Workshop Day: Tuesday, September 23
Quick Guide to Workshops:
Discovery Workshops
Workshop A:
Evaluating Target Selection & Exploring Novel Targets to Improve Tumor Targeting & Specificity
Workshop B:
Exploring Next Generation Combination & Armoring Technology to Improve Efficacy of Cell Therapy
Clinical Workshops
Workshop C:
Overcoming Challenges with Patient Access to Improve Clinical Trial Onboarding
Workshop D:
Understanding How to Conduct Clinical Trials to Meet Regulatory Expectations & Gain Approval
Manufacturing Workshops
Workshop E:
Delving into the Specifics of Quality Control to Improve Success Rate & Meet Regulatory Requirements
Workshop F:
Optimizing Manufacturing Technologies to Adapt to Varying Cell Types & Next Generation Armoring Technologies
Full Workshop Day Agenda:
8:00 am Morning Check-In & Coffee
09:00 am Workshop A: Evaluating Target Selection & Exploring Novel Targets to Improve Tumor Targeting & Specificity
Synopsis
With the recent success of cell therapy against solid tumors and long-standing success against hematological tumors, tumor targeting is on everyone’s mind. The need to find new targets and overcome complex tumor microenvironment is the key focus and the next best thing to ensure your cell therapy is successful.
Join this workshop to:
- Review and analyze the limitations of existing targets
- Explore the importance of novel target discovery such as Claudin 18, BCMA, CD20 and more
- Navigate the challenges of target expression in cancerous cells vs healthy cells
- Improving tumour targeting to reduce off target toxicities
- Utilize software and AI screening tools to identify novel targets
09:00 am Workshop C: Overcoming Challenges with Patient Access to Improve Clinical Trial Onboarding
Synopsis
The increasing innovation in cell therapy demandsan increase in clinical trials and accessing patients that meet the criteria you require. With the lack in physician education on the benefit of cell therapies and selective challenges with patient access, only a handful of patients receive the treatments they should be. The biggest question is how to increase patient access and recruit people to ensure you are running successful clinical trials.
Join this workshop to:
- Bridge the gap between you and physicians to increase patient referrals
- Learn the importance of patient selection with regard to risk tolerance and differing patient profiles
- How to translate cell therapy administration to make it an outpatient procedure
- Show proof of concept and increase patient and physician confidence in your trials
- Address the competitive landscape to improve enrolment in clinical trials
09:00 am Workshop E:
Delving into the Specifics of Quality Control to Improve Success Rate & Meet Regulatory Requirements
Delving into the Specifics of Quality Control to Improve Success Rate & Meet Regulatory Requirements
Synopsis
Quality control is a focus for everyone during cell therapy manufacturing and is equally a challenge. Whether it is quality control for manufacturing process or during analytical development, it is something that is ever prevailing and important in improving success rate, increasing safety, and reducing costs. With emerging novel technology, quality control methods need to be updated and you need to ensure it meets regulatory guidelines.
Join this workshop to:
- Set critical quality attributes required for your cell therapy products
- Explore different potency, purity and sterility assays to help maintain product quality
- Validate quality control strategies ahead of time to reduce costs
- Convince regulatory authorities your quality control strategies are better than the traditional ones
- Overcome variability in manufacturing to maintain high quality
12:00 pm Lunch & Networking
1:00 pm Workshop B:
Exploring Next Generation Combination & Armoring Technology to Improve Efficacy of Cell Therapy
Exploring Next Generation Combination & Armoring Technology to Improve Efficacy of Cell Therapy
Synopsis
With new approvals, partnerships and investments in the cell therapy field the most important thing is to utilize and innovate the latest technology to ensure success and stay ahead of the curve. Next generation armoring, combination and gene editing technologies are the best way forward.
Join this workshop to:
- Review CRISPR, next-generation sequencing and other gene editing tools
- Learn about novel combination technologies and their success in improving efficacy
- Utilize novel technologies to overcome tumor microenvironment
- Armor T-cells to prevent T-cell exhaustion
1:00pm Workshop D: Understanding How to Conduct Clinical Trials to Meet Regulatory Expectations & Gain Approval
Synopsis
The increased regulatory scrutiny on cell therapy means the need to better understand what regulatory guidelines need to be met, how to meet regulatory expectations and more. Additionally, with the FDA releasing new guidance for cell therapy development, there are a lot of questions.
Join this workshop to:
- Unpack the new guidance and understand what it means for your trials
- Analyze what prevents the regulatory agencies from approving certain trials and products
- Understand what a successful IND submission looks like to ensure your IND is accepted
- Harmonize global regulatory requirements to ensure approval globally
- Interpret regulatory guidance and learn from examples on how to apply the guidance
1:00 pm Workshop F:
Optimizing Manufacturing Technologies to Adapt to Varying Cell Types & Next Generation Armoring Technologies
Optimizing Manufacturing Technologies to Adapt to Varying Cell Types & Next Generation Armoring Technologies
Synopsis
While autologous cell therapies have been the go-to, allogeneic and in vivo cell therapies are slowly making their way to center stage. With these developments, there are also novel armoring and gene editing technologies that are being innovated. All of these technologies and innovations have a direct impact on manufacturing processes and the success of cell therapy development.
Join this workshop to:
- Review the different nature of allogeneic, autologous and in vivo therapies and how that affects manufacturing processes
- Address the unique manufacturing challenges associated with each type
- Translate and optimize manufacturing process for all cell types to reduce manufacturing timelines
- Analyze how gene editing technologies affect manufacturing
- Standardize manufacturing guidelines to reduce variability