FDA Appoints New Officers
Joanne Less has become the acting director of the US Food and Drug Administration's Office of Combination Products (OCP).
Joanne Less has become the acting director of the US Food and Drug Administration’s Office of Combination Products (OCP). Less replaces Mark Kramer, who recently resigned as FDA’s director of the OCP. Less is currently the associate director for clinical research and government affairs in the Center for Devices and Radiological Health and is that Center’s expert on the laws, regulations, and policies governing the clinical investigation of medical devices, particularly those related to human subject protection.
Jim Shugars has been named the director for the Office of Information Technology, CDER (OIT–CDER). Jim will report to the FDA CIO and manage the IT staff that supports CDER. Jim has served as acting director for OIT-CDER for over a year. Jim works with a wide range of government and contract personnel in defining, developing, and implementing automated systems.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Oligonucleotide Analysis in Pharmaceutical Quality Control
January 14th 2025Melting point determination using ultraviolet-visible (UV-Vis) spectrophotometry can be used as a sequence-specific method for identifying therapeutic oligonucleotides in pharmaceutical quality control. This method offers a simple, highly selective approach to differentiate between isomers and ensure the integrity of oligonucleotide active pharmaceutical ingredients (APIs) and drug products.
