Peter Blume, MD
Affiliated Foot & Ankle Surgeons
Pioneering podiatric surgery — and saving diabetics’ limbs
“You’re going to lose your leg. Or, you can see Peter Blume.”
It may sound dramatic, but for diabetics faced with the bleak prospect of losing a limb, Peter Blume, MD might be their only hope.
The podiatric surgeon finds himself at the forefront of diabetic limb preservation and reconstruction, and has worked and traveled tirelessly to keep patients here and abroad standing on their own two feet.
Blume practices at Affiliated Foot and Ankle Surgeons on Blake Street, a practice started 54 years ago by his podiatrist father, James Blume, who still practices there at age 79.
His schedule is exhausting even to think about. He sees upwards of 50 patients at Blake Street three days a week, operates two days a week at Yale-New Haven Hospital, does the rounds there over the weekend, and teaches surgical residents. This is in addition to a massive amount of research and a long list of publications (current count is 119) that he and his team put out.
While evidence of his awards, certifications and recognitions are made visible upon entering his office, he speaks altruistically of his work, while a deep concern for his patients’ well being is evident in his speech.
“I do it all — bunions and basic foot surgeries, and arthritic surgery — but my excitement is in diabetic limb preservation,” Blume says. “You’re rewarded when a patient comes back and they’re walking in a shoe, and they have returned to a somewhat more stable life.”
After finishing his residency at Georgetown Medical Center in 1994 he decided to pursue a plastic surgery fellowship — not for the face, but for reconstructing extremities in those with diabetes or gangrene. It was an “unheard of” move at the time. Even 15 years ago, he said, treatment was relatively rudimentary and the amputation rate was high.
“I learned how to do skin grafting and flaps, and all sorts of reconstruction, and then applied those principles to limb preservation,” he says. “When I started, this whole process was quite limited. There were very few institutions that had limb teams.”
With staggering diabetes statistics — just over eight percent of the U.S. population now has the disease and more than 60 percent of non-traumatic lower limb amputations occur in those with it — the need is greater than ever. Up to 40 percent of Blume’s patients are diabetic. And while amputation is necessary for some, he views it as a last resort, since those that lose one limb are 50 percent more likely to lose the other within five years.
He relays the story of a train conductor patient, now on a hopeful path to recovery.
“He’s maybe 51 years old, and was told he was going to lose his foot. He’s got a wife and family; we’ve got to do something,” he says. “Our goal is to get him back to work. Otherwise, he can’t support his family, he’ll have to go on disability and Medicare and sit at home. He’ll be devastated.”
His use of an external fixating device called the Ilizaroff apparatus, which sets a patient’s foot in place with the aid of metal wires that pass through the bone (think of the spokes on a bicycle wheel), earned him the Ilizaroff Award of Excellence at the International External Fixation Symposium last year.
Blume traveled to Siberia, and later Greece and Italy to hone his skills with the device.
“I’m one of maybe two in the state that uses them at the volume I do,” he says. “I’m known in the community and the Northeast at large as the guy that does Ex-Fix and limb preservation. That’s my forte.”
This is evident by the number of referrals he gets from hospitals all over the region, even New York and New Jersey. While it might seem a no-brainer for these tools to be used more broadly, Blume says being centered at Yale provides the finances, manpower and skill set that other hospitals may not have.
“You have to remain at a big academic center — it takes a lot of hands,” he says. “I may have a colleague with me, then three residents. Someone has to hold the frame, then drill. It takes a lot, plus needing a team of residents and big staff to manage the diabetic problems, the cardiac issues and the vascular surgery issues .
“That’s why I like where we are,” Blume concludes. “I want to be in New Haven, because I get to see patients from everywhere.”
But the technological advances don’t necessarily make treating patients easier. Some of the biggest obstacles he’s faced with lie in an overall lack of education and attentiveness in some patients and the larger population.
Lifestyle and healthy eating habits are key, but with most his patients not even having sensation in their feet, detecting a problem becomes that much more difficult. Something as simple as checking your shoes to make sure you don’t spend the next few days with debris bruising your feet can make all the difference.
He often will have to talk with patients ahead of time to make sure they have an adequate support system at home.
“There are a lot of social issues that play a role here. We always say, ‘Don’t do the surgery unless you can do the post-op, because we don’t want a disaster,” he says. “The easy route is, we can cut your leg off. But we can save it. It’s going to take time and you have to work with me. I can’t achieve this on my own.”
He acknowledges all this is compounded by social and economic issues.
“Some people are just trying to work and stay afloat; the last thing they care about is how much they eat, and checking their sugar,” he says. “That’s why this isn’t just a disease, it’s a social issue.”
While government regulations and expanding insurance coverage make seeking treatment easier, Blume says he still treats some patients without insurance — including at a once-a-month orthopedic indigent clinic at Yale for no cost.
