Fighting infection post-surgery with an antibiotic gel, developing a meniscus implant for temporomandibular joint (TMJ) patients, and attacking skin cancer with a microneedle bandage were three of the latest four innovative medical technologies selected for funding through the Wallace H. Coulter Translational Research Partners II (TPII) Program (Coulter Program) this year at the University of Pittsburgh.
The Coulter Program, a campus-wide effort led by Pitt’s Swanson School of Engineering, identifies, selects, funds, and mentors translational research by clinician-bioengineer teams that address unmet clinical needs through innovative technologies. The University was awarded a $3.54 million grant from the Wallace H. Coulter Foundation in Fall 2011 (one of only six awards nationwide), supplemented by $1.665 million in matching funds from the University’s School of Medicine, Swanson School of Engineering, and Office of Technology Management.
This is the Coulter Program’s second year of funding at Pitt; the program launched last year with four inaugural medical technology awards. Twenty-five proposals were submitted for consideration during this round of funding.
“We are excited because these technologies have already generated promising early animal test results, are being patent-protected, have significant clinical and commercial potential, and would benefit from a business focus and a financial “push” toward commercialization,” explained Pratap Khanwilkar, PhD, MBA, professor of bioengineering at the Swanson School and Coulter Program Director. “The Coulter Program at Pitt is pleased to provide funding to these research groups in order to transfer these potentially ground-breaking technologies from the work bench to the bedside.”
Teams competing for Coulter Program funding are required to participate with Pitt MBA and law school students in a 4-month “From Bench Top to Bedside” course. This course is designed to teach researchers how to develop key deliverables such as a business model, business plan, product development plan, and investment pitch necessary to assess the clinical and commercial potential of each technology. The projects are then evaluated and selected by the Coulter Program’s oversight committee and mentored by advisors, comprised of clinicians experienced in translation, business leaders accomplished in medical device commercialization including regulatory affairs and reimbursement, large medical device company representatives, and local and national angel investors and venture capitalists.
The McGowan Institute for Regenerative Medicine affiliated faculty members’ projects funded include:
TheraGel: Prevent Infection of Implanted Devices
Bioengineering Co-PI: Yadong Wang, PhD, professor, Department of Bioengineering, University of Pittsburgh
Clinical Practitioner Co-PI: David Schwartzman, MD, professor of medicine, University of Pittsburgh
Summary: Despite best practices, infection of permanently implanted devices remains a serious problem post-surgery. Although uncommon, the ramifications of such infections are severe. Current products for infection prevention are cumbersome to use – which often complicates implantation – and have short release windows. New technologies to eliminate these problems would be of great human and economic value. TheraGel delivers high-dose antibiotics for a sustained period locally to a region encompassing a freshly implanted device. The in-situ gel solidifies upon tissue contact, conforms around the anatomical shape of the implanted device, and fills any voids, thus ensuring sterility and eliminating infection. Over the past year with the seed funding from Coulter TPII, the research team has demonstrated efficacy of the material in an animal model which mimics the human condition. Full TPII funding will be used to optimize TheraGel for this purpose and position it for commercialization.
MatriDisc: An Inductive, Scaffold-Based Device for Reconstruction of the TMJ Meniscus
Bioengineering Co-PI: Bryan N. Brown, PhD, assistant professor, Department of Bioengineering, University of Pittsburgh
Bioengineering Co-PI: Alejandro J. Almarza, PhD, assistant professor, Departments of Oral Biology and Bioengineering, University of Pittsburgh
Clinical Practitioner Co-PI: William L. Chung, MD, DDS, associate professor, Departments of Oral and Maxillofacial Surgery, University of Pittsburgh
Summary: Temporomandibular joint (TMJ) disorders affect more than 10 million Americans per year. For many patients, the only available treatment is removal of the joint meniscus, and there are no clinically effective options for replacement of the meniscus following removal. Matridisc is an “off-the-shelf” novel device for reconstruction of the TMJ meniscus. Particulate extracellular matrix (ECM) encased within sheets of ECM provides a resorbable interpositional “pillow” and an anchoring site to mimic the shape and size of the TMJ meniscus. With the seed funding from Coulter TPII, MatriDisc has become a fully developed and translation ready device in the past year. Currently, this project is preparing for a first-in-human clinical trial that will de-risk the opportunity to attract additional follow-on funding and commercialization partners.
Bioengineering Co-PI: Louis Falo, Jr, MD, PhD, chairman, Department of Dermatology, professor, Departments of Dermatology and Bioengineering, University of Pittsburgh
Clinical Practitioner Co-PI: Larisa Geskin, MD, associate professor, Department of Dermatology, director, Cutaneous Oncology Unit, University of Pittsburgh
Summary: Skin cancer is the most commonly occurring cancer in the United States. Fifty percent of the population after age 65 is expected to develop skin cancer, the majority diagnosed with Basal Cell Carcinoma (BCC). BCC occurs typically on the face, head, or neck and is a highly disfiguring disease. Current therapies involve invasive surgical procedures that are time-consuming, associated with patient recovery/morbidity, and are expensive. Skinject PatchITTM is a novel, single use, topical drug delivery patch that, like a common adhesive bandage, is applied to the affected skin of those diagnosed with skin cancer. Skinject PatchIT is based on a proprietary patent-pending Micro-Needle Array drug delivery platform that uniquely delivers a potent generic chemotherapeutic agent and modifier to kill existing skin cancer and induce an immune response to prevent the cancer’s re-occurrence. This project is ready to start human clinical trials at Pitt in two orphan indications, has confirmed high physician and patient acceptance from initial customer feedback, and has already received significant interest from several investors.
Illustration: University of Pittsburgh, Swanson School of Engineering.