University of Michigan
The University of Michigan is one of the best public research universities of the United States and a leader in higher education.
Permeating all 19 Schools and Colleges, research is central to the University of Michigan’s mission and comprises nearly $1.3 billion in annual expenditures. The University of Michigan is a strong advocate of promoting collaboration and interdisciplinary research initiatives that involve faculty and students across campus.
Since 1817, the University has provided a national model of a complex, diverse, and comprehensive public institution of higher learning that supports excellence in research, provides outstanding undergraduate, graduate, and professional education, and demonstrates commitment to service through partnerships and collaborations that extend to the community, region, state, nation, and around the world.
The University's mission directs the institution “to serve the people of Michigan and the world through preeminence in creating, communicating, preserving and applying knowledge, art and academic values, and in developing leaders and citizens who will challenge the present and enrich the future."
The University serves its student body of more than 44,000, retains an eminent faculty of 7,200, and its libraries hold more than 14 million volumes. Michigan's excellence in higher education rests on the outstanding quality of its schools and colleges, fourteen of which accept undergraduate students, as well as on national recognition of individual departments and programs and on the many major scholarly and creative contributions of its faculty.
More than 100 of its graduate programs are ranked Top Ten in their fields, indicating a remarkable breadth and depth of excellence. Michigan is a national leader in securing private sector support from its friends and alumni; it has more than 540,000 living alumni around the world. The University is governed by an elected Board of Regents, each member of which is elected to an 8-year term (without term limits). Dr. Mark S. Schlissel is President of the University.
Excellence in Patient Care, Medical Education and Research
Michigan Medicine (MM), formerly the University of Michigan Health System, is home to one of the largest health care complexes in the world. It has been the site of many groundbreaking medical and technological advancements since the Medical School first opened in 1850.
Nationally Ranked Healthcare in 15 Specialties
Today, Michigan Medicine continues to deliver the Michigan Difference through cutting-edge research and premier patient care. According to U.S. News and World Report, we’re among the best in the nation in a broad range of adult and pediatric specialties. We’ve earned national recognition from other hospital-quality organizations, too.
Michigan Medicine, is one of the largest hospitals in Michigan and a premier academic medical center made up of:
- U-M Hospitals, Health Centers and Clinics
- University of Michigan Medical School and its Faculty Group Practice
- Clinical activities of the University of Michigan School of Nursing
- One of the nation’s largest biomedical research communities
- Michigan Health Corp. - the legal entity that allows the Health System to enter into partnerships, affiliations, joint ventures and other business activities.
Michigan Medicine’s vision is to create the future of health care through discovery and to become the national leader in health care, health care reform, biomedical innovation and education.Linkages with other health care and nonprofit institutions foster better care, research, and education in Michigan and beyond. These affiliations include: MidMichigan Health,Trinity Health-Michigan, VA Ann Arbor Healthcare System, Blue Cross Blue Shield of Michigan, Sparrow Health Systems, Pennant Health Alliance, Physician Organization of Michigan, Radiation Oncology Network, Crittenton Hospital (cardiac surgery), four rehabilitation facilities, Paradigm (international genomics consortium), the Regional Alliance for Healthy Schools (public schools), and Hurley Medical Center (emergency & pediatric care, dialysis).
Michigan Medicine is creating health care innovation through discovery. According to the U-M Office of Research, the total amount of research expenditures for the Medical School and School of Nursing in FY 2016 was $541.4 million, the vast majority of which is funded by external sponsors. The number of invention disclosures from the Medical School/Michigan Medicine during this same time frame was 169. As a major employer, center for research, and hub for training health and science professionals, Michigan Medicine impacts the local, state and U.S. economies in many ways.
