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The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial.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

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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Cancer thriver and rare disease care partner Stacy Hurt is Parexel’s first Patient Ambassador and “secret weapon” to develop patient-centric clinical trials.

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Mitigating FSP talent shortfalls through development

Clinical research lacks workers — but in FSP, we’re training the professionals we need

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Adapting drug supply strategies to modern study models

As decentralized trials gain prevalence, clinical supply chains can flex to meet new needs.

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Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions

Just because the COVID pandemic disrupted business operations, the importance of data integrity in manufacturing has not diminished. Accurate data is the foundation of product quality. How can...

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New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

Over the past decade, there has been a proliferation of real-world data (RWD) sources that sponsors can use to generate real-world evidence (RWE) for a wide range of purposes across the product...

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Patient Advocacy Groups: A vital partner for sponsors that understand how to engage with patients

Julie has spent more than 25 years advocating for patients with chronic diseases, both professionally and personally. She has extensive experience in recruiting, engaging, and retaining patients...

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Patients as Partners 2022: Moving from Insights to Action

Empowered patients are the touchstone of modern healthcare. Yet, in a highly regulated industry, with scores of stakeholders, novel scientific questions and methodologies, emerging technologies...

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Toward more inclusive studies: Reaching and retaining patients from underrepresented communities

Across the clinical research community, we’re working toward creating more inclusive studies. By recruiting and supporting patients from underrepresented communities, we help ensure equitable...

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End-to-end risk management: Getting the most from your program

In every clinical trial, risk management is a must. However, it can start to feel routine: add some lines to a spreadsheet, move on to the next risk, and check the box that risk management is...

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Chris Learn joins Parexel as Head of the Cell and Gene Center of Excellence

Chris Learn, Ph.D., PMP, recently joined Parexel as Vice President, Head of the Cell and Gene Center of Excellence. During Chris’ first week, we asked him to share his professional experiences,...

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Getting to ‘No’ fast is more important when you are small

Drug development is a complex business. Historically, less than 8% of product candidates are reported to have made it from Phase I to market. One effective way to mitigate risk is to weed out weak...

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Six steps to maximize inclusivity within medical communications | Part 1: Race and Ethnicity

Our world is multiracial, multicultural, and multi-ethnic. Delivering meaningful communications that resonate with as many people as possible is important to embrace diverse thinking. Using...

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For payment systems to evolve to deal with reimbursement and market access challenges, payers are taking a new look at evidence generation and data usage. Medicines are so specialized today that...

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Three Ways Early-Stage Companies Can Attract Investors

During decades in this industry, I've seen biotech funding fluctuate. Right now, financings, deals, and M&As are blazing hot. In my experience, companies that raise money when they can but...

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What's the Future of FSP?

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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