April 21, 2021

This paid piece is sponsored by South Dakota Biotech.

Penny Sattgast began her business hoping to bring needed resources to South Dakota’s growing biotech industry.

Four years later, PCS Biotech Services has found traction with its mix of clinical trial management, USDA product licensure and quality assurance consulting and is positioning itself for further success.

Sattgast, who previously worked for Elanco Animal Health and served as a clinical trial study director and scientist, has nearly two decades of diverse clinical trial management, vaccine licensure and laboratory experience in the biologics industry.

We caught up with her to learn the latest on her business and the direction she sees it – and the industry – going.

Congratulations on your four-year business anniversary. How has your business evolved in the past four years?

Thank you, as I am so thankful to own a business that continues to grow year by year!

Although I remain busy providing services for larger biotech companies, I also have found a market niche with smaller companies that inherently need someone experienced in numerous aspects of R&D product development and licensure.

You began by offering a broad range of services. Which ones have seemed to find the most traction within the area biotech field?

When I first launched in 2017, I assumed that because most of my experience was in animal health biologics, I would immediately need to diversify into the human health space to help “pay the bills.” Surprisingly, a large percentage of my business to date continues to remain from animal health companies. More specifically, high demand continues for USDA regulatory guidance; quality control and auditing services for clinical and laboratory trials, manufactured products and processes; and driving USDA protocol and report submissions across the finish line.

What have been some of the most rewarding experiences for you in growing your company?

On the personal side, I would most definitely say the flexibility it creates to set my own schedule. If I want to drive from Pierre to Aberdeen for my son’s football game, I have that freedom and can make up the time on evenings and weekends or whatever it takes to get the work done.

From the business side, it is very rewarding being a pivotal part of “the team,” while helping companies drive their key milestones and submissions one step closer and closer towards product licensure. In addition, as a scientist, I have found the benefit of learning more and more about the business development and finance/investment perspective of the industry to be quite fascinating!

I also would be remiss if I left out how rewarding it is to continually meet and expand my network with passionate biotech entrepreneurs and industry peers from not only South Dakota but from all over the United States and other countries. The opportunities to be involved on the cutting edge of novel and exciting biotech technologies never gets old and keeps me engaged as a scientist.

What has been your biggest surprise in business ownership? 

I would say how considerably more time it takes — than I originally anticipated — to take care of what I refer to as the nonrevenue-generating tasks. When you are a sole-proprietor LLC, you do not just get the title of president and founder, but you also get the title of administrative assistant, accountant, custodian, sales and marketer, IT manger and HR rep, just to name a few.

How would you say the overall biotech landscape in South Dakota has changed in the past for years? And how do you anticipate it continuing to grow?

South Dakota inherently has a diverse biotech industry as evidenced by the agriculture, health care, life sciences, environmental and engineering sectors we have here. From the lens of serving on the South Dakota Biotech Association board of directors and as a biotech consultant, I have been able to witness the biotech landscape grow in a dynamic fashion, which I attribute to the hard work and fantastic collaboration of many entities.

I have seen the private sector, the universities and the state time and time again work together as evidenced by the USD Discovery District, the GEAR Center and, just more recently, the progress to move forward with the Dakota Bioproducts Innovation Institute. These are just a few of the many exciting things going on in South Dakota, which are successful due to these types of collaborations. In addition, organizations like the South Dakota Biotech Association and the Governor’s Office of Economic Development are two more examples of many that work to not only promote South Dakota biotech businesses but also work to ensure the needed resources and networking connections are available to continue fostering the growing biotech landscape.

Where do you see your business going? What’s next for you?

I see PCS continuing to grow by creating a healthy and diverse portfolio of both animal health and human health projects. Regardless of FDA or USDA governance, the need for companies to remain efficient while balancing tight budgets along with strict milestones is directly dependent upon experienced individuals in both the regulatory and quality space. I also plan on expanding my marketing efforts with companies that need guidance with incorporating Good Clinical Practice or Good Laboratory Practice quality standards into their operations.

Is there anything else you’d like to add?

Because South Dakota is a state that offers security, stability, safety and fantastic networking opportunities, I feel blessed to live and operate a business here!

To get connected and learn more about the South Dakota biotech industry, click here.