The University of Michigan hospitals are among the safest and most effective hospitals in the country, according to a national ranking from the Leapfrog Group, a respected independent health care quality rating organization. Only two hospitals in the country, including MM, have earned these quality designations simultaneously: an “A” grade from the Hospital Safety Score system since 2012, a place on the Leapfrog Group’s Top Hospitals list, and designation as one of Truven Health’s 100 Top Hospitals. MM has more than 500 physicians named to the 2015-16 Best Doctors in America list, compiled by the Boston-based Best Doctors Inc. In July 2015, the annual U.S. News and World Report survey of hospitals ranked U-M as the No. 1 hospital in Michigan and 11th Best Hospital in the nation. MM placed in the national top tier in 15 of 16 adult specialty areas, with 11 specialty areas increasing their rankings from the previous year’s list; Urology and Ophthalmology both ranked in the Top 10 nationwide. The same year, C.S. Mott Children’s Hospital was the only hospital in Michigan to be nationally ranked in all 10 pediatric specialty areas. The rankings are based on a compilation of data points that serve as indicators of a hospital’s performance in patient safety, specialty-specific performance, survival of patients, nurse staffing and reputation. This is the 24th year in a row that MM has been recognized for strong across-the-board performance on a national level. Additionally, MM has the fourth-largest residency program in the U.S. In 2015, U-M residency programs earned a No. 6 national ranking and a top spot in all ranked specialties. In 12 of those specialties, U-M ranked in the top 10. In the Midwest region, MM ranked No. 1 in five specialty areas, including dermatology, family medicine, otolaryngology, psychiatry and surgery. These rankings were compiled by the physician network Doximity and U.S. News & World Report. For more than 140 years, the University of Michigan has operated both health care facilities and a medical school. Major health initiatives include the Michigan StrokeNet coordinated by the UMMS Stroke Program, where nine hospitals in Southeast Michigan form one of 25 regional stroke networks across the nation funded by NIH to streamline stroke research. The UM Comprehensive Cancer Center is one of 41 centers designated "comprehensive" by the National Cancer Institute and one of 23 institutions that make up the National Comprehensive Cancer Network, which sets national guidelines for consistent, high-quality and cost-effective cancer care.
The MM is situated on 128 acres with more than 52 buildings constituting 6.2 million gross square feet of space, located just north of the University's central campus. In 2016, MM’s three hospitals, 40 outpatient locations (with more than 150 clinics), and extensive home care operations handled 2.3 million visits and more than 45,400 inpatient hospital stays. With an operating budget of $3.3B in FY15, the University of Michigan Hospitals and Health Centers (UMHHC) are fully self-supporting and do not receive funding from the State of Michigan’s General Fund. UMHHC's financial stability also is reflected in its excellent bond ratings with both Moody's Investors Service Inc. and Standard & Poor's. This bond rating is among the highest in health care systems across the industry and reflects a strong and sustainable financial position. The annual activity of MM in FY16 includes: Total licensed beds: 1,000; Clinic locations and offices throughout Michigan: 150+; Inpatient Discharges: 48,793; Observation Cases: 17,827; Outpatient Visits: 2.1 million; Emergency Services/Urgent Care Visits: 104,219; Surgical Cases: 54,342; Survival Flight Missions: 1,227; Deliveries: 4,400. Faculty, staff and students for FY16 include: total faculty and staff: over 26,000; FTE faculty members: 2,700; FTE nurses: ~5,000; medical students: 708; graduate students: 588; postdoctoral fellows: 604 residents and fellows: ~1,200.
U-M Medical School
The University of Michigan Medical School began in the year 1850 with five faculty members, 90 students, and five physicians seeking additional training. The School currently has 3,514 faculty members teaching 708 medical students, 1,190 interns and residents, 588 graduate students, and 604 postdoctoral fellows, as well as other groups of learners. The Medical School offers three faculty tracks: Instructional Track (906); Research Track (325); and Clinical Track (1,144). Additionally, the School has 315 clinical lecturers/lecturers.
