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08: R-D Quality-Compliance [clear filter]
Sunday, June 23
 

9:00am

SC28: #28: R&D QA Comprehensive Quality Strategy: An Approach to Managing Quality Risks Throughout the Drug Development Lifecycle
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-508-L04-P; CME 3.25; IACET 3.25; RN 3.25

Quality oversight of drugs throughout the product development lifecycle is complex and crosses many functions, and at times it can be challenging to communicate and manage the quality risks identified along the way. This short course will begin with a brief review of ICH E6 (R2) and the impact to the clinical development enterprise. The group will then examine points to consider regarding the principles and benefits of a quality management framework as a foundation in setting tolerance limits, managing issues, identifying and mitigating risks, and applying analytics as part of quality risk management. Through hands-on experience with hypothetical case studies developed for this course, you will design a proactive approach for the identification and management of quality risks and issues; develop thresholds for triage thereby setting tolerance limits; and experience design trending leading to analytics to identify future signals and risks. You will leave with knowledge and access to materials that will enable you to design a framework for identification and mitigation of quality risks as well as management of issues with tolerance limits which could reside in your own organization’s risk management program.
The instructors will take you through the development of a cross functional quality strategy frame work in an R&D QA organization which, when implemented will proactively identify, manage, and communicate quality risks across the R&D GxP functions throughout drug development lifecycle. Examples will be workshopped to demonstrate how this methodology can help assure confidence in the quality oversight in preparation for submission to regulatory agencies and for inspections. The value of this approach will be shown, revealing the positive impact on drug development and the potential for enhanced relationships with regulatory agencies.
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe the risk process;
  • Design a comprehensive quality strategy to manage risk throughout the drug lifecycle and establish Quality Tolerance Limits and Issue Management;
  • Discuss ways to implement a cross functional quality strategy frame work to identify, manage, and communicate quality risks across the R&D GxP functions.



Speakers
avatar for Victoria Burk

Victoria Burk

Director R&D Quality Assurance, AbbVie, Inc.
Vicki Burk is the R&D Quality Assurance director of Combination Products and Medical Devices at AbbVie. She leads a team responsible for Design Quality Assurance and the R&D Combination Product and Device Quality System. Vicki is also the business process owner for the R&D Comprehensive... Read More →
avatar for Kevin Grebner

Kevin Grebner

Director, Clinical Quality Assurance, AbbVie, Inc.
Kevin Grebner is a director in R&D Quality Assurance at AbbVie. Kevin leads the Program Management team responsible for developing and managing the Clinical QA strategy in support of compounds throughout the development life cycle. In his 32 year career at Abbott/AbbVie, Kevin has... Read More →
avatar for Tim Grey

Tim Grey

Director,R&D Quality Systems, AbbVie, Inc.
Tim Grey joined AbbVie in December 2013. He is currently Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team. Tim has spent his career developing, applying, and implementing quality systems principles across the GxP product... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

SC41: #41: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop
Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-518-L04-P; CME 6.50; IACET 6.50; RN 6.50

According to the FDA (as well as other regulators), CAPA management and lack of proper investigation of challenges is a top observation among companies in the industry. This short course will demonstrate by using interactive case study sessions how to perform a proper investigation into a robust root cause analysis using industry standard tools, in a toolkit approach. Also, challenges will be presented of proper CAPA planning and defining appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. We will use direct case studies from various FDA 483s to show real-life situations on how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals and auditors involved in Good Clinical, Laboratory, or Manufacturing Practices.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe and train individuals on best industry practices in CAPA management;
  • Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and Effectiveness Checks to ensure compliance and remediation of observations;
  • Discuss case studies that will help solidify how to use the different tools and why to use each one.



Speakers
avatar for Christy Mazzarisi

Christy Mazzarisi

Associate Director, Development Operations, Q&C/CTD, Kinapse
Accomplished Quality Systems Professional with a broad background in Pharmaceutical and Laboratory sciences with R&D and commercial manufacturing (sterile and non-sterile) experience with 15 years industry practice. Overall background and specialties include GMP and GLP; which has... Read More →
avatar for Danielle Metzger

Danielle Metzger

Manager, Development Operations, Q&C, Kinapse
Accomplished Quality Professional with a broad background in Pharmaceutical life sciences having R&D and commercial (sterile/non-sterile) experience with over 20 years practice. Specialize in Deviation/CAPA Management and TrackWise systems. Well versed in cGMP knowledge, FDA/EU regulations... Read More →


Sunday June 23, 2019 9:00am - 5:00pm
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:30pm

SC34: #34: Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-513-L04-P; CME 3.25; IACET 3.25; RN 3.25

The current clinical trial climate demands that sponsors find ways to reduce clinical trial complexity, drug development costs, and get more value from R&D budgets. Risk-based monitoring (RBM) allows organizations to target site monitoring activities for which risks can be best managed and deliver the greatest benefit to the study, and to become more effective and efficient in using resources, while increasing quality and patient safety. Participating TransCelerate Member Companies came together in 2012 to establish a model approach to high-quality RBM. To date, this effort has published a position paper on risk based monitoring, as well as several articles focused on sharing advancements, best practices and lessons learned from member companies adoption experience, all of which are publicly available. This short course, will define core concepts and main principles of the methodology, share key tools and discuss their use, share experiences and lessons learned, and address important questions about RBM and its implementation. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for professionals involved with clinical and data operations.

Learning Objectives

At the conclusion of this short course, participants should be able to:
  • Define core concepts and main principles of the TransCelerate risk-based monitoring (RBM) methodology;
  • Discuss the use of key tools in the RBM process;
  • Identify common challenges with effective monitoring and discuss how they can be addressed through appropriate use of the RBM methodology.



