During initial meetings with clients, while taking on board project details, hopes and ambitions, we will often recommend – ‘We would suggest you seek scientific advice?’ as a first step. Seeking scientific advice in Europe or elsewhere, may seem daunting and may not at first be what you consider to be the best way to progress your product development. It is a way to understand and manage the risks within a development programme.
The scientific advice process will aid development teams identify the most appropriate way to generate robust evidence on a medicine’s benefits and risks.
For a medicine to be authorised, developers must demonstrate that it is:
At any point in the development process the team can request guidance and direction from an agency on the best methods and study designs to generate robust information to establish these three key attributes
The marketing authorisation application will reflect the outcome of the scientific advice procedures (or justify why a different approach has been taken) by the inclusion of the relevant data. . The Agency assesses this information and determines whether the medicine is safe and beneficial to patients.
Scientific advice is offered differently depending on the agency contacted. Some national agencies provide both written and face to face advice. Many clients prefer the latter option as this allows agency dialogue with the potential to discuss alternative development strategy as required. The UK national agency – The Medicines Healthcare Regulatory Agency (MHRA) – offer advice at many levels, from initial GMP Inspection advice or the classic drug development advice on one or all the quality, safety or efficacy pillars. The cost of meetings varies depending on the extent of the advice required. Requesting a meeting at the MHRA can take up to 8 weeks to organise and fees range from £3-5000.
Seeking National advice is a helpful tool to help determine the most appropriate regulatory strategy. It can sometimes lead to conflict if approaching two or more agencies looking for a common position on the development of a medicines, especially when seeking clarification on a clinical study design.
For medicines that can only be submitted via the centralised procedure (such as Oncology, Biological, New Chemical Entities, Orphan medicines) then scientific advice route is more straightforward. A meeting is requested directly with the European Medicines Agency (EMA), now based in Amsterdam who will offers insight and a single opinion on your drug development pathway across the member states.
Full scientific advice at the EMA at first sight may seem expensive (approximately €70,000) but becomes cost effective if you are a Small Medium Enterprise (SME) as reductions apply for certain types of medicines and applicants:
- there is a 75% fee reduction for medicines for rare diseases, known as orphan medicines;
- micro, small and medium sized companies (SMEs) have a 90% fee reduction.
Questions that can be considered during any scientific advice process could be:
- quality aspects (manufacturing, chemical, pharmaceutical and biological testing of the medicine),
- non-clinical aspects (toxicological and pharmacological tests designed to show the activity of the medicine in the laboratory),
- clinical aspects (appropriateness of studies in patients or healthy volunteers, selection of endpoints, i.e. how best to measure effects in a study, post-authorisation activities including risk management plans),
- methodological issues (statistical tests to use, data analysis, modelling and simulation).
An interesting read on the scientific process can be found within this recent publication – a patient journey through the registration of a centrally authorised medicine.
Although Scientific advice provides development teams with insight into what work needs to be done to support an application, applicants need to understand that:
- it is not a pre-assessment of the benefits and risks of a medicine
- does not guarantee that a medicine will receive marketing authorisation.
It will, however:
- add clarity and insight to the thought process of the regulators
- provide feedback (useful for investors) on the development pathway required to a successful submission.
JensonR+ Limited have a team of experienced regulatory professionals to help advise and support you through both national (UK and other agencies) and European scientific advice procedures.
Contact us at firstname.lastname@example.org.