White Paper - Drug Discovery Digest

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Drugs

Drugs FDA Hospitals Government

Analysis Chemical: EPA releases white paper for second part of the risk evaluation for asbestos

Agency IQ

AUGUST 11, 2023

EPA releases white paper for second part of the risk evaluation for asbestos The Environmental Protection Agency has published a white paper on the quantitative human health approach to inform the Risk Evaluation for Asbestos, Part 2.

White paper: A patient-centric and inclusive approach to patient recruitment

Antidote

OCTOBER 18, 2024

Improving health literacy for more equitable access to clinical trial research Low health literacy is a major concern in healthcare. Statistics show that nearly 88% of Americans struggle with health literacy , and this issue is not evenly distributed across the population.

Clinical Trials

Clinical Trials Trials Disease Research

Analysis Chemical Thank You EPA releases white paper for second part of the risk evaluation for asbestos

Agency IQ

AUGUST 11, 2023

EPA releases white paper for second part of the risk evaluation for asbestos The Environmental Protection Agency has published a white paper on the quantitative human health approach to inform the Risk Evaluation for Asbestos, Part 2. Small manufacturers, importers, and processors are not included in this requirement.

Production

Production Regulations Disease

Can we use plastic waste to build roads, buildings, and more?

SCIENMAG: Medicine & Health

JULY 18, 2023

In a new white paper commissioned by the National Academies of Sciences, Engineering, and Medicine (NASEM), Lepech and Li study the current status, challenges, and needs of recycling plastics in a circular economy, and examine the long-term durability and environmental […]

Engineering

Engineering Science

EPA issues white paper exploring the adoption of structured content and digital pesticide labels

Agency IQ

NOVEMBER 20, 2023

The EPA’s Office of Pesticide Programs (OPP) is in the developmental stage of creating a structured pesticide and digital pesticide label. Both labels would provide the framework for the consistent placement and order of the regulated portions of pesticide label information, with the digital label organizing the contents as data.

Regulations

Hybrid FSP/FSO Solutions Enable Flexibility and Agility to Keep Biotech Trials On Time and On Budget

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.”

Trials

Trials Clinical Trials Clinical Development Clinical Research

A Clear Path to Education Affordability Requires Meeting Patients Where They Are

Drug Channels

SEPTEMBER 22, 2023

To learn about CoverMyMeds’ medication affordability solutions that engage patients, download the CoverMyMeds white paper: Overcoming Affordability Challenges with Patient-Centered Solutions. Read on for Kristina’s insights. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

Pharmacy

Pharmacy Production Drugs

Predictive Oncology enters biomarker discovery market after successful retrospective ovarian cancer study yields compelling results

Predictive Oncology

JULY 24, 2024

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? Company expands AI/ML driven capabilities to pursue novel biomarker discovery to predict patient outcomes and drug response in oncology.

Marketing

Marketing Hospitals Drugs

Genetic testing of patients with atrial fibrillation can alert clinicians to potential development of life-threatening conditions

SCIENMAG: Medicine & Health

MARCH 27, 2024

Philadelphia, March 28, 2024 – Although the vast majority of clinicians do not view atrial fibrillation (AF) as a genetic disorder, a White Paper in the Canadian Journal of Cardiology, published by Elsevier, analyzes the current understanding of genetics and the role of genetic testing in AF and concludes there is an increasing appreciation that […] (..)

Heterogeneous and curated biobank of live-cell tumor samples retains highly reproducible drug response data for drug and biomarker discovery

Predictive Oncology

AUGUST 15, 2024

White paper validates highly reproducible drug response data. Complete the form below to download the white paper. The post Heterogeneous and curated biobank of live-cell tumor samples retains highly reproducible drug response data for drug and biomarker discovery appeared first on Predictive Oncology.

Drugs

Drugs Drug Development

Heterogeneous and curated biobank of live-cell tumor samples retains highly reproducible drug response data for drug and biomarker discovery

Predictive Oncology

AUGUST 15, 2024

White paper validates highly reproducible drug response data. Complete the form below to download the white paper. The post Heterogeneous and curated biobank of live-cell tumor samples retains highly reproducible drug response data for drug and biomarker discovery appeared first on Predictive Oncology.

