After more than 21 years leading process, product, and technical development efforts at Merck and Takeda, Piper Trelstad, Ph.D., joined the Bill & Melinda Gates Medical Research Institute in January 2022. On the Business of Biotech, we'll dive into how this full-fledged clinical-stage biopharmaceutical company is tackling health problems that challenge some of the world's most vulnerable populations. Listen now!
In an exclusive interview, FDA’s Peter Marks discusses CBER priorities, PDUFA VII funding, and improving the dialogue between regulators and drug makers.
Ray Therapeutics CEO Paul Bresge and 4BIO Capital Managing Partner Dmitri Kuzmin, Ph.D., break down the deal that launched Ray and ponder the risk of a mission-driven biopharma CEO.
Less than 10% of novel compounds that enter Phase 1 clinical trials obtain FDA approval, which is why we followed a detailed road map for budgeting and advancing our new therapy at each stage of development.
The projected growth of the clinical research industry demands that the workforce keep pace with the workload — and it must be diverse and research-ready. What’s at stake? Nothing more than the risk of delaying approvals of new treatments for patients who need them.
Learn how the use of real-world data supports regulatory decisions and approvals, and personalized treatments through digital technologies and therapies, while maximizing value and efficiency with data and analytics.
Regular assessments of a partnership’s value in terms of supply chain, operational efficiency, data analysis, and more can optimize and extend the product life cycle.
Discover how technological advancements have created the Internet of Things (IoT), in which numerous devices, including wearables like fitness trackers, can all be connected through software and cloud computing.
Understand the advantages of unit/bi-dose nasal delivery technology, application of QbD processes for inhaled product development, and why to outsource inhalation development and manufacturing.
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