PHARMA SPECIAL
The Pharma Outsourcing Best Practices Panel had been a fixture at Chemspec Europe for years
“ The good old days of ‘ make at any cost ’ up to launch have gone ,” Keay agreed . “ Now we have to be resourceefficient in everything when you look at a product - the process , the plant , the people , materials , capex and opex , waste , energy , carbon sequestration - and you have to look at all these things from Day One .”
The other way of gaining leverage with customers in his view is to have differentiating technologies and / or integration into different material streams . “ You have to look at the most cost- and resource-efficient way of producing . The chemist ’ s mantra of ‘ Lets ’ just make the product ’ is not right . You also need the chemical engineers , QA and others in the circle to tackle the challenge from the start .”
For any new product AVN Corporation takes on , said Steve Hedrick , chairman and CEO , sustainability , cost structures and efficiencies all have to built in at the front end . Not all products on the market today have those efficiencies built in and scale still matters but “ the way forward does not include that . We have to get it right first time and then continually improve on that .”
Buying into CROs
Like Siegfried , PHT acquired a CRO – a Swiss biotech ’ s R & D centre in China – to get into the early phases at a suitable scale for its relatively small size . CROs and CDMOs , in Yu ’ s view , “ are two different animals ”. They need totally different analytical capabilities and strategies . With only about 5-10 % of projects going forward , the CRO element covers its costs back at best in order to feed later-stage work .
Because of complex and costly reregistration issues , pharma companies do not want to change a process late on in development , Spaene said . “ If you start in the early phases , there is no excuse .” This could also help change the landscape , as CDMOs will work with the customer from the start to develop a sustainable process , using fewer solvents and creating APIs with lower CO 2 footprints . It will be their responsibility to get the process right from scratch .
CDMOs will not be the frontrunners in making the huge investments needed in artificial intelligence ( AI ), panellists agreed ; it can only be Big Pharma . But if AI can be made to work , said Spaene , it will reinforce the need for earlier collaboration because an AI system that knows your equipment , it can develop a process that is a perfect fit , achieving both cost-efficiency and speed to market .
Big Pharma is already making its moves into AI , said Hedrick . What the time-scale will be is anyone ’ s guess but it will happen and CDMOs cannot afford to ignore it . Kaus believes that it will take Design of Experiments to a new level , making small molecule development much faster .
No upstream investment
Some believe a shrinking of the supplier base on the scale envisaged will lead to drastic differences in how pharma companies and CDMOs work together . Kaus and Yu were not so sure , given how closely they collaborate already . However , Yu noted , pharma companies are increasingly disinclined to invest in additional capacity for projects at CDMO sites .
“ A single take-or-pay arrangement and investment upstream in the supply chain are both very difficult to come by these days ,” Hedrick agreed . “ Customers will sit with us in the labs , the pilot plants ,
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