Stephan Kutzer, CEO, Alcami
A: I Think The Jury’s Still Out On Adc’s Potential For Market And Medical Success. Yes, most agree that overall the concept of ADCs is brilliant, but after all this time, we have not seen the breakthroughs the industry needs to support ADCs’ medical potential and commercial success. Further, it’s not clear if the investment community will continue to finance development and capacity. Where’s the ‘Wow’ factor? It takes a huge investment to launch new capacity, and already, as many might argue, there is enough capacity and volume to meet the market’s near-term demand for ADCs. Regardless, time will tell if investors will continue to fund R&D and additional capacity to support further ADC development until we see it meet its potential. In the meantime, Alcami, like others, will continue to invest in the aseptic filling technologies and the HPAPI handling infrastructure that underpins the sophisticated biologics processing capabilities the industry is demanding.
Luca Mantovani, CEO, INFA Group
A: [ADCs are a] huge challenge in terms of manufacturing and capital investment because you have to build both biologic and chemical synthesis capabilities. In my view, it might be understood because you need two sets of skills for ADC development. [ADCs are a] huge challenge in terms of manufacturing and capital investment because you have to build both biologic and chemical synthesis capabilities. Setting up organizations which have both skills is definitely a huge investment for a company. I would say that most of the people who are evaluating [ADCs] are probably hesitating entering this market because of this huge barrier.
Franck Pavan, CDMO Department Manager, Injection products, Pierre Fabre
A: I think that ADCs made a breakthrough since 2010. This is a tremendous outcome for the pharmaceuticals laboratories for the treatment of cancers, and these therapy-targeted products will be aiming to treat specific needs, small pathologies, not wide treatments with a wide spectrum. I’ve been involved in several ADCs’ projects, and the results on the patients which have been treated initially by those types of technologies and products were amazing. The initial ADC on the market was not strongly binded to the toxic agents, and the side effects were too powerful. Today, the new technologies which have been implemented by the laboratories prevent the toxic agent from being released until it reaches its target. That’s a real improvement to the technology, which accelerates marketing of the products and will quickly move the products to the market in the future. The corollary to that is the price of such technologies, which is very high. For highly regulated countries, this is a small hurdle as the market can support it, so the ADCs will move forward for sure. The landscape is crowded as there are a lot of new companies which are trying to be involved in such new technologies by providing new linkers technologies and other companies trying to find new payloads for ADCs as this last technology is very active due to lack of candidates.
Nagraj Bokinkere, Technical Director, Business Development, Eastman Kodak
A: I think it’s expected but not fully quantified. There’s really a lot of uncertainty around what it would really take to manage that kind of growth. And certainly if you’re a traditional pharma person, it would be much more of a square start than upgrading or backing into by adding small pieces of equipment. It would be more of a holistic view that would be needed, so that adds a different kind of capital. There’s a reasonable amount of capital just for the development piece. I’m specifically talking about the lab-based development work and that alone certainly already has a significantly higher [investment].