ISR Reports recently published the third edition of its Clinical Development Outsourcing Models report. I spoke to Andrew Schafer, president at ISR Reports, about the report, what we can learn from the responses, and what we can expect to see in clinical outsourcing models moving forward.
This is part 2 of a three-part article series on how best to procure, manage, and implement best practices in the complicated CRO market.
But what best practices can you employ to ensure you and your site personnel are seeing eye-to-eye? Carrie Melvin, VP of Global Clinical Operations at TESARO, addressed the topic at the 2018 Clinical Leader Forum in Philadelphia. Proper communication will help ensure monitors are properly trained, protocol deviations are prevented, and data is collected timely and accurately.
Allena Pharmaceuticals has quickly made the move from a discovery- to a clinical-stage company. Allena went public about eight months ago and already has a product (ALLN-177) that addresses a rare disease population and is also in a much broader, Phase 3 clinical trial.
The disconnect between increased investment/activity and output points to continuing significant challenges in the global clinical trials market. Here we examine three of the leading issues facing the biopharmaceutical industry today.
Bilingual U.S. board-certified physicians who have a track record of research and publications and and the fact that trial costs are significantly lower in the region, makes Latin America very attractive for U.S. life sciences companies looking to conduct cost-effective and ethical OUS clinical trials.
INmune Bio is focused on the innate immune system, which is part of a system that has two components - adaptive and innate. Until recently, most activity was focused on the adaptive side, because of the attention being paid to CAR-Ts and checkpoint inhibitors. INmune is targeting the innate system by focusing on MDSCs.
Oramed Pharmaceuticals hopes to make oral delivery of medicines a reality for all patients. The company is focused on taking many treatments that have only been available via intravenous injections and making them available to patients via oral dosage.
The many challenges sponsors face performing clinical trials led Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, to remark in 2017 that the clinical trial system is broken. But if that’s the case, how do we uncover the underlying problems and bring all stakeholders together to fix them?
As the CRO industry continues to consolidate at breakneck speed, how pharma and biotech seek external development expertise and labor support for their potential compounds has evolved. Strategic preferred provider partnerships have often turned out to be neither strategic nor preferred, leading many companies to rethink their entire research strategy and revisit insourcing (traditional staffing) and the functional service provider (FSP) models.
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