Sometimes a client comes to DHC with a request that shifts dramatically upon our experts’ evaluation of available documents and gathering of additional information. In this instance, a small-to-midsize company with an understanding of clinical needs (but with limited regulatory experience) initially came to DHC for document review and help with providing a list of pre-IND questions. Their goals included an expansive vision for their product development and an urgency to get a pre-IND meeting accepted within 30 days of project initiation for investor/fundraising purposes. In addition to the time constraints, the original goal was ambitious because the product is intended to be used in combination with various other products and could also be used to treat patients across multiple disease indications. The client was originally planning to send a package proposing this full range of treatment options to FDA.
Prior to engaging with DHC, another consultancy had begun this work for the client. The client came to DHC because they were experiencing concerns about timelines and the lack of attention that they felt that their project was receiving. Upon receipt, DHC recognized that the package as prepared by the other consulting practice was inadequate for submission to FDA and that the regulatory advice was inappropriate for the development pathway. Specifically, the previous consultants didn’t recognize that the original proposed clinical development plan was not feasible due to detailed regulatory constraints. DHC consultants identified the regulatory challenges: a meeting package with this wide of a developmental scope would make it through regulatory review in the time available, and likely would not be possible without a step-wise development plan. DHC therefore helped the client narrow the focus of their initial product development to ensure that they would reach the clinic as quickly and efficiently as possible. This more expedient development pathway still allowed for their future goals to be realized…it just used a more step-wise approach.
The client achieved their first business goal: a timely and concise FDA submission. Successful completion of the meeting provided the client with responses clarifying FDA’s expectations for launching the first clinical trial. The client also now has a detailed understanding of how to segment their goals in order to maximize each opportunity before moving on to the next. Focusing a first step of development is necessary for even those most expansive long-term visions.
The first need was to clarify the client’s ultimate goals for the product and then identify a way—by narrowing the scope—that they could get regulatory feedback in short order so as to get their product to the clinic quickly, which was also a goal of their investor. DHC worked with the client to revise the clinical development plan, simplify the trial design and patient population, and help author both the meeting package and the clinical trial synopsis. Authoring the clinical section of a pre-IND requires a deep understanding of patient populations, disease indications, manufacturing processes, regulatory expectations, and the inherent limitations of all of the above. DHC brought a team of relevant subject matter experts to the project to ensure that all of these considerations were addressed.
The client’s previous engagement with another consultancy had gone poorly, without the client receiving either sufficient attention or adequate advice. In contrast, DHC was able to step in quickly and meet the challenging timeline due to our unique combination of nimbleness and depth and breadth of CGT knowledge.
Once DHC took over the protocol synopsis and focused on linking product end goals to clinical development, the preparation of the pre-IND meeting request and briefing package went swiftly. Additionally, our writers prepared pre-IND questions intended to maximize probability of success in obtaining clear FDA feedback.
