Bridging Science to Health, LLC

A Full Service Bio-Pharmaceutical Consulting Enterprise

 Cassandra MacArthur
(720) 530-4457
Tim Burke
(216) 201-0294
Bridging Science to Health Regulatory
Quality
CMC-Manufacturing
Pre-Clinical
Clinical
Special Services

Cassandra MacArthur, P.M.

President of Regulatory Affairs, Drug Development and Compliance

Cassandra MacArthur Cassandra MacArthur adds thirty years of successful experience to Bridging Science to Health, LLC in basic research, biotech, biopharmaceutical and medical device industries that include the development of small molecules, biologics, proteins, peptides, oligonucleotides, diagnostics, medical device products, herbal and supplement products.

Ms. MacArthur’s senior management positions include Chemistry, Manufacturing and Quality (CMC), Project Management, Regulatory and Quality, in addition to a successful career in Basic Research at the Salk Institute for Biological Studies and Scripps Clinic and Research Foundation. As the interim VP of Project Management, Regulatory and Quality Assurance, Cassandra successfully directed as lead project manager, a pre-clinical rhesus monkey GLP study for an international (China) anti-bioterrorism project-initiating preclinical monkey supportive care studies including hands on training and GLP quality systems development and translation to support significant government contracts.

Cassandra’s principal roles in the preparation of 9 NDAs (1 Orphan Drug and 2 Fast Track submissions), 20 INDs, 5 BLAs, 17 510K’s, 2 IDEs, 3 PMAs, 2 ANDAs and 2 CTx significantly contributed to all these submission’ approvals. Cassandra has held a lead function in the successful management and launch of four manufacturing sites (two International) for Drug Substances and their Drug Products for process and analytical development, product registration and market launch.

Cassandra MacArthur’s basic research included independent and collaborative research for the isolation, full characterization and the clinical relevance of a novel cytokine from human alveolar macrophages. This work supported the publication of ten major journal articles and a book chapter. This broad range of scientific and industry experience supports the unique, cost effective strategic development and the due diligence investigation of multiple based products for various essential life augmenting indications.

Click Here for Cassandra MacArthur Curriculum Vitae