In this ISSUE

Europe to Stay Open for Non-Human Primate Research

TransCelerate Establishes Technology Common Protocol Template and Collaborates with the FDA/NIH

Regulatory

Biosimilars Overcome Hurdles, Move into Mainstream

The FDA ruling that exempts biosimilar makers from waiting an extra six months after approval to distribute a new product should help overcome delays in future biosimilar sales, writes Jill Wechsler.
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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
Live Webcast: Tuesday, September 19 at 2:00pm BST and Thursday, September 28 at 10am EDT

Patient Centricity

Measuring Adoption and Value of Patient Engagement

Recent studies may help break down barriers to implementing patient-centric initiatives.
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Minimal Residual Disease Detection: Key Considerations for Clinical Development in Oncology
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Protocol Design

Data Shows Pharma is not Fully Incorporating Patient Endpoints Study Design

In this article, we will analyze themes from asthma patient conversations via HealthUnlocked, an online healthcare social network, and compare these themes to asthma clinical trial endpoints from large pharma studies.
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Shortening Biosimilar Development: A Case Study Integrating Early Clinical (Phase I) with late phase (Phase III) Biosimilars Development
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Trial Management

Perspectives on Past, Present, and Future of Clinical Trials

As we mark a milestone year for our publication, several guest contributors look at the complexity issues in drug development still to overcome.
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Coming to terms with Patient Centricity
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