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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
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
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
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
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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