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Summary

Selecting and describing doses for advanced therapy medicinal products (ATMPs) presents key differences to working with traditional pharmaceuticals. While traditional small or large molecule drugs usually illicit their activity and are then cleared by the in the body, cell and gene therapies may expand or proliferate after administration to exert their effects.

Cell-based therapies are considered as ‘living drugs’ and factors affecting treatment efficacy can include unknown identity of the active cell subset and variable transduction efficiency, cell viability and function.  For in vivo gene therapy doses may be based on unfamiliar characteristics such as vector titre, number of viral particles or vector genomes. This talk will introduce fundamental concepts around dosing of novel cell and gene therapies.

Amisha Desai
Amisha Desai
Lead Pharmacist for Clinical Trials
University Hospitals Birmingham NHS Foundation Trust

Amisha Desai is LeadPharmacistfor Clinical Trials at University Hospitals Birmingham NHS Foundation Trust, part of the Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC) and the Experimental Cancer Medicine Centre (ECMC). She is a member of the UK Pharmacy Working Group for advanced therapy medicinal products (ATMPs).

After qualifying as a pharmacist in 2002, Amisha began her career at the Royal Wolverhampton Hospital NHS Trust as a junior pharmacist and subsequently went on to specialise in Oncology and Aseptic Services before moving on to University Hospitals Birmingham as a Specialist Oncology Trials Pharmacist in 2009. Amisha took up her current post in 2010. Amisha has experience in the delivery of a range of clinical trials from Phase I, first in man studies to Phase IV post-marketing studies, some using novel and advanced therapies, such as novel chemotherapeutic drugs, monoclonal antibodies, cell therapies and gene therapy, all in a variety of therapeutic settings. She has experience of setting up trust-sponsored studies, acting the sponsor pharmacist and has close working relationship with the University of Birmingham (UoB) as a pharmacy advisor for a number of their trials.

Amisha has delivered a number of training sessions to the UoB CRCTU on the role of pharmacy in clinical trials and a workshop for the undergraduate Masters in Pharmacy at UoB.