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Monday, June 17
 

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

11:00am PDT

#116: Navigating the Trusted, Responsible, and Ethical Horizon of Artificial Intelligence: Uniting Healthcare Perspectives
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-529-L04-P; CME 1.00; RN 1.00

Artificial Intelligence (AI) is making its presence known in health care, presenting unprecedented opportunities and challenges. It is crucial to devise strategies that ensure its ethical and responsible utilization for the betterment of health care and society. This imperative can only be met by harnessing the collective power of the broad Healthcare ecosystem. Join us for an engaging DIAmond session featuring esteemed panelists from technology companies, pharmaceuticals, patient advocacy groups, and academia/research to delve into how we can leverage the momentum of AI while establishing a foundation of trust. In this session, we will address the following questions: • How is the health care data landscape evolving in conjunction with AI, and what implications does it hold in terms of opportunities and concerns for our stakeholders? • What expectations do stakeholders have of us as leaders in ensuring ethical innovation? • What emerging practices, supported by real examples and lessons learned, are paving the way for the integration of ethical considerations into actionable strategies? • Where should we seek cross-sector partnerships to further propel momentum and establish standards for the ethical and responsible deployment of AI? Let us unite in paving the way towards a future where innovation is fueled by trust, driven by the responsible utilization of our burgeoning capabilities.

Learning Objectives

Define responsible innovation and ethical use of artificial intelligence (AI) in health care and life sciences; Explore the intersection of ethical considerations with technological advancements; Examine the role of cross-sector partnerships in driving trusted and responsible AI use.

Chair

Martin Hodosi, MSc

Speaker

Panelist
Junaid Bajwa, MD, MBA, MSc, FRCP

Panelist
Karla Childers, MS

Panelist
Dave deBronkart



Speakers
avatar for Martin Hodosi

Martin Hodosi

Partner, Healthcare and Life Sciences Practices, Kearney, United Kingdom
More than a decade of experience in Strategy Consulting across sectors, with 8+ years across value chains in Pharmaceuticals, MedTech and Life Sciences. Focused on helping biopharma Research & Development (R&D) leaders bring superior treatments to patients more quickly by transforming... Read More →
avatar for Junaid Bajwa

Junaid Bajwa

Practicing Physician, UK’s National Health Service; Chief Medical Scientist, Microsoft Research, United Kingdom
Junaid is the Chief Medical Scientist at Microsoft Research and a practicing physician in the UK’s National Health Service. Junaid has worked across primary care, secondary care, and public health settings in addition to acting as a payer, and policymaker within the UK, where he... Read More →
avatar for Karla Childers

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 →
avatar for Dave deBronkart

Dave deBronkart

Patient Advocate, E-Patient Dave, LLC, United States
"e-Patient Dave" deBronkart is a cancer survivor and former high tech marketer, a founding member of the HL7 FHIR Patient Empowerment Workgroup, the BMJ patient advisory panel, and the Society for Participatory Medicine. He was the Mayo Clinic’s 2015 Visiting Professor in Internal... Read More →


Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  14: DIAmond, Forum
 
Tuesday, June 18
 

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 on Clinical Trials
Kevin Bugin, PhD, MS, RAC

Clinical Trials Transformation Initiative (CTTI): Innovation though collaboration
Sara Bristol Calvert, PharmD

Patient Perspectives on ACT EU: Foundational to Clinical Trial Priorities
Deborah Collyar

Advances in Clinical Trials: WHO update
Marion Laumonier, MSc



Speakers
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 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 →


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

#269: For Whom the Cell Tolls: Ethics in the Era of Precision Medicine
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-601-L04-P; CME 1.00; RN 1.00

This session will discuss how precision medicine will combine medicine and technology in unique ways to maximize healthcare services and outcomes. At the heart of the issue lie ethical concerns related to privacy, informed consent, and social justice.

Learning Objectives

Analyze latest ethical expectations and challenges; Discuss potential future innovation platforms providing significant benefit to be gained from precision medicine; Recognize the bioethical challenges and opportunities ahead.

Chair

James Wabby, MHS

Speaker

Bioethics Cases and Policy Development
Terry Church, DrSc, MA, MS

Ethical Frontiers: Navigating Transplant and Genetic Ethical Considerations in Patient Care
Amanda Burkhardt, PhD



Speakers
avatar for Amanda Burkhardt

Amanda Burkhardt

Assistant Professor, Alfred E. Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States
Prior to joining USC Mann faculty, Amanda M. Burkhardt was an adjunct assistant professor at the University of California, Irvine, in the School of Medicine, Department of Physiology & Biophysics; and lecturer in the Department of Biological Sciences at California State University... Read More →
avatar for Terry Church

Terry Church

Assistant Professor, Alfred E Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States
Dr. Terry David Church is currently an Assistant Professor in Regulatory and Quality Sciences at the University of Southern California, Mann School of Pharmacy and Pharmaceutical Sciences. He is Assistant Director of Pharmacy Undergraduate Programs. Prof. Church's academic focus is... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →


Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  06: TranslationalDelivery Tech-PrecMedicine, Forum
  • Format Forum
  • Level Basic
  • Featured Topics Ethics
  • Level Basic
  • Feature Topics Ethics
  • Credit Type ACPE, CME, RN
  • Tags 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 →
avatar for Sara Reed

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

#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
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 →
avatar for Karla Childers

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 →
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 →
CO

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 →
avatar for Catina O'Leary

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

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
avatar for Karla Childers

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 →


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

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
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 →
DM

Dezbee McDaniel

CEO/Co-Founder, Clinispan Health, United States
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 →
avatar for Jane Myles

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
 

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