Drugs

Drugs Drug Development

Nuclear medicine global initiative reports worldwide challenges and opportunities in theranostics education

SCIENMAG: Medicine & Health

JUNE 23, 2023

Reston, VA—Leaders from 12 nuclear medicine organizations around the world have issued a white paper about the challenges and opportunities in theranostics education. Published in the June issue of The Journal of Nuclear Medicine, the report outlines the current theranostic educational and accreditation offerings across the globe.

An Integrated End-to-End Approach to Antibody Drug Conjugate Development and Manufacturing

Fierce BioTech

JUNE 24, 2024

An Integrated End-to-End Approach to Antibody Drug Conjugate Development and Manufacturing In this white paper, Lonza experts delve into the common challenges encountered by ADC developers. Read this white paper to learn more. Read this white paper to learn more.

Drugs

Drugs Drug Development Production Research

Increasing the probability of technical success in drug development using AI and patient heterogeneity

Predictive Oncology

AUGUST 8, 2024

A recent white paper released by Predictive Oncology’s highlights the challenge of late-stage clinical trial failures and the company’s ability to better navigate those obstacles and increase the probability of technical success which is a key metric in target selection, clinical trial design and pipeline replenishment.

Drug Development

Drug Development Clinical Trials Animal Testing Trials

Managing data as a product with distributed reference and master data

The Pharma Data

FEBRUARY 5, 2021

In this white paper, H. Download the white paper to understand: The different types of data within an organization, and the challenges they pose. Unleash the power of distributed data management by downloading the white paper. Oberkampf, C. Senger and M.

Production

Production Marketing Research

The use of Predictive Oncology’s EndoPrep™ with FUJIFILM Wako’s PYROSTAR™ demonstrates the ability to reduce protein interference with a variety of common proteins.

Predictive Oncology

JULY 26, 2024

EndoPrep as a sample treatment system to be used with FUJIFILM PYROSTAR ES-F/Plate Download white paper here Interested in partnering with us? Please fill out the form below. appeared first on Predictive Oncology.

Treatment

A Clear Path to Medication Affordability Requires Meeting Patients Where They Are

Drug Channels

SEPTEMBER 22, 2023

To learn about CoverMyMeds’ medication affordability solutions that engage patients, download the CoverMyMeds white paper: Overcoming Affordability Challenges with Patient-Centered Solutions. Read on for Kristina’s insights. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

Pharmacy

Pharmacy Production Drugs

Antibody Profiling: Decoding the Humoral Immune System

Fierce BioTech

APRIL 10, 2024

Get your FREE white paper to understand the challenges in disease diagnosis, the impact of antibody biomarkers, and the nuances of antibody screening for biomarker discovery.

Disease

Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

Conversations in Drug Development Trends

MARCH 12, 2024

For a more in-depth look at biomarkers, check out our white paper. The IO biomarker field is rapidly evolving—check out this white paper for the latest details regarding IO biomarkers. Below, we discuss some validated circulating oncology biomarkers, their implementation, and key operational considerations.

Clinical Trials

Clinical Trials Immune Response Trials Disease

Double-blinding And Removing Bias With Over-encapsulation

The Pharma Data

NOVEMBER 16, 2020

White Papers / Tech Papers. While there are many blinding options available, over-encapsulation remains the most popular method adopted by sponsors to meet regulatory demands. Source link.

Your Guide to the Ultimate Pharmaceutical Product Improvement Tool

Fierce BioTech

MAY 14, 2024

Your Guide to the Ultimate Pharmaceutical Product Improvement Tool This white paper will review how automating the annual product quality review (APQR) process can help pharmaceutical companies simplify and optimize their product quality review process, to make informed product quality decisions quicker and on a more routine and proactive basis.

Production

Production Pharmaceuticals Pharmaceutical Companies

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

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

Clinical Trials Pharmacy Clinical Pharmacology FDA

Exploring The World Of Medicated Chewing Gum

The Pharma Data

NOVEMBER 11, 2020

White Papers / Tech Papers. Chewing gum as a dosage format for pharmaceutical applications in the OTC market stands out as a fast growing, innovative dosage format. Source link.

Pharmaceuticals

Pharmaceuticals Marketing

A Comprehensive and Flexible Approach to CMC for Fab and Fc-Fusion Development Programs

Fierce BioTech

MAY 29, 2024

Read this white paper to learn more. Read this white paper to learn more. lbarrick Wed, 05/29/2024 - 10:41 New molecular formats are gaining momentum in today’s market.

