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Top 10 Drug Discovery Trends at the Top 20 Pharma

PerkinElmer

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.

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Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Conversations in Drug Development Trends

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.

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Analysis Life Sciences Thank You CDER’s Office of Pharmaceutical Quality to reorganize, citing need to address ‘pain points’

Agency IQ

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.”

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A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House

FDA Law Blog: Biosimilars

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.

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Codon Digest: Vaccine Printer Go Brrrrr!

Codon

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
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Codon Digest: Vaccine Printer Go Brrrrr!

Codon

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