Start with the end in mind: Planning your clinical trial strategy early on
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 […]
Keeping your EU submissions moving with our Regulatory-on-Call service
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 […]
Speaking up: How a conversation with the regulators can set the stage for success
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 […]
Report study results or face a big stick: the pros of regulatory penalties
Reporting your clinical trial results is both a legal requirement and a moral imperative. Whether your product failed early on, failed in later-stage trials, or was successful, the data from those trials could be transformational. Until recently, though, companies faced few consequences if they didn’t report their results. In April 2021, the FDA threatened to […]
Data protection to take centre stage in 2021
Blog series: Maintaining Regulatory Momentum in the Covid-19 era: In early December, the EMA announced that it had been hit by a cyber-attack and that documents related to the Pfizer-BioNTech Covid-19 vaccines had been accessed. The agency issued a brief announcement after the attack to say a full investigation had been launched but provided no […]
Why Transparency in reporting negative results is key for public trust
A recent perspective piece published in the New England Journal of Medicine highlights an issue that I have long felt reflects poorly on the industry, and that is public mistrust in ’Big Pharma’. This issue has come to the fore with the race to bring a Covid-19 vaccine to market. While the authors talk about […]
Why the Hiatus to Clinical Trials Amid Coronavirus is a Chance to Improve Processes
It’s hard to consider a bright side to the current coronavirus pandemic the world finds itself in, but the delays and temporary suspension of many clinical trials do present an opportunity to step back and address gaps in many trial processes. The question, then, is how can you use this time efficiently and effectively to […]
Two in one go: Don’t shy away from joint consultation with EMA and HTAs
It’s understandable that companies tend to be focused first on getting their products approved. But that’s just part of the battle. The other part is getting your products paid for. In July 2017, EMA began offering consultations in parallel with the European Network for Health Technology Assessment (EUnetHTA). The objective is to ensure that you […]
Can you Meet GMP Requirements? The Importance of Preparing Manufacturing Data
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, […]
Lost in translation: Manoeuvring through the complex world of regulatory language
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 […]
Dream big but remain focused: Why lofty goals can derail the development process
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 […]