“It’s part of what we do,” he says. “Let’s just get you better.”
Blume has lent his expertise all over the world, and even visited Cuba last year to look at a breakthrough epidermal compound being developed there. Next spring he’ll lecture in China, where he says the meat-and-carbohydrate-centered Western diet is becoming more common.
Blume is determined to help his patients through the disease intact, and is all the more grateful to have the resources New Haven has to offer at his fingertips.
“We’re not just saying, ‘Hey, we do diabetic foot surgery and we’re really great, so you should come here.’ We put our heart and soul into it through research, education, teaching, and a comprehensive approach.”
Jeannette W. Connelly
Parish Nursing and Community Outreach Center
Cardiac Rehabilitation Center
A former heart patient helps heart patients — with lots of heart
When Jeannette Connelly enters a room full of heart patients at Griffin Hospital’s Cardiac Rehabilitation Fitness Center, her infectious smile and cheery attitude calms them down and makes them feel right at home and part of the group. She volunteers on Thursdays at the rehab center, where she has served for 11 years, and at the hospital’s Parish Nursing and Community Outreach Center for the past five years.
Connelly suffered a heart attack 18 years ago while working as an industrial engineering administrator at Sikorsky Aircraft, from which she retired in 1997.
“I began my cardiac rehab treatment here at Griffin Hospital and just fell in love with the place,” she recalls. “I joined the fitness center here and after a few years, I started as a volunteer.”
Her eight-hour-plus day begins at about 7:15 a.m. with morning exercises for patients at the cardiac rehab center. “Because I’m a former heart patient, I know what they’re going through,” explains Connelly. “So I talk with them, put their minds at ease, get to know them better and reassure them. We have a lot of fun.” She points out that there aren’t any televisions in the center so she relies on conversation and communication with the patients.
“Communication is the key,” says Connelly. “We all have a story to tell, and they tell me theirs. We may not get too deeply into it, but they want me to know what their experience with a heart attack was like because they know I went through the same experience they did.”
Connelly says the patients, who on any given day number between five and 15 out of a total of 50, talk about their children, what they did before retirement and what they want for the future. “I’ve had many friendships come out of my work here,” she notes. “It’s a great experience.”
Connelly plans and hosts several luncheons yearly for the center’s patients and works extra hours on hospital events when extra help is needed. “The husbands bring their wives and wives bring their husbands,” says Connelly. “We get about 40 people at each luncheon. So far, we’ve done 26 this year. It’s really been a good way to get to know people.”
“I know when Jeannette has arrived in the rehab center because soon afterward, I hear laughter coming from the room,” says Eunice Lisk, manager of cardiac rehab. “She puts people at ease. A lot of the people who come to the center have come for many years. At the same time, new patients enter the program gradually and that’s where Jeannette is really great. She welcomes them, makes them feel comfortable, answers their questions and shows them around. She explains the equipment and introduces the new patients to those who’ve been there a while. She’s a smiling, friendly face for them to see.”
Lisk says Connelly’s outgoing personality is a precious asset to the center. “New patients there are a little overwhelmed and have never been to a cardiac fitness center before. They’re oftentimes scared but Jeannette is always friendly, sweet and approachable. I think these traits are very key to making people feel comfortable. If she senses there is a problem with a patient, she’ll clue me in on it. She’s a great communicator.”
At the outreach center, “I do anything that the nurses don’t have time to do,” says Connelly. “It may be filing or copying one day, putting stamps on envelopes on another day — whatever is needed, I’m here to help.” And whatever doesn’t get done during the day, Connelly takes home to work on. “I spread it out on my kitchen table, finish what needs to be done and bring it back the next day.”
“She is the consummate volunteer,” says Daun Barrett, director of community outreach, for whom Connelly works at the Parish Nursing and Community Outreach Center. “She is phenomenal. She accompanies us on the [community outreach] van, handles registration for us and interacts with adults, children, everybody in such a kind and welcoming way.” The 32-foot van, which needs at least two people on board to operate, conducts health care-oriented visits at about 30 sites a month throughout the hospital’s service area.
Barrett notes that no job is too big or too small for Connelly. “You couldn’t pay her enough to do what she does for free,” she says. “We gave her a key to the outreach center because she needs to bring the work she does at home back there. That was her idea.”
Connelly has received the One Heart Touching Another volunteer award from the Women in Heart Disease committee, of which she is a member along with Barrett and Lisk. She also volunteers at the Orange Agricultural Fair and the Red Cross Bloodmobile.
In her spare (!) time, she reads mysteries, watches foreign films and travels. “And I go to lunch with friends whenever I can,” she adds, laughing. Connelly has two sons, two daughters and admits to being a doting grandmother to her only grandchild.
