It has become more important than ever to start thinking and talking about your drug development plan as early as possible. From more complicated protocols and adaptive design to electronic data capture and electronic patient reported outcomes – new technologies are creating opportunities but also adding to the complexity of a clinical trial design. That […]
There is very often a them-and-us mentality when it comes to how biotech companies think about the regulators. New companies, in particular, tend to view what is said by the regulators as prescriptive and are afraid to speak to them or get the scientific advice that is available. However, if they did take time to […]
The regulatory process is complex and can be very difficult to navigate. It’s not just about gathering data and meeting milestones, but also about understanding the regulatory language. Often, young biopharma companies come to me after completing a scientific advice procedure with the regulators and are under the impression that the agency in question have […]
Start-ups and emerging biotech companies often start out with lofty goals about what their products can do. That’s very noble but it’s also an easy way to run out of money halfway through the development process. While it’s good to have long-term goals, success depends on developing a well-defined target product profile (TPP). Start with […]
Patient-engagement or patient-centricity is now widely spoken about, but it’s rarely brought into the process of product development early on. As a regulatory consultant, my role is to fulfil the objectives of our clients as I help them navigate the clinical trial approvals process and I strongly believe that this would be a good point […]