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Monday, June 20
 

1:15pm CDT

#109: Risk-Based Monitoring in Clinical Trials: An Evolution of Practices During the COVID Pandemic
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-512-L04-P ; CME 1.00; RN 1.00

The industry embraced an enormous shift during the global pandemic. This panel will report out on a two-year analysis conducted on over 6,000 clinical trials. We looked at the study-level and surveyed how risk-based and approaches are being adopted

Learning Objectives

Describe how risk-based approaches are being used in the industry, and how adoption shifted during the pandemic; Identify components that are being underutilized (e.g., centralized monitoring) and discuss potential benefits of adopting them; Explain how your organization can benefit from taking a risk-based quality management approach to every study

Chair

Brian Barnes, MA

Speaker

Panelist
Nicole Stansbury

Panelist
Paula Jo Butler, MA

Panelist
Lauren Garson

Panelist
Jennifer Glonke Stewart, MBA


Speakers
avatar for Brian Barnes

Brian Barnes

Director, Risk Management Strategy, Global Clinical Development Operations, BioNTech, United States
Brian has 17 years in clinical development and has specifically supported RBQM for ten years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Association of Clinical Research Organizations (ACRO) RBQM... Read More →
avatar for Paula Butler

Paula Butler

Senior Director, Operational Transformation and Performance (OTP), IQVIA, United States
Paula Jo Butler has over 35 years of experience in the Clinical Research Industry serving roles within Biostatistics and Project Management. She is currently IQVIA’s Senior Director of Operational Transformation and Performance (OTP). Her leadership experiences include oversight... Read More →
avatar for Lauren Garson

Lauren Garson

Senior Director, Clinical Strategy, Veeva Systems, United States
Lauren joined Veeva in 2018 and is a Sr Director in the Vault Clinical Operations Strategy team. She is responsible for Vault eTMF, SSU, CTMS and Payments for Enterprise level customers and is the lead strategist for Vault Risk Based Study Management. She is passionate about ensuring... Read More →
avatar for Nicole Stansbury

Nicole Stansbury

VP, Global Clinical Trial Management, Syneos Health, United States
Nicole Stansbury, Vice President, Clinical Trial Management, joined Syneos Health in February 2019 and is responsible for global clinical trial management and monitoring strategy. Prior to leading the global CTMs at Syneos, Nicole led the Global Central Monitoring team and risk -based... Read More →
avatar for Jennifer Stewart

Jennifer Stewart

Executive Director, Clinical Data Sciences, Premier Research, United States
As Executive Director, Jennifer Stewart coordinates the efforts of Premier Research’s global Clinical Data Sciences department, offering expertise in clinical data management and data surveillance. She plays an active role in corporate initiatives for improving quality, efficiency... Read More →

Monday June 20, 2022 1:15pm - 2:15pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   08: RD Quality-Compliance, Forum
  • Level Intermediate
  • Featured Topics COVID-19
  • Level Intermediate
  • Feature Topics COVID-19
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:00pm CDT

#133: New Tools for Creating Flexible and Sustainable Master Protocols
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-526-L04-P ; CME 1.00; RN 1.00

Master protocols enable innovative complex trials but can be highly detailed and challenging to review, which can impede their successful implementation. The TransCelerate Common Protocol Template can be a framework for developing master protocols.

Learning Objectives

Identify key considerations for preparing master protocols; Apply the Common Protocol Template to master protocols; Recognize opportunities to utilize the IMI EU-PEARL integrated research platform framework, including a master protocol template, to set up a platform trial.

