Blog

Rare Disease Research – Why we do what we do

July 28, 2022

Systemic juvenile idiopathic arthritis – can we do better? When I was a young pediatrician choosing my career path, I...

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Blog

A Regulatory Perspective on Cell and Gene Therapy in Oncology

July 18, 2022

The past decade has produced many promising innovative cell and gene therapies (CGTs) to treat human diseases. CGT products, which...

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Blog

Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection

June 27, 2022

The International Conference on Harmonization/Good Clinical Practice E6 (ICH GCP) lays out clear expectations for both the sponsor and investigators...

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Blog

Optimizing Trial Efficiency with Bayesian Dose Escalation Designs

April 14, 2022

As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods of dose escalation to...

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Blog

The Potential of Biosimilars – for Drug Makers and Patients

March 24, 2022

The production of biosimilar drugs remains at a rapid pace, and represents not only an advantage for patients, but a...

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Blog

The Multifaceted Role of the Nonclinical Expert at the Center of Drug Development Teams

March 14, 2022

Product development teams getting started on preclinical exploration of a potential treatment need a certain set of specialists on board....

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Blog

The Black Box of Anti-COVID-19 Monoclonal Antibodies: An Overview, Definitions, and Terminology

March 14, 2022

We learned on 25 January 2022 that the U.S. Federal Drug Administration (FDA) halted use of most monoclonal antibodies for...

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Expediting Treatments to Oncology Patients in Need: Understanding the FDA’s Accelerated Pathways

March 10, 2022

In recent years, we have observed a significant increase in use of expedited programs offered by the U.S. Federal Drug...

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Blog

The Case for Early Regulatory Consideration for Clinical Development of Chimeric Antigen Receptor T cell (CART)

January 20, 2022

Chimeric Antigen Receptor T cell (CART) has revolutionized the treatment of hematological malignancies, including B-cell acute lymphoblastic leukemia, B-cell lymphomas,...

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Blog

Great News from EMA in December: Three New Treatments for COVID-19

January 12, 2022

December 2021 brought great news for European COVID-19 patients, their health care providers, and the whole population suffering from medical...

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