PPD

OCTOBER 8, 2024

The PPD™ clinical research business of Thermo Fisher Scientific helps clients create all manner of flexible outsourcing solutions, many of which are detailed in our recent white paper, “Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships.”

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Trials Clinical Trials Clinical Development Clinical Research 98

Predictive Oncology

JULY 24, 2024

Company expands AI/ML driven capabilities to pursue novel biomarker discovery to predict patient outcomes and drug response in oncology. Read our white paper below that details the multi-year study conducted with UPMC Magee-Women’s Hospital. Download white paper here Interested in partnering with us?

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PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions.

International 87

International Clinical Development Clinical Trials Clinical Research 87

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

JULY 16, 2024

Our recent white paper explores the many ways in which a functional service provider (FSP) engagement delivers key pharmacovigilance (PV) capabilities necessary across the product life span and across different geographical regions. China: In 2020, China overhauled its PV requirements.

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Compliance Regulations Production Trials 98

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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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

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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Trials Disease Drug Development Clinical Trials 78

EG Life Sciences

FEBRUARY 15, 2023

The year 2022 reflected a transformative path for the drug development industry. Every year, the FDA’s Center for Drug Evaluation and Research (CDER) clarifies to drug developers required study design elements, as well as other data needed on the drug application to support a full and comprehensive assessment.

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Drug Development FDA Approval Drugs Virus 52

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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Drug Development Drugs 52

Alta Sciences

SEPTEMBER 5, 2024

New Findings on the Sinclair Nanopig™ in Safety Studies blussier Thu, 09/05/2024 - 18:00 HTML Recent Scientific Data Challenges the Status Quo Our most recent white paper presents detailed genomic, proteomic, and functional data on the Sinclair Nanopig™’s metabolism and immune systems. Read it now! ​​​​​​ WHITE PAPER Questions?

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Drug Development Drugs Research 40

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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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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Biochemical Assays Drugs Small Molecule Pharma Companies 52

The Pharma Data

SEPTEMBER 1, 2020

Dive into Medidata’s white paper to find out the best practices and new testing methods clinical trial sponsors are using to immerse patients into clinical trials for a better patient experience and for more enhanced data quality. Download your copy today to find out how to digitally transform your clinical trials. .

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FDA Law Blog: Biosimilars

APRIL 8, 2024

This year’s report noted that CDER’s Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. In a display of the competition within the generic industry that keeps margins low , this total included 118 new drug applications and 956 generic drug applications.

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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 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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Clinical Trials Trials Treatment Compliance 52

Drug Channels

FEBRUARY 23, 2021

Let’s melt away this foul February with our monthly selection of scorching news from around the drug channel. In this issue: Payers confess: Patients lose from copay accumulators Humana joins the Express Scripts GPO Hospitals vs. PBMs over specialty pharmacy white bagging Let’s all follow the Buy-and-Bill Dollar! More to come.

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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. As a diverse group of malignancies, they each have several subtypes and states, varying from person to person.

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Treatment Therapies Disease Protein Expression 78

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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The Pharma Data

NOVEMBER 20, 2020

Survey results reveal the supply chain has had significant challenges with drug shortages, limited access to critical medicines, increased production costs and heightened concerns around drug counterfeiting, diversion and theft. .

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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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PPD

OCTOBER 12, 2023

Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required. Food and Drug Administration (FDA). DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects.

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Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

The Pharma Data

SEPTEMBER 11, 2020

Starpharma experimenting with Gilead’s antiviral drug for easier administration. Melbourne-based Starpharma has announced it has applied its novel DEP drug delivery technology to create a long ? acting, water-soluble version of remdesivir.

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The Pharma Data

JULY 28, 2021

As one of the largest manufacturers of affordable generic medicines, Teva saves patients and payers around the globe billions of dollars each year in lower prescription-drug costs,” said Alex Brill, CEO of MGA. Drawing on years of policy experience, the MGA team uses analytics to help identify, quantify and solve economic policy problems.

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Marketing Biosimilars Pharmaceuticals Drugs 52

The Pharma Data

MARCH 20, 2021

Recent hot topics include: • Artificial Intelligence • Commercialization • Digital Health • Drug Safety • Formulation Strategies • Market Access • Improving Manufacturing Capacity • Real-world Evidence • Regulatory and Policy Developments • Software as a Medical Device . For example, for awareness building, an infographic may be chosen.

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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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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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H1 Blog

NOVEMBER 15, 2023

Anti-kickback laws are federal statutes designed to protect patients from paying more than necessary for medical services or devices by preventing physicians from receiving kickbacks or bribes in exchange for referring patients to certain providers or prescribing certain drugs.

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Compliance Science Regulations Pharmaceutical Companies 59

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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Clinical Trials Trials Pharma Companies Clinical Research 52

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. Our Rare Disease and Pediatric Center of Excellence provides deep pediatric knowledge and experience to drug developers across all therapeutic areas.

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PPD

JUNE 17, 2024

When outsourcing some or all key functions to an FSP provider, a drug developer gains access to a wider pool of talent, including specialized functional, scientific and technical experts. Download our white paper The post The Power of Bespoke Hybrid FSP/FSO Solutions appeared first on PPD.

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Clinical Trials Clinical Development Trials International 52

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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International Research Drug Development Pharmaceuticals 52

The Pharma Data

AUGUST 7, 2020

For more pivotal trends from regulatory bodies, download MasterControl’s white paper to find out how the FDA is modernizing its plans to change the regulatory landscape to improve public health.

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Clinical Trials Trials Packaging Therapies 52

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. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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Therapies Engineering Production FDA 59

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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Drug Development Drugs 52

Agency IQ

JULY 8, 2024

EPA publishes interagency framework on antifungal and antibiotic resistance from pesticides The EPA has published a draft framework for an interagency collaboration on better understanding the impact of pesticides on the efficacy of human and animal drugs, with a specific focus on the effectiveness of antibacterial and antifungal drugs.

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