Speakers
avatar for Barbara Suarez

Barbara Suarez

Director, Clinical Study Support, GlaxoSmithKline
Barbara A. Suarez, M.S., Director of Clinical Study Support for the US Local Operating Company at GlaxoSmithKline Pharmaceuticals. Over the course of 20 years within the industry, Barbara has served in diverse roles of increased responsibilities within Clinical Operations. Since 2013... Read More →
avatar for Rodrigo Perez

Rodrigo Perez

CSU Risk-Based Monitoring (RBM) Business Lead, Sanofi
Rodrigo Perez, based in Mexico City, has more than 12 years of experience in clinical research working for Sanofi’s Clinical Study Unit (CSU) in different roles (CRA, Study Manager, and Operations Manager, among others). Graduated from Universidad La Salle, Rodrigo has a bachelor’s... Read More →


Sunday June 23, 2019 1:30pm - 5:00pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Monday, June 24
 

11:00am

#115: Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2)
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-529-L04-P; CME 1.00; IACET 1.00; RN 1.00

The key characteristics of a QMS with a focus on how the size of an organization impacts the QMS characteristics and their risk-based methodologies, including what key learnings organizations of varying sizes can learn from each other’s experiences.

Learning Objectives

Discuss the differing characteristics of a QMS based on the size of the organization; Compare how these characteristics changed in preparation for ICH E6 R2 implementation; Determine whether risk-based approaches vary based on organizational size and what organizations of different sizes can learn from each other.

Chair

Jay A Turpen

Speaker

Assessing Your Clinical Quality Management System: A Comprehensive Review of TransCelerate’s CQMS Assessment Tool
Michael Husovich

Please enter Presentation Title
Lenna Kimball, MBA

Panelist
RJ Doornbos, RPh



Speakers
avatar for Michael Husovich

Michael Husovich

Director, Global R&D Quality, Amgen Inc.
Michael is currently Director of Global R&D Quality Operations at Amgen. Michael is responsible for advancing Amgen's R&D Quality Management System including Business Process Management, Document Management, Issue CAPA Management, Quality Risk Management and driving Operational Excellence... Read More →
LK

Lenna Kimball

Vice President of of Clinical Operations, Lyell Biotech
avatar for Jay Turpen

Jay Turpen

Senior Consultant, The Avoca Group
Jay Turpen is a Senior Consultant with The Avoca Group. He has been in the pharmaceutical industry for 30 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new... Read More →
avatar for RJ Doornbos

RJ Doornbos

Head of Global Quality Systems, Global Quality, Bristol-Myers Squibb Company
RJ Doornbos has over 25 years experience in Pharmaceutical Industry in Brand and Generic concentrated in the areas of GxP Quality, Regulatory Affairs and Pharmaceutical Sciences. She has held various roles in Schering-Plough, Merck, Allergan/Teva and more recently in BMS where she... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#145: Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-545-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present pillars of effective vendor oversight and governance. A panel of experts will provide perspectives on benefits, lessons learned and challenges of various models.

Learning Objectives

Discuss the importance of comprehensive and transparent vendor oversight in light of increasing partnerships and outsourcing; Identify and review real life examples of issues and how to effectively address in both new and ongoing vendor relationships; Discuss ways to improve and accelerate trust in relationships.

Chair

Leo Dodds, MBA

Speaker

Panelist
Judith Sernatinger, MA

Panelist
Albert Cosenza, MS



Speakers
avatar for Albert Cosenza

Albert Cosenza

Head, Vendor and Capacity Management, Johnson & Johnson
A Pharmaceutical executive with a passion for building successful partnerships between vendors and corporations. As the cross-sector head of vendor and capacity management, he is responsible for providing strategic leadership for vendor management and oversight, as well as capacity... Read More →
avatar for Leo Dodds

Leo Dodds

Partner, Triradial Solutions
A biopharma executive and management consultant with a background in statistics and business operations. Leo helps clients accelerate their success strategies through leading practice and experience-based methods. His experience spans both commercial and R&D operations and his focus... Read More →
avatar for Judith Sernatinger

Judith Sernatinger

Vice President, Global Head of Quality, Prothena Biosciences Inc
Judith is a Quality Management Executive recognized for her ability to collaborate to build quality organizations and processes that drive patient safety and product quality. As VP, Global Head of Quality at Prothena Biosciences, she is responsible for Quality strategic planning and... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#164: Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-561-L04-P; CME 1.00; IACET 1.00; RN 1.00

The importance of periodic screenings (e.g. assessments, mock inspections) to ensure good inspection health. An interactive and colorful discussion of how being prepared by getting a thorough ‘check-up’ is the best way to be ready for an inspection.

Learning Objectives

Demonstrate how periodic screenings are an important part of inspection readiness; Discuss where hidden challenges lurk and how mock inspections can bring these items to light; Identify appropriate remediation plans that are organizationally focused and not study specific.