Treatment

Treatment Disease Production Marketing

Straight to Market in an Autoinjector

Fierce BioTech

APRIL 10, 2024

Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors.

Marketing

Efficient-Pro Medium and Feed 1 enable rapid and seamless upstream process development and scale-up for CHO-K1 cells

Fierce BioTech

JULY 18, 2024

Efficient-Pro Medium and Feed 1 enable rapid and seamless upstream process development and scale-up for CHO-K1 cells Download the white paper to learn how this innovative solution can help optimize your mAb production processes.

Laboratories

Laboratories Production

Blueprint for Modern Patient Recruitment

Fierce BioTech

JANUARY 26, 2024

This white paper is a culmination of insights from leaders in the field and proprietary data analysis, offering a guide to modernizing patient recruitment strategies in clinical trials. Blueprint for Modern Patient Recruitment Every day, a clinical trial is delayed due to recruitment planning issues. Download now. Download now.

Clinical Trials

Clinical Trials Trials Science

Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

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

Trials Disease Drug Development Clinical Trials

The Stage Gate© Model: A Proven Approach to Streamline Biomanufacturing

Fierce BioTech

DECEMBER 22, 2023

This white paper explains how Resilience utilizes a Stage-Gate approach to technology transfer and biomanufacturing. This white paper explains how Resilience utilizes a Stage-Gate approach to technology transfer and biomanufacturing. Download now.

Research

Location Matters: The Value of a Phased Approach to Medical Device Site Strategy

Fierce BioTech

DECEMBER 21, 2023

Location Matters: The Value of a Phased Approach to Medical Device Site Strategy Unlock the secrets to successful manufacturing site investment with this white paper. dfarris Thu, 12/21/2023 - 09:10 Unlock the secrets to successful manufacturing site investment with this white paper.

Antibodies: The Breakthrough Past, Blockbuster Present and Cutting-Edge Future

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

Therapies Drug Development Research Drugs

Why Is It So Difficult to Get Physician Affiliations Right?

Fierce BioTech

NOVEMBER 27, 2023

In this white paper you'll learn factors influencing the rate of change, including specialties, demographics, and more. In this white paper you'll learn factors influencing the rate of change, including specialties, demographics, and more. The healthcare provider landscape is incredibly dynamic. Download now.

Making the connection: Global perspectives on consumer-centric marketing

The Pharma Data

JANUARY 11, 2021

Download a copy of this white paper and explore the power of consumer-centric marketing. . Download a copy of this white paper and explore the power of consumer-centric marketing. Harness the power of “big tech” to build more targeted digital marketing content. Download Your Copy.

Marketing

Marketing Production

Planning for success in cell-based manufacturing

Fierce BioTech

OCTOBER 17, 2024

This white paper details the importance of quality assessments from preclinical to commercial phases. Planning for success in cell-based manufacturing Selecting quality raw materials is crucial for developing GMP-compliant processes for recombinant proteins and monoclonal antibodies.

Global perspectives on consumer-centric marketing

The Pharma Data

FEBRUARY 5, 2021

Harness the power of “big tech” to build more targeted digital marketing content.

Marketing

Marketing Production

Overcome Challenges and Secure Successful Technology Transfers of Complex Biological Products in Sterile Manufacturing

Fierce BioTech

NOVEMBER 6, 2023

This white paper delivers an analysis of critical success factors for effective technology transfer. This white paper delivers an analysis of critical success factors for effective technology transfer. This white paper delivers an analysis of critical success factors for effective technology transfer.

Production

How the FSP Model Augments Biotech Sponsors’ Internal Capabilities

PPD

OCTOBER 21, 2024

Our white paper on the topic examines reasons biotech companies use the functional service provider (FSP) model to support their clinical development activities and the value that FSP engagements bring to these organizations.

International

International Clinical Development Clinical Trials Clinical Research

Effective Technology Transfers for Mammalian-Derived Biologics

Fierce BioTech

NOVEMBER 13, 2023

Download this White Paper today to learn more. Effective Technology Transfers for Mammalian-Derived Biologics As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step.

Research

Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Conversations in Drug Development Trends

APRIL 4, 2024

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. To ensure transparency, accountability, and adherence to standards, document rigorously throughout the entire study.

