Name
Richard Ridgewell
Educational Degrees
BA, PhD
Education
* Postdoctoral Research, Renal Pharmacology and Toxicology, Medical College of Ohio, Toledo, OH
* PhD, Medicinal Chemistry, University of Minnesota, Minneapolis, MN
* Bachelor of Arts, Chemistry, University of Minnesota, Minneapolis, MN
Expertise
Biologics/Biotherapeutics/Biotechnology, Drug/Pharmaceutical Development, GLP Study Auditing, Inhalation and Respiratory Toxicology, Pharmacokinetics/Toxicokinetics, Regulatory Toxicology, Risk Assessment, Safety Pharmacology
Specialties
General Applications
* Drug Discovery - lead optimization and development candidate nomination
* Guide establishment of the integrated nonclinical drug development plan
* Provide or guide Project Team subject matter expertise and leadership
* Design, monitor and interpret finding for nonclinical safety, efficacy and exposure (PK / ADME) studies
* Guide selection of clinical starting dose and estimate of efficacious dose based on nonclinical data
* Integrate nonclinical findings; prepare for decision points
* Evaluate, select, and initiate interactions with Contract Research Organizations
* Conduct GLP and technical facility audits
* Write / review / edit Expert Reports, White Papers, Study Reports, etc.
* Prepare or review / edit global regulatory submissions – IND / CTA, NDA / BLA, Investigator’s Brochures
* Contribute to interactions between sponsors and global regulatory authorities
* Prepare gap analysis and needs assessment for drug development programs
* Provide subject matter expertise for due diligence evaluation of potential in-licensing opportunities

Therapeutic Areas (Pharmacology Models)
* CNS (Epilepsy and Traumatic Brain Injury)
* Inflammation (arthritis and immunomodulation)
* Pulmonary (inhalation and nasal inhalation routes)
* Oncology

Drug Metabolism & Pharmacokinetics
* Monitor and evaluate bioanalytical method validation and sample analysis
* Review / interpret PK results
* Guide design radiolabeled ADME studies; review / interpret results
* Provide guidance for execution and interpretation of findings for drug-drug and drug-transporter interactions, and metabolite identification and implications for human safety assessment

Toxicology and Toxicokinetics
* Provide guidance for execution of the nonclinical safety assessment plan and integration of findings
* Guide establishment of NOAEL and First-In-Human dose based on toxicological findings and cross-species pharmacokinetics


Experience
* Leadership in the pharmaceutical industry and contract research
* Focused on scientific and regulatory aspects of nonclinical drug development
* Expertise in the integration of nonclinical findings toward prediction of human dose and exposure, efficacy, and safety toward successful drug development
* Effective in cross-functional leadership, collaborative research, and knowledge-driven decision making
Address
7822 142nd Avenue NW
City
Ramsey
State
MN
Zip Code
55303
Country
USA
Telephone
6128686175