BTEC 675 Semester Project – Craft a Commercialization Plan for a Biotechnology Product

Each student is to select a product concept from among a list of options (see below and Appendix A), and prepare and present a Commercialization Plan. The project is initiated by becoming a subject matter expert on the underlying technology followed by intensive research into the market opportunity. The subject matter of a Commercialization Plan is outlined in Appendix B. Each product concept was selected because it is a real commercial opportunity for the sponsoring faculty member or company. As such, the Commercialization Plan has significant value to the sponsor; therefore, each student is expected to perform with the utmost professionalism in preparing the plan. In return, each student will gain invaluable, credible and real-world experience in devising a plan for the commercial development of a biotechnology product.
The written plan should be address each point in Commercial Plan outline. The plan is expected to be thoroughly researched and well documented. Begin by learning about the product and technology. Meetings and dialog with the sponsor are critical to success. Students should use the course lectures and textbook as the primary references for learning about the concepts in each section of the plan. Additional reference materials are suggested in the course syllabus. However, much of the information needed for each plan will be gathered from primary and secondary literature sources. To organize the research and writing, draft versions of certain sections of the plan are due according to the schedule below. At the end of the semester, each student will give an oral presentation to the class and the sponsoring group on their plan.
Due Dates:
Draft section 1 – Sep 30

Appendix A: BTEC 675 Product Concepts
Western Optimization Kit (WOK)
Sponsor: Dr. Stephen Miller, Department of Biological Sciences, UMBC
Protein detection by Western blot analysis is one of the most fundamental and commonly used methods in gene/protein function research. Western detection is needed both to determine protein abundance in cells/tissue samples and as a component of co-immunoprecipitation analyses. Detection requires good antibody interactions with the protein of interest, and as such, success hinges on finding the proper conditions for these interactions, because the interactions can (and often are) greatly affected by the antibody-protein environment. Finding the proper antibody binding conditions can often be very laborious as it requires preparation of buffer solutions that vary in pH, buffer chemical, salt concentration, non-ionic detergent, and blocking agent (BSA and non-fat dry milk are the two most common). A Western detection kit that contains various stock reagents (10x stocks of several commonly used buffers varying in pH; 10x stocks of salts and non-ionic detergents such as TWEEN or Triton; BSA and non-fat dry milk) that can be used in up to 10 or more different recommended combinations could greatly streamline optimization. Ideally dozens if not hundreds of combinations would be tested in advance on a number of different antibody-protein situations to determine which should be recommended as the most likely to work.
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Appendix B: BTEC 675 – Commercialization Plan Outline
1. Market Opportunity 1.1. Market need1.1.1. What customer need is addressed
1.1.2. Identify how that need is currently addressed and its shortcomings
1.1.3. Indicate the degree of “pain” or urgency for a solution
1.1.4. Include a transition to introduce the product being proposed

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1.2. Innovation and Product Solution 1.2.1. In layman’s terms, describe succinctly what product or service you are planning to deliver that address the market/customer need
1.2.2. Include a picture or diagram to explain concept
1.2.3. Describe what is innovative about your approach
1.2.4. Introduce key technology objectives of the development plan

1.3. Industry Overview 1.3.1. Provide a brief description of the industry and where you fit within it
1.3.2. Discuss the implications for your business model
1.3.3. Describe your immediate customers and provide specific examples of potential or actual customers
1.3.4. Describe the types of channels your company will employ to reach the targeted customers when you are ready to initiate sales

1.4. Market 1.4.1. Market definition
1.4.2. Geographic location (domestic, international, both)
1.4.3. Market size
1.4.4. Differentiate between broad and niche market
1.4.5. Market growth and trends 1.4.5.1. Include graphic
1.4.5.2. Describe any hurdles that will need to be overcome to enter this market

 

1.5. Impact 1.5.1. Expand upon the significance by talking about the Societal, Educational, and Scientific benefits, as appropriate.
1.5.2. Add a concluding statement regarding the innovation and the overall significance of the work

 

2. The Business Model 2.1. The Company 2.1.1. Describe the type of company to be created
2.1.2. Be sure to indicate the corporate structure

2.2. Brief Description of Company 2.2.1. Mission
2.2.2. Core competencies needed
2.2.3. Describe how the company will be structured financially being sure to identify current sources of investment, as appropriate
2.2.4. Provide a forward looking statement regarding the company’s vision and how this technology relates to it

2.3. Commercialization Strategy 2.3.1. Discuss the strategy to be used to generate revenue from your innovation (i.e. how will you bring the product/service to the market – direct, license, joint venture, strategic partnership?). Justification/Rationale
2.3.2. Describe your plan for “exiting” the investment

2.4. Method of Revenue Generation 2.4.1. Describe the revenue streams to be implemented in bringing your product/technology to market (licensing, product sales or other)

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2.4.2. Discuss dates you anticipate your first revenues from each stream and when you expect to reach “break even”

