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

PPD

Machine learning is a subset of AI that identifies patterns in large datasets, leveraging identifiable conditions or attributes that are needed to inform sample selection for trials and other prospective data. It identifies cases in instances where diagnosis codes and other information available in each database are too non-specific to do so.

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New targeted therapies show promise in lung cancer treatment

Drug Target Review

2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. 18 Indeed, early-phase clinical studies exploring TsAbs in solid tumours have recently commenced.

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AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. About AlgoTherapeutix AlgoTx was founded in 2018 by Stéphane Thiroloix and Olivier Bohuon to develop topical treatments for complex pain and was incubated by Paris Biotech Santé. 15, 2020 07:15 UTC.

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The Evolution of Adaptive Protocols: Early Clinical Development

PPD

Instead of the standard approach where studies are designed to address a primary focus, a parallel study method — a format that incorporates multiple endpoints and objectives, modifications, treatment arms and dose selections into a single protocol — is being rapidly adopted.

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Continuous Innovation with WorldwideEdge™ — A World of a Difference in Bioanalytic Operations

Conversations in Drug Development Trends

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Bioanalysis to support drug development requires meticulous attention to detail across many clinic and laboratory disciplines.

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Getting the Pulse on Biopharma and Biotech Companies: Differing Perspectives on Clinical Development

PPD

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). ADUHELM is indicated for the treatment of Alzheimer’s disease. Please see the full Prescribing Information. INDICATION.