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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.

Parexel Biotech

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Early Planning & Development
Bioteching with Kate Bertolet

Bioteching with Kate Bertolet

Kate Bertolet, Chief of Staff for Parexel Biotech operations, talks about motivating her study teams and the drive to meet the unmet needs of the patients.

Previous Flipbook

What to know about FDA INTERACT meetings

Our regulatory expert and former FDA regulator Steve Winitsky shares his advice on planning and preparing for an effective INTERACT meeting.
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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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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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How biotechs can strengthen their value story with advanced analytics

Read five ways biotech companies can enhance their value story with advanced analytics.

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Three strategies for articulating a coherent product value story

Articulating a coherent product value story from the start of development can help companies attract investors.

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The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial.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

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Expedited Pathways Comparisons - US EU CHN

Slides presented during virtual roundtable, entitled "Making expedited regulatory pathways work for global drug development programs"

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Pharma Talk Radio: Building a Successful Relationship with your Development Partner

Skip Sands, SVP and Senior Medical Officer of Parexel Biotech, discusses practical examples of how to build and maintain a relationship based on mutual trust

Learn More
What to know about FDA INTERACT meetings

Our regulatory expert and former FDA regulator Steve Winitsky shares his advice on planning and preparing for an effective INTERACT meeting.

Read More
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...

Learn More
Five tips for effective early engagement with regulators and payers

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How a joined-up development strategy pays off for early-stage biotechs

Parexel Biotech’s Nate Akers, VP, Business Development, and Vicky Hsu, Head of Operations in Asia discuss the importance of aligning clinical execution with a clearly defined regulatory strategy.

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Four Keys to a Smoother Clinical Development Journey

Whitepaper recently published in Fierce Biotech providing perspectives on how the right partner can help bring all the disciplines together for a successful development program.

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Parexel Biotech Brochure

Learn about the services and approaches that Parexel Biotech offers to help you make an exponential difference in patients’ lives.

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Opportunities for biotechs in precision medicine: bringing important new therapies to patients and value to the company

For biotech companies, precision medicine holds tremendous promise for innovation – for newly designed drugs, new technologies for drug delivery, and engineered cell or gene therapies.

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Patient registries: Defining the patient

Parexel’s Leanne Larson, Corporate VP and WW Head, Real-world Evidence speaks with Deborah Collyar, cancer survivor and President of Advocates in Research about the importance of Real-world Evidence

Watch Video
Genomics & biomarkers: Answers in the blood

Parexel’s Anita Nelsen, SVP, Translational Medicine and Michelle Hoiseth, Chief Data Officer, Corporate VP speak with Ashley Druckenmiller about caring with her two sons with hemophilia and the benefi

Watch Video
Cell and gene therapies: for biotechs, collaboration is key to successful innovation

Learn more about what to look for in the right CRO partner to overcome logistical and operational challenges in cell and gene therapy product development.

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