SLAS 2019 Americas Sample Management Symposium

As new chemical entities go through the later stages of drug discovery to become new medicines, the management of different kinds of samples are encountered.  The following topics maybe covered in this session:
• Drug product supply
• Clinical supply chain considerations
• Clinical biosample management innovation
• Ensuring integrity of the medicine supply chain

Multiple pre-analytical issues are routinely encountered within clinical trials. Bioanalytical laboratories attempt to control for these variables during assay validation, but are often challenged by real world conditions and logistical constraints. In this talk we’ll go through relevant guidance documents and case studies from Pfizer clinical trials.

This talk will review complexity of CAR T cell clinical trials, with focus on the biomarker and exploratory research that is inherent to such trials and sampling required to support such research.  In the context of allogeneic CAR T trials, there is interest in understanding patient, tumor and T cell donor attributes that are associated with efficacy or safety.  Thus sampling and research plans are quite complex.  In trials with complex biomarker endpoints, the ability to achieve a globally acceptable informed consent is a challenge, and one that must be addressed so as to preserve the ability to generate robust data across the entire trial population.  The ICH E18 Guidance was developed in part to harmonize guidance and expectations on the conduct of genomic research within clinical trials.   Some elements of this Guidance will be discussed.

Biobanks play an integral role in research and precision medicine
by collecting, processing, storing, and distributing high-quality biological material and associated
data. Through the adoption and implementation of standards, biobanks can ensure the integrity,
authenticity, and traceability of their products to enhance reproducibility in research. In
preparation for ISO 20387 (ISO 20387:2018, Biotechnology – Biobanking – General Requirements for
Biobanking) accreditation by the American Association of Laboratory Accreditation (A2LA), the
Cornell Veterinary Biobank (CVB) developed and implemented a quality management system
(QMS) in compliance with this standard, and the information was compiled into a quality
manual. Procedures describing the control of documents and records were implemented first to
provide a foundation on which to build the QMS, followed by procedures for documenting the
identification of risks and opportunities, improvements, and corrective actions following
nonconforming outputs. Internal audit and management review programs, consisting of both
procedures and a schedule, were developed and implemented. Procedures for the governance and
management of the CVB were generated, including: confidentiality and impartiality policies;
facilities and equipment maintenance, calibration and monitoring; staff training and
competency; and evaluation of external providers. All processes on scope were described, along
with the validation and verification of methods to ensure its reproducibility, robustness, and the
fitness-for-purpose of the biological material and data produced. Training sessions were held during implementation to ensure all staff were familiar and would conform to the procedures. In
April of 2019 the CVB was assessed by A2LA for compliance with ISO 20387, and became the
first biobank to receive accreditation to this standard.