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Wednesday, June 29
 

10:30am EDT

#312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies
Limited Capacity seats available

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



Chair
avatar for Michelle Beharry

Michelle Beharry

Senior Non-Clinical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA)
Michelle spent 4 years in the pharmaceutical Industry as a regulatory/investigative toxicologist, then joined the MHRA and is now a Senior Pharmaco-Toxicologist. Principally, this involves the assessment of nonclinical data for Clinical Trials and Marketing Authorisation applications... Read More →

Speakers
AH

Anthony Holmes

Head, Technology Development, NC3Rs
Anthony Holmes is Head of Technology Development at the NC3Rs. He oversees a programme of work focusing on the interface between academia and industry and the acceleration of technologies out of the science base and in to application to reduce animal use and address scientific and... Read More →


Wednesday June 29, 2016 10:30am - 11:30am EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am EDT

#321: Office of Pharmaceutical Quality Update
Limited Capacity seats available

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



Chair
avatar for Robert Iser

Robert Iser

Acting Director, Office of Process and Facilities, OPQ, CDER, FDA
Bob joined the FDA in 2003. He is currently the acting Director of the Office of Process & Facilities. Prior to the formation of OPQ, Bob was acting Associate Director for Policy Development in OPS. He was also a Division Director and CMC Team Leader in OGD. Prior to joining the FDA... Read More →

Speakers
avatar for Michael Kopcha

Michael Kopcha

Director, Office of Pharmaceutical Quality, CDER, FDA
With more than 25 years of pharmaceutical industry experience, Dr. Kopcha’s areas of expertise include formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management. Before joining FDA, Dr. Kopcha served as vice president... Read More →
avatar for Lawrence Yu

Lawrence Yu

Deputy Director, Office of Pharmaceutical Quality, CDER, FDA
Dr. Lawrence X. Yu is the Deputy Director for Science and Director of Chemistry at the Office of Generic Drugs, Food and Drug Administration, overseeing CMC review operation, policy development, and regulatory research with over 140 staff scientists. He is also adjunct Professor of... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Forum

4:00pm EDT

#360: Biomarkers and Sample Stability: Bottlenecks in Study Planning, Ensuring Sample Stability as the Key for Reliable Lab Results
Limited Capacity seats available

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



Chair
HS

Hermann Schulz

Executive Vice President, Synlab Pharma Institute
Before founding INTERLAB in 1994, Hermann Schulz held senior R&D positions in Pharma for 12 years. He was a Board member of the German Society of Pharmaceutical Medicine for 6 years, is visiting professor for applied clinical pharmacology and has written more than 35 scientific publications... Read More →

Speakers
avatar for Paul Travis

Paul Travis

Exec. Director, Medpace Global Labs, Medpace
Paul Travis MSc, Executive Director of Global Business Strategy at Medpace Laboratories. +25 years of Experience in R&D within the pharma and contract research industries. Attained MSc in Biomedical Science & began career with Ciba Geigy UK, working in early research and development... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm EDT
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Session
 
Thursday, June 30
 

10:45am EDT

#411: Nonclinical Statistics for Chemistry, Manufacturing, and Control: Case Studies and Regulatory Perspective
Limited Capacity seats available

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



Chair
avatar for Surya Chitra

Surya Chitra

Consultant, Biostatistics and Statistical Programming, Savio Group Inc
Surya Chitra, PhD, MBA, is an experienced biostatistics and pharmacology professional currently working as a R&D consultant for pharmaceutical/ biotechnology companies with 25+ years experience in the industry. He has previously worked at Endo Pharmaceuticals, AstraZeneca and Merck... Read More →

Speakers
CD

Cassie Dong

Mathematical Statistician, Division of Biometrics VI, OTS, CDER, FDA
Cassie is a Statistics Reviewer in CMC Review Team at office of Biostatistics, FDA and holds a Masters in Chemistry and PhD in Statistics. She joined FDA in 2012. Her primary review work concentrates on the analytical similarity assessment and product quality control. She also has... Read More →
CL

Charles Li

Statistician, Teva Pharmaceuticals
Charles has been working as a statistician in Teva Phamaceuticals for 2 years. He is working primarily on non-clinical statistics projects. His job includes: (1) the analysis for immunogenicity assays, cut-point determination for the screening, confirmatory, neutralizing antibody... Read More →
avatar for Shu Zhang

Shu Zhang

Statistician, GlaxoSmithKline
Shu Zhang is a non-clinical statistician in GlaxoSmithKline. She received a concurrent PhD degree in Biochemistry and MS degree in Statistics at Iowa State University and has 8 years of pharmaceutical industry experience in supporting non-clinical areas including CMC and discover... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Session