Christelle Dagoneau explains how Px are Helping Pharma and Biotechs from R&D up to clinical stage




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Video title: Christelle Dagoneau explains how Px are Helping Pharma and Biotechs from R&D up to clinical stage
Released on: December 22, 2010. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, Fintan Walton talks to Christelle Dagoneau, PhD, Business Development Director, PX'Therapeutics.
Focus and expertise of PX'Therapeutics
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here at BioPharm America in Boston. On this show I have Christelle Dagoneau, who is Director of Business Development & Marketing at a company called PX'Therapeutics, Grenoble, France. Welcome to the show.
Christelle Dagoneau:
Thank you.
Fintan Walton:
Christelle, tell us about PX'Therapeutics, it's a company that's just about 10-years old, what is the focus of our business?
Christelle Dagoneau:
So we are CRO and CMO company meaning that we are selling R&D and biomanufacturing services to pharma and biotech companies basically we help them to develop their biological product recombinant protein and monoclonal antibody from R&D up to clinical stage.
Fintan Walton:
Right, so you know clearly the whole process of developing protein based therapeutic as you say is complex, because you've got to get the early stages right be able to get a proper protein expressed, so the early stage research that you do is that really focused on trying to optimize the expression systems are you actually involved in the drug discovery process itself?
Christelle Dagoneau:
Actually can be both, I mean we are most of a time only involved in the development of that process, but on some cases we can also help our clients to optimize their gene of interest, their sequence by modifying the protein and so generating some IP on it, but that's only a few cases most of the time our clients come with a sequence for gene with Cne and we start most of the time from scratch and we develop only the first, we benchmark the expression system, we select the right one bacterial mammalian et cetera, and then from here we develop production and purification of protocol either for only research grade applications or for large scale pharmaceutical applications programs will be different.
Fintan Walton:
Sure, so you know one of the areas that you were strong in beginning was really a bacterial expression systems, they're not easy to deal with so you can over come issues like solubilization of the proteins and so forth and refolding of protein at natural state is that part of your expertise?
Christelle Dagoneau:
Yes that's actually our main expertise, most companies knows us for our expertise in E. coli so bacterial expression so we have specific expertise in the refolding, because we know that half proteins we are working on are produced as inclusion bodies so you need to solubilize them and to refold them and that's a very tricky part of the process, so that's were we have got very good scientist, but also on beside of bacterial expression we also do mammalian cell culture and we are working in over-expression system, so today's half, half I would say the company bacterial, mammalian systems.
Clients of PX'Therapeutics
Fintan Walton:
Right, and the type of clients that you have are they tend to be biotech companies are it does large pharmaceutical companies come to you as well?
Christelle Dagoneau:
Again it's both, but usually they do not come for the same type of projects, so we are working with small and medium biotech company and virtual one for I would say the world development program so most of the time those company they come with nothing, the gene sequence and we work with them during one-year, two-year, three-years to develop to perform overstep of their projects the feasibility study to choose the right expression system, process development to develop a process which will be scalable at some point to develop all the analytics and then to perform the preclinical and clinical manufacturing for phase one to two clinical trials, so that's really for biotech companies who do not have any research lab and are seeking our support, for pharma company it's different, because usually they have their own manufacturing capacities, so what we do we do research contract where they came with plenty of different candidates to explore and just as an example we can handle up to 10 or 20 candidates at the same time and we can have six most programs where again it starts from scratch 20 genes well for some they can need some optimization, we do the molecular biology, the development of protocol and at the end we can provide batches of 20 milligram of protein for example of the 20 candidates and those batch are used by the pharma company to do proof of concept in animals and once they've got to it usually they do a process development and the manufacturing in house that's really how it works.
Techniques to overcome issues of post translation effects like glycosylation
Fintan Walton:
Right, and you know one of the things about doing making proteins of course is post-translational effects like glycosylation and so forth have you got all the techniques to overcome those issues?
Christelle Dagoneau:
I mean you know in terms of techniques here we are talking both mammalian and cellular expression, so the idea is really to we try to find the right system which will overwrite profile of glycosylation and then so we've got all of the analytical either in-house or we've got partners to try and allign glycosylation profile for example, but then if for example our clients need some PEGylation or you know we can also interface with other company or it's technology to improve glycosylation properties, so we are expert in production and purification and analytics, but then if there is an overall technology required we will just interface to incorporate it.
Fintan Walton:
Right, so that's an important point you are making particularly in degree of purification, so production is one thing then purification to pharmaceutical grade you have that capability?
Christelle Dagoneau:
Yes for sure.
Fintan Walton:
Right, and do you have examples of proteins that or peptides that you produce which are now commercially developed or is it?
Christelle Dagoneau:
Not commercially, because we started I mean the company is 10-years old. We started with the development of biopharmaceutical in 2004 before that it was more protein for R&D applications. So now anyway we've been working on a lot of biopharmaceutical candidates so the one which have a most advanced are in Phase I other were results have been obtained are about to go to Phase II, so that's the most advanced and right now we've got proteins in Phase I, in pre clinical, in process development, but not commercial, not at yet.
Business model and new manufacturing facility
Fintan Walton:
What's the business model do you are you a clearly a service based company or do you take a royalty on future sales of the product as well, how is the business model actually work?