The University has had notable "firsts" in medicine: it was among the first of the state-supported universities to have a medical school (1850), it had the first teaching hospital owned by a university (1869), and it had the first university department of roentgenology (1917). Given these circumstances, teaching and research were early priorities. Medical School alumni include Nobel Prize winners, a former U.S. Surgeon General, leaders of Fortune 500 companies, and faculty at the best educational and research institutions around the world. With 20,600 alumni, the School is second in the nation in the number of alumni who are faculty members at academic institutions across the country. Thousands of University of Michigan Medical School graduates provide the highest quality of care to patients in the United States and throughout the world. Today the Medical School graduates approximately almost 200 physicians annually and is consistently ranked as one of the top institutions in the nation. In US News & World Report's 2016 Best Medical Schools rankings, the University of Michigan Medical School placed #5 for primary care and #10 for research. The Medical School has 20 clinical and nine basic sciences departments, as well as the Unit for Laboratory Animal Medicine. Teaching, research, and clinical care often cross traditional departmental boundaries, particularly in the School's 39 interdisciplinary research centers and institutes, including the Comprehensive Cancer Center, the Geriatrics Center, the Cardiovascular Center, and the Michigan Institute for Clinical and Health Research.
Faculty members lead research efforts in a broad scope of basic and clinical science areas. In FY2016, the Medical School received $520.5 million in awards from all external sponsors. Annual NIH grant funding awarded to the School's clinical researchers and biomedical scientists reached $310.6 million in FY2016, which places UMMS 10th of medical schools in the nation in terms of NIH grants awarded (2.6% of the market share). In FY 2016, Medical School researchers filed a record-breaking 169 reports of new inventions with the U-M Office of Technology Transfer, and the Medical School was awarded a total of 43 new patents.
In 2013, a Fast Forward Medical Innovation initiative, led by Dr. Kevin Ward, was created to unify Medical School efforts to nurture commercialization and entrepreneurship activity in close collaboration with U-M Technology Transfer. The initiative integrates activities of the Office of Research's Business Development group and the MTRAC for Life Sciences commercialization fund with partners across campus, such as the College of Engineering's Center for Entrepreneurship and the U-M Business Engagement Center.
In addition to their work in research and education, faculty in clinical departments provide inpatient and outpatient care within Michigan Medicine (MM), which includes three major hospitals and multiple health centers and outpatient clinics. MM provided 2.1 million outpatient visits and more than 48,800 hospital discharges in FY2016. The Medical School's physical plant is comprised of 64 buildings (including 26 at the North Campus Research Complex), encompassing 4.1 million square feet.
Michigan Institute for Clinical & Health Research (MICHR)
The Michigan Institute for Clinical & Health Research (MICHR) strives to enable and enhance clinical and translational research by educating, funding, connecting, and supporting University of Michigan (U-M) investigators. MICHR’s ultimate goal is to accelerate the translation of scientific discoveries, resulting in improved health for local, national, and global communities. MICHR provides U-M researchers with the training, tools, and services necessary to speed discovery of new ways to diagnose, treat, and prevent disease. Specifically, MICHR develops research talent through its predoctoral and postdoctoral education programs; helps investigators launch their ideas through pilot grant funding and consultation; connects researchers with community groups, clinics, practice-based networks, and potential study volunteers; and supports research teams with clinical research management services, including biostatistical design and analysis, study management and monitoring, data management, a clinical trials office for industry partnerships, and a fully-equipped and professionally-staffed clinical research unit. U-M established MICHR as a centralized resource to transform translational research in 2006, and a NIH Clinical and Translational Science Award has supported MICHR since 2007.
