article thumbnail

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

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 59
article thumbnail

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

Antidote

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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

PPD

are outsourced to a contract research organization (CRO) partner. 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 95
article thumbnail

Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

Conversations in Drug Development Trends

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.

article thumbnail

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

Fierce BioTech

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 52
article thumbnail

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

Predictive Oncology

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.

article thumbnail

Managing data as a product with distributed reference and master data

The Pharma Data

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.