Key dates:

1. It's 8/22/2022, and it's the start of clinical trials at the University of Oklahoma, who has partnered with the Stephenson Cancer Center

2. Follow the guidelines listed in the Ramp-Up Production spreadsheet

*** Assume you are the project manager in August, 2022 to create a ramp-up production plan on Excel

You will use the attached Gaant Chart Template for the project plan for the ramp up.

• For this Gaant, you'll need to have the following phases:
  • Capacity analysis of resources
    • You will need to do some very general internet research on what you need to make a pill caplet (materials, packaging, equipment, people)
  • Clinical Trial Phases
    • Creating the ramp-up schedule
    • Scheduling patients
    • Monitoring inventory of the pills
    • Monitoring inventory of the materials that go into making the pills
  • Start of Production Phase
    • Monitoring the inventory of the materials to make the pills
    • Monitoring production performance of the manufacturing of the pills.
    • Monitoring the shipping of the pills to pharmacies.
• As you can see, there are bullet points underneath each of the phases - those are key activities (as examples) that could go under each phase. You may think of more than this. With your knowledge of departmental functions within an operation, identify the appropriate department and of course good dates for the plan.
• For the actual ramp up plan that you will create. you will use the Ramp up Production spreadsheet for the the actual plan

 

Background You are the team at the University of Oklahoma who just received FDA approval of the OK-1 (SHetA2) pill for the treatment of ovarian, cervical, and other gynecological cancers You have partnered with the Stephenson Cancer Center in Oklahoma City to administer the pills NOTE: The story behind the launch of the clinical trial is in the weekly folder of the course. Clinical Trials Phase 1 Phase 2 Phase 3 Tests the safety of the treatment (the safety of the drug) and the max tolerable dosage level Tests the efficacy of the treatment (the drug) at the optimal dosage Compares the performance of the treatment (the drug) to the performance of other treatments, including a placebo if applicable. The results of each phase are reviewed by the Institutional Review Board (IRB) and the FDA to be approved to enter the next phase of the clinical trials. Assumptions Each patient in the clinical trial will start out with the highest daily dose, which is 3 pills per day, 7 days per week Note: Your spreadsheet is set up in weekly buckets, so do the math. Clinical Trial Phase 1 lasts 5 weeks with 40 patients Clinical Trial Phase 2 lasts 47 weeks with 500 patients, with the daily dose of 2 pills per day for cerivcal cancer patients, 7 days per week, 1 pill per day for ovarian cancer patients For this Clinical Trial Phase 2, for every 1 woman diagnosed with ovarian cancer, 9 women are diagnosed with cervial cancer, so, you'll need to plan the production of the OK-1 pill appropriately Clinical Trial Phase 3, which lasts another 52 weeks, you need to study 2500 patients across that time period in the same ratio as for clinical trial Phase 2. Start of Production - after 2 years of clinical trials, the FDA approves the OK-1 pill. 604,000 women each year get diagnosed with cervical cancer; 20,000 women per year get diagnosed with ovarian cancer Start of Production - based on the diagnosis and how many pills per day per cancer, plan production. Deliverables Use the Production Schedule tab to ramp up production of the pill to get through the entire spreadsheet (all 3 clinical trials plus the Start of Production with the balance of the spreadsheet) Guidelines For Clinical Trials, all phases, your patients will consume all pills that you need to make available to them. So, you will have zero inventory of these pills to start and zero as you distribute the pills When Start of Production hits, the pill manaufacturer has a max capacity of 9 million pills per week Questions to Answer: Q1 - Does your pill manufacturer have enough capacity for the start of production to keep up with demand? Yes or No The research shows that this pill can also be preventative, meaning that if taken at the correct dosage per day, it can prevent cancer. For those who are not diagnosed with cervical or ovarian cancer, 1 pill can prevent both. The latest census data show that there are 108,133,727 women above the age of 18 in the U.S. Q2- With the possibility of prevention, can your pill manufacturer keep up with demand if all women in the U.S 18 and older take it at the precribed dosgae? Yes or No? Q3 - How many manufacturers each with a capacity of 9 million pills per week would you need for all women in the U.S. 18 and older?