MICHR Facilities and Resources at the North Campus Research Complex
MICHR occupies 26,000 square feet of office space in a single-story building that is part of the North Campus Research Complex. The MICHR administrative space includes six shared meeting rooms that accommodate 50 or more people, a fully equipped training room that accommodates 40 people, and multiple small meeting rooms that may be used for interviews and short video production. MICHR shares the North Campus Research Complex with the IRB, administrative offices for both U-M’s and the Medical Schools’ Offices of Research, the clinical trials office of the U-M Comprehensive Cancer Center, the U-M Office of Technology Transfer, and the U-M Business Engagement Center, creating a hub for clinical and translational research administration. Housing these resources in such close proximity fosters an unprecedented level of communication, collaboration, and sharing of best practices between these units.
MICHR PROGRAMS & SUPPORT SERVICES
Education and Mentoring Group (EMG):
MICHR’s Education and Mentoring Group (EMG) provides multidisciplinary education, career development, and mentoring programs for members of clinical and translational research teams across U-M. Offerings include: 1) mentored research programs including (1a) the Mentored Clinical Scientists Career Development Program (MICHR K), (1b) the Postdoctoral Translational Scholars Program, (1c) the Practice-Oriented Research Training program for clinical staff and faculty, and (1d) a pre-doctoral Summer Immersion program; 2) educational and training initiatives including (2a) clinical trials training for faculty and staff, (2b) mentoring education and training, and training in (2c) scientific writing and (2d) research methods; 3) degree and certificate programs including (3a) the Master of Science in Clinical Research and (3b) the Translational Research Education Certificate; 4) research and evaluation studies to demonstrate the impact of our competency- based approach to education; and 5) consultation to other U-M units regarding educational initiatives.
EMG Facilities and Resources: EMG has a number of resources that facilitate educational content development and provide faculty, trainees, and mentors with an enhanced learning and teaching environment. Specifically, EMG has multimedia production software, a video camera, and audio recording equipment available for developing digital learning content. In addition, the North Campus Research Complex has a multimedia studio that can accommodate and facilitate webinar production and presentation, remote meeting access, and blended-learning training techniques that combine online and face-to-face instruction.
Pilot Grant Program (PGP)
MICHR’s Pilot Grant Program (PGP) offers funding to facilitate and support innovative research across the translational spectrum. PGP encourages interdisciplinary collaborations that promote the development of transformative solutions for improving patient and community health outcomes. PGP funds three research approaches (investigator initiated, collaborative, and community-based participatory research) across the different phases of translational research (bench-to-bedside, beside-to-practice) for a variety of investigators (basic, clinical, and social scientists and community partners).
Research Development Core (RDC)
MICHR’s Research Development Core (RDC) offers no-cost consultation and grant editing services to investigators during all stages of proposal development. During consultations, the RDC team advises on hypotheses, specific aims, study design, biostatistics, future research directions, and grantsmanship; matches research ideas with funding sources; and suggests potential collaborators and mentors. RDC’s grant editors review proposals and provide edits to strengthen clarity, flow, and grammar. In the past five years, RDC has provided support for 406 grant proposals and research ideas resulting in >$51M in external funding.
MICHR’s Biostatistics Group offers consultation, collaboration, and mentoring throughout the lifecycle of a study. Services include grant proposal development, protocol development, study implementation, and manuscript development. MICHR’s faculty and staff biostatisticians provide expertise in research design, randomization scheme development and implementation, data analysis planning and implementation, data quality assessment, and database review. Consultations are free of charge. Biostatisticians will serve as study co-investigators, team statisticians, or statistical analysts for a fee.
Communities Engagement (CE) Program
MICHR’s Communities Engagement (CE) program provides consultation, education, and funding to support research projects in community and practice-based settings. CE services and funding are available to a broad base of partners, including academics, community members, health providers, and others engaged in collaborative research efforts to improve community and population health. MICHR also maintains a strong, active council of community partners who work together to foster university-community research partnerships and facilitate specific community-engaged research projects.