Chair

Nancy Tam, MS

Speaker

Industry Update
Madhavi Gidh-Jain, PhD

Industry Update
Mary Lynn Mercado, PhD


Speakers
avatar for Nancy Tam

Nancy Tam

Head of Medical Writing, Pfizer Inc, United States
Nancy Tam is the Head of Medical Writing at Pfizer and has more than 20 years of experience as a medical writing professional in the biopharmaceutical industry. Nancy has a longstanding interest in clinical trial design and serves as a business process owner for the interventional... Read More →
avatar for Madhavi Gidh-Jain

Madhavi Gidh-Jain

Global Medical Writing and Document Management Head, Sanofi, United States
Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices... Read More →
avatar for Mary Lynn Mercado

Mary Lynn Mercado

Senior Group Head Regulatory Writing, Novartis Pharmaceuticals Corporation, United States
Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas... Read More →

Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session |   04: MedAffairs-SciComm, Session
 
Tuesday, June 21
 

9:00am CDT

#202: Innovations in Risk Minimization: Methods, Tools, and Design Approaches
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-540-L04-P ; CME 1.00; RN 1.00

This session will discuss various methods of collecting information and conducting needs assessment in the safe use of medicines.

Learning Objectives

Describe ethnographic methods for engaging with key stakeholders to collect information and conduct needs assessment; Discuss ethnographic methods as a tool for risk minimization materials development from rapid prototyping through user testing; Identify how to incorporate human factors into the entire process of risk minimization tools development to ensure optimum human-centric design; Describe the roles of human factor studies in safe use of medicines.

Chair

Anthony Gbadebo Oladipo, PharmD, MPH

Speaker

Ethnographic Methods for Human-Centered Design of Risk-Minimization tools in the Era of COVID-19
Anthony Gbadebo Oladipo, PharmD, MPH

What is the Place of Human Factors Studies in Helping Ensure Safe Use of Pharmaceuticals?
Brian Edwards, DrMed

Ethnographic Methods for Human-Centered Design of Risk Minimization Materials in the Era of COVID-19
Moira Kyweluk, PhD, MPH


Speakers
avatar for Brian Edwards

Brian Edwards

Managing Director, Husoteria Ltd, United Kingdom
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
MK

Moira Kyweluk

Head of Healthcare and Life Sciences, Senior Research Director, idea couture, A Cognizant Company, United States
Dr. Moira Kyweluk, PhD, MPH leads Healthcare & Life Sciences for Idea Couture, a Cognizant Digital Business specializing in patient-centered design. As a medical anthropologist and public health professional, she leverages innovative qualitative and mixed-methods research with patients... Read More →
AO

Anthony Oladipo

Senior Scientific Director, Risk Management, Pharmacovigilance & Patient Safety, AbbVie, Inc., United States
Dr. Oladipo began his Pharmacovigilance carrier over 20 years ago and worked as scientist and leader in PV and Risk Management at Medimmune, AstraZeneca, ProStrakan and Duramed/ Barr until recently as Senior Scientific Director in Benefit Risk Management at AbbVie. He his passionate... Read More →

Tuesday June 21, 2022 9:00am - 10:00am CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Session

11:00am CDT

#219: Post-Approval Safety Studies: Approaches to Assessing Medication Exposure and Potential Safety Risks During Pregnancy
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-554-L04-P ; CME 1.00; RN 1.00

Historically, regulators have required sponsors to collect pregnancy safety information in the post-marketing setting through prospective registries. However, pregnancy registries have practical barriers to enrolling subjects and often suffer from the lack of an adequate control group, inadequate power to achieve study objectives, high operational cost, a lack of generalizability, and long timelines before results are available to support clinical decisions. There is increasing opportunity and ability for real-world data and real-world evidence (RWD/E) from claims and electronic health record (EHR) databases to address some of the challenges seen with registries and more efficiently answer the question of drug safety during pregnancy. Retrospective database studies allow for observation of patients representing a broad population – not just those self-selected for registry enrollment or referred by providers, and the larger sample size enables faster accumulation of data and ultimately insight into patient safety. This session will discuss various fit-for-purpose pregnancy study options to inform a future framework that includes prospective registries, retrospective database studies, single-arm safety studies or enhanced pharmacovigilance with criteria dependent on the patient population in scope. In addition, the recent EMA guideline on good pharmacovigilance practices for pregnancy prevention programs will be discussed.

