Loading…
or to bookmark your favorites and sync them to your phone or calendar.
arrow_back View All Dates
Wednesday, June 18
 

8:30am EDT

Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

Reporting of safety reports to FAERS using ICH E2B (R3) format. The presenters will discuss scenarios, system readiness, testing approach, challenges and lesson learned for a successful implementation and onboarding.

Learning Objectives

Recognize that FDA is live with E2B R3 standard and will require reporting of Investigational New Drug (IND) and postmarket safety reports to be submitted to FAERS. Describe how to prepare and be ready to submit electronically. Understand reporting scenarios, system readiness, testing approach, challenges and lesson learned both from FDA’s and industry’s perspective.

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

8:30am EDT

From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Forum
Level: Basic

This session explores adverse event collection, processing, and actioning fundamentals as critical for integrating patient safety within teams, organizations, and the broader clinical research and patient care ecosystems.

Learning Objectives

Propose improvements within the drug safety landscape to adverse event reporting, processing, decision-making, and communication; Appraise stakeholder roles in protecting patients and promoting public health; Discuss opportunities for adverse event stakeholders to collaborate across the health care continuum (clinical development, safety, advocacy) to converge clinical research and clinical ca

Chair

Allison Cuff Shimooka, MBA

Speakers
avatar for Allison Cuff Shimooka

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States
Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

8:30am EDT

Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Forum
Level: Intermediate

This session will share healthcare professionals' (HCP) perceptions about participating in clinical research as non-investigators. We will address the challenges and opportunities for HCP participation, aligned to the FDA guidance on DCTs as well as Point of Care Trials.

Learning Objectives

Analyze healthcare professionals' (HCPs) perceptions, both positive and negative, about participating in clinical research; Evaluate which routine care trial assessments HCPs might conduct as part of trials and assess study fit; Identify key strategies to engage HCPs in trial participation without requiring them to become investigators; Share resources to assist teams in navigating regulatory documentation.

Chair

Jane Myles, MSc

Speakers
avatar for Jane Myles

Jane Myles

Program Director, Decentralized Trials and Research Alliance
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 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

8:30am EDT

Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Efficiencies and Regulatory Review
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Basic

This session will provide an update on recent industry initiatives to transform towards a data-centric protocol, demonstrate real use cases leveraging digital protocol information, and share thoughts on how to prepare for the change required.

Learning Objectives

Understand how various digital protocol collaborations are working together including ICH M11, Transcelerate/CDISC Digital Data Flow, and the HL7 Vulcan Unified Digital Protocol; Demonstrate the digital protocol in action from design through regulatory review; Prepare for the implementation and change management required to realize the benefits of a digital protocol.

Chair

Chris Decker, MS

Speaker

Transforming the Study Protocol from a Document-Centric to a Data-Centric World to Enable AI, Drive Automation, and Design Be
Chris Decker, MS

Preparing for ICH M11: Am I Prepared?
Robert DiCicco, PharmD


Speakers
avatar for Chris Decker

Chris Decker

President and Chief Executive Officer, CDISC, United States
Chris is recognized industry wide as a leading technology and standards expert for designing, developing, and implementing complex process and technology solutions. He brings years of experience serving in various executive-level positions across software development, clinical research... Read More →
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. Rob joined TransCelerate from IBM Watson Health where he was the Deputy Chief Health Officer. At IBM he worked closely with software designers and developers to inform product roadmaps. Rob also... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

8:30am EDT

Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

Poor study management, misconduct, and data falsification threaten regulatory decisions on product safety and efficacy. This session will cover regulatory guidelines and case studies of clinical trial electronic systems, risk assessment strategies.

Learning Objectives

Describe regulatory expectations for electronic systems in clinical trials, including electronic health records (EHRs); Examine criteria for evaluating whether these systems are suitable for trials. Discuss methods for identifying and mitigating fraud and misconduct risks in these systems; Understand case studies of fraud and mismanagement to emphasize the need for thorough risk assessments.

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

8:30am EDT

How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

This session will exemplify the complexity of regulatory frameworks for PACs based on an IFPMA/Clarivate study. An expert panel from industry and agencies will discuss potential solutions and lessons learnt on reliance implementation for PACs

Learning Objectives

Explain the different regulatory frameworks for PACs compared to WHO and EMA; Understand lessons learnt from reliance implementation for PACs to facilitate supply of medicinal products.

Chair

Lesbeth Caridad Rodriguez, MS

Speakers
LR

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

8:30am EDT

Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate

Experts representing industry, non-profit, research, regulatory, and payor perspectives will explore key hurdles and solutions to rare disease treatment development, from recruitment and diagnosis to late-stage development and access after accelerated approval.

Learning Objectives

Identify hurdles and solutions to clinical trial recruitment, incl. early diagnosis and newborn screening; Explore approaches to patient stratification, disease understanding, and novel biomarkers, while de-risking late-stage development in competitive and high-failure landscapes; Examine challenges of market access and pricing after accelerated approval, and gain insights into addressing payer-specific concerns to ensure equitable access.

Wednesday June 18, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  14: DIAmond, Session

8:30am EDT

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Wednesday June 18, 2025 8:30am - 9:30pm EDT
TBD
Component Type: Session
Level: Intermediate

The session reports the CIOMS WG XII Benefit-Risk Balance for Medicinal Products that formulates key principles for lifecycle benefit-risk assessments to inform decision-making and further the development of medicines that patients need.

