Industry Insights with… Sheila Lawson

Welcome to the latest blog in our Industry Insights series, where we ask our experts to share their in-depth expertise on topics within the pharmaceutical industry. We recently asked our Chemistry, Manufacturing and Controls (CMC) Regulatory Specialist, Sheila Lawson, to share her knowledge of early phase regulatory dossier development.
Sheila has over 30 years’ experience in the pharmaceutical industry and has spent nearly half of that time specialising in the preparation of regulatory dossiers. Here, Sheila discusses the advantages of consulting dossier teams and her tips for the successful preparation of CMC dossiers.

What are the advantages of consulting dossier teams when preparing regulatory dossiers?

The dossier team has the expertise necessary to help clients. We develop the required documentation and assure regulatory agencies that the specific Quality/CMC elements of the submission package have been considered during the development process. As the Arcinova dossier team is located in our all-in-one facility, we have the advantage of being closer to the action. This means that we can discuss any challenges with our in-house subject matter experts to quickly find solutions.

Please can you describe the process of developing a regulatory dossier for a client?

The process of developing a regulatory dossier varies depending on whether the clients wants a stand-alone service or a fully integrated CMC service. When a client contacts us with a drug to develop we can manage the whole project on-site. The regulatory dossier team would then get involved in describing the manufacture and control of the drug substance and the investigational medicinal product (IMP) in the appropriate sections of the dossier. If the full Quality/CMC package is not required we can provide the drug substance or drug products section only, or parts thereof.

In other cases, where the pharmaceutical material has been manufactured on another site, we will work with the client or their contractor to gather the appropriate information for the drug substance and/or drug product sections. In these situations, we can perform a gap analysis or review of the information available prior to preparing the Quality/CMC sections, to ascertain if there are any potential regulatory concerns, which might be raised during regulatory review.

We regularly prepare dossiers for first-in-human and up to Phase II early development clinical studies and can support the preparation of both Investigational Medicinal Product Dossiers (IMPD) and Investigational New Drug (IND) applications, or help to transfer the Quality/CMC elements from an IMPD to an IND, or vice-versa.

What are the main challenges in preparing CMC dossiers?

One of the main challenges is ensuring all information is available in a timely manner and is assembled into a detailed and comprehensive format to meet the submission date, where the Quality/CMC information is often on the critical path. Well-organised and focussed personnel are key to drive the process and assemble the myriad of information, with regular team meetings to discuss progress and ensure issues are identified, assessed and resolved.

How important is it to provide a CMC dossier service for clinical trials studying radiolabelled pharmaceuticals?

Clients rely on the knowledge of their contractors for the radiolabelled components of drug development. At Arcinova, we specialise in providing regulatory dossiers for clinical trials designed to study the absorption, metabolism and excretion of radiolabelled pharmaceuticals. We have the expertise to advise clients with what is required in that specific situation and can work directly with the scientists in the isotope labelling team.

How do you maintain awareness of changing regulatory requirements?

An important part of maintaining awareness of changing regulatory requirements is maintaining close communication with other specialists in the field. We keep-up-to-date by sharing insights with other specialists at meetings and seminars, and we are members of regulatory organisations such as The Organisation for Professionals in Regulatory Affairs (TOPRA).

How important is communication when helping clients prepare dossiers?

Communication is critical for success. Typically, a regulatory dossier can take approximately 10 to 12 weeks to complete. During this time, it is important that we are in regular contact with the client. This is particularly important if you are providing a fully integrated service, where multiple teams are working on the project. Program management can be offered by Arcinova to aid the provision of data from multiple teams or companies.

Finally, do you have any tips for the successful preparation of CMC dossiers?

The help of an experienced CMC regulatory specialist is invaluable when developing CMC dossiers, to deliver clear and precise documentation. At the start of every project, you need to make sure that you have all the information required to assemble a high quality and complete dossier. For dossier teams, it is important that you know your process well and have the expertise at hand to guide the client through every stage of the process.


If you would like to learn more about CMC dossier preparation and the work of our Regulatory and Consultancy team, please get in touch here