Please summarize your experience leading to your role as Sr. Director of Business Development
I’ve always been in the contract development and manufacturing (CDMO) environment, and I spent the first half of my career in analytical labs. Those roles were focused on contract testing and characterization to support the manufacture of biologics – back then it was mostly proteins, fusion proteins, and antibodies.
Halfway through my career, I switched over to a business development role within the CDMO space. I mostly worked with large molecules, and my exposure and responsibilities evolved alongside the prevalence of newer modalities. The main growth in the area has been in cell and gene therapies.
In my previous role at Millipore-Sigma, I was responsible for the product characterization and analytical development business. This included all aspects of the business: commercial, operations, project management, and operational excellence and supporting all biologic modalities and ATMPs. My main interests lie in cell and gene therapy, so I wanted to work within a space strictly focused on that area. It’s an area where there is so much therapeutic potential, that is supported well by Genezen because of its size, flexibility, and willingness to grow and adapt to trends in the CMC side of cell and gene therapy.
What influenced your switch from the lab and operations to the commercial?
I grew up in a family business, so I’ve always had business in my blood. I enjoy interacting with customers and trying to figure out what they are trying to achieve and determine the best way to help them with the available resources.
Speaking with customers helps me understand their priorities and concerns as well as learn the bigger picture. Piecing together the customer’s vision is fascinating to me, and I find it very rewarding to support and enable their success.
What are the key lessons you have learned throughout your 20 years in pharma and biopharma product development?
Planning is key. This is especially important in biologics, where there are a lot of process variables as well as potential heterogeneity in the product. Unexpected issues cause delays and are often expensive.
These variables are best evaluated in the process development stages and the more that you understand them in relation to the finished product the better. For example, achieving a high titer or a high concentration is appealing in and of itself, yet it does not give much insight into the performance of the molecule or vector in a biological environment (in or ex vivo). In some cases, you may have to sacrifice titer for a higher-performing product profile and the earlier you have the tools to evaluate this the better.
This perspective comes from my analytical and characterization background, but really understanding a molecule or vector’s behavior, e.g. transduction potential, is vital to therapeutic and financial success.
Do you have any words of wisdom that you would give to others in pharma and biopharma BD roles?
Continuous learning and improvement are something that can benefit anyone in the biopharma space. The reality of working in such a fast-moving industry is that no one is coming out of a role or even a university with all the information under their belt. The industry is advancing quickly, and the cell and gene space is moving faster and in more directions than most areas, so if you want to get into cell and gene therapy, take a bit of time to orient yourself with how the space is developing. Get a baseline level of understanding of vectors, immunology, and the current key challenges, and then jump on this fast-moving, high-momentum train where we are all learning in real-time.
What have been some of your most notable moments in the Life Science industry?
I’ve been at the heart of transitioning traditional biologics business to supporting evolving and emerging modalities such as those within cell gene therapy and other ATMPs. Developing innovative gene therapy products with clients, while supporting traditional biologics has generated many notable moments. In the end, these transformative therapies change the lives of patients, and it was great to be a part of their development. From a business perspective, this has challenged us to support new and emerging modalities and sub-modalities. Being flexible and reshaping a business with the available talent and capital to serve new and emerging markets has been a general highlight and a necessary strategy for future success.
In your new role as Sr. Director of Business Development, where do you see growth in the industry?
I see growth occurring across the board of cell and gene therapy. When looking at vectors, we’re getting news about successes more regularly now which increases investor confidence in the segment. This kind of success is common throughout the cell and gene space.
I think some challenges that we are facing serve as opportunities. For example, the challenges of autologous therapies are well understood – from logistics to product stability considerations. Addressing needle-to-needle obligations and constraints with efficiencies where possible (vector and cell manufacturing) is just one example of streamlining. In that one example, a lot of activity is required, and the opportunity is there for efficiencies to be made.
You’ll be attending various tradeshows/conferences as part of the Genezen team – what are the critical topics of conversation to be having at these events?
Funding and capital markets are big topics now. The overarching feeling is that a lot of great advancements are being made, but the question many are asking is what’s going to happen when people are tightening up and focusing on just the lead asset. It’s an interesting conversation that leads to the question of how much is needed to invest upfront. Answering this question requires you to understand your product and how much money is needed to alter the process so that it is scalable and cost-effective across clinical stages and beyond.
I think the topic is still going to be capacity from the CDMO perspective. Lead times for development capacity and raw materials have been a limiting factor for some time now. Genenzen has invested heavily in purpose-built capacity and implemented a proactive process where we’re acquiring and keeping an inventory of some of the most common consumables.
What are you looking forward to hearing more about when engaging with companies?
I like to hear about where and when people are challenged. Are their problems simply in capacity or are they more technical in nature – scaling, process performance, process costs? This problem-solving mentality also fits well within Genezen. We do not intend to be another company doing the same work. It is not a capacity play for us, but an intention to add long-term value to processes and assets by helping our customers make the best decisions possible early in development. Talking to our market is the best way to hear about these challenges and figure out ways to address them.
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