Learning Objectives

Provide an update on Benefit-Risk Balance for Medicinal Products issued by CIOMS WG XII; Learn about the conduct of high quality, balanced and comprehensive lifecycle benefit-risk assessments using the structured benefit-risk framework; Provide strategic guidance patient-centric benefit-risk assessment methodologies to improve transparency and understanding amongst key stakeholders.

Chair

Claudia Ana Ianos, MD

Speaker

speaker
James Buchanan, PharmD


Speakers
avatar for James Buchanan

James Buchanan

President, Covilance LLC, United States
Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and... Read More →
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Senior Director, Safety Risk, Pfizer Inc, Switzerland
Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 12 years of... Read More →
Wednesday June 18, 2025 8:30am - 9:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

10:30am EDT

From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

This forum will explore the implications of ICH M14, focusing on practical approaches to using its data sources. Participants will examine how ICH M14 impacts various stakeholders and how collaboration between these groups can be enhanced.

Learning Objectives

Discuss and demonstrate the operational implications of ICH M14; Illustrate simplified and more practical approaches for utilizing the data sources introduced in ICH M14; Differentiate how ICH M14 impacts multiple industry stakeholders, including big pharma, small pharma, CROs, and data network providers.

Chair

William Blumentals, PhD

Speakers
WB

William Blumentals

Head of Pharmacoepidemiology, Specialty Care, Sanofi, United States
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

10:30am EDT

Trustworthy AI Solutions for Next-Generation Pharmacovigilance
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

Despite advances in AI and Generative AI, its routine use in pharmacovigilance (PV) and high-risk applications is limited. This session will explore what’s needed to enable trusted use, highlighting technical challenges with multistakeholder input.

Learning Objectives

Demonstrate and discuss how Generative AI can facilitate the future approach in augmenting PV systems in a trusted, compliant, and transparent manner; Summarize the opportunities and challenges with such an approach.

Chair

Jens-Ulrich Stegmann, MD, RN

Speakers
avatar for Jens Stegmann

Jens Stegmann

Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV, GSK
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Forum

10:30am EDT

Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Partnerships are crucial to overcoming the challenges clinical trials face in Africa. We will present the current landscape, provide key pointers on navigating it, and share case studies demonstrating the key importance of involving Africa in trials.

Learning Objectives

Recognize the importance of including Africa in clinical trials; Identify challenges of conducting clinical trials in Africa; Apply knowledge to successfully conduct global clinical trials in Africa.

Chair

Lynda Mante

Speakers
LM

Lynda Mante

Director, Clinical Trial Regulatory Management, IQVIA, Ghana
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

10:30am EDT

Patient Referral: Is It Hope or Hype?
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

This highlights the challenges of using real-world data (RWD) for patient referral in clinical trials, focusing on issues like data variability, lack of investigator training, and insufficient incentives. It proposes strategic solutions to overcome these barriers.

Learning Objectives

Identify innovative strategies for patient recruitment using RWD referrals that challenge existing practices; Propose new methods for integrating naïve sites into the clinical trial process to expand participation; Evaluate the potential impact of broader patient inclusion on clinical trial outcomes.

Chair

Sanghita Bhattacharya, PhD

Speaker

Patient Referral: Is It Hope or Hype?
Barbara Isquith Arone, MS

Patient Referral: Is It Hope or Hype?
Karen Correa, PhD

Patient Referral: Is It Hope or Hype?
Irfan A. Khan, MD


Speakers
avatar for Sanghita Bhattacharya

Sanghita Bhattacharya

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

Irfan Khan

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

Barbara Isquith Arone

Vice President, Evidence Generation for Medical Affairs, IQVIA
Barbara has worked within late phase research for 20+ years, 18 with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →
KC

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim
avatar for Joan Chambers

Joan Chambers

Senior Consultant, Tufts CSDD, United States
As the Chief Operating Officer for CenterWatch, Joan is responsible for the business operations, financial performance, marketing, and sales of the company along with setting strategic direction. Joan's work experience includes: CHI, Tufts CSDD at Tufts University, Thomson CenterWatch... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

10:30am EDT

Research in Participants with Progressive Cognitive Impairment: Best practices for ensuring continuing informed consent
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Advanced

The session will describe informed consent in research participants with cognitive decline, discussing behavioral cues and consent/assent requirements for ethical practices when participants lose the ability to provide informed consent during a study

Learning Objectives

Understand the ethical and operational challenges of engaging participants with cognitive impairment; Describe ethical options for retaining participants with cognitive impairment in clinical trials; Review best practices for informed consent/ caregiver consent/participant assent when the ability to give consent is lost during the course of a trial

Chair

Karla Childers, MS

Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson
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 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

10:30am EDT

Regulatory and HTA Considerations When Using External Evidence to Support Single Arm Trials During Global Drug Development
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Basic

Single Arm Trials (SATs) are an important tool for drug development. The session while focusing on EMA and FDA guidance documents on SATs, will discuss how external information can support the needs and expectations of regulators and HTA globally.

Learning Objectives

Identify the appropriate settings and considerations for using external evidence in designing single-arm trials; Discuss strategies for advancing global drug development with single-arm trials, addressing differing perspectives among regulators and between regulators and HTA representatives.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca
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 →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

10:30am EDT

Leveraging AI and Structured Content Authoring Tools in Regulatory Medical Writing: A 1-Year Look
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Following up on 1-year of use with AI and structured content authoring tools. The implementation of these tools, their successes, pitfalls, and metrics. This session is planned to be a follow up to the 2024 presentation.

Learning Objectives

A comprehensive understanding of the successes achieved through one year of using AI and structured content authoring tools in regulatory medical writing processes; Explain pitfalls encountered along the way as well as the presenting relevant metrics for evaluation and future directions for improvement.

