EMA has published data showing that products subject to Scientific Advice have a greater probability of success at MAA.
Nature Reviews Drug Discovery | AOP, published online 17 April 2015; doi:10.1038/nrd4621
Why Kinesys as your Scientific Advice Partner?
At Kinesys we can help you answer the key questions about Scientific Advice (SA) including:
- When do you request Scientific Advice on your development programme, what questions do you ask, and to whom? And how does this process fit with your overall Development Strategy? How does the Scientific Advice process work within different Authorities? How do you follow up on the advice?
- If you are conducting a global development programme, do you approach Regulatory Agencies simultaneously in EU and US?
- How do you resolve conflicting advice from different EU authorities and different requirements between EU and other Regulatory Agencies including US FDA, PMDA and CFDA?
- How do you avoid conducting studies for only one region and generate a genuine global registration package?
- Which EU national competent authoritiesare most capable of advising on your particular product?
- Do you seek Scientific Advice from Regulators and advice from Health Technology Assessment bodies simultaneously?
Kinesys’ experience and expertise in this area is essentially based on high quality people, sound strategy and informed guidance. Kinesys in combining this experience and expertise can help you ensure a successful outcome. At Kinesys, we typically help preparing, submitting and we execute many Scientific Advice Applications, per year, both to the EMA, the FDA and National Competent Authorities.
In recent years, we have aided the development of novel and important products for respiratory diseases, CNS conditions, oncology and haematology indications (including anti-PD1, Bcl2 inhibitor, Anti-HER2, VEGF inhibitor and PARP inhibitors etc.), acute stroke, epilepsy, diabetes and other metabolic diseases, rheumatology, psoriasis, systemic infection, GVHD, hormone replacement, and patients requiring blood replacement factors, among others. In all cases, this has required us to embark on a Scientific Advice process for our clients.
With an average of over 20 years pharma experience, Kinesys’ Principals, Senior Consultants and Advisory Board have a successful history in development and registration of NCEs and biotech products. Our combined expertise and practical approach provide a highly differentiated, high quality service.
Contact us and we will be happy to help iron out your Scientific Advice problems.
Background to Scientific Advice?
Companies almost always approach EU national competent authorities (NCA) or the European Medicines Agency (EMA) with specific scientific questions at least once before submission of a Marketing Authorisation Application (MAA). Questions usually relate to Quality, Nonclinical, Clinical, Statistics and Regulatory aspects of development. The importance of Scientific Advice and these meetings centres on:
- Proactive, collaborative interactions that can improve chances of approval within optimum timelines and can often be a differentiating factor for pharmaceutical companies in bringing their products to market.
- An early dialogue with regulatory authorities, which provides guidance on the appropriate design of tests and studies. Following this guidance will minimise the risk of related, major objections during evaluation of the MAA.
- Ultimately, taking Scientific Advice ensures that time and money are only invested in a development programme that is acceptable in principle to Regulators – this is why Scientific Advice is now considered to be an essential step in any development path.
- It is becoming more common to seek advice from Health Technology Agencies, and this can be done simultaneously with EMA and NCAs.