Body
Unit Policy
Title
Eshelman School of Pharmacy: Center for Nanotechnology in Drug Delivery (CNDD) Bylaws
Introduction
Purpose
The purpose of this policy document is to establish the vision, mission, governance structure, membership criteria, and operational framework of the Center for Nanotechnology in Drug Delivery (CNDD) at UNC. It defines how the Center advances interdisciplinary research, education, and translation of nanotechnology-based drug delivery and diagnostic innovations to improve human health.
Scope
This policy applies to all CNDD members, leadership, advisory committees, and affiliated faculty and staff across UNC, partner institutions, and appointed adjunct or emeritus members who participate in or contribute to the Center’s activities.
Policy
1. Vision and Mission
Background. The need for the discovery and development of innovative technologies to improve the delivery of therapeutic and diagnostic agents in the body is widely recognized. The use of nanoscale technologies to design novel drug delivery systems and devices is a rapidly developing area of biomedical research that promises breakthrough advances in therapeutics and diagnostics. The “next generation” therapies must be able to deliver new and existing active pharmaceutical ingredients (APIs), biotherapeutic agents (e.g., proteins/polypeptides, nucleic acids) and vaccines to focal areas of disease or to tumors to maximize clinical benefit while limiting untoward side effects. Modern bioimaging technologies in combination with site-specific delivery of imaging agents in the body can detect and precisely map disease-affected cells and tissues, allowing monitoring the disease progression and the outcomes of therapies. Combining therapeutic and imaging agents in the single delivered species can allow simultaneous therapy and diagnostics (“theranostics”). The Center for Nanotechnology in Drug Delivery (CNDD) was established in June 2007 within UNC Eshelman School of Pharmacy. The CNND focus is to safely and efficiently translate new therapeutic and imaging agents from bench to bedside with the goal to improve human health.
The CNDD serves to unify existing diverse technical and scientific expertise in biomedical and material science research at the UNC through its world-class interdisciplinary drug delivery and nanomedicine program. Therefore, primary goal of the CNDD is to provide a foundation for synergistic research that translates into clinical benefits for diseases that currently have limited treatment options while simultaneously developing a critical and “visionary” area of science where the State of North Carolina is a world-leader.
Vision: To improve health by enhancing the efficacy and safety of new therapeutic and imaging agents through the discovery and application of innovative methods of drug delivery.
Mission – Discover, Integrate and Translate: Discover and apply nanotechnology and advanced drug-delivery systems to decrease the failure rate of new APIs, biotherapeutic agents and vaccines caused by poor absorption, or distribution, significant drug toxicity, and rapid metabolism or excretion. Integrate nanotechnology-based therapeutics with imaging and diagnostics to create "theranostic" interventions. Facilitate the translation of new molecular-entity discoveries into human clinical trials.
2. Center Membership
The Center is a multi-disciplinary, multi-departmental entity, involving faculty members who 1) share the vision and mission of the Center, 2) are appointed as the Center members, and 3) contribute to the Center’s work. The Center includes the following membership categories: Core Members, Adjunct Members and Emeritus Members.
2.1. Core Members
The Core Members are full-time faculty appointed from members from UNC, North Carolina State University (NCSU) and Duke University. The Center Core Members 1) conduct and promote nanomedicine and drug delivery research, 2) contribute to inter-, multi-, or trans-disciplinary collaborations, and 3) support new technology development, translation, education, training, and dissemination.
The Center Core Members are expected to:
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Actively participate in meetings, retreats, and symposia held by the Center;
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Actively participate in the Center internal review panels and other committees;
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Timely and accurate submit annual and special requests for research progress, other support, publications, and biosketches. Requests may come from the Center, program leaders, core facility leaders, and others. [Note: annual updates are not required of Adjunct or Emeritus members.]
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Create and maintain a research profile on the UNC CNDD website;
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List Center affiliation on curriculum vitae and biosketch; and
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Acknowledge membership and Center support (particularly from core facilities and pilot projects) in publications, abstracts, posters, and presentations.
Members (including Adjunct and Emeritus) receive discounted services (when available) and/or priority service at Center-sponsored core facilities. They also receive timely notification of the Center's seminars, symposia, and other events. A subset of members may participate in the Center's educational and translational activities. Members may apply for the Center’s developmental research project funding (when available).
At present, CNDD includes 23 Core faculty members from the following universities, schools and departments:
UNC:
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Division of Molecular Pharmaceutics, UNC Eshelman School of Pharmacy: Kristy M. Ainslie, Eric M. Bachelder, Elena Batrakova, Rahima Benhabbour, Shawn Hingtgen, Leaf Huang, Michael Jay, Alexander V. Kabanov, Sam Lai, Chris Luft, and Marina Sokolsky.
