predictive health strategic plan - emory...

Predictive Health Institute

Strategic Plan

September 2005

submitted by:

Kenneth Brigham, M.D. Claire Sterk, Ph.D.

Francois Sainfort, Ph.D.

Robert W. Woodruff Health Sciences Center

Steering Committee members

CONFIDENTIA

Gang Bao, Ph.D. Doug Bremner, M.D. Raymond Dingledine, Ph.D.Robert Drazin, Ph.D. Merrick Furst, Ph.D. Ernest Garcia, Ph.D. Don Giddens, Ph.D. Phillip Hills Xiaoping Hu, Ph.D. Dean Jones, Ph.D. Kathleen Kinlaw, M.Div. Howard Kushner, Ph.D. Eva Lee, Ph.D.

Planning Committee(subset of the Steering

R. Wayne AlexandeKenneth Brigham, MFadlo Khuri, M.D. Jeffrey Koplan, M.DAllan Levey, M.D. Lanny Liebeskind, PKathy Parker, R.N., Francois Sainfort, PSanjay Saini, M.D. Claire Sterk, Ph.D. Frank Stout ex officio Christi Carmichael Shari Capers, R.N.,Lynn Cunningham, Ron Sauder

L

Dennis Liotta, Ph.D. Richard Lipton, Ph.D. Robert Nerem, Ph.D. Kimberly Rask, M.D., Ph.D. Leslie Real, Ph.D. Dong Shin, M.D. David Stephens, M.D. Ora Strickland, R.N., Ph.D. Ken Thorpe, Ph.D. Eberhard Voit, Ph.D. Steve Warren, Ph.D. Cornelia Weyand, M.D. Stuart Zola, Ph.D.

members Committee)

r, M.D., Ph.D. .D.

.

h.D. Ph.D. h.D.

M.B.A. M.S., M.B.A.

2 of 77


Acknowledgements: The Principle Investigators of the project wish to thank each member of the Steering Committee for their unselfish commitment to the work of the Institute. Many hours were spent in committee preparations, report development and other essential work. This plan could not have been created without their dedication, intellectual drive, creativity, and belief in the Predictive Health paradigm. The Principle Investigators also wish to thank Michael Johns and Don Giddens for their leadership and inspiration throughout this planning and organizational period. It is their vision that brought this group together and their unwavering support that has enabled the work to progress. The Steering Committee members gratefully acknowledge the support of the Robert W. Woodruff Health Sciences Center Fund, Inc. for financial support of this project. The Committee is working with a two-year grant from the fund to develop and implement the Predictive Health Institute.

CONFIDENTIAL 3 of 77


Table of Contents Plan Sections Page

1. Executive Summary (click here) 6 2. Introduction (click here) 8

Background and rationale

The Planning Process Concept What others are doing

3. Vision and Opportunities at Emory and Georgia Tech (click here) 31

Mission Vision Structure

4. Critical Infrastructure, Cultural, (click here) 33

and Environmental Factors 5. Implementation Plan (click here) 35

Administrative structure (click here) Content (click here) Facilities (click here) Finance (click here) Marketing and Identity (click here) Communication (click here)

6. Implementation Priorities (click here) 49

Institutional oversight Creation of Executive Board Appointment of Interim Director Creation of Advisory Board/Scientific Advisory Board Creation of faculty search committee Create memorandum of collaboration between Emory and Georgia Tech

Administration Academic Budgetary Personnel Purchasing IT support Research



Grant administration Infrastructure utilization Office of Grants and Contracts

IRB Animal resources

Organization of Projects Woodruff projects underway

Selection of appropriate scientific projects Resource utilization

FacultyRelations Parking plan Develop transportation from C-L to both Emory and GT Plan for philanthropic campaign

Renovation of C-L space, plan for phased growth Consider plan for free standing building Plan for recruitment of endowed chair faculty Plan for associated faculty Emory/GT and public web page Create communication plan for public/scientific awareness

Establish navigation plan for moving “well persons clinic” people through space to appropriate rooms Students

Plan for other, yet unspecified transition issues. 7. Appendices (click here) 53

1. Resource inventory 2. Timeline of activity since December 2004 3. Estimated costs worksheet 4. Key faculty recruitment targets 5. Architectural vision 6. IBM Solutions Roadmap 7. Symposium planning 8. Web site structure and function 9. Timeline for year 2 and beyond 10. Woodruff Foundation funded projects



1. Executive Summary Biomedicine in the United States is largely focused on diagnosing, treating and

exploring mechanisms of disease---end organ failure. The result is a system that is inefficient, increasingly expensive and not accessible to a large portion of the population. For the first time in history, there is an opportunity to harness the potential of evolving science and technology to create a new biomedicine that is affordable, accessible and efficient and enables human beings to live happier more productive lives.

The concept of Predictive Health proposes to shift resources and effort to focus on health rather than disease. Predictive Health anticipates the course of an individual’s health status, based on leading edge science and technology, and prescribes interventions that proactively optimize wellness throughout an individual’s lifetime. Predictive Health is a revolutionary approach to health and health care that moves from a reactive, disease-focused system to a pro-active health-focused system: disease becomes a medical failure. Such a revolution in the health system is possible because of existing and rapidly developing technologies and because there is wide recognition that the current system does not work and cannot be sustained.

Although other institutions have established programs that address some aspects of the concept, Emory University and Georgia Tech are uniquely equipped to create an integrated approach to health that takes optimal advantage of leading edge science and technology and involves the multiple disciplines required to make the necessary major changes from current practice possible. Accordingly, the Emory Georgia Tech Predictive Health Institute will integrate scientific research, education and technology with personalized healthcare. The Institute will pioneer strategies to translate Predictive health into ethical and economically and socially feasible practice for the benefit of humanity. The Institute will bring together a range of activities and disciplines, including sophisticated technology, innovative basic and applied science, and experts in ethics, health policy, economics, business, law and behavioral sciences in a highly interactive setting to address all aspects of a revolutionary approach to biomedicine. The essence of the Institutes goals can be summarized as:

• To define and measure health using cutting edge basic and applied scientific research

• To discover optimal biomarkers of health and understand their interrelationships

• To determine the best interventions to optimize health through an individual’s or a populations lifetime

• To design, using insight from scientific research, ethics, economics and policy, a predictive health system that can be applied to individuals and populations

The Institute will be a collaborative effort between Emory University and Georgia Tech. An administrative structure will consist of a Director, an Executive Committee composed of representatives of both institutions and an Advisory Board that will advise the Director and the Executive Committee. Faculty in the Institute will consist of a leading group of scholar/investigators who will occupy 11 fully endowed chairs and will be housed in a physical institute to be located in space at Emory Crawford Long Hospital that is renovated to produce an external character and an internal design that



express the goals and foster the function of the Institute. These faculty will be dedicated to the Institute, but will hold appointments and tenure in appropriate departments at either institution. In addition to these leading faculty, there will be up to 20-25 institute faculty who are major scholar/investigators and other investigators who may spend part time in the institute on specific projects. The functional organization of the Institute will be a three dimensional grid that integrates enabling technologies, generic processes and enabling disciplines as the three axes into multidisciplinary teams with a common focus.

Although a broad range of disciplines and technologies will be represented within the Institute, including nanotechnology, ethics, policy and economics, business, law, etc., the Institute will of necessity be populated in phases as programs develop. Because of perceived opportunity and need, the following areas should have initial priority as occupants of the Institute building:

• Computational Biology/Bioinformatics/Systems Biology • Regenerative Health • Chemical Biology Discovery • Biomarker Network Analysis and Visualization • Genetics/Epigenetics • Molecular Imaging • A Well Persons Clinic • A Biorepository • State of the Art Conference and Communication Facilities Projected costs based on staged renovation of space and phase-in of recruitment of

leading faculty over 5 years are approximately $51M. Revenue for that same period based on reasonable estimates of productivity of recruited faculty totals approximately $57M. Annual projections show revenues exceeding expenses by midway in the third year of operation. Beyond year 5 expenses decrease dramatically while grant revenue would be expected to continue to increase.

Aggressive efforts should be made to bring international attention to the Institute as a major effort of Emory and Georgia Tech. An International Symposium---Seeking Ponce’s Dream: The Promise of Predictive Health---will be held on the Emory campus on December 19-20, 2005. Major figures in the health and literary communities will participate in the symposium and it will provide the occasion for formal announcement of the establishment of the Institute and dissemination of materials that describe its mission and structure. Additional marketing efforts should include national advertising in print media, a well designed and maintained web page, publication of scientific and lay articles, development of white papers and mailings to selected parties. The Symposium should become an annual event that continues to draw attention to the Institute and the universities.

The Institute is a major undertaking that promises to place Emory and Georgia Tech at the forefront of biomedicine. A detailed implementation plan with an aggressive time line should be pursued in parallel with identification of funding sources and stellar candidates for leading Institute faculty.



2. Introduction Definition

Predictive Health anticipates the course of an individual’s health status, based on leading edge science and technology, and prescribes interventions that proactively optimize wellness throughout an individual’s lifetime. Predictive Health is a revolutionary approach to health and health care that moves from a reactive, disease-focused system to a pro-active health-focused system: disease becomes a medical failure. Purpose of the Emory Georgia Tech Predictive Health Institute Plan Biomedicine in the United States is largely focused on disease---end organ failure. A significant portion of the human and monetary resources devoted to biomedical research and clinical care is spent on organ and disease focused activities including irreversible processes. Fully a third of the national Medicare budget is spent in the last year of life and a third of that amount is spent in the last month of life, often in expensive and futile care in intensive care units. Dramatic but increasingly expensive interventions may be effective in the short run, but their effects on quality of life are often problematic. This arrangement is not sustainable. Social need, cost and new fundamental discoveries will force major changes in the biomedical enterprise. We aim to develop and implement a biomedical enterprise that considers new discoveries, associated costs and societal needs with the goal of transforming what may be the best disease care system in the world to the best health care system. Traditionally, health has been defined as the absence of disease, a definition without much utility in a health focused system (theoretically to declare a person healthy it would be necessary to rule out every possible disease, at best an impractical effort). There is a need to focus the formidable power of the research enterprise---basic, translational and clinical---on developing a positive definition of health in quantitative terms. This would provide the tools essential for health surveillance, risk assessment and premorbid diagnosis as well as the knowledge base for developing interventions at early stages of deviation from health that would preclude progression to end organ failure.

The changing paradigm of health care is driven by the rapidly advancing fields of genomics and proteomics. Predictions are that the technology for genome sequencing (genomics) and measuring serum concentrations of a thousand proteins relevant to health and disease (proteomics) will be easy and cheap enough to be applied to individual health care in ten years. Other technologies such as metabalomics, nanotechnology, molecular imaging and bioinformatics, can add additional detail to characterizing health, further enhancing the ability to measure health and detect tendencies toward disease. However, science and technology will only provide the tools. Translation of these advances into a health care system invokes a host of issues---ethical, social, behavioral, economic, political, legal, commercial---that will have to be addressed in the process of designing and implementing a health based system. Advances in those areas need to proceed in parallel with the science with efforts in all areas informed by rich transdisciplinary communication among investigators who have



motive and opportunity to interact. An institute could create motive and opportunity.

The Planning Process Origins This initiative began in a series of discussions between Drs. Michael Johns and Don Giddens that took place during 2003. On October 15, 2003, Drs. Johns and Giddens convened several key people from the Woodruff Health Sciences Center and the Georgia Tech College of Engineering and charged them to use the NIH Roadmap as a guide to identifying promising collaborations between the two institutions. The group was encouraged to identify “big ideas” that would make significant gains in cross-institutional cooperation. This group identified three areas of the NIH Roadmap that are particularly relevant to Emory and GT: nanomedicine, bioinformatics and computational biology, and molecular imaging. Workshops held during early 2004 resulted in a summary report to Drs. Johns and Giddens with the main recommendation to establish an “Institute for Personalized Medicine at Emory and Georgia Tech”. Full documentation of these meetings with description of those key needs and compelling arguments is contained in the March 10, 2004 memo from Drs. Robert Rich and Francois Sainfort to Drs. Johns and Giddens. The March 10 memo recommends that a steering committee and working groups be established to expand upon the concept of Personalized Medicine, refine the ideas and propose a plan of action.

Parallel to this joint initiative from the Woodruff Health Sciences Center and Georgia Tech College of Engineering, the Emory Department of Medicine proposed the Human Health Initiative to develop a new and enhanced model of healthcare, arguing that Emory is in a unique position to assume a leadership role in developing such a model. The Human Health Initiative proposed the goals of developing a quantitative definition of health, establishing health surveillance techniques, and, ultimately, causing disease to become a medical failure. Integral to this concept is the inclusion of the major disciplines of the Emory School of Medicine, the School of Nursing, the School of Public Health, the School of Business and the Law School. The relationship with Georgia Tech is central and critical to success, as are deeper relationships with the Centers for Disease Control and Prevention and other national entities located in the Atlanta area.

The intellectual framework and recommendations from the Emory-Georgia Tech report, and the new scope and mission of the Human Health Initiative proposal, were merged into a new initiative entitled, “Establishing an Institute for Predictive Medicine”. And submitted by Robert Rich, M.D., Executive Associate Dean for Research, School of Medicine, in May, 2004 to Dr. Michael Johns and the Woodruff Health Sciences Center Funds review committee. Funding was awarded for the period FY ’05-’06 to prepare the necessary strategic planning foundation and to begin early implementation work for the planned Institute. It is this core group, consisting of Dr. Rich, Dr. Brigham, Dr. Sainfort and Dr. Sterk, who were charged with opening the exploration and early development of the project. Implementation of the Working Group

In June 2004 Dr. Robert Rich convened this core group for an organizational meeting to initiate preliminary work for the Predictive Health project. Subsequently the



core group was expanded to include seven members, including representatives from Strategic Planning as well as administrative support. The work was organized around the following four topical areas: Institute Scope and Definition, Resource Inventory and Benchmarks/Best Practices, Operational Design Outline, and Detailed Work Plan & Process Structure. Outlines for Institute Scope and definition and operational design were completed by July 13, 2004 and August 17, 2004 respectively. At that time a request for a Steering Committee was made with the goal to recruit approximately 15 additional people from both Emory and Georgia Tech. The Working Group continued to meet separately from the Steering Committee and maintained the primary responsibility for managing project tasks and deadlines. On September 13 the Working Group discussed the Year 1 Work Plan and reviewed Steering Committee nominations. The Working Group decided to meet twice a month to keep business flowing and for timely action on emerging issues. By the September 28 meeting, a list of 35 Steering Committee candidates had developed. This beginning list was further refined before being submitted for review to Dr. Johns and then to the WHSC Leadership Council. Formal invitation letters were sent over the signatures of Drs. Johns and Giddens. On November 12 the signed nomination letters were distributed to each of the twenty-two selected Emory and Georgia Tech faculty and Deans (See Appendix I for list of committee members with their affiliations and interests). All members of the Working Group were also members of the Steering Committee. Upon Dr. Rich’s departure to assume the position of Dean of the Medical School at the University of Alabama at Birmingham in September, 2004, Dr. Brigham assumed the chair of this effort at the request of Dr. Johns. Steering Committee activities December 21 was the inaugural meeting of the entire Steering Committee and Working Group. From this date through the present the Steering Committee has met on a monthly schedule (a time line of activities of the committee beginning in December, 2004 is shown in Appendix 2). Most Steering Committee members were given a Theme assignment that reflected their area of expertise. These Theme assignments were designed to create a summary of key information surrounding the disciplines and technologies needed to create the Institute. Theme leaders were directed to utilize whatever resources and other faculty would be required to generate a focused review of their Theme. Phase I summaries were written which detailed the strengths, weaknesses and opportunities present in the Emory and Georgia Tech environment. Transforming investments needed to make significant changes were also described. By the middle of March there were nineteen written reports that are being used in part to generate this report. The Phase II reports, initiated in April, contain a quantitative analysis and description of the Phase I findings. Again, each Theme leader produced a document detailing the estimated costs, in human and in capital needs, and the estimated facilities requirements of their area. These findings are used in part to develop the final strategic plan for the Institute.