“We’re a community here at Griffin,” says Connelly. “If I were younger and looking for a job, I’d work at what I’m doing here as a volunteer. I have found it to be very rewarding. When I retired, I felt a lack of accomplishment. Then I came here and said, ‘This is what I’m supposed to be doing.’ I love what I do because it’s a good ‘people’ job.”
Cornell Scott-Hill Health Center
Cornell Scott-Hill Health Center provides life-giving care to an underserved population
The need for quality health care in New Haven’s underserved neighborhoods was dire in 1968, when the Hill Health Center opened as a much-needed community resource.
More than four decades later it’s just as vital to the city, if not more so, say administrators. The facility — renamed the Cornell Scott-Hill Health Center two years ago in honor of its longtime director — provides services for low-income populations that otherwise might not receive medical care.
“I don’t know how some folks would manage without the health center,” says Andrea Jackson-Brooks, president of the center’s board of directors. “It’s an unbelievable resource. Our main emphasis has always been access to quality health care. We don’t turn anyone away.”
Established as one of the first community health centers in the country, CSHHC provides comprehensive, quality health care at a sliding-fee cost.
“We are not a free clinic but we are required to have programs for the less able [to pay],” says Rob Rioux, director of community relations and corporate development. If the center did not exist there’d be “substantial” difficulties for various uninsured and underinsured populations, he adds.
From flu clinics to dental care to HIV-related services to help for the homeless, CSHHC aims to detect and fill community needs, says Rioux.
The concept of creating federally qualified community health centers to serve disadvantage neighborhoods evolved from the War on Poverty/Great Society policies of the Lyndon B. Johnson Administration. CSHHC was the first such health-care facility established in Connecticut, the result of a partnership with the Yale School of Medicine.
Today, in addition to New Haven, a total of 16 CSHHC facilities serve populations in West Haven, Ansonia, Derby, Seymour, Shelton, Oxford and Naugatuck. CSHHC is headquartered at 400 Columbus Avenue in New Haven.
Patients who need to be hospitalized are referred to Yale-New Haven Hospital or the Hospital of Saint Raphael in New Haven, or Griffin Hospital in Derby.
“We’ve had longstanding partnerships with those hospitals,” says Rioux, adding that the collaborations shatter a common myth equating community health centers with inferior care. For example, he says, “You see the same cardiologist [at CSHHC] that practices at Yale, so you see very, very high-quality [care] here.”
Services include internal medicine, OB/GYN, pediatrics, dentistry, nutrition, social work, psychology and psychiatry, to name some of the medical and health-related care options. CSHHC also has several school-based health centers and offers programs that include HIV/AIDS education and outreach, pregnant teen care, a child and family guidance clinic, a drug and alcohol detoxification program and a homeless shelter and outreach.
“Our goal is to help you become independent,” Rioux says.
That remains in line with the goal of the late Cornell Scott, the first CEO of CSHHC. Scott served in the position for 40 years before his death in 2008. Jamesina Henderson is now the center’s CEO.
“[Scott] was totally centered on the concept of a community health center,” says Jackson-Brooks. “He was responsible for situating it in the middle of the community. He was on the ground running with this. At the time, there were virtually no affordable, quality health services to a large segment of the community in New Haven.”
Scott began to helm CSHHC the same year he earned a master’s degree in public health from the Yale School of Medicine — a testament to his commitment, according to Jackson-Brooks.
“That’s how dedicated he was,” she says. Scott “had his finger on the pulse of everything going on with health care.”
In 1997 CSHHC won the Johnson & Johnson Community Health Care Crystal Award, presented each year for organizational excellence in meeting community health-care needs of the underserved. Some 33,000 patients (210,000 encounters) are served annually by the facility, which has a staff of 500 caregivers.
CSHHC is funded through a combination of federal, state and local grants, with additional revenue from service payments through Medicaid, third-party insurers and sliding fees charged to the uninsured.
However, the recession is taking its toll. This May 30 non-clinical employees were laid off to help address economy-induced threats to funding sources. Coupled with this development is the fact that health-care costs continue to be outside the means of a substantial number of New Haven-area residents.
“We are in a terrible state as far as health care is concerned,” says Jackson-Brooks. An expensive medical treatment “can wipe you out — if you’re fortunate enough to be able to pay for it. I think the situation is getting worse instead of better.”
In light of the precarious economic horizon, CSHHC probably will be looking to direct more of its efforts to fundraising, notes Rioux.
“We need to develop an annual appeal and let people know what’s happening here,” says Rioux. He notes that the number of people seeking health-care services at CSHHC has risen over the years, especially among the working poor and those who have dropped out of what used to be considered something of a middle-class safety net.
“We’ve seen an increase in utilization by people who traditionally might not have used our services. We’ve become an option for them,” Rioux says.
Despite the economic climate, CSHHC continues to press forward in its mission to serve the community, says Rioux. He notes that plans are in place to open a new Hamden facility in early 2012 that will center on primary care and family counseling. And structural and aesthetic improvements at existing facilities are ongoing, he says.
“One of the biggest changes we’ve undergone over the last few years us a rededication to the environment of care,” he says, citing, for example recent lighting, walkway and waiting room enhancements.
“We’re really demonstrating we want this to be a welcoming, warm environment for people,” Rioux says. “Even if it’s just the simple things — better signage or a new coat of paint — that matters as well.”
Sue Fitzsimons, RN, Ph.D.
Senior Vice President of Patient Services
Yale-New Haven Hospital
How Sue Fitzsimons helped set the bar higher for YNHH nursing
On May 24, 200 nurses assembled in a Yale-New Haven Hospital auditorium to listen to a live phone call from Craig Luzinski, director of the American Nurses Credentialing Center’s Magnet Recognition Program. They were about to learn whether five years of efforts to improve the status of nurses at the hospital would result in Magnet designation for high-quality nursing.
After Luzinski uttered the word “Congratulations,” screams and cheers drowned out the rest of his comments. Among those savoring the moment was Sue Fitzsimons, the hospital’s senior vice president of patient services –– and the driving force behind the extraordinary feat.
“Sue was the visionary leader who persuaded us to go for it,” says Yale New Haven Health System Executive Vice President and COO Richard D'Aquila. “Under her leadership the hospital, after a long and difficult process, was able to achieve what only about six percent of hospitals achieve.”
Just 391 hospitals in the world are Magnet designated. All but five are in the U.S.
Connecticut has two: YNNH and Middlesex Hospital.
The Magnet program “recognizes the quality of your nursing staff,” Fitzsimons says, “but the hospital is designated because the nurse can’t work in an environment where the hospital doesn’t support 88 standards across four domains.”
To achieve Magnet designation, the nursing staff must excel in areas including transformational leadership, exemplary professional practice, new knowledge, innovations and improvements and empirical quality outcomes.
The application form is daunting. “It is 15 volumes weighing over 40 pounds,” says
Fitzsimons, who grew up on Long Island and earned a BSN at Cornell in 1968 and a master’s in nursing at New York University in 1974. After working as a staff nurse at New York Hospital and Long Island Jewish Hospital and as an instructor of nursing at Queensboro Community College, she moved to Ohio, where she completed a Ph.D. in education at the University of Dayton in 1983.
Fitzsimons spent the next two decades in the Buckeye State, teaching nursing at two universities, honing her administrative skills as senior vice president of hospital operations at Miami Valley Hospital in Dayton and earning accolades and awards.
“I was recruited in 1997 to become the chief nursing officer and senior vice president for patient services at Yale-New Haven Hospital,” says Fitzsimons, who today oversees a nursing staff of some 2,800.
Fitzsimons already had some experience with the Magnet Recognition Program at Miami Valley Hospital, where she was seeking Magnet designation. “We were not fully there when I left Dayton,” she says. “When I came here I had multiple conversations about it with [YNNH President and CEO] Marna [Borgstrom], and the conversation continued with her and Rick D'Aquila.
“You don’t do this in a silo,” she adds. “The entire organization needed to be involved, and we actually hired a staff. I have a Magnet coordinator, who is a full-time nurse who spends her day thinking about this, a project coordinator and two consultants to ensure that our interpretation of the standards was correct.
“For five years, we looked at what’s the best way to do it and visited places that had been successful,” Fitzsimons says.
That’s not unusually long, according to Luzinski.
“We call it a journey, which results in the transformation of an organization into one that can address and meet all the criteria,” he says. “It takes time to innovate and change the culture and put infrastructure in place where nurses have a voice.”
The process, Luzinski adds, typically requires a leader with “the energy and tenacity” to succeed.
Even though Fitzsimons possesses those qualities, D’Aqulia says, he was “a little worried about Magnet.
“It was a great aspiration but it was a very heavy lift,” he says. “I had my doubts that we could meet the requirements, which were very stringent. My biggest fear is that we would get really close and not get it. And that would be demoralizing.”
One requirement, transformational leadership, dealt with “how the organization supports leadership, mentorship and successor planning for nurse leaders,” Fitzsimons explains. “We had to describe and demonstrate with data or examples over time that this organization had achieved this. Right from the beginning, I began an education of the organization and tempered the message for different employee groups to explain what transformational leadership is, why do you do it, why it is important and what will it take to get there.”
But once each group, including physicians and admitting staff, understood its role in supporting nurses, “The light bulb went off,” Fitzsimons says.
“When you start out, you’re a novice at it and the staff are not sophisticated,” she adds. “You work and evolve with them and become experts over time. Once you reach maturity you have a well-honed machine for staff engagement that results in staff who are committed, with less turnover.”
The process required continuous oversight and feedback.
“As we got close to document submission and knew we would get visited, it had to be a large educational effort involving the entire organization,” Fitzsimons says.
The hospital filed the Magnet application on August 2, 2010. As part of the review, examiners spent four days at YNNH, from March 29 to April 1, 2011, interviewing more than 300 nurses and meeting with other medical staff and community members.
Then began the waiting game.
“I’ve never been so anxious, and I’m usually pretty cool,” Fitzsimons says.
Relief came on May 24, 2011, with the confirmation of Magnet designation.
“I’ve had a long career and there are things I’m proud of but this is right up there,” Fitzsimons says. “I feel I have created a legacy, which is a really nice feeling, and it has improved patient outcomes, led to all sort of opportunities for nurses, and really elevates your nursing staff to get the recognition it deserves.”
Fitzsimons is not resting on her laurels.
“In four years we will apply for redesignation,” she says. “I brought the team together the day after [Luzinski’s phone call] and told them as challenging as it was to get to this point, redesignation is more challenging and now is the time to start planning.
“They were like, ‘We need a break.’
“And I said, ‘Well, that’s too bad.’”
Hospital of Saint Raphael
An HSR nurse at the forefront of a movement to make lifesaving defibrillators much more widely available
Working as a cardiac nurse has given Sherri Hopkins the chance to see a lot of miracles. But there’s also the other end of the spectrum.
“We see things sometimes when it’s too late,” says Hopkins of patients suffering from cardiac arrest who cannot be saved.
Hopkins, who works as a registered nurse at the Hospital of Saint Raphael, wants to increase such patients’ chances of surviving heart trauma. She has been on a crusade the past few years, educating patients and the public alike on the life-saving benefits of automatic external defibrillators (AEDs).
“For every minute that goes by without CPR [cardiopulmonary resuscitation] or the shock of an AED, your chances of survival goes down by ten percent,” Hopkins explains. “The faster you apply an AED, the better the chance of survival is.” She adds that even for survivors, the longer the time span between the onset of an attack and eventual resuscitation, the greater the chance that heart and/or brain damage will occur. “It’s irreversible — you can’t get that back,” says Hopkins.
An AED is an electronic device that assesses the immediate need of a person suffering from cardiac arrest and delivers a shock, or a series of shocks, as required. Instructive prompts guide the person administering the device on steps to take in using the device.
Immediate access is key, says Hopkins. “The goal is to get an AED on a person within the first three minutes.”
That’s why Hopkins has been advocating for installation on AEDs in public places, including offices and schools. A cofounder of the Connecticut chapter of the Sudden Cardiac Arrest Association (SCAA), she has testified before the state legislature in Hartford about public need for the devices.
“My inspiration is a 17-year-old I met [there] who had been saved by an AED,” says Hopkins. The teen inspired Hopkins to push even harder in her quest to make AEDs accessible in schools. With teens, previously undetected cardiac problems can become manifest during athletic practices and events, she adds.
Hopkins also wants to create a formal network of Connecticut-based cardiac arrest survivors, especially those who were resuscitated with AEDs. She believes not only that they can serve as an extended support system, but also help educate the public about the importance of AEDs.
Hopkins personally spends a lot of time doing just that.
“Now that I’m a nurse, my favorite thing to do is teaching patients. I believe that if patients are educated, that will help them stay out of the hospital,” she says.
Though sure about her mission now, Hopkins, 39, didn’t always know she was destined for a career in health care. She jokes that she settled on nursing by process of elimination.
“I went to Derby High School. One day my high school guidance counselor said, ‘What do you want to be?’” recalls Hopkins, a Derby native. She perused a list that included choices such as accounting, social work and psychology, as well as nursing. She made a mental note of the careers she did not want (accounting was definitely out) leaving the possibilities, nursing among them.
“I always wanted to help people,” she says, “and I enjoy the sciences.”
After making the decision, Hopkins prepared for a career in health care. She studied nursing at American International College in Springfield, Mass., and decided to specialize in cardiac nursing.
“I just find the heart fascinating,” she says, noting that the life-sustaining organ often is taken for granted. “We don’t think about it. We don’t think about how our hearts beat. I’m fascinated by the heart and what it does — the function of its muscles.”
She’s been at St. Raphael’s since 1993, working first as a CNA/student nurse. Two years later she joined the staff as an RN. Her dedication over the years has made her the most recent recipient of the hospital’s Nurse of the Year Award.
“I love the St. Raphael community,” Hopkins says. “I think they have something special there. It doesn’t feel corporate. It doesn’t have that sterile feel to it.”
Hopkins’ supervisor, Sharon Wood, RN, describes Hopkins as a “motivator.
“She just is a doer,” says Wood, who is HSR’s manager of nursing resources. “She was always the one to get everybody motivated, so it didn’t surprise me when she got involved with the school system” to encourage AED acquisition. What’s more, says Wood, “It doesn’t surprise me she is now getting this [BNH Healthcare Hero] honor. Whenever I need something done, she’s my go-to person. She’s wonderful, and has a lot of energy. She inspires me to do more.”
Wood adds that the BNH and other outside honors, along with the hospital’s own recognition of Hopkins, may well lead to even greater responsibility and leadership roles. “Some day she’ll make a wonderful [hospital] official,” predicts Wood.
Hopkins lives in Naugatuck with her husband Peter and their children, boys aged 12 and ten and nine-year-old twin girls. That brood provides an added incentive for speaking to parent groups about the importance of having AEDs in schools.
“Think of the time it could take for 911 to get there,” says Hopkins, adding that not all law-enforcement vehicles are equipped with AEDs in case of an emergency. Hopkins notes that Good Samaritan laws cover AEDs, releasing from liability anyone who might be reluctant to use the device for fear of being sued for inadvertent mishaps.
As Hopkins focuses, through SCAA, on enlisting others to discuss how an AED saved their lives, she’s intent on expanding the Connecticut chapter. “We’re searching for survivors and heroes,” she says, “or even if they’ve lost somebody to cardiac arrest. One woman in the chapter was instrumental in getting AEDs in airlines. Her husband died in-flight [after suffering from cardiac arrest]. They had nothing for him and he died. She wants to do something — she feels driven to do something about it.”
Whether in offices, schools or other public places, Hopkins plans to continue getting the word out about how important it is to have AEDs readily available on the premises to increase the chances of surviving cardiac arrest.
“It’s the leading cause of death; 300,000 people a year die from cardiac arrest,” says Hopkins. When [a person dies from cardiac arrest] there’s a chain reaction. Somebody’s life will get changed. When you really think about it, people’s lives are affected through education.
“I just feel like I have this information and I don’t want to keep it to myself.”
Both locally and nationally, the health care industry continues to evolve at a nearly revolutionary pace.
Earlier this year New Haven’s two major teaching hospitals — Yale-New Haven and the Hospital of Saint Raphael — reached an historic agreement to effect a merger. Elsewhere in New Haven County. Waterbury Hospital and St. Mary’s Hospital forged a similar deal.
In both cases the deals were hailed as landmark compacts that would buoy the two financially struggling Catholic hospitals, streamline service delivery in the Elm and Brass Cities, respectively, and eliminate costly duplication of services. In both cases, the rubber will truly meet the road for the first time in 2012, and the business and health-care communities will be observing with a keen eye.
In the Silver City (Meriden), officials at Protein Sciences say they are mere months from successfully completing trials on its game-changing flu vaccine. Closer to home, Quinnipiac University made great strides toward the opening of Connecticut fifth school of medicine, which hopes to welcome its first class in autumn 2013.
At a dynamic and exciting time in health care, Business New Haven for the fourth consecutive year celebrates the very best that the industry has to offer — from physicians and nurses to researchers and educators to administrators and volunteers. All of them have devoted their lives to caring for others in need.
They are an extraordinary group of individuals and organizations, with extraordinary stories to tell. We hope you enjoy their stories as much as we have enjoyed bringing them to you.
Harry H. Penner
Harry Penner’s footprints surround Connecticut’s bioscience industry
It’s not easy to find a New Haven bioscience company that doesn’t have Harry Penner’s name somehow connected with it. He has helped develop at least a dozen companies and is now focused on growing three more here in New Haven.
He believes he has all bases covered with one prescription drug company, one that specializes in diagnostics and one consumer-supplement business.
Affinimark Technologies is developing a test for the presence of cerebral spinal fluid, called Cerebrostrip, for used in trauma situations and surgery.
“There’s currently no test available — certainly not quickly and inexpensively — for this,” Penner explains. “It’s a very fun diagnostic opportunity."
Penner and Vincent Pieribone are Affinimark’s co-founders. The company was launched with funding from Connecticut Innovations Inc. (CII) and Launch Capital. “It’s an ‘all-Connecticut’ kind of thing,” he says. “Having the office on Temple Street very close to Yale helps.”
Penner also is developing New Haven Pharmaceuticals, a prescription drug company developed largely on the strength of intellectual property, pending patent applications, and, yes, technology out of Yale.
“The proximity to the scientists who are generating technology is not only convenient, but also extremely important to regular updating of that technology and communication with potential investors and partners,” Penner says.
