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Latest Executive Roundtables

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Articles

Pharm Exec recently convened a cross-section of industry experts to review current and pending efforts to turn great science into good oncology practice.

Oncology: Pathways to Progress

From the depths of the Great Recession, Pharm Exec called in pros on all sides of the M&A business to help us deal.

A Season in Financial Hell

In the third part of this roundtable discussion, experts discuss the issues with data that AI must overcome.

Peer Exchange: AI’s Data Advantage

In the second part of this roundtable discussion, experts discuss how the industry is handling AI in the marketing space.

Peer Exchange: Marketing With AI

In this first part of this roundtable discussion, experts discuss the current perception of AI and how this is impacting adoption.

Peer Exchange: Embracing AI in Pharma

Industry experts, in a roundtable discussion, explore the evolution of brand engagement in the age of AI, including the growing importance of message relevance—and, for pharma, going where the information is. 


Today’s New Messaging Mix: The State of Pharma Marketing in 2024

Roundtable: Current State of the Pharma Sales and Marketing Sales Force

Final Thoughts

The panelists provide their closing thoughts on CAR T-cell therapies and what they look forward to as these therapies become popular beyond cancer, extending to autoimmune diseases as well. There is hope to remove manufacturing bottleneck so patient demand and access can improve.

Videos

The future of CAR T-cell therapies will continue to improve as they expand to other patients in need. 

The Future 

The panelists explain how they hope CAR T-cell clinical trials will improve over time. Tactics like developing scalable manufacturing techniques, having adaptive manufacturing, streamlining regulatory approval, and gaining early feedback from regulatory bodies will help quicken clinical trial processes. 

Delivering the same safe product to a patient while improving timelines of clinical trials

Looking Towards the Future of CAR T-cell Trials

Patient Selection

Patient selection is a key component to the success of a clinical trial. A CAR T-cell study protocol is critical in outlining the site, the desired patient diagnosis, biomarkers of the tumor, and prior treatments. Building on key components from episode seven of collaboration, the panelists outline how working close with sites allow for stronger patient selection.

Obtaining the right patient population for a CAR T-cell clinical trial is based off several factors from both the patient and the site. 

Patient Selection and Recruitment for Clinical Trials

Collaboration with Sites

Clinical trials involve a lot of moving parts which require a good relationship between a sponsor, CRO, and site. Having logistical and study coordinators are one tool to better ensure everything is moving along and communication is upkept. Setting up meetings with these individuals on a regular basis go a long way for addressing challenges head-on and maintaining a collaborative relationship. The panelists dive into these strategies and more.

Effective strategies for fostering strong communication and teamwork with a clinical trial site. 

Collaboration with Clinical Trial Sites

Site Selection

Site selection for CAR T-cell clinical trials is a complex process that requires the right expertise, capability, and facility. Infrastructure is another major factor to consider as patients will often stay at the site after dosing to be safely monitored. The panelists walk 

 through the criteria they look for when selecting a site for their clinical trials.

How the right site can set up for a successful clinical trial for CAR T-cell therapy. 

Site Selection for CAR T-cell Trials

The future of cell and gene therapy

Regulatory agencies are open to changes within the review process which means the uptake of CAR T-cell therapy will change the landscape itself. This is especially true with large-scale commercialization. Information sharing between global agencies will also be helpful in advancing the science forward.

Transferring knowledge and continuing to work together with regulatory agencies will lead to changes in approval going forward. 

The Future of Regulatory Processes in Cell and Gene Therapy

FDA Regulation

The regulatory landscape for CAR T-cell therapies is constantly evolving with the FDA establishing their own guidelines needed for approval. Often, the approval can be long and difficult to obtain. Panelists examine their own strategies that have increased collaboration and support from the FDA.

Examining hurdles surrounding FDA approval and how to streamline the process 

FDA Regulations for CAR T-cell Therapy

IBC Approval

IBC approval has become a larger hurdle when conducting clinical research. This review process often adds two to three months to the timeline that must be accounted for in order for CAR T-cell sites to be IBC certified. It requires training from both the sponsor and CRO perspective. Our panelists highlight how to work through this process and what extra thought is needed behind planning for clinical trials.

Proper planning can assist in the institutional biosafety committee (IBC) review process when preparing for CAR T-cell clinical trials. 

Approaching Institutional Biosafety Committee Approval for CAR T-cell Therapy

Key Challenges

CAR T-cell therapies involve genetically modifying a patient’s T cells which requires careful oversight by regulatory agencies to maximize safety and efficacy. This in turn often leads to complex regulatory challenges. The panelists explain some of these challenges and what they do to face them. 

Understanding how pharmaceutical companies can navigate regulatory oversight through streamlined techniques and logistical planning.

Key Challenges within CAR T-cell Clinical Trials

Introduction of Panelists

e Roundtable video series, Robert Alaburda, Associate Editorial Director, talks with several experts about the building blocks for success in CAR T-cell clinical trials. The panelists introduce their expertise and background in clinical trials.

Panelists set up for addressing the clinical trial landscape, key challenges, regulations, and the future of cell and gene therapy.

Executive Roundtable

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