What You Didn't Know
About Dr. Tom
For many, a mustached man in a Hawaiian shirt may bring to mind Magnum P.I. But in the life science community, that mustached – and bearded — man in the Hawaiian shirt is Dr. Tom at Pii.
Tom Ingallinera, RPh., PhD (affectionately known as Dr. Tom), is the vice president of Business Development, Technical Support, at Pharmaceutics International, Inc. Many know Dr. Tom as one of Pii’s subject matter experts with more than 45 years of experience in pharmaceutical development, and expertise in complex dosage forms of all types. He has advised on product development programs across the continuum, from pre-formulation through commercial production.
What many may not know about Dr. Tom is he also has experience as a retail and hospital pharmacist while working his way through graduate school, but he is most proud of the drugs he developed for unmet medical needs over the years of his pharmaceutical career.
An Inherent Love of Science
Dr. Tom always knew he would have a future in science. His love of science can be easily attributed to his father, a chemical engineer who worked for Allied Chemical.
He has vivid memories of reading books about science as a young student growing up for 12 years in West Virginia. “Of course, there was no Internet back then, but I had my encyclopedia and my All About books,” he recalls. In school, he stayed on the science path, taking advanced courses. But he also found a passion for mathematics. “A company called IBM offered an advanced math program at my parochial school. It was a really expensive program at that time, $25, where it involved a film projected onto a screen and you could do math problems at your own pace. I was able to get through Algebra 2 and Geometry in eighth grade.”
By the time Dr. Tom was sixteen-and-a-half, he had graduated from Baton Rouge High School in Louisiana. But he is quick to point out that he actually attended four different high schools in multiple states. His dad was transitioning jobs from West Virginia to Hopewell, Virginia to Louisiana. “All the chemical plants in the mid-1960s were moving to where the oil was and that was Louisiana and Texas.” In fact, his dad was working on a project building one of the country’s largest chemical plants on the Mississippi River. The family had apartments in Louisiana and a home in Virginia, and moved back and forth between the two.
A Record-Number of NDA Filings
After high school, Dr. Tom attended Louisiana State University (LSU). Because he was younger than his cohorts, his parents wanted him to live at home and commute to LSU. He took advanced Calculus and was on the math major track. The next summer, his dad got him a job with Allied Chemical as an analytical chemist. That started his love of chemistry, so he switched his major to Chemistry. Prior to starting his senior year, he realized he didn’t want to be a chemist. “A friend of mine from high school told me his neighbor was a pharmacist. I didn’t know what I had to do to become a pharmacist. I had to look on a map to see where the pharmacy school was in north Louisiana. I transferred to pharmacy school even though I only had six credit hours in Chemistry left to graduate.”
Dr. Tom attended School of Pharmacy at Northeast Louisiana University, which is now University of Louisiana, Monroe. “I kept up with my advanced science courses and learned a lot about drugs, but I really didn’t want to be a pharmacist either.
By this time, Dr. Tom had met his wife and got married. The newlyweds decided they would move to Richmond, Virginia for Dr. Tom to attend graduate school at the Medical College of Virginia, now Virginia Commonwealth University. He was on full scholarship, getting paid as a teaching assistant in pharmacy.
Also located in Richmond was Philip Morris, which had gifted the university $1 million to develop gas chromatographic mass spectrometry to identify molecular weights of compounds and measure compounds in biological fluids. “I got heavily involved in pharmacokinetics to measure drug levels for epilepsy drugs and did my dissertation in pharmacokinetics using Phillip Morris equipment.”
In 1977, Dr. Tom received a call from the School of Pharmacy at Medical College of Virginia asking if he knew anything about injectable drugs. As it turns out, in the time
between earning his BS in Pharmacy and starting grad school, Dr. Tom did a pharmacy residency at the Medical College of Virginia hospital where he did IV-admixture. “So, I told them, ‘Yeah, I know a little bit about it.’” They asked if he could help with a project they were doing with A.H. Robins Company in Richmond just down the street from where he was attending school. A.H. Robins hired him part time to help with package inserts for injectable products.
“I remember that the secretarial pool at A.H. Robins typed my PhD dissertation. This was probably one of the last typed dissertations before computers.”
A.H. Robins had some very successful drugs, and in 1984, they acquired a sterile production facility in Cherry Hill, NJ, called Elkins Sinn, which was making generic injectable dosage forms. But they didn’t have an R&D group, so they asked me to move to New Jersey. “My wife was pregnant at the time with our youngest son. When I told her they wanted us to move to New Jersey and that they’d pay for the move, she went into labor that night!”
During his time at Elkins Sinn, Dr. Tom filed more than 40 ANDAs and oversaw 40-plus employees in analytical and formulation development. He played a key role in filing the first NDA on a branded product for morphine called Duramorph and Infumorph.
The best part about working for A.H. Robins for 11 years, Dr. Tom says, is that it was family owned and they treated everyone at the company like family. “Mr. Robins would call me every so often to see how things were going. In 1986, he found out that my dad was very sick. The next day, I received two airfare tickets for my wife and me to fly back to Louisiana to see my dad right before he passed away.”
