F1 - Tackling the challenges of nanomedicines – Are we ready?

Capital suite 3

Organised by the FIP Hospital Pharmacy Section and the Non-Biological Complex Drugs (NBCDs) Working Group hosted by Lygature


Vinod Shah (NBCD Working Group, USA) and John Hertig (FIP Hospital Pharmacy Section, USA)


Nanomedicines, like liposomal doxorubicin, paclitaxel-albumin and iron carbohydrates have arrived in clinical reality. Follow-on copies of nanomedicines have been approved and granted marketing authorization by FDA and EMA with the aim to reduce costs and increase drug availability. However, the complexity of such drugs with regard to both, their manufacturing and handling in clinical practice has been ignored or underestimated, which has resulted in lack of safety and/or efficacy.

The symposium will be focused on what nanomedicines are and what makes them so different from conventional drugs, what advantages they have to offer and why the regulatory approval landscape for nanomedicines and their follow-on is so complex. The FIP statement of policy “Pharmacist’s authority in product selection: therapeutic interchange and substitution” will be discussed and evidences about nanomedicines, lacking in this document, will be provided. Finally, the pivotal role of the hospital pharmacists as experts handling nanomedicines will be described.

Four selected speakers (from academia, industry, clinical practice and hospital pharmacy) will each give 40-minutes lectures. This will be followed by a 30 minutes panellist podium discussion on how the emerging science on nanomedicine might impact the recently released “FIP Statement of Policy on the Pharmacist’s authority in pharmaceutical product selection: therapeutic interchange and substitution”. A 30 minutes refreshment break will be included in the activity.


  1. 09:00 – 09:10 Introduction by the chairs – Nanomedicines are reality: Challenges associated to these drugs
  2. 09:10 – 09:45 What are nanomedicines?
    Beat Flühmann (Vifor Pharmac Management Ltd. and NBCD Working Group, Switzerland)
  3. 09:45 – 10:20 Why go nano in therapeutics?
    Stephan Mühlebach (University of Basel and NBCD Working Group, Switzerland)

10:20 – 10:40 Coffee/tea break

  1. 10:40 – 11:15 Regulatory challenges for nanosimilars
    Vinod Shah (NBCD Working Group, USA)
  2. 11:15 – 11:50 Implications in pharmaceutical practice by using nanomedicines
    Gunar Stemer (Vienna General Hospital – Medical University, Austria)
  3. 11:50 – 12:50 Panel discussion
  4. 12:50 – 12:55 Conclusion by the chairs

12:55 – 13:00 Room refresh

Learning Objectives

At the end of this session, participants will be able to:

  1. Tell the differences between nanomedicines and conventional drugs
  2. Explain the advantages and challenges related to the use of nanomedicines
  3. Inform on nanomedicines, nanosimilars
  4. Describe the practical implications for evaluation selection and handling of nanomedicines in the clinic.

Type of session: Knowledge-based