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03: Data-Data Standards [clear filter]
Monday, June 24
 

11:00am

#112: Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-526-L04-P; CME 1.00; IACET 1.00; RN 1.00

We will present methods and success stories from three rare disease patient organizations that have collected meaningful patient experience data. Panelists will share their insights and challenges for data collection including surveys and patient registries.

Learning Objectives

Describe the importance of participating in registries and the methods by which data is collected; Identify strategies for overcoming the challenges of patient engagement to help provide pathways towards accelerating rare disease research.

Chair

Laura Trutoiu, PhD

Speaker

Panelist
Monica Weldon

Panelist
Pamela Mace, RN



Speakers
PM

Pamela Mace

Executive Director, Fibromuscular Dysplasia Society of America
At the age of 37, Pam Mace was diagnosed with a rare disease called Fibromuscular Dysplasia (FMD). She struggled with her health for the first few years after her diagnosis and realized that medical professionals had no real understanding of the disease. Pam became an advocate for... Read More →
LT

Laura Trutoiu

Director of Research, The Association For Creatine Deficiencies
Laura is a computer scientist and the Director of Research for the Association for Creatine Deficiencies. She holds a PhD in Robotics from Carnegie Mellon University and she has conducted research in several top industry labs including Disney Research, Industrial Light and Magic... Read More →
avatar for Monica Weldon

Monica Weldon

President/Chief Executive Officer, Bridge the Gap - SYNGAP Foundation
In November of 2012, Monica's twin son, Beckett, was the first to be diagnosed at Texas Children's Genetics Clinic with the gene mutation SYNGAP1 (6p21.3). When Beckett was 4 months old, she noticed he was not meeting the same milestones as his twin sister. Monica then began a journey... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:30pm

Community Meet Up: Discussion on Data Quality, Real-Time Calculated Metrics, Compliance
Component Type: Forum
Level: Basic

For any conference attendees interested in the topic of data quality, real-time calculated metrics across systems and all while staying in line with the highest level of compliance. This discussion includes (but is not limited to): • Peer insights & challenges • Machine learning • Artificial intelligence • Disparate data • Workflow insights • Leveraging your current systems

Chair

Adam Federman


Speakers
AF

Adam Federman

Director, Business Development, Remarque Systems


Monday June 24, 2019 12:30pm - 1:30pm
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-550-L04-P; CME 1.00; IACET 1.00; RN 1.00

Data visualization can transform and advance clinical trial safety analysis. Discover the latest data visualization use cases for safety and how dynamic data exploration yields meaningful data review, better patient outcomes and trial efficiency.

Learning Objectives

Discuss various data visualization examples that can be applied to the area of clinical trial safety analysis; Outline key benefits and efficiencies statisticians, medical monitors, and others in charge of safety can achieve through data visualizations that are being used in this area of clinical trials today.

Chair

Demi Niforos, MS

Speaker

Summary of Safety Visualization Efforts
William Wang, PhD

Panelist
Nathan Bennett, PhD, MA



Speakers
DN

Demi Niforos

Vice President, Biostatistics and Statistical Programming, eClinical Solutions
Demi Niforos is VP, Biostatistics and Statistical Programming for eClinical Solutions and has more than 20 years of drug development experience in both the CRO and Pharmaceutical/Biotech environments. Prior to joining eClinical Solutions she held leadership roles in biostatistics... Read More →
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →


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

3:30pm

#159: Understanding the Data Journey In Virtual Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-556-L04-P; CME 1.00; IACET 1.00; RN 1.00

Virtual trials promise to improve clinical research. New methods of data collection and usage also bring new challenges. This forum will model the journey of data in a virtual trial, identify key challenges, and offer solutions for sponsors and CROs.

Learning Objectives

Recognize data collection and usage challenges at all stages of virtual trials; Design successful data practices in a virtual trial.