Chair

David Meats, II

Speaker

Speakers
Louise Lind Skov, PhD

Speaker
Eishita Agarwal, MSc


Speakers
DM

David Meats

Director, Regulatory Services Management, Certara
EA

Eishita Agarwal

Digital Innovation Manager, Medical Writing, GSK, India
Eishita, a Biochemistry Master’s graduate, brings 12 years of experience in pharmaceuticals, specializing in Clinical and Regulatory medical writing at GSK for 9 years. Transitioning to Digital Innovation Lead in 2021, she drives collaboration to integrate cutting-edge tech into... Read More →
avatar for Louise Lind Skov

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark
Louise is Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development of innovative... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Session

10:30am EDT

Why Patient Involvement is a Must Have to Ensure Accessibility to Digital Health Technologies and Development of Patient Relevant Clinical Endpoints
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

This session will demonstrate how a patient voice enhances the simultaneous DHT/patient journey to produce potential improvements/efficiencies in patient experience, data capture/quality, equitable access, and site/participant burden

Learning Objectives

Demonstrate the value of patient involvement to improve engagement and user experience in application of DHTs in clinical research; Discuss key issues with accessibility of patient-reported outcome measurements; Explore how to incorporate patient-defined measurements into potential clinical endpoint development to better align with patient experience.

Chair

Stacy Hurt, MBA, MHA

Speaker

Lets Make Sure Accessibility is Considered in ePRO Best Practices: Are We Risking Our Data?
Florence Mowlem, PhD, MSc

Patient Involvement to Improve Use of eCOA in Clinical Trials
Stacy Hurt, MBA, MHA

Patient-Defined Flare Measurement Development in Conditions with Known Flares
Nell Meosky Luo


Speakers
SH

Stacy Hurt

Artist, Ms,Stella O Houligan's Catnip Quilts
FM

Florence Mowlem

Chief Scientific Officer, Umotif, United Kingdom
Flo is an expert eCOA scientist who has spent her career advising and guiding organizations on the electronic capture of COAs and the use of DHTs in clinical trials. She has a deep knowledge of clinical research, study design, and leveraging technology to support it, having worked... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum

10:30am EDT

Navigating the Challenges of Drug Delivery Using a Novel Device
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Explore the evolving regulatory landscape of combination products for the delivery of cell and gene therapies. This session will provide essential insights into the current regulatory frameworks for drug delivery systems.

Learning Objectives

Analyze the regulatory challenges that may exist for novel combination products; Identify regulatory strategies for resolving challenges.

Chair

John Lockwood

Speaker

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Sarah Fairfield, MBA, RAC


Speakers
JL

John Lockwood

Sr. Director, Cencora Pharmalex, United States
John Lockwood, RAC, is the Senior Director of Medical Devices/IVDs for the Americas at Cencora PharmaLex, where he is responsible for managing and expanding Medical Device Services related to quality and regulatory. John has more than 25 years of experience in quality, regulatory... Read More →
avatar for Sarah Fairfield

Sarah Fairfield

Associate Director, RA Device and Combination Products (Digital Device and Softw, AbbVie
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Session

10:30am EDT

Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

This forum will address need for a global development strategy aimed at enhancing patient access to new drugs and maximizing business opportunities in Japan. The panelists will consist of members from pharma industry associations, agency and academia

Learning Objectives

Maximize value of innovative products for the global market including Japan; Apply learnings to clinical development strategy to expand target patients and market effectively; Enhance access to innovative drugs for children and patients with rare diseases; Influence regulators, industry, and trial sites to improve the local environment and reduce burdens in global simultaneous development.

Chair

Toshiharu Sano, RPh

Speakers
TS

Toshihiro Sano

Associate Vice President, Head of Clinical Operations, Merck Sharp & Dohme LLC , United States
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Forum

10:30am EDT

Do Flexible Trial Approaches Impede Data Quality? Perception vs Reality
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Basic

This panel will discuss whether flexible operational approaches like decentralization, embedding trials in clinical practice, and allowing setting adjustments will affect data quality. Real and perceived impediments to data quality will be explored.

Learning Objectives

Identify flexible trial approaches and their benefits and limitations; Assess when flexible trial approaches may impede data quality; Discuss solutions for maintaining data quality.

Chair

Lindsay Kehoe, MS

Speakers
avatar for Lindsay Kehoe

Lindsay Kehoe

Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
Lindsay Kehoe, M.S., C.G.C., is a senior project manager at the Clinical Trials Transformation Initiative (CTTI), where she manages the development and implementation of CTTI projects. She has convened teams around disease progression modeling, embedding trials into clinical practice... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Forum

10:30am EDT

Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Forum
Level: Intermediate

This forum will address the implementation of innovative clinical trial designs. Specific examples will be discussed and regulatory efforts to foster innovation will be examined to identify opportunities to increase stakeholder understanding.

Learning Objectives

Identify precedents and opportunities to adopt innovative trial designs in severe, chronic diseases; Describe and assess regulatory efforts to foster clinical trial innovation; Identify mechanisms to enhance public awareness regarding implementation of clinical trial innovation in drug development.

Chair

Samantha Roberts, PhD

Speakers
SR

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States
Samantha Roberts is a regulatory policy and intelligence expert with over 15 years of experience analyzing and shaping regulatory policies and frameworks. Following a post-doctoral fellowship at FDA CBER, she worked as Director of Scientific Affairs at Friends of Cancer Research and... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

10:30am EDT

Practical Implementation of MRCTs Based on ICH E17 Guidelines
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Hear directly from the regulators and industry about the challenges and opportunities in applying the ICH E17 guidelines. Some cases based on ICH E17 guidelines will be presented in the panel. Panelists will be asked to make comments for each case regarding points to consider in planning or evaluating results (including acceptability for regulatory submission) for each case.