Small Molecule

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies

Autoantibodies: Powerful Biomarkers in Cancer Precision Medicine

Fierce BioTech

JUNE 1, 2023

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. The unique patterns of autoantibody production mirror the highly heterogeneous nature of cancer.

Treatment

Treatment Production Research

Six Trends to Watch in the New Healthcare Economy

Drug Channels

MAY 20, 2021

To learn more, download Six trends and tactics to thrive in the new healthcare economy , a free white paper from Wolters Kluwer. She explains how coordinated intelligence can help businesses improve effectiveness in the new healthcare economy. Read on for Karen’s insights. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc.

Drug Development

Drug Development Drugs

New Findings on the Sinclair Nanopig™ in Safety Studies

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?

Drug Development

Drug Development Drugs Research

Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ for (Bio)Pharmaceuticals Safety Assessment

Alta Sciences

JULY 23, 2024

Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ for (Bio)Pharmaceuticals Safety Assessment tchichekian Tue, 07/23/2024 - 12:14 Publication White paper_Sinclair Nanopig Data_v3.pdf pdf Tags Preclinical Research URL [link] Category White Paper Weight 5

Pharmaceuticals

Pharmaceuticals Research

Does the Drug Shortage White Paper Fall Short?

Analysis Chemical: EPA releases white paper for second part of the risk evaluation for asbestos

Trending Sources

White paper: A patient-centric and inclusive approach to patient recruitment

Analysis Chemical Thank You EPA releases white paper for second part of the risk evaluation for asbestos

Can we use plastic waste to build roads, buildings, and more?

EPA issues white paper exploring the adoption of structured content and digital pesticide labels

Hybrid FSP/FSO Solutions Enable Flexibility and Agility to Keep Biotech Trials On Time and On Budget

A Clear Path to Education Affordability Requires Meeting Patients Where They Are

Predictive Oncology enters biomarker discovery market after successful retrospective ovarian cancer study yields compelling results

Genetic testing of patients with atrial fibrillation can alert clinicians to potential development of life-threatening conditions

Heterogeneous and curated biobank of live-cell tumor samples retains highly reproducible drug response data for drug and biomarker discovery

Heterogeneous and curated biobank of live-cell tumor samples retains highly reproducible drug response data for drug and biomarker discovery

Nuclear medicine global initiative reports worldwide challenges and opportunities in theranostics education

An Integrated End-to-End Approach to Antibody Drug Conjugate Development and Manufacturing

Increasing the probability of technical success in drug development using AI and patient heterogeneity

Managing data as a product with distributed reference and master data

The use of Predictive Oncology’s EndoPrep™ with FUJIFILM Wako’s PYROSTAR™ demonstrates the ability to reduce protein interference with a variety of common proteins.

A Clear Path to Medication Affordability Requires Meeting Patients Where They Are

Antibody Profiling: Decoding the Humoral Immune System

Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

Double-blinding And Removing Bias With Over-encapsulation

Your Guide to the Ultimate Pharmaceutical Product Improvement Tool

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Exploring The World Of Medicated Chewing Gum

A Comprehensive and Flexible Approach to CMC for Fab and Fc-Fusion Development Programs

Straight to Market in an Autoinjector

Efficient-Pro Medium and Feed 1 enable rapid and seamless upstream process development and scale-up for CHO-K1 cells

Blueprint for Modern Patient Recruitment

Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

The Stage Gate© Model: A Proven Approach to Streamline Biomanufacturing

Location Matters: The Value of a Phased Approach to Medical Device Site Strategy

Antibodies: The Breakthrough Past, Blockbuster Present and Cutting-Edge Future

Why Is It So Difficult to Get Physician Affiliations Right?

Making the connection: Global perspectives on consumer-centric marketing

Planning for success in cell-based manufacturing

Global perspectives on consumer-centric marketing

Overcome Challenges and Secure Successful Technology Transfers of Complex Biological Products in Sterile Manufacturing

How the FSP Model Augments Biotech Sponsors’ Internal Capabilities

Effective Technology Transfers for Mammalian-Derived Biologics

Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Autoantibodies: Powerful Biomarkers in Cancer Precision Medicine

Six Trends to Watch in the New Healthcare Economy

New Findings on the Sinclair Nanopig™ in Safety Studies

Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ for (Bio)Pharmaceuticals Safety Assessment

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