Introduction to ATMP lectures

March 30/31 we are offering free lectures on the basics of ATMP drug development!

These introductory lectures form the basis of the Karolinska Institutet hosted PhD course in ATMP.  While this course is now full, the lectures will be open to non PhDs hoping to gain a better and broader understanding of the ATMP field. We will give a basic background on the whole ATMP chain to better prepare those new to the field for our conference program. Places are limited to please register soon to avoid missing out. Contact Heather Main for more information.

Location – von Behring meeting room, Alfred Nobels Allé 8, Floor 9. 14152 Huddinge.

Program summary:

Monday 30th March – ATMP definition and regulation

9:00-9:35 – Introduction to PhD course

9:35-10:35 – What is an ATMP?

9:35-10:05 – What is an ATMP? The science behind cell and gene therapy – Paul Kingham
10:05-10:35 – Introduction to the whole ATMP chain – Evren Alici

Short break

11:00-12:45 – How are ATMPs regulated?

11:00-11:30 – Research v biobank product development – Kristina Kannisto
11:30-12:00 – Rules, regulations and guidelines – Vera Franzen
12.00-12:45 – Adapting ATMP research to GMP – Evren Alici

lunch break

14:00-15:10 – Product specification and manufacture.

14:00-14:20 – Pre-clinical testing and product safety/function – Lindsay Davies
14:20-14:40 – Toxicity, pharmacodynamics/kinetics and safety testing – Moustapha Hassan
14:40-15:10 – Deviations – Jenny Enger

15:10-17:00 – PhD course examination work

Tuesday 31st March – From manufacture to the market

9:00-10:35  Preparing for clinical trial

9:00-9:30 – Scaling up and scaling out – Michael Chrobok
9:30-10:15 – QC, TPP/CMC, IMPD – Lilian Walther Jallow
10:15-10:35 – Concomitant medication – TBA

short break

11:00-12:30 – From clinical trial to the market

11:00-11:30 – Clinical study protocol, IB – Hareth Nahi
11:30-12:00 – Value chain/commercialisation – Johan Hyllner
12:00-12:30 – Valuation of cell therapy products – TBA

lunch break

13:30-14:20 – From clinical trial to the market

13:30-13:50 – Health Economy – Dag Larsson
13:50-14:20 – Ethics – commercialisation of donated tissue, patient consent – Mats Hansson

14:20-15:00 – PhD course introduction to practical session
15:00-17:00 – PhD course examination work