PPD

OCTOBER 2, 2024

A recent white paper from the PPD™ clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years, moving from capabilities that were previously built up and maintained in-house, to the multiple outsourcing models available today.

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Fierce BioTech

JULY 28, 2023

jsabatino Fri, 07/28/2023 - 11:29 In this white paper, we look at the past, present and future of antibodies as therapies, explaining how the modality became a key pillar of the biopharma industry—and looking forward to the methods and technologies that could unleash its full potential in the years to come. Download here!

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure. Here are a few of our lessons learned: 1.

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Drug developers must consider ways to remove these barriers to enhance their ability to recruit and retain trial participants.

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Conversations in Drug Development Trends

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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Drug Channels

MAY 20, 2021

Karen examines trends in drug development, pricing, and healthcare. To learn more, download Six trends and tactics to thrive in the new healthcare economy , a free white paper from Wolters Kluwer. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

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Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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The Pharma Data

JANUARY 18, 2021

There is no way to eliminate the risk of failure. However, there are ways to reduce these risks. Learn more in this whitepaper from Recipharm. Source link.

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PerkinElmer

FEBRUARY 18, 2021

Industry leaders reveal how high throughput screening is changing in R&D What do you think are the major trends in drug discovery R&D? A PerkinElmer White Paper offers a detailed look at the findings. Here, we summarize the top 10 survey findings on drug discovery trends for the top 20 Pharma leaders in R&D.

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PPD

MARCH 21, 2024

When participating in clinical trials, pediatric populations require distinct considerations for their safety and well-being — which can present unique challenges for drug developers. A number of strategies can be adopted to put the needs of the child at the center of the study.

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H1 Blog

AUGUST 10, 2023

To learn more about how Medical Affairs teams can leverage AI for smarter drug development, download our Custom White Paper with First Word Pharma: How AI Can Save Medical Affairs from Drowning in Data. Look for more content in our upcoming AI Content Hub.

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The Pharma Data

OCTOBER 16, 2020

We are in the process of finalizing arrangements with a global leader in drug development to assist in our development activities as we work toward a potential IND filing targeted in 2021.”. Download Medidata’s white paper to learn how to virtualize clinical trials and bring new therapies closer to patients.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Common CMC Issues for Phase 1 IND Study. The workshop is also discussed in Cell & Gene here and here.

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The Pharma Data

DECEMBER 28, 2020

Scopus is a biopharmaceutical company whose lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. Dr. Russell has managed all aspects of the drug development and regulatory approval processes for oncology and non-oncology drug candidates. NEW YORK , Dec.

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The Pharma Data

SEPTEMBER 9, 2020

Receive expert-led insight from Dr. Heiner Oberkampf, Head of Data Governance at OSTHUS and learn how to: Digitally transform a drug development strategy. Develop a fully automated environment to significantly boost research efforts.

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Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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Conversations in Drug Development Trends

NOVEMBER 21, 2023

Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis.

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Conversations in Drug Development Trends

MARCH 1, 2024

To help determine if a master protocol could be a good fit for your study, check out this white paper for a more comprehensive overview of the appropriateness of master protocols in different contexts. Here are some relevant factors below: What Are the Advantages of a Master Protocol? Contact us.

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Conversations in Drug Development Trends

AUGUST 14, 2024

Historically, these indications have challenged the one-size-fits-all treatment approach due to patient variability, such as genetic differences in drug metabolism and underlying health conditions. Hematological cancer cells can also develop resistance to therapies over time, reducing treatment effectiveness.

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Conversations in Drug Development Trends

JULY 29, 2024

However, the complex nature of T2D requires a multidimensional treatment approach that extends beyond drug therapy. Research suggests that a combination of drugs and devices is most effective for managing T2D. These treatments offer cardiometabolic benefits and potential promise in mental health.

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PPD

JUNE 17, 2024

Often, however, a hybrid use case will fit into one of these general categories: 1) An existing FSO arrangement needs additional expertise or resources to support a specific study function, requiring the developer to scale or augment that FSO arrangement with FSP services.

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PPD

DECEMBER 19, 2023

Ready to fuel more efficient drug development? Read our white paper to learn the keys to successfully implementing functional service partnerships. LEARN MORE The post Dedicated Roles Keep FSP Projects on Schedule appeared first on PPD Inc.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

If two or more doses are discovered to have comparable efficacy, the lowest effective dose should be used in the registration trial to help minimize the toxicity effects when the drug is used in a broader heterogeneous patient population. You can learn more about biomarkers and how to use them in oncology studies in this white paper.

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PPD

JULY 9, 2024

Companies developing new drugs and inventing new medical devices face a wide range of challenges. This requires an expert RA team capable of processing large volumes of routine submissions to support any changes to manufacturing, market expansion, or safety and quality reporting — for every drug or device in the company’s portfolio.

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