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Claudia Zylberberg, Founder/Chair of Board/Senior Advisor at Akron Bio, reflects on two decades of working within the advanced therapies industry as Phacilitate celebrates 20 years of operating in the field.
First of all, could you tell me a little bit about your career over the last 20 years?
Over the past 20 years, the field of cell and gene therapy has experienced tremendous growth and excitement. Starting from research at universities, the industry has now progressed to the point where industrialized products are being tested in clinical trials for patients. At Akron, the goal was to create compliant products that could be used alongside these therapies, with a focus on CAR-T cell therapy, and corporate banking.
In the early years, I envisioned the need of standardization and introduced it at Akron. Akron worked on standardization efforts, particularly with fetal bovine serum as a supplement for growing mesenchymal stem cells. The team was instrumental in creating a chapter at the USP (United States Pharmacopeia) and continued to contribute to various organizations such as ISCT (International Society for Cell and Gene Therapy), Alliance of Regenerative Medicine, and the creation of the Standard Coordinating Body. Participation in workshops and collaborations, including with the National Academy of Science Forum of Regen Med, helped raise awareness and understanding of the industry’s progress and future growth
I believe strongly in education and participated in developing curricula for the training workforce, as well as early education with a book called, ‘You’re Full of Genes’.
After many years of hard work, including obtaining numerous therapy approvals, many great products created at Akron Bio, and the other entities that I was able to co-found, I have been able to work on the development of a range of products that have supported the industry’s growth. This has enabled patients worldwide to access novel and more curative treatment options.
The last 20 years have been an exciting period filled with great achievements in the cell and gene therapy field.
What inspired you to first get into cell and gene therapy?
I believe the future of medicine holds numerous untapped tools within our biology that can be harnessed for intelligent treatments against complex diseases. I cannot emphasize enough the importance of listening to our bodies, as they hold the key to finding the cures we need. By learning from our biology and creating better treatment options, we can improve healthcare for humanity.
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What changes have you observed from the industry over the last 20 years? What’s changed, what challenges have arisen (or changed)?
- Manufacturing technologies
- The understanding of how cell biology works and being able to create CQA’s
- Analytical developments
- The creation of standards
- Working towards GMP materials and workforce development
- Creating clinical models and education
- Closer relationships with regulators and payors
What key industry events or milestones (positives or challenging) have stood out to you over the last 20 years? Or what key events have shaped or rocked the industry over the last 20 years?
- Emily Whithead’s story, and 10 years of being cancer-free
- Phacilitate’s move from DC to Miami after a huge storm (that I pushed so hard for!)
- First cell therapy CAR-T approvals, validating years of work!
- Cycles of valleys and excitement in the investment community
- The resilience over the pandemic years
What memories do you have of the first Phacilitate event you ever attended?
Great parties and networking events. All of them have so many special moments, that are all funny in perspective!
What do you expect to see from the industry over the next 20 years?
The movement and passing on of many colleagues, which in a way gives a sense of time and value of what we do, together, as a community.
If you could speak to yourself 20 years ago, what would you say? Would you have any advice or pearls of wisdom to share with yourself from 20 years ago?
Keep going forward, the field is the right one, and you are going to succeed. The cures and new methods of treatment are going to revolutionize medicine and patients’ life expectancy.
What would you say to anyone considering attending Phacilitate’s 2024 Advanced Therapies Week?
It is a great event, a whole package. A holistic view of an industry, with the latest information and insights, including great speakers, relevant content, and essential networking opportunities for growth and brainstorming to keep growing. It is a must-attend event for the year.
