PPD

DECEMBER 5, 2023

Non-footprint countries are regions where drug developers lack a physical presence, often in emerging markets or remote areas. These countries offer new opportunities for drug developers to access additional resources, ensure project continuity and rely on localized expertise for recruitment, regulatory insights and more.

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PPD

DECEMBER 12, 2023

Drug developers using functional service partnerships (FSPs) are taking an increasing interest in the follow-the-sun business model to optimize operations, transitioning work across global locations as the sun rises and sets.

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Compliance Clinical Research Trials Clinical Trials 52

Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

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Clinical Trials Therapies Regulations Clinical Development 52

Vial

MARCH 1, 2024

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

Conversations in Drug Development Trends

AUGUST 15, 2023

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. You have the oversight you need.

Clinical Development 52

Clinical Development Government Clinical Trials Trials 52

Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Unflinching attention to detail is required to manage AME study participants In AME studies, our top priority is balancing participant comfort and compliance with high-quality data collection.

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Clinical Trials Pharmacy Clinical Pharmacology FDA 80

PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. It’s an effective way to manage capacity and labor uncertainty and provides drug developers the option to retain knowledgeable, proven personnel.

Clinical Research 59

Clinical Research Regulations Packaging Drug Development 59

Vial

MARCH 27, 2024

Sponsors must also be cognizant of additional costs associated with more rigorous services such as data management and analysis, maintaining regulatory compliance, and providing individual site monitoring. Personnel salaries, site rentals, and equipment maintenance are other necessary expenses associated with clinical trials.

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Clinical Trials Trials International Compliance 52

The Pharma Data

APRIL 6, 2022

In addition, all G&A functions – Finance, People & Organization, Ethics, Risk & Compliance, Legal, and Communications & Engagemenz – will be integrated on global and country levels. Change in Global Drug Development (GDD) Leadership. Novartis has appointed Shreeram Aradhye, M.D.,

International 52

International Pharmaceuticals Drug Development Marketing 52

The Pharma Data

DECEMBER 27, 2020

The newly executed PIPE financing is subject to customary closing conditions and is expected to close on December 30, 2020, and was done in compliance with applicable Nasdaq rules and priced at the “Minimum Price” (as defined in the Nasdaq rules). and Versant Ventures. Cowen served as the sole placement agent for each of the PIPE financings.

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Clinical Trials Compliance Clinical Development Production 52

Molecule Blog

MARCH 17, 2023

Clinical development kicks off when the company files an IND with the FDA , progressing through Phase I for safety, Phase II for early signs of efficacy, and Phase III for determining full approval. Unlike investment DAOs, BioDAOs generate returns to finance R&D rather than distribute profits to stakeholders.

Engineering 52

Engineering Research Clinical Trials Government 52

The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. drug development initiative from 2012 to February 2019. Before joining Acorda, Ms.

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Clinical Trials Trials Production Therapies 40

Conversations in Drug Development Trends

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions.

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Clinical Research Trials Clinical Trials Research 69

Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. Pivotal (i.e.,

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FDA Small Molecule Science Immune Response 40

PPD

NOVEMBER 8, 2022

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. Six Predictions for the Drug Development Industry in 2023 1.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

Agency IQ

AUGUST 2, 2024

On the medicines side, the EMA’s Methodology Working Party is slated to take on guidelines on the use of AI in clinical development. Analysis and what’s next Even with HHS re-organizing to take a more concerted lead on AI policy, the FDA is continuing ahead with its own projects.

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FDA Laboratories Pharmacy Government 40

Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

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