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Monday, June 16
 

12:10pm EDT

#115 CH: Leading Teams Through Organizational Change and Layoffs: Best Practices for Change Management
Monday June 16, 2025 12:10pm - 12:40pm EDT
L Street Bridge
Component Type: Workshop
Level: Advanced

Learn best practices for leading teams through change and layoffs with confidence and empathy. Gain strategies to communicate effectively, maintain morale, and ensure business continuity. Leave with actionable insights to navigate transition.

Learning Objectives

Identify key change management strategies to lead teams effectively through organizational change and layoffs; Demonstrate effective communication techniques to maintain trust, morale, and engagement during transitions; Develop action plans to support employees, minimize disruption, and ensure business continuity.

Chair

Vidya Narayanaswamy, MBA, MSc

Speakers
avatar for Vidya Narayanaswamy

Vidya Narayanaswamy

Senior Consultant, IPM, United States
Vidya Narayanaswamy is a Senior Consultant at IPM, bringing over 12 years of experience across the life sciences industry—from early development through late-stage programs and global regulatory submissions. She holds an MS in Biotechnology and an MBA with a focus on Leadership... Read More →
Monday June 16, 2025 12:10pm - 12:40pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   07: ProjectManagement-StrategicPlanning, Workshop

1:30pm EDT

#119 CH: Development of Regulatory Strategies for Global Evaluation of Post Approval Changes and Lifecycle Management of Drug Products
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Advanced

Post-approval changes are inevitable throughout a drug product's life cycle. Due to the complex regulations in ROW countries (the rest of the world), approval of these post-approval changes usually takes several years globally.

Learning Objectives

Recognize the importance of post-approval changes in a product life cycle; Analyze the complexity of implementing post-approval changes and its impact on the commercial drug product supply; Propose the key requirements to take steps industry-wide to solve A global problem needs a global solution.

Chair

Ana Sengupta, MBA, MS, RAC

Speakers
avatar for Ana Sengupta

Ana Sengupta

Director Regulatory Affairs CMC, Mirum Pharmaceuticals, Inc., United States
Ana Sengupta, Director in Regulatory Affairs at Mirum Pharmaceuticals, Inc. She has more than 25 years of pharmaceutical industry experience and 15 years of direct experience in global regulatory affairs of drugs and biologics. Before working at Mirum Pharmaceuticals, she worked in... Read More →
Monday June 16, 2025 1:30pm - 2:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   10: RegCMC-Product Quality, Workshop
 
Tuesday, June 17
 

11:40am EDT

#231 CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD
Component Type: Workshop
Level: Intermediate

Digitized protocols can support more efficient workflows and help clinical operations teams accelerate trials. This interactive session will discuss the benefits of protocol digitization along with strategies and opportunities for adoption.

Learning Objectives

Learn how digital protocols can reduce the time and effort needed to manage trials from end-to-end, ultimately accelerating trials and bringing drugs to market faster; Discover how digital protocols are already driving connections and efficiencies at research sites; Understand how industry peers are addressing protocol digitization, including challenges, opportunities, and learnings.

Speakers
DM

Denise Meade

Vice President, Life Sciences and MedTech, Verily, United States
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   02: ClinTrials-Ops, Workshop

1:00pm EDT

#238 CH: Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts
Tuesday June 17, 2025 1:00pm - 1:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

This session explores evolving AI policies, governance frameworks, and the path toward harmonized AI regulation to ensure safe, ethical, and effective AI adoption in pharma.

Learning Objectives

Analyze key global AI regulations and their impact on pharmaceutical R&D and compliance requirements; Distinguish between different regional AI regulatory frameworks and identify strategies for harmonizing AI governance across jurisdictions; Apply best practices for AI risk management, ethics, and lifecycle monitoring in pharmaceutical AI implementation.

Chair

Christina Mack, PhD, MPH

Speaker

Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts
Alex Asiimwe


Speakers
AA

Alex Asiimwe

Head of RWE Generation & Partnerships, Gilead, United Kingdom
avatar for Christina Mack

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States
Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →
Tuesday June 17, 2025 1:00pm - 1:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   03: Data-Tech, Workshop

3:00pm EDT

#257 CH: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
L Street Bridge
Component Type: Workshop

Currently some activities focus on accelerating rare diseases drug development by using tools and methods such as real-world data, Patient Centred Outcome measures integration, streamlined gene editing and technology transfer platforms, and innovative clinical trials designs.