Chair

Grace M Crawford, MS

Speaker

Panelist
Barbara Maley

Panelist
Lauren Blomberg

Panelist
Gina C Lucas

Panelist
Matthew Krumrai



Speakers
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality and Compliance, AstraZeneca
Grace joined MedImmune in April 2015 to lead the Clinical Quality & Compliance function. Prior to joining MedImmune, Grace spent over 21 years at ICON where her main focus was leading the Clinical QA Department. She is active in industry participating in forums such as the Society... Read More →
avatar for Barbara Maley

Barbara Maley

Sr. Consultant, The Avoca Group
Barb Maley is a Quality Assurance professional with 29 years of research experience including 26 years within the pharmaceutical industry (GLP and GCP) and 17 years hands-on experience within Quality Assurance and Continuous Improvement. Barb has extensive experience providing quality... Read More →
LB

Lauren Blomberg

GCP Inspection Lead, Quality and Continuous Improvement, GCTO, Merck & Co., Inc.
Lauren Blomberg is an Associate Director, GCP Inspection Lead within the Global Clinical Trial Operations department at Merck & Co., Inc. Lauren has over 10 years of GCP and PV experience in the pharmaceutical industry, with expertise in Inspection Preparation and Inspection Management... Read More →
avatar for Matthew Krumrai

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie
Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →
GL

Gina Lucas

Director, Strategic Advice, AstraZeneca Pharmaceuticals LP
Gina Lucas is a professional with over 25 years of GXP QA pharmaceutical industry experience. Her current role includes providing GCP strategic direction for Immuno-oncology programs at AstraZeneca including providing quality and compliance advice during study conduct, submission... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

5:15pm

#175 EE: Data Analytics Use in Quality Processes
Component Type: Workshop
Level: Advanced

Roche is using data analytics as a key component for planning and conducting audits and providing ongoing support to our study teams. A brief overview will be given, and participants will be invited to share their experiences.

Learning Objectives

Discuss how Roche is integrating data analytics into issue/audit management; Describe how other companies are/will be using data analytics in support of their quality processes.

Chair

Eileen Magruder, DrMed, MD

Speaker

Facilitator
Alaina Barros



Speakers
avatar for Alaina Barros

Alaina Barros

Principal Auditor/Quality Program Lead, Genentech, A Member of the Roche Group
Alaina Barros has worked within the pharmaceutical industry for 17+ years in the areas of manufacturing, clinical operations and quality. She is currently employed with Genentech, a member of the Roche Group, as a Quality Program Lead/Principal Auditor.
avatar for Eileen Magruder

Eileen Magruder

Senior Auditor, Product Development Quality- PDQ-AFM, Genentech, A Member of the Roche Group
Eileen E. Magruder, MD has over 20 years of experience as a GCP and PV auditor. She is currently a senior auditor for the Product Development Quality - Audit and Finding Management team at Genentech, Inc., a member of the Roche Group.


Monday June 24, 2019 5:15pm - 6:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

8:00am

#212: Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4)
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-580-L04-P; CME 1.25; IACET 1.25; RN 1.25

This is the kickoff to a GxP series on the importance of implementing quality standards in early drug development conducted in academia and start-ups that govern how a compound is to be manufactured, tested in animals and studied in clinical trials.

Learning Objectives

Define GxP, G(R)P, GMP, GTP, GLP, and GCP; Discuss the importance of GxPs in manufacturing and translational research; Identify the challenges of implementing GxPs in an academic research and development environment.

Chair

Nancy Pire Smerkanich, DrSc

Speaker

Panelist
Eunjoo Pacifici, PharmD, PhD

Panelist
Paul W. Price, PhD, MS

Panelist
Andrew Norris, PhD

Panelist
Gary Gilleskie, PhD

Panelist
Susan E Vogel, BSN, RN



Speakers
avatar for Gary Gilleskie

Gary Gilleskie

Acting Director, Biomanufacturing Training and Education Center, North Carolina State University
Dr. Gary Gilleskie has been with NC State’s Biomanufacturing Training and Education Center (BTEC) since 2007 and is currently BTEC’s Acting Director. Gary’s work at BTEC focuses on downstream processing of biopharmaceuticals, including protein therapeutics, vaccines, and gene... Read More →
AN

Andrew Norris

Director of Research, BCN Biosciences
Dr. Andrew Norris has a varied background in both business and the technology sector. He is co-founder of The Midvale Group LLC in 2002, consulting in both the technology and biotechnology sector. Dr. Norris has also co founded BCN Biosciences, a company with principal focus in the... Read More →
avatar for Eunjoo Pacifici

Eunjoo Pacifici

Director, International Center for Regulatory Science: Assistant Professor, University of Southern California
Dr. Pacifici worked at Amgen conducting clinical research focusing her efforts initially on managing U.S. investigational sites and central laboratories. She then moved to the Asia Pacific/ Latin America group interfacing with local clinical and regulatory staff in Japan, People’s... Read More →
avatar for Paul Price

Paul Price

Regulatory Officer, Office of Regulatory Affairs, DAIT, National Institute of Allergy and Infectious Diseases, NIH
Dr. Price is a Regulatory Officer with NIH, NIAID, DAIT, ORA . Paul received his Ph.D. in Biology (Immunology) from Georgetown University, and completed post doctorate training at the Department of Microbiology and Immunology, University of MD School of Medicine. Paul has over 35... Read More →
avatar for Nancy Smerkanich

Nancy Smerkanich

Assistant Professor, Department of Regulatory & Quality Sciences, USC School of, University of Southern California
Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →
SV

Susan Vogel

Clinical Research Oversight Manager, National Institute of Allergy and Infectious Diseases, NIH
Susan Vogel is a Clinical Research Oversight Manager within the Office of Clinical Research Policy and Regulatory Operations (OCRPRO)/ Division of Clinical Research (DCR)/ NIAID/ NIH. Ms. Vogel has 18 years of experience in the clinical trials management environment and has been providing... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#211: Pharmacovigilance Reporting and Quality
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-579-L04-P; CME 1.25; IACET 1.25; RN 1.25

Expectations for quality and compliance in pharmacovigilance process and systems continues to rise Having a comprehensive quality system, including a robust CAPA process, is now essential for both good quality management and to drive continuous improvement. CAPA is also a focus of inspection by many key regulatory authorities. Meanwhile, the global expansion pharmacovigilance and evolving safety requirements continue to add complexity, increasing the challenge of executing consistently in a compliant manner. This is exemplified in the challenges presented by assuring proper distribution of safety report to the right person at the right time as well as in the management of Reference Safety Information (RSI) and Investigator's Brochures (IBs) according to the EU requirements.

