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AOHS Biotechnology

Lesson 10Bringing a Product to Market

In this lesson, students begin working on their culminating project: analyzing the feasibility of bringing a fluorescent soda product to market. Through project activities they learn about the process of bringing a biotechnology product to market and discover the challenges of scaling up production and testing the proposed product for safety and effectiveness. After learning how to read scientific literature, they conduct the research they will need in order to suggest their own version of a naturally carbonated fluorescent soda made with recombinant DNA.

Advance Preparation This lesson launches the culminating project for the course. Review Teacher Resource 10.4,

Guide: Fluorescent Soda Culminating Project, before beginning this lesson, and prepare Teacher Resource 10.5, Handout: Fluorescent Soda Project Brief, for distribution to students.

Students will work in teams of four or five to complete their culminating project. Before this lesson begins, determine how you will form project teams. Students will be working closely in these teams throughout the rest of the course, so the formation of the teams is an important decision.

Prior to Class Period 2, have all equipment and materials ready for the activity as indicated in Teacher Resource 10.2, Activity Guide: Zombie Outbreak.

In Class Period 2, you will need access to the YouTube video “A History of Clinical Research” at https://www.youtube.com/watch?v=vYBtlItAT3c.

If your school does not allow access to YouTube, you may wish to download the video to your computer in advance using KeepVid (see www.keepvid.com) or a similar program.

Prior to Class Period 4, create a set of questions for students to answer to review for the quiz. Use Teacher Resource 10.6, Quiz: Bringing a Biotech Drug to Market and Teacher Resource 10.7, Answer Key: Bringing a Biotech Drug to Market Quiz to decide on this set of questions.

In Class Periods 3, 6, and 7, students need access to computers with word processing software and/or Internet. Ideally, there would be one computer for each student.

This lesson includes some introductory information on how to read scientific papers. If you have your own preferred method for teaching students to read scientific literature, you may wish to make adjustments to that part of this lesson.

This lesson is expected to take 7 class periods.

Copyright © 2014‒2016 NAF. All rights reserved.

http://www.keepvid.com/

https://www.youtube.com/watch?v=vYBtlItAT3c

AOHS BiotechnologyLesson 10 Bringing a Product to Market

Lesson FrameworkLearning ObjectivesEach student will:

Summarize the steps in clinical testing for new biotechnology products* Evaluate motivations for bringing products to market Categorize constraints on bringing products to market

*This is one of the 16 key learning objectives assessed by the NAFTrack Certification end-of-course exam for this course.

Academic Standards Apply the fundamentals of biochemistry, cell biology, genetics, mathematical concepts,

microbiology, molecular biology, organic chemistry and statistics to conduct effective biotechnology research and development of products (CCTC Standards HL-BRD, 2)

Demonstrate basic knowledge of recombinant DNA, genetic engineering, bioprocessing, monoclonal antibody production, nanotechnology, bioinformatics, genomics, proteomics and transcriptomics to conduct biotechnology research and development (CCTC Standards HL-BRD, 3)

Demonstrate the principles of solution preparation, sterile techniques, contamination control, and measurement and calibration of instruments used in biotechnology research (CCTC Standards HL-BRD, 4)

Summarize and explain the larger ethical, moral, and legal issues related to biotechnology research, product development and use in society (CCTC Standards HL-BRD, 6)

Gather and synthesize information about the technologies that have changed the way humans influence inheritance of desired traits in organisms (Next Generation Science Standards 2013, MS-LS4-5, Biological Evolution: Unity and Diversity)

Refine the design of a chemical system by specifying a change in conditions that would produce increased amounts of products at equilibrium (Next Generation Science Standards 2013, HS-PS1-6, Matter and its Interactions)

Practice speaking and active listening skills (National Health Science Standards 2015, 2.15) Apply personal safety procedures based on Occupational Safety and Health Administration

(OSHA) and Centers for Disease Control (CDC) regulations (National Health Science Standards 2015, 7.21)

Apply safety techniques in the work environment (National Health Science Standards 2015, 7.31) Observe all safety standards related to the Occupational Exposure to Hazardous Chemicals