To foster the internal collaboration and development of a common body of knowledge necessary to have the Steering Committee work as a unified team, each Theme leader gave a fifteen minute presentation of their Theme area to the group. These presentations were designed to display to the group how each Theme will



integrate with and support the Institute goals, along with providing a view of the major contributions available from each Theme. Sub-committees

During January 2005 two other sub-committees were formed from Steering Committee membership. The composition of these committees is given in Appendix I.

The Symposium Committee was created and charged with planning for the expected fall 2005 national/international predictive health symposium which will become the Institute’s first public viewing. The Symposium Committee is nearing completion of plans for the symposium to take place at the Emory Conference Center on December 19-20, 2005. The symposium is titled “Seeking Ponce’s Dream: The Promise of Predictive Health”. Committed outside major speakers include Dr. Lee Hood, Founder, Institute for Systems Biology, Dr. Ralph Snyderman, former President of Duke Healthcare and the popular author Tom Wolfe. A number of additional eminent speakers from Emory, Georgia Tech and elsewhere are being recruited to participate. A “hold the date” memo will be sent shortly to a national mailing list and plans finalized for the symposium with a projected attendance of approximately 500. Appendix 7 contains a copy of the “hold the date” memo and a tentative program outline. This Symposium is designed to be the public announcement of the Emory/GT Institute and an opportunity to showcase the commitment to this revolutionary shift in healthcare delivery.

The Economic, Epidemiological and Behavioral Outcomes Committee was created with the charge to analyze the possible outcomes of the anticipated research and to complement biomedical investigators with epidemiological, behavioral, economic and policy inquiries. The intent is that new tests, techniques, policies and procedures will be analyzed for their potential impact on the healthcare system. A group of health policy and economic specialists comprise this committee that is charged with this ongoing evaluation responsibility. The first pilot project, the Department of Medicine project on biomarkers of oxidative stress, is now being examined.

During March 2005 it was realized that more specific work needed to be done in several key organizational areas. New, additional sub-committees were formed from among the Steering Committee membership and other faculty. The additional sub-committees and their charges are listed here:

Administrative Structure – develop how the Institute will relate to Emory and to Georgia Tech

Functional Organization – develop an internal organizational structure Content – determine what technologies, disciplines, and programs will be housed in the Institute

Facilities – determine what physical plant will be required Finance – develop a financial model for projected income, expenses, and mechanisms for funding These sub-committees each met separately on their own schedules, and

presented reports to the Steering Committee at monthly intervals. Presentation details can be found on the web site at https://www.whsc.emory.edu/ph. Information generated by these committees provides the core of content for this report in Sections 5 through 8.


https://www.whsc.emory.edu/ph


A working name for the project Much discussion has gone into the working name of this initiative. From the early meetings continuing through the present, the committees have grappled with an appropriate name for the Institute. The medical buzz-words of predictive, prospective and personalized health or medicine each have their own history and connotations with the medical community and the lay public. Predictive Medicine was changed to Predictive Health because the focus is not on medicine – the treatment of illness - but on health. The working name of “Predictive Health Institute” is functioning as a distinguishing identifier within Emory and Georgia Tech but may well evolve into another, unique title as an appropriate descriptive vocabulary develops around this project. Following a special meeting of the Content sub-committee on August 13, 2005, the title “The Emory Georgia Tech Predictive Health Institute” was adopted and is how the organization will be referred to in this document. The Committee recognizes that only the University Board of Trustees can create an Institute. The use of Institute in this report and in other materials reflects the recommendation of the planning committees and is done with the full realization that Board action will be required to make this a reality. Normal work processes

A normal working process entailed the Working Group convening at bi-weekly intervals to discuss ongoing action items. The Symposium and Economic, Epidemiological and Behavioral Outcomes committee chairs reported to the Working Group after each of their meetings with updates and for further guidance. The Steering Committee, meeting monthly, was utilized for overall direction of Institute planning and programmatic recommendations. Through April ’05 the Steering Committee was involved in the presentation of Theme reports to the entire group by each of the key faculty Theme leaders. After the Theme reports were completed the Steering Committee devoted efforts toward finalizing the Institute Strategic Plan.

As a means to better understand the unique perspective of each Committee member, and to further team identity, Ken Brigham, Chair of the Steering Committee and Working Group, conducted a series of individual meetings with the committee members. These were one-on-one sessions held in the members’ offices, both at Emory and on the Georgia Tech campus, and consisted of broad, open-ended discussions of each members’ views on the Predictive Health initiative and how their particular work contributed to or integrated with the initiative goals. These highly useful meetings contributed to the broader understanding of available Institute resources and capacities, and of Institute relevance to the broader Emory/Georgia Tech environment. Site visits to model institutions

A series of site visits were conducted to investigate those programs or organizations that the committee identified as particularly relevant to the Initiative. The visits were purposeful reconnaissance missions intended to learn the strengths, weaknesses, organizational design and program successes of these existing programs.

Institute for Systems Biology: The visit to the Institute for System Biology, Seattle, WA was viewed as successful and has contributed to the Committee’s thought processes on



goals and structure. Dr. Lee Hood dedicated an entire morning to our visit. He and his COO reviewed the ISB history and mission, and compared his experience with our plans. Although Dr. Hood’s processes and structure are not entirely congruent with our environment, the core success factors are translatable to our academic setting. In particular is the open workspace, the collaborative work environment, an emphasis on bioinformatics as a core resource, a broad interdisciplinary scientific composition, and a clear focus on science. Washington University: The BioMed 21 initiative at Wash U represents their effort to build a biomedical program and promote the clinical sciences. After about three years of discussions, the initiative was launched with the purpose of using well-phenotyped healthcare system patients for genotyping, to develop a data mining informatics capability, and to conduct a new generation of clinical trials using genetic information in context with phenotypic information. Three new entities will be created to support the initiative goals: a Genome Science Center, a translational pathology core within the Cancer Center, and a Division of Clinical Sciences within the education program to expose more PhD’s to the biological sciences. This initiative is still very much in the development stages, with the Genome Science Center being the core resource and with plans to use this Center as the vehicle for offering seed fund grants of $50K each for sequencing projects. The initiative leader describes issues with the University hospital which so far has not provided support for the initiative goals. The Broad Institute, a new collaboration between MIT and Harvard University, developed from projects underway in Eric Lander’s laboratory at the conclusion of the human genome project. To not loose the investment in technology and people which had accrued during the project, the Institute was created to provide a stage for the next steps in their scientific program. A gift of $100M from philanthropist Eli Broad launched the Institute. While a new, free-standing building is under construction the Institute continues to function in the renovated warehouse space currently occupied by the Lander lab and the genome project. The Institute functions within the MIT structure with all MIT administrative systems used for operations (HR, purchasing, financial management, OSP, etc.) Staff are MIT employees while faculty members belong to their home institutions with Broad affiliations. Projects are not accepted at the Broad unless they are unique and cannot be conducted in the faculty member’s home facilities. Institute size is limited to about 12 key faculty members, with the intent of keeping the Institute flexible, responsive and manageable. Two groups, the Genome Center and Chemical Biology, are the nucleus of the Institute. Major technology resources contained within the facility are genotyping, chemical screening, computational expertise (analytical and bioinformatics) and collaborative space.

The Pacific Health Summit 2005: The Pacific Health Summit, held in Seattle, was the inaugural event of what will become an annual series of seminars on the future of healthcare. Focus was on the Pacific rim areas but the overall concepts is applicable to worldwide health. Attendance consisted of over 300 people representing 16 nations. This meeting, sponsored by the Fred Hutchison Cancer Center, included presentations from Dr. Zerhouni of the NIH, Andrew von Eschenbach of NCI, Uwe Rheinhart of



Princeton, Lee Hartwell from Fred Hutchison, and other notable academic, industry and political leaders. One take-home lesson is that Emory and Georgia Tech do not own the predictive health concept. Most of the presentations used similar vocabularies and concepts to what is currently discussed in the Emory and Georgia Tech planning processes. Another is that Emory/GT are not early leaders. We need to move quickly and decisively to stay current with current thinking in these areas. And, Emory/GT does have a strategic advantage in the integrated approach being developed. Further details of these visits can be found on the web site https://www.whsc.emory.edu/ph and in the Appendices.

Overall, the working environment developed into an efficient process whereby the smaller Working group handled issues that arose and made those decisions needed to continue moving toward the Institutes’ near and long term goals. This information was transmitted at monthly intervals to the Steering Committee that, by the nature of this larger body, was more deliberative and was largely focused on developing the broad Theme information. Discrete activities, such as the Symposium planning process and the outcomes analysis group, were given their own committee structure to best handle these tasks off of the normal Working Group business agenda. Liaison with Drs. Johns and Giddens was maintained by regular meetings between Drs. Brigham and Johns, as well as by frequent interactions between Dr. Jeff Koplan (a member of both the Working Group and the Steering Committee) and Dr. Johns.

Concept Health is a dynamic concept that will continually change as technology advances and society responds. However, some constant dimensions of health include physical and mental well-being, a capacity to respond favorably to perturbations (from molecular to broad environmental challenges), and quality of life. The concept of a Predictive Health Institute is to create a health focused program that integrates basic, translational and clinical research with clinical care, education of health professionals and expertise

in academic areas essential to implementing a radically new approach to health care. The general concept (What will it do?) is illustrated in figure 1. The implementation strategy (How will it do it?) is illustrated in figure 2.

Figure 1: What will the Instititute do?

The Health/Disease Continuum

NormalLow risk

NormalHigh risk

Predisease

Earlydisease

Latedisease

Predictive Health

Contemporary Medicine

HEALTH

DISEASE


https://www.whsc.emory.edu/ph


The goals of the Institute are to develop a quantitative positive definition of health that will enable health surveillance, risk assessment and premorbid diagnosis and to discover new interventions at the earliest stages of deviation from health that will restore the healthy state at the time when that is likely to be most feasible (figure 1). Disease should become a medical failure. These goals will be accomplished by highly interactive teams of basic and clinical scientists and clinicians all of whom are focused on health. A basic hypothesis of the Institute is that there are a limited number of generic biological processes that characterize the healthy state and that detectable alterations in these processes can predict essentially all human diseases before organ

function is affected (figure 2). Emory is uniquely positioned to implement this concept since we have the essential scientific strengths in many relevant areas. Collaboration of outstanding scientists and clinicians with differing expertise would assure success. The Institute will be a collaboration among scientists from different disciplines and clinicians that would focus on defining health in quantitative terms, developing clinically useful

tools for detecting deviations from the healthy state and developing interventions that are effective at restoring the healthy phenotype prior to the development of disease. Basic, translational and clinical research and clinical care would not be viewed as separate activities, but as a spectrum of highly integrated activities that serve as the foundation of the process of acquiring and applying new knowledge and educating the next generation of biomedical professionals.

Figure 2: How will the Institute do it?

Generic Pathways

Specific DiseasesCardiovascular

Diseases

Chronic Lung Diseases

Diabetes

Cancer

Other DiseasesNeurological

Diseases

Determinants of Health

Environment

Genetics Behavior

Oxidative Stress

Development and

Senescence

Regeneration and Repair

Other Generic Pathways

Immunology and

Inflammation

Disciplines

Education

Finance and Economics

Public Policy

Ethics

Systems Biology

Population Biology

Technologies

Genomics/ Metabolomics/ Proteomics

Molecular Imaging

Bioinformatics

Nanomedicine

Quantitative Medicine

Novel Therapeutics

The science and technology will not be developed in a social vacuum. The institute will include as integral members of the investigative team, experts from many fields---ethicists, economists, behaviorists, anthropologists, epidemiologists, systems analysts, business experts, legal experts, political scientists---who will address issues related to translating the new science into society. The health care system of the future will be built from both ends simultaneously---acquiring new science and technology that provide the essential tools and knowledge at one end and designing an optimal socially practicable implementation system at the other end---in a highly integrated and interactive process with a common focus and goals.

What Others are Doing A number of academic, private and industrial institutions have initiated programs



that address one or another part of the health care challenges and opportunities presented by developing science and technology. However, these tend to be either focused exclusively on developing technology, application of traditional preventive medicine programs or on commercial interests. Several of those activities are described briefly here. It will be apparent that the proposed Institute has several unique characteristics that distinguish it from all of the efforts underway elsewhere. Those characteristics are addressed directly later.

Private initiatives

Institute for Systems Biology This independent organization, structured as a not-for-profit, is fully engaged in systems biology research. Not affiliated with an academic institution, but wearing some of the characteristics of academia, the institute is a purposely small, focused, interdisciplinary group of scientists. Scientific areas of expertise include biology, physics, chemistry, computing, mathematics, medicine, immunology, biochemistry and genetics, making this a broadly interdisciplinary group.

They are organizationally very flat. Of the 170 staff members, there are eleven faculty, about nine administrative staff, and the rest are scientific laboratory workers. Of the administrative staff, two are in HR, two are in finance, and five are in IT support. ISB runs on a $28M annual budget with $5M of this being for direct operations. ISB has its own grant management office, its own IRB, and contracts directly with the NIH for federal grants. They have a negotiated indirect cost rate of 76%. Their stand-alone building encloses about 64,000 sq/ft of total floor space.

