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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.] In addition, a new Office of Pharmaceutical Quality Research (OPQR) will oversee all research and a new Office of Quality Assurance (OQA) will oversee training and development of staff as well as enterprise project management and the Quality Management System.

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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

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. Biotechnology and Biomanufacturing; Harnessing Research and Development to Further Societal Goals.” The first goal under Theme 1—Goal 1.1—is The four panels of experts focused on: (1) Current U.S.

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Codon Digest: Vaccine Printer Go Brrrrr!

Codon

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. 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
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Codon Digest: Vaccine Printer Go Brrrrr!

Codon

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. 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