WIRB Copernicus Group (see story, page 30) is not the only pharmaceutical services umbrella company making waves in the Route 1 corridor.

Certara, a company that owns three companies in the biosimulation business, and one that provides regulatory writing services, is planning a move to 100 Overlook Center into the space formerly occupied by Rockwood Holdings (U.S. 1, October 15, 2014). Rockwood, a holding company in the lithium and specialty chemical business, was bought by Louisiana-based Albermarle and its corporate headquarters was closed in February.

From its founding in 2008 until now, Certara has had a low profile, operating out of shared office space in Carnegie Center. The company’s entire executive team will work out of the new office. CEO Edmundo Muniz says the new space offers room to add new executives as well as expand its business development, science, sales, marketing, medical regulatory writing, and consultancy staff.

In a press release, the company says it plans to add an education center where the it can conduct scientific and product training for life science industry professionals.

Certara was created in 2008 when the owner of Tripos, a drug discovery company based in St. Louis, Missouri, purchased Pharsight, a Cary, North Carolina-based maker of clinical modeling and simulation software. The resulting holding company was named Certara, which is Latin for certitude.

Later, Certara bought Simcyp. The UK-based company, founded in 2001, specializes in predicting how drugs would react not in a generic human body but in specific populations of patients.

Biosimulation is the intersection of two disciplines: genetics and computing. With the knowledge of the human genome, makers of biosimulation software try to use computers to simulate how chemicals would react with the human body. “The integration of those two relatively different disciplines harnesses synergistic power of both sciences that together explain how the human body works and how drugs work,” Muniz says.

Tripos has been in the biosimulation business since 1979, when computer-aided drug discovery was just getting started. Today biosimulation is becoming a major part of drug development, with analysts predicting the biosimulation market to reach $1.7 billion by the end of 2017, compared to the overall $68 billion drug research market. Biosimulation is used in addition to real-world clinical trials to predict the effects of drugs being researched in an effort to prevent costly failures of drugs late in the approval process.

“If you can use the biosimulation to avoid doing a costly study, of course this work is encouraged by the regulators as long as science deems it appropriate,” Muniz says. “Doing a clinical study could be harmful to patients.”

Muniz says Certara recently had a client that had a central nervous system drug that was in late stage development and about to be approved by the FDA. But first, the company had to conduct several studies of potential drug-drug interactions, each of which would have cost millions of dollars. Instead of testing the drugs on real patients, the company received approval to use computer simulations, and then provided the resulting data to the FDA.

Biosimulation also provides a way around the mathematical reality that there are almost infinite potential drug combinations, and testing each one in a clinical trial would be impossible, Muniz says. “In a way, biosimulation is one of the most cost-effective ways of conducting clinical development, not only in terms of time, but in cost, and in terms of harming patients. When you conduct drug-drug interaction trials, you have to actually expose patients to potentially harmful drug-drug interactions. Obviously, if you had to do it, it would be for the good of humankind, but you would nevertheless have to expose patients to risk.”

Doing the whole thing by number crunching would be preferable — so long as the simulation was accurate. Achieving accuracy requires not only immense computing power, but the expertise of staff. “One pharmo-kinetic model may have 10 to 20,000 lines of code,” Muniz says.

Currently Certara has about 10 people working in the recently-created Princeton headquarters, and about 350 worldwide. About 100 of those employees are scientists and medical doctors with advanced degrees. The company has only had a presence in Princeton since mid-2014.

“This is a pharmaceutical corridor, and the concentration of pharmaceutical companies and biotech businesses is significant here,” Muniz says. “Being close to our clients would create significant interactions and easy communication.”

Together, the companies that make up Certara have had a hand in developing hundreds of drugs over the years. Muniz says their clients have had 20 drugs approved in the last 18 months.

Design with the aid of massive computing power has already revolutionized the aerospace industry, defense, and weather prediction. Muniz hopes to bring healthcare, a relative latecomer to the game, into the same realm.

Muniz grew up in the Dominican Republic. “That means I have to know how to dance, salsa and merengue very well, and I should know how to play baseball very well,” Muniz says. He is the son of an Exxon executive and a homemaker. Muniz recalls that by age 7, he knew he wanted to be in medicine.

“I dissected all kinds of animals everywhere, which my mother would find under the bed and in the bathroom. It was a fantastic time. I fell in love with biology, which led me to choose medicine as a career.

He earned a medical degree from the Autonomous University of Santo Domingo, and a Ph.D. in population planning and international health and a master’s in population planning from the University of Michigan’s school of public health. After that, he completed a residency in epidemic intelligence services, investigating outbreaks of infectious disease.

Muniz then joined Eli Lilly, where he worked for 11 years working in various senior executive roles including head of worldwide pharmacovigilance and epidemiology, the cardiovascular business unit leader, and vice president of oncology and clinical development.

He later became president of Kirax Corporation and served there until 2014, when he became CEO of Certara and began to oversee its expansion.

In addition to the biosimulation companies, Certara owns Synchrogenix, a Wilmington, Delaware-based pharmaceutical writing company that has been doing business for 30 years.

In contrast to the high-tech world of computer simulation, pharmaceutical writing has been a distinctly human-powered endeavor. But in January, Synchrogenix acquired Clingenuity, a Cincinnati-based company that uses artificial intelligence to automate certain aspects of the paperwork that go into getting a drug approved.

Kelly Kendle, CEO of Synchrogenix, says the amount of writing required when submitting a drug for FDA approval is staggering. Back in the days of all-paper documents, she says, that would mean literal mountains of paper. “For a new chemical, we’re talking hundreds of thousands of pages of written text and data. To support that written text, there would be pictures,” she says. On the day of actually filing an application, Synchrogenix used to load up a tractor-trailer with binders and send it to Washington. Once there, it would take up entire rooms lined with bookcases.

Synchrogenix was founded about 30 years ago to support Delaware’s then-dominant chemical and agricultural industries, which needed to get approval from the EPA before introducing their products to the marketplace. When those industries moved overseas, Synchrogenix had an army of trained science writers looking for something else to do. Fortunately, the pharmaceutical industry filled the void, and Synchrogenix was able to change its focus.

Although many of Synchrogenix’s 100 employees are highly trained scientists, much of the work is pure drudgery. It involves copying and pasting data and checking it for consistency. Editing data tables and text tables is something that can be automated without too much trouble. But even in simple procedures, it’s possible to introduce human error. That, Kendle says, is where Clingenuity’s AI will come in handy. “You’re taking out some of the risk that introducing multiple writers can introduce,” she says.

She doesn’t anticipate a downsizing of staff to go along with the more efficient computer. “We’re going to need writers to create nuance within the document or interpret the data,” she says. “You don’t need them to copy and paste from a protocol of a study into a report.”

Although much of the writing Synchrogenix makes is technical, destined to be read by very few people, eloquence has its place. The company often writes clinical overview position papers that are meant to convince regulators to approve a drug or allow development to continue. These papers, although based on data, have to be written persuasively.

“That is where I think most writers bring their highest skill-set to bear,” she says. “You’re looking at the situation and the challenges and putting together a story and a rationale that the data supports, but which is not just repeating the data that’s collected.”

Muniz says adding Clingenuity to Synchrogenix will allow technology to augment the skills of its regulatory writers. It’s all part of the company’s overall mission to make drug development faster, cheaper, and more accurate.

“Being able to influence significantly the speed and cost and reliability of drug development is very meaningful to us,” he says.

Certara, 103 Carnegie Center, Suite 300, Princeton 08540; 888-708-7444; Edmundo Muniz, chief executive officer. www.certara.com.

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