Learning Objectives

Explore how ICH E17 guidelines are being implemented in the conduct of multiregional clinical trials; Evaluate the limitations, gaps, and opportunities for applying the guideline globally.

Speaker

Panelist
William Wang, PhD


Speakers
avatar for William Wang

William Wang

President, Merck & Co, Inc
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

10:30am EDT

Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Lapses in quality have resulted in CLRs, impacting approvals and threatening supply. This session will discuss enhancements to oversight by sponsors/applicants and approaches to improve collaborative problem solving across organizations.

Learning Objectives

Understanding the current state of quality across organizations and trends for delays in regulatory approvals due to cGMP issues; Explain the approaches for enhancing oversight, including quality systems for early detection and correction; Improving contracts, agreements, and expectations between organizations for improved communication and collaborative problem solving.

Chair

Holly Kleinschrodt

Speaker
Patrick Saunders

Speaker
Rosemary Orciari

Speaker
Patrick Saunders


Speakers
HK

Holly Kleinschrodt

Head, Device Quality, Astellas, United States
Holly Kleinschrodt has over 20 years of experience in the medical device and pharmaceutical industry. Her experiences have included Quality Assurance, Manufacturing, and R&D. She has contributed to technologies such as implantable heart valves and rings, consumable infusion sets and... Read More →
RO

Rosemary Orciari

Senior Directory, Reg Intel, Policy and QMS Lead, Pfizer, United States
PS

Patrick Saunders

Senior Director, Quality, Lilly del Caribe, Eli Lilly & Co., United States
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

10:30am EDT

Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

Aftificial Intelligence (AI) is being adopted across the medicine lifecycle to increase insights into data and improve efficiency of processes, for the benefit of public and animal health. This session will address key elements to enable the safe and responsible use of AI.

Learning Objectives

Explore AI opportunities across the medicine lifecycle; Examine the legal ecosystem of AI across jurisdictions and identify opportunities for convergence; Understand how regulators worldwide are developing guidance to support AI innovation in the medicine lifecycle; Discover other strategic AI initiatives, including approaches to leveraging AI with healthcare data.

Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session

10:30am EDT

Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Basic

This interactive workshop designed by a behavioral scientist from Tufts CSDD will provide an experiential learning experience covering levers that can enhance leadership effectiveness using an inclusive leader framework.

Learning Objectives

Identify specific inclusive leadership behaviors that can enhance individual and team-level outcomes; Learn about the challenges and barriers associated with inclusive leadership practices; Discuss evidence-based ways to practice inclusive leadership that resonate with all employees.

Chair

Jennifer Kim, PhD

Speaker

What's Next for Developing Inclusive Leaders? 
Christine Mayer-Nicolai, PharmD

Challenges of Leading Inclusively in Cross-Functional, Mixed Teams
Tamei Elliott, MS


Speakers
avatar for Jennifer Kim

Jennifer Kim

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

Christine Mayer-Nicolai

Vice President, Regulatory and Scientific Policy, Merck Healthcare KGaA
Dr. Christine Mayer-Nicolai, VP, Regulatory & Scientific Policy at Merck Healthcare KGaA, Germany is based in Darmstadt and Washington, DC. She is leading the development of Merck Healthcare regulatory policy priorities, identifying, and responding to global regulatory and legislative... Read More →
avatar for Tamei Elliott

Tamei Elliott

Associate Director, Scientific Programs, DIA, United States
Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

1:45pm EDT

Addressing Challenges in Devices Safety Monitoring
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Basic

This session will discuss the challenges in safety surveillance for medical devices relating to incident capture, data standards and terminologies. Looking at the impact on signal detection and how these barriers can be overcome to improve patient safety.

Learning Objectives

Describe challenges and barriers in the capture of adverse incident data for medical devices; Discuss novel approaches to enhance signal detection for medical devices; Assess opportunities for better ways of working across different stakeholders in device vigilance activities.

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

1:45pm EDT

AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

This session will review the 3Rs (replacement, refinement, reduction) of animal use in non-clinical drug development research, and how new technologies including AI, Victorian Clinical Genetics Services (VCGs) and organoids are introducing innovative ways to meet these ethical principles.

Learning Objectives

Understand the “3Rs” (replacement, refinement, reduction) of ethical animal use in non-clinical drug development research; Review how new technologies including AI, VCGs and organoids are being explored to follow these ethical principles as part of the overall drug development program.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Julie Frearson


Speakers
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting
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 →
JF

Julie Frearson

Senior Vice President, Chief Scientific Officer, Charles River Laboratories, United States
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

1:45pm EDT

Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Japan's regulatory authorities have enacted various measures to strengthen drug R&D and accelerate clinical development, particularly for regenerative medicine, pediatric, and orphan drugs, offering great prospects for biopharma/ biotech companies.

Learning Objectives

Examine PMDA's efforts to address Japan's drug lag and promote an accelerated clinical development environment; Evaluate the trial landscape and analyze the challenges in developing Regenerative Medicine, Orphan, and Pediatric drugs in Japan; Develop strategies for Japan to engage in multi-regional trials, considering the unique aspects of conducting clinical studies in the country.