This session will explore these hot topics in pharmacovigilance quality and compliance and provide insight on current expectations.

Learning Objectives

Describe the trending of PV audit findings and how to detect systemic issues before the proliferation of conflicting or redundant CAPA and constructing CAPA hygiene; Discuss how to develop a CAPA at the right level of detail, with reasonable timelines and root cause classifications; Identify the changing landscape related to Reference Safety Information (RSI) and perspectives on navigating RSI complexities in light of new EU requirements; Discuss approaches for consideration in context of global

Chair

Matthew Krumrai

Speaker

CAPAs, CAPAs Everywhere: How Effective are They and How Can they be Improved?
Kelly Traverso

Optimizing Global Safety Reporting in Clinical Trials Using Local Laws
Steven Beales

Global Clinical Trials and the Complexities of Reference Safety Information (RSI)
Andrea Best, DO, MPH



Speakers
avatar for Steven Beales

Steven Beales

Senior Vice President, Scientific and Regulatory, ePharmaSolutions, a WIRB-Copernicus Group Company
Steven Beales is the SVP of Scientific and Regulatory at WCG and co-chair of the Safety Reporting Reference Model working group. Steven has led the implementation of Clinical Trial Safety Portals for over 100 countries, working with 1 each of the top 3 Pharmaceutical, Biotech and... Read More →
avatar for Andrea Best

Andrea Best

Executive Medical Director, AbbVie, Inc.
Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical... Read More →
avatar for Kelly Traverso

Kelly Traverso

Consulting Specialist Leader, Deloitte
Kelly has over 17 years of industry and consulting experience in Life Sciences. She has significant consulting experience in the areas of Quality, Pharmacovigilance, R&D and Regulatory Affairs. Projects she has led and provided extensive subject matter expertise on include, Process... Read More →
avatar for Matthew Krumrai

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie
Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#228: Emerging Safety Challenges in New Oncology Treatments
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

Immuno-oncology (IO) agents are emerging as essential tools to treat a wide range of solid tumors and their indications for use continue to expand. However, the antitumor immune activity of these agents can also be a threat to healthy tissue, resulting in novel presentations of adverse reactions, sometimes with highly undesirable outcomes. Early recognition and intervention can have a dramatic effect outcomes, particularly for very rare events that are progressive. However, presentation can mimic other less serious conditions that do not require early intervention. Thus, these immune-mediated phenomena have become the focus of intense exploration.

This session will provide a very brief conceptual overview of these agents, followed by two presentations. the first presentation will include methodological considerations for identifying potential predictors, such as transcriptomic biomarkers or specific interleukins, etc., that might aid prevention, facilitate early detection, or predict mortality. The second presentation will provide regulatory considerations in ensuring that benefits of these products outweigh their risks. Both presentations will include examples to illustrate key points. The session will conclude with an opportunity for Q&A.

Learning Objectives

Outline basic mechanistic aspects related to the efficacy and safety of immuno-oncology agents; Describe methodological considerations when identifying utility of markers that can help in the prevention or early diagnosis of IO-associated adverse events; Discuss considerations in benefit-risk assessment and communication for these agents.

Chair

William Gregory, PhD

Speaker

Checkpoint Inhibitor-Associated Myocarditis: Prevention or Early Detection?
Tarek Hammad, MD, PhD, MS, MSc, FISPE

Regulatory Challenges in Benefit/Risk Assessment and Labeling of Immuno-Oncology Agents
Meredith K. Chuk, MD, MHS



Speakers
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
avatar for William Gregory

William Gregory

Worldwide Medical and Safety, Pfizer Inc
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
avatar for Tarek Hammad

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme
Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Hematology and Oncology Products in CDER at the FDA.


Tuesday June 25, 2019 10:30am - 11:30am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#239: Improving Clinical Trial Risk Management: How To Leverage the IRB's Designed Purpose
Component Type: Session
CE: ACPE 1.00 Application UAN: 0286-0000-19-598-L04-P; CME 1.00; IACET 1.00; RN 1.00



Speaker

Approach to Advancing Proactive Quality Through the Implementation of an Integrated Quality Risk Management Framework
Fidelle Jarmon, MS

CRO Perspective
Ben Quartley, PhD



Speakers
FJ

Fidelle Jarmon

Director, Risk Management, Bioresearch Quality and Compliance, Janssen
Fidelle has been with Johnson & Johnson for 10 years. She is currently the Director of Risk Management in the Bioresearch Quality & Compliance organization at Janssen. She is responsible for the further development, implementation, and continuous improvement of the Integrated Risk... Read More →
avatar for Ben Quartley

Ben Quartley

Head of Feasibility, Patient Recruitment and Engagement, Covance
Ben has spent more than 20 years in the Pharmaceutical Industry and has broad experience in Project management and Clinical Operations, having worked at a Site Management Organization, large Pharma and CROs. Early in his career he saw the challenges of accurately planning and delivering... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#266: Electronic Systems: Are Yours Fit for Purpose?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-617-L04-P; CME 1.25; IACET 1.25; RN 1.25

Electronic systems play a critical role in the conduct of clinical trials, but when inadequately validated and maintained to ensure that they are fit for use for their intended purpose, they may significantly impact the quality and reliability of clinical trial data. In this session, we will discuss examples of electronic systems commonly used to conduct clinical trials and expectations for their validation and maintenance. Examples of frequently encountered issues impacting data quality will be presented and discussed. The role of quality assurance, in maintaining oversight of these systems will also be considered. Perspectives from regulators and regulated industry will be provided.

