A focus on collaborations By Christina Wichmann
Elizabeth Woo, PhD (Betty) serves as the Vice President of Cell, Gene and Advanced Therapies at Thermo Fisher Scientific. In her current role, Betty leads a busi- ness focused on fit-for-purpose solutions for cell and gene therapy (CGT) innovators, by integrating CGT products and services across Thermo Fisher. Prior to her current role, Betty led a corporate team focused on strategic collaborations with Thermo Fisher global custom- ers. Betty has held business, tech- nical, and commercial leadership positions at Thermo Fisher over the past 20 years, with a common thread of providing enabling tech- nology to serve customers.
Prior to joining Thermo Fisher, Betty served in various leadership roles at Cellomics, a biotechnology start- up, spanning product management to business development and strategic marketing. Betty started her professional career on the faculty of University of Pittsburgh Medical School in the Department of Pharmacology, where she also completed her post-doctoral stud- ies. Betty obtained her doctorate in pharmacology from the George Washington University School of Medicine and Health Sciences.
Betty serves on several advisory boards including the Standards Co- ordinating Body, the International Society for Cell & Gene Therapy, Carnegie Museum of Natural History, and the Pittsburgh Life Sci- ences Greenhouse.
For laboratorians not currently working in advanced therapies, would you provide a summary (i.e., elevator speech) on cell and gene therapies? Of course – the cell and gene therapy (CGT) industry is regularly making headlines, and for very good reason. There’s a lot of excitement right now around this emerging class of therapeu- tics, particularly in areas like cancer and inherited disorders like sickle cell anemia where patients have limited treatment options. What’s unique about CGT is these therapies hold the potential to not just prevent and treat diseases, but to potentially cure them. This is because these therapies work by addressing the root cause of diseases, which can be found at the level of the patient’s DNA. In brief, gene therapies work by introduc- ing genetic material into the patient to inactivate, modify, or replace the gene(s) associated with the disease. Alternatively, a patient’s cells can be removed from their body and the genetic modifica- tions can be made in a laboratory, then returned to the patient’s body, and this is known as gene-modified cell therapy. Though CGT holds incredible prom-
ise, the actual number of commercially available therapies is currently just over 20 in the U.S. That said, there is a robust clinical pipeline of thousands of candidates, and CGT remains an active area for science and technology devel- opment. The demand is there, and the pressure is on to bring these therapies to market faster and more affordably.
What are Thermo Fisher’s primary strategies when it comes to helping advance cell and gene therapies? To help advance cell and gene therapies, we’ve integrated our broad portfolio of fit-for-purpose products into flex- ible workflow solutions to help CGT developers confidently move their CGT assets from R&D through clinical devel- opment, and then scale to commercial manufacturing. Our differentiating value lies in supporting both build and buy strategies for our CGT customers, including quality and regulatory exper- tise, leading supply chain capabilities, and a customer-centric focus. While internal collaboration drives bet- ter solutions and customer experience, external collaboration is a key driver of our innovation strategy. We listen closely to what our customers need and design
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our products and workflow offerings based on our learnings. Our strategies work best when we partner with CGT developers early. As an example of the benefits of early collaboration, we have an ongoing strategic partnership with Arsenal Biosciences, Inc., a clinical-stage company developing programmable, autologous T-cells to treat solid tumors. Our collaboration has thrived, not only due to early access to technology, but by cultivating a close working relationship, transparency, and importantly, a shared vision. This vision is to advance and opti- mize their manufacturing workflows with urgency to get into the clinic faster and with the confidence that the processes will hold up to CMC and regulatory scrutiny. Earlier in the year we celebrated the opening of our cGMP cell therapy manu- facturing facility housed at the University of California, San Francisco’s Medical Center’s Mission Bay campus. Being at the center of this CGT ecosystem, we engage with world-class researchers, clinicians, and ultimately, patients, pro- viding early access to our technologies and our team’s expertise. The feedback we receive informs our innovation strat- egy and together, we can help developers overcome many of the CGT manufactur- ing challenges that must be addressed to bring new treatments to market at scale.
The U.S. Food and Drug Administration has approved numerous gene therapies the past couple years for diseases such as bladder cancer and Duchenne muscular dystrophy. What upcoming approvals do you foresee in the next five years for gene therapies? With over 2,000 clinical trials for cell and gene therapies underway, the next five years will bring further growth and several key approvals. Recently, the focus has been on the innovative companies developing gene editing treatments for sickle cell, with approval(s) expected later this year. Sickle cell is a rare disease with limited treatment options, so a poten- tial gene editing cure would be a major milestone for patients. Furthermore, one of the treatments being developed by Vertex and CRISPR Therapeutics would be the first gene editing treatment based on CRISPR-Cas9, if approved. While it is difficult to predict exactly
which diseases will see approvals in the next five years, I expect that many more treatments will emerge and be approved
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