Remove Clinical Development Remove Information Remove Trials
article thumbnail

The rising impact of biomarkers in early clinical development

Drug Target Review

Advanced strategies and tools are being implemented to establish the safety and efficacy of new therapeutic modalities, with the development of new biomarkers becoming one of the most relevant approaches for enhancing the precision and utility of early-stage studies.

article thumbnail

Navigating Clinical Development Challenges to Advance Idiopathic Pulmonary Fibrosis Treatments

PPD

The complexity of diagnosing IPF, understanding its root causes, and translating preclinical findings to clinical success make it a challenging disease for drug development. However, recent advancements and strategic approaches in clinical trials offer hope that additional treatments are on the way.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Harnessing AI and Real-World Data: The Future of Clinical Development

PPD

Real-world data paired with machine learning is a game changer in drug development RWD is becoming increasingly important in influencing the drug development landscape, particularly when used to develop the natural history and patient journey through disease.

article thumbnail

9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey

Conversations in Drug Development Trends

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You can expect transparency.

article thumbnail

Why radiopharmaceuticals are gaining ground in the fight against cancer

Drug Target Review

This dual role enables him to bridge research and clinical practice, ensuring scientific innovation is directly informed by patient care. “As Protocol development can be a complex and meticulous process,” he explains, “as it’s crucial to ensure that trial candidates meet the necessary inclusion criteria.”

Therapies 100
article thumbnail

Amgen Unveils Phase 2 Obesity Trial Results for Monthly Maritide at ADA’s 85th Scientific Sessions

The Pharma Data

This study explored the effects of beginning treatment with lower starting doses of MariTide to improve tolerability while maintaining clinical benefit. Both data sets now provide foundational insight into the design and direction of Amgen’s upcoming Phase 3 MARITIME clinical development program.

Trials 40
article thumbnail

CMC Content for Global Clinical Development of Pharmaceuticals

The Premier Consulting Blog

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region.