Guidelines for Final Design Report

Format

50-page (single-spaced, 12-point font, 1" margins on all sides) team document, in sections outlined below. Use Nature style to cite all in-text citations and references with complete titles. Final report should be accompanied by a letter of transmittal that explains which portions of the document were contributed by each team member.

Grading

Each team member receives both a team and individual grade, with the team grade weighted 25%, the individual grade 75%.

Deadlines

Post draft by Ses #20; hard copy of final group document due on Ses #24. The document should read like it has been written by a single author. Upload as one document and assign one person to proofread for consistency across the entire design report.

Overview

Your final report is a team-authored document that describes your therapeutic/diagnostic design and contains the five sections listed below. Please use visuals wherever appropriate, and use subsections to organize the major sections described below. You should presume an audience of fellow biological engineers, who would make a funding decision based on your document. Keep this audience in mind as you choose what information to present and in what detail.

Sections of the Report

Please include the following front matter, in this order:

• Abstract — informative abstract (500 words maximum)
• Title Page
• Table of Contents — the paper will be divided into sections as indicated below, which should be further subdivided as needed. One person will be the principal author of each section (e.g., Section 3.a.i, dose-response of nanodevice against cancer cells in cell culture ... by John M. Essigmann).
• List of Figures and Tables
  1. Clinical Motivation and Review of Available Treatment Technologies
  2. Design Overview
  3. Design Description
  4. In vitro and in vivo Preclinical Testing
  5. Clinical Testing
• Acknowledgements
• References

1: Clinical Motivation and Review of Available Treatment Technologies (5-6 pages)

Introduce clinical context of your disease and disease etiology (cite sources to support your claims here). Briefly discuss current therapies and problems with current approaches (what they don't address points to your approach). Support your claims with data from the literature.

2: Design Overview (3-4 pages)

Provide an overview of your approach. Describe the basic features of your team's design. Is it hypothesis-driven or a proof-of-principle experimental therapeutic, and why? If project is hypothesis-driven, does the design work? If project is proof-of-principle, how does the design work? How would you "prove" that the design works? (Save specifics about proposed therapeutics for Section 3.)

3: Design Description and Rationale (15-20 pages)

Detailed description of how your design works. Explain why have you selected this design? Be sure to address your rationale in terms of the science involved, intellectual property issues, and clinical considerations. How does your design improve on existing design or set a novel approach to treatment? Modeling/calculations carried out by your team to support your design rationale or guide in vitro/in vivo preclinical or clinical testing plans should be included in sections 3, 4, or 5 as appropriate for your team.

4: In vitro and in vivo Testing (6-7 pages)

What critical experiments would you suggest to test your design? Discuss both in vitro and in vivo tests. Explain why a particular test was chosen,limitations, and expected outcomes. What animal models are relevant for preclinical testing?

5: Clinical testing: Testing the Experimental Therapeutic (6-7 pages)

How will you validate your own methods? What about subsequent trials? How will you demonstrate efficacy (in comparison to other therapeutics and relative to cancer-appropriate measurements)? How will you prove the stated mechanism of action? What experimental methods would you use to test for safety?

6: Timeline for Development & Conclusion (5 -6 pages)

Were this therapeutic to be commercially developed, what stages would you establish for its development? What milestones would you need to reach in each stage in order to move on to the next stage? Address scientific, safety, scale-up, and funding-related stages and milestones. What about patents?

Acknowledgements

Acknowledge useful discussions you may have had with people within/outside MIT (other than the teaching staff), or other key resources you have employed.

References

Please include a properly formatted style list of all references cited. A good target for number of references would be 50-60 sources with an emphasis on primary scientific literature.