Webinar On-Demand: Clinical Biosafety 101

In this On-Demand Webinar we discuss the fundamental strategies to gain practical insights for navigating aspects of biosafety within clinical settings. This session covers key topics including an introduction to Clinical Biosafety, Bloodborne pathogens, current NIH regulations, implications of NIH sponsorship, and specific case studies highlighting biosafety in clinical environments. Gain clarity on compliance requirements and best practices to ensure seamless adherence to regulations.

Deepen your understanding of Clinical Biosafety and gain practical knowledge that can enhance safety protocols within your facility. During this session, we address the following three learning objectives:

• Insight into Current NIH Regulations and Sponsorship Implications
• Practical Strategies for Implementing Biosafety Protocols in Clinical Settings
• Understanding Biosafety Challenges through Real Case Studies

About the presenters

Sarah Ziegler, Ph.D., RBP, CBSP (ABSA)
Vice President of IRB, IBC and Biosafety

Sarah Ziegler, Ph.D., is responsible for leading the IRB, IBC and Biosafety services at Sitero. Dr. Ziegler is an ABSA certified biosafety professional and is passionate about ensuring the safety of workers and the community during biomedical research. She has previously served as an IBC chair, Biosafety Officer and Responsible Official for multiple research institutions. She has also consulted on projects as an SME for Select Agents, Biorisk Management, facility design and Laboratory Operations. Dr. Ziegler was previously the Deputy Director of the National Bio and Agro-Defense Facility (NBAF) with the USDA where she supervised laboratory operations and Biorisk management. Dr. Ziegler received her Ph.D. from the University of Texas Medical Branch in Biomedical Science and was a Post-doctoral Fellow in the National Biosafety and Biocontainment Training Program (NBBTP).

Sabena Blakeney, Ph.D., RBP, CBSP (ABSA)
Biosafety Advisory Board Member

Sabena Blakeney, Ph.D., serves as a subject matter expert on biological safety as a Sitero consultant. Her experience includes developing biosafety and select agent programs and associated documents, executing laboratory audits, incident investigations, training activities, and assisting with IBC approvals on human gene transfer studies at clinical trial sites. She has also performed biosafety reviews of laboratory drawings and advised on workflows and biorisk concerns. Additionally, Dr. Blakeney has over 10 years of laboratory research experience, including four years at Plum Island Animal Disease Center on research involving foreign animal disease control and eradication measures. She completed a post-doctoral fellowship with the National Biosafety and Biocontainment Training Program and is a Certified Biological Safety Professional (CBSP) and Registered Biosafety Professional (RBP) through ABSA International.

Antony Schwartz, Ph.D., CBSP (ABSA)
Biosafety Advisory Board Member

Antony Schwartz, Ph.D., is an ABSA International Certified Biological Safety Professional and a microbiologist with extensive experience in biological risk assessment, clinical biosafety, and laboratory biosecurity solutions. Dr. Schwartz has held roles as the Institutional Biosafety Officer and Select Agent Program Responsible Official with the U.S. federal government, healthcare and academic institutions. During the COVID-19 pandemic, he developed biosafety policies and procedures for clinical trials and research laboratories working with the SARS-CoV-2 virus and patient samples, as well as recommendations for personnel protective equipment (PPE) for healthcare staff. He led a team that implemented a large-scale N95 decontamination and reuse process for a healthcare facility. Dr. Schwartz is an active member of ABSA International previously serving as a Councilor.