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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

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.

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

PPD

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

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Leveraging AI Solutions for Clinical Trial Efficiencies

PPD

About us The PPD clinical research business of Thermo Fisher Scientific , the world leader in serving science, enables our customers to accelerate innovation and increase drug development productivity. Ready to learn more about how to leverage AI and machine learning to maximize your clinical trial efficiency?

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Redefining Acceleration of the Drug Development Journey

PPD

Companies can benefit from solutions such as our Accelerator Drug Development, leveraging the combined strength of Thermo Fisher Scientific’s 360˚ Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) services , which provides CDMO, CRO and clinical trial supply chain capabilities that further streamline (..)

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Coordinating the Cell Journey: Essentials in Early Clinical Development

PPD

Enhance Your Cell Therapy and Rare Disease Clinical Program with an Early Development Services Partner Our dedicated, global and highly experienced clinical logistics monitoring team can assist you through the Phase Ib journey.

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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.

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Navigating Varying Regulatory Feedback in Clinical Oncology Trials: A Guide for Clinical Research Professionals

Conversations in Drug Development Trends

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. As we look towards future developments in oncology and beyond, the importance of strategic regulatory planning and execution cannot be overstated.