, Grants, Neuroscience, Lifesciences, Oncology

Experience

President

LeadingEdge Pharmtox, LLC

2023-10 - Present · 3 yrs

Kearney, MO

Drug development expert focusing on nonclinical small and large molecule drug development, regulatory submissions, and nonclinical issues resolution.

Nonclinical and Regulatory Program Lead

DermDefense Inc

2015-1 - Present · 11 yrs 9 mos

Drug development company focusing on medical countermeasures to sulfur mustard exposure to protect the war fighter from skin, ocular, and pulmonary injury. The Animal Rule will be used to request regulatory approval.

Professor of Pharmacology, Toxicology & Therapeutics (Adjunct Volunteer)

University of Kansas Medical Center

2017-3 - Present · 9 yrs 7 mos

Kansas City, Missouri Area

Nonclinical and Early Development Strategy

OncoBay Clinical (now Kapadi)

2022-6 - 2025-9 · 3 yrs 4 mos

Florida, United States

Vice President, Nonclinical Development

Elevar Therapeutics

2021-9 - 2022-6 · 10 mos

Kansas City, Missouri, United States

Senior Director, Nonclinical & Early Clinical Development

Voisin Consulting Life Sciences (VCLS)

2020 - 2021-9 · 1 yr

Lenexa, Kansas, United States

Nonclinical subject matter expert in biologics, small molecules, cell and gene therapy, oncology, medical countermeasures, dermatology. I am looking forward to helping you advance your drug development programs.

Principal Consultant

Parexel

2018-1 - 2019-12 · 2 yrs

Kansas City, Kansas

Nonclinical subject matter expert in cell and gene therapy, biologics, oncology, enzyme replacement therapy, medical countermeasures, dermatology.

Director, Executive Consultant

Cardinal Health

2013-12 - 2017-12 · 4 yrs 1 mo

Overland Park, Kansas

Grant Writing, Regulatory Program Management, Regulatory Submissions. Enzyme Replacement Therapy Programs (Rare and Orphan Disease Space) CAR-T Program Management, Nonclinical & Regulatory Excipient, Impurity, and Degradation Product Issues

President

Leading Edge PharmTox

2012-7 - 2015-11 · 3 yrs 5 mos

Durham, North Carolina

President- providing preclinical and clinical drug development, due diligence and partnering strategy expertise PRECLINICAL EXPERTISE • Preclinical program planning and study designs • Managing CRO and vendor selection • Managing study execution and report completion • Preclinical issue resolution and gap analysis • Pharmacology, ADME/PK, safety pharmacology, and toxicology studies • Preparation and interactions with FDA and global regulatory authorities (briefing documents, dossiers, etc) • Preparation of pharmacology, PK /metabolism and toxicology sections for regulatory submissions such as INDs, CTAs, IMPDs, NDAs and MAAs • Representation at Regulatory Authority meetings CLINICAL SPECIALTIES • POC and PK study design and CRO partner selection • Managing clinical PK, PK/PD, BE and POC studies • Preparation of corresponding clinical sections for INDs, CTAs, NDAs and MAAs • Regulatory Authority meetings

Vice President Nonclinical Development

Novan Therapeutics

2012-8 - 2013-5 · 10 mos

Durham, North Carolina

Led nonclinical development of dermal therapeutics for acne, wound healing, bacterial infections and anti-androgen indications such as androgenic alopecia. Awarded $7.8 million contract by BARDA to develop a medical countermeasure for thermal burns