DIA 2024 Global Annual Meeting: Full Schedule

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

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 →

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 →

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 →

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

Format Session
Level Intermediate
Featured Topics Ethics, Rare Disease, Special Populations
Level Intermediate
Feature Topics Ethics,Rare Disease,Special Populations
Credit Type ACPE, CME, RN
Tags Session

2:15pm PDT

#137: Options to Consider When Balancing Risk, Timelines, Cost, and Patient Centricity While Meeting Project Optimus Guidelines

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-537-L04-P; CME 1.00; PDU 1.00 PMI 2166YE3LVS; RN 1.00

Review principles of FDA's Project Optimus and discuss the impact on oncology clinical development strategies. Scenario analysis with risk management is needed to balance project cost, timelines, patient centricity and health equity approaches.

Learning Objectives

Describe the essential points of FDA's Project Optimus Guidance and how it may impact drug development; Discuss how project managers and oncology development teams gain insight into options to consider in order to balance cost, timelines, and risk during dose finding/dose optimization in new molecular entities and new indications.

Chair

Nancy Linda Styple

Speaker

Patient Update
Julia Maues, MA

Industry Update
Gary Wilkinson, PhD

Project Management Considerations for Project Optimus
Nancy Linda Styple

Speakers

Nancy Styple

Project Management Leader, Bayer AG, United States

Nancy has been excited to work in Program Management for over 20 years and is a strong advocate for the work that Project Managers and Project Leaders deliver along the value chain in drug development. Nancy starting as a bench research scientist in biotech and has experience in multiple... Read More →

Julia Maues

Patient Advocate, Patient-Centered Dosing Initiative, United States

Julia Maues spearheads the Patient-Centered Dosing Initiative (PCDI), challenging conventional cancer drug dosing practices and prioritizing patient well-being alongside efficacy. She is co-founder of GRASP (Guiding Researchers and Advocates to Scientific Partnerships), an organization... Read More →

Gary Wilkinson

Director of Clinical Pharmacology, Ryvu Therapeutics, Poland

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 05: Patient-Focused Drug Dev, Session | 07: ProjectManagement-StrategicPlanning, Session

Format Session
Level Intermediate
Featured Topics Risk Management
Level Intermediate
Feature Topics Risk Management
Credit Type ACPE, CME, PMI, RN
Tags Session

8:00am PDT

#206: Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-561-L04-P; CME 1.00; RN 1.00

Integrating patient-experience data (PED) in medicines regulation for better patient-centered outcomes is a priority for medicines regulators, including the FDA and the EU network. The FDA’s program on patient-focused drug development (PFDD) has yielded 4 scientific guidelines on PED, while in the EU work is ongoing to produce a reflection paper outlining pathways for progress, marking an initial step toward smoother PED integration in medicine development. The session will present the US and EU's position in this regard and draw on the experience in applying existing guidance to date.

Learning Objectives

Describe the work done by FDA’s Patient-Focused Drug Development (PFDD) program on scientific guidelines on patient-experience data (PED), challenges and future outlook; Describe how work is progressing in the EU to foster the generation and use of patient-experience data in medicines regulatory decision-making.

Chair

Steffen Thirstrup, MD, PhD

Speaker

Co-Chair
Robyn Bent, MS, RN

US Patient Representative
Karin Hoelzer, DVM, PhD

EMA Update
Juan Garcia-Burgos, MD, PhD

EMA Update
Rosa Gonzalez-Quevedo

US Industry Representative
Maria Apostolaros, JD, PharmD, MS, RPh

EU Industry Representative
Solange Corriol-Rohou, DrMed, MD, PhD

Speakers

Maria Apostolaros

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States

Maria Apostolaros is currently a Deputy VP of Science and Regulatory Advocacy at PhRMA in DC, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to live... Read More →

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States

Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →

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, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands

Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation... Read More →

Rosa Gonzalez-Quevedo

Scientific Research Officer, European Medicines Agency, Netherlands

Karin Hoelzer

Senior Director, Policy and Regulatory Affairs, NORD, United States

Dr. Karin Hoelzer directs Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD®). She works closely with pharmaceutical and biotech partners to ensure public policy supports innovative approaches and new treatments, and adequately incorporates patient... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session