Standard (safety Data Sheets [SDSs]) (National Health Science Standards 2015, 7.41) Comply with safety signs, symbols, and labels (National Health Science Standards 2015, 7.42) Evaluate roles and responsibilities of team members (National Health Science Standards 2015,

8.11)

Copyright © 2014‒2016 NAF. All rights reserved. 2


AssessmentAssessment Product Means of Assessment

Quiz on bringing a biotech drug to market (Teacher Resource 10.6)

Answer Key: Bringing a Biotech Drug to Market Quiz (Teacher Resource 10.7)

Organizer: Project Work Flow (Student Resource 10.8)

Assessment Criteria: Project Work Flow Organizer (Teacher Resource 10.9)

Notes: Project Research (Student Resource 10.10)

Assessment Criteria: Project Research Notes (Teacher Resource 10.10)

Prerequisites Ability to measure accurately using pipets Knowledge of bacteria culture technique Knowledge of sterile technique

Instructional Materials Teacher Resources

Teacher Resource 10.1, Presentation 1 and Notes: Bringing a Biotech Drug to Market, Part 1 (includes separate PowerPoint file)

Teacher Resource 10.2, Activity Guide: Zombie Outbreak Teacher Resource 10.3, Presentation 2 and Notes: Bringing a Biotech Drug to Market, Part 2

(includes separate PowerPoint file) Teacher Resource 10.4, Guide: Fluorescent Soda Culminating Project Teacher Resource 10.5, Handout: Fluorescent Soda Project Brief Teacher Resource 10.6, Quiz: Bringing a Biotech Drug to Market Teacher Resource 10.7, Answer Key: Bringing a Biotech Drug to Market Quiz Teacher Resource 10.8, Example: Culminating Project Presentation (separate PowerPoint file) Teacher Resource 10.9, Assessment Criteria: Project Work Flow Organizer Teacher Resource 10.10, Assessment Criteria: Project Research Notes Teacher Resource 10.11, Key Vocabulary: Bringing a Product to Market Teacher Resource 10.12, Bibliography: Bringing a Product to Market

Student Resources Student Resource 10.1, Reading: Soda Industry Seeking Innovation Student Resource 10.2, Note-Taking Guide: Bringing a Biotech Drug to Market, Part 1



Student Resource 10.3, Reading: Bringing a Biotech Drug to Market, Part 1 Student Resource 10.4, Reading: Scaling Up Protein Production Student Resource 10.5, Note-Taking Guide: Bringing a Biotech Drug to Market, Part 2 Student Resource 10.6, Reading: Bringing a Biotech Drug to Market, Part 2 Student Resource 10.7, Internet Research: Bringing GE Food to Market Student Resource 10.8, Organizer: Project Work Flow Student Resource 10.9, Reading: All About Scientific Papers Student Resource 10.10, Notes: Project Research

Equipment and Supplies LCD projector and computer with speakers for PowerPoint presentations and to view an example

culminating project An up-to-date video player on a computer ready to show a YouTube video Computers with word processing software and Internet access (one per student) Whiteboard, blackboard, or flip chart Materials for the zombie outbreak activity (see Teacher Resource 10.2, Activity Guide: Zombie

Outbreak)

Lesson StepsStep Min. Activity

CLASS PERIOD 1

1 20 Think, Pair Share: Soda Industry Seeking InnovationStudents begin thinking about the challenges of bringing a biotechnology product to the market in the context of the “soda challenge” they will work on for their culminating project.

Begin class by asking students what they know about crowdsourcing. Make sure the discussion touches on the following points:

Crowdsourcing is when an organization invites the general public to participate in a new project, product, or business. In many cases, the organization invites ideas or suggestions from the public.

Crowdfunding is similar, but it involves inviting people to contribute financially to get a new product, project, or business started.



Step Min. Activity

Ask students to read over Student Resource 10.1, Reading: Soda Industry Seeking Innovation. Explain that this is a good example of how a business might crowdsource ideas for a new product.

