Dr’s Pratt and McNicholas will discuss strategies for patenting biosimilars in conjunction with FDA regulations and how to overcome the challenges of FDA approval.
Dr. Pratt provides strategic advice regarding FDA requirements to manufacturers, distributors, importers and exporters of a wide range of medical and health products, including medical devices, drugs, dietary supplements, nutraceuticals, biologics and cosmetics. In her FDA practice, she advises clients on requirements for marketing clearance or approval, registration and listing, labeling and advertising, imports and exports, Good Clinical Practice, Good Laboratory Practice, and use of investigational drugs and devices.
Dr. McNicholas advises clients in the development and commercialization of worldwide patent portfolios. She writes and prosecutes patent applications for a broad range of life science technologies. Her practice includes conducting patentability and freedom-to-operate assessments, evaluating intellectual property, and mining both developing and mature patent portfolios for additional patenting opportunities to maximize value.
Other topics to be discussed at the conference include bi-specific and multi-specific fusion proteins, modified proteins, antibody drug conjugates, patenting strategies, non-IG scaffolds, antibody fragments, new peptide approaches, nutraceuticals, advances in expression systems, immunogenicity, aggregation, subvisible particles, stability and delivery of proteins.
Also presenting at the 4th Protein Discovery & Therapeutics Conference are organizations active in the field including Affibody, Affimed, Albany Medical College, Ambrx, Anaptysbio, Centyrex, ImmunGene, Johnson & Johnson, MacroGenics, MedImmune, Merus, Micromet AG, NCI, NIH, Nektar Therapeutics, Novartis, NovImmune SA, Pfizer, Profectus BioSciences, RC Technologies, Roche, Scripps Research Institute, Zyngenia and other experts in protein therapeutics.