RA Biosimilar Recruitment

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs.

Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …

Brexit: Leveraging the Mutual Recognition Agreement to Mitigate Potential Risk With Commercial Drug Product Release Testing

The Brexit1 deadline has been extended once again – now to January 31, 2020 – and a withdrawal deal seems likely given the result of the December 12 general election. However, drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product …

Image of Hand Pressing Futuristic Tablet

Impact to the Bioanalytical Community of the FDA Issuance of the Draft Guidance on Biomarker Qualification: Evidentiary Framework

The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers.  It is intended to cover a regulatory gap related to the use of biomarkers outside of specific drug programs.  As such, this Draft Guidance supports the Qualification of Drug Development Tools …

Immuno-Oncology Studies

Emerging Immuno-Oncology Therapies: Life After Checkpoint Inhibitors

The clinical approval of biological therapeutics inhibiting CTLA-4 (ipilimumab), PD-1 (nivolumab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) has ushered in a revolution in the field of cancer immunotherapy. Thus far, the approvals have occurred in a small number of cancer histotypes including melanoma, non-small cell lung cancer and urothelial cancers, …

Pharmacovigilance & Risk Management for Biosimilars: Unique Challenges & Possible Solutions

Biological medicines (biologics) have made substantial contributions to the treatment of many chronic and serious diseases such as cancers, chronic inflammatory diseases and some rare genetic disorders, and are expected to provide significant therapeutic benefits to many patients who would otherwise have had limited treatment options.

Opportunities for Biomarkers in Immuno-Oncology

Exploring New Opportunities for Biomarkers in Immuno-Oncology

Pharmaceutical companies are increasingly relying on biomarkers to deliver precision medicine in immuno-oncology. Biomarkers can accelerate drug development and reduce the overall cost; they also allow sponsors to identify failed treatments sooner so that resources are not wasted on expensive, late-stage trials with unsafe or inactive compounds. Finally, these tests …

Biosimilars Covance

A Creative Solution to Address the Biosimilar Boom

Identifying viable study sites presents a challenge in many clinical trials. Biosimilar development is especially challenging as the number of sponsors preparing to broaden access to today’s blockbuster biologics, by providing lower-cost biosimilar alternative, continues to grow. While this flood of research activity will make a significant improvement for patient …

Purple DNA Strand

Immuno-Oncology Studies: Optimizing Design, Recruitment and Execution

The rise of immunotherapy has been meteoric — there are now well more than 1,000 immuno-oncology (IO) trials ongoing according to clinicaltrials.gov. Finding and enrolling the appropriate patients for these potentially revolutionary treatments has presented a profound challenge, one that was recently covered in the aptly titled New York Times …