The Importance of Regulatory Project Management

ART PODCAST | SEASON 3 | EPISODE 5

In this episode of Advancing Revolutionary Therapies, Martha Plaza, Manager of Regulatory Affairs, Project Management at Veristat, talks to Jessie Scheimann and Karen Lo, both of whom are Project Managers in Regulatory Affairs at Veristat, about the importance of regulatory project management. Sponsors are familiar with the role of a Regulatory Strategist on the core team but have less familiarity with the responsibilities of a Project Manager.

Check out the full episode to learn more about the invaluable contributions and responsibilities of a Regulatory Project Manager – or read the summary below.

The Role of a Regulatory Project Manager

Martha: What is a Regulatory Project Manager?

Karen Lo: A Regulatory Project Manager is someone who manages regulatory projects related to drug, biologic, or device development and the relevant communications and submissions to the health authorities and regulatory consulting.

Regulatory submissions can include early development submissions such as IND (investigational new drug applications) in the US and CTAs (clinical trial applications) outside of the US; all the way to end of product development leading to marketing applications like NDA (New Drug Application), BLA (Biologics License Application) in the US, NDS (New Drug Submission) in Canada, and MAA (Marketing Authorization Application) in Europe.
Veristat regulatory consulting projects will typically cover an array of services, including early development gap analyses or roadmaps, CMC and toxicology guidance, clinical development plans in conjunction with our strategic consulting team, and assistance with any other strategy related to a Sponsor’s program.

Regulatory Project Manager vs Regulatory Strategist

Martha: What skills does a Project Manager (PM) bring to the project that is different than what a Regulatory Strategist can provide?

Jessie Scheimann: While both regulatory strategists and project managers are regulatory professionals, the PM is more involved with the day-to-day maintenance of the projects as well as coordinating the efforts of other functional areas. These skills and tasks include:

Managing the timeline - the PM keeps everyone moving toward the goal, sometimes under very tight timeline constraints.
Resourcing - it is the responsibility of the PM to identify any needed experts that need to be brought on the project. This could be additional strategists, statisticians, CMC experts etc.
Communication - the PM ensures that this cross functional team that has been built has access to the same information and everyone is working together toward the same end. This is usually done by the PM leading team meetings and follow-up emails.
Organization - the PM maintains a “library” of source materials for the team in one easy to find location. The PM also sets up the internal files and systems so the team can work collaboratively.
Finance - the PM manages the budget, approves timecards, and initiates contract changes as needed.

These project managers excel at thinking “outside of the box.” Every project is different. Each submission is unique and brings its own nuances that must be addressed creatively. With a project manager performing these activities, this frees the subject matter experts to focus on their primary roles.

Martha: Are regulatory strategists and project managers both consistently active or is one role more active than the other based on the lifecycle of the project?

Karen Lo: The roles are different based on the lifecycle of the project.

For example, the Regulatory Strategist plays the principal role during the pre-IND stage. They provide guidance and support the sponsor on the development of the Briefing Package, attend and participate in Agency meetings, and can assist in addressing any questions. During this phase, the strategist is an essential member of the team.

However, once the IND stage begins, the Project Manager steps into the principal role and the regulatory strategist plays a supporting role. At this point, there are now multiple functions in play such as CMC, non-clinical, medical writing, publishing and sometimes biostatistics. Coordination of these functions requires heavy involvement of a Project Manager.

Strategic Considerations for Planning your IND Submission

Leverage a Regulatory Project Manager at a CRO

Martha: If the Sponsor has their own regulatory lead, is a regulatory project manager at Veristat still needed?

Jessie Scheimann: Yes, the Veristat Project Manager leads the multi-functional team internally and serves as the primary point of contact for the Sponsor. Given all the components to a marketing application, it's essential that there is a Project Manager to spearhead the Veristat activities and ensure progress is on track.

A Project Manager is like a conductor. The core team is the orchestra, and the Project Manager is there to ensure all the core functions coordinate well with each other.

The Sponsor’s regulatory lead will be doing the same on their end and therefore works closely with the Veristat Project Manager so that both sides are functioning as one cohesive team. This relationship will exist regardless of whether the team is working towards an initial IND or a marketing application.

Martha: What are some of the challenges you both have faced or observed as a Regulatory Project Manager and how did you overcome them?

Jessie Scheimann: In one instance, a Sponsor came to us in the NDA stage where they had many updates on the data sets produced by a different CRO, that they were using for the integrated summary of efficacy (ISE). Because of this, the outputs were not lining up, and there were many inconsistencies. Unfortunately, this led to a refuse-to-file (RTF) for the NDA prior to the Sponsor engaging Veristat. The Sponsor then came to Veristat, and the regulatory PM pulled together a cross-functional team of experts in the areas of regulatory strategy, programming, and statistics that then worked with the Sponsor and original CRO to audit and address the dataset and programming issues in preparation for the resubmission.

Martha: Would you say that Veristat rescued the application?

Jessie Scheimann: Yes, Veristat assisted the Sponsor with the NDA re-submission, seven months after the initial refuse-to-file, and within nine months the product received FDA approval.

Karen Lo: The challenge I’ve noticed as a regulatory PM is that many sponsors, particularly in early development, are operating with a very lean project team. Each team member ends up wearing multiple hats and how we as PMs can help is to oversee the big picture by managing timelines, setting up document review cycles and to ensure key stakeholders are involved in a timely manner. This helps these lean teams to stay on track and ensure timelines are met.