Strategic partnerships have changed dramatically in the last 20 years. Regardless of your model, one thing is certain: All of them will have their own issues and challenges. What’s important is how you choose to address those outsourcing challenges when bumps in the relationship inevitably occur.
Researchers have known about Angelman syndrome for 50 years. Despite the research that has been done, there is still no treatment option available to patients. Ovid Therapeutics now faces several challenges in bringing a potential treatment through a critical Phase 3 trial.
While pursuing hid PhD in chemical engineering at MIT, Armon Sharei developed an interest in novel cell therapies. That interest led him to a discovery that today is the foundation of SQZ Biotech, a cell-therapy company where he serves as CEO. Sharei discovered a new method of inserting materials into cells more effectively than anything that currently existed.
Real-world evidence (RWE) has become a topic everyone wants to discuss. Several executives I have spoken to recently believe it will continue to grow in importance. But why the sudden interest in RWE?
Mary Elizabeth Williams is a journalist and an author. She is also a patient who has with metastatic melanoma who participated in a Phase 1 immunotherapy clinical trial. There is much that pharma can learn from her in terms of how companies approach clinical trials and drug development.
In his role as product line owner for digital health at Janssen, Mark Sapp leads a team that works directly with different therapeutic areas inside the company. “Our focus is helping our clinical teams get from point A to point B,” says Sapp. “We assist them with taking their idea and scaling it up, identifying the clinical endpoints they hope to achieve, and helping them stay focused on the results they need to generate.”
Developing cures for many diseases will require research into genetic data of the type 23andMe is collecting. The company is also collecting user information via voluntary surveys, asking users several questions every time they log on. The company now has, on average, over 350 data points (which 23andMe calls phenotypic information) on each customer. This information is helping the company match patients to trials.
In March 2019 I had the opportunity to interview Jennifer Newman, Global Project Leader, Regulatory Affairs/Clinical Operations for Celldex Therapeutics. Newman was once part of the largest implementation of risk-based monitoring (RBM) and was able to share insights from her experience.
In March 2019 I had the opportunity to interview Jennifer Newman, Global Project Leader, Regulatory Affairs/Clinical Operations for Celldex Therapeutics. Newman was once part of the largest implementation of risk-based monitoring (RBM) and was able to share insights from her experience.
Idorsia Pharmaceuticals Ltd was founded in June 2017 and came about as a result of the acquisition of Actelion Pharmaceuticals by Johnson & Johnson. Transition agreements allowed the company to use legacy systems from the prior company for a period of 18 months. By the time the agreements expired, Idorsia would have to design its own systems landscape.