Advice from founder and President Lee Hood, Ph.D., to us in forming the Institute is to identify 3-4 well-established senior people who want to build something unique and then make them an offer they cannot refuse. We need to determine and then articulate what we want to accomplish, and we need to create a culture that can execute effectively and give people enough security that they will feel free to take risks. Academic Institutions

Several academic institutions have initiated programs designed to integrate the sciences and to build interdisciplinary teams. The stated goal is usually to promote interdisciplinary, translational research that carries with it the particular flavor and emphasis of the founding institution. Some have built dedicated facilities (Stanford, Wash U., Whitehead Institute) and others have drawn faculty around programs using existing infrastructure (Duke, Johns Hopkins). We include here efforts that employ novel techniques and structures to further the creative, barrier-crossing investigative science that we wish to foster even though their thematic focus may be different than ours (Isaac Newton Institute, National Center for Ecological Analysis and Synthesis--NCEAS).

Duke University The Duke healthcare model is heavily influenced by the Snyderman emphasis on prospective health care. We have seen how Duke is utilizing its employee population to build a prospective medicine model utilizing personal health “coaches” to assist patients in successfully implementing their personalized health plan.

There is a formal collaboration between Duke University and the Center for the Advancement of Genomics intended to create the first fully integrated practice of genomic medicine. The new (launched in 2000) Institute for Genome Sciences and



Policy is the Duke response to the needs of genomic medicine, and will play a key role in addressing the scientific and ethical issues surrounding this new practice of medicine.

Whitehead Institute for Biomedical Research The Whitehead Institute was formed in 1982 as a financially independent research institution affiliated with M.I.T. through its teaching activities. The Whitehead accepts MIT graduate students for research and training in its laboratories and MIT, in turn, considers all Whitehead faculty for appointment to faculty level positions at MIT. All current Whitehead faculty are full-fledged members of the MIT Biology Department. The Institute is guided by its director, its faculty, by a Board of Directors chaired initially by John Sawhill, and by a Board of Advisory Scientists composed of some of the world's most eminent biologists.

Jack Whitehead dreamed of identifying the best young minds in biomedical science and giving them the freedom to follow their scientific instincts. The ideal setting, he believed, would be a small, self-governed research center, affiliated with a leading research university. Such a center would encourage collaboration and free young scientists from the constraints inherent in a large teaching institution. New ideas would come to fruition more rapidly because of the shared mission—the pursuit of excellence in biomedical research.

The initial Whitehead gift of $35M funded construction of the new building. An additional $5M per year in guaranteed operating income was provided for through an endowment of $100M. There are 200 students, post-docs, fellows, physicians and visiting scientists housed in the Whitehead. 12 faculty comprise the full-time teaching and research group.

Broad Institute Founded in 2003, this is a joint effort between MIT, Harvard University and the Whitehead Institute. With origins in The Center for Genome Research, this center served as the flagship of the Human Genome Project, the international effort to identify the blueprint for a human being. Founded in 1990, the Center grew to become one of the largest genome centers in the world and an international leader in the field of genomics, the study of all of the genes in an organism and how they function together in health and disease. Today, the Center houses a broad range of thriving research programs combining structural genomics, medical and population genetics, and clinical medicine. The Center's annual budget is $80 million, and it employs 250 people, including scientists and medical researchers from Whitehead, MIT, and Harvard.

The scientific framework of the organization consists of four areas: Programs (cell components, states and circuits, chemical biology, medical population genetics, and cancer), Initiatives (metabolic diseases, psychiatric disease, infectious disease and inflammatory disease), Platforms (enabling technologies of genome sequencing, molecular profiling, genetic analysis, chemistry), and Computational Biology and Bioinformatics.

Washington University The BioMed 21 initiative, designed to reorganize and reorient the biological sciences at Wash U., is intended to reshape University culture over the next 10 years. The stated goal of the initiative is to rapidly convert the knowledge of the genetic blueprint of human beings into effective, individualized treatments.

This is a more conventional initiative, taking place fully within the academic and financial structure of the University. It occupies four physical locations: a reconstructed



area adjacent to the Genome Sequencing Center, a new 250,000 sq/ft building in the medical campus for translational research, the Farrell Learning and Teaching Center, and a 40,000 sq/ft facility designed to facilitate development of mouse models for human diseases.

A major goal is to acquire $300M in resources from NIH funding and gifts from friends and supporters. The three major organizational and scientific components are: the Center for Genome Sciences, the Division of Clinical Sciences, and the Center for Biological Imaging.

Johns Hopkins The McKusick-Nathans Institute of Genetic Medicine has as its mission to further the understanding of human heredity and genetic medicine, and use that knowledge to treat and prevent disease. To that end, the Institute is working to consolidate all relevant teaching, patient care and research in human and medical genetics at Johns Hopkins and to provide national and international leadership in genetic medicine. It serves as a focal point for interactions between diverse investigators to promote the application of genetic discoveries to human disease and genetics education to the public. It builds upon past strengths and further develops expertise in the areas of genomics, developmental genetics, and complex disease genetics. In addition, it is hoped it will catalyze the spread of human genetic perspectives to other related disciplines by collaboration with other departments within Hopkins. This organization, located within Johns Hopkins, conducts basic and translational genetic research. Their program emphasis does not extend to work beyond genetics, and does not directly tie to other Johns Hopkins departments and centers. While collaboration with other disciplines is a stated goal, it is not a hard-wired component of their structure.

The Isaac Newton Institute for Mathematical Sciences at Cambridge The Newton institute, a thirteen year old think-tank for mathematical issues, is housed in a new and impressive structure designed from the beginning to stimulate creative thinking. Meeting rooms are plentiful as is computer connectivity. A compelling feature is the installation of chalk boards in all meeting rooms, the elevators, and inside the rest room stall doors. While the practicality of all these locations can be questioned, their placement sends an unmistakable signal that creativity is encouraged and is part of the mission of the institute. The Institute for Mathematical Sciences is a national and international visitor research institute. It runs research programs on selected themes in mathematics and the mathematical sciences with applications in a very wide range of science and technology. It attracts leading mathematical scientists from the UK and from overseas to interact in research over an extended period. Attending scientists are not employees of the Institute or of Cambridge, they come to the Institute to work on specific projects for limited periods of time.

National Center for Ecological Analysis and Synthesis NCEAS is an interesting collaborative organization affiliated with UCSB. The physical structure is off-campus but the affiliation with UCSB affords opportunities to take advantage of the unique research environment. The NCEAS entertains proposals within its areas of research focus, then forms working groups around those proposals which are chosen for funding. Working groups meet several times over a two or three year period, develop a conclusion or finding from the projects, and publish the result(s). In addition to working groups, NCEAS appoints Center Fellows with appointments of 3-12 months and postdoctoral



fellows for up to two-year appointments. Center infrastructure includes meeting rooms and offices with plentiful computational and AV support. The computing environment is particularly strong with hardware and software appropriate for demanding modeling, statistical, visualization, and data management projects. Funding is provided through the NSF, the State of California, and UCSB. Innovative science is conducted by bringing researchers together in a non-permanent environment for the express purpose of creating something new during their affiliation with the center. Commercial ventures

There is burgeoning interest and activity in the for-profit arena in areas directly and indirectly associated with predictive health. Most visible are those companies with predictive in their names, such as the Predictive Medicine Centers of America, Inc.. This chain offers comprehensive analysis of the clients' health and review of all test results with personalized development of a long term health management program, all conducted by local board certified physicians. This clinical information is gathered with state-of-the-art diagnostic imaging systems such as ultrasound, CT, MRI and in some cases Positron Emission Tomography (PET) in combination with extensive blood, vascular genetic, nutritional, metabolic and hormone profiles in combination with an extensive physical examination. No referral from an independent physician is required, the company functions as a stand-alone business whose services are essentially a high-powered executive physical examination. Overall, the commercial ventures, other than deCode, work from a business plan aimed at the seemingly lucrative self-referral market. This market takes advantage of the personal need or desire for more medical information, and of the disposable income of these individuals who are willing to pay for testing on a speculative basis. These are not research-based endeavors, and are only competition to the Institute in the sense that they can channel dollars and customers away by their quasi-medical presentations and consumer oriented marketing. deCode is the exception in this group with its focus on developing biopharmaceuticals through traditional channels based on information derived from their unique genetic database.

Predictive Medicine Centers of America, Inc. This company bundles an array of existing diagnostic tests in a grouping much like an Executive Health screen. High-end diagnostics are used and convey an image of cutting edge medicine. This is an all-comers market where anyone can purchase the diagnostic tests they wish to undergo.

deCode is a biopharmaceutical company applying its discoveries in human genetics to the development of drugs for common diseases. Their population approach and resources have enabled the isolation of key genes contributing to major public health challenges from cardiovascular disease to cancer. These genes are providing the company with drug targets rooted in the basic biology of disease. The company currently has seven lead programs in drug discovery and development within their target spectrum of 50 of the most common diseases. deCode makes its unique population genomic database available to research institutions, including Emory, enabling a broad utilization of its data. The Emory Department of Neurology has a strong collaborative affiliation with deCode.

Power3 Medical is a leading edge biotechnology company engaged in the early detection, monitoring, and targeting of diseases through the analysis of proteins. This company utilizes proteomics in the discovery of protein biomarkers, drug pathways, and



mechanisms of disease. Current commercial offerings include a ductal aspirate analysis for breast cancer, a serum neurodegenerative disease test, and a serum resistance to chemotherapeutics screen. The breast cancer test utilizes a screen of patient fluid against their panel of 120 biomarkers. The neurodegenerative disease test detects and distinguishes between Alzheimer’s, ALS and Parkinsons. This group offers their analysis to any qualified health care entity but does not become involved in patient care activity nor do they offer genetic or ethics counseling.

Pharmaceutical Companies

Bioalliance Pharma aims to become a leader in developing novel approaches for treating HIV and cancer based on its novel position in the field of drug resistance. Resistance to drugs leads to therapeutic failure and is recognized as a growing public health problem. BioAlliance has chosen cancer and severe infections as its first field of intervention. The company offers HIV predictive resistance assays, nanotechnology drug delivery vehicles, adhesive technology to locate drug delivery systems, and a new chemical entity unit that basically screens novel compounds for bioactivity. This company is filling a niche in the personalized medicine arena with highly focused research programs and specialized drugs.

MDS Pharma Services This company, a medium-sized drug development company focuses on providing early drug development processes up through and including Phase III clinical trials. In addition to conventional drug development activity, MDS offers a biomarker discovery laboratory service. This is a proteomic based process for identifying and validating pharmacodynamic markers of drug activity. Another specialized product is their Predictive Medicine/Pharmotif solution utilizing a proprietary chemogenomics database (DrugMatrix) for gene expression microarray analysis of drug candidates. Large pharma can utilize MDS as an outsource vendor for some drug development work without investing large sums themselves in specialized services. Another niche service in the predictive arena that enables incremental change toward a personalized medicine environment.

Millenium Pharmaceuticals Millennium is using genetic tools to define disease endpoints at the molecular rather than phenotypic (combined genetic and environmental) level to determine which groups and subgroups of patients will respond to a treatment in development, and which patients will fail to respond. In addition, a better understanding of the human genome allows us to better understand the mechanisms of drug toxicity, leading to the development of potentially superior drugs that minimize serious adverse reactions. Millenium is focusing on the molecular aspects of disease and treatment to carve a specialized niche for themselves in the pharma market. To date, Millenium has met stated investor milestones, has developed biomarker-directed drugs, and is advancing their version of personalized medicine. Industry

IBM Life Sciences IBM has a large life sciences program within its comprehensive information technology business. Several medical centers (Duke, Mayo) have aligned with the IBM team and are becoming part of the information-based medicine initiative. The clever acronym (IBM) leads this system whereby routine healthcare information, the data found in an electronic medical record, is integrated with



biomedical data to form a more complete repository of patient data. These early adopters will have real-time access to clinical, genomic and proteomic data enabling clinicians to prescribe more targeted, effective treatments, with the goal of producing better outcomes and achieving lower costs for the system. While selling hardware and software is always an IBM goal, this Life Sciences program also bundles their consulting business into a new package that is proving attractive to the healthcare market.

Siemens, AG Siemens has a broad array of healthcare related products and services, encompassing the traditional imaging platforms to new products that promise full integration of healthcare data management and treatment. Efficiency is a word used often in the Siemens literature which speaks to their consulting emphasis on integration of new and existing systems. Disease specific emphasis is in Cardiology, Neurology, Oncology, Women’s Health, Orthopedics, Urology and Vascular Disease. All these areas are beneficiaries of advanced imaging techniques, the Siemens strength, with a traditional emphasis on high technology diagnostic capabilities.

GE Healthcare GE Healthcare moves beyond GE’s traditional imaging strengths through the acquisition of several biotechnology companies. These acquired companies offer products in information technologies, medical diagnostics, patient monitoring systems, disease research, drug discovery and biopharmaceuticals, all products which are dedicated to detecting disease earlier and tailoring treatment for individual patients. As such, GE is building a predictive medicine platform but it is too early to tell if this will have major impact on the field. Corporate sponsorship is being granted for the 2005 Pacific Health Summit in Seattle.

Emory-Georgia Tech Resources and Opportunities Following are brief summaries of existing resources and opportunities for transforming investments in several areas in the Emory Georgia Tech environment that are relevant to Predictive Health. These summaries are from oral and written evaluations by members of the Steering Committee with special expertise in each of the areas.

Determinants of Health

Genetics/Epigenetics Emory has unusual potential to capitalize on the development of genomic

medicine. The large multi-ethnic, well phenotyped patient population of Emory Healthcare is a rich resource for discovery-based clinical research. Such patient populations are the most valuable commodities in developing the practice of predictive medicine. The entire concept of predictive medicine evolved from the discipline of human genetics. The concept of genomic medicine integrates throughout all disciplines of medicine. It is the rare and exceptional disorder without known genetic risk.

Strengths in the Emory environment include the new Center for Medical Genomics, soon to be led by the former director of genomic laboratory medicine at GlaxoSmithKline. This is a CLIA-certified lab capable of a whole array of genotyping, sequencing and genome expression studies. The Department of Genetics has begun recruiting bridging faculty, those people trained in a clinical medical specialty and trained in human genetics. Areas that could use improvement involve bringing Georgia Tech into this vision. Computational sciences and nanotechnology can significantly



accelerate genomic medicine and this connection between Emory and Georgia Tech has yet to be exploited.

The chart below, also included in the appendix, lists those investigators identified within the Emory and Georgia Tech environment who have active epigenetic research programs and interests.

Epigenetic related work is underway within Yerkes, the Department of Genetics, Department of Biology, the Department of Chemistry, and the Mathematics department within the Georgia Tech College of Sciences.

