Partnering & Outsourcing Editorial

  1. Allena Creates Oral Biologics To Treat Metabolic and Kidney Disorders

    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.

  2. 3 Major Challenges With Global Clinical Trials — And How To Overcome Them

    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.

  3. Should You Conduct Your Medical Device Clinical Trial In Latin America?

    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.

  4. Phase 1 Trial Targets The Immune System, Not The Cancer

    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.

  5. Oramed Manages Contract Partners To Bring Oral Insulin To Patients

    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.

  6. Clinical Trials: Not Broken, But In Need Of Repair

    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?

  7. Is A Functional Service Provider (FSP) Model The Right Fit For Your Clinical Study?

    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.

  8. A Simulation-Based Approach To CRO Selection

    Protocol or clinical trial simulations have been on the radar screen of the industry for quite some time as a technique for optimizing trial design and decision making.

  9. Pediatric Cancer Trials: Is There A Solution?

    Why is it so hard to develop drugs for children with cancer? And what can be done about it? Those questions are central to a new study published in JAMA Oncology that explores new business models for funding drug development to treat pediatric cancers.

  10. CRO Selection 101 — How To Get Started

    This three-part article series will look at how best to procure, manage, and implement best practices in this complicated market.