Scientific Advice Service
When an Asia-based pharmaceutical company wanted to speed time-to-market for its generic to a leading brand-name drug, it engaged ELC Group to help to get the product successfully launched in European markets on its first submission – and as the first in its market.
Based in Asia, this generic pharmaceutical company had extensive in-house formulation expertise but limited regulatory resources. It knew the regulatory path for this product was complex since other companies had tried – and failed – to gain regulatory approval from European agencies. The product would need to follow an extensive guidelined path that was widely variable to the FDA development path.
With the expiration of the current patent holder’s drug sales license just a matter of weeks away, the client chose ELC Group to provide all the scientific advice and guidance it urgently needed to maximize its chances of approval and become the first generic to launch a non-infringing product in European markets.
ELC Group solution
ELC Group immediately undertook an extensive review of the available drug data to first determine the potential validity of undergoing the submission process. Having established strong grounds were in place for success, the ELC team next prepared the client for the submission process itself and acted as the client’s representative in dealing with Europe’s regulatory bodies.
ELC Group brought together its technical and quality experts to review the client’s initial formulation and drug data and establish, in the first instance, whether it was appropriate to proceed with a possible submission. Having confirmed that the available data was rigorous and appropriate, ELC Group then mobilized its intimate knowledge of the regulatory framework and the internal workings of the regulatory agencies involved to prepare the submission strategy on behalf of the client.
- ELC Group’s technical and quality experts reviewed all available drug data from the perspective of the regulatory assessors and were able to confirm the data was acceptable and that the client had a strong case for success.
- Next, ELC Group prepared the client’s chemists and other experts in readiness for the types of questions they were likely to encounter at the scientific advice meeting.
- ELC Group prepared a scientific advice package to finalise the Quality documentation and prepare the client for a clinical strategy. Because the client was not based in Europe, ELC Group attended the meeting on its behalf, having gained an agreement that the client’s experts could participate via a teleconference link.
- ELC Group was able to follow-up closely with agency to clarify further questions before the clinical program was implemented.
- Client and ELC Group continued a close coordination throughout the development process in order to address any possible non-compliance issues. The outcome of the meeting had resulted in a revision from the EU of the relevant guideline with a renewed perspective of how EU addresses such complex developments (subsequent released guideline of use of EU and US reference product for clinical developments and re-draft of therapeutic area guideline released in 2012)
- Having established strong grounds to proceed, ELC Group generated initial submission materials and ensured the client’s drug data was presented appropriately and in a manner that would address the assessor’s requirements. Using its on-the-ground contacts, ELC Group procured a timely submission date for the client.
- Based on feedback received during the scientific review, ELC Group prepared the final dossier for submission, which was approved on the first application. As a result, the client became the first to go to market in Europe with its generic bioequivalent drug.
- By pre-evaluating the initial submission data, ELC Group ensured that this small to medium-sized pharmaceutical company did not waste valuable time and money embarking on a submission that was inappropriate or unlikely to succeed. It could be confident that the submission process was a valid step to take at this point in time.
- The pre-evaluation and detailed questioning of the client’s chemists and medical experts undertaken by ELC Group’s technical and quality experts meant the strongest possible submission could be prepared.
- ELC Group was able to use its agency contacts to secure an application date that met the client’s requirements in terms of launching its generic product as close as possible to the expiration of the patent holder’s current brand drug sales license.
- The client was able to depend on ELC Group to act as its local representative in Europe. This meant its technical and medical experts were able to continue to work in Asia and participate in the submission process via teleconferences and video conferences. This saved the company extensive cost in terms of travel and loss of high-value individuals who would otherwise have had to be based in Europe for a number of weeks.
- Being the first generic to launch in Europe gave the client a significant commercial advantage over its competitors.