Donna D. Walczak, Ph.D.
President and Founder, Cayuga Consulting

Dr. Walczak trained initially in biochemical pharmacology (SUNY at Buffalo), virology/oncology (SUNY at Buffalo), and neuropharmacology (University of Toronto). While serving as a Principal Scientist in the US Army Medical Service Corps (Walter Reed Army Institute for Research), she received additional training in Project Management and Personnel Management. Click here for Donna Walczak Curriculum Vitae.

Dr. Walczak completed her clinical training via the Clinical Research Fellowship at Burroughs Wellcome in North Carolina (UNC Chapel Hill and Duke University). Subsequently, she has been successful in clinical development for the pharmaceutical, biotechnology and device industries for more than 25 years. She has extensive experience in a broad range of therapeutic areas and all phases of clinical development, including numerous IND, NDA, and BLA submissions in eCTD format, as well as meetings with the FDA (pre-IND, End of phase 2, pre-NDA, and Advisory Panel) Click here for Listing of Therapeutic Area and Submissions Experience.

A longtime member of the American Medical Writer's Association, Dr. Walczak leads a diverse group of medical writers, coordinates client statistical and data management activities, and manages the electronic document and bibliographic services provided by Cayuga Consulting. Click the following links for fact sheets on services offered by Cayuga Consulting.

Clinical Research | Electronic Document Services | Posters | Regulatory Submissions

Education

• Postdoctoral Fellowship in Clinical Research and Drug Development, Burroughs Wellcome Co., the School of Medicine, University of North Carolina, Chapel Hill, NC, and Duke University, Durham NC
• Doctor of Philosophy, Department of Pharmacology, University of Toronto, Toronto, Ontario, Canada, 1977-1983
• Master of Science (Virology), Department of Natural Sciences, Roswell Park Memorial Institute, Graduate Division, State University of New York at Buffalo, Buffalo, NY, 1976-1977
• Bachelor of Science, Department of Biochemical Pharmacology, School of Pharmacy, State University of New York at Buffalo, Buffalo, NY, 1972-1976

Drug Development Experience

• President, Cayuga Consulting, Providence, RI, 1999-Present
• Vice President, Clinical Research, Clinical Research Management, Inc. 2000-2012
• Director, Clinical Research and Regulatory Affairs, Ergo Science Corporation, Charleston, MA, 1998-1999
• Associate Manager, Clinical Affairs (Interim Team Leader, Infergen Program), Amgen, Boulder CO, 1996-1998
• Senior Clinical Research Scientist, Solvay Pharmaceuticals, Marietta, GA, 1991-1996
• Research Toxicologist, Neurotoxicology Division - Environmental Protection Agency, Research Triangle Park (RTP), NC, 1990-1991
• Visiting Scientist, Laboratory of Molecular and Integrative Neurosciences (cross-appointment), National Institute of Environmental Health Sciences RTP, NC, 1990-1991
• Independent Consultant, Clinical Research Phases 1-3, 1990-1991

Graduate and Postgraduate Training

• Basic Sciences: inorganic and organic chemistry, general biochemistry, protein chemistry, physical chemistry, medicinal and natural product chemistry, structure-activity relationships, receptor pharmacology, analytical biochemistry, pharmacokinetics, drug metabolism, intermediary metabolism and disease.
• Pharmacology/Pharmacokinetics/Physiology/Toxicology: principles of chemotherapy, principles of pharmacology, advanced pharmacology, basic and advanced pharmacokinetics, pharmacokinetic modeling, metabolism in mass balance studies, behavioral pharmacology, intermediary metabolism and antimetabolite pharmacology, pathophysiology and disease processes, general physiology, immunology, virology, and principles of toxicology.
• Clinical Drug Development: principles of drug development; basic, intermediate and advanced CRA training; basic, intermediate and advanced regulatory affairs training; intermediate and advanced medical writing; biostatistics; and indication-specific training in various therapeutic areas. Additional continuing medical education classes available on request.
• Personnel and Project Management: principles and techniques of project management, equal opportunity issues and personnel management practices, targeted interviewing techniques, personnel assessment, principles of education and training, principles and practices in effective leadership, total quality management.