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Sandy Alfano, Expert in Pharmacy and Ethics of Human Subjects Research, Retires

May 23, 2024
by Christina Frank

Sandra Alfano, PharmD, became interested in pharmacy when she was 16 years old and working the front counter at a local drugstore in her hometown of Waterbury, Conn. “I very quickly became interested in the pharmacy aspects, so the owner took me under his wing,” Alfano says. “He had mentored about a dozen young people before me and modeled a very caring and careful healthcare provider.”

Alfano, research scientist (general internal medicine), Yale School of Medicine (YSM), and senior research analyst, Conflict of Interest Committee, Yale University, will retire in June. She won a Hospital Pharmacist of the Year award by the state of Connecticut Society of Hospital Pharmacists in 1993 and was inducted as a fellow of the American Society of Health System Pharmacists in recognition of sustained practice excellence in 1996.

After receiving her undergraduate degree from the University of Connecticut in 1978, Alfano earned a doctorate in pharmacy from Duquesne University in Pittsburgh, Pa. in 1980. She joined Yale New Haven Hospital (YNHH) that year, mentoring pharmacists as they transitioned from a role primarily responsible for dispensing medications, to a clinical practice role in which they were responsible for providing pharmaceutical care to patients in the hospital.

In 1998, Alfano became interested in the clinical trial arena and took over as director of the research pharmacy, a specialty pharmacy that handles all storage, preparation, dispensing, and accountability for YSM researchers conducting clinical trials on investigational drugs used in human research participants.

David Fiellin, MD, professor of medicine (general medicine) and director of the Program in Addiction Medicine, recalls developing a study with Alfano on the treatment of patients with opioid use disorder in primary care in 1998.

“There was less appreciation of the ravages of opioid use disorder and the importance of medication treatment for patients at the time, and certainly less appreciation of the need to expand access to places like primary care to provide treatment,” says Fiellin. “We were using a medication (buprenorphine) that had yet to be approved by the U.S. Food and Drug Administration, but Sandy was focused on providing this type of care and providing the medication to my nurses and to the patients in a very nonjudgmental, matter-of-fact manner. She wanted to make sure that we could do this for our patients and was very receptive if there were issues around patients who had maybe missed a dose or needed to come in for additional doses. She was just very, very accommodating and very thoughtful about the rigor of the study, all of which I really appreciated.”

Alfano’s growing interest in clinical trials led her to pivot away from pharmacy and into oversight of human subjects research. She had been a member of the Institutional Review Board (IRB), also known as the Human Investigation Committee (HIC), at YSM for 20 years, eventually becoming chair of the organization and joining the faculty in 2005. Her primary goal was advocating for ethical conduct in human subjects research.

One of the most exciting aspects of her role as chair, Alfano says, was having the opportunity to speak to colleagues in different institutions worldwide about how the United States approaches ethical research with humans.

“I was fortunate enough to get involved in international collaborations with colleagues in Russia, China, and Colombia, helping those folks understand the concepts of research ethics and how to build a program to protect human subjects in research. Other countries don't always have the same core values that we have. So, that really was a dance, but it was terribly interesting to me to learn of other practices and to visit other countries.”

Walter Kernan, MD, professor emeritus of medicine (general medicine), worked with Alfano on a landmark clinical trial on stroke prevention, called the IRIS (Insulin Resistance Intervention after Stroke) trial, from 2006 until 2016.

“At the time, this was one of the largest and most expensive clinical trials that the National Institutes of Health had funded at Yale,” Kernan says. “It involved 160 sites around the world, 4,000 patients, and a controversial drug. Sandy was our guide at the IRB throughout this complex project. Every week some new question came up about research ethics or research conduct for which we needed advice. I cannot imagine a more well-informed or generous partner at the IRB than Sandy.

“She was an extraordinary guide in the sense of leading us through the controversies and challenges of research ethics. She had an uncanny ability to help us find solutions to practical challenges that safeguarded patient interests and ethical imperatives.

She would say, let's figure out how we can protect patients, achieve the highest standards in ethics, and overcome your practical challenges. The work we do in research is very hard. The problems often seem intractable, and you need a partner like Sandy to help you figure out how to do it right without losing your mind.”

Cathleen M. Montano, JD, CIP, assistant director with the Human Research Protection Program (HRPP), calls Alfano “an incredibly well-informed scientific mind in our department. She was an expert in all kinds of biomedical research. As both an IRB member and IRB chair, she set a very high standard with her methodical preparation in her review of every submission that came through. She was a star in the HRPP.”

As a chair of the IRB’s biomedical panel, Alfano spearheaded an initiative to develop an injury policy in regard to human subject research. Subjects needed to be appropriately informed about coverage of costs should they sustain an injury during their participation that was related to the research, so it was clear whether or not the diagnosis and the treatment of that injury would be covered by a sponsor of the research or would be on the subject's own insurance or personal private payment.

“Sandy brought leaders from all walks of the medical school to join in the discussion and development of this policy,” Montano says. “It is dogma in our world, and it's due to Sandy having really put all of the necessary pieces together and bringing all the essential people together to agree on a position, including general counsel. It was a very thoroughly vetted process and a very well-crafted policy.”

Montano says Alfano was also very generous with her time as an educator. “She would give up her lunch hour for weeks on end in the summers to review with staff the materials that they need to prepare to sit for the certified IRB professional exam. And Sandy had a very high success rate with every staff member who went through her self-made program. She made the materials up and she just sat through and read through the regulations with the staff and drove home good examples for them to put in their heads to really, really understand the regulatory nature of our work.”

In 2018, Alfano took a part-time position as a senior research analyst on Yale University’s Conflict of Interest Committee. In this role, she worked with faculty who may have had outside financial interests that could potentially affect their objectivity when doing research.

“We set up a third-party resource to protect trainees who were working in the labs of faculty members who have outside financial interests,” says Jill Pagliuca, director of the Conflict of Interest Office. “Sandy was instrumental in writing the proposal for and then brainstorming how we could safeguard not only the objectivity of the research, but also ensure that students who were working in laboratories with faculty who hold significant outside financial interests were being protected as well.”

“Sandy has a strong ethical background. She has a talent for distilling very complex information and conveying it in a manner which is understandable. She met every challenge. I have enormous appreciation for Sandy. She was a force for good in this institution.”

The Department of Internal Medicine at Yale School of Medicine is among the nation's premier departments, bringing together an elite cadre of clinicians, investigators, educators, and staff in one of the world's top medical schools. To learn more, visit Internal Medicine.

Submitted by Julie Parry on May 23, 2024