ATMP and Market Access seminar in Sweden – Postponed

As a result of the increased spread of the Corona virus and due to the Public Health Agency’s now changed assessment of the risk level for the spread of the virus – an increase in risk level to “Very High risk” we have decided to postpone our planned seminar: Optimizing the path to market for ATMP’s.

We hope to reschedule the seminar later in the year and we will provide you all with more information closer to the time.

If you would like to talk to one of our team about how we can support, you and your teams drug development program please do not hesitate to contact us.

Kind regards

NDA Group & Cirio Advokatbyrå


NDA Group and Cirio Advokatbyrå would like to welcome you to our breakfast seminar, Optimizing the path to market for ATMPs.

Our presenters will discuss integrated product development for ATMPs to meet regulatory and HTA requirements and models for realizing product value.

Date: Tuesday 31st of March 2020 – Postponed
Time:  08:30- 11:30 (Breakfast served at 08:30, seminar starts at 09:00)
Venue: Cirio Advokatbyrå, Mäster Samuelsgatan 20, 8th floor, Stockholm
Registration: RSVP by Friday 27th March 2020

This seminar is focused on the challenges of ATMP development and market access with case examples of approved products. The option of an integrated product development to cover both regulatory and HTA expectations will be presented, together with information on regulatory, HTA and market access support available for ATMP developers

Our speakers for the day:

  • Paula Salmikangas, Director of Biopharmaceuticals and ATMP, NDA Group
  • Ben Continsouzas:  Senior Consultant, Project Manager at NDA Advisory Service
  • Per Hedman, Partner, Cirio Law firm
  • Anders Burén, Senior Counsel, Cirio Law firm

The state of the Swedish orphan pipeline

In a short piece on the rare and orphan disease pipeline in Sweden, Business Sweden, together with SwedenBIO, have outlined the current state of Swedish orphan development. The report describes a vibrant drug development landscape that is reflective of the global move towards orphan development and the strong emphasis on oncology.

Over the last 19 years Swedish companies have been granted 60 orphan designations in the EU and 47 in the US. Unsurprisingly, oncology and neurology are the leading therapeutic areas representing 38% and 11% of the Swedish orphan pipeline respectively.

In total, Swedish companies are developing orphan drugs in 16 different therapeutic areas and it is interesting to note that transplantation comes in as the third largest area of interest in terms of number of compounds.

If the number of products in the pipeline and the activity of the life science networks and communities are any measures of future success – the Swedes and Danes are in for a very exciting ride!

In addition to the findings outlined in the report, we have looked at the geographic origin of the companies contributing to this space and two areas clearly dominate this development; Stockholm/Uppsala and Medicon Valley in the Malmö/Lund/Copenhagen region.

If we were to include Danish companies in the Medicon Valley area, we are sure the picture would change, but the two regions are undeniable hot-spots when it comes to pursuing orphan targets in the Nordics.

The Swedish biotech stage is thriving and expanding – at last count the industry organisation, SwedenBIO, had 265 member companies and it keeps growing. Medicon Valley Alliance is a network of life science organisations, from academia and local health care bodies, to life science companies and service providers, that span the Copenhagen/Malmö/Lund region. They have also grown at a steady pace and comprises over 250 organisations today.

If the number of products in the pipeline and the activity of the life science networks and communities are any measures of future success – the Swedes and Danes are in for a very exciting ride!

You can read the original report at over at Business Sweden’s website.