For a roadmap to IND the most commonly asked questions are: how much time will it take us to get to IND, how much will it cost, and what are the key milestones? These requests typically arise from early preclinical stage programs just beginning their transition from discovery to formal product development. Often clients will have demonstrated in vitro proof-of-concept and completed one or more pilot animal studies. The client may also have high level CMC development and nonclinical study plans for which they are seeking DHC review and input. In other cases, clients come to DHC during mid- to late-stage preclinical development, wanting to ensure that their nonclinical IND-enabling study plan is appropriately aligned with CMC activities. Having a clear and well thought out, integrated cross-functional project plan that includes timelines, costs and value inflection milestones is also a critical success factor for fundraising.
A DHC-provided roadmap to IND ensures a robust review and deep technical (and industry-specific) understanding of a program’s current standing, with a clear set of recommendations of next steps. Some clients begin pursuing those next steps immediately, while others use the roadmap to enter a fundraising round first. A detailed roadmap demonstrates to investors a cohesive plan for use of proceeds, including activities, costs, timelines, and inflection points.
An effective roadmap to IND considers both efficacy and safety through the lens of the client’s business strategy and risk tolerance. It addresses timeline and budget, including an in-depth expectation of what the client’s future capital needs will be over time. Typically, a deliverable will include a Gantt chart to provide side-by side tracking of various nonclinical, clinical, regulatory and CMC activities to ensure that these are synched up appropriately in a way that will translate into an achievable timeline. Tying costs into this chart is also necessary for identifying where in the process the client might need a cash infusion.
Capturing regulatory interactions is critical: when should a pre-IND meeting be planned in the schedule? Would the product be appropriate for and benefit from an INTERACT meeting or from another early engagement forum such as CBER Advanced Technologies Team (CATT)? The roadmap will include where those interactions make sense in terms of the overall project architecture and what data sets should be viewed as ‘must haves’ versus ‘nice to haves’ to enable a successful regulatory engagement.
DHC consultants build an understanding of the intended clinical use of the product and the proposed efficacy models and then collaborate and consult with the client to understand the overall development trajectory as well as key driving factors such as what the study needs are in order to determine a starting clinical dose. Depending upon the complexity of the model and the dose administration procedure, DHC will discuss and advise on appropriate study plans to support the intended use. DHC can provide advice on guiding delivery methodology: whether an off-the-shelf option is available or if a custom device is needed (and if so, what the development path for that device may look like).
Some clients already have draft nonclinical study designs to consider and some need assistance in putting them together. DHC consultants take into account suitable study size, what the endpoints are, how many studies are needed, how to determine dose-ranging, selecting a suitable CRO, and so on.
Upon client request, DHC consultants offer a draft study plan complete with current pricing information from one or more CDMOs/CROs. Vetting and selection recommendations for choosing a manufacturing partner may be another DHC project; see (link to CMO selection) for such an example.
Sometimes the IND roadmap is supported by a hiring plan, should the company be in growth mode. DHC’s industry experience allows for a keen eye on what expertise will be needed at what point in time and how and when to allocate a full-time employee in-house vs. when to contract out support.
On occasion DHC receives an accompanying request to build a pitch deck for a round of fundraising. Investor interest can be dependent on receiving the details laid out in a roadmap, because knowing each step of the process not only increases investor confidence but helps to define use of proceeds and identify the critical value inflection points that will enable each future round of fundraising.
