Tech transfers: what are the drivers of complexity?
In our earlier blogpost we wrote about the factors that can make or break your technology transfer. Among others, we paid attention to the question: what determines the complexity of a tech transfer? It turned out the two most important parameters for complexity are whether the market is a new or existing market for the company, and whether it’s a new or existing product. In this blogpost, we will dive into these complexities a little bit more and provide you with some useful tips to minimise the complexity of your tech transfers.
New versus existing products
The complexity of a tech transfer largely depends on the product and the market. Bringing a new product onto a new market is the biggest challenge. After all, launching a new product requires starting with a lot of research. Furthermore, you need to invest in validation and qualification to prove your product is correctly produced, packaged, labelled and transported. In case of an existing product, these activities have already been conducted for the greater part and a lot of data is already documented. Note that a new product can be defined in various ways. It can be a completely new product, for example a new medicine or vaccine, but also an improvement to an existing product.
Want to know more about the success factors and reasons for delay of technology transfers? Read our blogpost ‘These factors can make or break your technology transfer’ or stay tuned for more tech transfer content!
New versus existing markets
Companies that want to bring a new product onto a new market, also need to dive into the requirements of this new market. The guidelines and legislations for launching new products vary from country to country and from region to region. The legislations and requirements in the United States are different than those in Europe, for example. Sometimes, two countries require the same documentation, which makes it possible to reuse documents, but this is not always the case. Therefore it’s important to accurately determine what documentation is required for the market concerned, as from the moment you start your transfer.
Also take into account the fact that legislations are continuously changing. At QbD, we noticed that this is especially important for smaller companies. If you submitted the right files in a country, this doesn’t mean you can reuse these files years of even months later. Always check whether you comply with the latest requirements, for example regarding the product shelf or storage life.
Maturity of the sites
In addition, the maturity of both the sending and the receiving site in a tech transfer is crucial. Logically, large companies with a lot of experience in tech transfer projects often have their tech transfers under control. They know how to organise these projects, partly because they learned from their mistakes in the past. Activities have been mapped out, there are procedures and step-by-step plans in place and they know which documentation is needed for each market. This way, these companies reduce the chance of overlooking things.
In smaller or less mature companies, tech transfer experience can sometimes be a little lacking. The people involved are less experienced, or there isn’t always a dedicated tech transfer team available. For these companies, it can be wise to invest in a tech transfer framework or a consultancy party that can provide support.
Tips and tricks for tech transfers
It’s important to realise that you can’t get around some of the complexities tech transfers present. Therefore, companies need to manage these types of projects the best they can. We’ve listed three tips.
1. Determine the scope of the transfer
Well begun is half done, especially in the case of tech transfers. Make sure to determine if it’s a transfer of information, technological expertise, processes, assets, or a combination of these aspects. Communicate duties and responsibilities to all parties involved. Take into account both the legal and organisational aspects. And last but not least, list all the possible risks and make sure to inform the management about possible complexities.
2. Keep your timelines realistic
A tech transfer is a complex process that involves various parties. It consists of a lot of different steps that often overlap or follow up each other. Be aware of the fact that you are often dependent on the follow-up of steps or input from others to finalise certain activities. A realistic timeline prevents falling short of expectations.
3. Invest in knowledge exchange
More and more companies have a tech transfer framework in place, so don’t hesitate to share best practices and benefit from this standardisation in tech transfers. For example via ISPE, that offers helpful videos, guidance documents and training on tech transfers, and also started a special interest group for everyone in Belgium involved in tech transfers. CMOs can also contribute to knowledge exchange, since they often work with various tech transfer companies and are able to share best practices from partners.
In our tech transfer blog series, we zoom in on the most important aspects of technology transfers. Are you facing a situation in which technology transfers is key? Don’t hesitate to contact us to discuss how we can help!
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