Monday, February 7, 2022

When the latest senior leader of University of Iowa Pharmaceuticals puts on her metaphorical chef’s hat, she and her team begin creating and refining recipes not for food, but for medicine.

Hima Bindu Gottam, MS, RAC, is the new director of pre-formulation and formulation development for the organization, which is part of the UI College of Pharmacy.

Hima Bindu Gottam

“I started my career as an analytical scientist, and that makes me well-rounded. But I really like Formulations because you can be creative," Gottam said, adding:

"It’s like cooking in your own kitchen.”

UI Pharmaceuticals provides contract-based pharmaceutical services. Its client roster includes small biotech and large pharmaceutical companies, university researchers, and governmental laboratories. The organization works with clients to develop, analyze, manufacture, and ship out potential future medicines to partners across the world.

Many of them form a relationship with UI Pharmaceuticals very early in their development process when researchers are thinking of applying for grant money to support a study that could end up—far down the road—as a new drug on the market. Many need help designing how they will formulate and then manufacture their product.

Enter Gottam.

She is a seasoned drug product developer and technical expert for formulation-related matters. She and her team help such early-stage clients flesh out their product vision and work to achieve it with scientific strategies. They take the formulation idea into the lab and begin conducting experiments. If all goes well, the group emerges from the lab with a recipe for a new product, or for a better version of an existing formulation.

“Our organization’s niche is early-stage clients who have never been in clinical trials before or are very early in the clinical trial process. There are unique issues that come up for clients in this window of time, and our strength is in working closely with them to find solutions,” said Joshua Sestak, chief business development officer of UI Pharmaceuticals. “Bindu leads these efforts.”

“By developing these relationships, these groups come back to UI Pharmaceuticals when the grant is awarded months or years later. Due to excellent work processes and customer service, clients often return to UI Pharmaceuticals to produce more of the drug product or a completely new product,” Sestak added.

Gottam will work with novel drugs that have not previously been studied or approved, known as 505(b)(1) drug development.

Often, the fate of the medicinal products that are conceived, developed, or manufactured at UI Pharmaceuticals is unknown unless reported on in the news, according to Sestak. “Not all end up a viable product, but others are successfully repurposed for something that seems to come out of left field.”

UI Pharmaceuticals’ clients come from around the world, Sestak added. “These products are aiming to fight cancer, cure pediatric diseases, prevent diabetes, or treat rare diseases. Every client product we load on a truck is a big deal. They all go out and help people.”

When a drug product leaves the formulation department, it won’t be loaded on a truck. Much work always remains. It is handed over to other scientists for further development.

Despite the long time frame, Gottam is clear on why she has such a zeal for this work.

“Within a year of graduating with my master’s degree, I was able to see success,” Gottam said. At that point, she was working for Ingenus Pharmaceuticals (formerly RiconPharma LLC), and had helped develop an oral form of a barbiturate used to treat or prevent seizures. “I had moved from the analytical department to formulations only six months before and was able to see my product on shelves with my client’s name.

“It made me feel so proud, to see that we were making a big difference in the world.”

Hima Bindu Gottam is a 2023 MBA candidate at the University of Colorado Denver. Overall, she has more than 11 years of product development experience. She has successfully developed multiple complex products—including oral, topical, transdermal, and injectable drug delivery systems.
Gottam and Sestak were among a large number of hires over the last few years. By the end of this year, UI Pharmaceuticals' staffing levels will have grown by a projected 122 percent of its 2018 workforce.