New Haven Pharmaceuticals is at the final stage, pre-approval, of its lead product, something Penner calls a high-tech time-release aspirin product licensed from a firm in France.
“We very serendipitously found new uses for aspirin were being developed — one for liver injury and one for foreign body reaction — and what better product to use with that than a 24-hour controlled reach aspirin?” he asks rhetorically.
And as so often happens with science, one discovery leads to another. “As you know, aspirin can irritate the stomach and the scientists over at Yale learned that zinc, when used in a certain way, can help GI [gastrointestinal] irritation and so that can be combined to create even more products,” Penner explains. “The zinc product by itself is being developed to treat reflux disease. That has been the most unique and coincidental or serendipitous set of circumstances, all of that coming together to create this very neat suite of programs that are now getting funded.”
Penner’s third company, Prevention Pharmaceuticals, focuses on nutritional supplements developed by Yale scientists. “Our proximity to Yale is key,” he says. “It’s about networks. What’s interesting about the supplements, the consumer health products, is there are not only ties to Yale; it [also] involves some of the same people as New Haven Pharmaceutical — almost like sister companies.”
Other companies with which he’s had varying degrees of involvement over time are RxGN, a clinical research organization (CRO) headquartered in Hamden, and Neurogen, where Penner was CEO from 1993 to 2001. He also was co-founder of Rib-X Pharmaceuticals, on whose board of directors he continues to sit, and he serves as an advisor to MAK Scientific, which seeks to commercialize technology from the University of Connecticut. Penner was also involved with Ikonisys and Genaissance for a number of years. He co-founded Marinas and was CEO there until 2008.
“There’s clearly variety in my day,” he acknowledges. “Just look at these three companies: You have Affinimark, New Haven Pharma and Prevention. We cover the consumer-health end of the spectrum to prescription drugs to diagnostics. The intellectual stimulation that comes from dealing with all of these things is incredibly gratifying.”
Oddly, Penner’s academic training is in the law — not science.
“There wasn’t even a biotechnology industry” when he was in school, Penner jokes. He holds a BA from the University of Virginia, a JD from Fordham and an LLM in international law from New York University.
“I did practice law for a few years and I enjoyed it, but I got tired of the Long Island-to-Manhattan commute,” says Penner. So in 1978, he and his wife relocated to Connecticut where he took a position with Boehringer Ingelheim.
“That’s where I cut my teeth in the pharmaceutical industry, largely from the legal side,” Penner recounts. In 1981, he went to work for Novo (now Novo Nordisk), where he was offered the opportunity to relocate to Denmark.
“As luck would have it, I was chosen to become a member of the top management of the company, becoming executive vice president and general counsel to the parent company in Denmark,” he explains. “That was quite a trip — literally and figuratively.”
Three years later he returned to Connecticut and opened a North American headquarters for Novo in New York City’s Chrysler Building. Three years after that, he saw an opportunity with Neurogen, and so began his local pharmaceutical career.
Penner has since served as bioscience advisor to the governor, as co-chair of the bioscience industry group Connecticut United for Research Excellence (CURE) and as chairman of the state’s Board of Governors for Higher Education. He currently sits on the boards Rib-X, New Haven Pharmaceuticals, Prevention Pharmaceuticals and Affinimark.
“By virtue of the rich treasure trove of talented people that have over the course of their careers worked at Bayer, Pfizer and the like, we have a wonderful group of people who are literally right here at our doorstep in New Haven,” Penner says. “We don’t have to go to another state or run into problems with communication with people who are not close by.”
Penner says one of the things that’s been most rewarding throughout his career is working with highly talented people at his various companies.
“Sometimes people worry that New Haven can’t attract the kind of talent that you find in Boston or the [San Francisco] Bay area,” Penner says. “It is more difficult, but we’ve had wonderful founding people with a breadth of experience.
“What I’m most hopeful about is that the state continues down the track that I think it’s on of putting even more money to work at Connecticut Innovations to spark new companies,” Penner says. “New companies generate new employment opportunities and create a larger tax base and that works out well for everybody.”
Protein Sciences Corp.
Protein Sciences closes in on a revolutionary flu vaccine
One month after the September 11, 2001 terrorist attacks, Meriden's Protein Sciences Corp. (PSC) found itself on the front lines of the war against bioterrorism. The company makes proteins from cells derived from viruses and can grow them quickly and accurately.
In an interview with BNH published 30 days after the attacks, then-CEO (now Executive Chairman) Dan Adams revealed that the federal Centers for Disease Control (CDC) told the company that “We were the only ones who could make a vaccine to protect people against the pandemic flu in time to make a difference.”
In the interview Adams himself suggested that the deadliest threat might be not from bio-terrorism but rather a reprise of the “Spanish” flu pandemic that killed 50 million people worldwide immediately following World War I — more than three times the number killed in combat during what was to date the bloodiest conflict in human history.