Format Session
Level Intermediate
Featured Topics Patient Focused, Regulator Perspectives
Level Intermediate
Feature Topics Patient Focused,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

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

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 →

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

Format Session
Level Basic
Featured Topics Ethics
Level Basic
Feature Topics Ethics
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#321: The ChatBot Will See You Now: Ethical Considerations in Incorporating AI into Informed Consent

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-639-L04-P; CME 1.00; RN 1.00

Generative AI is gaining traction in trial communications, with goals of expediency and efficiency. New technologies should incorporate patient views and ethical frameworks to keep human interactions that are desirable, necessary, and useful.

Learning Objectives

Describe the ethical framework that encompasses informed consent for clinical research; Evaluate goals for the use of artificial intelligence (AI) in clinical trials and how these goals interact with ethical goals for consent; Discuss how to incorporate patient and participant needs and perspective into AI-assisted clinical trial information and communication.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Patient Perspective Update
Deborah Collyar

Industry Update
Karla Childers, MS

Industry Update
Catina O'Leary, PhD

Speakers

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 →

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States

Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →

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 →

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States

Catina O’Leary, PhD, is President and CEO at Health Literacy Media (HLM), a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications with a wide range of global partners. Before joining HLM in 2012, Catina was Assistant... Read More →

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session

Format Session
Level Advanced
Featured Topics Artificial Intelligence (AI), Ethics, Patient Focused
Level Advanced
Feature Topics Artificial Intelligence (AI),Ethics,Patient Focused
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#323: Driving Capacity Building, Equity, and Geographic Expansion in Clinical Trials

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-641-L04-P; CME 1.00; PDU 1.00 PMI 2166PJJJ85; RN 1.00

90% of trials are performed in higher-income countries. In this session, the audience will learn directly from stakeholders about establishing infrastructure in low and/or middle income countries (LMICs) and how building capacity can improve quality of care and outcomes for patients.

Learning Objectives

Describe global research expertise and identifying gaps on a local level; Identify approaches to translate local research expertise to global research excellence; Recognize successful strategies for long-term sustainability and growth.

Chair

Muhammad Ali Hameed, CPA, MBA

Speaker

Facilitator
Twanna L Davis, MBA

Facilitator
Jeanine Condo Condo

Speakers

Jeanine Condo

Chief Executive Officer, CIIC-HIN, Rwanda

Twanna Davis

Global Head, Clinical Trial Services, Executive Advisor - Purpose Africa, Purpose Life Science, Canada

Twanna Davis is the Head of Clinical Trial Solutions at Purpose Life Sciences. In her role, Twanna oversees all functional services necessary to execute full-service global clinical trials. She has over 25 years of experience in clinical operations, directing multiple applicable services... Read More →

Muhammad Ali Hameed

Chief Operating Officer, Population Health Research Institute, Canada

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 07: ProjectManagement-StrategicPlanning, Session

Format Session
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI)
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI)
Credit Type ACPE, CME, PMI, RN
Tags Session

10:00am PDT

#326: Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-644-L04-P; CME 1.00; RN 1.00

In this session, we will discuss international efforts to promote regulatory convergence and expand the use of reliance to bring these highly complex therapies to market earlier, particularly in less developed countries.

Learning Objectives

Describe how international harmonization, collaboration, and reliance principles can be effectively applied to the regulation of cell and gene therapies; Discuss the key considerations and regulatory challenges associated with bringing complex, innovative medicines such as cell and gene therapy products to less experienced, emerging markets.

Chair

Ginny Beakes-Read, BSN, JD

Speaker

FDA Update
Julia Tierney, JD

WHO Update
Samvel Azatyan, MD, PhD

PMDA Update
Yasuhiro Kishioka, PhD

Industry Update
Maria Antonieta Tony Roman, MPharm

EMA Update
Anabela Marcal, PharmD

Speakers

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →

Ginny Beakes-Read

Head, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States

Ms. Beakes-Read is VP, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Amgen leading the... Read More →

Yasuhiro Kishioka

Reviewer Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... Read More →

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands

Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →

Maria Antonieta Roman

Head Regulatory Policy Emerging Markets LATAM, Novartis, Mexico

Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality... Read More →

Julia Tierney

Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States

JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Cell and Gene Therapy, Regulatory Reliance, Regulatory Collaboration
Level Intermediate
Feature Topics Cell and Gene Therapy,Regulatory Reliance,Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Session

1:15pm PDT

#350: ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-653-L04-P; CME 1.00; RN 1.00

Discussion of ICH work to harmonize recommendations for inclusion of patient’s perspective in drug development. Patient group representatives will also highlight key considerations for clinical research and development of international standards.

Learning Objectives

Discuss ICH’s portfolio for inclusion of patient’s perspective in drug development and outline specific case examples; Describe the patient perspective in clinical research and identify key considerations that may be relevant for the international community in developing standards; Evaluate linkages between ICH’s mission and key interests of patient, health care professional, and life science communities.

Chair

Amanda Marie Roache, MS

Speaker

Moderator
Theresa Mullin, PhD

ICH E22 Patient Preference Studies
Brett Hauber, PhD, MA

ICH Patient Engagement
Francesco Pignatti, MD

Patient Perspective on Engagement to Inform Drug Development
Nicholas Brooke, MBA

Speakers

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 →

Brett Hauber

Senior Director, Patient Preference Elicitation, Pfizer Inc, United States

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States

Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 05: Patient-Focused Drug Dev, Session

Format Session
Level Basic
Featured Topics Patient Focused, ICH
Level Basic
Feature Topics Patient Focused,ICH
Credit Type ACPE, CME, RN
Tags Session

2:15pm PDT

#356 RT: Roundtable Discussion: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent

Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

Chair

Karla Childers, MS

Speakers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 05: Patient-Focused Drug Dev, Session

Featured Topics Ethics
Feature Topics Ethics
Tags Session

3:15pm PDT

#366: The Intersection of Patient-Experience Data and Benefit-Risk Analysis

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-666-L04-P; CME 1.00; RN 1.00

This session will explore how patient experience data (PED) can be used to inform benefit-risk analysis. The panel will include discussion on regulators’ views and incorporation of PED and successful case examples.

Learning Objectives

Describe the role patient experience data (PED) plays in benefit-risk analysis; Identify how to develop PED in a way that can inform regulatory decision-making; Discuss if and how new diversity and inclusion regulations will impact the development of PED and regulators’ interpretation of benefit-risk.

Chair

Allison Martin, MS
Victoria DiBiaso, BSN, MPH, RN

Speaker

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: FDA Update
Michelle Campbell, PhD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: EMA Update
Francesco Pignatti, MD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: patient Update
Hollie Schmidt, MS

Speakers

Allison Martin

Director, Regulatory Science and Policy, North America, Sanofi, United States

As a Director on Sanofi’s Regulatory Science and Policy North America team, Allison is responsible for advancing regulatory science and strategically engaging in regulatory policy efforts. In this role, Ms. Martin collaborates with internal and external stakeholders to identify... Read More →

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States

Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →

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 →

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

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 19, 2024 3:15pm - 4:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI), Patient Focused, Risk Management
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI),Patient Focused,Risk Management
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#373: Patient-Centric Approaches in Summaries and Data Return

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-672-L04-P; CME 1.00; RN 1.00

Join us for a multi-stakeholder discussion to learn more about the practical tools and considerations available to help sponsors get started or improve their participant communications including lay protocol synopses, lay summaries, and participant data return.

Learning Objectives

Recognize the problems in explaining benefit and risk to patients and lay audiences; Define meaningful communication of information to research participants; Identify how evolving collaborations, proactive planning, interoperability, digital health advancements, and secure data management enable participant data return options that do not compromise data integrity, confidentiality, or submission timelines.

Chair

Jean Sposaro, MHS, LLM

Speaker

Individual Participant Data Return: Feasible, Personal, and Actionable Options to Support Informed Decision-Making
Jean Sposaro, MHS, LLM

Patient Perspective
T.J. Sharpe, PMP

Speakers

Jean Sposaro

Director, Global Drug Development Operations, Industry Collaborations, Bristol-Myers Squibb Company, United States

Healthcare Provider, Researcher, Patient Advocate, Bioethics, Pharmaceutical Law & Policy Professional advancing science through impactful collaboration with stakeholders across the R&D ecosystem to "co-create a healthier future". Optimizing global collaborations as enablers of innovation... Read More →

T.J. Sharpe

Patient Engagement Expert, Consultant, United States

T.J. Sharpe is a speaker, writer, and patient expert consultant working with top pharmaceutical companies and clinical research stakeholders seeking sustained, ingrained, consistent patient engagement. A Stage IV melanoma survivor given two years to live, his continuation from survivorship... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session

Format Session
Level Intermediate
Featured Topics Patient Focused
Level Intermediate
Feature Topics Patient Focused
Credit Type ACPE, CME, RN
Tags Session

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

Using Influencers to Recruit Hard-to-Engage Populations
Lara Lane

Using Influencers to Recruit Hard-to-Engage Populations
Jane Elizabeth Myles, MSc

Using Influencers to Recruit Hard-to-Engage Populations
Dezbee McDaniel

Speakers

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 →

Dezbee McDaniel

CEO/Co-Founder, Clinispan Health, United States

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 →

Jane Myles

Program Director, Decentralized Trials and Research Alliance (DTRA), United States

Jane has over 25 years of experience improving clinical trials and patient experiences. She has focused on driving innovation in trial design and execution to accelerate getting medicines to patients. Jane transitioned from molecule focus to portfolio focus about 14 years ago, first... 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

Format Session
Level Intermediate
Featured Topics Ethics, Special Populations
Level Intermediate
Feature Topics Ethics,Special Populations
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#408: Targeting Hope for Oncology Patients: Perceptions and Considerations for Genetic Testing and Precision Medicine

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-684-L04-P; CME 1.00; RN 1.00

This session provides new thinking and examples of how to design and implement qualitative research around genetic testing and precision medicine for oncology patients.

Learning Objectives

Discuss approaches to designing, executing, and analyzing qualitative research around patient perceptions of genetic testing and precision medicine; Discuss unmet needs around patient education and the integration of genetic counselor into care team; Examine the application of a behavioral framework to understand decision to get a genetic testing for oncology patients.

Chair

Wesley D Peters, MS

Speaker

Measuring Value in Oncology: Are we Keeping Pace with Science?
Solange Corriol-Rohou, DrMed, MD, PhD

Targeting Hope for Oncology Patients: Perceptions and Considerations for Genetic Testing and Precision Medicine
Jennifer Malinowski, PhD, MS

Speakers

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France

Wesley Peters

Research Specialist II, Patient Experience, Evidera/Thermo Fisher Scientific, United States

Wes Peters is a public health professional with over 7 years of experience in the Life Science industry. Wes received his Master of Science in Public Health (MSPH) from the Johns Hopkins Bloomberg School of Public Health with a focus in Health Education and Health Communication. Currently... Read More →

Jennifer Malinowski

Director, Access and Policy Research, Johnson & Johnson Innovative Medicine, United States

Dr. Malinowski is a sought-after expert for precision medicine and genomics, bioethics, health economics and outcomes research, and is a certified clinical guideline methodologist. A proven leader, she has substantial experience building a culture of engagement and inclusion across... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 12: Value-Access, Session

Format Session
Level Intermediate
Featured Topics Patient Focused
Level Intermediate
Feature Topics Patient Focused
Credit Type ACPE, CME, RN
Tags Session

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

Ruby Ford

Research Analyst, Tufts School of Medicine, United States

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 →

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 →

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 →

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck Kgaa, Darmstadt, Germany, United States

Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →

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

Format Session
Level Basic
Featured Topics Patient Focused, Diversity Equity and Inclusion (DEI)
Level Basic
Feature Topics Patient Focused,Diversity Equity and Inclusion (DEI)
Credit Type ACPE, CME, RN
Tags Session