Development & Commercialisation of Nanomedicines - An Industry Perspective

Special Roundtable Session

Date/Time: Monday, July 23, 2018 - 10:00 AM to 12:00 PM

About

Nanomedicines have consistently shown their ability to improve therapeutic index in pre-clinical models particularly in cancer, and the need to use nanomedicines is increasing with diversification of industrial portfolios and requirement to deliver new modalities to access traditionally “non-druggable” target space. However translation of nanomedicines into clinical trials and eventually as commercial products to benefit patients has been slow [1]. Gaining intracellular delivery of peptides, or nucleic acid based large molecules to either knock down or produce proteins or for gene editing and exploiting the CRISPR revolution accelerates the needs for better understanding of the biological processes and creation of advanced drug delivery systems beyond the traditional epr effect for successful translation into the clinic and to patients.

This session will provide a brief overview of where there has been successful translation of nanomedicines, highlight some newer emerging applications of nanomedicines [2] that may transform growing areas of biology (e.g immunotherapies) and new modalities (e.g. RNA delivery) as well as focussing on the main reasons for attrition to date and learnings from them. An open discussion into the translational issues in the clinic (due to limited understanding of the disease and availability of poor disease models)[3], challenges in scale up and manufacture, and analytical characterisation required to ensure robust product quality will form the key focus of the roundtable. These issues will be addressed from an Industrial perspective including discussions on:

  • Disease led design of nanomedicines to ensure determination of the correct target product profile and selection of the right patients to improve clinical translation
  • New manufacturing techniques to enable cost effective scale up and robust products
  • Advanced analytical characterisation techniques required to determine critical quality attributes of the product to ensure reproducible in vivo performance from both a safety and efficacy perspective in humans.

1. Hare, J.I., et al., Challenges and strategies in anti-cancer nanomedicine development: an industry perspective. Advanced drug delivery reviews, 2016. 2. P Tyagi, J. A. Subramony, Nanotherapeutics in oral and parenteral drug delivery: Key learnings and future outlooks as we think small Journal of Controlled Release 272 (2018) 159–168 3. J. Shi, P.W. Kantoff, R. Wooster, O.C. Farokhzad, Cancer nanomedicine: progress, challenges and opportunities, Nat. Rev. Cancer 17 (2017) 20–37