Chair

Jon Roth, MBA

Speaker

Panelist
Oladele Babalola

Panelist
Robert A. DiCicco, PharmD

FDA Update
Vaishali Popat, MD, MPH

FDA Update
Isaac R. Rodriguez-Chavez, MHS, PhD, MS



Speakers
OB

Oladele Babalola

Associate Director, Data Management, Apellis Pharmaceuticals
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →
avatar for Vaishali Popat

Vaishali Popat

Associate Director of Biomedical Informatics and Safety Analytics, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as staff training on the use of new review tools to make the evaluation of pre-marketing data... Read More →
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Clinical Research Methodology, Reg Compliance and Policy Development, OMP, CDER, FDA
Dr. Isaac R. Rodriguez-Chavez serves as a FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Past positions in the last 20 years... Read More →
avatar for Jon Roth

Jon Roth

VP, Data Sciences and Biometrics, Biorasi
With over 25 years of clinical trial experience, including a decade as CEO/CTO of a clinical data driven CRO, and a penchant for innovative approaches to clinical study management featuring big data analysis and on-study analytics of live and historical clinical study data, Jon has... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

8:00am

#206: Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data
Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

This panel discussion will explore ways to improve connectedness of clinical data in today's CDM world and talk about if Single Source of Truth, Integrations or IoT (Internet of Things) are the best ways to move forward.

Learning Objectives

Describe why, what, where, when and how of data integrations between clinical systems; Describe recent technologies in CDM world and how these technologies are increasing the need for efficient integrations; Identify current challenges in data integrations between clinical systems; Discuss ways to improve efficiency of integrations and use cases where technology has improved integration.

Chair

Joby John, DDS

Speaker

Panelist
Nick Neri, MS

Panelist
Kelly Ritch, MBA, MS

Panelist
Jennifer Price



Speakers
avatar for Joby John

Joby John

Senior Director, Technology Operations, Bioclinica
Dr Joby John is a versatile Clinical Research executive with over 16 years of experience in managing end to end clinical services like EDC, CDM, SDTM, SAS, IWRS, eTMF to name a few. She has worked with a wide array of global Pharma companies, CROs and FSPs in setting up and managing... Read More →
avatar for Nick Neri

Nick Neri

Director of Data Services & Integration, ERT
Mr. Neri has over 20 years of industry experience, and has established himself as a thought leader in the industry for applying next generation concepts and technologies to the clinical research space. He currently serves as Director, Data Integration and Services, CoE at ERT. Previously... Read More →
avatar for Jennifer Price

Jennifer Price

Senior Director, Clinical Data Management, Paidion Research
Jennifer has 25+ years of pharmaceutical industry experience with Biometrics, Data Management and related technologies. Jennifer currently is the head of Data Management for Paidion Research, a Pediatric CRO. In this role, Jennifer is responsible for the collection and management... Read More →
KR

Kelly Ritch

VP, Clinical Trial Solutions, ArcheMedX
Dynamic and innovative executive with 20 years experience creating, managing, and driving high-performance, outcomes, and long-term value. Strategic thinker with strong analytical skills as well as a proven ability to affect positive change and significantly improve business processes... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#229: An Industry Collaboration on Pharmacovigilance Analytics
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-592-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss an initiative and how it is facilitating biopharmaceutical companies to enable earlier and systematic identification of potential safety issues to help minimize harm to patients, improve quality of analytic methods to improve product development, and deliver accelerated method development through collaboration and piloting. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 12:45-1:45PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Discuss methods for collaborating and innovating in analytics to improve patient safety; Identify how to build awareness of opportunities for greater alignment across the industry in signal detection and management; Describe industry best practices of current and future signal detection and management.