Christelle Dagoneau:
Yes fee for service 100% because actually that's what most of our clients requires they want to remain you know the owner of what we develop for them, so and it's really understandable. So you know we put our expertise for the development of those biopharmaceuticals and we are paid for our fees but then our clients they own the process that have been developed and they can exploit it and we do not get any royalties, there's been a few cases where it was different, but it's really a very, very few cases. But in terms of business model we do fee for service, but we also on beside do R&D collaborative programs, so it's in a way to walk with some clients sometimes.
Fintan Walton:
Okay, and in terms of you know building the, you are building your business you currently based in Grenoble, but you are doing two things as I understand and one is you've got a presence here in the US, but also you are about to launch or your new manufacturing facility in mammalian cells, you want to tell us about both those events?
Christelle Dagoneau:
Okay, so first the set up of a new manufacturing unit so we've got the first one since 2004, so this one was related to bacterial and yeast expression and so years after years we've been working on proteins expressed and antibody expressed in (indiscernable) cells and you know mammalian cells, so it made sense to us to create a new faculty, so it's gonna be a set up at the moment it's been a equiped, it's going to be audited by the end of the year and so we shall have our first compliance by the end of 2010. So that's the first thing, so it's gonna be a small scale production unit as the first one, so 100 to 200 liter that is enough for pre clinical or Phase I compliance and also for niche market, because it's a novel area that we are targeting and for the development in the United States so we hope fees so so it was two-years now understand (indiscernable). And we are coming here quite often and the view is that we we've had American clients four-years now and we really feel that we have something to bring to American clients very good science, specific small scale capacities relieve the opportunity to have only one path now to do everything from R&D to clinical stage manufacturing and that's not always the case in all you know all of the other CRO or CMOs, so it makes sense to us to develop our position here.
Christelle Dagoneau's perspective on biotech industry in current economic climate
Fintan Walton:
Okay, and finally when we look at the industry at the moment, particularly the biotech industry it's not exactly the best time for biotech companies, from your perspective from building the business are you still getting lots of business coming through from both biotech companies and pharma companies in the current climate?
Christelle Dagoneau:
Yes, actually it's true that it's difficult. I mean setting R&D and Phase I, Phase II manufacturing services it's very difficult activities and old CROs, CMOs shall see the same. Anyway there is a need for companies like ours, so even if it's not easy everyday if we disappear there will be a lack of expertise somewhere, because there are biotherapeutics which are being developed and which needs expertise and there is not so much expertise you know in the field. So yes it's difficult, but anyway there are projects they try to find funding and so they become our clients and so years after year we develop the company and we hope that we use to be doing that et cetera.
Fintan Walton:
But I suppose one of the part of the reason for the question is if there is a temptation for you to take some risk with the projects with some of these companies wishing to take things forward, do you get your clients or potential clients coming to you and saying well can you do some manufacturing for us, but share some of the risk and the cost?
Christelle Dagoneau:
Usually if the propose to share it's meaning that we are ready to give us some parts of you know their property, their projects and most of the time they prefer to pay and to remain the you know anti owner of the project, so usually and it's not how, it's not this way and that's that those projects are handled.
Fintan Walton:
Christelle Dagoneau, thank you very much indeed for coming on the show.
Christelle Dagoneau:
Thank you for inviting me.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Christelle Dagoneau
Director
Christelle Dagoneau joined PXT in November 2005 as Business Development Director. Before that, Christelle Dagoneau held various marketing & business development positions mostly in health and life science sectors both in France & in the UK. She holds a PhD in Organic chemistry from the Lyon University and a Master in Technology Management from Grenoble Business School.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialisation.
PX'Therapeutics
PX'Therapeutics Funded in 2000 in Grenoble, France, Protein'eXpert has been offering contract research services focusing on the engineering and development of valuable and complex recombinant proteins. Protein'eXpert has then extended its range of services to the biomanufacturing of therapeuticprotein products for early clinical trials via its integrated subsidiary PX'Pharma in 2004. PX'Pharma has been providing dedicated contract services for process development & scale-up optimization, preclinical and clinical cGMP production. In 2007, a new subsidiary named PX'Monoclonals was created to propose services ranging from the generation of high affinity murine monoclonal antibodies to the development of chimeric and humanized antibodies for therapeutic use. On September 2008, Protein'eXpert became PX'Therapeutics. This change of name reflects the company's strategy to accompany biotech and pharma clients all along the development of their biotherapeutic candidates with a mission to optimize timelines and bring value to their pipeline. The combination of protein expertise and manufacturing capabilities of the PX'Therapeutics group allows ensuring a seamless transfer from the discovery stage up to clinical manufacturing steps for complex biotherapeutic projects (therapeuticproteins, recombinant vaccines and monoclonal antibodies). In August 2010, PX'Therapeutics offers new services for absolute quantification of proteins based on PSAQ method through a new subsidiary PROMISE Advanced Proteomics which is a spin-off company from the "Exploring the Dynamics of Proteomes" laboratory (CEA/INSERM/UJF). By the end of Q3-2010, a new cGMP mammalian cell culture facility will also be authorized and opened to our clients and partners.