About the Summit

The 13th Annual IMPACCT Real-World Evidence (RWE) Summit is scheduled for October 27–29, 2025, in Boston, MA. This industry-focused event unites experts across clinical, commercial, and market access teams to advance the use of Real-World Evidence (RWE) and Real-World Data (RWD) in drug development, regulatory submissions, and payer negotiations.

Key Event Highlights

• Focus Areas: Integration of AI and machine learning to improve data quality, pipeline automation, and predictive analytics, along with strategies for cross-functional collaboration and integrated evidence planning.
• Programming: A pre-conference day dedicated to payer and regulatory alignment, followed by two days of sessions featuring over 20 in-practice case studies and discussion-based workshops.
• Participation: More than 140 industry pioneers from leading pharmaceutical and biotech companies, including Pfizer, AstraZeneca, Moderna, and AbbVie.
• Networking: Over 6 hours of dedicated cross-functional networking, including speed networking sessions and a drinks reception.

Evolution of RWE

Over the last decade, particularly following the 21st Century Cures Act, RWE has become a strategic imperative across the product lifecycle. Key developments include:

• Diverse Data Sources: RWE now utilizes high-volume data from electronic health records (EHRs), wearables, mobile apps, and social media, rather than just retrospective claims.
• Rigorous Methodology: Interpretation is now more standardized, utilizing frameworks like propensity score matching and synthetic control arms to improve credibility.
• Regulatory Support: Regulatory bodies like the FDA and EMA have issued guidance to foster transparency and trust in RWE.

Persistent Challenges

Despite progress, significant hurdles remain:

• Data Quality: Real-world data (RWD) is often unstandardized, inconsistent, and lacks the research-focused collection process of randomized controlled trials.
• Bias and Confounding: RWD is inherently prone to selection bias and reverse causality, which complicates causal inferences.
• Interoperability and Privacy: Fragmented health systems and strict privacy regulations (e.g., GDPR, HIPAA) hinder data integration and patient journey mapping.

Future Trends

Dr. Zou highlights three trends reshaping biopharmaceutical development:

• AI-Powered Analytics: Enhances speed and depth in identifying patterns, predicting disease trajectories, and improving pharmacovigilance.
• Integrated Evidence Planning (IEP): Combines diverse data types to support submissions and market access.
• Unstructured Data: NLP and LLM tools are being used to extract insights from clinical notes, radiology reports, and patient-reported outcomes.

Case Study

At Pfizer, Dr. Zou's team successfully used RWD to provide necessary reference information to the Japanese PMDA for lorazepam IV in pediatric patients, supporting regulatory approval when clinical trial data was limited.