Epigenetics is an area of genetics that is of increasing interest to the Predictive

Health group. Epigenetic phenomena reflect the environmental and behavioral influences on an individuals’ genome, and as such is a key element in the Predictive Health mission to identify fundamental aspects and determinants of health. Behavior and Animal Models

Experts in various aspects of behavior are scattered throughout the institution. Health behaviorists are housed in the School of Public Health. Sociologists, psychologists, psychiatrists and others are involved in collaborative research that links to sophisticated technologies. The developing Molecular Imaging Center, which involves both PET and MRI is a potential strength in this area. There is a developing focus on neurodegenerative diseases and a grant application for an Alzheimer’s Center as a collaboration between the Department of Neurology and the Yerkes Primate Center is currently under review. There is a developed link to the National Center for Research Resources and the process of developing a test bed for nonhuman primates is underway. A Biomedical Informatics Research Network consortium of which the Yerkes Center is a component will provide transparent access to databases and new technologies including imaging, microarrays, and sophisticated new behavioral assays.

A transforming investment would be in bioinformatics that should serve as a centerpiece of the Institute. Seamlessly linked technologies that researchers and clinicians alike can access will enable them to go forward with the kinds of discovery



and intervention that will be essential to success of the Institute. Bioinformatics will serve as the cornerstone for this possibility.

Environment

Interactions of humans with their environments are a major focus of programs at the CDC, Georgia Tech and the Rollins School of Public Health. These programs involve investigators with expertise in different areas including environmental engineering, epidemiology, air and water safety, nutrition and obesity and many other relevant areas. Elucidation of the influences of environment in the broadest sense on gene expression, metabolic consequences and disease risk will be essential to understanding the new paradigm and will provide important clues to novel interventions aimed at preserving health. The Institute would provide the opportunity to expand the concept of environmental science and to relate this body of knowledge more intimately to preservation of health and risk of disease.

Generic Pathways Oxidative Stress Rigorous control of oxidation processes is essential for normal cell and organ function. Gradual accumulation of oxidative damage leading to progressive dysfunction is thought to be a central element in ageing. It follows that progressive oxidative damage might also be related to chronic conditions associated with ageing, such as: cardiovascular disease; inflammation; immune dysfunction leading to arthritis; susceptibility to infections; malignancy; and neurodegenerative diseases. Compelling evidence exists implicating a role for excessive oxidation in the pathogenesis of these diseases. One possible implication of this mechanistic construct is that multiple diseases share excessive oxidative stress as a common predisposing condition that antedates, perhaps by years or decades, the clinical disease.

There has been intense interest (and progress) in measuring indicators of oxidative stress in human subjects. These efforts elsewhere have focused primarily upon advanced stages of cardiovascular diseases. At Emory a unique environment with a focus on ROS has developed that involves multiple departments, both clinical and basic. Interdisciplinary efforts are translating fundamental concepts of oxidation biology into novel measurements of reduction/oxidation (redox) balance in humans with the goal of relating redox state to preclinical/premorbid correlates of atherosclerotic cardiovascular disease. Preliminary data in subjects selected for the absence of clinical evidence of cardiovascular disease support this idea. Increased oxidative stress in those studies also correlated positively with psychometric indicators of depression. Thus, oxidative stress may be an important indicator of susceptibility not only for cardiovascular disease but also for neuropsychiatric (and likely other) conditions.

Since oxidation correlates with premorbid cardiovascular disease, the absence of oxidative stress may be a measure of “health”. Defining health as a specific molecular phenotype rather than as the absence a “disease” could be a signature program for the Institute that would provide interventions, hygienic or medical, that would preserve health. Achieving these goals would require interactions of multiple departments at Emory and Georgia Tech and would leverage existing strengths in genetics, bioinformatics, proteomics, redox chemistry, cell biology, nanotechnology, molecular



imaging and radiology, biomedical engineering, cancer biology, and nutrition, and public health. The environment and concepts here, taken as a whole, appear to be unique and offer the potential for altering our system from a focus of “disease treatment” to one of “health preservation”. Regeneration and Repair

Regenerative Medicine, the study of tissue repair and replacement by progenitor cells, is a truly cross-disciplinary and evolving field that encompasses virtually every aspect of medicine. The potential here at Emory University is truly unique because of our great strengths in multiple areas of medicine that to reap the greatest rewards from regenerative medicine including cardiovascular, pulmonary and neurosciences. This, coupled with the presence of the internationally recognized tissue engineering initiative at Georgia Tech places Emory in a very unique position to make great strides in this area.

The activities in regenerative medicine are beginning to grow within multiple areas at Emory including cardiovascular The major opportunity for improvement is to coordinate and focus existing activities and to add supplemental expertise in both basic stem cell biology and applied clinical research.

The establishment of a cohesive group of investigators is an absolutely essential component of Emory’s formal move into regenerative medicine. Almost by definition, the field requires individuals with differing expertise in a wide variety of areas. For a regenerative medicine thrust to be successful, we must coordinate these activities under one central group in order to channel our efforts and promote productive synergy. In addition, the effort must initially be well funded by internal funds as established Emory University investigators need support to develop their interests and expertise in this area.

Inflammation and Immunity

Atlanta is a special environment with strong basic and translational research in immunology, public health and quantitative technologies. Emory has a young but strong immunology and inflammation program that has received national and international recognition. We have a strong graduate training program in immunology and molecular pathogenesis. Our Georgia Tech partners are interested in novel antigen delivery technology, immune systems biology, bioinformatics and quantitative immune responses. We have programs with both the GRA and CDC, and these approaches to population based studies through the CDC and other collaborations are a major Emory strength. Current areas of emphasis are vaccine development, measurement of cellular immune response, rejection and tolerance, and microbial immune response. Areas that could use improvement are signaling, innate immunity, B cell immunity, immune regulation, and a greater emphasis on human immune responses. A transforming investment would be a research building or floor to create an interdisciplinary environment for investigators working across the research spectrums of immunology and inflammation and supporting technologies. More clinical space is needed for translational research, and more recruits are needed to strengthen human immunology, immune signaling, innate immunity, B cell immunity and immunogenetics.



Development and Senescence The Lowance Center has built a network of interactions throughout the University

to GT as well as the CDC. Current strengths involve cardiology biomarkers, pathogenic mechanisms in vasculitis, in vitro priming of immune response in middle aged and elderly donors, inflammatory pathways in carotid artery disease, characterizing failure of immune tolerance in rheumatoid arthritis, generating 3-D constructs of human arteries to study vascular inflammation.

A transforming investment would require the development of an infrastructure aimed at identifying and recruiting healthy individuals from the community, follow donors for maintenance or loss of health, data warehousing of long-term follow-up, prospective banking of DNA, RNA and proteins, the procurement, banking and categorization of tissue samples (beyond blood) from health donors and from patients with defined disease states. Such an infrastructure is currently lacking. Identification, recruitment and follow-up of study individuals are left to each investigator. Coordinating such efforts would be a major improvement towards preparing Emory for the clinical research landscape described in the NIH Roadmap initiative.

Technologies Nanomedicine

Nanomedicine is an emerging field which integrates three areas: nanotechnology, molecular biology and medicine. There are three themes which operate within this field: studies of protein nanomachines and complexes in living cells, development of nanostructured probes for molecular imaging and basic biological imaging, and engineering nanodevices for disease diagnosis, treatment and prevention. Emory with its medical school, Georgia Tech with its College of Engineering and the jointly run Department of Biomedical Engineering make us well positioned in nanomedicine. Other unique environmental factors include the established collaboration between nanotech engineers, biomedical researchers and clinicians, and superb administrative support.

Strengths include rapidly increasing NIH funding in nanotechnology science and the applications of nanotechnology in cancer and cardiovascular research. Opportunities are found in the areas of recruitment of additional bio-nanotechnology experts to help establish a national nanotech center, expansion of research into neuroscience and infectious diseases, enhanced organization between Emory and GT, and development of a training program leading to a successful T grant application.

A transforming investment would consist of a core facility within an Institute building. This facility would provide centralized space for research and be an attractant for new faculty.

Imaging

Strengths in this multi-disciplinary area include the various organizational units of the PET Center/Core (Doug Bremner), the PET chemistry program (Mark Goodman), the Biomedical Imaging Technology Center (Xiaoping Hu), the Frederik Philips MR Research Center (John Oshinski), the BME optical imaging program (G. Bao and S. Nie), Yerkes Neuroscience Research Facility (S. Zola), and the WHSC Imaging Services (S. Saini). Opportunities include the necessity of recruiting a faculty expert in



gene reporter imaging, and the acquisition of needed instruments such as microCT and microSPECT scanners and a dedicated research cyclotron. Above all, an organizing structure is needed to pull together the fragmented resources to function as a research unit focused on common scientific goals.

A transforming investment would be to create a multi-disciplinary imaging institute to integrate existing imaging modalities where imaging research, image archiving, analysis and visualization would be centralized. (These were also recommendations of the July 8, 2003 report) Computational Biology/Bioinformatics/Systems Biology

Faculty at Georgia Tech working in related areas of bioinformatics are linked together through the PhD and MS programs in Bioinformatics through the Center for Bioinformatics and Computational Biology. Some faculty focus on basic biological science research with others who focus on translational research, which includes clinical/medical modeling informatics analysis. Much of the Georgia Tech focus is on advancing the modeling and computational tools for bioinformatics.

A transforming investment is the major investment needed for computational facilities, high-speed internet access, efficient servers and backups, and a good IT team to maintain a secure and robust computational infrastructure. Faculty should be hired in this targeted area of bioinformatics. A physical location within the Institute will benefit the researchers by enabling them to interact with researchers in all areas within the Predictive Medicine domain. Quantitative Medicine

Strengths, although quantitative medicine is not yet a recognized theme at Emory, include that research and clinical practice already underway which is quantitative in nature. This includes medical imaging, bioinformatics, metabolomics/proteomics, and molecular imaging. The opportunity is to integrate these areas and develop collaborative research in quantitative medicine themes. A transforming investment would be the recognition and promotion of organized, collaborative research consisting of both basic and translational components. This would move us to the forefront of the field. Proteomics/Metabolomics/Genomics

Emory and Georgia Tech do not appear to have any special advantages other than the potential complementation of strengths that could optimally utilize these technologies.

Transforming investments are envisioned in four areas: • Gene expression array needs standardization and a quantitative format. A

commercial alliance with array producers could provide lower cost expression arrays to perform a broad range of predictive tests. Investments would be required to support information management and bioinformatics capabilities.

• Proteomics needs the development of quantitative procedures to enable the development of a cumulative human proteome data library. The recruitment of clinical proteomics faculty (possibly a GRA position) is needed as is the stimulated use of clinical proteomics analyses for predictive health research.



• Metabolomics needs are the establishment of date-streaming to a cumulative NMR human metabolomics data library, the acquisition of a 900 MHz NMR spectrophotometer with flow cell, and stimulation of methods development for FT/MS use in quantitative metabolomics. An overriding requirement is the need for quality, high-density data analysis,

transmission and storage capabilities. A Center for High-Density Data, if created, could provide divisions for each of the three approaches along with an associated Reference Library Management and Bioinformatics support structure. Key to any of these approaches will be the recruitment of new faculty into these areas and provision of robust bioinformatics and other complementary analytical procedures.

Novel Therapeutics (Drug Development)

Emory and Georgia Tech both posses active programs in drug discovery and development. Major successes in developing new pharmacologic agents have been achieved and there is expertise and infrastructure for development of small molecule pharmacotherapeutics. These efforts include collaborations among the School of Medicine, Emory College and Georgia Tech. There is ample opportunity for those collaborations to develop further and the predictive health focus could stimulate that outcome.

A transforming investment would be the expansion, in personnel and space, of the Emory Chemistry-Biology Drug Discovery Center. This would permit expanded access to its high throughput screening and chemical synthesis services. In addition, high quality laboratory space, proximate to both universities and available for university-based spinout ventures, would greatly facilitate the drug development process.

Disciplines

Business Goizueta and its faculty can integrate with Predictive Health in multiple areas.

These include the development of strategy and organizational design and the commercialization of products and services, through the Zyman Brand Institute marketing, brand management and development services, and the specialized financial skills of asset evaluation as applied to the valuation of licensed products or services that may spin off of the Institute.

Strengths include the significant teaching skills that can be applied to executive leadership related to new ventures, managing highly lateral organizations, and leadership. Weaknesses that exist include the topic of health care management. Other top tier b-schools have teaching and research relationships with their associated health science centers, and Goizueta should capitalize on this opportunity to assist RIPH while developing new internal competencies. A transforming investment would be the development of a health care track. This could take the form of joint degree programs such as a PhD/MBA. Others would be specialized tracks for MD’s and other healthcare professionals through the existing Executive MBA program. Accomplishing this would require faculty expansion to include health care specialists.



Ethics Strengths include the demonstrated commitment of Emory Center for Ethics

faculty to ethics research, scholarship, education and outreach to the Health Sciences. There is a demonstrated commitment to increasing the research emphasis and to support University schools, divisions and Institutes in growing their capacity to incorporate Ethics into their plans. C for E faculty are partnering with Health Sciences faculty to deepen the Emory commitment to Bioethics. Classes are taught in Values of Science and Medical Ethics. University leadership has identified ethics as a defining element of what makes Emory unique.

A transforming investment would be the intentional creation of a mechanism to insure that ethical issues are considered and addressed in all core components and in research projects. Funding for faculty would enable a dedicated, integral ethics presence providing a novel edge to research. This ethicist would allow the creation of companion ethics grants to explore interdisciplinary and translational ethics issues with a corresponding impact on education and training of our students. Population Health

Population health is a major focus of virtually all of the departments in the Rollins School of Public Health. In addition, the CDC has elaborate programs with this focus. These entities will bring deep expertise and experience with population studies and intervention design that will be invaluable in developing the new biomedicine. Integration of population and individual health into the program will enable the Institute to bridge between the two approaches.

A transforming investment would be the enhancement of our capacity in bioinformatics, epidemiology and decision theory/cost utility analysis. Finance and Economics

The Emory Center on Health Outcomes and Quality offers strength in health outcomes studies and is a natural partner to Predictive Health. There will be ongoing questions about cost and benefits of these new techniques and we will be uniquely positioned to address many of these resource and policy questions. This builds upon the 2020 Vision of the WHSC.

Three strategic clinical areas that are leading threats to health are Cancer, Chronic Disease and Mental Health. The Center has ongoing programs and expertise in the analysis of social and economic issues surrounding these threats. Existing Center methodological strengths are in economics and health outcomes measurement. No other organization has pulled this expertise (jointly with Predictive Health) together in this manner. This new organization, along with local and regional partners, gives Emory a unique position that will enable the development of new theoretical frameworks for bridging science, policy, education and practice. Unique outcomes can include: ability to teach trainees in multidisciplinary methods, service to a broader community, expanded ability for early adoption of cutting edge policy, procedure and processes leading to an ahead-of-the-curve healthcare system, enhanced reputation leading to increased ability to attract consumers, practitioners and scholars, and employees who all want to be part of a culture that actively supports health improvement.