Participant Recruitment Program
MICHR’s Participant Recruitment Program provides an array of services for research teams needing support to recruit, enroll, and retain participants. The Recruitment Program offers consultations to faculty and other clinical research team members and can conduct recruitment analysis and strategic planning. This includes developing robust recruitment plans, creating timelines, and estimating costs. The Recruitment Program also maintains UMClinicalStudies.org, which provides research teams with a database of >25,000 individuals interested in research participation. The database recommends studies to participants on topics of interest to them and recommends participants to research teams based on participants’ responses to health profile questions.
Clinical Research Informatics (CRI)
MICHR’s Clinical Research Informatics (CRI) team consists of staff who have specialized knowledge and experience in clinical research systems and processes. CRI develops, implements, and supports cutting-edge informatics software for clinical research investigators and currently provides researchers with three electronic data capture and clinical data management tools. The first, Research Electronic Data Capture (REDCap), is a secure web-based application that provides an intuitive interface for data entry, audit trails, automated export and import procedures, and advanced features such as branching logic and calculated fields. The second, V-OC OpenClinica® Enterprise Edition™, is a web-based application that is validated and compliant with regulatory requirements and other standards, which researchers can use by engaging MICHR data managers. V-OC is recommended for single or multi-site clinical research projects. The third, Mi-OC OpenClinica® Enterprise Edition™, is the non-validated version of OpenClinica that researchers can use to build and manage their own databases. Mi-OC is recommended for data that will not be used to support a new drug or device submitted to the FDA, federally contracted clinical trials, or industry-sponsored trials.
MICHR IND/IDE Investigator Assistance Program (MIAP)
The MICHR IND/IDE Investigator Assistance Program (MIAP) provides comprehensive regulatory support, guidance, and education services to investigators involved in Food and Drug Administration (FDA) regulated clinical research. MIAP's primary focus is providing regulatory assistance to sponsor-investigators of drugs, biologics, and medical devices. This includes Investigational New Drug (IND) and Investigational Device Exemption (IDE) services such as: regulatory needs assessments; exemption rationale development; assistance with FDA meeting preparation; assistance with IND and IDE application submissions, including protocol and informed consent development assistance for regulatory compliance, document preparation, and FDA contact and correspondence; sponsor investigator training; and ongoing study assistance, including safety reporting, FDA annual report preparation, protocol amendments, and IND/IDE closeout.
Clinical Research Management (CRM)
MICHR’s Clinical Research Management (CRM) group provides the highest quality operational and regulatory support for single and multi-center clinical studies in accordance with Standard Operating Procedures, Good Clinical Practice, and appropriate regulatory requirements. The CRM team includes Certified Clinical Research Professionals with experience in both clinical research and project management. CRM assists investigators with database development, in which a team of skilled developers work with study teams to design project databases built for efficient collection, management, and analysis of research data. CRM also provides study monitoring services for clinical trials, including IND/IDE required monitoring services; site initiation, interim, and close-out visits; pre- and post-audit reviews; and NIH/DoD preparation visits. In addition, CRM provides study teams with mentoring focused on data management and study management.
Michigan Clinical Research Unit (MCRU)
The Michigan Clinical Research Unit (MCRU) provides the resources and infrastructure necessary to conduct human clinical research protocols at U-M. MCRU’s clinical core services and physical facilities provide investigators access to research nurses, medical assistants, and lab personnel. MRCU also provides MCRU2U, a mobile research service, for clinical study teams. The mobile team supports simple protocol-specific services such as blood draws and ECGs throughout UMHS, at participants’ homes, and at other locations within an hour of the U-M campus.
MCRU Facilities and Resources: The main performance site for MCRU is in the U-M Medical School’s Cardiovascular Center (CVC) located at the center of the U-M Medical Campus. The MCRU facility comprises approximately 7,400 square feet of space, including research-only outpatient examination rooms, research-only overnight stay beds in private rooms, and administrative offices. This location also houses a research exercise physiology area, a procedure room, a nursing workspace, a medical preparation and storage room, a patient/subject intake area, an equipment storage space, clean holding rooms, a principal investigator and study coordinator workroom, a staff locker room, a metabolic kitchen, a specimen processing laboratory, a patient waiting area, and a dining area for participants.
