Kathy Ackley, Oligonucleotide CMC Consultant

You were Senior Director of Operations and then the Vice President of Development overseeing the process development and analytical development teams at all Nitto Denko Avecia locations. What was the best moment? And what was the worst?
The best moments were always related to the people with whom I worked. Creating a work environment where employees can grow personally and professionally is one of the most important jobs a manager has. I loved seeing people grow their careers, especially the new chemists coming right out of school. I still get excited when I hear about their promotions or read papers that they publish. The worst moments were always related to times when customer expectations were not met. Chemistry is challenging, and scaling up chemistry for the first time is not always successful. I never liked having to tell a client when a technical problem occurred on a project. Many people don’t realize that the people that work at CMOs want the client’s drug development program to succeed just as much as the client does. We go into the CMO business because we want to be a part of making new drugs that help people.

You spent over 15 years working in contract manufacturing organizations (CMO) serving the pharmaceutical industry, with a strong focus on oligonucleotides. In your opinion, how has this industry evolved over time? What do you consider to be the most important milestones?
The biggest change I see is the explosion in demand for therapeutic oligos, and this has driven more investment by equipment manufacturers, raw material suppliers and CMOs. In the early years, the manufacturing capacity at the CMOs exceeded what the market needed. This situation didn’t make for a very sustainable business model. Now we see so much demand that existing CMOs are expanding capacity and new companies are entering the oligo CMO field. The most important milestones are the string of FDA approvals for oligo therapeutics. Those approvals have shown that oligos are a viable pharmaceutical platform.

mRNA-based vaccines have played a pivotal role during these pandemic years. In your view, what lies ahead for this technology?
This technology will continue to grow. The pandemic generated an unprecedented amount of clinical data on mRNA-based vaccines. Drug developers will use all that data to further improve the technology. I believe that we will see big advances in immuno-oncology applications of mRNA soon.
Hopefully this technology will open new avenues of treatment for patients.