Chair

Edward C. Ian, MBA

Speakers
avatar for Edward Ian

Edward Ian

Senior Executive Officer, Mediscience Planning Inc., Japan
Edward Ian began his career as a lab. scientist and expanded his work into clinical development. His extensive experience with multinational companies in APAC and the US has made him a seasoned executive with expertise across a wide range of areas within the clinical research and... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

1:45pm EDT

ICH Pharmaceutical Quality Knowledge Management Platform Global Regulatory Assessment and Industry-Vision to Reality
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

ICH is advancing a global technology platform for multi-region collaborative review for CMC Post Approval submissions and inspections. Industry and regulators will discuss the platform’s governance, security, financing, and operations and outlook.

Learning Objectives

Explain the drivers, purpose, and plan for the ICH hosted PQKM Collaboration Platform in your organization; Describe the platform operating framework under ICH including goveranance and operation for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.

Chair

David C. Isom

Speakers
DI

David Isom

Senior Director, Global Regulatory Policy and Intelligence, Pfizer Global Produc, Pfizer Inc
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

1:45pm EDT

Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

As Asia’s post-marketing surveillance evolves with the use of RWD, aligning these changes with US and European frameworks is essential. This session will cover Asia’s regulatory shifts and provide insights for global harmonization efforts.

Learning Objectives

Evaluate how the integration of RWD into post-marketing surveillance has improved safety monitoring and formulate strategies for applying these practices within your own organization's regulatory and safety frameworks; Analyze case studies on PMS in Asia to propose actionable approaches for implementing database-driven RMP systems in your organization, enhancing selective safety measures.

Chair

Juyoung Shin, PharmD, MPH

Speakers
avatar for Juyoung Shin

Juyoung Shin

Professor, College of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

1:45pm EDT

Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Industry leaders explore how biopharma is leveraging data foundations and technological advancements, including AI/ML, to improve access and representation in clinical trials, moving from DEI planning to tangible progress in clinical research.

Learning Objectives

Identify key areas where tech and analytics facilitate health equity advancement, focusing on achievable, tech-enabled outcomes; Illustrate concrete use cases where tech and data can support equitable clinical research, such as community outreach, recruitment, and measurement against diversity action plans; Discuss non-technical success factors needed to wholly support data-driven tech

Chair

Katrina Rice, MS

Speakers
avatar for Katrina Rice

Katrina Rice

Chief Delivery Officer, Data Services, eClinical Solutions, United States
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 20 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

1:45pm EDT

Evolving Regulatory Considerations for Medical Affairs Communications
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Intermediate

This session will cover FDA developments relevant to Medical Affairs activities, including guidance and enforcement on sharing "scientific information about unapproved uses" (SIUU), responding to medical misinformation, and presenting efficacy data.

Learning Objectives

Identify recent FDA policy developments that are relevant to common Medical Affairs activities; Assess potential legal/regulatory risk of current and new Medical Affairs activities in light of these developments.

Chair

Torrey Cope, JD

Speakers
avatar for Torrey Cope

Torrey Cope

Partner, Sidley Austin LLP
Torrey Cope advises clients on a wide range of FDA regulatory issues. He is an experienced regulatory lawyer who regularly works on legal matters involving good clinical practice (GCP) and other requirements for clinical trials, marketing authorization, promotion, good manufacturing... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  04: MedAffairs-SciComm, Forum

1:45pm EDT

Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Intermediate

This panel discussion explores the diverse strategies employed by organizations in managing their portfolio across the value chain. Experts will discuss how systems, tools, benchmarks and visualizations are utilized to enhance decision-making.

Learning Objectives

Describe the different Portfolio Management approaches used across the pharmaceutical value chain in organizations of varying size; Outline success factors for effective Portfolio Management within your own organization.

Chair

Erin Mulrooney, MSc, PMP

Speakers
EM

Erin Mulrooney

Director, Portfolio Management, Daiichi Sankyo, Inc
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  07: ProjectManagement-StrategicPlanning, Forum

1:45pm EDT

Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Overview of risk assessment methodologies used by regulatory authorities to decide on pharmacovigilance inspection planning and frequency including collaborative efforts to learn, develop and collaborate on current processes.

Learning Objectives

Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

1:45pm EDT

Africa's Evolving Regulatory Landscape
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

Dialogue between key stakeholders on AMA operationalization, proposals on improved collaboration, regulatory harmonization and convergence, reliance pathways and other strategies for an efficient and sustainable regulatory system in the continent.

Learning Objectives

Evaluate progress made on AMA operationalization including achievements so far with the support of partners; Discuss key insights and lessons from the Continental Pilot; Identify the way forward for successful implementation of revised AU Model Law; Cultivating a sustainable regulatory ecosystem in Africa employing good regulatory practices and agilities as well as prioritizing capacity building.

Chair

Saba Berhane, BSN, MPharm

Speakers
SB

Saba Berhane

Manager, Regulatory Affairs, IFPMA, Switzerland
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

EMA Town Hall
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Intermediate

In this session, leaders from the EMA will provide an update on regulatory priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Describe EMAs regulatory initiatives and strategic priorities; Identify opportunities for engagement with the regulators.

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

Innovative Operating Models in Regulatory Affairs Driving Value, Efficiency, and Success
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Advanced

Operating models and company’s culture can affect an organization’s value and efficiency. This session will delve into Regulatory Affairs operating models, including opportunities and challenges, providing best practices for your organization.

Learning Objectives

Compare and contrast operating models being used by regulatory affairs organizations that are driving greater value, efficiency, and career empowerment; Understand successes and challenges with different operating models.

