DRGD 403 Assignment Brief

Date due: by Midnight, Sunday 8^th August 2026 or before
Project: Assigned Therapeutic Product

1. Oral Presentation

Wednesday 29^th July from 9:00 am to Noon

You will be accorded a 4 min time slot to give a PowerPoint presentation on progress on your Assignment, a 2 min time slot for Questions and Answers about your presentation, and two presentations on which you will be one of two lead questioners. This should  provide insight into what else you need to do to complete your assignment report.

2. Assignment Report

due Sunday 8^th August by email to me (furneaux@vuw.ac.nz)

Prepare a written report assessing the drug discovery and development of your assigned therapeutic product,  of approximately  ~1,500 words in Calibri 11 point font or similar plus references, images and Claim Sets analysis (these not being in the Word Count).

It will comprise the following sections:

Executive summary at the front which can be bullet points that capture:

a) the most important findings of the assignment

b) is written in the same order as the main report

c) only features material present in the main report

d) is readable separately from the main report

Main report with the following sections providing your analysis of:

i. what the product is and how it is made
ii. what intellectual property protection it has
iii. what path to commercialisation has been followed and
iv. what value has been created, what costs have been incurred, what is the social impact

Claim Sets Analysis: as separate attachment, a copy of the Claims from the first US Patent protecting the product, with Independent Claim sets identified (included as part of the 40% of mark).

Tell me what you know for sure, what you think is going on, and what you wanted to know but couldn’t find information on. Include references to your sources of information, preferably using “Cite as you write”.

Please use the marking schedule as a guide as to the length and detail of each section, observing that your Intellectual Property analysis should feature prominently.

Getting you on the right track

By Friday 17^th July, so that I can make sure you have correctly identified the subject matter, please email me (richard.furneaux@vuw.ac.nz) with:

• The structure (or description if a more complex therapeutic) of the active pharmaceutical ingredient; and
• A link to a website that has information on this therapeutic product. :

Guidance

The focus of this exercise is for you to gain familiarity with:

• Extracting key information on patent protection, clinical trials and commercialisation steps and evaluating the “state of play”
• Formulating concise briefing notes on this “state of play”.

These are the sort of questions you may want to consider when interrogating the available information and in preparing your report:

Product Analysis

What is the pharmaceutical product – either on the market or under development

• What is the API or functional component
• What does it treat
• How does it work
• How is it made (chemical synthesis scheme or description of production methodology)

Intellectual Property

(I expect you to put half your effort on this)

• Who invented it
• What patents protect the product
• Identify the first US patent protecting the product, what types of patent claims (that cover the product, process for making it, and its uses) have been made – independent claims sets
• Is the compound specifically named or shown by structure and in which claim(s)
• Is the compound specifically exemplified in the patent
• Was access to third party IP required
• What challenges did the assignee have to overcome in gaining patent protection during prosecution
• How long did it take to get patent protection in each country
• Has there been litigation over breach of patent(s)
• What role do trade secrets play

Path to commercialisation

• Who championed the commercialisation
• What clinical trials were conducted
• What has been the timeline for development
• What has been the investment
• What was the most advanced portfolio of evidence provided to regulators
• What regulations apply to the product
• What are the side effects

Value creation

• What uses has the product been approved for and in what jurisdictions
• When was the product launched and where
• Has it been approved and/or funded in New Zealand by Medsafe
• What is its competitive advantage
• What are its competitor products
• What are its sales
• How many patients take the medicine
• Have any problem arisen from its use
• What does it cost and who/how is this determined
• Who has benefitted financially
• What are the social impacts
• What were the dramas along the way – give me the juicy bits!

DRGD403 Assignment Marking Rubric