In part two of my discussion with Miguel Forte, CEO at Zelluna Immunotherapy and ISCT’s Chief Commercialization Officer, he answers my questions about the Society’s near-term goals and objectives as well as his top areas of focus as CCO.
Harris: As a member of ISCT’s Board of Directors, help us understand the Society’s near-term top projects, goals, and desired outcomes.
Forte: ISCT is an association of academic and industry professionals, and regulatory professionals, which are involved in multiple steps of research development and commercialization of cell and gene therapy products. ISCT promotes and supports the delivery of cell and gene therapy products to patients for unmet medical needs.
We focus on all aspects that impact production, delivery, and clinical documentation, as well as reaching to the market with this product.
There are three pillars that are essential to ISCT.
The first pillar is the academic pillar, which brings all the academics who are doing fundamental research or clinical research in cell and gene therapy.
The second pillar is the regulatory group, which brings together a series of individuals involved in the regulatory discussion, in regulatory functions, in the public sector or in private companies, but also in lab institutions, in any circumstance.
The third and final pillar, which is industry community, which I lead within the ISCT as a Commercial Officer and Chair of the Commercialization Committee. We bring together several organizations that are involved either in manufacturing or in providing solutions for manufacturing, or by being part of the industrial development of products.
We aim to find thought leadership positions, best practices, and we engage with key stakeholders be it regulators or payers, as well as the public in general, and take the position on relevant topics.
In our first discussion, we covered a relevant topic, which is unproven cell therapies. Another relevant topic is to engage on new guidance. Recently, the FDA published for consultation a series of new guidance on cell and gene therapy, which obviously we analyze; we take a position and provide feedback to the FDA, EMA, and others.
Harris: As Chief Commercialization Officer, explain your focus areas.
Forte: As Chief Commercialization Officer, I lead the industry community within the membership of ISCT. In other words, I lead all the members that have responsibility in an industrial organization — either manufacturing or clinical development or commercialization.
When there is a good idea in academia — to transform that good idea, that good scientific idea, that good scientific evidence into a product that can be commercialized — there’s an industrial path that goes all the way from the manufacturing, the clinical development, and the launch of the product.
It’s the individuals in the different organizations that are involved in those steps, (i.e. industrializing and making a product commercially available to patients). Those individuals that are members of ISCT get together in an industry community within ISCT.
The Commercialization Committee brings all these individuals together, and we have three areas of focus.
The first area of focus is manufacturing and cost of goods. The second focus area is business models and investment, because we’re reaching out more and more to the investor community, which is a significant stakeholder that enables and supports the development of these products.
The third focus area is clinical development and patient associations and patient perspectives or patient access. As more and more products reach the market, we’re moving from research and manufacturing to launch and making these products available to the patients.
The way I tend to say it is if we adapt these products to what the market needs, we will get an adoption by the market to these products. In the end, the right patients will be treated with the right product, delivering the right value to these patients.
It’s this perspective of supporting the multiple steps of the development of the product so that we can reach the patient in optimal condition and as fast as possible — that it is the mission of the Commercialization Committee, which is the Industry Community within the membership of ISCT.