MCRU’s Outpatient Clinical Research Unit is located in the Domino's Farms extension approximately four miles from the medical campus in northeast Ann Arbor. This unit houses 10 exam rooms, including a research physiology room. All aspects of the unit are compliant with the Joint Commission on Accreditation of Healthcare Organizations. Shared space includes a waiting room, patient carrels, a patient intake area, an equipment room, a double secure-locked documentation room, an audit/exam room, a patient food preparation room, a staff kitchen, patient showers, and handicap accessible bathrooms. A 140 square-foot wet laboratory is contiguous with the patient facility. It contains two tabletop centrifuges, computers with internet connection for follow-up on patient laboratory values, a label printer for blood draws, and supplies for drawing blood and preparing aliquots for storage. The laboratory also contains a small specimen refrigerator, two -86° specimen freezers, and one -20° specimen freezer.
Institute for Healthcare Policy & Innovation (IHPI)
The Institute for Healthcare Policy and Innovation (IHPI) is a campus-wide institute that was approved by the University of Michigan Board of Regents in 2011. IHPI’s mission is to enhance the health and well-being of local, national, and global populations through innovative, interdisciplinary health services research. IHPI defines health services research broadly to include all scholarly work relevant to the structure, practice, utilization, cost, quality, equity, and community outreach of healthcare. The Institute’s priorities include evaluating the impact of healthcare reform, promoting greater value in healthcare, improving the health of communities, and creating innovations in healthcare information technology and processes of care.
IHPI encompasses more than 20 partner research groups focusing on a diverse array of issues such as cancer surveillance and outcomes, health communications, value-based insurance design, chronic disease management, mental health, patient safety, injury prevention, child health, healthcare engineering, bioethics, social sciences, clinical outcomes, health policy, disease-specific research, and women’s healthcare. IHPI provides the venue and resources to bring these groups together to accelerate knowledge and inform public and private efforts to optimize the healthcare experience for patients, providers, and payers.
With over 500 individual health services researchers from across the University, as well as several nonprofit and private-sector collaborators, IHPI’s membership forms one of the nation’s largest communities of physicians, nurses, other clinical and public health professionals, health and social scientists, economists, and policy analysts dedicated to studying how health care works and what can be improved. IHPI members lead multiple statewide collaborative quality initiatives (CQIs). These CQIs seek to address health care safety and quality for some of the most common, complex, and costly areas of surgical and medical care, including kidney and heart disease, surgical and nursing care, children’s health, mental health, and healthcare cost, quality and access issues. IHPI members represent 14 University of Michigan Ann Arbor schools and colleges, 2 University of Michigan Institutes, and 2 University of Michigan Flint and Dearborn schools and colleges. 67% of members are affiliated with the Medical School, 14% with the School of Public Health, 5% with the School of Nursing, and 14% from the other schools and colleges.
In 2012, IHPI opened an administrative home at the University of Michigan’s North Campus Research Complex (NCRC) to facilitate even greater collaboration among researchers. IHPI’s footprint at NCRC includes more than 85,000 square feet of space that supports multidisciplinary interaction, and includes formal and informal collaboration spaces and cutting-edge, information-sharing technologies. Currently, over 400 IHPI members, staff, and trainees are located in IHPI space at NCRC.
Core services to support and enhance the research and dissemination capacity of all IHPI members include 1) access to big data, technical assistance, and analytical expertise through the Data and Methods Hub, 2) communications and policymaking support through the Impact Accelerator, and 3) education and training programs and services available to faculty and students. In addition, the IHPI Strategic Initiatives Catalyst was launched in 2016 to help identify, evaluate, prioritize, implement, and provide management and administrative support for signature projects aligned with IHPI’s strategic priorities in research/evaluation and education/training. Initiatives currently in progress or at various stages of development include: evaluation of the Michigan Medicaid expansion (Healthy Michigan); implementation of a neighborhood-based community health worker demonstration project in Detroit; exploration of ways to enhance value and appropriateness of care within the University of Michigan Health System, and influence national policy; launch of the National Poll on Healthy Aging; and strategies for addressing the opioid epidemic in Michigan.