Chair

Alison Maloney, PhD, MBA, MS

Speakers
avatar for Alison Maloney

Alison Maloney

Head of Regulatory Affairs Americas, Bayer HealthCare Pharmaceuticals, United States
Alison Maloney is currently the Head of Regulatory Affairs Americas for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

1:45pm EDT

Potency Measurements for Cellular and Gene Therapy Products
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Advanced

This session will offer a comprehensive overview of the FDA’s expectations for potency testing, and insights into industry practices. It will explore how regulatory flexibility concerning potency can facilitate and accelerate the development process.

Learning Objectives

Gain Insight into the global regulatory landscape on potency requirement for CGT products; Understand the latest FDA’s guidelines regarding potency testing and industry perspectives; Explore the Role of Surrogate Assays enhancing the overall potency assurance strategy; Learn from Industry Peers: Examine the approaches adopted by members of BIO companies to meet regulatory expectations.

Chair

Lesbeth Caridad Rodriguez, MS

Speakers
LR

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

1:45pm EDT

Unleash the Potential of Synthetic Data and Digital Twins Using AI to Accelerate Medical Product Development
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Session
Level: Basic

This session aims to explore the potential, innovative and safe applications of these technologies in the realm of drug and medical device development, featuring speakers from health authorities, academia and/or industry.

Learning Objectives

Describe what synthetic data and digital twins are; Apply AI to generate synthetic data and digital twin; Illustrate the potential of synthetic data and digital twins in medical product development.

Chair

Di Zhang, PhD

Speakers
DZ

Di Zhang

Associate Director of RWE Statistics, Teva, United States
Di Zhang is the Associate Director of RWE Statistics and Data Science at Teva Pharmaceuticals. Her research interests include causal inference, RWE study designs and methods, the utilization of machine learning in clinical trials and real-world applications and leveraging real-world... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session

1:45pm EDT

Transforming Industry through Mentorship
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD
Component Type: Forum
Level: Basic

This panel discussion will offer valuable insights and practical strategies for organizations looking to implement or refine mentorship programs that drive professional development, organizational cohesion, and a culture of continuous learning.

Learning Objectives

Analyze how mentorship reduces silos and evaluate its impact on engagement, retention, and growth; Learn how to assure success of mentoring programs through clear roles and responsibilities; Illustrate examples fostering collaboration; Summarize mentorship evolution via success stories; Differentiate reverse mentorship's role in reducing hierarchies.

Chair

Carol Morales

Speakers
CM

Carol Morales

Lead, Quality Management and Capabilities, Astellas, United States
Carol Morales is a Quality Management and Capabilities professional at Astellas, leading the QA Astellas Professional Development Program, which includes the Chicago State University Pharm D Rotation and Mentor Intensive Program. With extensive experience in business development... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Forum

2:45pm EDT

Workshop: AI in Healthcare (Industry and Regulators)
Wednesday June 18, 2025 2:45pm - 3:45pm EDT
TBD
Component Type: Workshop
Level: Intermediate

The healthcare industry is rapidly transforming with AI, necessitating new regulations for its use in drug development. This session proposes collaboration between pharma, biotech, and regulators to co-create a framework ensuring AI-driven innovation

Learning Objectives

Understand the key challenges and regulatory considerations in scaling AI-driven solutions for drug development in healthcare. Explore strategies for effective collaboration between pharma, biotech, and regulatory bodies to create a unified AI framework. Identify actionable steps to ensure AI integration in healthcare is safe, transparent, and compliant with evolving regulations.

Chair

Sridevi Nagarajan, PhD, MS, MSc

Wednesday June 18, 2025 2:45pm - 3:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Workshop

4:00pm EDT

Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

This session aims to explore the application of AI to drug labeling to enhance pharmacovigilance, reduce medication errors, and improve patient safety. Presenters will discuss the complexities and share real examples from both end-user and technology perspectives.

Learning Objectives

Discuss opportunities to apply artificial intelligence (AI) to drug labeling to enhance labeling review, surveillance activities, and medication error reduction; Identify the complexities and barriers to applying AI techniques to modernize labeling-related activities.

Chair

Jim W. Barrett, PhD, MSc

Speaker

The Present and Future of Product Labels for Post Marketing Surveillance
Jim W. Barrett, PhD, MSc


Speakers
JB

Jim Barrett

Senior Data Scientist, Uppsala Monitoring Centre (UMC), Sweden
Jim is a senior data scientist at Uppsala Monitoring Centre (UMC), where he has worked for the past 4 years. In that time, Jim has worked on several projects including advanced signal detection methods, tools to facilitate analysis of large case series and NLP methods for mining structured... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

4:00pm EDT

Examining Bias in Lung Cancer Study Protocols: Lessons Learned
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

This session will be based on a recent Tufts Center for the Study of Drug Development (CSDD) study that examined lung cancer studies to examine how and whether exclusion criteria could hinder the participation of racial minority patients. The panel will feature experts from the Tufts CSDD tea

Learning Objectives

Identify areas within a study protocol where bias can manifest to adversely exclude marginalized patient populations; Discuss approaches, strategies, and lessons-learned to help de-bias protocol design.

Chair

Jennifer Kim, PhD

Speaker

Overcoming Re-Design Efforts of Study Protocols
Kim Ribeiro, MS


Speakers
AD

Abigail Dirks

Data Scientist, Tufts CSDD, United States
Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →
avatar for Jennifer Kim

Jennifer Kim

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

Kim Ribeiro

Chief Client Officer, Inside Edge Consulting Group, United States
Kim Ribeiro, MLS (ASCP) CM, MS, has over 10 years of clinical trial patient experience with her most recent position being at AbbVie. She has a strong focus on strategy development for patient engagement, recruitment and retention planning as well as digital outreach and raising clinical... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Session

4:00pm EDT

Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

We’ve all heard the hype around emerging technologies and what it means for our industry, but when it comes down to adding value on the ground today, what advancements are actually making a difference in drug discovery, development, and distribution?

