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Biotech Resources

Browse our Biotech resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

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Crafting an early genomics strategy in oncology drug development

Crafting an early genomics strategy in oncology drug development

Discover three key considerations for crafting a successful genomic biomarker strategy in this article.

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101 guide for real-world evidence

We have created this guide to simplify the terminology of real-world evidence (RWE) and outline some of the strategic options available.
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Top ten rules for success in decentralized trials

In this article, we summarize what we’ve learned and outline the top 10 rules for a successful DCT.

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How to accelerate oncology clinical trials through site relationships and patient insights

Learn how all stakeholders benefit when patients and their insights are at the heart of every aspect of clinical development.

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Tips for building your oncology reimbursement strategy

In this infographic, we share five tips for building an effective reimbursement strategy for your oncology product.

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101 guide for real-world evidence

We have created this guide to simplify the terminology of real-world evidence (RWE) and outline some of the strategic options available.

Learn More
Top ten rules for success in decentralized trials

In this article, we summarize what we’ve learned and outline the top 10 rules for a successful DCT.

Read More
We need faster endpoints for targeted cancer drugs, and there is one

As a former regulator, Jorge shares his perspectives for the need of more faster endpoints to measure how targeted cancer drugs can benefit patients. He believes it can be created by combining two...

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Three risk management strategies for expedited approvals

Three risk management strategies for drug developers who wish to take full advantage of expedited pathways to achieve reimbursable innovation for the benefit of patients.

Watch Video
Impact of COVID-19 on Drug Development in Rare Disease and Oncology

Key findings from a recent discussion with Parexel regulatory experts and the rare disease patient advocacy group Sara’s Cure.

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Leveraging Real-world Evidence in a Rare Disease Oncology Drug Approval

Parexel experts discuss a recent project involving a Rare Disease Oncology therapeutic, in which our experts leveraged Real-world Evidence and FDA/Regulatory expertise to develop and execute a Synthet

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Whitepaper: COVID-19 Vaccination in Cancer Patients

In this whitepaper, we address the unique variables, optimal timing, and immunogenic considerations for vaccinating individuals with cancer.

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Top 10 Myths About Working with the FDA for an Oncology Drug Approval

Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

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Parexel Biotech – a patient-centric approach is in our DNA

Hear firsthand from Monica about her personal journey as a clinical trial participant to understand the value of easing patient burden

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Oncology CoE brochure

Building oncology trials for those who need them most.

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On-demand webinar: Roadmap for Oncology Drug Development

Insights on regulatory and trial design considerations for drug development in oncology.

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Crafting a genomics strategy early is key for successful oncology drug development

Discover three key considerations for crafting a successful genomic biomarker strategy in this article.

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Infographic: Top 10 myths about working with FDA for oncology drug approval

Amy McKee, VP of Regulatory Consulting for Parexel and former Deputy Director of the FDA Oncology Center of Excellence, shares valuable insights about knowing when and how to engage with regulators.

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The Parexel Podcast | Episode 12: ASCO20 Debrief: The latest in cell and gene therapy

In 2020, ASCO went virtual for the first time. While the format was different, one thing was clear: despite all that is happening in the world, there are still many patients in need. Todd Shuster,...

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The future of clinical trials is now: Decentralized Clinical Trials

Parexel’s Decentralized Clinical Trials represent an opportunity to rethink and refresh how research studies are conducted.

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Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations

The global cancer drug market is set to maintain strong growth over the next decade due to factors such as environmental pollution, population aging, and poor lifestyles that leave...

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