SMi has released an exclusive interview with industry expert Christiane Niederlaender, Director at AMBR Consulting Ltd, ahead of the upcoming RNA Therapeutics conference this February.
SMi recently interviewed industry expert Christiane Niederlaender, Director at AMBR Consulting Ltd., who will be speaking at the RNA Therapeutics conference. Here is a snapshot of what was discussed:
The Oligonucleotide Therapeutics market has matured greatly over recent years, what key differences have you noticed in the last year regarding significant developments?
“The Oligonucleotide sector has seen an increase in regulatory approval, in particular, for the RNAi based therapies. My personal focus, however, is on RNAs that are biological medicines, and in this sector I see a lot of promise in the new mRNA-based vaccines, some of which are biologicals, where new developments mean that these products are now more stable, and have better translation. At the same time, CRISPR Cas approaches are now entering the clinic and the very first clinical results seem to show promise.”
What are your thoughts on the developing regulatory expectations around RNA Therapeutics and how is this currently impacting your role?
“From a regulatory perspective CRISPR Cas approaches are perhaps the most challenging. Due to the specifics of the legislation in Europe, these products can fall into a variety of medicine categories each with slightly differing regulatory implications. I think it will be important for regulators to come to an understanding of how to standardize their regulation bearing the risk profile in mind. Some of these considerations also apply to mRNA therapies.”
The full version of the interview and event brochure are available to download online at www.therapeutics-rna.com/prcom6
Christiane Niederlaender will be presenting on "When RNA Therapeutics are Biological Medicines: Regulatory Considerations for the EU":
- Classifications of RNA therapeutics within the medicines framework
- RNAs in CRISPR approaches and the CMC considerations
- Key regulatory issues as highlighted by case studies
Focus Day: 18 February 2020
Conference: 19-20 February 2020
Copthorne Tara Hotel, London, UK
Proudly sponsored by:
ChemGenes | Thermo Fisher Scientific
For sponsorship enquiries contact Alia Malick on +44 (0)20 7827 6168
For all delegate enquiries, contact Hakam Panum on +44 (0)20 7827 6128
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk