Health Care

N.J. rejects Trinitas’ application to become a Level II Trauma Center

Trinitas Regional Medical Center’s application to become a Level II Trauma Center was rejected by the state Department of Health on Friday, ROI-NJ has confirmed.

Officials at Trinitas said they are currently reviewing the seven-page rejection letter (which can be read below).

Requests for comment from the Department of Health were not immediately returned.

Trinitas, which has been in a prolonged fight to earn Level II designation, appeared to be moving in that direction in January, when its efforts received approval from the state’s health planning board.

Trinitas, which is in Elizabeth, began its latest effort to become a Level II Trauma Center in the fall of 2017, when the state asked hospitals in Union County to apply for the designation — recognizing that the county did not have a Level II center in its borders.

Trinitas CEO Gary Horan openly argued his case for the designation, citing — among other reasons — that Elizabeth is one of the 10 most violent cities in the state and Trinitas’ emergency room is one of the busiest in the state — one that handles many extreme trauma cases, such as wounds from gunshots and stabbings.

Trinitas’ application was met with opposition from officials at University Hospital in Newark, as well as Newark elected officials, who argued that granting the designation would result in a loss of business and financial harm to University Hospital.

Officials at the hospital and more than a dozen elected officials in the Newark/Essex County area sent six letters of opposition to the Department of Health last April.

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Juniper adds Pa. senior housing community to its portfolio

Bloomfield-based Juniper Communities has added to its portfolio of managed and owned senior housing communities, with the acquisition of a Chestnut Hill, Pennsylvania, residence.

The Terrace at Chestnut Hill adds 70 personal care units and 33 memory care units to Juniper’s portfolio, becoming the company’s 12th senior housing building in Pennsylvania.

“We are very excited to extend our signature programs to benefit residents and their families, the team of associates and the professional health care community,” Juniper founder and CEO Lynne S. Katzmann said in a prepared statement.

The community employs 95 people, and Juniper said it is striving to retain them.

“Expanding our presence in the Pennsylvania market enables Juniper to consolidate market share and pilot additional ancillary services within a concentrated hub,” Katzmann said.

The property at 495 E. Abington Ave., will now operate as The Terrace at Chestnut Hill, a Juniper Managed Community.

Financial terms of the acquisition were not disclosed.

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Certara announces it has a new CEO

Certara announced Thursday it has named a new CEO.

Dr. William F. Feehery.

The Princeton-based drug development solutions company said Dr. William F. Feehery has been named CEO and member of the board of directors, effective June 3.

Feehery previously was at DuPont Industrial Biosciences where he served as president since 2013. He joined DuPont in 2002 and before that had experience in venture capital and was a consultant for the Boston Consulting Group.

“I am excited to join Certara, an exceptional company that is reducing the cost, time, and risk of drug development. I could not have made a better choice than to join the company at this exciting time in its growth trajectory,” Feehery said. “Certara’s track record for optimizing drug development and patient care decision-making by leveraging its integrated portfolio of quantitative and in silico capabilities is impeccable. The company has already had a significant positive impact, helping to bring safer and more effective new therapies to market efficiently. The healthcare field is ripe for accelerated innovation of this type and Certara is poised to lead the market.”

Certara also announced Dr. Edmundo Muniz, who’s been Certara’s CEO since June 2014, will become a member of the board of directors and chair of the board’s newly-created science committee.

“We are very pleased to welcome Bill to Certara. Bill’s broad and diverse background in technology and commercial operations position him well to lead the company. We are confident that his technical, operational and commercial expertise will serve him well as he takes the company to its next level of growth,” Sheri McCoy, Certara chairman of the board, said. She went on to say that “we also want to thank Edmundo for the great work he has done in establishing the vision and strategy that has resulted in Certara becoming the world leader in model-informed drug development and a critical innovator in modeling and simulation.”

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CDI’s Perlin wins $33M grant to develop new antibiotics, as bacteria increasingly grow resistant to treatment

More than 2 million people are sickened every year in the U.S. with antibiotic-resistant infections, resulting in at least 23,000 deaths, according to the federal Centers for Disease Control and Prevention.

One of the heads of the Center for Discovery and Innovation at Hackensack Meridian Health will get a chance to change that.

Dr. David Perlin, the chief scientific officer of CDI, was awarded a $33.3 million grant by the National Institutes of Health to develop new antibiotics to overcome deadly bacteria in hospitals that have become resistant to current treatments, HMH officials announced last week.

Perlin and CDI will use the five-year grant to establish a Center of Excellence for Translational Research, a public-private partnership that brings together prominent scientists from the CDI, as well as other institutions and industry, HMH officials announced.

“We are embarking on a new era for antimicrobial discovery,” Perlin said. “By bringing together leading researchers from academia and the commercial sector in a highly interactive collaborative partnership, and providing comprehensive resources that support drug discovery, we can overcome many of the barriers that limit antibiotic development and help to reinvigorate the drug pipeline.”

In the era before antibiotics, infectious diseases were a leading cause of death worldwide, and the introduction of antibiotics in the 1940s changed the fate of countless millions. Yet, drug resistance emerged rapidly, and its steady march has led to the evolution of multidrug-resistant, or MDR, strains that can be resistant to all known antibiotics.

Health officials feel the threat to human health is profound, jeopardizing advances in modern medicine and creating a major health crisis.

Hackensack Meridian Health CEO Robert Garrett said working to solve the issues is the reason CDI was established.

“This is exactly why we created our new Center for Discovery and Innovation — to deliver tomorrow’s breakthroughs today,” he said. “We are proud to receive this record grant, which will produce new therapies to tackle drug-resistant infections and save lives.”

Dr. Andrew Pecora, chief innovation officer at Hackensack Meridian Health, agreed.

“This grant reflects the core mission of the CDI to rapidly translate scientific innovations to address critical unmet clinical needs,’’ he said.

CDI, located at the campus of the Hackensack Meridian School of Medicine at Seton Hall University in Clifton and Nutley, is comprised of three areas of research: cancer and infectious disease; multiple myeloma; and regenerative medicine.

CDI officials feel Perlin — whose arrival at CDI was announced earlier this month — is the perfect choice for the grant, calling him a highly accomplished researcher and administrator who has played a major role in advancing the national research agenda to overcome drug-resistant infections.

Perlin’s primary expertise is in drug discovery, mechanisms of antifungal drug resistance and rapid diagnosis of drug resistant bacterial and fungal pathogens in cancer, transplant and other high-risk patients, CDI officials said. Perlin has published more than 250 papers and book chapters and co-authored two-books.

Senior researchers assembled by Perlin include Sean Brady, a chemical biologist at the Rockefeller University in New York City; David Alland, an infectious disease expert at Rutgers New Jersey Medical School; Thomas Dick, a drug discovery expert at the CDI; Richard Ebright, a biochemist at Rutgers’ Waksman Institute of Microbiology; and Terry Roemer, founder and chief scientific officer of Prokaryotics Inc., a biopharmaceutical company focused on the discovery and development of novel antibiotic classes that target multidrug-resistant bacterial infections.

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Elnahal: Report on state’s psychiatric hospitals coming soon

The state Department of Health is set to issue a report soon on how the state’s four adult psychiatric hospitals are doing.

Commissioner Shereef Elnahal told ROI-NJ the report will include a number of policies and regulatory recommendations, which would need the support of the Legislature and Gov. Phil Murphy to put in place.

“We’re about to release a nine-month progress report in our 18-month plan that’s going to go through all of our improvements,” Elnahal said.

“Just to give you a teaser of that, (there’s been) over a 30 percent reduction of violent episodes and assaults from last year. So, this is comparing the beginning of the administration to now.”

The statistic matches a quarter-over-quarter comparison from January 2017 to January 2018, when Elnahal first announced the action plan in August 2018.

The report will include both highlights and areas the state has more work to do, Elnahal said.

“I took what I had learned in quality improvement at the VA (U.S. Department of Veterans Affairs) — we brought it to the state psychiatric hospitals,” Elnahal said.

The DOH’s 18-month plan is focused on an analysis of the hospitals, as a result of a focus on the psychiatric facilities that began under Gov. Chris Christie’s administration.

“The intent of the analysis was to provide an assessment of the organizational and operational issues affecting each psychiatric hospital, and to provide recommendations to meet the challenges with the overall goals of achieving the most important objective: improving the quality of patient care delivered to service recipients,” according to the plan in August.

“The scope of the engagement included: review of the current inventory of services, human resources and staffing assessments, clinical issues, operations issues, governance and administration functions, finance, and physical plant issues.”

Elnahal said in August that the goal of the plan was to have the psychiatric hospitals, which have come under the spotlight as the opioid crisis hit the state, operate like other acute care hospitals.

“Our vision is to have the hospitals operate as one health system of regional psychiatric facilities using the same clinical and patient safety standards,” he said last year.

“Just like acute care hospital systems or a children’s hospital, our regional psychiatric hospitals should be specialized hospitals where patients are treated, stabilized and then returned to the community — with the supports they need.”

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HMH’s Center for Discovery and Innovation adds Barer, Perlin to roster

Hackensack Meridian Health announced its board of directors and other leaders of the new Center for Discovery and Innovation — a research center it launched on the new medical school campus in Clifton and Nutley.

Dr. Sol J. Barer was named chair of the board of directors and Dr. David S. Perlin was named chief scientific officer, according to a Monday statement from HMH.

The CDI is in what used to be the Roche Institute of Molecular Biology, and is focused on translating research into clinical solutions.

“The Hackensack Meridian Health Center for Discovery and Innovation is bringing together the greatest minds in science and medicine to make significant breakthroughs in cancer, infectious diseases and regenerative medicine research,” said Robert Garrett, CEO of HMH. “With Dr. Barer as chair of the board of directors and Dr. Perlin as chief scientific officer, CDI will continue to push the boundaries of medicine forward.”

Barer is a biotechnology industry veteran, and the founder and former chairman, CEO, president and chief operating officer of Celgene Corp. He is also on the board of directors of Teva Pharmaceuticals, which recently moved its headquarters to New Jersey, is a managing partner at SJ Barer Consulting and advisor to the Israel Biotech Fund.

“The Center for Discovery and Innovation encourages critical advances in medicine by bringing together today’s best and brightest to enhance patient outcomes,” Barer said. “As chair of the board of directors, I look forward to transforming biomedical research by empowering innovation.”

Perlin is a biomedical researcher and administrator, and widely recognized as a global leader in antifungal drug resistance, molecular diagnostics and drug discovery, according to the statement from HMH.

Perlin is the former executive director of the Rutgers New Jersey Medical School’s Public Health Research Institute and former director of the Rutgers Regional Biocontainment Laboratory.

“This is an incredible time to be in the field of science, where diseases that were once considered untreatable are now curable,” Perlin said. “The Center for Discovery and Innovation is accelerating the timeline from discovery to treatment. In my role as chief scientific officer, I am excited to work with top researchers in the field to develop innovative therapies to treat some of the world’s most difficult diseases.”

Dr. Andrew Pecora, chief innovation officer at Hackensack Meridian Health, said the CDI, whose goal is to encourage development of intellectual property, is leading the way in research and innovation, and the addition of Perlin and Barer grows its influence.

“Dr. Barer and Dr. Perlin are two of the most influential medical minds of our time, and, through their visionary leadership, we will transform patient care through groundbreaking research and clinical expertise,” Pecora said.

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Only fair that Trinitas gets Level II trauma status

Recent news detailed the overcrowding that is being experienced by Newark’s University Hospital and the need for $10 million from the state for expansion of that facility. In recent articles, people associated with University incorrectly stated Trinitas Regional Medical Center’s trauma volume and capabilities. Trinitas is seeking approval to become a Level II Trauma Center. Assemblywoman Eliana Pintor Marin (D-Newark) and University’s acting CEO, Judith Persichilli, both maintained that granting Level II trauma status to Trinitas will siphon patients and thereby hurt University Hospital. I cannot let these comments go unanswered.

Joseph P. Cryan

Trinitas already treats more than the minimum number of 350 trauma cases required for it be designated a Trauma Center, and has done so for more than eight years. This was the unanimous finding of the State Planning Board. And, for many years, Trinitas has operated successfully in stabilizing critically ill and injured patients, and transferring them to University when appropriate for Level I care. The trauma system in New Jersey depends on this high degree of collaboration between Level I and Level II facilities, as well as community hospitals.

Now is not the time to begin building silos.

University Hospital states that Trinitas becoming a Level II Trauma Center will result in $20 million in lost revenue to University if it lost 250 patients to Trinitas. That would amount to $80,000 per patient. This is simply not the case. Even if University did lose cases, the financial losses would be a fraction of that amount. Indeed, the formalization of a Level I and Level II relationship between Trinitas and University could result in more patients coming to University, not less. The bottom line is the people of the greater Elizabeth community also deserve a trauma center.

After an accident, no patient wants to be driven past one hospital to wait in traffic to go to a further hospital. Every patient wants to be taken to the closest hospital possible to be cared for or, at a minimum, stabilized. Designating Trinitas a Level II formally recognizes its expertise and allows the doctors to do what they are trained to do — take care of trauma patients.

In an emergency, it does matter how close you are to the care you require. Did you know that Boston, with its population of 500,000, nearly rivals Union County in number of residents? But there’s a profound difference. Boston has seven Level I trauma centers and two Level II trauma centers — but Union County has zero trauma centers. We simply cannot keep the status quo of one trauma center in Newark serving two of the state’s largest urban areas. Everyone knows that getting from any place in Union County to Newark in a short amount of time is nearly impossible.

This thinking correctly prompted the State Health Planning Board to unanimously overturn the Department of Health’s initial rejection of Trinitas’ trauma application. I was there, I heard the discussion. There was no reason to vote otherwise. Approval was obvious, as the need was well-proven and capabilities carefully documented.

The bottom line is the people of the greater Elizabeth community also deserve a trauma center.

Homeland Security officials have labeled the section of the New Jersey Turnpike in Elizabeth and Newark as the most dangerous two miles in America. The current arrangement of having just one trauma center — located in Newark — is unacceptable to those of us living and working in Elizabeth and Union County.

You don’t need to search far to find evidence of Trinitas’ commitment to the well-being of my community. In just the last year, Trinitas invested $18.7 million (raised entirely by the Trinitas Health Foundation, with not a penny from the state) in an expansion of its Emergency Department that nearly doubled the number of treatment beds and added four Intensive Care Unit rooms (two of which are Trauma ICU rooms). The project also addressed the emotional aspect of emergency care, providing separate treatment areas with specialized expertise for children, seniors and behavioral patients. Trinitas sees nearly 70,000 emergencies each year, and it does it very well. It is anxious to be formally recognized for this level of care and become a true, Level II trauma center for the people who live, work and visit Union County.

Trinitas is not seeking to cause harm to University, and there is no credible evidence that designation of Trinitas as a Level II trauma center will have any material financial impact on University. Trinitas has a long history of working with University and will continue that practice.

The residents of the greater Elizabeth community are not second-class citizens. We are not a suburb of Newark, nor should special interests be chosen over patient care. Decisions on trauma care should be based on the needs of the community. The citizens of Elizabeth and the rest of Union County deserve the respect and the equal fairness afforded to New Jersey citizens everywhere. For the safety and peace of mind of my constituents, Trinitas’ application for Level II Trauma Center designation must be approved. To do otherwise would be a decision that will not withstand scrutiny, and will not best serve New Jersey’s patients.

Joseph P. Cryan (D-Union) is a state senator representing the 20th District.

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University Hospital names Elnahal its CEO; health commissioner will leave Murphy administration

The University Hospital board of directors voted Wednesday afternoon to approve state Department of Health Commissioner Dr. Shereef Elnahal as the Newark medical center’s new CEO and president.

Elnahal was one of at least three finalists and was expected to be named, several sources previously told ROI-NJ.

Sources familiar with Elnahal’s thinking but who were not authorized to speak publicly said he was interested in the Newark-based position — after being approached to apply — because of the amount of time he was already spending on the hospital.

University Hospital’s board voted to install Elnahal, who will replace interim CEO Judith Persichilli, on July 15.

In a statement Wednesday, Elnahal said he was excited for the new role.

“It’s been my greatest honor to serve in the (Gov. Phil) Murphy administration,” he said.

During my tenure, we accomplished much to advance the governor’s agenda for social justice in health: restoring funding for women’s health care to reach over 10,000 additional women, serving thousands of women of color to target black infant and maternal mortality, setting the foundation for the state’s public health approach to the opioid epidemic, improving the state’s psychiatric hospitals, helping to preserve the gains New Jersey has made with the Affordable Care Act and overseeing the largest expansion of the state’s medical marijuana program in its history.”

Elnahal said he intends to revive the community’s trust in the hospital, which was recently damaged by its handling of virus outbreaks and infections.

Gov. Phil Murphy, who appointed Elnahal to the commissioner role, expressed his support for the decision.

University Hospital
University Hospital in Newark.

“It is bittersweet to see Dr. Elnahal leave the Department of Health for his new role as the CEO of University Hospital,” he said in a statement.

“Over the past year and a half, Shereef has proven again and again that he was the perfect choice for our administration’s first commissioner of health. Whether it was guiding the state through a troubling viral outbreak, working with the first lady to tackle maternal health disparities or ensuring that more patients than ever before will have access to medical marijuana, he has made us proud. While I am sad to see him leave the Department of Health, I am immensely happy to see him continue his service to the people of New Jersey and some of our most underserved residents at University Hospital.”

University Hospital board Chair Tanya Freeman thanked Persichilli for her work and welcomed Elnahal.

“We are confident that his strong leadership and creativity will be the driving force necessary to continue the momentum we have begun to develop over the last several months as we craft a strategic plan for the future,” she said. “The board is also deeply grateful to the selfless work of Judy Persichilli during this transition period. She has brought a culture of transparency and gratitude to the leadership team that is felt by our patients, employees, and community.”

Health Care Quality Institute CEO Linda Schwimmer also expressed her support for the choice.

“I’ve worked with Dr. Elnahal since we served as co-chairs of Gov. Murphy’s health transition team,” she said in a statement.

“I’ve seen firsthand his incredible energy and commitment to quality, safety and equity in health care. He’s a strong and compassionate leader who will be a trusted partner for the Newark community. Dr. Elnahal’s experience at the (Veterans Administration) and New Jersey Department of Health will help him create and execute a vision for the future of University Hospital and its role as a patient-centered research and teaching hospital. It’s an inspired selection. The state was also lucky to have someone of Judy Persichilli’s caliber and experience willing to step in and take the helm during such a challenging time in the history of University Hospital.”

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Outlook Therapeutics names new SVP, clinical development

Outlook Therapeutics Inc., a clinical-stage biopharmaceutial company based in Cranbury, announced it has named Jennifer M. Kissner to the role of senior vice president, clinical development.

Kissner, who has extensive experience in therapeutic product development, most recently served as vice president, clinical development at Clearside Biomedical. Previously, she was director, clinical development at Acucela and held roles of increasing responsibility in retina development at Alcon.

“We would like to extend a warm welcome to Jennifer and are excited that she has joined the Outlook team,” Terry Dagnon, chief operating officer at Outlook Therapeutics, said. “Dr. Kissner’s extensive clinical development expertise, specializing in wet AMD and other retina diseases, will be an important asset to Outlook Therapeutics as we continue to advance the ONS-5010 program.”

The company also announced Kenneth M. Bahrt, chief medical officer, has left the company to pursue other opportunities. Outlook said it does not intent to replace the role.

“On behalf of the entire Outlook team, I would like to thank Dr. Bahrt for his valuable contributions to the Company for the past four years and wish him the best in his future endeavors,” Lawrence Kenyon, CEO, president and chief financial officer, Outlook Therapeutics, said. “These organizational changes reflect the continued evolution of Outlook Therapeutics as part of our strategy to focus on retinal diseases.”

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Humanizing health care is key to messaging, Montclair’s OptiBrand Rx says

Explaining that it takes a decade and millions of dollars to bring a drug to market doesn’t evoke sympathy from an irate public.

Explaining how drugs save lives does.

And it’s helped Montclair-based OptiBrand Rx, a global consulting company, find a niche in the life sciences industry.

OptiBrand Rx is helping pharmaceutical companies change from traditional brand marketing to a more targeted approach.

The stories of how those drugs have saved lives, targeting whom they are meant for through advertising and discussing the value proposition in relation to a patient’s life are some of the ways OptiBrand Rx is helping the industry change its messaging to a value proposition approach.

Dominick Cirigliano, OptiBrand’s executive vice president of strategic research, said the idea is catching on.

“We’ve doubled the size of our business in the last year and a half,” he said.

Payor and insurance companies have the pertinent information — the costs of each disease or problem — and weighing that overall cost with the cost of the new medication is where the value proposition comes from.

The strategy of educating clients and honing in on a message — rather than hoping for mass-market success — has been a successful service line the company began offering in 2012.

“We found out very quickly people valued our thinking quite a bit,” Cirigliano said.

The company does about $20 million in revenues annually and has grown from just two to 40 employees.

It has projected another 30% growth this year — but Cirigliano said the company already is on pace to beat that expectation.

The company has figured out how to bridge the gap between the scientists who create the drugs and the business minds who run the pharma companies and focus on selling and mass-producing it.

“A lot of these pharma companies, they’re scientists,” Cirigliano said. “They’ve invented these drugs, they’ve dedicated their lives to bringing them to market, so they’re not communicators, necessarily.”

Which is why there isn’t enough education around the products and who they are best for, Cirigiliano said.

“That’s what we help do,” he said. “We help make sure it’s clear to physicians, clear to patients … even pharmacists and payors.”

The pressure on the pharma industry due to a public outcry over rising drug costs, paired with the spotlight on sales and advertising from court cases over the opioid crisis, also has changed the spending habits of the drug companies, Cirigliano said.

Cirigliano said the biggest thing is that pharma has backed off spending on ads and promotion, and is spending more time on communicating how to use products better.

“It’s a big change,” he said. “The old days of merchandising and acting more as a traditional consumer goods company has stopped.”

In addition, the science has improved.

Drugs are more efficacious and have fewer side effects, and are able to target specific diseases, Cirigliano said.

This means that they are successful in keeping people alive longer, which increases their value, which is why costs go up, he said.

The goal is to show the value proposition, the end benefit for the patient and the cost savings, Cirigliano said.

Especially since drugs affect different people differently.

“There’s always going to be some individualities to taking medication,” Cirigliano said.

That includes patients who are noncompliant. If a patient doesn’t feel the symptoms, they may stop taking medication, and that could complicate matters and land them in a hospital — which then increases their cost of care, he said.

One thing OptiBrand can’t do is figure out how patients can access cheaper drugs.

The problem, in Cirigliano’s opinion, is that cheaper drugs will be less effective than the brand-name drugs, so the patient will get what they pay for.

“We’re not an education company, we’re not out there to educate the general public,” he said.

“It’s really our job to help the pharmaceutical companies with what is the market perception, what are the things they’re going to have to consider when telling the story about their products.”

The company also focuses on over-the-counter drugs, which pose their own problems.

“The challenge is people are more educated, there’s a lot more information available thanks to the internet — (and) not all of it is good information,” he said. “So, trying to educate people is less physician- or practitioner-oriented, it’s a little more weighted towards consumers.

“So, how do you talk to consumers so they understand the different options and they can make a more educated decision? You have to make sure you’re clear and you have to be honest. If you fool somebody once and they use your product and they don’t have a good experience with it, they’re never going to buy it again.

“So, it’s important that the right people are using the right product at the right time.”

But the company hasn’t always been focused on pharmaceuticals; it has also had clients in the consumer brand space. A look at its website reveals an expansive list of top brands such as Starbucks, M&Ms, McDonald’s, Burger King, GM, Mercedes-Benz and Gerber.

“It’s a small part of our business, but it’s something we get requests (for) and it’s good to have diversity,” he said.

The company moved its global headquarters from New York City to Montclair in 2009, after which it has opened satellite offices in Florida and Quebec, along with NYC.

“Most of our big clients are here in New Jersey,” Cirigliano said. “Obviously, it’s a pharma hotbed. Also, a lot of the companies headquartered in New York had left.”

Being outside of New Jersey is important, too.

“A lot of that is the research, we do a lot of global work, so we have a presence in Montreal and Europe … we do a lot of work out of Switzerland,” Cirigliano said.

Cirigliano said the company also is hoping to expand to the Midwest and West Coast, and sees the pharmaceutical industry as the place to be.

“We’re not here to make sure our clients make the most money, we are here to make sure the patients benefit from the product properly,” he said. “When that happens, everyone wins, including the pharma companies.

“That’s been the change over the years is recognizing the fact that being clear and specific about using the product is much more beneficial than traditional marketing methods of blasting it out.”

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