In this project we were tasked with coming up with a solution to a world problem using biology and biotechnology.
Here is the driving question and objective specifically for this project: Driving Question: How can we use biotechnology to solve a current issue in the world? Objective: Students will work collaboratively in teams of 3 and will use their knowledge and understanding of biology to |
identify a real world problem and create a proposal to a biotechnology company to further your research or create/invest in your product.
The problem that my group decided to focus on was unwanted pregnancies in the United States and our solution to that problem was creating a form of male birth control; similar to common female birth control pills. We wanted to chose this topic, because as young women in a heavily populated male class and field interest we wanted to create something that would help dissolve double standards of men and women regarding birth control and who is responsible. This was also a creative and different idea that no one else was doing a project on so we jumped at the chance to have a topic that is interesting, relatable, and that would involve/result in talking about equality for men and women in society. Unfortunately, this concept did have limitations as we were not able to physically make this product but we did our best to research the best way to create and market the pill. We also created a survey that we sent around to the school getting input from each grade (freshman, sophomore, juniors, seniors) about their stance on this topic and questions in general about their mental health. In our presentation we also used a lot of information from this survey to reference and use as evidence. Any graphs or charts you see in this website update are from our survey; it is our data we collected. Click the button below to see our survey!
The problem that my group decided to focus on was unwanted pregnancies in the United States and our solution to that problem was creating a form of male birth control; similar to common female birth control pills. We wanted to chose this topic, because as young women in a heavily populated male class and field interest we wanted to create something that would help dissolve double standards of men and women regarding birth control and who is responsible. This was also a creative and different idea that no one else was doing a project on so we jumped at the chance to have a topic that is interesting, relatable, and that would involve/result in talking about equality for men and women in society. Unfortunately, this concept did have limitations as we were not able to physically make this product but we did our best to research the best way to create and market the pill. We also created a survey that we sent around to the school getting input from each grade (freshman, sophomore, juniors, seniors) about their stance on this topic and questions in general about their mental health. In our presentation we also used a lot of information from this survey to reference and use as evidence. Any graphs or charts you see in this website update are from our survey; it is our data we collected. Click the button below to see our survey!
Our final product would be to create and implement male birth control in the form of a pill, and if it is successful then later administered at a shot. We want this product to be targeted at males at around age 16 or older, as we found in our survey that this is the age most boys have already hit puberty. We want to start at this age, because we feel that this is the age that most boys alson start to become sexually active (as seen from our survey and insight) so administering this when they are younger will prevent unwanted pregnancies in the future for them. Hormone and ingredient wise it will have varying levels of testosterone, progestin, and GnRH. These hormones will indirectly increases testosterone levels. (Testosterone is a male sex hormone that controls sperm development. The “sex” hormone in males). Increasing the testosterone slows the sperm production by suppressing hormones released from the pituitary gland, but not too much where the testosterone is out of control. We want to be sure that the selection of hormones are thoughtful as we do not want there to be any major negative side effects to our product or effectiveness. However
there would still be the possibility the same as when females take hormonal birth control. The science behind the hormones and other details like our action plan will be furthered explained later on.
General Details About Final Product:
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3D renderings of what our pill will look like for an idea of shape and color
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Male Birth Control Today:
There have been attempts before to create male birth control, so this is by no means a new idea. The reason our form would be the most effectful and popular is because we would make sure that it has the best formula and has healthy levels of all hormones. One that was recently being tested was re-called for bad side effects. Some forms of birth control in the making now and previously have used similar combinations of hormones, but again we would make sure ours is just the most effective and market our product to compete with other brands. There have been trial testings of birth control that actually deforms the sperm and growth cycle of sperm, but we think that is too drastic and a simpler hormonal path is safer long term. Hence we chose a safer hormonal choice that can be reversed.
There have been attempts before to create male birth control, so this is by no means a new idea. The reason our form would be the most effectful and popular is because we would make sure that it has the best formula and has healthy levels of all hormones. One that was recently being tested was re-called for bad side effects. Some forms of birth control in the making now and previously have used similar combinations of hormones, but again we would make sure ours is just the most effective and market our product to compete with other brands. There have been trial testings of birth control that actually deforms the sperm and growth cycle of sperm, but we think that is too drastic and a simpler hormonal path is safer long term. Hence we chose a safer hormonal choice that can be reversed.
