Ph.D. University of Texas at Austin

Post-doctoral training: Yale University Medical School 

• -- Pharmaceutical regulatory strategy and non-clinical development plans.       
  
• -- Design/review toxicology and safety pharmacology protocols.     
  
• -- Genetic Toxicology for drugs, chemicals, foods, etc.
  
• -- Review/edit draft reports and regulatory documents.       
  
• -- Prepare IND/NDA non-clinical sections, CTD tables, international regulatory documents, integrated summaries, expert reports, CIB’s, documents for FDA meetings, responses to regulatory toxicology questions from government agencies, white papers on toxicological topics, literature reviews, etc.     
  
• -- Client preparation for FDA meetings.     
  
• -- Resolve impurity and degradent issues and qualifications.    
  
• -- Due diligence; evaluate in-licensing candidates.    
  
• -- Prepare/review out-licensing dossiers to maximize value.     
  
• -- Assess GLP compliance and fraud vulnerability.     
  
• -- Attend scientific/regulatory meetings and write detailed customized reports.
• -- Scientific editing for Asian, European, African and South American scientists and regulatory professionals.
  
• -- Customized GLP training for study directors and scientific staff 
  
• -- Coaching for Pharmaceutical Toxicologists to improve performance and achieve potential
  

• -- Solid track record of problem-solving and problem-prevention.     
  
• -- Special expertise in regulatory genetic toxicology.    
  
• -- Numerous approved IND, NDA (FDA CDER and CBER), and European EMEA submissions. 
  
• -- Experience with a variety of therapeutic categories, including metabolic, cardiovascular, antiviral, anticancer, anti-infective, immunomodulatory, dermal, and neurological drugs.                             
  
• -- Extensive practical experience with pharmaceutical and biotech drug development.     
  
• -- Presentations to FDA.        
  
• -- Member US Pharma ICH Genetic Toxicology Task Force.
  
• -- Member ILSI Committee on Alternative Carcinogenicity Assays.    
  
• -- Current clients range from large multinational pharmaceutical firms to small biotech firms worldwide.
  
• -- See website for more details.