Regulatory and Technical boundaries for phage therapy and FMT in animals

Join us on 17 October to discuss the regulatory and technical issues hindering the development and use of phage therapy and faecal microbiota transplantation (FMT) in animals. The aim of the workshop is to bring together scientists, industry and regulatory agencies for a constructive discussion to overcome the regulatory and technical barriers and facilitate the approval and the market uptake of these alternatives to antimicrobials

PROGRAMME

SESSION ON PHAGE THERAPY

09.00-09:10: Welcome by the AVANT coordinator, Luca Guardabassi, UCPH, Denmark

09.10-09:30: Challenges in developing a phage-based product against enterotoxigenic E. coli in pigs, Michela Gambino, UCPH, Denmark

09.30-10.00: Challenges in manufacturing phage-based products: the industry perspective, Frenk Smrekar, JAFRAL, Slovenia

10.00-10.30: Regulatory requirements for the authorisation of veterinary medicinal phage products, Javier Pozo Gonzalez, EMA

10.30-10.45: Kahoot quiz on phage therapy (download Kahoot )

10.45-11.15: Coffee break

11.15-12.00: Roundtable discussion with the speakers and and representatives from the Danish Medicines Agency (Lotte Dahl and Martin Bronislaw Oleksiewicz), chaired by Klaus Helmann, KLIFOVET, Germany

12.00-13.00: Lunch break

SESSION ON FAECAL MICROBIOTA TRANSPLANTATION (FMT)

13.00-13:15: Challenges in developing a FMT protocol to prevent post-weaning diarrhoea in pigs, Thomas Thymann, UCPH, Denmark

13.15-13.30: FMT in hospitals: what can we learn from our colleagues in human medicine? Maria Vehreschild, Cologne University Hospital, Germany (online pre-recorded)

13.30-13.45: Use of FMT for control of viral diseases of swine, Megan Niederwerder, Kansas State University, USA (online pre-recorded)

13.45-14.05: Current regulatory challenges in the development of microbiome products, Mirja Huhtinen, Orion Pharma, Finland

14.05-14.20: Bacteriotherapy in healthy suckling piglets: success parameters to consider, Alexandre Thibodeau, University of Montreal, Canada (online live)

14.20-14.30: Kahoot quiz on FMT (download Kahoot )

14.30-15.00: Coffee break

15.00-15.45: Roundtable discussion with the speakers and representatives from the Danish Medicines Agency (Lotte Dahl and Martin Bronislaw Oleksiewicz), chaired by Klaus Helmann, KLIFOVET, Germany

15.45-16.00: Wrap-up conclusions and meeting closure, Luca Guardabassi, UCPH, Denmark

Event Venue & Nearby Stays

Festeauditoriet, 17 Bülowsvej, Copenhagen , Denmark