Mini-Symposium: Formulation – Friend or Foe


Formulation should be considered during early drug discovery and development studies in order to deliver the drug to the site of action at the right concentration and time, in safety manner. If correctly addressed, the formulation is a “friend”, significantly contributing to progression of a project. If unaddressed, the lack of a suitable formulation can be a “foe”, jeopardizing outcome of a project. Translation of early formulation knowledge to suit the more regulated studies during clinical development is also of great importance.

In this workshop industrial experts will present strategies and approaches to deal with formulation items during drug discovery and the early development process, for both small molecules and biologic drug candidates.

Please, take the chance to discuss your own project with the speakers during the day.

The workshop is a joint activity between the SciLifeLab Drug Discovery and Development platform and Sweden Drug Delivery Industry Group (SDDIG).

Program

 

08:30
Registration

Coffee and Sandwich

09:00
Welcome

Per Arvidsson, SciLifeLab Drug Discovery and Development Platform, Stockholm
Kristian Sandberg, SciLifeLab Drug Discovery and Development Platform, Uppsala
Tuulikki Lindmark, TuuLifeScience AB, Uppsala

09:10
Introduction to the NextBioForm

Anna Fureby, RISE Research Institutes of Sweden AB, Stockholm

09:25
Introduction to the Swedish Drug Delivery Forum (SDDF)

Christel Bergström, Uppsala University, Uppsala

09:40
Introduction to Formulation and Drug Delivery

Jonas Johansson, Science & Innovation, AstraZeneca R&D, Gothenburg

10:00
Coffee break
10:30
Preclinical formulation, small molecules

Tuulikki Lindmark, TuuLifeScience AB, Uppsala

11:15
Preclinical formulation, biologics

Jonas Fransson and Susanne Wood, SOBI, Swedish Orphan Biovitrum AB, Stockholm, Sweden

12:00
Lunch
13:00
Preclinical scale up, process development and Chemistry, Manufacturing, and Controls (CMC)

Jonas Fransson, SOBI, Swedish Orphan Biovitrum AB, Stockholm, Sweden

13:45
Small molecules: approaching formulation to clinical studies (CMC, GMP-API)

Tuulikki Lindmark, Consultant, Uppsala
Christina Erixon, Apotek Produktion & Laboratorier AB, Stockholm
Nicolaas Schipper, RISE Research Institutes of Sweden AB, Södertälje

14:30
Coffee
15:00
Production for first time in human (FTiH) – what to consider (choice of formulation, placebo etc)?

Christina Erixon, Apotek Produktion & Laboratorier AB, Stockholm
Hanna Envald, Apotek Produktion & Laboratorier AB, Stockholm
Katrine Jelksäter, Apotek Produktion & Laboratorier AB, Stockholm

15:30
Success story

Susanne Bredenberg, Emplicure AB, Uppsala

15:45
Future trends in drug delivery

Jonas Johansson, Science & Innovation, AstraZeneca R&D, Gothenburg

16:00
Clinical studies – introduction

Anders Millerhovf, Clinical Trial Consultants (CTC) AB, Uppsala, Sweden

16:15
Concluding remarks

Per Arvidsson, SciLifeLab Drug Discovery and Development Platform, Stockholm
Kristian Sandberg, SciLifeLab Drug Discovery and Development Platform, Uppsala
Tuulikki Lindmark, TuuLifeScience AB, Uppsala

16:20
Networking with refreshments

Registration

Registration is now closed for the event. Requests of late registrations can be managed via e-mail to david.gotthold@scilifelab.se.