Learning Objectives

Discuss the importance of ensuring that electronic systems used to conduct clinical trials are adequately validated and fit for intended purpose; Describe how regulators evaluate electronic systems; Discuss the role of quality assurance in ensuring regulatory compliance of electronic systems used by their organizations.

Chair

Jean M. Mulinde, MD

Speaker

MHRA Perspective
Gail Francis

FDA Perspective
Cheryl Grandinetti, PharmD

Industry Perspective
Jonathan Raymond Andrus, MS



Speakers
avatar for Jonathan Andrus

Jonathan Andrus

Chief Business Officer, Clinical Ink
Jonathan is responsible in helping sponsors and CROs better leverage eSource, eCOA and ePRO. At Clinical Ink, he is responsible for P&L across products and services and he is also focused on building partnerships with customers. Mr. Andrus joined Clinical Ink from BioClinica where... Read More →
avatar for Gail Francis

Gail Francis

Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA)
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Health Scientist, Policy Analyst, OSI, OC, CDER, FDA
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Senior Policy Advisor, OSI, OC, CDER, FDA
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:00pm

#267: Translating Academic Research Into Product Development: The What and Why of cGMP in Translational Science (Part 2 of 4)
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-618-L04-P; CME 1.25; IACET 1.25; RN 1.25

As part of a series on GxP, this session will define cGMP and describe the importance of regulatory preparedness in developing a translational program, and how academic and medical institutions are preparing the next generation work force.

Learning Objectives

Describe the basics of cGMP and the quality and regulatory requirements of drug manufacturing;. Explain how cGMP and GTP are implemented in cell and gene therapy;Discuss how academic institutions can implement programs to prepare students and support industry professionals in the area of GMP manufacturing.

Chair

Paul W. Price, PhD, MS

Speaker

The What and Why of cGMP
Paul W. Price, PhD, MS

cGMP Training in an Academic Environment: BTEC’s Program for Developing a Skilled Workforce for the Biopharmaceutical Industry
Gary Gilleskie, PhD

Overview of the Relevant Regulations Covering Human Cells, Tissues, and Cellular and Tissue-Based Products
Olive Sturtevant, MS, MT



Speakers
avatar for Gary Gilleskie

Gary Gilleskie

Acting Director, Biomanufacturing Training and Education Center, North Carolina State University
Dr. Gary Gilleskie has been with NC State’s Biomanufacturing Training and Education Center (BTEC) since 2007 and is currently BTEC’s Acting Director. Gary’s work at BTEC focuses on downstream processing of biopharmaceuticals, including protein therapeutics, vaccines, and gene... Read More →
avatar for Paul Price

Paul Price

Regulatory Officer, Office of Regulatory Affairs, DAIT, National Institute of Allergy and Infectious Diseases, NIH
Dr. Price is a Regulatory Officer with NIH, NIAID, DAIT, ORA . Paul received his Ph.D. in Biology (Immunology) from Georgetown University, and completed post doctorate training at the Department of Microbiology and Immunology, University of MD School of Medicine. Paul has over 35... Read More →
avatar for Olive Sturtevant

Olive Sturtevant

Senior Administrative Director, Cell Manipulation Core Facility, Dana-Farber Cancer Institute
Olive has 30 plus years in blood banking, clinical laboratory management and cellular manufacturing. In her current role, she is directly responsible for the Financial and Administrative oversight, Regulatory Compliance, Quality Control, Quality Assurance, Materials Management and... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#293: Real World Evidence: How Does its Use Challenge Quality and Compliance Programs?
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-635-L04-P; CME 1.25; IACET 1.25; RN 1.25

Evaluation of real world evidence (RWD) in the context of regulatory decision making depends not only on the evaluation of the methodologies used to generate the evidence, but on the reliability and relevance of the underlying RWD. FDA uses on-site inspections and data audits to evaluate all aspects of the conduct and reporting of FDA regulated research including data derived in real world settings. Speakers will provide views from regulatory perspective.

Learning Objectives

Discuss the importance of reliable data derived from sources other than traditional clinical trials to support regulatory decision making; Identify factors that FDA considers for assessing the reliability of real world data through on site inspections.

Chair

Kassa Ayalew, MD, MPH

Speaker

CPRD Update
Susan Beatty, MSc

FDA Update
Ni Aye Khin, MD, MS

Industry Update
Jonathan Raymond Andrus, MS



Speakers
avatar for Jonathan Andrus

Jonathan Andrus

Chief Business Officer, Clinical Ink
Jonathan is responsible in helping sponsors and CROs better leverage eSource, eCOA and ePRO. At Clinical Ink, he is responsible for P&L across products and services and he is also focused on building partnerships with customers. Mr. Andrus joined Clinical Ink from BioClinica where... Read More →
avatar for Kassa Ayalew

Kassa Ayalew

Branch Chief, Office of Scientific Investigations, Office of Compliance, CDER, FDA
Kassa Ayalew, M.D., M.P.H. is a Branch Chief for Good Clinical Practice Assessment Branch at the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease... Read More →
avatar for Susan Beatty

Susan Beatty

Clinical Operations Manager, The Clinical Practice Research Datalink Group (CPRD); MHRA
Susan joined CPRD in 2017 as Clinical Operations Manager, responsible for the delivery of CPRD’s Interventional Research services. Previous to this role, Susan has over 18 years’ experience in clinical research, with senior positions at Oxford Biomedical Research Centre and Oxford... Read More →
NK

Ni Khin

Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA
Dr. Ni Khin is currently Division Director in Division of Clinical Compliance Evaluation, Office of Scientific Investigations, CDER, FDA. In this position, she provides regulatory scientific oversight for CDER assigned bioresearch monitoring activities. She participates in onsite... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Advanced
  • Featured Topics Real World Evidence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
 
Wednesday, June 26
 

8:00am

#311: Improving Trial Quality by Better Preparing Site Teams
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-652-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will describe new CTTI recommendations that provide a pathway for: Implementing a more efficient and effective means of investigator qualification, determining whether a site team is a good fit for a particular protocol, and improving the understanding of how to apply GCP principles to the conduct of clinical trials.