Learning Objectives

Discuss fit-for-purpose pregnancy safety study options including prospective registries, real-world data retrospective database studies, single-arm safety studies, enhanced pharmacovigilance or a combination of studies to inform a future framework for pregnancy safety studies; Describe industry, FDA, and EMA current thinking of various study types, criteria, and requirements for post-approval pregnancy safety studies.

Chair

Chelsea O'Connell, MS, RAC

Speaker

FDA Perspective: Postapproval Safety Studies in Pregnant Individuals
Leyla Sahin, MD

Assessing Need and Effectiveness of Pregnancy Prevention Programs: A Crucial Piece of the Jigsaw
Priya Bahri, PhD, RPh

Fit-for-Purpose Pregnancy Safety Study Designs: Considerations for Developing a Framework
Rohini Hernandez, PhD, MPH

Barriers and Future Considerations to Generating Meaningful Safety Data from Post-Approval Safety Studies in Pregnancy
Lockwood Taylor, PhD, MPH


Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
avatar for Rohini Hernandez

Rohini Hernandez

Director, Center for Observational Research, Amgen, United States
Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior... Read More →
avatar for Leyla Sahin

Leyla Sahin

Deputy Director for Safety, DPMH, OND, CDER, FDA, United States
Dr. Sahin is an ob/gyn who is the Deputy Director for Safety in the Division of Pediatrics and Maternal Health in the Office of New Drugs in CDER. She has led various maternal health related scientific and regulatory/policy initiatives. She was a working group member on the HHS Task... Read More →
avatar for Lockwood Taylor

Lockwood Taylor

Senior Principal, Real-World Strategy and Innovation, IQVIA, United States
Dr. Lockwood Taylor is a Senior Principal on the Real World Strategy and Innovation team at IQVIA. An epidemiologist by training with specific expertise in RWE for regulatory submissions, signal detection and evaluation, and post-approval safety studies in pregnancy, Lock has 15... Read More →

Tuesday June 21, 2022 11:00am - 12:00pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Forum

1:45pm CDT

#243: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-566-L04-P ; CME 1.00; RN 1.00

This session will focus on examining how technology can be leveraged to make clinical trials more widely accessible, inclusive and efficient and how “intentionally collected data” from EHRs can be used for prospective clinical research. Join the DIA Good Clinical Practices & QA Community for a follow up round table discussion (session #256 RT) on Tuesday, June 21, 3:00pm - 4:00pm.

Learning Objectives

Identify how technology can be useful in making clinical trials more inclusive; Recognize how EHR-derived data can contribute to the design and conduct of clinical trials; Discuss the potential for prospective data to be captured at the point of care through the EHR.

Chair

Neal Meropol, DrMed

Speaker

Regulatory Perspective
Donna Rivera, PharmD, MSc

Industry Perspective
Kent Thoelke

Investigator Perspective
Stephanie L. Graff, MD, FACP


Speakers
avatar for Neal Meropol

Neal Meropol

Vice President of Research Oncology, Flatiron Health, United States
Neal J. Meropol, MD is a medical oncologist, clinical investigator and outcomes researcher who serves as Vice President of Research Oncology at Flatiron Health. In this role, he provides scientific and clinical leadership in leveraging Flatiron’s technology platforms to close the... Read More →
avatar for Stephanie Graff

Stephanie Graff

Assistant Professor, Brown University; Director of Breast Oncology Program, Brown University
Dr. Stephanie Graff, MD, FACP is Director of Breast Oncology at Lifespan Cancer Institute, Legorreta Cancer Center at Brown University in Providence, Rhode Island. She serves as co-lead of Breast Cancer Translational Research Disease Working Group and Assistant Professor of Medicine... Read More →
avatar for Donna Rivera

Donna Rivera

Associate Director for Pharmacoepidemiology, OCE, FDA, United States
Donna R. Rivera, PharmD., MSc., is the Associate Director of Pharmacoepidemiology in the Oncology Center of Excellence at the US Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real World Data (RWD) and RWE for regulatory... Read More →
KT

