Dear Science Advisory Board Member,
We're back from this week's onsite coverage of the 2022 Cell & Gene Meeting on the Mesa (MOTM), held in beautiful Carlsbad, CA, and organized by the Alliance for Regenerative Medicine (ARM). It was a terrific event that attracted a record number of attendees, which is testimony to the tremendous growth of the cell and gene therapy (CGT) industry and ARM as an international advocacy organization for the sector.
The MOTM was the first time we heard from Timothy Hunt, ARM's new CEO. Hunt kicked off the meeting laying out his vision for the industry and emphasizing the need to engage all major stakeholders. He said that while these technologies have the power to potentially change patients' lives, stakeholders such as regulators and patient advocacy groups have real concerns that must be addressed.
"The concerns of payers, policy makers, ethicists, and others are no longer theoretical -- it is here and it's real," Hunt said. "We're going to need to meet these important stakeholders not where we are but where they are, and really listen to their questions and concerns."
Among the other highlights of the MOTM was Dr. Peter Marks, PhD, director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration (FDA), who delivered a virtual keynote address. As the FDA's top biologics regulator, Marks said the use of a "cookbook" for developing CGT products and global regulatory convergence could help to facilitate their development and take them to the next level.
Despite a "bright future" for CGT and a "robust" global pipeline, Marks told the meeting that there are some challenges that need to be addressed, including disparate requirements among different countries -- from preclinical tests to manufacturing -- that make it difficult for patients in certain areas of the world to have access to therapies, particularly those with rare diseases.
The CGT sector will also continue to face investment and regulator challenges in the near term. That's the consensus of companies in the space who participated in a workshop at this week's MOTM. Looking at what's next for the CGT industry in 2023 and beyond, the companies called out familiar hurdles to commercialization -- including the current investment environment -- and what they can do to mitigate growing market pressures.
We'll have onsite video interviews we conducted from the meeting, which will be posted to our MOTM 2022 webpage next week. So please check it out!