Point out that the people who participate in crowdsourcing activities need to have a certain amount of knowledge and interest in the specific field―in this case, biotechnology. Participating in crowdsourcing can be a great opportunity for students who are studying in a field to contribute to actual work being done in that field.

Ask students:

What questions would this company need to answer in order to successfully launch this new product?

Give students a few minutes to write in their notebook. Then pair students up and ask them to share their thoughts with their partner. After a few minutes of partner sharing, invite pairs to share their questions with the rest of the class.

List student questions on the board. Work with students to group the questions into logical categories, such as science, manufacturing, and business.

Explain that in this lesson, students are going to look more closely at what needs to happen to bring a biotechnology product into the market.

2 30 Presentation: Bringing a Biotech Drug to Market, Part 1This activity gives students an in-depth look at phases 1 and 2 of the process of bringing a biotechnology drug to market. It also develops students’ listening and note-taking skills.

To prepare, make notes to guide class discussion using Teacher Resource 10.1, Presentation 1 Notes: Bringing a Biotech Drug to Market, Part 1. Have Teacher Resource 10.1, Presentation 1: Bringing a Biotech Drug to Market, Part 1 (separate PowerPoint file), ready to show as a full-screen slideshow using an LCD projector.

Summarize what the presentation will cover and refer students to Student Resource 10.2, Note-Taking Guide: Bringing a Biotech Drug to Market, Part 1. Tell students to use the flow chart on the guide to organize their notes as they view the presentation.

Present the slideshow. Use the notes you prepared previously and the questions on the slides to encourage class discussion.

This presentation is duplicated as Student Resource 10.3, Reading: Bringing a Biotech Drug to Market, Part 1. If an LCD projector is unavailable, students can read the presentation, answer the discussion questions in their notebook, and discuss their answers as a class. This student resource is also useful for review.

After the presentation, divide the class into pairs or groups of three and have them compare their notes for completeness and accuracy by referring to Student Resource 10.3, Reading: Bringing a Biotech Drug to Market, Part 1. Invite each pair or triad to share what they learned.

Tell students that although biotechnology researchers are able to identify many possible products, most of those proposed products do not work. One of the important challenges in the biotechnology industry is to better understand which drugs will be effective before doing expensive testing.



Step Min. Activity

You may want to gauge student understanding by assessing Student Resource 10.2, Note-Taking Guide: Bringing a Biotech Drug to Market, Part 1 on a credit/no-credit basis.

CLASS PERIOD 2

3 20 Role Play: Zombie OutbreakThis activity provides a context for students to appreciate the need for clinical trials and FDA approval of drugs.

Prior to the activity, refer to Teacher Resource 10.2, Activity Guide: Zombie Outbreak, and prepare for the role play.

At the beginning of the activity, give each student an A cup and a B cup with the candies in them. After students have received their cups, tell the class that there has been a Zombie disease outbreak on campus. Explain that the pills in cup A cost $6 each and are a popular dietary supplement called Zombie-X, Natural, Super-Charged Immune Defense and Disease Blocker. The pills in cup B cost $850 each and are a brand-name drug called Zombexa. Zombexa is FDA approved to prevent Zombie infection. Tell students they have a choice—to take the pills in cup A or cup B or to not take any pills and hope for the best. So that students understand that price is an issue, tell them that they (or their families) will have to pay the school back for whichever pill they take. Have students make their choice, and have several student volunteers collect the cups with the pills that were not purchased.

Explain that students will now simulate what occurs during a disease outbreak. Have each student collect a test tube and a disposable transfer pipet. (Remind students to not taste the liquid.) Tell them to move around the room and have “conversations” with three to five students. Fewer conversations works better for small classes. Each conversation is represented by transferring some liquid from one student’s test tube to the other student’s test tube and vice versa. Tell students to have three to five conversations and to then return to their seat with their test tube.

Explain that you will use a test to see who has been infected. Quickly add a small amount of phenolphthalein indicator to each student’s test tube. If the solution turns pink it means that the student came into contact with someone infected by Zombie.

Once everyone has been tested for infection, explain to students that if they took Zombexa in cup B they were protected from the disease, and if they took the Zombie-X or nothing they will likely become a Zombie.

