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Biosimilar Development: Are therapeutic clinical trials needed?

Biosimilar Development: Are therapeutic clinical trials needed?

In this article, Regulatory expert, Cecil Nick, looks at the latest MHRA guidance and what the future holds for biosimilar development.

Previous Article

Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some...
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Clinical pharmacology, modeling and simulation to support FIH study design

A major challenge in drug development is the translation of candidate molecules from the preclinical phase to the clinical setting. The key elements to be considered are the pharmacology,...

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Choosing a partner to successfully navigate the next five years

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Master Protocol Trials: What Are the Elements of Success?

The shortcomings of traditional study designs have come into sharp relief during the COVID-19 pandemic. Regulatory agencies and the research community alike have responded, acknowledging the need...

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CNS Summit Recap: The Future is Collaborative

Innovation is the lifeblood of research and development in any industry. Scores of industry efforts spanning digital therapeutics, data sciences and decentralized clinical trials represent the...

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Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some...

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Clinical pharmacology, modeling and simulation to support FIH study design

A major challenge in drug development is the translation of candidate molecules from the preclinical phase to the clinical setting. The key elements to be considered are the pharmacology,...

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Actigraphy advances a patient-first approach: Reduce patient burden — and make the most of valuable data

In a patient-centric clinical trial, we focus first on patient needs, finding ways to make participation simpler, more comfortable, and less invasive...

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Rethinking FSP outsourcing

Why a programmatic approach yields better results

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What COVID Taught Us About Focus, Innovation, and Leadership

Well before the COVID-19 pandemic struck in early 2020, drug developers were struggling to become more efficient. At industry conferences, executives, regulators, and investigators lauded new...

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Highlights from ISMPP Asia Pacific Meeting 2021

The recent Asia Pacific Meeting of ISMPP held from 10–11 September 2021 was attended by professionals from pharmaceutical firms, medical communication agencies, and academic journal publishers to...

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Capitalizing on sensors in clinical trials

For successful integration, you’ll need technical, logistical, and therapeutic expertise

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Example of a Lifecycle Management Strategy

Example of an Oncology Lifecycle Management (LCM) Strategy

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Example of R&D and Commercial Strategy

Two real life examples of R&D and Commercial Strategy

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Example Pharmacovigilance Strategy

Two real life examples from 2019 and 2020

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Example of Regulatory Strategy Delivery

Two examples from 2019 and 2020

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When personal challenges shape professional purpose

A rare disease — and a part-time job — showed Lisa Dilworth what she was meant to do.

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3 steps for making your CRO relationships more successful

During the twenty years I served as a chief medical officer for small and emerging biotech firms, selecting the right contract research organization (CRO) was one of the most important decisions I...

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A patient-centric approach to managing clinical trial complexity

The average length of a clinical study cycle is on the rise and has been for decades. Look at any five-year period: cycles are seven to 10 percent longer than in the five years immediately prior.

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Highlights from ASCO: Our experts weigh in

The ASCO Annual Meeting gathers oncology professionals from around the world to discuss the latest in cancer research and treatment. This year’s five-day event included more than 2,500 abstract...

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Four reasons to conduct robust natural history studies before clinical trials

Lucas Kempf, former regulator, reflects on his time at the FDA and outlines why companies should invest in a high-quality natural history study.

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Breaking through complex regulations and science speak – thinking “patients first” in lay language summary development

In this blog, our experts explore how to develop multi-purpose, patient-centric lay language summaries with the patient audience firmly in mind.

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