John Z. Ayanian, M.D., M.P.P., Director
The University of Michigan
North Campus Research Complex
2800 Plymouth Road
Ann Arbor, MI 48109-2800
Fast Forward Medical Innovation (FFMI)
With 422 invention disclosures and 160 issued patents in 2015, U-M has tremendous potential to create a positive impact on human health and society. To facilitate the translation of discoveries to impact, the Fast Forward Medical Innovation (FFMI) program was established in 2014 to accelerate the transformation of biomedical innovations into patient and health impact. While the number of academic medical center innovation programs around the nation is growing, FFMI remains unique in its integration of 1) product development funding and mentorship through an “Innovation Navigator” Program, 2) industry engagement via a business development team, and 3) innovation and commercialization education. The combination of these strategically integrated programs enables FFMI to build and nurture a culture supportive of biomedical innovation with the goal of accelerating new products coming to market as well as to catalyze clinical-translational scientists to think differently about their research.
FFMI's FOUR KEY STRATEGIES
FFMI Funding & Mentorship programs provide milestone-driven innovation, commercialization funding, and expert mentorship.
FFMI offers consultation for multistage technology development, funding, and mentorship for successful commercialization of biomedical discoveries, across U-M campus and also as a statewide biomedical Innovation Hub. Fast Forward Medical Innovation offers researchers a number of funding opportunities to help advance biomedical research projects. From the statewide MTRAC for Life Sciences Innovation Hub to U-M internal funds, resources, and personalized funding consultations, FFMI gives researchers valuable guidance and support as they navigate the path to successful commercialization.
FFMI Commercialization Education: Programs Accelerating Commercialization Education (PACE)
Whether you’re a med student, fellow, clinician, or seasoned researcher, PACE from Fast Forward Medical Innovation offers a broad spectrum of innovation and commercialization educational opportunities. PACE provides valuable mentorship and will give you a deep, real-world understanding of strategy and tactics helping you gain valuable insight into successfully translating your research to market.
FFMI Business Development
Every day, stakeholders across healthcare are forming novel partnerships in an effort to accelerate new technologies to market. Fast Forward Medical Innovation Business Development team members are alliance managers, building and executing successful relationships between U-M Medical School researchers and their potential corporate partners. By using creative partnering methods, including precompetitive consortia, sponsored research, and co-development, the team connects collaborators and works with them to navigate the system and take translational research to a successful outcome.
FFMI Statewide Innovation Hub
The Michigan Translational Research and Commercialization for Life Sciences Innovation Hub is a statewide program supporting translational research projects in life sciences with high commercial potential, with the ultimate goal of positively impacting human health. Innovators from all schools at the University of Michigan, other institutions of higher education, non-profit research centers, and hospital systems across Michigan are eligible to submit projects for funding consideration. The program offers early-stage funding opportunities through Mi-Kickstart, and Mi-TRAC is our funding program for mid-stage commercialization projects. MTRAC for Life Sciences Innovation Hub/Mi-TRAC/Mi-Kickstart have awarded millions of dollars in funding since launch. CLICK HERE to see our Project Awards.
The MTRAC for Life Sciences Innovation Hub is co-managed by the U-M Medical School’s Fast Forward Medical Innovation Program and U-M Tech Transfer. It has an operating budget of $4.05M, with half of the funds coming from the State of Michigan’s Michigan Strategic Fund (MSF) and the remainder coming from participating institutions. The program reinforces the commitment of the MSF, the Michigan Economic Development Corporation, and the U-M to entrepreneurship as a dynamic catalyst for economic growth, allowing for greater collaboration and ultimately increasing the number of start-ups, jobs, industry licenses, and investment for Michigan.