Chair

Andres Gomez, PhD, MPH

Speaker

Panelist
John Van Stekelenborg, PhD, MBA, MSc

Panelist
Neal Grabowski, MS



Speakers
AG

Andres Gomez

Vice President, Head of Epidemiology, Safety Science, and Analytics, Bristol-Myers Squibb
Dr. Gomez joined at Bristol Myers Squibb Company as an Associate Director of Pharmacoepidemiology in the Global Pharmacovigilance and Epidemiology department in 2003. He currently heads the epidemiology, safety science and analytics groups which is accountable for the real world research... Read More →
NG

Neal Grabowski

Director, Global Patient Safety and Labeling, Amgen Inc.
Neal Grabowski joined Amgen in 2014 as the Signal Management Officer responsible for signal detection and management processes including the implementation of numerous systems, process oversight and continual improvement and vendor management. He is currently the Head of Safety Signal... Read More →
avatar for John Van Stekelenborg

John Van Stekelenborg

Director, Group Lead, Methods and Analysis, Johnson & Johnson
John van Stekelenborg is the Head of the Methods & Analysis group in the Global Medical Safety department of Janssen, the Pharmaceutical Companies of Johnson & Johnson. John has been with J&J since 2002 and assumed leadership of the M&A group in 2011 where he leads a group of data... Read More →


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

2:00pm

#259: FDA Data Standards Update
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-611-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA CDER and CBER implemented a joint data standards strategy in 2018, with a supporting action plan that is a PDUFA VI commitment. This session will focus on accomplishments and challenges.

Learning Objectives

Explain current and emerging data standards at FDA; Describe the FDA's data standards process and collaborations with stakeholders.

Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

CBER Study Data Standards Update
Wei (Lisa) Lin, MBA, PMP

CDER Update
Ethan Chen, MBA

CDER Update
Ta-Jen Chen, MS

CDER Update
Vaishali Popat, MD, MPH



Speakers
avatar for Ethan Chen

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA
Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led the several critical initiatives as the CDER... Read More →
TC

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Sr. Informatics Advisor, FDA
Ron Fitzmartin is Senior Project Manager, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
avatar for Wei (Lisa) Lin

Wei (Lisa) Lin

Study Data Standards Manager, Office of Director, CBER, FDA
Lisa Lin has worked as a Study Data Standards manager at FDA CBER for over a year. Currently she is responsible for all study data standards projects in CBER, including data validation, evaluation and testing of SEND standard for CBER, data analysis tool training and support. Before... Read More →
avatar for Vaishali Popat

Vaishali Popat

Associate Director of Biomedical Informatics and Safety Analytics, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as staff training on the use of new review tools to make the evaluation of pre-marketing data... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#261: Patient Experience Data: How Could this Data Enhance Decision-Making at Different Stages of Medical Product Development?
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-613-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will provide an opportunity for key stakeholders to discuss examples of various types of patient experience data, and how this data could potentially inform decision-making at different stages of medical product development.

Learning Objectives

Define patient experience data; Describe types of patient experience data that could inform medical product development; Discuss how patient experience data can inform decision making at different stages of medical product development.

Chair

Meghana Chalasani, MHA

Speaker

FDA Perspective
Michelle Campbell, PhD

Panelist
Elizabeth Hart, MD

Panelist
Isabelle Lousada, MA

Panelist
Kristina Bowyer, LPN



Speakers
avatar for Kristina Bowyer

Kristina Bowyer

Executive Director of Patient Advocacy, Ionis Pharmaceuticals
Kristina Bowyer is the Executive Director of Patient Advocacy & Engagement at Ionis Pharmaceuticals. Kristina has worked at Ionis for over 26 years and has spent the last seven years successfully building Ionis’ internal patient engagement program to ensure that the patient perspective... Read More →
MC

Michelle Campbell

Division of Neurology Products, Office of New Drugs, CDER, FDA
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes for the Division of Neurology Products, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a... Read More →
avatar for Meghana Chalasani

Meghana Chalasani

Senior Research Analyst, Office of the Center Director, CDER, FDA
Meghana Chalasani currently serves as a senior research analyst for the Patient-Focused Drug Development (PFDD) Program in FDA’s Center for Drug Evaluation and Research (CDER). She works closely on CDER’s various PFDD initiatives and provides strategic, regulatory, program, and... Read More →
avatar for Isabelle Lousada