Two years later that fear hit home nearly everywhere across the globe when the World Health Organization identified SARS as a new disease in 2003.
SARS spread rapidly and infected thousands of people around the world, including people in Asia, Australia, Europe, Africa as well as the Western Hemisphere..
SARS is caused by a member of the coronavirus family of viruses (the same family that can cause the common cold). It is now believed the 2003 epidemic started when the virus spread from small mammals in China, possibly initially infected by a bat.
By 2005 fear that another flu, Avian Flu virus (H5N1), would find its way to the U.S. Promising results by Protein Sciences in treating chickens against the flu convinced the FDA to put a PSC vaccine on the fast track.
It was a track that Adams had been hoping to move down since 1995. That’s when first contacted the board of Protein Sciences at a time when the Meriden bioscience company was struggling under the challenge of creating a vaccine for HIV/AIDS.
The company was short on funds and without a CEO when Adams, an experienced biotech entrepreneur, contacted the board. Adams had in 1976 founded and was CEO of drugmaker Biogen (now Biogen Idec, a $25 billion company) as well as three other biotechs.
The board told Adams they were seeking new capital and would look for a CEO after they raised the money. Adams responded that PSC would need a CEO first in order to raise money. Shortly thereafter Adams was named Protein Sciences’ new CEO.
Adams first decision was to jettison work on the HIV/AIDS vaccine. Although he believed the technology showed promise, the effort had been “mismanaged.”
While development of the AIDS vaccine was lost, the lessons learned in creating vaccines and growing proteins in a novel way were not.
Says Adams: “My philosophy was we’re going to patent around [the licenses, originally acquired from Texas A&M University], so when they expire we will own the field.”
In biotech to own something is to buy it first. And although the company's human trials for the FluBlok vaccine results were praised in scientific literature, the costs to the company were significant. According to current PSC CEO Manon Cox, “One clinical trial cost us $20 million alone.”
And while the reality that a truly deadly pandemic was possible and arising from “natural causes” was getting the attention of health officials, things were getting harder for PSC to fund operations and growth.
By 2007 the U.S. Department of Health & Human Services had committed $8.5 billion to address concerns of a pandemic flu through expanding existing vaccine facilities and funding new technologies.
However, much of that money continued to be directed to large pharmaceutical companies and much of that to traditional vaccine methods.
With a traditional vaccine a virus is grown and either killed or weakened so it won't transmit the disease. The body reacts to it and makes antibodies, which destroy the virus.
Cox says that traditional vaccine production is not up to the challenge of a true pandemic. “The process is long — it can sometimes take up to 12 months to identify and modify the viruses so that it will provide the correct immune response and can be grown in eggs,” she explains. Eggs are the traditional medium for creating vaccines and pose their own unique set of problems that can slow vaccine production.
The Protein Sciences approach is different. “It is pluck [a piece of genetic code from the virus] and play,” says Cox, and we use insect cells as production facility. Instead of giving people virus that has been killed we only give that part of the virus” that will generate antibodies in the human host.
In the event of pandemic Cox says it is much safer to work with as well. “Since we just use some genetic code which cannot cause disease, you don’t need to work with a [potentially] deadly virus that is pathogenic,” she says.
By starting with the known cause, Cox says PSC can literally have a workable vaccine in days not months.
Currently traditional vaccine manufacturing capacity would only meet a small fraction of worldwide demand for vaccine, and capacity for the Third World would be completely inadequate in the event of pandemic.
In 2008, Protein Sciences announced the sale of the company for $78 million as word of a major U.S. government contract surfaced.
The development would be funded and finished by the acquirer, Emergent BioSolutions of Rockville Md. Emergent provided immediate funding to shore up Protein Sciences, but the deal soon fell apart with acrimony and lawsuits a plenty.
In early 2009 H1N1 surfaced as a potential pandemic virus. Like many flus H1N1 started in birds and was transferred to pigs, which is why it was initially called swine flu. With pigs as hosts the flu became more suitable for transmission to humans.
Eventually more than 17,000 people worldwide would die, in part due to lack of supply of vaccines.
In 2009 PSC won a contract from the Biomedical Advanced Research and Development Authority of the U.S. Department of Health & Human Services for up to $150 million for the development, clinical testing and eventual manufacturing of its FluBlok vaccine. This June PSC received its second-round payment of $40 million.
As concerns of pandemic flu has spread globally, the company also received payments from its Japanese licensee, which recently signed a development deal with a Astellas, a major Japanese pharmaceutical company.
Adams says he’s been frustrated by the pace of final approval for the vaccine, but expects it within a few months.
It may come sooner if more folks see the current movie Contagion, featuring a deadly worldwide pandemic.