Kathleen Baran, Ph.D., DABT

Services Offered: Nonclinical toxicology, safety pharmacology services, pharmacokinetics and toxicokinetics consulting services.

Pharmaceutical, Biotechnology, and Medical Devices Experience: With over 20 years experience directing and outsourcing preclinical studies, including pharmacology, safety pharmacology, toxicology and toxicokinetics, Kathleen Baran provides professional, hands-on technical expertise to pharmaceutical and medical device companies in such areas as:

• Strategic planning of preclinical development programs
   
• Cost and time effective outsourcing and management of preclinical studies to support Phase I/II/III clinical testing
   
• Preclinical and nonclinical data review and interpretation
   
• Preparation of the preclinical  portions of regulatory submissions
   
• Representation during regulatory interactions
   
• Due diligence

Prior to forming TOX-TK Associates, Dr. Baran was Senior Director of Preclinical Development at POZEN Inc. from 2000 to 2004, where she was responsible for program design, outsourcing, data interpretation, drafting regulatory submissions, and attending regulatory meetings for several NCEs and combination migraine therapies. Dr. Baran’s broad experience includes drug and device R&D positions at 3M (1995-2000) and Procter & Gamble (1983-1995), where she:

• Managed preclinical programs and was a project team member for anti-infective, cardiovascular (cardiotonic and anti-arrhythmic), osteoporosis, immunomodulatory, oral care and anti-inflammatory NCEs;
   
• Performed device safety evaluations with dental, wound care, casting, implantable biodegradable and cardiovascular materials;
   
• Served on the  ISO 10993 Technical Advisory Committee (harmonized international guidelines for the safety assessment of medical devices), and
   
• Directed in-house toxicology studies, and managed outsourced programs.

At POZEN, she designed several NDA programs and successfully rationalized the testing to FDA.  Recently, Dr. Baran has coordinated preclinical development planning activities and conducted toxicokinetic data analysis and report preparation for several small pharmaceutical companies.  She has designed preclinical testing programs to support lead selection through IND filing, including costing and timelines.

Dr. Baran earned a BS in Biology from Hiram College and a Ph.D. in toxicology from the University of Mississippi.  Dr. Baran has been a full member of the Society of Toxicology and has held certification in the American Board of Toxicology for nearly 20 years.

The BioPharm Team
c/o PharmSupport
202 NC Highway 54, Suite 101
Durham, NC 27713
(919) 403-7704 (phone)
inquiries@biopharmteam.com (e-mail)