Bristol-Myers Squibb (BMS) and Nektar Therapeutics have announced a partnership deal worth up to $3.6 billion that will lay out a new path for immuno-oncology (I/O) combination therapies.
When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted. The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Around the holidays, I reminisce about family dinners: three generations under one roof for a few hours, catching up on the past year. My mother presided over the festivities for several decades until her passing. For 10 years, she was a survivor of a rare cancer. She had two surgical resections and treatments before the cancer returned. There was only one approved orphan drug, which was 50 percent effective in decreasing mortality for six months. There weren’t many options in clinical trials and no Internet patient-centric community for information and support.
Learn how clinical development technologies and advanced analytics navigate sponsors through the challenges of patient scarcity to transform precision oncology research.
The reasons behind the physician monitors’ reluctance, and what technology needs to offer to convince monitors their work can be more efficient — quickly detecting safety signals and speeding time to submission.
Increasingly central in the course of drug development is the inclusion of observational studies, including registries, which provide insights missing from traditional interventional studies.
This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.
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The special requirements that must be met as the cloud as adopted by life sciences organizations.
How to be sure that the solution you’ve chosen is best suited to completing this task with speed and ease.
What can be done to that the technology opening new doors in the capture and analysis of clinical data, and the guidance responsible for regulating them, keep up with one another?
In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.
Selecting a partner is challenging, but with the right information you can simplify your efforts and increase your likelihood of making the best decision.