Optimize your deal qualification process for technology industry

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hello there my name is Charlie maher I'm the global director for process and manufacturing technology I'd like to introduce Beth Haas she's one of our principal consultants who specializes in technology transfer we have a conversation today about technology transfer best practices Beth hi everybody we're going to talk today about technology transfer and some of the things that you can do to make it a little bit easier for your organization yes when performing a technology transfer you have to think well what is it first so in my mind you have to separate that technology transfer into specific stages and we're going to talk about that next we want to crosslink activities and deliverables and know what stage those need to be those need to happen there are a lot of moving parts and it's a puzzle that has to be solved a fun puzzle for some people and I think it's kind of fun and very satisfying when it works but the trick is that every truck transfer is unique and it makes standardization very difficult technology transfer is essentially product realization it fits right in with the product lifecycle that's presented in IC h q10 from product concept product development then which shows technology transfer commercial manufacture and prod discontinuation but the reality is is that technology transfer really spans the whole lifecycle it should start in product concept move with it through defensive product development obviously the culmination is with commercial manufacturer and sometimes it actually goes into practice continuation if you're if the reason that you're doing the discontinuation is to transfer that product to another location technology transfer implements the product and process knowledge to achieve operational readiness that completes all the CMC requirements needed for filing and realtor approvals before you start your technology transfer it's really important to understand what classifications it falls under there are two classifications that I often look at the first is the lifecycle phase that's everything that starts with clinical or clinical so if you're transferring say from clinical stage one to clinical stage 2 stage 2 to stage 3 or stage 3 to commercial these CMC requirements are only going to be a subset of what you really have to implement for commercial manufacturer clinical phase 3 once you reach that point it needs to be paralleling you can't take jump tech transfer program because the CMC requirements should be starting to get put in place and all the elements that are needed should be for the auto transfer transfer should be getting in developed development commercial is often talked about for technology transfer and that's essentially the same thing as clinical phase 3 - marketed product this terminology is often used for api's or drug substances because they don't have the same use of the clinical phases when they do their new product development and then finally there's a commercial to commercial and this is essentially just the transfer of a marketed product from one manufacturing location to a new one so you need to really understand where you are in that lifecycle phase to know what elements the CMC need to be transferred next is knowing the implications of your sending unit and your receiving unit sites and what what implications does would entail are dependent on whether that site's internal or external to your organization so the first kind of transfer you may do is an internal to internal transfer so that's where you're going for one internal site to another internal site these are usually considered the easiest kind of technology transfers because there's integrative systems that will help you to streamline that knowledge transfer there's interconnectivity there's cooperation between sites all of that is already in place however the only consideration for internal to internal is you might want to consider the impact if you're going global with that and for instance if you're moving from a US site to an EU site or an Asia site those tech transfers have to then incorporate the considerations for language barriers maybe's communications and also interpretations of quality managed system the next is internal to external or external internal this is where the internal site is typically the marketing authorization holder and though is the one legally responsible for that technology transfer in that product they are the ones that need to have complete oversight of whatever's happening at the external manufacturer so they're likely going to have their own team as well as a team for tech director at both locations in order to facilitate that oversight the final one is the external to external transfers and in my mind these are the most complex for knowledge transfer because it's not always easy for those two sites to talk to each other and facilitate that knowledge transfer many times in these little these instances the marketing authorization holder has to act as the middle person to provide the knowledge from one site to another depending on how the con business contracts have been established that can make it very difficult for ensuring knowledge transfer the FDA also requires that you have a technology transfer process in place this is just an example of one it's a five stage process starting from feasibility going through qualification you may add more stages for your organization and the level of oversight your organization wants to have I recommend having checkpoints between each stage so that you can have a steering committee approve and agree that the activities and deliverables have been accomplished to the point where they want to take the risk to move on next so if you're looking at these stages using this five stage approach you think well where did where does the technology transfer actually begin and this is actually really important because oftentimes the technical knowledge transfer doesn't start until the business decision has been made one to perform