Part of Unit: Product Design, Procedures, Licensure and Regulations
Lesson Plan Overview / Details
Students will conduct a long-term research project designed to guide them in understanding the stages in product development.
- Three classes
- 50 Minutes
- 7-10 weeks of student research out of class
- 10 - 15 Minutes
California Career and Technical Education Standards
- HSMT.A.A5.1 Understand the process of developing biotechnology products in an industrial set...
- HSMT.A.A5.2 Understand the role of preclinical and clinical trials in biotechnology product ...
- HSMT.A.A5.3 Know the role of quality assurance in clinical trials.
- HSMT.FS.9.1 Understand the characteristics and benefits of teamwork, leadership, and citizen...
- HSMT.FS.9.3 Understand how to organize and structure work individually and in teams for effe...
California Academic Content Standards (Reinforced)
- ELA.9-10.LS.2.2b Deliver expository presentations that convey information and ideas from primary ...
- ELA.9-10.LS.2.2d Deliver expository presentations that include visual aids by employing appropria...
- ELA.9-10.LS.2.2f Deliver expository presentations that use technical terms and notations accurately.
- ELA.9-10.LS.2.3d Apply appropriate interviewing techniques that respond correctly and effectively...
- ELA.9-10.W.RT.1.3 Use clear research questions and suitable research methods (e.g., library, elect...2
- ELA.9-10.W.RT.1.7 Use appropriate conventions for documentation in the text, notes, and bibliograp...2
- ELA.9-10.W.RT.1.8 Design and publish documents by using advanced publishing software and graphic p...
Objectives and Goals
- Students will understand the stages that a product goes through before being released to the public.
- Students will learn the role of quality control during hte entire outline of product development.
- Students will work in pairs to conduct exhaustive research, organize information, and create a final presentation to a group of peers.
- Students will together over an extended period to reach the final presentation.
Activities in this Lesson
- To Take or Not... - Hooks / Set
As students enter class, hand them two Dixie cups (one cup labeled A and one cup labeled B) and a test tube half filled with liquid with a transfer pipet. Have students read and follow the message board on their way to seats and take out the required materials (legal scientific notebook and black pen).
Explain to students that the “pill” (actually a piece of candy like a smartie) in Dixie cup labeled “A” was made by a small biotech company that has not been FDA approved for consumption. The small biotech company is claiming the pill cures a specific disease (teacher may leave it general or pick a specific disease). The pill in Dixie cup “B” was FDA approved for the same disease. Have students choose to 1.) take pill A, 2. take pill B, or 3. take none of the pills. The student must record their choice in their legal scientific notebooks.
Then have students “bump” into one another and share a little squirt of liquid. Have them “bump” into a minimum of 3 peer students and a maximum of 5. Depending on the teacher’s comfort level with the students, the teacher can play mood music like Marvin Gaye’s Let’s Get It On. For the lab to make these solutions, look at the Disease Transmission Lab.
Have students sit down and then go around and squirt a “diagnostic test” in each students’ test tube. If the tube’s liquid remains clear, the student is healthy and disease-free. If the test tube liquid turns pink, the student may or may not have caught the disease depending on the following:
1. If the student chose to take pill A (the pill not FDA approved), explain that the company was mistaken with their claims and research. The pill, in fact, does not prevent the disease and they now are sick. They took the risk of taking a pill that hadn’t been FDA approved.
2. If the student chose to take pill B from Dixie cup B (the FDA approved pill), they are safe and healthy. Since students picked pill B, they have antibodies to fight off the infection and they will not get sick (for a dramatic visual scene, the teacher can squirt in the test tube and turn the liquid clear again).
3. If the student opted out of taking a pill, they have the disease.
The teacher then asks why FDA approval is so important. The discussion will lead to the teacher asking the class what are the steps required for FDA approval – what does a product have to go through before it reaches mass society? This discussion leads to the background research and start of the Product Productivity Pipeline semester project.
- Introduce the Second Semester Project - Lecture
Direct student attention to the Product Production Pipeline Handout. The teacher calls on various students randomly to read the introductory sentences of the assignment in the background section. Have students actively read as they follow along. Explain that this is the second semester major project and students will be working on this assignment over the next seven weeks. There will be some days in class where students will finish lab early and have time to work but the majority of the research will need to be done outside of class time (I have the lab open at lunch for students to come work).
