GMP Quality, Analytical Operations, and CMC Regulatory
Like so many of us, I spend a lot of time thinking about the end of the drug development process: the patients that will receive the therapies. In a previous role I was able to work on a therapy that has since been commercialized and it gave me joy to know it is helping so many children. At Dark Horse, I have the opportunity to positively impact multiple programs and therefore multiple therapies, meaning that my daily work has a chance to eventually reach so many more people who need them. Being a consultant became an opportunity to scale myself.
The other huge deciding factor was the experts I’d be working with here. I’d worked with some Dark Horse people before and so I knew from experience that they were top of the class. When all of your colleagues are this skilled, you can have complete confidence in them from the start. The chance to be supported and mentored by the best in the field is an opportunity that rarely presents itself.
Cell and gene therapy is evolving so rapidly that you have to be open to new information and guidance at all times. Working with so many people—whether they’re clients or colleagues—both provides me with maximum exposure to the newest information and also allows me to share and spread that knowledge. I believe each of us are able to accelerate the field’s growth through our exposure to each other’s constantly varying experiences.
Everything in C> is challenging but quality feels especially so. For autologous therapies, consider that each donor is a unique individual and that their genetic material is our starting point. That means that we have a huge degree of variability at the very beginning of the process. When you think of it that way you can realize why a quality focus is particularly critical here: developers must account for an unmatched level of variability from the start.
You can see a lot of change and improvements in the ways we can characterize our products and in the analytical techniques that are available. As the space grows, so does the range of methods that we can choose between, so we are able to be particularly thoughtful about our process. That luxury wasn’t there when the field was younger than it is now. In other words, analytical advances positively affect quality and also, regulatory.
The more regulatory guidelines we receive, of course, the better off the field is. We do have much more information now than we used to and I sense that regulatory agencies are open to a dialogue. It’s not like some other fields where the process is more of an open and shut procedure. There will always be issues to tackle and so we need to prepare for the C> regulatory process to bring with it more back and forth than there would be for simpler products. And some of those conversations should happen early on.
I firmly believe that regulators have the chance to be an effective partner in the process when sponsors are prepared to address therapeutic development from all angles, demonstrating transparency and product knowledge inside and out. In a best-case scenario this dialogue could even help advance the field further if we consider questions asked during the regulatory process to be an opportunity to consider deeper characterization or analytical testing.
Invest in people and expertise, always. Many companies have proven procedures, but they’re not going to work the same way in the field of cell and gene. The outcome will be different and if you don’t seek out C>-specific experience, it will be a much longer and more frustrating road than it has to be.
I would tell them to do their homework first. There are so many opportunities out there for self-education on the basics. Webinars, white papers, internship opportunities: anything someone can do to immerse themselves in the field will provide them with an important foundation.
I come from a family with a lot of pharma and medical experience. My parents are both pharmacists, as is my grandmother, and my uncle is a doctor. As a child, I’d go to the pharmacy after school to be with my parents. I’d watch them work, and I knew then that I wanted to be a part of the pharma field. My interest was different than theirs’, though. I wanted to learn the mechanisms; how do medicines work in the body on a molecular level?
I knew you’d ask me that and I don’t even know where to start, because I have so many passions and hobbies that there just isn’t enough time in the world to do all of them! I love to spend my time in an active way; in the winter, my husband and I snowboard and in the summer, we kite-surf. I love music and dancing, especially salsa. Before COVID I used to dance three or four times a week. Whenever I’d travel somewhere, whether for work or for pleasure, I’d look up salsa classes in the area so that I could dance while I was there. Everyone in the community is always so welcoming and we all shared the same language of dance so I could just show up and join a group anywhere.
Philadelphia, San Francisco, New York…there are probably at least 15 cities where I’ve joined in as sort of a salsa tourist. In Philadelphia we danced right outside the Museum of Art, near the steps from Rocky! Once I went to Budapest for a salsa workshop with teachers from all over Europe, which was just amazing. And when I lived in London, I had my own local salsa community. We recently moved to Essex, though, and I haven’t found all the places here yet.
Aerials! Silks and hoops and hammocks: I try to go at least once a week. It’s very difficult but so amazingly freeing and enjoyable. Existing up in the air and learning how to maneuver like that is magical, and it feels so wonderful. Imagine the range of movement you can get and how it feels to bend backwards upside down! It’s the perfect counterpoint to sitting at a desk during the day and is also an excellent workout.
I suppose my goal is to cherish every day and make the most of every moment, whether before or during the pandemic. It matters to me to feel satisfaction in my work and to really enjoy it, and then to also live to the fullest outside of work. My husband and I have an 18-month-old daughter and so far, as a COVID-era baby, she’s been limited to doing things just at home. I’m excited about being able to bring her out into the world with us soon and show her everything there is to see. She’s going to have such fun with us!
Our families are from different parts of Poland but it turns out that we’d been in the same university in Poland at the same time without ever meeting one another! He was in IT and I was in chemistry, so maybe that explains it. We’ve been together for seven years now, married for three, and I enjoy that when we go to Wrocław to visit my family he also feels at home because he knows the area and has university friends to see and catch up with.
We had a wedding that lasted for four days! We wanted to be married near the seaside (where we go for kite-surfing now and where I always went with my parents, growing up) and there was just so much to do. It was the party of my lifetime! We started out with a smaller group of about 50 people for the ceremony on the first day and then the rest of the guests (about 100 people total) came in and we had beach parties and barbeques and dancing. Weddings usually seem to go by in a flash and I wanted to have the chance to really spend time with everyone who came. Four days made that possible. I highly recommend it!
This looks…challenging, to say the least, doesn’t it?
Scroll down for a bonus winter photo!
Alicja and her husband enjoying the snow!