Kent Thoelke

Former Chief Innovation Officer, ICON, Consultant, Ireland

Tuesday June 21, 2022 1:45pm - 2:45pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session |   03: Data-Tech in Clinical Trials, Session

4:15pm CDT

#276: Rethinking Fundamental ICH CMC Guidelines: Analytical Procedures, Stability, Specifications, and Risk Assessment
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-589-L04-P ; CME 1.00; RN 1.00

Global leaders in pharmaceutical quality will discuss significance of revision of ICH guidelines on analytical procedures, stability, specifications, and risk assessment, impact to product lifecycle, and implementation.

Learning Objectives

Discuss ICH’s ongoing work to modernize fundamental CMC guidelines to support continual improvement and innovation in manufacturing technologies and approaches; Identify objectives of guideline revisions: Q9(R1) Quality Risk Management, guidelines on Stability, Q2 Analytical Validation, development of Q14 guideline on Analytical Procedure Development; Examine ICH’s multi-year strategy.

Chair

Amanda Marie Roache, MS

Speaker

Update on ICH Q9: Quality Risk Management
Stephen Mahoney, JD, MS

Overview and Discussion of Q14 Analytical Procedure Development and Revision of Q2(R21) Analytical Validation
Nina S. Cauchon, PhD, RAC

The ICH Quality Discussion Group (QDG): ICH as Enabler of Innovation in Global Quality
Ingrid Markovic, PhD


Speakers
avatar for Nina Cauchon

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States
Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
avatar for Stephen Mahoney

Stephen Mahoney

Executive Director, Global Compliance Policy and External Collaboration Americas, Genentech, A Member of the Roche Group, United States
Stephen Mahoney is an Executive Director in Global Quality and Compliance at Genentech, Inc. In this role, he advises senior leaders on critical regulatory and manufacturing matters. Previously, Stephen served as a Compliance Officer in the FDA's Center for Drug Evaluation and Research... Read More →
avatar for Ingrid Markovic

Ingrid Markovic

Senior Science Advisor for CMC, Office of the Center Director, CBER, FDA, United States
Ingrid Markovic, Ph.D. serves as the CMC Policy Lead in the CBER Office of the Center Director where she spearheads CMC Policy activities partnering with internal and external stakeholders to ensure consistent interpretation and application of CMC policies and programs. In the international... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  10: RegCMC-Product Quality, Forum |   11: Statistics, Forum
  • Level Advanced
  • Level Advanced
  • Credit Type ACPE, CME, RN
  • Tags Forum
 
Wednesday, June 22
 

9:00am CDT

#302: Mission-Driven Research Partners: How Patient Advocacy Organizations Can Help Advance Your Therapeutic R&D Programs
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-22-594-L04-P ; CME 1.00; RN 1.00

Similar to CROs, many patient advocacy organizations (PAOs) provide services to advance therapeutic R&D programs in alignment with their missions. Case studies of successful PAO engagements and best practices for these partnerships will be discussed. Join the DIA Patient Engagement Community for a follow up round table discussion (session #355 RT) on Wednesday, June 22, 3:00pm - 4:00pm.

Learning Objectives

Identify patient advocacy organizations (PAOs) with high-quality resources and expertise to contribute to the success of your therapeutic development program; Compare the process of working with PAOs to working with traditional CROs and academic partners; Create efficiencies in your pipeline by building positive relationships with PAOs early and throughout the development of your programs.

Chair

Hollie Schmidt, MS

Speaker

Patient Perspective
Danielle Kerkovich, PhD

Industry Perspective
Melissa Dupont

Patient Perspective
Richard Mohs, PhD


Speakers
avatar for Melissa Dupont

Melissa Dupont

R&D Patient Engagement Lead, Sanofi, United States
Melissa's role is part of the Patient Informed Development and Health Value Translation Team, she is overseeing primarily the Neurology portfolio. This role is the face of Sanofi R&D to external Patient Advocacy organizations. A major responsibility of this role is to drive the patient... Read More →
DK

Danielle Kerkovich

Director of Research Development and Partnerships, International Fibrodyslasia Ossificans Association (IFOPA), United States
Ask Danielle about nonprofit medical research foundation strategies and you'll get a lively discussion of how building a well-informed, multifaceted strategy is the difference between expensive hope and real progress. In my role with the International Fibrodysplasia Ossificans Progressiva... Read More →
avatar for Richard Mohs

Richard Mohs

Chief Scientific Officer, Global Alzheimer’s Platform Foundation, United States
Richard C. Mohs is the Chief Science Officer for the Global Alzheimer’s Platform (GAP) Foundation, a patient-centered, non-profit organization enhancing the speed and quality of clinical trials for Alzheimer’s disease. He retired in 2015 from Eli Lilly and Company where he held... Read More →
avatar for Hollie Schmidt

Hollie Schmidt

Vice President of Scientific Operations, Accelerated Cure Project, United States
Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →

Wednesday June 22, 2022 9:00am - 10:00am CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   05: Patient Engagement, Forum

11:00am CDT

#320: De-Risking Decentralized: Understanding the Dimensions of Risk and Maximizing Data Quality in Decentralized Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-610-L04-P ; CME 1.00; RN 1.00

How should your organization be monitoring risk in decentralized trials? This session will share insights of how to ensure effective oversight of dimensions of risk in decentralized trials and quality of participant self-generated data.

Learning Objectives

Discuss the evolving landscape of decentralized research; Appraise new sources of risk in decentralized trials and approaches to mitigate risks; Demonstrate how centralized monitoring technologies provide effective oversight of key risks and ensure quality for participant self-generated data; Propose opportunities to maximise patient engagement through analysis of participant usage metrics.

Chair

John James Hall, PhD

Speaker

Industry Update
Lynne Cesario

Industry Update
Patrick Nadolny, MS

Industry Update
Richard Young


Speakers
avatar for John Hall

John Hall

Senior Vice President, Europe and AsiaPac, CluePoints, Belgium
John is a senior life sciences executive with over 20 years of experience in the life sciences industry. He is currently SVP at CluePoints, a leader in the field of RBQM, where he leads commercial activities across Europe and Asia Pacific and CluePoints decentralised trial strategy... Read More →
MA

Mayank Anand

Vice President and Head, Global Data Strategy and Management, GlaxoSmithKline
PN

Patrick Nadolny

Global Head, Clinical Data Management, Sanofi, France
Global Head, Clinical Data Management, Sanofi Chair of the SCDM Innovation Committee SCDM Board Member Mr. Nadolny has almost 30 years of industry experience across pharmaceutical, device and biologics as well as technology solution development. Mr. Nadolny is a pragmatic leader focusing... Read More →
LC

Lynne Cesario

Senior Director, Global Risk Based Monitoring Lead, Pfizer Inc, United States
avatar for Richard Young

Richard Young

Vice President, Vault CDMS Strategy, Veeva Systems, United Kingdom
As a veteran of almost 25-years in life sciences, Richard has held multiple operational roles in Pharma and CRO organisations, such as GlaxoWellcome, Novo Nordisk, Chiltern and Parexel, before moving into eClinical Solutions, with Cmed and Medidata. Today, Richard brings Veeva customers... Read More →

Wednesday June 22, 2022 11:00am - 12:00pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   08: RD Quality-Compliance, Forum

1:45pm CDT

#342: Democratizing Data for Cancer Research and Real-World Evidence Generation
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-622-L04-P ; CME 1.00; RN 1.00

This forum will explore how collaboration and improved access to data across the cancer research and healthcare data ecosystem can lead to innovations in diagnosis and treatments. A panel of high-level experts from industry, academia and data-focused non-profits will provide their viewpoints on the data sharing landscape, progress to date, lessons learned, and ideas to ensure future sustainable success.

Learning Objectives

Describe the cancer research and healthcare data landscape; Discuss the importance of collaboration across key stakeholder groups; Explore innovative ideas for future success, especially around diagnosis and treatment.

Chair

Bron Kisler

Speaker

Panelist
Samuel Volchenboum, MD, PhD, MS

Panelist
William Louv, PhD

Panelist
Robert Stephen Miller, MD, FACP

Panelist
Karla Childers, MS


Speakers
avatar for Bron Kisler

Bron Kisler

Senior Advisor, Clinical Research Data Sharing Alliance, United States
Most recently, Bron has worked with the Founders and Board of Directors for the Clinical Research Data Sharing Alliance to launch this new non-profit alliance in 2021. He is globally recognized for his leadership in clinical research and international standards development with more... Read More →
WL

William Louv

Chief Executive Officer, Project Data Sphere, United States
Bill was named Chief Executive Officer of the CEO Roundtable on Cancer effective March 2022 after serving as Interim CEO since January 2022. He joined Project Data Sphere in April 2018, bringing with him broad leadership experience in statistics, epidemiology, and information technology... Read More →
avatar for Robert Miller

Robert Miller

CMO, ASCO
Robert S. Miller, MD, FACP, FASCO, FAMIA is a medical oncologist and informaticist who is Chief Medical Science Officer, CancerLinQ®, a health technology platform for oncology developed by the American Society of Clinical Oncology (ASCO) to improve quality of cancer care and advance... Read More →
SV

Samuel Volchenboum

Co-Founder, Chief Medical Officer, Litmus Health, United States
Dr. Volchenboum is an associate professor of pediatrics and the associate chief research informatics officer for the Division of Biological Sciences at the University of Chicago. He is the Dean of Masters Programs, and he designed and launched the UChicago Master’s in Biomedical... Read More →

Wednesday June 22, 2022 1:45pm - 2:45pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum

4:15pm CDT

#367: Local Conduct for Global Clinical Trials: Focus on Japan, Latin America, and Africa
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-635-L04-P ; CME 1.00; RN 1.00

Global clinical trials are a necessity for any development company with registration and marketing aspirations. The pharmaceutical markets of Japan, Latin America, and Africa each have unique attributes that warrant consideration for developers looking to study and eventually market products locally. This session will discuss key considerations for each market as well as observed changes to the local landscape that have come as a result of the COVID-19 pandemic.

Learning Objectives

Describe updates on trial conduct in Latin America, Japan, and Africa to include regulatory considerations, opportunities for innovation, and the changes to local study conduct as a result of the COVID-19 pandemic; Discuss perspectives on the future development landscape in these markets.

Chair

Earl Seltzer, MBA

Speaker

Clinical Research in Latin America: The Know-Hows of Successful Patient Enrollment and Engagement Strategies
Sara Tylosky, MBA

Navigating Clinical Development Landscape and Turning Innovation into Success in Japan
Edward Ian, MBA

Planning and Conduct of Clinical Trials in Africa: Where are We in 2022?
Pierre Brichot, MS


Speakers
avatar for Earl Seltzer

Earl Seltzer

Senior Director, Global Feasibility, Labcorp Drug Development, United States
Earl Seltzer has over 17 years of industry experience shared across clinical investigator sites in the United States and working at CROs in the strategic planning and feasibility space. At Labcorp, Mr Seltzer leads the global feasibility team as part of the larger, feasibility recruitment... Read More →
avatar for Edward Ian

Edward Ian

Senior Executive Officer, Mediscience Planning Inc., Japan
Edward Ian began his career as a lab. scientist and expanded his work into clinical development. His extensive experience with multinational companies in APAC and the US has made him a seasoned executive with expertise across a wide range of areas within the clinical research and... Read More →
avatar for Pierre Brichot

