Event Date: 10/07/2012 01:00
"Making Gene and Cell Therapy Medicines a Reality"
July 10 - 11 2012
Gibson Hotel, Dublin, Ireland.
The IMB has sponsored a special prize for the best poster at this meeting.
It was a unique event organised jointly by the Irish Medicines Board (IMB) and the Parenteral Drug Association (PDA) - Ireland Chapter dealing with the exciting topic of bringing Advanced Therapies like cell and gene therapy to commercial realisation.
Aims of the Seminar
Presentations given on the day are available to view/download at the link below:
1. Making Gene and Cell Therapy a Reality - Janice Soreth
2. Gene Therapy in the Clinic - the CF Odyssey - N. Gerry McElvaney
3. Harmonisation of the Assessment of Multinational Clinical Trials - Agnieszka Przybyszewska
4. Hospital Exemptions: IMB Policy and Experience to Date - Sarah O'Meara
5. The Authorisation of Hospital Exempt Manufacturers - Patrick Costello
6. Cell Therapies - Challenges from an Industry Perspective - Ron Fedechko and Tricia Harbinson
7. A Tale of Two Cities: Journey to ATMP Manufacture in Newcastle and Galway - Bertie Craig
8. Regulation of Cell- and Tissue-based Therapeutic Products - Srinivasan Kellathur
9. Gene Therapy Products for Clinical Trials - Advice on Data Requirements - Matthias Renner
10. Oxford BioMedica Manufacturing Site 2 Starting up a Biopharmaceutical Facility for Gene Therapy Products - Christopher Morgan
11a. Limbal Stem cells - An eye to the future Part 1 - Sandra Shaw
11b. Limbal Stem cells - An eye to the future Part 2 - Sandra Shaw
12. Cell-based Medicinal Products for Clinical Trials - Advice on Data Requirements - Paula Salmikangas
13. The Clinical BioManufacturing Facility Our Experience Manufacturing Adenoviral Vectors for Human Use - Eleanor Berrie
14. Reglazing the Eye - Finbarr O'Sullivan
15. Tissue Engineering Scaffolds for Cell and Gene Delivery - Fergal O'Brien
16. uniQure - Harald Petry
17. Introduction to Advanced Therapy Medicinal Products Regulation - Maura O'Donovan
18. Clinical Trial Applications - IMB Procedure - Una Moore
19a. Challenges wth Advanced Therapies from the EU regulatory perspective Part 1 - Christian Schneider
19b. Challenges wth Advanced Therapies from the EU regulatory perspective Part 2 - Christian Schneider
Who Should Attend
IMB PDA ESOF 2012 Satellite Conference - "Making Gene and Cell Therapy Medicine a Reality"
This very successful meeting was held as a satellite conference to the July ESOF bi-annual science conference held to celebrate Dublin's branding as the European City of Science for 2012. The meeting was jointly organised by the Parenteral Drug Association ( Ireland Chapter) and the IMB and focused on the regulatory framework and challenges of translating exciting basic science discoveries related to molecular and cell biology into actual commercial gene or cell thereapies. It brought together leading experts from regulatory agencies such as EMA, IMB, FDA and other European regulators together with a visitor from the Singapore Health Sciences Authority. In addition, there were experts from academia and industry and patient representation during the conference. The two-day conference had four themes running through it -
1. pure reserach and innovation
2.developmental issues bringing research to industry produciton scale
3.issues arising in clinical trials and their regulation
4.the regulatory regime relating to advanced therapies generally in terms of patient protection
The first session focussed on the science of cell and gene therapy. The afternoon session on the industry perspective covering gene and cell therapy performed in commerical and public facilities. On the second day, focus was on the regulatory requirements with speakers from EMA, IMB, FDA and in the afternoon a session on clinical trials including current research being conducted in Dublin and elsewhere. Full details can be provided on the programme and a copy of the presentations is available at the IMB ESOF link. Approximately 110 attended the two day meeting and there were 12 poster presentations provided mainly by post-graduate researchers at Ireland's universities.
All-in-all, the meeting was a great success. The IMB obtained very useful positive publicity out of the event and accordingly issued a press statement. The organising committee did a very good job putting the meeting together and considerable thanks are due to IMB staff for putting such work in to making the conference a success.