We also created a slideshow presentation that conveyed all of our points. Below you can see our slideshow that we presented to our class on the last day of class in front of some judges that also asked us some comprehension questions.
For this project we had to choose a problem to focus our biotechnology resources on and try to help solve it. Our problem that we chose to focus on was unwanted pregnancies. “Approximately 50 percent of all pregnancies in the United States are unplanned, and of these, 43 percent will end in abortion.” (CDC: National Health Statistics Report). People are getting pregnant when they are not financially or mentally stable or prepared to have children. This can lead to rising children in foster care, which is not good for the kids or society in general. The children being born are not being given the best opportunities or life for that reason and some states don’t allow abortion now so that option is taken away for expecting mothers. This kind of invention that allows both partners to be active with family planning can help reduce unwanted or unplanned pregnancies.
Detailed Description of Solution
The male birth control we want to create will have varying levels of testosterone and progestin as these two hormones are able to suppress the natural production of sperm along with other hormones. We want to be sure that the selection of hormones are thoughtful as we do not want there to be any negative side effects to our product or effectiveness. We also want to make sure the product will not negatively hinder the boys mental or physical health. It will be administered through a pill (a shot later if successful) of some form to the boys through parental consent; also available if the boys themselves want to do it at anytime. We chose to use pills because we found in our school survey that most boys were opposed to getting shots, as
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A pie chart from our survey backing up our age idea
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A pie chart supporting the need for contraceptives in youth from our survey
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some people are afraid of needles, so a pill could be an effective alternative for people not willing to get a shot. We want to use androgen/progestin and GnRH combination because this indirectly increases testosterone levels. (Testosterone is a male sex hormone that controls sperm development.) Increasing the testosterone slows the sperm production by suppressing the LH and FSH released from the pituitary gland. From the other options we have researched, this combination seemed the most safe and reasonable in comparison to affecting the sperm growth cycle/not producing them correctly. This is a hormonal contraceptive, and the effects are the same as female birth control-the effects will stop when you stop taking it.
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Action Plan
“Clinical trials that support FDA approvals of new drugs have a median cost of $19 million, according to a new study by a team including researchers from Johns Hopkins Bloomberg School of Public Health” (John Hopkins University). In conjunction with the cost for production and other preliminary researching/marketing our total cost for this form of male birth control to reach global scales will be around $25 million dollars to pitch our product.We will need to firstly create the product. The hormones we will be using are androgen/progestin and we will be creating this in the form of both a pill and a shot (to
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allow people with options). This combination of hormones increases the production of testosterone which control sperm development. Increasing the testosterone slows the sperm production by suppressing the LH and FSH released from the pituitary gland. Many other forms of male birth control use hormones such as androgen and progestin receptor modulators slow sperm production by changing the shape of the molecular receptors that bind androgen and progestin so that the male reproductive cells will not correctly produce sperm. These routes are more dangerous, because while these are hormones so their actions can be reversed, our option is much safer. Instead of changing the form of sperm we want to focus on something more safe that will not cause worry in the future. This is why we want to use the hormones to reduce the amount of sperm produced. We would also need to research prior attempts at male birth control studies to see what exactly happened, and what we can fix to make our procut better and the most effective.
Steps to get approved by FDA:
*Our tests performed would specifically focus on men, but our group of men would have a variety of factors (not all the same race, health factors…).
Steps to get approved by FDA:
- Preclinical (animal) testing.
- An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
- Phase 1 studies (typically involve 20 to 80 people).
- Phase 2 studies (typically involve a few dozen to about 300 people).
- Phase 3 studies (typically involve several hundred to about 3,000 people).
- The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
- Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
- After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
- If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
- The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
- The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
- FDA reviewers will approve the application or issue a complete response letter
*Our tests performed would specifically focus on men, but our group of men would have a variety of factors (not all the same race, health factors…).
Marketing
After we would get approval the next step is advertising our product and getting the word out there. We will advertise our product by using some different forms of advertising.
- Direct mailing
- Newspapers and Magazines
- Radio advertising
- Television advertising
- Outdoor/mural advertising
- Social media advertising
Benefits of Investing
- The start of dissolving the double standards between men and women
- Responsibility of family planning
- Hormonal; easily reversed
- More effective than other forms of mechanical male birth control
- Reduced unwanted pregnancies
- Safer sex
To Better Understand:
Birth Control is the practice of preventing unwanted pregnancies, especially by use of contraception. This can be taken like our product in a pill, IUD, implants, shots, condoms, vasectomy, or abstinence. This relates to our project, because the product that we are creating will be a new form of birth control for men similar in ways to female birth control.
