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Redefining Acceleration of the Drug Development Journey

PPD

It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drug development. However, getting essential treatments to patients quickly and safely requires more than just technological innovation. billion in 2023 to 1.2 billion in 2035.

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Future-proofing drug development with GenAI

Drug Target Review

Given macro healthcare influences (eg, economic uncertainty, environmental changes) and the numerous available treatments for major diseases, drug developers may need to reassess their therapeutic strategies. This has led drug developers to unintentionally limit their potential within chosen therapeutic spaces.

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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Conversations in Drug Development Trends

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

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Key Trends Drug Developers Need to Know to Succeed

PPD

As the pharmaceutical industry continues to evolve, drug developers encounter new challenges and opportunities in their pursuit of innovation. In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends.

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Managing Opportunities and Risks in Generative AI Use for Clinical Research

PPD

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. These domains are ripe for innovation. Errors jeopardize patient safety, regulatory compliance and trust.

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Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

PPD

Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.