Use the washtub to collect the test tubes and transfer pipets with the help of student volunteers.

Explain that dietary supplements are not subject to clinical trials and that the FDA does not investigate their claims. Only FDA-approved medicines have been evaluated for their safety and effectiveness.

Share the following quote from http://www.consumer.ftc.gov/articles/0261-dietary-supplements with students:

Dietary supplements may seem like harmless health boosters. But while some have proven benefits, many don't. Unlike drugs, dietary supplements aren't evaluated or reviewed by FDA for safety and effectiveness, and even "natural"


http://www.consumer.ftc.gov/articles/0261-dietary-supplements

http://www.consumer.ftc.gov/articles/0261-dietary-supplements


Step Min. Activity

supplements can be risky depending on the medicines you take or the medical conditions you have. In recent years, hundreds of supplements also have been found to be tainted with drugs and other chemicals. Always talk to your doctor before you take a new supplement, and avoid any supplement claiming it's a "cure."

Ask several students to explain why they chose Zombie-X or Zombexa. One reason that may emerge is cost. Follow up by asking students to discuss their opinion about the value of ensuring good health care for everyone.

4 15 Video: Clinical TrialsStudents watch a video to learn more about the role clinical trials have played in the advancement of medicine.

Project the video “A History of Clinical Research,” which is available to view at https://www.youtube.com/watch?v=vYBtlItAT3c .

If your school does not allow access to YouTube, you may wish to download the video to your computer in advance using KeepVid (see www.keepvid.com) or a similar program.

When the video is complete, ask students to write a quick three-minute response in their notebook reflecting on how their life would be different without clinical trials.

Ask several students to share their responses. If time permits, you may wish to discuss the relationship between the price of drugs and the need for clinical trials. For example, the Zombexa in the Zombie Outbreak role play was much more expensive, but it had been FDA approved, which means it had gone through clinical trials.

5 15 Reading: Scaling Up ProductionStudents gain insight into one set of obstacles a recombinant protein product must overcome to reach the market.

Refer students to Student Resource 10.4, Reading: Scaling Up Protein Production. Explain that this reading highlights the challenges involved with increasing production of a biotechnology recombinant protein product from bench top to industrial scale. As they read, tell students to highlight or underline the specific challenges the biotechnology company faces as it scales up production.

Three minutes before the end of the class period, have students share the challenges they identified. Tell students that manufacturing in biotechnology is one of the most difficult and complex industrial processes to carry out.

CLASS PERIOD 3

6 20 Presentation: Bringing a Drug to Market, Part 2Students learn about phases 3 and 4 of the process of bringing a biotechnology product to market.


http://www.keepvid.com/

https://www.youtube.com/watch?v=vYBtlItAT3c


Step Min. Activity

To prepare, make notes to guide class discussion using Teacher Resource 10.3, Presentation 2 Notes: Bringing a Biotech Drug to Market, Part 2. Have Teacher Resource 10.3, Presentation 2: Bringing a Biotech Drug to Market, Part 2 (separate PowerPoint file), ready to show as a full-screen slideshow using an LCD projector.

Summarize what the presentation will cover and refer students to Student Resource 10.5, Note-Taking Guide: Bringing a Biotech Drug to Market, Part 2. Tell students use the flow chart in the guide to organize their notes as they view the presentation.

Present the slideshow. This presentation is also duplicated as Student Resource 10.6, Reading: Bringing a Biotech Drug to Market, Part 2, to use according to your preferences.

After the presentation, divide the class into pairs or groups of three and have them compare their notes for completeness and accuracy by referring to Student Resource 10.6. Invite each pair or triad to share their thoughts and questions.

Tell students that the rigorous clinical testing process is the only way to determine effectiveness of a drug.

Tell students that they will take a quiz on the drug development process in Class Period 5, and that they will review for the quiz during the next class period. Encourage students to look over their notes and readings from this lesson at home and make a list of any questions that are confusing them.

7 30 Internet Research: Bringing GE Foods to MarketStudents learn the process for bringing genetically engineered (GE) food products to market.

