Advancing Revolutionary Therapies
Advancing Revolutionary Therapies
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. Listen as members of Veristat’s regulatory team bring to light the invaluable contributions and responsibilities of the Regulatory Project Manager, known for their problem-solving mindset.
Bringing a novel Therapeutic to market is an art here. VAs Stat Thought leaders as they draw on their specialized expertise to offer insight on timely, relevant topics that impact clinical development, the regulatory landscape, and patient access to these novel therapies.
Speaker 2:Hello and welcome to Art Podcasts, Advancing Revolutionary Therapies, a podcast series presented by the Centers of Excellence at Barad. My name is Martha Plaza, Manager of Regulatory Affairs project Management at Barad. Today I'll be joined by my colleagues Jesse Shyman and Karen Lowe, both of whom are project managers in regulatory affairs here at Veta as we discuss the importance of regulatory project management. Welcome, Jesse and Karen.
Speaker 3:Hi, Martha. Thanks for having us.
Speaker 4:Hey, Martha. Pleasure to be here.
Speaker 2:So I'm gonna start by asking you, Karen, just what is a regulatory project manager?
Speaker 3:Well, Martha, to put it simply, I would describe a regulatory project manager as someone who manages regulatory projects related to drug or 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 I N D, 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, VLA Biologics license application in US nds, New drug submission in Canada, and MAA marketing Authorization application in Europe. Our regulatory consulting projects will typically cover an array of services including early development, gap analysis 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.
Speaker 2:Thank you, Karen. A lot of sponsors understand the importance of a regulatory strategist on the team, but often wonder why a project manager is also needed. What skills do project managers bring to the project that are different than what a regulatory strategist can provide?
Speaker 4:Martha, this is Jesse. While both strategists and PMs 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 driven 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, et cetera. 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 is also responsible for setting up the internal files and systems so the team can work collaboratively. Finance the PM manages the budget, approves timecards, initiates contract changes as needed. These projects managers excel at outside the box thinking every project is different. Each submission is unique and brings it's own nuances that have to be addressed creatively With the PM performing these activities. This really frees up the subject matter experts to focus on their primary roles.
Speaker 2:Thank you, Jesse. You explained the role of the strategist and the project manager, so it beg the next question. Are both roles active continuously or is one role more active than the other based on the life cycle of the project?
Speaker 3:Hi Martha. This is Karen. I can answer that the roles are different based on the life cycle of the project. For example, the regulatory strategist plays the principle role during the pre I n D 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 i n D stage begins, the project manager steps into the principal 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. So we now step into the principal role with the regulatory strategist playing a supporting role.
Speaker 2:Thank you, Karen. Now, if the sponsor has their own regulatory lead, is a regulatory project manager at Verta still needed?
Speaker 4:Hey Martha, this is Jesse again. The answer is yes. The VER stat project manager leads the multi-functional team internally answers 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 bear stat activities and ensure project progress is on track. They're 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 sponsors regulatory of leave will be doing the same thing on their side, and therefore works closely with the bear stat 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 I n D or a marketing application.
Speaker 2:Interesting point, Jesse. Now, what are some of the challenges you both have faced or have observed as regulatory project managers and how did you overcome them? Jesse, let's start with you.
Speaker 4:So for one instance, a sponsor came to us in the DA stage where they had many updates on the data sets produced by different CR that they were using for the integrated summary of efficacy. Because of this, the outfits were not lining up and there were many inconsistencies. Unfortunately, this did lead to a refuse to file for the NDA prior to the sponsor engaging Barad. The sponsor then came to Barad and the regulatory PM pulled together a cross-functional team of experts in the areas of regulatory strategy, programming and statistics, but then worked with the sponsor in original CRO to audit and address the data set and programming issues in preparation for the resubmission.
Speaker 2:So would you say that Veta rescued the application?
Speaker 4:Yes. Martha, you could say that because Veta then assisted the sponsor with the NDA resubmission seven months after the initial refused a file, and within nine months the product received FDA
Speaker 2:Approval. Thank you. Jesse, what about you, Karen?
Speaker 3:The challenge I've noticed 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.
Speaker 2:Thank you, Jesse and Karen for the discussion. I'm glad we can get together to get your take on this topic. Veristat has a wealth of experience in all facets of clinical regulations and can help you develop a detailed strategic plan tailored to your product that will reduce your regulatory risk. I encourage you to listen to future episodes of our regulatory podcast series and to reach out through the links available on the Aris step website. You can also subscribe to Art podcast on your favorite podcast player. Thank you for listening. Until next time,
Speaker 1:Don't miss an episode. Subscribe to Art Podcasts on your favorite podcast player today.