Transforming investments would include dedicated resources enabling the



Center to move from a consulting structure to a fully embedded, integrated health services research center, office space for expanded research program, recruitment of senior scholars, development of population based data sources, legal support to address employee participation and privacy issues. There should be a focused effort to develop a long term economic model that transitions the health system over time from a disease to a health focus.

Disease and Organ Focused Programs Cardiovascular Disease The cardiology programs in the Emory Department of Medicine are among the leading such programs in the world. The institution’s rich history in this area, the large, productive and avant garde research program and the highly ranked clinical cardiology program combined make this one of the strongest academic programs in the institution. Especially appropriate to the Institute and the concept of predictive health is the expertise in oxidant stress and its relationship to cardiovascular disease. Work conducted in this program is the basis of a predictive health project supported by the Woodruff Fund that links directly to the Institute planning process. The development of new biomarkers of oxidant stress and the establishment of a biomarkers analytical laboratory are tangible evidence of the division’s direction and relevance to the changing paradigm in biomedicine. Neurologic Disease

There is outstanding potential for predictive health approaches in the neurosciences at Emory. Current strong activities include: existing interdisciplinary clinical programs several neurological diseases, outstanding genetics research in brain diseases, tremendous strengths in Neurosciences at Yerkes with a new Neuroscience Research Facility, a top-ten NIH funded neurology department, an interdisciplinary Center for Neurodegenerative Disease, a number-one ranked interdisciplinary graduate program involving Emory and GT/BME faculty, a unique academic-industry alliance with decode, SPH programs collaborating on the epidemiology of neurological diseases, and image research programs for PET and MRI with a new NIH biomarker project for Alzheimer’s prediction.

Opportunities to improve include the need for additional faculty researchers in proteomics, genetics, and imaging for the neurosciences. Also, enhanced interactions among clinical neuroscientists and colleagues in cardiology, endocrinology and others.

Transforming investments would include a neurosciences imaging facility for clinical research at Wesley Woods, recruitment of several new senior faculty focused on genetics and molecular epidemiology and imaging of neuropsychiatric disorders that can bridge genetics, public health, neurology and psychiatry, and a bioinformatics infrastructure and faculty to develop this area for neurosciences and a bridge to GT strengths. Cancer

Current strengths include drug discovery, a prostate cancer program that included a Program Project Grant and substantial funding from the Department of Defense, a genetic instability Program Project and a Center of Cancer Nanotechnology



Excellence. Additional strengths include national leadership roles in prevention and disparity research occupied by several Cancer Center faculty. Several strong collaborations between the Winship Cancer Institute and investigators at Georgia Tech are in progress and those relationships are continually developing. Cancer biology and its relationship to disease risk and potential therapies should be a vital component of the Institute with strong connections to the School of Public Health and other units of the University.

Transforming investments would include additional faculty experts in bioinformatics, nanotechnology chemists, molecular epidemiologists, phase I clinical trials specialists, behavioral scientists and molecular oncologists, and the space to house these programs.



3. Vision and opportunities at Emory and Georgia Tech Vision

The Institute vision is that “The Emory Georgia Tech Predictive Health Institute will integrate scientific research, education and technology with personalized healthcare. The Institute will pioneer strategies to translate Predictive Health into ethical and economically and socially feasible practice for the benefit of humanity”

To realize this broad, groundbreaking and joint vision will require the full cooperation and closely aligned efforts of Emory University and Georgia Tech. Fortunately, both organizations have strong, compelling visions and missions that are guiding the operations of these two world-class schools. It is within these missions that the seeds of the collaborative effort underway with Predictive Health has found root, and is expressing these efforts within the development of this Plan.

The Emory University vision and mission is: “Emory: A destination university internationally recognized as an inquiry-driven,

ethically engaged, and diverse community, whose members work collaboratively for positive transformation in the world through courageous leadership in teaching, research, scholarship, health care, and social action. Emory University's mission is to create, preserve, teach, and apply knowledge in the service of humanity.”

Emory faculty and administration are united in the application of these positive, transforming attributes toward the creation and implementation of the new medicine as the standard for healthcare, education and research activity across the region, the nation and the world.

The Georgia Tech vision and mission statement includes the following: “Our vision is bold: ‘Georgia Tech will define the technological research university

of the 21st century and educate the leaders of a technologically driven world’. Our mission is clear: ‘to provide the state of Georgia with the scientific and technological knowledge base, innovation, and workforce it needs to shape a prosperous and sustainable future and quality of life for its citizens.’ It is achieved through educational excellence, innovative research, and outreach in selected areas of endeavor”.

With these guiding principles the collaboration with Emory is a good fit to conduct the highly technical and sophisticated research needed to advance the Institute goals. Application of enabling disciplines and technological advances will further the interests and research portfolios of both organizations. Structure

Bringing together two organizations of this caliber can be a daunting endeavor. Structural differences could lead to operational issues further into the relationship. A primary difference between the schools is the private school environment of Emory and the state public school environment of Georgia Tech. Governance of the Institute is proposed to be through an Executive Steering Committee comprised of Emory and Georgia Tech senior leaders. Differences in philosophy, institutional goals and regulatory requirements will need to be worked out through this body to minimize any harmful effects on the Institute. Careful attention needs to be paid to providing buffers for the Institute so that it can function optimally utilizing the best capabilities of both institutions.



It is fully expected that this will be a mutually beneficial and landmark collaboration between Emory and Georgia Tech. Maintaining the optimism and energy around this project can be partially assured by the creation of a detailed operating agreement. This agreement should be the governing document that proscribes and explains how routine operational interfaces will function.



4. Critical Infrastructure, Cultural and Environmental Factors Culture of collaboration:

Emory and Georgia Tech, although populated with the typical academic silos, are fortunate to harbor an undercurrent of willing collaboration across the disciplines and across the institutions. The faculty are aware of the benefits that accrue from open intellectual exchange across the disciplines, and Predictive Health is providing a catalyst for collaboration on a scale without precedent across the institutions. The work performed by the Institute committees during the last year and the work expended in the Emory University Signature Themes reflects the unselfish cooperation in the Emory and Georgia Tech environments. Continuing and expanding upon this culture will be essential to the full implementation of Predictive Health goals and for the realization of the new Emory model of healthcare. Attention must be paid, in the details of workspaces and in faculty incentives, to ensure mutual benefit from collaborative activities.

Outward looking philosophy:

Both organizations have plans and aspirations to become recognized as world class institutions. These world-view cultures support the broad goals of the Institute. The Institute effects will be felt, through the exportable model of the new medicine, on a global scale, and so will significantly contribute to the Emory and Georgia Tech internationalization efforts. Information technology (IT):

Current IT infrastructure at Emory consists of fragmented, isolated systems utilized by the various entities on campus. Emory University maintains the informatics backbone enabling communication across the enterprise and to the outside world, but each operating unit is responsible for their own internal systems. The Colleges either buy or provide their own IT support. Emory Healthcare has a large IT office responsible for running the clinical information systems across the healthcare network. The Health Sciences Center has independent IT operations within each of the Schools that do not directly communicate with one another. Consequently, information and communication remains within isolated pockets that are largely defined by academic units and not necessarily by areas of interest or collaborations. Researchers of necessity have developed their own databases and data storage systems with uneven strategies for data security. Because of this, data is not readily shared, and researchers are not aware of relevant or interesting work going on in their immediate neighborhood unless actively sought out.

Georgia Tech is renowned for their engineering and computational expertise, and already operates with a sophisticated internal IT architecture. It is expected that when the Emory IT infrastructure upgrades are implemented, there will be reasonably effortless electronic communication ongoing between the two organizations.

To realize the full impact of the Predictive Health promise, a highly integrated system will be required that permits the fluid transfer of information across the many individual units. Information transfer and access will be the vital commodity driving the



Institute toward the creation of the New Medicine with all the related impacts on health policy, medical education, and consumer education and behavior.

A recently completed IBM survey of the Woodruff Health Sciences Center IT landscape consisted of a high-level scan across the Health Sciences Center with extensions into the University environment. The survey consisted of about forty five interviews with key faculty and administrators and a detailed analysis of the current IT infrastructure. Recommendations included in the final document, the Solution Roadmap Technical Review, describe an integrated information management structure that permits the bridging of the Research, Clinical, and IT/Operational objectives (see appendix 10). The plan, if adopted, will create new integrated research oriented information architectures over about a four to five year time frame. If fully implemented, Emory will have a sophisticated system where researchers, whether clinical or basic, regardless of Emory location, will be able to access relevant information contained anywhere in the system. The Predictive Health Institute goals require the fluid access to relevant information across the enterprise, making a forward-looking IT environment a necessity.

Conditions are very good for Emory to transform its IT structure into a system that will enable the realization of Predictive Health goals. By doing so, Emory will also become a leader in IT design and implementation.



5. The Implementation Plan

Members of the Steering Committee divided into small working groups to analyze the organizational needs of the institute. Reports were summarized and presented at regularly scheduled Steering Committee meetings. Presentation materials, where available, can be found on the Predictive Health web site.

The essence of the Institute’s goals can be summarized as: To define and measure health using cutting-edge, basic and applied scientific

research. To discover optimal biomarkers of health and understand their interrelationships. To determine the best interventions to optimize health through an individual’s or a

population’s lifetime. To design, using insight from scientific research, ethics, economics and policy, a

predictive health system that can be applied to individuals and populations. Although the ultimate composition of the activities taking place within the walls of

the Institute will evolve as the program develops, the committee felt that several areas should be given priority consideration as early occupants. These areas provide an opportunity to leverage current strengths at Emory and Georgia Tech and identify areas where development will be essential to the global Institute goals. These thrust areas are: Bioinformatics/Computational Biology Chemical Biology Discovery Biomarker Network Analysis and Visualization Genetics/Epigenetics Regenerative Health Molecular imaging Healthy Cohort/Well Clinic

It is recognized that other disciplines will have serious, significant involvement in the work of the Institute and might well have a presence within the physical facility.. These areas, such as ethics, behavioral sciences, economics, health policy, law and business, are not yet fully integrated into the planned organization. A mechanism for full integration will be developed during the implementation activities. Administrative structure (year01)

An administrative structure should be put in place that functionally relates the Institute to the two academic institutions and addresses the several administrative issues that this association raises.

The organizational mission of the Institute is defined as: “The Emory Georgia Tech Predictive Health Institute will integrate scientific research, education and technology with personalized healthcare. The Institute will pioneer strategies to translate Predictive Health into ethical and economically and socially feasible practice for the benefit of humanity”

Leadership of the Institute should consist of three distinct offices: an Executive Board, an Executive Committee and/or Scientific Advisory board, and a Director’s office. The Executive board will be populated with senior leadership from Emory and Georgia Tech. This group will direct the funds flow between the two institutions and the Institute,



and provide broad guidance and direction to Institute activity. The Executive Committee/Science Advisory Board will have a mixture of external and internal individuals selected for their particular scientific or academic expertise, and will advise the Director and the Executive Board on policy issues, scientific directions, regulatory compliance and other operational exigencies. The number of members is not determined, and will realistically vary in time as the needs of the Institute and the parent organizations evolve. An outline of the proposed administrative structure is shown in the figure below.

The Director should have a comprehensive view of the Predictive Health mission and be able to skillfully expand upon the collaborative, interdisciplinary teamwork in place to propel the Institute, Emory, and Georgia Tech into a world-leading position. A major responsibility of the Director will be to recruit candidates for the endowed chairs. It is envisioned that ten endowed chairs in addition to an endowed chair occupied by the Director will be available and offered to individuals who will then be intellectual drivers, catalysts for collaborative engagement, and icons for the scholarly vision of the Institute. All faculty selections will be made by the Director, with the advice and consent of Department Chairs, selecting those scientists and scholars noted for their pre-eminence in their field, but with equal weight placed on their buy-in to the Institute’s mission and their enthusiasm for creating and nurturing creative, synergistic environments involving multiple disciplines.

Ea

R E x te rn a la d m in is tra t iv e

s tru c tu reR e la t io n s h ip s w ith in

a n d b e tw e e n th es p o n s o r in g in s t itu t io n s

E x e c u t iv eB o a rd

x e c u t iv e C o m m itte en d /o r S c ie n t if ic

e v ie w b o a rdD ire c to r

A s s o c ia te fa c u lty

F u ll-t im e In s titu te fa c u ltyfu n d e d b y th e In s titu te

E n d o w e dC h a irs ~ 1 0

C o lle g e o fE n g in e e r in g

C o lle g e o f C o m p u tin g

C o lle g e o f S c ie n c e

O th e rs

C o lle g e o f A r ts a n dS c ie n c e s

S c h o o l o f M e d ic in e

S c h o o l o f P u b licH e a lth

S c h o o l o f N u rs in g

Y e rk e s

O th e rs

Occupants of the eleven endowed positions will hold tenure either at Emory or Georgia Tech. These tenured positions will be assigned to the Institute but chair occupants will hold academic positions and their tenure will reside in the school, college or department of either institution appropriate for their area of expertise. Appointment, promotion and tenure decisions will be recommended by the Director and the appropriate representatives of the candidates department to the Institute Executive Board for further action.

Other administrative functions such as purchasing, payroll, grant administration, financial reporting and other normal operating functions will be conducted through established Emory University departments and mechanisms. The Institute will not duplicate operational functions that already exist in the Emory environment. A written



collaboration agreement governing relationships between Emory and Georgia Tech should be developed to guide and clearly define the everyday interactions between these two institutions related to Institute business. Implementation of the “Virtual Institute” (year 01)

There should be a formal announcement of the establishment of the Institute and the naming of the Interim Director. This would be best done in conjunction with the Symposium to take place on December 19-20, 2005 and should include major efforts to attract national attention. Consideration should be given to some national advertising, for example advertisements in the New York Times or other widely distributed popular vehicles that call the world’s attention to this effort. In conjunction with the Symposium, a high quality brochure should be developed describing the Institute that is aimed at a general audience and distributed to all attendees and perhaps more widely to the mailing list for Symposium invitations.

Investments from the Woodruff Fund approaching two million dollars have been committed to projects in the Woodruff Health Sciences Center that are directly related to the Predictive Health Initiative (the projects are listed in Appendix 10). These projects will be coordinated into a Virtual Institute during the next year supported by the second year of funding of the Predictive Health Initiative from the Woodruff Fund. Coordination will consist of two kinds of opportunities for fostering interdisciplinary communication and potentially identifying new collaborative activities: regular seminars attended by investigators from each of the projects and small “affinity group” informal meetings. The group seminars will take one of several formats:

Presentation of each project’s goals and progress to the entire group. These will be structured so as to allow extensive discussion and should identify potentially productive smaller “affinity groups”.

