Newsletter | November 14, 2023

11.14.23 -- Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture



Comparing FDA And EMA Approaches To AI/ML In Drug Development And Manufacture

Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern. 


Extractables And Leachables: Risk Management And Analytical Solutions

Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

Recent Innovations And Enhancements To Pharmaceutical Spray Drying

Finding alternative solvent approaches could allow for lower volumes of less toxic solvents, significantly improving both the environmental and human health implications of new drugs produced.

Adapting To Change: API Custom Development And Manufacturing

A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase 2/3 trials.

Nanoparticle-Enabled Formulation And Drug Delivery Solutions

Discover how revolutionary and environmentally sustainable nanoparticle technologies coupled with innovative formulation approaches can address drug solubility issues and add value for patients.

PBPK Modeling: Mitigating Absorption Risks In Early Drug Development

Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.

Meeting The Challenge Of Rising API Complexity

Review award-winning AI and vast data that propel a leading predictive retrosynthesis technology and how Lonza tailored its performance to suit the needs of process chemists in preclinical route design.


Dewpoint Therapeutics Enters Strategic Partnership With Evotec

Cabaletta Bio Receives FDA Clearance Of CABA-201 IND Application

Biotheus Enters Into Strategic Partnership With BioNTech

AviadoBio Announces FDA IND Clearance & Fast Track Designation For AVB-101

Prostate Cancer Drug Candidate Developed At UTHSC Goes To First Clinical Trial

Duke-NUS & Japan-Based IPGaia Announce Partnership To Accelerate Innovation

First In Human Trial Of New Drug Raises Hopes For Patients With Relapsed Blood Cancer

9xchange Biopharma Marketplace Partners With PhaseV

Crown Bioscience Introduces OrganoidXplore

BioPhy Launches AI Platform To Accelerate The Trillion Dollar Drug Dev Market

New Antifungal Molecule Kills Fungi Without Toxicity In Human Cells, Mice


DPI Formulation Development And Manufacturing

Can You Run Crude Samples Using An SPR Instrument?


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