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Business & Regulation Standards & Regulation

FDA Warning Letters: September 2024 Edition

| Stephanie Vine | 3 min read

Here’s a look at recent violations cited in FDA Warning Letters: fly pupae, cross contamination, trial dosing errors, and more.

Business & Regulation Trends & Forecasts

The Multifaceted Future of Pharma

| Stephanie Vine

We asked over 100 industry professionals for their views on the future of the pharma and biopharma industries.

Discovery & Development Formulation

The Liquid Challenge

| Louise Carpenter | 4 min read

Regulators want more pediatric formulations. Companies often turn to liquids, but there are specific challenges that need to be considered.

Business & Regulation Trends & Forecasts

The Building Blocks of Engagement

| Aaron Bean | 3 min read

Shifting trends demand a change in how pharma field reps interact with healthcare professionals

Business & Regulation Digital Technologies

The Changing Landscape of Decentralized Clinical Trials

| Diane Leclerc | 2 min read

How technology is enabling new access to clinical trials for those without the means to participate in traditional methods

Business & Regulation Standards & Regulation

The Demands and Ethical Obligations of the DSCSA

| Matt Sample, Gregg Gorniak | 3 min read

The deadline for the US Drug Supply Chain Security Act is approaching.

Business & Regulation Business Practice

Why Pharma Must Embrace AI and Open Source

| Brendan Frey | 4 min read

With open minds and open sources, the future is foundational – and bright.

Manufacture Advanced Medicine

The Digital Dream

| Alexander Seyf | 4 min read

Digitalization can transform the operation and performance of the cell and gene therapy manufacturing space, to the benefit of all.

Manufacture Advanced Medicine

The Elite Athlete Concept for Cell Therapy

| Yelena Bronevetsky, James Lim | 4 min read

How metabolic conditioning could improve cell therapy potency and persistence.

Discovery & Development Drug Discovery

Let's Go In Vitro: Scalable 3D Models in AI Drug Discovery

| Jan Lichtenberg | 3 min read

AI is generating new drug discovery solutions for a rapidly changing industry

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