Who's On Your Team? Roles & Responsibilities on Your Operations Team

It's easy to underestimate what it takes to get an IND application out the door. It's not enough to have a great drug candidate -- you have to tell an effective story with accuracy and integrity -- and that requires the right team, with each member ensuring they effectively carry out their responsibilities in conjunction with everyone else. Today, you'll learn about everyone you need to set your application up for success.

The Effective Operations Team

At its most basic, here's who you need on your operations team, whether internal to your company or outsourced to vendors/service providers, in order to carry out a successful submission.

The Medical/Technical/CMC Writer

Ensuring you have an experienced writer with the right subject matter knowledge to help craft the documents you need for a submission is vital. For instance, a Medical Writer is needed to author a protocol that ensures the safety and efficacy of your trial as well as clearly communicates the goals and methodology to your IRB and the FDA. Similarly, a CMC writer should be an expert in authoring your Module 3 documents so they are clear and consistent. Other sections and documents require different sets of expertise. Ensuring you have a writing team with the comprehensive skills you need to author a compliant submission is a huge key to your application's success.

The Subject Matter Expert

For interpretation of data, review of important documents such as Chemistry, Manufacturing & Controls, and ensuring the science behind your application is sound, you'll need a Subject Matter Expert (SME) on your team. This should be someone with experience with the indication and type of drug in your application.

The Quality Assurance/Control Associate(s)

Assuring the accuracy and integrity of the data in your application is absolutely imperative for success with your application. A QA/QC Associate with fantastic attention to detail should be a priority on your team to ensure there are no consistency issues or outright errors with your data.

The Regulatory Publisher

Having the best data in the world won't mean anything if you can't get it to FDA. You need a Regulatory Publisher who can ensure all the technical components of your application are correct, including correctly formatted documents, PDFs that adhere to FDA guidance, and eCTD submissions that will pass technical validation to successfully pass through the Electronic Submission Gateway. Sometimes people think publishers just hit a few buttons and magically produce a compliant submission, but a good publisher does far more than that. They see documents and interact with stakeholders from basically every stage of clinical and regulatory development, so ensuring you have an expert regulatory publisher will give you one more secret weapon to identifying and solving issues others who are more siloed may not see. The best regulatory publishers contribute to the comprehensiveness, consistency and overall quality of your submissions.

Regulatory Systems/RIMs Strategist/Document Specialist

21 Part 11, mandates certain legal requirements to electronically create, modify, maintain, archive, retrieve, or transmit documents to FDA under specific measures in a controlled environment. Electronic document/regulatory systems professionals often collaborate with the company's IT team to ensure companies have access to and are trained on the use of robust validated and fully compliant document management systems. This includes not only hosting the environments but also building processes around handling regulatory documentation.

The Project Manager

The role that ties everything together is that of the Project Manager. An effective Project Manager has your milestones and timelines at the top of mind and ensures everyone stays on track and on the same page, working together toward the common goal of a successful application. The more complex the timelines are, and the more team members are added, the more important a project manager becomes.

Honorable Mention: The Regulatory Strategist

While a Regulatory Strategist is not technically a part of the Biotech Operations Team, we would be remiss if we left this critical role out. A great Regulatory Strategist can make or break your negotiations and pathway to commercial marketing of your product. These key professionals are knowledgeable of regulatory guidelines and regulations. They have studied regulatory precedents in your indication and can navigate FDA discussions and meetings as well as advise and troubleshoot challenges. They are also great for managing commitments that are helpful for a more seamless strategy.

Conclusion

As you can see, there are many important team members when it comes to putting together a successful IND application (and beyond). A gap in any one of these roles can put your milestones at high risk. How do you know if you have everyone and everything you need for success? Well, that's why they call us SWOT! We're experts at finding and filling gaps in your operations teams and systems to ensure you're set up to help you adapt to whatever challenges come your way so you can accomplish your goals and bring life-changing solutions to the patients who need them. Contact us to learn more.