# BME100 f2016:Group3 W8AM L1

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# OUR TEAM

 Name: Kayla Pociejewski Name: Alexandria Castillo Name: Bianca Silva Juarez Name: Madison Kleszcz Name: Midori King

# LAB 1 WRITE-UP

## Health Care Issue

Alzheimer's Disease is an aggressive form of dementia in which a, "...progressive and irreversible cognitive decline" occurs (1). Alzheimer's Disease affects 5.2 million Americans alone and within the country, about $100 billion is spent on care for these patients (2). This disease is projected to grow as life expectancy continues to increase, thus a cure or a preventative measure is necessary to prevent millions of more Americans from developing this disease. While the cure for AD is still unknown, recent studies suggest that the pathology of the disease relates to the formation of the Aβ amyloid in the brain (3). Moreover, it is the solubility of the Aβ that distinguishes a healthy brain from an Alzheimer's affected brain. In fact, an Alzheimer's brain contains approximately three times as much soluble Aβ than the average brain. However, the amount of insoluble Aβ in the brain does not specifically correlate with how advanced the disease is or how many amyloid plaques are in the brain affecting the disease. As technology advances, decreasing the amount of soluble Aβ in the brain may be the solution to reversing the effects of the disease, but for now, Alzheimer victims just take medications to slow down the progression of the disease (3). Currently, the only "solutions" to Alzheimer's disease are medications that slow the degradation of the disease by slowing the process by which the disease destroys neurotransmitters. The following drugs are used to mask the effects of Alzheimer's disease: Donepezil Galantamine Memantine Rivastigmine Donepezil and Memantine These drugs work in two different ways. Donepezil, galantamine, and rivastigmine use cholinesterase inhibitors to slow down the process of the disease breaking down neurotransmitters. Memantine, a NMDA receptor antagonist, focuses on the regulation of the glutamate which is a crucial neurotransmitter in the brain that is responsible for memory. This drug administers calcium to the cells to help regulate cell signaling in the memory and learning portion of the brain. As the Alzheimer's disease takes over patients' bodies, the risk of the patients forgetting to take their medication increases. Therefore, a caretaker is typically necessary to monitor the intake of medication on a regular basis to increase the advantages of the drugs. Paying for these caretakers or even falling in the role of caring for a loved one proves to be highly expensive. Furthermore, in order to take care of loved ones in these early stages of the disease, family or friend caretakers "lose over$15,000 in annual income as a result of reducing or quitting work to meet the demands of caregiving" on average (2). The simple act of forgetting to take medication can be the start of this financial loss that effects many families every year.

In attempt to minimize this issue, our group plans to create a implantable device that distributes the medication to Alzheimer's patients in a timely manner. The design of the device is similar to that of an insulin pump, however, it will include key features such as a heart rate monitor, blood pressure monitor, etc. that the patients' doctors will have access to in order to make sure the patient is safe. Furthermore, in case of a fall or a panic attack, the heart rate of the patient will rise and someone will be able to immediately respond to the scene and prevent any further damage. Overall, our device will eliminate the need for close monitoring or a caretaker in the beginning stages of the disease, thus saving money, hospital visits, and allowing both the life of the patient and their family the opportunity to live a more functional life.

1

     Huang, Xudong, Robert D. Moir, Rudolph E. Tanzi, Ashley I. Bush, and Jack T. Rogers. (2004) Redox-Active Metals, Oxidative Stress, and Alzheimer's Disease Pathology.


2

     Latest Alzheimer's Facts and Figures.(2016). Alzheimer's Association. Retrieved from http://www.alz.org/facts/


3

       McLean, C. A., Cherny, R. A., Fraser, F. W., Fuller, S. J., Smith, M. J., Konrad Vbeyreuther, Bush, A. I. and Masters, C. L. (1999), Soluble pool of Aβ amyloid as a determinant of severity of


## Competitors

Our main competitor is an older device called Intellidrug which administered a Alzheimer-fighting drug to patients through an implantable device.

