Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today the expansion of its Pharmacology-Toxicology team with the addition of two new senior consultants with more than two decades of combined experience in research, discovery, preclinical development, nonclinical development, and regulatory affairs.
Christopher M. Scull, Ph.D. and Pauline McEwan, Ph.D. joined Biologics Consulting as senior consultants, and will work directly with biopharmaceutical companies to create and implement proven nonclinical approaches to expedite the movement of products into the clinic trials and through marketing authorization. Scull and McEwan will be responsible for planning and monitoring pharmacology and toxicology studies, interfacing with toxicology CROs, preparing for and participating in FDA meetings, evaluating toxicology data, and reviewing and writing regulatory documents (pre-IND briefing packages, IND, BLA/NDA) for a variety of Biologics Consulting’s clients. The addition of these two consultants expands the firm’s pharmacology-toxicology capabilities to meet the growing demand for regulatory and product development support.
“The cornerstone of our success is our team of consultants and professional services staff, who are subject-matter experts with decades of industry and FDA experience. The addition of Christopher Scull and Pauline McEwan further underscores our commitment to identifying and hiring the most qualified professionals to expertly guide our clients through the regulatory process,” commented Norman Baylor, Ph.D., President of Biologics Consulting. “These new team members bring skills and abilities to Biologics Consulting that will seamlessly integrate with our existing team and bolster our pharmacology-toxicology capabilities.”
Prior to joining the team at Biologics Consulting, Christopher M. Scull, Ph.D. was the Global Director of Discovery Sciences at Innovimmune Biotherapeutics. He has more than 10 years of experience managing R&D projects spanning research, discovery, preclinical development, and regulatory affairs. He also has expertise in design and management of nonclinical IND-enabling pharmacology and toxicology studies, including data review and writing/auditing study reports. Scull is experienced in the development of both small molecules and biologics, including antibodies and T-cell therapies. Additionally, he is an accomplished author/reviewer of FDA submissions for several novel therapies that have successfully entered human clinical use.
Pauline McEwan, Ph.D. has more than 12 years of experience as a consultant in nonclinical development of a broad range of drugs, biologics, medical devices and combination products. She has specific proficiency in gene therapy, viral and immune therapies and cardiovascular therapeutics, as well as expertise in combination products inclusive of drug-drug, drug-device and biologics-device combinations. Prior to her consulting career, Pauline held the position of Director of Research and Development at Miravant Medical Technologies for cardiovascular drug-device combinations. Additionally, she served as a Steering Committee Member at Guidant Corporation and was a Principal Scientist at Celladon Corporation.
About Biologics Consulting (www.biologicsconsulting.com/)
Biologics Consulting Group, Inc. is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. Founded in 1993, Biologics Consulting has built a record of achievement, assisting clients worldwide with nonclinical and clinical, product development and regulatory compliance challenges.
Biologics Consulting has served more than 3,500 companies in 53 countries, and in the past four years, it has contributed to more than 50 original INDs, 75 BLAs/NDAs (full and supported), 80 510Ks, and 42 IDEs.