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BE 241A

Fall 2012

Term Project for BENG 241A Foundations of Tissue Engineering Science Tissue engineering requires the integration of biological sciences including metabolism and (patho)physiology, with engineering analysis. Engineering formalization includes problem definition, problem analysis, design, development, and testing. The integrative approach usually requires attention to multiple spatial scales, from molecular, cellular, tissue, organ, to organ systems, and to a variety of time scales, from <1s to >1yr. The term project is intended to allow you to (1) learn about a specific medical disease or condition of interest to you, (2) review the latest advances in Tissue Engineering related to this disease, (3) apply the bioengineering method, within a guided framework, in order to propose a solution based on a tissue engineering approach, and (4) write a complete and concise proposal. The project will be due in phases, as described below. Please note the following issues. Teamwork. The project will be completed in teams of 2. At the end of the course, each teammate will be surveyed to assess the contribution of their teammates and themselves. In each of the documents handed in, please include an Acknowledgments and Contributions section where you can identify, briefly, who provided substantive assistance to you in the project (i.e., the acknowledgment part), and also who on your team did what. Document Formatting. Each part of the report should be turned in electronically as a document that is 11 pt Arial font, line spacing set at exactly 12 pt (or single-spacing), ≥0.5” margins all around. Each page should have a header that includes your name, date, project title, Team #, as well as a footer that includes the page number. Figures. In the form of sketches, photos, and schematic diagrams are an essential part of the proposal. A carefully constructed figure will help portray and also amplify the information that is described in text. All figures must have a title and description. If a figure from another source is copied or adapted, it must be referenced in the figure description. Figures should be imbedded in the text and count towards the page limit. While several figures are encouraged, excessive use of figures without much text should be avoided. References. Each part should also be turned in with a References section that is a cumulative list of references which are cited in the appropriate locations in your document. Under References, provide the full citation using a standard format (e.g., New England Journal of Medicine). Most websites are not appropriate (i.e. Wikipedia). If a website is appropriate, make sure to include accession date for internet. Citations to references should be provided for text that need support and for figures that are copied or adapted.

Ted. All documents should be uploaded to Ted as a .doc or .docx file under the appropriate assignment. The team assignments need only be submitted by one team member. Use a filename that includes your team #. The size of the file should be reasonable (e.g., <5 MB). Updates & Grading. You are encouraged to update prior sections, so that your Final Project represents an integrated design. If you make changes to a section handed in for a prior phase, please indicate that using the revision mode of Microsoft Word, with a vertical line in the margin. Writing Tips. The report is to be in the form of a proposal, somewhat similar to that which might be submitted to the National Institutes of Health (NIH) or the National Science Foundation (NSF). Guidelines for general format and discussion of good grantsmanship are detailed at the web sites below. Helpful Websites NIH. NIH evaluation criteria are: • Significance: Does the study address an important problem? • Approach: Are the design and methods appropriate to the address the aims? • Innovation: Does the project employ novel concepts, approaches, or methods? • Investigator: Is the investigator appropriately trained to carry out the study? • Environment: Will the scientific environment contribute to the probability of success? NSF. The main body of the proposal should be a clear statement of the work to be undertaken and should include: objectives for the period of the proposed work and expected significance; relation to longer-term goals of the PI's project; and relation to the present state of knowledge in the field, ... and to work in progress elsewhere. The statement should outline the general plan of work, including the broad design of activities to be undertaken, an adequate description of experimental methods and procedures and, if appropriate, plans for preservation, documentation, and sharing of data, samples, physical collections and other related research products. Brevity will assist reviewers and Foundation staff in dealing effectively with proposals.

Each proposal will follow the same, basic outline: Cover Page: Title, Date, Authors, Abstract A. Objective, Hypothesis and Aims B. Background and Significance C. Bioengineering Problem Definition and Analysis D. Innovation E. Approach F. Human Subjects G. Vertebrate Animals H. Acknowledgements I. References Phase 1: Team Formation & Selection of Medical Problem (Week 2) The formation of teams will be done based on your interest in a particular medical disease. For ideas on types of designs that may be appropriate, good sources of ongoing work are Research Grants, sponsored by the NIH,, and the NSF, Phase 2: Background and Significance (Weeks 3-5) Title, Date, Authors (1 page) • Please include a cover page with this information, appropriate for the group/individual effort. B. Background and Significance (max 6 pages, at least 4 must be text) This section should define the problem and current solutions, i.e., the medical disease/condition, current treatments, and the Tissue Engineering State-of-the-Art. B.1. Introduction and Clinical Manifestations (~1/4 page) General statements about disease, classification and subtypes. What are the clinical symptoms and sequelae? B.2. Clinical Incidence and Epidemiology (~1/4 page) How prevalent is the disease? Among particular subsets of the general populations? Are people from certain regions or genetic background affected? B.3. Pathogenesis (~1/2 page) How does the disease start and progress? What are the underlying mechanisms of disease, at the molecular, cellular, tissue, and organ levels? B.4. Bioengineering Basis for Therapy (~1/2 page) What are the quantitative needs for therapy in terms of tissue composition, structure, function, and metabolism? At the cellular level, How many cells of various types are present? What are their metabolic functions, quantitatively? At the tissue level, same issues for matrix components? At the organ level, same issue—how are the cells, matrices, and tissues integrated to form an overall functioning tissue?