Each student will need access to a computer, word processing software, and the Internet for this activity.

Refer students to Student Resource 10.7, Internet Research: Bringing GE Food to Market, and assign students to groups of three or four. Also assign each student to a computer. Tell them that they will answer the questions on the student resource using the listed websites and then make a diagram of the steps of the GE food development process.

Ten minutes before the end of the activity, ask students to present the information they gathered. Then have students discuss the following questions:

What might motivate a biotechnology company to create a GE food product? What are constraints that might prevent a biotechnology company from bringing a

GE food product to market?

CLASS PERIOD 4

8 30 Culminating Project Work: Project LaunchStudents begin working on their culminating project by studying the project requirements and forming their project teams.

Before this class period begins, review Teacher Resource 10.4, Guide: Fluorescent



Step Min. Activity

Soda Culminating Project, and Teacher Resource 10.5, Handout: Fluorescent Soda Project Brief. Revise the handout in any way that seems helpful and make copies, one per student.

Also before this class begins, determine how you will organize students into their project teams.

When class begins, distribute copies of Teacher Resource 10.5, Handout: Fluorescent Soda Project Brief.

Students will see that this is connected to the innovation challenge they will watch in the example culminating project presentation in the next period. Explain that students are now better prepared to respond to the challenge because of what they’ve learned in this lesson about bringing products to market.

Divide the class into teams and explain that these are their project teams for completing the challenge. Instruct students to read over the project brief with their team. Ask each team to choose one member to serve as the recorder. The recorder should create a two-column chart on a piece of paper, with the columns labeled as follows:

Things We Know Questions We Have

Allow students approximately 10 minutes to review the project brief and discuss it in their project team. Then open up a class discussion. Make sure students understand that they need to carefully develop a list of questions that must be answered and identify challenges to bringing the new soda to market as well as research and write an annotated procedure for making the fluorescent soda. They will identify relevant concerns and issues, and consider the safety risks and ethical implications of the new soda. Then each team will make a presentation of their feasibility analysis explaining why the company should or should not pursue development of fluorescent soda. Let students know they will be presenting their recommendations as a PowerPoint presentation to an audience that will include businesspeople and scientists who will represent the Research and Development department at Super Soda Company.

You may choose to answer some of students’ questions at this time, but keep in mind that the project is intended to be an opportunity for discovery, so it’s acceptable for students to move forward without having all their questions answered.

Point out to students that they now have another reason to make sure they really understand how to bring a product to market: they need to know it for their projects. To make sure they know the basics, let students know they will be taking a quiz on that subject during the next class period. They will use the rest of this class period to review for the quiz, and they should also plan to study at home.

9 20 Review Game: Bringing Products to MarketStudents review what they have learned to prepare for a quiz on the drug development process.

Before class begins, generate a list of review questions that pertain to content on the upcoming quiz. Use Teacher Resource 10.6, Quiz: Bringing a Biotech Drug to Market, to guide the development of the review questions.

Assign students to small groups (or allow them to work in their project teams) and



Step Min. Activity

determine the order in which the groups will go in front of the class.

Explain the game rules to students. Each group gets points for each question they answer correctly. Ten points are awarded to the group if the student who is asked the question answers correctly. Five points are awarded to the group if the student who is asked the question asks another student for help and that student answers correctly. Once every student in a group has received a question, that group is done and the next group goes in the front of the class.

Tell students that if a group does not give the correct answer, you will share the answer. Remind students to take notes to help them study for the quiz.

Carry out the activity and keep a point tally for each group. The winning group is the group with the highest score at the end of the game.

At the end of the class period, remind students to continue reviewing their notes to study for the quiz for homework.

CLASS PERIOD 5

10 25 Quiz: Bringing Drugs to MarketStudents demonstrate their individual understanding of the drug development process.

Distribute Teacher Resource 10.6, Quiz: Bringing a Biotech Drug to Market. Students answer the questions individually. The quiz should take 20 minutes. Collect and review the answers with the class using Teacher Resource 10.7, Answer Key: Bringing a Biotech Drug to Market Quiz.

