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How to Optimize Drug Development by Combining FSO and FSP Models

PPD

Awarded by specific function, in which a CRO could provide single or multiple services, such as site monitoring, data management, post-approval monitoring or clinical supply services, across numerous protocols. Most often done using the vendor’s systems and standard operating procedures (SOP).

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A Biotech Midsummer’s Madness

LifeSciVC

As the CEO of Lifordi Immunotherapeutics, an ADC company developing treatments for autoimmune and inflammatory diseases, there are three components to manufacture, multiple international CDMOs to manage, and complex supply chains to navigate. I can tell you that CDMO summer shutdowns are a real thing.

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Tech Transfer Tools: The Requirements and Uses of Manufacturing Process Descriptions

The Premier Consulting Blog

technical operations, product development or process development) to an internal or external receiving unit (e.g., clinical manufacturing, commercial manufacturing, or contract manufacturing organization). Development of the manufacturing process description The development of the MPD is an iterative process.

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VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

The Pharma Data

VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. Pfizer is collaborating with Vivet on the clinical supply of VTX-801 for the Phase 1/2 clinical trial.

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The golden era of GLP-1 drugs: How will it impact medicine and society?

BioPharma Drive: Drug Pricing

He quickly moved into the role of Clinical Principal Investigator and became Chief Medical Officer in 2020. He is certified in Internal Medicine and Gastroenterology and is also a Fellow of the American College of Gastroenterology.

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FDA’s AI tool ‘Elsa’ is here, and the industry has questions

BioPharma Drive: Drug Pricing

These are exactly the applications where current generative AI … completely excels and where we see similar gains in drug development and scientific review internally at Lantern Pharma,” he said. This is the appropriate approach, according to Panna Sharma, CEO and president of Lantern Pharma, an AI-focused biopharmaceutical company.

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Transforming cancer care through clinical excellence

Drug Target Review

In clinical research, I have brought over 25 compounds to market and supported five more while leading a quality assurance organisation. My proudest achievement is my leadership journey building legacy organisations, processes and tools in clinical operations. She has managed a portfolio of ~1,500 clinical trials a year.