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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The two broadest categories of drug development can be separated into the preclinical and clinical research stages.

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eBook: Unlocking Undruggable Targets

DrugBank

The world of drug discovery is in a state of transformation, with advancements in biotechnology opening doors to new possibilities for targeting previously "undruggable" disease mechanisms. The Power of Drug Repurposing Explore the immense potential of drug repurposing as a strategy for targeting undruggable targets.

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An Evolving Regulatory Environment for Rare and Orphan Diseases

Advarra

The law established the Office of Orphan Products Development , providing financial incentives for pharmaceutical companies to develop orphan drugs and making it more viable to invest in orphan drug research and development. The impact was clear: Between 1983 and 2020, FDA approved 599 orphan drugs.

Disease 52
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ACTIV Update: Making Major Strides in COVID-19 Therapeutic Development

NIH Director's Blog: Drug Development

Yet the quest to save more lives from COVID-19 isn’t even close to being finished, and researchers continue to work intensively to develop new and better treatments. ACTIV was founded last April to accelerate drug research that typically requires more than a decade of clinical ups and downs to develop a safe, effective therapy.

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Innovation Drives Excellence, Innovent Successfully Held 2020 Virtual R&D Day

The Pharma Data

Dr. Liu shared his over 30 years of R&D experience in drug development both in the global pharmaceutical companies and world renowned scientific research institutions. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

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Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

Commission Regulation (EC) No 847/2000 set the rules, defining an orphan drug as one “that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made.” no available treatment.

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Origins of the Lab Mouse

Codon

Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments. Today, somewhere on the order of 30 million rodents are used yearly in biomedical research in the U.S.