A detailed CMC plan, encompassing all manufacturing related aspects for bringing your product to the market is an absolute requirement in determining your Product Development strategy. Based on our extensive biotechnological experience, we strongly advise our sponsors to start from at the end. Envisioning how your product reaches the end user, and then backtracking the steps, defines the pivotal product development, regulatory, financial, operational, and business strategy. This is what we call thinking from the back-end. This path has the distinct advantage of allowing you to answer any question from any stakeholder along the way.
After the excitement of a first candidate product discovery, you want to smoothly transition your product to the market. To transition your candidate to a commercial product requires not only time and expertise, but also a business plan, funding, budgets, a clinical and regulatory strategy, a development and production strategy. One of the main items to address is the manufacturing strategy from Phase I clinical studies up to commercial manufacturing. This is all written down in a detailed Product Development Plan that plots the way from early development to market launch. It is essential to have this information available to prevent a repeat of your Phase I clinical trial, because the manufacturing process needed to be significantly re-designed to be able to handle commercial scale.
Therefore, we recommend to lock in important assumptions on the presumed market of the product, including:
(I) product indication and perceived follow up market introductions,
(II) size of expected patient population,
(III) yearly demand per patient,
(IV) target dose,
(V) market penetration,
(VI) distribution channel
These parameters determine the commercial manufacturing requirements such as production scale, number of manufacturing runs per year and stability requirements. In turn, such parameters provide critical input data to feed into the Product Development Plan for all stage of process development including Phase I clinical testing. It will further anchor your main raw material choices, equipment selection, and facility requirements to name but a few. For example, think about the choice of doing one 10,000 L bioreactor run versus 10 runs of 1,000 L. Such choices have significant consequences to consider for setting the objectives of your process development activities. By choosing a process, you have to look in detail to raw material costs and production costs to calculate possible margins (important for investors) versus the commercial price of the medicine. Will the process translate in Cost of Goods that allow a healthy market price when the product is launched?
Batavia Biosciences aids its partners and sponsors in delivering a full-fletched Product Development Plan, which subsequently translates into a realistic Process Development Plan to bring a candidate product into Phase I and beyond. Based on the available client information we deliver an all-encompassing project plan in which all required activities are fully integrated including process development, clinical manufacturing, safety and efficacy studies, regulatory, clinical strategy, detailed timelines and budget estimations, and contingency planning.
Reach a qualified expert today to discuss your project: Contact us!