Why IDEA set out to provide sponsors with a trusted, independent EU legal representative While the Clinical Trials Regulation has clarified the role of the legal representative, IDEA Regulatory’s founder Dr Francisco Harrison recognised early on that it was more complicated and involved than many sponsors and CROs interpreted it to be. Having supported clients […]
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 […]
Despite having talented teams, small companies are forced to work with limited resources and access to specific expertise. They often lack the resources and experience in navigating specific regulations, the nuances of working in different countries and have limited time to spend on regulatory intelligence. Working with a regulatory expert who is familiar with your […]
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 […]
There is much talk today about patient-centricity in the clinical trials, from discussions about how to ease the burden for patients, to how to empower and engage patients. But to my mind a central aspect of patient centricity that is poorly addressed is how patients and advocacy groups get better access to medical research, or […]
In drug development, it’s often the area you least expect that causes the most problems. In my experience, one of the biggest hold-ups to completing regulatory submission dossiers relates to manufacturing, not the safety and efficacy data. The information needed for the Investigational Medicinal Product Dossier (IMPD) or CTD Module 3 (M3) — stability testing, […]
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 […]
In a previous blog post (Linked here), I raised the issue of patient-centricity and my concern that it is being used more as a marketing tool than a way to build truly patient-centric products. To shift that thinking, there needs to be broad commitment to bringing patients into the fold at every stage of the […]
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 […]