Learning Objectives

Describe and explain the advancements in data analytics and emerging technologies that are adding value to biopharma companies today.

Chair

Jessica Federer, MPH

Speakers
avatar for Jessica Federer

Jessica Federer

ex-CDO, Bayer AG, United States
Jessica is an investor and board member adept at deploying technology to make meaningful advancements for both business and society. She was one of the first Chief Digital Officers in the pharma industry, leading the digital transformation for Bayer A.G. across the Pharmaceutical... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Forum

4:00pm EDT

Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

Data privacy has been a long-standing challenge for RWD sharing and evidence generation across geography. This session will discuss privacy-preserving approaches that enable data access, sharing and collaboration in industry, academia and regulatory

Learning Objectives

Outline privacy-preserving approaches for accessing and sharing real-world data (RWD); Share use cases leveraging various applications (e.g., federated learning networks, synthetic data) in industry, academia and regulatory for RWE generation; Examine regulatory perspectives, methodological challenges and identify future development needs.

Chair

Echo Wang, DrPH, MPH

Speakers
EW

Echo Wang

Director, Outcome Research, Merck Co., United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  03: Data-Tech, Session

4:00pm EDT

Collaborating for Equity: The FDA OMHHE REACH Consortium's Partnership with Federally Qualified Health Centers and Community Health Workers
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

Federally Qualified Health Centers and Community Health Workers are vital in reaching underserved populations, often serving as the first point of contact for healthcare in these communities. By partnering with these trusted entities, the REACH Consortium can bridge the gap between clinical research and underrepresented groups, ensuring that clinical trials are more inclusive and reflective of the populations they aim to serve. This session is crucial as it highlights the role of grassroots partnerships in advancing health equity and showcases effective models that can be replicated in other regions.

Learning Objectives

identify key components of the partnership between the REACH Consortium, FQHCs, and CHWs; Leverage the strengths of Federally Qualified Health Centers and Community Health Workers to effectively raise awareness and promote participation in clinical trials among underrepresented populations; Foster greater inclusivity and accessibility for diverse populations in clinical research.

Chair

Perla Nunes

Speakers
avatar for Perla Nunes

Perla Nunes

Patient Advocate, Community Outreach and Clinical Research DEI Consultant, United States
Ms. Nunes' research career began at Hoffmann-LaRoche, where she worked in drug discovery. In NC she worked in at at the Cannon Research Center of Atrium Health focusing on preclinical and clinical research areas related to oncology and immunology. She worked at Duke University's CTSI... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Forum

4:00pm EDT

Successful Patient Input to Regulatory and Health Technology Assessment Processes Along the Development Path: Examples of How to Optimize Impact
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

To guide patient focused drug development, patient input is sought by regulators and Health Technology Assessment (HTAs) in different ways around the world. The session will explore options to increase impact on development through greater coordination and information sharing.

Learning Objectives

Understand different options and processes for patient input into regulatory and HTA advice across key product development milestones. Explore best practices in maximising the overall impact of patient input on development plans. Identify policy and process changes that would allow continuous improvement and learning across the various set pieces for patient engagement.

Chair

Adam Heathfield, PhD

Speakers
avatar for Adam Heathfield

Adam Heathfield

Senior Director, Patient and Health Impact, Pfizer
Adam has worked for Pfizer for over 10 years. His current role is Senior Director in Pfizer’s Patient and Health Impact division. Previously, Adam has worked in Pfizer’s international policy division and led Pfizer’s work on science policy in Europe for several years. Adam initially... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  05: Patient-Impact-Product-Dev, Session

4:00pm EDT

Quality Briefs from Inception to Operationalization: How to Engage Internal Stakeholders
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

There is an opportunity to inspire and engage internal stakeholders on the value proposition of the Quality Brief. Sponsors will weigh in on the challenges and opportunities related to the value of the Quality Brief for their internal stakeholders.

Learning Objectives

Understand the internal value proposition for the Quality Brief and its application throughout the QMS and beyond; Apply different tactics to persuade and engage internal stakeholders on the value and application of the Quality Brief.

Chair

Kiernan Trevett, MSc

Speakers
avatar for Kiernan Trevett

Kiernan Trevett

Quality Policy Lead, Genentech, A Member of the Roche Group
Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP... Read More →
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
avatar for Jennifer Emerson

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany
Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session

4:00pm EDT

Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

This session will provide an opportunity for key stakeholders, including regulators, product developers and patients to discuss best practices around patient experience data, including planning, collecting, and submitting such data to regulators.

Learning Objectives

Become familiar with current expectations for regulator/sponsor interactions related to patient experience data that will be used in regulatory submissions; Understand common pitfalls for submission of patient experience data in regulatory applications, and how to avoid them.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

4:00pm EDT

Beyond Weight Loss: Pioneering the Future of Obesity Drug Development
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

This forum on obesity drug development helps the audience understand the present landscape, participate in discussions on the prevention and treatment of comorbidities, and assess various strategies in enhancing clinical trial efficiency.

Learning Objectives

Understand the present landscape, opportunities, and challenges of obesity drug development; Delve into discussions on the prevention and treatment of comorbidities associated with obesity; Assess various considerations and strategies in enhancing the efficiency of obesity drug development.

