DIA 2016 Annual Meeting

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The session will address the nonclinical regulatory development of robust human tissue (HT) technologies/models, validation, applications and the possible future switch from in vivo animal models to HT technologies.

Learning Objectives

Discuss the acceptability of human tissue (HT) technologies data in support of clinical trials and MAA submissions; Identify nonclinical requirements for the use of data generated with HT technologies; Describe validation of models; Identify GLP requirements.

Chair

Michelle Cathian Beharry, MS

Speaker

Overcoming Barriers to Human Tissue Use for Safety Assessment
Anthony Holmes, PhD

The Use of Human Tissue Technologies in Support of Clinical Trials and Marketing Authorization Regulatory Submissions
Michelle Cathian Beharry, MS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-606-L04-P; CME 1.25; IACET 1.25; RN 1.25

The formation of the Office of Pharmaceutical Quality (OPQ) is a milestone in FDA efforts to assure the quality and availability of medicines to the public. OPQ's motto of "One Quality Voice" is manifested in the organizational construct that provides functional expertise but enables a team approach to regulatory review and inspection. This session will outline current status and ongoing initiatives underway in OPQ and will provide the audience with access to selected OPQ senior leadership.

Learning Objectives

Discuss current updates on initiatives and implementation strategies for the Office of Pharmaceutical Quality (OPQ); Identify additional information regarding forthcoming activities in OPQ.

Chair

Robert Iser, MS

Speaker

Panelist
Michael Kopcha

Panelist
Lawrence X. Yu, PhD

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The need for biomarkers means that expertise in handling frozen samples is required. This session will present strategies and solutions to ensure both that frozen specimens are correctly collected and shipped and that they arrive in stable conditions at the lab where biomarkers can be reliably tested.

Learning Objectives

Discuss how handling of critical biological samples is essential to be able to rely on the lab results obtained after testing; Describe how to collect, handle, store and ship samples appropriately.

Chair

Hermann Schulz, DrMed

Speaker

Piecing Together a Successful Biomarker Strategy: A Catalyst for Precision Medicine
Paul Travis, MSc

Ensuring Sample Stability When Handling Biomarkers
Hermann Schulz, DrMed

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-586-L04-P; CME 1.25; IACET 1.25; RN 1.25

Due to recent regulatory issues in manufacturing, statistical tools are used increasingly to understand manufacturing data. This provides opportunities to improve the evaluation of safety, quality, and efficacy criteria specified by regulators.

Learning Objectives

Discuss lessons learned in the use of statistics in pharmaceutical manufacturing; Identify the challenges and opportunities with application of nonclinical statistics; Describe the regulatory developments in the CMC area and the opportunities for statistical applications.

Chair

Surya P. Chitra

Speaker

A Case Study of Statistical Analysis of Integration Site Assay in the Application of Gene Therapy
Shu Zhang, PhD

Overview of CMC Area Statistics
Cassie Dong, PhD

Quality by Design Case Studies for Biologics/Biosimilars
Charles Li, MS