Learning Objectives

Identify the limitations of current approaches to preparing investigators for conducting clinical trials; Describe strategies for eliminating the distinction between the “qualifying” and “preparing” investigators; Implement actionable recommendations to support a more fit-for-purpose, risk-based, and streamlined approach to investigator requirements.

Chair

Sabrina Comic-Savic, MD, MPH

Speaker

Panelist
Christine Marie Hildebrand

Panelist
Jimmy Bechtel

Industry Update
Janette Sylvia Panhuis, BSN, MBA, RN



Speakers
avatar for Jimmy Bechtel

Jimmy Bechtel

Senior Project Manager, Society For Clinical Research Sites (SCRS)
Jimmy brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum as a data specialist, patient recruiter and operations manager. On the pharma side where he worked... Read More →
avatar for Christine Hildebrand

Christine Hildebrand

Physician Assistant, Sub-Investigator, Clinical Operations Lead, Amici
My name is Christine M. Hildebrand. I am a certified Physician Assistant and have been a clinical researcher and Sub Investigator for over 12 years. I received my undergraduate degree in Health and Nutrition Science from Brooklyn College and I trained at SUNY Downstate Medical Center... Read More →
avatar for Janette Panhuis

Janette Panhuis

Chief Operating Officer, Population Health Research Institute
Janette Panhuis is the Chief Operating Officer of Population Health Research Institute (McMaster) in Hamilton, Ontario, Canada. Ms. Panhuis joined PHRI in 2009 as the Director, Quality Assurance responsible for Quality Systems. Janette brings over 20 years of pharmaceutical research... Read More →
avatar for Veronica Todaro

Veronica Todaro

Chief Operating Officer, Parkinson's Foundation
Veronica (Ronnie) Todaro, M.P.H., has led the national programs of the Parkinson’s Disease Foundation (PDF) since joining the organization in 2004. In this role, she has pioneered national programs focused on patient engagement both at PDF and in the broader community. She has advocated... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Advanced
  • Featured Topics Student Programming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

8:00am

#312: Translating Academic Research into Product Development: The Importance of Understanding GLPs at an Early Stage (Part 3 of 4)
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-653-L04-P; CME 1.25; IACET 1.25; RN 1.25

As part of a series on GxP, this session will describe GLP requirements for successful translation of academic research projects. GLP requirements for toxicity studies must be met before FDA allows new therapies to proceed to human clinical trials.

Learning Objectives

Describe the characteristics GLPs; Recognize where GLP fits in the development cycle of a medical products being developed in academia; Identify how GLPs in academia can help to translate innovate therapies into products more efficiently.

Chair

Isabel Lauren Jackson, PhD

Speaker

An Introduction to Good Laboratory Practice (GLP) Regulations: What Are They, and How Did We Get Here?
Jon Carl Mirsalis, PhD, MS

Translating Academic Research into Product Development: Implementation of a Quality Management System in Academic Laboratories to Improve Data Quality, Traceability, and Reproducibility.
Isabel Lauren Jackson, PhD

Translating Drug Discovery From Academia and Important Criteria for Success
Andrew Norris, PhD

Perception Versus Experience: The Advantages of Academic Research and Development Partners and Limitation of Commercial CRO's
John L McManus



Speakers
avatar for Isabel Jackson

Isabel Jackson

Associate Professor, University of Maryland School of Medicine
Dr. Jackson is an Associate Professor, Dept. of Radiation Oncology and serves as Deputy Director of the Division of Translational Radiation Sciences at the University of Maryland School of Medicine (UMSOM). Her subject matter expertise is in the field of tumor and normal tissue radiobiology... Read More →
JM

John McManus

Principal, EVS Partners
avatar for Jon Mirsalis

Jon Mirsalis

Vice President, Translational Development, SRI Biosciences
Jon C. Mirsalis, Vice President of Translational Development at SRI International, manages all regulated medical product development at SRI. His group has advanced over 175 drugs from early development into clinical trials; over 20 have reached the market. Dr. Mirsalis received his... Read More →
AN

Andrew Norris

Director of Research, BCN Biosciences
Dr. Andrew Norris has a varied background in both business and the technology sector. He is co-founder of The Midvale Group LLC in 2002, consulting in both the technology and biotechnology sector. Dr. Norris has also co founded BCN Biosciences, a company with principal focus in the... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 14A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#338: Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-669-L04-P; CME 1.00; IACET 1.00; RN 1.00

Best practices for development and maintenance of IRT systems will be discussed. Examples of systems that were inadequately developed resulting in significant impacts on study conduct, data quality, and data reliability will be presented.

Learning Objectives

Describe the importance of ensuring that interactive response systems (IRT) used to conduct clinical trials are adequately validated and maintained; Discuss how errors resulting from IRT systems impact study conduct, data quality, and data reliability.

