PPD

FEBRUARY 10, 2025

A recent white paper from the PPD clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 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. .

Clinical Trials 52

Clinical Trials Trials Regulations Production 52

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).

Therapies 59

Therapies Engineering Production FDA 59

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Researchers often employ cell therapy studies for oncology indications, and the U.S.

Trials 69

Trials Clinical Trials Drug Development Therapies 69

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.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

Agency IQ

JULY 8, 2024

BY WALKER LIVINGSTON, ESQ | JUL 3, 2024 4:40 PM CDT Background: FIFRA and antimicrobial pesticides Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the EPA is responsible for the regulation of pesticides in the United States. More than 3 million occur annually in the U.S., resulting in more than 35,000 deaths.

Virus 40

Virus Production Regulations FDA 40

Codon

APRIL 30, 2023

5/ Lots O’ Gene Therapies Not one, but two applications for sickle-cell gene therapies have been submitted to the F.D.A. If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans.

Vaccine 52

Vaccine DNA Engineering RNA 52