For the condition you're working on ( Alzehimer), note what similar treatments or devices are on the market

Question 1

There is no cure currently available for Alzheimer's disease, but medication and better management strategies are known to temporarily improve the symptoms. Incorporation of drugs and non-drug approaches is necessary for better management of the disease. A notable treatment available on the market and approved by the Food and Drug Administration for Alzheimer's disease is aducanumab (Sindhu, Goyal, Tsao, 2021). It is a human antibody that targets protein beta-amyloid and reduces amyloid plaques, the brain lesions associated with Alzheimer's. Other medications include antidepressants for low mood and irritability like citalopram, anxiolytics for anxiety and resistance and antipsychotic medications for aggression, delusions and hostility. The non-drug approach can also be used in managing behavioral symptoms, which includes creating a calm environment for the patient, monitoring personal comfort, acknowledging requests and exploring various solutions.

Question 2

The estimated annual healthcare cost of treatment of Alzheimer's disease is $56,000 per patient in formal care. That translates to $277 billion annually ("high costs of Alzheimer's," 2018). The cost is expected to increase as the population ages. Additional costs include lost wages and productivity of the patient and caregivers, as well as costs associated with morbidity of caregivers.

Question 3

            In creation of new drugs, I will choose screening of natural compounds over synthetic chemistry because there is more structural diversity and novelty as compared to synthetic compounds. A significant number of natural chemicals have the ability to interact with proteins and other biological molecules. Natural compounds are more complex in structure, which allows for more selective binding to targets. Synthetic drug sources tend to have few therapeutic effects and are most likely known to cause unacceptable side effects as compared to natural compounds.

Question 4

If I identify a lead compound that works against the disease in a test tube at a given effective concentration after screening, I would immediately move to animal models with the compound to ascertain its toxicity evaluation, or first modify the lead compound, creating a new lead compound when it does not have sufficient bioavailability and distribution within the body to reach the receptor site. The overall pathway of drug discovery is well structured in such a way that it includes selection of a drug target, identification of a lead compound, modifying the compound for toxicity testing in animals, and selection of a drug candidate for clinical testing. The end result should elicit the desired response in animals’ models of the human disease.

Question 5

Assuming that I will be working with a small startup or biotech to move my product through FDA Phase 1 and Phase 2 clinical trials, the three components for which I would require a CRO are determining the highest dosage a human can take without serious side effects, the best mode of administration, and evaluating its safety. The use of CRO helps in evaluating medications, their combinations, and medical devices, which are crucial in testing new methods of diagnosing, treating, or preventing health conditions by allowing the safety and effectiveness of a new drug before being approved for use by the public.

Question 6

Bioresearch Central is an organization in Kansas City that I can hire a CRO from for Phase 1 and Phase 2 FDA clinical trials because they are well equipped to support startups in the pharmaceutical medical industry with excellent experience in a range of bioresearch services like discovery, toxicology, and bioanalytical trials. They have contributed to the successful development of a variety of pharmaceutical products currently used to treat medical conditions.

Question 1

There is no cure currently available for Alzheimer's disease, but medication and better management strategies are known to temporarily improve the symptoms. Incorporation of drugs and non-drug approaches is necessary for better management of the disease.

Question 2

The estimated annual healthcare cost of treatment of Alzheimer's disease is $56,000 per patient in formal care.

Question 3

            In creation of new drugs, I will choose screening of natural compounds over synthetic chemistry because there is more structural diversity and novelty as compared to synthetic compounds

Question 4

If I identify a lead compound that works against the disease in a test tube at a given effective concentration after screening,

Question 5

Assuming that I will be working with a small startup or biotech to move my product through FDA Phase 1 and Phase 2 clinical trials, the three components for which I would require a CRO are determining the highest dosage a human can take without serious side effects, the best mode of administration, and evaluating its safety

Question 6

Bioresearch Central is an organization in Kansas City that I can hire a CRO from for Phase 1 and Phase 2 FDA clinical trials because they are well equipped to support startups in the pharmaceutical medical industry with excellent experience in a range of bioresearch services like discovery, toxicology, and bioanalytical trials