Newsletter | February 6, 2025

02.06.25 -- Biopharma R&D Faces Productivity And Attrition Challenges In 2025

REGULATORY & COMPLIANCE

FDA Issues Draft Guidance: Study Of Sex Differences In The Clinical Evaluation Of Medical Products

The U.S. FDA's recent draft guidance on the Study of Sex Differences in the Clinical Evaluation of Medical Products deduces that individuals whose sex is assigned as “female” at birth are underrepresented in clinical trials. The public comment period ends April 7.

What Does 2025 Hold For Pharma?

Look at what’s in store for pharma and life science in 2025. While we see many recurring themes, 2025 promises to be filled with unexpected — and possibly unprecedented — developments.

Why Compassionate Use Should Not Replace Rigorous Clinical Trials

While compassionate use and expanded access programs provide lifesaving treatments outside clinical trials, a lack of structured protocols can lead to compromised efficacy and safety evaluations.

5 Ways FDORA Will Impact Clinical Research Sponsors

While the FDA Omnibus Reform Act of 2022 is slowly changing aspects of clinical research, explore five main ways studies are currently being impacted and what trial teams can do about it.

Writing Multiple Marketing Applications Simultaneously

A mid-size pharmaceutical company found success in a partnership that aided them in completing medical writing marketing applications on an accelerated timeline.

Safety And Regulatory Compliance Solutions

IQVIA offers a complete approach that combines safety, regulatory, quality, and medical information to transform and sustain compliance.

OUTSOURCING MODELS

Biopharma R&D Faces Productivity And Attrition Challenges In 2025

Evaluate WP of Thought Leadership Daniel Chancellor discusses trends for 2025 as the surge in R&D, coupled with rapidly evolving industry dynamics, presents a productivity and attrition challenge for the industry.

Moving Through Obstacles On The Path To Commercialization

Leaders in the clinical trials field answer questions about transitioning from clinical development to commercialization and the strategic foresight, operational excellence, and adaptability required.

Drug-Drug Interaction (DDI) Studies

An innovative development platform with the unique ability to fully integrate DDI studies can accelerate timelines and improve the likelihood of downstream success.

Your Global CRO Partner In Oncology And Hematology

Learn about an organization dedicated to providing personalized and adaptive trial solutions and managing complex oncology and hematology clinical trials.

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