a technology transfer and two to actually figure out where the receiving units going to be so you they might come in and start working on the technology transfer and the project wrist stage determining where those risk factors are but at that point that business strategies already set oftentimes I see that technology transfer teams are not formed until even after the project first phase they're saying okay we've assessed the risk and we agreed we're going to move forward so now let's just do that all knowledge transfer promise eyes that you need to look at these technical aspects and assess them a little earlier all the way back into feasibility just to determine if there's going to be something that's going to impact the business goals for that top technology transfer next it's also important to have the right technology transfer team in place first of all you need to have a solid technology transfer project manager assigned to coordinate all the cross functional requirements and have knowledge of what the CMC needs will be for that technology transfer these teams have a broad range of functional experience obviously first there's the business team they start out presenting that strategy finding the customers knowing the markets the next is your tech consult your tech transfer p.m. leaving that team you have to have processed knowledge for Kostis chemistry and engineering analytical is a key piece covering raw materials and price controls product stability both development and covering both development and quality control functions in the organization and you have engineering that's for capital installation and qualification Manufacturing is often needed much early in a technology transfer to know that your operational readiness is going to be established with the knowledge transfer that's occurring regulatory is a key apiece because they set the strategy and that strategy needs to be known and should not change very much throughout the technology transfer quality is a integral part across all these functional areas of proving documents establishing the QMS and knowing that everything's being done from a compliance standpoint and finally sourcing and supply chain an important for production planning logistics and material sourcing to identify long lead items and plant windows that are needed for the transfer and as I mentioned before you may need separate teams that are cross-functional at both the sending and receiving sites so let's talk about what makes the text transfer be successful I always advocate that you set boundaries for the tech transfer establishing what it's going to be its end point and that end point would be what defines its success some people would say well process validation batch release using right time right first time execution is what's important for this tech transfer other point places might say well once the regulatory filing is submitted that would denote the end of the tech transfer or even even further than that going all the way to Pai approval others are the budget goals being achieved and the time to market requirements so you've done it in the time that's needed and finally it may not be over until there's an official handover to the commercial team knowing that everything's in place for full operational running is knowing these success factors upfront is important to understand how to prioritize your tech transfers then the last slide I have areas on touch points and the touch point that I'm going to talk about today is well you know you've done all this you have a tech transfer process you have a tech transfer p.m. that's really strong we have a dedicated cross-functional team and a clear charter so why what's so hard why is it still having problems with the knowledge transferring getting the process ready what keeps it from being standardized and streamlined in the main a main aspect in my mind from all the tech transfers I've done is that sometimes there's a lock of transparency between the sending and receiving units they don't always have the ability to communicate openly and they may have to use a middleman so that's a problem because you know your knowledge transfer is now playing telephone the next thing is these oh sorry I'm going to go back the next thing is the communication that's established between the sending and receiving units is often set by contractual agreements so it's you need to be careful in those contractual agreements if it's important for the technology transfer to have the streamline knowledge management system to ensure that those contractual agreements align with the communications that's apart and then we need early agreement on regulatory strategy in the markets involved the earlier you can get that and place the better for technology transfer often markets might be added or the strategy might change midstream on a technology transfer and that completely impacts the timeline and involvement of some of the functional areas as we discuss technical risk might not have been assessed soon enough and so you might learn some information when you start doing that knowledge transfer that will impact business goals in the boundaries and assumptions that we use to establish the tech transfer and finally you know having the ability to leverage your testing requirements at the sending unit or external labs and being able to synergize between all of the units can allow your tech transfer become streamlined should the tech or actual agreements be established so you can do so so I hope that you've learned a little bit today about technology transfer and what can what you can do from a best practice standpoint to help you perform them in your organization but thank you very much for that discussion I appreciate it and look forward to having conversations with our potential clients and I'd like to share with you our contact information worldwide of course I'm available to have a conversation about your tech transfer needs as as Beth in Europe and Asia we have worldwide teams that are able to support your needs those contacts are also provided on this slide