Learning Objectives

Identify innovative methodologies, technologies and tools for innovative therapy development; Collaborate with an innovative Rare Disease research Ecosystem and recall its funding opportunities.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Speaker
Andrew Thomson, PhD, MA, MS


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop
 
Wednesday, June 18
 

11:40am EDT

#330 CH: Pharmacoequity: The Route to Representative Clinical Trials in the Current Political Environment
Wednesday June 18, 2025 11:40am - 12:10pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

In the current political environment where anything related to diversity is at risk, ensuring clinical trials represent the real world is a scientific imperative, not a DEI initiative. The concept of pharmacoequity not only aims to balance the needs

Learning Objectives

Understand the concept of pharmacoequity; Explain how to apply pharmacoequity to ensure representative clinical trial.

Chair

Dyan Bryson

Wednesday June 18, 2025 11:40am - 12:10pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   02: ClinTrials-Ops, Workshop

12:20pm EDT

#334 CH: Addressing Key Challenges in Global Biosimilar Development and Regulation
Wednesday June 18, 2025 12:20pm - 12:50pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

Explore National Regulatory Authorities’ expectations for quality data packages for biosimilars in the context of rapidly evolving regulatory science, including advanced analytical tools and the opportunity to reduce clinical data requirements.

Learning Objectives

Examine challenges identified by National Regulatory Authorities regarding review of quality data packages for biological products; Identify trends in regulatory expectations for analytical vs. clinical data and use of advanced analytical tools in biosimilar development; Understand opportunities and challenges in the use of public standards to meet regulatory expectations for biosimilars.

Chair

Allison Radwick, PhD, RPh

Speakers
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Wednesday June 18, 2025 12:20pm - 12:50pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Workshop |   15: Content-Hubs, Workshop

1:00pm EDT

#335 CH: Can Drug Repurposing Benefit Drug Development In Children and In Paediatric Rare Diseases?
Wednesday June 18, 2025 1:00pm - 1:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

Using case examples, the session will be an interactive discussion to share learnings and the impact of the use of drug repurposing from different end users such as industry and academia with input from regulators, patients and HTA representatives.

Learning Objectives

Understand drug repurposing and share lessons learnt so far based on case examples; Identify what could be opportunities using repurposing for rare diseases; Explain what has been done as part of the pilot on repurposing initiated by EMA at the end of 2021.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Can Drug Repurposing benefit drug development in Children & in Paediatric Rare Diseases?
David Sidney Ross, MBA, MSc, PMP, RAC


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for David Ross

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States
David Ross (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →
Wednesday June 18, 2025 1:00pm - 1:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop

3:00pm EDT

#355 CH: Business Agility in the Age of AI - Why Zooming in Matters Just as Much as Zooming Out
Wednesday June 18, 2025 3:00pm - 3:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

Digital transformation at the C-suite level promises significant ROI but must be done purposefully. Attendees will explore strategic considerations in implementing AI with thought-provoking Q&A, cutting through the noise of the widespread AI buzz.

Learning Objectives

Evaluate perceived versus actual ROI for generative AI, balanced with lessons learned in past decades from traditional AI and automation; Define how to upskill internal teams to use AI effectively and responsibly while achieving business goals; Apply current understanding to brainstorm digital transformation avenues for teams and businesses beyond what is being done currently with AI.

Chair

Jason Casavant, JD

Speakers
avatar for Jason Casavant

Jason Casavant

Executive Director, Medical Writing, Synterex, Inc., United States
Jason Casavant is a 25-year veteran in the industry and is the current head of medical and regulatory writing at Synterex, Inc. Over his career, he has held various positions in medical and regulatory writing, QA/QC, operations, training, and site monitoring.
Wednesday June 18, 2025 3:00pm - 3:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   03: Data-Tech, Workshop
 
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201
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Ballroom
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Innovation Theater 2
Innovation Theater 3
L Street Bridge
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Room 145-147 Lobby
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TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
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