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Division of Chemical Biology & Medicinal Chemistry, UNC Eshelman School of Pharmacy: Rihe Liu, and Alex Tropsha
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William Zamboni
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Department of Chemistry, UNC College of Arts and Sciences: Joseph DeSimone
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Department of Ophthalmology, UNC School of Medicine: Han Zongchao
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Department of Radiology, UNC School of Medicine: Matthew Parrott
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Department of Radiation Oncology, UNC School of Medicine: Andrew Wang
UNC/NCSU:
Duke University:
2.2. Adjunct and Emeritus Members
The Center may also appoint Adjunct or Emeritus members, who normally, would also have an Adjunct or Emeritus faculty appointments in any of the academic units at UNC. Usually, Adjunct members are industry professionals or faculty members from outside of UNC, NCSU and Duke University, who have distinguished themselves in drug delivery and nanomedicine research, and have committed and demonstrated the ability to contribute to the CNDD goals. The Adjunct or Emeritus members of the Center can reside in the United States or abroad. Adjunct and Emeritus members of the Center have same expectations and benefits of membership as the regular members with the exceptions as indicated above.
At present, there are 6 Adjunct members:
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Tatiana K. Bronich of the University of Nebraska Medical Center, Omaha, NE
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Natalia L. Klyachko of the M.V. Lomonosov Moscow State University, Russia
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Robert Luxenhofer, Julius-Maximilians-Universität Würzburg, Germany
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Kazunori Kataoka of the University of Tokyo, Japan
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Aaron M. Mohs of the Wake Forest University – Virginia Tech School of Biomedical Engineering and Sciences, Winston-Salem, NC
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Judy Riffle, of Virginia Tech, VA
There are no Emeritus members at this time.
2.3. Center Members Appointment/Reappointment
All the above-cited Center members participate in the Center activities. Other faculty interested in drug delivery and nanomedicine will be encouraged to apply to become members of the Center. Each application will be evaluated based on the research interest, evidence of successful scholarly activity and potential to contribute to the Center’s goals. The CNDD director (see below) based on the recommendation of the Center Appointment/Reappointment committee makes new membership appointments or reappointments of the existing members. The Appointment/Reappointment committee includes at least three Center faculty members other than the CNDD director and is elected by the vote of the majority of Center faculty members. The Appointment/Reappointment Committee will review the individual memberships at five-year intervals. The Memberships of those who are not actively contributing to the Center’s goals will not be renewed. For the above-cited, Center members five years period starts from the date of approval of this document.
3. Center Administration and Budget
The CNDD is administered by the director, who is appointed by the Dean of the UNC Eshelman School of Pharmacy and reports to the Associate Dean for Research. At present, the director of CNDD is Dr. Alexander V. Kabanov, Mescal S. Ferguson Distinguished Professor, Division of Molecular Pharmaceutics, who reports to Dr. Alex Tropsha, the Associate Dean for Research, UNC Eshelman School of Pharmacy.
The Director provides the vision, leadership, scientific direction and expertise, and administrative oversight for the Center. The director is also principally responsible for the organization, administration, and development of the Center. This includes implementing the programmatic structure, taking the lead role in research, developing the CNDD core facilities, organizing symposia/workshops, mentoring junior scientists, attracting talented new scientists, and conducting outreach and marketing/public relation activities. The Center director, together with the management structure described below, should enable the Center to achieve the following goals:
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Establish a creative environment, cross-disciplinary synergy, innovation, and scientific excellence in basic and applied drug delivery and nanomedicine research;
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Provide an environment for continuous growth and development that will establish junior scientists as independent investigators and enrich research of established scientists;
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Strengthen existing programs and develop promising new areas of research for UNC and the State of North Carolina.
To assist the director in administrative and programmatic matters, an associate CDDN director(s) or deputy director(s) may be appointed by the Center director with the approval of the Dean. The Center director appoints the Internal and External Advisory Committees. These Committees will be established by spring 2015.
Internal Advisory Committee: This committee includes the scientific and administrative leaders at the UNC who will provide systematic internal evaluation of the Center’s operations and provide administrative advice and oversight. The Committee meets on a semi-annual basis, and then annually or on an as needed basis thereafter.
External Advisory Committee: This committee consists of external scientists representing the key areas of the Center’s research focus/activities. The Committee provides external oversight and an independent mechanism for assessment of the Center’s activities as well as an evaluation of the proposed Center’s research projects and core facilities. It also provides authoritative advice on strategic planning, allocation of resources, and targeting of emerging funding opportunities. The Committee meets annually and provides written critiques of the Center as part of the evaluation process to the Center Director.