Isabelle Lousada

Chief Executive Officer and President, Amyloidosis Research Consortium
As a former patient, Lousada has spent 20 years dedicated to patient advocacy, accelerating drug development, and promoting awareness of rare diseases. Lousada founded the Amyloidosis Research Consortium (ARC) in 2015 to address the critical needs in clinical trials and related research... Read More →
EH

Elizabeth Hart

Physician, Office of Tissues and Advanced Therapies, CBER, FDA


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

8:00am

#317: Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-657-L04-P; CME 1.25; IACET 1.25; RN 1.25

Industry and FDA experts will share how to operationalize ICH E9(R1) to design trials with clinically meaningful endpoints. Forum will include a summary from the DIA Stats Community GTQR Series, the Oncology Drug Development Working group on Estimands, and Tipping Point analysis to account for missing data.

Learning Objectives

Discuss key elements of ICH E9(R1) and GTQR; Define estimands and ongoing efforts for implementation; Identify how to apply estimands in oncology with time-to-event endpoint; Describe an overview and examples of applying tipping point analysis to explore the impact of missing data assumptions on study results, along with key considerations during the planning stage of these sensitivity analyses.

Chair

Munish Mehra

Speaker

Estimand Framework and its Impact on Oncology Drug Development: Findings From An Industry-Wide Working Group
Yi Liu, PhD

Assessment of Tipping Point Analysis for Handling Various Types of Missing Data
Martin Clancy, MSc

Estimands for Efficacy Analyses
Thomas J. Permutt, PhD



Speakers
MC

Martin Clancy

Senior Statistician, PHASTAR
I'm a Senior Statistician at PHASTAR, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services by providing expert consultants and delivering in-house projects. Working in a Contract Research Organisation (CRO) for the past 4 years... Read More →
avatar for Yi Liu

Yi Liu

Director Biostatistics, Nektar Therapeutics
Yi Liu got her Ph.D. degree in Statistics from the department of Statistics at The Ohio State University. She is currently a director at Nektar Therapeutics responsible for clinical trials in collaborations with external partners and CMC and biomarker related statistical analyses... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Dr. Munish Mehra, is a drug development expert with Tigermed, providing services to Pharmaceutical and Biotechnology companies to design, analyze and report on Phase 2 and 3 studies. He has represented several sponsors at pre-IND, End of Phase 2 and pre-NDA meetings. He is a frequent... Read More →
avatar for Thomas Permutt

Thomas Permutt

Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA
Tom Permutt is Associate Director for Statistical Science and Policy, Office of Biostatistics, Center for Drug Evaluation and Research at FDA. Tom’s contributions to causal inference in clinical trials date from 1989 when he proposed an instrumental-variable estimator of the effect... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 11B 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 Forum

2:00pm

#360: Identification of Medicinal Products: FDA's Perspective and Approach
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-684-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will discuss FDA's perspective on the five ISO standards for Identification of Medicinal Products and its approach to conformance, as well as its collaboration with industry and other regulatory agencies.

Learning Objectives

Identify the five ISO IDMP Standards; Describe FDA's approach to IDMP conformance; Explain the current scope of the FDA's IDMP approach.

Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

FDA Update
Ta-Jen Chen, MS

Defining Substances for the IDMP Using the GSRS
Lawrence Nicholas Callahan, III, PhD



Speakers
TC

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Sr. Informatics Advisor, FDA
Ron Fitzmartin is Senior Project Manager, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
LC

Lawrence Callahan

Chemist, OCS, OCPP, Office of the Commissioner, FDA
Larry Callahan obtained his Ph.D. in Chemistry from the University of Chicago. He was previously employed at FDA, NIH and the United States Pharmacopiea (USP). He has been involved in Nucleic Acid, HIV, tuberculosis research and the development of analytical methods for biotechnology-derived... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA