Loading…
Attending this event?
Simple
Expanded
Grid
By Venue
02: ClinTrials -ClinOps [clear filter]
Monday, June 17
 

11:00am PDT

#106: Machine Learning and Simulations to Facilitate Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-520-L04-P; CME 1.00; RN 1.00

The past decade has seen significant strides in machine learning and AI technologies. This session will provide an in depth investigate the various uses of machine learning and AI-based simulations within clinical development, ranging from data analysis, endpoint selection, the potential improvement of decision making within trial teams by clarifying tradeoffs to clinicians and statisticians, and more.

Learning Objectives

Describe the potential benefits of simulations in clinical trial protocol development and trial analysis, and the benefits of employing machine learning tools throughout clinical development; Discuss the novel approaches to conducting studies with such tools incorporated and relate to the regulatory guidance for adaptive trial design where relevant.

Chair

Raviv Pryluk, PhD

Speaker

Doing More with Less: Using ML to Drastically Improve Trial Simulation and Design
Raviv Pryluk, PhD

Clinical Trial Simulation: the Antidote to Wishful Thinking
Sam Miller, MSc

Digital Twins for Clinical Trials
Charles Fisher, PhD


Speakers
avatar for Raviv Pryluk

Raviv Pryluk

PhaseV, United States
Raviv is the co-founder & CEO of PhaseV, a technology company that leverages causal-ML and advanced software capabilities to support advanced & innovative clinical trials. Raviv holds a B.Sc. and M.Sc. in engineering from the Technion (Cum Laude) and Ph.D. in computational neuroscience... Read More →
CF

Charles Fisher

Founder and Chief Executive Officer, Unlearn.AI, United States
SM

Sam Miller

Head of Strategic Consulting, Exploristics, United Kingdom
Sam has over 25 years’ experience as a statistician in the pharmaceutical industry. At Exploristics, he oversees the Statistical Consulting team. With a BA in Mathematics from the University of Cambridge and an MSc in Statistics from University College London, Sam has broad knowledge... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Session

11:00am PDT

#105: The Intersection of Science, Ethics, and Participant Collaboration in Pediatric Rare Disease Product Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-519-L04-P; CME 1.00; RN 1.00

Experts in pediatric rare disease product development, pediatric ethics and patients/advocates discuss designing studies to best benefit the patient, and how patients/caregivers assess risks and benefits in early phase trials.

Learning Objectives

Discuss the ethical and scientific considerations for designing studies for rare diseases that impact children, including the level of evidence needed to initiate early phase trials; Discuss how patients and caregivers weigh the risks of early-phase studies against the benefits of a potential treatment for their rare disease, especially when there are limited to no other options.

Chair

Donna Snyder, MD

Speaker

Ethical Considerations for Including Children in Rare Disease Trials
Donna Snyder, MD

Update from ORPURM/DRDMG
Mehul Desai, MD

Patient Perspective
Mark Dant

Patient Perspective
Ryan Dant


Speakers
avatar for Donna Snyder

Donna Snyder

Executive Physician, WCG, United States
Donna Snyder, MD, MBE is the Executive Physician of WCG where she contributes subject matter expertise and operational guidance across WCG to ensure that research will be conducted to the highest ethical standards. Prior to WCG, Dr. Snyder served as the leader and Senior Pediatric... Read More →
avatar for Mark Dant

Mark Dant

Volunteer Executive Director, The Ryan Foundation, The Ryan Foundation for Rare Disease Research, United States
Mark is the Founder and Volunteer Executive Director of the Ryan Foundation and is the former Board Chair of the of the EveryLife Foundation for Rare Diseases. Mark and his family founded the Ryan Foundation in 1992 shortly after their only child Ryan was diagnosed with MPS I. Since... Read More →
avatar for Ryan Dant

Ryan Dant

Patient Advocate, The Ryan Foundation for Rare Disease Research, United States
Ryan Dant is a long-time patient advocate diagnosed at the age of three with Mucopolysaccharidosis type 1 (MPS 1), a rare lysosomal storage disorder. When doctor’s predicted Ryan’s life to be cut short due to the disease, Ryan’s parents, Mark and Jeanne, spearheaded the funding... Read More →
avatar for Mehul Desai

Mehul Desai

Medical Reviewer, ORDPURM/DRDMG, OND, CDER, FDA, United States
Mehul Desai M.D. is a medical officer in the Division of Rare Diseases and Medical Genetics (DRDMG), Office of New Drugs (OND), Center for Drug Evaluation Research (CDER), with the US Food and Drug Administration (FDA). Dr. Desai has clinical development experience in both the pharmaceutical... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

12:00pm PDT

#117 CH: Rare Diseases Multistakeholder Collaboration Towards Regulatory Endorsed Innovative Clinical Development Approach
Component Type: Workshop
Level: Intermediate

ERDERA focuses on accelerating rare diseases drug development by combining real-world data processing, Patient Centered Outcome measures integration, a streamlined gene editing and technology transfer platforms, and innovative clinical trials designs.

Learning Objectives

Identify innovative methodologies, technologies and tools for innovative therapy development; Prepare a collaboration with an innovative Rare Disease research Ecosystem and recall its funding opportunities.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Facilitator
Alexandre Betourne, PharmD, PhD


Speakers
avatar for Alexandre Betourne

Alexandre Betourne

Executive Director, Critical Path Institute, United States
Alexandre Bétourné, PhD, PharmD, is Executive Director for the Rare Disease Cures Accelerator-Data and Analytics Platform initiative. Dr. Bétourné holds both a PhD and a PharmD from the University of Toulouse in France. Before joining C-Path, he worked with a team of senior U.S... Read More →
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines... Read More →

Monday June 17, 2024 12:00pm - 12:30pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  15: Content Hubs, Workshop |   02: ClinTrials -ClinOps, Workshop

12:15pm PDT

#118 RT: Roundtable Discussion: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development
Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development (Monday, June 17 | 11:00AM - 12:00PM PDT). Space is limited.

Chair

Lindsay McNair, MD, MPH, MS

Speakers
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →

Monday June 17, 2024 12:15pm - 1:15pm PDT
Ballroom 20 Lobby San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   02: ClinTrials -ClinOps, Session

2:15pm PDT

#132: The Cost of Moving the Needle on Clinical Trial Representation: Strategies for Diversity Budget Planning and Resourcing
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-532-L04-P; CME 1.00; RN 1.00

Evidence shows that improving diversity in clinical trials requires early planning. The session presents a cost analysis and case examples from an expert panel on the impact of incorporating patient diversity tactics and resources early in the process.

Learning Objectives

Discuss how to quantify the cost and resources required to execute tactics that increase clinical trial diversity; Explain how the exclusion of patient diversity tactics in budget planning impacts diversity and overall study milestones; Identify considerations that can influence leadership decision-making around diversity during the budget planning process.

Chair

Lloryn Hubbard

Speaker

Industry Update
Ryan Brown, MPA

Industry Update
Steve T. Satek, MBA

Industry Update
Monica Eason


Speakers
avatar for Lloryn Hubbard

Lloryn Hubbard

Head of Patient Diversity, PPD Part of Thermo Fisher Scientific, United States
As head of Patient Diversity at PPD, Lloryn has strategic oversight over the company’s clinical trial health equity efforts and leads a team of specialists focused on optimizing drug development for inclusive patient representation. With 15 years of experience in the pharmaceutical... Read More →
avatar for Ryan Brown

Ryan Brown

Regional Vice President, Trial Landscape, H1, United States
Ryan Brown is the Regional Vice President of Trial Landscape Sales for H1, a cutting-edge health tech company that utilizes AI and DE&I performance data to enable more diverse and effective clinical trials. With 15+ years of experience driving diversity initiatives, Ryan is a sought-after... Read More →
ME

Monica Eason

Clinical Operations Portfolio Leader, Genentech, A Member of the Roche Group, United States
SS

Steve Satek

Executive Vice President, Flourish Research, United States

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Session

2:15pm PDT

#131: Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-531-L04-P; CME 1.00; RN 1.00

The ICH E11A guidance advances use of pediatric extrapolation in three areas: (1) role of exposure-response; (2) statistical implications of using external data; and (3) extrapolation of safety. After an overview, these three areas will be explored.

Learning Objectives

Define pediatric extrapolation and three components of extrapolation concept; Describe role of exposure-response in supporting data extrapolation from reference to target pediatric population; Examine the impact of extrapolation on false positive rate of a pediatric clinical trial; Outline impact of pediatric extrapolation on generation of safety data in the target pediatric population.

Chair

Robert "Skip" Nelson, MD, PhD

Speaker

FDA Update on ICH E11A EWG on Pediartic Extrapolation
Lynne Yao, MD

Industry Update
Forrest Williamson, PhD

Industry Update on ICH E11A EWG on Pediatric Extrapolation
Brenda Cirincione, PhD, MS


Speakers
avatar for Robert Nelson

Robert Nelson

Senior Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics... Read More →
BC

Brenda Cirincione

Vice President, Clinical and Quantitative Pharmacology, Vertex, United States
Brenda Cirincione has over 20 years of research experience in Clinical Pharmacology and Pharmacometrics. She received a PhD in pharmaceutical sciences and a MA in statistics from the University of Buffalo, State University of New York, and has experience working in businesses across... Read More →
FW

Forrest Williamson

Director of Pediatrics, Statistical Innovation Center, Eli Lilly and Company, United States
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session |   11: Statistics-Data Science, Session |   02: ClinTrials -ClinOps, Session

3:30pm PDT

#146: Past, Present, and Future: How Industry and FDA are Handling the Evolving Clinical Trial Diversity Regulatory Landscape
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-545-L04-P; CME 1.00; RN 1.00

This forum will include discussion among multiple sponsors sharing their first-hand, cross-therapeutic area experience on notable trends and challenges they have faced in preparing these early diversity plan submissions. Panelists will also address how they plan to adapt to more expansive categories enumerated within diversity action plan guidance and share reflections on recently released FDA guidances on this topic (i.e. diversity action plans, post market approaches to obtain data on underrepresented populations, collection of race and ethnicity data). Additionally, panelists will discuss what policy deliverables and clarifications they would like to see reflected in the final guidances. The panel will also include FDA’s perspective and reflections from 2 years of diversity plan submissions as well as any considerations as we look to the future.

Learning Objectives

Describe best practices and regulatory feedback on diversity plan submissions.; Compare the perspectives of both FDA and sponsors about the current landscape of trial diversity-related guidances, including the latest diversity action plan guidance.; Discuss how by using an interactive audience feature where we seek others’ experience compiling and feedback from the FDA on diversity plan submissions.

Chair

Dylan Bechtle, MS

Speaker

Industry Update
Andrea Doyle

Industry Update
Del Smith, PhD, MS

Industry Update
Stacy Holdsworth, PharmD

FDA Update
Tamy Kim, PharmD


Speakers
DB

Dylan Bechtle

Associate Director, Regulatory Policy Lead- US, Johnson & Johnson, United States
Dylan is an Associate Director in Johnson and Johnson Innovative Medicine's Global Regulatory Policy and Intelligence (GRPI) group. Dylan leads J&J’s regulatory policy efforts around clinical trial diversity. He is interested in the intersection of novel clinical methodologies (e.g... Read More →
AD

Andrea Doyle

Head, Global Regulatory Affairs, Neurology, Sanofi, United States
SH

Stacy Holdsworth

Associate Vice President, US Regulatory Policy & Strategy, Eli Lilly and Company, United States
Stacy Holdsworth is the Associate Vice President for U.S. Regulatory Policy & Strategy at Eli Lilly and Company. Her primary responsibilities are to lead a team of regulator professionals in the development and implementation of an external regulatory policy agenda that encourages... Read More →
avatar for Tamy Kim

Tamy Kim

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
Tamy Kim is the Director for Regulatory Affairs and Policy at FDA's Oncology Center for Excellence and the Associate Director for Regulatory Affairs in the Office of Oncologic Diseases (OOD). Dr. Kim is responsible for developing policies and procedures affecting the review of products... Read More →
avatar for Del Smith

Del Smith

Co-Founder and Chief Executive Officer, Acclinate Inc., United States
Del is the co-founder and CEO of Acclinate, a trusted digital health company focused on greater health equity through inclusive research. He has built a diverse team and AI/ML platform to help the pharmaceutical and healthcare industry access and engage communities of color so that... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum
 
Tuesday, June 18
 

8:00am PDT

#203: Feasible Site Feasibility Assessments: Rethinking Business as Usual to Reduce Burden, Timelines, and Costs for Sustainability
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-558-L04-P; CME 1.00; RN 1.00

In 2021, recommendations to reduce site feasibility assessment burdens was released.. Current industry and CRO methods remain costly and inefficient, and delay trial start-up and patient access to clinical trials.

Learning Objectives

Describe the impact of non-standardized study feasibility assessments across the industry; Discuss opportunities and solutions around improvements to the site feasibility assessment process; Apply new methods to streamline feasibility assessments and improve study start-up timelines.

Chair

Trevor Joseph Cole, MBA, RN, PMP

Speaker

Panelist
Kristen Ballesteros, PhD, MS

Panelist
Suanna S. Bruinooge, MPH

Panelist
Ramya Thota


Speakers
avatar for Trevor Cole

Trevor Cole

Associate Director, WCG, United States
Trevor Cole is currently an Associate Director at WCG Clinical. Trevor has a bachelor’s degree in health science, an MBA in healthcare management and project management, and is a registered nurse, certified research coordinator, and certified project management professional. Trevor's... Read More →
avatar for Kristen Ballesteros

Kristen Ballesteros

Associate Director, Feasibility Strategy, Thermo Fischer Scientific, PPD, United States
Dr. Ballesteros is an expert in feasibility strategy, with a focus in hematology and oncology over the last 7 years. Her current role encompasses data curation and analysis to support operational strategy, including a key role in site identification. As PPD's Feasibility SME for diversity... Read More →
avatar for Suanna Bruinooge

Suanna Bruinooge

Chief and Division Director, Research Strategy and Operations Center, American Society of Clinical Oncology, United States
Suanna Bruinooge, MPH, is the Chief and Division Director of Research Strategies and Collaborations in ASCO’s Center for Research and Analytics (CENTRA). CENTRA generates and analyzes oncology data to foster innovation in research and patient care and help develop evidence related... Read More →
avatar for Ramya Thota

Ramya Thota

Associate Professor, Intermountain Medical Oncology - IMC, United States
Dr. Thota is a GI medical oncologist at Intermountain Health, Utah. She finished her subspecialty Hematology and Medical Oncology fellowship training from Vanderbilt University, Nashville, Tennessee. She receives research funding from American Cancer Society Clinician Scientist Development... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum

10:00am PDT

#220: Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-571-L04-P; CME 1.00; RN 1.00

Many rare diseases share the same underlying molecular etiology that are therapeutically targetable. Basket trial design based on molecular etiology enables more patients to gain access to clinical trials and accelerate identification of new therpies

Learning Objectives

Recognize the potential of basket trial design in rare disease; Apply basket trial design in rare diseases with share molecular etiologies.

Chair

David Andrew Pearce, PhD

Speaker

Shared Platforms Approaches/Technologies for Rare Diseases
Philip (P.J.) Brooks, PhD

Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases
Christina Waters, PhD, MBA


Speakers
avatar for David Pearce

David Pearce

President of Innovation and Research/Chair International Rare Disease Research, Sanford Health, United States
David Pearce is President of Innovation & Research for Sanford Health. He completed his undergraduate Bachelor of Science Degree with honors in biological sciences at Wolverhampton Polytechnic in 1986. He gained his PhD in 1990 at the University of Bath, UK Dr. Pearce has been researching... Read More →
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →
CW

Christina Waters

Chief Executive Officer and Founder, RARE Science, Inc., United States
Dr. Christina Waters has been responsible for leading medical research in a broad range of organizations ranging from academia and disease – focused non-profits to biotech and large pharmaceutical companies. Her broad range of experience in basic, translational and clinical research... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum

10:00am PDT

#222: External Control Arms at Scale: Multicenter, Multisource Infrastructure for External Control Arms
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-573-L04-P; CME 1.00; RN 1.00

The speakers will discuss how to enable external control arms (ECAs) at scale. The session will shed light on how to overcome the scalability and quality challenges of real-world data preparation to scale up ECAs from ad hoc projects to enterprise-level machinery for pharmaceutical clinical development function. It will also include ongoing work to create enterprise infrastructure for high-quality evidence generation using ECAs, including selected results from multicenter ECAs in several therapeutic areas.

Learning Objectives

Explore strategies to address the inherent challenges of real-world data (RWD) preparation at scale for external control arms (ECAs), including data scalability and quality; Describe how to transition from ad hoc ECA projects to an enterprise-level approach that ensures data quality, processing efficiency, and trustworthiness in analytical results for pharma clinical development.

Chair

Mayur Saxena, PhD

Speaker

Industry Update
Jussi Leinonen

Industry Update
Victoria Chia, PhD, MPH

Industry Update
Hongwei Wang

Industry Update
Jingyu (Julia) Luan, PhD


Speakers
avatar for Mayur Saxena

Mayur Saxena

Chief Executive Officer, Droice Labs, United States
As an entrepreneur and scientist, Mayur has concentrated on advancing medicine with high-noise, big data analysis. Before founding Droice, he played key roles in several startups, including co-founding a biotechnology firm in the diabetes space. He earned his BTech at IIT Kanpur and... Read More →
avatar for Victoria Chia

Victoria Chia

Executive Director, Center for Observational Research, Amgen Inc, United States
Victoria Chia has 15+ years of experience at Amgen Inc as a pharmacoepidemiologist. She currently leads the oncology therapeutic area in the Center for Observational Research. She has worked on oncology and neurology products, supporting multiple products through the product lifecycle... Read More →
JL

Jussi Leinonen

Strategic Project Lead, Bayer , Finland
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States
Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing... Read More →
avatar for Hongwei Wang

Hongwei Wang

Director/ Senior Research Fellow, AbbVie, United States

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum

10:00am PDT

#221: Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-572-L04-P; CME 1.00; RN 1.00

Improving access and minimizing burdens are critical to ensuring diverse representation in clinical trials. Panelists will discuss efforts to improve patient access to oncology clinical trials through streamlined protocols and decentralized elements.

Learning Objectives

Describe the impact of incorporating decentralized elements (DE) into oncology clinical trials (CTs) on data integrity, patient safety and regulatory approvals; Explain how DE elements increase patient access and recognize opportunities to implement DE; Identify ongoing barriers to implementing DE into CT protocols and solutions to address operational challenges in expanding access to care.

Chair

Suanna S. Bruinooge, MPH

Speaker

How Sponsors, CROs, and Sites Can Work Together
Craig H Lipset, MPH

Meta-Analysis of Trials During COVID
Joseph Unger, PhD, MS

Implementing Trials in Large Healthcare System
Ramya Thota


Speakers
avatar for Suanna Bruinooge

Suanna Bruinooge

Chief and Division Director, Research Strategy and Operations Center, American Society of Clinical Oncology, United States
Suanna Bruinooge, MPH, is the Chief and Division Director of Research Strategies and Collaborations in ASCO’s Center for Research and Analytics (CENTRA). CENTRA generates and analyzes oncology data to foster innovation in research and patient care and help develop evidence related... Read More →
avatar for Craig Lipset

Craig Lipset

Managing Partner, Clinical Innovation Partners, United States
Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the... Read More →
avatar for Ramya Thota

Ramya Thota

Associate Professor, Intermountain Medical Oncology - IMC, United States
Dr. Thota is a GI medical oncologist at Intermountain Health, Utah. She finished her subspecialty Hematology and Medical Oncology fellowship training from Vanderbilt University, Nashville, Tennessee. She receives research funding from American Cancer Society Clinician Scientist Development... Read More →
avatar for Joseph Unger

Joseph Unger

Associate Professor, Fred Hutchinson Cancer Center, United States
Dr. Joseph Unger is a biostatistician and health services researcher. He uses big data to understand more about cancer patients’ treatment outcomes and disparities, especially as they pertain to barriers to participating in clinical trials. He has been at the forefront of efforts... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   02: ClinTrials -ClinOps, Forum

12:30pm PDT

#241 CH: Practical (and Real) AI and Advanced Automation in New Product Planning and Clinical Development
Component Type: Workshop
Level: Basic

Realizing the value of AI and Advanced Automation tools is no longer hypothetical - real value is being created by the thoughtful application of these tools. We will explore pragmatic examples and opportunities within this working session.

Learning Objectives

Create a pragmatic approach for developing and implementing AI and Advanced Automation tools within their organizations; Describe how to develop a plan, implement and calculate and measure ROI for such tools.

Chair

Bryan Katz, MBA

Speakers
BK

Bryan Katz

Chief Strategy Officer, Propharma Group, United States

Tuesday June 18, 2024 12:30pm - 1:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  15: Content Hubs, Workshop |   02: ClinTrials -ClinOps, Workshop

1:15pm PDT

#252: Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-590-L04-P; CME 1.00; RN 1.00

The speakers will discuss regulatory and industry perspectives on sponsor and investigator responsibilities when incorporating decentralized clinical trials features in a trial to ensure trial participant safety, data reliability and quality and inspection readiness.

Learning Objectives

Describe various design features of decentralized clinical trials (DCT), including use of digital health technologies for remote data capture; Discuss what sponsors should do upfront in the planning and during the conduct of the trial and where the risks to data integrity lie in trials incorporating DCT features; Discuss the core elements of an FDA inspection; Identify steps to ensure inspection readiness for clinical investigators and sponsors.

Chair

Cara Alfaro, PharmD

Speaker

FDA Update
Cara Alfaro, PharmD

Industry Update
Jonathan Andrus, MS

MHRA Update
Jason Wakelin-Smith


Speakers
avatar for Cara Alfaro

Cara Alfaro

Senior Pharmacologist, OSI, OC, CDER, FDA, United States
Dr. Alfaro received her B.S. in pharmacy from Purdue University and her Pharm.D. from the Ohio State University. She completed a residency and research fellowship in psychiatric pharmacy at the University of Texas Health Science Center at San Antonio. In 1998, she joined NIH as a... Read More →
avatar for Jonathan Andrus

Jonathan Andrus

President & COO, CRIO, United States
Mr. Andrus brings over 25 years of executive management, operational, quality, and business experience to CRIO. Most recently he served as Chief Strategy Officer for Clinical Ink. Prior to that, he served as Senior Vice President for BioClinica (now Clario), where he led the e-clinical... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Session |   08: RD Quality-Compliance, Session

1:15pm PDT

#246: The State of Clinical Trials in 2024: Are We Making the Grade?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-584-L04-P; CME 1.00; RN 1.00

This forum will present metrics developed and tested to understand progress for improving trials by 2030. A panel will provide work in areas of metrics for assessing progress in improving trials and understanding the state of clinical trials in 2024.

Learning Objectives

Discuss current efforts to establish metrics for assessing progress on efforts to improve trials, including improvements to trial design quality and representativeness of trials; Identify areas of trial improvements that may be measured or assessed; Appraise metrics approaches for relevance to improving specific areas of trial operations.

Chair

Summer Starling, DrPH, MPH

Speaker

Panelist
Jennifer Miller, PhD

Panelist
Linda B Sullivan, MBA


Speakers
avatar for Summer Starling

Summer Starling

Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
avatar for Jennifer Miller

Jennifer Miller

Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, Yale School of Medicine, United States
Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to... Read More →
avatar for Linda Sullivan

Linda Sullivan

Senior Fellow, Tufts Center For the Study of Drug Development, United States
Ms Sullivan has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations optimize processes to improve financial and quality outcomes. She is the founder and served as Executive Director of the Metrics Champion Consortium, an... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   02: ClinTrials -ClinOps, Forum

1:15pm PDT

#245: The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-583-L04-P; CME 1.00; RN 1.00

Accelerating Clinical Trials in the EU (ACT EU) and the successful launch of the clinical trial regulation have modernized the clinical trial environment. This session is focused on how Europe is embracing the change and will also present other international initiatives offering opportunities for collaboration.

Learning Objectives

Describe how ACT EU, together with other EU initiatives, is providing a platform to optimize clinical research and development, and fostering innovation through joint collaborations between member states, ethics committees, and stakeholders, bringing tangible benefits for patients, sponsors, and regulators; Discuss other international clinical trial initiatives and potential areas of collaboration.

Chair

Ana Zanoletty Perez

Speaker

FDA Update
Shari Targum, MD, MPH, FACC, FACP

Academic Update
Sara Bristol Calvert, PharmD

Patient Advocate Perspective
Deborah Collyar

WHO Update
Marion Laumonier, MSc


Speakers
avatar for Sara Calvert

Sara Calvert

Director of Projects, Clinical Trials Transformation Initiative (CTTI), United States
Dr. Sara Bristol Calvert is currently the Director of Projects at the Clinical Trials Transformation Initiative (CTTI). Prior to this role, she was a CTTI Senior Project Manager which included leading projects in Diversity in Clinical Trials, Single IRB, Registry Trials, HABP/VABP... Read More →
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR), United States
Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic... Read More →
avatar for Marion Laumonier

Marion Laumonier

Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland
Marion Laumonier is currently Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →
avatar for Ana Zanoletty Perez

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →
ST

Shari Targum

Deputy Director, Office of Clinical Policy, OC, FDA, United States
Dr. Shari Targum has over 30 years of clinical, industry and regulatory experience. She began her FDA career in 1999 as a Medical Officer and then Team Leader in CDER's Division of Cardiovascular and Renal Products and she has held positions of increasing authority in CDER and CBER... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

3:15pm PDT

#265: Practical Approaches and Resources to Optimize Advocacy Group - Industry Collaborations: An Update on the PALADIN Consortium
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-597-L04-P; CME 1.00; RN 1.00

This session will discuss patient advocacy groups and pharmaceutical companies and the co-created the patient advocacy leaders and drug development industry network (PALADIN), a US focused pre-competitive and disease agnostic Consortium, to advance the pace of medicines development.

Learning Objectives

Describe progress made by PALADIN (patient advocacy leaders and drug development industry network), a pre-competitive alliance of 20+ organizations formed in 2023; Discuss how the Consortium was established, it’s mission and governance; Identify year one resources created to optimize collaborations; Discuss priority year two activities and long-range plans.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speaker

Practical Approaches and Resources to Optimize Advocacy Group - Industry Collaborations: An Update on the PALADIN Consortium
Kenneth Getz, MBA

Patient Perspective
Hollie Schmidt, MS


Speakers
avatar for Victoria DiBiaso

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, Sanofi, France
Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Center For the Study of Drug Development, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... 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 →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum

3:15pm PDT

#264: Enhancing Adoption of Innovative Approaches in Clinical Trials
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-596-L04-P; CME 1.00; RN 1.00

This forum will explore the U.S. FDA Center for Drug Evaluation and Research's portfolio of clinical trial innovation activities, including its newly established CDER Center for Clinical Trial Innovation (C3TI). C3TI serves as a central hub supporting innovative approaches to clinical trials aimed at improving the efficiency of drug development. Speakers from the FDA will elaborate on C3TI and its role in supporting innovative clinical trial designs. The FDA presenters will be joined by industry and patient speakers for a panel discussion on opportunities to enhance implementation and adoption of innovative approaches in clinical trials, aiming to ensure patient-centric trial design, improve the efficiency of clinical trials, increase the participation of diverse populations, and, in turn, accelerate the development of safe and effective new drugs.

Learning Objectives

Discuss key challenges or barriers to implementation and adoption of innovative approaches in clinical trial design, conduct, and execution; Discuss strategies to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Ella Balasa

Panelist
Michelle Rohrer, PhD

Panelist
Allison Cuff Shimooka, MBA


Speakers
avatar for Meghana Chalasani

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States
Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She is the program manager for the CDER Center for Clinical Trial Innovation and also co-leads the New Drugs Regulatory... Read More →
avatar for Kevin Bugin

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →
avatar for Michelle Rohrer

Michelle Rohrer

Senior Vice President, Global Head of Product Development Regulatory and Policy, Genentech Roche, United States
Michelle Rohrer, PhD is Global Head of Product Development Regulatory and Policy. Michelle has worked at the company for 27 years, starting as a post-doctoral fellow. She has worked as a clinical scientist, team leader, and regulatory strategist. In 2013, Michelle was named by the... Read More →
avatar for Ella Balasa

Ella Balasa

Patient Advocate and Engagement Consultant, Balasa Consulting, United States
Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information... Read More →
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, Transcelerate Biopharma Inc, United States
Allison serves as the Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for translating TransCelerate’s strategic vision into operational plans in close partnership with the leadership team, member companies, and Board of Directors. She... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum

4:30pm PDT

#280: Innovation, Agility, and Accessibility in Trial Execution: Collaboration Among Labs, Pharmacies, and Research Enablers
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-693-L04-P; CME 1.00; RN 1.00

This forum will feature discussion on the challenges and opportunities associated with integrating health care providers in non hospital or physician office settings into the clinical research infrastructure. The forum will have case studies on successful trial execution using complimentary contributions from diagnostic providers, home care providers, pharmacies, and clinics embedded in retail settings.

Learning Objectives

Describe the opportunities related to potential trial participant engagement via alternative channels; Identify challenges and barriers to overcome in order to realize value in such innovative solutions; Define situations where optimization of research delivery can be deployed and pathways of doing so.

Chair

Earl Seltzer, MBA

Speaker

Optimizing Mobile Visits with Technology:Better Geographic, Demographic, and Sociographic Representation
Josh Rose, MBA

Supporting Decentralized Clinical Trial Delivery and Diversity in Research Through Partnerships
Irfan A. Khan, MD

How Pharmacy and Benefits Management can Support the Clinical Development Continuum
Krystyna Chmura, MPH

Exploring the Role of Diagnostic Providers in Optimizing Clinical Trial Recruitment
Kristen Andrews


Speakers
avatar for Irfan Khan

Irfan Khan

Founder and Chief Executive Officer, Circuit Clinical, United States
Dr. Khan is a cardiologist and the founder & CEO of Circuit Clinical, one of the fastest growing Integrated Research Organizations in the US. His work is focused on democratizing access to clinical trials.
avatar for Krystyna Chmura

Krystyna Chmura

Clinical Trials Solutions Sr. Advisor, Life Sciences Data, Evernorth Health Services, United States
Krystyna Chmura is a seasoned public health professional with experience in clinical research, drug lifecycle, pharmacy benefit management, and payer markets. At Evernorth, the health services division of The Cigna Group that serves more than 190 million people, Krystyna works with... Read More →
avatar for Earl Seltzer

Earl Seltzer

Senior Director, Partnerships and Innovation, CTI, United States
Earl Seltzer has 19 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 CTI, Mr Seltzer leads the therapeutic strategy team and supports innovation in trial delivery and... Read More →
avatar for Josh Rose

Josh Rose

Chief Executive Officer, Hawthorne Effect, United States
Josh Rose, CEO, Hawthorne Effect, is a clinical research industry veteran with more than 20 years of experience. Hawthorne Effect is pioneering the way clinical trials are delivered in the patient’s home or community to drive better study outcomes. Prior Hawthorne, Josh led the... Read More →
KA

Kristen Andrews

Head, Research Site Enablement, Labcorp , United States
Kristen Andrews, Head of Research Site Enablement at Labcorp, has over 25 years of experience in the clinical trials industry. Starting as a clinical research coordinator, her career has progressed through increasing levels of responsibility and leadership first at research sites... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum

4:30pm PDT

#279: Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-611-L04-P; CME 1.00; RN 1.00

In this forum, speakers from regulatory, industry, and research organizations will discuss methodological considerations and evaluate various innovative use cases in different settings that integrate real-world data (RWD) in clinical designs.

Learning Objectives

Discuss global regulatory guidance, frameworks, and best practices for real-world data (RWD) in innovative hybrid study designs for regulatory purposes; Describe innovative approaches and statistical methods for integrating RWD and clinical trial data for clinical decision-making; Appraise use cases where RWD have been used in hybrid study designs to support clinical and regulatory development.

Chair

Rachele Hendricks-Sturrup, DrSc, MA, MSc

Speaker

Panelist
Mehmet Burcu, PhD, MS

Panelist
Christina Mack, PhD, MPH

Panelist
Catherine C. Lerro, PhD, MPH


Speakers
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States
Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within... Read More →
avatar for Mehmet Burcu

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States
Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →
avatar for Catherine Lerro

Catherine Lerro

Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States
Dr. Lerro is a senior pharmacoepidemiologist in the Oncology Center of Excellence at the US FDA. Prior to joining the FDA, she trained at the National Cancer Institute in the Division of Cancer Epidemiology and Genetics. She holds a doctorate degree and masters in public health from... Read More →
avatar for Christina Mack

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States
Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   03: Data-Tech, Forum |   11: Statistics-Data Science, Forum |   02: ClinTrials -ClinOps, Forum
 
Wednesday, June 19
 

8:00am PDT

#302: Have a Safe Trip: Clinical and Patient Alignment in Clinical Trials with Psychedelics
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-623-L04-P; CME 1.00; RN 1.00

This discussion will provide the setting and background of clinical trials of psychedelics and issues to consider. The session will provide details with a clinical trial participant providing example feedback and insight from that perspective.

Learning Objectives

Discuss the conflicted background of psychedelic clinical trials; Discuss reasonable expectations for clinical trial progression; Identify one participant’s perspective from two clinical trials; compare and contrast the participant perspective with standard clinical outcomes.

Chair

Currien MacDonald, MD

Speaker

Panelist
Sara Reed, MA


Speakers
avatar for Currien MacDonald

Currien MacDonald

Medical Chair Director, WCG, United States
Dr. Currien MacDonald has lead the medical chairs at WCG for the past 7 years. Prior to that, Dr. MacDonald served for four years as the medical director for Aspire IRB, another WCG company. After graduating top of his class from the University of Minnesota Medical School, Dr. MacDonald... Read More →
SR

Sara Reed

Video Production, Consultant, United States
Sara Reed holds a MFA in Documentary Media from Northwestern University. With over a decade of freelance video production experience spanning the U.S., Canada, Central/South America, and Africa, she’s contributed to projects for renowned clients such as Discovery, HBO, NASA, and... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

10:00am PDT

#318: Defining an Inclusive Clinical Trials Approach in Europe
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-636-L04-P; CME 1.00; RN 1.00

This forum will address industry challenges in the recruitment and retention of underserved populations in clinical research, and explores how regulators, physicians, sponsors and others can work together to develop solutions to tackle health equity.

Learning Objectives

Identify a proposal for addressing underrepresentation of underserved populations in Europe; Describe regulatory and industry perspectives in addressing recruitment and retention challenges for multi-regional clinical trials; Discuss best practices that can help shape inclusivity of clinical trials across borders.

Chair

Ambily Banerjee, PhD

Speaker

ACT-EU Efforts from EMA Perspective
Ana Zanoletty Perez

Evolving FDA Perspective Based on Learningd from DAP Submissions on What Diversity Looks Like
M. Khair ElZarrad, PhD, MPH

Industry Perspective of Community Engagement in Europe: A Case Study
Monique Adams, PhD, MS

CT Network One-Pager v2
Nicholas Brooke, MBA


Speakers
avatar for Ambily Banerjee

Ambily Banerjee

Senior Director/Head of Diversity in Clinical Trials, Johnson and Johnson Innovative Medicine, United Kingdom
After a decade as an academic scientist, following a Ph.D. in Molecular Biology, Ambily moved to GSK Regulatory Affairs, where she held increasingly senior roles in Global Regulatory Affairs and Internal Audit. She also led the race and ethnicity Employee Resource Group, EMBRACE... Read More →
avatar for Monique Adams

Monique Adams

Executive Director, Global Head Diversity and Inclusion in Clinical Trials, Sanofi, United States
Monique Adams is the Executive Director, Global Head of Diversity and Inclusion in Clinical Trials, or DICT, at Sanofi where she drives the pharmaceutical company’s vision, strategy, and implementation of a holistic framework for DICT. Monique has a Ph.D. in Pharmacology from the... Read More →
avatar for Nicholas Brooke

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), PFMD, Belgium
Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
avatar for M. Khair ElZarrad

M. Khair ElZarrad

Director, Office of Medical Policy, CDER, FDA, United States
Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
avatar for Ana Zanoletty Perez

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   02: ClinTrials -ClinOps, Forum

1:15pm PDT

#345: Regulatory Considerations in Trial Design for Cell and Gene Therapies
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-648-L04-P; CME 1.00; RN 1.00

Cell and gene therapies have enormous potential to address unmet medical need. The application of validated clinical trials design tools along with biomarkers to assess safety and endpoints can help address regulatory uncertainty.