B.5. Conventional Treatments (~1/2 page) What are the types of conventional treatments? Pharmacological-classes of drugs, modes of action? Surgical? What is their effectiveness? What are pros and cons? B.6. Tissue Engineering Therapies (~2 pages) What are approved TE treatments, by what company, etc? What types of treatments are in clinical trials (may be hard to find)? What experimental therapies are being investigated (group these based on approach)? This section should be an in-depth and comprehensive review of all major advances in the last two years, to set the stage for each individual project. Use subsections. H. Acknowledgments and I. References • Accumulate these sections, with each Part turned in. • Under Acknowledgments, provide a running record of consultations, names of people, dates and time spent for consultation. • See above for References format Phase 3: Idea Formulation (Week 5-7) A. Objective, Hypothesis, and Aims (1 page max) Objective: Elaborate on the medical condition you will address. Explain what the tangible and intangible costs are of the condition to persons affected and to society at large. Describe the aspect of the overall problem you will address in this proposal and your approach, including a statement of the hypothesis you intend to test if your project is based on a strictly scientific concept or, if based on an engineering design, state the engineering objective. Include a diagram or figure to describe your device if appropriate. Describe your expected outcome, and how this will lead to a broader solution. Aims: State the specific objectives (aims) of the Phase I research and development effort, including the technical questions you will try to answer to determine the Phase I feasibility of the proposed approach. State concisely and realistically what the proposed research is intended to accomplish in terms of its potential for technological innovation and commercial application. Define the proposed product to ultimately be developed. Include milestones for each of the aims and how the proposal relates to your long term goals. See lecture for more info Title Page, including Abstract • Modify the title as is appropriate for your individual project. • Note your name, separately from that of your group members. • Draft an abstract. Use only 0.5 page, <300 words. The abstract should summarize the importance of the research and your idea itself. H. Acknowledgments and I. References See above.

Phase 4: Design Proposal (Week 8-10) C. Bioengineering Problem Definition and Analysis (3 pages max) • 1 page for the engineering problem definition and goals, including a schematic. • 2 pages for possible solutions, with engineering analysis and calculations. Typically, the key to the success of a novel tissue engineering solution is a definition of a specific problem in engineering terms, and development of an analytical or computational solution. To emphasize the need for modeling, this part should be developed into a homework-like problem and solution. The problem should have an engineering schematic. Considerations: Does the problem reflect an appropriate mechanistic (rather than phenomenological) analysis? D. Innovation (~1 paragraph to ½ page) Explain how your project's research can refine, improve, or propose a new application of an existing concept, method, instrumentation, or clinical intervention OR how it can shift a current paradigm. E. Approach (4 pages max) Outline the experimental design and the procedures to be used to accomplish each of the specific aims of your project. Include means by which the data will be collected, analyzed and interpreted. Describe any new methodology and the advantages over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. Give specific performance targets. Use various appropriate subheadings. End with a conclusion statement. Experimental Design can be described in several ways. Typical nowadays is to have three sub-sections under each specific aim: (a) Rationale (summarize background and preliminary data that specifically are related to this experimental approach, restate hypothesis if relevant), (b) Proposed Development & Studies (describes fabrication & experiments in detail), (c) Anticipated Results and Limitations (this is where you mention what you might expect to find, and that you have solutions in hand for anticipated problems.) Considerations: Is the experimental design adequate to achieve the aims? Is there sufficient detail to conduct the design validation? F. Human Subjects (no page limit, but be succinct) If there will be no human subjects, so state. If you intend to use human subjects in any way, you must address a large number of issues, including: A detailed description of the involvement of human subjects. Characteristics about the study population such as age, number, sex, ethnic background, etc., and if the ratios represent local population distributions. Criteria for inclusion or exclusion and plans for recruitment of subjects. Potential risks - physical, psychological, social, legal or other - and their likelihood and seriousness. Describe procedures for minimizing potential risks. Explain why risks are reasonable in relation to anticipated benefits. Provide assurance of adherence to human subjects regulations. If a test article is involved, describe in detail the status of FDA approval.

G. Vertebrate Animals (no page limit, but be succinct) If there will be no animal subjects, so state. If you plan to use vertebrate animals, you must address a number of issues, including: A detailed description of the proposed use of the animals in work previously outlined in C, above. Identify species, strains, ages, sex and numbers of animals to be used. Justify the use of animals and their numbers. Provide information on the veterinary care. Describe procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices where appropriate to minimize discomfort, distress, pain and injury. Describe the anesthesia method to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel of Euthanasia of the American Veterinary Medical Association. If not, provide a justification for not following the recommendation. H. Acknowledgments and I. References See above.