Define Opportunity

Background, Problem Statement, Goal Statement: Background The company has launched four drug products in the past 12 months into the market. In each case, because the drugs have many potential uses and benefits for patient care, the clinician community is very interested in learning about all the potential uses and how the interventions may benefit their patients. However, there are strict regulatory rules in place that limit where and how a drug can be used, and may not include all the potential benefits that have not yet been formally studied and reviewed and approved. As a result, the Marketing team in educating and promoting the drug product is trying its best to provide a comprehensive overview of the drug product, but also needs to be mindful of not promoting its use beyond the government approvals. The Marketing, Medical, and Market Access teams are all involved and have a role in launching each and every company drug product. In doing this work, they will often hold various meetings, calls, checkpoints and exchange documents, updates, technical information, and stakeholder interactions as the company works as a whole team to launch a product. Problem statement The Marketing team working in the field educating clinicians on the new product are sometimes speaking about matters that are beyond the government-approved use of the product. This is against best practice rules in the pharmaceutical industry. Goal Statement The Company needs to become better aligned with the best practice rules and also continue to meet the needs of the clinician community.

Build Understanding

Process Assessment, Cause Analysis: Status of project Active On Track Objective The objective will be to have new structure, process, guidelines, protocols etc. in place so that the Marketing team can apply them on these next two launches. Opportunity From the baseline information gathered through the experiences of the last four drug product launches, the issue being faced by the Marketing team is common enough to justify that the Company takes action to address it. With a new approach to managing the situation, the Company will be better positioned in meeting the standards of the industry while also providing the needed information to inform the best patient care by clinicians. There is even an opportunity for the Company to become a leader amongst the pharmaceutical industry in demonstrating the best and most appropriate way to meet the needs of government regulations and the practical needs of clinicians. Baseline data The Marketing, Medical, and Market Access teams are all involved and have a role in launching each and every company drug product. In doing this work, they will often hold various meetings, calls, checkpoints and exchange documents, updates, technical information, and stakeholder interactions as the company works as a whole team to launch a product. In each of the last four launches, it has become apparent that the issue of having the Marketing team speaking with clinicians and being put in a position to answer queries beyond government approval of the drug product is very common: 4/4 of the drug products launched have had some form of this issue arise. Over 75% of the Marketing team representatives have reported having this issue. The clinicians are both oncologists and non-oncologists (depending on each drug, different specialists are involved in determining its use for patient care)

Manage Change

Stakeholder & Communication Strategies: (Identify key groups or individuals who may impact, influence or be affected by the change and actions required to build their engagement and support.) Stakeholder map Internal Team, including Executive leadership Clinicians Government representatives Pharmaceutical industry representatives Communication plan The Team Membership will be responsible for developing workflow processes that formally involve the Marketing team involving the Medical team in delivering the out of scope information needs of the clinician community. The larger team will meet regularly over the course of the next two drug product launches and specifically have an agenda item to track the progress of this Project. This will include reporting and monitoring the instances where the Marketing team was faced with the issue and how they were able to involve the Medical team to support when needed. The results of the Project on reducing the number of times the Marketing team was unable to meet the clinician needs or the industry standards will be reported to the Executive Leadership Team. Governance/sponsorship Head of Market Access Senior Leadership team of Canada

Question: using the above project charter

Identify 3 change resistance with root cause

provide 3 mitigation tactics