Pierre Brichot

Founder, MCT, Tunisia
Founder of MCT, Regional CRO specialized in Middle East and Africa. MCT has more than 140 team members based in the following countries : Tunisia, Egypt, Lebanon, Morocco, Jordan, UAE, Oman, Saudi Arabia, Senegal, Gambia, Ivory Coast, Ghana, Sierra Leone, Mali, Benin, Nigeria, Uganda... Read More →

Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Session
 
Thursday, June 23
 

10:00am CDT

#405: How the Heck do I Get this Digital Endpoint to Work in my Clinical Trial? Nuts and Bolts for Trials Teams
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-648-L04-P ; CME 1.00; RN 1.00

This panel will discuss how the Playbook Clinical Trials Dossier has the action-oriented tools you need to help deploy a digital clinical measure in your clinical trial. Learn to use them to make better decisions faster.

Learning Objectives

Describe the optimal approach to selecting, developing, and deploying fit-for-purpose, meaningful digital clinical measures across clinical research; Determine right questions and when to ask while operationalizing digital clinical measures into a clinical trial; Apply the resources in The Playbook's Clinical Trials Dossier to navigate the multi-stakeholder process of planning for and running a clinical trial.

Chair

Jeanne Chung, MBA

Speaker

Digital Clinical Measures: Tools to Make Better Decisions Faster
Matt Biggs

Developing Novel Endpoints Using Voice Measurement
Jessica Robin, PhD

Current Challenges of Digital Clinical Measures in Drug Development
Jie Ren, PhD


Speakers
avatar for Matt Biggs

Matt Biggs

Vice President of Applied Science, ActiGraph, United States
At ActiGraph, I'm a member of our Scientific Department which specializes in digital health technologies. Over the past 10 years, I've had the opportunity to assist clinical trials, national cohort studies, and scientific research globally. With a focus on sensor selection, technology... Read More →
avatar for Jeanne Chung

Jeanne Chung

Program Lead, Digital Medicine Society (DiMe), United States
Jeanne is Program Lead at Digital Medicine Society (DiMe) bringing strategy, execution and innovation through her investment banking, management consulting, and entrepreneurship experience. She currently leads DATAcc - the digital health measurement collaborative community of 50 member... Read More →
avatar for Jie Ren

Jie Ren

Principal Scientist, Global Digital Analytics and Technologies, Merck & Co., Inc., United States
Jie champions digital endpoint development efforts and supports the implementation of digital health technologies in clinical development at Merck.
avatar for Jessica Robin

Jessica Robin

Director, Clinical Research, Winterlight Labs, Canada
At Winterlight Labs, I lead our clinical research program, which includes internal validation and development research, academic collaborations and clinical trials. In this role, I oversee study design, design analysis plans and help communicate the results of our studies relating... Read More →

Thursday June 23, 2022 10:00am - 11:00am CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum
  • Level Intermediate
  • Featured Topics Digital
  • Level Intermediate
  • Feature Topics Digital
  • Credit Type ACPE, CME, RN
  • Tags Forum
 
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Exh Hall Community Area
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Exhibit Hall Booth #1719
Exhibit Hall Theater #1
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Exhibit Hall Theater #3
Level 3 F2 Entrance
Meeting Rm Lobby Level 1
Meeting Room Lobby
Room 175
Room 176
Room 178
Room 179
Room 180
Room 183 A
Room 183 B
Room 183 C
Room 184
Room 185 AB
Room 185 CD
Room 186
Room 187
Room 375 A Zone 1
Room 375 A Zone 2
Room 470 A
Room 470 B
Room 471 A
Room Skyline 375 CDE
Skyline Ballroom Foyer
TBD
Virtual
  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • AI and Machine Learning
  • COVID-19
  • Data Science
  • Decentralized Trials
  • Digital
  • Diversity Equity and Inclusion
  • Innovative Trial Design
  • Patient Perspective
  • Personalized Health Care
  • Regulator Perspective
  • Remote Work
  • RWD-RWE
  • Special Populations
  • Student Programming