Chair

Jean M. Mulinde, MD

Speaker

FDA Perspective
Phillip D. Kronstein, MD

MHRA Perspective
Stephen Vinter



Speakers
avatar for Phillip Kronstein

Phillip Kronstein

Team Leader, Division of Clinical Compliance Evaluation, OSI, CDER, FDA
Phillip Kronstein, M.D. is a Team Leader for the Good Clinical Practice (GCP) Assessment Branch in the Division of Clinical Compliance Evaluation (DCCE)/Office of Scientific Investigations (OSI) at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Senior Policy Advisor, OSI, OC, CDER, FDA
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Stephen Vinter

Stephen Vinter

Operations Manager GLPMA and Laboratories Group, Medicines and Healthcare products Regulatory Agency (MHRA)
Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#363: Neurodegenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-687-L04-P; CME 1.25; IACET 1.25; RN 1.25

Intense research on the multiple fronts advanced our understanding of neurodegenerative diseases. Many disease-specific animal models have been used to test emergent medicines in neurology. Genetics and mechanism of neuronal pathogenesis contributed greatly and has created a wealth of knowledge and became the bases for novel technologies and multiple therapeutic targets for these neurodegenerative diseases. There is however substantial difficulty in choosing/accessing an optimal model or choosing measurements which would be truly informative of the product’s efficacy in neurodegenerative rare diseases or more prevalent diseases like pediatric neurodegenerative diseases and Alzheimer’s. This session will discuss nonclinical models supporting efficacy in rare neurodegenerative conditions, looking also at the challenges in early development in pediatric neurodegenerative diseases and highlight successes and failures in the development of treatments for dyslipidemia that may be applicable to the treatment of neurodegenerative diseases like Alzheimer’s disease.

Learning Objectives

Describe the importance and value of nonclinical in vivo models in rare neurodegenerative conditions and share highlights on the challenges in early development in pediatric neurodegenerative diseases; Identify optimal strategies for testing putative Alzheimer therapies; Recognize how to select and qualify biomarkers to identify patient and measure relevant drug activity; Define how to apply lessons from development of drugs to prevent Alzheimer Dementia.

Chair

Dinah Duarte, MSc

Speaker

Rare Neurodegenerative Diseases: Early-Stage Challenges and Optimal Animal Models in Orphan Drug Development
Dinah Duarte, MSc

Alzheimers Disease Prophylaxis: Lessons from Lipid Therapeutics
Richard Scheyer, MD

The Challenges in Early Development in pediatric Neurodegenerative Diseases
Scott Demarest, MD



Speakers
SD

Scott Demarest

Assistant Professor, Departments of Pediatrics and Neurology, University of Colorado School of Medicine; Children's Hospital Colorado
Scott Demarest received a Bachelor of Science in biology from the University of Texas at Austin before going on to medical school at the University of Texas Health Science Center in San Antonio. He completed his residency in Pediatrics and child neurology at Children's National Health... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Richard Scheyer

Richard Scheyer

Vice President, Medical, Medpace
Dr. Richard Scheyer is VP Medical at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from SUNY... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#366: Translating Academic Research into Product Development: Integrating GCP Training into the Process (Part 4 of 4)
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-690-L04-P; CME 1.25; IACET 1.25; RN 1.25

As part of a series on GxP, this session describes how approaches to better ensure quality in IITs can lead to more efficient product development. Monitoring/auditing, routine quality functions in industry-trials, are often lacking in IITs.

Learning Objectives

Explain how quality initiatives in investigator-initiated trials (IITs) can lead to more efficient product development; Identify benefits of self-study modules to cross-train clinical trial professionals in essential concepts and practical approaches to monitoring/auditing; Describe the challenges to implementation of monitoring and auditing training programs.

Chair

Eunjoo Pacifici, PharmD, PhD

Speaker

Academic Perspective
Amelia Rose Spinrad, MS

Industry Perspective
Stan Jhee, PharmD

NIH Perspective
Susan E Vogel, BSN, RN



Speakers
SJ

Stan Jhee

Corporate Vice President, Parexel
Dr. Jhee is a clinical pharmacologist with expertise in a wide range of early drug development studies from First-in-Human through Proof-of-concept. His work involves drugs in a variety of therapeutic areas. However, a significant portion of the programs are in Neurology and Psychiatry... Read More →
avatar for Eunjoo Pacifici

Eunjoo Pacifici

Director, International Center for Regulatory Science: Assistant Professor, University of Southern California
Dr. Pacifici worked at Amgen conducting clinical research focusing her efforts initially on managing U.S. investigational sites and central laboratories. She then moved to the Asia Pacific/ Latin America group interfacing with local clinical and regulatory staff in Japan, People’s... Read More →
avatar for Amelia Spinrad

Amelia Spinrad

Regulatory Knowledge Support Administrator, USC International Center For Regulatory Science
Amelia Spinrad, MS is currently a Regulatory Knowledge Support Administrator working at the International Center for Regulatory Science on projects with the Southern California Clinical and Translational Science Institute (SC-CTSI). She manages a regulatory research and her main project... Read More →
SV

Susan Vogel

Clinical Research Oversight Manager, National Institute of Allergy and Infectious Diseases, NIH
Susan Vogel is a Clinical Research Oversight Manager within the Office of Clinical Research Policy and Regulatory Operations (OCRPRO)/ Division of Clinical Research (DCR)/ NIAID/ NIH. Ms. Vogel has 18 years of experience in the clinical trials management environment and has been providing... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#365: Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-689-L04-P; CME 1.25; IACET 1.25; RN 1.25

The abundance of data collected in clinical research offers an increasing opportunity for insights into risks, quality, and compliance.To realize the full value, the data must be harnessed in a manner that is useful and meaningful, which can be a challenge. The key lies in developing analytics and models that provide insights. Leveraging data is particularly valuable in an environment where Risk Based Monitoring (RBM) is now the norm and the models and dashboards derived from analytics can proactively indicate risks and issues. Interpretation can drive compliance and quality decision making and a focus on what matters most. Advanced analytics and machine learning can also be leveraged to detect irregularities that may indicate falsification and misconduct.