The Central Biorepository (CBR), a unit of the University of Michigan Medical School Office of Research, is state-of-the-art research infrastructure with a mission to facilitate discovery and improve healthcare outcomes by providing high-quality, highly annotated biospecimens donated for basic, clinical and translational research. The CBR meets and exceeds biospecimen best practices described by the International Society for Biological and Environmental Repositories and is accredited by the College of American Pathologists (CAP) Biorepository Accreditation Program.
The repository is populated through CBR partnerships with investigators, departments, centers, and institutes that collect biospecimen resources for their own research and commit to sharing samples for additional, approved research uses. Michigan Medicine patients enrolled in CBR programs provide consent for broad use of biospecimens, as well as controlled access to clinical data contained within the electronic health record.
Biorepository processes are included in a quality management system (QMS) to ensure maintenance of specimen integrity for the duration of the storage. The QMS includes version-controlled standardized operating procedures, scheduled and documented equipment calibration and maintenance, internal audit procedures, information systems backups, and personnel training programs with competency testing. Sample chain of custody is secured and tracked throughout the life cycle of the biospecimen using barcodes and a commercially available laboratory information management system (LIMS) tailored to meet UMMS needs. Frozen samples are stored in monitored and alarmed liquid nitrogen vapor phase cryogenic freezers and -80°C mechanical freezers. Liquid nitrogen is supplied on-demand from an external bulk-tank and plumbed into each storage unit, including the -80°Cs, where it serves as a back-up cooling mechanism. Mechanical freezers, temperature-monitoring devices and other key equipment are connected to the emergency power grid, powered by two diesel-fired generators. Biorepository services also include sample aliquotting, DNA and RNA isolation, nucleic acid quantification, and sample distribution management.
The CBR LIMS securely integrates with a research data warehouse containing detailed clinical information sourced from the electronic health record. This connection allows U-M scientists to interrogate the biorepository and discover samples of interest from a research-specific, clinically defined cohort of individuals. Access to biospecimens and associated data is subject to regulatory and steering committee approval.
The CBR and lab occupies 4,200 square feet, comprising a 2,200-square-foot freezer storage space and 2,000-square-foot wet lab. Access to the labs is controlled, where entrance to the wet lab requires a key code and the freezer facility is badged-entry only. The CBR has current capacity for up to 1,200,000 biological samples in 2 ml tubes. There are eight upright -80°C freezers and eight LN2 vapor phase storage units, each configured for 46,565 and 65,610 2mL cryovials, respectively. The CBR has space for up to 10 additional cryogenic storage freezers or 10 -80°C freezers, or a combination thereof.
Freezers, refrigerators, ambient temperatures, and laboratory humidity are monitored via NIST-calibrated sensors connected to a 900 MHz, web-based monitoring system, called TempTrak. Use of the biorepository and its service is on a fee-for-service recharge basis.
Animal Care & Use Program
Animal husbandry will be provided by the staff of the Unit for Laboratory Animal Medicine (ULAM) under the guidance of supervisors who are certified by the American Association for Laboratory Animal Science (AALAS). Veterinary care will be provided by ULAM faculty members (11) and veterinary residents (8). As of January 2017, eleven members of the faculty are diplomates of the American College of Laboratory Animal Medicine (ACLAM). The University of Michigan is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC, Intl) and the animal care and use program conforms to the standards of “The Guide for the Care and Use of Laboratory Animals,” Revised 2011. The program includes required inspections of animal facilities, review of all funded projects for humane use of animals, and the appropriate use of surgical anesthesia, analgesics, and tranquilizers. The University of Michigan has filed an assurance statement on these matters with the Office of Laboratory Animal Welfare (OLAW).