PLM in Sanofi: Safer Projects & Accelerated Timelines for Development

Product lifecycle management is a holistic approach to emerging product and process knowledge that spans the stages of a product from conception through to commercialisation, thus improving the manufacturing process and quality of products. 

Philippe Lienard, Head of the Early Development Unit at Sanofi explains the approach they have taken in the anticipation method for chemical stability which has resulted in safer projects and accelerated the timeline for development.

Pharma IQ: Philippe, could you describe what’s happening in the industry currently around the whole latest product lifecycle management strategies and how this can be used to optimise product development processes? 
P Lienard: So to optimise the product development process we are particularly involved in some in-silico approach to assess the properties of the candidate to enter in development, and the benefit of this will be to anticipate any potential issues regarding, for example, chemical stability, solubility, crystalinity, whatever property will be very key for the drug development.
Pharma IQ: What strategies do you use at Sanofi to design and create safer products?
P Lienard: So the strategy is to test the compound on several animal models and for this we have to address a formulation for animals.  Generally, those formulations are designed to anticipate the clinic formulation and so it allows us to determine the safe dose, the maximum tolerated dose, and it’s a good starting point for the first treatment.
Pharma IQ: And can you tell us a little bit about how the gap has been made smaller between research and development and those people who are interested in commercialising products?
P Lienard: Yes.  The gap between research and development became smaller because we have now representatives of the development closely working with the research divisions and it helps really to design a better candidate to then accelerate the development.
Pharma IQ: And how can communication be improved between both departments, because they’re both very different? Can you give us some tips on what you do at Sanofi to improve this communication and thus create a product a little bit faster than what you have been doing previously?  
P Lienard: So generally speaking the communication is not a problem within Sanofi.  We are working as a team, so focused on programmes, and so we are doing project review meetings and in those meetings all people can bring their contribution to the programme.  Generally it’s open, issues are discussed and addressed and very often resolved in the same day, or at least an action item list is stated and agreed to address the issues.
Pharma IQ: Brilliant.  Philippe, can you talk to us a little bit about the presentation you’re going to give at the PLM event taking place in Berlin?
P Lienard:  Sure.This presentation will particularly focus on the anticipation method for chemical stability.  So it’s a combination of literature regarding degradation chemistry that is not very well communicated in the pharma industry, and also in-silico method with molecular modelling used to predict the chemical weakness of a drug candidate. It’s a new approach that we have put in place three to four years ago and his method really has a benefit on the research programme because it helps to design safer projects, safer candidates for a project and, like I said previously, accelerate the timeline for development.
Pharma IQ: Wonderful, Philippe.  Thank you for that overview.  And finally, can I ask you what you are looking forward to most from this year’s event?
P Lienard: I’m looking for networking with other people like me, sharing experience, benefitting of their different approach, and improving my network, enlarging my network.
Pharma IQ: Wonderful, Philippe, and thank you so much for your time this morning and we look forward to hearing you speak. 
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Interview by Niamh Madigan