Topical presentations by experts in a given field either within the Emory-Georgia Tech community or invited outside speakers.

“Journal club” discussions, especially of breakthrough/big idea publications that are relevant to predictive health.

Demonstrations of new technologies and discussions of potential applications Presentations by potential candidates for Institute faculty positions Fast breaking data presentations from predictive health projects or review of

such from other investigators. Faculty (yrs 01-05)

A faculty search committee consisting of senior members of the Emory and Georgia Tech faculty should be appointed immediately. This group should begin to identify world leaders in areas of priority for the Institute and to research their accomplishments and academic and personal situations that may be relevant to their recruitability. By the time the funds necessary for renovations, endowments, recruitments and other Institute related needs are identified, there should be a list of outstanding candidates in hand so that recruitment can be conducted on an aggressive time scale.

The core faculty of the institute will consist of occupants of eleven fully endowed chairs to be recruited over the next five years (the Director and ten additional senior investigators). The eleven endowed Chair candidates should be stellar internationally



recognized scholar/investigators. They could come from among current faculty, but it is anticipated that the majority will come from outside the current Emory or Georgia Tech faculty, infusing the program with new blood. Current Emory/GT faculty will be eligible to hold a Chair, but the desire to not rob departments and schools of their key faculty plus the need to expand the scientific capabilities of the overall environment means that most candidates will be external. Faculty will be recruited jointly by the Institute Director and the relevant departmental chair. Once selected, appointments will be made in the Institute and in a home academic department dependant upon their specialty. Tenure will reside in the departments. Primary office and laboratory space will be within the Institute although additional space may be provided in the home department.

There will be other faculty with full-time engagement in Institute projects. These faculty will also have primary appointments in the Institute with secondary appointments in a home academic department, and may or may not be tenure eligible. Primary office and laboratory space will be within the Institute with additional space provided if needed in the home department. These appointments may be finite or renewable depending on the nature and productivity of the associated projects.

Associate faculty will be those faculty with some affiliation to the Institute such as a secondary appointment or funding from an Institute project. The primary appointments of these faculty will be within their home department, as will their office and laboratory space.

Because one of the basic tenets of the Institute is to not duplicate resources or work that can be done equally well in existing facilities on campus, laboratory space will be reserved for those unique projects, facilities, equipment and infrastructure that fall within Institute mission and goals and complement existing activities.

Visiting Scholars and Institute Fellows will be brought into the Institute on a project basis or by invitation. These individuals will be used to enhance project development when needed and to advance the educational mission through seminars, publications, development of teaching materials and other related activity. These individuals will be provided office and laboratory space as needed for finite periods of time, but they will not be permanent employees of Emory University or Georgia Tech.

The adjacent diagram attempts to illustrate the clustering of faculty around the core Institute group, with strong affiliations to the home academic departments whether at Georgia Tech or Emory.

Associate faculty

Full-time Institute facultyfunded by the Institute

EndowedChairs ~ 10

College ofEngineering

College of Computing

College of Science

Others

College of Arts andSciences

School of Medicine

School of PublicHealth

School of Nursing

Yerkes

Others

A key characteristic of core faculty will be the desire to participate in, not just tolerate, collaboration in fundamentally interdisciplinary ways. The Institute will foster a new level of multidisciplinarity and collaboration. It is expected that core faculty will be recruited because of their scientific reputations and accomplishments with equal



consideration given to their record of enthusiasm for establishing and maintaining productive interdisciplinary relationships. Functional organization (yrs 01-05)

The essence of the Institute is the focus of multiple disciplines on common problems. The Institute by design will be a high performance organization requiring a nimble internal structure to allow rapid evolution of science and facilities to keep pace with the expected accelerated development of the new medicine in its theory and application and to optimize interdisciplinary communication and collaboration. Such a nimble structure, which also permits optimal management direction, often takes the form of a matrix. The Institute is envisioned as a three-dimensional matrix (see adjacent figure as an example of how such a matrix might look) with intersecting nodes of expertise in the generic pathways, the enabling technologies, and the enabling disciplines. Such an organization will permit rapid evaluation of strengths and weaknesses within the organization by the evaluation of how many of the desired nodes are occupied by current or projected faculty members. The matrix also functions as a hiring guide by illustrating those nodes or areas which need additional support. If consistently applied, the matrix will assist the Director and the Board in evaluating the interdisciplinary environment, the composition of the faculty and the content of specific projects.

Internal matrix organizationGeneric pathways, and Enabling

Technologies and Disciplines

t

Anthropology

Enablingdisc ip lines

Ethics

Public Policy

Behavioral Sciences

t

Anthropology

Enablingdisc ip lines

Ethics

Public Policy

Behavioral Sciences

Enabling technologies

Generic processes

Redoxbiology

GeneticsImmunityand Inflammation

Regenera ivemedicine

Generic processes

Redoxbiology

GeneticsImmunityand Inflammation

Regenera ivemedicine

The matrix organization is not a new concept, being found in practice at many organizations including Emory and Georgia Tech. This particular application is noteworthy due to its deliberate design intent of minimizing or eliminating the existing academic and functional silos. Institute goals and policies along with careful faculty recruitment will create a culture that both requires and nurtures interdisciplinary behavior.

Because of this constitutional need for flexibility and close communication, it is expected that the Institute will not grow physically much beyond the envisioned 20-25 major faculty housed within its walls. Growing larger brings the risks of inertia and the development of a hierarchical bureaucracy that characteristically develops as organizations expand. The Institute’s influence and impact will certainly grow beyond its walls as Predictive Health becomes fully developed. University resources will accrue to participating Schools and Colleges as programs and grant support spread outward



through participating faculty and collaborative projects. Content (yrs01-05)

What is done as a part of the Institute will include activities taking place within the Institute walls and collaborative connections between Institute investigators and others across the two universities. The content of the Institute represents those core areas of expertise that define what the Institute will be and how it will interact with the outside scientific and academic community. The Content sub-group recommends that four areas---Computational biology/Bioinformatics, Genetics/Epigenetics, Inflammation & Immunity, and Regenerative Medicine—.comprise thematic cores of the Institute. Other activities that will contribute to all of these areas include molecular imaging, small molecule drug discovery, a biorepository and an outpatient well persons clinic. In addition, it is important to include other disciplines---ethics, health economics, business, law, sociology, etc---as integral participants in the overall process of designing a new and practicable health system.

What should be contained within the walls of the Institute is influenced by the nature of the activity, the needed and available space, timing, existing and developing programs and priority areas for recruitment. A goal is to create an entity that will make it possible to conduct research that is not possible in current facilities. The Institute should be an intellectual “magnet” for scholars interested in the mission of the Institute and committed to broad interdisciplinary communication. Strong consideration should be given to including the following areas within the physical institute during the early stages of its development: Computational Biology/Bioinformatics/Systems Biology The ability to accumulate, store, retrieve and interpret large amounts of data of many different kinds will be essential to the success of the Institute. Resources and expertise in these areas should be given highest priority. There are existing strengths, especially at Georgia Tech, but additional expertise will need to be recruited as well. Regenerative Health There are several pockets of activity in this area in both institutions. These should b e consolidated into a Regenerative Health Program/Center that is housed in the Institute and has extensive collaborative connections with both Institutions. Chemical Biology Discovery There is a recently federally funded center and an emerging productive discovery activity present in the College and the School of Medicine. The Institute could be a home for this activity that could focus on development of novel classes of pharmaceuticals that are directed at maintaining health as opposed to treating disease. Biomarker Network Analysis and Visualization Development and validation of biomarkers of health is essential to development of predictive health in all of the areas of Institute focus. This would include analytical facilities, but also the bioinformatics/computational biology support that will define biomarker networks that comprise more robust predictive algorithms. Genetics/Epigenetics A genetic component will be essential to any effort in predictive health. The developing area of epigenetics is especially attractive as a component of the Institute because it has the promise of linking genomics with environment and behavior and because there may be the opportunity for Emory/Georgia Tech to emerge



as leaders in this area with successful recruiting based on the enormous strengths already present. Molecular Imaging Essential to the clinical application of the Predictive Health concept will be relatively non-invasive methods for obtaining detailed information about organ and cellular structure and function. These methods will be the tools for defining health and detecting early risk and premorbidity and the Institute should be a location where new methodologies are being conceived, developed and tested. Emory and Georgia tech have considerable strengths in this area. This area would include portions of the highly successful nanotechnology investigations that are ongoing as Emory-Georgia Tech collaborations. A Well Persons Clinic Such a facility should be included within the Institute as a place to follow well cohorts of subjects who are participating in prospective health focused studies that will represent the proof of principle investigations that will be the factual basis for design of the new health system. A Biorepository Essential to all of the clinical/translational investigations will be the collection, cataloguing, storing, and security of samples obtained form human beings. Such repositories (called Biobanks) have a number of technical, ethical and scientific issues that must be dealt with so that although this is a support activity, it is also a source of interesting questions for scholarly pursuit. State of the Art Conference and Communication Facilities These should include not only conference rooms, but teleconferencing facilities, broadband electronics, leading edge display technologies. Communication within the Institute and between the Institute and collaborators and interested parties in the Universities, the community and the world will be essential to the mission of the Institute.

Other areas that should be specifically mentioned because of their relevance and potential for contributing in major ways to the Institute goals include nanotechnology, health policy and economics, ethics, business, technology transfer and behavioral sciences. It is virtually certain that some of these areas will be represented within the physical Institute as the program evolves. Functional connections in all of these areas will be critical to the Institute goals. Facilities

The Institute will need a home. It is recognized that existing facilities on the Emory or Georgia Tech campus will not permit implementation and development of this initiative within contiguous space. To build a new building will require site preparation with the accompanying permits and regulatory approvals. The Emory campus does not seem to have a suitable site for a building of the size needed for Institute programmatic needs. And, an Emory site would not be conducive to Georgia Tech faculty participation and might be an impediment to the fluid collaboration and transparent boundaries needed for this endeavor. Additionally, access by the public will be limited on the Emory campus due to the increasing congestion on the Clifton corridor and the resulting lack of convenient parking.

An attractive alternative is the available space within the Crawford-Long hospital. The recent opening of the Medical Office tower has shifted the operating rooms, imaging areas, and labor and delivery to the new building leaving behind vacant space. There are approximately 40,000 sq.ft. of available space which, if renovated, could



house the Institute through its development phase and possibly continue to serve as the creative epicenter of the Institute even when new construction provides room for expansion

The character of the space occupied by the Institute will strongly affect the perception (by those working there and by others) and whether it functions effectively to promote interdisciplinary inquiry. The Institute should have an identity both externally and internally and a character that distinguishes it from a traditional hospital or clinic., The available space at Crawford Long lends itself to meeting those criteria. The space is concentrated at the northwest corner of the building. This provides an opportunity whereby a unique external identity could be created by capturing and redesigning the exterior of that portion of the building. The building that would be designated as the Institute would face toward the Georgia Tech campus and would be visible to passersby from the primary north-south freeway bisecting the city.

Manuel Zeitlin Architects have provided a preliminary concept of how that space might be developed to meet the principal needs of the Institute. In this concept, the 1960’s era annex is transformed from a non-descript and dated building into a signature facility for an Institute at the forefront of healthcare technology. The renovated building could feature a delicate appearing skin of glass protected by a cocoon of metallic screens in a metaphorical nod to the Institute’s mission to protect a fragile life from the genetic, environmental and physical forces working upon it (see adjacent exterior sketches). The metal cocoon shields the interior from direct western sunlight, while allowing generous

daylighting into the work spaces and views of the city beyond. Interior work spaces would be designed as open areas with maximal opportunity for interactions among scholars and investigators working in dry or wet lab space (a sketch of a dry lab work space is adjacent). A video presentation is contained on the web site that includes examples of how floor plans could be structured. Appendix 5 provides some additional detail as well.

Renovation could proceed



with an initial 12,500 sq/ft of space configured to house administrative, programmatic and first-recruited faculty needs with additional space renovated as needed. The plan provides for about 40,000 sq/ft of occupied space by the end of year five, although inclusion of available contiguous space could provide 10,000 or so additional square feet.

Alternatively, the entire space could be renovated at once which would provide economies of construction but would increase the up front costs and would create vacant space that would cost the Institute rent and would not generate indirect cost income until occupied. Renovation costs, using $250 sq/ft as an estimated build-out cost (of 40,000 sq ft), will be approximately $10 million.

If constructed in a modular design, this space would remain top grade research space that could form a permanent home for the Institute even with construction of new facilities that would permit expansion or alternatively could be made available for other University needs if the entire Institute eventually moves into a new facility on the Crawford-Long campus. Advantages inherent in the Crawford-Long location include:

Proximity to both Georgia Tech and Emory University Access to hospital infrastructure for clinical needs such as the proposed “well

clinic”. Public parking and ready access from major thoroughfares A development boost for the SoNo urban revitalization plan The opportunity to build a structure with less restrictive planning needs than

present on the main campus The opportunity to eventually erect a mixed-use building which would be

attractive to other biotechnology, industry, retail and housing uses The opportunity to engage private donors who do not typically contribute to

Emory campus programs The opportunity to solicit government programmatic funding Relatively low-cost renovations needed to begin utilization of the space Renovated space, once not needed by the Institute, could be available as

prime facilities for other Emory programs Disadvantages to the Crawford-Long location include:

Separation from the main campus could discourage or make difficult the fluid interactions that are needed

Faculty may resent spending time commuting through mid-town traffic Parking must be convenient and plentiful, with no extra fees extracted for



parking passes at both Emory main and at Crawford-Long Programs located here are at risk of becoming isolated from mainstream

activity Financing

The financial data presented below represents endowment activity estimates from the Development office, renovation cost estimates from the Facilities office, and NIH grant revenue estimates based on current NIH funding levels for these types of grants.

