Aldevron Breakthrough Blog

Innovating Together

November 4, 2024 by Sadik Kassim

Overcoming Cell Therapy Manufacturing Challenges with Danaher and UPenn

It’s no secret that cell therapy has incredible potential. Its impact on patients worldwide is already evident, offering hope and solutions to those who commonly have very limited options. I recently had an inspiring reminder of this impact at an Aldevron event in Fargo, ND, where we watched, Of Medicine and Miracles, a documentary about the first CAR-T treatment of a pediatric cancer patient, Emily Whitehead.

During the event, I also spoke with Aldevron team members who recently attended the Emily Whitehead Foundation’s Believe Ball and heard first-hand stories from patients about the way that cell therapy had saved their lives.

Currently, there are six FDA-approved CAR-T therapies and more than 1,000 programs in ongoing clinical trials. However, not all patients in desperate need of these cures have access to them. The extremely high costs and lack of high-quality, accessible immunotherapies mean they are far from being readily accessible to all the patients that need them. This is largely due to the overarching challenges in scaling manufacturing in a cost- and time-effective manner across the entire industry.

Collaborating for Innovation
To tackle the complex challenges in the cell therapy manufacturing process, collaboration across the ecosystem is crucial. By working together—academic centers, biotechnology companies, pharmaceutical organizations, and beyond—we can achieve the most impactful results. This is why Danaher launched the Beacon for Cell Therapy Innovation with the University of Pennsylvania last year.

This initiative is part of the Danaher Beacons program, which funds pioneering scientific research in academic settings, such as the University of California’s Innovative Genomics Institute (IGI), Duke University, and Stanford University. The Beacon with UPenn aims to develop new technologies that will improve the consistency of clinical outcomes for patients. Together, we’re collaborating to accelerate the delivery of next-generation cell therapies to patients.

Our teamwork with UPenn is greatly inspired by Aldevron’s long-standing relationship with the prestigious university. Aldevron’s founders, Michael Chambers and John Ballantyne, have strong relationships with the institution and when building the company, they always kept partnerships between academic pioneers and industry front and center to accelerate the development of potentially life-saving therapies.

At Danaher, we’ve embraced that spirit and continued this partnership with UPenn and Dr. Carl June, the renowned immunologist and pioneer of T-cell engineering for cancer and HIV therapies. Dr. June’s lab is a leading center in cell & gene therapy, and it is highly esteemed in the industry and beyond. These collaborations have led to innovations in manufacturing nucleic acids like DNA and RNA.

As the CSO/CTO of Danaher Genomic Medicines, I’m excited about furthering the mission of Danaher’s Beacon partnership to advance and enable the field for greater adoption of high-quality therapeutics, ultimately meeting the need for patients.

Addressing Bottlenecks Together
Currently, CAR-T manufacturing is expensive, inconsistent, and time-consuming. Similar to other Beacons, the Beacon with UPenn aims to identify bottlenecks in the current workflow and enhance reproducible manufacturing efficiency. Given the complexity of manufacturing CAR-T therapies, reducing uncertainty and increasing consistency is essential for improving accessibility. Our ultimate goal is to reduce the time to get therapies to patients and reach more individuals in need.

Together, we are developing new technologies to improve the consistency of clinical outcomes for patients, leveraging the complementary capabilities of Danaher operating companies and UPenn. By addressing these pain points for therapeutic developers and patients, we hope to enable more breakthroughs and create new possibilities for therapies. Our efforts are focused on achieving reliable, high-quality manufacturing of cell therapies, with a clear vision towards improving access.

Looking to the Future
At Aldevron and across Danaher, we’re all driven by a mission of getting life-changing treatments to patients more quickly and efficiently, so that they can have the most impact. Through all our Beacons, we are helping make this vision a reality.

As we look to the future, Aldevron exemplifies Danaher’s commitment to advocating for patients in desperate need of cures. This fall and beyond, Aldevron team members have demonstrated their dedication to advocacy through their hard work and engagement with causes that connect to a broader mission. Through their optimism, collaboration, and dedication, we are making strides toward ensuring more patients have access to transformative and lifesaving therapies.

I’m excited to see what we can continue to achieve through our innovation and advocacy efforts. The impact on patients is what makes our work so fulfilling, and I look forward to seeing how we can create broader access and greater adoption of these therapeutics, leading towards a world where every cure is possible!

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ABOUT THE AUTHOR


Sadik Kassim

Sadik Kassim, Ph.D. is a scientist and executive with extensive experience in the biotechnology industry with a specific focus on cell and gene therapy bioprocessing and translational research. Currently, he serves as Chief Technology Officer of Genomic Medicines for the Life Sciences companies at Danaher Corporation.

Most recently, he was Chief Technology Officer at Vor Bio where he built the technical operations team responsible for process development, analytical development, supply chain and manufacturing support of a CRISPR gene-edited HSPC product and oversaw the company’s pre-clinical CAR-T research efforts.

Prior to Vor, Sadik served as Executive Director at Kite Pharma and led the development of manufacturing processes for autologous CAR-T and TCR-based cell therapies. As the Chief Scientific Officer at Mustang Bio, Sadik managed the foundational build-out of the company’s preclinical and manufacturing activities. Earlier in his career, he was Head of Early Analytical Development for Novartis’ Cell and Gene Therapies Unit.

Sadik and his teams have contributed to the successful BLA and MAA applications for three of the commercially available CAR-T therapies: Kymriah, Yescarta, and Tecartus. Sadik completed his post-doctoral research training at the National Cancer Institute with Dr. Steven Rosenberg, the University of Pennsylvania Gene Therapy Program with Dr. Jim Wilson, and Johnson and Johnson’s Immunology Discovery group. Sadik holds a Bachelor of Science degree in Cell and Molecular Biology from Tulane University and earned his PhD in Microbiology and Immunology from Louisiana State University.