edsiegwartParticipant24 May 2018 at 8:41 amPost count: 3
I’m working for a CRO that is ending its microbiology drug development service. I’m looking into forming a spin out anti-infective CRO, but am keen on making sure that I get what potential clients want and need at start up, right from the business plan.
I have a decent handle on what my current clients want (because I’ve been doing it) but I’ve always had the feeling that there was an element of ‘going through the motions’ and only being able to provide the same raft of tests, when I have the capacity to offer different/broader testing that could be more useful.
Can anyone provide a broader insight on what a current era antibiotic drug development service should provide? Would you be happier if the contractor remained as an option for ‘off the shelf’ tests (eg MICs, time-kill, toxicity, surveillance, trial support etc)? Or again, do you feel that a CRO in this space isn’t really helpful at all? I’ve heard from at least one person who feels that academia can fill the space (but I’m not sure I agree).
I do have a feeling that there is a large chunk of the industry who don’t really understand the importance of these kind of CROs in this space. But the question is, do we promote them and back up their value or push towards alternative ways of gathering drug development data?
Also I would be very keen on working more closely with academic/charitable organisations for low costs, with the key aim in being a supporting service for those in anti-infective development, particularly in the early stages. The only issue here would be garnering enough volume of work to make it viable.
Any thoughts on the above are welcome.François FranceschiExpert28 May 2018 at 8:33 amPost count: 7
I think that a CRO in that space has a place, especially if you already have a customer base. In the US I have seen this type of activity performed by the big CRO outlets (eg. Eurofins), and by academic labs working as a CRO, as you pointed out. Nevertheless, there are successful CROs that are exclusively dedicated to the microbiology aspects of anti-infective discovery and development (eg. JMI-labs and Micromyx). I think that most people in the early phases of discovery will be fine with “off the shelf” services, but you should have the capability to access contemporary clinically relevant strains that are geographically diverse and that represent the prevalent mechanism of resistance. That brings me to the next point, having access to clinical strains with known genomic sequence and where phenotypes and genotypes can be correlated is becoming the norm, so those capabilities would also be very important to have. If you have contacts with academic labs doing antibacterial early discovery, that will be a good place to start, those labs normally need support to perform the assays needed to advance their initial hits into the next phase.
François F.Ursula TheuretzbacherExpert28 May 2018 at 10:36 amPost count: 10
The number of companies with a focus on antibacterial drug R&D has increased and the need for services will likely follow this trend. To my opinion the success of a spin-out depends on a good existing relationship with clients and tailored know-how and services. A general microbiology service with mainly in vitro testing may be less attractive due to strong competition. Academia is quite successful with delivering off the shelf complex tests and models. I guess it really depends on your special expertise and existing contacts to find a good niche.David ShlaesExpert29 May 2018 at 1:42 pmPost count: 5
In my experience, the greatest need among academics and start-ups is in establishing a TPP and then in designing and executing appropriate screening paradigms and later, translational studies to enable preclinical development. This requires a fairly broad expertise that might be appropriate for an individual with appropriate experience or a team of experts.edsiegwartParticipant1 June 2018 at 8:50 amPost count: 3
Thanks all for the points above.
As far as setting up goes, I think I have most of what I need that I can inherit from the current set up (good contact list, solid relevant isolate collection, budget for BD/marketing, experienced (very small) team etc). The question remains if its something that the industry as a whole wants and more importantly needs.
I’ve been reading through the Access to Medicine Foundation’s 2018 AMR benchmark report, which is an excellent overview of a snapshot of the industry. I’m sure the committee writing it are aware there are other anti-infective SMEs involved which they missed out for the sake of focus, but nowhere in the whole report does it mention the contribution of CROs in the space. I know that privately owned CRO organisations (JMI, IHMA, Evotec, Eurofins, Micromyx) are fairly integral to the process of the development of so many of compounds stated. Not to mention the ones on the list I know I have worked on as part of this company in its various forms (GR Micro, Quotient, LGC). Largely the input comes from the isolate collections built through surveillance activities and industry specific testing expertise. Only the very best specialised government/academic set ups could come close to the same services, and in these cases they often operate the same as a CRO does anyway.
So, does the industry want, need and/or understand the CROs?
If it doesn’t want them why is that the case (do people view them as shady black cloaked industry types interested in profits)? If it doesn’t need them then why do they exist?
These are important questions I need to fundamentally understand if I am going attempt to build something new and hopefully, better (although I know sponsors working with other CROs are very happy with what they’re getting!).
EdedsiegwartParticipant28 August 2018 at 8:10 amPost count: 3
Just wanted to say that I’ll be attending the ASM/ESCMID meeting in Lisbon next week, and I’d be very keen to discuss any of the points raised above with anyone else attending.
Recent discussions I’ve had with people have centred around having specialised services with good collaborative links to the other services required in drug development, to form an interlinked web of the testing services needed. As there is no ‘one stop shop’ that can handle the work required for the whole process.
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