Fort Collins, Colorado, may be known for its dozens of local microbreweries, yet Jack McLane brews up concoctions of a different kind: medicines. In this town in the foothills bordered by the Rocky Mountains, the vice president of clinical development at Tolmar works alongside his team of scientists, chemists, and engineers within the three hundred thousand square feet of high-tech laboratories and manufacturing facilities. Together at the pharmaceutical company’s headquarters they invent and distribute remarkable products for patients around the world.
Tolmar’s anticipated 20 percent growth caught McLane’s attention, and he joined the company in July 2014. He felt his breadth of experience at large pharma and small biotech companies could boost the company’s trajectory. “It was one of those opportunities where, intellectually, the stimulation and the potential of helping a company grow was really important to me,” says McLane, who has devoted his career to tackling diseases like Parkinson’s, Alzheimer’s, schizophrenia, and more.
McLane’s background certainly equipped him for the task at Tolmar. He began his career as a postdoctoral researcher at the Yale University School of Medicine after earning a master’s degree and a PhD in biology from the University of Rhode Island. He has not only worked with R&D, but with marketing, finance, and regulatory functions as well. He has managed clinical trials, budgets, strategic operations, and US FDA applications for pharma, including Hoffmann-La Roche and Clinquest—the latter immediately prior to Tolmar.
“I’ve always been interested in making sure I’m working on products that are going to be safe as well as effective for patients,” McLane says. “It drives me to make sure we’re doing good science and making sure we really are thinking about the end result.”
The end result at Tolmar comprises a portfolio of innovative generic and proprietary products in therapeutic areas, and its twenty-four FDA-approved products range from dermatologic care to palliative treatment of prostate cancer. “There’s an awful lot of competition in the market today for different drugs,” McLane says. “But we’re looking at what’s affordable for the patients and giving them products that will help them have better healthcare overall.”
Currently, Tolmar is working on a number of drugs for severe neurological disorders and other neurological conditions with injectable drugs. “It’s exciting because these drugs have shown to be very effective in having a longer time that it acts in the body between having to take doses,” McLane explains. “And for patients with neurological disorders, it means they get much better treatment over time.”
McLane’s chief role is ensuring that the benefits of Tolmar’s products outweigh the risks, and he says that pharmacovigilance is crucial both to patients’ health and the company’s success. His team’s deep knowledge of the drugs’ pharmacology applies to multiple facets of product development, including the safety information listed on packaging inserts. It also requires a proactive understanding of how each product’s molecular structure could interact with patients’ diverse physiologies.
“Each drug they develop has unique characteristics, and you have to look at them and think robustly,” McLane says. “You have to make sure you’re thinking of how to summarize the data that you’ve collected and present it in the best format for the regulatory submissions to the FDA. And that strategy of presentation and choosing the best set of trial designs—that’s what I’m able to bring forward.”
“I’ve always been interested in making sure I’m working on products that are going to be safe as well as effective for patients.”
Tolmar has 5–10 products getting ready for clinical trials each year according to McLane, taking 2–5 years each before applying for FDA approval. While McLane says that each company is different in his experience, at Tolmar, generic drugs typically take 9–14 months for FDA approval, whereas proprietary products, known as new molecular entities, typically will take about 1–2 years to get approved.
As Tolmar’s vice president of clinical development, he’s constantly designing the best clinical development programs and evaluating the process carefully to ensure teams can understand and respond if a product safety issue arises. That attention to operational strategy contributes directly to product innovation.
McLane explains that his insight into the marketplace and what consumers are looking for directly influence clinical methodology. “We ask, ‘Is there a way to extend the formulation so that patients can take a drug a little less frequently and still maintain the drugs’ effectiveness?’” McLane says. It also helps the drug formulators identify the market objective and, in this case, adjust the time the product remains active in the body.
Looking ahead, McLane sees Tolmar expanding more and more into injectable-type products. “It’s a unique swath,” he says. “There are not a lot of companies that have this ability to formulate products that, for example, have a long release time or long activity in the body.”
Tolmar’s global expansion is also implementing clinical trials and speeding up evaluations while working to spread health benefits to populations that may often find getting treatments difficult. McLane says they also have one clinical trial that’s particularly interesting because it’s working with pediatric patients suffering from a rare disease. Plus, Tolmar has partnerships with global companies that distribute its products in more than sixty-seven countries, and McLane says Tolmar certainly aims for continuous progress.
“This is a company that definitely wants to keep growing and really establish itself as a good, solid, thoughtful company that really is working on innovative and appropriate products,” he says. “Employees contribute to real-world work. We want to make sure we have meaningful employment here in Northern Colorado.”
Everest Clinical Research is a proud partner of Tolmar, delivering value through our commitment to quality, customer focus, and flexibility. Everest is a full-service CRO to the biopharmaceutical and medical device industries for project management, clinical operations, data management, biostatistics and programming, IRT/IWRS, pharmacovigilance/drug safety, medical writing, and regulatory submissions. www.ecrscorp.com
“Fisher Clinical Services is proud to work with Tolmar and its forward-thinking leaders like Jack McLane to make the world healthier. For more than twenty-seven years, Fisher Clinical Services has been committed to delivering the highest-possible value and ensuring adherence to the utmost level of quality, performance, reliability, and sustainability standards while serving the packaging and distribution requirements of clinical trials across the globe. We look forward to continuing to support Tolmar in their studies.”