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ICE IGERT Trainee Contributes to Product Development at Genzyme

Achievement/Results

Adhesions are post-surgical fibrous bands that form between organs as a result of the trauma caused by surgery. Organ tissues are very delicate and even the most minor contact can cause enough trauma to create adhesions. Once formed, adhesions can lead to many complications. They are the leading cause of small bowel obstruction and can also cause infertility and chronic pelvic pain. In order to remove the adhesions, the patient must undergo a second procedure where the surgeon physically detaches them. While effective, this method is undesirable as it causes additional pain for patient, incurs additional medical expense, and can lead to the formation of new adhesions.

Only two companies have developed biomaterials that are approved for use as adhesion barriers to prevent adhesion formation in open abdominopelvic surgical procedures. Genzyme Corporation’s adhesion barrier, Seprafilm®, was approved by the FDA in 1996 for open abdominal and GYN procedures. After a surgical procedure has been completed, Seprafilm® is wrapped around the traumatized organ(s), where it adheres and forms a gel that prevents adhesion formation. Within a few days, Seprafilm® is reabsorbed and eliminated by the body, leaving healthy tissue behind.

Seprafilm® is only approved for use in open abdominal and GYN procedures (i.e. procedures where the surgeon opens up the abdomen for direct access to the organs and exposing them to the operating room environment). As medicine progresses, many of the abdominal procedures once performed as open procedures are now being performed with a minimally invasive technique known as laparoscopy. During a laparoscopic procedure, the surgery is performed through small incisions with the aid of a camera. This procedure eliminates the need for the organs to be exposed to external environments and minimizes handling. While this reduction in handling has lowered the risk of adhesions, they do still occur. With the frequency of laproscopic procedures on the rise, the lack of an approved adhesion barrier has become problematic. The Biomaterials Science and Engineering group at Genzyme Corporation is addressing this unmet medical need through the development of an adhesion barrier for laparoscopic use.

During a six month graduate co-op at Genzyme, Erika Saffer (ICE IGERT trainee, chemical engineering) assisted in the development of this novel adhesion barrier product. Erika was responsible for introducing variation in the formulation of the material and investigating the resulting property changes through a series of in vitro experiments. The results of these experiments allowed for the selection of lead candidates for in vivo evaluation. During the in vivo studies, Erika was responsible for material formulation and support during the surgery. These studies were very useful to us as they allowed the team to see how the material applied and handled, as well as how the material performed as an adhesion barrier over time. These observations allowed researchers to identify some material characteristics that could be improved through changes in the formulation.

Through this co-op, Erika gained insight about how research is conducted in an industrial setting. Erika commented on her experience, “In contrast to academic research, industrial research is, understandably, very product driven. The goal of an industrial research team is to understand the product as best they can while moving it to market as quickly as possible. Knowing that the product I was working on has a chance to reach the market someday was a very gratifying experience for me. I also learned that industry relies on academic research labs for expertise in areas that could aid in the development and understanding of their products. The research I performed at Genzyme was very relatable to my PhD thesis research, which is focused on the development and characterization of hydrogels for biomaterial applications. This connection made the experience even more valuable for me, as it allowed me to see how the skills and techniques I have learned so far in my PhD program can directly translate to an industrial setting.”

Address Goals

The ICE IGERT program strives to train an interdisciplinary workforce at the interface of engineering and the life sciences that is poised to accept leadership positions in academia and industry. Erika’s industrial co-op highlights innovative workforce development programs enabled by the ICE IGERT program. During her time at Genzyme, Erika gained valuable experience contributing to a multi-disciplined technical team, applying her knowledge for product development, and exploring career path options for her own professional development.