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!

Therapies 52

Therapies Drug Development Research Drugs 52

The Pharma Data

FEBRUARY 5, 2021

With the digitalization process, data has become the center of both traditional and research-intensive industries. In this white paper, H. Download the white paper to understand: The different types of data within an organization, and the challenges they pose. Oberkampf, C.

Production 52

Production Marketing Research 52

Fierce BioTech

JUNE 1, 2023

Download the white paper to learn more about the diagnostic potential of antibodies. Download the white paper to learn more about the diagnostic potential of antibodies. Autoantibodies: Powerful Biomarkers in Cancer Precision Medicine Autoantibodies hold great diagnostic potential for early cancer detection.

Production 52

Production Treatment Research 52

Conversations in Drug Development Trends

FEBRUARY 21, 2024

We recently published a white paper discussing the value of proactive AME studies, best practices, and lessons we’ve learned over the years to help optimize your study. At Worldwide, our early phase team has conducted these studies for over 20 years, gaining invaluable experience and insights into best practices for an AME study.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

Advarra

MAY 26, 2023

The Association of American Cancer Institutes (AACI) recently published a white paper titled Collaboration to Develop Recommendations to Improve Trial Activation Timelines. The task force focused on three main areas of study activation: contract negotiation, budget development, and trial start up committee reviews.

Clinical Research 52

Clinical Research Trials Clinical Trials Research 52

EG Life Sciences

FEBRUARY 15, 2023

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. The year 2022 reflected a transformative path for the drug development industry.

Drug Development 52

Drug Development FDA Approval Virus Drugs 52

Conversations in Drug Development Trends

MARCH 7, 2024

Are there differential financial incentives to encourage sponsors to initiate early phase clinical research under a CTA, and how do those incentives compare to incentives that exist to initiate the same research under an IND? For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

Clinical Trials 52

Clinical Trials Trials FDA Drug Development 52

PPD

OCTOBER 12, 2023

Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance. DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects. The post Informed Design of Bioanalytical PCR Assay Testing Parameters appeared first on PPD Inc.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

PPD

AUGUST 28, 2024

Researchers often employ cell therapy studies for oncology indications, and the U.S. A seasoned provider of contract research organization (CRO) solutions will infuse hybrid and decentralized solutions into studies, with experts that provide the breadth and depth of experience required to deploy mobile sites, wearables and more.

Trials 52

Trials Clinical Trials Therapies Drug Development 52

Conversations in Drug Development Trends

MARCH 20, 2024

To learn more about these various genes and how they can affect your clinical trial participants, as well as to understand the full extent of the power of pharmacogenomics, check out our white paper. The post How Pharmacogenomics Can Benefit Your Clinical Trial appeared first on Worldwide Clinical Trials.

Clinical Trials 52

Clinical Trials Trials Compliance Treatment 52

PerkinElmer

FEBRUARY 18, 2021

A PerkinElmer White Paper offers a detailed look at the findings. These simple, stable compounds, used to treat various conditions, are the focus for 78% of preclinical research. For the minority of companies working with large molecules and biologics, most said they were in a phase of clinical research.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 52

The Pharma Data

SEPTEMBER 11, 2020

Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease. The Covid-19 command center was created to provide sponsors of clinical trials pursuing in-house Covid-19 research with an AI-powered data analytics platform. Saama Technologies, Inc. ,

Clinical Trials 52

Clinical Trials Pharma Companies Hospitals Trials 52

H1 Blog

NOVEMBER 15, 2023

For more information on how to build effective and compliant engagement plans, download our white paper: How AI Can Save Medical Affairs from Drowning in Data. The planning and execution of a KOL engagement strategy can be a complex process, with numerous considerations for compliance.

Compliance 59

Compliance Science Regulations Pharmaceutical Companies 59

PPD

MARCH 21, 2024

Partnering with a contract research organization (CRO) that has deep experience in pediatric clinical trials enables drug developers to successfully implement these strategies, which also have the potential to enhance study startup time, ease the burden on pediatric patients and their caregivers, and ultimately improve retention rates.

Clinical Trials 52

Clinical Trials Trials Drug Development Treatment 52

Agency IQ

JULY 8, 2024

The EPA stated that for fungal pathogens, current research indicates that some antifungal pesticides may lead to resistant organisms that pose a threat to human and animal health. The EPA notes that it is unable to quantify the percentage of U.S.-based based fungal infections that come from antimicrobial resistant fungi.

Virus 40

Virus Production Regulations FDA 40

The Pharma Data

MARCH 31, 2022

™, Janssen seeks to elevate PAD research, collaboration, education and screening for communities placed at increased risk of cardiovascular disease. ™ has three main areas of focus: driving research, collaborating with powerful partners, and empowering individuals and communities. Through Save Legs. Change Lives. Change Lives.™

Disease 52

Disease Pharmaceutical Companies Pharmaceuticals Research 52

The Pharma Data

OCTOBER 16, 2020

This week’s round up features a digital solution for adapting clinical trials to ease the burden on the clinical research industry and an in vitro model that mimics the human airway epithelium using a newly developed technology platform. BetterLife conducts patient centric study via a fully remote clinical trial. Source link.

