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Monday, June 15
 

11:00am EDT

#402: Future Vigilance Approaches: What Data Sources will have the Biggest Impact on Patient Care?
Monday June 15, 2026 11:00am - 12:15pm EDT
118AB
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-510-L04-P; CME 1.25; RN 1.25

This forum will see different stakeholders discussing what they consider as future priority areas for our vigilance activities and what data sources offer the greatest opportunities for delivering a bigger impact on patient care.

Learning Objectives

Describe the changes in availability and use of different data sources for safety surveillance across the healthcare landscape in the future; Identify the challenges for data collection, monitoring and assessment of safety data from evolving real world use of healthcare products; Discuss the opportunities this represents for vigilance and how to deliver greater impact on patient care.

Chair

Alison Cave

Speaker

Panelist
Phil Tregunno

Panelist
Angela Radcliff


Speakers
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
AR

Angela Radcliff

Lead, Research and Early Development, Digital Performance, Bristol Myers Squibb, United States
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Forum |   03: Data-Tech-AI, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance,Data Management & Data Standards
  • Tags Forum

11:00am EDT

#407: The Great Debate: Using AI in Patient-Facing Materials
Monday June 15, 2026 11:00am - 12:15pm EDT
105AB
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-515-L04-P; CME 1.25; RN 1.25

Artificial intelligence is influencing how pharmaceutical companies plan to develop patient-facing materials (promising faster production, improved readability, and more personalized education) —while also raising questions about accountability, empathy, trust, bias, and accuracy. In this “Great Debate” session, two industry presenters will offer contrasting perspectives on whether AI should directly generate or refine patient communications and will share practical examples of technologies being used today. A patient advocate will ground the discussion in real-world needs and expectations, helping participants leave with actionable guardrails for adopting AI responsibly and keeping patients at the center.

Learning Objectives

Discuss the role of AI in patient-facing materials and practical guardrails; Identify key benefits and limitations of AI-enabled communication workflows in the pharmaceutical industry; Assess ethical and trust considerations for AI-influenced patient communications—such as transparency, bias, inclusivity, empathy, and the potential for misinformation—through both industry and patient-advocate lenses.

Chair

Regina Lynn Preciado

Speaker

The Great Debate: Using AI in Patient-Facing Materials
Christine Marie Von Raesfeld

The Great Debate: Using AI in Patient-Facing Materials
Kimbra Edwards, PHD

The Great Debate: Using AI in Patient-Facing Materials
Irene Kuhlman, MS


Speakers
avatar for Kimbra Edwards

Kimbra Edwards

Senior Director, Health Communication Services, Center for Information & Study on Clinical Research Participation (CISCRP) , United States
Kim Edwards is the Senior Director of Health Communication Services at the Center for Information and Study on Clinical Research Participation (CISCRP). CISCRP is a non-profit organization focused on increasing awareness and understanding of clinical research participation. Kim oversees... Read More →
avatar for Irene Kuhlman

Irene Kuhlman

Global Labeling Strategist, Bayer, Netherlands
After obtaining her MSc in Biomedicine, Irene began her career in various science and health communication roles at non-profit organizations. She then transitioned to Regulatory Affairs, where she worked for 14 years as a local and EU Regulatory Manager at the Dutch Bayer affiliate... Read More →
avatar for Regina Lynn Preciado

Regina Lynn Preciado

VP, Content Strategy Solutions, Content Rules, Inc., United States
Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech... Read More →
avatar for Christine Von Raesfeld

Christine Von Raesfeld

Board member/community liaison, The Light Collective, United States
Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Forum |   03: Data-Tech-AI, Forum
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Medical Affairs & Scientific Communication
  • Feature Topics Artificial Intelligence
  • Tags Forum

11:00am EDT

#409: Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI
Monday June 15, 2026 11:00am - 12:15pm EDT
203AB
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-518-L04-P; CME 1.25; PDU 1.25 PMI 216641I1NS; RN 1.25

In this session, we will focus on the evolving role of the quality assurance professional, show you how to manage your professional development as a project, and build skills to deliver measurable outcomes in the age of AI.

Learning Objectives

Recognize the evolving role of the quality assurance professional in the age of AI and how to align with emerging expectation; Apply project management principles to strategically plan and execute your personal upskilling journey in AI; Discuss how to build a personalized career roadmap using practical tools and frameworks to stay relevant, resilient, and future-ready.

Chair

Michael Pelosi, MA, MBA

Speaker

Smarter Roles, Stronger Skills: AI in Workforce Evolution
Haleh Valian, PHD

Compliance to Competence: How AI and New Regulations Are Reshaping the Quality Professional
Jeremy Jones, MS

Quality in the Age of Agents: A Look Back From the AI-Driven Future
Roshan D'Souza


Speakers
avatar for Roshan D'Souza

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom
Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →
JJ

Jeremy Jones

Director, R&D Quality Operations & Excellence, BeOne Medicines, United States
Jeremy Jones is Director of R&D Quality Operations & Excellence at BeOne Medicines, where he leads R&D Quality Operations & Excellence across global research, clinical development, and pharmacovigilance activities. With over 12 years of leadership experience, he specializes in cross-GxP... Read More →
avatar for Michael Pelosi

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States
Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.
HV

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States
Dr. Haleh Valian is a data-driven executive leader with nearly three decades of experience spanning biotechnology, healthcare, finance, and advanced analytics. She is currently the Director of R&D Decision Quality Analytics and Innovation at Biogen, where she leads the strategic transformation... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session |   09: RD-Quality-Compliance, Session
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Interest Area Health Technology & AI,Quality Assurance / Control & CMC
  • Feature Topics Artificial Intelligence
  • Tags Session

11:00am EDT

#412: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis
Monday June 15, 2026 11:00am - 12:15pm EDT
201AB
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-523-L04-P; CME 1.25; RN 1.25

This session aims to provide a comprehensive analysis of the FDA's practice of publicly posting CRLs. We will examine the past year's data, identify emerging trends, and assess the implications of this transparency initiative.

Learning Objectives

Discuss FDA's process for issuing and publicly posting Complete Response Letters (CRLs); Analyze trends in CRLs over the past year, including common reasons for issuance; Evaluate the benefits and potential drawbacks of public CRL disclosure.

Chair

Lina AlJuburi, PHARMD, MSC

Speaker

Panelist
Eva Temkin, LLM

Panelist
Amanda Conti

Panelist
Eric Gascho


Speakers
avatar for Lina AlJuburi

Lina AlJuburi

Head, Regulatory Science and Policy, North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
avatar for Amanda Conti

Amanda Conti

Senior Research Analyst, Agencyiq By Politico, United States
EG

Eric Gascho

Vice President, CRD Associates, United States
Eric is a Vice President at CRD Associates and the Executive Director of the Coalition for Health Funding, positions he has held since 2024. He has extensive experience in a variety of legislative and regulatory policy issue areas, including federal budget and appropriations, public... Read More →
avatar for Eva Temkin

Eva Temkin

Partner, Arnold & Porter, United States
A partner in Arnold & Porter's Life Sciences and Healthcare practice, Eva provides strategic counsel to clients regarding significant and complex issues associated with FDA-regulated pharma and biotech. Formerly the acting Director for Policy in FDA's Office of Therapeutic Biologics... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Forum

4:00pm EDT

#452: Mentorship Myth Busters: Moving Beyond Misconceptions
Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-547-L04-P; CME 1.00; PDU 1.00 PMI 2166DNFT53; RN 1.00

Mentorship Myth Busters uses a courtroom-style format where attendees vote on mentorship myths and learn from experts. The REAL framework guides participants toward inclusive, flexible, and sustainable mentoring practices.

Learning Objectives

Assess mentorship myths using interactive cases; Differentiate mentorship from management; Apply the REAL framework to build inclusive, flexible, lasting mentoring relationships.

Chair

Carol Morales

Speaker

Mentorship Myth Busters: The Court of REAL Mentorship
Leslie Sam

Mentorship Myth Busters: The Court of REAL Mentorship
Tywnia Brewton

panelist
Sabhorak Horn, PHARMD, MBA, RPH


Speakers
avatar for Tywnia Brewton

Tywnia Brewton

Executive Director, Human Resources, United States
Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →
avatar for Sabhorak Horn

Sabhorak Horn

Medical Omnichannel Education Manager, Eli Lilly and Company, United States
Sabhorak Horn is a licensed pharmacist with a dual degree from the Philadelphia College of Pharmacy. Sabo is driven by his long-term vision of leading innovation in pharma. He is passionate about medical affairs as the bridge between data, people, and real-world impact, with a growing... Read More →
avatar for Carol Morales

Carol Morales

Lead, Quality Management and Capabilities, Astellas, United States
Carol Morales is a Quality Management & Capabilities Lead with a strong focus on professional development, mentorship, and building sustainable learning cultures within the life sciences. She brings extensive experience in designing and leading development initiatives that bridge... Read More →
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session

4:00pm EDT

#457: Understanding the Misconceptions and Myths around Surrogate Endpoints
Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-548-L04-P; CME 1.00; RN 1.00

Explore the science and debate surrounding the FDA’s use of surrogate endpoints in drug approvals, with a focus on their role in addressing unmet medical needs. This session will bring together diverse perspectives to clarify misconceptions.

Learning Objectives

Describe an evidence-based overview of the development and utilization of surrogate endpoints in FDA approvals; Examine the increasing reliance on surrogates, particularly case studies in fields like rare diseases and oncology, where overall survival data may be years away; Discuss ways to incorporate the patient and provider perspective to understand what constitutes “meaningful” endpoints.

Chair

Bridget Doherty, MPH, MS

Speaker

Panelist
Kara Berasi, PHARMD, MS

Panelist
Jenny Myers Ahlstrom

Panelist
Alexis Reisin Miller, JD


Speakers
JA

Jenny Ahlstrom

Founder & CEO/Multiple Myeloma Patient, HealthTree, United States
KB

Kara Berasi

CEO, Haystack Project, United States
Kara Berasi started working in patient advocacy after her son was diagnosed with a rare disease. She has a personal passion to change the landscape of care as it relates to those living with rare diseases. She is the CEO of Haystack Project, an umbrella organization representing over... Read More →
avatar for Bridget Doherty

Bridget Doherty

Director, Access and Policy Research, Johnson & Johnson, United States
Bridget Doherty, MPH, MS, is a strategic policy, research, and communications professional with extensive experience in pharmaceuticals, medical devices, and healthcare publishing. Currently serving as the Director of Access and Policy Research at Johnson & Johnson Innovative Medicine... Read More →
avatar for Mary Thanh Hai

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States
Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →
avatar for Alexis Miller

Alexis Miller

Head, Global Regulatory Policy, MSD, United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Basic
  • Area Evidence Innovation
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Feature Topics Evidence Innovation
  • Tags Forum
 
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DIA 2026 Global Annual Meeting
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
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  • Global Alignment in Practice
  • Patient-Centered Design and Experience
  • Student and Early Career Pathway
  • Therapeutic Pathways
  • Trust and Responsible Innovation