To conclude, tell students that the in-depth knowledge they have gained about drug development has helped prepare them for their work on the culminating project. After class, assess the quizzes using Teacher Resource 10.6.

11 20 Culminating Project Work: Reviewing the ExampleStudents review an example project to gain a deeper understanding of what their final product should include.

Explain that students will now have an opportunity to view a presentation that is similar to what their final presentations should look like. Let students know that in this case the innovation challenge was to create yogurt that glowed. Make sure students understand that “glowing” and “fluorescing” are not the same thing.

Tell students that although the product is different, this presentation was for a similar innovation challenge, so it meets the same criteria as their presentation will meet. Ask students to get out their project brief (Teacher Resource 10.5) and to take notes on the following questions as they view the example presentation:

How does the information in this presentation compare with the information you are supposed to provide? Did this team do a good job of including all the important information?

What steps do you think this team had to take to find or figure out this information? Make a list.



Step Min. Activity

Using an LCD projector and a computer with speakers, show Teacher Resource 1.1, Example: Culminating Project Presentation (separate PowerPoint Show file), as a slideshow with audio. When you open the file, the slideshow should begin. (Tip: Right-click the file and select Show. Or, to start the show from within PowerPoint, click the slideshow icon at the bottom of the PowerPoint window. Press Esc to end the show.) Make sure you have speakers turned on so that you can hear the audio narration. Periodically remind students to take notes on the two questions as they view the presentation.

When the presentation is over, ask students to share their thoughts on the first question. Students should be able to recognize that the example presentation includes the same type of information students are expected to provide about their fluorescent soda.

Next, direct students’ attention to Student Resource 10.8, Organizer: Project Work Flow. Explain that this organizer is designed to help students figure out the sequence of steps they need to take to complete their project as well as gather their initial thoughts by answering some questions. Indicate the assessment criteria at the end of the resource and answer any questions. Ask students to work together in their project team to complete Student Resource 10.8, using the notes they took during the example presentation. You may wish to show the presentation again while students are working on this task.

When approximately five minutes remain in class, ask students to wrap up their work, and assess Student Resource 10.8 using Teacher Resource 10.9, Assessment Criteria; Project Work Flow Organizer. To help you determine how well students have predicted the steps they will need to take to complete the project, also refer to Teacher Resource 10.4, Guide: Fluorescent Soda Culminating Project, for a list of project steps.

12 5 Homework: How to Read Scientific PapersStudents prepare to begin their research by reading about scientific papers.

For homework, ask students to read Student Resource 10.9, Reading: All About Scientific Papers. Explain that in order to complete their project, students will need to read scientific papers. This is a specific skill that they will need in the future if they are going to study scientific subjects in college or work in a scientific field as an adult.

Instruct students to read Student Resource 10.9 and highlight, circle, or underline five key things they learned about reading scientific papers.

CLASS PERIOD 6

13 50 Culminating Project Work: Soda ResearchStudents practice their scientific research skills and begin work on the research component of their culminating project.

Begin class by returning students’ copies of Student Resource 10.8, Organizer: Project Work Flow. Take time to clear up any significant misunderstandings about the process. Point out that the next step students need to take in the process is to begin their research. As they learned from their homework reading, they will need to be able to



Step Min. Activity

read scientific papers in order to do their research.

Call on volunteers to share one important thing they learned from reading Student Resource 10.9. Compile a list of the most important points on the board. Students are likely to mention some of the reading tips presented at the end of Student Resource 10.9, but also make sure to review the sections of a research paper so students are familiar with that terminology before they begin their research.

Ask students to look through Student Resource 10.10, Notes: Project Research. Explain that this resource will help them to be thorough and organized as they conduct their research. Point out the assessment criteria at the end of the resource and answer any questions.

Tell students how you want them to cite sources. Suggest any websites that you want them to start with as well; several are listed in Teacher Resource 10.4, Guide: Fluorescent Soda Culminating Project. If students have Internet access, consider having them share project files using a service such as Dropbox or Google Drive.