A Pharma Road Well Traveled
Unfortunately, A.H. Robins soon faced some financial trouble. and was immediately acquired by American Home Products (Wyeth Ayerst). In 1991, he left to head up process development at a new sterile product facility for Burroughs Wellcome in Greenville, NC which he thought would never be merged or acquired. During his time at Burroughs Wellcome, Dr. Tom was on the team that developed AZT, the cocktail for AIDS. He also developed the synthetic lung surfactant Exeosurf Neonatal drug. He stayed with Burroughs Wellcome until the company was acquired by Glaxo At the time, he was working with Genzyme on leuprolide for prostate cancer. “But Glaxo was not interested in the project. I told Genzyme that Glaxo wanted to kill the project. Genzyme asked me to work for them instead.”
Working for Genzyme meant traveling to Switzerland quite a bit and proved to be a challenge at times. Dr. Tom recalls getting stuck in southern France during an airline strike and having to take a train to Geneva instead. “And another time, I was on the train, I noticed a man who wasn’t breathing. He had no pulse. I called conductor. We had to go through three train stops to get an ambulance to pick him up because in Switzerland they won’t let their trains get off schedule!"
Working at Genzyme, Dr. Tom says the leuprolide project was being funded by Astra Pharma and was close to FDA approval. Then, once again, an acquisition killed his project when Zeneca bought Astra, and had a competing product on the market. again this project was killed.
“Because I had a no compete clause in my contract, it is totally demoralizing and totally destroys your self-esteem when you put your heart and soul into these projects and they are killed by mergers and acquisitions.”
Dr. Tom moved on by starting Infimed Therapeutics and developed an extended-release human growth hormone (HGH) product. His team quickly discovered that HGH works best with daily injections, so it never made it out of clinical trials.
Then in 2001, he received a call from AAI in Wilmington, North Carolina, which wanted to open an injectable contract manufacturing site in South Carolina. They asked Dr. Tom to head the facility, so he moved to South Carolina. Interestingly, Syed Abidi, the Founder of Pii, also had a career at AAI. “We didn’t know each other though because our time at AAI did not overlap.”
Dr. Tom remained with AAI four years managing the facility and building the injectable business. In 2004, one of his AAI clients was starting an injectable generic company called Parenta, and asked Tom to come head up his development programs. This company was eventually bought by Sandoz so Dr. Tom became a consultant for a while and then went to work for BioCryst in Alabama supporting a drug to treat pandemic flu. Eventually, BioCryst ran into financial difficulties, and Dr. Tom had to lay off 55 people, as well as himself.
Dr. Tom was talking to Pii at the time about a soft gel development program. “I visited Pii and told them the project was ultimately canceled and they asked me to come work with them. and that is how I ended up at Pii.”
Passing Down the Science Gene
Just as Dr. Tom’s dad was his role model, he feels his passion for science was instilled in his three sons. He proudly talks about their accomplishments. His oldest worked with him in the lab at Genzyme and now runs a food co-op in Asheville, North Carolina. “Companies that don’t have their own FDA-approved kitchens use his FDA facility to manufacturer their products, such as mustard and hot sauces.”
Dr. Tom’s middle son wasn’t sure of his career path, so he attended community college in Charleston, SC, and was hired by Dr. Tom as a janitor in the warehouse at AAI One of the chemists asked him to do some work in the lab. He decided he liked chemistry and ended up studying at University of South Carolina and became a pharmaceutical scientist. He went on to work at Parenta, Patheon, and Acerta Therapeutics where he helped take a drug from concept and discovery to FDA approval in 18 months. He is now on his third start-up and enjoys life in San Francisco with his wife and two kids. Dr. Tom’s youngest son attended Clemson and ultimately became a chemist. He worked for AAI for eight years, Pii for almost four years, and is now working on the west coast close to his brother.
An Industry Crisis
When asked to rate the current state of the life science industry, Dr. Tom pauses and simply states: “We’re in a crisis.” He points to a shortage of manufacturing facilities due to the mergers and acquisitions he has witnessed. “Clients are desperate to find places to manufacture their products.”
He adds that COVID has caused an increase in need for manufacturing vials, which has added to the crisis by creating shortages such as vials and filters.
“One of the ways Pii is addressing these issues to by taking on more complex, potent, and toxic products. Other companies don’t want to handle them, but we don’t shy away from them.”
Dr. Tom is an optimist and concludes: “Our industry will come out on the other side of this crisis and leading the pack will be Pii.”
And why the Hawaiian shirt? Dr. Tom always loved Jerry Garcia ties, which dressed up his formal office wear when suits were norm. “So, in today’s casual dress world, the Hawaiian shirt is a colorful version to replace the fun ties – and they show up so well on Zoom!”
Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) located in Hunt Valley, Maryland. The experienced scientists, engineers, and staff at Pii pride themselves on adroitly employing a phase appropriate method of drug development for the prudent use of their client’s resources as they solve challenging problems. In addition to offering end-to-end development services, Pii manufactures a variety of dosage forms to include complex parenteral drugs and has a wealth of analytical testing capabilities. Its Hunt Valley campus has four aseptic suites with lyophilization capabilities. Our talented professionals stand ready to help!