Pharma Focus America
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Current Issue - Issue 03

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Issue 03 | 2024

  • Foreword
  • Strategy
  • Research & Development
  • Clinical Trials
  • Manufacturing
  • Information Technology
  • Expert Talk

Issue 03

CURRENT ISSUE

Foreword

Exploring the Disruptive Force of 3D Printing in Pharmaceuticals

Welcome to the third edition of Pharma Focus America....

Strategy

New MHLW Guidance Aims to Facilitate Inclusion of Japanese Participants in Global Clinical Trials

On September 13, 2023, the Ministry of Health, Labour and Welfare’s (MHLW’s)...

Research & Development

Beyond the Blueprint: mRNA’s in Promise Immunotherapy

The current landscape of cancer immunotherapy has seen significant advancements in recent years...

Clinical Trials

Revitalizing Research

Prioritizing Participant-centric Strategies to Accelerate Clinical Trials

We all know someone – a loved one, friend, or close acquaintance...

Applications and the Limitations of Real-World Data in Gene Therapy Trials

With an estimated 7,000 rare diseases touching the lives of over 350 million people globally, the challenge is immense

Manufacturing

Data Exchange in Pharmaceutical Manufacturing

Balancing Collaboration and Competition

In the pharmaceutical industry, the importance of sharing proprietary information plays a crucial role in driving innovation.

Revolutionizing Drug Manufacturing with 3D Printing

Three-dimensional (3D) printing is an advanced additive manufacturing technique that constructs complex products

Digitalization of a Novel Advanced Modular Continuous Pharmaceutical Drug Substance Manufacturing Process

In this work, the digital transformation process is demonstrated through a continuous pre-heating process which is a critical unit operation used in continuous API synthesis

Twin-Screw Granulation

An Alternative Continuous Granulation Approach

Melt granulation using hot-melt extrusion is one of the promising alternative approaches to producing granules.

The Journey of Mass Spectormetry in Biopharmaceuticals CMC Development

Mass Spectrometry (MS) is playing a bigger role than ever in supporting biopharmaceutical CMC development

Information Technology

The Emerging World of Smart Pills, Patches, and Implants

Innovative AI-Enabled Drug Delivery Systems

In the past, monitoring gastrointestinal status required invasive procedures or imaging tests external to the body.

A Ǫuick start Guide for Successful Cloud Migration of Global Pharmacovigilance (GPV) IT Applications

In the ever-evolving regulatory landscape of Global Pharmacovigilance (GPV)

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