Grace M. Furman, PhD, DABT
Nonclinical Toxicology Expert
As CEO/President of Paracelsus, Inc., Grace provides professional toxicology services to the pharmaceutical industry as an independent consultant. She made the decision to become independent in mid 2006, at which time she was Senior Director of Regulatory Safety Assessment in Pfizer’s Drug Safety Research and Development department. Paracelsus commenced conducting business as a corporate entity in January 2007. Grace’s area of professional expertise relates to regulatory toxicology as applied to development of novel small molecule therapeutics.
ONCORD, Inc.
Clinical Development and Regulatory Affairs
Susan Jerian, MD and David Essayan, MD are co-principal consultants at ONCORD, Inc., a consulting firm providing clinical development and regulatory affairs expertise. They have worked with numerous pharmaceutical and biotechnology companies and academic researchers in North America, Europe, Australia and Asia. They specialize in challenging and complex development programs. Susan and David have a proven track record of bringing products through the development process, including pre-IND, IND and NDA/BLA/MAA approval.
Christine M.N. Smith, Ph.D.
Pharmaceutical Development (CMC) Expert
Christine provides professional expertise on CMC from the pre-clinical stage through commercialization. She has had hands-on experience in the areas of API, formulation, process, analytical methods, regulatory strategy, quality, and technical writing, working with peptides, small-molecules, parenterals, orals, non-conventional formulations, and drug-device combination products. Prior to consulting, Christine served as Executive Director, Product Development at Amylin Pharmaceuticals where she led the CMC department.
Deborah Jezior
Clinical Operations Consultant
DA Jezior Consulting
Deb has worked in the pharmaceutical industry in both CRO and sponsor companies for over 24 years. She has successively held positions from CRA through various levels of management from the CRO perspective, and has managed and overseen the clinical programs from the sponsor side, including building clinical operations departments in both types of organizations. Her main therapeutic areas include oncology, CNS, and infectious disease.
Neil Edwards
European Regulatory Affairs Expert
Sirius Regulatory Consulting Ltd
Niel is Managing Director at Sirius Regulatory Consulting, a progressive Regulatory Affairs and Drug Development Consultancy supporting the global pharmaceutical industry to achieve product development and regulatory approval in Europe.