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.
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Beyond SaaS: How Service-as-a-Software and Agentic AI Are Powering Labs of the Future
July 18th 2025Globally, scientific labs generate unprecedented volumes of data through cloud-based platforms, yet most of this valuable information remains fragmented and buried across different systems. While traditional software-as-a-service (SaaS) solutions have addressed the accessibility problem, labs still struggle with data overload, forcing scientists to spend countless hours searching for information that should be readily available. This whitepaper presents AI-powered SaaS, the next advancement in lab informatics that is transforming how lab workers interact with their data, enabling natural language conversations that deliver contextualized insights exactly when needed.
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.