Citations: A.E., Moscicka, Czarnecka, K., & Ciach, T. (2007). IntelliDrug Implant for Medicine Deliveryin Alzheimer’s Disease Treatment. Retrieved August 31, 2016, from http://onlinelibrary.wiley.com/doi/10.1002/masy.200750720/epdf

Giannola, L. I., Padern, C., De Caro, V., Florena, A. M., Wolff, A., & Campisi, G. (n.d.). New Prospectives in the Delivery of Galantamine for Elderly Patients Using the IntelliDrug Intraoral Device: In Vivo Animal Studies. Retrieved August 31, 2016, from http://www.eurekaselect.com/70972/article

Hanlon, M. (2007, February 1). The Intellidrug tooth implant. Retrieved September 03, 2016, from http://newatlas.com/go/6778/

Moscicka, A. E., Czarnecka, K., & Ciach, T. (n.d.). IntelliDrug implant for medicine delivery in Alzheimer’s disease treatment. Retrieved August 31, 2016, from http://www.ifpan.edu.pl/paj/biomat/abstracts/pdf/a024_moscicka.pdf

## Customer Validation

Patient
According to the Alzheimer Association, there are approximately 5.2 million Americans suffering from Alzheimer's. It is also stated that Alzheimer's is the sixth leading cause of death in the United States and that every 66 seconds, someone in the United States develops Alzheimer's disease. Therefore, our product will help the growing number of patients with Alzheimer's by creating an easier way to deliver the medical drugs directly to the body so patients do not forget to take their medicine.

Payer
Private insurance or Medicaid/Medicare would be responsible for the payment of this product.

Physician
According to the Mayo Clinic, they type of physicians that are familiar with memory and mental function disorders such as Alzheimer's are neurologist, psychiatrists, and geriatricians.

Provider
The providers for our product would be outpatient surgery centers and hospitals.

Purchaser
A potential purchaser for our product is biotech company named Accera. This company's mission is to discover and create biotech products that will address the unmet needs in brain health such as Alzheimer disease. In addition, another research center that may take interest in our product is the Department of Neurology at Brigham and Women’s Hospital. They along with Harvard Medical School have partnered up to create a research center called, The Center for Alzheimer Research and Treatment (CART). CART's mission is to "improve the early diagnosis of Alzheimer’s disease (AD) employing more sensitive clinical evaluations, biological markers, and neuroimaging; and to assess promising new treatments for AD" (Center for Alzheimer Research and Treatment).

Sources: Accera, Inc. | A new hope in Alzheimer's disease. (n.d.). Retrieved September 06, 2016, from http://www.accerapharma.com//

Alzheimer's disease. (2015). Retrieved September 06, 2016, from http://www.mayoclinic.org/diseases-conditions/alzheimers-disease/diagnosis-treatment/departments-specialties/orc-20167134

Center for Alzheimer Research and Treatment. (2015, September 18). Retrieved September 06, 2016, from http://www.brighamandwomens.org/Research/labs/CART/Our_Mission.aspx

Latest Alzheimer's Facts and Figures. (2016). Retrieved September 06, 2016, from http://www.alz.org/facts/

## IP Position

Please take a look at the following table to find a summary of current patents related to the design of our device:

## Fundability Worksheet Scores

Competitors
When looking at the Fundability Criteria scoring guidelines, we would score our product as a "2" based upon the fact there there is a competitor out there with a similar product. Our leading competitor is Intellidrug, but based upon their research they haven't released any knew information or studies that could potentially allow their product to be more beneficial than the one we are currently creating. The score of "2" on our product meets the criteria description of "competitors exist but clinical improvements are still being sought."

Customer Validation
The Fundability Criteria scoring guidelines state that in order to receive a score of a "1" or "2" based on the requirements. A "1" states that there is a hesitant interest to purchase or not enough customer feedback to-date. This score can be understandable since there is only one product that has been on the market to meet the needs of its consumer. Since there is only one product similar, this means that there isn't enough data or feedback to report what issues need to be fixed. A "2" states that masses have expressed interest to purchase. This also connects to our product based upon the fact that the amount of people that are effected by Alzheimer's is growing and the growth for better treatments is impeccable. Scoring a "2" in this field would fit the product based on the amount of potential customers that would be affected by this product.

IP Position

The current IP position on our product would score a "2" based on the requirements. Scoring a "2" means that the are non-provisional(s) filed and pending or issued patents, but they are weak. Our product would receive a "2" because there are similar products on the market and there are patents that have been filed but they haven't been revisited since 2003. This means that there is room for improvement on the product and new patents can be filed in order to reach the new needs of the purchasers. There are currently three different patents that would suit this product but considering the circumstances of a new design for a completely different disease would mean that the product sales would increase at a large rate.