PM: Setting a Meeting Agenda

Background

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.

PMs must successfully reconcile opinions held by team members, and must communicate a decision-making process to stakeholders during meetings and in emails.

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.

• List of the members from Meeting #1 and identify whether the members are: primary decision makers, stakeholders, or peripheral to the goals of your meeting
• Separately, identify the points of conflict in the meeting and the members involved in each conflict
• Identify potential solutions and the pros/cons of each solution in an adjacent column
• Decide who needs to attend Meeting #2 and indicate that on your spreadsheet

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.

Task 2:

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.

• Assign an individual responsible for each of your action item, and how you plan to obtain compliance, because program managers are responsible for the deadlines to be set and met. For example, you could ask the CSO to great a slide for the basic science, and the commercial team to create a slide to predict market size.
• Predict who in the meeting may be resistant to your proposal and how you want to influence or communicate with them.
• Identify what the next steps would be if there is non-agreement in the subsequent meeting; in other words, define what might be an appropriate escalation process and who ultimately makes the decision.

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 meeting objectives and goals
• The rationale for your position
• What action items your team needs to complete in order to implement your recommendation
• Share potential sources of conflict and possible solutions

The deliverables for this sim are listed within the individual tasks. Refer to the tasks above for specific instructions. 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:

New Indication (clinical and scientific teams) vs. New method of delivery (commercial and scientific teams)

Clinical team: Christian Martinez, Dr. Rosa

Commercial team: Rob Watson, Andrea Nguyen, Sam Davis

Scientific Team: Dr. Star, Jeremy Russet

Pros and Cons:

New Indication

New Delivery Method

Goals / Objective of Meeting #2

• determine if a new indication or a new method of delivery would be the most profitable to take for Diclofenac

Meeting #2 suggested attendees:

List of action items

• Mr Davis, Ms Nguyen and Dr Star are required to provide preclincal and available human data on the efficacy of the topical application
• Drs Ross, Star and Russet should provide preclinical and available human data for the efficacy of Diclofenac in actinic keratosis and forms of skin cancer
• The commercial team is to provide a market analysis for each option
• Drs Pala and Martinez need to weigh in on all the supporting information to make the final call

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.

Resources

• FDA glossary of terms
• Infographic of the FDA drug approval process
• Diclofenac on Wikipedia
• What is an IND and is it different from getting approval for a new indication of an FDA-approved drug?
• What is an indication?
• Meeting facilitation from SeedsForChange: What is facilitation? How is it different from leading a meeting? How to deal with conflict?
• The differences between program and project management.

Skills

Skills used to perform this task:

• Discerning important information from unimportant information
• Time management
• Pre-meeting alignment; setting agendas
• Facilitating a meeting
• Influencing without authority
• Problem solving/critical thinking
• Breaking down complex tasks into manageable components

Skills used in Program Management:

• Sifting through complicated issues to identify important information
• Communication via presentations, email, phone, and in-person conversations
• Understanding group dynamics, motivations, conflicts
• Communicating complex issues in a digestible format for senior management
• Problem solving/critical thinking

Additional responsibilities of a PM professional

• Creating timelines and meeting schedules with the team
• Communicating with team members to get progress on milestones and obtaining team deliverables
• Defining the level of risk (high, medium, low) for non-completion or non-compliance for action items, and how it affects the overall goal. An example for this simulation: Person X must complete a rough draft of the indication with data within 24 hours. Risk to project if not completed: High (because rough draft is required for approval)