About Us
 
Brenda P. Fielding – President, & Vice-President, Regulatory Affairs
Brenda Fielding is the Founder, Chairman of the Board and President of Regulus Pharmaceutical Consulting, Inc. She has more than 20 years experience in the pharmaceutical and biotechnology industry, primarily in the area of Regulatory Affairs and Quality. She has held senior management positions in US pharmaceutical and biotechnology companies, including Cortech, Gilead Sciences, and Napro BioTherapeutics, Inc. (now Tapestry Pharmaceuticals, Inc.). She has been involved in the successful clinical development of novel drugs, biologics, and drug delivery systems, over a wide range of therapeutic areas including oncology, anti-infectives, immunotherapeutics and ophthalmology.  She regularly represents clients at meetings with Regulatory Authorities, including the US Food and Drug Administration. Brenda received her BSc from London University, UK and attended graduate school in London.   Brenda has been the invited speaker at numerous drug development and regulatory affairs seminars and conferences, and has chaired symposia for professional organizations.

Clara Li, MS - Director, Regulatory Affairs
Clara Li is a Director of Regulatory Affairs with over 17 years of experience in the FDA-regulated industries in the areas of regulatory affairs, strategic drug development, quality assurance, and global project management. She has expertise in drugs and biologics for the US, European, and Canadian markets and has played regulatory and strategic roles in the development of novel therapeutics for a wide range of therapeutic areas including immunology, inflammation, autoimmune, oncology, neurology, pulmonary, cardiovascular, metabolism, and hematology. Clara has worked for companies including Amgen, Synergen, and NaPro and consulted for large and small biotech and drug companies. Clara is one of the founding members of Regulus Pharmaceutical Consulting. She received her BS and MS degrees in Biological Sciences from Stanford University.

Kip Vought - Director, Regulatory Affairs
Kip Vought is a Director of Regulatory Affairs with over 15 years of pharmaceutical experience.  Kip is involved with all aspects of pharmaceutical development including clinical, nonclinical, and chemistry, manufacturing and control (CMC) for the major regulatory markets including the US, EU, Canada and Australia.  His pharmaceutical experience encompasses both proprietary and generic drugs, where he has worked as an analytical chemist, R&D project manager and in regulatory affairs.  Kip has a strong background in CMC development and in the management of post-approval changes for both drug substances (active pharmaceutical ingredients) and drug products during all stages of development and post-marketing.  Drug substance experience includes small and large molecules, extracted and semi-synthetic drugs from plants and animals, biologic and fermentation products.  Drug product experience includes various routes of administration including enteral, inhalation, topical and parenteral.  Kip's expertise is used in strategic drug development (clinical, nonclinical and CMC) across several therapeutic areas and generics, meeting with regulatory agencies, due diligence on proprietary and generic drugs and drug companies, writing of pharmaceutical development and biopharmaceutics sections for CTDs, writing of environmental assessments, and the development and evaluation of in vitro dissolution methods. Kip received his Bachelors degree in Chemistry from the University of Miami and holds a Regulatory Affairs Certification from RAPS (US). He is one of the founders of Regulus Pharmaceutical Consulting, Inc.

Nikolas Burlew - Director, Quality Assurance
Nik Burlew, is the Director of Quality Assurance for Regulus. Since 1992 Nik has worked in the biotechnology, renewable energy and pharmaceutical development fields. His experience includes manufacturing and process development, including pharmaceutical quality assurance, quality system development and implementation, and auditing and inspections in both GMP and GLP environments. In addition to preparing chemistry and manufacturing regulatory documentation in support of new drug applications, he has had hands-on experience in the production of API, bulk sterile biologics and solid dose pharmaceuticals. Nik received his BA degree in Environmental, Population and Organismic Biology from the University of Colorado and is certified as a Quality Assurance Professional in GLP (RQAP-GLP). He is a member of the Society of Quality Assurance, the Parenteral Drug Association and has been a speaker for RAPS.

Jennifer Williams, MBA - Associate Director, Regulatory Affairs
Jennifer Williams is an Associate Director of Regulatory Affairs for Regulus. She has more than 15 years of experience in regulatory affairs with emphasis on generic drugs, including product labeling for US and international registrations. Jennifer has a Bachelors degree in Biology and Education from Minnesota State University and holds an MBA from the University of Colorado in Boulder. Prior to joining Regulus, she held senior positions in Syntex, AKZO and Sandoz.

Catherine McCall, D. Phil - Sr. Regulatory Scientist
Dr Catherine McCall provides regulatory, preclinical and clinical project management services, and clinical and technical writing.  Her scientific expertise is Immunology. Dr McCall has 20 years experience in the biotechnology industry, setting up and running basic research groups and acting as project manager for preclinical programs.  Prior to joining Regulus, she worked at PPD Development as a medical writer and consultant for preclinical model development.  At ThermoBiostar she led a group researching new diagnostic embodiments of the company’s optical immunoassay platform, previous to this she established and managed a veterinary allergy group at Heska Corporation, developing novel diagnostics and therapeutics for companion animal allergies.  Prior to joining Heska, Dr McCall worked as a project manager and as a research manager in the field of allergy at Cortech.  Dr McCall also has experience coordinating preclinical and clinical research in the field of cancer immunotherapeutics at her first industry position as research director at Cell Technology Inc. Dr McCall obtained her doctorate in immunology at Oxford University, and was a postdoctoral research fellow at the University of Heidelberg, Germany, and the University of Colorado Health Sciences Center, Denver. She has over forty peer-reviewed research publications and over fifteen patents issued or in process.

Kelly W. Creighton, PhD – Associate Director, Quality Assurance
Kelly Creighton is an Associate Director in our Quality Assurance Group, where his scientific background is applied to the development of quality systems for biotechnology products, and cell-and tissue-based therapeutics. Dr Creighton also performs client quality system audits and onsite inspections of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). Skilled in technical writing, he also participates in developing regulatory submissions for the US and Europe. Kelly earned his BS in Animal Science from New Mexico State University and his Masters and PhD in Animal Nutrition and Reproductive Physiology from the University of Nebraska.

Bruce Feistner – Associate Director, Regulatory Affairs
Bruce Feistner is an experienced regulatory affairs professional with over 13 years experience in the pharmaceutical and biotechnology industry.  He has been responsible for the preparation and submission of clinical trial applications and marketing applications in the USA, Canada and Europe. Bruce has played strategic regulatory roles in the development of therapeutics for a wide range of disease areas, including oncology. He earned his BS in  Biological and Biophysics, Oregon State University, and is Regulatory Affairs Professional Society Certified (RAC).

Jean Hoos – Controller
Jean Hoos brings a depth and breadth of strategic and operational financial management experience gained from over 25 years with a variety of start-up and established companies in Colorado. She has also served in a senior management capacity in a number of the biopharmaceutical firms that have grown up in the Boulder valley including Cell Technology, Biostar , NaPro BioTherapeutics, Nexstar, and Proligo. She has been a key resource during due diligence and acquisitions in the local biotech industry and has helped smooth the transition of financial systems as companies have reorganized under new management. Ms. Hoos holds a degree in Accounting from the University of Colorado.