June 2013 | VOL. 12, NO. 6 | www.McGowan.pitt.edu
NIH Grant to Improve Treatment of Wet Age-Related Macular Degeneration Received
The National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), awarded Qrono Inc. a Small Business Technology Transfer (STTR) Phase I grant for $256,000 to improve the treatment options for wet age-related macular degeneration (wet AMD) and fund further development of the company’s predictive modeling technology for the design of long-acting injectable (LAI) drug formulations. The research will be conducted in collaboration with The Little Lab at the Swanson School of Engineering at the University of Pittsburgh.
Headed by McGowan Institute for Regenerative Medicine faculty member Steven Little, PhD, chair of the Department of Chemical and Petroleum Engineering, associate professor, and Bicentennial Alumni Faculty Fellow of the University of Pittsburgh Swanson School of Engineering, the Little Lab explores synthetic drug delivery strategies that mimic those of cells and tissues in order to enhance (or alternatively endow new) biological functionality. To this end, researchers explore new ways to produce complex presentations of bio-active molecules over time and space. The mission is twofold. Specifically, researchers aim to utilize biomimetic delivery systems to achieve both: 1) enhanced therapeutic efficiency for future drug formulations (e.g. “medicine that imitates life”) as well as 2) understanding of basic biological processes that are otherwise obscured without engineering tools that can be tuned to replicate multi-modal cellular “language.”
Wet AMD is a leading cause of vision loss among older adults and can progress very quickly due to abnormal blood vessel growth behind the retina. Ranibizumab and bevacizumab are two drugs that target the proteins that cause this abnormal growth. However, because treatments with these drugs require a monthly eye injection, patient non-adherence (up to 67%) is a major problem. Qrono’s new LAI formulation for these drugs will reduce the injection frequency to once every 3 months or even 6 months which should improve patient adherence and thereby enable better patient outcomes.
Dr. Little said, “This grant will further enable research that builds upon our ongoing collaboration with Qrono. It is an excellent example of how an academic-industry collaboration can enable better medications.”
“We are grateful that the grant reviewers recognized the potential of our technology,” said Larry Zana, Qrono CEO & Co-Founder, “and we appreciate the support of NIGMS for this research.” The grant will also enable Qrono to demonstrate that its predictive modeling technology, called QronoMetricsTM, can be used to produce LAI formulations for a wide range of target pharmaceuticals in an unprecedented, rapid period of time. In Phase I, Qrono will develop LAI formulations for ranibizumab, bevacizumab, and two other active pharmaceutical ingredients. Upon successful completion of Phase I, Qrono will be eligible to apply for Phase II funding that will extend its predictive models to cover preclinical and clinical pharmacokinetic data.
QronoMetricsTM offers three key advantages in the production of custom controlled-release and microencapsulated systems:
- Removes the trial and error required by traditional design techniques, resulting in faster time-to-market, reduced development cost, and reduced risk.
- Reduced active pharmaceutical ingredient costs, up to 60% less.
- Critical parameters automatically identified for quality by design (QbD) manufacture.
Fully operational since 2012, Qrono Inc. is a specialty pharmaceutical company enabling better medications, h3er patient adherence, improved patient outcomes, and faster time-to- market for new medications using an innovative technology to create long-acting injectable (LAI) formulations. These long-acting drug formulations enable a single administration of active pharmaceutical ingredient to provide a therapeutic effect ranging from several days to many weeks or months. Our pipeline strategy focuses on LAI controlled release formulations of drugs with known safety profiles in therapeutic areas with either high non-adherence (e.g., antipsychotics and ophthalmology), or where LAIs can add therapeutic value (e.g., medical countermeasures and oncology).
SCIENTIFIC ADVANCES
McGowan Institute for Regenerative Medicine Has a Strong Presence at ASAIO Annual Conference
The American Society for Artificial Internal Organs (ASAIO) hosted the 59th Annual Conference in Chicago June 12 – 15, 2013. The Conference attracted over 600 attendees with a broad range of interests. This Conference included presentations from up to 350 speakers from more than a dozen countries. McGowan Institute for Regenerative Medicine affiliated faculty members and their representative PhD candidates presented many technical papers. Faculty members represented included (in alphabetical order):
- James Antaki, PhD, associate professor in biomedical engineering, Carnegie Mellon University
- Christian Bermudez, MD, associate director cardiothoracic transplant division of cardiac surgery, University of Pittsburgh Medical Center
- Harvey Borovetz, PhD, distinguished professor and chair in the Department of Bioengineering, Swanson School of Engineering, University of Pittsburgh
- William Federspiel, PhD, William Kepler Whiteford professor of chemical engineering, surgery and bioengineering, University of Pittsburgh
- Marina Kameneva, PhD, research professor of surgery, University of Pittsburgh School of Medicine
- Ergin Kocyildirim, PhD, assistant professor, Department of Cardiothoracic Surgery, University of Pittsburgh
- Mauricio Rojas, MD, assistant professor, Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, University of Pittsburgh
- William Wagner, PhD, director, McGowan Institute for Regenerative Medicine
- Peter Wearden, MD, PhD, assistant professor of cardiothoracic surgery, Children’s Hospital of Pittsburgh
The Conference is truly unique in that it provides a forum for individual researchers to present not only to fellow investigators, but also to members of industry and to government representatives who will be involved in regulatory affairs as the projects are developed into the production of clinical devices. The ASAIO Annual Conference provides continuing education for accreditation for physicians, nurses, and perfusionists.