2.5. Management Team and Personnel 2.5.1. Provide an overview of the organizational structure and the number of employees
2.5.2. This should be time-related over a five year period

 

3. Product/Technology and Competition 3.1. Customer Discovery and Product/Technology 3.1.1. Provide information gathered from customer interviews to verify that the advantages/benefits of your technology fulfill the critical needs (“pain points”) for your customer
3.1.2. Describe the features of your Phase II technology and how they translate into a succinct value proposition
3.1.3. Discuss pricing and the method used to validate the customers’ willingness to pay
3.1.4. Indicate the basis for purchase decision by customer 3.1.4.1. Hurdles to overcome

3.1.5. Discuss the costs to produce the product/service 3.1.5.1. Include any assumptions that underlie the cost model

 

3.2. Competition 3.2.1. Describe current competitive landscape
3.2.2. Discuss strengths and weaknesses of competing technologies/companies and how your technology/innovation will allow your team to compete and win relative to the strengths and weaknesses of competing technologies/companies
3.2.3. Make sure that your discussion includes both direct and indirect competition
3.2.4. Include table contrasting your product with competitive approaches on dimensions of significance to the customer
3.2.5. Describe changes in landscape anticipated over the next few years (i.e. when your product/service reaches the market)

3.3. Intellectual Property Landscape 3.3.1. Describe intellectual property landscape – i.e. other key patents of competitors
3.3.2. Describe the due diligence taken to confirm that company has “freedom to operate” relative to the technology/innovation

3.4. Company IP Strategy (historical and going forward) 3.4.1. Description of corporate strategy to protect IP going forward with rationale and timeline provided
3.4.2. As appropriate, indicate the other IP you may need to acquire in order to address the market opportunity

 

4. Finance and Revenue Model 4.1. Estimate of funding needed 4.1.1. Table of tasks to be funded from present through 3 years
4.1.2. Be sure to include technical, marketing, manufacturing, and intellectual property milestones as appropriate
4.1.3. Discussion of table, providing a sound basis for discussion of funding needed

4.2. Evidence of support 4.2.1. Discussion of appropriate contacts, leads, relationships and agreements already in place validating that there is a path to the necessary funds
4.2.2. Provide letters of support, as appropriate 4.2.2.1. Detail the relevance of each letter and provide a description of the entity that is providing the letter

 

4.3. Model for Projecting Revenues for 5 years post Phase II 4.3.1. Include annual pro forma income statements for 3 years
4.3.2. Discuss assumptions made when developing the model and how you have validated them

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Evaluation Criteria for Semester Project:
FOLLOWING INSTRUCTIONS
Level of Achievement
General Presentation
Reasoning, Argumentation
Exemplary (4pts)
The written assignment contains all the required elements designated in the instructions (as above).
Document is typed, single-spaced, 11 point font with ¾” margins, and 6 pages in length.
Document is organized as instructed.
The writer demonstrates that they have read the instructions and understand the assignment.
WRITING STRUCTURE
Level of Achievement
General Presentation
Reasoning, Argumentation
Exemplary (4 pts)
The writer has indicated the purpose of their paper and the paper contains an appropriate introduction
Literature citations are appropriate and cited correctly using accepted standards.
Graphs, tables and figures are appropriate content, referenced correctly, titled correctly and with 10 pttype on the captions.
The writer clearly demonstrates that they have the ability to logically organize their arguments in their writing.
The writing is clear and concise. The design of the paper is logical, organized, and can be easily followed by the reader.

 

 

MARKET AND BUSINESS MODEL
Level of Achievement
General Presentation
Reasoning, Argumentation
Exemplary (4 pts)
Was the subject introduced in a thorough yet concise way so as to effectively present the background information?
Was the state-of-the-art adequately presented?
Was the significance and innovation of the idea sufficiently addressed.
The writer demonstrates that they are knowledgeable about the field presented.
The sections followed a logical progression drawing the reader to a conclusion.
The hypothesis underlying the product concept is supported by experimental evidence.

FINANCIAL MODEL
Level of Achievement
General Presentation
Reasoning, Argumentation
Exemplary (4 pts)
The writer has designed appropriate experiments and those experiments are clear and logical. The experimental design is capable of adequately addressing the aims.
The concept of variables is discussed and it is clear what variables are being controlled and which are being manipulated. If appropriate, positive and negative controls are included.
The author has included a clear, concise, and testable hypothesis.
The writer demonstrates that they fully understand the process of experimental design.
The writer demonstrates that they understand how to set up and control an experiment.
The writer demonstrates their ability to generate a good scientific hypothesis.

WRITING MECHANICS
Level of Achievement
General Presentation
Reasoning, Argumentation
Exemplary (4 pts)
Almost the entire essay contains correct grammar.
Almost the entire essay contains correct spelling.
Almost the entire essay contains correct punctuation.
The writer clearly demonstrates that they can structure grammatically correct sentences using proper spelling and punctuation.