Homeostasis is defined as the process by which an organism maintains a stable environment. Homeostasis can be seen all throughout the world, specifically in humans. Things such as blood pressure, blood sugar, and oxygen levels are all maintained using homeostasis, and the human body does its best to achieve a balance of all of these things. This relates to our project, because the introduction of more hormones into the body will lead to the body trying to come to some sort of balance. With these pills the body of men will go through homeostasis and positive and negative feedback loops, because these are natural processes that happen biologically.
Feedback Loops are the amplification of biological inputs and outputs that are caused, or are causing, a certain event or scenario.
A Positive Feedback Loop is amplifies changes and this usually results in moving the state of the matter away from it's stability (making it more unstable). A Negative Feedback Loop is when a change is "buffered" or not amplified on a greater scale and as a result is able to maintain the state if the matter's equilibrium and make it more stable. Our experiment focused on negative feedback loops as we were trying to observe a state of stability or balance. Feedback loops relate to this project because, they allow living organisms to achieve homeostasis. Once again these are processes that our bodies regularly go through and would be a factor in the introduction of new hormones.
The endocrine system is the collection of glands that produce hormones that regulate metabolism, growth and development, tissue function, sexual function, reproduction, sleep, and mood. This relates to our project, because this is the system that is being affected and the hormones would be apart of in the body.
The pituitary gland is an organ that can be found at the base of the brain. It produces many hormones that travel throughout the body, directing certain processes or stimulating other glands to produce other hormones. This relates to our project, because the pituitary gland is most affected by the hormones we are inserting in the body and is part of the endocrine system.
Testosterone is a steroid hormone that is produced in the testes, but also other places in the body. It stimulates the development of male sexual characteristics. Progestin is a type of medication which is used in hormonal birth control. Gonadotropin-releasing hormone (GnRH) is a releasing hormone also apart of our hormonal birth control that releases some other naturally occurring hormones in the body. This relates to our project, because these are the hormones that we want to combine to make our birth control.
Birth Control is the practice of preventing unwanted pregnancies, especially by use of contraception. This can be taken like our product in a pill, IUD, implants, shots, condoms, vasectomy, or abstinence. This relates to our project, because the product that we are creating will be a new form of birth control for men similar in ways to female birth control.
Homeostasis is defined as the process by which an organism maintains a stable environment. Homeostasis can be seen all throughout the world, specifically in humans. Things such as blood pressure, blood sugar, and oxygen levels are all maintained using homeostasis, and the human body does its best to achieve a balance of all of these things. This relates to our project, because the introduction of more hormones into the body will lead to the body trying to come to some sort of balance. With these pills the body of men will go through homeostasis and positive and negative feedback loops, because these are natural processes that happen biologically.
Feedback Loops are the amplification of biological inputs and outputs that are caused, or are causing, a certain event or scenario.
A Positive Feedback Loop is amplifies changes and this usually results in moving the state of the matter away from it's stability (making it more unstable). A Negative Feedback Loop is when a change is "buffered" or not amplified on a greater scale and as a result is able to maintain the state if the matter's equilibrium and make it more stable. Our experiment focused on negative feedback loops as we were trying to observe a state of stability or balance. Feedback loops relate to this project because, they allow living organisms to achieve homeostasis. Once again these are processes that our bodies regularly go through and would be a factor in the introduction of new hormones.
The endocrine system is the collection of glands that produce hormones that regulate metabolism, growth and development, tissue function, sexual function, reproduction, sleep, and mood. This relates to our project, because this is the system that is being affected and the hormones would be apart of in the body.
The pituitary gland is an organ that can be found at the base of the brain. It produces many hormones that travel throughout the body, directing certain processes or stimulating other glands to produce other hormones. This relates to our project, because the pituitary gland is most affected by the hormones we are inserting in the body and is part of the endocrine system.
Testosterone is a steroid hormone that is produced in the testes, but also other places in the body. It stimulates the development of male sexual characteristics. Progestin is a type of medication which is used in hormonal birth control. Gonadotropin-releasing hormone (GnRH) is a releasing hormone also apart of our hormonal birth control that releases some other naturally occurring hormones in the body. This relates to our project, because these are the hormones that we want to combine to make our birth control.
