Strategic EMA advice saves costs and accelerates drug development.

EMA Scientific Advice - Leveraging Regulatory Dialogue to Save Time and Money for Drug Development

Composite image showing 3 medical staff in conversation and an a large clock set at 10 minutes to 2.

Context

A company from Asia needed support with the EMA Scientific Advice for their drug-device combination product. The client prepared a draft briefing document for the advice meeting, however, due to their unfamiliarity with the EU process and the complexities of the drug-device product, they needed specialised technical input. Support for the science advice focused on Chemistry, Manufacturing, and Controls (CMC) and clinical development but also had questions on preclinical development and implications for the product’s classification. Hence, to manage this project required a multidisciplinary team.

Lumis' solution

Lumis’ addressed each of the client’s concerns as follows:

Expert Team: Lumis’ Senior Regulatory Project Manager led a team of experts to review the range of topics from Chemistry, Manufacturing, and Controls (CMC) to biostatistics and medical writing

Project Management: The priority was to maintain regular communication to permit iterative rounds of document reviews in line with the project timelines

Presubmission Meeting: Due to the manufacturer’s uncertainty around some technical questions, we recommended and organised a presubmission meeting with the EMA

SME Status: Lumis recommended the manufacturer seeks SME status as per Commission Recommendation 2003/361/EC, whereby Lumis will act as the representative. This saved the client

Result

Ask Well, Advised Well: By helping the client formulate carefully constructed probing questions, they received feedback which helped them simplify their manufacturing quality controls and clinical trial design (endpoint selection and statistical design). This saves them time and money in the development process.
Strategic Value: The EMA advice was critical to reshape the client’s development strategy – in particular, for clinical and manufacturing development. The client subsequently devised a new strategy which was more closely aligned with the regulator’s expectations. This will increase their chances of market authorisation whilst mitigating financial risks – such as inappropriately designed clinical trials.
SME Status: Cost Reduction: By encouraging the client to pursue SME status, we saved them approximately €90,000 (i.e. 90% fee reduction on approximately €100k EMA fee)
Product Classification: By using our overlapping experience in medical devices and biopharmaceuticals, we could recognise a device component of the product early on. We subsequently provided a solution to develop this component in compliance with the Medical Devices Regulation (EU) 2017/745. This demonstrates our ability to look at the “bigger picture” for a product’s development.
Submission on schedule: The submission was completed as originally forecasted in the kick-off meeting.
In budget: The project was delivered within the original agreed budget.

Why this matters to sponsors

Lumis have the breadth and depth of expertise to deliver complex drug development regulatory tasks. These efforts provide great strategic value by aligning development pathways with regulator expectations. We appreciate the financial constraints of small start-up, innovative manufacturers. So we also have the project management capabilities to respect project timelines and costs whilst also devising further cost-saving solutions to clients.