Search results for Drug Development

<![CDATA[Developing New Therapies Across Multiple Regulatory Landscapes]]>

What actually drives speed in complex drug development programs

Learn how early coordination across functions, phases and partners can reduce risk and accelerate drug development.

FDA floats new clinical trial reforms; Takeda punts Denali brain drug

In its budget request, the agency proposed a way to speed up early drug testing and help smaller biotech firms. Elsewhere, two startups raised megarounds.

<![CDATA[Model Examples]]>

Organoids as Predictive Translational Models for Drug Development

Retrospective clinical concordance supports earlier, patient-relevant decisions. The post Organoids as Predictive Translational Models for Drug Development appeared first on GEN -...

FDA Makes Moves to Modernize Drug Development, Clinical Trial Paradigm

On April 28, 2026, the Food and Drug Administration (FDA) unveiled two major announcements as part of its initiative to “advance the implementation of real-time clinical trials.” I...

U.S. Medical Centers Need a New Model for Drug Discovery and Development

China’s faster, more efficient model is forcing U.S. competitors to rethink how they innovate.

Faster Process Development via “Transfer Learning”

An emerging machine learning based technique called transfer learning has the potential to help drug companies reuse historical data to create predictive models that can help accel...

Utilizing AI to Facilitate Combination Product Development

Specific examples of AI/ML usage by pharma companies through the combination product development process

Old Drugs, New Tricks: FDA’s Drug Repurposing Initiative

By Charles D. Snow & Kalie E. Richardson —

<![CDATA[FDA’s Shift Signals a New Era for Data-Driven Drug Development]]>

Organoids Drive Human-Relevant Drug Discovery

Organoids, spheroids, and other complex cellular models allow scientists to recreate aspects of tissue structure and function in the laboratory. These systems now play a central ro...

Critical Path Institute Unveils New Coalition to Propel Human-Relevant Drug Development Tools

TUCSON, Ariz., and AMSTERDAM — May 19, 2026 — In a transformative step for drug development and regulatory science, the Critical Path Institute (C-Path) has officially launched the...

Accelerating Organoid Adoption Set to Transform Cancer Drugs

Today’s organoid companies underscore proof points in the ability to model complex human biology with high fidelity. At the same time, the government’s evolving regulatory stance i...

FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases

As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.”), the U.S. Food and Drug Adminis...

FDA Announces New Real-Time Clinical Trial Initiative to Expedite Development, but at What Cost?

By Mark A. Tobolowsky & James E. Valentine —

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

WEDNESDAY, April 29, 2026 — The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon...

The Changing Landscape of New Approach Methodologies

Now more than ever, NAMs need to be considered a core aspect of modern drug development – and scientists, decision-makers, regulators and governments must keep pace with this evolv...

Biotech Insights - Spring 2026

Regulatory Overview: Post-Approval Changes to Marketed Drugs - The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently...

Japanese Pharma Companies Turning to CDMOs Earlier in Product Life Cycle

The bottleneck isn’t discovery anymore. It’s execution. In peptides, programs are running into challenges around analytical complexity, scaleup, and the availability of key raw mat...

<![CDATA[Maximizing Drug Impact]]>

Ensuring Sustainability Throughout Drug and Device Development

How the biopharma and drug delivery industries actively move to embed sustainability into core principles, products and processes

Medikamente: Effizientere Entwicklung mit KI und Petrischale

Künstliche Intelligenz und Mini-Organe aus der Petrischale helfen in der Pharma-Branche im Wettlauf gegen die Zeit – sie optimieren den Entwicklungsprozess.

How to Use Real-World Data to Improve Drug Development, Starting with the Patient Journey

[Sponsored] A new eBook explores how using real world data from patients can help drug developers improve outcomes for non-small cell lung cancer and other patient populations. Th...