Will you please introduce Pace Life Sciences and its contribution to the sector?

GK: In summary, Pace Life Sciences is a CDMO that supports companies with their drug development activities. We help them formulate products from tablets, to capsules, or the more complex gene therapies that will eventually be used in clinical trials. We also develop and validate all the analytical methods that support the characterization of those clinical trial materials, that assess purity and determine the shelf life of the product. 

FT: Along with our analytical formulation labs, we now also have centralized casting sites where we can produce all of the materials, as well as manufacturing facilities where we can make the tablets and capsules, fill the sterile products, and so on.

You recently acquired BioPharma Global. What prompted this decision and how did it change your work? 

GK: Before we acquired BioPharma Global, we would be asked if we could support matters like writing the NDA, supporting the CMC section or the application for a new pharmaceutical product. We had to say no at the time because we lacked the necessary expertise and would refer people to other consulting firms. The acquisition of BioPharma Global changed this. Pace® is now able to assist companies with their filings and FDA submissions. It does not fundamentally alter who we are, but rather allows us to exercise our expertise in multiple areas to support customers working to bring new drugs and therapies to market. We like to think of ourselves as a one-stop shop.

You support a wide range of therapeutic areas; which are currently driving demand?

FR: For several years, we focused on small molecule development, then moved on to biologics, proteins, antibodies, and so on. For a while, that was our busiest area. In the last 4-5 years, however, the focus has shifted to gene therapy. COVID certainly favored this, given that a large portion of the world's population now has a gene therapy product floating around in their bloodstream. It has been demonstrated to work, and everyone is now jumping into the game. Every biopharmaceutical puts their own spin on it (different types of RNA, delivery systems, etc.), but they all want the same thing: to get to clinical trials and eventually to the market. Because we were an early entrant in this area, now almost half of our work is related to gene therapy applications.

When gene therapies were just starting out, our main concern was characterization of the system, whereas today we are more concerned with the biology behind it. In reality, when the few billion doses of an RNA element were released to the world through COVID vaccines, the characterization was fairly minimal.

Now, the bar is being raised, and Pace® is actually on the cutting edge in this regard; we are not just doing the basic quality control work that people require, but are delving deeper into biological readouts, for example, to ensure that these systems are all characterized.

What are the most challenging aspects of the life science sector in North America, in your opinion?

GK: I believe it is the overall general economic slowdown. Many of the customers we work with are early-stage companies relying on funding from various sources. We recently had a customer call it quits due to banking difficulties caused by rising interest rates, which rendered them insolvent. We therefore run the risk that some of the projects out there will not get funded. That is the challenge we are keeping an eye on. Certainly, it could impact our work, but it also impacts the commercialization of potentially helpful new drugs and therapies. 

Would you say that the attention the pharma sector received during the global pandemic has increased investor interest in this sector?

GK: I believe so, particularly for emerging to medium sized companies, where much innovation occurs. But while funding really ramped up initially, my perception now is that some of the funding is slowing down due in part to the banking challenges I mentioned.

Looking ahead, what are you most excited about at Pace Life Sciences and in your industry as a whole?

GK: On one hand, I am excited about the expanded service capabilities we are able to offer our clients - from discovery to formulation, and manufacturing to central laboratory testing. Pace® has a comprehensive offering. But I am also excited about the growth in biologics and gene therapies. I look at COVID as a proving ground that these therapies have promise, which makes this future aspect of our business very bright.

FT: I certainly agree with Greg's sentiment there. I began working in gene therapy nearly 30 years ago, but encountered toxicity and safety issues that caused the industry to fall apart for about a decade. It was only when RNA therapies started coming into form that it came back, so I am happy I stayed the course and can be involved in the process of actually turning them into products. When we were doing this in the late '90s, it was just a dream. A dream that somehow, we might be able to deliver DNA and cure tumors. Now we are actually seeing it happen.