Tell students that the first thing they need to do is look up the procedure for creating a nongenetically modified organism―naturally carbonated soda. They should write down the details of that procedure, making sure to specify which microorganisms are used.

Assign students to computers and give them time to research. Circulate through the classroom to answer questions and keep students on task.

When the period is about halfway over, ask students to raise their hands if they have found a good explanation of the procedure for creating a nongenetically modified organism―naturally carbonated soda. Make a point to work with students who have not yet found a reliable source for their information.

When approximately 10 minutes remain, ask students to begin wrapping up their research. Remind them to make note of what sources they used. Tell students that they need to have a written copy of the soda-making procedure in their lab notebook, as well as a list of the microorganisms used, before the start of Class Period 7. If students were unable to get that information during this class period, they will need to finish for homework.

CLASS PERIOD 7

14 45 Culminating Project Work: Organism ResearchStudents collaborate with team members and identify topics that need further investigation.

Ask students to move into their project teams and compare the procedures they found for soda-making, as well as the list of microorganisms used. As they do so, check in briefly with each team. Ideally, students have found similar (or identical) procedures. If a team has found two (or more) significantly different procedures, work with them to determine which procedure is likely to give them the best chance of success.

Guide students to recognize that there are two microorganisms that could be transformed to make the fluorescent soda (yeast and bacteria). Tell students they will use this class period to research options for fluorescent proteins and what organisms can provide those fluorescent genes.



Step Min. Activity

Again, assign students to computers and have them use most of the period to do research. Circulate through the room to answer questions and keep students on task.

When approximately 15 minutes remain in class, ask students to wrap up their research. Remind them to cite any sources they have been using.

Tell students that they will need to keep doing their research for homework. Let them know that during Lesson 11 they will meet to share their research and make some important decisions about their procedure and which fluorescent DNA they will use. Give students a due date for turning in their research, sometime before Class Period 3 in Lesson 11, and assess it using Teacher Resource 10.10, Assessment Criteria: Project Research Notes. Students will need their notes in Class Period 5 of Lesson 11.

15 05 Culminating Project Work: Check-inStudents share a quick response on how their work is progressing so far.

When approximately 10 minutes remain in class, ask students to vote on how they are feeling about the project so far by showing thumbs up, thumbs down, or thumbs sideways (if they are confused or unsure). Make note of any teams that are indicating they may need additional support.

If time permits, invite a few students to share their reasons for why they voted as they did.

ExtensionsContent Enrichment

Have students read about the “breakthrough therapy designation” granted by the FDA. Discuss as a class how the expedited review process for drugs with this designation works. Then have students work in teams to research one of the FDA-approved breakthrough drugs. Ask each team to prepare a PowerPoint presentation or poster, including background information on the target disease, the name and manufacturer of the breakthrough drug, and current status of the drug. Some useful links are:o http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/

FDASIA/ucm329491.htmo http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/

FDASIA/ucm341027.htm o http://www.focr.org/breakthrough-therapies

Have students work in teams, using the Internet, to research common nutritional deficiencies in children around the world. Make list on the board of what students learn. Then ask each team to propose a novel genetically modified crop to address one of the common nutritional deficiencies it found. Have teams make a poster explaining how the change would address the need and why it would be marketable. Have each team present its proposal and have students vote on the three best proposals. Some useful links are:

o www.who.int/nutrition/topics/vad/en/


http://www.who.int/nutrition/topics/vad/en/

http://www.focr.org/breakthrough-therapies

http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm





o www.who.int/nutrition/topics/ida/en/

STEM Integration Mathematics: Have students review the following statistics on drug development:

o 250 out of 10,000 candidates are tested in preclinical researcho 5 out to 250 candidates are tested in clinical trials o 1 out of 5 candidates are approved by the FDA

Ask students to calculate the overall percentage of drugs that are approved and the percentage of drugs that make it through each stage.

Technology: If your students have access to the Internet or you have the technology to use apps in your classroom, instruct students to research, take notes, and collect photo media using Pinterest for their project research.


http://www.who.int/nutrition/topics/ida/en/

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