Reflection:
In this project two areas that I performed well in were leadership and time management. The first skill that I exhibited in this project was leadership. A specific example of when I utilized this skill was at the beginning of the project. Immediately on the first day I took charge and divided out the roles and plans for my group. Additionally whenever my group mates were unsure of what they should be doing, I was the first person they asked what they should be doing or what I wanted them to do. The second skill that I utilized was time management. For this specific project, we had hard deadlines for different parts like research and proposals before our final product, and this helped me understand and keep on track of what we should be doing and when we needed to have it done. a specific example of when I exemplified this trait was at the end of our project on the last day, we realized that all of our information was done and all we had to do at that point was practice. It was nice knowing we had accomplished all of our tasks on time and we were not left rushing to complete something that was not our best work.
In this project, two areas that I need to continue improving on for next year are assertiveness and collaboration. The first trait that I still need to work on is assertiveness. This proved to be an issue when I realized that I was doing a lot of the work for my group and my teammates were not pulling their weight. I was struggling at points to do all the work, because I did not have that much help but this happened from my lack of assertiveness. In the future I will be sure to be clear wit my group that they need to do their part so in general the project and our time together can be more enjoyable and not as one sided as this one was. The second skill that I still need to improve upon is collaboration. This proved to be an issue a few days into the project when I needed one of my teammates to email their grandma (our selected mentor) who is a doctor for help in our research. I put it off when she did not give me the email to turn in, but we realized soon that we needed to get it in before the deadline for that section of the project. In the end we did get the email sent and turn in our paper on time, but it was not as easy as it should be. In the future I will be sure that I communicate with my group about issues or things that need to be done more effectively by being specific about what needs to be done, where, and by when.
All in all, this was probably my favorite project all year! It was exciting to find a way to combine my interest of female equality and rights with biotechnology. It also lets my group and I relate to this topic on a different level, since we are all women that are able to connect to this topic and what this invention would mean to us on a different level. This project allowed a lot of creative freedom, which I really enjoyed and was able to get more involved with the project that way. I really hope that in the future someone somewhere will be able to make a product like this for real and break the stereotype around birth control and social problems from unwanted pregnancies.
In this project two areas that I performed well in were leadership and time management. The first skill that I exhibited in this project was leadership. A specific example of when I utilized this skill was at the beginning of the project. Immediately on the first day I took charge and divided out the roles and plans for my group. Additionally whenever my group mates were unsure of what they should be doing, I was the first person they asked what they should be doing or what I wanted them to do. The second skill that I utilized was time management. For this specific project, we had hard deadlines for different parts like research and proposals before our final product, and this helped me understand and keep on track of what we should be doing and when we needed to have it done. a specific example of when I exemplified this trait was at the end of our project on the last day, we realized that all of our information was done and all we had to do at that point was practice. It was nice knowing we had accomplished all of our tasks on time and we were not left rushing to complete something that was not our best work.
In this project, two areas that I need to continue improving on for next year are assertiveness and collaboration. The first trait that I still need to work on is assertiveness. This proved to be an issue when I realized that I was doing a lot of the work for my group and my teammates were not pulling their weight. I was struggling at points to do all the work, because I did not have that much help but this happened from my lack of assertiveness. In the future I will be sure to be clear wit my group that they need to do their part so in general the project and our time together can be more enjoyable and not as one sided as this one was. The second skill that I still need to improve upon is collaboration. This proved to be an issue a few days into the project when I needed one of my teammates to email their grandma (our selected mentor) who is a doctor for help in our research. I put it off when she did not give me the email to turn in, but we realized soon that we needed to get it in before the deadline for that section of the project. In the end we did get the email sent and turn in our paper on time, but it was not as easy as it should be. In the future I will be sure that I communicate with my group about issues or things that need to be done more effectively by being specific about what needs to be done, where, and by when.
All in all, this was probably my favorite project all year! It was exciting to find a way to combine my interest of female equality and rights with biotechnology. It also lets my group and I relate to this topic on a different level, since we are all women that are able to connect to this topic and what this invention would mean to us on a different level. This project allowed a lot of creative freedom, which I really enjoyed and was able to get more involved with the project that way. I really hope that in the future someone somewhere will be able to make a product like this for real and break the stereotype around birth control and social problems from unwanted pregnancies.