DIRECTIONS

Please find the two questions on the following pages. Your answers are limited to six pages for each question, single-spaced in Calibri 11 pt font with 1” margins. Your final submission should be no more than a total of 12 pages. If necessary, you may use more than six pages for a question provided you answer another question in less than six pages and the total number of pages in the returned document does not exceed 12. Many of you will be able to answer the questions in less than eight pages, and I encourage you to do so. Please cite all references using any format that will allow me access to the information. I do NOT require MLA or other formats, but ensure there is enough information for me to read the paper/article/web page.

Your grade will be dependent on the thoughtfulness, thoroughness, and accuracy of the content. Since there is an extended period, you are also expected to be concise and use proper grammar and spelling.

Question 1.

You have recently been promoted to the position of Chief Scientific Officer (CSO) at a medium-sized biotech company in Montgomery County, MD (an obvious advantage afforded you for taking this course). The focus of the company is the development of a recombinant protein-based poliovirus vaccine that is administered sublingually. You have been tasked with giving a talk to a group of venture capitalist in support of the company’s drive to secure funding for a phase 3 clinical trial. Below is a list of topics that you are to discuss during your talk. You have blocked off 2 hrs to write down details of what you plan to include during your time in front of the venture capitalists.

• Topic 1: Discuss the production process of your company’s vaccine, how it was tested in the pre-clinical setting and key favorable results that facilitated clinical development.

• Topic 2: Detail the immune response elicited after immunization with your company’s vaccine and provide some insight into how your company’s sublingual product may be able to protect against infection as well as disease.

• Topic 3: Describe the clinical trials your company has been through thus far with the vaccine including the three major players involved in the process. Outline the key data that will be gathered during the phase 3 trial and how it will be used to advance the product. Detail why you are conducting the phase 3 trial in a developing country (Kenya) and the ethical or non-ethical ramifications your company conducting the trial overseas.

• Topic 4: Vaccines come with inherent risks and poliovirus vaccines have had several past instances of significant risks. Describe the past issues with poliovirus vaccine production and immunization and how your vaccine will be able to avoid those issues.

• Topic 5: Outline the factors that favor and prohibit eradication of the disease. Ensure that one item you discuss is the role of your company’s vaccine in the eradication effort of poliovirus.

• Topic 6: Opponents of vaccination list several reasons why they are opposed to the practice. List several of the opposition points and potential ways that your company’s vaccine may be viewed as more widely acceptable.

• Topic 7: Finally, there are already two successful polio vaccines and the WHO has targeted the next several years for worldwide eradication. Why should venture capitalist invest in your vaccine at this point in the overall picture? (Hint: You must convince them to invest…, your job and grade are largely dependent on their level of investment).

Question 2.

The bioethics of medical intervention, specifically vaccination, is fraught with differences in perspectives, frequently between the good of an individual versus the good of a group or society. The ethical standards governing policy decisions involving vaccine research have evolved over the past several decades but are mainly based on three fundamental ethical principles (Respect For Persons, Beneficence, and Distributive Justice).

In the first part of your answer, discuss the ethical principles that apply to the following two scenarios:

• Employers requiring influenza vaccination of employees.

• Schools requiring student immunizations before enrollment.

In the second portion of your answer, please state two common reasons cited by the anti-vaccination movement. Chose one reason that has a justified rationale and a second with unfounded rationale. State the reason and rationale and why the opposition is or is not based in facts. Finally, provide some insight into how you would rationally discuss vaccination with someone blindly opposed and with someone who is blindly supportive of vaccination.