Learning Objectives

Discuss regulatory considerations for cell and gene therapies including the use of data modeling in clinical trial design and the application of biomarkers both for safety assessment and measures of outcome; Discuss how to plan for meeting regulatory requirements and be able to incorporate these plans into your company’s drug development plans.

Chair

Kanwaljit Singh, MD, MBA, MPH

Speaker

Regulatory Considerations for Development of Pediatric Cell and Gene Therapies: FDA Update
Najat Bouchkouj, MD

Regulatory Consideration for Pediatric Cell and Gene Therapies - Industry Perspective
Paulla Dennis

Path from Bench-to-Bedside for a Cell and Gene Therapy Drug Product
Stephanie Cherqui, PhD


Speakers
avatar for Najat Bouchkouj

Najat Bouchkouj

Associate Director for Pediatrics (Acting), Office of Clinical Evaluation, FDA, United States
Dr. Najat Bouchkouj is the Acting Associate Director for Pediatrics in the Office of Clinical Evaluation, OTP, CBER, FDA. Dr. Bouchkouj joined the FDA in 2016. She earned her medical degree from Damascus University, Syria and completed a residency in Pediatrics at the State University... Read More →
avatar for Stephanie Cherqui

Stephanie Cherqui

Director, UC San Diego Gene Therapy Initiative, University of California San Diego, United States
Stephanie Cherqui is Professor in the Department of Pediatrics, Division of Genetics at the University of California San Diego. She is also the Director of the UC San Diego Gene Therapy Initiative. Her laboratory primarily centers on two research areas: the development of hematopoietic... Read More →
PD

Paulla Dennis

Senior Director, Rare Diseases, Advanced Therapies, and Pediatrics, Fortrea, United States
• Paulla Dennis, Senior Director, is a leading member of the Rare Disease, Advanced Therapies, and Paediatric Team (RAPT) with over 20 years in the clinical research industry. Paulla has expertise in global phase I through IV pediatric and rare disease operational strategy and planning... Read More →
avatar for Kanwaljit Singh

Kanwaljit Singh

Executive Director, International Neonatal Consortium, Critical Path Institute, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  06: TranslationalDelivery Tech-PrecMedicine, Session |   09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

1:15pm PDT

#346: A Clinical Research Workforce in Crisis: Imperatives for a Sustainable Staffing Model
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-649-L04-P; CME 1.00; RN 1.00

The clinical research workforce crisis threatens to undermine the entire drug development ecosystem. This session will discuss the glaring disconnect between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that’s in dire straits. It will feature a variety of industry leaders who will frame the issue and share lessons, solutions, and workforce development models that can be emulated globally to help build the next generation of clinical researchers--diverse and research ready.

Learning Objectives

Discuss the extent of the clinical research workforce crisis, including a diminishing pool of experienced clinical research professionals a ‘war for talent’ that is driving high and unsustainable turnover; Identify factors contributing to this crisis; Describe promising steps that can help with future workforce development.

Chair

Susan Landis

Speaker

Industry Update
Jimmy Bechtel, MBA

Industry Update
Meghan McKenzie, MA

Academic Update
Jonathan Watanabe, PharmD, PhD


Speakers
avatar for Susan Landis

Susan Landis

Executive Director, Association of Clinical Research Professionals (ACRP), United States
Susan Landis serves as the Executive Director for the Association of Clinical Research Professionals. Prior to joining the Association, Susan led Strategic Engagement & Marketing Communications for the Duke Clinical Research Institute (DCRI). While at Duke, Susan established and led... Read More →
avatar for Jimmy Bechtel

Jimmy Bechtel

Vice President, Site Engagement, Society for Clinical Research Sites (SCRS), United States
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 Meghan McKenzie

Meghan McKenzie

Patient Inclusion and Head, Equity, Chief Diversity Office, Genentech, A Member of the Roche Group, United States
Meghan McKenzie works in Patient Inclusion and Health Equity in Genentech’s Chief Diversity Office (CDO). She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity. Genentech’s... Read More →
avatar for Jonathan Watanabe

Jonathan Watanabe

Associate Dean, Pharmacy Assessment and Quality | Prof, Clinical Pharmacy, University of California Irvine, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  07: ProjectManagement-StrategicPlanning, Session |   13: ProfDevelopment, Session |   02: ClinTrials -ClinOps, Session

1:15pm PDT

#349: Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-652-L04-P; CME 1.00; RN 1.00

This forum provides a general view and challenges of the study design in cell and gene therapy trials. A panel of experts interpret FDA guidance, share their own experience for study design, and discuss the trends in this area.

Learning Objectives

Describe regulatory principles of the trial design for cell and gene therapy products; Identify specific design elements such as selection of study population; Discuss the selection of control, safety monitoring; Discuss challenges and new trends.

Chair

Yao-Yao Zhu, MD, PhD

Speaker

Panelist
Katherine A. High, MD

Panelist
Vaishali Popat, MD, MPH

Clinical Considerations for Oncology Cell and Gene Therapy Trials
Ke Liu, MD, PhD


Speakers
avatar for Yao-Yao Zhu

Yao-Yao Zhu

Regulatory Affairs Director, AstraZeneca, United States
Yao-Yao Zhu, MD, PhD, has over 15 years of regulatory experience. She is currently a Regulatory Affairs Director for cardiovascular, renal, and metabolic diseases at AstraZeneca (AZ). Prior to AZ, she was a head of Global Regulatory Affairs at Biosion for antibody products in oncology... Read More →
avatar for Katherine High

Katherine High

Co-Founder and Former President, Sparks Therapeutics; Visiting Professor, Rockefeller University, United States
Dr. Katherine High is the former President at Spark Therapeutics, a biotech company that she co-founded in 2013. Under Dr. High’s leadership, Spark received FDA approval of the first AAV gene therapy product in the US, a treatment for a rare form of congenital blindness. Dr. High... Read More →
avatar for Ke Liu

Ke Liu

Chief Development Officer, Marengo Therapeutics, United States
As Chief Development Officer of Marengo Therapeutics, Ke Liu joins Marengo with over 20 years of experience in the field of oncology, immuno-oncology, and cell and gene therapy, most recently serving as Senior Vice President and led the key regulatory activities at Sana Biotechnology... Read More →
avatar for Vaishali Popat

Vaishali Popat

Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
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 safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum |   04: MedAffairs-SciComm, Forum

2:30pm PDT

#358 CH: RBQM (Risk-Based Quality Management): What Topics Should be Discussed with Whom in the Room?
Component Type: Workshop
Level: Intermediate

Critical-to-Quality (CtQ) factors are key to determining which protocol-related processes and variables matter. These should be defined cross-functionally during risk assessment and built into all functional plans to have a common focus and approach.

Learning Objectives

Define Critical-to-Quality (CtQ) variables; Streamline CtQ to all functional plans for common approach; Understand the benefits from reduced SDR/SDV by focusing on CtQ as variables that matter.

Chair

Terry Katz, MS

Speakers
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Wednesday June 19, 2024 2:30pm - 3:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  15: Content Hubs, Workshop |   02: ClinTrials -ClinOps, Workshop

3:15pm PDT

#360: More than Meets the Eye: AI’s Potential to Identify Skin Manifestations of Internal Disease in Patients of Color
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-660-L04-P; CME 1.00; RN 1.00

Unlocking AI's potential to facilitate diversity in clinical trials demands inclusive images capturing skin manifestations of internal diseases across races and ethnicities. Join our panel to learn more about inclusive innovation in AI solutions.

Learning Objectives

Discuss the importance of photographs and images in AI algorithms to identify internal diseases impacting patients of color and how that supports clinical trial enrollment; Identify the questions to ask of AI solution providers to ensure imagery is inclusive; Describe what’s being done to improve imagery in AI learning to drive clinical trial diversity.

Chair

Pamela Simpkins, MBA

Speaker

Patient Update
Tricha Shivas, MS

Industry Update
Lionel Phillips, MBA

Industry Update
Brian H Johnson


Speakers
avatar for Pamela Simpkins

Pamela Simpkins

Managing Partner, Mezzopointe. LLC, United States
Biopharma R&D executive with 26+ years in the industry and nearly a decade as an institutional investor. Expert in R&D Finance with a proven track record in accelerating development of key pipeline assets to achieve regulatory approval and market authorization. Built, led and sold... Read More →
BJ

Brian Johnson

Vice President, R&D Technology, Takeda, United States
avatar for Lionel Phillips

Lionel Phillips

President, Inside Edge Consulting, United States
avatar for Tricha Shivas

Tricha Shivas

Chief of Staff and Strategy, Foundation For Sarcoidosis Research, United States
Tricha Shivas joined the Foundation for Sarcoidosis Research (FSR) in December of 2020. As the Chief of Staff and Strategy, she works with various stakeholders including individuals living with sarcoidosis. Through her career she has built strong stakeholder relations, created comprehensive... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session |   11: Statistics-Data Science, Session |   02: ClinTrials -ClinOps, Session

3:15pm PDT

#361: Recruitment Optimization in Clinical Trials: Looking Towards an Adaptive Future
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-661-L04-P; CME 1.00; RN 1.00

Recruitment is a significant building block of clinical trials and also one of the greatest challenges, often having a direct influence on trial success or failure. In-efficiencies associated with patient recruitment may lead to prolonged trial durations, increased costs, and delays in bringing effective treatments to market. This session will explore methods for predicting the effect of different recruitment patterns on trial progression, outcomes and likelihood of the trial to meet its goals and present newly available technologies and trial design measures for successfully advancing recruitment.

Learning Objectives

Describe the considerations of recruitment rate optimization in clinical trials and adaptive trials in particular; Discuss the available technologies and methodologies for optimizing recruitment via dedicated software, patient advocacies, databases and registries and the evaluation of trade-offs between trial duration and sample size requirements within a variety of adaptive trial designs as compared with standard fixed designs.

Chair

Raviv Pryluk, PhD

Speaker

Time is Life: Leveraging Innovation in Clinical Trials for Rapid Recruitment
Tanya Russell, PhD, MS, RPh

Potential for Leveraging AI/ML in Pre-Trial Recruitment Modelling
Jenny Higley, MS

Demystifying Site Engagement: Leveraging an Omnichannel Approach with Data-Driven Clinical Analytics
Sanghita Bhattacharya, PhD

Optimizing Clinical Trial Site Selection: Balancing Recruitment Efficiency and Population Diversity
Raviv Pryluk, PhD


Speakers
avatar for Raviv Pryluk

Raviv Pryluk

PhaseV, United States
Raviv is the co-founder & CEO of PhaseV, a technology company that leverages causal-ML and advanced software capabilities to support advanced & innovative clinical trials. Raviv holds a B.Sc. and M.Sc. in engineering from the Technion (Cum Laude) and Ph.D. in computational neuroscience... Read More →
avatar for Sanghita Bhattacharya

Sanghita Bhattacharya

Associate Director Data Science , Feasibility and Analytics, Clinical Operations, Johnson & Johnson Innovative Medicine, United States
Sanghita leads the DS strategy and Pathway for clinical trial feasibility for Cardiovascular Metabolism and Pulmonary Hypertension Therapeutic Areas in Janssen R&D Data Science. Sanghita has been within the healthcare sector for 14 years, with experience in both MedTech as well as... Read More →
JH

Jenny Higley

Director, Head of Feasibility CoE, Biogen, United States
Jenny has 20 years of clinical research experience and is currently the Director of the Feasibility Center of Excellence at Biogen, where she has worked for the past four years. Jenny’s career also includes CRO and ARO experience from IQVIA, Syneos Health, and the Duke Clinical... Read More →
TR

Tanya Russell

Vice President, Integration Lead, Pfizer Inc, United States
Tanya Russell recently moved into a new role as Vice President, CD&O Integration Lead supporting the R&D integration of Seagen and Pfizer into one Pfizer Oncology department. For the last 3+ years, Tanya was Pfizer’s Oncology and Rare Disease Clinical Operations Head with accountability... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session |   03: Data-Tech, Session |   02: ClinTrials -ClinOps, Session

4:30pm PDT

#374: Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-673-L04-P; CME 1.00; RN 1.00

The forum will consist of regulators and industry experts who were the authors of the ICH E17 guidelines. As regulators and sponsors, they will provide first-hand narrative on their experiences in implementing the ICH E17 guidelines.

Learning Objectives

Discuss the status of adoption of ICH E17 guidelines on conduct of multiregional clinical trials (MRCT) by the regulators and industry. • Identify reasons behind slow uptake of the ICH E17 guidelines. • Discuss points for increasing usage of E17 for conduct of MRCT and simultaneous global development.

Chair

Yoshiaki Uyama, PhD, RPh

Speaker

PMDA Perspective
Yoko Aoi, PhD

Pharmaceutical Industry Perspective
Romi Singh, PhD

FDA Update
Douglas Pratt

Taiwan Perspective
I-Chun Lai, MD, MS

China Perspective
Yangfeng Wu, MD, PhD


Speakers
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
avatar for Yoko Aoi

Yoko Aoi

Deputy Review Director, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yoko Aoi is a deputy review director of Office of New Drug V responsible for review and scientific advice on oncology drugs. After joining PMDA, Dr. Aoi was involved in review and scientific advice on new drugs for rheumatoid arthritis, asthma, COPD etc. (2011-2016) and planning... Read More →
avatar for I-Chun Lai

I-Chun Lai

Director, Consultation Division, Center for Drug Evaluation, Taiwan
Dr. I-Chun Lai graduated with her medical degree from Taipei Medical University in Taiwan in 2001 and worked as a physician until 2007, when she joined the Center for Drug Evaluation (CDE) in Taiwan. In 2013, she received her Master of Science from the Institute of Health Policy and... Read More →
DP

Douglas Pratt

Supervisory Medical Officer, OVRR, CBER, FDA , United States
avatar for Romi Singh

Romi Singh

Head, Regional Regulatory Sciences, Asia, Pfizer Inc, United States
Dr. Rominder (Romi) Singh has extensive scientific and management experience at top biopharmaceutical companies--Pfizer, Amgen, Merck and GlaxoWellcome. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international... Read More →
YW

Yangfeng Wu

Executive Director, Peking University Clinical Research Institute, China
Professor Wu is the Executive Director of Peking University Clinical Research Institute. He has been principal investigators of tens of research projects sponsored by national and international founding agencies including China Ministry of Science and Technology, China Natural Science... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum
  • Format Forum
  • Level Intermediate
  • Featured Topics ICH
  • Level Intermediate
  • Feature Topics ICH
  • Credit Type ACPE, CME, RN
  • Tags Forum

4:30pm PDT

#371: Using Influencers to Recruit Hard-to-Engage Populations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-670-L04-P; CME 1.00; RN 1.00

Influencers are community connectors that can be leveraged to expand patient recruitment, particularly for hard-to-engage populations. We will discuss how influencers can engage patient audiences for clinical trial participation.

Learning Objectives

Discuss the power of influencer marketing to improve clinical trial participation, including among diverse populations; Describe how to build an effective influencer campaign — matching the right influencer to your objectives; Develop effective digital assets; Identify how to maximize exposure among a captivated audience.

Chair

Sarah McKeown-Cannon

Speaker

Industry Update
Lara Lane


Speakers
LL

Lara Lane

Director, Clinical Operations, Ironwood Pharmaceuticals, United States
As Director of Clinical Operations at Ironwood, Lara is responsible for developing and executing clinical operations program strategies, ensuring the delivery of high-quality results. With 20+ years of expertise in the industry, her work experience has spanned across clinical sites... Read More →
SM

Sarah McKeown-Cannon

Vice President, Growth, Publicis Health, United States
Sarah McKeown-Cannon (she/her/hers) provides innovative patient recruitment and engagement solutions that enrich study experiences and deliver measurable results. She is driven by her commitment to making a difference in people's lives, by understanding all the dimensions that make... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   02: ClinTrials -ClinOps, Session
 
Thursday, June 20
 

8:00am PDT

#404: Meeting in the Middle: Best Practices for Collaboration Between Medical Affairs and Clinical Development
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-680-L04-P; CME 1.00; RN 1.00

Medical affairs and clinical development enhance the scientific credibility of the company (and its products) with established and emerging clinical investigators These collaborations may also improve study recruitment techniques.

Learning Objectives

Design new activities which require participation from both medical affairs and clinical development; Demonstrate how the medical affairs team can provide real-world data to help inform study designs and execution; Critique case studies of successful collaborations.

Chair

J. Lynn Bass, PharmD, RPh

Speaker

Industry Update
J. Lynn Bass, PharmD, RPh

Industry Update
Rebecca A. Vermeulen, RPh

Industry Update
Sonja Wesley Hokett, PharmD, MS, MSc


Speakers
avatar for J. Lynn Bass

J. Lynn Bass

Senior Director, Medical Science Liaisons, BridgeBio, United States
In her 25+ years of industry experience, Lynn has served in both individual and leadership positions within Medical Affairs at both large and start-up companies. She is currently Sr. Director, Medical Science Liaisons at BridgeBio, where she is building and leading a field medical... Read More →
avatar for Sonja Hokett

Sonja Hokett

Executive Director/Head of Medical Managed Care, BioXcel Therapeutics, United States
Residing in Branson, Missouri, Sonja holds PharmD degree from the University of Louisiana Monroe, Master of Science degree in Hospital Pharmacy Administration from the University of Houston, and Executive Master's degree Health Economics, Policy & Management from the London School... Read More →
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum |   04: MedAffairs-SciComm, Forum

9:15am PDT

#410: The Impact of Racial Discrimination on the Patient Clinical Trial Experience
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-685-L04-P; CME 1.00; RN 1.00

The session will share findings from a recent mixed-method study that examined the different types of racial microaggressions patients experience while participating in clinical trials and how these interactions affect their experience.

Learning Objectives

Describe findings from a recent study examining common forms of racial discrimination experienced by patients in clinical trials; Discuss the impact that these interactions can have on patient-reported outcomes, including patient trust and willingness to participate in another study at that site or location; Discuss evidence-based solutions that can reduce exclusion in clinical trials.

Chair

Jennifer Kim, PhD

Speaker

How Microaggressions Can Impact the Patient Experience in Clinical Trials
Sharon Rivera Sanchez

Research Perspective: The Science of Exclusion in Clinical Trials
Ruby Madison Ford, MPH

Amplifying the Patient Voice: Incorporating the Patient Experience
Perla Nunes

Industry Update
Rodney Winley

Industry Update
Elizabeth Rosenkrands-Lange, MPH, MS


Speakers
avatar for Ruby Ford

Ruby Ford

Research Analyst, Tufts School of Medicine, United States
avatar for Jennifer Kim

Jennifer Kim

Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Assistant Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining how diversity, equity and inclusion dynamics impact individual, group, and organizational outcomes... Read More →
avatar for Sharon Rivera Sanchez

Sharon Rivera Sanchez

Patient Advocate and Founder, Trials of Color, United States
I am Sharon Rivera-Sanchez, founder & CEO of Trials of Color and Saving Pennies 4 A Cure, non-profits 501-C3 organizations founded in 2018, & Trials of Color in 2022. The mission is to educate, advocate, and empower cancer patients with a primary focus on Diversity in Clinical trials... Read More →
avatar for Perla Nunes

Perla Nunes

Patient Advocate, Community Outreach and Clinical Research DEI Consultant, United States
Ms. Nunes' research career began at Hoffmann-LaRoche, where she worked in drug discovery. In NC she worked in at at the Cannon Research Center of Atrium Health focusing on preclinical and clinical research areas related to oncology and immunology. She worked at Duke University's CTSI... Read More →
ER

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, United States
RW

Rodney Winley

Senior Director, R&D Patient Partnerships, CSL Behring, United States

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   02: ClinTrials -ClinOps, Session
 
Filter sessions
Apply filters to sessions.
Sunday, June 16
Monday, June 17
Tuesday, June 18
Wednesday, June 19
Thursday, June 20
Ballroom
Ballroom 20 A/ Zone 1
Ballroom 20 BC/ Zone 2
Ballroom 20 D/ Zone 3
Ballroom 20 Lobby
Ballroom 6 Lobby
Content Hub Sails Pav
Exhibit Hall
Exhibit Hall B 1
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Posters Exhibit Hall
Room 11AB
Room 14AB
Room 15AB
Room 16AB
Room 17AB
Room 1AB
Room 2
Room 5AB
Room 6A
Room 6B
Room 6C
Room 6D
Room 6E
Room 6F
Room 7AB
Room 8
Sails Pavilion
TBD
USS Midway
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Focused Drug Dev
  • 06: TranslationalDelivery Tech-PrecMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Format
  • Forum
  • Session
  • Tutorial
  • Workshop
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • Artificial Intelligence (AI)
  • Cell and Gene Therapy
  • Decentralized Clinical Trials (DCTs)
  • Digital Technology
  • Diversity Equity and Inclusion (DEI)
  • Ethics
  • ICH
  • Patient Focused
  • Rare Disease
  • Real-World Data (RWD)- Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Reliance
  • Risk Management
  • Special Populations
  • Student Programming