Newsletter | February 25, 2025

02.25.25 -- FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

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FEATURED EDITORIAL

FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products

The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.

INDUSTRY INSIGHTS

Identify Lead Solid Form Early To Reduce Timelines And Downstream Costs

Devoting early-phase resources for solid form understanding and screening during a drug’s development lifecycle is critical, as doing so can help save time and resources on the path to market.

How To Build An Effective Protein Degrader

Explore four essential questions to ask yourself when developing a PROTAC molecule to ensure you’re on the right track to protein degradation success.

Optimizing Time And Cost Efficiency In Cell Line Development

Discover a system that automates mAb purification, reducing time and costs in cell line development while improving reproducibility, with faster processing than traditional methods.

Specializing In Small And Early-Stage Partners, Not Just Small Batches

Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

End-To-End Manufacturing: Small Volume Commercial Products

To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

Three Key Considerations For Optimizing Process Development

When it comes to process development, timing, technology, and partners all merit careful consideration. Explore expert insights into these three crucial factors.

Rapid Drug Repurposing With Human Airway Lung-Chips

In this presentation, we introduce the human Airway Lung-Chip, which can model influenza virus infection and evolution in vitro and evaluate therapeutics for both influenza and SARS-CoV-2.

Local Delivery For Treatment Of Lung Cancer

Explore two case studies where lung cancer therapies were delivered to the lung by dry powder inhaler, confirming local delivery is a promising route to treat lung cancer.

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Tampere University Licenses To Theravia A Drug Molecule Intended For Treating EB

Conduit Pharmaceuticals & Charles River To Evaluate AZD1656

Akeso Announces IND Acceptance For AK139

Kexing Biopharm Obtained IND Approval For Its Self-Developed GB05 From U.S. FDA

U.S. FDA Accepts Gilead's NDA For Twice-Yearly Lenacapavir

Sonnet BioTherapeutics Announces Plans To Advance The Development Of Its ADC Platform

Launch Of Joint Demonstration Experiment Of Remote Provision Of GPU Computing Power

SOLUTIONS

Antibody Discovery & Engineering Services

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