eXmoor Pharma is proud to launch their 2024 webinar series “It’s All About Manufacturing”. Join us over the coming months as we host four engaging webinars that will explore some of the challenges faced by todays Cell and Gene Therapy (CGT) sector and provide expert advice on overcoming them.
CGT’s hold so much potential for patients with unmet medical needs and consequently there is widespread enthusiasm to fast-track approvals for new treatments. However, the complexities of these new modalities can lead to significant program delays and there is no such thing as a standard development plan. With each drug substance, manufacturing process and clinical trial being so unique, every program strategy is highly bespoke and customised. Setbacks in the Chemistry, Manufacturing, Controls (CMC) plan can result in clinical delays, regulatory challenges, and downstream manufacturing problems. It is therefore crucial to consider and develop a holistic CMC strategy to maximise chances of a successful product approval.
This webinar will include talks and contributions from leading industry experts from Resolution Therapeutics, Quell Therapeutics and eXmoor Pharma.
The webinar will cover the importance of keeping the end in mind as you transition through the development journey. We will discuss the importance of generating a holistic CMC plan for the Cell & Gene Therapy landscape to guide the translation from clinic to commercial effectively. We will discuss key CMC considerations to improve the likelihood of commercial success. These considerations will assist in identifying the prioritisation in the product development program and ensure decisions are based on in-depth product know-how.
The webinar will also showcase how effective cost of goods models can be utilised to inform critical decisions that need to be made early on in the development cycle which have a significant impact on the future profitability. Applications of cost of goods models inform optimal process design, efficient scheduling, manufacturing strategy such as build or buy, portfolio prioritisation, ultimately helping to balance risk-reward by accelerating programs and reducing cost. This approach ensures that an integrated program is developed with the end in mind.
Key Learning Objectives
- Understand the importance of generating a holistic CMC plan early in the development journey.
- Learn about decision support tools to aid in the development of Cell & Gene Therapies.
- Discover strategies for phase-appropriate process & analytical development for CGT’s.
- Explore best practices for process optimization, technology transfer, and manufacturing scale-up to maximise chance of successful commercialisation.
Unlock the future of medicine with our exclusive webinar! Gain unparalleled insights from trailblazers from the advanced cell and gene therapy industry. Discover the comprehensive, end-to-end strategies for successfully bringing groundbreaking therapies to market. Don't miss this opportunity to learn from the best—secure your spot now!
Register Now