Tawni Koutchesfahani, Director of Supply Chain at Relypsa, recently attended our 2018 American Biomanufacturing Summit. One of her key takeaways from the event was around how the paradigm of manufacturing and QA operations is changing and the ways in which it needs to change. We asked her to share her thoughts on the Generis blog.
By Tawni Koutchesfahani, Director of Supply Chain, Relypsa
Let’s take a step back and think about where we were 38 years ago. In 1980, Martin Cline made the first attempt to modify human DNA. By 1989, National Institutes of Health approved the first nuclear gene transfer in humans. Since 1989, there have been over 2,000 clinical trials completed. If we fast forward to where we are now, gene therapy is now being viewed as the key to our future for many therapies. Last year, the industry hit some key milestones. Kite Pharma received its approval with Yescarta, and Novartis succeeded with Kymriah.
Though these are significant highlights, the past addresses rare diseases. In turn, manufacturing of the gene therapy meets the market for a small population. As these therapies get approval for commercialization, the manufacturing models are not currently made for large scale, which poses a threat for the market. Thus, the whole notation of how we have been manufacturing has to change. How we have been producing in GMP environments has to change. How we have been implementing our quality systems has to change. This paradigm shift brings about the thought of how companies will address the future value stream map, as manufacturing of gene therapy will revolutionize the fundamental of manufacturing, quality, and supply chain operations. The past has been focused on what is best for the production facilities, and now the future value stream map must be focused on personalization and responding to the needs of the patients.
The future will generate new value. There will be centers to provide flexibility to the patients, but again this will generate new challenges in relation to the manufacturing model, how quality control is implemented, how the product moves from different points, and how rapid decision makers are involved. Currently, product is produced in mass volume, in closed systems, with human intervention, as processes are still manual. The future will need good operators, but a much more skilled pool of workers. We must take a step back to think about how decisions are made from a manufacturing view as there are different elements of time pressure needed to allow for this level of personalized production. Currently, there is safety stock built to allow for time to generate material. We will have to determine how the model will reflect real-time production in a timely manner. There is also the future view of understanding how to transport and distribute gene therapies. Think about the current model of how supply and demand are forecasted – these models have worked for mass production with predictable demands. Thus, we must learn to work with a forecast that is based on low-mass production tied with a personalized view.
The future is bright. With many challenges ahead, disruption in manufacturing, quality, and supply chain is upon us. As leaders, we must start seeing the future now, so we can be ready for it. I am purely excited. Are you?
Tawni Koutchesfahani is an accomplished operations leader in the medical device and biotech sector. In 2016, Tawni was the Director of Manufacturing Strategy at Relpysa, working closely with Relypsa’s global contract manufacturing sites. Currently, she serves as the Director of Supply Chain at Relypsa. Prior to joining Relypsa, Tawni was a key manufacturing leader within the Baxalta (spin‐off as a public company from Baxter) manufacturing network for its BioScience division as well as Baxter’s BioSurgery division since 2009. In her last role at Baxalta, Tawni oversaw an organization responsible for producing high-volume commercial and clinical products. Tawni earned an M.S. in Chemical Engineering from the University of California, Berkeley, and a B.S. in Chemical Engineering from the University of California, Santa Barbara.
LinkedIn: https://www.linkedin.com/in/tawnik | Twitter: @Tawni_K