Projected revenue for years 1 through 7 (fiscal years ‘06 through ‘12):

Revenue FY '06 FY '07 FY '08 FY '09 FY '10 FY '11 FY '12Endowment income 190,000 380,000 665,000 855,000 1,045,000 1,045,000 1,045,000Research (grants and gifts) 1,620,000 3,240,000 7,220,000 9,140,000 12,160,000 12,160,000 13,660,000Institutional support 1,100,000 1,100,000 1,100,000 1,100,000 1,100,000 1,100,000 1,100,000Space (indirect cost recovery) 255,000 680,000 1,360,000 1,360,000 2,040,000 2,040,000 2,040,000

Total 3,165,000 5,400,000 10,345,000 12,455,000 16,345,000 16,345,000 17,845,000 Projected expenses for years 1 through 7 (fiscal years ’06 through ’12):

Expenses FY '06 FY '07 FY '08 FY '09 FY '10 FY '11 FY '12General and Admin 717,000 735,510 754,575 774,213 794,439 818,272 842,820Endowments 4,000,000 4,000,000 6,000,000 4,000,000 4,000,000 0 0Start-up 666,666 1,333,332 2,333,331 2,333,331 2,333,331 1,333,332 666,666Research 56,700 58,401 60,153 61,958 63,816 65,731 67,703Education 175,000 175,000 175,000 175,000 175,000 175,000 175,000Equipment 1,000,000 1,000,000 1,000,000 1,000,000 1,000,000 250,000 250,000Space (rent and renovation) 3,179,000 180,000 3,305,000 180,000 3,305,000 180,000 180,000

Total 9,794,366 7,482,243 13,628,059 8,524,502 11,671,586 2,822,335 2,182,189 Break-even summary:

02,000,0004,000,0006,000,0008,000,000

10,000,00012,000,00014,000,00016,000,00018,000,00020,000,000

FY '06 FY '07 FY '08 FY '09 FY '10 FY '11 FY '12

Dol

lars Revenue

Expenses

These projections assume phasing the endowed chairs over 5 years and include




oft Excel ksheet

MicrosWor

The resources required to operate and develop the Institute are expected to come primarily from philanthropy, grant funding for projects, indirect cost recovery for facilities, and institutional support. A draft seven year budget is attached as Appendix 3 and can be accessed by clicking this icon. This draft budget document contains details which contributed to the summaries above.

the endowments at $2M per chair for eleven total chairs, additional start-up packages of $1M over 3 years for each of the chairs and additional large equipment costs as well as operating expenses. Major costs for implementation will be space renovation, funding the endowed chairs, and providing start-up packages for faculty. Revenue is estimated assuming that each chair holder brings 2 RO1 grants and that there is an additional PO1 grant in years 3, 5 and 7. The chart clearly shows that as the chair faculty are recruited and start-up packages are expensed, the steady-state expenses are at a much lower level than during the first five years. According to the plan, during year 3 the Institute will be at break-even and thereafter will have a positive bottom line.

Costs are organized into three major categories; Programmatic/Administrative,

Lead Faculty, and Facility. The Programmatic/Administrative costs consist of a salary line for the Director, core directorship funding, and administrative salaries for an Administrator, Development Officer and a Public Relations position. The Lead Faculty expenses represent the sum of the annual expenses for Chair salary plus estimated development package costs. The Facility cost represents dollars estimated as needed for renovation of existing space for interim housing of Predictive Health programs and facilities.

Other costs not allowed for in this model are: those faculty salary costs to be borne by the home departments, whether offset by

grant support or from other departmental sources staff salaries for post-docs, fellows, and laboratory support staff. These costs are

expected to be supported from grants or other discretionary funds equipment. An estimate of $5M for likely initial equipment costs is included in the

projection. There are no other equipment expenses in this model, the assumption being that the majority of equipment will be purchased with grant funds

other programmatic expenses which have not yet been identified but which may be materially important to Institute operations Total five year revenue is anticipated from NIH funds for about $57 million in direct

and indirect costs. This assumes an equivalent of two RO1’s per Chair candidate and a projected PO1 series grant by year 3, a second PO1 grant by year 5, and a third by year 7. Expecting a minimum equivalent of two RO1’s per Chair candidate is reasonable because any person considered for these positions needs to be senior enough to bring this much funding with them, or they should not be considered. Likewise the three PO1 grants are a reasonable expectation for faculty within an Institute of this

$56,800,000TOTAL

$15,000,000P Series(two expected)

$41,800,000RO1 and equivalent(two per endowed chair)

Grant revenue estimate (conservative)


magnitude.

The Development office with the Finance sub-committee estimates that, without any endowments, the Institute should expect a five-year total of $25 million to pay operating expense, support the lead faculty, and renovate available space. Endowments will be sought for those expenses. Approximately $20 million will fund the operating expenses including building rent and other programmatic needs. Twenty-two million dollars will fund eleven endowed Chairs, producing about $95,000 per year per Chair for salary support at the current endowment payout rate. Construction of a free standing new building on a vacant footprint adjacent to Crawford Long Hospital that would provide a total of 200,000 square feet of space to house the Institute would cost approximately an additional $60M.

A major emphasis from the Development office will be to identify a major donor or donors who are willing to commit sufficient funds to warrant naming either the Institute, the building, or both, in their honor. It is estimated that a minimum of $40 million will be needed to name the Institute, and a minimum of $33 million to name a free-standing building. A donor contributing both amounts, $73 million, will have naming rights to the entire program and facility. This total number is in keeping with current trends in philanthropy and represents a reasonable target for a donor campaign.

Capital costs are allowed for the building construction only. Other significant equipment or facility modifications may require additional capital above the amount built into the model. Marketing and Identity

Development of the Institute has progressed while using the name “Predictive Health Institute”. This committee is charged with investigating alternative names that would resonate clearly with the general public, philanthropy, and the scientific community. Additionally, the committee is charged with early development of a logo, other business communication needs, as well as the charge to develop materials and strategies needed to link the Emory name with this new medicine.

Early work involved a discussion with the Emory Healthcare Department of Marketing and a consulting group, 800 degrees. The plan was to survey the Steering Committee with an instrument created for Predictive Health by the consultants. First responses were not specific enough to generate a focused document, so the process was deferred until a later time.

Current plans are to resume concentrated effort in the implementation phase of the Institute when more is known about the scientific focus of the Institute, the faculty and disciplines contained, and any philanthropic necessities that may influence the naming process.

The term Predictive Health has some baggage associated with it in the minds of the public, the medical community and even our Steering Committee. Predictive health seems to imply a clairvoyant insight into a person’s health fate with overtones of astrology and determinism. Other opinions are that the term is too bland and does not adequately convey the scope of activity planned across the Emory and GT campuses. And, there may not be sufficient differentiation in Predictive Health from other programs who offer what they call personalized, predictive or preventative medicine programs.



There are commercial entities in operation selling neutraceuticals or complex “executive physicals” and the image of this institute should clearly convey its uniqueness.

Careful thought and planning needs to be applied to the eventual creation of those marketing and identity tools such as a name, logo, and marketing plan to fully capture the adventure and revolutionary developments in human healthcare that the institute will pioneer. Communications

“Getting the word” out to the scientific community will be a priority as the implementation phase of the plan begins. There will be a need for focused communications to facilitate recruitment of those key faculty members as well as more general communications to the public, to policy makers and to governmental agencies. Several communication avenues are recommended.

Symposium: an international symposium is planned for December 19-20, 2005. This symposium is intended to be the public announcement of the Predictive Health Institute and its programs. Taking place at the Emory Conference Center, a group of invited speakers and guests will discuss the future of medicine in light of the current scientific and diagnostic developments taking place at Emory and at other institutions. By the end of the seminar, it is planned that Emory will be the place that individuals in decision making positions think of when Predictive Health is discussed. Publications based on the symposium can help transform this first event into an annual meeting of national and international reputation. Appendix 7 includes the current notification materials and draft program outline.

Mailings: A selection of brochures, well-defined for different target audiences, should be developed for periodic mailings. Specific programs will be developed within the Institute that will require targeted communication for maximum impact on the community. The Emory and GT communications offices will be utilized in the development and application of materials and mailing lists.

Articles: In addition to the expected scientific publications, there should be a series of ongoing articles placed in prominent Emory and GT and more broadly circulated publications describing ongoing activities at the Institute. The Institute web page can be an effective vehicle for e-publishing articles of relevant interest to the varied communities and strategic partners of the Institute. Additionally, the Institute leaders may decide to place various articles about Institute activity, goals and plans in general print media as an outreach to community leaders, decision makers and citizens. For the Institute to realize its goal of transforming medicine in the new century, a broad spectrum of written communication will be a necessary feature of Institute operations.

Web page: A comprehensive web page will be an essential tool for the Institute. Modern communications relies heavily on web page information to reach the largest audience possible. A good web page is a high-impact communication tool which accrues benefits to both the Institute and to the parent organizations. Web page content would include the usual organizational information, program goals and accomplishments, current news, searchable research articles, calendars of public and scientific presentations, symposium proceedings, and other yet to be determined content.

White papers: The Institute should periodically publish thought-pieces that



explain the intellectual and scientific underpinnings of Predictive Health, both as now conceived and as the concept develops in the future. These papers would serve as an information source documenting the intellectual growth of the Institute. Not all papers should be of a scientific nature so they can provide reference material for mainstream media communications. When posted on the web site, this would function as electronic publication and would increase Institute and Emory/GT visibility on search engines such as Google. This is not an insignificant feature when we know that modern information search strategies often, if not usually, involve an internet search by one of the major engines.



6. Implementation Priorities

Following is a list of activities that will comprise the implementation of the strategic plan for the Institute.

• Creation of Executive Board Establish charter, begin regular meetings Membership list (Dr. Johns, Dr. Giddens, Pres Wagner, Ken Brigham) Document overall goals for Institute Plan recruitment of permanent Director and key faculty

• Appointment of Interim Director • Creation of Advisory Board/Scientific Advisory Board

Establish charter, begin regular operations Membership list: to be determined, strong input from Executive Board Define research parameters, oversight process Define meeting calendar and provision for special meetings as needed

• Creation of faculty search committee High level panel to conduct national/international search for Chair candidates

• Create memorandum of collaboration between Emory and Georgia Tech Details of operating agreement to include: Governance Relationships between operating areas Usage of University infrastructure HR Finance and accounting Office of Sponsored Projects IRB Clinical Trials office Approval by Executive Board Dissemination to Schools, Colleges, Chairs and faculty

• Organization of projects Woodruff project underway in Dept. of Medicine, $400,000 total over FY ’05 and ‘06

Seven Woodruff projects initiating Sept 1 2005, $1.85M over FY ’05 and ‘06 Track projects and document results as an Institute portfolio Plan five years out – look for maximum return in investment, monetarily and scientifically

• Faculty relations Plan parking location and costs (free for faculty) Develop transportation from C-L to both Emory and GT Existing Emory shuttle Existing GT trolley extension to C-L Evaluate dedicated system needs Monitor development of issues around movement between locations

• Plan for philanthropic campaign Establish development liaison person Establish campaign focus, set targets and goals



Track results • Renovation of C-L space, plan for phased growth

Total 40,000 sq.ft. available at C-L Initial 12,500 sq.ft., add blocks of 12,500 sq.ft. (or more) as needed when key faculty are recruited

• Consider plan for free standing new building • Plan for recruitment of endowed chair faculty

Identify candidates Plan development packages customized to research needs Allocate space and resources as appropriate Plan acquisition of capital equipment as appropriate

• Plan for associated faculty Allocate space as appropriate: research needs and/or funding availability

• Emory/GT and public web pages Preserve core information in current private web site Create new public web page Create an internal, secure space for Emory/GT personnel

• Provide for usual information dissemination plus any unique programmatic touches that may be relevant

Mechanism to schedule meeting rooms Links to resources within and without Emory/GT, calendars

• Create plan for scientific and public programs Visiting Scholars Determine programmatic needs Solicit applications for position or directly contact preferred individuals Fellowships Identify funding Establish programs – may be tied to specific laboratories or programs Does not need to be physically in Institute space

Advertise for candidates Public programs---Develop schedule, identify speakers and topics, develop materials, advertise (liaison with WHSC communications office)

• Communications plan for public/scientific awareness Newsletter for general release Glossy, pertinent news about research, programs and outreach Scientific updates e-distribution to mailing list available from web site for downloading Newspaper advertising for “well clinic”

• Establish navigation plan for moving “well clinic” people through space to appropriate rooms

Signage in building, outside of building

The Gannt chart below provides an overall visual timeline for accomplishing these several tasks essential to implementation of the strategic plan.



A full size chart is located in appendix 9



Appendix 1: Committee members and affiliations Don Giddens, Ph.D. Wayne Alexander, M.D., Ph.D. Professor Professor Dean, College of Engineering Chair, Department of Medicine Georgia Institute of Technology School of Medicine Georgia Research Alliance Eminent Scholar Emory University Xiaoping Hu, Ph.D. Gang Bao, Ph.D. Professor Professor Director, Biomedical Imaging Technical Center Biomedical Engineering Department of Biomedical Engineering Georgia Institute of Technology Georgia Tech/Emory University and Emory University Georgia Research Alliance Eminent Scholar Doug Bremner, M.D.

Professor Dean Jones, Ph.D. Professor Psychiatry/Radiology Director, Clinical Biomarkers Laboratory School of Medicine Department of Medicine Emory University School of Medicine Emory University Kenneth Brigham, M.D. Professor

Vice-Chair, Research Fadlo Khuri, M.D. Professor Department of Medicine Associate Director, Clinical Trials and Translational Research

School of Medicine Emory University

Winship Cancer Institute Emory University Ray Dingledine, Ph.D. Professor and Chair

Department of Pharmacology Kathleen Kinlaw, M.Div. Professor School of Medicine Director, Ethics Center Emory University Graduate School Emory University Robert Drazin, Ph.D. Professor

Organization and Management Jeff Koplan, M.D., M.P.H. Professor Goizuetta School of Business Vice President for Academic Health Affairs Emory University Robert W. Woodruff Health Sciences Center Emory University Merrick Furst, Ph.D.

Professor Assoc. Dean, Undergraduate Programs Howard Kushner, Ph.D.

