Back by popular demand, the 2019 industry heatmap provides a high level overview of the latest developments in the European novel therapy manufacturing space across The United Kingdom, Belgium, Greece and Switzerland, among others.
With the 2018 commercialisation of prominent Autologous therapies such as KITEs Yskarta and Novartis’ Kymriah in the global market, more and more companies are beginning to move towards commercially based products. Yet despite these unquestionable industry growths, challenging issues can hinder – and even halt – groundbreaking progress in its tracks. There are still no established routes to market and with continuous changes in regulatory requirements across different global markets achieving any form of standardisation is difficult.
Download this free resource to gain valuable insights on some of the biggest challenges:
- globalising production and commercialisation
- cost efficiency
- regulatory pathways
- supply and logistics
With many therapies advancing to later clinical trial phases and moving even closer to commercialisation, Pharma IQ have created an industry report overview of the key European cell and gene therapies, pinpointing the stage of research or development. Some of the biggest challenges to commercialise include quality assurance, quality by design, scalability and cost efficiency, but there is no doubt that the competitive nature of this industry only further enhances these challenges. Using an interactive list, the industry report summaries these key topics and aims to evaluate strategies developed by leading experts to provide you with the best tips on how to overcome the hurdles of commercalisaion.
Additional key benefits of downloading the report:
- Evaluation of the global trend for expansion
- Predictions from the FDA commissioner of where cell and gene therapy products will be by 2025
- Summary of the commercalisation progress of advanced therapy trials
Download the Cell and Gene Therapy Industry Report now.
In this exclusive interview conducted ahead of this year’s Cell and Gene Therapy Manufacturing conference, Simon Briggs, Product Steward Cell and Gene Therapy Unit – Kymriah, C&G Technical Operations, Novartis shares his views on how to successfully achieve commercialisation.
With increased pressures on process scalability and regulatory compliance, Simon Briggs highlights some of the challenges and solutions Novartis have faced when transitioning from clinical to commercialisation.
Download our latest interview to get the answers to the following questions:
- Where is Novartis now in terms of a worldwide launch of Kymriah? What are your next priorities?
- Looking back on the transition between clinical and commercial, did your strategy for commercialisation meet the realities you were expecting? And if not, why don’t you think they did?
- You mentioned there are a few success factors to achieving commercialisation. Are there any other critical success factors that you’d like to highlight?
- What would you say about the current market paradigm for sustainable autologous therapies in terms of manufacturing capabilities and routes to commercialisation?
Download this free presentation on how to design a robust and cost-effective ‘off-the-shelf’ supply chain for your cell therapy. With insights from Bone Therapeutics’ PhD Production Associate Director, Anne-Sophie LeBrun, this presentation is designed to ensure that your manufacturing process is as efficient and cost effective as possible
The Bone Therapeutics presentation will give you insights on:
- Examining cell therapy as a game changer for orthopaedic indications
- Identifying major indications and on-going clinical trials
- Evaluating the feasibility of large-scale manufacturing
- Understanding the journey from a scientific concept to a commercial concept
- Setting the objectives and taking capacity and costs into consideration
- Assessing the feasibility of cell expansion and storage
- Plus more.
Fill in your details to download this free presentation.
The cell and gene therapy manufacturing sphere continues to mature rapidly, with a growing number of companies moving towards commercialising products. This report includes a European Heatmap which provides a high level overview of the latest developments in the European cell and gene therapy manufacturing space, in addition to an detailed industry update which provides information about therapy development throughout Europe.
As cell and gene therapy production continues to move towards commercialisation, it faces new challenges relating to the scalability of manufacturing processes. Both autologous and allogeneic therapies hold their own unique obstacles relating to production and treatment; and the promise of personalised medicines is not without hindrances related to both cost and availability.
We interviewed Andrew Finnerty, General Manager, CCMI Ireland at NUI Galway to discuss this topic in more detail and build a better understanding of how the rapid expansion of this market has brought about new challenges relating to manufacturing scalability , and what will this mean for the future of personalised cell and gene therapies.
Fast on its way to becoming a multibillion-dollar market, the global cell and gene therapy industry is booming. However, challenges mean that almost three decades after the first gene therapy trial, only three gene therapies have been approved in the EU and one in the United States. This article will look into the challenges around development and manufacturing that need to be addressed so that ambitious pharma and biotechs can continue to develop these innovative medicines.
The cell and gene therapy manufacturing sphere continues to mature rapidly, with a growing number of companies moving towards commercialising products. This infographic provides a high level overview of the latest developments in the European cell and gene therapy manufacturing space, looking at which therapies are moving into commercialisation in order to treat a wide range of conditions and diseases.
In response to the region’s strengthening presence with the therapeutic method, Pharma IQ presents this Cell and Gene Manufacturing hotspot map.