Drug Discovery World

SEPTEMBER 29, 2022

This white paper expands on three key factors – cost, time, and innovation – and illustrates how integrating these factors will minimise the challenges and ensure success in outsourcing drug discovery. Three common questions regarding the challenges when considering outsourcing partners for drug discovery.

Small Molecule 130

Small Molecule Assay Development DNA Biochemical Assays 130

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.

Therapies 59

Therapies Engineering Production FDA 59

The Pharma Data

MARCH 20, 2021

A schematic of domain and functional organization of two of the major structural proteins of SARS-CoV-2, Nucleocapsid protein as a target viral antigen for assay development. Based on our discovery experiments, we decided upon nucleocapsid protein as our target antigen for assay development.

Virus 52

Virus Assay Development Laboratories RNA 52

Agency IQ

JULY 21, 2023

In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology. The paper, published in November 2021, primarily focused on the potential for ctDNA to serve as an early endpoint.

FDA 40

FDA Clinical Trials DNA Treatment 40