Professor College of Computing Nat C. Robertson Distinguished Professor Georgia Institute for Technology Rollins School of Public Health & Graduate Institute for Liberal Arts Ernest Garcia, Ph.D. Emory University Professor Department of Radiology

School of Medicine Eva Lee, Ph.D. Associate Professor Emory University Director, Center for Operations Research in Medicine

Industrial and Systems Engineering Georgia Institute of Technology and Associate Professor



Winship Cancer Center School of Medicine Emory University

Sanjay Saini, M.D. Professor Chair, Department of Radiology School of Medicine Emory University Allan Levey, M.D. Professor

Chair, Department of Neurology Dong Shin, M.D. Professor School of Medicine Department of Oncology Emory University Winship Cancer Institute Emory University Lanny Liebeskind, Ph.D. Professor

Department of Chemistry David Stephens, M.D. Professor Senior Associate Dean, Research Director, Division of Infectious Diseases Emory College Department of Medicine School of Medicine Dennis Liotta, Ph.D. Emory University Professor Department of Chemistry

Emory College Claire Sterk, Ph.D. Professor Chair, Behavioral Science and Health Education Richard Lipton, Ph.D. Associate Dean, Research Professor Rollins School of Public Health Assoc. Dean, Special Projects Emory University College of Computing Georgia Institute of Technology

Frank Stout Vice President, Research Administration Robert Nerem, Ph.D. Office of Research Professor Emory University Chair, Department of Engineering in Medicine Georgia Institute of Technology

Ora Strickland, R.N., Ph.D. Professor Kathy Parker, R.N., Ph.D. Family and Community Nursing Professor School of Nursing Adult and Elder Health Emory University School of Nursing Emory University

Ken Thorpe, Ph.D. Professor Leslie Real, Ph.D. Chair, Health Policy and Management Professor Rollins School of Public Health Department of Biology Emory University Emory College Eberhard Voit, Ph.D. Kimberly Rask, M.D., Ph.D. Professor Associate Professor Department of Biomedical Engineering Health Policy and Management Georgia Tech/Emory University Rollins School of Public Health Georgia Research Alliance Eminent Scholar Emory University Steve Warren, Ph.D. Francois Sainfort, Ph.D. Professor Professor Chair, Department of Genetics Health Systems, Industrial and Systems

Engineering School of Medicine Emory University Associate Dean for Interdisciplinary Programs College of Engineering

Georgia Institute of Technology



Cornelia Weyand, M.D. Professor Lowance Center for Human Immunology Department of Medicine School of Medicine Emory University Stuart Zola, Ph.D. Professor Director, Yerkes National Primate Center Emory University ex officio Lynn Cunningham, M.S., M.B.A. Research Institute for Predictive Health Emory University WHSC Strategic Planning Office: Sara Atwater, M.P.H., M.B.A. Planning Associate Strategic Planning Shari Capers, R.N., M.B.A., M.H.A Associate Vice-President Strategic Planning



Appendix 2: Timeline of activity since December 2004



Appendix 3: Estimated costs worksheet



Appendix 4: Key faculty recruitment targets The recruitment and appointment of faculty leaders will be a critical part of the implementation work. The plan is to phase the hiring with approximately two per year over the five year plan. Close coordination with the philanthropy plan will be necessary to ensure sufficient endowment funds for each planned Chair. The plan does not address which Chairs should be recruited first, or what disciplines the Chairs should represent. This will be determined through the ongoing activity of the Executive Board and the Advisory Committee.

0

2

4

6

8

10

12

FY '06 FY '07 FY '08 FY '09 FY '10

Faculty positions

Faculty positions



Appendix 5: Architectural vision

The new Predictive Health Institute will be housed in a rehabilitated section of the Crawford Long Hospital. The 1960’s era annex is transformed from a non-descript and dated building into a signature facility for an Institute at the forefront of medical technology. The newly renovated building will feature a delicate skin of glass protected by a cocoon of metallic screens in a metaphorical nod to the Institute’s mission to protect a fragile life from the genetic,

August 26, 2005 CONCEPTUAL DESIGN PROPOSAL Emory – Georgia Tech Predictive Health Institute
environmental and physical forces working upon it. The metal cocoon shields the interior from direct western sunlight, while allowing generous daylighting into the work spaces and views of the city beyond. As part of Emory University and Georgia Tech’s ongoing commitment to the environment, the building will be engineered to meet LEED Silver Certification. LEED is a national standard for sustainable building developed by the U.S. Green Building Council. See www.usgbc.org for more LEED information.

http://www.usgbc.org/


Appendix 5 cont.:

The first phase of development will include the renovation of at least the second and third floors with some programmatic functions potentially located on the fourth floor. There are four basic components of the building program: Well Clinic, Administration and Conferencing, Dry and Wet Labs. Rather than allotting an entire floor to a particular zone as is typical of laboratory design, the zones are stacked vertically throughout the building and connected with open, vertical circulation cores. The diagrams on the left show how each zone can be accommodated on the second floor. The Well Clinic is located at the front of the building along Linden and can be accessed from the ground floor. Wet Labs are located at the far south end where mechanical systems can be more easily accommodated. Labs can extend into the western end of the Crawford Long Hospital as needed. Dry Labs are located between the clinic and Wet Labs and serve to connect the two. They could consist of open, mobile workstations and small conference areas that serve as not only workspaces, but also as places for interaction and programmatic integration.

Second Floor Plan Diagrams (Top – Bot.: Well Clinic area, Dry Labs, Wet Labs.)

Third Floor Plan Diagrams (Top – Bot.: Administration, Dry Labs, Wet Labs.)

The third floor diagrams to the left show how the laboratory and administration zones are stacked above their counterparts on the second floor. Each zone has a vertically communicating, open atrium core for free circulation of information and personnel throughout each zone and throughout the building. Administrationand conferencing stacks above the Well Clinic and the Wet and Dry Labs stack through the second and third floors. Much of the circulation through the building can be collected in a central area that offers common amenities creating shared paths and destinations. This centralization combined with the openness of the plan offers the opportunity for chance encounters, information exchange and “water cooler inspiration.”



Appendix 6: IBM Solutions Roadmap executive summary (draft form)

Predictive Health Purpose The vision that the synergistic juxtaposition of clinical practice, scientific research, and effective data management will perpetuate lower costs, better care, and healthier patients has been the dream of most Academic Medical Research Centers for years. Today, the advances of Information Technology and the honed tenets of Predictive Health can truly make that dream into a reality. A Predictive Health initiative is often seen as the conduit to curing disease before it strikes. The integration and mining of typically disparate phenotypic and genotypic data inevitably leads to discoveries in patient care. Such discoveries thus identify clinical protocols that may be applied in clinical practice, prospectively. Accordingly, Emory seeks to bridge its Clinical, IT/Operational, and Research objectives.

Figure 1: Predictive Health Foundation

ClinicalCare

IT/Operational Research

PredictiveHealth

Such goals and objectives for a Predictive Health Institute are summarized across: 1. Establishing the competitive advantage in the field of Predictive Health 2. Attracting and retaining world class physicians, clinicians, and researchers at Emory

University 3. Investing wisely in the business and technical processes required to gain an Emory

competitive advantage 4. Optimizing Emory’s existing infrastructures, technologies and resource investments 5. Optimizing the researchers’ productivity by streamlining their ability to access and utilize

data more effectively 6. Aligning with the NIH Roadmap for Medical Research (please see Appendix M for specifics) 7. Optimizing the grant approval structure to improve grant approval rates 8. Introducing enabling technologies to the research disciplines 9. Enhancing Cohort Management capabilities 10. Improving quality, efficiency, and consistency of patient care (prospective and retrospective)

Emory – Predictive Health Solution Definition Emory’s goal to become a leader in Predictive Health and a “Destination University” has been fostered in recent years by investments toward achieving that goal which include, but are not limited to: EeMR environment within Emory Healthcare Clinical PHR repository foundation within Emory Healthcare Yerkes National Primate Research Center Predictive Health initiatives under the direction of Dr. Brigham Neurology infrastructure to enable the deCode communication structure NuTec infrastructure to enable Oncology research

The Three-Phase Solution Roadmap, which was based on collaboration with key Emory IT,



Research, and Administrative staff, will continue to build on the Emory investments to date by recommending a focus on research data relevant to the three major disease states:

o Cardiology o Neurology o Oncology

In addition to the three major disease states the common thread of “Omics” (Proteo, Cyto, Pharmaco, Geno, and Metabalo) data, is included in our data consolidation strategy long term. The Three-Phase approach outlined in this document points to a Personalized Health Repository (PHR) repository as the major component of the solution architecture. The PHR would act as the central repository of the critical clinical and research data for the construction of a strong foundation for research, discovery and advanced healthcare quality analytics. In Phase One, the Clinical Data Warehouse (CDW) will be augmented to create a Personalized Health Repository (PHR) within a Portal-based framework of enterprise data for the three major disease states from the following systems: EeMR Cardiac Databank Neurology DB Oncology (NuTec landing zone foundation: Cancer Anatomic Pathology, Radiation

Oncology, Cancer Registry) The final components of the Phase One deliverables will include:

1. A Cohort Management Application 2. A Cardiology Follow-up Application 3. A Text Mining Application

Phases Two and Three will enhance the Phase One foundation by adding priority data sources that will be validated at the conclusion of each preceding phase, introducing advanced textual mining techniques, integrating and/or interfacing with additional Emory Healthcare and Emory University legacy systems, external third party data sources (i.e. caBIG, BIRN), and public data sources, advanced query, analytics and data mining techniques, and document annotation as needed.

Solution Benefits and Payback The benefits to the Emory Solution are numerous and overarching. Some of the benefits include but are not limited to:

1. Provides a collaborative environment for researchers and clinicians to perform and publish analysis that can be shared with the community to foster additional research and provide better patient care via the implementation of more comprehensive disease management programs

2. Provides a forum for the integration of clinical, genomic, and imaging data 3. Extends the researchers arm to efficiently access and integrate available public data to

support the research disciplines. 4. Augments the data accuracy and consistency of institutional data through the creation of

a centralized and uniform data model that is linked with EeMR 5. Enables a three tiered high level of security enforced through a layered approach that

works within and enforces the current Emory research authorization guidelines and provides for the auditing and tracking of data access.

6. Leverages Emory’s existing investments in infrastructure, tools, and other technologies that will enable a more expedient and cost-effective deployment of the PHR.

Payback is further decomposed in the body of this document spanning the areas of Research, Clinical Quality, and IT/Operational from hard, soft, and intangible value calculations. A few



highlights are listed below: 1. Emory could move up one or more NIH rankings through the increased sponsored

research that will be enabled by the Emory Solution, with each NIH ranking step representing approximately $10-20 million in funded research."

2. A PHI solution should show payback within the 3rd year of at least 10%. 3. A PHI solution will lead to an increase in “academic currency” (more publications, grants,

and visibility), all of which support Emory’s goal of becoming a “Destination University.”

Cost Estimates The total cost of implementing a Predictive Health environment at Emory is estimated to be between $18 million and $20 million over 3 years. This cost reflects an investment in current technology enhancements, development related services (internal and external), and continuing research staff and operating costs.



Appendix 7: Symposium planning Save the date notice (draft form) to be broadly distributed.

SAVE THE DATE

December 19-20, 2005

Seeking Ponce’s Dream

The Promise of Predictive Health: A Symposium

Presented by the Emory / Georgia Tech Predictive Health Institute Emory Conference Center

Atlanta, Georgia

Someday we will be able to identify patients at risk for disease long before symptoms appear and stop disease before it starts.

Even had Juan Ponce de Leon found the fabled fountain of youth, it still would not have saved the explorer

from an arrow when he visited “Pascua de Florida” in 1521. Today, the promise of prolonged, if not perpetual health is as potent a motivator as it was for Ponce de Leon. Existing and emerging science and

technology give substance to the hope, even expectation, that we can understand health and how to keep it at a depth that was unimaginable even a decade ago. We will know how to live longer and better, but

translating that understanding into practice poses challenges beyond science and technology. Extended life spans will require major changes in how human beings – scientists, health practitioners, people in general –

behave.

This symposium will engage biomedical scientists and leading thinkers in conversations about what the new biomedicine can be and how we can make it work.

The Research Institute for Predictive Health — a collaboration between Emory University and the Georgia

Institute of Technology — is creating a new model of health and healing for the 21st century. This new paradigm will define the unique intrinsic and environmental characteristics that predict disease risk for individuals and will emphasize definition and maintenance of health rather than treatment of disease.

Keynote Speakers Lee Hood, PhD Institute for Systems Biology, Seattle Ralph Snyderman, MD Duke University Health System Tom Wolfe Author Other Invited Speakers Include: Martin Blaser, MD New York University Medical Center Linda Griffith, PhD Massachusetts Institute of Technology Emory and Georgia Tech Presenters Include: Michael M.E. Johns, MD Jeffrey Koplan, MD, MPH David H. Ledbetter, PhD Francois Sainfort, MD David Stephens, MD The Research Institute for Predictive Health gratefully acknowledges the support of the Robert W. Woodruff Health Sciences Center Fund for making this symposium possible.

Look for more information in early fall. If you have questions, please contact Lynn Cunningham at [email protected] or 404-727-6543. To register today, visit www.______



Sample of day 1 agenda (draft)

D ay 1- D ecem ber 19, 2005 O pening – M . Johns 8:30- 8:40 am 10 m in K eynote L ecture –L . H ood 8 :40 – 9:00 am 20 m in B iology of H ealth : G enes ( D . Ledbetter) Speaker 1 S teve W arren, PhD

C hair, D ep t of G enetics E m ory U niversity 9 :00 – 9:30 am 30 m in

Speaker 2 9 :30 – 10:00 am 30 m in M ini-panel 10:00 – 10:20 am 20 m in B R EA K 10:20 – 10:50 am 30 m in B iology of H ealth : In fections (D . S tephens) Speaker 1 M artin B laser, M .D . 10:50 – 11:20 am 30 m in P rofessor and C hair D epartm en t of M edicine P rofessor o f M icrobio logy N Y U M edical C enter Speaker 2 D avid S tephens, M .D . 11:20 – 11:40 am 20 m in P rofessor and E xecutive V ice-C hair C hief, D ivision of Infectious D iseases D epartm en t of M edicine E m ory U niversity School o f M edicine M ini-panel 11:40 – 12:00 noon 20 m in LU N C H 12:00 noon–1:00 pm 60 m in B iology of H ealth : O xidative S tress (W . A lexander)

Speaker 1 S tan H azen, M D , PhD 1 :00 – 1:30 pm 30 m in C leveland C lin ic

Speaker 2 1 :30 – 2:00 pm 30 m in M ini-panel 2 :00 – 2:20 pm 20 m in

B R EA K 2 :30 – 3:00 PM 30 m in



Appendix 8: Web site structure and function The Institute web site has been a valuable tool for Committee members and other involved individuals to stay current in Institute planning activities. The web site, protected from outside viewing by a password, serves as the repository of all committee and sub-committee meeting agendas and minutes. Additionally, the Interim Report and the University Theme report are located here. These four screens serve as examples of what is located on the web site. The first screen is the introductory page which displays in the top menu bar all subsequent choices. The second screen is the Overview page. This area contains an index on the left margin of each committee and group that functioned within the Institute planning process. This screen is what is displayed when the “Steering Committee” then “Administrative Structure” menu item is selected. Here are the meeting minutes and presentation slides.



The “Summary Reports” section contains the Interim Report and the Signature Theme report. Implementation plans described in the body of this report contain detail for how this web page will be expanded and, where applicable, extended to private access within Emory and Georgia Tech, and to public access as needed.



Appendix 9: Timeline for years 1 through 5



Appendix 10: Woodruff Foundation funded projects

The Woodruff project for FY ’05 is “Initiation of a Study of Biomarkers of Oxidant Stress as Predictors of Health and Disease Risk”, Wayne Alexander, PhD, MD, Principal Investigator. This is funded at $200,000 in FY ’05 and $200,000 in FY ’06.


predictive health strategic plan - emory...

Documents