B4 Gene-based therapy 101

Monday 11 September 2017
COEX Convention & Exhibition Center : Room 208 A/B 1 hours

Organised by the FIP Social and Administrative Pharmacy Section and the FIP Industrial Pharmacy Section

Chairs: Tara Hehir (Locum pharmacist, Australia)


Gene-based therapy and individualised medicines are considered the future of medicine. Many people have heard of individualised medicines, but most will not know what they are or how they are made.  Pharmacists may not be sure of what these drugs could mean to their patients, or their practice of pharmacy. The financial implications of personalised medicine are being understood now in many countries, as the price for these drugs, which affect smaller populations, may be high. Also, a number of newer therapies require companion diagnostics to confirm genetic markers.

The clinical development path for gene-based therapies and targeted drugs differs from that of previous therapies as well. As not all patients have the same genetic make-up, not all patients will be appropriate for new, targeted therapies — a notion which brings unique challenges to drug development and patient selection. In this session, we aim to explain what gene-based therapy is by covering the drug development process, including patient selection, gene target selection and choice of delivery. The session will also focus on unique monitoring requirements and, in some cases, regulatory requirements associated with genetic-based therapy.

There are many nuances and this session will provide simple, clear and useful information for all pharmacists on individualised, gene-based therapy.

Learning objectives

At the conclusion of this application-based session, participants will be able to:

  1. Express what gene-based therapy is clinically and what the benefits are for patients.
  2. Differentiate how targeted therapies differ from historical treatments in the drug development and approval process.
  3. Compare the different drug delivery pathways for individualised medicines, including compounding and specialty pharmacies.
  4. Advocate for targeted therapies monitored by pharmacists and the implications of drug labelling.


12:30 – 13:00

1. What is clinically unique about gene-based therapies?

Cyril Usifoh (University of Benin, Nigeria)

13:00 – 13:30

2. From research to the patient - How are these new drugs made and provided?

Speaker TBA

13:30 – 14:00

3. Targeted therapies and patient care - Monitoring inpatients and outpatients

Jae-Gook Shin (Inje University, Republic of Korea)