Kragie BioMedWorks (R)

Drug Delivery Optimization and Enhancement
Novel routes of administration for established therapies and indications
Design of efficient pharmacodynamic parameters/biomarkers for formulation testing
Pharmacokinetic/pharmacodynamic modeling
Drug registration strategies for franchise extension related to new formulations

Preclinical Assessment and development of biological surrogates markers
First in Man studies: when and how to do
Clinical Trials: design, data analysis and report writing, Phase I - IV
Adverse Event: interpretation and investigation
New Drugs: indications, dosing, drug labeling (Package Insert)
NDA/IND applications: planning / writing / review
Investigating unmet clinical needs: new indications for approved drugs
505(b)2  NDA strategies

Portfolio development and pipeline strategies
Technology transfer activities in biotechnology
Venture capital project assessment: evaluation of biotechnology intellectual property and FDA regulatory strategies
Drug Development strategies: preclinical through postmarketing phases
White Paper reports on market niches, estimate trends

Expert Witness testimony and background information
Case assessments
Due Diligence Assessments
Patent review and expert reports

Newsletter articles: both print and online media
Science and Medical publications arising from preclinical and clinical studies
Grant writing assistance: government, nonprofit and for profit enterprises
Reports on research breakthroughs in biotechnology

Hormonal influence on drug metabolism and effect
Drug-thyroid hormone membrane transporters
Aromatase Assay to screen reproductive toxicity
Assessment of potential endocrine disrupters
Computer 3D modeling of small molecules and their pharmacophores
Reproductive and pediatric labeling sections of Package Inserts
Development and assessment of addiction therapies
Design and interpretation of drug interaction studies
Speciality Areas: aromatase, estrogen, thyroid hormone, ADHD safety issues