Chair

Jingyu (Julia) Luan, PhD

Speakers
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States
Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

4:00pm EDT

FDA Rare Disease Town Hall
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

This annual town hall provides a forum for senior FDA officials to reflect on key trends and discuss opportunities in rare disease drug development and review. Officials answer moderated and audience burning questions facing the work that they do.

Learning Objectives

Describe new FDA programs and initiatives intended to help facilitate development of drugs for rare diseases; Evaluate opportunities for sponsors and patient stakeholders to engage with regulators; Identify current trends in challenges and opportunities facing orphan drug development.

Chair

James Valentine, JD, MHS

Speakers
avatar for James Valentine

James Valentine

Director, Hyman, Phelps & McNamara, PC
James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

4:00pm EDT

International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

Regulators will showcase how working together to advance regulatory science is key for new approaches. Participants will discuss how to efficiently translate drug development tools into practice, how industry and not-for-profits can drive innovation.

Learning Objectives

Learn about the usefulness of engaging in advancing regulatory science tools and subsequent translation into research practice, product development and evaluation; learn about global regulatory convergence and activities towards new regulatory science approaches to enable new products.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

4:00pm EDT

Regulatory Perspectives on the Adoption of Advanced Manufacturing Technologies
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

Advanced manufacturing (AM) can be a tool to strengthen drug manufacturing and supply chain robustness. Regulatory programs are dedicated to facilitating the adoption and regulation of AM technologies to improve drug development and manufacturing.

Learning Objectives

Share regulatory efforts to support advanced manufacturing, including global regulatory developments from EMA and FDA; Describe avenues available to industry and academia to support development of advanced manufacturing technologies; Discuss priority areas for regulatory consideration to promote the adoption of advanced manufacturing technologies.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session

4:00pm EDT

Considerations for Adaptive Design Using Bayesian Methods: An Update on ICH E20
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Advanced

In this session, we will provide a brief overview of the evolving ICH E20 effort with the goal to provide a transparent and harmonized set of principles for the design, conduct, analysis, and interpretation of adaptive clinical trials.

Learning Objectives

Considerations specific to adaptive design using Bayesian methods will be discussed. Opportunities and challenges of using Bayesian methods in the regulatory setting will also be highlighted.

Chair

Amy Xia, PhD

Speakers
AX

Amy Xia

Vice President, Biostatistics, Design, and Innovation, Amgen Inc.
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Session

4:00pm EDT

Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

Regulatory, industry, and academic organizations discuss modern approaches to clinical drug development by describing novel methods and use cases integrating real-world data and AI to generate real-world evidence, with focus on oncology.

Learning Objectives

Discuss global regulatory guidance and frameworks supporting innovative designs using real-world data as well as approaches to inclusion of artificial intelligence (AI); Describe innovative approaches and statistical methods for use of hybrid trial designs and examples of AI informed studies for clinical decision making; Discuss areas of current need and promote community collaboration.

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  11: Statistics-Data Science, Forum

4:00pm EDT

Business Agility: Applying Strategic and Critical Thinking to Recognize Global Business Environment and Adopt Strategies
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Session
Level: Intermediate

The session aims to enhance the participant's ability to recognize the global business environment, focusing on critical factors influencing business strategy. We will illustrate adopting business and regulatory strategies to evolving landscapes.

Learning Objectives

Identify key factors and trends influencing the biotechnology and pharmaceutical industries; Evaluate the impact of these trends on business and regulatory strategies; Propose strategic adaptations to address evolving industry and regulatory challenges.

Chair

Lawrence Fine, PhD, MBA

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session
 
  • Filter By Date
    Jun 9 - 19, 2025
    June 2025
    SunMonTueWedThuFriSat
    1234567
    891011121314
    15161718192021
    22232425262728
    2930 
  • Filter By Venue
    Washington, D.C., USA
    All
    TBD
    Virtual
  • Filter By Type
    01: ClinSafety-PV
    All
    Forum
    Session
    02: ClinTrials-Ops
    All
    Forum
    Session
    Tutorial
    Workshop
    03: Data-Tech
    All
    Forum
    Session
    Tutorial
    Workshop
    04: MedAffairs-SciComm
    All
    Forum
    Session
    05: Patient-Impact-Product-Dev
    All
    Forum
    Session
    06: PersonalizedMed-ComboProd-Diagnostics
    All
    Forum
    Session
    Tutorial
    07: ProjectManagement-StrategicPlanning
    All
    Forum
    Session
    Tutorial
    08: RD-Quality-Compliance
    All
    Forum
    Session
    Tutorial
    09: Regulatory
    All
    Forum
    Session
    Tutorial
    10: RegCMC-Product Quality
    All
    Session
    Tutorial
    11: Statistics-Data Science
    All
    Forum
    Session
    Tutorial
    12: ProfDevelopment
    All
    Forum
    Session
    Tutorial
    Workshop
    13: Spotlight
    All
    Forum
    Session
    14: DIAmond
    All
    Forum
    Session
    20: Short-Courses
    All
    Tutorial
  • Format
    Forum
    Session
    Tutorial
    Workshop
  • Level
    Advanced
    Basic
    Intermediate
  • Timezone
Share Modal

Share this link via

Or copy link

Filter sessions
Apply filters to sessions.
Filtered by Date - 
Clear filter
Monday, June 9
Tuesday, June 10
Wednesday, June 11
Thursday, June 12
Sunday, June 15
Monday, June 16
Tuesday, June 17
Wednesday, June 18
Thursday, June 19
TBD
Virtual
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 20: Short-Courses
  • Format
  • Forum
  • Session
  • Tutorial
  • Workshop
  • Level
  • Advanced
  • Basic
  • Intermediate