Synthesize information from a meeting, identify the stakeholders, and define project next steps
Program managers (PM) in any field manage multiple people’s involvement in a project while working to achieve the project goals and stakeholders’ aims. PMs are often placed in a position of leadership where they have little or no authority in the decision making process. PMs must successfully juggle the opinions of multiple stakeholders within the company, such as input from the commercial, clinical, manufacturing, and R&D teams.
Aside from critical thinking, the ability to formulate proposals with limited information and excellent communication skills are necessary to succeed.
Note: Program management and project management are two different job titles. In some organizations, program managers are subject matter experts, whereas project managers function as lead facilitators and oversee project completion and resources. Program managers may also be responsible for financial aspects of the project or aspects that relate to the business as a whole. These roles can overlap or be identical depending on the organization. Check the additional resources section to learn more.
For this exercise, you are part of a team of program managers that is responsible for overseeing multiple drugs and devices from conception until they reach the public. You and your team are working to get new indications approved for a medication. Your goal is to keep team members on track with the overall project milestones and each member’s deliverables.
Identify stakeholders, key decision makers, and areas of conflict from Meeting #1 (information linked below).Review the Meeting #1 notes and determine the relevant information needed to finalize the team’s recommendation to the CEO in Meeting #2. Include information regarding additional indications and/or formulations for Diclofenac to pursue for FDA approval, and what would happen if Meeting #2 ends in a non-agreement status. General information about the drug and notes from Meeting 1 are provided for this simulation.To help organize the information, we suggest creating an Excel file or a Word document that organizes the stakeholders. You would likely share this plan with your manager before holding the meeting.
Note: If you’re struggling with determining who’s a decision maker, it’s okay! Here’s a Wikipedia article on senior management to help you understand the structure and different roles inside biotech and pharmaceutical companies.
Create a list of action items for your team to complete in the meetingPlan for Meeting #2 by defining the goals and action plan. It may also be useful to anticipate potential areas of conflict.
For this task, it may be helpful to create a separate action item list, or enter this information into your deliverable from Task 1.
|Organize a slide deck to present the information
When facilitating difficult decisions, program managers often take a position or make a recommendation. They also anticipate different stakeholders’ comments and prepare their responses. Decide on a course of action and proceed. There is no wrong answer.Create a 1-3 slide presentation that defines objectives and action items. The slides should be self-explanatory and easy to understand, and should include:
The deliverables for this sim are listed within the individual tasks. Refer to the tasks (above) for specific instructions. The deliverables are as follows: (Task 1) a spreadsheet to organize stakeholders, (Task 2) a list of action items for a future meeting, and (Task 3) a slide deck to present the information.
Program: Indications for Diclofenac
Case: Diclofenac was acquired from BayRx. It is an oral anti-inflammatory agent currently indicated for the treatment of Rheumatoid Arthritis (RA). The company would like to re-visit indications for Diclofenac and determine which of new indication, formulation or delivery method would be most profitable.
Meeting attended by:
Areas of Conflict:
Clinical team: Christian Martinez, Dr. Rosa
Pros and Cons:
New Delivery Method
Goals / Objective of Meeting #2
Meeting #2 suggested attendees:
List of action items
The CCO, Dr.Ross, and Mr.Russet are most likely to oppose my recommendation for the new method of delivery. My argument would be that while a new indication has yielded some promising results, a new method of application would enable a faster track for Diclofenac to the market, with a sizable target population providing considerable profits. As alternative anti-inflammatories are expected to enter the market in the next 3-4 years, having Diclofenac available in different applications to established users would give us an edge. Moreover, getting an approval for a new method of delivery has a greater chance of approval with the FDA compared to a new indication.
Skills used to perform this task:
Skills used in Program Management:
|Additional responsibilities of a PM professional
Simulation authors: Linet Mera, PhD
Simulation vetted by professionals at Genentech and a start-up in Boston.