TSRL’s CEO Reflects on What It Takes for a Preclinical CRO to Thrive for 40 Years

In an industry where few independent preclinical CROs last more than a decade, TSRL’s 40-year milestone is a rare achievement. Founded in 1986 in Ann Arbor, Michigan with a vision to improve drug delivery for small molecules, the company has evolved into a science-first CRO known for its keen sense of strategy, high data quality, and lasting relationships across academia and industry.

Leading the company into its fifth decade is Dr. Elke Lipka, whose career spans leadership roles at Parke-Davis, Pfizer, and Esperion Therapeutics, where she developed deep expertise in pharmacokinetics, formulation development, and drug safety evaluations for small molecules and biologics. Under Dr. Lipka’s leadership, the company has remained agile, expanded its impact, and been recognized as the top NIH funding awardee in Michigan over the past five years. 

To celebrate the company’s 40th anniversary, we sat down with Dr. Lipka to reflect on TSRL’s legacy, its evolution, and where she sees the company heading next.

Question: What was the original mission of TSRL, and how has that evolved over the decades?

Answer: The company, under the leadership of Dr. Gordon Amidon, was originally focused on optimizing drug delivery solutions for small molecules, focusing on their physicochemical and biopharmaceutical characteristics. That focus contributed to the development of the Biopharmaceutics Classification System (BCS) and the FDA guidance that followed. We also concentrated on simulating drug product performance in vivo, which led to the development of the GastroPlus software in collaboration with Simulations Plus, Inc. That technology, licensed from the University of Michigan, generated royalties for both the university and TSRL over 14 years.

In the mid-2000s, with Dr. John Hilfinger stepping into a larger leadership role, TSRL began developing biologics, including gene therapy approaches for glioma and inflammatory bowel disease (IBD). Another key area at that time was the development of prodrugs for approved drug candidates, thereby improving their therapeutic efficacy and safety profiles and helping create new intellectual property (IP) around highly de-risked products.

After I joined in 2007, we launched our preclinical accelerator concept, expanding collaborations with investigators and universities across the US and Europe. This model gave us the flexibility to pursue a risk-balanced portfolio of product candidates, make timely no-go decisions, and maintain a team of seasoned pharmaceutical scientists. More recently, due to shifts in NIH funding and increased market demand, we’ve expanded the CRO side of our business to offer expert consulting and preclinical services.

Q: Few preclinical CROs make it to 40 years. What do you believe has been the key to TSRL’s staying power?

Answer: It comes down to a few key things: strategic positioning, the ability to pivot quickly, and a portfolio approach instead of launching and shuttering multiple individual start-up companies. This provides continuity of people and processes that is not easily achieved within a NewCo. We have also had exceptional success with NIH SBIR funding and benefit from a vast network of academic researchers and industry product developers.

Q: What have been some of the most pivotal scientific or strategic milestones in TSRL’s history?

Answer: Over the years, several milestones have defined TSRL’s trajectory. In the 1990s, the company entered a joint venture with BF Goodrich (PORT Systems), which ultimately led to the sale of a controlled‑release patent in 1997. That same year, TSRL licensed what became the GastroPlus® technology to Simulations Plus, a collaboration that culminated in the sale of its stake for $6 million in 2014. TSRL also played a meaningful role in shaping the US FDA’s Biopharmaceutics Classification System (BCS) guidance released in 2000. In 2007, the company strengthened its scientific foundation by acquiring a highly experienced team following the Pfizer Ann Arbor site closure. 

Starting in 2014, under my leadership, TSRL expanded research collaborations across the United States and Europe, resulting in the in‑licensing of several high‑value assets. More recently, the formation of MicroPatchRx, Inc., which holds the rights to a microarray patch (MAP) platform licensed from Queen’s University in Northern Ireland, and the successful raise of more than $12 million in NIH funding advanced the zanamivir MAP program towards a Phase 1 clinical trial slated for 2Q 2026.

Q: What do you think the original founder would be most proud of if he were to set foot inside TSRL now?

Answer: I recently met up with TSRL’s original founder Dr. Gordon Amidon to talk about this, and I think he is most proud of the fact that TSRL continues to thrive independently and has grown beyond reliance on any one individual, including himself. The company has shown, time and again, that it can recognize new opportunities, respond thoughtfully to change, and adapt as the industry evolves. 

I know that he takes great pride in the resilience of the team and in the way TSRL has maintained its scientific integrity while navigating shifting funding environments, emerging technologies, and new business models. Most of all, I think he’s proud that the organization he helped build remains relevant, trusted, forward‑looking, and science-driven decades later.

Q: You took on the role of CEO following a legacy of deep scientific leadership. What has that transition meant for you personally and professionally?

Answer: It allows me to shape TSRL’s culture into one that emphasizes integrity, quality, efficiency, and a robust business sense combined with a deep knowledge of product discovery and development. We are a lean operation without stifling bureaucracy or inflated egos. Everyone’s voice counts at the table, and we make decisions quickly and transparently, with a deep understanding of the underlying science.

One of the many things that I have learned during this journey is that if you pick the right people, you can achieve great things. And they are not necessarily the ones that others would identify as “rock stars”. These are the people who put their heads down and do incredible work, often times far from the limelight. I have been told that this is something I need to talk about more!

This approach has led to an executive leadership team of three accomplished women, and a diverse team of scientists and operations experts. It has created a collaborative culture where egos stay at the door, and that makes a huge difference. It allows us to be laser-focused on the tasks and problems at hand and has led to a highly synergistic team performance. Being CEO has also made me reflect on what kind of leader I want to be by comparing my own values, skills, and style to those of others.

Q: How has TSRL built trust across so many long-term client partnerships?

Answer: Trust at TSRL has always been built through respect, transparency, integrity and delivering on timelines. We take timelines seriously and communicate clearly, especially when decisions or adjustments are needed. Clients know what to expect from us and that reliability goes a long way. Just as important, we invest in real relationships with the people we work with. Over time, many of those professional relationships turn into genuine partnerships built on mutual understanding and shared goals. And, again, good science drives decision-making.

That level of trust does not come from transactions alone. It comes from showing up, doing the work well, and standing behind it every step of the way.

Q: What excites you most about the future of TSRL and the broader industry?

Answer:  I’m really excited about growing the preclinical CRO side of our business and, at some point, finding a strategic partner to continue to support our growth. The pace of change in the pharmaceutical and biotechnology industry is fast, and I believe that building depth in key development areas where we can plug into gaps for clients or other CROs will let us create real value. It also gives our team the chance to stretch and grow into their full potential.

Q: If you could summarize TSRL’s story in one word, what would it be and why?

Answer: Integrity. Throughout our entire history, we have consistently made decisions based on our values, even when that meant walking away from some opportunities. In the long run, that focus and understanding of what is truly important pays off with collaborators and clients, as well as in our overall reputation in the industry.

“Science-first” could also apply in this case, but for me, integrity comes before all else. It is the foundation, and it is missing in far too many corners of business and politics today.

Learn more about TSRL’s leadership as a preclinical CRO and send the team a message here.