Clinical Trials 52

Clinical Trials Trials Pharma Companies Clinical Research 52

The Pharma Data

JULY 28, 2021

On behalf of clients, MGA conducts original data analysis, constructs economic models, conducts research, writes white papers and expert reports and offers strategic advice. Drawing on years of policy experience, the MGA team uses analytics to help identify, quantify and solve economic policy problems. Source link: [link].

Marketing 52

Marketing Biosimilars Pharmaceuticals Drugs 52

Drug Discovery World

SEPTEMBER 29, 2022

For these reasons and others, many biotech and pharmaceutical companies – along with government research labs and academic institutions – rely on contract research organizations (CROs) for drug discovery services.

Small Molecule 130

Small Molecule Assay Development DNA Biochemical Assays 130

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. At a February 2024 joint workshop with the U.S.

Regulations 40

Regulations Trials Science Clinical Trials 40

The Pharma Data

AUGUST 7, 2020

These manufactured antibodies have been developed and manufactured by Eli Lilly and Company ’s Lilly Research Laboratories in a partnership with AbCellera. The LY-CoV555 antibodies are infection fighting that can bind to the surface of viruses and prevent the virus infecting cells.

Clinical Trials 52

Clinical Trials Trials Packaging Therapies 52

Conversations in Drug Development Trends

JULY 29, 2024

Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research. DEXA (Dual-Energy X-ray Absorptiometry) is the optimal method for accurately measuring body composition in clinical research.

Clinical Research 52

Clinical Research Research Clinical Trials Treatment 52

Conversations in Drug Development Trends

MARCH 12, 2024

For a more in-depth look at biomarkers, check out our white paper. Based on previous studies, a single marker may be insufficient, and therefore, research points to the need for a “composite biomarker” made up of multiple markers meaningfully combined to inform the current disease state.

Clinical Trials 72

Clinical Trials Immune Response Trials Disease 72

Agency IQ

JULY 21, 2023

In 2019, the advocacy organization, Friends of Cancer Research (FOCR) organized a multi-stakeholder initiative comprised of industry, government, and academia to find out. In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology.

FDA 40

FDA Clinical Trials DNA Treatment 40

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

Therapies 59

Therapies Engineering Production FDA 59

The Pharma Data

DECEMBER 28, 2020

Dr. Hofstein completed his postdoctoral training and research in the Department of Neurobiology at Harvard Medical School. Mr. Weild authored and co-authored a number of definitive white papers that were key catalysts for new legislation and regulatory reforms, including the JOBS Act. Hofstein received his B.Sc.

Pharmaceuticals 52

Pharmaceuticals Government Pharmaceutical Companies Therapies 52

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. This research ultimately influenced the creation of a new submission process for the client.

Compliance 52

Compliance Regulations Production International 52

The Pharma Data

MARCH 20, 2021

The Kluyver Center for Genomics of Industrial Fermentation in Delft, Holland, is a consortium of several different Universities and Research Centres. We would like to thank Frederick Aboka for providing us with this initial insight into his research project, and are pleased that we were able to supply him with the CO2 sensor InPro 5000.

Bioinformatics 52

Bioinformatics Production Laboratories Engineering 52

The Pharma Data

JANUARY 7, 2021

The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs).

Production 52

Production FDA Pharmaceuticals Marketing 52

Conversations in Drug Development Trends

APRIL 4, 2024

Understanding and implementing the ICH M10 guidelines is not just a regulatory requirement; it’s a step towards more efficient and effective pharmaceutical research. To take a deeper dive into these guidelines, read our Q&A white paper , where industry-leading experts answer some common questions on bioanalytical guidance.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals International 80

The Pharma Data

SEPTEMBER 9, 2020

Develop a fully automated environment to significantly boost research efforts. . Effectively implement findable, accessible, interoperable and reusable data principles to help guide the selection of technologies in labs. Improve productivity and data integration by driving the use of semantic systems.

Production 52

Production Laboratories Compliance Government 52

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.

Trials 78

Trials Disease Drug Development Clinical Trials 78

Conversations in Drug Development Trends

NOVEMBER 21, 2023

We thought, thousands of drugs haven’t been researched for thousands of other indications, so how can we disrupt the model? Dr. Fajgenbaum was determined to live, so he set out to leverage his limited medical training, scouring existing research literature and studying his body to find a treatment.

Disease 78

Disease Treatment Clinical Trials Clinical Development 78

Conversations in Drug Development Trends

MARCH 1, 2023

The advent of outsourcing in clinical research came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. See how to unlock the full power of your CRO partner in our white paper, Optimal Outcomes in Clinical Research and Product Development.

Clinical Research 52

Clinical Research Clinical Trials Science Trials 52

Conversations in Drug Development Trends

AUGUST 14, 2024

Recent Advancements in Biomarker Research The latest advancements in biomarker research have further elevated the biomarker’s role in disease diagnosis, treatment, and monitoring. Check out our white paper to learn more about our services, or contact our team to find out how we can help support your oncology drug development program.

Treatment 78

Treatment Protein Expression Therapies Disease 78

PPD

DECEMBER 19, 2023

According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internal research shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models. Read our white paper to learn the keys to successfully implementing functional service partnerships.

International 52

International Research Pharmaceuticals Drug Development 52

PPD

JUNE 17, 2024

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) Download our white paper The post The Power of Bespoke Hybrid FSP/FSO Solutions appeared first on PPD.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52