This session will explore the potential of data analytics and modeling as applied to risk-based monitoring activities as well as quality assurance oversight of risk-base monitoring.

Learning Objectives

Design an innovative and efficient sampling SDV method reflecting trends of data error occurrence; Assess how measured risk changes over time, comparing change in risk relative to operational attributes, and judging the effects of risk-based monitoringon risk mitigation; Define key changes to risk-based monitoring programs that may require changes to quality assurance oversight, including audit programs; Discuss how site audits may shift focus from on-site audit activities to remote.

Chair

Matthew Krumrai

Speaker

Statistical Models of Risk Flux Reveal Dynamics of Risk-Based Monitoring Managed Clinical Trials
Kristin Stallcup, MS, PMP

Study on Designing a Method of Sampling SDV in a Clinical Trial Using Audit Trail Data
Yuhi Sakajiri

Subject Data Analysis and Potential Fraud and Misconduct Analysis for Data Quality in Clinical Trials
Wei Xue, DrPH

Maintaining Quality Assurance in a Risk-Based Monitoring Environment
Matthew Krumrai



Speakers
avatar for Matthew Krumrai

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie
Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →
avatar for Yuhi Sakajiri

Yuhi Sakajiri

Student, Waseda University
Yuhi Sakajiri (born in Chiba, Japan, in May. 1995) received B.Eng. degrees in Industrial and Management Systems Engineering from the Waseda University, Japan, in 2018. Since 2018, he engaged in quality management research at the university's M.Eng. course. His research interest is... Read More →
avatar for Kristin Stallcup

Kristin Stallcup

Senior Director, Covance
Kristin Stallcup brings 15 years of industry experience in various trial management capacities. Currently she serves as senior director responsible for implementation and adoption of the Xcellerate Informatics suite into business process. Previously she served in central monitoring... Read More →
WX

Wei Xue

Centralized Monitoring Manager, IQVIA
Wei Xue is a Centralized Monitoring Manager in Data Trial Execution in IQVIA. Her expertise spans in statistical and machine learning analysis in risk-based monitoring, predictive analysis and potential fraud and misconduct analysis in clinical trials industry. Wei got her Doctor... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#387: Global Perspective on ICH E8(R1): General Considerations for Clinical Trials
Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-677-L04-P; CME 1.25; IACET 1.25; RN 1.25

Experts from the ICH E8(R1) working group provide an overview of the revisions to the ICH E8(R1) guideline on General Considerations for Clinical Studies and discuss how the revised guideline will support improved study design and conduct.

Learning Objectives

Discuss how the revised ICH E8 Guideline on General Considerations for Clinical Studies will modernize guidance for clinical study design; Describe how to identify critical-to-quality factors to support the meaningfulness and reliability of clinical study results; Discuss how the revised guideline will address a broader range of study designs and data sources.

Chair

Amanda Marie Roache, MS

Speaker

Panelist
Kerstin Koenig, PhD, MSc

Panelist
Mark S. Levenson, PhD

Panelist
Joanne Palmisano, MD, FACP

EMA Update
Agnès Saint-Raymond, DrMed, MD



Speakers
avatar for Kerstin Koenig

Kerstin Koenig

Executive Director, Research and Development Quality, Merck KGaA
Kerstin Koenig, PhD is the Head of Research & Development Quality, Merck Healthcare KGaA, Darmstadt, Germany. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of GRP, GLP... Read More →
avatar for Mark Levenson

Mark Levenson

Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER, FDA
Mark Levenson is the Director of the Division of Biometrics 7 in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of FDA. At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug... Read More →
avatar for Joanne Palmisano

Joanne Palmisano

Vice President, Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc
Joanne Palmisano, MD, FACP, FRAPS Dr. Palmisano is a global regulatory leader with extensive biopharmaceutical drug development expertise in small molecule and biologics in multiple therapeutic areas. As Vice President Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc... Read More →
avatar for Amanda Roache

Amanda Roache

Operations Research Analyst, OCD, CDER, FDA
Amanda Roache is FDA's ICH Coordinator and has served as an Operations Research Analyst in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration since 2012. Ms. Roache works in CDER's International Program and facilitates scientific exchanges with... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

9:00am

#409: Case Studies From FDA and MHRA: Good Clinical Practices
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-723-L04-P; CME 1.25; IACET 1.25; RN 1.25

If you were not able to join in person on day two of the FDA-MHRA Good Clinical Practice Workshop, Data Integrity in Global Clinical Trials – Are We There Yet? last October, and missed the case study sessions, you will have a second chance in this Workshop. Attendees will work with regulators on two of the previously presented case studies to investigate data integrity and discuss the impact of their findings on overall study reliability.

Learning Objectives

Evaluate how data management practices may impact data integrity and reliability; Discuss how data integrity is key to vendor selection; Describe and evaluate the impact of data blinding on data reliability; Evaluate how audit trails may be used to assess data integrity.

Chair

Gail Francis

Speaker

MHRA Perspective
Stephen Vinter

FDA Perspective
Jean M. Mulinde, MD



Speakers
avatar for Gail Francis

Gail Francis

Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA)
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Senior Policy Advisor, OSI, OC, CDER, FDA
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Stephen Vinter

Stephen Vinter

Operations Manager GLPMA and Laboratories Group, Medicines and Healthcare products Regulatory Agency (MHRA)
Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA