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Tuesday, June 16
 

1:45pm EDT

#530: The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-570-L04-P; CME 1.25; RN 1.25

This pilot explored using synthetic AI patient personas to review clinical trial materials when real patient input was challenging due to time pressure. Alignment with actual patient feedback and potential for scalability was demonstrated.

Learning Objectives

Describe how synthetic AI patient personas can augment real patient input to personalize and improve patient trial experience; Identify the data requirements and limitations for building synthetic AI personas.

Chair

Robina Weermeijer

Speaker

Panelist
Jason Binder, MA

Panelist
Himanshu Manchanda, PHD

Panelist
Sabina Kineen


Speakers
JB

Jason Binder

Founder & CEO, Ember, United States
Jason Binder is the Founder and CEO of Ember, building the first continuous, real-world dataset of patient and caregiver decision-making in oncology. A former pharma data and clinical strategy leader with experience at AstraZeneca, Genentech, and Merck, he focuses on integrating AI... Read More →
avatar for Sabina Kineen

Sabina Kineen

Lived Experience Expert, Fabry Support & Information Group, United States
Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →
HM

Himanshu Manchanda

Machine Learning Scientist, Bayer, Germany
RW

Robina Weermeijer

Boehringer Ingelheim, Netherlands
Robina Weermeijer is a Trial Patient & Site Engagement Lead within Global Clinical Development Operations, based in Amsterdam. With a strong focus on enhancing patient and site experiences in clinical trials, she works to elevate patient and site voices. In addition, she plays a key... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   03: Data-Tech-AI, Session

1:45pm EDT

#533: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-573-L04-P; CME 1.25; RN 1.25

AI pilots are everywhere; enterprise impact is rare. Governance separates AI that works once from AI that works reliably. Join pharma, regulator, and tech leaders to explore how data ownership, content models, and process controls enable trustworthy AI.

Learning Objectives

Explain why scalable AI requires foundational data, content, and process governance; Design governance mechanisms that align data standards (IDMP, CDISC) with structured content management principles; Evaluate regulatory expectations and industry hurdles related to data integrity, reliance, and trust in AI-driven or assisted processes; Assess and address organizational gaps that limit AI deployment.

Chair

Vanni Carapetian, MPH

Speaker

Industry Perspectives on AI + Governance: Policy
Andrew Robertson, JD, PHD

Industry Perspectives on AI + Governance: Tech
Jeff Steinke

Industry Perspectives on AI + Governance
Vada Perkins, MS


Speakers
avatar for Vanni Carapetian

Vanni Carapetian

Senior Director, Regulatory Data, Genentech, A Member of the Roche Group, United States
Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →
avatar for Vanni Carapetian

Vanni Carapetian

CMC RA, Strategy and Operations, Executive Director, Gilead Sciences, Inc, United States
Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
avatar for Andrew Robertson

Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States
Andrew Robertson, PhD, JD, is Vice President and Head of Global Regulatory Policy & Innovation at Takeda. He leads Takeda’s global regulatory science and policy agenda, shaping engagement with FDA, EMA, PMDA, WHO, and other authorities, and guiding strategy on initiatives such as... Read More →
JS

Jeff Steinke

Founder, TE Digital Limited, United Kingdom
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

4:15pm EDT

#547: Increasing Vigilance Transparency: When is the Right Time to Publish Safety Signals?
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-582-L04-P; CME 1.00; RN 1.00

A forum sharing different perspectives from international regulators & patients on when is the right time to publish information on safety signals from spontaneous data. We will explore how we can meet patient needs without leaving unanswered questions.

Learning Objectives

Discuss the challenges and opportunities that could present for patients from having early access to information on safety signals arising from spontaneous data from international regulators; Assess how patient preferences can be evaluated and incorporated in safety monitoring and risk management communications.

Chair

Sarah Vaughan

Speaker

Panelist
Michael Mittelman

Panelist
Peter Hjelmstrom, MD, PHD

Panelist
Lisa Wolf, PHARMD


Speakers
avatar for Peter Hjelmstrom

Peter Hjelmstrom

Director/CEO, Uppsala Monitoring Centre (UMC), Sweden
Peter Hjelmström is the Director/CEO of Uppsala Monitoring Centre (UMC) and he has overall responsibility for the operations of the centre. Peter is physician and scientist, with MD and PhD degrees from Karolinska Institutet, and he did his postdoctoral fellowship at Yale University... Read More →
MM

Michael Mittelman

Chairman, American Living Organ Donor Fund, United States
avatar for Sarah Vaughan

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
avatar for Lisa Wolf

Lisa Wolf

Deputy Director, Division of Pharmacovigilance I, OSE, CDER, FDA, United States
Dr. Lisa Wolf joined the Division of Pharmacovigilance-I (DPV-I), Center for Drug Evaluation and Research, US Food and Drug Administration in 2016, where she served as a Safety Evaluator for gastroenterology products, followed by Team Leader covering multiple therapeutic areas, and... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Forum
  • Audience Basic
  • Area Patient-Centered Design and Experience
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance,Patient Engagement
  • Feature Topics Patient-Centered Design and Experience
  • Tags Forum

4:15pm EDT

#548: Clinical Research Training for Community Cancer Centers: A Pilot to Extend Clinical Trials into Diverse Catchment Areas
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-584-L04-P; CME 1.00; RN 1.00

This pilot project aimed to upskill community cancer centers to carry out clinical trials. ACCC and ACRP identified needs and provided self-study and instructor-led training that improved learner knowledge and confidence.

Learning Objectives

Describe the challenges faced by research-naïve and low trial capacity programs at community cancer centers in conducting clinical research; Recognize the role of professional training in preparing community cancer centers to implement clinical trials; Integrate learnings from a training pilot that helped advance foundational knowledge and confidence among clinic healthcare staff.

Chair

David Vulcano Landis, MBA

Speaker

Panelist
Ruma Bhagat, MPH

Panelist
Pete Fronte, MBA


Speakers
avatar for Ruma Bhagat

Ruma Bhagat

Process Excellence Leader, Genentech, A Member of the Roche Group, United States
avatar for Pete Fronte

Pete Fronte

Founder and Chief Executive Officer, Altura, United States
Pete Fronte, MBA is President/CEO of Altura. During the past 30 years Mr. Fronte has been a leader in developing technology and services to expand clinical study participation for patients and building quality-based research centers within primary care organizations and community... Read More →
avatar for Susan Landis

Susan Landis

CEO, 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 David Vulcano Landis

David Vulcano Landis

CEO, Association of Clinical Research Professionals (ACRP), United States
David is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards and initiatives. He currently serves as the Chief Executive Officer of the Association of Clinical Research Professionals and previously served as the Vice... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Session

4:15pm EDT

#555: Adapting Regulatory Frameworks to Address Mass Distribution of Unapproved or Unauthorized Medicines
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-589-L04-P; CME 1.00; RN 1.00

This forum will address the rise of illegal mass manufacturing of unapproved medicines, which threatens patient safety. Participants will discuss current regulations and the need for new rules to ensure drug supply chain integrity and promote safety.

Learning Objectives

Describe the landscape for the exponential growth in the distribution of unapproved or unauthorized medicines; Identify risks associated with illegal large-scale manufacturing of unregulated and untested compounded drugs; Discuss regulator perspectives on the issues relating to the mass distribution of unapproved medicines; Explain current regulatory frameworks and how to adapt them.

Chair

Brad Jordan, PHD

Speaker

TBD
Shabbir Safdar

Panelist
Andrew Funk, PHARMD, RPH

ANVISA Perspective
Renato Lopes Hurtado, MSC, RPH


Speakers
avatar for Andrew Funk

Andrew Funk

Director, Member Relations/Government Affairs, NABP, United States
Andrew Funk, PharmD, Director of Member Relations and Government Affairs, NABP Andrew Funk is the Director of Member Relations and Government Affairs for the National Association of Boards of Pharmacy (NABP). With more than a decade of experience in pharmacy regulation—including... Read More →
RL

Renato Lopes Hurtado

head the Management of Inspection and Health Surveillance of Medicines and Pharm, ANVISA, Brazil
Manager of the Medicines and Pharmaceutical Ingredients Inspection Department (GIMED) at Anvisa, the Brazilian Health Regulatory Agency. A pharmacist with a Master’s and a PhD candidate (UnB), he is a certified Lead Auditor (ISO 9001/19011). His career features extensive experience... Read More →
avatar for Brad Jordan

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.
SS

Shabbir Safdar

Executive Director, Partnership for Safe Medicines, United States
Shabbir Imber Safdar is the executive director of the Partnership for Safe Medicines and hosts the True Crime and Medicine Safety and the Imitation Nation "all things counterfeit" podcast. He sits on the editorial board of the Journal of Illicit Trade, Financial Crime, and Compliance... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session
 
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