When I reflect on my career journey, three lessons stand out: opportunities are only missed when they are not taken, discomfort is often where growth begins, and not knowing exactly what you want can sometimes open the door to what comes next.

For sponsors advancing novel therapeutics, development timelines directly influence strategic milestones, investor confidence, and how quickly programs can progress toward clinical validation. Acceleration impacts not only the pace of development, but also how early key decisions can be made, and how much flexibility remains as programs advance.

The recent adoption of ICH Q14, Analytical Procedure Development, and the revised ICH Q2(R2), Validation of Analytical Procedures, effective since June 2024, represents a significant evolution in regulatory expectations for analytical procedure development, qua

Over the past three decades, drug development has evolved rapidly—driven by new technologies, tighter timelines, and greater collaboration. CROs like Altasciences have transformed, shifting from service providers to strategic partners.

Hybrid medicines are drugs based on an approved active substance (or previously approved drug) and have a different route of administration, format, strength, or indication from the original reference product. 

They require approval for market authorization based on both data from the original reference medicine, and from new clinical trials on the modified version.