The UNC Eshelman School of Pharmacy supports a full-time, 1 FTE position (salary and benefits) for an administrative/staff assistant to the Center. Other personnel including research faculty, postdoctoral scientists, core directors and staff members can be appointed by the Director in the Center. The appointments of the research faculty and postdoctoral scientists are administered through their home departments and/or laboratories. The UNC Eshelman School of Pharmacy pays the salary of the CNDD director, and Center faculty are paid by their respective universities/departments/units.
Additional administrative and operating expenses are borne by one or more of the following sources: director’s grants and contracts, Center operating budget, salary release dollars, and indirect cost recovery dollars. In addition, the Center is expected to apply for federal funding to support activities consistent with its mission. These includes, but are not limited to, Center grant(s), program project grant(s) and other sources of programmatic funding from the National Institute of Health (NIH) and/or other agencies and foundations.
4. Center Activities
The long-term goal of the CNDD is to become an independent, self-sustaining, nationally recognized center of excellence in the area of drug delivery and nanomedicine. This includes the development of a strong cadre of productive CNDD researchers who have the ability to obtain resources to sustain the Center. This will be achieved through successful mentoring of junior investigators as well as identifying potential faculty recruits, assisting the recruitment and development of new CNDD faculty members who have strong potential to make impactful contributions to the Center’s area of focus. Successful faculty development and recruitment programs will strengthen the proposed Center and the overall research enterprise at the UNC.
The successful Center will also develop a robust and diversified research portfolio in order to sustain a growing research program in its focus area in the conditions of the highly competitive landscape for federal funding. Toward this goal the Center will develop and/or actively participate in development and implementation of new research initiatives, pilot projects, and/or major proposals with potentially high impact. There would be a significant increase in the level of the extramural research support including NIH or other federal grants submitted by CNDD scientists. Another example of a mechanism to support the proposed CNDD research activities is through center and Program Project–sized grants and other program funding through the NIH or other agencies.
The Center will develop and implement strategies to increase funding success rates and better position its faculty members for success (e.g., roundtable discussions, grants-in-development sessions, mock reviews). A strong, cross-disciplinary program in drug delivery and nanomedicine with productive scientists and collaborations should increase the success rate of grant submissions. This, in turn, will strengthen the core facilities and further propel the School, University and campus-wide research initiatives. The successful research program focused on drug delivery and nanomedicine, development of new productive collaborations within the CNDD, support of these collaborations by the Center and other University core facilities, all will contribute to the accomplishment of the Center’s goals.
The Center will develop productive research collaborations and partnerships across several schools, institutes, and centers on the UNC campus, as well as other universities and institutions across the State. The Center will enhance research infrastructure at UNC by developing and supporting new research core facilities in its focus areas, developing and maintaining state-of-art instrumentation and services that help research of the CNDD faculty members and make impactful contributions to the research enterprise overall. The Center will actively engage in developing of formal partnerships and collaborative agreements with other institutions, the submission of consortia proposals (e.g., cooperative grants with industry), the submission of proposals with key partners in support of the initiatives of the UNC Eshelman School of Pharmacy.
The Center will greatly enhance the visibility and the national and international reputation of the UNC Eshelman School of Pharmacy in the CNDD research focus area. The Center will organize and support national and international conferences (such as the International Nanomedicine and Drug Delivery Symposium NanoDDS), research and educational or development workshops (such as Carolina Nanoformulation Workshop), and other research and educational events in the CNDD research focus area. The Center will establish itself and its various enterprises as the global brand and thereby will contribute to the global reputation of the UNC Eshelman School of Pharmacy as the World’s premier institution that will attract the best and brightest talent in the world in the area of nanomedicine and drug delivery.
5. Measures of Success
The specific measures/criteria of success will include number of research publications in peer-reviewed journals, book chapters and books written/edited, scientific presentations, and invited presentations by Center core faculty members number of patents filed and issued, number of grants submitted and funded, amount of research funding, program size, growth of requests for CNDD membership, formation, functionality, and practical use of the Center Core facilities, number of graduate students and post-doctoral scientists successfully trained, number of visiting scientists and guest speakers, conferences and meetings organized and other measures of success consistent with the Center’s mission. The contribution of the Center to the economy will be measured by the number of the patent applications, license agreements, and faculty-founded company per year resulting from the research of the CNDD members.
Contact Information
Primary Contact
Name: Kim L.R. Brouwer, PharmD, PhD, Interim Dean
Telephone: 919-966-1122
Email: esop_dean@unc.edu