However, to start the project students have to conduct background research as evidenced by the anticipatory activity. Students have two tasks to complete:
1. Students need to first research the various stages of the product pipeline and complete table one (on page one of Product Productivity Pipeline Handout).
2. Students will go online to Genentech website, click on “Genentech’s Development Pipeline” from the home page, choose two products currently in Genentech’s pipeline and complete table two (page two from Product Productivity Pipeline Handout).
- Product Production Pipeline [ Download ]
- Internet Modeling - Demo / Modeling
At this late date of the school year, students are aware of good practices on searching on the internet. To search online, students should type in various key words to preferred search engines (like Google). My school has online reference to our library. I demonstrate again to students how to access the online library and tell them the passwords. This is modeling how to complete task one.
Go online and show students the Genentech website ( http://www.gene.com). Demonstrate how to get to Genentech’s pipeline. Show them that by clicking on a specific product a new screen pops up with information for that product. Explain to students that this is how they complete table two.
- Checking for Understanding - Group Work
Have students copy both tables found on pages one and two of the Product Productivity Pipeline in their legal scientific notebook. Each table should be one page.
As the students are copying the tables down, walk around and question students on an individual basis. Ask questions that allow them to recall back the two tasks they are to complete:
1. Research the stages of the product pipeline and complete table one.
2. Go to Genentech, research two products currently in their pipeline and fill out table two.
- Student Work Time - Projects
Students are working in pairs to conduct research but they individually fill out both tables in notebooks. Therefore, answers in tables will be similar with working pairs but not identical.
Once both tables have been completed, students may choose from the list on page four of the Product Productivity Pipeline Handout. Have students pick a first and second choice. The teacher can sign up working pairs as they choose to not have overlaps of products. Students may also pick products (if the teacher desires). I suggest having students pick products from a list generated by BayBio ( http://www.baybio.org) specifically on their California cures site ( http://www.californiacures.org).
Once the group has a product picked out, hand them a manila folder. Have students label the folder with names, date started, and product studying.
The teacher needs to demonstrate to students reminding how to properly reference research. On the Smart Board, go to Google. Type Citation Machine. Click on http://citationmachine.net/ and then click on APA on the left side of the page. Remind students that science uses APA formatting while English uses MLA. Demonstrate how to use the webpage to reference the Genentech website and tell students they will need to start a Bibliography of their own for their research for this project. Have students follow the Proper Citation Student Handout for future reference on proper citations. I have students glue this handout into their notebooks for use for the entire year.
Students then conduct research. They first identify all the companies involved in development of the product. Then they pick the company with the largest role in product development. Research is completed on the major company.
Next students will research and answer all the questions on page three of the Product Productivity Pipeline handout on their specific chosen product. This will take seven to eight weeks. Most of the research is conducted outside of class, however, if students finish labs or activities early they may work during class.
- Final Presentation - Closure
After a period of seven to eight weeks, students will present final presentation. To build the presentation, students followed the Product Productivity Pipeline Handout. Teachers may or may not choose to give stduents class time to create the final presentation. Some teachers like to use PowerPoint. Others like to use Google Presentation. The advantage to Google Presentation is all the group members can work on the presentation without having to meet as long as there is internet access.
Have two to three groups present a day at the start of class. The remainder of the class may be spent doing other activities/labs.
- Assessment Types:
- Projects, Interviews,
Every two weeks, the teacher checks and assigns points for five research articles for active reading and proper referencing on the bibliography. The teacher may ask individual groups questions from the assignment to check for completeness of research (i.e. ask the questions students are trying to answer with their research).
At the conclusion of the project, students turn in the manila folder with all the exhaustive research, turn in the final presentation and present to the class. The teacher can follow the supplied rubric for grading of Product Production Pipeline projects.
NOTE: I emphasize that students need to become experts on their product and the main company producing the product. They should be able to present without reading off notes or reading from the screen. Students should also be able to answer questions at the conclusion of the presentation. Each presentation takes roughly seven to ten minutes which includes concluding questions from the audience.
- Product Production Pipeline Rubric [ Download ]