The ASAIO 60th Anniversary Conference will be held in Washington, DC, June 18-21, 2014. Dr. Wearden is the program chair.
To view the abstracts from this year’s conference, click here.
Living Donor Kidney Transplants: Increasing the Number of Kidneys Available for Transplantation
Eleven years ago, McGowan Institute for Regenerative Medicine affiliated faculty member Ron Shapiro, MD, professor of surgery at the University of Pittsburgh and the Robert J. Corry chair in transplantation surgery at the Thomas E. Starzl Transplantation Institute, performed life-changing kidney transplant surgery on patient, Darian DeLuca of Westmoreland County. This year, Ms. DeLuca graduated from Kiski Area High School and when she received her diploma, she took a little part of her uncle, Greg George, with her. Mr. George was her kidney donor for this life-changing living-donor surgery.
Living donor kidney transplantation is a type of transplant in which a healthy kidney from a living person (the donor) is taken out and used to replace the unhealthy kidney of another person (the recipient). This procedure was the first type of transplant ever.
There are several benefits to having a living donor. With a living donor, the transplant is planned for a time when the person waiting for the kidney is in the best condition. From the day a person is first placed on the waiting list for a kidney transplant, he or she may wait 2 to 10 years to get a kidney from someone who has died. With a living donor transplant, there is no waiting.
Many studies have shown that recipients of a live donor kidney transplant have better outcomes than recipients of a deceased donor. A kidney from a living donor is placed into the recipient as soon as it is removed from the donor. This improves the chances that the kidney will function immediately. A kidney from a deceased donor may need to be stored many hours before it can be transplanted.
For the donor, there is the additional benefit of knowing that he or she has contributed to another person’s life in a very meaningful way.
Finally, living donor kidney transplants increase the number of kidneys available for transplantation.
Ms. DeLuca, who will need to take anti-rejection medicine for the rest of her life, has gained a deeper understanding and appreciation for the life-changing gift from her uncle in the years since the transplant.
“When I was little, I didn’t know what was going on except, when I was in dialysis, I remember my mom had to get rid of her cat,” she recalled. “I knew it was something serious because that cat was like my everything and she had to get rid of it because I was on dialysis and I wasn’t allowed around animals. I remember my dad, seeing all my family depressed and worried, is what really caused me to want to get better.”
McGowan Institute Welcomes New Affiliated Faculty members
The McGowan Institute Executive Committee appointed six new affiliated faculty members at their quarterly meeting in May. Please join us in welcoming them.
Jonathan Cheetham, VetMB, PhD, Diplomate ACVS is a Research Scientist at Cornell University. His major professional interests include the upper airway and orthopedic equine surgery and peripheral nerve repair, including restoring function in the larynx, nasopharynx and trachea using tissue engineering, reinnervation and functional electrical stimulation.
Nils Loewen, DMSC, MD, PhD is an Assistant Professor of Ophthalmology and the Director of the Glaucoma Section, Glaucoma Fellowship Program, and Electronic Health Records at the University of Pittsburgh Medical Center. Clinically, he specializes in glaucoma and cataract care. He focuses his research on bioengineering of the ocular outflow system to lower eye pressure.
Michael Oertel, PhD is an Assistant Professor in the Department of Pathology at the University of Pittsburgh. His research aims to identify the essential characteristics and properties of cells that effectively repopulate the liver and the tissue microenvironment conditions that foster repopulation by transplanted cells critical for developing liver repopulation protocols for future clinical application.
Justin Weinbaum, PhD is a Research Assistant Professor in the Department of Bioengineering at the University of Pittsburgh. He focuses his research on extracellular matrix (ECM) remodeling in the context of vascular tissue engineering and regenerative medicine. He employs a “cell-centered” approach for tissue engineering that exploits the cell-instructive properties of molecules in the native ECM known as matricellular proteins.
Kathryn Whitehead, PhD is an Assistant Professor in the Department of Chemical Engineering at Carnegie Mellon University. Her research focuses on engineering safe and effective drug delivery systems capable of achieving therapeutic outcomes in biological models and, ultimately, in humans.
Yong Yang, PhD is an Assistant Professor in the Department of Chemical Engineering at West Virginia University. His main research focus is on nano/micro devices and systems, and his interests are in stem cell technology, micro/nanotechnology, biomaterials, biomimetics, polymer thin film, and polymer nanocomposites.
Welcome to all!
AWARDS AND RECOGNITION
McGowan Institute Affiliated Faculty Member Selected for Innovation in Education Awards Program
McGowan Institute affiliated faculty member, Lance Davidson, PhD, professor and Wellington C. Carl Faculty fellow, Department of Bioengineering and Developmental Biology, University of Pittsburgh, is the recipient of one of seven Teaching Proposals for Innovation in Education Awards Program. His project, titled “Assessing the Flip: Reengineering a Large Lecture Course in Bioengineering,” aims to enhance the problem-solving and analytical skills of students. To do this, Dr. Davidson will “flip” the structure of the traditional course. Rather than straight lectures, students will study class materials online with the aid of several multimedia tools. Their class time will be spent developing critical-analysis. This project will be codirected by Carsten Stuckenholz, an adjunct instructor in the Department of Bioengineering and a research associate in the Division of Hematology/Oncology, School of Medicine.
The Innovation in Education Awards Program was established in 2000 and is designed to encourage instructional innovation and teaching excellence. The selection committee chooses proposals that show promise for introducing innovative approaches to teaching than can be applied in a variety of courses.
McGowan Institute Affiliated Faculty Member Receives 2013 Edison Awards Gold Medal
Eric Beckman, PhD, the George M. Bevier professor of engineering and co-director of the Mascaro Center for Sustainable Innovation within the University of Pittsburgh’s Swanson School of Engineering, has won an Edison Awards 2013 Gold Medal in the category of Surgical Aids for his work with TissuGlu® Surgical Adhesive—a product established from core technology developed at the University of Pittsburgh. The award, which recognizes excellence in new product and service development, marketing, and design and innovation, was announced April 26.
Dr. Beckman is cofounder of and equity holder in Cohera Medical, the developer of TissuGlu®—a product designed to reduce the need for surgical drains in plastic surgery procedures. It is resorbable, biocompatible for internal use, and forms a h3 bond between tissues. Dr. Beckman’s research encompasses two major areas: (1) the use of carbon dioxide as either a solvent or a raw material and (2) polymer chemistry and processing.
McGowan Institute Affiliated Faculty Member Participates in Provost’s Inaugural Lecture Series
Michael Boninger, MD, professor and Physical Medicine and Rehabilitation Endowed Chair in Pitt’s School of Medicine and director of the UPMC Rehabilitation Institute, described advances in assistive technologies in his presentation, “And the Winner Is … Reflections on Assistive Technology,” a part of the Provost’s Inaugural Lecture Series. In his presentation, he said now he believes physiatry, or rehabilitation medicine, is “the greatest branch of medicine” because it allows physicians to restore functional ability and quality of life.
Dr. Steven Little named the Society for Biomaterials Special Interest Group Representative
Steven Little, PhD, chair of the Department of Chemical and Petroleum Engineering, associate professor, and Bicentennial Alumni Faculty Fellow of the University of Pittsburgh Swanson School of Engineering, was named the Society for Biomaterials Special Interest Group Representative, a 2-year appointment. The Society’s Special Interest Groups provide a forum for networking and new ideas within a focused environment. Previously, Dr. Little served as the chair of the Drug Delivery Special Interest Group. The Society for Biomaterials is a professional society which promotes advances in biomedical materials research and development by encouragement of cooperative educational programs, clinical applications, and professional standards in the biomaterials field.
McGowan Institute Faculty Member Named ASME Chair
David Vorp, PhD, associate dean for research, Swanson School of Engineering, University of Pittsburgh, and the William Kepler Whiteford professor of bioengineering, with secondary appointments in the Departments of Cardiothoracic Surgery and Surgery at the University of Pittsburgh, was recently named the 2013-2014 chair of the Biomedical Engineering Division, American Society of Mechanical Engineers. ASME (founded as the American Society of Mechanical Engineers) promotes the art, science, and practice of multidisciplinary engineering and allied sciences around the globe.
McGowan Faculty Member Named Full Professor
Yadong Wang, PhD, effective May 1, was named a professor in the Department of Bioengineering, Swanson School of Engineering, University of Pittsburgh. Dr. Wang’s research focuses on creating biomaterials that present controlled chemical, physical, and mechanical signals to cells, tissues, and organs. The ultimate goal is to control how the human body interacts with these materials. He is especially interested in applications of biomaterials in the cardiovascular, nervous, and musculoskeletal systems.
Regenerative Medicine Podcast Update
The Regenerative Medicine Podcasts remain a popular web destination. Informative and entertaining, these are the most recent interviews:
#124 – Dr. Jonathan Cheetham is a Research Scientist at Cornell University. Dr. Cheetham discusses his research restoring function in the larynx, nasopharynx and trachea using tissue engineering, reinnervation and functional electrical stimulation techniques.
Visit www.regenerativemedicinetoday.com to keep abreast of the new interviews.