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The Art of Recruitment and Talent Development in FSPs

PPD

Resourcing: The Bigger Picture For study sponsors, predicting the level of staff and services necessary for any given trial is one of the first and most important challenges. Our commitment to the success of our FSP engagements — and therefore to the success of those studies or trials — is clear from the outset.

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AMGEN RECOGNIZED FOR OUTSTANDING ESG PERFORMANCE

The Pharma Data

1 Improve the diversity of its workforce as well as the diversity of patients participating in clinical trials of potential new Amgen medicines. Provide employees with enhanced mental health support, including programs focused on communities of color, as well on the pandemic-related challenges facing parents.

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Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

SPA allows sponsors to gain regulatory perspective on whether a proposed trial design is adequate to support a marketing application, though the ultimate approval decision is based on the data submitted for review. FDA accepted the Lykos NDA in February 2024, and the submission received priority review.

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ATICAPRANT

New Drug Approvals

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] hours following a single dose of 10 mg, which supported the 4 mg to 25 mg dosages that aticaprant is being explored at in clinical trials. [13] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2]

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The Year (and a Half) in Review: 2022

KIF1A

This is one of the most foundational tools needed to prepare for upcoming clinical trials so families, scientists and regulators can identify measurable improvements in KAND symptoms as the result of new treatments. 160+ patients are currently enrolled in the KIF1A Patient Registry and Natural History Study.

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Article FDA Thank You FDA makes significant qualitative changes in its final guidance on quantitative information in drug advertising

Agency IQ

e.g., “ In a clinical trial, Drug X reduced the risk of stroke by 50%. By way of example , if a company claims that a trial showed that 68% of patients treated with Drug X experienced a reduction in blood glucose levels, they should also note the reduction experienced by patients treated with the standard of care or placebo.

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PQ Bypass Releases Positive 24-Month Data from the DETOUR1 Clinical Trial for Percutaneous Femoropopliteal Bypass at VIVA 2020

The Pharma Data

The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). An illustration of a completed Detour Procedure (Graphic: Business Wire).