Dr. O’Connor will discuss “Towards Biosimilar Monoclonal Antibodies: A CRO’s Perspective” at the conference, which is sponsored by the European Generic medicines Association (EGA). As the official representative body of the European generic and biosimilar pharmaceutical industry, the EGA plays an important consultative role in the development of European health-care policy-making.
“We’re proud that Dr. O’Connor has been invited to speak at this prestigious annual European Union event,” said MDS Pharma Services President David Spaight. “In her role as leader of our Biopharmaceutical Development consulting group, she provides scientific and regulatory guidance to our clients who are developing biologic drugs, including biosimilars. Her presentation will showcase the expertise gained over more than 20 years in regulatory affairs for the pharmaceutical, medical device, and food industries.”
Dr. O’Connor worked for the U.S. Food and Drug Administration (FDA) for 16 years in the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research, the Center for Veterinary Medicine, the Center for Food Safety and Applied Nutrition and the Office of the Commissioner. As a pharmacology and toxicology reviewer in CBER, she specialized in drugs produced by biotechnology and worked on hundreds of investigational new drug (IND) applications and pre-IND applications for biotechnology drugs. She was the lead pharmacology reviewer for six Biologic License Applications.
After leaving the FDA, Dr. O’Connor ran a private consulting practice with a focus on biopharmaceutical development, and contributed a chapter to a reference book on the subject – Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials by Joy A. Cavagnaro (Editor).
She holds a BA in Biology and MS and PhD in Animal Science and Biochemistry from Amherst College, the University of Maryland and the University of Florida, respectively.
About MDS Pharma Services
MDS Pharma Services, a business unit of MDS Inc., is committed to delivering quality service on-time. We offer a full spectrum of resources to meet the drug-discovery and development needs of the pharmaceutical and biotechnology industries. With numerous facilities strategically located around the world, we apply advanced scientific and technological expertise throughout the drug discovery and development process - from lead optimization, pre-IND research, early clinical research (bioequivalence, phases I-IIa) and bioanalysis through to global clinical development (phases IIb-IV), central lab and centralized cardiac services. For more information, visit our website at www.mdsps.com.
About MDS Inc.
MDS Inc. (TSX: MDS; NYSE: MDZ), a global life-sciences company that provides market-leading products and services that our customers need for the development of drugs and diagnosis and treatment of disease. We are a leading global provider of pharmaceutical contract research, medical isotopes for molecular imaging, radiotherapeutics, and analytical instruments. MDS has more than 5,000 highly skilled people in 29 countries. Find out more at www.mdsinc.com or by calling 1-888-MDS-7222, 24 hours a day.
