CGT Release

Release Testing as a Cell and Gene Therapy Manufacturing Bottleneck

Pharma's Almanac

LNP Analytics

Beyond Particle Size: Building a Complete Analytical Strategy for LNPs

Pharma's Almanac

API Oversight

Can Regulatory Reliance Make Global API Oversight More Efficient?

Pharma's Almanac

NAMs

The EMA Builds a Regulatory Safe Harbor for New Approach Methodologies

Pharma's Almanac

Oncolytic Viruses

Turning Oncolytic Viruses into Manufacturable Cancer Therapies

Luisa Amoedo Otero

Recipharm Advanced Bio

Drug Shortage

What It Actually Takes to Engineer a Drug Supply Chain Out of Shortage

David Alvaro, Ph.D.

Pharma's Almanac

CCS and CMC

Packaging Returns to the Center of CMC Strategy

Pharma's Almanac

iPSCs

For iPSC Therapies, Manufacturing Consistency May Mean Preserving Function

Pharma's Almanac

Development CDMO

The Case for Earlier CDMO Involvement in Drug Development

David Alvaro, Ph.D.

Pharma's Almanac

Potency Assurance

Why Potency Cannot Be Reduced to a Release Assay in Active Immunotherapy Development

David Alvaro, Ph.D.

Pharma's Almanac

Preparedness

Preparing Manufacturing Networks for the Next Pandemic

Pharma's Almanac

Supply Chain

Supply Chain Resilience in 2026: Any Progress?

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Device Integration

Medical Device Integration: Exploring the Benefits and Challenges to Effective Implementation

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Stem Cells

Stem Cell Therapies: Close to Transforming Promise into Real Patient Outcomes

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Rare Cancer CGT

Developing Cell and Gene Therapies for Rare Oncology Applications

David Alvaro, Ph.D.

Pharma's Almanac

Data Integrity

Data Integrity: Drivers, Challenges, and Key Program Elements

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Adaptive Trials

Designing for Change: Adaptive Clinical Trials and the Evolving Path to Regulatory Acceptance

Pharma's Almanac

Personalized

Regulatory Innovation for a More Personalized Era of Medicine

Pharma's Almanac

Expedited Pathways

Accelerated Pathways: Are They Delivering on Their Promise?

David Alvaro, Ph.D.

Pharma's Almanac