Conversations in Drug Development Trends

APRIL 4, 2024

Stability Tests: For small molecule, only -20°C stability testing is required, while large molecule need both -20°C and -70°C tests if samples are intended for storage at these temperatures. Select the right partner with experience meeting regulatory standards for all target markets.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

Agency IQ

NOVEMBER 10, 2023

Read AgencyIQ’s analysis of FDA’s QMM White Paper here.] What the offices will focus on: OPQA I and II are set to focus on small-molecule product assessments. OPQA III will “focus on drug substance assessment for both large and small molecule products.”

Pharmaceuticals 40

Pharmaceuticals Small Molecule Science FDA 40

PerkinElmer

FEBRUARY 18, 2021

Dr. Eckelt conducted 23 hour-long, 1:1 interviews over five months in 2020 to gather market insights on how the top 20 Pharma are increasing productivity, efficiency, and speed of drug discovery in the short and long-term. A PerkinElmer White Paper offers a detailed look at the findings. Small molecules are making a comeback.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 52

FDA Law Blog: Biosimilars

JANUARY 24, 2024

If this vision is achieved, the United States can bring innovative biotechnologies and products to markets faster while building a more robust supply chain ecosystem. capacity and technologies to support small molecule API production, including the impact of key starting material availability on U.S.

Small Molecule 67

Small Molecule Government Production Drugs 67

Codon

APRIL 30, 2023

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. Note: I’m employed by the company and a co-author on the paper.) vander Straeten et al. Cell Systems. Nature Communications. See you next week.

Vaccine 52

Vaccine DNA Engineering RNA 52

Codon

APRIL 30, 2023

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. Note: I’m employed by the company and a co-author on the paper.) vander Straeten et al. Cell Systems. Nature Communications. See you next week.

Vaccine 52

Vaccine DNA Engineering RNA 52