In an increasingly interconnected world, the transfer of technology between different stakeholders and across borders is becoming an integral process in many industries, including pharmaceuticals. As the market continues to expand, it brings the promise of new research and improved therapies to a broader, global audience of patients through large-scale manufacturing and development.
The global pandemic really shone a spotlight on the power of technology transfer
The release of the coronavirus’s genetic sequence was the catalyst for uniting the global research community in sharing and transferring knowledge about the disease, which ultimately saved the lives of millions worldwide. In the face of adversity, this collaborative effort was a pivotal turning point in our response to the outbreak and, with it, a renewed hope for the future of global research partnerships.
Simplifying the complex: Understanding technology transfer
At face value, the process of technology transfer is simple – it’s the movement of knowledge and data from one place to another. I liken this process to following one of my mother’s recipes in my very own kitchen – spending hours trying to source the same ingredients, following the same process and techniques to replicate the exact taste as the original version.
Building a more innovative and sustainable healthcare system through technology transfer
In a pharmaceutical setting, technology transfer typically leads to more research, ongoing investment or improvements in servicing, and production of medications, granting more people access to new treatment options. But it’s not limited to new medicines alone. Legacy medicines produced by larger pharmaceutical companies, which risk losing profitability after patent expiry, can find new life through the transfer to speciality firms, like Pharmanovia, who focus on a medicine’s lifecycle management. These medicines can be revitalised by leveraging existing knowledge to enhance and evolve the product – often referred to as incremental innovation.
This can include new administration formats, such as patches, films, and nasal sprays, which can be bolted onto existing medicines, and used alongside or instead of tablets, liquids, and injections to make medicines easier to use. New formulation approaches to excipients can also mitigate known side effects.
But, like my mother’s recipes, this is not as simple and straightforward as it sounds, in fact, it’s a meticulous process that, if not systematically followed, can easily go wrong.
Navigating common pitfalls and challenges
After years of refining this process, Pharmanovia has identified what makes a successful transfer and what the common pitfalls to avoid are. Here are some key insights to be aware of:
- Plan early: bring technology transfer into early discussions. If you wait until a deal is signed, you’ve already lost valuable time that could have been used to develop a comprehensive knowledge transfer plan that can minimise disruptions later down the line. For example, a critical early step would be to initiate a dossier remediation which involves making updates and corrections to all documentation associated with the product, including the standardisation of all data. This critical quality assurance step can often be overlooked and cause costly delays if not addressed early.
- Mitigating single points of failure: this does form part of the meticulous planning process mentioned above, but it’s worth stressing the importance of identifying potential risks and implementing appropriate mitigation strategies, so as to avoid disruptions to product supply and quality. By dual-sourcing active pharmaceutical ingredients (API) and packaging from different providers, you can circumvent single points of failure and build supply-chain resilience. The unstable market due to recent global events has demonstrated the importance of this.
- Know your contract development and manufacturing organisation (CDMO): the market for outsourcing transitions (via CDMOs) has soared in the last few years with no signs of stopping. Bringing in a third party does, of course, bring its own set of complications, but it does have the benefits of helping to offset. However, no two CDMOs are the same. Therefore, always do thorough due diligence to understand a potential partner’s technology transfer capabilities, product expertise, and platform capabilities. It’s vital that you select the right partner for your unique business needs and with common values and priorities.
- Good partnerships are key: transparency and mutual trust between the drug developer and CDMO is vital; therefore, driving a positive, collaborative culture is key. Whether it’s getting to know the donor site or placing your own employees at the receiving site to work alongside the CDMO – building good relationships will help to foster a positive team spirit and the ability to work together to quickly solve any problems identified.
Unleashing the potential of technology transfer
The COVID-19 pandemic has highlighted how technology transfer can significantly influence society. It has opened doors for advancing our healthcare systems by fostering partnerships and driving treatment innovation. As we embrace this dynamic approach to research and development, it’s essential for us as industry leaders to work together with governments and key stakeholders to establish a governance framework to help facilitate this complex process. Through a more fluid and collaborative approach, we can deliver meaningful benefits to both patients and society.